Quiver News

• Zoom debuts AI Companion 3.0 with agentic AI, delivering powerful new features and work surfaces to transform how teams communicate and collaborate across its platform
• Zoom Business Services to launch agentic AI features for Customer Experience and Zoom Virtual Agent to redefine customer and employee interactions

SAN JOSE, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Today Zoom Communications, Inc. (NASDAQ: ZM) introduced a new era of productivity, intelligent collaboration, and connection, unveiling AI Companion 3.0, with powerful new agentic AI innovations across Zoom Workplace and Zoom Business Services. Announced at Zoomtopia 2025, the company’s annual flagship conference, the innovations showcase Zoom’s vision for agentic AI-first capabilities. Designed to transform how users work, Zoom’s agentic AI turns conversations into action with personalized AI assistance, giving users the power to perform at their best, every day, across multiple surfaces.

“Our customers’ most important conversations happen on Zoom, and now those conversations can result in critical insights to fuel real progress,” said Eric S. Yuan, founder and CEO of Zoom. “With AI Companion 3.0, our agentic AI can understand users’ specific context, priorities, and goals to help them cut through the noise, focus on what matters most, and drive meaningful business outcomes.”

AI Companion 3.0: the ultimate intelligent work companion

Zoom’s vision for the future of work is a unified platform where AI acts as a seamless, intelligent layer. AI Companion 3.0 and the new Zoom Workplace and Business services innovations are at the heart of this vision. More than just an AI assistant, AI Companion works across the Zoom platform and compatible third-party integrations to help users turn conversations into action through deeper conversational insights, save time by tackling administrative tasks, and deliver higher-quality work.

Uncover deeper insights

AI Companion will be able to use agentic AI to retrieve and synthesize internal enterprise knowledge, such as from meeting and phone call transcripts, chat history, and shared documents, with external insights (e.g., publicly available market research and industry data) via unified, context-aware search to deliver critical information at the right time. This will allow users to garner deep insights and receive essential information from their conversations, docs, third-party apps, multiple meeting platforms, in-person meetings, and the web.

With new AI note-taking capabilities, users with paid Zoom Workplace accounts can optimize their manual notes with AI Companion in all of their Zoom meetings, and also for in-person meetings and meetings that take place outside of Zoom, such as on Microsoft Teams, Google Meet, and WebEx (coming soon).

Optimize the workday
Proactive agentic skills can help manage busywork so users can focus on what matters. New capabilities, such as “free up my time,” meeting preparation, group assistance, and in-meeting recommendations, help users stay informed by offering the right information at the right time so they can complete their tasks with less effort.

AI Companion, with its new, outcome-focused prompts, will help drive results by helping users identify, prioritize, and complete tasks across the Zoom platform — including meetings, phone calls, chats, and emails — so nothing falls through the cracks.

Deliver high-quality work faster

Users can interact with AI Companion as a collaboration partner to uplevel their work with less guidance because it already understands their context. It knows their most recent and frequent conversation topics and important projects, providing suggested actions and tailored responses to help them deliver the best possible outputs.

AI Companion 3.0 introduces a new work surface in web browsers and the Zoom Workplace desktop app to deliver a single coherent AI experience regardless of where users are working. The work surface dynamically adapts and offers a full breadth of context, turning scattered information into actionable intelligence.

With new writing assistance and deep research skills, users can generate comprehensive, data-driven reports and polished documents using internal and external data sources.

Advanced AI platform innovations

Zoom is pushing the boundaries of communication with new AI and platform features for Zoom Workplace, including new lifelike meeting avatars, the ability to generate clips from presentations, and support for Model Context Protocol (MCP) that will allow customers and developers to configure tools for customer and virtual agents.

The addition of real-time voice translation for Zoom Meetings helps Zoom users collaborate more easily with global colleagues and partners with the Zoom quality that organizations know and love. This is supported by a recent evaluation commissioned by Zoom in which Zoom’s real-time translated captions solution was found to deliver greater accuracy than leading competitors using MetricX standard: 28% more accurate for English-to-French translations and 14% more accurate for English-to-Spanish translations.

Customized solutions

For organizations that need agentic AI that is more tailored to their business needs, Custom AI Companion now offers the ability to create and deploy custom AI agents. Available beginning today, this low-code builder empowers admins to create and deploy tailored AI solutions directly to their employees, with access to a comprehensive, rich tooling library and pre-built templates for various workflows. Additionally, admins can connect to pre-built, third-party agents and use the Agent2Agent (A2A) protocol to get work done across applications.

AI Companion 3.0 capabilities are expected to be generally available in November 2025, at no additional cost with the paid services in Zoom Workplace accounts. The Custom AI Companion add-on is available for $12 per user, per month.

Visit the Zoom newsroom for more information on the latest innovations that enhance collaboration and productivity across Zoom Workplace.

Zoom Business Services supercharges customer and employee experiences

Zoom’s commitment to businesses extends beyond collaboration, with new innovations in its Customer Experience (CX) suite and Zoom Virtual Agent (ZVA), including AI-first features designed to enhance agent performance, improve customer experience, and provide actionable insights for leaders.

Zoom customer experience innovations announced at Zoomtopia include the ability to automate support agent tasks with Agentic AI Expert Assist, uncover business intelligence from customer data with CX Insights, and extend quality oversight to virtual agent interactions with Automated Quality Management. Additionally, Zoom is introducing a “bring your own voice” capability to ZVA, allowing companies to create a more consistent and on-brand conversational experience.

Zoom is bringing the power of agentic AI beyond customer support and into the earliest stages of the customer journey. With Zoom Revenue Accelerator (ZRA), sales teams gain AI-driven capabilities that take on the heavy lifting of prospecting, follow-up, and scheduling. ZRA’s new agentic prospecting skill scans event lists and other lead sources, intelligently identifies high-potential prospects, initiates personalized outreach across channels like email and SMS, and even schedules initial touchpoints.

Visit the Zoom newsroom for more information on the latest innovations for Zoom Business Services.

Watch Zoomtopia Live

Tune in to Zoomtopia today for the Americas and tomorrow, September 18, for APAC, EMEA, and Japan to learn more about these innovations. Unless otherwise noted, these innovations will be available to Zoom customers on September 17, 2025. For more information about these announcements and Zoom’s new AI for Good program , visit the Zoom newsroom .

About Zoom
Zoom’s mission is to provide an AI-first work platform for human connection. Reimagine teamwork with Zoom Workplace — Zoom’s open collaboration platform with AI Companion that empowers teams to be more productive. Together with Zoom Workplace, Zoom’s Business Services for sales, marketing, and customer experience teams, including Zoom Contact Center, strengthen customer relationships throughout the customer lifecycle. Founded in 2011, Zoom is publicly traded (NASDAQ:ZM) and headquartered in San Jose, California. Get more information at zoom.com .

The statements contained here are for informational purposes only and may not be incorporated into any contract. Any services, products, or functionality referenced that are not currently available are subject to change at Zoom’s sole discretion and may not be delivered as planned or at all. Customers who purchase from Zoom should make their purchase decisions based on currently available pricing, features, and functions.

Zoom Public Relations
Travis Isaman
[email protected]

BOCA RATON, Fla., Sept. 17, 2025 (GLOBE NEWSWIRE) -- NewtekOne, Inc. (“NewtekOne” or the “Company”) (NASDAQ: NEWT) and Patriot Financial Partners, L.P. (“Patriot”) announced today that they have completed a transaction pursuant to which in exchange for all of Patriot’s 20,000 shares of the Company’s convertible preferred stock, Series A, $0.02 par value per share (the “Series A Preferred Stock”) and $10.0 million in cash, the Company issued to Patriot 2,307,692 shares of its common stock, par value $0.02 per share (the “Common Shares”). With the exchange, Patriot relinquishes the right to convert the 20,000 shares of convertible preferred stock into 950,800 shares of common stock. The Common Shares were issued to Patriot in a private placement transaction in reliance on Section 4(a)(2) of the Securities Act of 1933, as amended. The Common Shares are subject to, among other things, a two-year transfer restriction.

The transaction is expected to boost the Company’s common equity tier one capital (“CET1 capital”) and tier one capital by $30 million. In addition, on a pro forma basis as of June 30, 2025, the transaction grows CET1 capital from $256 million to $286 million. Moreover, the impact of this transaction, when combined with $48.357 million of net proceeds from the offering of depositary shares that closed August 20 ^th , increases, on a pro forma basis as of June 30, 2025, tier one capital by $78.357 million from $256 million to $335 million and tangible book value per common share to approximately $10.74.

Barry Sloane, NewtekOne’s Chairman, President, and Chief Executive Officer, commented, “We are pleased that one of our longer-term institutional shareholders expressed confidence in our business strategy and management team by exchanging the 20,000 shares of Series A Preferred Stock it originally acquired for $20 million and $10 million in cash for 2.3 million Common Shares, and agreeing to a two-year lock-up of the Common Shares. We believe the boost to capital and to the capital ratios and the accretion to tangible book value per share more than outweighs the EPS dilution associated with the newly issued shares. We appreciate our investment relationship with Patriot that is now approaching three years. Patriot’s knowledge and understanding of NewtekOne is supported by Patriot maintaining a seat on the board of directors of our bank subsidiary, Newtek Bank, N.A.”

Kirk Wycoff, Managing Partner of Patriot Financial Partners, said, “We are excited to exchange our Series A Preferred Stock for NewtekOne common equity, to make an additional $10 million investment in NewtekOne common shares, and to retain our position as a long-term shareholder. We have been impressed with NewtekOne’s operational execution since it converted to a financial holding company in early 2023.”

Mr. Wycoff continued, “We believe that NewtekOne’s business strategy and operating model centered around technology, efficiency, and profitability is ideally situated to become one of the leading players in the industry in a constantly evolving banking environment and that NewtekOne and Newtek Bank have constructed an operating model the banking industry can follow.”

About Patriot Financial Partners

Patriot is a growth equity firm providing capital and strategic support to banks and financial services-related companies throughout the U.S. Patriot has invested $1.3 billion across 89 transactions since its founding in 2007.

About NewtekOne, Inc.

NewtekOne ^® , Your Business Solutions Company ^® , is a financial holding company, which along with its bank and non-bank consolidated subsidiaries (collectively, “NewtekOne”), provides a wide range of business and financial solutions under the Newtek® brand to independent business owners. Since 1999, NewtekOne has provided state-of-the-art, cost-efficient products and services and efficient business strategies to independent business owners across all 50 states to help them grow their sales, control their expenses, and reduce their risk.

NewtekOne’s and its subsidiaries’ business and financial solutions include: banking (Newtek Bank, N.A.), Business Lending, SBA Lending Solutions, Electronic Payment Processing, Accounts Receivable Financing & Inventory Financing, Insurance Solutions and Payroll and Benefits Solutions . In addition, NewtekOne offers its clients the Technology Solutions (Cloud Computing, Data Backup, Storage and Retrieval, IT Consulting and Web Services) provided by Intelligent Protection Management Corp. (IPM.com)

Newtek ^® , NewtekOne ^® , Newtek Bank ^® , National Association , Your Business Solutions Company®, One Solution for All Your Business Needs® and Newtek Advantage® are registered trademarks of NewtekOne, Inc.

Note Regarding Forward-Looking Statements
Certain statements in this press release are “forward-looking statements” within the meaning of the rules and regulations of the Private Securities Litigation and Reform Act of 1995 are based on the current beliefs and expectations of NewtekOne's management and are subject to significant risks and uncertainties. Actual results may differ materially from those set forth in the forward-looking statements.    See “Note Regarding Forward-Looking Statements” and the sections entitled “Risk Factors” in our filings with the Securities and Exchange Commission which are available on NewtekOne's website (https://investor.newtekbusinessservices.com/sec-filings) and on the Securities and Exchange Commission’s website (www.sec.gov). Any forward-looking statements made by or on behalf of NewtekOne speak only as to the date they are made, and NewtekOne does not undertake to update forward-looking statements to reflect the impact of circumstances or events that arise after the date the forward-looking statements were made. The pro forma regulatory capital and financial information presented herein is provided for illustrative information purposes only and is not necessarily, and should not be assumed to be, an indication of the actual amounts of such measures that would have been achieved had the transaction been completed as of the date indicated, or that may be achieved as of any future dates or periods.

SOURCE: NewtekOne, Inc.

Investor Relations & Public Relations
Contact: Bryce Rowe
Telephone: (212) 273-8292 / [email protected]

MALVERN, Pa., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Vishay Intertechnology, Inc. (NYSE: VSH) today introduced a new series of Automotive Grade AC line rated ceramic disc safety capacitors that are the industry’s first with a Y1 rating to be offered in a surface-mount casing. Combining their Y1 rating of 500 V _AC and 1500 V _DC with high capacitance to 4.7 nF, the Vishay BCcomponents SMDY1 Automotive Series devices are designed to provide EMI / RFI suppression and filtering in harsh, high humidity environments.

AEC-Q200 qualified with PPAP available, the capacitors released today will be used in on-board chargers (OBC), traction inverters, battery management systems (BMS), e-compressors, and AC/DC converters in electric (EV), hybrid electric (HEV), and plug-in hybrid electric (PHEV) vehicles. For these applications, the devices offer high humidity resistance with a Class IIB humidity grade (in accordance with IEC60384-14 annex I) and can withstand the 85 / 85 / 1000 h test.

Allowing for surface-mount assembly with a reflow soldering process, SMDY1 Automotive Series capacitors reduce production costs. Unlike leaded components, the devices offer a low, flat profile on the PCB to enable flat casings or backside PCB mounting without the clearance space required by through-hole capacitors.

RoHS-compliant and halogen-free, the components consist of a copper-plated ceramic disc and feature encapsulation made of flame-resistant epoxy resin in accordance with UL 94 V-0. The devices are available in two case sizes: the C case with a creepage distance of 10 mm and the D case with a creepage distance of 14.5 mm.

Device Specification Table:

Samples and production quantities of the SMDY1 Automotive Series are available now, with lead times of 12 weeks.

Vishay manufactures one of the world’s largest portfolios of discrete semiconductors and passive electronic components that are essential to innovative designs in the automotive, industrial, computing, consumer, telecommunications, military, aerospace, and medical markets. Serving customers worldwide, Vishay is The DNA of tech. ^® Vishay Intertechnology, Inc. is a Fortune 1000 Company listed on the NYSE (VSH). More on Vishay at www.Vishay.com .

The DNA of tech ^® is a registered trademark of Vishay Intertechnology, Inc.

Vishay on Facebook: http://www.facebook.com/VishayIntertechnology
Vishay Twitter feed: http://twitter.com/vishayindust

Link to product photo :
https://www.flickr.com/photos/vishay/albums/72177720328910748

Link to datasheet :
http://www.vishay.com/ppg?28582 (SMDY1 Automotive Series)

For more information please contact:
Vishay Intertechnology
Peter Henrici, +1 408 567-8400
[email protected]
or
Redpines
Bob Decker, +1 415 409-0233
[email protected]

• 71% of respondents believe AI will either be a top priority or important to the future of public safety
• 67% of public safety agencies surveyed recently implemented cybersecurity protections
• 48% expect to use drones or robots on a daily basis within 5 years
  
  

BASKING RIDGE, N.J., Sept. 17, 2025 (GLOBE NEWSWIRE) -- A new study released today by Verizon reveals that nearly half of first responders anticipate daily use of Artificial Intelligence (AI) and drones or robots within the next five years*. The Verizon Frontline Public Safety Communications Survey also highlights increased investment in cybersecurity protections and a growing demand for highly-reliable network connectivity, with 78 % of first responders surveyed reporting that access to a reliable and resilient network has resulted in better communications in the field.

Now in its fifth year, the survey – commissioned by Verizon Frontline and conducted by Lexipol – provides crucial insight into first responders’ current use of mission-critical communications technology and their perspectives on emerging public safety innovations.

“The Verizon Frontline 2025 Public Safety Communications Survey highlights several pivotal trends reshaping this market. First and foremost, it reinforces that network reliability and resilience remain the cornerstone of public safety operations - without it, advanced capabilities like priority and preemption become meaningless to first responders in critical moments,” said Alison Brooks, IDC Research VP, Worldwide Public Safety.

Brooks added that the survey findings also challenge the perception that public safety lags in technology adoption.

“We're seeing a dramatic 13-point year-over-year surge in AI interest, with nearly half of respondents planning to integrate AI into their daily operations within five years while drone adoption and usage is expected to triple over the same timeframe. The FAA's recent decision to relax visual line-of-sight requirements will only accelerate this trend, making drone integration an immediate priority rather than a distant consideration for public safety agencies," said Brooks.

AI and drone usage poised for explosive growth.

While just 15% of respondents currently utilize drones and robots daily, a striking 48% expect to integrate this technology into their daily operations within the next five years. This represents a significant shift in tactical capabilities and priorities for first responders.

Similarly, despite only 12% of respondents currently employing AI solutions regularly, a substantial 46% anticipate daily use of these solutions within the next five years. The survey also noted a significant year-over-year increase in the number of respondents who view AI as a "top priority" (up 12%) or "important" (up 28%) for their agency's future.

“An increasing number of first responders are leveraging advanced communication tools and emerging technologies in their day-to-day operations,” said Maggie Hallbach, President, Verizon Frontline. “For example, the enhanced situational awareness provided by AI and the increased access to inhospitable and remote environments that robots and drones enable are helping revolutionize public safety and emergency response.”

Agencies fortify against cyber threats

In an era of escalating ransomware attacks and third-party breaches, cybersecurity remains a paramount concern for public safety agencies, according to this year’s survey. A compelling 67% of public safety agencies reported implementing new cybersecurity protections into their operations within the last year, demonstrating a proactive approach to safeguarding critical infrastructure and data.

A reliable network is as important as ever

For the second consecutive year, first responders identified access to a reliable and resilient network as the most critical feature for both day-to-day (65% to 75%) and emergency response (64% to 73%) communications. This consistent emphasis underscores the foundational role of robust connectivity in effective public safety operations.

“The results of our fifth annual public safety communications survey reflect key trends we’re seeing across the public safety landscape: the urgent need for cybersecurity investment, accelerated awareness and adoption of AI and the necessity of a reliable network," said Hallbach. “Whether it’s during routine operations or disaster response efforts, public safety agencies simply cannot afford downtime, whether that’s due to a cyber breach, an unreliable network or the use of outdated technology.”

Other findings and standout statistics from the survey include:

• 33% of first responders expect AR and VR to be used daily in five years, up from just 8% today.
• 57% of respondents have more than 20 years of experience in public safety.
• 20% of respondents reported connected vehicles were a top priority for their agency, second only to 5G connectivity.
  
  

To read the entire Verizon Frontline Public Safety Communications Survey, visit our website .

_{*Based on results of the 2025 Verizon Frontline Public Safety Communications Survey}

_{Verizon Communications Inc. (NYSE, Nasdaq: VZ) powers and empowers how its millions of customers live, work and play, delivering on their demand for mobility, reliable network connectivity and security. Headquartered in New York City, serving countries worldwide and nearly all of the Fortune 500, Verizon generated revenues of $134.8 billion in 2024. Verizon’s world-class team never stops innovating to meet customers where they are today and equip them for the needs of tomorrow. For more, visit verizon.com or find a retail location at verizon.com/stores.}

_{VERIZON’S ONLINE MEDIA CENTER: News releases, stories, media contacts and other resources are available at verizon.com/news . News releases are also available through an RSS feed. To subscribe, visit www.verizon.com/about/rss-feeds/ .}

Media contact:
Eric Durie
[email protected]

MIAMI BEACH, Fla., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Thomas J. Herzfeld Advisors, Inc., an SEC-registered investment advisor, today announced the commencement of a Tender Offer by Herzfeld Credit Income Fund, Inc. (NASDAQ: HERZ) (the “Fund”). Under the terms of the Tender Offer the Fund is offering to purchase up to 5% of outstanding shares of the Fund at 97.5% of NAV.

The Fund announced the Tender Offer in a press release on August 25, 2025.

The Fund has offered to purchase up to 5% of the currently outstanding common shares of the Fund, par value $0.001 per share (the “Common Shares”) at 97.5% of Net Asset Value (“NAV”) per Common Share (determined as of the close of ordinary trading on the NASDAQ Capital Market on October 15, 2025) for cash, upon the terms and subject to the conditions contained in the Offer to Purchase dated September 17, 2025 and the related Letter of Transmittal. Shareholders of the Fund should read the Offer to Purchase, the Letter of Transmittal and related exhibits, as they will contain important information about the Tender Offer. These and other filed documents will be available to investors for free both at the website of the Securities and Exchange Commission ( www.sec.gov ) and from the Fund ( www.herzfeld.com/HERZ ).

Requests for more information, questions and requests for additional copies of the offer materials, please contact EQ Fund Solutions, LLC, the Information Agent for the Tender Offer, at (877) 536-1555.

About Thomas J. Herzfeld Advisors, Inc.

Thomas J. Herzfeld Advisors, Inc., founded in 1984, is an SEC registered investment advisor, specializing in investment analysis and account management in closed-end funds.

More information about the advisor can be found at www.herzfeld.com .

Past performance is no guarantee of future performance. An investment in the Fund is subject to certain risks, including market risk. In general, shares of closed-end funds often trade at a discount from their net asset value and at the time of sale may be trading on the exchange at a price which is more or less than the original purchase price or the net asset value. There can be no assurance that any Share repurchases will reduce or eliminate the discount of the Fund’s market price to the Fund’s net asset value per share. An investor should carefully consider the Fund’s investment objective, risks, charges and expenses. Please read the Fund’s disclosure documents before investing.

Forward-Looking Statements

This press release, and other statements that Thomas J. Herzfeld Advisors, Inc. (“TJHA”) or the Fund may make, may contain forward looking statements within the meaning of the Private Securities Litigation Reform Act, with respect to the Fund’s or TJHA’s future financial or business performance, strategies or expectations. Forward-looking statements are typically identified by words or phrases such as “trend,” “potential,” “opportunity,” “pipeline,” “believe,” “comfortable,” “expect,” “anticipate,” “current,” “intention,” “estimate,” “position,” “assume,” “outlook,” “continue,” “remain,” “maintain,” “sustain,” “seek,” “achieve,” and similar expressions, or future or conditional verbs such as “will,” “would,” “should,” “could,” “may” or similar expressions. TJHA and the Fund caution that forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Forward-looking statements speak only as of the date they are made, and TJHA and the Fund assume no duty to and do not undertake to update forward-looking statements. Actual results could differ materially from those anticipated in forward-looking statements and future results could differ materially from historical performance. With respect to the Fund, the following factors, among others, could cause actual events to differ materially from forward-looking statements or historical performance: (1) shares of the Fund may trade at a discount from Net Asset Value; (2) the Fund is expose to risks associated with equity and equity-linked securities to the extent that adverse equity market conditions could negatively impact the ability of the borrowers to make payment of interest and/or principal with respect to loans underlying the CLOS in which the Fund invests; (3) as a “non-diversified” investment company, the Fund’s investments involve greater risks than would be the case for a similar diversified investment company (5) the Adviser’s judgment about the attractiveness, relative value or potential appreciation of a particular security or investment strategy may prove incorrect; (7) market disruption risks, including certain events that have had a disruptive effect on the securities markets, generally, such as pandemics, terrorist attacks, war and other geopolitical events, hurricanes, droughts, floods and other natural disasters; (8)risk of investment in CLOs and related securities generally (9) dependence on managers of the CLOs in which the Fund invests (10) risks associated with investing in CLOs generally. Annual and Semi-Annual Reports and other regulatory filings of the Fund with the SEC are accessible on the SEC’s website at www.sec.gov and on TJHA’s website at www.herzfeld.com/herz , and may discuss these or other factors that affect the Fund. The information contained on TJHA’s website is not a part of this press release.

Contact:
Tom Morgan
Chief Compliance Officer
Thomas J. Herzfeld Advisors, Inc.
1-305-777-1660

Watch the “What This Means” segment here

MINNEAPOLIS, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company delivering fluid management solutions for critically ill patients, today announced that it participated in a Virtual Investor “What This Means” segment .

For the segment, Ryan Marthaler, Vice President of Product Marketing & Business Development of Nuwellis, discussed the Company’s recent news release announcing that the National Institutes of Health (NIH) has awarded an approximately $3 million multi-year grant to its development partner, Koronis Biomedical Technologies Corporation (KBT). The NIH-supported program will accelerate Vivian™, Nuwellis’ dedicated pediatric continuous renal replacement therapy (CRRT) device in development for patients under 20 kilograms, and advance core software and firmware that strengthen the company’s broader portfolio.

The Virtual Investor “What this Means” segment featuring Nuwellis is now available here .

About Nuwellis

Nuwellis, Inc. (Nasdaq: NUWE) is a medical device company dedicated to transforming the lives of patients suffering from fluid overload through science, collaboration, and innovation. The company is focused on commercializing the Aquadex SmartFlow ^® system for ultrafiltration therapy. Nuwellis is headquartered in Minneapolis, with a wholly owned subsidiary in Ireland. For more information visit www.nuwellis.com or visit us on LinkedIn or X, formerly known as Twitter.

For further information, please contact:

Investor Contact:
JTC Team, LLC
Jenene Thomas
(908) 824-0775
[email protected]

Media Contact:
Leah McMullen
Director of Communications
[email protected]

NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- EXL [NASDAQ: EXLS], a global data and AI company, has been recognized by Everest Group as a Leader in its Healthcare Data, Analytics and AI Services PEAK Matrix® Assessment 2025.

The Everest Group report highlights EXL’s comprehensive portfolio of healthcare analytics solutions and platform solutions. The report cites EXL’s focus on data, analytics as well as its deep domain expertise and robust partner ecosystem as key strengths.

“In healthcare, maximizing the value of data is essential for better patient outcomes and operational efficiency. Yet, issues such as fragmentation, silos and lack of standardization hinder progress, which is driving organizations to focus on data unification, governance and privacy to build secure, integrated systems,” said Priya Sahni, vice president at Everest Group. “EXL differentiates itself with its modular healthcare platform, which integrates diverse datasets to deliver actionable insights across population health, care coordination, quality and financial analytics. Its investments in healthcare-focused intellectual property tools, along with gen AI integration, highlight its commitment to high-impact automation. EXL’s industry-specific LLMs, as well as strategic partnerships with NVIDIA and Databricks, further positions the company as a Leader in the report.”

The report analyzed 32 leading healthcare data and analytics services providers using Everest Group’s PEAK Matrix®, a proprietary framework that measures an organization’s impact created within the market and the ability to deliver solutions successfully. Market Impact is evaluated through market adoption, portfolio mix and value delivered. Vision & Capability, the measurement for successful solution delivery, is assessed through vision and strategy, scope of offered services, innovation and investments and delivery footprint. The report uses this framework to classify service providers into Leaders, Major Contenders and Aspirants.

“From clinical records to diagnostic images and insurance claims, the healthcare system generates a staggering volume of data. To turn this structured and unstructured information into actionable insights, providers and payers need data and AI solutions that helps them collaborate to streamline processes—and ultimately deliver better results,” said Vivek Jetley, president and head of insurance, healthcare and life sciences, EXL. “We’re proud to earn this Leader recognition and look forward to helping our clients deliver significant outcomes and develop powerful new solutions for improving healthcare.”

To read more about the Everest Group 2025 report, click here for the custom version of the report. For more information about EXL’s healthcare solutions, click here .

About EXL

EXL (NASDAQ: EXLS) is a global data and AI company that offers services and solutions to reinvent client business models, drive better outcomes and unlock growth with speed. EXL harnesses the power of data, AI, and deep industry knowledge to transform businesses, including the world's leading corporations in industries including insurance, healthcare, banking and capital markets, retail, communications and media, and energy and infrastructure, among others. EXL was founded in 1999 with the core values of innovation, collaboration, excellence, integrity and respect. We are headquartered in New York and have approximately 61,000 employees spanning six continents. For more information, visit www.exlservice.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. You should not place undue reliance on those statements because they are subject to numerous uncertainties and factors relating to EXL's operations and business environment, all of which are difficult to predict and many of which are beyond EXL’s control. Forward-looking statements include information concerning EXL’s possible or assumed future results of operations, including descriptions of its business strategy. These statements may include words such as “may,” “will,” “should,” “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate” or similar expressions. These statements are based on assumptions that we have made in light of management's experience in the industry as well as its perceptions of historical trends, current conditions, expected future developments and other factors it believes are appropriate under the circumstances. You should understand that these statements are not guarantees of performance or results. They involve known and unknown risks, uncertainties and assumptions. Although EXL believes that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect EXL’s actual financial results or results of operations and could cause actual results to differ materially from those in the forward-looking statements. These factors, which include our ability to maintain and grow client demand, our ability to hire and retain sufficiently trained employees, and our ability to accurately estimate and/or manage costs, rising interest rates, rising inflation and recessionary economic trends, are discussed in more detail in EXL’s filings with the Securities and Exchange Commission, including EXL’s Annual Report on Form 10-K. You should keep in mind that any forward-looking statement made herein, or elsewhere, speaks only as of the date on which it is made. New risks and uncertainties come up from time to time, and it is impossible to predict these events or how they may affect EXL. EXL has no obligation to update any forward-looking statements after the date hereof, except as required by federal securities laws.

Disclaimer

Licensed extracts taken from Everest Group’s PEAK Matrix® Reports, may be used by licensed third parties for use in their own marketing and promotional activities and collateral. Selected extracts from Everest Group’s PEAK Matrix® reports do not necessarily provide the full context of our research and analysis.  All research and analysis conducted by Everest Group’s analysts and included in Everest Group’s PEAK Matrix® reports is independent and no organization has paid a fee to be featured or to influence their ranking.  To access the complete research and to learn more about our methodology, please visit Everest Group PEAK Matrix® Reports .

About Everest Group
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Complete 26-week results further demonstrate that combining semaglutide with trevogrumab (anti-GDF8/anti-myostatin) helped prevent about half of semaglutide-induced loss of lean mass, while increasing fat mass loss

Numeric improvements in metabolic and lipid parameters including waist circumference, blood pressure, cholesterol, triglycerides and A1C, were observed across all treatment groups

TARRYTOWN, N.Y., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) today announced updated analyses from the ongoing Phase 2 COURAGE trial investigating novel combinations of semaglutide (GLP-1 receptor agonist) and trevogrumab (anti-GDF8/anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity. The complete 26-week results were consistent with interim data previously reported , demonstrating that the addition of trevogrumab with or without garetosmab could significantly reduce the loss of lean mass associated with semaglutide-induced weight loss; the results confirmed that 33% of weight loss induced by semaglutide was due to loss of lean mass, and that adding trevogrumab could prevent about half of this lean mass loss. The results were presented as a late-breaking oral session at the 61st Annual Meeting of the European Association for the Study of Diabetes (EASD) in September 2025.

"These complete 26-week COURAGE results demonstrate a meaningful opportunity to preserve muscle mass while enhancing fat loss," said Julio Rosenstock, M.D., Lead PI and Senior Scientific Advisor Velocity Clinical Research at Medical City and Clinical Professor of Medicine, University of Texas Southwestern Medical Center, Dallas. “These encouraging early data, with positive trends in lipid parameters, warrant further studies to confirm the potential of trevogrumab’s role in preserving lean muscle mass during weight loss, especially in combination with incretin-related therapies.”

COURAGE was designed to investigate the quality of weight loss in patients with obesity (BMI ³30 kg/m ² ). Treatment is divided into two 26-week periods comprised of a weight-loss phase and a weight-maintenance phase. The three primary efficacy endpoints were assessed in this analysis at week 26 (end of weight-loss phase), and included percent change from baseline at week 26 in lean mass, fat mass and body weight. During the weight-loss phase, patients were randomized to receive semaglutide 2.4 mg alone or in combination with trevogrumab 200 mg (lower dose), trevogrumab 400 mg (higher dose) or higher-dose trevogrumab plus garetosmab 10 mg/kg (triplet).

At this analysis, 33% of semaglutide-induced weight loss was due to lean mass loss, while patients in all combination groups had improvement in body composition including lean mass preservation and greater fat loss compared to semaglutide alone. Detailed results of this analysis from baseline to week 26 include:

SE= Standard Error
NOTE: Lean mass and fat mass was calculated using dual-energy X-ray absorptiometry (DXA) scan, while body weight was measured using a scale; as a result, the lean and fat mass numbers may not exactly sum to body weight. Total weight loss is defined as the sum of lean mass loss and fat mass loss. Results are based on least-squares means derived from MMRM analysis using efficacy estimand that excludes data after the treatment discontinuation.
***p<0.001; *p<0.05; p-values are for the primary endpoints of % change from baseline at week 26 in each category, and were not corrected for multiplicity.

Numerical improvements in metabolic and lipid parameters, secondary and exploratory endpoints, were seen across all treatment groups, including improvements in waist circumference, blood pressure, cholesterol, triglycerides and A1C.

The combination of semaglutide with trevogrumab was generally well-tolerated; Adverse events that occurred in ≥5% of participants in any treatment group included muscle spasms, nausea, constipation, fatigue, diarrhea, headache, vomiting, gastroesophageal reflux disease, upper respiratory tract infection, nasopharyngitis, UTI, influenza and COVID-19. Most of these events were mild to moderate in severity.

As previously reported, the triplet combination of semaglutide with both antibodies had a substantially higher rate of discontinuations due to tolerability issues and other adverse events. Two deaths occurred in the triplet group, one due to an undetermined cause in a patient with multiple cardiovascular risk factors and the second due to a cardiac arrest in a person with a history of cardiovascular disease. Regeneron has not identified a causal association between treatment and these events.

After 26 weeks, patients enter into the weight-maintenance phase in which they receive either higher-dose trevogrumab monotherapy or placebo through the end of the trial (week 52).

The safety and efficacy of trevogrumab and garetosmab have not been evaluated by any regulatory authority.

About Regeneron in Obesity
Obesity is a complex, multifaceted disease and a growing public health concern that affects more than a billion people worldwide. Despite the revolutionary impact of GLP-1 receptor agonists (GLP-1RAs) on weight loss, the quality of this weight loss can be negatively impacted because these agents can cause profound muscle loss. Moreover, a high percentage of patients cycle on and off treatment – while off treatment they can regain almost all of the weight lost, but mostly in the form of fat, leaving them with negatively altered body composition.

At Regeneron, we are developing a pipeline focused on the quality of weight reduction. We have several independent approaches focused on promoting and preserving muscle during weight loss, so as to increase the amount of fat loss since adiposity is the principal driver of comorbidities and metabolic diseases associated with obesity. In addition, Regeneron has an extensive pipeline of agents to address some of these co-morbidities and metabolic diseases, which have the potential to be combined with GLP-1RAs. The combination of our science, pipeline, research and clinical innovation uniquely positions us to make a meaningful difference in obesity and obesity-related diseases.

About Regeneron's VelocImmune ^® Technology
Regeneron's VelocImmune technology utilizes a proprietary genetically engineered mouse platform endowed with a genetically humanized immune system to produce optimized fully human antibodies. When Regeneron's co-Founder, President and Chief Scientific Officer George D. Yancopoulos was a graduate student with his mentor Frederick W. Alt in 1985, they were the first to envision making such a genetically humanized mouse, and Regeneron has spent decades inventing and developing VelocImmune and related VelociSuite ^® technologies. Dr. Yancopoulos and his team have used VelocImmune technology to create a substantial proportion of all original, FDA-approved fully human monoclonal antibodies. This includes Dupixent ^® (dupilumab), Libtayo ^® (cemiplimab-rwlc), Praluent ^® (alirocumab), Kevzara ^® (sarilumab), Evkeeza ^® (evinacumab-dgnb), Inmazeb ^® (atoltivimab, maftivimab and odesivimab-ebgn) and Veopoz ^® (pozelimab-bbfg). In addition, REGEN-COV ^® (casirivimab and imdevimab) had been authorized by the FDA during the COVID-19 pandemic until 2024.

About Regeneron
Regeneron (NASDAQ: REGN) is a leading biotechnology company that invents, develops and commercializes life-transforming medicines for people with serious diseases. Founded and led by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to numerous approved treatments and product candidates in development, most of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye diseases, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, neurological diseases, hematologic conditions, infectious diseases, and rare diseases.

Regeneron pushes the boundaries of scientific discovery and accelerates drug development using our proprietary technologies, such as VelociSuite ^® , which produces optimized fully human antibodies and new classes of bispecific antibodies. We are shaping the next frontier of medicine with data-powered insights from the Regeneron Genetics Center ^® and pioneering genetic medicine platforms, enabling us to identify innovative targets and complementary approaches to potentially treat or cure diseases.

For more information, please visit www.Regeneron.com or follow Regeneron on LinkedIn , Instagram , Facebook or X .

Forward-Looking Statements and Use of Digital Media
This press release includes forward-looking statements that involve risks and uncertainties relating to future events and the future performance of Regeneron Pharmaceuticals, Inc. (“Regeneron” or the “Company”), and actual events or results may differ materially from these forward-looking statements. Words such as “anticipate,” “expect,” “intend,” “plan,” “believe,” “seek,” “estimate,” variations of such words, and similar expressions are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. These statements concern, and these risks and uncertainties include, among others, the nature, timing, and possible success and therapeutic applications of products marketed or otherwise commercialized by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Products”) and product candidates being developed by Regeneron and/or its collaborators or licensees (collectively, “Regeneron’s Product Candidates”) and research and clinical programs now underway or planned, including without limitation Regeneron’s clinical program investigating novel combinations of semaglutide (GLP-1 receptor agonist) and high- or low-dose trevogrumab (anti-GDF8 /anti-myostatin) with or without garetosmab (anti-activin A) for the treatment of obesity as discussed in this press release; uncertainty of the utilization, market acceptance, and commercial success of Regeneron’s Products and Regeneron’s Product Candidates and the impact of studies (whether conducted by Regeneron or others and whether mandated or voluntary), including the studies discussed or referenced in this press release, on any of the foregoing or any potential regulatory approval of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above); the likelihood, timing, and scope of possible regulatory approval and commercial launch of Regeneron’s Product Candidates and new indications for Regeneron’s Products, such as those referenced above for the treatment of obesity; the ability of Regeneron’s collaborators, licensees, suppliers, or other third parties (as applicable) to perform manufacturing, filling, finishing, packaging, labeling, distribution, and other steps related to Regeneron’s Products and Regeneron’s Product Candidates; the ability of Regeneron to manage supply chains for multiple products and product candidates and risks associated with tariffs and other trade restrictions; safety issues resulting from the administration of Regeneron’s Products and Regeneron’s Product Candidates (such as those referenced above) in patients, including serious complications or side effects in connection with the use of Regeneron’s Products and Regeneron’s Product Candidates in clinical trials; determinations by regulatory and administrative governmental authorities which may delay or restrict Regeneron’s ability to continue to develop or commercialize Regeneron’s Products and Regeneron’s Product Candidates; ongoing regulatory obligations and oversight impacting Regeneron’s Products, research and clinical programs, and business, including those relating to patient privacy; the availability and extent of reimbursement or copay assistance for Regeneron’s Products from third-party payors and other third parties, including private payor healthcare and insurance programs, health maintenance organizations, pharmacy benefit management companies, and government programs such as Medicare and Medicaid; coverage and reimbursement determinations by such payors and other third parties and new policies and procedures adopted by such payors and other third parties; changes in laws, regulations, and policies affecting the healthcare industry; competing drugs and product candidates that may be superior to, or more cost effective than, Regeneron’s Products and Regeneron’s Product Candidates (including biosimilar versions of Regeneron’s Products); the extent to which the results from the research and development programs conducted by Regeneron and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; unanticipated expenses; the costs of developing, producing, and selling products; the ability of Regeneron to meet any of its financial projections or guidance and changes to the assumptions underlying those projections or guidance; the potential for any license, collaboration, or supply agreement, including Regeneron’s agreements with Sanofi and Bayer (or their respective affiliated companies, as applicable), to be cancelled or terminated; the impact of public health outbreaks, epidemics, or pandemics on Regeneron's business; and risks associated with litigation and other proceedings and government investigations relating to the Company and/or its operations (including the pending civil proceedings initiated or joined by the U.S. Department of Justice and the U.S. Attorney's Office for the District of Massachusetts), risks associated with intellectual property of other parties and pending or future litigation relating thereto (including without limitation the patent litigation and other related proceedings relating to EYLEA ^® (aflibercept) Injection), the ultimate outcome of any such proceedings and investigations, and the impact any of the foregoing may have on Regeneron’s business, prospects, operating results, and financial condition. A more complete description of these and other material risks can be found in Regeneron’s filings with the U.S. Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2024 and its Form 10-Q for the quarterly period ended June 30, 2025. Any forward-looking statements are made based on management’s current beliefs and judgment, and the reader is cautioned not to rely on any forward-looking statements made by Regeneron. Regeneron does not undertake any obligation to update (publicly or otherwise) any forward-looking statement, including without limitation any financial projection or guidance, whether as a result of new information, future events, or otherwise.

Regeneron uses its media and investor relations website and social media outlets to publish important information about the Company, including information that may be deemed material to investors. Financial and other information about Regeneron is routinely posted and is accessible on Regeneron's media and investor relations website (https://investor.regeneron.com) and its LinkedIn page (https://www.linkedin.com/company/regeneron-pharmaceuticals).

LAKEWOOD, NJ, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Reliance Global Group, Inc. (Nasdaq: RELI) (“Reliance”, “we” or the “Company”) today announced that it has completed its first digital asset purchase under its recently launched Digital Asset Treasury (“DAT”) initiative, acquiring Ethereum (ETH). The purchase represents the initial step in Reliance’s broader plan to build a diversified digital asset portfolio, with future investments expected to include leading cryptocurrencies such as Bitcoin, Ethereum and Solana.

The Company plans to fund these activities through a combination of cash reserves and other approved corporate financing tools. Reliance’s DAT initiative is structured to pursue long-term capital appreciation through blockchain-based participation.

As part of this strategy, Reliance has also formed a dedicated Crypto Advisory Board (“CAB”) to guide management and the Board of Directors in the oversight, risk management, and execution of digital asset initiatives. The CAB will provide expertise on treasury management, blockchain integration, and governance practices critical to the Company’s expansion into digital assets.

Ezra Beyman, Chairman and Chief Executive Officer of Reliance Global Group, stated, “This first Ethereum transaction is an important milestone for Reliance as we expand into digital assets. It demonstrates our commitment to ensuring that our operational systems – covering custody, governance, accounting, and compliance – are equipped to support this strategy on a larger scale. Reliance expects to continue purchasing Ethereum and other digital assets in measured increments, applying a disciplined approach to capital allocation as the treasury position develops over time.”

“Our entry into Ethereum underscores our conviction that blockchain technology is rapidly shaping the future of both finance and insurance. With the added oversight of our Crypto Advisory Board, we are confident this strategy provides shareholders with a forward-looking opportunity while maintaining our focus on responsible execution and risk management.”

Reliance has a longstanding history of leveraging artificial intelligence, data mining, and innovative distribution models to deliver competitive, technology-enabled insurance solutions through RELI Exchange and 5MinuteInsure.com . By applying similar innovation to the blockchain ecosystem, the Company seeks to pioneer the convergence of InsurTech and decentralized finance.

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. You can identify these statements by terminology such as “may,” “should,” “could,” “would,” “will,” “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “continue,” “potential,” and similar expressions. Forward-looking statements in this press release include, without limitation, statements regarding:

• Our expectation that building a diversified digital asset portfolio, beginning with Ethereum, may enhance our long-term treasury strategy and shareholder value;
• Our belief that disciplined participation in blockchain-based markets can provide both capital appreciation and potential yield opportunities over time;
• Our expectation that the formation of the Crypto Advisory Board will provide the expertise, oversight, and governance needed to execute our digital asset strategy responsibly;
• Our belief that integrating blockchain capabilities with our existing AI-driven InsurTech platforms positions Reliance at the forefront of innovation in both insurance and decentralized finance; and
• Other statements relating to our future financial performance, business strategy, technology developments, capital allocation, and operational execution.

These forward-looking statements are based on a number of assumptions, including that: (i) the Company is able to successfully implement its digital asset treasury strategy as approved by the Board; (ii) cryptocurrency and blockchain markets remain sufficiently stable to allow for execution of our strategy; (iii) regulatory and accounting frameworks evolve in a manner consistent with our ability to participate in digital asset markets; and (iv) no material adverse changes occur in market, economic, or regulatory conditions.

Actual results could differ materially from those anticipated due to a variety of risks and uncertainties, including: volatility or declines in cryptocurrency markets; challenges in executing and managing digital asset investments; regulatory or accounting changes that adversely impact digital asset holdings or blockchain-based initiatives; technological risks related to custody, cybersecurity, or blockchain integration; competitive pressures from InsurTech, blockchain, or digital asset market participants; and other factors described under “Risk Factors” in our Registration Statement on Form S-1, Annual Report on Form 10-K, and other filings with the Securities and Exchange Commission.

You are encouraged to carefully review our Annual Report on Form 10-K for the year ended December 31, 2024, as amended, as well as other SEC filings, for a more complete discussion of these and other risks and uncertainties. Except as required by law, Reliance Global Group Inc. undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

Contact:
Crescendo Communications, LLC
Tel: +1 (212) 671-1020
Email: [email protected]

DENVER, Sept. 17, 2025 (GLOBE NEWSWIRE) -- 247marketnews.com , a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, reports that as Wall Street continues to reprice smaller equities amid a broadening rally, TEN Holdings (NASDAQ: XHLD), a provider of event planning, production, and broadcasting services through its operating subsidiary Ten Events, has emerged as a compelling opportunity in a market rapidly rotating into small and mid-cap names.

As the S&P 500's Calmar ratio (a risk-adjusted return metric) stands at 0.347 over the last decade versus the Russell 2000's 0.124, the current rotation underscores small-caps' asymmetric upside amid moderating inflation and policy easing.

The Russell 2000, a benchmark for small-cap performance, has demonstrated resilience amid shifting economic tides, including Federal Reserve rate cuts that historically favor smaller firms. Over the past year through mid-2025, the index has edged out the S&P 500 by 3.8%, with year-to-date gains of 3.2%, as investors pivot.

TEN Holdings, through its operating subsidiary Ten Events, is redefining the event planning and production space with its advanced Xyvid Pro Platform and its newly launched SaaS solution, Ten Events Pro (“Ten Pro”). Designed for enterprise-grade virtual, hybrid, and in-person events, Xyvid Pro delivers studio-quality broadcasts, real-time interactivity, and analytics that power high-impact engagements, from global product launches to investor meetings. With the live and virtual events markets projected to exceed $1.6 trillion combined by 2030, TEN Holdings is uniquely positioned to capture share through proprietary technology tailored to the evolving needs of modern organizations. The launch of Ten Pro via an Early Adopter Program in July 2025 marks a pivotal move toward a scalable, cloud-based SaaS model, offering predictable pricing, global accessibility, and seamless customization through a subscription platform built for today’s digital-first economy.

TEN Holdings’ transition to SaaS is more than a product evolution, it’s a value transformation. Subscription-based software platforms in public markets have consistently commanded premium valuations, with 7–10x revenue multiples, as investors seek high-margin, recurring revenue models. Ten Pro aligns with this trend, enabling rapid scale in the $18.2 billion event management software space while unlocking steady cash flows and real-time user insights. The Early Adopter Program is already driving platform refinements to accelerate adoption. With capital flowing into high-growth SaaS stocks, XHLD offers a timely entry into a company at the inflection point of digital transformation.

XHLD stands as a compelling play in the surging small-cap space, where the Russell 2000 Index has outperformed the S&P 500 by key margins in recent months, signaling a long-overdue rotation.

Organizations interested in participating in the Early Adopter Program or learning more about Ten Pro can contact [email protected]

Contact [email protected] for Analyst Report coverage and other investor/public relations services.

About TEN Holdings, Inc. (NASDAQ: XHLD)

TEN Holdings, Inc. is a provider of event planning, production, and broadcasting services. Through its subsidiary, Ten Events, the Company delivers virtual, hybrid, and physical event experiences, supported by proprietary technologies including the Xyvid Pro platform. From enterprise town halls to major virtual conferences, TEN Holdings enables clients to deliver high-impact content and communications at scale.

Learn more at www.tenholdingsinc.com

24/7 MARKET NEWS, INC (247) Disclaimer
Please go to https://247marketnews.com/ten-holdings-event-solutions/ for additional 247marketnews.com XHLD disclosure. 247 has been paid by Microcap Advisory for providing ongoing XHLD market outreach and other services. This press release may include technical analysis for informational purposes only and should not be construed as financial or investment advice. Trading stocks involves risks, and readers should consult with their financial advisor before making investment decisions. PAID EDITORIAL DISCLOSURE: This is a paid editorial communication intended for informational purposes only. 247 is a third-party media provider and has been compensated by one or more featured companies. Please review 247’s Full Disclaimer https://www.247marketnews.com/disclaimer/ .

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company's ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company's ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.

CONTACT:
24/7 Market News
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ARLINGTON, Va., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Fluence Energy, Inc. ("Fluence") (NASDAQ: FLNC), a global market leader delivering intelligent energy storage systems, services, and asset optimization software, today announced that it has been named a Tier 1 energy storage supplier in the inaugural S&P Global Commodity Insights Premier List of Tier 1 Cleantech Companies.

The annual list recognizes leading suppliers across four technology categories: solar PV modules, solar PV inverters, energy storage systems, and wind turbines. Companies are evaluated using a rigorous six-point methodology that considers market presence, manufacturing scale and diversification, financial performance, sustainability factors, and other key indicators. The classification, which will be updated annually, is designed to provide clarity and transparency for developers, offtakers, and financiers seeking resilient and reliable partners in the cleantech industry.

“This recognition from S&P Global Commodity Insights underscores our position as a global market leader and a trusted partner for our customers,” said Julian Nebreda, President and Chief Executive Officer, Fluence. “Being named a Tier 1 company for energy storage systems validates our commitment to bankability, scale, and sustainable innovation. It is a testament to the dedication of our team and the value we deliver to customers worldwide as we transform the way we power our world.”

The recognition adds to a growing list of recent accolades for Fluence. In August 2025, the company was named to Newsweek and Plant-A Insights Group’s list of America’s Greatest Companies 2025, which evaluates organizations on financial strength, workforce performance, innovation, and sustainability. The previous month, in July 2025, the Australian Clean Energy Council honored the Liddell Battery Project, developed with AGL and BlackRock Industries, with its Equity, Inclusion, and Diversity Award.

About Fluence
Fluence Energy, Inc. (Nasdaq: FLNC) is a global market leader delivering intelligent energy storage and optimization software for renewables and storage. The Company's solutions and operational services are helping to create a more resilient grid and unlock the full potential of renewable portfolios. With gigawatts of projects successfully contracted, deployed, and under management across nearly 50 markets, the Company is transforming the way we power our world for a more sustainable future.

For more information, visit our website , or follow us on LinkedIn or X . To stay up to date on the latest industry insights, sign up for Fluence's Full Potential Blog .

Cautionary Statement Regarding Forward-Looking Statements

The statements contained in this press release that are not historical facts are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, without limitation, beliefs, assumptions, prospects, plans, and objectives of management. Such statements can be identified by the fact that they do not relate strictly to historical or current facts. When used in this press release, words such as "may," "possible," "will," "should," "expects," "plans," "anticipates," "could," "intends," "targets," "projects," "contemplates," "commits", "believes," "estimates," "predicts," "potential," or "continue," or the negative of these terms or other similar expressions and variations thereof and similar words and expressions are intended to identify such forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking.

The forward-looking statements contained in this press release are based on our current expectations and beliefs concerning future developments, as well as a number of assumptions concerning future events, and their potential effects on our business. These forward-looking statements are not guarantees of performance, and there can be no assurance that future developments affecting our business will be those that we have anticipated. These forward-looking statements involve a number of risks, uncertainties (some of which are beyond our control), or other assumptions that may cause actual results or performance to be materially different from those expressed or implied by these forward-looking statements, which include, but are not limited to such factors set forth under Item 1A."Risk Factors" in our Annual Report on Form 10-K for the fiscal year ended September 30, 2024, filed with the Securities and Exchange Commission ("SEC") on November 29, 2024, and in other filings we make with the SEC from time to time. New risks and uncertainties emerge from time to time and it is not possible for us to predict all such risk factors, nor can we assess the effect of all such risk factors on our business or the extent to which any factor or combination of factors may cause actual results to differ materially from those contained in any forward-looking statements. Should one or more of these risks or uncertainties materialize, or should any of the assumptions prove incorrect, actual results may vary in material respects from those projected in these forward-looking statements. You are cautioned not to place undue reliance on any forward-looking statements made in this press release. Each forward-looking statement speaks only as of the date of the particular statement, and we undertake no obligation to publicly update or revise any forward-looking statements to reflect events or circumstances that occur, or which we become aware of, after the date hereof, except as otherwise may be required by law.

Media Contact
Shayla Ebsen, Director of Communications
Email: [email protected]
Phone: +1 (605) 645-7486

Analyst Contact
Lexington May, Vice President of Investor Relations and Sustainability
Email: [email protected]
Phone: +1 (713) 909-5629

Flywire enhanced SFS offering with new, real-time integration into leading ERP Unit4 (Agresso)

Four new SFS client go-lives feature Unit4 and Banner integrations as well as real-time payments and real-time student account information

Flywire also unveiled an enhanced solution for managing U.S. loans for students studying in the U.K. market

BOSTON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Flywire Corporation (Flywire) (Nasdaq: FLYW) reaffirmed its commitment to the U.K. higher education sector, unveiling enhancements to its successful Student Financial Software (SFS) solution. With powerful direct integrations into ERPs Banner Ethos and Unit4 (Agresso), Flywire delivered its first SFS implementations featuring real-time student account presentment for U.K. customers, which is then linked to Flywire payment capabilities. Flywire also introduced an enhanced solution to enable U.K. higher education institutions to automate and manage the U.S. loan disbursement process.

Flywire’s SFS Solution Solves an Unmet Need for U.K. Institutions

Currently, many higher education institutions in the U.K. lack a unified student portal offering. The payer and administrative experiences are often disparate and frustrating for payers and manual and time-consuming for administrators. In particular, U.K. institutions are challenged with enabling students to see an accurate and up-to-date account balance, providing students with flexible payment plans, and burdened with time spent sending billing and payment communications manually.

Flywire’s SFS solution solves these client problems by providing a full service student account portal that sits on top of a school’s receivable system and offers payers robust self-service functionality. This includes viewing account details in real time, making one time payments, enrolling in payment plans, automated communications, access for authorised users, and more.

Building on its successful track record with education payments in the U.K., Flywire continues to invest in its SFS solution to meet client demand. With real-time integration into institutions’ finance systems critical for improved visibility and streamlined reconciliation, Flywire successfully launched three new SFS implementations specifically for clients running on Unit4 (Agresso), one of the most broadly used ERPs in the UK higher education sector, as well as one client running on Banner Ethos. Additionally, these clients also benefitted from first-of-its-kind functionality, including payment plans, real-time payments and real-time student account information, enabling payers to view up-to-date and accurate account balances and make immediate payments. The speed and success of these launches, with all three design partners live ahead of the summer peak, underscore the strength of Flywire’s product and the impact of its continued investment in implementation resources to support growing demand.

One design partner, Kingston University, deployed Flywire's SFS solution as they required a modern and intuitive student portal that surfaced debt from their Unit 4 finance system in real-time to help enhance the student payment experience, all while driving significant back-office efficiencies across their internal teams.

The impact of the implementation was immediate, with the portal going live ahead of the new academic year. Since its launch, the university has seen marked improvements in student satisfaction and has freed up staff to focus on more meaningful engagement with students.

“Kingston University needed a more modern and transparent way for students to handle their payments, and Flywire's SFS solution delivered ,” said Chris Billington, Head of Finance Shared Services at Kingston University. “ The platform's ability to show real-time data and simplify the payment process has transformed how our students interact with us financially. This has also helped reduce some of the administrative burden for our staff, allowing them to focus on more valuable student engagement. It's a best-in-class product that sets a new benchmark for student financials .”

Enhanced U.S. loans solution automates complex workflows for inbound loan funds

Flywire also unveiled an enhanced solution for managing loans from the U.S. government and other, third-party alternative sources for students studying in the U.K. market. Featuring Flywire’s distinctive receivables and payables capabilities, the solution enables U.K. institutions to securely receive funds owed to their institution and easily deliver the excess funds to students. Flywire now powers a complete loan disbursement solution for U.K. institutions from a single platform, enabling clients to seamlessly and compliantly process loans and properly apply funds to student accounts. This is all part of Flywire's strategy of providing comprehensive capabilities to manage the major domestic and cross-border money movement flows on behalf of its client institutions.

Currently, institutions in the U.K. have a very manual process for receiving U.S. loan payments from third-party funding sources. They typically spend excessive time manually processing payments, have difficulty obtaining student bank details to send credit details to, and deal with a highly regulated process with annual audits, among other challenges. Furthermore, U.S. students studying at U.K. institutions feel a lack of transparency around the entire process, which makes it difficult to plan and budget for their daily living expenses abroad.

Flywire’s updated solution solves these problems by providing beneficiary management, loan disbursement processing, foreign exchange calculation, and incoming and outgoing payment processing, all within a single platform. With automation and full transparency built in, Flywire enables institutions to securely receive and reconcile U.S. loan payments more easily and quickly, while eliminating manual work and ensuring accuracy throughout the funds flow.

Detailed features of Flywire’s solution include:

• Performing the foreign exchange to calculate the loan amount to send to the schools as an incoming payment and the excess amount (if applicable) to be sent to the student as an outgoing payment
• Automatically creating and sending the incoming and outgoing payments once funds have been received from the third party
• Updating the student account once the funds are disbursed
• Enabling clients to comply with loan program rules

"At Glasgow Caledonian, we are continually seeking ways to bridge the gap in education affordability and simplify complex financial processes for our international students,” said Emma Burns, Head of Operational Services - Finance at Glasgow Caledonian University. “ Flywire's capability to digitally disburse U.S. loan payments is a significant step forward, promising to enhance efficiency and security for both the university and our students. This streamlined approach not only reduces administrative burden but also ensures that critical funds reach student accounts promptly and reliably, allowing them to focus on their studies without unnecessary financial anxieties."

About Flywire

Flywire is a global payments enablement and software company. We combine our proprietary global payments network, next-gen payments platform and vertical-specific software to deliver the most important and complex payments for our clients and their customers.

Flywire leverages its vertical-specific software and payments technology to deeply embed within the existing A/R workflows for its clients across the education, healthcare and travel vertical markets, as well as in key B2B industries. Flywire also integrates with leading ERP systems, such as NetSuite, so organizations can optimize the payment experience for their customers while eliminating operational challenges.

Flywire supports more than 4,800* clients with diverse payment methods in more than 140 currencies across more than 240 countries and territories around the world. The company is headquartered in Boston, MA, USA with global offices. For more information, visit www.flywire.com . Follow Flywire on X , LinkedIn and Facebook .

*Excludes clients from Flywire’s Invoiced and Sertifi acquisitions

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding Flywire’s expectations of its education business. Flywire intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “believe,” “may,” “will,” “potentially,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “project,” “target,” “plan,” “expect,” or the negative of these terms, and similar expressions intended to identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. Important factors that could cause actual results to differ materially from those reflected in Flywire's forward-looking statements include, among others, the factors that are described in the “Risk Factors” and “Management's Discussion and Analysis of Financial Condition and Results of Operations” sections of Flywire's Annual Report on Form 10-K for the year ended December 31, 2024, and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, which are on file with the Securities and Exchange Commission (SEC) and available on the SEC's website at https://www.sec.gov/ . The information in this release is provided only as of the date of this release, and Flywire undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

Contacts

Media:

Sarah King
[email protected]

Investor Relations:

Masha Kahn
[email protected]

DENVER, Sept. 17, 2025 (GLOBE NEWSWIRE) -- 247marketnews.com , a pioneer in digital media dedicated to the swift distribution of financial market news and corporate information, reports that recent capital raises position VENU (NYSE American: VENU) with more than $45 million to allocate toward new amphitheater projects. When VENU first went public, the company raised approximately $55 million through its initial equity financings, from a $32 million private placement, IPO proceeds, and private investor funds. Management has treated those funds as impact capital, leveraging it into more than $1.3 billion in ongoing construction.

That’s a better than 23-to-1 return in asset creation in under a year, underscoring the efficiency of VENU’s model.

The most recent $45 million funding round is earmarked for the development of the new Sunset McKinney and Sunset Broken Arrow amphitheaters, as well as for working capital and general corporate purposes. The Sunset Broken Arrow project alone represents an estimated $107 million development in Oklahoma, designed to become a premier, all-season venue under the VENU brand.

The Sunset Broken Arrow is all about luxury, as the 12,500-seat venue will feature more than 200 Luxe FireSuites with natural gas fire pits and customizable seating, four Ultra Suites, and the exclusive Aikman Club with 175 lifetime memberships. Each suite will include premium food and beverage service, VIP parking, and dedicated access, redefining the fan experience for live entertainment.

The luxury FirePits will heat up concert goers this fall as cooler weather arrives. Management has estimated $200 million in LuxeFire and FirePit sales for 2025, and the upcoming Q3 report on November 22 should provide investors with further insight into progress.

VENU’s CEO, J.W. Roth, has personally purchased over $5 million worth of Luxe FireSuites and plans to scale to $20 million within a year, underscoring his confidence in both the product and VENU’s long-term growth. That insider commitment validates demand and strengthens credibility as the company advances toward its $200 million 2025 sales target.

About VENU Holding Corporation

VENU Holding Corporation (NYSE American: VENU) is redefining the live entertainment landscape through a national network of premium amphitheaters powered by its Luxe FireSuites model. With partnerships like AEG and Aramark, and an active development pipeline of over $5 billion (including $1 billion underway), VENU is building the next generation of destination venues, where investors, fans, and artists come together in a hospitality-first experience.

Please click here to read Cenorium’s full Venu analyst report on 247marketnews.com.

For the full 24/7 Market News VENU report and in-depth insights, visit: Read 24/7 Market News VENU Report/

Contact [email protected] for Analyst Report coverage and other investor/public relations services.

About 24/7 Market News

24/7 Market News (24/7 MN) is a leading market news platform for public companies. As a pioneer in digital media, 24/7 MN is dedicated to the swift distribution of financial market news and information. 24/7 MN takes great pride in creating innovative public relations campaigns that help clients reach the target audience.

24/7 MARKET NEWS, INC (247) Disclaimer and Disclosure
PAID EDITORIAL DISCLOSURE: 247MarketNews.com has been compensated $2,500 per week by MicroCap Strategies for ongoing press and editorial coverage of VENU. This is a paid editorial communication intended for informational purposes only. Please review 247’s Full Disclaimer https://www.247marketnews.com/disclaimer/ . This press release may include technical analysis for informational purposes only and should not be construed as financial or investment advice. Trading stocks involves risks, and readers should consult with their financial advisor before making investment decisions. Please go to https://247marketnews.com/venu-disclosure/ for additional 247marketnews.com VENU disclosure information.

CONTACT:
24/7 Market News
[email protected]

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements that are subject to various risks and uncertainties. Such statements include statements regarding the Company's ability to grow its business and other statements that are not historical facts, including statements which may be accompanied by the words "intends," "may," "will," "plans," "expects," "anticipates," "projects," "predicts," "estimates," "aims," "believes," "hopes," "potential" or similar words. Actual results could differ materially from those described in these forward-looking statements due to a number of factors, including without limitation, the Company's ability to continue as a going concern, general economic conditions, and other risk factors detailed in the Company's filings with the SEC. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company does not undertake any responsibility to update such forward-looking statements except in accordance with applicable law.

PITTSBURGH, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Matthews International Corporation (NASDAQ GSM: MATW) (“Matthews” or the “Company”) announced today that its Matthews Engineering business is hosting an Energy Summit at its Development Center in Vreden, Germany, on September 17-18, 2025.

The summit will convene a select group of industry experts, leading battery manufacturers, automotive OEMs, thought leaders, and innovators, to explore the latest advancements in battery manufacturing and energy technologies. The location of the event also gives Matthews Engineering the opportunity to showcase its new Development Center. The cutting-edge facility is dedicated to industrial process optimization, technological innovation, and the development of sustainable solutions for the future.

Attendees will have the opportunity to hear from industry experts and academia on the latest developments on dry transfer coating for DBE, powder processing, next-gen battery types, and hydrogen fuel cell production solutions.

The summit will be moderated by Dr. Veronika Wright, a leading voice in the EV and battery industry. Featured presenters include experts from The University of Chicago, Fraunhofer IWS, Fraunhofer UMSICHT, Technical University of Braunschweig, Addionics, and Factorial Energy, among others.

About Matthews Engineering
Matthews Engineering is an architect of engineering solutions, specializing in the design and manufacture of specialty machines and production equipment for demanding, continuous industrial manufacturing processes. With over 75 years of experience and a legacy of trusted brands - Saueressig Engineering, Olbrich, and Polytype Converting - we provide intelligent processes, technical excellence, and unmatched precision for future-proof production technologies. From lab-scale formulation to full-scale production, we combine deep engineering expertise with a comprehensive understanding of materials and process behavior, to help customers optimize resources, increase efficiency, and accelerate innovations. Our core technologies cover all crucial process steps like calendering, coating, embossing, laminating, and printing - empowering future-focused industries to transform complex substrates into high-performance products where precision, reliability, and efficiency are essential. Through our global Development Centers, we enable customers to simulate, validate, and scale new processes under real-world conditions, ensuring a seamless transfer into series production.

About Matthews International
Matthews International Corporation operates through two core global businesses – Industrial Technologies and Memorialization. Both are focused on driving operational efficiency and long-term growth through continuous innovation and strategic expansion. The Industrial Technologies segment evolved from our original marking business, which today is a leading global innovator committed to empowering visionaries to transform industries through the application of precision technologies and intelligent processes. The Memorialization segment is a leading provider of memorialization products, including memorials, caskets and cremation and incineration equipment, primarily to cemetery and funeral home customers that help families move from grief to remembrance. In addition, the Company also has a significant investment in Propelis, a brand solutions business formed through the merger of SGK and SGS & Co. Propelis delivers integrated solutions including brand creative, packaging, print solutions, branded environments, and content production. Matthews International has over 5,400 employees in 19 countries on four continents that are committed to delivering the highest quality products and services.

Matthews International Corporation
Corporate Office
Two NorthShore Center
Pittsburgh, PA 15212-5851
Phone: 412.442.8200

EMERYVILLE, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- XOMA Royalty Corporation (NASDAQ: XOMA) (“XOMA Royalty” or the “Company”), a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health, today announced the Company has successfully completed its previously announced tender offer to acquire all outstanding shares of HilleVax, Inc. (NASDAQ: HLVX) (“HilleVax”) common stock for a price per share of $1.95 in cash (the “Cash Amount”), plus one non-tradeable contingent value right (“CVR” and together with the Cash Amount, the “Offer Price”).

The tender offer and related withdrawal rights expired one minute after 11:59 p.m. Eastern Time on Monday, September 15, 2025 (the “Expiration Date”). As of the Expiration Date, a total of 39,214,689 shares of HilleVax common stock were validly tendered, and not validly withdrawn, representing approximately 77.48% of the outstanding shares of HilleVax common stock as of the Expiration Date.  As of the Expiration Date, the number of shares validly tendered in accordance with the terms of the tender offer and not validly withdrawn satisfied the minimum tender condition, and all other conditions to the tender offer were satisfied or waived.  Immediately after the Expiration Date, XOMA Royalty irrevocably accepted for payment all shares validly tendered and not validly withdrawn and expects to promptly pay for such shares.

Following the closing of the tender offer, a subsidiary of the Company, XRA 4 Corp., merged with and into HilleVax (the “Merger”), and all shares of HilleVax common stock that had not been validly tendered were converted into the right to receive the Offer Price.  As a result of the Merger, HilleVax became a wholly owned subsidiary of XOMA Royalty.  Prior to the opening of trading on The Nasdaq Stock Market LLC (“Nasdaq”) on September 17, 2025, all shares of HilleVax common stock will cease trading on Nasdaq, and HilleVax intends promptly to cause such shares to be delisted from Nasdaq and deregistered under the Securities Exchange Act of 1934, as amended.

Advisors
XOMA Royalty was represented by Gibson, Dunn & Crutcher LLP. Leerink Partners acted as the exclusive financial advisor and Latham & Watkins LLP acted as legal counsel to HilleVax.

About XOMA Royalty Corporation
XOMA Royalty is a biotechnology royalty aggregator playing a distinctive role in helping biotech companies achieve their goal of improving human health.  XOMA Royalty acquires the potential future economics associated with pre-commercial and commercial therapeutic candidates that have been licensed to pharmaceutical or biotechnology companies.  When XOMA Royalty acquires the future economics, the seller receives non-dilutive, non-recourse funding they can use to advance their internal drug candidate(s) or for general corporate purposes.  XOMA Royalty has an extensive and growing portfolio of assets (asset defined as the right to receive potential future economics associated with the advancement of an underlying therapeutic candidate). For more information about XOMA Royalty and its portfolio, please visit www.xoma.com or follow XOMA Royalty Corporation on LinkedIn .

Forward-Looking Statements/Explanatory Notes
Certain statements contained in this press release are forward-looking statements, including statements regarding the payment and timing of payment of the Offer Price to former HilleVax common stockholders and the ability and timing of delisting of HilleVax common stock.  In some cases, you can identify such forward-looking statements by terminology such as “expect,” “may,” or “will,” the negative of these terms or similar expressions.  These forward-looking statements are not a guarantee of XOMA Royalty’s performance, and you should not place undue reliance on such statements.  These statements are based on assumptions that may not prove accurate, and actual results could differ materially from those anticipated due to certain risks including that XOMA Royalty does not achieve anticipated net cash after winding down HilleVax’s operations, that the timing of the payment or delisting may be delayed and that there are no payments made under the CVRs.  Other potential risks to XOMA Royalty meeting these expectations are described in more detail in XOMA Royalty’s most recent filing on Form 10-Q and in other filings with the Securities and Exchange Commission (“SEC”).  Any forward-looking statement in this press release represents XOMA Royalty’s beliefs and assumptions only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date.  XOMA Royalty disclaims any obligation to update any forward-looking statement, except as required by applicable law.

EXPLANATORY NOTE: Any references to “portfolio” in this press release refer strictly to milestone and/or royalty rights associated with a basket of drug products in development.  Any references to “assets” in this press release refer strictly to milestone and/or royalty rights associated with individual drug products in development.

WESTBROOK, Maine, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Synergy CHC Corp. (NASDAQ: SNYR) , a leading consumer health and wellness company, today announced a strategic distribution partnership with AlaBev , one of the Southeast’s premier beverage distributors, to expand retail availability of its flagship FOCUSfactor® Focus + Energy functional beverage line and brain-health energy shots .

Under this agreement, AlaBev will distribute FOCUSfactor products to more than 5,000 grocery, convenience, and specialty retailers across Alabama , making the clinically supported cognitive performance brand widely accessible to consumers seeking clean, science-backed energy and focus solutions .

AlaBev: A Century of Distribution Strength

With nearly 120 years of experience and three strategically located warehouses , AlaBev has built a reputation as a trusted direct-store-delivery (DSD) distributor , partnering with global and emerging brands to deliver exceptional retail execution across the Southeast. By leveraging AlaBev’s long-standing retail relationships, Synergy CHC is positioned to accelerate market penetration in one of the nation’s fastest-growing wellness and functional beverage markets.

Synergy CHC Expands FOCUSfactor® Nationwide

The AlaBev partnership represents a significant milestone in Synergy’s Southeast expansion strategy , building on momentum as FOCUSfactor® beverages and shots gain traction with health-conscious consumers, athletes, and professionals seeking performance-driven brain health products. This announcement comes as functional beverages continue to outpace traditional energy drinks , driven by growing consumer demand for nootropic ingredients, natural focus boosters, and cognitive health support .

Jack Ross, CEO of Synergy CHC Corp., commented: “AlaBev is a proven distributor with deep roots in Alabama, a stellar reputation for execution, and a strong track record of scaling brands across the Southeast. Their reach and operational expertise make them an ideal partner to accelerate FOCUSfactor’s growth in this important market. This partnership ensures Alabama consumers will gain easier access to our beverages and shots designed to deliver mental clarity, sustained energy, and overall cognitive performance—benefits that align perfectly with today’s wellness-driven lifestyle.”

Michael Silinsky, CFO of AlaBev, added: “FOCUSfactor®” is a brand that stands out in the rapidly growing functional beverage category, and we’re excited to bring its unique focus-and-energy benefits to retail partners across Alabama. AlaBev’s mission has always been to connect consumers with innovative, high-quality products, and this collaboration with Synergy is a natural fit. Together, we look forward to building FOCUSfactor into a household name across our state.”

Driving Market Awareness and Shareholder Value

The new distribution agreement underscores Synergy’s commitment to expanding its functional beverage business through targeted regional partnerships that deliver brand awareness, sales growth, and shareholder value . With AlaBev’s deep market expertise and Synergy’s portfolio of science-backed wellness brands, FOCUSfactor® is well positioned for a strong debut across Alabama.

With momentum building in multiple geographies and product categories, the company expects to announce additional retail wins, new distribution deals, and market expansion updates in the months ahead.

About Synergy CHC Corp.

Synergy CHC Corp. develops and markets consumer health and wellness products, led by its flagship brands FOCUSfactor ^® and Flat Tummy ^® . FOCUSfactor ^® , a clinically studied brain health supplement and functional beverage line with a 25-year legacy, enjoys established distribution in the U.S., Canada, and the U.K. through major retailers including Costco, Walmart, Amazon, BJ's, and Walgreens, among others. The brand continues to accelerate growth, penetrating new markets both domestically and internationally, with recent retail wins across mass, grocery, pharmacy, convenience, and wholesale channels poised to drive meaningful gains in late 2025. Flat Tummy ^® complements Synergy's portfolio as a lifestyle brand focused on women's wellness and weight management.

Investor Relations
Gateway Group
Cody Slach, Greg Robles
949.574.3860
[email protected]

PALI-2108 demonstrated favorable safety, with no serious adverse events, lab abnormalities, or EKG concerns

Phase 1b data demonstrated 100% clinical response and promising signals regarding the efficacy of PALI-2108 in ulcerative colitis (UC) using FDA-defined endpoints

Biomarker analyses showed normalization of 186 genes linked to fibrosis and Crohn’s disease strictures, supporting translational potential in fibrostenotic Crohn’s disease (FSCD)

Patient dosing in the Phase 1b FSCD study is expected to begin in 2H 2025; Phase 2 IND submissions anticipated in 1H 2026

Carlsbad, CA, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Palisade Bio, Inc. (Nasdaq: PALI) (“Palisade,” “Palisade Bio,” or the “Company”), a clinical-stage biopharmaceutical company developing precision therapies for autoimmune, inflammatory, and fibrotic diseases, today announced new data from its ongoing clinical program evaluating PALI-2108, a first-in-class, ileocolonic-targeted PDE4 B/D inhibitor. The results are to be presented in an oral session at the STAR Consortium Annual Meeting – the accompanying slides are now available here .

The Phase 1b UC cohort demonstrated rapid and consistent clinical activity, with all patients responding to treatment. While the study was shorter in duration than standard induction trials and not powered for efficacy, there was promising signals of clinical improvement, with 2 of 5 patients achieving remission after only seven days. These improvements were reinforced by favorable histology and biomarker changes that confirmed local PDE4 engagement and broad immunologic resolution. Together with the strong safety and PK profile observed in the Phase 1a study, the results highlight PALI-2108’s differentiated potential as both an anti-inflammatory and anti-fibrotic therapy.

“These results highlight the differentiated profile of PALI-2108, demonstrating strong safety, rapid clinical activity, and broad biomarker engagement in ulcerative colitis, while reinforcing its potential as the first targeted anti-fibrotic therapy in Crohn’s strictures,” said JD Finley, Chief Executive Officer of Palisade Bio. “We are excited to advance this program into its next stage of development as we prepare for Phase 2.”

Key Clinical Findings

Phase 1a Safety and Pharmacokinetics (n=84, SAD/MAD)

• No serious adverse events (SAEs) and no lab or EKG abnormalities observed.
• Well tolerated at single doses up to 450 mg and multiple BID doses up to 50 mg.
• Extended half-life and colon-targeted bioactivation support once-daily dosing.
  

Phase 1b Ulcerative Colitis (UC) Cohort (n=5, 7 days)

• All patients (5/5 patients) showed a clinical response as measured by modified Mayo score
• Two of the 5 patients achieved clinical remission based on FDA-defined endpoints
• 62.8% mean reduction in modified Mayo score (~4-point absolute decrease)
• Histologic improvements: Nancy Index ↓58%, Robarts Index ↓56%, Geboes Score ↓36%
• Inflammatory biomarkers reduced: fecal calprotectin ↓~70%, hsCRP ↓~15%
• Mechanistic biomarkers improved: colon tissue cAMP ↑~27%, tissue lymphocytes ↓~29%, tissue PDE4B ↓~71%

Translational Relevance to FSCD

• 186 fibrotic gene markers elevated at baseline in UC patients were reduced at endpoint.
• Data support anti-fibrotic potential of PALI-2108 in FSCD.

Dr. Mitchell Jones, Chief Medical Officer, added, “What stands out is the consistency across clinical, histologic and mechanistic readouts in UC. The rapid clinical responses and biomarker improvements we observed support PALI-2108’s targeted engagement of PDE4 biology and reinforce its potential to become a best-in-class oral therapy for UC. Importantly, the same mechanistic pathways also support anti-fibrotic activity, which we believe extends the opportunity into FSCD. By advancing UC as our lead indication, we are prioritizing a clear regulatory and clinical path while maintaining the broader potential of this program.”

For more information about the Phase 1a/b clinical study, visit clinicaltrials.gov and reference identifier NCT06663605 . Data from the planned Phase 1b FSCD study, together with results from Palisade’s completed Phase 1a/1b trials in UC, will support the Company’s planned Phase 2 IND submissions to the U.S. Food and Drug Administration (FDA) in the first half of 2026.

About PALI-2108
PALI-2108 is an orally administered prodrug engineered for gut-restricted delivery of PDE4 B/D inhibition to the terminal ileum and colon. Activated by bacterial enzymes in the lower intestine, PALI-2108 achieves high local tissue concentrations while minimizing systemic exposure. This design aims to maximize anti-inflammatory and anti-fibrotic effects while reducing class-related tolerability issues such as nausea and headache that have historically limited systemic PDE4 inhibitors.

About Palisade Bio
Palisade Bio is a clinical-stage biopharmaceutical company focused on developing and advancing novel therapeutics for patients living with autoimmune, inflammatory, and fibrotic diseases. The Company believes that by using a targeted approach with its novel therapeutics it will transform the treatment landscape. For more information, please go to www.palisadebio.com .

Forward Looking Statements
Any statements contained in this communication that are not statements of historical fact may be deemed to be forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to: statements regarding the safety and tolerability, PK and drug release characteristics, clinical response and clinical efficacy rates and dosing requirements of PALI-2108 based on the Company’s preclinical studies and data from its Phase 1a/b clinical study; indications and anticipated benefits of PALI-2108, including the potential of PALI-2108 to treat FSCD; and the expected timing of the Company’s planned Phase 1b clinical study of PALI-2108 for the treatment of FSCD and the planned Phase 2 clinical study of PALI-2108 for the treatment of UC. These forward-looking statements are based on the Company’s current expectations. Forward-looking statements involve risks and uncertainties. Important factors that could cause actual results to differ materially from those reflected in the Company’s forward-looking statements include, among others, the timing of enrollment, commencement and completion of the Company’s clinical trials; the Company’s reliance on PALI-2108, and its early stage of clinical development; the risk that prior results, such as signals of safety, clinical response, clinical efficacy, activity, dosing or durability of effect, observed from preclinical or clinical trials, will not be replicated or will not continue in ongoing or future studies or clinical trials involving the Company’s product candidates in clinical trials focused on the same or different indications; the Company’s ability to secure additional financing to fund future operations and development of its product candidates; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2024, filed with the Securities and Exchange Commission (“SEC”) on March 24, 2025, and the Quarterly Reports on Form 10-Q or other SEC filings that are filed thereafter. Investors are cautioned not to put undue reliance on these forward-looking statements. These forward-looking statements speak only as of the date hereof, and the Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
[email protected]

Source: Palisade Bio

SAN DIEGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- LPL Financial LLC , a leading wealth management firm, today announced the release of the first-of-its-kind annual Advisor Growth Study (AGS). The comprehensive research study pulls from six years of structured data (2018–2024) from over 14,000 financial advisors across business models, geographies and growth stages to identify behaviors that consistently drive strategic growth.

As one of the largest aggregators of proprietary advisor data, LPL created the AGS to provide insights into industry trends that drive growth for financial advisors and institutions. The data is enhanced through supervised machine learning and explainable AI to identify behaviors that lead to sustainable growth in the wealth management industry.

Advisor Benchmarking: From Instinct to Insight to Action

Leveraging the firm’s scale and data, LPL converted the AGS insights into the Advisor Growth Index (AGI or Index), an early-stage diagnostic tool for advisors and institutions that affiliate with LPL. Working in a 1:1 consultative process between LPL and advisors, the AGI evaluates advisor and institution performance across client acquisition, development and retention — allowing advisors and institutions to benchmark themselves against industry top performers and identify the most productive path forward for growth.

According to the study, the advisors and institutions with the highest AGI scores demonstrate the most consistent growth patterns, with businesses in the top quartile growing assets under management (AUM) three times the rate of median performers, on average. The AGI score is intended to provide advisors and institutions with clear insight into their performance patterns and outline a practical starting point for making meaningful improvements.

AGI scores are dynamic, letting advisors and institutions track progress over time, visualize the effectiveness of business changes and evolve their strategies with support from the LPL ecosystem.

“With the Advisor Growth Study, LPL sought to answer the question, ‘What separates top-growing advisors and institutions from their peers?’” said Matt Enyedi, chief client officer at LPL Financial. “By analyzing six years of proprietary performance data from thousands of practices, spanning all business models, affiliations and stages, the AGS is unlike traditional benchmarking tools that rely on self-reported surveys. We're drawing from objective data, enhanced through supervised machine learning and artificial intelligence to identify behaviors that lead to sustainable growth.

“These are not anecdotal guesses; these are actionable learnings, backed by data, tested across business models and proven in the field,” he added.

Four Traits of Successful Advisors

The AGS uncovered four behaviors that distinguish top-growing businesses from their peers. On average, advisors and institutions who exhibited even two of the following four areas saw growth rates over five times when compared to their peers.

• Establish Growth Foundation: Top growers prioritize clients with long-term potential, build operational efficiency and align infrastructure with scalable growth. They establish clear growth priorities, using data to identify one to two areas of focus and take targeted action. For example, study data shows that top growers maintain a well-balanced client mix with:
  • A median client aged 60 or younger, and
  • Typically, less than 35% of clients in the decumulation phase.
    
• Segment Clients: Every client has unique needs, and top-performing advisors and institutions segment clients and refine service models based on factors like AUM, life stage, planning complexity, growth potential and personal fit. Segmentation best practices demonstrate that:
  
  
  • 30-60% of growth comes from clients with the top 10% of AUM, and
  • Approximately 35% of growth comes from clients who have $500,000 or more under management.
    
• Deeply Serve Clients: The most successful advisors and institutions prioritize thoughtful planning and tailored support for complex needs. They focus on deepening engagement with existing clients and the next generation using the planning process as a gateway to richer conversations and sustained relationships. Data shows that:
  
  
  • Advisors and institutions holding 60%+ of client assets in advisory saw consistent gains over brokerage year-over-year.

• Drive New Client Acquisition: With an intentional approach to new client acquisition, high-growth businesses use data to target high-potential prospects by leveraging strategic M&A opportunities, centers of influence and digital marketing. Study data highlights that top advisors and institutions:
  • Achieved high rates of new client acquisition — 10%+ of clients are new each year — with the average new client AUM increasing year-over-year.

“In today’s advisory landscape, growth is no longer a luxury, it’s a necessity,” said Kraleigh Woodford, executive vice president of growth strategy and enablement, LPL Financial. “As the demand for advice continues to build, advisors and institutions will need tools and solutions that help them scale and grow on their terms. We see both advisors and the industry leveraging LPL’s Advisor Growth Study and the Advisor Growth Index as essential tools to inform growth with confidence.”

LPL’s annual Advisor Growth Study (Research) and Advisor Growth Index (Diagnostic Tool) are part of the company’s Advisor Growth System — a comprehensive, data-driven framework that helps advisors and institutions benchmark their performance, identify growth opportunities and execute strategic improvements with LPL's support. The complete system is available at no cost to LPL advisors and institutions.

To download a copy of the annual Advisor Growth Study, please visit: go.lpl.com/advisorgrowthstudy .

About LPL Financial

LPL Financial Holdings Inc. (Nasdaq: LPLA) is among the fastest growing wealth management firms in the U.S. As a leader in the financial advisor-mediated marketplace, LPL supports over 29,000 financial advisors and the wealth management practices of approximately 1,100 financial institutions, servicing and custodying approximately $1.9 trillion in brokerage and advisory assets on behalf of approximately 7 million Americans. The firm provides a wide range of advisor affiliation models, investment solutions, fintech tools and practice management services, ensuring that advisors and institutions have the flexibility to choose the business model, services, and technology resources they need to run thriving businesses. For further information about LPL, please visit www.lpl.com .

Securities and advisory services offered through LPL Financial LLC (“LPL Financial”), a registered investment adviser and broker-dealer. Member FINRA/SIPC.

Throughout this communication, the terms “financial advisors” and “advisors” are used to refer to registered representatives and/or investment advisor representatives affiliated with LPL Financial.

We routinely disclose information that may be important to shareholders in the “ Investor Relations ” or “ Press Releases ” section of our website.

Media Contact:
[email protected]
(402) 740-2047

Tracking #: 797157

KANSAS CITY, Kan., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cingulate Inc. (NASDAQ: CING), a biopharmaceutical company utilizing its proprietary Precision Timed Release™ (PTR™) drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, today announced it has entered into a commercial supply agreement with Bend Bio Sciences for the manufacturing of CTx-1301(dexmethylphenidate HCl), the company’s lead asset for the treatment of attention deficit/hyperactivity disorder (ADHD).

CTx-1301 is a novel, extended-release tablet formulation of dexmethylphenidate designed to address major limitations of current ADHD therapies. Cingulate submitted its NDA to the FDA for CTx-1301 on July 31, 2025.

Strategic Partnership Drives Commercial Readiness

Under the new agreement, Bend Bio Sciences will serve as the exclusive commercial manufacturer of CTx-1301 in the United States through 2028, if approved by the FDA, and Cingulate has committed to purchasing 100% of its overall U.S. commercial supply of CTx-1301 from Bend, following and subject to any FDA approval. This strategic arrangement provides manufacturing security and operational efficiency as Cingulate prepares for potential market entry.

"Following our successful NDA submission last month, this exclusive manufacturing partnership with Bend Bio Sciences marks another pivotal step in our commercialization strategy," said Jay Roberts, Executive Chairman of Cingulate. "This agreement not only secures our manufacturing capabilities but demonstrates our commitment to delivering consistent, high-quality supply of CTx-1301 to serve the millions of patients who need ADHD treatment options."

Bend Chief Executive Officer Owen Murray stated, "We’re proud to expand our years-long partnership with Cingulate as they advance this important next-generation therapy into commercial manufacturing. The complexity and precision required for this multi-phase release tablet aligns perfectly with our technical strengths in modified-release dosage forms and oral solid drug delivery. It's a formulation designed with the patient in mind and we’re honored to support its success.”

About Attention Deficit/Hyperactivity Disorder (ADHD)
ADHD is a chronic neurobiological and developmental disorder that affects millions of children and often continues into adulthood. The condition is marked by an ongoing pattern of inattention and/or hyperactivity-impulsivity that interferes with functioning or development. In the U.S., over 20 million patients have been diagnosed with ADHD. Among this group, 12 million are adults and over 8 million are under the age of 17. According to the CDC , just 53.6 percent of all children and teens with ADHD reported they were actively treating their symptoms with medication in 2022, with 65–90 percent demonstrating clinical ADHD symptoms that persist into adulthood. Current market trends demonstrate that adult ADHD prevalence is larger and growing faster than the child and adolescent segments combined.

About CTx-1301
Cingulate’s lead candidate, CTx-1301, utilizes Cingulate’s proprietary PTR drug delivery platform to create a breakthrough, multi-core formulation of the active pharmaceutical ingredient dexmethylphenidate, a compound approved by the FDA for the treatment of ADHD. Dexmethylphenidate is part of the stimulant class of medicines and increases norepinephrine and dopamine activity in the brain to affect attention and behavior. While stimulants are the gold standard of ADHD treatment due to their efficacy and safety, the long-standing challenge continues to be providing patients with an entire active-day duration of action. CTx-1301 is designed to precisely deliver three releases of medication at the predefined time, ratio, and style of release to provide patient care in one tablet.

About Precision Timed Release™ (PTR™) Platform Technology
Cingulate is developing ADHD and anxiety disorder product candidates capable of achieving true once-daily dosing using Cingulate’s innovative PTR drug delivery platform technology. It incorporates a proprietary Erosion Barrier Layer (EBL) providing control of drug release at precise, pre-defined times with no release of drug prior to the intended release. The EBL technology is enrobed around a drug-containing core to give a tablet-in-tablet dose form. It is designed to erode at a controlled rate until eventually the drug is released from the core tablet. The EBL formulation, OralogiK™, is licensed from BDD Pharma. Cingulate intends to utilize its PTR technology to expand and augment its clinical-stage pipeline by identifying and developing additional product candidates in other therapeutic areas in addition to Anxiety and ADHD where one or more active pharmaceutical ingredients need to be delivered several times a day at specific, predefined time intervals and released in a manner that would offer significant improvement over existing therapies. To see Cingulate’s PTR Platform, click here .

About Cingulate Inc.
Cingulate Inc. (NASDAQ: CING), is a biopharmaceutical company utilizing its proprietary PTR drug delivery platform technology to build and advance a pipeline of next-generation pharmaceutical products, designed to improve the lives of patients suffering from frequently diagnosed conditions characterized by burdensome daily dosing regimens and suboptimal treatment outcomes. With an initial focus on the treatment of ADHD, Cingulate is identifying and evaluating additional therapeutic areas where PTR technology may be employed to develop future product candidates, including to treat anxiety disorders. Cingulate is headquartered in Kansas City. For more information, visit Cingulate.com .

About Bend Bioscience
Formed from three specialist CDMOs, Bend Bioscience offers bolder science and bigger impact across small molecule capabilities and enabling technologies. From pre-clinical to commercial scale, Bend provides its clients with the highest levels of service and science, combining the broad capabilities of a large CDMO with the flexibility and speed of an expert partner. We employ our scientific expertise to optimize formulation designs with a focus on enhanced pharmacokinetics, and deploying enabling technologies such as spray dried dispersions, particle engineering, multi-particulate dosage forms and modified release technologies to affect desired release profiles and in vivo bioavailability. Our partnering approach brings molecules through the clinic, to scaled manufacturing and launch through our network of three specialized, newly expanded facilities in the U.S., from where we offer accelerated solutions for orphan, breakthrough and specialty programs, as well as tech transfer expertise to ease transition from early development to commercial production.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include all statements, other than statements of historical fact, regarding our current views and assumptions with respect to future events regarding our business, including statements with respect to our plans, assumptions, expectations, beliefs and objectives with respect to product development, clinical studies, clinical and regulatory timelines, market opportunity, competitive position, business strategies, potential growth opportunities, the potential approval and commercialization of CTx-1301 and other statements that are predictive in nature. These statements are generally identified by the use of such words as “may,” “could,” “should,” “would,” “believe,” “anticipate,” “forecast,” “estimate,” “expect,” “intend,” “plan,” “continue,” “outlook,” “will,” “potential” and similar statements of a future or forward-looking nature. Readers are cautioned that any forward-looking information provided by us or on our behalf is not a guarantee of future performance. Actual results may differ materially from those contained in these forward-looking statements as a result of various factors disclosed in our filings with the Securities and Exchange Commission (SEC), including the “Risk Factors” section of our Annual Report on Form 10-K filed with the SEC on March 27, 2025, and our other filings with the SEC. All forward-looking statements speak only as of the date on which they are made, and we undertake no duty to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Investor & Media Relations:
Thomas Dalton
Vice President, Corporate Communications, Cingulate
[email protected]
(913) 942-2301

MELBOURNE, Australia, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Propanc Biopharma, Inc. (Nasdaq: PPCB) (“Propanc” or the “Company”), a biopharmaceutical company developing novel cancer treatments for patients suffering from recurring and metastatic cancer, today announced that a certificate of grant for the Company’s “proenzyme composition” patent was received from the US Patent & Trademark Office (USPTO). The patent specifically captures a future clinical dose of the Company’s lead asset, PRP. This is the fourth US patent granted in this key strategic jurisdiction. Currently, the Company’s intellectual property portfolio consists of 90 patents filed in major jurisdictions relating to the use of PRP against solid tumors.

The proenzymes composition patent is an important part of the IP portfolio covering a possible future clinical dose of PRP, as the Company advances to a Phase 1B, First-In-Human (FIH) study in advanced cancer patients suffering from solid tumors. The patent has also been granted in other major jurisdictions such as Europe, Japan and throughout Southeast Asia. PRP is targeting the global metastatic cancer treatment market, projected to be worth US$111.2 billion by 2027, according to Emergen Research.

“We continue to grow our intellectual property portfolio in the United States, which is our most important jurisdiction,” said Mr. James Nathanielsz, Propanc’s Chief Executive Officer. “Our lead asset, PRP, is an exciting method to prevent and treat metastatic cancer from solid tumors without the severe, or even serious side effects often associated with standard therapies. PRP is relatively non-toxic because it does not kill cancer cells directly but induces cell differentiation so that they become less malignant and die off naturally. This unique phenomenon is specific to PRP, which acts as an ‘EMT (epithelial to mesenechymal transition) modulator’, enforcing the cancer cells to behave more as a normalized cell so that it is no longer a threat. We are pushing towards the commencement of the Phase 1B study next year. We are also pursuing every avenue for raising sufficient capital and employing a digital asset diversification strategy to ensure optimal cash flow as we advance PRP towards important clinical milestones.”

About Propanc Biopharma, Inc.

Propanc Biopharma, Inc. (the “Company”) is developing a novel approach to prevent recurrence and metastasis of solid tumors by using pancreatic proenzymes that target and eradicate cancer stem cells in patients suffering from pancreatic, ovarian, and colorectal cancers. For more information, please visit www.propanc.com .

The Company’s novel proenzyme therapy is based on the science that enzymes stimulate biological reactions in the body, especially enzymes secreted by the pancreas. These pancreatic enzymes could represent the body’s primary defense against cancer.

Forward-Looking Statements

All statements in this press release that are not historical are forward-looking statements, including, among other things, statements relating to the Company’s expectations regarding its market position and market opportunity, expectations and plans as to its product development, manufacturing and sales, and relations with its partners and investors, made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections regarding its business, operations and other similar or related factors. Words such as “may,” “will,” “could,” “would,” “should,” “anticipate,” “predict,” “potential,” “continue,” “expect,” “intend,” “plan,” “project,” “believe,” “estimate,” and other similar or related expressions are used to identify these forward-looking statements, although not all forward-looking statements contain these words. You should not place undue reliance on forward-looking statements because they involve known and unknown risks, uncertainties, and assumptions that are difficult or impossible to predict and, in some cases, beyond the Company’s control. Forward-looking statements are not guarantees of future actions or performance. Actual results may differ materially from those in the forward-looking statements as a result of a number of factors, including, without limitation, risks and uncertainties related to market conditions, as well as those risks described under “Risk Factors” in the prospectus related to the proposed offering and those described in the Company’s filings with the SEC. The Company undertakes no obligation to revise or update information in this release to reflect events or circumstances in the future, even if new information becomes available.

Company:
Propanc Biopharma, Inc.
James Nathanielsz
+61-3-9882-0780
[email protected]

Investor Contact:
[email protected]

BOSTON and LONDON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Akari Therapeutics, Plc (Nasdaq: AKTX), an oncology biotechnology company developing novel payload antibody drug conjugates (ADCs), today announced that it has filed a provisional patent application with the United States Patent and Trademark Office (USPTO) covering the Company’s antibody drug conjugate (ADC) platform using Akari’s spliceosome payload PH1 for treating cancer by modulating alternative splicing within cancer cells. This patent application represents a new patent family to further extend Akari’s proprietary position with respect to the Company’s novel payload, PH1 (a novel Thailanstatin analog).

Abizer Gaslightwala, President and Chief Executive Officer of Akari Therapeutics commented, “These novel data included in our provisional patent application continue to demonstrate the advances in our understanding of spliceosome modulation and the growing potential of our PH1 payload to build first-in-class ADCs that work in unique ways from current options, and could potentially drive differentiated clinical outcomes and remissions for cancer patients in the future. We will continue to progress our exciting research on our spliceosome modulating payload PH1 and present evolving data and insights. This specific provisional patent application increases the scope of our intellectual property estate and enables long term value creation for Akari and potential partners we elect to work with on our ADC portfolio.”

The new application relates to how Akari’s novel PH1 payload demonstrates its ability to modulate the spliceosome to disrupt alternative splicing drivers and the subsequent synthesis of proteins needed for cancer tumors to survive and grow.

Alternative splicing (AS) leads to the production of functionally distinct protein isoforms. Cancer cells hijack this process to produce isoforms that support the "hallmarks of cancer," a set of capabilities that often tumors acquire, which contribute to the growth, proliferation, and survival of the cancer in the tumor microenvironment, and a host of other deleterious effects. Changes in AS have been linked to almost all aspects of tumor formation and cancer growth and metastasis, including changes affecting cancer cell metabolism, inhibiting apoptosis (delaying natural cell death), cell cycle control, evading the immune system, invasion of cancer cells to other tissues/organs (metastasis and spreading), and resistance of cancer cells to current therapies. Disrupting AS is a central, generalized approach to target all cancers at a fundamental level of their survival and growth, including those difficult cancers driven by specific spliced variants (i.e. AR-v7 in prostate cancer) or cancers driven by other known factors (i.e. ,VEGF, HER2, Caspase-2). This opens up the possibilities and potential for Akari to become a leader in developing therapies against a wide range of cancers utilizing spliceosome modulation using Akari’s ADC platform.

This provisional patent application is a culmination of the exciting and groundbreaking work in alternative splicing Akari is progressing with its novel ADC payload PH1. This patent also adds to the body of knowledge already established around the PH1 payload including its potent cytotoxicity and robust immune cell activation demonstrated in multiple preclinical cancer models. The Company is committed to applying this expanded knowledge around disrupting alternative splicing to advance its current ADC portfolio, consisting of AKTX-101 (Trop2 ADC with PH1 payload), as well as future programs (AKTX-102, undisclosed target with PH1 payload).

About Akari Therapeutics

Akari Therapeutics is an oncology biotechnology company developing next-generation spliceosome payload antibody drug conjugates (ADCs). Utilizing its innovative ADC discovery platform, the Company has the ability to generate ADC candidates and optimize them based on the desired application to any target of interest. Akari’s lead candidate, AKTX-101, targets the Trop2 receptor on cancer cells and with a proprietary linker, delivers its novel PH1 payload directly into the tumor. Unlike current ADCs that use tubulin inhibitors and DNA damaging agents as their payloads, PH1 is a novel payload that is a spliceosome modulator designed to disrupt RNA splicing within cancer cells. This splicing modulation has been shown in preclinical animal models to induce cancer cell death while activating immune cells to drive robust and durable activity. In preclinical studies, AKTX-101 has shown to have significant activity and prolonged survival, relative to ADCs with traditional payloads. Additionally, AKTX-101 has the potential to be synergistic with checkpoint inhibitors and has demonstrated prolonged survival as both a single agent and in combination with checkpoint inhibitors, as compared to appropriate controls. The Company is generating validating data on its novel payload PH1 to continue advancing its lead asset, as well as other undisclosed targets with this novel payload.

For more information about the Company, please visit www.akaritx.com and connect on X and LinkedIn .

Cautionary Note Regarding Forward-Looking Statements

This press release includes express or implied forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, about the Company that involve risks and uncertainties relating to future events and the future performance of the Company. Actual events or results may differ materially from these forward-looking statements. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity” “will likely result,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding the ability of the Company to advance its product candidates for the treatment of cancer and any other diseases, and ultimately bring therapies to patients. These statements are based on the Company’s current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific. A number of important factors, including those described in this communication, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: the Company’s need for additional capital; the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, synergies, economic performance, indebtedness, financial condition and losses on the future prospects, business and management strategies for the management, expansion and growth of the business; risks related to global as well as local political and economic conditions, including interest rate and currency exchange rate fluctuations; potential delays or failures related to research and/or development of the Company’s programs or product candidates; risks related to any loss of the Company’s patents or other intellectual property rights; any interruptions of the supply chain for raw materials or manufacturing for the Company’s product candidates, including as a result of potential tariffs; the nature, timing, cost and possible success and therapeutic applications of product candidates being developed by the Company and/or its collaborators or licensees; the extent to which the results from the research and development programs conducted by the Company, and/or its collaborators or licensees may be replicated in other studies and/or lead to advancement of product candidates to clinical trials, therapeutic applications, or regulatory approval; uncertainty of the utilization, market acceptance, and commercial success of the Company’s product candidates; risks related to competition for the Company’s product candidates; and the Company’s ability to successfully develop or commercialize its product candidates. While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov. The Company assumes no, and hereby disclaims any, obligation to update the forward-looking statements contained in this press release except as required by law.

Investor Relations Contact

JTC Team, LLC
Jenene Thomas
908-824-0775
[email protected]

MAYFIELD VILLAGE, OHIO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- The Progressive Corporation (NYSE:PGR) today reported the following results for the month ended August 31, 2025:

See Progressive’s complete monthly earnings release for additional information.

About Progressive

Progressive Insurance ^® makes it easy to understand, buy and use car insurance , home insurance , and other protection needs. Progressive offers choices so consumers can reach us however it’s most convenient for them — online at progressive.com , by phone at 1-800-PROGRESSIVE, via the Progressive mobile app, or in-person with a local agent.

Progressive provides insurance for personal and commercial autos and trucks, motorcycles, boats, recreational vehicles, and homes; it is the second largest personal auto insurer in the country, a leading seller of commercial auto, motorcycle , and boat insurance, and one of the top 15 homeowners insurance carriers.

Founded in 1937, Progressive continues its long history of offering shopping tools and services that save customers time and money, like Name Your Price ^® , Snapshot ^® , and HomeQuote Explorer ^® .

The Common Shares of The Progressive Corporation, the Mayfield Village, Ohio-based holding company, trade publicly at NYSE: PGR.

Company Contact:
Douglas S. Constantine
(440) 395-3707
[email protected]

The Progressive Corporation
300 North Commons Blvd.
Mayfield Village, Ohio 44143
http://www.progressive.com

Download PDF: Progressive August 2025 Complete Earnings Release

HONESDALE, Pa., Sept. 17, 2025 (GLOBE NEWSWIRE) -- James O. Donnelly, President and Chief Executive Officer of Norwood Financial Corp (NASDAQ Global Market - NWFL) and its subsidiary Wayne Bank, announced that the Board of Directors has declared a $0.31 per share cash dividend, which is payable on November 3, 2025, to stockholders of record as of October 15, 2025. The $0.31 per share is a $0.01 increase over the per share dividend declared in the third quarter of 2024.

Mr. Donnelly commented, “The Board is extremely pleased to provide our shareholders with this quarterly dividend. It reflects the Company’s financial strength and strong capital position which has contributed to our solid performance.”
Norwood Financial Corp, through its subsidiary, Wayne Bank operates fifteen offices in Northeastern Pennsylvania and fourteen offices in Delaware, Sullivan, Ontario, Otsego and Yates Counties, New York. As of June 30, 2025, Norwood had total assets of $2.365 billion, loans outstanding of $1.791 billion, total deposits of $1.998 billion and total capital of $225 million. The Company’s stock is traded on the Nasdaq Global Market under the symbol “NWFL”.

Forward-Looking Statements
Statements contained in this news release that are not historical facts are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from those currently anticipated due to a number of factors, which include, but are not limited to, factors discussed in documents filed by the Company with the Securities and Exchange Commission from time to time. The Company does not undertake and specifically disclaims any obligation to update any forward-looking statement, whether written or oral, that may be made from time to time by or on behalf of the Company.

HONESDALE, Pa., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Lewis J. Critelli has announced his retirement from the Board of Directors of Norwood Financial Corp (the “Company”) (Nasdaq Global Market-NWFL) and its subsidiary, Wayne Bank, effective September 16, 2025. The Board of Directors also announced the appointment of Dr. Andrew A. Forte, current Vice Chairman of the Board, to Chairman of the Board, as well as director, Kevin Lamont, to Vice Chairman of the Board.

Mr. Critelli stated, “It's truly been my privilege and honor to serve the shareholders, customers, employees and communities of Norwood and Wayne Bank. We have achieved much together and created a strong bank with deep roots in our communities. I have every confidence that Norwood will continue to grow and prosper under the outstanding leadership of Jim Donnelly with the support of Andy Forte and the entire Board. The Company is indeed positioned to have great success in the future.”

“I am very grateful for Lew’s leadership for the Bank and mentorship to me during his time here,” said Jim Donnelly, President and CEO of Wayne Bank and Norwood Financial Corp. “Under his leadership, we have achieved growth and become a stronger organization. He will be missed even while his legacy will be felt for many years to come. “As we transition Board leadership, I am pleased to have Andrew step into the Chairman role to continue the momentum we are building through the rest of 2025 and beyond.”

“On behalf of the entire Board of Directors, I wish to thank Lew for his many years of leadership. We wish him all the best in retirement,” “The Board has named Lew Chairman Emeritus to honor his service to Norwood Financial and Wayne Bank.” said Dr. Forte. “As we move ahead, I and the rest of the Board look forward to working with Jim and the leadership team to achieve our objectives and become a stronger bank committed to serving our customers and communities.”

Lewis J. Critelli was appointed as Chairman of the Board of Directors on April 26, 2022. Mr. Critelli retired as President and Chief Executive Officer of the Company and the Bank on May 9, 2022, after a long and distinguished banking career of over forty years. He joined the Bank in 1995 as Chief Financial Officer and had served as President and CEO for the Bank since 2010. Under his leadership, the Company had three successful acquisitions and expanded into new markets in Pennsylvania and Upstate New York.

Dr. Andrew A. Forte is the President of Forte, Inc., a family-owned corporation which operates the Stroudsmoor Country Inn, a hospitality and banquet facility in Stroudsburg, Pennsylvania. He has a Doctoral Degree in management from the Lubin School of Business, Pace University. He is a Certified Public Accountant, who practiced public accountancy with KPMG as an Audit Manager through June 1985. His financial and accounting background brings valuable expertise to the Board and his participation in our local community for over 40 years brings knowledge of the local economy and business opportunities for the Bank.

Kevin M. Lamont was appointed to the Board of Directors upon the completion of the Company’s acquisition of North Penn Bancorp, Inc. on May 31, 2011. Prior to the merger, he served as the Chairman of the Board of North Penn Bancorp, Inc. and North Penn Bank. He is also President of Lamont Development Company, Inc. Mr. Lamont developed, owned and operated two major assisted living communities in Northeast Pennsylvania. Mr. Lamont has been a licensed Nursing Home Administrator in Pennsylvania since 1980 and has extensive experience in all aspects of business management and finance. His participation in our local community for over 44 years brings knowledge of the local economy and business opportunities for the Bank.

The Board also announced the appointment of both Marissa Nacinovich, D.M.D. and James Shook to the Board of Directors.

A dedicated dentist and lifelong advocate for community service, Dr. Nacinovich has been serving patients in Wayne County for nearly two decades. After earning her Doctorate of Dental Medicine from Temple University, where she was inducted into Omicron Kappa Upsilon and the Stomatognathic Honor Society, she joined Zefran Dental Group in 2007 and became a full partner in 2009. In addition to her thriving dental career, she has devoted her time to numerous local organizations, including the Wayne County Children’s Christmas Bureau, the Wayne Highland School District, and youth sports programs.

Dr. Nacinovich has also been recognized as a speaker at community and academic events, most recently serving as the commencement speaker at Forest City Regional High School in 2022. Beyond her professional and volunteer work, she is passionate about music, athletics, and the outdoors—performing with the Wayne Choralaires and Gram Baxtr, golfing, skiing, and camping with her family. A proud resident of Honesdale since 2007, she continues to balance her professional excellence with her commitment to family and community.

James Shook is a lifelong Hawley resident, community leader, and accomplished entrepreneur with over 30 years of business and public service experience. As President and Owner of Lake Region Supermarket for 25 years, he grew the business into a multi-million-dollar operation employing more than 80 people and earned recognition as both International (2006) and United States (2019) Retailer of the Year from the Independent Grocer’s Alliance. In 2023, Mr. Shook was elected Wayne County Commissioner, where he serves as Chair of the Wayne County Prison Board and Board Member of the Wayne Pike Workforce Alliance, while also consulting for Bozzuto’s Incorporated.

Beyond business and government, Mr. Shook has been honored with the Salvation Army’s Doing Good Award (2016), the Atlas Award for Citizenship (2023), and even a local proclamation of James Shook Day in Hawley (2017). He is the founder of the Lake Region Community Dock Foundation, a nonprofit that supports local emergency services, students, and families in need, and has held leadership roles with the Lake Wallenpaupack Watershed Management District, the Chamber of the Northern Poconos, and the Wayne County Workforce Investment Board. Deeply rooted in family and community, Mr. Shook continues to blend entrepreneurial vision, civic service, and philanthropy to strengthen Wayne County and the greater region.

“I am honored to welcome James and Marissa to the Board.” said Jim Donnelly, President and CEO of Wayne Bank and Norwood Financial Corp. “Each brings a wealth of professional expertise, a proven commitment to service, and a deep connection to our community. Their leadership and passion for making a difference will strengthen our mission and help us continue building a brighter future for Wayne County."

About Norwood Financial

Norwood Financial Corp is the parent company of Wayne Bank, which operates from sixteen offices throughout Northeastern Pennsylvania and fourteen offices in Delaware, Sullivan, Ontario, Otsego and Yates Counties, New York. The Company’s stock trades on the Nasdaq Global Market under the symbol “NWFL”.

Forward-Looking Statements

The Private Securities Litigation Reform Act of 1995 contains safe harbor provisions regarding forward-looking statements. When used in this discussion, the words “believes”, “anticipates”, “contemplates”, “expects”, “bode”, “future performance” and similar expressions are intended to identify forward-looking statements. Such statements are subject to certain risks and uncertainties, which could cause actual results to differ materially from those projected. Those risks and uncertainties include, among other things, changes in federal and state laws, changes in interest rates, our ability to maintain strong credit quality metrics, our ability to have future performance, our ability to control core operating expenses and costs, demand for real estate, government fiscal and trade policies, cybersecurity and general economic conditions. The Company undertakes no obligation to publicly release the results of any revisions to those forward-looking statements which may be made to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.

SAN DIEGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Kratos Defense & Security Solutions, Inc. (Nasdaq: KTOS), a Technology Company in the Defense, National Security and Global Markets and the National Chung-Shan Institute of Science and Technology (NCSIST) have partnered to introduce the Mighty Hornet IV Attack UAV, a revolutionary transformation of the MQM-178 target drone. This advanced UAV will be showcased at the upcoming Taipei Aerospace & Defense Technology Exhibition (TADTE), held September 18-20 at the Taipei Nangang Exhibition Center.

NCSIST's collaboration with Kratos, which includes an agreement for Kratos to market the Mighty Hornet IV internationally, highlights the UAV's potential to meet global defense needs. The modified MQM-178's high-speed capabilities, including a speed of Mach 0.8, high G maneuvering, and a service ceiling of greater than 35,000 feet, make it an ideal base platform for this transformation.

Kratos Tactical Firejet

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/3bc0c308-8b97-4b71-9adf-cafc6d62d03d

Steve Fendley, President of Kratos Unmanned Systems Division , said, "The Mighty Hornet IV marks a significant leap in military capability for Taiwan and a natural extension of the aerial target support Kratos has provided Taiwan for the last 15 years. This groundbreaking collaboration truly highlights Kratos' commitment to innovation and excellence in the defense sector."

The Mighty Hornet IV not only embodies cutting-edge technology but also benefits from proven performance in collaborative exercises. Recent demonstrations showcased the MQM-178's reliability and adaptability, reinforcing its role in Manned-Unmanned Teaming (MUM-T) and loitering munition scenarios and validating its impressive flight characteristics.

Don't miss the chance to witness the unveiling of the Mighty Hornet IV at TADTE 2025. This event will spotlight Taiwan's commitment to innovation and resilience in defense, underscoring Kratos's integral role in shaping the future of military technology.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (NASDAQ: KTOS) is a technology, products, system and software company addressing the defense, national security, and commercial markets. Kratos makes true internally funded research, development, capital and other investments, to rapidly develop, produce and field solutions that address our customers’ mission critical needs and requirements. At Kratos, affordability is a technology, and we seek to utilize proven, leading-edge approaches and technology, not unproven bleeding edge approaches or technology, with Kratos’ approach designed to reduce cost, schedule and risk, enabling us to be first to market with cost effective solutions. We believe that Kratos is known as an innovative disruptive change agent in the industry, a company that is an expert in designing products and systems up front for successful rapid, large quantity, low-cost future manufacturing which is a value add competitive differentiator for our large traditional prime system integrator partners and also to our government and commercial customers. Kratos intends to pursue program and contract opportunities as the prime or lead contractor when we believe that our probability of win (PWin) is high and any investment required by Kratos is within our capital resource comfort level. We intend to partner and team with a large, traditional system integrator when our assessment of PWin is greater or required investment is beyond Kratos’ comfort level. Kratos’ primary business areas include virtualized ground systems for satellites and space vehicles including software for command & control (C2) and telemetry, tracking and control (TT&C), jet powered unmanned aerial drone systems, hypersonic vehicles and rocket systems, propulsion systems for drones, missiles, loitering munitions, supersonic systems, space craft and launch systems, C5ISR and microwave electronic products for missile, radar, missile defense, space, satellite, counter UAS, directed energy, communication and other systems, and virtual & augmented reality training systems for the warfighter.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements relate to a variety of matters including, without limitation, Kratos’ expectations regarding the use of the proceeds from the public offering, the pipeline for opportunities, and Kratos’ success with respect to such opportunities, as well as other statements that are not purely statements of historical fact. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements including, but not limited to: risks and uncertainties related to market conditions as well as general economic factors. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 29, 2024 and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

Press Contact:
Claire Cantrell
[email protected]

Investor Information:
877-934-4687
[email protected]

LOS ANGELES, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Preferred Bank (NASDAQ: PFBC) , one of the largest independent commercial banks in California, today reported that the Board of Directors has declared a quarterly cash dividend of $0.75 per share, which will be paid on October 21, 2025 to holders of record as of October 7, 2025.

About Preferred Bank

Preferred Bank is one of the larger independent commercial banks headquartered in California. The Bank is chartered by the State of California, and its deposits are insured by the Federal Deposit Insurance Corporation, or FDIC, to the maximum extent permitted by law. The Bank conducts its banking business from its main office in Los Angeles, California, and through twelve full-service branch banking offices in the California cities of Alhambra, Century City, City of Industry, Torrance, Arcadia, Irvine (2 branches), Diamond Bar, Pico Rivera, Tarzana and San Francisco (2 branches) and two branches in New York (Flushing and Manhattan) and one branch in the Houston suburb of Sugar Land, Texas. Additionally, the Bank operates a Loan Production Office in Sunnyvale, California. Preferred Bank offers a broad range of deposit and loan products and services to both commercial and consumer customers. The Bank provides personalized deposit services as well as real estate finance, commercial loans and trade finance to small and mid-sized businesses, entrepreneurs, real estate developers, professionals and high net worth individuals. Although originally founded as a Chinese-American Bank, Preferred Bank now derives most of its customers from the diversified mainstream market but does continue to benefit from the significant migration to California of ethnic Chinese from China and other areas of East Asia.

• ELI-002 induced mKRAS-specific T cell responses in 99% of evaluable patients (89 of 90) who were treated with the investigational vaccine immunotherapy
• Robust mKRAS-specific T cell responses were observed with an average of 145.3x increase over baseline (median 44.3x; range 2.13-1310x), consistent with prior ELI-002 Phase 1 trial results
  
• T cell responses included both mKRAS-specific CD4 and CD8 T cells in 85% of patients
  

BOSTON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Elicio Therapeutics, Inc. (Nasdaq: ELTX, “Elicio” or the “Company”), a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer, today announced immunogenicity testing data showing that approximately 99% of evaluable patients (89 of 90) enrolled in its ongoing Phase 2 AMPLIFY-7P trial who were administered ELI-002 7P generated strong mKRAS-specific T cell responses, with an average increase of 145.3x over baseline responses, consistent with observations from prior Phase 1 trials of ELI-002.

Robert Connelly, Chief Executive Officer of Elicio, commented, “We are extremely encouraged by the T cell immunogenicity data from the ongoing Phase 2 ELI-002 7P trial. The robust T cell responses observed are highly consistent with our positive Phase 1 results and further enhance our confidence in the ongoing Phase 2 trial, as T cell immune responses in ELI-002 2P and ELI-002 7P Phase 1 trials were significantly correlated with clinical activity in minimal residual disease positive (“MRD+”) patients. These important data set the stage for the final disease-free survival analysis in the AMPLIFY-7P trial, which is anticipated to occur in the fourth quarter of 2025.”

Phase 2 AMPLIFY-7P Immunogenicity Data

^a Responses shown are best overall responses vs baseline for assessable patients at any timepoint during the assessment period, measured among T cell Responders; TBD = To be Determined; MRD = Minimal Residual Disease
^b Measured among evaluable patients with samples assessable by Ex Vivo Intracellular Cytokine Staining assay
^c McNeil L.K., et al. 1473 AMPLIFY-7P phase 1a: lymph node-targeted amphiphile therapeutic cancer vaccine in patients with high relapse risk KRAS mutated pancreatic ductal adenocarcinoma and colorectal cancer. Journal for ImmunoTherapy of Cancer. 2024;12. https://doi.org/10.1136/jitc-2024-SITC2024.1473
^d Overall Antigen Response Rate calculated as the percentage of positive mKRAS-specific T cell responses among all evaluated patients against all vaccine antigens
ELI-002 2P: Data cutoff 24-Sept-24; ELI-002 7P Phase 1: Data cutoff 24-Sept-24; ELI-002 7P Phase 2: 22-Aug-25

Building on the ELI-002 2P (AMPLIFY-201) and ELI-002 7P (AMPLIFY-7P) Phase 1 trials, which enrolled only MRD+ patients, the Phase 2 AMPLIFY-7P trial also includes MRD-negative (“MRD–”) patients. If Phase 2 results are supportive, expanding to a broader population could enable more PDAC patients to benefit from the vaccine, and also enhance the commercial opportunity for Elicio.

The Company recently published updated Phase 1 ELI-002 2P (AMPLIFY-201) data in Nature Medicine . The results showed that an mKRAS-specific T cell response of approximately 9x over baseline was correlated with clinical activity, including delayed relapse or death in MRD+ patients (i.e., patients who are ctDNA positive or have increased serum tumor biomarkers, such as CA19-9, following completion of locoregional therapy). Responses, including both CD4 and CD8 T cell subsets, showed further correlation with clinical activity.

An Independent Data Monitoring Committee (“IDMC”), following its pre-specified interim review of the unblinded safety and efficacy data in the Company’s Phase 2 AMPLIFY-7P trial, recently recommended that the trial continue to the final analysis without modifications, which Elicio believes is an indication that ELI-002 7P has shown preliminary signals of efficacy.

The Company remains blinded to the Phase 2 trial clinical efficacy outcomes and to any correlation between observed T cell responses and antitumor response in patients.

About ELI-002

Elicio’s lead product candidate, ELI-002, is a structurally novel investigational Amphiphile (“AMP”) cancer vaccine that targets cancers that are driven by mutations in the KRAS-gene—a prevalent driver of many human cancers. ELI-002 is comprised of two powerful components that are built with Elicio’s AMP technology consisting of AMP-modified mutant KRAS peptide antigens and ELI-004, an AMP-modified CpG oligodeoxynucleotide adjuvant that is available as an off-the-shelf subcutaneous administration.

ELI-002 2P (2-peptide formulation) has been studied in the Phase 1 (AMPLIFY-201) trial in patients with high relapse risk mKRAS-driven solid tumors, following surgery and chemotherapy (NCT04853017). ELI-002 7P (7-peptide formulation) is currently being studied in a Phase 1/2 (AMPLIFY-7P) trial in patients with mKRAS-driven pancreatic cancer (NCT05726864). The ELI-002 7P formulation is designed to provide immune response coverage against seven of the most common KRAS mutations present in 25% of all solid tumors, thereby increasing the potential patient population for ELI-002.

About the Amphiphile Platform

Elicio’s proprietary AMP platform delivers investigational immunotherapeutics directly to the “brain center” of the immune system – the lymph nodes. Elicio believes this site-specific delivery of disease-specific antigens, adjuvants and other immunomodulators may efficiently educate, activate and amplify critical immune cells, potentially resulting in induction and persistence of potent adaptive immunity required to treat many diseases. In preclinical models, Elicio observed lymph node-specific engagement driving therapeutic immune responses of increased magnitude, function and durability. Elicio believes its AMP lymph node-targeted approach will produce superior clinical benefits compared to immunotherapies that do not engage the lymph nodes based on preclinical studies.

Elicio’s AMP platform, originally developed at the Massachusetts Institute of Technology, has broad potential in the cancer space to advance a number of development initiatives through internal activities, in-licensing arrangements or development collaborations and partnerships.

The AMP platform has been shown to deliver immunotherapeutics directly to the lymph nodes by latching on to the protein albumin, found in the local injection site, as it travels to lymphatic tissue.

Elicio Therapeutics, Inc. (Nasdaq: ELTX) is a clinical-stage biotechnology company advancing novel immunotherapies for the treatment of high-prevalence cancers, including mKRAS-positive pancreatic and colorectal cancers. Elicio intends to build on recent clinical successes in the personalized cancer vaccine space to develop effective, off-the-shelf vaccines. Elicio’s AMP technology aims to enhance the education, activation and amplification of cancer-specific T cells relative to conventional vaccination strategies, with the goal of promoting durable cancer immunosurveillance in patients. Elicio’s ELI-002 lead program is an off-the-shelf vaccine candidate targeting the most common KRAS mutations, which drive approximately 25% of all solid tumors. Off-the-shelf vaccine approaches have the potential benefits of low cost, rapid commercial scale manufacturing, and rapid availability of drug to patients especially in neo-adjuvant settings and for prophylaxis in high-risk patients, contrary to personalized vaccines approaches. ELI-002 is being studied in an ongoing, randomized clinical trial in patients with mKRAS-positive pancreatic cancer who completed standard therapy but remain at high risk of relapse. ELI-002 also has been studied in patients with mKRAS-positive colorectal cancer (“CRC”) in Phase 1 trials. The updated AMPLIFY-201 Phase 1 data for PDAC and CRC was presented at the ESMO Immuno-Oncology Congress 2024 and included a 16.3-month median recurrence-free survival and 28.9-month median overall survival for the full study population. In the future, Elicio plans to expand ELI-002 to other indications including mKRAS positive lung cancer and other mKRAS positive cancers. Elicio’s pipeline includes additional off-the-shelf therapeutic cancer vaccines candidates, including ELI-007 and ELI-008, that target BRAF-driven cancers and p53 hotspot mutations, respectively. For more information, please visit www.elicio.com.

Cautionary Note on Forward-Looking Statements

Certain statements contained in this communication regarding matters that are not historical facts, are forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, known as the PSLRA. These include statements regarding Elicio’s planned clinical programs, including the timing and outcome of planned clinical trials; the timing of the expected final disease-free survival analysis of the Phase 2 AMPLIFY-7P clinical trial; the potential of Elicio’s product candidates and the anticipated benefits and goals of Elicio’s AMP platform, approaches and technology, including the significant correlation of T-cell immune responses with ELI-002 2P and ELI-002 7P in Elicio’s Phase 1 trials with clinical activity in MRD+ patients; the potential for any correlation between the immunogenicity data from the Phase 2 AMPLIFY-7P trial and clinical efficacy outcomes; Elicio’s belief that the IDMC’s recommendation that the Phase 2 AMPLIFY-7P trial continue to the final analysis without modifications indicates that ELI-002 7P has shown preliminary signals of efficacy; the potential to expand to a broader population with supportive Phase 2 results, to enable more PDAC patients to benefit from the vaccine and to expand Elicio’s commercial opportunity; the potential for future expansion of ELI-002 to other indications, including mKRAS positive lung cancer and other mKRAS positive cancers; Elicio’s plans to develop and commercialize its product candidates, including ELI-002; the timing of initiation of Elicio’s planned clinical trials; the timing of the availability of data from Elicio’s clinical trials, including the final disease-free survival analysis from the Phase 2 AMPLIFY-7P trial anticipated in the fourth quarter of 2025; the timing of any planned investigational new drug application or new drug application; Elicio’s plans to research, develop and commercialize its current and future product candidates; Elicio’s estimates regarding future revenue, expenses, capital requirements and need for additional financing; the potential benefits and effectiveness of off-the-shelf vaccine approaches; and other statements regarding management’s intentions, plans, beliefs, expectations or forecasts for the future and, therefore, you are cautioned not to place undue reliance on them. No forward-looking statement can be guaranteed, and actual results may differ materially from those projected. Elicio uses words such as “anticipates,” “believes,” “plans,” “expects,” “projects,” “future,” “intends,” “may,” “will,” “should,” “could,” “estimates,” “predicts,” “potential,” “continue,” “guidance,” and similar expressions to identify these forward-looking statements that are intended to be covered by the safe-harbor provisions of the PSLRA. Such forward-looking statements are based on Elicio’s expectations and involve risks and uncertainties; consequently, actual results may differ materially from those expressed or implied in the statements due to a number of factors.

New factors emerge from time to time, and it is not possible for Elicio to predict all such factors, nor can Elicio assess the impact of each such factor on the business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. These risks are more fully discussed under the heading “Risk Factors” in Elicio’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 31, 2025, Elicio’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2025, filed with the SEC on May 13, 2025, and Elicio’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the SEC on August 7, 2025, as updated by subsequent reports and other documents filed from time to time with the SEC. Forward-looking statements included in this release are based on information available to Elicio as of the date of this release. Elicio does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this release, except to the extent required by law.

Investor Relations Contact
Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

TARPON SPRINGS, Fla., September 17, 2025 – Allarity Therapeutics, Inc. (“Allarity” or the “Company”) (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated, dual PARP and WNT pathway inhibitor—today announced that its CEO, Thomas Jensen, has been invited to present at the upcoming Biomarkers & Precision Medicine 2025 conference in London, organized by Oxford Global.

In addition to his presentation, Mr. Jensen will be interviewed by Oxford Global’s editorial team to provide further insights into Allarity’s research and its innovative DRP ^® companion diagnostic platform. The interview will be featured on Oxford Global’s online content portal.

Presentation Details:

• Event: Biomarkers & Precision Medicine 2025
• Presentation Title: A Gene Expression Based Biomarker For Predicting Response To Treatment With Stenoparib
• Date: Wednesday, October 1, 2025
• Time: 4:00 PM

Mr. Jensen will be available for individual meetings during the conference to explore business development prospects. Attendees are encouraged to book one-on-one sessions in advance.

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the WNT signaling pathway. Aberrant WNT/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking WNT pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP ^® Companion Diagnostic
Allarity uses its drug-specific DRP ^® to select those patients who, by the gene expression signature of their cancer, may have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be enhanced. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP ^® platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients across dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for dozens of anti-cancer drugs, has been extensively published in the peer-reviewed literature.

About Allarity Therapeutics
Allarity Therapeutics, Inc. (NASDAQ: ALLR) is a clinical-stage biopharmaceutical company dedicated to developing personalized cancer treatments. The Company is focused on development of stenoparib, a novel PARP/tankyrase inhibitor for advanced ovarian cancer patients, using its DRP ^® technology to develop a companion diagnostic that can be used to select those patients expected to derive the greatest clinical benefit from stenoparib. Allarity is headquartered in the U.S., with a research facility in Denmark, and is committed to addressing significant unmet medical needs in cancer treatment. For more information, visit www.allarity.com .

Follow Allarity on Social Media
LinkedIn: https://www.linkedin.com/company/allaritytx/

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements provide the Company’s current expectations or forecasts of future events. The words “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements regarding Mr. Jensen's planned participation and presentation at the Biomarkers & Precision Medicine 2025 conference, the potential utility and benefits of the Company's DRP® companion diagnostic platform to pre-select patients and predict response to stenoparib, and the Company’s ability to advance its clinical programs and engage in business development opportunities. Any forward-looking statements in this press release are based on management’s current expectations of future events and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, risks related to the success, timing, and results of clinical trials, the ability to obtain regulatory approval for stenoparib and other product candidates, the Company's ability to commercialize its products, secure sufficient capital to fund its operations, protect its intellectual property, and navigate the competitive landscape in the biopharmaceutical industry. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our Form 10-K annual report filed with the Securities and Exchange Commission (the “SEC”) on March 31, 2025, available at the SEC’s website at www.sec.gov, and as well as discussions of potential risks, uncertainties and other important factors in the Company’s subsequent filings with the SEC. All information in this press release is as of the date of the release, and the Company undertakes no duty to update this information unless required by law.

###

Company Contact:
[email protected]

Media Contact:
Thomas Pedersen
Carrotize PR & Communications
+45 6062 9390
[email protected]

Attachment

• Allarity Therapeutics Press Release - Allarity Therapeutics CEO to Present at Biomarkers & Precision Medicine 2025

KIRKLAND, Wash., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Kestra Medical Technologies, Ltd. (Nasdaq: KMTS), a wearable medical device and digital healthcare company, today announced the appointment of Elizabeth Kwo, M.D. as an independent director to its board following her election at the company’s annual general meeting of shareholders held earlier this month.

“I am pleased to welcome Dr. Kwo to the Kestra board of directors,” said Brian Webster, President and CEO of Kestra Medical Technologies. “As a physician, healthcare executive, and entrepreneur, she brings extensive experience building and scaling digital health platforms and advancing data-driven care models to improve patient outcomes. Her expertise and perspective will be invaluable as we accelerate adoption of our lifesaving Cardiac Recovery System platform.”

Dr. Kwo currently serves as Chief Commercial Officer of Everly Health, Inc, a diagnostics-driven digital healthcare company. She previously served as Deputy Chief Clinical Officer for Anthem, VP and GM of Provider Networks at American Well, and Entrepreneur in Residence at Harvard Medical School's Office of Technology Development. She has also founded multiple venture-backed companies, including the educational platform New Pathway and digital healthcare company InfiniteMD. Dr. Kwo is board certified in preventive care and occupational medicine and remains active as a practicing physician. She earned her M.D. from Harvard Medical School, an M.P.H. from the Harvard T.H. Chan School of Public Health, an M.B.A. from Harvard Business School, and a B.A. from Stanford University.

“I’m honored to join Kestra’s board of directors at such a pivotal time,” said Dr. Kwo. “Kestra’s commitment to protecting patients through innovation in cardiac recovery deeply resonates with me. I look forward to contributing my experience in digital health and care-model innovation to help advance the company’s mission and expand its impact for patients and providers.”

About Kestra
Kestra Medical Technologies, Ltd. is a commercial-stage wearable medical device and digital healthcare company focused on transforming patient outcomes in cardiovascular disease using monitoring and therapeutic intervention technologies that are intuitive, intelligent, and connected. For more information, visit www.kestramedical.com .

MIAMI, Sept. 17, 2025 (GLOBE NEWSWIRE) -- InspireMD, Inc. (Nasdaq: NSPR) (“InspireMD” or the “Company”), developer of the CGuard® Prime carotid stent system for the prevention of stroke, today announced the appointment of Dan Dearen to its Board of Directors. Mr. Dearen brings nearly 40 years of leadership experience in the medical device and life sciences sectors, with a proven track record of guiding MedTech companies through critical financial milestones and delivering shareholder value through execution.

“We are pleased to welcome Dan to InspireMD’s Board of Directors,” said Marvin Slosman, Chief Executive Officer of InspireMD. “He brings extensive experience, financial expertise, and strategic insight to InspireMD as we advance on our mission to lead the carotid intervention market and execute our long-term value-creation strategy. His arrival is perfectly timed as we continue our U.S. commercial launch of CGuard Prime and advance our position in the market.”

“I look forward to working with Dan and the entire InspireMD Board as we continue to build our business and advance our growth,” said Paul Stuka, Chairman of the InspireMD Board of Directors. “Dan’s track record of execution and leadership experience make him an ideal addition to our Board, and we look forward to his contributions.”

“I am honored to join the Board of InspireMD at this pivotal time for the company. With FDA approval for the CGuard Prime stent system in hand, InspireMD has the potential to change the standard of care in vascular medicine and greatly improve the lives of patients,” said Mr. Dearen. “This is a remarkable time for the company, and I look forward to supporting the team through this vast opportunity for growth.”

Mr. Dearen previously served as President, co-Founder, and Chief Financial Officer of Axonics, Inc., During his tenure, Axonics went public and became one of the fastest-growing companies in the medical device sector, helping over 300,000 patients find relief from bladder and bowel dysfunction. Axonics, Inc. was acquired by Boston Scientific in November 2024 for $3.7 billion.

Until July 2024, Mr. Dearen also served as Chair of the Audit Committee and a Board member at Endotronix, a medical device company leveraging pulmonary artery (PA) pressure and vital sign data to improve care for patients with heart failure. He currently holds the same roles at JenaValve Technology, a developer of innovative transcatheter heart valve (THV) solutions, and BetaBionics (NASDAQ: BBNX), the creator of the iLet Bionic Pancreas, an autonomous insulin delivery system that determines every insulin dose for patients with diabetes. Prior to co-founding Axonics, Mr. Dearen held the role of Chief Operating and Financial Officer at Vessix Vascular, a medical device company focused on hypertension therapies, which Boston Scientific acquired in 2012 for $425 million.

Mr. Dearen’s appointment to the Board of Directors follows the appointment of Mr. Ray Cohen, announced in July 2025.

About InspireMD, Inc.
InspireMD seeks to utilize its proprietary MicroNet ™ mesh technology to make its products the industry standard for carotid stenting by providing outstanding acute results and durable, stroke-free long-term outcomes. InspireMD’s common stock is quoted on Nasdaq under the ticker symbol NSPR. We routinely post information that may be important to investors on our website. For more information, please visit www.inspiremd.com .

Forward Looking Statements
This press release contains “forward-looking statements.” Forward-looking statements include, but are not limited to, statements regarding InspireMD or its management team’s expectations, hopes, beliefs, intentions or strategies regarding future events, future financial performance, strategies, expectations, competitive environment and regulation, including expectations regarding U.S. commercial launch and expansion. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential”, “scheduled” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the company’s control, and cannot be predicted or quantified and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, risks and uncertainties associated with our history of recurring losses and negative cash flows from operating activities; substantial doubt about our ability to continue as a going concern; significant future commitments and the uncertainty regarding the adequacy of our liquidity to pursue our complete business objectives; our need to raise additional capital to meet our business requirements in the future and such capital raising may be costly or difficult to obtain and could dilute out stockholders’ ownership interests; market acceptance of our products; an inability to secure and maintain regulatory approvals for the sale of our products; negative clinical trial results or lengthy product delays in key markets; our ability to maintain compliance with the Nasdaq listing standards; our ability to generate revenues from our products and obtain and maintain regulatory approvals for our products; our ability to adequately protect our intellectual property; our dependence on a single manufacturing facility and our ability to comply with stringent manufacturing quality standards and to increase production as necessary; the risk that the data collected from our current and planned clinical trials may not be sufficient to demonstrate that our technology is an attractive alternative to other procedures and products; intense competition in our industry, with competitors having substantially greater financial, technological, research and development, regulatory and clinical, manufacturing, marketing and sales, distribution and personnel resources than we do; entry of new competitors and products and potential technological obsolescence of our products; inability to carry out research, development and commercialization plans; loss of a key customer or supplier; technical problems with our research and products and potential product liability claims; product malfunctions; price increases for supplies and components; insufficient or inadequate reimbursement by governmental and other third-party payers for our products; our efforts to successfully obtain and maintain intellectual property protection covering our products, which may not be successful; adverse federal, state and local government regulation, in the United States, Europe or Israel and other foreign jurisdictions; the fact that we conduct business in multiple foreign jurisdictions, exposing us to foreign currency exchange rate fluctuations, logistical and communications challenges, burdens and costs of compliance with foreign laws and political and economic instability in each jurisdiction; the escalation of hostilities in Israel, which could impair our ability to manufacture our products; and current or future unfavorable economic and market conditions and adverse developments with respect to financial institutions and associated liquidity risk. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise .

Investor Contacts:
Webb Campbell
Gilmartin Group LLC
[email protected]
[email protected]

Highlights

• Mr Donald Trump Jr. (through his associated entity) holds 1,500,000 securities in MMA.INC
• Mr. Donald Trump Jr. serves alongside Conor McGregor, MMA.INC’s most prominent investor, as Strategic Advisor to MMA.INC for a 2 year term
• Mr Donald Trump Jr. brings invaluable technology and media expertise as Director of Trump Media and Technology Group and as Co-Founder of World Liberty Financial
  

New York, NY, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Mixed Martial Arts Group Limited (NYSE American: MMA) (“MMA” or the “Company” and doing business as MMA.INC).

As announced on September 9, 2025, MMA.INC has appointed Donald Trump Jr. as a Strategic Advisor. In this role, Mr. Trump Jr. will provide advice to the board and management, leveraging his expertise and experience in technology, media, and brand building to expand MMA.INC’s global recognition and to accelerate commercialization of its combat sports technology platforms.

Mr Donald Trump Jr has commenced his role and joins Conor McGregor, MMA.INC’s most prominent investor, as a Strategic Advisor, strengthening the Company’s leadership as it continues to grow following partnerships such as its collaboration with UFC Gym Group.

In connection with the appointment, MMA.INC has entered a 24 month Strategic Advisor Agreement with Mr Donald Trump Jr. and pursuant to which he will provide advisory services. As consideration for the advisory services, MMA.INC issued 1,500,000 securities, each exercisable into one ordinary share to an entity affiliated with Mr Donald Trump Jr. No shares issued upon exercise may be sold, transferred, or otherwise disposed of for a period of 12 months from their date of issuance except with the prior written consent of MMA.INC.

About Mixed Martial Arts Group Limited

Mixed Martial Arts Group Limited (MMA.INC) is revolutionizing the combat sports industry by driving participation and engagement across fans, athletes, coaches, and gym owners. The company operates four core business units:

With over 5 million social media followers, 530,000 user profiles, 50,000 active students, 18,000 published gyms and 800 verified gyms across 16 countries, MMA continues to transform the martial arts landscape and deliver unparalleled value to its stakeholders.

For more information, visit www.mma.inc or follow us on social media:

Forward-Looking Statements

This press release may include forward-looking statements. Any statements contained herein regarding our strategy, future operations, financial position, future revenues, projected costs, prospects, plans and objectives of management, other than statements of historical facts, are forward-looking statements. The forward-looking statements included herein include or may include, but are not limited to, statements that are predictive in nature, depend upon or refer to future events or conditions, or use or contain words, terms, phrases, or expressions such as “achieve,” “forecast,” “plan,” “propose,” “strategy,” “envision,” “hope,” “will,” “continue,” “potential,” “expect,” “believe,” “anticipate,” “project,” “estimate,” “predict,” “intend,” “should,” “could,” “may,” “might,” or similar words, terms, phrases, or expressions or the negative of any of these terms. Any statements contained in this press release that are not based upon historical fact are based on current expectations, estimates, projections, opinions and/or beliefs of the Company. Such statements are not facts and involve known and unknown risks, uncertainties, and other factors. Prospective investors should not rely on these statements as if they were facts. Actual revenue may vary to current sales due to factors such as participant churn, cancellations, and changes in payment schedules, membership terms or pricing changes. Any references to verified gyms, partner gyms, user profiles refer to a database profile that has been claimed or created across the MMA.inc platform, which includes TrainAlta.com, BJJ Link, Hype, MixedMartialArts.com and Steppen. Forward-looking statements involve a number of known and unknown risks and uncertainties, including, but not limited to, those discussed in the “Risk Factors” section of the Form 20-F for the fiscal year ended June 30, 2024 filed with the SEC. Given the risks and uncertainties, readers should not place undue reliance on any forward-looking statement and should recognize that the statements are predictions of future results which may not occur as anticipated. New risk factors emerge from time to time, and it is not possible for management to predict all such risk factors, nor can it assess the impact of all such factors on the Company’s business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. You should carefully read the factors described in the “Risk Factors” section of the Form 20-F for the fiscal year ended June 30, 2024 filed with the SEC to better understand the risks and uncertainties inherent in our business and industry, and any underlying forward-looking statements. Except where required by law, the Company assumes no obligation to update, withdraw or revise any forward-looking statements to reflect actual results or changes in factors or assumptions affecting such forward-looking statements.

Media Contacts

Mixed Martial Arts Group Limited
E: [email protected]

- Efficacy and safety results from successful NAVIGATE Phase 2b trial of CD388 for prevention of influenza illness featured in late-breaking presentation

- Preclinical data demonstrating potential efficacy of CD388 to prevent H5N1 infection featured in oral presentation

SAN DIEGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cidara Therapeutics, Inc. (Nasdaq: CDTX), a biotechnology company using its proprietary Cloudbreak ^® platform to develop drug-Fc conjugate (DFC) therapeutics, today announced two presentations during the International Society for Respiratory Viruses (ISRV) 8 ^th AntiViral Group (AVG) Meeting and 3 ^rd International Meeting on Respiratory Pathogens (IMRP) . The conference is taking place September 17-20, 2025, in Singapore. The presentations highlight efficacy and safety data on CD388, Cidara’s non-vaccine influenza preventative, from the successful Phase 2b NAVIGATE study, as well as preclinical data on the efficacy of CD388 to prevent infection in H5N1 animal models.

“These two oral presentations further highlight the potential of CD388 to provide season long protection against influenza as well as activity against highly pathogenic pandemic strains like H5N1,” said Jeffrey Stein, Ph.D., president and chief executive officer of Cidara. “The Phase 2b presentation represents the first description of CD388 NAVIGATE study data in an academic setting. Importantly, the preclinical results of CD388 in a ferret model suggests that CD388 has the potential to provide prophylactic protection from this potentially deadly viral infection. We look forward to disclosing additional details on the safety, PK and virology data from our Phase 2b NAVIGATE study at upcoming conferences this fall.”

Late-Breaking Abstract Title: NAVIGATE: A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Dose-ranging Trial to Evaluate the Efficacy and Safety of CD388 for Prevention of Influenza Illness in Healthy Adults
Presenter: Rick Bright, Ph.D. Bright Global Health, Cidara Therapeutics
Session: AVG Session 3
Session Date and Time: Wednesday, September 17, 2025, 3:50 p.m. – 4:05 p.m. SGT

Summary: The Phase 2b NAVIGATE study was conducted to evaluate the safety and efficacy of a single subcutaneous dose of CD388 for the prevention of laboratory-confirmed influenza in healthy, unvaccinated adults. Over 5,000 adults aged 18-64 years old without risk factors for complications from influenza were randomized to receive CD388 (150mg, 300mg, or 450mg) or placebo. The primary endpoint was preventative efficacy over 24 weeks against laboratory confirmed influenza. Overall, CD388 demonstrated it was well tolerated with statistically significant, single-dose protection against influenza illness over 24 weeks.

Abstract Title: A Single Prophylactic Dose of CD388 Provides Protection Against Highly Pathogenic Bovine-Origin Influenza A (H5N1) Virus in the Ferret Model
Presenter: Andreev Konstantin, Ph.D. St. Jude Children’s Research Hospital
Session: Parallel Session 2 (Track 1)
Session Date and Time: Friday, September 19, 2025, 10:30 a.m. – 12:30 p.m. SGT

Summary: The prophylactic efficacy of CD388 was evaluated against lethal A (H5N1) infection in ferrets. Ferrets untreated with CD388 displayed pronounced weight loss, neurological symptoms, and survival endpoints at 4-8 days post-inoculation. A single subcutaneous dose of CD388 at 3 mg/kg administered 24 hours before H5N1 virus inoculation protected 75% of ferrets from death. A 10 mg/kg dose of CD388 provided 100% survival in ferrets. CD388-treated animals exhibited reduced weight loss and clinical symptoms versus control. Overall, CD388 substantially reduced viral titers in the upper and lower respiratory tracts of ferrets and prevented viral neuroinvasion and systemic spread to other organs.

The abstracts from Cidara’s two presentations will be available on the Cidara corporate website under “publications” following the meeting.

Cidara will also be hosting a lunch symposium at the conference on Friday, September 19, 2025, from 1:00 – 1:45 p.m. SGT in the Grand Ballroom 1, Level 4, Waterfront Conference Centre. The symposium is titled “CD388: A New Modality for Broad Influenza Protection in Healthy and High-Risk Populations,” and will be co-chaired by Frederick G. Hayden, M.D., FACP and Rick Bright, Ph.D., along with Cidara’s SVP, clinical operations, Corrina Pavetto, and Cidara’s chief scientific officer, Les Tari, Ph.D. as speakers.

About Cidara Therapeutics
Cidara Therapeutics is using its proprietary Cloudbreak ^® platform to develop novel DFCs comprising targeted small molecules or peptides coupled to a proprietary human antibody fragment. Cidara’s lead DFC candidate, CD388, is a long-acting antiviral designed to achieve universal prevention of seasonal and pandemic influenza with a single dose by directly inhibiting viral proliferation. In June 2023, CD388 was granted Fast Track Designation by the FDA. Cidara announced positive top-line results from its Phase 2b NAVIGATE trial in June 2025. Cidara is headquartered in San Diego, California. For more information, please visit www.cidara.com .

Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies and are generally preceded by words such as “anticipates,” “expect,” “intends,” “believes,” “may,” “plan” or “will”. Forward-looking statements in this release include, but are not limited to, statements related to the potential benefits of and future plans for CD388, whether the Phase 2b NAVIGATE Trial results will be predictive of efficacy or safety in a Phase 3 trial, and whether the results of a preclinical trial in a ferret model may predict the activity of CD388 against the H5N1 strain or any strain of pandemic influenza in humans. Such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events, or results to differ materially from those projected in the forward-looking statements, such as unanticipated delays in or negative results from Cidara’s clinical trials and other risks related to clinical development, delays in action by regulatory authorities, other obstacles associated with the enrollment of patients or other aspects of CD388 or other DFC development, having to use cash in ways other than as expected and other risks and uncertainties associated with Cidara’s business in general. These and other risks are identified under the caption “Risk Factors” in Cidara’s Quarterly Report on Form 10-Q for the quarterly period ended June 30, 2025 and other filings subsequently made with the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. Cidara does not undertake any obligation to publicly update any forward-looking statements, whether as a result of the receipt of new information, the occurrence of future events or otherwise.

INVESTOR CONTACT:
Brian Ritchie
LifeSci Advisors
(212) 915-2578
[email protected]

MEDIA CONTACT:
Michael Fitzhugh
LifeSci Communications
(628) 234-3889
[email protected]

SUMMARY AND KEY POINTS:

• Cerence’s Audio AI suite is now integrated into Audio Weaver, created by DSP Concepts.
• Cerence AI’s full Audio AI suite, including Speech Signal Enhancement, Emergency Vehicle Detection (EVD) and In-Car Communication (ICC), is now available through Audio Weaver.
• Several leading automakers are already using the integrated solution to improve the in-cabin experience.
  

BURLINGTON, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Cerence Inc. (NASDAQ: CRNC) (“Cerence AI”), a global leader pioneering conversational AI-powered user experiences, today announced the integration of its industry-leading Audio AI suite into Audio Weaver , created by DSP Concepts , the global leader in embedded audio software. The integration enables customers to seamlessly deploy Cerence AI’s innovative automotive audio solutions within Audio Weaver’s powerful audio development platform.

Audio Weaver is production-proven in millions of consumer and automotive products worldwide and supports deployment from a wide range of vendors including ARM, Cadence, Qualcomm, NXP, and STMicroelectronics. Cerence’s Audio AI solutions now available as ready-to-go modules in Audio Weaver include:

• Speech Signal Enhancement : A suite of hands-free, advanced sound-processing technologies designed to clean up microphone inputs by removing background noise, enabling Cerence AI's high-performing in-car assistants to accurately interpret drivers’ and passengers’ speech.
• Emergency Vehicle Detection : In-car technology that alerts drivers about approaching emergency vehicles. EVD is especially critical as vehicles become increasingly autonomous. It identifies sirens from police cars, firetrucks, and ambulances from up to 800 meters away, pinpointing the direction the emergency vehicle is traveling. EVD can then either advise a driver to step in and manually pull to the side of the road or guide an autonomous vehicle to take action and ensure that the emergency vehicle can safely pass.
• In-Car Communication: Voice processing technology that enhances conversations between passengers in a vehicle by amplifying and clarifying speech. ICC uses microphones and speakers strategically placed throughout the cabin to create a seamless and natural communication experience, even in noisy environments, fostering a comfortable and connected atmosphere inside the car.
  

Several leading automakers have already implemented Audio AI through its integration with Audio Weaver, enhancing the in-car user experience and creating a safe environment for drivers.

“This collaboration brings together two leaders in audio innovation to unlock tremendous value for our customers and their drivers,” said Nils Schanz, Executive Vice President, Product & Technology, Cerence AI. “Automakers can now leverage the combined force of Cerence AI and DSP Concepts’ leading automotive audio technology to deliver an optimized in-car audio experience.”

“The automobile is the most complex audio product on the market, and audio processing is critical to delivering comfort, safety and personalization,” said Steve Ernst, Head of Automotive, DSP Concepts. “Combining our automotive signal processing leadership with Cerence AI’s expertise in conversational and audio AI helps automakers design and deliver the best possible in-cabin audio experience while reducing development cycles and engineering overhead.”

Cerence AI’s integration with DSP Concepts’ Audio Weaver is now available worldwide. For more information about Cerence’s Audio AI suite, visit www.cerence.com/cerence-products/audio-ai .

To learn more about Cerence AI, visit www.cerence.ai , and follow the company on LinkedIn .

About Cerence Inc.
Cerence Inc. (NASDAQ: CRNC) is a global industry leader in creating intuitive, seamless, AI-powered experiences across automotive and transportation. Leveraging decades of innovation and expertise in voice, generative AI, and large language models, Cerence powers integrated experiences that create safer, more connected, and more enjoyable journeys for drivers and passengers alike. With more than 525 million cars shipped with Cerence technology, the company partners with leading automakers, transportation OEMs, and technology companies to advance the next generation of user experiences. Cerence is headquartered in Burlington, Massachusetts, with operations globally and a worldwide team dedicated to pushing the boundaries of AI innovation. For more information, visit www.cerence.ai .

Contact Information

Kate Hickman | Tel: 339-215-4583 | Email: [email protected]

CHICAGO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- With synthetic identities now linked to a record number of newly opened accounts, U.S. lenders faced more than $3.3 billion in exposure for the year ending 2024. This alarming trend underscores the urgent need for financial institutions such as auto lenders, mortgage lenders and credit unions to harness all available data to detect and prevent synthetic identity fraud at the point of account creation. New research from TransUnion (NYSE: TRU) reveals that key traits and behavioral characteristics found in public data can play a critical role in identifying these deceptive identities before they pose a risk.

Synthetic identities are carefully constructed using a blend of authentic and fabricated information—often incorporating stolen Social Security numbers, fictitious names, digital contact details and behavioral patterns that mimic legitimate consumer activity. These identities are engineered to appear credible and frequently bypass traditional identity verification systems, making them particularly difficult to detect using conventional methods.

There is no single blueprint for how criminals perpetrate synthetic identity fraud, which adds to its complexity. Increasingly, organizations face the challenge of distinguishing genuine customers from synthetic ones, especially when these false identities exhibit consistent, low-risk behavior that closely mimics that of real individuals. To stay ahead of evolving threats, organizations must leverage advanced detection tools capable of isolating and analyzing specific traits, behavioral patterns and characteristics that are frequently associated with synthetic identities.

“While the presence of living characteristics such as vehicle ownership, voter registration or familial connections is not a definitive solution to detecting synthetic identities, it represents an important piece of the broader identity puzzle,” said Steve Yin, senior vice president and global head of fraud at TransUnion. “These attributes alone cannot confirm authenticity, but when combined with credit header data, they offer valuable context that contributes to forming a clear picture of identity. By isolating and evaluating these elements, organizations can strengthen their ability to differentiate between real and synthetic identities with greater precision.”

There are a number of living characteristics that, when present, indicate an identity to be significantly more likely to be synthetic. For example, no known relatives and no motor vehicle registrations occur in 30-50% of all synthetic identities and increase the likelihood of being synthetic by up to 7x vs. legitimate identities. Other top characteristics that raise red flags include missing voter and vehicle registrations or having no record of property ownership on file. Notably, every synthetic identity analyzed showed no open bankruptcies, making it a universal trait among them.

TransUnion’s Synthetic Fraud Model is designed to proactively identify a wide range of public data indicators, along with numerous other risk factors, to help uncover synthetic identities before they can cause financial harm. By analyzing these signals early in the customer journey, the model enables organizations to take preventive action with greater confidence and precision.

At the same time, the model enhances operational efficiency by reducing the need for manual reviews and minimizing customer friction. This allows lenders to streamline their processes while improving fraud detection rates—catching more fraudulent activity with greater accuracy and speed, and ultimately protecting both their customers and their bottom line.

Yin added, “Just as fraudsters relentlessly exploit every tactic available to pursue their deceptive financial objectives, lenders must be equally vigilant and proactive in their defense. Solutions like TransUnion’s Synthetic Fraud Model empower lenders to detect risk at every stage of the customer lifecycle—starting with account creation—by identifying the absence of real-life attributes, helping to prevent fraud and minimize financial losses.”

To learn more about strategies to protect from digital risk with a clear picture of identity, click here . To learn more about how TransUnion’s TruValidate Synthetic Fraud Model can help lenders detect synthetic identity fraud while increasing approval rates for legitimate customers throughout the customer lifecycle, click here .

About TransUnion (NYSE: TRU)
TransUnion is a global information and insights company with over 13,000 associates operating in more than 30 countries. We make trust possible by ensuring each person is reliably represented in the marketplace. We do this with a Tru™ picture of each person: an actionable view of consumers, stewarded with care. Through our acquisitions and technology investments we have developed innovative solutions that extend beyond our strong foundation in core credit into areas such as marketing, fraud, risk and advanced analytics. As a result, consumers and businesses can transact with confidence and achieve great things. We call this Information for Good ^® — and it leads to economic opportunity, great experiences and personal empowerment for millions of people around the world. http://www.transunion.com/business .

NEEDHAM, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Candel Therapeutics, Inc. (Candel or the Company) (Nasdaq: CADL), a clinical-stage biopharmaceutical company focused on developing multimodal biological immunotherapies to help patients fight cancer, today announced that an abstract was accepted for an oral presentation at the 2025 American Society for Radiation Oncology (ASTRO) Annual Meeting, taking place from September 27 to October 1, 2025, in San Francisco, CA. The oral presentation will feature data from the Company’s phase 3 clinical trial of CAN-2409 in patients with intermediate-to-high-risk localized prostate cancer.

Details are as follows:

CAN-2409 – Localized Prostate Cancer

• Abstract Title: Phase 3, Randomized, Placebo Controlled Clinical Trial of CAN-2409+Prodrug in Combination with Standard of Care External Beam Radiation (EBRT) for Newly Diagnosed Localized Prostate Cancer
  
• Presenter: Glen Gejerman, MD, MBA, Hackensack University Medical Center, Hackensack, NJ
  
• Session Title: SS 03 - GU 1: Advances in Localized Prostate Cancer
  
• Session Date/Time: Sunday, September 28, 2025; 2:30 PM - 2:40 PM PT
  
• Location: Room 24, Moscone Center, San Francisco, CA
  
  

The abstract has also been selected for inclusion in ASTRO’s Science Highlights - Genitourinary Cancer session on Sunday, September 28 at 8:00 a.m. PT in Room 24, which will provide a high-level overview of top-rated research in the field.

About Candel Therapeutics

Candel is a clinical-stage biopharmaceutical company focused on developing off-the-shelf, multimodal viral immunotherapies that elicit an individualized, systemic anti-tumor immune response to help patients fight cancer. Candel has established two clinical-stage multimodal biological immunotherapy platforms based on novel, genetically modified adenovirus and herpes simplex virus (HSV) gene constructs, respectively. CAN-2409 is the lead product candidate from the adenovirus platform.

The Company recently completed a pivotal, placebo-controlled, phase 3 clinical trial of CAN-2409 in localized prostate cancer, conducted under a Special Protocol Assessment agreed with the U.S. Food and Drug Administration (FDA), which achieved the primary endpoint supported by secondary endpoints. The Company also reported successful phase 2a clinical trials of CAN-2409 in non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The FDA also granted Regenerative Medicine Advanced Therapy Designation to CAN-2409 for the treatment of newly diagnosed localized prostate cancer in patients with intermediate-to-high-risk disease. The FDA had previously granted Fast Track Designation to CAN-2409 in NSCLC and prostate cancer, and Fast Track Designation and Orphan Drug Designation to CAN-2409 in PDAC.

CAN-3110 is the lead product candidate from the HSV platform and is currently in an ongoing phase 1b clinical trial in recurrent high-grade glioma. Initial results were published in Nature and CAN-3110 received Fast Track Designation and Orphan Drug Designation from the FDA. Finally, Candel’s enLIGHTEN™ Discovery Platform is a systematic, iterative HSV-based discovery platform leveraging human biology and advanced analytics to create new viral immunotherapies for solid tumors.

For more information about Candel, visit: www.candeltx.com .

Forward-Looking Statements

This press release includes certain disclosures that contain “forward-looking statements,” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, without limitation, express or implied statements regarding the timing and advancement of current and future development programs; expectations regarding the therapeutic benefit of the Company’s platforms, including the ability of its platforms to improve overall survival and/or disease-free survival of patients living with difficult-to-treat solid tumors; and expectations regarding the potential benefits conferred by regulatory designations. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and important factors that may cause actual events or results to differ materially from those expressed or implied by any forward-looking statements contained in this press release, including, without limitation, those risks and uncertainties related to the timing and advancement of development programs; expectations regarding the therapeutic benefit of the Company’s programs; that final data from the Company’s preclinical studies and completed clinical trials may differ materially from reported interim data from ongoing studies and trials; the Company’s ability to efficiently discover and develop product candidates; the Company’s ability to obtain and maintain regulatory approval of product candidates; the Company’s ability to maintain its intellectual property; the implementation of the Company’s business model, including strategic plans for the Company’s business and product candidates; and other risks identified in the Company’s filings with the U.S. Securities and Exchange Commission (SEC), including the Company’s most recent Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, each as filed with the SEC and any subsequent filings with the SEC. The Company cautions you not to place undue reliance on any forward-looking statements, which speak only as of the date they are made. The Company disclaims any obligation to publicly update or revise any such statements to reflect any change in expectations or in events, conditions, or circumstances on which any such statements may be based, or that may affect the likelihood that actual results will differ from those set forth in the forward-looking statements. Any forward-looking statements contained in this press release represent the Company’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date.

Investor Contact
Theodore Jenkins
Vice President, Investor Relations and Business Development
Candel Therapeutics, Inc.
[email protected]

Media Contact
Ben Shannon
Vice President
ICR Healthcare
[email protected]

Sale of the low-pressure coolant ODIN ^™ enables NANO Nuclear to sharpen focus on its portfolio of gas-cooled technologies — KRONOS MMR ^™ , LOKI MMR ^™ , and ZEUS ^™ — and maximize developmental and regulatory efficiencies and long-term commercial advancement.

New York, N.Y., Sept. 17, 2025 (GLOBE NEWSWIRE) -- NANO Nuclear Energy Inc. (NASDAQ: NNE) (“Nano Nuclear” or the “Company”), a leading advanced nuclear energy and technology company, today announced the signing of a letter of intent for the proposed sale of its ODIN™ low-pressure coolant microreactor design and all associated intellectual property to Cambridge Atom Works, a United Kingdom based advanced reactor developer who is already developing ODIN for NANO Nuclear on an outsourced consulting basis.

The letter of intent calls for a total purchase price of $6.2 million, with a $250,000 upfront non-refundable down payment to NANO Nuclear and a $5.95 million payment in 2026 as well as future low single-digit royalties payable to NANO Nuclear based on net sales if and when ODIN is commercialized. The transaction remains subject to execution of definitive documentation and the satisfaction of customary closing conditions.

This strategic transaction reflects NANO Nuclear’s positioning and consolidation of its micro reactor portfolio to maximize developmental and regulatory efficiencies and long-term commercial advancement. The sale of ODIN would streamline NANO Nuclear’s product line, enabling it to concentrate resources on its related portfolio of gas-cooled, advanced, highly modular microreactors: the KRONOS MMR ^™ Energy System, LOKI MMR ^™ , and ZEUS ^™ .

The sale of ODIN to Cambridge Atom Works, which is led by University of Cambridge nuclear science leaders, also seeks to build on the momentum generated within the industry following the recent agreement between the United States and the United Kingdom to accelerate nuclear power development. The newly announced Atlantic Partnership for Advanced Nuclear Energy represents a significant step toward aligning regulatory frameworks and scaling down licensing timelines for next-generation advanced nuclear reactors in both countries.

“Following our acquisition of the patented, gas-cooled KRONOS MMR™ and LOKI MMR ^™ micro reactor technologies earlier this year, NANO Nuclear has assumed a leadership role in advancing the next generation of nuclear reactors in the United States,” said Jay Yu, Founder & Chairman of NANO Nuclear. “As our product portfolio expanded, we conducted an internal review to best align with the energy goals and the increasing demand for reliable power in our target markets. While we remain confident in the ODIN design, we concluded that a sale of the low-pressure cooled ODIN to a natural buyer familiar with the technology would allow us to move more efficiently going forward with our gas-cooled reactor portfolio. This strategic sale is designed to allow us to recoup our investment in ODIN to date and creates the potential for our receipt of future royalty revenue, all while enabling us to focus our development efforts on our flagship reactor technology to help ensure timely progress across our key projects. Moreover, this decision also comes at a fitting moment, as the recently announced Atlantic Partnership for Advanced Nuclear Energy underscores government support in both the United States and the UK for technologies such as ODIN and the KRONOS MMR. By aligning our portfolio with this momentum, we are positioning NANO Nuclear to benefit from strengthened transatlantic collaboration and policy support.”

NANO Nuclear continues to focus on the patented KRONOS MMR ^™ Energy System as its flagship, high technology readiness program. Developed in collaboration with some of the world’s leading institutions, the KRONOS MMR is an advanced stationary micro modular reactor. A single-unit configuration of the KRONOS MMR is designed to deliver up to 45 MWth, while a multi-unit configuration can deliver giga-watt level power while significantly enhancing energy resiliency and economics. NANO Nuclear is currently working with the U.S. Nuclear Regulatory Commission (NRC), through the University of Illinois Urbana Champaign (UIUC), to license KRONOS MMR within the United States, with site preparation and other activities already moving forward at UIUC. NANO Nuclear is also working on a developmental KRONOS MMR reactor in Ontario, Canada.

In addition, NANO Nuclear’s recently acquired engineering and manufacturing facility in Oak Brook, Illinois, strategically situated in the center of North America, positions NANO Nuclear to further its plans for construction, testing, regulatory licensing, and commercial deployment of its technologies across the United States and Canada.

Figure 1 - NANO Nuclear Energy Inc. Signs Letter of Intent to Sell its ODIN ^™ Portable Low-Pressure Coolant Microreactor to Cambridge Atom Works Ltd. for $6.2 million plus future royalties.

Synergies Between KRONOS ^™ , LOKI ^™ , and ZEUS ^™

NANO Nuclear highlighted that retaining the LOKI MMR ^™ and ZEUS ^™ microreactors was a strategic decision, as the reactors share most of their underlying features with the flagship KRONOS MMR ^™ Energy System.

“Continued development of our KRONOS MMR will have direct benefits for LOKI and ZEUS, providing value and benefit across our portfolio,” said Florent Heidet, Ph.D., Chief Technology Officer and Head of Reactor Development of NANO Nuclear . “Together, they form a complementary offering, enabling us to achieve synergistic development, regulatory and ultimately commercial progress. As KRONOS MMR advances through construction and licensing, LOKI and ZEUS directly benefit from the aligned technology, regulatory, and supply chain efficiencies.”

“The shared foundation of our reactor portfolio should help us improve performance, manufacturability, and regulatory efficiency, while allowing us to maximize shareholder value and protect against developmental cost overruns,” said James Walker, Chief Executive Officer of NANO Nuclear . “We look forward to closing the ODIN sale by the end of 2025, if not sooner.”

About NANO Nuclear Energy Inc.

NANO Nuclear Energy Inc. (NASDAQ: NNE) is an advanced technology-driven nuclear energy company seeking to become a commercially focused, diversified, and vertically integrated company across five business lines: (i) cutting edge portable and other microreactor technologies, (ii) nuclear fuel fabrication, (iii) nuclear fuel transportation, (iv) nuclear applications for space and (v) nuclear industry consulting services. NANO Nuclear believes it is the first portable nuclear microreactor company to be listed publicly in the U.S.

Led by a world-class nuclear engineering team, NANO Nuclear’s reactor products in development include its lead project, the patented KRONOS MMR ^™ Energy System , a stationary high-temperature gas-cooled reactor that is in construction permit pre-application engagement with the U.S. Nuclear Regulatory Commission (NRC) in collaboration with University of Illinois Urbana-Champaign (U. of I.), “ ZEUS” , a solid core battery reactor, and the space focused, portable LOKI MMR ^™ , each representing advanced developments in clean energy solutions that are modular, on-demand capable, advanced nuclear microreactors.

Advanced Fuel Transportation Inc. (AFT) , a NANO Nuclear subsidiary, is led by former executives from the largest transportation company in the world aiming to build a North American transportation company that will provide commercial quantities of HALEU fuel to small modular reactors, microreactor companies, national laboratories, military, and DOE programs. Through NANO Nuclear, AFT is the exclusive licensee of a patented high-capacity HALEU fuel transportation basket developed by three major U.S. national nuclear laboratories and funded by the Department of Energy. Assuming development and commercialization, AFT is expected to form part of the only vertically integrated nuclear fuel business of its kind in North America.

HALEU Energy Fuel Inc. (HEF) , a NANO Nuclear subsidiary, is focusing on the future development of a domestic source for a High-Assay, Low-Enriched Uranium (HALEU) fuel fabrication pipeline for NANO Nuclear’s own microreactors as well as the broader advanced nuclear reactor industry.

NANO Nuclear Space Inc. (NNS) , a NANO Nuclear subsidiary, is exploring the potential commercial applications of NANO Nuclear’s developing micronuclear reactor technology in space. NNS is focusing on applications such as the LOKI MMR ^™ system and other power systems for extraterrestrial projects and human sustaining environments, and potentially propulsion technology for long haul space missions. NNS’ initial focus will be on cis-lunar applications, referring to uses in the space region extending from Earth to the area surrounding the Moon's surface.

For more corporate information please visit: https://NanoNuclearEnergy.com/

For further NANO Nuclear information, please contact:
Email: [email protected]
Business Tel: (212) 634-9206

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NANO Nuclear Energy X PLATFORM

Cautionary Note Regarding Forward Looking Statements

This news release and statements of NANO Nuclear’s management in connection with this news release contain or may contain “forward-looking statements” within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. In this context, forward-looking statements mean statements related to future events, which may impact our expected future business and financial performance, and often contain words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “potential”, “will”, “should”, “could”, “would” or “may” and other words of similar meaning. In this press release, forward-looking statements including, among others, those relating to (i) the timing for the closing of the proposed sale of the ODIN reactor, (ii) the anticipated benefits to NANO Nuclear of such proposed sale and (iii) NANO Nuclear’s development, regulatory and commercial plans, each as described herein, These and other forward-looking statements are based on information available to us as of the date of this news release and represent management's current views and assumptions. Forward-looking statements are not guarantees of future performance, events or results and involve significant known and unknown risks, uncertainties and other factors, which may be beyond our control. For NANO Nuclear, particular risks and uncertainties that could cause our actual future results to differ materially from those expressed in our forward-looking statements include but are not limited to the following: (i) risks related to our U.S. Department of Energy (“DOE”) or related state or non-U.S. nuclear licensing submissions, (ii) risks related the development of new or advanced technology and the acquisition of complementary technology or businesses, including difficulties with design and testing, cost overruns, regulatory delays, integration issues and the development of competitive technology, (iii) our ability to obtain contracts and funding to be able to continue operations, (iv) risks related to uncertainty regarding our ability to technologically develop and commercially deploy a competitive advanced nuclear reactor or other technology in the timelines we anticipate, if ever, (v) risks related to the impact of U.S. and non-U.S. government regulation, policies and licensing requirements, including by the DOE and the U.S. Nuclear Regulatory Commission, including those associated with the recently enacted ADVANCE Act and the May 23, 2025 Executive Orders seeking to streamline nuclear regulation, and (vi) similar risks and uncertainties associated with the operating an early stage business a highly regulated and rapidly evolving industry. There are also risks associated with the proposed sale of the ODIN reactor design, including the risk that (i) such sale may not be consummated, (ii) the buyer may be unable to fund the purchase price and (iii) ODIN may never been licensed or commercialized, which would deny NANO Nuclear royalties. Readers are cautioned not to place undue reliance on these forward-looking statements, which apply only as of the date of this news release. These factors may not constitute all factors that could cause actual results to differ from those discussed in any forward-looking statement, and NANO Nuclear therefore encourages investors to review other factors that may affect future results in its filings with the SEC, which are available for review at www.sec.gov and at https://ir.nanonuclearenergy.com/financial-information/sec-filings . Accordingly, forward-looking statements should not be relied upon as a predictor of actual results. We do not undertake to update our forward-looking statements to reflect events or circumstances that may arise after the date of this news release, except as required by law.

Attachment

• Figure 1

BELGRADE, Mont., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Today, Bridger Aerospace Group Holdings, Inc. (“Bridger” or “Bridger Aerospace”), (NASDAQ: BAER, BAERW), one of the nation’s largest aerial firefighting companies, applauded the announcement by the Departments of Interior and Agriculture of a Wildland Fire Service Plan to modernize federal wildfire response as part of a coordinated action to implement the President's Executive Order 14308, Empowering Commonsense Wildfire Prevention and Response .

Sam Davis, Bridger’s Chief Executive Officer stated, “Consolidating federal capabilities and bringing together wildland fire programs that have long operated across multiple agencies will help us respond more quickly and effectively at the early stages of a wildfire to save lives, protect property, and reduce the hazards faced by firefighters.”

As part of the announcement, the Department of the Interior issued Secretary’s Order 3443 , which directs the establishment of the U.S. Wildland Fire Service with a plan for implementation in January 2026. The Department of Agriculture also released its own memorandum to modernize and strengthen America's wildfire prevention and response system.

The Wildland Fire Service Plan will focus on five interdependent priorities:

• Address systemic inefficiencies and modernize aviation and coordination systems
• Strengthen interagency wildfire coordination and response
• Improve federal partnerships and reduce administrative burden
• Ensure wildfire research, technology, and IT investments are mission-ready
• Integrate pre- and post-fire activities into a complete wildfire strategy

Additionally, the bipartisan Fire Ready Nation Act of 2025 passed the Senate unanimously last week. This legislation seeks to strengthen federal wildfire forecasting, prevention and response capabilities, addressing the growing needs in the wildland-urban interface and ensuring a coordinated program within the National Oceanic and Atmospheric Administration (NOAA). Key provisions include establishing a permanent Fire Weather Services program to authorize wildfire response services, funding for new technologies to improve forecasts of wildfire conditions, testing new tools for firefighting, including unmanned aircraft for data collection, and sharing NOAA data across federal agencies to improve fire weather data collection and coordination.

“The Wildland Fire Service Plan and the Fire Ready Nation Act come on the heels of the 2025 Executive Order on Wildfire Response which is already leading to a significant change in how the country approaches and fights wildfires,” Davis added. “With Bridger’s significant Air Attack fleet, including modern fire imaging and surveillance aircraft, and the world’s largest private Super Scooper fleet, we believe we are uniquely positioned as the nation refocuses efforts on preparedness and aggressive Wildfire Suppression. This commitment, on top of the 2026 budget for the new U.S. Wildland Fire Service, will have a significant positive impact on the entire wildland fire community.”

About Bridger Aerospace
Based in Belgrade, Montana, Bridger Aerospace Group Holdings, Inc. is one of the nation’s largest aerial firefighting companies. Bridger provides aerial firefighting and wildfire management services to federal and state government agencies, including the United States Forest Service, across the nation, as well as internationally. More information about Bridger Aerospace is available at https://w w w.bridgera e rospace.com .

Investor Contact
Alison Ziegler
Darrow Associates
201-220-2678
[email protected]

Media Contact
Devin Johnson
Bridger Aerospace
406-919-5980
[email protected]

TORONTO, Sept. 17, 2025 (GLOBE NEWSWIRE) -- FirstService Corporation (TSX and NASDAQ: FSV) (“FirstService”) announced today that its subsidiary, Roofing Corp of America (“RCA”), has acquired Springer-Peterson Roofing & Sheet Metal (“Springer-Peterson”) and A-1 All American Roofing Co. (“A-1 All American”). These two tuck-under acquisitions further enhance RCA’s presence in key markets within the U.S. Sun Belt region. The existing management teams of both businesses have retained minority equity interests and will continue to oversee their respective day-to-day operations. Terms of the two transactions were not disclosed.

Founded in 1982 with its head office in Lakeland, Florida, Springer-Peterson is the leading provider of roofing installation and repair services to blue chip commercial customers and local institutions across Central Florida. This transaction builds upon our existing strong leadership position in the Southwest region of the state.

Headquartered in San Diego, California and established in 1996, A-1 All American is a commercial roofing contractor serving a broad range of customers including homeowner associations, hotels, property managers and building consultants. This addition further expands RCA’s market-leading position along the coast of California.

“These two transactions further bolster RCA’s presence in two large and growing roofing markets. In addition to expanding our geographic footprint in Florida and California, both companies bring a roster of long-standing commercial customers,” said Randy Korach, CEO of RCA. “We welcome the leaders and teams of Springer-Peterson and A-1 All American to the RCA family and look forward to working together to serve our clients and drive further growth.”

ABOUT FIRSTSERVICE CORPORATION

FirstService Corporation is a North American leader in the essential outsourced property services sector, serving its customers through two industry-leading service platforms: FirstService Residential, North America’s largest manager of residential communities; and FirstService Brands, one of North America’s largest providers of essential property services delivered through individually branded company-owned operations and franchise systems.

FirstService generates more than US$5.4 billion in annual revenues and has approximately 30,000 employees across North America. With significant insider ownership and an experienced management team, FirstService has a long-term track record of creating value and superior returns for shareholders. The Common Shares of FirstService trade on the NASDAQ and the Toronto Stock Exchange under the symbol “FSV”, and are included in the S&P/TSX 60 index.

For the latest news from FirstService Corporation, visit www.firstservice.com .

FORWARD-LOOKING STATEMENTS

This press release contains statements that constitute “forward-looking statements” within the meaning of applicable securities legislation, including, but not limited to, the expected closing of the proposed transaction, the impact of the proposed transaction on FirstService’s business and future financial and operating results and the scope of the expected financing for the proposed transaction. Much of this information can be identified by words such as “expect to,” “expected,” “will,” “estimated” or similar expressions suggesting future outcomes or events. FirstService believes the expectations reflected in such forward-looking statements are reasonable but no assurance can be given that these expectations will prove to be correct and such forward-looking statements should not be unduly relied upon.

Forward-looking statements are based on current information and expectations that involve a number of risks and uncertainties, which could cause actual results or events to differ materially from those anticipated. These risks include, but are not limited to, risks that: FirstService is unable to promptly and effectively integrate RCA’s businesses; management’s time and attention is diverted on transaction-related issues; FirstService or RCA is unable to retain key personnel; and other risks related to FirstService’s business, including those identified in FirstService’s annual information form for the year ended December 31, 2024 under the heading “Risk factors” (a copy of which may be obtained at www.sedarplus.ca) and Annual Report on Form 40-F filed with the United States Securities and Exchange Commission (a copy of which may be obtained at www.sec.gov), and subsequent filings. Forward-looking statements contained in this press release are made as of the date hereof and are subject to change. All forward-looking statements in this press release are qualified by these cautionary statements. Unless otherwise required by applicable securities laws, we do not intend, nor do we undertake any obligation, to update or revise any forward-looking statements contained in this press release to reflect subsequent information, events, results or circumstances or otherwise.

COMPANY CONTACTS:

Jeremy Rakusin
CFO
FirstService Corporation
(416) 960-9566

AUSTIN, Texas, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Rein Therapeutics ("Rein") (NASDAQ: RNTX), a biopharmaceutical company advancing a novel pipeline of first-in-class medicines to address significant unmet medical needs in orphan pulmonary and fibrosis indications, today announced the publication of novel data on its lead drug candidate, LTI-03, in iScience, a peer-reviewed, open-access journal published by Cell Press.

The paper, titled “LTI-03 peptide demonstrates anti-fibrotic activity in ex vivo lung slices from IPF patients,” reports how LTI-03 was tested directly on lung tissue donated by patients with idiopathic pulmonary fibrosis (IPF) who underwent lung transplant. In this model, LTI-03 showed signs of reducing scarring and protecting lung cells, reinforcing its potential as an important new therapy.

Key Highlights

1. The study used real lung tissue donated by IPF patients. These samples continued to show scarring activity for several days, making them a highly relevant way to test new therapies.
2. LTI-03 reduced multiple scarring pathways (including TGFβ, VEGF, PDGF, and FGF), while also lowering collagen production and inflammatory signals in diseased lung tissue.
3. Unlike nintedanib, the FDA-approved standard-of-care drug, LTI-03 achieved these effects without causing cell damage or death in patient samples, reinforcing the drug’s strong safety profile.
4. The findings add to the growing body of evidence that LTI-03 has the potential to become a meaningful new therapy for IPF.

Brian Windsor, PhD, Chief Executive Officer of Rein Therapeutics, commented, “Using a highly relevant translational model, this peer-reviewed publication provides further validation of LTI-03’s broad anti-fibrotic effects in IPF lung tissue. These data support our ongoing Phase 2 RENEW trial, where we are evaluating LTI-03 in patients living with IPF, a disease with very limited treatment options and high unmet need.”

Urgent Need

IPF is a progressive fibrotic lung disease that affects approximately 100,000 people in the U.S. and more than 70,000 in the U.K. Median survival is just 3–5 years from diagnosis, even with currently approved therapies. The global market for IPF treatments is projected to exceed $11 billion by 2031, underscoring the urgent need for more effective approaches.

Next Steps

Rein recently announced regulatory approval from the U.K.’s MHRA to initiate the Phase 2 RENEW trial of LTI-03. The trial will evaluate safety, tolerability, and changes in lung function in up to 120 patients, with initial data expected in 2026.

The full article can be found here:

https://www.cell.com/iscience/fulltext/S2589-0042(25)01698-0

About Rein Therapeutics

Rein Therapeutics is a clinical-stage biopharmaceutical company advancing a novel pipeline of first-in-class therapies to address significant unmet medical needs in orphan pulmonary and fibrosis indications. Rein's lead product candidate, LTI-03, is a novel, synthetic peptide with a dual mechanism targeting alveolar epithelial cell survival as well as inhibition of profibrotic signaling. LTI-03 has received Orphan Drug Designation in the U.S. and is in clinical development. Rein's second product candidate, LTI-01, is a proenzyme that has completed Phase 1b and Phase 2a clinical trials for the treatment of loculated pleural effusions. LTI-01 has received Orphan Drug Designation in the U.S. and E.U. and Fast Track Designation in the U.S.

Forward-Looking Statements

This press release may contain forward-looking statements of Rein Therapeutics, Inc. ("Rein", the "Company", "we", "our" or "us") within the meaning of the Private Securities Litigation Reform Act of 1995, including statements with respect to expectations for the Company’s LTI-03 product candidate. We use words such as "anticipate," "believe," "estimate," "expect," "hope," "intend," "may," "plan," "predict," "project," "target," "potential," "would," "can," "could," "should," "continue," and other words and terms of similar meaning to help identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors as well as the risks disclosed in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year ended December 31, 2024, which is on file with the United States Securities and Exchange Commission (the "SEC") and in subsequent filings that the Company files with the SEC. These forward-looking statements should not be relied upon as representing the Company's view as of any date after the date of this press release, and we expressly disclaim any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Rein Investor Relations & Media Contact:

Investor Relations

[email protected]

HAUPPAUGE, N.Y., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Dime Community Bancshares, Inc. (NASDAQ: DCOM) (the “Company” or “Dime”), the parent company of Dime Community Bank (the “Bank”), announced the expansion of its commercial lending platform with the addition of several seasoned banking professionals. The following individuals have joined Dime:

• Ryan Kent has joined as Director of Commercial Strategic Initiatives. He was previously a Senior Manager at Deloitte and prior to that a Senior Managing Director at Webster Bank
• Elvis Grgurovic has joined as Co-Head of the Mid Corporate vertical. He was previously a Managing Director at Webster Bank
• Eric Pelletier has joined as Head of Syndications. He was previously a Managing Director at Webster Bank
• Matt Greene has joined as a Senior Vice President in the Mid-Corporate and Specialty Finance vertical. He was previously a Senior Managing Director at Webster Bank
• Barry Renow has joined as Senior Vice President in the Mid-Corporate and Specialty Finance Vertical. He was previously a Senior Vice President at BHI USA
  

Stuart H. Lubow, President and Chief Executive Officer of Dime, commented: “We are excited to add several talented individuals as we continue to execute on our growth plan. The hires align with our focus of building a diversified commercial loan portfolio. Dime is the bank-of-choice for top tier talent looking to join a dynamic, client-focused institution with a flat organizational structure that enables speed and agility.”

Thomas X. Geisel, Senior Executive Vice President of Commercial Lending, commented: “The addition of these high-performing professionals strengthens our capabilities across core areas including mid-corporate and specialty lending, and loan syndications. Each of them will play an important role in scaling our platform and delivering value to our clients through customized credit solutions, industry expertise and responsive service.”

ABOUT DIME COMMUNITY BANCSHARES, INC.

Dime Community Bancshares, Inc. is the holding company for Dime Community Bank, a New York State-chartered trust company with over $14 billion in assets and the number one deposit market share among community banks on Greater Long Island ⁽¹⁾ .

Dime Community Bancshares, Inc.
Investor Relations Contact:
Avinash Reddy
Senior Executive Vice President – Chief Financial Officer
Phone: 718-782-6200; Ext. 5909
Email: [email protected]

¹ Aggregate deposit market share for Kings, Queens, Nassau & Suffolk counties for community banks with less than $20 billion in assets.

FORWARD-LOOKING STATEMENTS
Statements contained in this news release that are not historical facts are forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks and uncertainties which could cause actual results to differ materially from those currently anticipated.

Access to additional capital further strengthens Digital Asset Treasury execution strategy

Preferred converts to common stock at $250 per Caliber share

SCOTTSDALE, Ariz., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Caliber (NASDAQ: CWD), a diversified real estate and digital asset management platform, today announced that it has closed a securities purchase agreement with an institutional investor for the sale of $15.9 million of perpetual convertible preferred equity and, separately, has established and activated an At-The-Market (ATM) equity program.

Under the preferred investment, Caliber issued 15,868 shares of Series B Preferred Stock at a purchase price of $1,000 per share, resulting in gross proceeds of $15,868,000. The Series B Preferred Stock is convertible, at the holder’s option, into Caliber common shares at $250 per share. The security carries no voting rights, pays no dividends or interest, and is ranked senior to Caliber’s Class A and Class B common stock, but junior to the Company’s Series A and Series AA Preferred Stock.

The Company also announced that it has filed a prospectus supplement with the U.S. Securities and Exchange Commission (“SEC”) to activate an ATM program further to which sales are to be made further to the Company’s existing $50 million shelf registration statement. At the outset, the Company has approximately $10.3 million of availability under the program. The ATM will provide Caliber with the ability to issue and sell shares of common stock from time to time, at prevailing market prices, in order to opportunistically raise capital to support its business initiatives, including the continued accumulation of Chainlink (LINK) tokens under its Digital Asset Treasury (DAT) strategy.

Lafferty & Co. is serving as lead sales agent for the ATM program, with Benchmark Company acting as co-manager.

“This perpetual preferred investment, paired with the flexibility of our new ATM program, strengthens Caliber’s balance sheet and provides us with capital to continue executing our strategy,” said Chris Loeffler, Chief Executive Officer of Caliber. “The terms of this preferred equity as a perpetual preferred with an attractive $250 per share conversion price highlights the strength and enthusiasm behind our move to build our LINK DAT.”

Caliber is the first Nasdaq-listed company to publicly announce the adoption of a treasury strategy anchored in Chainlink (LINK). Through this initiative, Caliber provides its shareholders with transparent, mark-to-market exposure to LINK while positioning itself at the intersection of real asset infrastructure and digital asset infrastructure.

About Caliber (CaliberCos Inc.)

Caliber (Nasdaq: CWD) is a diversified alternative asset manager with over $2.9 billion in Managed Assets. For more than 16 years, Caliber has delivered value across market cycles with its private equity real estate investment platform, specializing in hospitality, multi-family residential, and industrial real estate. This includes the formation, operation and management of investment vehicles that acquire, develop, hold, and manage the servicing of commercial and residential real estate services. In 2025, Caliber launched a Digital Asset Treasury strategy anchored in Chainlink (LINK). This initiative bridges real and digital asset investing, offering investors access through both publicly traded equity (Nasdaq: CWD) and Caliber’s private equity real estate funds .

Forward-Looking Statements

This press release contains “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled “Risk Factors” in the final prospectus related to the Company’s public offering filed with the SEC and other reports filed with the SEC thereafter. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

CONTACTS :
Caliber Investor Relations:
Ilya Grozovsky
+1 480-214-1915
[email protected]

WILMINGTON, N.C., Sept. 17, 2025 (GLOBE NEWSWIRE) -- nCino, Inc. (NASDAQ: NCNO), the leading provider of intelligent, best-in-class solutions, today announced the launch of nCino Integration Gateway, a purpose-built Integration Platform as a Service (iPaaS) that transforms how banks, credit unions, and fintech partners connect their technology ecosystems. Formerly known as Glyue by Sandbox Banking , Integration Gateway delivers dynamic integration capabilities directly to financial institutions and enables fintech partners to power their own integration services, expanding nCino's addressable market by offering connectivity solutions within third-party ecosystems.

The solution eliminates integration bottlenecks by seamlessly connecting your systems, enabling faster adoption and deployment of new technology. This approach allows institutions to utilize AI-driven applications with ease, eliminate manual data silos, and create connected customer experiences that drive competitive advantage.

"Integration Gateway has been an ideal solution for our digital transformation needs, delivering seamless API connectivity that enables us to innovate efficiently while maintaining the robust governance we require,” said John Sullivan, Executive Vice President and Chief Information Officer at BankNewport. “nCino's deep understanding of banking operations and API architecture has been instrumental in accelerating our institution's growth through intelligent data connectivity."

Integration Gateway delivers accelerated time-to-value through existing compatible integrations for 14+ core banking platforms and 50+ financial services solutions, eliminating the extensive customization required by generic integration platforms. This reduces implementation time significantly while ensuring direct business impact.

"The technology we're building now represents a once-in-a-generation opportunity to fundamentally transform how financial institutions operate," said Ravi Balasubramanian, Vice President of Innovation and Integrations at nCino. "Integration Gateway creates the intelligent architecture that enables them to innovate at the speed of their ambition."

The platform's enterprise-grade governance includes built-in audit trails, user access controls, role-based permissions, and SAML support. These governance features help customers meet internal IT policies and external compliance requirements including CFPB Section 1033, GLBA, and FFIEC guidelines.

"Integration Gateway is the data backbone for the future of banking," said Skye Isard, Vice President of Integration and API Platforms at nCino. "We've built an integration platform that empowers banks and credit unions to efficiently connect new and legacy systems, unlocking their ability to transform."

Integration Gateway technology is already proven in the market, trusted by over 100 North American financial institutions ranging from $500M to $200B+ in assets. The platform is available immediately to banks, credit unions, and technology providers throughout the United States. Learn more about nCino Integration Gateway here .

About nCino

nCino (NASDAQ: NCNO) is powering a new era in financial services. The Company was founded to help financial institutions digitize and reengineer business processes to boost efficiencies and create better banking experiences. With over 2,700 customers worldwide - including community banks, credit unions, independent mortgage banks, and the largest financial entities globally - nCino offers a trusted platform of best-in-class, intelligent solutions. By integrating artificial intelligence and actionable insights into its platform, nCino is helping financial institutions consolidate legacy systems to enhance strategic decision-making, improve risk management, and elevate customer satisfaction by cohesively bringing together people, AI and data. For more information, visit www.ncino.com .

Media Contact

Mara D’Auria

[email protected]

Forward-Looking Statements: This press release contains forward-looking statements about nCino's financial and operating results, which include statements regarding nCino’s future performance, outlook, guidance, the benefits from the use of nCino’s solutions, our strategies, and general business conditions. Forward-looking statements generally include actions, events, results, strategies and expectations and are often identifiable by use of the words “believes,” “expects,” “intends,” “anticipates,” “plans,” “seeks,” “estimates,” “projects,” “may,” “will,” “could,” “might,” or “continues” or similar expressions and the negatives thereof. Any forward-looking statements contained in this press release are based upon nCino’s historical performance and its current plans, estimates, and expectations and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent nCino’s expectations as of the date of this press release. Subsequent events may cause these expectations to change and, except as may be required by law, nCino does not undertake any obligation to update or revise these forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual results to differ materially including, but not limited to risks associated with (i) adverse changes in the financial services industry, including as a result of customer consolidation or bank failures; (ii) adverse changes in economic, regulatory, or market conditions, including as a direct or indirect consequence of higher interest rates; (iii) risks associated with acquisitions we undertake, (iv) breaches in our security measures or unauthorized access to our customers’ or their clients' data; (v) the accuracy of management’s assumptions and estimates; (vi) our ability to attract new customers and succeed in having current customers expand their use of our solution, including in connection with our migration to an asset-based pricing model; (vii) competitive factors, including pricing pressures and migration to asset-based pricing, consolidation among competitors, entry of new competitors, the launch of new products and marketing initiatives by our competitors, and difficulty securing rights to access or integrate with third party products or data used by our customers; (viii) the rate of adoption of our newer solutions and the results of our efforts to sustain or expand the use and adoption of our more established solutions; (ix) fluctuation of our results of operations, which may make period-to-period comparisons less meaningful; (x) our ability to manage our growth effectively including expanding outside of the United States; (xi) adverse changes in our relationship with Salesforce; (xii) our ability to successfully acquire new companies and/or integrate acquisitions into our existing organization; (xiii) the loss of one or more customers, particularly any of our larger customers, or a reduction in the number of users our customers purchase access and use rights for; (xiv) system unavailability, system performance problems, or loss of data due to disruptions or other problems with our computing infrastructure or the infrastructure we rely on that is operated by third parties; (xv) our ability to maintain our corporate culture and attract and retain highly skilled employees; and (xvi) the outcome and impact of legal proceedings and related fees and expenses.

Recent advances in understanding venous malformation disease pathogenesis highlight the PI3K/AKT/mTOR pathway as a key driver of disease proliferation, spurring real-world off-label use of systemic rapamycin (sirolimus)

Publication includes a systematic review of 26 studies evaluating the use of rapamycin for the treatment of venous malformations

Study authors highlight unmet clinical need for venous malformations and lack of FDA-approved pharmacologic options while advocating for an FDA-approved targeted topical formulation of rapamycin for patients with cutaneous venous malformations

WAYNE, Pa., Sept. 17, 2025 (GLOBE NEWSWIRE) -- (Nasdaq: PVLA) Palvella Therapeutics, Inc . (Palvella), a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no U.S. Food and Drug Administration (FDA)-approved therapies, today announced the publication of a manuscript in Lymphatic Research and Biology which summarizes a systematic literature review of rapamycin for the treatment of venous malformations (VMs). The manuscript supports the scientific rationale and clinical potential of Palvella’s QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin) for the treatment of cutaneous VMs, currently under evaluation in the Phase 2 TOIVA trial with top-line data anticipated in mid-December 2025.

"This publication highlights the significant unmet need in the management of cutaneous venous malformations and the large, growing real-world experience that rapamycin as a therapy can benefit patients with this challenging disease," said Joyce Teng, M.D., Ph.D., Professor of Dermatology and Pediatrics at Stanford University. "Data summarized in this review further strengthen the scientific and clinical rationale for a targeted, non-systemic approach to treat cutaneous venous malformations which currently have no FDA-approved therapy."

Lymphatic Research and Biology is a peer-reviewed journal dedicated to delivering the most current advances and developments in the genetics, biology, pathology, and diseases and disorders of the lymphatic system. The publication, titled "Sirolimus for Venous Malformations: A Systematic Review of Efficacy and Safety," reviews 26 studies comprising 98 patients treated with rapamycin (also known as sirolimus) for VMs. In addition to Dr. Teng, leading clinicians in the field of vascular malformations, including Michael Kelly, M.D., Ph.D., pediatric hematologist and oncologist at Cleveland Clinic, and Megha Tollefson, M.D., pediatric dermatologist at Mayo Clinic, contributed to the publication. Key findings from the publication included:

• Recent advances in the pathogenesis of VMs have implicated abnormal activation of the phosphatidylinositol 3-kinase (PI3K)/protein kinase B (AKT)/mammalian target of rapamycin (mTOR) signaling pathway, a critical intercellular pathway that plays a central role in venous malformation expansion and proliferation.
• Interventional treatments, including surgery, sclerotherapy, and laser therapy, are highlighted as potentially inadequate for VMs patients with extensive, cutaneous, or invasive disease.
• The majority of patients showed evidence of treatment efficacy with off-label rapamycin, despite an inadequate response to previous standard treatment; improvements were noted in several areas, including bleeding, functional capacity, quality-of-life measurements, and other clinical signs.
• Across the studies, there was no difference in efficacy based on mutation subtype, although not all studies reported on mutation subtype.
• A targeted, topical formulation of rapamycin could provide clinical benefit for cutaneous VMs by achieving therapeutic levels in the dermis while minimizing the risk of off-target effects of oral rapamycin.
  

"There is a serious unmet need in cutaneous VMs, with no FDA-approved therapies and a high burden of disease leading to physical and functional impairment and psychological distress," said Jeff Martini, Ph.D., Chief Scientific Officer of Palvella. "This systematic review supports a potentially important role for rapamycin in venous malformations, and further validates Palvella’s approach to potentially address cutaneous venous malformations with QTORIN™ rapamycin, our innovative 3.9% rapamycin anhydrous gel. We look forward to announcing top-line results from our fully enrolled Phase 2 TOIVA study later this year."

Palvella recently announced the completion of enrollment of the Phase 2 TOIVA trial with 16 patients enrolling in the study. The program is focused on evaluating QTORIN™ rapamycin for the treatment of cutaneous VMs, a disease for which there are currently no FDA-approved therapies for the estimated more than 75,000 diagnosed patients in the U.S. In April 2024, the FDA granted Fast Track Designation to QTORIN™ rapamycin for the treatment of VMs.

About Cutaneous Venous Malformations
Cutaneous VMs is a serious, rare genetic disease caused by mutations in genes that cause overactivation of the PI3K/mTOR signaling pathway, leading to dysregulated growth of malformed veins within the skin. These malformations can cause substantial morbidity and functional impairment, significantly impact quality of life, and are associated with bleeding, swelling, ulceration, thrombosis, and other potential complications. An urgent need exists for an FDA-approved, targeted, localized therapy to treat cutaneous VMs. While published case studies and real-world evidence have provided preliminary evidence of clinical benefit from the off-label use of systemic mTOR inhibitors for venous malformations, there are currently no FDA-approved therapies for the estimated more than 75,000 diagnosed patients with cutaneous VMs in the U.S.

About Palvella Therapeutics
Founded and led by rare disease drug development veterans, Palvella Therapeutics, Inc. (Nasdaq: PVLA) is a clinical-stage biopharmaceutical company focused on developing and commercializing novel therapies to treat patients suffering from serious, rare genetic skin diseases for which there are no FDA-approved therapies. Palvella is developing a broad pipeline of product candidates based on its patented QTORIN™ platform, with an initial focus on serious, rare genetic skin diseases, many of which are lifelong in nature. Palvella’s lead product candidate, QTORIN™ 3.9% rapamycin anhydrous gel (QTORIN™ rapamycin), is currently being evaluated in the Phase 3 SELVA clinical trial in microcystic lymphatic malformations and the Phase 2 TOIVA clinical trial in cutaneous venous malformations. For more information, please visit www.palvellatx.com or follow Palvella on LinkedIn or X (formerly known as Twitter).

QTORIN™ rapamycin is for investigational use only and has not been approved or cleared by the FDA or by any other regulatory agency for any indication.

Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended (Securities Act)). These statements may discuss goals, intentions, and expectations as to future plans, trends, events, results of operations or financial condition, or otherwise, based on current beliefs of the management of Palvella, as well as assumptions made by, and information currently available to, the management of Palvella. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as “may,” “will,” “should,” “would,” “expect,” “anticipate,” “plan,” “likely,” “believe,” “estimate,” “project,” “intend,” and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements include, but are not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Palvella’s clinical development plans and related anticipated development milestones, Palvella’s cash and financial resources and expected cash runway, and the potential of, and expectations regarding, Palvella’s programs, including QTORIN™ rapamycin, and its research-stage opportunities, including its expected therapeutic potential and market opportunity. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various factors, including, without limitation: the ability to raise additional capital to finance operations; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize, Palvella’s product candidates, including QTORIN™ rapamycin; the outcome of early clinical trials for Palvella’s product candidates, including the ability of those trials to satisfy relevant governmental or regulatory requirements; the fact that data and results from clinical studies may not necessarily be indicative of future results; Palvella’s limited experience in designing clinical trials and lack of experience in conducting clinical trials; the ability to identify and pivot to other programs, product candidates, or indications that may be more profitable or successful than Palvella’s current product candidates; the substantial competition Palvella faces in discovering, developing, or commercializing products; the negative impacts of global events on operations, including ongoing and planned clinical trials and ongoing and planned preclinical studies; the ability to attract, hire, and retain skilled executive officers and employees; the ability of Palvella to protect its intellectual property and proprietary technologies; reliance on third parties, contract manufacturers, and contract research organizations; and the risks and uncertainties described in the filings made by Palvella with the Securities and Exchange Commission (SEC), including the annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, filed with or furnished to the SEC and available at www.sec.gov. The events and circumstances reflected in our forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Palvella may face. Except as required by applicable law, Palvella does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.

Contact Information
Investors
Wesley H. Kaupinen
Founder and CEO, Palvella Therapeutics
[email protected]

Media
Marcy Nanus
Managing Partner, Trilon Advisors LLC
[email protected]

BOSTON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- CervoMed Inc. (NASDAQ: CRVO), a clinical stage company focused on developing treatments for age-related neurologic disorders (CervoMed or the Company), today announced that the promising development program and potential benefits of neflamapimod for the treatment of Dementia with Lewy Bodies (DLB) were highlighted in a presentation on advances in DLB drug development by Dr. James Galvin at the 150 ^th Annual American Neurological Association (ANA) conference held September 13-16, 2025 in Baltimore, Maryland.

“We are excited to continue showcasing neflamapimod’s promising disease-modifying benefit at ANA. Following the positive data showing neflamapimod reduced the risk of clinically significant worsening on the Clinical Dementia Rating Sum of Boxes (CDR-SB) in our Phase 2b trial, including a 74% risk reduction relative to placebo in patients who have a low likelihood of having concomitant AD pathology, we are actively preparing to begin a Phase 3 trial in DLB patients and expect to reach alignment on the design of that trial with the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025,” said John Alam, MD, Co-Principal Investigator of the RewinD LB trial and CEO of CervoMed. “We are focused on rapidly advancing this potentially effective and tolerable therapeutic agent for a disease state with profound unmet need which is devastating for patients and their families.”

Details of the ANA presentation are as follows:
Session: Behavioral Neurology and Dementia: Therapeutic Advances in Neurodegenerative Diseases
Presenter: James E. Galvin, MD, MPH, Professor of Neurology at the Miller School of Medicine in Miami, Co-Principal Investigator of the RewinD-LB study and member of the Board at the Lewy Body Dementia Association (LBDA)
Date: September 16, 2025
Time: 11:00 AM to 12:30 PM

The slides from the presentation that included neflamapimod results will be accessible in the Investor section of CervoMed’s website, https://www.cervomed.com/, following the presentation.

About the RewinD-LB Phase 2b Trial in Dementia with Lewy Bodies
The initial phase of RewinD-LB was a randomized, 16-week, double-blind, placebo-controlled clinical trial evaluating oral neflamapimod (40mg TID) in 159 patients with DLB, followed by a 32-week neflamapimod-only treatment Extension phase. Patients with AD co-pathology, as assessed by plasma ptau181 levels, were excluded from the trial. Compared to patients with “pure” DLB – who may comprise up to 50% of the total diagnosed DLB patient population at any given time – DLB patients with AD co-pathology have significant, irreversible neuronal loss in the hippocampus that limits response to treatment. The primary endpoint in the trial is change in the CDR-SB, and secondary endpoints include the Alzheimer's Disease Cooperative Study — Clinical Global Impression of Change, the Timed Up and Go test, and a cognitive test battery. The RewinD-LB trial was funded primarily by a $21.3 million grant from the National Institutes of Health’s National Institute on Aging, disbursed over the course of the trial as costs were incurred. The trial included 43 sites across in the United States, the United Kingdom, and the Netherlands. The initial phase of the study did not effectively evaluate the clinical activity of 40mg TID neflamapimod compared to placebo because the batch of neflamapimod capsules utilized during the placebo-controlled phase of the study did not lead to the plasma drug concentrations expected with such a dose. However, in the Extension phase, a portion of patients were administered a more recently manufactured batch of capsules that achieved targeted plasma drug concentrations, allowing the effects of 40 mg TID neflamapimod treatment to be effectively evaluated during the Extension phase, with patients receiving the newer capsules serving as an active drug arm. Outcomes in these patients were compared with those in the subset of patients who continued to receive the older batch of capsules during the Extension phase, which served as a control arm.

About CervoMed
CervoMed is a clinical-stage company focused on developing treatments for age-related neurologic disorders. The Company is currently developing neflamapimod, an investigational, orally administered small molecule brain penetrant that inhibits p38 mitogen-activated protein kinase alpha. Neflamapimod has the potential to treat synaptic dysfunction, the reversible aspect of the underlying neurodegenerative processes that cause disease in DLB and certain other major neurological disorders. The Company’s recently completed Phase 2b trial evaluated neflamapimod in patients with DLB.

Forward-Looking Statements
This press release includes express and implied forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, regarding the intentions, plans, beliefs, expectations or forecasts for the future of the Company, including, but not limited to: the therapeutic potential of neflamapimod, including the degree of sustainability of any therapeutic effects; the anticipated timing and achievement of clinical and development milestones, including the Company’s announcement of additional data, if any, from the RewinD-LB Phase 2b clinical trial and any meeting or correspondence between the Company and the FDA; any other expected or implied benefits or results, including that any initial clinical results observed with respect to neflamapimod in the RewinD-LB trial will be replicated in later trials; and the timing of the initiation of any potential future trials or interactions with regulatory authorities, including the Company’s need to acquire sufficient funding for any Phase 3 trial of neflamapimod in DLB. Terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “aims,” “seeks,” “intends,” “may,” “might,” “could,” “might,” “will,” “should,” “approximately,” “potential,” “target,” “project,” “contemplate,” “predict,” “forecast,” “continue,” or other words that convey uncertainty of future events or outcomes (including the negative of these terms) may identify these forward-looking statements. Although there is believed to be reasonable basis for each forward-looking statement contained herein, forward-looking statements by their nature involve risks and uncertainties, known and unknown, many of which are beyond the Company’s control and, as a result, actual results could differ materially from those expressed or implied in any forward-looking statement. Particular risks and uncertainties include, among other things, those related to: the Company’s available cash resources and the availability of additional funds on acceptable terms; the results of the Company’s clinical trials, including RewinD-LB; the likelihood and timing of any regulatory approval of neflamapimod or the nature of any feedback the Company may receive from the FDA; the ability to implement business plans, forecasts, and other expectations in the future; general economic, political, business, industry, and market conditions, inflationary pressures, and geopolitical conflicts; and the other factors discussed under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024 filed with the U.S. Securities and Exchange Commission (SEC) on March 17, 2025, and other filings that the Company may file from time to time with the SEC. Any forward-looking statements in this press release speak only as of the date hereof (or such earlier date as may be identified). The Company does not undertake any obligation to update such forward-looking statements to reflect events or circumstances after the date of this press release, except to the extent required by law.

Investor Contact:
PJ Kelleher
LifeSci Advisors
[email protected]
617-430-7579

Media
Argot Partners
[email protected]
212-600-1902

• Once-daily oral brepocitinib 30 mg demonstrated clinically meaningful and statistically significant improvement compared to placebo on the primary endpoint and all nine key secondary endpoints, including measurements of skin disease, muscle disease, steroid-sparing effect, and rapidity of onset
• On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean Total Improvement Score (TIS) of 46.5 compared to 31.2 for placebo (p=0.0006​), even with nearly twice as many patients coming off background steroids on brepocitinib 30 mg compared to placebo
• More than two thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60)
• Consistent dose response was seen between 30 mg and 15 mg dose arms, establishing 30 mg dose as optimal in this setting
• Safety profile was consistent with previous clinical trials of brepocitinib and NDA filing is planned for calendar 1H 2026
• Roivant will host an investor call to discuss these updates today, September 17, 2025, at 8:00 a.m. EDT

BASEL, Switzerland and LONDON and NEW YORK and DURHAM, N.C., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Roivant (Nasdaq: ROIV) and Priovant Therapeutics today announced positive results from the Phase 3 VALOR study evaluating brepocitinib in dermatomyositis (DM).

On the primary endpoint, brepocitinib 30 mg achieved a week 52 mean TIS of 46.5 compared to 31.2 for placebo (p=0.0006​). A statistically significant difference between brepocitinib 30 mg and placebo on mean TIS was seen at all time points, including as early as week 4. This result represents the first ever positive outcome for a 52-week placebo-controlled trial in DM, and the first ever positive registrational trial for a targeted therapy in DM.

“Dermatomyositis is an incredibly debilitating autoimmune disease for patients, and we urgently need novel, approved efficacious therapies,” said Dr. Ruth Ann Vleugels, M.D., M.P.H., M.B.A., Heidi and Scott C. Schuster Distinguished Chair in Dermatology, Founding Director of the Autoimmune Skin Disease Center and Connective Tissue Disease Clinics at Brigham and Women's Hospital and Program Director for the Dermatology-Rheumatology Fellowship at Harvard Medical School. “The VALOR study’s success represents a groundbreaking moment for the dermatomyositis field, and the results reinforce brepocitinib’s potential to serve as a deeply impactful treatment option for a substantial number of dermatomyositis patients once approved.”

Brepocitinib also demonstrated clinically meaningful and statistically significant improvement over placebo on all nine key secondary endpoints. Dose-dependent response between brepocitinib 30 mg and brepocitinib 15 mg was seen consistently across the primary and secondary endpoints.

Approximately 75% of patients entered the VALOR study on background steroids, with a mean baseline dose of 12.2 mg/day in the brepocitinib 30 mg arm and 11.3 mg/day in the placebo arm. Of these patients on background steroids, 62% of brepocitinib 30 mg patients achieved a steroid dose ≤2.5 mg/day by the end of the study (compared to 34% for placebo) and 42% of brepocitinib 30 mg patients were able to come off steroids altogether (compared to 23% for placebo).

Even against this backdrop, clinical improvement in the brepocitinib 30 mg arm was rapid, deep, lasting and broad, both in absolute terms and relative to placebo:

• Brepocitinib demonstrated clinically meaningful and statistically significant improvement relative to placebo on the CDASI (skin), MMT-8 (motor strength) and HAQ-Disability Index (patient questionnaire around daily living activities requiring functional muscle strength, like getting dressed or walking up five steps).
• More than two-thirds of brepocitinib 30 mg patients experienced at least a moderate response (TIS≥40), and nearly half experienced a major response (TIS≥60); of patients who entered the trial with moderate-to-severe skin disease, 44% on brepocitinib 30 mg achieved cutaneous clinical remission by week 52, compared to 21% on placebo.
• Both TIS and CDASI achieved statistically significant separation from placebo as early as week 4 and sustained that separation at every assessment out to one year; median time to a TIS≥40 response was approximately 8 weeks.
  

The observed brepocitinib 30 mg safety profile was consistent with previous brepocitinib clinical trials. Adverse events of special interest (AESIs), which included malignancy, cardiovascular events, and thromboembolic events, did not occur with greater frequency in the brepocitinib 30 mg arm than the placebo arm.

“We are thrilled with the results of the VALOR study, and I would like to thank all of the patients, investigators, and study site staff who contributed to this important research achievement,” said Ben Zimmer, Priovant CEO. “We are excited to continue working towards the rapid approval of brepocitinib in dermatomyositis and our broader goal of developing brepocitinib as a transformational therapy for multiple highly morbid autoimmune diseases where the need for novel efficacious therapies is greatest.”

“The VALOR study is a hallmark example of what Roivant does best: identify a high value program with a differentiated mechanism of action, focus on creative development plans in indications like DM with high unmet need, and deliver on clinical execution excellence,” said Mayukh Sukhatme, Roivant President and Chief Investment Officer. “I am extremely proud of Roivant’s continued track record with VALOR as the 12th consecutive positive Phase 3 study for the company – an unparalleled achievement and a testament to Roivant’s unrelenting focus on clinical strategy and execution.”

Priovant plans to file an NDA for brepocitinib in dermatomyositis in the first half of 2026.

About Dermatomyositis
Dermatomyositis (DM) is a multi-organ idiopathic inflammatory condition that affects approximately 50,000 adults in the United States. DM is characterized by debilitating muscle weakness and skin lesions. DM-related muscle weakness causes significant impairment to daily living activities, such as walking up stairs, carrying groceries, and getting dressed. Dermatomyositis rashes often affect large portions of a patient's body including the scalp and are often disfiguring and painful. No targeted therapies are approved for DM, and a majority of patients require high-dose chronic oral corticosteroids.

About the VALOR Study
VALOR was the longest and largest interventional DM study ever conducted, enrolling 241 subjects globally. Subjects were randomized 1:1:1 to brepocitinib 30 mg, brepocitinib 15 mg and placebo, with one-year of double-blind treatment. The primary endpoint was the difference at week 52 between brepocitinib and placebo in mean Total Improvement Score (TIS), a composite endpoint of multiple measures of DM disease activity.

Investor Conference Call Information
Roivant will host a live conference call and webcast at 8:00 a.m. EDT on Wednesday, September 17, 2025, to discuss the Phase 3 results for brepocitinib in dermatomyositis. To access the conference call by phone, please register online using this registration link . The presentation and webcast details are available under “Events & Presentations” in the Investors section of the Roivant website at https://investor.roivant.com/news-events/events . The archived webcast will be available on Roivant’s website after the conference call.

About Priovant

Priovant Therapeutics is a biotechnology company dedicated to developing novel therapies for autoimmune diseases with high morbidity and few available treatment options. The company's lead asset is brepocitinib, a dual selective inhibitor of TYK2 and JAK1. Through dual TYK2/JAK1 inhibition, brepocitinib distinctively suppresses key cytokines linked to autoimmunity—including type I IFN, type II IFN, IL-6, IL-12, and IL-23—with a single, targeted, once-daily oral therapy. Brepocitinib recently generated positive Phase 3 data in dermatomyositis, and an NDA submission is planned for the first half of 2026. Brepocitinib is also being evaluated in non-infectious uveitis (Phase 3) and cutaneous sarcoidosis (Phase 2).

About Roivant
Roivant (Nasdaq: ROIV) is a biopharmaceutical company that aims to improve the lives of patients by accelerating the development and commercialization of medicines that matter. Roivant’s pipeline includes brepocitinib, a potent small molecule inhibitor of TYK2 and JAK1 in development for the treatment of dermatomyositis, non-infectious uveitis and cutaneous sarcoidosis; IMVT-1402 and batoclimab, fully human monoclonal antibodies targeting FcRn in development across several IgG-mediated autoimmune indications; and mosliciguat, an inhaled sGC activator in development for pulmonary hypertension associated with interstitial lung disease. We advance our pipeline by creating nimble subsidiaries or “Vants” to develop and commercialize our medicines and technologies. Beyond therapeutics, Roivant also incubates discovery-stage companies and health technology startups complementary to its biopharmaceutical business. For more information, visit https://roivant.com .

Roivant Forward-Looking Statements
This press release contains forward-looking statements. Statements in this press release may include statements that are not historical facts and are considered forward-looking within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”), and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), which are usually identified by the use of words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “should,” “would” and variations of such words or similar expressions. The words may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. We intend these forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Exchange Act.

Our forward-looking statements include, but are not limited to, statements regarding our or our management team’s expectations, hopes, beliefs, intentions or strategies regarding the future, and statements that are not historical facts, including statements about the clinical and therapeutic potential of our product candidates, the availability and success of topline results from our ongoing clinical trials and any commercial potential of our product candidates following applicable regulatory approvals. In addition, any statements that refer to projections, forecasts or other characterizations of future events, results or circumstances, including any underlying assumptions, are forward-looking statements. Actual results may differ materially from those contemplated in these statements due to a variety of risks, uncertainties and other factors.

Although we believe that our plans, intentions, expectations and strategies as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a number of risks, uncertainties and assumptions, including, but not limited to, those risks set forth in the Risk Factors section of our filings with the U.S. Securities and Exchange Commission. Moreover, we operate in a very competitive and rapidly changing environment in which new risks emerge from time to time. These forward-looking statements are based upon the current expectations and beliefs of our management as of the date of this press release, and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Except as required by applicable law, we assume no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

NANAIMO, British Columbia, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), a leading lifestyle and consumer-packaged goods company, announced that its premium craft cannabis brand Broken Coast is launching BC Selects, a new limited-edition line of premium cannabis flower that features unique phenotypes from its proprietary genetic library. The first strain in this series, Sprits 26 , is now available exclusively in British Columbia, underscoring Broken Coast’s dedication to precision and excellence in craft cannabis production.

BC Selects exemplifies Broken Coast’s highest standard of phenotype selection, providing consumers with access to small-batch, non-irradiated flower selected for their exceptional qualities, including dense cola structure, abundant trichomes, and pronounced terpene profiles. Each release in this series will be exclusive and limited, underscoring Broken Coast’s commitment to prioritizing quality over quantity.

Sprits 26 (the 26th phenotype from a Spritzer lineage) delivers a balanced hybrid experience with a minty, earthy profile and a sweet, gassy finish. It features 28–34% THC , 2–5% terpene content , and dominant terpenes including nerolidol, caryophyllene, and geranyl acetate . Available in 3.5 g whole flower , Sprits 26 sets the tone for future BC Selects product drops.

Alongside the BC Selects debut, Broken Coast is introducing a modern expression of Blue Dream in 7 g whole flower and 3 × 0.5 g pre-roll formats . This pheno-hunted, small batch version of the iconic cultivar preserves its classic sweet blueberry and herbal notes while delivering contemporary consistency and structure through Broken Coast’s hallmark indoor, hand trimmed, slow cured process.

“BC Selects is about pushing the boundaries of craft,” said Blair MacNeil, President, Tilray Canada. “By curating the most exceptional phenotypes from hundreds of in‑house genetics, we’re giving consumers access to strains that truly represent the pinnacle of Broken Coast’s cultivation expertise.”

Products will be available through authorized retailers and provincial online stores beginning this month; availability and formats vary by province.

About Broken Coast

Broken Coast is raising the standard for craft cannabis through the relentless pursuit of purity. It’s late nights. It’s long days. It’s an incurable obsession with pursuing the purest, most quintessential expression of the plant that began in 2013 on the pristine coast of Vancouver Island and continues to inspire us every single day.

For us, striving for purity isn’t a sprint – it’s an infinite marathon. We believe patience is a virtue and we know real quality can’t be rushed. That’s why we take our time phenohunting through thousands of plants, unsatisfied until we discover the most exceptional expressions of genetics. It’s why we monitor our grow rooms for temperature, airflow, nutrition, and humidity. And why we adhere to strict procedural and environmental protocols to maximize purity, quality, and customer satisfaction.

This uncompromising, unrelenting pursuit ensures we grow big, beautiful buds that deliver quality you can see, smell and taste. Creating pristine, high-quality cannabis takes care and time, which is why we take ours in the pursuit of purity.

For more about Broken Coast, visit brokencoast.com and follow @BrokenCoastCanada on Instagram.

About Tilray Brands

Tilray Brands, Inc. (“Tilray”) (Nasdaq: TLRY; TSX: TLRY), is a leading global lifestyle and consumer packaged goods company with operations in Canada, the United States, Europe, Australia, and Latin America that is leading as a transformative force at the nexus of cannabis, beverage, wellness, and entertainment, elevating lives through moments of connection. Tilray’s mission is to be a leading premium lifestyle company with a house of brands and innovative products that inspire joy and create memorable experiences. Tilray’s unprecedented platform supports over 40 brands in over 20 countries, including comprehensive cannabis offerings, hemp-based foods, and craft beverages.

Products under the Broken Coast brand are promoted and sold by Tilray’s wholly-owned subsidiary, Aphria Inc.

For more information on how we are elevating lives through moments of connection, visit Tilray.com and follow @Tilray on all social platforms.

Forward-Looking Statements

Certain statements in this communication that are not historical facts constitute forward-looking information or forward-looking statements (together, “forward-looking statements”) under Canadian and U.S. securities laws and within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, that are intended to be subject to the “safe harbor” created by those sections and other applicable laws. Forward-looking statements can be identified by words such as “forecast,” “future,” “should,” “could,” “enable,” “potential,” “contemplate,” “believe,” “anticipate,” “estimate,” “plan,” “expect,” “intend,” “may,” “project,” “will,” “would” and the negative of these terms or similar expressions, although not all forward-looking statements contain these identifying words. Certain material factors, estimates, goals, projections, or assumptions were used in drawing the conclusions contained in the forward-looking statements throughout this communication. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses, or current expectations concerning, among other things, the Company’s ability to commercialize new and innovative products worldwide. Many factors could cause actual results, performance, or achievement to be materially different from any forward-looking statements, and other risks and uncertainties not presently known to the Company or that the Company deems immaterial could also cause actual results or events to differ materially from those expressed in the forward-looking statements contained herein. For a more detailed discussion of these risks and other factors, see the most recently filed annual information form of Tilray and the Annual Report on Form 10-K (and other periodic reports filed with the SEC) of Tilray made with the SEC and available on EDGAR. The forward-looking statements included in this communication are made as of the date of this communication and Tilray does not undertake any obligation to publicly update such forward-looking statements to reflect new information, subsequent events, or otherwise unless required by applicable securities laws.

Contacts:
Media: [email protected]
Investors: [email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/b23b0cc6-06c8-4ec0-ac66-691b8a808b7a

Organizational restructuring including a 50% reduction in workforce that is anticipated to result in annualized cost savings of approximately $13M

John Volpone appointed Chief Operating Officer, in addition to his current role as President

Dr. Adam Craig, Executive Chairman, to have oversight over clinical development

BOSTON, Sept. 17, 2025 (GLOBE NEWSWIRE) -- X4 Pharmaceuticals (Nasdaq: XFOR), a company driven to improve the lives of people with rare hematology diseases, today announced a strategic restructuring designed to sharpen operational focus and align resources with the Company’s long‑term strategy to successfully complete the 4WARD Phase 3 trial in patients with moderate and severe chronic neutropenia.

As part of this initiative, X4 will reduce its workforce by 50%, a step anticipated to result in annualized cost savings of approximately $13 million.

Corporate Updates

• John Volpone has been appointed Chief Operating Officer (COO), in addition to his current role as President. In this expanded role, Mr. Volpone will oversee day‑to‑day operational management and business execution across the Company.
• Dr. Adam Craig, Executive Chairman, will oversee clinical development.
• As part of the workforce reduction, Natasha Thoren, Chief Legal & Compliance Officer; Mary DiBiase, Chief Operating Officer; and Mark Baldry, Chief Commercial Officer will be exiting the Company.
• Dr. Christophe Arbet‑Engels, MD, PhD, Chief Medical Officer, is resigning for personal reasons and will remain available to support transition activities.

“The new X4 management team has taken the first step in streamlining the organization to effectively execute and complete the 4WARD Phase 3 trial,” said Dr. Adam Craig, Executive Chairman of X4. “Over the coming weeks, we plan to continue to drive operational efficiencies, consolidate resources, and strengthen our leadership structure. With these changes, we expect to be well positioned to become a world‑class hematology company, beginning with the advancement of mavorixafor into chronic neutropenia. We remain deeply grateful to our dedicated team for their hard work and commitment during this period of transformation.”

About X4 Pharmaceuticals
X4 is delivering progress for patients by developing and commercializing innovative therapies for those with rare hematology diseases and significant unmet needs. Leveraging expertise in CXCR4, X4 has successfully developed mavorixafor, an orally available CXCR4 antagonist that is currently being marketed in the U.S. as XOLREMDI ^® in its first indication. The company is also evaluating additional uses of mavorixafor and is conducting a global, pivotal Phase 3 clinical trial ( 4WARD ) in people with certain chronic neutropenic disorders. X4 is headquartered in Boston, Massachusetts. For more information, please visit www.x4pharma.com .

X4 Forward Looking Statements
This press release contains forward-looking statements within the meaning of applicable securities laws, including the Private Securities Litigation Reform Act of 1995, as amended. These statements may be identified by the words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target,” or other similar terms or expressions that concern X4’s expectations, strategy, plans, or intentions. Forward-looking statements include, without limitation, implied or express statements regarding the expected cost savings from the workforce reduction, the expected results of the restructuring of business operations and future plans for the Company. Any forward-looking statements in this press release are based on management’s current expectations and beliefs. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond X4’s control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: the workforce reduction does not result in the anticipated cost savings described herein; the results of the restructuring of business operations are not as anticipated; and other risks and uncertainties, including those described in the section entitled “Risk Factors” in X4’s most recent Annual Report on X4’s Form 10-K, as well as in other filings X4 makes with the Securities and Exchange Commission, including its quarterly report on Form 10-Q, from time to time. X4 undertakes no obligation to update the information contained in this press release to reflect new events or circumstances, except as required by law.

X4 Investor Contact:
Candice Masse
astr partners
[email protected]

Denifanstat met all primary and secondary endpoints versus placebo

Denifanstat was generally well tolerated

Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, for development in acne

SAN MATEO, Calif., Sept. 17, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported that data from a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet’s license partner Ascletis Bioscience Co. Ltd. (Ascletis) will be presented at the European Academy of Dermatology and Venerology (EADV) 2025 Congress taking place September 17-20, 2025 in Paris, France. Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of world.

The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled, multicenter clinical trial in China to evaluate the safety and efficacy of denifanstat for the treatment of patients with moderate to severe acne, defined as Investigator’s Global Assessment (IGA) scores of 3 and 4. This trial enrolled 480 patients who were randomized 1:1 into two treatment arms to receive denifanstat 50mg or placebo, once daily for 12 weeks. Primary endpoints included the percentage of treatment success (defined as an IGA score of 0 (clear) or 1 (almost clear) with at least a 2-point decrease from baseline), the percentage change in total lesion count, and the percentage change in inflammatory lesion count. Denifanstat met all primary and secondary endpoints and was generally well tolerated.

EADV Oral Presentation Details:

“FASN inhibition represents a novel mechanism of action for the treatment of acne, a condition that impacts more than 50 million people in the U.S. annually, with limited innovation over the last 40 years,” said David Happel, Chief Executive Officer of Sagimet. “While Ascletis continues to advance denifanstat for approval in China, Sagimet initiated a Phase 1 first-in-human clinical trial with a second FASN inhibitor, TVB-3567, that we plan to develop as a novel therapeutic option for patients with moderate to severe acne.”

About Sagimet Biosciences

Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet has recently initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S. For additional information about Sagimet, please visit www.sagimet.com .

About Acne

There are 5.1 million acne patients treated by dermatologists annually in the U.S., and a total U.S. acne market of over 50 million people. ^1,2 There is no cure for acne; and due to its pathology, most patients require chronic management and multiple courses of treatment for flare control annually. Additionally, adherence to topical therapies is lower than with oral agents, with an estimated 30% to 40% of patients not adhering to their topical treatments. ³

1. Bickers DR, et al. J Am Acad Dermatol . 2006;55(3):490-500.
2. American Academy of Dermatology. Burden of Skin Disease. 2017. www.aad.org/BSD.
3. Purvis CG, Balogh EA, Feldman SR. Clascoterone: How the Novel Androgen Receptor Inhibitor Fits Into the Acne Treatment Paradigm. Ann Pharmacother. 2021;55(10):1297-1299. doi:10.1177/1060028021992055.
   
   

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding: the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions.

The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates Sagimet may develop; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements; and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov . You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Investor Contact:
Joyce Allaire
LifeSci Advisors
[email protected]

Media Contact:
Michael Fitzhugh
LifeSci Advisors
[email protected]

WALTHAM, Mass., Sept. 17, 2025 (GLOBE NEWSWIRE) -- TScan Therapeutics, Inc. (Nasdaq: TCRX), a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer, today announced the acceptance of two abstracts, one as an oral presentation and another as a poster presentation, at the upcoming American College of Rheumatology (ACR) Convergence 2025 being held October 24 – 29 in Chicago, IL.

“While we remain focused on oncology, our proprietary TargetScan technology is also well suited for identifying novel targets in T cell-driven autoimmune disorders,” said Gavin MacBeath, Ph.D., Chief Executive Officer. “We are excited to present our initial findings at the upcoming ACR Convergence. Among other discoveries, we believe we have identified several shared T-cell targets in Ankylosing Spondylitis. Therapeutic targets for AS have remained elusive despite decades of research and these recent novel discoveries, which are critical to advancing the next generation of therapeutics for autoimmune disorders, highlight the power of our TargetScan technology.”

Oral Presentation Details:

Title: TargetScan Platform Identifies Targets of CD8+ T cells in Ankylosing Spondylitis and Birdshot Uveitis
Authors: Adam Weinheimer, Olivia Pryor, Catalina Burbano, Tyler Heath, Livio Dukaj, Shoshana Bloom, Jackson Lirette, Alexander Cristofaro, Laurie Barefoot, Shrikanta Chattopadhyay, Andrew Ferretti, Cagan Gurer
Abstract Number: 0888
Session Name: Abstracts: T Cell Biology & Targets in Autoimmune & Inflammatory Disease
Session Date/Time: Monday, October 27; 10:00 - 11:30 a.m. Central Time
Presentation Time: 10:45 - 11:00 a.m. Central Time
Location: Poster Hall

Poster Presentation Details:

Title: Identification of Novel HLA Class II–Restricted Autoantigens in Scleroderma and Ulcerative Colitis Using TargetScan
Authors: Olivia Pryor, Catalina Burbano, Nathaniel Bagge, Rutuja Kulkarni, Heather F Jones, Livio Dukaj, Shoshana Bloom, Jackson Lirette, Candace Perullo, Jinyu Zhu, Teagan Parsons, Ira Jain, Rakshika Balasubramaniyam, Kenneth L Jahan, Vivin Karthik, Alexander Cristofaro, Laurie Barefoot, Shrikanta Chattopadhyay, Kim M Cirelli, Mollie M Jurewicz, Andrew Ferretti, Cagan Gurer
Abstract Number: 0997
Session Name: T Cell Biology & Targets in Autoimmune & Inflammatory Disease Poster
Session Date/Time: Monday, October 27; 10:30 a.m. - 12:30 p.m. Central Time
Location: Poster Hall

A copy of the presentation materials will be added to the “ Publications ” section of the Company’s website at tscan.com once presentations have concluded.

About TScan Therapeutics, Inc.

TScan is a clinical-stage biotechnology company focused on the development of T cell receptor (TCR)-engineered T cell (TCR-T) therapies for the treatment of patients with cancer. The Company’s lead TCR-T therapy candidates are in development for the treatment of patients with hematologic malignancies to prevent relapse following allogeneic hematopoietic cell transplantation (the ALLOHA™ Phase 1 heme trial). The Company has developed and continues to expand its ImmunoBank, the Company’s repository of therapeutic TCRs that recognize diverse targets and are associated with multiple HLA types, to provide customized multiplex TCR-T therapies for patients with a variety of cancers (the PLEXI-T™ Phase 1 solid tumor trial). The Company is currently enrolling patients into both clinical programs.

Forward-Looking Statements

This release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including, but not limited to, express or implied statements regarding the Company’s plans, progress, expectations, and timing relating to the Company’s autoimmune disorders program, including but not limited to, identification of targets; the progress of the autoimmune disorders program being indicative or predictive of the success of such program; the Company’s current and future research and development plans or expectations; and the potential benefits of any of the Company’s proprietary platforms, multiplexing, or current or future product candidates in treating patients. TScan intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as, but not limited to, “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “anticipate,” “project,” “target,” “design,” “estimate,” “predict,” “potential,” “plan,” “on track,” or similar expressions or the negative of those terms. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions, and uncertainties. The express or implied forward-looking statements included in this release are only predictions and are subject to a number of risks, uncertainties and assumptions, including, without limitation: TScan’s expectations regarding its preclinical studies being predictive of clinical trial results; the timing of the launch, initiation, progress, expected results and announcements of TScan’s preclinical studies, clinical trials and its research and development programs; TScan’s plans relating to developing and commercializing its TCR-T therapy product candidates, if approved, including sales strategy; estimates of the size of the addressable market for TScan’s TCR-T therapy product candidates; TScan’s manufacturing capabilities and the scalable nature of its manufacturing process; TScan’s estimates regarding expenses, future milestone payments and revenue, capital requirements and needs for additional financing; TScan’s expectations regarding competition; TScan’s anticipated growth strategies; TScan’s ability to attract or retain key personnel; TScan’s ability to establish and maintain development partnerships and collaborations; TScan’s expectations regarding federal, state and foreign regulatory requirements; TScan’s ability to obtain and maintain intellectual property protection for its proprietary platform technology and our product candidates; the sufficiency of TScan’s existing capital resources to fund its future operating expenses and capital expenditure requirements; and other factors that are described in the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of TScan’s most recent Annual Report on Form 10-K and any other filings that TScan has made or may make with the SEC in the future. Any forward-looking statements contained in this release represent TScan’s views only as of the date hereof and should not be relied upon as representing its views as of any subsequent date. Except as required by law, TScan explicitly disclaims any obligation to update any forward-looking statements.

Contacts

Heather Savelle
TScan Therapeutics, Inc.
VP, Investor Relations
857-399-9840
[email protected]

Melissa Forst
Argot Partners
212-600-1902
[email protected]

NEW YORK, Sept. 17, 2025 (GLOBE NEWSWIRE) -- Axsome Therapeutics, Inc. (NASDAQ: AXSM), a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) disorders, today announced six presentations across its broad portfolio of innovative neuroscience products and product candidates at Psych Congress 2025, being held September 17 - 21, 2025, in San Diego, California.

Details of the presentations are as follows:

Major Depressive Disorder

• Title: Initiating Auvelity ^® (dextromethorphan 45 mg-bupropion 105 mg) in Patients with Major Depressive Disorder: Expert Panel Consensus Recommendations
  Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
  Lead Author: Anita H. Clayton, MD, Professor and Chair of Psychiatry and Neurobehavioral Sciences at the University of Virginia School of Medicine
  Poster Number: 184

Alzheimer’s Disease Agitation

• Title: Efficacy and Safety of AXS-05 in Alzheimer's Disease Agitation: Results From ACCORD-2, a Phase 3 Randomized Withdrawal Double-Blind Placebo-Controlled Study
  Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
  Lead Author: Jeffrey Cummings, MD, ScD, Vice Chair of Research, UNLV Department of Brain Health
  Poster Number: 47

Narcolepsy

• Title: Impact of AXS-12 on Symptom Severity and Functional Impairment in Narcolepsy: Results from the Phase 3 SYMPHONY Trial
  Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
  Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
  Poster Number: 118

• Title: ENCORE: Topline Results of a Phase 3 Open-Label Extension and Randomized-Withdrawal Trial of AXS-12 in Narcolepsy
  Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
  Lead Author: Richard Bogan, MD, FCCP, FAASM, Associate Clinical Professor at the University of South Carolina School of Medicine in Columbia, SC
  Poster Number: 42

• Title: Residual Symptom Burden in Patients with Narcolepsy Satisfied with Treatment: Subgroup Analysis from the CRESCENDO Survey
  Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
  Lead Author: Michael Thorpy, MD, Director of the Sleep-Wake Disorders Center at the Montefiore Medical Center and Professor of Neurology at Albert Einstein College of Medicine, New York, NY
  Poster Number: 110

Obstructive Sleep Apnea (OSA)

• Title: Effects of Solriamfetol on Neuropsychological Outcomes in Patients with Obstructive Sleep Apnea in the Real-World SURWEY Study
  Presentation Date and Time: Friday, September 19, 1:30 - 3:00 p.m. and 6:00 - 7:15 p.m.; Saturday, September 20, 1:30 - 3:00 p.m. PT
  Lead Author: Yaroslav Winter, MD, Mainz Comprehensive Epilepsy and Sleep Medicine Center, Department of Neurology, Johannes Gutenberg-University, Mainz, Germany
  Poster Number: 116

About Axsome Therapeutics

Axsome Therapeutics is a biopharmaceutical company leading a new era in the treatment of central nervous system (CNS) conditions. We deliver scientific breakthroughs by identifying critical gaps in care and develop differentiated products with a focus on novel mechanisms of action that enable meaningful advancements in patient outcomes. Our industry-leading neuroscience portfolio includes FDA-approved treatments for major depressive disorder, excessive daytime sleepiness associated with narcolepsy and obstructive sleep apnea, and migraine, and multiple late-stage development programs addressing a broad range of serious neurological and psychiatric conditions that impact over 150 million people in the United States. Together, we are on a mission to solve some of the brain’s biggest problems so patients and their loved ones can flourish. For more information, please visit us at www.axsome.com and follow us on LinkedIn and X .

Forward-Looking Statements

Certain matters discussed in this press release are “forward-looking statements”. The Company may, in some cases, use terms such as “predicts,” “believes,” “potential,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. In particular, the Company’s statements regarding trends and potential future results are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the commercial success of the Company’s SUNOSI ^® , AUVELITY ^® , and SYMBRAVO ^® products and the success of the Company’s efforts to obtain any additional indication(s) with respect to solriamfetol and/or AXS-05; the Company’s ability to maintain and expand payer coverage; the success, timing and cost of the Company’s ongoing clinical trials and anticipated clinical trials for the Company’s current product candidates, including statements regarding the timing of initiation, pace of enrollment and completion of the trials (including the Company’s ability to fully fund the Company’s disclosed clinical trials, which assumes no material changes to the Company’s currently projected revenues or expenses), futility analyses and receipt of interim results, which are not necessarily indicative of the final results of the Company’s ongoing clinical trials, and/or data readouts, and the number or type of studies or nature of results necessary to support the filing of a new drug application (“NDA”) for any of the Company’s current product candidates; the Company’s ability to fund additional clinical trials to continue the advancement of the Company’s product candidates; the timing of and the Company’s ability to obtain and maintain U.S. Food and Drug Administration (“FDA”) or other regulatory authority approval of, or other action with respect to, the Company’s product candidates, including statements regarding the timing of any NDA submission; the Company’s ability to successfully defend its intellectual property or obtain the necessary licenses at a cost acceptable to the Company, if at all; the Company’s ability to successfully resolve any intellectual property litigation, and even if such disputes are settled, whether the applicable federal agencies will approve of such settlements; the successful implementation of the Company’s research and development programs and collaborations; the success of the Company’s license agreements; the acceptance by the market of the Company’s products and product candidates, if approved; the Company’s anticipated capital requirements, including the amount of capital required for the commercialization of SUNOSI, AUVELITY, and SYMBRAVO and for the Company’s commercial launch of its other product candidates, if approved, and the potential impact on the Company’s anticipated cash runway; the Company’s ability to convert sales to recognized revenue and maintain a favorable gross to net sales; unforeseen circumstances or other disruptions to normal business operations arising from or related to domestic political climate, geo-political conflicts or a global pandemic and other factors, including general economic conditions and regulatory developments, not within the Company’s control. The factors discussed herein could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

Investors:
Ashley Dong
Director, Investor Relations
(929) 687-1614
[email protected]

Media:
Darren Opland
Senior Director, Corporate Communications
(929) 837-1065
[email protected]