Quiver News

NVIDIA Connect Supports Advanced Technology Companies Developing AI-powered Products

Part of NVIDIA’s Connect Program is to Promote, Assist, and Identify Go-To-Market Opportunities

SKYX Expects to Include its All-In-One Smart Platform and Hub, in Collaboration with NVIDIA’s AI Features, in Future U.S. and Global Projects, Including the Upcoming $4 Billion Miami, Florida Smart City

NVIDIA Connect is Designed to Help Build AI Solutions Faster, Accelerate Growth, and Maximize Opportunities while Delivering a Range of Significant AI Ecosystem Advantages, as Well as Free Benefits

SKYX’s Technologies Expansion Provides Additional Opportunities for Future Recurring Revenues, AI Services, Monitoring, and Subscriptions Through Interchangeability and Upgrades, Among Others

MIAMI, Jan. 08, 2026 (GLOBE NEWSWIRE) -- SKYX Platforms Corp. (NASDAQ: SKYX) (d/b/a SKYX Technologies) (the “Company” or “SKYX”), a highly disruptive smart home platform technology company with over 100 pending and issued patents globally and over 60 lighting and home décor websites, with a mission to make homes and buildings become safe and smart as the new standard, today announced it has joined the NVIDIA Connect Program, gaining access to NVIDIA’s cloud and AI ecosystem to support the development of SKYX’s all-in-one smart home platform and hub, as well as its broader portfolio of advanced smart home products.

SKYX’s all-in-one smart home platform and hub comprises numerous safety, security, and smart home features including Wi-Fi and repeaters, AI ecosystem, voice, and app controls, 911 emergency calling feature, smoke and CO detectors, thermostat, speakers, room-to-room intercom, emergency light, safety night light, color changing light, among others.

The NVIDIA Connect Program, cloud, and AI ecosystem accelerates and offers significant advantages for SKYX’s all-in-one smart home platform and hub including the following:

• Access to NVIDIA's world-class GPU-accelerated AI development ecosystem, including advanced frameworks for speech recognition, anomaly detection, real-time analytics, and scalable cloud inference.
• Advances the Company's vision of transforming the ceiling into the AI-powered brain of the home, enabling the all-in-one SKYX platform to deliver intelligence across six distinct domains, such as voice, audio, safety, environmental, behavioral, and predictive.
• Powers a secure, privacy-first cloud infrastructure leveraging NVIDIA's GPU and DPU technologies to process anonymized device data, enabling fleet-wide learning while ensuring enterprise-grade security and data protection.
• Supports the Company's long-term roadmap, including next-generation safety intelligence, computer vision, healthcare applications such as elderly monitoring and fall detection, and whole-home connectivity through Wi-Fi mesh extension, Matter protocol and capabilities.
• Joining a global ecosystem of AI innovators leveraging NVIDIA technology, reinforcing SKYX's commitment to delivering the most intelligent and comprehensive smart home platform available.

SKYX Patented All-In-One Smart Home Platform and Hub

Khadija Mustafa, SKYX’s Senior AI Advisor and former Global Business & AI leader at Microsoft & G42, said; “This is a significant development that positions SKYX to lead the smart, safe home and AI solutions category. Since joining SKYX as Lead AI Advisor, our focus has been on expanding the company’s AI opportunities and capabilities. Aligning with NVIDIA and its programs was a top priority from the outset. NVIDIA’s Connect Program and broader AI ecosystem provide SKYX with meaningful advantages to accelerate innovation, strengthen differentiation, and lead the advanced smart and safe home segment. Combined with SKYX’s progress in home safety standardization, this collaboration has the potential to be truly game-changing for homes and buildings.”

Rani Kohen, Founder and Executive Chairman of SKYX, said; “This is a significant and very exciting development for SKYX. The NVIDIA Program gives us a tremendous advantage toward our safe and smart home goal. Utilizing NVIDIA’s programs and the benefits of its Connect and AI ecosystem can be game changing for our Company and Shareholders.”

For SKYX All-In-One Smart Platform and Hub Video Demo: Click Here

About SKYX Platforms Corp.

• For more information about SKYX Platforms Corp. go to SKYX.com
• As electricity is a standard in every home and building, our mission is to make homes and buildings become safe-advanced and smart as the new standard. SKYX has a series of highly disruptive advanced-safe-smart platform technologies, with over 100 U.S. and global patents and patent pending applications. Additionally, the Company owns over 60 lighting and home decor websites for both retail and commercial segments. Our technologies place an emphasis on high quality and ease of use, while significantly enhancing both safety and lifestyle in homes and buildings. We believe that our products are a necessity in every room in both homes and other buildings in the U.S. and globally. For more information, please visit our website at https://skyplug.com/ or follow us on LinkedIn .
• SKYX’s technologies provide opportunities for recurring revenues through interchangeability, upgrades, AI services monitoring, and subscriptions. Company is focused on the “Razor & Blades” model and its product range includes its advanced ceiling electrical outlet (Razor) and its advance and smart home plug & play products (Blades) including its advance and smart home plug & play platform products, lighting, recessed lights, down lights, EXIT signs, emergency lights, ceiling fans, chandeliers/pendants, holiday/kids/themes lights, indoor/outdoor wall lights among other. Company’s plug & play technology enables an installation of lighting, fans, and smart home products in high-rise buildings and hotels within days rather than months.
• Company’s total addressable market (TAM) in the U.S. is roughly $500 billion with over 4.2 billion ceiling applications in the U.S. alone. Expected revenue streams from retail and professional segments include product sales, royalties, licensing, subscription, monitoring, and sale of global country rights.

Forward-Looking Statements

Certain statements made in this press release are not based on historical facts, but are forward-looking statements. These statements can be identified by the use of forward-looking terminology such as “aim,” “anticipate,” “believe,” “can,” “could,” “continue,” “estimate,” “expect,” “evaluate,” “forecast,” “guidance,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “outlook,” “plan,” “potential,” “predict,” “probable,” “project,” “seek,” “should,” “target” “view,” “will,” or “would,” or the negative thereof or other variations thereon or comparable terminology, although not all forward-looking statements contain these words. These statements reflect the Company’s reasonable judgment with respect to future events and are subject to risks, uncertainties and other factors, many of which have outcomes difficult to predict and may be outside our control, that could cause actual results or outcomes to differ materially from those in the forward-looking statements. Such risks and uncertainties include statements relating to the Company’s ability to successfully launch, commercialize, develop additional features and achieve market acceptance of its products and technologies and integrate its products and technologies with First-party platforms or technologies; the Company’s efforts and ability to drive the adoption of its products and technologies as a standard feature, including their use in homes, hotels, offices and cruise ships; the Company’s ability to capture market share; the Company’s estimates of its potential addressable market and demand for its products and technologies; the Company’s ability to raise additional capital to support its operations as needed, which may not be available on acceptable terms or at all; the Company’s ability to continue as a going concern; the Company’s ability to execute on any sales and licensing or other strategic opportunities; the possibility that any of the Company’s products will become National Electrical Code (NEC)-code or otherwise code mandatory in any jurisdiction, or that any of the Company’s current or future products or technologies will be adopted by any state, country, or municipality, within any specific timeframe or at all; risks arising from mergers, acquisitions, joint ventures and other collaborations; the Company’s ability to attract and retain key executives and qualified personnel; guidance provided by management, which may differ from the Company’s actual operating results; the potential impact of unstable market and economic conditions, including recent measures adopted by the federal government, on the Company’s business, financial condition, and stock price; and other risks and uncertainties described in the Company’s filings with the Securities and Exchange Commission, including its periodic reports on Form 10-K and Form 10-Q. There can be no assurance as to any of the foregoing matters. Any forward-looking statement speaks only as of the date of this press release, and the Company undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by U.S. federal securities laws.

Non-GAAP Financial Measures

Management considers earnings (loss) before interest, taxes, depreciation and amortization, or EBITDA, as adjusted, an important indicator in evaluating the Company’s business on a consistent basis across various periods. Due to the significance of non-recurring items, EBITDA, as adjusted, enables management to monitor and evaluate the business on a consistent basis. The Company uses EBITDA, as adjusted, as a primary measure, among others, to analyze and evaluate financial and strategic planning decisions regarding future operating investments and potential acquisitions. The Company believes that EBITDA, as adjusted, eliminates items that are not part of the Company’s core operations, such as interest expense and amortization expense associated with intangible assets, or items that do not involve a cash outlay, such as share-based payments and non-recurring items, such as transaction costs. EBITDA, as adjusted, should be considered in addition to, rather than as a substitute for, pre-tax income (loss), net income (loss) and cash flows used in operating activities. This non-GAAP financial measure excludes significant expenses that are required by GAAP to be recorded in the Company’s financial statements and is subject to inherent limitations. Investors should review the reconciliation of this non-GAAP financial measure to the comparable GAAP financial measure. Investors should not rely on any single financial measure to evaluate the Company’s business.

Investor Relations Contact:

Jeff Ramson
PCG Advisory
[email protected]

A photo accompanying this announcement is available at https://www.globenewswire.com/NewsRoom/AttachmentNg/13461e59-836b-4c5a-8676-e1f57b6cc2b2

DALLAS, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Beneficient (NASDAQ: BENF) (“Ben” or the “Company”), a technology-enabled platform providing exit opportunities and primary capital solutions and related trust and custody services to holders of alternative assets, today announced it has closed on the financing of an approximately $3 million primary capital commitment for Cork & Vines Fund I, LP (“Fund”), a fund managed by Cork & Vines GP, LP, an asset manager investing in opportunities within the premium experiential, luxury dining segment with a differentiated culinary and strategic wine program focus.

The transaction follows the Company’s initial GP Primary Capital transaction with Cork & Vines that closed in early 2025. In exchange for an interest in the Fund, the Fund received approximately $3 million in stated value of shares of the Company’s Resettable Convertible Preferred Stock (the “Preferred Stock”), which is convertible at the election of the holder into shares of the Company’s Class A common stock, subject to the terms and conditions of the transaction documents. As a result of the transaction, the collateral for the Company’s ExAlt loan portfolio is expected to increase by approximately $3 million of interests in alternative assets.

“We are excited by our second closing with Cork & Vines and the continued expansion of our GP Primary Capital Program,” said James Silk, Beneficient Interim CEO. “It’s a great way to start the new year as we work to continue to close transactions that drive shareholder value and enhance the value of the collateral backing our ExAlt loan portfolio.”

Beneficient’s GP Primary Commitment Program is focused on providing primary capital solutions and financing anchor commitments to general partners during their fundraising efforts while immediately deploying capital into our equity. Through the program, Beneficient seeks to help satisfy the up to $330 billion of potential demand for primary commitments to meet fundraising needs.

About Beneficient
Beneficient (Nasdaq: BENF) – Ben, for short – is on a mission to democratize the global alternative asset investment market by providing traditionally underserved investors − mid-to-high net worth individuals, small-to-midsized institutions and General Partners seeking exit options, anchor commitments and valued-added services for their funds− with solutions that could help them unlock the value in their alternative assets.

Its subsidiary, Beneficient Fiduciary Financial, L.L.C., received its charter under the State of Kansas’ Technology-Enabled Fiduciary Financial Institution (TEFFI) Act and is subject to regulatory oversight by the Office of the State Bank Commissioner.

For more information, visit www.trustben.com or follow us on LinkedIn .

Contacts
Matt Kreps: 214-597-8200, [email protected]
Michael Wetherington: 214-284-1199, [email protected]
Investor Relations: [email protected]

Forward Looking Statements
Except for the historical information contained herein, the matters set forth in this press release are forward-looking statements within the meaning 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 Transactions. The words ”anticipate,” "believe,” ”continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” ”plan,” “possible,” “potential,” “predict,” “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. Forward-looking statements are based on our management’s beliefs, as well as assumptions made by, and information currently available to, them. Because such statements are based on expectations as to future financial and operating results and are not statements of fact, actual results may differ materially from those projected.

Important factors that could cause actual results to differ materially from those expressed in the forward-looking statements include, among others: the ultimate outcome of the Transactions, including obtaining the requisite vote of securityholders, and the risks, uncertainties, and factors set forth under “Risk Factors” in the Company’s most recent Annual Report on Form 10-K and its subsequently filed Quarterly Reports on Form 10-Q. Forward-looking statements speak only as of the date they are made. The Company assumes no obligation to update forward-looking statements to reflect actual results, subsequent events, or circumstances or other changes affecting such statements except to the extent required by applicable law.

Forward-looking statements speak only as of the date they are made. Readers are cautioned not to put undue reliance on forward-looking statements, and, except as required by law, the Company assumes no obligation and does not intend to update or revise these forward-looking statements, whether as a result of new information, future events, or otherwise.

RENO, Nev., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Dragonfly Energy Holdings Corp. (Nasdaq: DFLI) (“Dragonfly Energy” or the “Company”), an industry leader in energy storage, today issued a Year-End Letter to Shareholders from its Chief Executive Officer and President, Dr. Denis Phares.

Dear DFLI Shareholders,

2025 marked an important inflection point in Dragonfly Energy’s history. We greatly improved our balance sheet, expanded our OEM footprint, and secured critical validation in heavy-duty trucking, including a commercial deployment from Werner Enterprises following a successful real-world pilot of our advanced idle-reduction power systems. These achievements helped us return to year-over-year revenue growth and position us to execute on the vision that drove us to become a public company three years ago.

The mission and strategy of the company have not changed. We aim to revolutionize energy storage through manufacturing innovations that will enable widespread adoption of Lithium-ion batteries, while also enabling domestic production. We are accomplishing these goals by engineering and assembling smart storage systems that we market and sell into focused high value commercial sectors, including RV, marine, rail, and trucking– leveraging an established brand demonstrating consistent execution.

We have taken decisive action in response to the tumultuous three years since we became a public company, characterized by inflation, rising interest rates, tariff uncertainties, and overseas price manipulation, all of which created an environment that stifled revenue growth and profitability. Operationally, we shifted our focus toward near-term revenue generating opportunities and effective cash management, accelerating commercial product development. On the capital structure side, we executed a comprehensive restructuring that reshaped our balance sheet. In the second half of 2025, we raised approximately $90 million through three common stock offerings and successfully negotiated a debt restructuring with our lenders, which included a $45 million cash prepayment, the conversion of $25 million of debt to equity, and the forgiveness of $5 million from the principal balance of the loan. Our total debt principal now stands at just $19 million with a significantly lower interest rate and extended covenant flexibility through 2026. As a result of this restructuring, we have emerged in a much stronger financial position to accomplish what we set out to achieve when we decided to become a public company in 2022.

I believe these actions represent a pivotal turning point for the company. For the majority of 2025, we were out of compliance with Nasdaq listing standards. After a panel review in June, we received an extension until November 10 and we were given a number of remediation tasks: 1) convert all outstanding preferred equity to common equity, 2) convert some portion of our senior debt to equity, 3) raise equity capital, and 4) have a reverse split approved by shareholders to ensure bid price compliance. Well in advance of November 10, we executed on all of these tasks and regained compliance on all standards - market cap, stockholder’s equity, and minimum bid price. I want to further address the reverse split that was completed in December. The optics of a reverse split are never ideal and can create near-term pressure on a stock. However, it is important to note this was a technical requirement by Nasdaq that addressed compliance to remain listed since our stock price had once again fallen below $1.00.

We are not the same company as last year having significantly strengthened the balance sheet and returned to year-over-year growth. We ended the year in a much stronger financial position, and I have never been more confident in the future prospects of the company.

As many of our investors are aware, Dragonfly Energy is unique in its combination of fundamental R&D and brand-driven commercial sales. Our research broadly addresses the application of dry aerosol-based processes to the novel manufacture of battery electrodes, replacing the conventional wet slurry-based processes. These processes enable significant cost reduction in the production of conventional Lithium-ion batteries, validated by a third-party analysis completed by Sphere Energy, while also facilitating the low-cost production of cells having a composite all-solid-state electrolyte. Dragonfly Energy has been proactive in protecting these technologies through a growing global patent portfolio, which currently stands at nearly 100 filed, pending, or granted patents. Our IP portfolio reinforces our evolution into a complete power systems provider.

Dragonfly Energy is also unique in its focus on vertical integration. Many Western battery technology companies are either cell-focused without downstream system capabilities or pack-focused without in-house electrochemistry expertise, often relying on Asian partners for cell manufacturing. This is where we excel. We are already well-known as a battery pack and system provider, and our ability to vertically integrate upstream as a cell manufacturer provides an incredible opportunity for value creation. Having established a world-class laboratory assembled in collaboration with partners like Tescan and Bruker, a domestic supply chain with partners like Ioneer (Domestic Lithium Supply), and in-house intellectual property and cell manufacturing expertise, I believe Dragonfly Energy is one of the best-positioned companies outside of Asia to contribute to the entire value chain from raw materials to storage systems.

Taking a look at our end markets, The RV market endured a painful post-COVID correction, exacerbated by stubbornly high interest rates. But this is a notoriously cyclical market. From a long-term value perspective, the important metric for us is the penetration of Lithium as an integral part of any RV energy system. This is where we gained significant traction. Dragonfly Energy’s systems are becoming increasingly standard on both motorized and non-motorized rigs at OEMs such as Thor brands including Airstream, Tiffin, and Keystone; Forest River brands such as FR3, OGV Vans and Pause; REV Group brands including Renegade and Midwest Automotive; and other leading manufacturers such as Leisure Travel Vans, Ember, and nuCamp, among others. We saw a 45% year-over-year increase in our RV OEM business in Q3 2025. The industry as a whole was flat, but we continue to gain meaningful market share.

Three primary factors drove this success. First, our engineering expertise combined with our U.S.-based manufacturing footprint enables superior quality, reliability, and technical support while also strengthening and diversifying our supply chain in the face of ongoing geopolitical uncertainty. Second, we continue to innovate in collaboration with our OEM customers. Since we are not simply importing finished products, we can tune systems down to the component level to meet the specific needs of individual OEM customers. And finally, our expertise in cell electrochemistry and our technology roadmap resonate with our large OEM customers. We regularly share our technology and product roadmap to ensure that we are headed in the same direction as our customers.

And we replicated this success beyond the RV sector, strengthening our position in several other strategic markets. Heavy-duty trucking represents our most significant near-term growth opportunity. Last year, we co-authored a technical whitepaper with PACCAR, considered one of the last true American manufacturers in heavy-duty trucking, focused on idle reduction solutions and validating the performance and relevance of our technology. The paper puts additional focus on health and comfort of the driver benefits driven by this technology.

The application of our systems to heavy duty trucking was a natural progression of what we accomplished in RV. A long-haul trucker’s behavior is analogous to a full-time RVer’s: a house battery bank charges during the drive, while operating house appliances during rest periods. Historically, trucks had to idle continuously during rest periods, resulting in higher fuel costs, accelerated engine wear, and driver discomfort. Our DualFlow Power Pack and All-Electric APU products significantly reduce and often even eliminate idling, delivering immediate, quantifiable benefits. Eliminating idling is the low hanging fruit in the trucking market, with the potential to save the industry billions of dollars in fuel and engine maintenance. As full electrification has proven more difficult than anticipated, the focus of the industry has turned to practical improvements that can be implemented today. In this regard, our approach has resonated with fleets, which many described as a “no-brainer”.

However, fleets are cautious. They move slowly in trying and adopting new technologies since lost revenue associated with down trucks is not acceptable – especially in the middle of a historic freight recession. While a multitude of fleets agreed to trial our systems through long-duration trials, pilots start small and grow slowly as data is collected and analyzed to ensure safety, reliability, and ROI. When the benefits are certain and the cash is available, fleets move. And now that our delisting threat is eliminated, our balance sheet stabilized, and pilot programs are showing positive results, we believe we are in a stronger position to increase our sales in this market.

Werner, an industry bellwether with a 9000-truck fleet, is the first big domino to fall for us. After engaging with us for nearly two years, and immediately following our recent debt restructuring, Werner selected our systems for installation on its latest order of new trucks. As of this week, they are all installed and on the road. Moreover, the DualFlow product is not limited to new trucks. In fact, we have demonstrated ROI for installation on existing trucks in fleets as well. We look forward to announcing more wins in the trucking market, at which point we believe we will be able to provide revenue guidance that does not prematurely divulge the activities of individual large fleets.

And beyond heavy duty trucking, we also expanded into several other exciting end markets. In marine, World Cat, the world’s largest manufacturer of power catamarans, expanded Dragonfly Energy systems across additional models, reinforcing our reputation for reliability in demanding environments. And in the rail sector, we recently announced a distribution partnership with National Railway Supply following the approval of AREMA’s first lithium battery standard, a standard our team helped shape through years of participation. These milestones show that our technology is gaining traction across multiple industries at once.

While the difficult economy continues to present headwinds, we are bullish on our growth prospects for 2026 as we experience continued momentum in RV, trucking, and adjacent markets.

Finally, I would like to share with you my appreciation for the resilience and commitment of Dragonfly Energy employees. Like many small cap companies, we have been put through the ringer due to the macroeconomic stresses and uncertainties over the last few years. And, as a public company, our trials and tribulations are far more visible and open to scrutiny. Dragonfly Energy’s employees have demonstrated an incredible work ethic and commitment to the mission of the company under these difficult circumstances. We are far stronger now than we were three years ago. I am bullish on 2026 and beyond because of our revenue diversification, technology portfolio, strengthened balance sheet, and the momentum we are building across multiple end markets. We have positioned Dragonfly Energy to capitalize on significant market opportunities while driving towards profitability. We believe the foundation is set for sustained growth and long-term value creation.

About Dragonfly Energy

Dragonfly Energy Holdings Corp. (Nasdaq: DFLI) is a comprehensive lithium battery technology company, specializing in cell manufacturing, battery pack assembly, and full system integration. Through its renowned Battle Born Batteries® brand, Dragonfly Energy has established itself as a frontrunner in the lithium battery industry, with hundreds of thousands of reliable battery packs deployed in the field through top-tier OEMs and a diverse retail customer base. At the forefront of domestic lithium battery cell production, Dragonfly Energy’s patented dry electrode manufacturing process can deliver chemistry-agnostic power solutions for a broad spectrum of applications, including energy storage systems, electric vehicles, and consumer electronics. The Company’s overarching mission is the future deployment of its proprietary, nonflammable, all-solid-state battery cells.

To learn more about Dragonfly Energy and its commitment to clean energy advancements, visit investors.dragonflyenergy.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical statements of fact and statements regarding the Company’s intent, belief or expectations, including, but not limited to, statements regarding the Company’s current financial position and market preparedness, the Company’s future results of operations and financial position, planned products and services, business strategy and plans, market size and growth opportunities, competitive position and technological and market trends. Some of these forward-looking statements can be identified by the use of forward-looking words, including “may,” “should,” “expect,” “intend,” “will,” “estimate,” “anticipate,” “believe,” “predict,” “plan,” “targets,” “projects,” “could,” “would,” “continue,” “forecast” or the negatives of these terms or variations of them or similar expressions.

These forward-looking statements are subject to risks, uncertainties, and other factors (some of which are beyond the Company’s control) which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Such factors include those set forth in the sections entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2024, and in the Company’s subsequent filings with the SEC available at www.sec.gov. If any of these risks materialize or any of the Company’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. There may be additional risks that the Company presently does not know or that it currently believes are immaterial that could also cause actual results to differ from those contained in the forward-looking statements. All forward-looking statements contained in this press release speak only as of the date they were made. Except to the extent required by law, the Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

Investor Relations

Eric Prouty

Szymon Serowiecki

AdvisIRy Partners
[email protected]

Source: Dragonfly Energy Holdings Corp.

CELEBRATION, Fla., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Zevra Therapeutics, Inc. (NasdaqGS: ZVRA) (Zevra, or the Company), a commercial-stage company focused on providing therapies for people living with rare disease, today announced that members of Zevra’s executive leadership team will present at the J.P. Morgan 44 ^th Annual Healthcare Conference in San Francisco, CA on Thursday, January 15, 2026, at 9:45 a.m. PT.

Additionally, management will be available for one-on-one meetings with registered conference attendees. A link to the live webcast will be accessible on the “ Events & Presentations ” page in the Investor Relations section of Zevra’s website at investors.zevra.com .

About Zevra Therapeutics, Inc.

Zevra Therapeutics, Inc. is a purpose-driven, commercial-stage company focused on bringing life-changing therapeutics to people living with rare diseases. The company’s commercialization of its lead product, marketed in the U.S. for Niemann-Pick disease type C (NPC), a rare, progressive neurodegenerative disorder, provides a strong corporate foundation and validates its ability to advance therapies. In addition, the company is broadening access through geographic expansion opportunities and has a pipeline of rare disease programs. Zevra is a patient-centric organization guided by our values of accountability, integrity, innovation and courage, with the goal of creating long-term value for patients, partners, and shareholders.

For more information, please visit www.zevra.com or follow us on X and LinkedIn .

Caution Concerning Forward-Looking Statements

This press release may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that do not relate solely to historical or current facts. Forward-looking statements are based on information currently available to Zevra and its current plans or expectations. They are subject to several known and unknown uncertainties, risks, and other important factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by the forward-looking statements. These and other important factors are described in detail in the “Risk Factors” section of Zevra’s Annual Report on Form 10-K for the year ended December 31, 2024, filed on March 12, 2025, Quarterly Report on Form 10-Q for the three and nine months ended September 30, 2025, filed on November 5, 2025, as well as Zevra’s other filings with the Securities and Exchange Commission. While we may elect to update such forward-looking statements at some point in the future, except as required by law, we disclaim any obligation to do so, even if subsequent events cause our views to change. Although we believe the expectations reflected in such forward-looking statements are reasonable, we cannot assure that such expectations will prove correct. These forward-looking statements should not be relied upon as representing our views as of any date after the date of this press release.

Investor Contact

Nichol Ochsner
+1 (732) 754-2545
[email protected]

Media Contact

Julie Downs
+1 (508) 246-3230
[email protected]

HOUSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV ) (“Plus” or the “Company”), a healthcare company developing and commercializing precision diagnostics and radiopharmaceuticals for central nervous system (CNS) cancers, announces the completion of a Type B meeting with the U.S. Food and Drug Administration (FDA) on next steps on REYOBIQ pivotal trial strategy for leptomeningeal metastases (LM). The meeting resulted in constructive discussion with the FDA regarding key elements of the potential pivotal study design for REYOBIQ in LM. Plus intends to incorporate the FDA’s feedback in the current dose optimization trial and seek alignment with the FDA on a revised protocol, likely later this year. The company’s goal is to be ready for a potential pivotal trial following completion of the current dose optimization trial and, ultimately, work towards the potential approval of REYOBIQ for patients affected by LM.

Highlights of FDA responses to the Company's key enquiries:

• Accelerated approval – FDA indicated that accelerated approval may be appropriate for the LM indication, but there are insufficient data to support the use of circulating tumor cells (CTCs) as an intermediate clinical endpoint. FDA and Plus discussed that additional steps would be necessary to validate CTCs as a surrogate endpoint to potentially support other future applications.
  
• Primary and key endpoints – FDA recommended that the study evaluate an endpoint with established clinical benefit, such as overall survival, while encouraging further study of patient reported outcomes and neurologic function as endpoints that could potentially support a marketing application. FDA and Plus aligned that CTCs could be considered for use as a secondary endpoint.
  
• Trial design and comparator group - FDA and Plus discussed a randomized controlled trial design approach and that the study may include an intrathecal chemotherapeutic as a comparator, as well as approaches to standardize the comparator and any additional interventions available under the trial protocol.
  
• Treated populations - FDA conveyed it may be reasonable to incorporate multiple histologies (i.e., multiple underlying disease etiologies) in a single trial.
  

“Our recent FDA end of phase meeting was constructive, and we hope will help us speed up our clinical development timelines and facilitate faster submission of an application for the approval of REYOBIQ for patients with LM,” said Dr. Marc H. Hedrick, President & Chief Executive of Plus Therapeutics. “As there are no approved drugs for LM, this discussion with the FDA early in clinical development will allow us to make relevant amendments to our current trial protocol and to begin meaningful planning for an anticipated pivotal trial. Furthermore, based in part on this meeting, we will plan to accelerate REYOBIQ commercial manufacturing and scale-up activities to meet an expedited timeline.”

About LM
Leptomeningeal metastases (LM) are a rare but severe complication of advanced cancer, affecting the fluid-lined structures of the central nervous system. LM occurs in approximately 5% of patients with metastatic cancer, with breast cancer, lung cancer, and melanoma being the most common sources. Median survival is typically 2-6 months, and effective treatment options are limited, highlighting the urgent need for novel therapies.

About REYOBIQ™ (rhenium Re186 obisbemeda)
REYOBIQ (rhenium Re186 obisbemeda) is a novel injectable radiotherapy specifically formulated to deliver direct targeted high dose radiation in CNS tumors in a safe, effective, and convenient manner to optimize patient outcomes. REYOBIQ has the potential to reduce off target risks and improve outcomes for CNS cancer patients, versus currently approved therapies, with a more targeted and potent radiation dose. Rhenium-186 is an ideal radioisotope for CNS therapeutic applications due to its short half-life, beta energy for destroying cancerous tissue, and gamma energy for real-time imaging. REYOBIQ is being evaluated for the treatment of recurrent glioblastoma, leptomeningeal metastases, and pediatric brain cancer in the ReSPECT-GBM, ReSPECT-LM, and ReSPECT-PBC clinical trials. ReSPECT-GBM is supported by an award from the National Cancer Institute (NCI), part of the U.S. National Institutes of Health (NIH), and ReSPECT-LM is funded by a three-year $17.6M grant by the Cancer Prevention & Research Institute of Texas (CPRIT). The Company’s ReSPECT-PBC clinical trial for pediatric brain cancer is supported by a $3 million grant from the U.S. Department of Defense’s Peer Reviewed Cancer Research Program.

About CNSide Diagnostics, LLC
CNSide Diagnostics, LLC is a wholly owned subsidiary of Plus Therapeutics, Inc. that develops and commercializes proprietary laboratory-developed tests, such as CNSide®, designed to identify tumor cells that have metastasized to the central nervous system in patients with carcinomas and melanomas. The CNSide® CSF Assay Platform enables quantitative analysis of the cerebrospinal fluid that informs and improves the management of patients with leptomeningeal metastases. For more information, visit https://www.cnside-dx.com/ .

About Plus Therapeutics
Headquartered in Houston, Texas, Plus Therapeutics, Inc. is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in leptomeningeal metastases (LM) and recurrent glioblastoma (GBM). The Company has built a supply chain through strategic partnerships that enable the development, manufacturing, and future potential commercialization of its products. For more information, visit https://www.plustherapeutics.com .

Forward-Looking Statements
This press release contains statements that may be deemed “forward-looking statements” within the meaning of U.S. securities laws, including statements regarding the potential study design for REYOBIQ in LM and the Company’s plans to plan to accelerate REYOBIQ commercial manufacturing, among others. All statements in this press release other than statements of historical fact are forward-looking statements. These forward-looking statements may be identified by future verbs, as well as terms such as “expect” “potential,” “anticipating,” “planning” and similar expressions or the negatives thereof. Such statements are based upon certain assumptions and assessments made by management in light of their experience and their perception of historical trends, current conditions, expected future developments and other factors they believe to be appropriate.

The forward-looking statements included in this press release could differ materially from those expressed or implied by these forward-looking statements because of risks, uncertainties, and other factors that include, but are not limited to, the following: the Company’s ability to maintain the listing of its common stock on Nasdaq; the early stage of the Company’s product candidates and therapies; the results of the Company’s research and development activities, including uncertainties relating to the clinical trials of its product candidates and therapies; the Company’s liquidity position and capital resources and its ability to raise additional cash; the outcome of the Company’s partnering/licensing efforts; risks associated with laws or regulatory requirements applicable to the Company; market conditions, product performance, litigation or potential litigation, and competition within the cancer diagnostics and therapeutics field; ability to develop and protect proprietary intellectual property or obtain licenses to intellectual property developed by others on commercially reasonable and competitive terms; challenges associated with radiotherapeutic manufacturing, production and distribution capabilities necessary to support the Company’s clinical trials and any commercial level product demand; and material security breach or cybersecurity attack affecting the Company’s operations or property. This list of risks, uncertainties, and other factors is not complete. The Company discusses some of these matters more fully, as well as certain risk factors that could affect its business, financial condition, results of operations, and prospects, in its reports filed with the SEC, including its annual report on Form 10-K for the fiscal year ended December 31, 2024, quarterly reports on Form 10-Q, and current reports on Form 8-K. These filings are available for review through the SEC’s website at www.sec.gov . Any or all forward-looking statements the Company makes may turn out to be wrong and can be affected by inaccurate assumptions it might make or by known or unknown risks, uncertainties, and other factors, including those identified in this press release. Accordingly, you should not place undue reliance on the forward-looking statements made in this press release, which speak only as of its date. The Company assumes no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made unless the Company has an obligation under U.S. federal securities laws to do so.

Investor Contact
CORE IR
[email protected]

NEW YORK, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq: AVXL), a clinical-stage biopharmaceutical company focused on developing innovative treatments for Alzheimer's disease, Parkinson's disease, schizophrenia, neurodevelopmental, neurodegenerative, and rare diseases, including Rett syndrome, and other central nervous system (CNS) disorders, today announced the appointment of Wolfgang Liedtke, MD PhD, as Senior Vice President, Global Head of Neurology.

Dr. Liedtke is a board-certified neurologist, who brings more than 25 years of extensive experience in developing and delivering innovative medicines in a broad range of CNS diseases, including genetic medicines and global therapeutic development. Most recently he was Chair of Neurology at Regeneron, where he oversaw the integration of discovery into 45 clinical trials (14 Phase 3 studies). As a renowned physician-scientist, Dr Liedtke has a proven track record of successfully conducting late-stage development programs, exemplified by his leadership in completing a CNS clinical trial with more than 11,000 patients, and his contributions to successful late-stage trials of dupilumab. He brings to Anavex deep expertise in neurodegeneration, pain research and translational neuroscience, combined with authorship of 160+ peer-reviewed publications, yielding a current h-index of 82.

“I'm delighted to welcome Dr Liedtke to Anavex at this crucial moment. His substantial experience will play an essential role as we continue working to enhance value for both patients and shareholders,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex. “Dr Liedtke’s broad and profound expertise in neurology will be a tremendous asset as we advance Anavex’s mission to transform brain health through improved patient outcomes by developing convenient oral personalized treatments.”

“There is a major global unmet need in Alzheimer’s, Parkinson’s, as well as neurodevelopmental disorders. I believe Anavex’s innovative patient-oriented precision medicine approach in neurology can meaningfully improve patient outcomes,” said Dr Liedtke. “I am excited to join the Anavex Team where patient-centered innovation is our passion in order to transform treatment of neuropsychiatric diseases once deemed untreatable.”

Prior to Regeneron, Dr Liedtke served 17 years as Tenured Full Professor at Duke University, where he established the Duke Pain Research Group, and founded two pain-focused clinics at Duke University Medical Center, providing clinical care for more than 5,000 patients. He was elected to the Medical Advisory Board of the U.S. Facial Pain Association where he is Lead Neurologist. Preceding Duke University, Dr Liedtke was Assistant Professor at The Rockefeller University where he discovered the TRPV4 ion channel, relevant for neuroinflammation and pain, and critically involved in TRPV4 channelopathy hereditary disorders including motor neuropathies. In addition to his TRPV4 discovery he also made key discoveries on gene regulation of the KCC2 neuronal chloride transporter, relevant for neurodevelopmental disorders, including pathologic pain, neural anti-aging and neuroprotection. Dr Liedtke’s profound translational expertise is highlighted by his works as a lead inventor on numerous U.S. patents and his recent election into the elite American Clinical and Climatological Association (ACCA).

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq: AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel therapeutics for the treatment of neurodegenerative, neurodevelopmental, and neuropsychiatric disorders, including Alzheimer's disease, Parkinson's disease, schizophrenia, Rett syndrome, and other central nervous system (CNS) diseases, pain, and various types of cancer. Anavex's lead drug candidate, ANAVEX®2-73 ( blarcamesine ), has successfully completed a Phase 2a and a Phase 2b/3 clinical trial for Alzheimer's disease, a Phase 2 proof-of-concept study in Parkinson's disease dementia, and both a Phase 2 and a Phase 3 study in adult patients and one Phase 2/3 study in pediatric patients with Rett syndrome. ANAVEX®2-73 is an orally available drug candidate designed to restore cellular homeostasis by targeting SIGMAR1 and muscarinic receptors. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer's disease. ANAVEX®2-73 also exhibited anticonvulsant, anti-amnesic, neuroprotective, and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy. The Michael J. Fox Foundation for Parkinson's Research previously awarded Anavex a research grant, which fully funded a preclinical study to develop ANAVEX®2-73 for the treatment of Parkinson's disease. We believe that ANAVEX®3-71, which targets SIGMAR1 and M1 muscarinic receptors, is a promising clinical stage drug candidate demonstrating disease-modifying activity against the major hallmarks of Alzheimer's disease in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid, and tau pathologies. In preclinical trials, ANAVEX®3-71 has shown beneficial effects on mitochondrial dysfunction and neuroinflammation. Further information is available at www.anavex.com . You can also connect with the Company on Twitter, Facebook , Instagram , and LinkedIn .

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

For Further Information:
Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email: [email protected]

Investors:
Andrew J. Barwicki
Investor Relations
Tel: 516-662-9461
Email: [email protected]

Dallas, TX, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Enovis™ Corporation (NYSE: ENOV), an innovation-driven, medical technology growth company, today announced that its management team will meet with investors at the 44th Annual J.P. Morgan Healthcare Conference with a presentation scheduled for Monday, January 12 ^th , 2026, at 4:30 p.m. PST (7:30 p.m. EST). A link to the live audio webcast, as well as a copy of the accompanying presentation slides and a replay of this event, will be available on the company’s website ( www.enovis.com ) at Events and Presentations.

About Enovis

Enovis™ (NYSE: ENOV) is a global medical technology innovator dedicated to improving lives by developing clinically differentiated solutions that enhance patient outcomes and restore motion for life. We partner with the brightest minds in health to advance care that is smarter, personalized, and more effective, while improving operational efficiency for surgeons and clinicians around the world. Enovis solutions impact the well-being of millions of patients wherever they are on their pathway to health. Discover more about Enovis at www.enovis.com

Availability of Information on the Enovis Website

Investors and others should note that Enovis routinely announces material information to investors and the marketplace using SEC filings, press releases, public conference calls, webcasts and the Enovis Investor Relations website. While not all of the information that the Company posts to the Enovis Investor Relations website is of a material nature, some information could be deemed to be material. Accordingly, the Company encourages investors, the media and others interested in Enovis to review the information that it shares on ir.enovis.com.

Contact:

Kyle Rose
Vice President, Investor Relations
Enovis Corporation
[email protected]

Dr. Theodosios Bisdas is a renowned vascular surgeon and Head of Clinic of Vascular Surgery at the Athens Medical Center

BERKELEY, Calif, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Profusa, Inc. (“Profusa” or the “Company”) (Nasdaq: PFSA), a commercial stage digital health company pioneering the next generation of technology platform enabling the continuous monitoring of an individual’s biochemistry, announces a collaboration with Theodosios Bisdas, M.D., Ph.D., FACS, Head of Clinic of Vascular Surgery, Athens Medical Center, Greece, and previously Associate Professor for Vascular Surgery, Universitätsklinikum Münster, Germany. Dr. Bisdas has extensive experience in innovative endovascular techniques and is a member of the advisory boards of several medical technology companies for new vascular prostheses. Under the agreement, Dr. Bisdas will adopt Lumee™ Oxygen tissue monitoring in his practice in Greece and in clinical studies that advance application of Lumee for home monitoring.

“Having used the Lumee Oxygen tissue monitoring in clinical trials, I look forward to integrating the technology in our practice at the Athens Medical Center. In addition, we will continue clinical evaluations of the platform for additional vascular applications where there is an unmet need. Based on my experience, the Lumee Oxygen tissue monitoring provides valuable treatment guidance and patient monitoring in both the inpatient and outpatient settings,” commented Dr. Bisdas.

Dr. Bisdas has extensive experience in endovascular interventions, and has led major research projects, including as principal investigator responsible for the largest open multicenter study (CRITISCH Registry) in the history of the German Society for Vascular Surgery for the treatment of critical ischemia of the lower extremities and diabetic foot.   In addition to his clinical work, he is involved in medical teaching, advises medical technology companies, and is committed to humanitarian projects. Dr. Bisdas has published over 100 scientific articles. He is a member of the scientific committee of eleven international congresses, a reviewer for several prestigious journals, and a member of the editorial boards of the Journal of Endovascular Therapy , Vascular Surgery and Innovative Surgical Science. Further, Dr. Bisdas is a member of the American Society for Vascular Surgery, co-founder of the first Summer Academy for Vascular and Endovascular Surgery of the German Society for Vascular Surgery and Vascular Medicine (DGG e.V.), and founder of the internationally renowned platform Vascupedia with over 10,000 users in 124 countries.

"We welcome Dr. Bisdas to our roster of vascular surgeons as we continue to expand our network to now add the Vascular Surgery Clinic at the Athens Medical Center, Greece,” said Ben Hwang, Ph.D., Profusa’s Chairman and CEO. “We look forward to our collaboration with Dr. Bisdas as he integrates our Lumee Oxygen tissue monitoring to his practice as well as identifying opportunities for future clinical partnerships as we evaluate additional vascular applications of our platform technology.”

About Profusa
Based in Berkeley, Calif., Profusa is a commercial stage digital health company led by visionary scientific founders, an experienced management team and a world-class board of directors in the development of a new generation of tissue-integrated sensors to detect and continuously transmit actionable, medical-grade data for personal and medical use. With its long-lasting, injectable and affordable biosensors and its intelligent data platform, Profusa aims to provide people with a personalized biochemical signature rooted in data that clinicians can trust and rely on.

“LUMEE”, “PROFUSA” and the PROFUSA logo are registered trademarks of Profusa Inc. in the United States, Canada, European Union, China, Japan, South Korea and Australia.

For more information, visit https://profusa.com.

Special Note Regarding Forward-Looking Statements
Certain statements in this press release (this “Press Release”) may be considered “forward-looking statements” within the meaning of the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements generally relate to future events or future financial or operating performance of Profusa. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “forecast,” “future,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “project,” “propose,” “seek,” “should,” “strive,” “will,” or “would” or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which may be beyond the control of Profusa and could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by Profusa and its management are inherently uncertain. Profusa cautions you that these statements are based on a combination of facts and factors currently known and projections of the future, which are inherently uncertain. There are risks and uncertainties described in the definitive proxy/final prospectus relating to the business combination, which has been filed with the SEC, and in other documents filed by Profusa from time to time with the SEC. These filings may identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements. Profusa cannot assure you that the forward-looking statements in this communication will prove to be accurate.

Contacts
Investor and Media Contacts
email: [email protected]
phone: 1 (212) 655-0924

VANCOUVER, British Columbia, Jan. 08, 2026 (GLOBE NEWSWIRE) -- ZenaTech, Inc. (Nasdaq: ZENA) (FSE: 49Q) (BMV: ZENA) ("ZenaTech"), a technology solution provider specializing in AI (Artificial Intelligence) drone, Drone as a Service (DaaS), enterprise SaaS, and Quantum Computing solutions, today announces it has completed its 20th acquisition. The most recent acquisition is L.D. King, Inc., a well-established civil engineering and land surveying firm based in the Los Angeles area, further strengthening its footprint for drone solutions in one of the most wildfire-sensitive and natural disaster-prone regions in the US. This acquisition caps a successful first year executing its Drone as a Service expansion strategy to enable drone accessibility at scale for the innovation of legacy, low tech or manual work. Since January 2025, the company has built a US and global business network which includes thousands of existing commercial and government client relationships.

“We have exceeded our first-year objectives for Drone as a Service, underscoring both the pace and discipline with which we are scale our roll up strategy of multiple industries ripe for drone modernizing, representing significant untapped opportunities for Drone as a Service applications. The global drone services market is growing at over 36 % annually and expected to reach $355 billion by 2032 according to Pragma Market Research, creating a substantial long-term opportunity for scalable, recurring revenue,” said Shaun Passley, Ph.D., ZenaTech CEO. “Our 20 ^th acquisition, L.D. King’s deep relationships and decades-long operating history provide an ideal platform to deploy our drone-enabled services at scale for existing government and building developer clients. We continue to expand into natural resources management expanded capabilities for future wildfire management, post-disaster assessments, and regional planning activities.”

Founded in 1965, L.D. King, Inc. has served Southern California for more than six decades, with a reputation for quality and long-term client relationships across public works, commercial, and residential projects. The firm’s multidisciplinary team of licensed professionals delivers comprehensive services ranging from land surveying and engineering to planning and construction management, addressing the diverse needs of municipal government agencies and private developers.

Building the Foundation for Drone as a Service Growth

• Established ZenaTech as a first-to-market leader pioneering a multi-service, globally scalable Drone as a Service network for government and commercial clients with 20 US and global acquisitions combined with two corporate stores
• Since its inception, Drone as a Service has focused on acquiring established, profitable businesses operating with legacy processes and modernizing them for growth through drone innovation, automation, and data-driven workflows
• Drone as a Service is now positioned to grow margins by integrating embedding AI-autonomous drone capabilities and certifying field technicians as licensed drone pilots, ZenaTech reduces labor intensity and streamlines operation costs
• Over the course of 2025, the company has been acquiring profitable businesses with an immediate revenue base, while expanding services and cross selling opportunities such as data analysis, automating maintenance, and new services like wildfire management, environmental monitoring, power washing, among others. Drone as a Service has now reached 20 acquisitions, ahead of its expected timeline

ZenaTech’s Drone as a Service business platform provides business and government clients with on-demand or subscription-based access to faster and superior drone-based services for a host of surveying, inspection, maintenance, power washing, inventory management, and precision agriculture services, without the capital costs or operational burdens of ownership. By acquiring established, profitable service companies currently using low-tech processes and ripe for drone innovation, ZenaTech is building a global, multi-service DaaS network of locations in communities anchored by existing customers and revenue, for next-gen drone integration designed for speed, precision, data, and safety benefits. The company is continuing to build its global business and network of locations as well as its integration of drones and new services.

About ZenaTech

ZenaTech (Nasdaq: ZENA) (FSE: 49Q) (BMV: ZENA) is a technology company specializing in AI drone, Drone as a Service (DaaS), enterprise SaaS and Quantum Computing solutions for mission-critical business applications. Since 2017, the Company has leveraged its software development expertise and grown its drone design and manufacturing capabilities through ZenaDrone, to innovate and improve customer inspection, monitoring, safety, security, compliance, and surveying processes. With enterprise software customers using branded solutions in law enforcement, government, and industrial sectors, and drones being implemented in these plus agriculture, defense, and logistics sectors, ZenaTech’s portfolio of solutions helps drive exceptional operational efficiencies, accuracy, and cost savings. The Company operates through global offices in North America, Europe, Taiwan, and UAE, and is growing its US DaaS business and network of locations through acquisitions.

About ZenaDrone

ZenaDrone , a wholly owned subsidiary of ZenaTech, develops and manufactures autonomous business drone solutions that can incorporate machine learning software, AI, predictive modeling, Quantum Computing, and other software and hardware innovations. Created to revolutionize the hemp farming sector, its specialization has grown to multifunctional drone solutions for industrial surveillance, monitoring, inspection, tracking, process automation, and defense applications. Currently, the ZenaDrone 1000 drone is used for crop management applications in agriculture and critical field cargo applications in the defense sector, the IQ Nano indoor drone is used for inventory management and security in the warehouse and logistics sectors, and the IQ Square is an outdoor drone designed for land surveys and inspections use in commercial and defense sectors.

Contacts for more information:

Company, Investors, and Media:

Linda Montgomery

ZenaTech

312-241-1415

[email protected]

Investors:

Michael Mason

CORE IR

[email protected]

Safe Harbor

This press release and related comments by management of ZenaTech, Inc. include “forward-looking statements” within the meaning of U.S. federal securities laws and applicable Canadian securities laws. These forward-looking statements are subject to the safe harbor provisions under the Private Securities Litigation Reform Act of 1995. This forward-looking information relates to future events or future performance of ZenaTech and reflects management’s expectations and projections regarding ZenaTech’s growth, results of operations, performance, and business prospects and opportunities. Such forward-looking statements reflect management’s current beliefs and are based on information currently available to management. In some cases, forward-looking information can be identified by terminology such as “may”, “will”, “should”, “expect”, “plan”, “anticipate”, “aim”, “seek”, “is/are likely to”, “believe”, “estimate”, “predict”, “potential”, “continue” or the negative of these terms or other comparable terminology intended to identify forward-looking statements. Forward-looking information in this document includes, but is not limited to ZenaTech’s expectations regarding its revenue, expenses, production, operations, costs, cash flows, and future growth; expectations with respect to future production costs and capacity; ZenaTech's ability to deliver products to the market as currently contemplated, including its drone products including ZenaDrone 1000, IQ Square and IQ Nano; ZenaTech's ability to develop products for markets as currently contemplated; ZenaTech’s anticipated cash needs and it’s needs for additional financing; ZenaTech’s intention to grow the business and its operations and execution risk; expectations with respect to future operations and costs; the volatility of stock prices and market conditions in the industries in which ZenaTech operates; political, economic, environmental, tax, security, and other risks associated with operating in emerging markets; regulatory risks; unfavorable publicity or consumer perception; difficulty in forecasting industry trends; the ability to hire key personnel; the competitive conditions of the industry and the competitive and business strategies of ZenaTech; ZenaTech’s expected business objectives for the next twelve months; ZenaTech’s ability to obtain additional funds through the sale of equity or debt commitments; investment capital and market share; the ability to complete any contemplated acquisitions; changes in the target markets; market uncertainty; ability to access additional capital, including through the listing of its securities in various jurisdictions; management of growth (plans and timing for expansion); patent infringement; litigation; applicable laws, regulations, and any amendments affecting the business of ZenaTech and other related risks ‎‎‎and uncertainties disclosed under the ‎heading “Risk Factors“ ‎‎‎‎in the Company’s Form F-1, Form 20-F and other filings filed ‎‎‎with the United States Securities and Exchange Commission (the “SEC”) on EDGAR through the SEC’s website at www.sec.gov . The Company undertakes ‎‎‎no obligation to update forward-‎looking ‎‎‎‎information except as required by applicable law. Such forward-‎‎‎looking information represents ‎‎‎‎‎managements’ best judgment based on information currently available. ‎‎‎No forward-looking ‎‎‎‎statement ‎can be guaranteed and actual future results may vary materially. ‎‎‎Accordingly, readers ‎‎‎‎are advised not to ‎place undue reliance on forward-looking statements or ‎‎‎information.‎

OMAHA, Neb., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Exodus Movement, Inc . (NYSE American: EXOD) ("Exodus" or “the company”), a leading self-custodial cryptocurrency platform, today announced an update to selected digital asset holdings of Exodus’ corporate treasury, as well as updated user and exchange provider processed volume metrics, as of December 31, 2025:

The Company ended the year with a debt-free balance sheet, reflecting disciplined capital management during a period of continued product expansion.

Exodus CFO James Gernetzke remarked: “During December, we fully paid off the debt incurred with Galaxy Digital as part of our announced acquisition of W3C, and we enter 2026 debt free. We expect additional future cash outlays as part of the W3C acquisition once the transaction closes.”

Selected Digital Asset Holdings (Unaudited)

• Bitcoin (BTC): 1,704 BTC as of December 31, 2025, compared to 1,902 BTC as of November 30, 2025.
• Ethereum (ETH): 1,898 ETH as of December 31, 2025, compared to 2,802 as of November 30, 2025.
• Solana (SOL): 12,473 SOL as of December 31, 2025, compared to 31,050 as of November 30, 2025.
  
  

Monthly Active Users (MAUs): 1.5 million as of December 31, 2025. That figure remains unchanged from 1.5 million MAUs as of November 30, 2025.

• Stable MAUs reflect a resilient, loyal core customer base as Exodus users continue to rely on Exodus across market cycles.
  
  

Swap Volume

• Exodus’ exchange provider processed volume was $360 million for the month of December 2025, of which $75 million (21%) originated from the company’s XO Swap partners. This volume compares with $549 million exchange provider processed volume in November 2025, of which $200 million (36%) originated from XO Swap partners.
  
  

About Exodus
Exodus is a financial technology leader empowering individuals and businesses with secure, user-friendly crypto software solutions. Since 2015, Exodus has made digital assets accessible to everyone through its multi-asset crypto wallets prioritizing design and ease of use.

With self-custodial wallets, Exodus puts customers in full control of their funds, enabling them to swap, buy, and sell crypto. Its solutions include XO Swap and Exodus Pay – industry-leading tools for swap aggregation, and an upcoming consumer card and payments experience using stablecoins.

Exodus is committed to driving the future of accessible and secure finance. Learn more at exodus.com or follow us on X at x.com/exodus .

Investor Contact
[email protected]

Media Contact
Aubrey Strobel/Elena Nisonoff, Halcyon Communications
[email protected]

Disclosure Information
Exodus uses the following as means of disclosing material nonpublic information and for complying with disclosure obligations under Regulation FD: websites exodus.com/investors and exodus.com ; press releases; public videos, calls, and webcasts; and social media: X (@exodus and JP Richardson's feed @jprichardson), Facebook, LinkedIn, and YouTube.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, may be forward-looking statements. Forward-looking statements are based on our beliefs and assumptions and on information currently available to us as of the date hereof. In some cases, you can identify forward-looking statements by the following words: “will,” “expect,” “would,” “should,” “intend,” “believe,” “expect,” “likely,” “believes,” “views”, “estimates”, or other comparable terminology.

Forward-looking statements in this document include, but are not limited to, management statements regarding management’s confidence in our products, services, business trajectory and plans, expectations regarding demand for our products, future acquisition expenses, and volatility and trading volumes of digital asset markets. Such forward-looking statements involve a number of risks, uncertainties and other important factors that could cause our actual results to differ materially from those expressed or implied by our forward-looking statements. Such factors include those set forth in “Item 1. Business” and “Item 1A. Risk Factors” of Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on March 6, 2025, as well as in our other reports filed with the SEC from time to time.

All forward-looking statements are expressly qualified in their entirety by such cautionary statements. Readers are cautioned not to place undue reliance on such forward-looking statements. Except as required by law, we undertake no obligation to update or revise any forward-looking statements that have been made to reflect events or circumstances that arise after the date made or to reflect the occurrence of unanticipated events.

NORTH PALM BEACH, Fla., Jan. 08, 2026 (GLOBE NEWSWIRE) -- SRx Health Solutions, Inc. (NYSE American: SRXH) (the "Company") today announced that the New York Stock Exchange (“NYSE”) has accepted the Company’s plan to regain compliance with the continued listing standards in Sections 1003(a)(i) and (ii) of the NYSE American Company Guide.

As previously disclosed, NYSE notified the Company on October 14, 2025 that the Company had fallen below the NYSE’s continued listing standard requiring a listed company to have stockholders’ equity of $4 million or more if the listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. With the NYSE’s acceptance of the Company’s plan to regain compliance, the Company’s listing is being continued pursuant to an extension with a targeted completion date of July 14, 2026 (the “Plan Period”). The Company will provide quarterly updates to the NYSE American during the Plan Period on its progress with the goals and initiatives outlined in the plan.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “believe,” “expect,” “intend,” “aim,” “plan,” “may,” “could,” “target,” and similar expressions are intended to identify forward-looking statements. These statements are based on current expectations and assumptions that are subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied. These risks include, but are not limited to, the ability to complete the proposed transaction, shareholder approvals, market conditions, regulatory considerations, and other risks described in the Company’s filings with the Securities and Exchange Commission. Forward-looking statements speak only as of the date made, and the Company undertakes no obligation to update them, except as required by law.

Company Contact
SRx Health Solutions, Inc.
Kent Cunningham, Chief Executive Officer

Investor Relations Contact
KCSA Strategic Communications
Valter Pinto, Managing Director
212-896-1254
[email protected]

Media Contact
KCSA Strategic Communications
Kristin Cwalinski, Senior Vice President
[email protected]

PETAH TIKVA, Israel, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Gilat Satellite Networks Ltd. (NASDAQ: GILT, TASE: GILT), a worldwide leader in satellite networking technology, solutions, and services, today announced that its management team will participate in the 28 ^th Annual Needham Growth Conference on Tuesday, January 13, 2026, taking place at the Lotte NY Palace Hotel in New York.

Mr. Adi Sfadia, Chief Executive Officer, and Mr. Gil Benyamini, Chief Financial Officer, will be available for one-on-one meetings with investors at the conference. Management will also host a fireside chat on January 13 at 10:15 a.m. Eastern Time.

A live webcast and replay of the fireside chat will be available on the Gilat investor relations website at www.gilat.com/investor-relations .

About Gilat

Gilat Satellite Networks Ltd. (NASDAQ: GILT, TASE: GILT) is a leading global provider of satellite-based broadband communications. With over 35 years of experience, we develop and deliver deep technology solutions for satellite, ground, and new space connectivity, offering next-generation solutions and services for critical connectivity across commercial and defense applications. We believe in the right of all people to be connected and are united in our resolution to provide communication solutions to all reaches of the world.

Together with our wholly owned subsidiaries Gilat Wavestream, Gilat DataPath, and Gilat Stellar Blu, we offer integrated, high-value solutions supporting multi-orbit constellations, Very High Throughput Satellites (VHTS), and Software-Defined Satellites (SDS) via our Commercial and Defense Divisions. Our comprehensive portfolio is comprised of a software-defined platform and modems, high-performance satellite terminals, advanced Satellite On-the-Move (SOTM) antennas and ESAs, highly efficient, high-power Solid State Power Amplifiers (SSPA) and Block Upconverters (BUC) and includes integrated ground systems for commercial and defense markets, field services, network management software, and cybersecurity services.

Gilat’s products and tailored solutions support multiple applications including government and defense, IFC and mobility, cellular backhaul, enterprise, aerospace and critical infrastructure clients all while meeting the most stringent service level requirements. For more information, please visit: http://www.gilat.com

Certain statements made herein that are not historical are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. The words “estimate”, “project”, “intend”, “expect”, “believe” and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties. Many factors could cause the actual results, performance or achievements of Gilat to be materially different from any future results, performance or achievements that may be expressed or implied by such forward-looking statements, including, among others, changes in general economic and business conditions, inability to maintain market acceptance to Gilat’s products, inability to timely develop and introduce new technologies, products and applications, rapid changes in the market for Gilat’s products, loss of market share and pressure on prices resulting from competition, introduction of competing products by other companies, inability to manage growth and expansion, loss of key OEM partners, inability to attract and retain qualified personnel, inability to protect the Company’s proprietary technology and risks associated with Gilat’s international operations and its location in Israel. For additional information regarding these and other risks and uncertainties associated with Gilat’s business, reference is made to Gilat’s reports filed from time to time with the Securities and Exchange Commission. We undertake no obligation to update or revise any forward-looking statements for any reason.

Contact:

Gilat Satellite Networks

[email protected]

Phase 3 Topline Results for Potential Best-in-Class Regimen for Treatment of HCV on Track for 2026

Topline Results from North American Phase 3 C-BEYOND Trial Expected Mid-2026; Results from C-FORWARD Trial Outside North America Expected Year-End 2026

C-BEYOND and C-FORWARD Are the First Global Phase 3 Head-to-Head Trials of Direct-Acting Antivirals for Treatment of HCV

Initiation of HEV Phase 1 Clinical Program for Product Candidate AT-587 Anticipated Mid-2026

BOSTON, Jan. 08, 2026 (GLOBE NEWSWIRE) -- Atea Pharmaceuticals, Inc. (Nasdaq: AVIR) (Atea or Company), a clinical-stage biopharmaceutical company engaged in the discovery and development of oral antiviral therapeutics for serious viral diseases, will present the Company’s strategic priorities for 2026 at the 44 ^th Annual J.P. Morgan Healthcare Conference, taking place January 12-15 in San Francisco. Atea ended 2025 in a strong financial position with cash and investments in the amount of $301.8 million at December 31, 2025, providing a cash runway that is expected to extend through 2027.

During the presentation, Atea will provide an update on the progress of its global Phase 3 program evaluating the potential best-in-class regimen of bemnifosbuvir (BEM) and ruzasvir (RZR) for the treatment of Hepatitis C virus (HCV). The Company will also detail challenges with current HCV therapeutics and the potential of Atea’s regimen to meaningfully address them. In addition, the Company will discuss opportunities to expand HCV treatment through further adoption of the test-and-treat model of care, which reduces treatment barriers through rapid diagnosis and immediate initiation of treatment following a positive HCV test result.

Additionally, Atea will provide an update on its Hepatitis E virus (HEV) program, including the selection of AT-587 as the lead product candidate, and review new in vitro and in vivo nonclinical study results.

“Across our antiviral pipeline, we continue to execute with discipline and urgency and are on track for the first Phase 3 HCV topline results in mid-2026,” said Jean-Pierre Sommadossi, PhD, Chief Executive Officer and Founder of Atea. “Our regimen of bemnifosbuvir and ruzasvir has a potential best-in-class profile that is both aligned to the needs of the current HCV patient population and well suited for the expanding test-and-treat model of care. This includes high efficacy, short treatment duration, low risk of drug-drug interactions and convenience with no food effect, which clinicians have been clear is necessary to increase cure rates and advance the global eradication of HCV.”

“In parallel, we’re excited to progress AT-587, a new, proprietary antiviral product candidate, for the treatment of HEV, a condition with growing infection rates among vulnerable patient populations and no currently available approved therapies,” added Dr. Sommadossi. “Atea was founded on a deep commitment to develop direct-acting antiviral therapies that address unmet needs or advance the standard of care for patients affected by serious viral diseases. This new program, for which we anticipate initiating a Phase 1 study mid-year, represents an important opportunity to offer immunocompromised and other high-risk patients a treatment option for HEV.”

Potential Best-in-Class Regimen for Treatment of HCV – Advancing Global Phase 3 Program Toward Topline Results

Atea continues to advance its global Phase 3 program evaluating the fixed-dose combination (FDC) of BEM, a nucleotide analog HCV NS5B polymerase inhibitor, and RZR, an HCV NS5A inhibitor, for the treatment of chronic HCV.

The global Phase 3 program consists of two open-label studies : C-BEYOND in North America and C-FORWARD outside North America. C-BEYOND is fully enrolled with over 880 patients, with topline results expected mid-2026 . C-FORWARD enrollment is expected to complete mid-2026, with topline results anticipated around year-end 2026 .

The primary endpoint for each trial is HCV RNA < lower limit of quantitation (LLOQ) at 24 weeks from the start of treatment and encompasses sustained virologic response 12 weeks post-treatment (SVR12) in each arm. Measurement at 24 weeks from the start of treatment is to ensure the primary endpoint measurement occurs at the same relative timepoint from the start of treatment in all patients. The primary endpoint will be assessed in the modified intent-to-treat population in C-BEYOND and the per-protocol population in C-FORWARD.

Results Presented at EASL and AASLD Support Best-in-Class Potential of Regimen

Results presented at both the European Association for the Study of the Liver (EASL) Congress 2025 and The Liver Meeting ^® 2025, the Annual Meeting of American Association for the Study of Liver Diseases (AASLD), support the potential best-in-class profile of the BEM/RZR regimen:

• In the Company’s Phase 2 study (n=275), the 8-week regimen of BEM/RZR achieved 98% SVR12 in the per-protocol, treatment-adherent population and 95% SVR12 in the efficacy-evaluable population.
• Resistance analyses demonstrated a high barrier to resistance, with no meaningful impact of baseline resistance associated substitutions on antiviral activity or clinical response.
• Phase 1 studies showed the commercial FDC had high relative bioavailability and can be administered with or without food or with H2-blockers (famotidine).
• Drug-drug interaction (DDI) studies indicated a low risk of clinically meaningful DDIs, including no interaction between bemnifosbuvir and ruzasvir and a standard human immunodeficiency virus (HIV) treatment, supporting the potential use of BEM/RZR in HCV patients co-infected with HIV. Data also demonstrated no need for dose adjustment of bemnifosbuvir in participants with hepatic or renal impairment.

Collectively, these results further the best-in-class potential of BEM/RZR as a short-duration, pan-genotypic, high-efficacy regimen suitable for all HCV patients, including those with comorbidities and complex medication regimens — a critical differentiator in the current treatment landscape.

Physician Survey Reinforces Need for a New, Best-in-Class Treatment Option for HCV

Independent quantitative market research conducted for the Company by IQVIA affirmed strong provider interest in an HCV treatment with the profile of the BEM/RZR regimen.

In a survey of healthcare providers who treat HCV patients, the research results revealed that these providers are seeking a new treatment option offering high efficacy, a short treatment duration and a low risk of DDIs to address the needs of the current HCV patient population, as up to 80 percent of patients take multiple medications to manage comorbidities and coinfections. The healthcare providers surveyed are among the 153 top prescribers of direct-acting antivirals (DAAs) in the US, including 86 gastroenterologist/hepatologists, 34 infectious disease specialists and 33 internal medicine specialists.

These market insights align directly with the attributes demonstrated by the regimen of BEM/RZR and validate its potential to address key unmet needs in the global HCV market, which is estimated at approximately $3 billion in net sales annually, of which approximately $1.5 billion is attributed to the US.

New Pipeline Expansion into HEV to Address Unmet Clinical Need

In Q4 2025, Atea announced a new development program targeting HEV, for which no approved DAA therapies currently exist. Leveraging Atea’s proprietary nucleos(t)ide prodrug platform and drug discovery expertise, Atea has selected as the lead product candidate AT-587, a nucleotide analog. AT-587 has demonstrated potent nanomolar antiviral activity against HEV in vitro . In in vivo single-dose nonclinical pharmacokinetic studies, AT-587 achieved high plasma concentrations of the surrogate of the active intracellular triphosphate metabolite across all species, including rats and monkeys. In vitro toxicology, pharmacology and DMPK data present a favorable preclinical profile for AT-587. Additional first-in-human enabling studies are ongoing and Atea anticipates initiating a Phase 1 study in mid-2026.

If successful, the HEV program could address a substantial unmet medical need for immunocompromised patients and other high-risk populations and represent a meaningful expansion of Atea’s antiviral franchise. Atea currently estimates a potential US and EU commercial market opportunity in the amount of $750 million to $1 billion.

Strategic Outlook & Pipeline Diversification

Atea remains dedicated to disciplined execution and judicious deployment of resources to maximize clinical and commercial potential. With HCV as its lead development pillar, now in global Phase 3 development, and HEV as a strategically important expansion of the Company’s antiviral pipeline, Atea aims to build a diversified antiviral portfolio to meet critical unmet medical needs. As the Company approaches key inflection points in 2026, including two topline Phase 3 readouts for HCV and a first-in-human study for HEV, Atea will continue to evaluate potential strategic transactions and global commercialization options to maximize reach and impact.

About HCV

HCV is a blood-borne, positive-sense, single-stranded (ss) RNA virus that primarily infects liver cells. HCV is a leading cause of chronic liver disease and liver transplants, spreading via blood transfusion, hemodialysis and needle sticks, with approximately 240,000 deaths occurring each year. Despite the availability of DAAs, HCV continues to be a significant global healthcare issue. An estimated 50 million people worldwide are chronically infected with HCV and there are approximately one million new infections each year. In the US, between 2.4 and 4.0 million people are estimated to have HCV with annual new infections outpacing treatment rates. HCV infections in the US predominate in patients in the age group between 20-49 years old, and it is estimated that less than 10% of HCV-infected patients in the US have cirrhosis. Chronic HCV infection is the leading cause of liver cancer in the US, Europe and Japan.

About HEV

HEV is a positive-sense, single-stranded RNA virus that primarily infects liver cells. Transmitted via the fecal-oral route, waterborne transmission of HEV (GT-1 and GT-2) causes acute epidemics in developing countries, while foodborne transmission (GT-3 and GT-4) causes chronic infection in immunocompromised people in developed countries. There are an estimated 20 million HEV infections annually, resulting in an estimated 3 million symptomatic cases and an estimated 70,000 HEV-related deaths. While the virus is self-limiting in certain patient populations, other patient populations, particularly those with compromised immunity, including solid organ transplant recipients, hematopoietic stem cell transplant (HSCT) recipients, patients with hematologic malignancies, and patients with pre-existing liver disease, are at risk of rapid progression to cirrhosis. Despite the growing number of patients in high-risk populations in the US and EU, there is currently no approved antiviral therapy available for the treatment of HEV, and the treatment currently used is indicated for other viruses and poses challenges including adverse events and limited HEV efficacy. Atea’s initial HEV clinical efforts will focus on developing a product candidate for the treatment of immunocompromised patients with HEV GT-3 and GT-4 infections.

About Atea Pharmaceuticals

Atea is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing oral antiviral therapies to address the unmet medical needs of patients with serious viral infections. Leveraging Atea’s deep understanding of antiviral drug development, nucleos(t)ide chemistry, biology, biochemistry and virology, Atea has built a proprietary nucleos(t)ide prodrug platform to develop novel product candidates to treat single stranded ribonucleic acid, or ssRNA, viruses, which are a prevalent cause of serious viral diseases. Atea plans to continue to build its pipeline of antiviral product candidates by augmenting its nucleos(t)ide platform with other classes of antivirals that may be used in combination with its nucleos(t)ide product candidates. Atea’s Phase 3 program is the regimen of bemnifosbuvir, a nucleotide analog polymerase inhibitor, and ruzasvir, an NS5A inhibitor, to treat HCV. Atea anticipates advancing AT-587, a nucleotide analog, into Phase 1 for the treatment of HEV. For more information, please visit www.ateapharma.com .

Forward-Looking Statements

This press release includes “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this press release include but are not limited to statements regarding the potential best-in-class profile of the bemnifosbuvir/ruzasvir regimen for the treatment of HCV, the potential opportunity to advance efforts to eradicate HCV, the potential to develop a product for the treatment of HEV, anticipated milestone events and timelines for clinical trials including the timeline for readout of the HCV Phase 3 clinical trials results and initiation of the HEV Phase 1 study, future results of operations and financial position including the cash runway, business strategy and outcomes of evaluation of strategic transaction and global commercialization options. When used herein, words including “expected,” “should,” “anticipated,” “believe,” “will,” “plans”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Atea’s current expectations and various assumptions. Atea believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Atea may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various important factors, including, without limitation, uncertainties inherent in the drug discovery and development process and the regulatory submission or approval process, unexpected or unfavorable safety or efficacy data or results observed during clinical trials or in data readouts; delays in or disruptions to clinical trials or our business; our reliance on third parties over which we may not always have full control; our ability to manufacture sufficient commercial product; competition from approved treatments for HCV; the timeline for the completion of the strategic alternatives review process is unknown and there can be no assurance that the process will result in any particular outcome; dependence on the success of Atea’s most advanced product candidates, in particular the bemnifosbuvir/ruzasvir regimen for the treatment of HCV; as well as the other important factors discussed under the caption “Risk Factors” in Atea’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2025 as such factors may be updated from time to time in its other filings with the SEC, which are accessible on the SEC’s website at www.sec.gov. These and other important factors could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While Atea may elect to update such forward-looking statements at some point in the future, except as required by law, it disclaims any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing Atea’s views as of any date subsequent to the date of this press release.

Contacts

Jonae Barnes
SVP, Investor Relations and Corporate Communications
617-818-2985
[email protected]

Joyce Allaire
LifeSci Advisors
[email protected]

Data readouts planned for CLN-978 across all three autoimmune indications in 2026, including single dose and repeat dosing data

Company to complete monotherapy expansion cohorts to determine recommended Phase 2 dose for CLN-049 pivotal registrational study and initiate combination study in frontline AML in Q4 2026

Zipalertinib rolling NDA submission expected to be complete in Q1 2026 and full enrollment of REZILIENT3 frontline study expected in H1 2026

Preliminary cash and investments of $439.0 million as of December 31, 2025; Runway into 2029

CAMBRIDGE, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Cullinan Therapeutics, Inc. (Nasdaq: CGEM; “Cullinan”), a clinical-stage biopharmaceutical company accelerating potential first- or best-in-class, high-impact therapies in autoimmune diseases and cancer, today provided a corporate update and shared anticipated business highlights for 2026.

“We have built strong momentum with CLN-978 and are pleased to share that we have completed multiple dose cohorts in our OUTRACE RA and OUTRACE SLE studies, and we have initiated dosing in our Sjögren’s disease study. This significant progress positions us to deliver the first company sponsored data with a CD19 T cell engager in autoimmune diseases. Throughout 2026, we will deliver data across all three indications, including important repeat dosing data in rheumatoid arthritis,” said Nadim Ahmed, President and CEO of Cullinan Therapeutics.

“Our CLN-049 program continues to advance following the presentation of compelling efficacy and favorable safety data at ASH 2025, which we believe enables an accelerated approval pathway. We plan to complete dose expansion in relapsed/refractory AML and TP53 m AML to rapidly determine a recommended Phase 2 dose, while also initiating a frontline combination study this year. Additionally, 2026 marks a pivotal milestone for zipalertinib, as Taiho completes the rolling NDA submission in the beginning of the year, and completes enrollment in the frontline study REZILIENT3 in the first half of 2026. In summary, we are focused on generating multiple catalysts for our two high-priority T cell engager programs, CLN-978 and CLN-049, positioning us for a transformative year ahead.”

Portfolio Highlights and Anticipated 2026 Milestones

Immunology

• CLN-978 (CD19xCD3 bispecific T cell engager): Rheumatoid arthritis (RA), systemic lupus erythematosus (SLE), and Sjögren’s disease (SjD)
  
• OUTRACE RA
  
  • Dose escalation is ongoing, and patients are currently being enrolled to the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
    
  • In Q2 2026, the Company plans to share initial data from the single target dose escalation portion of the study with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
    
  • In Q3 2026, the Company plans to share initial repeat dosing data, including B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
    
• OUTRACE SLE
  
  • Dose escalation is ongoing, and patients are currently being enrolled in the 30-microgram dose cohort. The 10- and 20-microgram dose cohorts are complete with no dose-limiting toxicities observed.
    
  • In Q2 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood, additional biomarker data, and preliminary clinical activity data.
    
• OUTRACE SjD
  
  • The Company has initiated patient dosing, and enrollment is ongoing in the 10-microgram dose cohort.
    
  • In Q4 2026, the Company plans to share initial data from Part A (single target dose escalation) with a focus on safety and B cell depletion in peripheral blood and tissue, additional biomarker data, and preliminary clinical activity data.
    
• Velinotamig (BCMAxCD3 bispecific T cell engager): Autoimmune diseases
  
  
  • In December 2025, Genrix Bio initiated a Phase 1 study in China in patients with autoimmune diseases, and initial clinical data from the study will be shared in Q4 2026. Cullinan intends to use the data generated to accelerate global clinical development of the program. Following the completion of the Genrix Bio Phase 1 study, Cullinan will conduct all further development of velinotamig in autoimmune diseases.
    
    

Oncology

• CLN-049 (FLT3xCD3 bispecific T cell engager): Acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS)
  
  
  • In December 2025, CLN-049 received Fast Track designation for the treatment of relapsed/refractory AML from the U.S. FDA and, in an oral presentation at the 2025 ASH Annual Meeting, the Company shared compelling clinical data in a heavily pretreated all-comer population of patients with relapsed/refractory AML. The Company plans to share an update from the dose escalation portion of the study in H2 2026.
    
  • In Q2 2026, the Company expects to initiate monotherapy dose expansion cohorts in patients with relapsed/refractory AML and TP53 m AML. In Q4 2026, the Company expects to complete enrollment for dose expansion to determine the recommended Phase 2 dose (RP2D) for an expected single arm pivotal registrational trial.
    
  • In Q4 2026, the Company plans to initiate a Phase 1/2 combination study in frontline AML.
    
  • Enrollment also continues in a parallel Phase 1 study in patients with AML and measurable residual disease (MRD) immediately following induction therapy.
    
• Zipalertinib (EGFR ex20ins inhibitor), collaboration with Taiho Oncology: EGFR ex20ins NSCLC
  
  
  • In November 2025, Taiho initiated a rolling submission of an NDA seeking accelerated approval of zipalertinib for the treatment of patients with relapsed EGFR ex20ins NSCLC. Taiho expects completion of the NDA submission in Q1 2026.
    
  • Taiho expects to complete enrollment of the pivotal study REZILIENT3 in 1L EGFR ex20ins NSCLC in H1 2026.
    
  • Cullinan is eligible to receive up to $130 million in payments for U.S. regulatory milestones and a 50/50 profit share in the U.S.
    
    

Cash Position and Cash Runway
Unaudited preliminary cash, cash equivalents, short- and long-term investments, and interest receivable were $439.0 million as of December 31, 2025. Consistent with prior guidance, Cullinan expects its cash resources to provide runway into 2029 under its current operating plan.

The Company expects to report its fourth quarter and full-year 2025 financial results in late February 2026 which will contain additional information required for a more complete understanding of the Company’s financial position and results of operations as of and for the year ended December 31, 2025.

About Cullinan Therapeutics
Cullinan Therapeutics, Inc. (Nasdaq: CGEM) is a biopharmaceutical company developing potential first- or best-in-class, high-impact therapies for autoimmune diseases and cancer. Cullinan pursues promising therapeutic targets while leveraging core expertise in T cell engagers, which are established in oncology and are now advancing into autoimmune diseases. With a clinical-stage pipeline built on a rigorous scientific approach and purposeful innovation, Cullinan is advancing its mission to deliver new standards of care for patients. Learn more about Cullinan at https://cullinantherapeutics.com/ , and follow Cullinan on LinkedIn and X .

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, express or implied statements regarding the company’s beliefs and expectations regarding: our preclinical and clinical developments plans and timelines for our product candidates, the clinical and therapeutic potential of our product candidates, the strategy of our product candidates, our research and development activities, our preliminary estimates of cash, cash equivalents, short- and long-term investments, and interest receivable as of December 31, 2025, our cash runway, and other statements that are not historical facts. The words “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “plan,” “potential,” “project,” “pursue,” “will,” 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 of future events and are subject to known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: the preliminary cash position reported herein reflects information available to us only at this time and may differ from our actual cash position as of December 31, 2025, including in connection with the completion of our financial statement closing procedures; uncertainty regarding the timing and results of regulatory submissions; the risk that any INDs, NDAs or other global regulatory submissions we may file with the United States Food and Drug Administration or other global regulatory agencies are not cleared or approved on our expected timelines, or at all; the success of our clinical trials and preclinical studies; the risks related to our ability to protect and maintain our intellectual property position; the risks related to manufacturing, supply, and distribution of our product candidates; the risk that any one or more of our product candidates, including those that are co-developed, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies; the effect of changes in global economic conditions, including uncertainties related to international trade policies, tariffs and supply chain dynamics on our business and operations; and the success of any collaboration, partnership, license or similar agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, including under the caption “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change, except to the extent required by law. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. Moreover, except as required by law, neither the company nor any other person assumes responsibility for the accuracy and completeness of the forward-looking statements included in this press release. Any forward-looking statement included in this press release speaks only as of the date on which it was made.

Contacts:

Investors
Nick Smith
+1 401.241.3516
[email protected]

Media
Rose Weldon
+1 215.801.7644
[email protected]

NEW YORK, Jan. 08, 2026 (GLOBE NEWSWIRE) -- AtaiBeckley Inc (NASDAQ: ATAI) (“AtaiBeckley” or the “Company”), a clinical-stage biotechnology company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments, today provided its outlook for 2026 ahead of attendance at the J.P. Morgan 44th Annual Healthcare Conference in San Francisco, California, on January 12 – 15, 2026.

Dr Srinivas Rao, Co-Founder and Chief Executive Officer of AtaiBeckley, said: “ Following the strategic combination of atai Life Sciences and Beckley Psytech completed last year and the recent corporate redomiciliation to the United States, we enter 2026 with meaningful momentum and a clear vision for the impact AtaiBeckley can deliver for people living with difficult-to-treat mental health conditions. Our pipeline is maturing at a pivotal moment for innovation in the mental health treatment landscape, and with financial resources expected to support operations into 2029, we are well prepared to execute. Our presence at the J.P. Morgan Healthcare Conference provides us with an important opportunity to engage with investors and strategic partners and highlight the progress we’ve made so far and the value we believe AtaiBeckley is positioned to deliver in the months and years ahead.”

Recent Clinical Updates and Anticipated 2026 Milestones

BPL-003: mebufotenin benzoate nasal spray for treatment-resistant depression (TRD) and alcohol use disorder

• Reported positive topline data from the eight-week, quadruple-masked, dose-finding, core stage of the Phase 2b clinical trial evaluating the efficacy and safety of a single dose of BPL-003 in patients with treatment-resistant depression (TRD) in July 2025. The study met its primary and all key secondary endpoints, and BPL-003 demonstrated rapid, robust and durable antidepressant effects with a single dose. Both 8 mg and 12 mg single doses of BPL-003 showed statistically significant and clinically meaningful reductions in depressive symptoms at all time points of the study compared to a 0.3 mg low-dose active control out to Week 8.
  
• Reported positive topline data from the eight-week open-label extension (OLE) study of the Phase 2b clinical trial of BPL-003 in patients with TRD in November 2025. The findings showed that a 12 mg dose of BPL-003, administered eight weeks after an initial dose, was generally well-tolerated and produced additional clinically meaningful antidepressant effects that were sustained for up to two months.
  
• Company anticipates providing guidance on the BPL-003 Phase 3 clinical program in Q1’26 with Phase 3 trial initiation in Q2’26, pending outcome of the scheduled End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA).
• Initiation of an additional cohort in an open-label Phase 2a study of BPL-003 in patients with TRD planned in Q1’26, with initial data expected in Q4’26. The study will evaluate a two-dose induction regimen of BPL-003, where patients who are also taking defined antidepressants will be given an 8 mg dose of BPL-003 followed by a second 8 mg dose two weeks later, and then followed for a further 10 weeks.
  

VLS-01: dimethyltryptamine (DMT) buccal film for TRD

• Company anticipates topline data from Elumina, the Phase 2, multicenter, double-blind, randomized, placebo-controlled trial of repeated doses of VLS-01 in 142 patients with TRD in H2’26
  

EMP-01: Oral R-enantiomer of 3,4-methylenedioxy-methamphetamine (R-MDMA) for social anxiety disorder (SAD)

• Announced granting of new patent covering EMP-01 (oral R-MDMA) from the United States Patent and Trademark Office in December 2025. US patent No. 12,492,178 includes claims to a highly-crystalline form of (R)-MDMA HCl and is expected to provide exclusivity through 2043.
• Last patient last visit in the exploratory Phase 2a study of EMP-01 (oral R-MDMA) in approximately 70 adults with social anxiety disorder occurred in Q4 ‘25, with topline data expected in Q1’26.

Recent Corporate Updates

• Completed the redomiciliation of Atai Beckley N.V. from the Netherlands to the United States (via Luxembourg) in December 2025. All issued and outstanding ordinary shares of Atai Beckley N.V. were exchanged on a one-for-one basis for newly issued shares of common stock of the Delaware company, AtaiBeckley Inc. The former shareholders of Atai Beckley N.V. are now the stockholders of the Delaware company. AtaiBeckley Inc’s common stock will continue to trade on NASDAQ under the trading symbol “ATAI”. The Company expects the redomiciliation to save costs, create alignment with its U.S. listing and shareholder base, simplify its corporate structure, streamline reporting requirements, and reduce the associated administrative burden for the Company and investors.
• Announced that AtaiBeckley Inc’s common stock had been added to the NASDAQ biotechnology index (NBI) in December 2025.

About AtaiBeckley Inc.

AtaiBeckley is a clinical-stage biotechnology company on a mission to transform patient outcomes by developing effective, rapid-acting and convenient mental health treatments. It was formed through the strategic combination of atai Life Sciences N.V. and Beckley Psytech Limited in November 2025. AtaiBeckley’s pipeline of novel therapies includes BPL-003 (mebufotenin benzoate nasal spray) for treatment-resistant depression (TRD), VLS-01 (DMT buccal film) for TRD and EMP-01 (oral R-MDMA) for social anxiety disorder, which are in Phase 2 clinical development. It is also advancing a drug discovery program to identify novel, non-hallucinogenic 5-HT2AR agonists for opioid use disorder and TRD. These programs aim to create new possibilities in mental health by providing effective, commercially scalable and convenient interventional psychiatry therapies that can integrate seamlessly into healthcare systems.

For the latest updates and to learn more about the AtaiBeckley mission, visit www.ataibeckley.com or follow the Company on LinkedIn and on X .

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “anticipate,” “initiate,” “could,” “would,” “project,” “plan,” “potentially,” “preliminary,” “likely,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these words. Forward-looking statements include express or implied statements relating to, among other things: our business strategy and plans; our runway; the potential, success and timing of development and progress of trials and related milestones of our product candidates such as EMP-01; expectations regarding our intellectual property portfolio, including our newly granted patent and plans for expansion of our patent portfolio; and the plans and objectives of management for future operations, research and development and capital expenditures.

Forward-looking statements are neither promises nor guarantees, but involve known and unknown risks and uncertainties that could cause actual results to differ materially from those projected, including, without limitation, the important factors described in the section titled “Risk Factors” in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”), as such factors may be updated from time to time in AtaiBeckley’s other filings with the SEC. AtaiBeckley disclaims any obligation to update or revise any forward-looking statements contained in this press release, other than to the extent required by applicable law.

Contact Information
Investor Contact:
[email protected]

Media Contact:
[email protected]

67% of additional patients (n=6) enrolled in the BEACON study achieved a complete response at 12 weeks with a mean UAS7 reduction of 31 points

75% of CSU participants (n=36) enrolled in the open label extension study achieved a complete response or well controlled disease at 12 weeks

With a median duration of follow up of more than 200 days on 63 participants in the open label extension study, KIT related AEs were low in frequency and predominantly low-grade events that resolved while on study

BEACON and open label extension data sets are now sufficient to select doses for the Phase 2b study of briquilimab in CSU planned to commence in the second half of 2026

Company to host conference call and webinar today at 8:00 a.m. ET

REDWOOD CITY, Calif., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Jasper Therapeutics, Inc. (Nasdaq: JSPR) (Jasper), a clinical stage biotechnology company focused on development of briquilimab, a novel antibody therapy targeting KIT (CD117) to address mast cell driven diseases such as chronic spontaneous urticaria (CSU), chronic inducible urticaria (CIndU) and asthma, is reporting positive updated clinical data from Jasper’s BEACON Phase 1b/2a study of subcutaneous briquilimab in adult participants with CSU, as well as from the open label extension study in CSU and CIndU. Treatment with briquilimab resulted in rapid disease control in the additional participants enrolled in the 240mg / 180mg Q8W cohort (n=6) in the BEACON study, with 83% of participants achieving a complete response by week 3 after the initial 240mg dose, and 67% reporting a complete response at 12 weeks. Similarly high levels of efficacy were demonstrated in the open-label extension study evaluating a 180mg Q8W dosing regimen, with 58% of CSU participants (n=36) achieving a complete response at 12 weeks.

“We are very pleased to present data from additional patients enrolled in the BEACON study, which reaffirms the potential of briquilimab to drive rapid and durable disease control in patients with CSU,” said Dr. Daniel Adelman, Acting Chief Medical Officer of Jasper. “We are also pleased by the performance of the 180mg Q8W dose in the open label extension study, with the strong efficacy observed in CSU and CIndU patients. Taken together with the favorable safety and tolerability profile observed in both studies, we believe these data are sufficient to support a differentiated profile for briquilimab in chronic urticaria. On behalf of the Jasper team, I’d like to thank the investigators and the patients who participated in the study, along with their families and caregivers.”

BEACON Study Design and Updated Data Summary:

The BEACON study is a randomized, double-blind, and placebo-controlled Phase 1b/2a trial evaluating multiple ascending doses of subcutaneous briquilimab as a therapy for adult patients with moderate to severe CSU despite treatment with high dose antihistamines. The primary endpoints are safety and tolerability of briquilimab and secondary endpoints are focused on clinical activity and PK/PD, including measurement of serum tryptase and mast cells in skin. Primary measurements used to assess clinical activity were the sum of the Hives Severity Score and the daily Itch Severity Score (ISS), as measured via the Urticaria Activity Score over 7 days (UAS7) on a 0 to 42-point scale.

The updated data includes the results from 8 additional participants enrolled into the 240mg /180mg Q8W cohort of the BEACON study since the last data update in July 2025, with 2 of those participants randomized to placebo. In patients dosed with briquilimab (n=6), the mean reduction from baseline in the UAS7 score was 31.0 points at 12 weeks. By week 3, complete responses (UAS7 = 0) were achieved by 83% of participants dosed with briquilimab, and at week 12, 67% of participants dosed with briquilimab reported complete responses.

Briquilimab continued to be well-tolerated in the BEACON study, with no dose limiting toxicities observed. Safety observations potentially related to KIT blockade were infrequent and generally limited to low grade events, none of which resulted in discontinuations or dose delays and the majority of which resolved during repeat dosing.

Open Label Extension Study Design and Updated Data Summary:

The open-label extension study in chronic urticarias is enrolling patients with CSU from the BEACON study as well as patients with CIndU from the SPOTLIGHT study who have completed study follow up. Participants in the open label extension are treated with 180mg of briquilimab on a Q8W dosing schedule. Jasper is reporting efficacy data from 36 patients with CSU and 17 patients with CIndU, all of whom completed at least 12 weeks of follow-up.

Briquilimab treatment continued to drive deep and durable disease control in the open label extension. At the 12 week assessment, 58% of CSU patients (n=36) achieved a complete response and 75% achieved either complete response or well controlled disease (UAS7≤6). In the CIndU portion of the open label extension study, efficacy measurements were taken every 8 weeks, and 65% of patients (n=17) achieved a complete response or partial response at 16 weeks, which was 8 weeks following administration of the second dose.

With a median duration of follow up of 205 days in 63 patients (46 CSU and 17 CIndU) briquilimab continued to be well-tolerated with no dose limiting toxicities observed. Safety observations potentially related to KIT blockade were infrequent and generally limited to low grade events, none of which resulted in discontinuations or dose delays and the majority of which resolved during repeat dosing.

“We are excited to present positive updated data from our chronic urticaria studies,” said Jeet Mahal, President and Chief Executive Officer of Jasper. “With the rapid onset of disease control, durable efficacy and a favorable safety profile supported by more than six months median follow up in more than 63 patients, briquilimab continues to demonstrate the potential for a compelling and differentiated product profile to address the high level of unmet need for patients with chronic urticaria. With these additional data from the BEACON and open label extension studies, we now have sufficient efficacy and safety data to enable dose selection for our planned Phase 2b study in CSU, which we expect to commence in the second half of 2026.”

Conference Call / Webinar

Jasper will host a conference call and webinar today at 8:00 a.m. ET. A live question and answer session with management will follow the formal presentation. A link to the webinar, including presentation slides, can be found here .

The presentation slides and a link to the live and archived webcast will also be available on the Events & News – Events page of Jasper's Investor Relations website.

About Jasper

Jasper is a clinical-stage biotechnology company focused on developing briquilimab as a therapeutic for chronic mast cell diseases. Briquilimab is a targeted aglycosylated monoclonal antibody that blocks stem cell factor from binding to the cell-surface receptor KIT, thereby inhibiting signaling through the receptor. This inhibition disrupts the critical survival signal, leading to the depletion of the mast cells via apoptosis which removes the underlying source of the inflammatory response in mast cell driven diseases such as chronic urticaria and asthma. Jasper is currently conducting clinical studies of briquilimab as a treatment in patients with CSU, CIndU and asthma. Briquilimab has a demonstrated efficacy and safety profile in patients and healthy volunteers, with positive clinical outcomes in CSU, CIndU and allergic asthma. For more information, please visit us at www.jaspertx.com .

Forward-Looking Statements

Certain statements included in this press release that are not historical facts are forward-looking statements for purposes of the safe harbor provisions under the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements are sometimes accompanied by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “expect,” “should,” “would,” “plan,” “predict,” “potential,” “seem,” “seek,” “future,” “outlook” and similar expressions that predict or indicate future events or trends or that are not statements of historical matters. These forward-looking statements include, but are not limited to, statements regarding briquilimab’s potential, including with respect to its potential in mast cell driven diseases such as CSU, CIndU and asthma, its potential to drive rapid and durable disease control in patients with CSU and the potential for a compelling and differentiated product profile to address the high level of unmet need for patients with chronic urticaria; briquilimab’s safety profile; the sufficiency of the data to support a differentiated profile for briquilimab in chronic urticaria; briquilimab’s ability to drive deep and durable disease control Jasper’s expectations regarding a registrational program in CSU, including the expected timing of the Phase 2b study and dose selection; ; and the topics expected to be discussed during the webinar. These statements are based on various assumptions, whether or not identified in this press release, and on the current expectations of Jasper and are not predictions of actual performance. These forward-looking statements are provided for illustrative purposes only and are not intended to serve as, and must not be relied on by an investor as, a guarantee, an assurance, a prediction or a definitive statement of fact or probability. Many actual events and circumstances are beyond the control of Jasper. These forward-looking statements are subject to a number of risks and uncertainties, including general economic, political and business conditions; the risk that the potential product candidates that Jasper develops may not progress through clinical development or receive required regulatory approvals within expected timelines or at all; the risk that clinical trials may not confirm any safety, potency or other product characteristics described or assumed in this press release; the risk that Jasper may be unable to raise capital to continue its operations and continue the BEACON study; the risk that Jasper will be unable to successfully market or gain market acceptance of its product candidates; the risk that prior study results may not be replicated, including the updated results for the BEACON study and open-label extension study reported in this press release; the risk that Jasper’s product candidates may not be beneficial to patients or successfully commercialized; patients’ willingness to try new therapies and the willingness of physicians to prescribe these therapies; the effects of competition on Jasper’s business; the risk that third parties on which Jasper depends for laboratory, clinical development, manufacturing and other critical services will fail to perform satisfactorily; the risk that Jasper’s business, operations, clinical development plans and timelines, and supply chain could be adversely affected by the effects of health epidemics; the risk that Jasper will be unable to obtain and maintain sufficient intellectual property protection for its investigational products or will infringe the intellectual property protection of others; and other risks and uncertainties indicated from time to time in Jasper’s filings with the SEC, including its Annual Report on Form 10-K for the year ended December 31, 2024 and subsequent Quarterly Reports on Form 10-Q. If any of these risks materialize or Jasper’s assumptions prove incorrect, actual results could differ materially from the results implied by these forward-looking statements. While Jasper may elect to update these forward-looking statements at some point in the future, Jasper specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing Jasper’s assessments of any date subsequent to the date of this press release. Accordingly, undue reliance should not be placed upon the forward-looking statements.

Contacts:

Alex Gray (investors)
Jasper Therapeutics
650-549-1454
[email protected]

Joyce Allaire (investors)
LifeSci Advisors
617-435-6602
[email protected]

Media:
[email protected]

First patients dosed in budoprutug PrisMN Phase 2 trial in pMN, with initial data expected second half 2026

Dosing ongoing in budoprutug Phase 1b/2a trial in ITP and Phase 1b trial in SLE; achieved regulatory clearance for SLE IND in China

First patients dosed in CLYM116 Phase 1 healthy volunteer study

Anticipating a data-rich 2026, with initial readouts from all ongoing budoprutug and CLYM116 studies

Strong financial position with cash runway expected into 2028

WELLESLEY HILLS, Mass., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Climb Bio, Inc. (Nasdaq: CLYM), a clinical stage biotechnology company developing therapeutics for patients with immune-mediated diseases, today announced progress updates for its budoprutug and CLYM116 programs. The Company also highlighted its strategic priorities and key anticipated milestones for 2026 and refreshed its financial guidance.

“Reflecting on 2025, we set out with ambitious goals, and I am proud of the substantial progress made across our clinical development and corporate objectives,” said Aoife Brennan, M.B., Ch.B., President and Chief Executive Officer of Climb Bio. “We are now primed for a fulsome evaluation of budoprutug, our anti-CD19 monoclonal antibody, with the initiation of four clinical trials and the clearance of our China IND. We also rapidly advanced CLYM116, our anti-APRIL monoclonal antibody, into the clinic and dosed our first subjects in less than one year after announcing the in-licensing transaction. Across the portfolio we achieved 20 regulatory clearances to conduct clinical trials and activated 45 trial sites globally, a testament to our robust clinical execution.”

“Looking ahead, 2026 is poised to be a transformative and data-rich year for Climb, with initial readouts expected from all our ongoing trials,” continued Dr. Brennan. “With CLYM116 for IgAN, budoprutug in pMN, ITP, and SLE, and the potential to evaluate lupus nephritis in a separate, parallel China SLE trial, our pipeline has the potential to address the high unmet need which exists across renal and other B-cell mediated diseases. Together, the anticipated datasets from our ongoing studies will inform the next steps in our mission to deliver differentiated treatments for immune-mediated diseases with substantial therapeutic and commercial potential.”

2025 Major Accomplishments and Pipeline Status

Budoprutug anti-CD19 monoclonal antibody

• Initiated Phase 2 Trial in Primary Membranous Nephropathy (pMN): In November 2025, FPI was achieved in the PrisMN Phase 2 trial. The study is designed to evaluate pharmacodynamics (including B cells, anti-PLA2R, and total immunoglobulin) and preliminary efficacy (including complete and partial remission) in pMN patients with persistent proteinuria despite optimized RAAS inhibition, and to identify a dose to carry forward into Phase 3 clinical development. In November 2025, the Company also published budoprutug pMN Phase 1b long-term outcome data at the 2025 American Society of Nephrology (ASN) Kidney Week that demonstrated long-term control of proteinuria.
• Initiated Phase 1b/2a Trial in Immune Thrombocytopenia (ITP): Dosing is ongoing in the open-label, dose-escalation Phase 1b/2a clinical trial of budoprutug in relapsed/refractory ITP designed to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B cell depletion and platelet counts. At the 2025 American Society of Hematology (ASH) conference in December, the Company presented a poster detailing the Phase 1b/2a trial design.
• Initiated Global Phase 1b Trial in Systemic Lupus Erythematosus (SLE) and Received Regulatory Clearance of SLE IND in China: Dosing is ongoing in the global, open-label, dose-escalation Phase 1b trial of a single dose of budoprutug in moderate to severe SLE to evaluate safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy, including B-cell depletion, autoantibody levels, and clinical activity. In December 2025, the Company received clearance of its investigational new drug application (IND) in China to initiate a separate, parallel China Phase 1b trial in SLE, which will complement our ongoing study and also seek to enroll SLE patients who have lupus nephritis.
• Initiated Subcutaneous (SC) formulation Phase 1 Trial: First cohorts were dosed in the Phase 1 trial in healthy volunteers, which is designed to evaluate bioavailability, pharmacokinetics, and pharmacodynamics, including B cell depletion, of the subcutaneous formulation of budoprutug.

CLYM116 anti-APRIL monoclonal antibody

• Obtained Exclusive License to Develop and Commercialize CLYM116: Entered into a technology transfer and exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (NEEQ Code: 874070, Mabworks) in January 2025 for the rights to develop and commercialize CLYM116 in the territory outside of Greater China.
• Presented Preclinical Data: Completed IND enabling studies and shared preclinical data highlighting the unique ‘sweeper’ mechanism and product profile at the 2025 ASN Kidney Week in November and reviewed the opportunity in IgAN at a CLYM116-focused R&D Spotlight Webcast in September 2025.
• Initiated Phase 1 Clinical Trial: In December 2025, the Company achieved FPI and completed dosing of the first cohort in the ongoing Phase 1 clinical trial in healthy volunteers to evaluate safety, pharmacokinetics, and pharmacodynamics.
• Regulatory Clearance of Mabworks IND in China: In December 2025, our partner, Mabworks, received clearance of its IND in China to initiate a Phase 1 trial.

Corporate Milestones and Cash Guidance

• Expanded senior leadership team with appointments of Edgar D. Charles, M.D., MSc as Chief Medical Officer, Perrin Wilson, Ph.D., as Chief Business Officer, Susan Altschuller, Ph.D., MBA as Chief Financial Officer, Adam Villa, MS, MBA as SVP, Technical Operations, and Ashley Jones as SVP, People & Workforce Strategy.
• Strengthened Board of Directors with the addition of industry veterans Kim Cobleigh Drapkin, CPA and Bo Cumbo.
• Refreshed financial guidance, with cash, cash equivalents, and marketable securities expected to fund operations into 2028.
  

2026 Anticipated Milestones

Budoprutug:

• SC formulation Phase 1: initial data from healthy volunteer study (H1 2026)
• China SLE Phase 1b: first patient dosed (H1 2026)
• PrisMN (pMN) Phase 2: initial data (H2 2026)
• ITP Phase 1b/2a : initial data, including preliminary efficacy (H2 2026)
• SLE Phase 1b: initial data, including preliminary efficacy (H2 2026)
  

CLYM116

• Phase 1: initial data from healthy volunteer study (mid-2026)
  

About Climb Bio, Inc.
Climb Bio, Inc. is a clinical-stage biotechnology company developing therapeutics for patients with immune-mediated diseases. The Company’s pipeline includes, budoprutug, an anti-CD19 monoclonal antibody that has demonstrated B-cell depletion and has potential to treat a broad range of B-cell mediated diseases, and CLYM116, an anti-APRIL monoclonal antibody being developed for IgA nephropathy. For more information, please visit climbbio.com .

About Budoprutug
Budoprutug is a clinical-stage, anti-CD19 monoclonal antibody being developed by Climb Bio to address a broad range of B-cell mediated, immune-driven diseases. Designed with enhanced effector function and low picomolar affinity, budoprutug targets and depletes CD19-expressing B cells, including plasma blasts that are key sources of pathogenic autoantibodies. Budoprutug clinical development is underway for three lead indications - primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE). Early clinical data suggest budoprutug may offer durable B-cell depletion, rapid reductions in autoantibodies, and clinical remission in pMN. A subcutaneous formulation is also in clinical development to enable broader patient access and potential home-based dosing. Budoprutug has been granted orphan drug designation by the FDA for the treatment of pMN.

About CLYM116
CLYM116 is a clinical-stage monoclonal antibody targeting APRIL (A Proliferation-Inducing Ligand), a key driver of pathogenic B-cell activity in autoimmune diseases. CLYM116 employs a novel pH-dependent bind-and-release ‘sweeper’ mechanism to potently block APRIL signaling, promote lysosomal degradation of APRIL, and recycle the antibody to extend its half-life. This differentiated design offers the potential for rapid, deep, and durable inhibition of APRIL with a favorable safety profile and less frequent dosing. CLYM116 is being advanced for the treatment of IgA nephropathy (IgAN) and may also have broader utility across other B-cell mediated diseases where APRIL plays a critical role.

Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation statements regarding: future expectations, plans and prospects for Climb Bio; expectations regarding the therapeutic benefits, clinical potential and clinical development of budoprutug and CLYM116; the anticipated timelines for reporting initial data from Climb Bio’s ongoing and planned clinical trials of budoprutug and CLYM116; the anticipated timeline for initiating Climb Bio’s parallel Phase 1b clinical trial of budoprutug in patients with systemic lupus erythematosus in China and the projected enrollment of patients with systemic lupus erythematosus that have lupus nephritis; the anticipated benefits of Climb Bio’s technology transfer and exclusive license agreement with Beijing Mabworks Biotech Co., Ltd. (“Mabworks”); the sufficiency of Climb Bio’s cash resources for the period anticipated; and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” “will,” “working” and similar expressions. Forward-looking statements are based on management’s current expectations of future events and are subject to a number of 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. Climb Bio may not actually achieve the plans, intentions or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. These risks and uncertainties include, but are not limited to, important risks and uncertainties associated with: the ability of Climb Bio to timely and successfully achieve or recognize the anticipated benefits of its technology transfer and exclusive license agreement with Mabworks; changes in applicable laws or regulation; the possibility that Climb Bio may be adversely affected by other economic, business and/or competitive factors; Climb Bio’s ability to advance budoprutug and CLYM116 on the timelines expected or at all and to obtain and maintain necessary approvals from the U.S. Food and Drug Administration and other regulatory authorities; obtaining and maintaining the necessary approvals from investigational review boards at clinical trial sites and independent data safety monitoring boards; replicating in clinical trials positive results found in early-stage clinical trials and nonclinical studies; competing successfully with other companies that are seeking to develop treatments for primary membranous nephropathy, immune thrombocytopenia, systemic lupus erythematosus, IgA nephropathy and other immune-mediated diseases; maintaining or protecting intellectual property rights related to budoprutug, CLYM116 and/or its other product candidates; the outcome of any legal proceedings or other disputes; managing expenses; and raising the substantial additional capital needed, on the timeline necessary, to continue development of budoprutug, CLYM116 and any other product candidates Climb Bio may develop. For a discussion of other risks and uncertainties and other important factors, any of which could cause Climb Bio’s actual results to differ materially from those contained in the forward-looking statements, see the “Risk Factors” section, as well as discussions of potential risks, uncertainties and other important factors, in Climb Bio’s most recent filings with the U.S. Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent Climb Bio’s views as of the date hereof and should not be relied upon as representing Climb Bio’s views as of any date subsequent to the date hereof. Climb Bio anticipates that subsequent events and developments will cause Climb Bio’s views to change. However, while Climb Bio may elect to update these forward-looking statements at some point in the future, Climb Bio specifically disclaims any obligation to do so, except as required by law.

Investors and Media
Carlo Tanzi, Ph.D.
Kendall Investor Relations
[email protected]

• Total Net Revenue Expected in the Range of $1,125 million to $1,195 million
• Total SUBLOCADE ^® Net Revenue Expected to be in the Range of $905 million to $945 million
• Non-GAAP Operating Expenses Expected in the Range of $430 million to $450 million
• Adjusted EBITDA Expected in the Range of $535 million to $575 million

RICHMOND, Va., Jan. 08, 2026 (GLOBE NEWSWIRE) -- Indivior PLC (Nasdaq: INDV) (“ Indivior PLC ” or the “ Company ”) today announced its full-year 2026 financial guidance.

“2025 was a transition year for Indivior in which we established the Indivior Action Agenda and completed Phase I – Generate Momentum – by growing U.S. SUBLOCADE net revenue, simplifying the organization and transforming our operating model,” said Joe Ciaffoni, Chief Executive Officer. “We enter 2026 well positioned to execute on Phase II – Accelerate – which includes accelerating U.S. SUBLOCADE dispense unit growth and SUBLOCADE net revenue throughout 2026 and immediately accelerating adjusted EBITDA and cash flow at a faster rate.”

“Our 2026 financial guidance reflects SUBLOCADE net revenue growth, driven by an acceleration in dispense units, and significant margin expansion from our simplified operating model,” said Ryan Preblick, Chief Financial Officer. “In 2026, we expect to grow SUBLOCADE net revenue by 11% at the midpoint of our guidance range while growing adjusted EBITDA by 35% and adjusted EBITDA margin by 14 percentage points.”

Recent Business Highlights :

• Completed Phase I of the Indivior Action Agenda — Generate Momentum – which included growing U.S. SUBLOCADE net revenue, simplifying the organization and transforming the Company’s operating model resulting in expected annual non-GAAP operating expense savings of at least $150 million.
• Entered Phase II of the Indivior Action Agenda – Accelerate – on January 1, 2026, which is focused on accelerating U.S. SUBLOCADE dispense unit growth and net revenue throughout 2026 and immediately accelerating adjusted EBITDA and cash flow at a faster rate.
• Gained inclusion in the S&P SmallCap 600 ^® index effective December 22, 2025.
• Received shareholder approval of the Company’s proposal to change its domicile from the U.K. to the U.S. and establish a new U.S. parent company, Indivior Pharmaceuticals, Inc. The change in domicile is expected to take effect on January 26, 2026.
• Concluded the legacy U.S. Department of Justice matter by paying in full the outstanding obligation of $295 million associated with the matter.
  

Full-Year 2026 Financial Guidance

About Indivior

Indivior Pharmaceuticals works to help change patients' lives by developing medicines to treat opioid use disorder (OUD). Our vision is that all patients will have access to evidence-based treatment for OUD and we are dedicated to transforming OUD from a human crisis to a recognized and treated chronic disease. Building on its portfolio of OUD treatments, Indivior has a pipeline of product candidates designed to expand on its heritage in this category. Visit www.indivior.com to learn more. Connect with Indivior on LinkedIn by visiting www.linkedin.com/company/Indivior .

Non-GAAP Financial Measures :

This announcement includes financial measures that are not defined by US GAAP, such as non-GAAP operating expenses, adjusted EBITDA, and adjusted EBITDA margin. These non-GAAP financial measures are not a substitute for, or superior to, results presented in accordance with US GAAP. Non-GAAP results as presented by the Company are not necessarily comparable to similarly titled measures used by other companies. As a result, these performance measures should not be considered in isolation from, or as a substitute analysis for, the Company's results as reported in accordance with US GAAP. Management performs a quantitative and qualitative assessment to determine if an item should be considered for adjustment.

Non-GAAP financial measures adjust for non-recurring items and other items representing significant expenses or income that we believe do not reflect the Company’s ongoing operations or the adjustment of which may help with the comparison to prior periods. Non-recurring items and other adjustments are excluded from non-GAAP financial measures consistent with the internal reporting provided to management and the Board. Examples of such items could include share-based compensation expense, income or restructuring and related expenses from the reconfiguration of the Company’s activities and/or capital structure, impairment of current and non-current assets, gains and losses from the sale of intangible assets, certain costs arising as a result of significant and non-recurring regulatory and litigation matters, and certain tax related matters. Beginning with our Q2 2025 financial release, adjusted EBITDA replaced non-GAAP operating income as a non-GAAP measure. The Company believes adjusted EBITDA may be useful to investors to understand the Company’s performance. In addition, the Company uses “adjusted EBITDA” in its annual incentive plan in which all executive officers participate. Share-based compensation has been excluded from non-GAAP operating expenses and adjusted EBITDA.

We have not provided the forward-looking U.S. GAAP equivalents for certain forward-looking non-U.S. GAAP metrics as a result of the uncertainty and potential variability of reconciling items. Accordingly, the Company has relied upon the exception in item 10(e)(1)(i)(B) of Regulation S-K to exclude such reconciliations, as the reconciliations of these non-U.S. GAAP guidance metrics to their corresponding U.S. GAAP equivalents are not available without unreasonable effort.

Important Cautionary Note Regarding Forward-Looking Statements :

This announcement contains certain statements that are forward-looking statements. All statements other than statements of historical fact are forward-looking statements. Forward-looking statements include, among other things, express and implied statements regarding: our financial guidance including with respect to total net revenue, SUBLOCADE net revenue; non-GAAP operating expenses, adjusted EBITDA, and adjusted EBITDA margin; expected SUBLOCADE dispense unit growth; expected continued price stability in SUBOXONE Film, expected annual operation expense savings; expected savings from our simplified operating model; and other statements containing the words "believe," "anticipate," "plan," "expect," "intend," "estimate," "forecast," “strategy,” “target,” “guidance,” “outlook,” “potential,” "project," "priority," "may," "will," "should," "would," "could," "can," the negatives thereof, and variations thereon and similar expressions. By their nature, forward-looking statements involve risks and uncertainties as they relate to events or circumstances that may or may not occur in the future.

Investors are cautioned that any such forward-looking statements are not guarantees of future performance and only express management’s beliefs regarding future results or events which, by their nature, are inherently uncertain and outside of management’s control or predict. Actual results may differ materially from those expressed or implied in these forward-looking statements due to a number of factors, including: lower than expected future sales of our products; greater than expected impacts from competition; unanticipated costs including the effects of potential tariffs and potential retaliatory tariffs; whether we are able to identify efficiencies; unknown liabilities; and the accuracy of our estimates regarding expenses, revenue, and capital requirements. For additional information about some of the risks and important factors that could affect our future results and financial condition, see “Important Cautionary Note Regarding Forward-looking Statements” and "Risk Factors" in Indivior's Annual Report on Form 10-K filed March 3, 2025, our Forms 10-Q filed May 1, 2025, July 31, 2025, and October 30, 2025, and our other filings with the U.S. Securities and Exchange Commission.

We have based the forward-looking statements in this report on our current expectations and beliefs concerning future events. Forward-looking statements contained in this report speak only as of the day they are made and, except as required by law, we undertake no obligation to update or revise any forward-looking statement, whether due to new information, or to reflect events or developments that occur after the date the statement was made.

For Further Information

Investors:
Jason Thompson
Indivior PLC
Tel: 804-402-7123
E-mail: [email protected]

Media:
Cassie France-Kelly
Indivior PLC
Tel: 804-594-0836
E-Mail: [email protected]