Calidi Biotherapeutics reported on its financial statements, emphasizing going concern assumptions and ongoing development of targeted genetic therapies.
Quiver AI Summary
Calidi Biotherapeutics, Inc. announced that its Annual Report for the fiscal year ended December 31, 2025, includes an audit report emphasizing that the financial statements are prepared under the assumption that the company will continue as a going concern. This disclosure complies with NYSE requirements and does not change previous filings. Calidi is focused on developing targeted genetic therapies, leveraging its proprietary RedTail platform, which uses an engineered oncolytic virus to deliver treatments to hard-to-reach tumor sites. Its lead candidate, CLD-401, is in IND-enabling studies targeting various cancers with significant unmet needs. The company also emphasizes the potential of its innovative approach to integrate T-cell engagers in solid tumors while cautioning investors about risks related to clinical trials and funding.
Potential Positives
- The inclusion of an audit report indicating that the financial statements were prepared under the assumption of the company continuing as a going concern suggests that the company believes in its sustainability and long-term viability despite current challenges.
- Calidi's proprietary RedTail platform, featuring an engineered enveloped oncolytic virus, represents a significant advancement in targeted genetic medicine, indicating the company's innovative approach in the biotechnology field.
- The ongoing IND-enabling studies of Calidi's lead candidate, CLD-401, targeting high unmet medical needs in multiple cancer types, underlines the potential impact of its therapies on critical health issues.
- The mention of novel approaches, including in situ T-cell engagers, showcases Calidi's commitment to advancing its pipeline and exploring new therapeutic strategies in oncology.
Potential Negatives
- The mention of the audit report emphasizing that the financial statements were prepared assuming the Company will continue as a going concern raises concerns about the Company's financial stability.
- The press release indicates potential risks to the Company's ability to raise sufficient capital to support ongoing and anticipated clinical trials, signaling possible financial difficulties.
- There are significant uncertainties regarding the Company's ability to receive FDA approval for its therapeutic candidates, which could impact future operations and investor confidence.
FAQ
What is Calidi Biotherapeutics?
Calidi Biotherapeutics is a biotech company focused on developing targeted genetic medicines using its proprietary RedTail platform for systemic delivery of therapies.
What does the recent audit report indicate?
The audit report emphasizes that Calidi's financial statements are prepared under the assumption that the company will continue as a going concern.
What is the RedTail platform?
The RedTail platform utilizes an engineered enveloped oncolytic virus designed for effective targeting and systemic delivery of genetic medicines to tumors.
What types of cancers does CLD-401 target?
CLD-401 targets non-small cell lung cancer, head and neck cancer, and other tumor types with significant unmet medical needs.
How can I find more information about Calidi Biotherapeutics?
More information can be found on Calidi's website at www.calidibio.com, including their corporate presentation and latest updates.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CLDI Insider Trading Activity
$CLDI insiders have traded $CLDI stock on the open market 1 times in the past 6 months. Of those trades, 0 have been purchases and 1 have been sales.
Here’s a breakdown of recent trading of $CLDI stock by insiders over the last 6 months:
- ALLAN CAMAISA sold 850 shares for an estimated $1,236
To track insider transactions, check out Quiver Quantitative's insider trading dashboard. You can access data on insider stock transactions through the Quiver Quantitative API insider transaction endpoint.
$CLDI Hedge Fund Activity
We have seen 12 institutional investors add shares of $CLDI stock to their portfolio, and 9 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- ARMISTICE CAPITAL, LLC added 879,000 shares (+inf%) to their portfolio in Q1 2026, for an estimated $209,905
- SABBY MANAGEMENT, LLC added 434,903 shares (+inf%) to their portfolio in Q1 2026, for an estimated $103,854
- WARBERG ASSET MANAGEMENT LLC added 250,000 shares (+inf%) to their portfolio in Q1 2026, for an estimated $59,700
- DRW SECURITIES, LLC removed 147,767 shares (-100.0%) from their portfolio in Q1 2026, for an estimated $35,286
- VIRTU FINANCIAL LLC added 54,526 shares (+256.7%) to their portfolio in Q1 2026, for an estimated $13,020
- ARAX ADVISORY PARTNERS added 37,345 shares (+inf%) to their portfolio in Q1 2026, for an estimated $8,917
- JANE STREET GROUP, LLC added 23,311 shares (+202.9%) to their portfolio in Q1 2026, for an estimated $5,566
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard. You can access data on hedge funds moves and 13F filings through the Quiver Quantitative API 13F endpoint.
Full Release
SAN DIEGO, May 22, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or “the Company”), a biotechnology company pioneering the development of targeted genetic medicines, today advised that its Financial Statements included in its Annual Report on Form 10-K for the year ended December 31, 2025, contained an audit report from its Independent Registered Public Accounting Firm with an explanatory paragraph emphasizing that the Consolidated Financial Statements were prepared assuming that the Company will continue as a going concern. Release of this information is required by Section 610(b) of the NYSE American Company Guide and does not reflect any change or amendment to any of the Company’s filings for the fiscal year ended December 31, 2025.
About Calidi
Calidi Biotherapeutics (NYSE American: CLDI) is a biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease. The company’s proprietary RedTail platform features an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites. This advanced enveloped technology is intended to shield the virus from immune clearance, allowing virotherapy to effectively reach tumor sites, induce tumor lysis, and deliver potent genetic medicine(s) to metastatic locations.
CLD-401, the lead candidate from the RedTail platform, currently in IND-enabling studies, targets non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need. Calidi continues to advance its pipeline utilizing the RedTail platform including its novel approach to incorporate in situ T-cell engagers in solid tumors.
Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com or view Calidi’s Corporate Presentation here .
Forward-Looking Statements
This press release may contain forward-looking statements for purposes of the “safe harbor” provisions under the United States Private Securities Litigation Reform Act of 1995. Terms such as “anticipates,” “believe,” “continue,” “could,” “estimate,” “expect,” “intends,” “may,” “might,” “plan,” “possible,” “potential,” “predicts,” “project,” “should,” “towards,” “would” as well as similar terms, are forward-looking in nature, but the absence of these words does not mean that a statement is not forward-looking. These forward-looking statements include, but are not limited to, statements concerning key milestones, including certain pre-clinical data, planned clinical trials, and statements relating to the safety and efficacy of Calidi’s therapeutic candidates in development. Any forward-looking statements contained in this discussion are based on Calidi’s current expectations and beliefs concerning future developments and their potential effects and are subject to multiple risks and uncertainties that could cause actual results to differ materially and adversely from those set forth or implied in such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that Calidi is not able to raise sufficient capital to support its current and anticipated clinical trials, the risk that early results of clinical trials do not necessarily predict final results and that one or more of the clinical outcomes may materially change following more comprehensive review of the data, and as more patient data becomes available, the risk that Calidi may not receive FDA approval for some or all of its therapeutic candidates. Other risks and uncertainties are set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s annual report filed with the SEC on Form 10-K on March 27, 2026, as may be amended or supplemented by other reports we file with the SEC from time to time. We disclaim any obligation to update any forward-looking statement to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events.
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