Calidi Biotherapeutics Provides Required NYSE American Disclosure
Rhea-AI Summary
Calidi Biotherapeutics (NYSE American: CLDI) announced that its audited 2025 Financial Statements in the Form 10-K include an audit report containing an explanatory paragraph stating the statements were prepared assuming the company will continue as a going concern. This disclosure is required under NYSE American Section 610(b) and involves no changes to Calidi’s 2025 filings.
Positive
- None.
Negative
- 2025 audited financials include an auditor explanatory paragraph on going concern
- NYSE American requires formal disclosure of going concern language in 2025 10-K
News Market Reaction – CLDI
In the May 26 session, CLDI gained 0.80%, reflecting a mild positive market reaction. Argus tracked a trough of -6.0% from its starting point during tracking. Our momentum scanner triggered 8 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| May 14 | Q1 2026 earnings | Neutral | -2.3% | Reported Q1 2026 net loss and cash of $6.8M with R&D updates. |
| May 13 | Conference presentation | Positive | +8.1% | Announced featured ASGCT talk on RedTail platform and CLD-401/CLD-501 data. |
| Apr 29 | AI partnership | Positive | -6.9% | Announced TransferAI partnership to streamline CLD-401 IND submission using AI. |
| Apr 21 | AACR CLD-401 data | Positive | -11.3% | Presented AACR data on CLD-401 showing IL-15 superagonist activity and immune effects. |
| Apr 20 | AACR T-cell engagers | Positive | -9.0% | Presented AACR data on RedTail T-cell engagers and named CLD-401 as lead asset. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent positive scientific and partnership updates often saw negative price reactions, while a conference presentation was met with a gain, suggesting inconsistent responses to news.
Over the last month, CLDI reported Q1 2026 results, multiple AACR data updates on lead asset CLD-401, and a strategic AI partnership to support an IND filing targeted by year-end 2026. Several of these scientific and partnership announcements were followed by declines of 6–11%, while a conference presentation on the RedTail platform saw an 8.11% gain. Today’s required disclosure about a going concern audit emphasis follows earlier filings that also referenced going concern doubts and low cash levels.
Key Terms
form 10-k regulatory
independent registered public accounting firm financial
going concern financial
nyse american company guide regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
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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