Calidi Biotherapeutics Announces Shareholder Letter from CEO

Rhea-AI Summary

Calidi Biotherapeutics (NYSE American: CLDI) issued a shareholder letter highlighting significant company developments under new CEO Eric Poma. The company's primary focus is advancing their RedTail platform, a systemic virotherapy platform for delivering genetic medicines to metastatic cancer sites.

Key developments include the appointment of Dr. Guy Travis Clifton as CMO, positive preclinical data presentations at AACR and ASCO meetings, and plans for an IND filing by end of 2026 for CLD-401, their lead RedTail candidate. The company also opened an IND for SuperNova virotherapy (CLD-201) with phase I trials expected to start by end of 2025.

Financially, Calidi reported $10.6 million in cash at Q1 2025 end, with reduced costs and lower burn rate. The company has retired most of its debt and is exploring partnership opportunities with leading biopharmaceutical companies.

Positive

• None.

Negative

• Limited cash position of $10.6M may require additional funding
• Lead candidate CLD-401 IND filing not expected until end of 2026
• Operating in difficult market conditions as acknowledged by management

Insights

Biotechnology Research Analyst

Calidi's CEO letter reveals strategic pivot to RedTail platform, leadership changes, and pipeline advances amid financial restructuring.

Calidi Biotherapeutics is undergoing significant transformation, with new leadership appointments including CEO Eric Poma and CMO Guy Travis Clifton signaling a strategic restructuring. The company has pivoted to prioritize their RedTail platform - a systemic delivery system for genetic medicines targeting metastatic cancer sites using engineered enveloped viruses - representing over a decade of research investment.

The preclinical data presented at AACR and ASCO suggests RedTail's differentiation through tumor-selective targeting and systemic delivery capabilities. Their lead candidate, CLD-401, delivers IL15 superagonist to tumor sites with IND-enabling studies underway and filing targeted by end of 2026. Additionally, they've opened an IND for their SuperNova virotherapy (CLD-201) with Phase I initiation expected by year-end.

Financially, Calidi closed Q1 with approximately $10.6 million in cash, while implementing cost reduction initiatives and debt retirement. This clinical-stage biotech appears to be realigning its resources toward its most promising assets while actively seeking partnership opportunities to accelerate development.

The extended timeline for CLD-401's IND filing (end of 2026) indicates a somewhat protracted path to clinical trials for their lead RedTail candidate, though the SuperNova program appears to be progressing more rapidly toward the clinic. The company's relatively modest cash position will likely necessitate additional financing before reaching significant clinical milestones.

SAN DIEGO, June 27, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the ability to deliver genetic payloads, issued the following shareholder letter from its Chief Executive Officer, Eric Poma, PhD.

Dear Shareholders,

2025 has been and will continue to be a transformative year for Calidi. We have made substantial changes in the company’s leadership, its focus and priorities, and in its balance sheet and operating expenses.

I am thrilled to have joined as Chief Executive Officer in April 2025. I am honored to lead this incredible organization and work alongside a team of talented individuals who are committed to advancing our novel therapeutic approaches to oncology. In May 2025, we further expanded our team by appointing Dr. Guy Travis Clifton as our Chief Medical Officer, Advisor and Consultant, adding critical expertise in clinical program advancement and regulatory strategy.

We have continued to advance our R&D pipeline. Of particular excitement is the rapid progress we have made with RedTail, the company’s approach to systemically delivering genetic medicines to metastatic sites in patients with advanced cancer using our proprietarily engineered enveloped virus. RedTail represents the culmination of over a decade of meticulous research and innovation at Calidi to create what we believe is the most advanced systemic virotherapy platform. Advancing this novel platform is the company’s main focus and priority.

Recent preclinical data presented at the AACR Annual Meeting and ASCO Annual Meeting demonstrate RedTail’s potent tumor-selective targeting, systemic reach, and delivery of genetic medicines to significantly improvement anti-tumor immune modulation. These attributes clearly differentiate RedTail within the rapidly expanding oncology market, with broad implications for both patient outcomes and shareholder value. Given the robust therapeutic versatility and the transformative potential of the RedTail platform, we are actively exploring partnership opportunities with leading biopharmaceutical companies. Such collaborations could further accelerate the development and commercialization of innovative therapies, expanding our market reach and enhancing long-term shareholder value.

Looking ahead, our roadmap for the next 18 months includes multiple critical milestones. We are working to complete IND-enabling studies ahead of an IND filing by the end of 2026 for our lead RedTail candidate that delivers IL15 superagonist to tumor sites, CLD-401. Our clinical strategy includes an aggressive dose-escalation study designed to swiftly demonstrate efficacy and validate the systemic administration of Redtail in patients with metastatic disease.

We are also excited to have opened an IND for our SuperNova virotherapy (CLD-201) in April of this year with the phase I expected to initiate by the end of 2025 in patients with advanced solid tumors. We believe this program has substantial advantages over other intratumoral oncolytic viruses.

Financially, we maintain a prudent stewardship of resources, closing Q1 2025 with approximately $10.6 million in cash. Calidi will continue to add to its balance sheet in a strategic manner. Over the last 12 months, we have substantially reduced costs and lowered the company’s burn rate while retiring the majority of the company’s debt. We believe these changes will allow the company to rapidly advance its pipeline, despite the difficult market conditions. Thank you for your continued confidence and investment in Calidi Biotherapeutics. I look forward to keeping you updated as we advance our groundbreaking RedTail platform and strive toward our vision: transforming cancer treatment to profoundly impact patient lives.

Sincerely,

Eric Poma, PhD
Chief Executive Officer
Calidi Biotherapeutics

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company pioneering the development a new generation of targeted immunotherapies. 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 gene therapies to metastatic locations.

The lead candidate from the Redtail platform, currently in IND-enabling studies, targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical need. Additionally, Calidi is developing protected virotherapies, in clinical-stage, for intratumoral and localized administration, focusing on a subset of injectable cancer indications.

Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

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 upcoming key milestones (including the reporting of interim clinical results and the dosing of patients), 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 Registration Statements filed with the SEC on (i) Form S-4 filed on August 2, 2023 and the corresponding prospectus filed on August 4, 2023, and (ii) on Form S-1 filed on April 15, 2024, and the Company’s periodic reports filed with the SEC Form 10-K filed on March 31, 2025 and Form 10-Q filed on May 14, 2025. These reports may be amended or supplemented by other reports we file with the SEC from time to time.

Contacts:

For Investors and Media:
Dave Gentry, CEO
RedChip Companies, Inc.
1-407-644-4256
CLDI@redchip.com

FAQ

What is Calidi Biotherapeutics' (CLDI) RedTail platform?

RedTail is Calidi's proprietary systemic virotherapy platform designed to deliver genetic medicines to metastatic cancer sites. The platform has demonstrated tumor-selective targeting and systemic reach in preclinical studies.

When will Calidi Biotherapeutics (CLDI) begin clinical trials for CLD-201?

Calidi expects to initiate Phase I trials for CLD-201 (SuperNova virotherapy) by the end of 2025 in patients with advanced solid tumors.

How much cash does Calidi Biotherapeutics (CLDI) have?

As of Q1 2025, Calidi reported approximately $10.6 million in cash, with reduced costs and lower burn rate after implementing cost-cutting measures.

Who is the new CEO of Calidi Biotherapeutics (CLDI)?

Eric Poma, PhD joined as Chief Executive Officer in April 2025, bringing leadership to advance the company's novel therapeutic approaches to oncology.

What are the major upcoming milestones for Calidi Biotherapeutics (CLDI)?

Key milestones include IND filing for CLD-401 by end of 2026, Phase I trial initiation for CLD-201 by end of 2025, and potential partnerships with biopharmaceutical companies.