Calidi Biotherapeutics Advances Targeted Cancer Therapy with Promising Preclinical Data

SAN DIEGO, CA – November 13, 2025 – Calidi Biotherapeutics, a clinical-stage biotechnology company focused on targeted cancer therapies, announced promising preclinical data for its lead candidate, CLD-401, and progress with its proprietary RedTail platform. The company also reported a successful $6.9 million public offering, bolstering its financial position for continued development. These advancements position Calidi as a key player in the evolving landscape of systemic oncolytic virotherapy and targeted genetic medicine delivery.

RedTail Platform: A Novel Approach to Cancer Treatment

Calidi’s RedTail platform utilizes an engineered enveloped vaccinia virus to deliver genetic medicines directly to tumor sites, even those located far from the initial injection point. Unlike many traditional oncolytic viruses, RedTail is designed for systemic administration, meaning it can be delivered intravenously. This approach addresses a significant challenge in the field – achieving effective delivery to metastatic disease. The platform’s key innovation lies in its ability to evade immune clearance, allowing the virus to reach and infect tumor cells while minimizing off-target effects. The company has further enhanced the platform with programmable membrane targeting capabilities, increasing its precision and efficacy.

“The ability to deliver a potent genetic payload systemically, while evading immune detection, represents a significant advancement in oncolytic virotherapy,” explained a source familiar with the company’s research. “This could open up new treatment avenues for patients with metastatic cancer, who often have limited options.”

CLD-401: Preclinical Data Highlights

CLD-401, Calidi’s lead candidate, is designed to deliver a high-potency IL-15 superagonist directly to tumor cells. IL-15 is a cytokine known to stimulate the activity of natural killer (NK) cells and T cells, boosting the body’s natural defenses against cancer. Preclinical data presented at recent scientific conferences, including the Society of Immunotherapy for Cancer (SITC) Annual Meeting, demonstrate that CLD-401 effectively protects against immune clearance and delivers the IL-15 superagonist to tumor sites with high efficiency.

Specifically, the data showed that the platform’s modified virus envelope, incorporating a chimeric CD55 receptor, significantly prolongs circulation time in the bloodstream, allowing for greater tumor penetration. Moreover, the delivered IL-15 superagonist effectively stimulates NK cell and T cell responses within the tumor microenvironment, inducing tumor regression in syngeneic murine models.

According to the company, the preclinical data support the advancement of CLD-401 into clinical trials, with an Investigational New Drug (IND) application anticipated by the end of 2026. The initial focus will be on patients with non-small cell lung cancer, head and neck cancer, and ovarian cancer – all disease types with high unmet medical need.

Financial Health and Competitive Landscape

Calidi Biotherapeutics’ recent $6.9 million public offering, combined with earlier funding rounds, provides the company with a solid financial foundation for its ongoing development programs. As of September 30, 2025, the company reported approximately $10.4 million in cash and restricted cash. While the company continues to experience net losses – reporting a $5.2 million loss for the third quarter of 2025 – management has demonstrated a commitment to fiscal responsibility, with a focus on reducing expenses and prioritizing capital allocation.

The competitive landscape in oncolytic virotherapy and targeted gene delivery is becoming increasingly crowded. Established players like Amgen (with its Imlygic product) and a growing number of biotech startups are all vying for a piece of this promising market. However, Calidi’s RedTail platform differentiates itself through its systemic delivery approach and its ability to overcome the challenges of immune clearance.

“The systemic delivery aspect is key,” stated a market analyst covering the biotechnology sector. “Many oncolytic viruses require direct intratumoral injection, which limits their utility in treating metastatic disease. Calidi’s approach has the potential to reach tumors throughout the body, offering a more comprehensive treatment option.”

The company’s Scientific Advisory Board, comprised of leading experts in oncology and virotherapy, provides further validation of its scientific approach. The board members, including Dr. Dimitri Zamarin and Dr. John Wrangle, bring a wealth of experience and expertise to the company’s development efforts.

The market for targeted cancer therapies is projected to continue growing rapidly in the coming years, driven by advancements in genomics, immunology, and gene editing. Calidi Biotherapeutics, with its innovative RedTail platform and promising clinical pipeline, is well-positioned to capitalize on this growth and contribute to the next generation of cancer treatments.