CLDI

EX-99.1

2 ex99-1.htm

EX-99.1

Exhibit 99.1

Calidi Biotherapeutics Reports First Quarter 2026 Financial Results and Recent Operational Highlights

-Presented new data on CLD-401 at the AACR conference in San Diego, CA, detailing the profound immune changes in the tumor microenvironment induced by CLD-401; IND filing for CLD-401 expected by end of 2026

-Presented new data on RedTail at the AACR conference in San Diego, CA detailing the use of the RedTail platform to create in vivo T-cell engagers that simultaneously express both a T-cell engager and a T-cell activator at high levels exclusively in the tumor microenvironment; presented new data on CLD-501, a TROP-2 in vivo T-cell engager

-Demonstrated $1 million reduction in general and administrative expenses from Q1-2025 to Q1-2026

-Speaker

presentation at ASGCT conference in Boston, MA highlighting IL15-SA expression may dramatically

expand the therapeutic window of IL-15-mediated treatment

-Speaker

presentation at IOVC conference showcasing the ability of the RedTail extracellular enveloped

and CD55-overexpressing virus (EEV) to avoid immune clearance

-Strategic partnership with TransferAI to drive efficiencies in IND submission process for CLD-401

SAN DIEGO, May 14, 2026 — (GLOBE NEWSWIRE) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today reported its first quarter 2026 operating and financial results and reviewed recent business highlights.

“We are excited about the continued progress at Calidi,” said Eric Poma, PhD, Calidi Biotherapeutics CEO. “We continue to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers.”

First Quarter 2026 and Recent Corporate Developments

-On April 21, 2026, presented new data at the American Association of Cancer Research (AACR) annual meeting in San Diego, California. Data at AACR detailed the profound immune changes in the tumor microenvironment induced by CLD-401 including the recruitment and activation of T, NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in the immunocompetent animal models. Immune activation of cell types that do not require antigen expression or HLA positivity represents a potential new mechanism of immune response that could drive efficacy in patients that have progressed or were refractory to current immune therapy

-On April 19, 2026, Calidi presented data at the AACR meeting that showcased RedTail viruses that can express both a functional T-cell engager, capable of binding targeted solid tumor cells, and IL-15 SA at high concentrations, allowing for simultaneous T-cell activation and high expression in situ of a T-cell engager. Localized expression of a T-cell engager and a T-cell activator may overcome the key challenges seen with T-cell engagers in solid tumors. The Company presented data on its first in situ T-cell engager, CLD-501, a T-cell engager targeting TROP2

-Recorded a $1.0 million reduction in general and administrative expenses from Q1-2025 to Q1-2026, demonstrating the Company’s commitment to efficient use of capital. The reduction was primarily due to reduced headcount, consulting, and rent expenses

-On May 14, 2026, presented as a featured speaker at the American Society for Gene and Cell Therapy (ASGCT) conference in Boston, Massachusetts, highlighting that the ability of CLD-401 to induce high levels of IL15-SA expression in the tumor microenvironment while maintaining low circulating levels may dramatically expand the therapeutic window of IL-15-mediated treatment

-On April 28, 2026, presented data at the Internation Oncolytic Virus Conference (IOVC) in Reykjavik, Iceland, showcasing the ability of the RedTail extracellular enveloped and CD55-overexpressing virus (EEV) to avoid immune clearance, replicate only in target cells, and deliver high concentrations of genetic medicine to sites of disease

-In April 2026, entered a collaboration with TransferAI to drive efficiencies in Calidi’s IND submission for CLD-401 by using TransferAI’s proprietary agentic artificial intelligence platform, SofieTM, including pre-built and customizable orchestrations for biopharma. TransferAI’s Sofie platform will work alongside Calidi’s teams, helping orchestrate complex regulatory workflows while preserving the rigor required for IND submissions, providing support for Calidi to achieves its goal of submitting the CLD-401 IND by year end

First Quarter 2026 Financial Results

The Company reported a net loss attributable to common stockholders of $4.4 million, or $0.43 per share, for the three months ended March 31, 2026, compared to a net loss attributable to common stockholders of $5.0 million, or $2.21 per share, for the same peri

EX-99.1

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EX-99.1

Exhibit 99.1

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results and Recent Operational Highlights

- Announced partnership with Australian CRO to accelerate initiation of CLD-401 clinical trial

- The Company has received feedback from the FDA through Type D interactions, and the Company believes its manufacturing and analytical approaches for CLD-401 are in alignment with FDA guidance; Calidi expects to file an IND by end of 2026

- Partnered with Matica Bio around the GMP manufacturing of CLD-401

- Presented new data on in situ T-cell engagers (TCEs) at 2026 AACR-IO conference

- Raised $6.5 million in public offering and ATM sales

SAN DIEGO, March 27, 2026 — (GLOBE NEWSWIRE) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today reported its fourth quarter and full-year 2025 operating and financial results and reviewed recent business highlights.

“We are extremely excited about the continued progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “We continue to advance CLD-401, the first lead from our RedTail platform, towards the clinic and have built a world-class scientific advisory board to aid those efforts. We have also expanded what the RedTail platform can do with our new approach of in situ T-cell engagers.”

Fourth Quarter 2025 and Recent Corporate Developments

-Partnered with Avance Clinical, a full-service contract research organization (CRO) with a proven track record and experience in obtaining regulatory approval and clinical trial initiation in Australia. The partnership is focused on rapidly initiating a first-in-human clinical trial for CLD-401 in Australia. CLD-401, the Company’s lead asset, is a systemically delivered oncolytic virus that replicates only in tumor cells. CLD-401 induces high concentrations of IL-15 superagonist (IL15 SA) expression in the tumor microenvironment while limiting peripheral exposure.

-In parallel, Calidi is pursuing an IND filing with the FDA by the end of 2026. Calidi has interacted with the FDA around the Company’s manufacturing and analytical approaches through its Type D meeting request process. The feedback it has received from the agency supports the use of this process for the clinical development of CLD-401.

-Partnered with Matica Bio, a leading CDMO in the field of oncolytic virus manufacturing, for the GMP manufacturing of CLD-401. Matica has successfully executed multiple oncolytic virus programs at its state-of-the-art, purpose-built GMP facility in College Station, Texas. That facility was designed specifically to support complex viral vector modalities like CLD-401.

-Presented data demonstrating the expression of an in situ T-cell engagers (TCEs) for solid tumors and the simultaneous expression of a T-cell activating agent (e.g., IL-15 SA) through its systemically delivered RedTail platform at the AACR Immuno-Oncology (AACR-IO) conference. High expression of in situ TCE coincident with expression of a T-cell activator in the TME may overcome the traditional limitations of TCEs in solid tumor.

-Raised $6.0 million in gross proceeds from an underwritten public offering with new and existing investors in Q1-2026 and $0.5 million in gross proceeds from the sale of stock under our ATM in Q4-2025, strengthening the balance sheet and extending Calidi’s cash runway.

Fourth Quarter 2025 Financial Results

The company reported a net loss attributable to common stockholders of $4.1 million, or $0.57 per share, for the three months ended December 31, 2025, compared to a net loss attributable to common stockholders of $4.1 million, or $3.23 per share, for the same period in 2024.

Research and development expenses were $2.4 million for the three months ended December 31, 2025, compared to $1.8 million for the comparable period in 2024, respectively.

General and administrative expenses were $2.1 million for the three months ended December 31, 2025, compared to $2.2 million for the comparable period in 2024, respectively.

Full Year 2025 Financial Results

The company reported a net loss attributable to common stockholders of $25.6 million, or $5.95 per share, for the year ended December 31, 2025, compared to a net loss attributable to common stockholders of $23.8 million, or $35.70 per share, for the year ended December 31, 2024.

Research and development expenses were $9.7 million for the year ended December 31, 2025, compared to $8.9 million for the year ended December 31, 2024, respectively.

General and administrative expenses were $10.5 million for the year ended December 31, 2025, compared to $12.9 million for the year ended December 31, 2024, respectively.

The company had approximately $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of Decembe