AI Earnings Predictions for Calidi Biotherapeutics Inc. (CLDI)

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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

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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

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Exhibit 99.1

Calidi Biotherapeutics Provides Corporate Update and Key Value Drivers for 2026

● Company intends to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, a systemically delivered and targeted genetic medicine engineered to deliver high concentrations of IL-15 superagonist to the tumor microenvironment in patients with metastatic disease.

● Calidi expects to present proof of concept data demonstrating the versatility of the RedTail platform and expanding its oncology platform with new payloads including the simultaneous delivery of tumor-localized BiTEs alongside T-cell amplifiers

● Calidi expects to present proof of concept data demonstrating the applicability of the RedTail platform in non-oncology indications.

SAN DIEGO, January 28, 2026 (GLOBE NEWSWIRE) – Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of systemically delivered, targeted genetic medicines, today recapped 2025 successes and provided an update on the Company’s upcoming 2026 milestones.

“I am incredibly proud of the Calidi team for their successful execution of our 2025 priorities,” said Eric Poma, PhD, Chief Executive Officer of Calidi. “We demonstrated that in clinically relevant immunocompetent murine models and ex vivo human immune assays, our RedTail platform has been engineered to prevent immune clearance after systemic administration and to only replicate in tumor cells with high specificity. Our data also demonstrate that the platform can effectively express genetic medicines at the tumor site at levels comparable to those achieved with localized dosing while avoiding systemic exposure. This reflects a scalable therapeutic approach that overcomes the limitations of tumor accessibility. I anticipate that we will complete our IND-enabling studies for CLD-401, the lead candidate from the RedTail platform, and submit an IND application by the end of this year.”

2025 Accomplishments

● First data presented on Calidi’s RedTail platform and selection of first lead candidate, CLD-401. CLD-401 is a tumor-tropic oncolytic virus designed to avoid immune clearance, home to metastatic sites after systemic administration, replicate only in tumors cells, induce an immune priming event at the tumor site, and express high levels of IL-15 superagonist, a potent cytokine that induces NK and T-cell responses to the tumor, in the tumor microenvironment (TME).

○ Presented new preclinical data surrounding CLD-401 at the American Society for Clinical Oncology (ASCO) on May 30, 2025, in Chicago, IL., demonstrating enhanced biological efficacy in clinically relevant immunocompetent tumor models through the delivery of IL-15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.

○

CLD-401

data presented at the Society of Immunotherapy for Cancer (SITC) on November 7, 2025, in National Harbor, MD., demonstrating that in syngeneic murine models, the RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites. The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure.

● Bolstered management team with hiring of new Chief Executive Officer and Chief Medical Officer with deep biopharmaceutical experience

○ CEO transition to Eric Poma, PhD, bringing more than 25 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development.

○ Appointed Guy Travis Clifton, MD, as CMO. Dr. Clifton is a practicing surgical oncologist with over 17 years experience in drug development, early phase and transitional translational trials, and cancer immunotherapy.

● Reconstituted Scientific Advisory Board with internationally esteemed advisors to support development of CLD-401 and advance the RedTail platform for the systemic delivery of targeted genetic medicine.

New members added in October 2025:

○ Mace L. Rothenberg, MD, FACP, former Chief Medical Officer of Pfizer, a physician executive with more than 30 years of experience in drug development, translational research, and risk benefit assessment; and

○ John Wrangle, MD, MPH, a thoracic oncologist and scientist and expert in translational immunotherapy with extensive experience around IL-15-based treatment in metastatic cancer.

● Reduced debt and G&A expenses

○ Calidi reduced term debt and notes payable (in

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Exhibit 99.1

Calidi Biotherapeutics Reports Third Quarter 2025 Financial Results and Recent Operational Highlights

●Presented new data at the Society of Immunotherapy for Cancer (SITC) annual meeting on CLD-401 protection from immune clearance after systemic administration; data also demonstrates that the platform can effectively express genetic medicines at the tumor site

●Established new Scientific Advisory Board to support development of CLD-401 and advance RedTail platform for the systemic delivery of targeted genetic medicine

●Continued expansion of RedTail platform capabilities with multiple additional payloads and programable membrane targeting, further advancing virotherapy in cancer and beyond oncology

●Raised $6.9 million gross proceeds through an underwritten public offering with new and existing investors that further strengthens the company’s balance sheet and extends its runway

SAN DIEGO, November 13, 2025 — (Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today reported its third quarter 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. “In our preclinical models, the RedTail platform continues to demonstrate its ability to potently and specifically deliver genetic payloads to metastatic tumor sites. CLD-401, the first lead from our RedTail platform, is advancing to clinical trials, and Calidi has built a world-class scientific advisory board to aid those efforts.”

Third Quarter 2025 and Recent Corporate Developments

●Presented new preclinical data surrounding CLD-401, the first lead compound from Calidi’s proprietary RedTail platform, at the Society of Immunotherapy for Cancer (SITC) on November 7th in National Harbor, MD., demonstrating that in syngeneic murine models, the RedTail platform is protected from immune clearance after systemic administration and can find and specifically replicate in tumor cells at metastatic sites. The data also demonstrate that the platform can effectively express genetic medicines at the tumor site in concentrations that are similar to what is achievable with localized dosing while avoiding systemic exposure.

●Established Scientific Advisory Board with internationally esteemed advisors to support development of CLD-401 and advance the RedTail platform for the systemic delivery of targeted genetic medicine.

The founding members of Calidi’s new SAB are:

●Mace L. Rothenberg, MD, FACP, former Chief Medical Officer of Pfizer, a physician executive with more than 30 years of experience in drug development, translational research, and risk benefit assessment;

●Dmitriy Zamarin MD, PhD, a medical oncologist and Section Head of Gynecologic Medical Oncology and Co-Director of the Center of Excellence for Gynecologic Cancer and a world leader in virotherapy for cancer;

●John Wrangle, MD, MPH, a thoracic oncologist and scientist and and expert in translational immunotherapy with extensive experience around IL-15-based treatment in metastatic cancer; and

●David T. Curiel, MD, PhD, a world leader in cancer immunotherapy and cancer virotherapy.

● Continued to expand the functionality of the RedTail platform; presented at the SITC meeting. The RedTail technology can now allow for “programmable membranes” in which targeting proteins are expressed in the viral envelope. Calidi is also exploring additional cell types outside of oncology that the platform is active in (i.e., activated immune cells) and is exploring additional payloads.

● Raised $6.9 million in gross proceeds from an underwritten public offering with new and existing investors, extending Calidi’s runway and increasing the total gross proceeds raised in all offerings in 2025 to $23.0 million.

Third Quarter 2025 Financial Results

The company reported a net loss $5.2 million for the three months ended September 30, 2025, compared to a net loss of $5.1 million for the same period in 2024. In 2025, a non-cash charge for deemed dividend on warrants increased net loss attributable to shareholders to $10.8 million. There was no such charge in the same period in 2024.

Net loss per share, basic and diluted, was $2.21 for the three months ended September 30, 2025, compared to $7.75 for the comparable period in 2024.

Research and development expenses were $2.4 million for the three months ended September 30, 2025, compared to $2.2 million for the comparable period in 2024.

General and administrative expenses were $2.7 million for the three months ended September 30, 2025, compared to $3.1 million for the comparable period in 2024.

The company had approximately $10.4 million in cash and $0.2 million in restricted cash as of September 30, 2

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Exhibit 99.1

Calidi Biotherapeutics Reports Second Quarter 2025 Financial Results and Recent Operational Highlights

●Presented preclinical data at the American Society of Clinical Oncology (ASCO) on CLD-401 demonstrating biological efficacy IL-15 superagonist delivery to metastatic tumor sites and reduced immune clearance through engineered CD55 membrane expression; IND filing expected by the end of 2026

●Received FDA Fast Track Designation for CLD-201, a first-in-class stem-cell loaded intratumoral viral therapy for the treatment of patients with soft tissue sarcoma

●Raised $4.6 million gross proceeds through a warrant inducement offering with existing investors that further strengthens the company’s balance sheet and extends its runway

SAN DIEGO, August 8, 2025 — (Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of targeted therapies with the potential to deliver genetic medicines to distal sites of disease, today reported its second quarter 2025 operating and financial results and reviewed recent business highlights.

“We are extremely excited about the progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “We believe our RedTail platform, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic genetic medicines to metastatic sites through systemic administration, will be a substantial breakthrough in the field of oncolytic viruses and tumor-targeted gene therapies. We look forward to leveraging our scientific, operational and capital markets experience to continue building on Calidi’s strong platforms.”

Second Quarter 2025 and Recent Corporate Developments

●Presented new preclinical data surrounding CLD-401, the first lead compound from Calidi’s proprietary RedTail platform, at the American Society for Clinical Oncology (ASCO) on May 30th in Chicago, IL., demonstrating enhanced biological efficacy in syngeneic tumor models through the delivery of IL15 superagonist to metastatic tumors sites after systemic administration. Calidi also demonstrated the engineered expression of CD55 on the enveloped virus, allowing the virus to avoid immune clearance and enabling systemic administration. The systemic administration of the CD55-expressing enveloped virus allows Calidi to target metastatic disease patients with high unmet need.

●Raised $4.6 million in gross proceeds from a warrant inducement offering with existing investors despite a challenging financing environment for the biotech industry, increasing the total gross proceeds raised in all offerings in 2025 to $15.7 million.

●Granted Fast Track Designation to CLD-201 by the U.S. Food and Drug Administration (FDA) for the treatment of patients with soft tissue sarcoma. CLD-201 is a first-in-class stem cell loaded intratumoral oncolytic viral therapy that has demonstrated significant advantages over current intratumoral oncolytic viral approaches. An IND for a Phase 1 study was successfully opened for CLD-201 in Q1-2025.

Second Quarter 2025 Financial Results

The company reported a net loss attributable to common stockholders of $5.7 million, or $1.99 per share, for the three months ended June 30, 2025, compared to a net loss attributable to common stockholders of $7.4 million, or $16.75 per share, for the same period in 2024.

Research and development expenses were $2.6 million for the three months ended June 30, 2025, compared to $2.2 million for the comparable period in 2024.

General and administrative expenses were $3.1 million for the three months ended June 30, 2025, compared to $3.6 million for the comparable period in 2024.

The company had approximately $5.3 million in cash and $0.1 million in restricted cash as of June 30, 2025, compared to $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology 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 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

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Exhibit 99.1

Calidi Biotherapeutics Reports First Quarter 2025 Financial Results and Recent Operational Highlights

-Bolstered management team with hires of Chief Executive Officer and Chief Medical Officer with deep biopharmaceutical experience

-Announced selection of IL15-superagonist as first payload to be delivered into tumors with Calidi’s first lead candidate using its systemic antitumor virotherapy platform, Redtail; IND filing expected in the second half of 2026

-IND cleared by FDA for CLD-201 clinical trial

SAN DIEGO, May 14, 2025 -- (Business Wire) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering the development of systemic oncolytic targeted immunotherapies with the potential to deliver genetic payloads, today reported its first quarter 2025 operating and financial results and reviewed recent business highlights.

“We are extremely excited about the progress at Calidi,” said Eric Poma, PhD, CEO of Calidi Biotherapeutics. “We believe our systemic antitumor virotherapy platform, Redtail, with its ability to protect virus from immune clearance and induce tumor lysis and the delivery of potent therapeutic proteins to metastatic sites, will be a substantial breakthrough in the field of oncolytic viruses and tumor-targeted gene therapies. We look forward to leveraging our scientific, operational and capital markets experience to continue building on Calidi’s strong platforms.”

First Quarter 2025 and Recent Corporate Developments

-CEO transition to Eric Poma, PhD. Dr. Poma brings more than 30 years of experience in the biopharmaceutical industry, with a strong record of capital fundraising, big pharma collaboration agreements, and clinical program development. Prior to joining Calidi, Dr. Poma served as CEO of Molecular Templates (NASDAQ: MTEM), where he raised over $250 million in equity financing and secured over $150 million in strategic capital through agreements with Takeda, Vertex and BMS. Dr. Poma received a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill, an M.B.A. from the Leonard N. Stern School of Business and a Bachelor of Science in Biology from the University of North Carolina at Chapel Hill.

-Appointed Guy Travis Clifton, MD, as Chief Medical Officer, Consultant and Advisor. Dr. Clifton is a practicing surgical oncologist with over 17 years of experience in drug development, early phase and translational clinical trials, and cancer immunotherapy. Since 2013, he has served as a practicing surgical oncologist in the US Army. He also served as the Chief Medical Officer and co-founder of Parthenon Therapeutics / Incendia Therapeutics from October 2020 to August 2024. Dr. Clifton received his Bachelor of Science in Chemistry from the United States Military Academy, West Point, and Doctor of Medicine from Vanderbilt University; completed his residency in General Surgery from the Brooke Army Medical Center; and fellowship in General Surgical Oncology at the University of Texas, MD Anderson Cancer Center.

-New preclinical data surrounding Calidi’s systemic antitumor virotherapy, Redtail, presented at the American Association for Cancer Research (AACR) Annual Meeting on April 27, 2025, in Chicago, IL., including IL15 superagonist as the first payload to be delivered into tumors. IL15 superagonist is a potent cytokine capable of generating robust and durable immune responses against tumors. The enveloped vaccinia virus is engineered for immune evasion and tumor targeting. Once within the tumor, these viruses exert a multimodal mechanism of action, including direct killing of tumor cells, induction of antitumor immunity, and delivery of transient, non-integrating genetic payload. The systemic administration of the enveloped virus allows Calidi to target metastatic disease patients with high unmet need.

-The U.S. Food and Drug Administration (FDA) cleared Calidi’s Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head & neck cancer and soft tissue sarcoma. With non-dilutive funding support from the California Institute of Regenerative Medicine (CIRM), the IND application included preclinical data demonstrating the potential of CLD-201 to evade viral inactivation by the patient’s immune system and effectively target and kill cancer cells. CLD-201 is a one-of-a-kind product that has never been manufactured before using adipose tissue-derived stem cells in combination with oncolytic vaccinia virus, demonstrating Calidi’s manufacturing know-how.

First Quarter 2025 Financial Results

The company reported a net loss attributable to common stockholders of $5.0 million, or $0.18 per share, for the three months ended March 31, 2025, compared to a net loss attributable to common stoc

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Exhibit 99.1

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights

-Announced demonstrated ability to deliver transient gene therapy (payload) to tumors using systemic antitumor virotherapy platform

-Filed IND in March 2025 for CLD-201 company sponsored Phase 1 trial to treat multiple solid tumors

-Commencement of recruitment for Phase 1 trial in patients with newly diagnosed high-grade glioma at Northwestern University hospital

-14 patients enrolled in Phase 1 trial conducted by City of Hope to treat recurrent high-grade glioma

SAN DIEGO, March 31, 2025 — (Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today reported its fourth quarter and full-year 2024 operating and financial results and reviewed recent business highlights.

“Calidi continues to make great progress on all three of our platforms; our systemic asset CLD-400 proved it can deliver a gene therapy payload to targeted tumors, we filed an IND for our solid tumor asset CLD-201, and our CLD-101 program treating high-grade glioma is advancing in two Phase 1 trials,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We think our multi-modal mechanism of action is a game changer in treating multiple deadly cancers, including metastatic cancer and lung cancer, solid tumors and high-grade glioma.”

Fourth Quarter 2024 and Recent Corporate Developments

-New data showed that a single dose of a tumor-selective triple knockout (“3KO”) RT virus genetically engineered to encode a specific immune-boosting payload (undisclosed) increased the antitumor immune response. These increased shifts in immune composition, driven by virotherapy encoding a payload, ultimately led to complete eradication of certain tested tumors in the preclinical model.

-In March 2025, Calidi filed an IND for a company sponsored, open label dose escalation trial of CLD-201 in adult patients with solid tumors, specifically with the indications of breast cancer, head & neck squamous cell carcinoma, and soft tissue sarcoma.

-In February 2025, Northwestern University hospital started recruiting for the CLD-101 Phase 1 clinical trial in patients with newly diagnosed high-grade glioma, an aggressive and often fatal form of brain cancer. This physician-led and NCI sponsored clinical trial, led by prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp, builds on the promising results from a prior Phase 1 trial involving 12 patients treated with a single dose of CLD-101 published in the prestigious journal The Lancet Oncology.

-City of Hope and Calidi announced the 14th patient treated in a physician-sponsored Phase 1 trial assessing the safety and feasibility of a multi-dosing regimen to treat recurrent high-grade glioma. This program has secured $12 million award from the California Institute for Regenerative Medicine (CIRM) to support this groundbreaking study.

Upcoming Anticipated Milestones

-Q2 2025: Payload and lead candidate information revealed on CLD-400 systemic platform

-Q2 2025: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients

-Q3 2025: First patient dosed in CLD-201 Phase 1 trial

Fourth Quarter 2024 Financial Results

The company reported a net loss attributable to common stockholders of $4.1 million, or $0.27 per share, for the three months ended December 31, 2024, compared to a net loss attributable to common stockholders of $8.2 million, or $0.23 per share, for the same period in 2023.

Research and development expenses were $1.8 million for the three months ended December 31, 2024, compared to $4.0 million for the comparable period in 2023, respectively.

General and administrative expenses were $2.2 million for the three months ended December 31, 2024, compared to $5.9 million for the comparable period in 2023, respectively.

Full Year 2024 Financial Results

The company reported a net loss attributable to common stockholders of $23.8 million, or $2.97 per share, for the year ended December 31, 2024, compared to a net loss attributable to common stockholders of $29.2 million, or $17.33 per share, for the year ended December 31, 2023.

Research and development expenses were $8.9 million for the year ended December 31, 2024, compared to $13.0 million for the year ended December 31, 2023, respectively.

General and administrative expenses were $12.9 million for the year ended December 31, 2024, compared to $16.0 million for the year ended December 31, 2023, respectively.

The company had approximately $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American

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Exhibit 99.1

Calidi Biotherapeutics Announces Bolstered Cash Balance and Termination of its Standby Equity Purchase Agreement

SAN DIEGO, January 28, 2025 (GLOBE NEWSWIRE) - Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced that its ending cash balance at December 31, 2024 was approximately $9.6 million. Due to Calidi’s bolstered cash balance and success in recent fundraising, including proceeds resulting from its At-The-Market Offering Agreement (“ATM”), Calidi terminated its Standby Equity Purchase Agreement (“SEPA”) with YA II PN, Ltd., an affiliate of Yorkville Advisors, effective January 23, 2025.

In connection with the SEPA executed in December 2023 and amended in January 2024, Calidi was granted the option to sell up to $25 million of common stock over a three-year period, subject to certain trading volume and beneficial ownership provisions. The shares underlying the SEPA have not been registered and Calidi did not exercise any option to sell such shares.

In the fourth quarter of 2024, Calidi secured $9.5 million in gross proceeds, before deducting expenses, through two public offerings, supplemented by $2.0 million from warrant exercises and $3.1 million from its ATM facility. In January 2025, Calidi announced another public offering that raised an additional $4.25 million in gross proceeds, before deducting expenses. These public offerings have bolstered Calidi’s cash position, and together with the availability of the ATM facility, positioned it to meet its capital needs without relying on the SEPA framework.

“Our decision to terminate the SEPA marks an important milestone in our financing strategy,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “With the successful completion of recent financing activities, we are well-positioned to focus on our clinical and operational goals and remove a potential overhang in our stock. This move aligns with our dedication to enhancing shareholder value while building our leadership in both targeted systemic and localized antitumor virotherapies.”

Calidi continues to make strides in the development of its innovative virotherapy platforms, with recent milestones including its systemic platform (RTNova enveloped virotherapies) abstract being accepted for presentation at the American Association for Cancer Research (AACR) Annual Meeting in April 2025 and IND clearance by FDA for a Northwestern University-led Phase 1b/2 trial of CLD-101 for high-grade gliomas with plans to start enrollment in the first quarter 2025.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies, are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com.

Preliminary, Unaudited Financial Disclosures

The data presented above is preliminary and unaudited, based upon our estimates, and subject to further internal review by management and compilation of actual results. Our closing procedures for the fourth quarter and year ended December 31, 2024 are not yet complete. Our management’s estimates are based upon preliminary information currently available from our business. While we expect that our results will be consistent with these preliminary and unaudited estimates, our actual results may differ materially from these preliminary estimates.

This preliminary financial information is not a comprehensive statement of our financial results for this period. Our actual results may differ materially from these estimates due to the completion of our financial closing procedures, final adjustments, and other developments that may arise between now and the time the closing procedures for the quarter are completed.

This preliminary financial information should not be viewed as a substitute for our full interim or annual financial statements prepared in accordance with U.S. generally accepted accounting principles. Accordingly, you should not place undue reliance on this preliminary financial information. The preliminary financial information has been prepared by, and is the responsibility of, our management. M

EX-99.1

2 ex99-1.htm

Exhibit 99.1

Calidi Biotherapeutics Reports Third Quarter 2024 Operating and Financial Results

- Announced FDA Clearance of the Northwestern University IND Application for NeuroNova (CLD-101) Clinical Trial in High-Grade Glioma.

- Presented data supporting RTNova (CLD-400), the company’s systemic antitumor virotherapy platform, at the International Oncolytic Virotherapy Conference (IOVC) in Rotterdam, Netherlands, the Society for Immunotherapy of Cancer (SITC) Annual Meeting, and at Immuno US 2024 in San Diego, California.

- Raised $2 million in a registered direct offering and concurrent private placement.

SAN DIEGO, November 12, 2024 —(Globe Newswire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today reported its operating and financial results for the third quarter ended September 30, 2024, and reviewed recent business highlights.

“Calidi continues to advance our development programs while expanding our industry-leading position in targeted antitumor virotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “In addition, we are pleased that Northwestern University has received U.S. FDA clearance to advance our CLD-101 program in the clinic for newly diagnosed high-grade glioma.”

Third Quarter 2024 and Recent Corporate Developments

- The U.S. Food and Drug Administration (FDA) has cleared Northwestern University’s Investigational New Drug (IND) application for Calidi’s NeuroNova (CLD-101). CLD-101 is a novel stem-cell based platform designed to deliver oncolytic viruses to tumors, enhancing their antitumor effects. The Phase 1b/2 clinical trial in newly diagnosed high-grade glioma is expected to commence in early 2025 at Northwestern University.

- Data was presented on RTNova (CLD-400), Calidi’s systemic antitumor virotherapy platform, at the International Oncolytic Virotherapy Conference (IOVC) in Rotterdam, Netherlands, at  Immuno US 2024 in San Diego, California and the Society for Immunotherapy of Cancer (SITC) annual meeting. RTNova is a systemic treatment designed for reduced elimination by the humoral immune system. It targets multiple tumor sites, killing tumor cells while altering the tumor immune microenvironment. This novel systemic therapeutic approach not only facilitates easier administration but also broadens the potential patient population who can benefit from this treatment.

- Calidi announced in October the completion of a definitive securities purchase agreement with certain institutional investors, raising $2 million in a registered direct offering and concurrent private placement.

Third Quarter 2024 Financial Results

The Company reported a net loss of $5.1 million, or $0.65 per share, for the three months ended September 30, 2024, compared to a net loss of $2.0 million, or $1.41 per share, for the same period in 2023.

Research and development expenses were $2.2 million for the three months ended September 30, 2024, compared to $3.3 million for the comparable period in 2023, respectively.

General and administrative expenses were $3.1 million for the three months ended September 30, 2024, compared to $4.0 million for the comparable period in 2023, respectively.

The Company had approximately $1.9 million in cash and $0.2 million in restricted cash as of both September 30, 2024 and December 31, 2023.

About Calidi Biotherapeutics:

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. 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

EX-99.1

2 ex99-1.htm

Exhibit 99.1

Calidi Biotherapeutics Reports Second Quarter 2024 Operating and Financial Results

- Launched Nova Cell subsidiary with $2 million investment from Dr. Ronald Rigor to advance Calidi’s Adult Adipose Allogeneic (AAA) stem cell innovative programs

- Strengthened team with the appointment of Dr. George E. Peoples, MD, FACS, adjunct professor of Surgical Oncology at MD Anderson Cancer Center, to the company’s Board of Directors, and the addition of Mark Gilbert, MD, scientist emeritus at the National Institutes of Health (NIH), to its Medical Advisory Board

- Received a new U.S. patent for the company’s novel SuperNova technology, positioning Calidi to advance its CLD-201 program into the clinic. The patent covers a unique cancer treatment combining stem cells and a smallpox vaccine, strengthening Calidi’s position in developing innovative therapies for advanced solid tumors

SAN DIEGO, August 13, 2024 —(Globe Newswire) — Calidi Biotherapeutics Inc. (NYSEAM: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today reported its operating and financial results for the second quarter ended June 30, 2024, and reviewed recent business highlights.

“Calidi is making solid progress across our development programs while continuing to innovate and expand our industry-leading position in targeted antitumor virotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “In addition, we are proud to have received a new U.S. Patent for our SuperNova technology, further strengthening our IP position as we advance the CLD-201 program into the clinic.”

Second Quarter 2024 and Recent Corporate Developments

- Announced a $2 million strategic investment in July 2024 by Dr. Ronald Rigor into its new subsidiary, Nova Cell, Inc. (“Nova Cell”), to advance Calidi’s Adult Adipose Allogeneic (AAA) stem cell innovative programs. Nova Cell was formed to be a technology service provider that develops innovative stem cell-based products using Calidi’s advanced cellular manufacturing process. Dr Rigor also invested an additional $1 million into Calidi to further its oncology pipeline of assets. In connection with Dr. Rigor’s investment, he was appointed as a member of Calidi’s Scientific and Medical Advisory Board.

- Appointed George Peoples, MD, FACS, to the company’s Board of Directors, as a Class II director. Dr. Peoples serves as a Professor of Surgery at the Uniformed Services University of the Health Sciences (USUHS) and an adjunct Professor of Surgical Oncology at MD Anderson Cancer Center.

- Appointed Mark Gilbert, MD, to the Calidi Medical Advisory Board. Dr. Gilbert most recently served as the Chief of the Neuro-Oncology Branch at NIH from 2014 to 2024. Under Dr. Gilbert’s leadership, his team of laboratory and clinical investigators conducted groundbreaking research that advanced science in the brain tumor field.

- Received patent covering novel SuperNova technology platform. The patent covers a composition where cells are incubated with an oncolytic virus for a defined period allowing the expression of at least one immunomodulatory protein or recombinant therapeutic protein encoded by the virus, by virtue of association of the virus, with the carrier cell. Calidi has shown preclinically the potential of SuperNova to shield the viral payload from the immune system allowing for its delivery to tumor sites. The SuperNova platform is composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus.

- Received $2.5 million gross proceeds during July and August 2024 pursuant to warrant exercises.

Second Quarter Financial Results

The company reported a net loss of $5.8 million, or $1.40 per share, for the three months ended June 30, 2024, compared to a net loss of $12.5 million, or $14.24 per share, for the same period in 2023.

Research and development expenses were $2.2 million for the three months ended June 30, 2024, compared to $3.2 million for the comparable period in 2023.

General and administrative expenses were $3.6 million for the three months ended June 30, 2024, compared to $3.4 million for the comparable period in 2023.

The company had approximately $0.8 million in cash and $0.2 million in restricted cash as of June 30, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentia

EX-99.1

2 ex99-1.htm

Exhibit 99.1

Calidi Biotherapeutics Reports First Quarter 2024 Operating and Financial Results

Three upcoming posters, including an update from ongoing Phase 1 trial of Calidi’s CLD-101 program, to be presented at 2024 ASCO Annual Meeting

Presented new data on the mechanisms of action of Calidi’s novel immunotherapies at the AACR Annual Meeting

Unveiled RTNova systemic platform allowing for ease of administration and ability to target multiple tumor types

Completed $6.1 million public offering

SAN DIEGO—(BUSINESS WIRE)— Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted virotherapies, today reported its first quarter 2024 operating and financial results and reviewed recent business highlights.

“Calidi’s current focus is on raising additional capital and implementing continued cost cutting measures in order to advance our promising pipeline of novel immunotherapies designed to successfully target and eliminate solid tumors across the body. We plan to present three posters at ASCO including an update from our ongoing trial with City of Hope for recurrent high-grade glioma,” said Allan Camaisa, CEO and Chairman of the Board at Calidi Biotherapeutics. “In parallel to our clinical progress, Calidi has strengthened our preclinical programs through our powerful R&D engine, unveiled our novel systemic delivery platform to target diverse tumor types, and executed a capital raise to strengthen our balance sheet. We believe these efforts will help propel the company through important milestones including an interim clinical update from our ongoing Phase 1 trial and the initiation of the Phase 1 trial with Northwestern University anticipated in the third quarter of 2024, subject to additional capital being raised.”

First Quarter 2024 and Recent Corporate Developments

● Announced upcoming poster presentations at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting. The posters will include an update from the Phase 1 trial in collaboration with City of Hope for CLD-101 in recurrent high-grade glioma. Additional posters will focus on preclinical data from the company’s RTNova (CLD-400) and CLD-201 platforms.

● Presented new data at the American Association for Cancer Research Annual Meeting (AACR) supporting CLD-101 and CLD-201’s first-in-class use of stem cells to protect and potentiate antitumor virotherapies. The results of experiments, conducted in collaboration with City of Hope, provide further detail around the unique stem cell-based mode of delivery and the therapeutic potential at the core of Calidi’s novel technology.

● Highlighted the company’s novel RTNova systemic platform, a targeted enveloped virotherapy, that has demonstrated preclinically the ability to resist inactivation by human serum and an ability to target diverse tumor types. This novel therapeutic approach has the potential to be available to a diverse patient population with different forms of cancer while remaining cost-effective and easy to administer.

● Closed public offering of 15,197,500 shares of common stock and accompanying warrants, with gross proceeds of $6.1 million.

First Quarter 2024 Financial Results

The company reported a net loss of $7.2 million, or $0.20 per share, for the three months ended March 31, 2024, compared to a net loss of $6.5 million, or $0.75 per share, for the same period in 2023.

Research and development expenses were $2.7 million for the three months ended March 31, 2024, compared to $2.6 million for the comparable period in 2023, respectively.

General and administrative expenses were $4.0 million for the three months ended March 31, 2024, compared to $2.8 million for the comparable period in 2023, respectively.

The company had approximately $1.2 million in cash and $0.2 million in restricted cash as of March 31, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.

About Calidi Biotherapeutics

Calidi Biotherapeutics (NYSE American: CLDI) is a clinical-stage immuno-oncology company with proprietary technology designed to arm the immune system to fight cancer. Calidi’s novel stem cell-based platforms are utilizing potent allogeneic stem cells capable of carrying payloads of oncolytic viruses for use in multiple oncology indications, including high-grade gliomas and solid tumors. Calidi’s clinical stage off-the-shelf, universal cell-based delivery platforms are designed to protect, amplify, and potentiate oncolytic viruses leading to enhanced efficacy and improved patient safety. Calidi’s preclinical off-the-shelf enveloped virotherapies are designed to target disseminated solid tumors. This dual approach can potentially treat, or even prevent, metastatic disease. Calidi Biotherapeutics is headquartered in San Diego, California. For more information, please visit www.calidibio.com .

Forward-Looking

Statements

This press rele

EX-99.1

2 ex99-1.htm

Exhibit 99.1

Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2023 Operating and Financial Results

-

City of Hope, a leader in cancer research and treatment, was awarded $5.3 million from California Institute for Regenerative Medicine (CIRM) to develop a treatment for metastatic ovarian cancer using Calidi’s licensed lead asset, NeuroNova (CLD-101)

-

Announced novel systemic enveloped oncolytic virotherapy platform, RTNova, designed to target diverse tumor types

-

Strengthened team with the appointment of three new members to Scientific and Medical Advisory Board and one member to Board of Directors

-

Issued new U.S. patent covering novel SuperNova (CLD-201) technology platform

SAN DIEGO, March 15, 2024 —(Business Wire) — Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today reported its fourth quarter and full-year 2023 operating and financial results and reviewed recent business highlights.

“Calidi continues to make great progress across our development programs while continuing to innovate and expand our industry-leading position in cell-based immunotherapies,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “We anticipate reporting an interim clinical update from our Phase 1 trial evaluating CLD-101 in high-grade glioma patients in collaboration with City of Hope in the second quarter of this year assuming we are successful in raising additional capital, and we were thrilled to recently strengthen our collaboration with City of Hope to evaluate CLD-101 for the treatment of ovarian cancer with the support of CIRM. In addition, we were proud to recently unveil our potentially paradigm-shifting advance in the treatment of advanced solid tumors, including lung cancer and metastatic disease, that required a systemic application, through our RTNova systemic delivery approach.”

Fourth Quarter 2023 and Recent Corporate Developments

-

City of Hope, a leader in cancer research and treatment, was awarded $5.3 million to further support preclinical translational studies, product manufacturing (using Calidi’s next generation manufacturing process) and clinical trial design for Ovarian cancer using Calidi’s licensed oncolytic virotherapy product, CLD-101. CLD-101 is a cutting-edge therapeutic candidate in Calidi’s NeuroNova program, comprising tumor-tropic neural stem cells (NSCs) that deliver an oncolytic adenovirus – CRAd-S-pk7 – selectively to tumor sites.

-

Publicly announced novel systemic enveloped oncolytic virotherapy program, RTNova (CLD-400), targeting advanced solid tumors, including advanced metastatic disease. The new program builds upon Calidi’s experience using stem cells to protect oncolytic viruses from inactivation by the patient’s immune system allowing for easier administration, increased cost-effectiveness, and the ability to reach a broad patient population.

-

Appointed Antonio Chiocca, M.D., Ph.D., David T. Curiel, M.D., Ph.D., and Burt L. Nabors, M.D., to the company’s Scientific and Medical Advisory Board. These physician scientists bring a deep expertise in oncology, hailing from top cancer research institutions and facilities.

-

Announced the appointment of David LaPré to the company’s Board of Directors. Mr. LaPré brings significant experience in technical operations strategy and execution in the pharmaceutical industry.

-

Received patent covering novel SuperNova technology platform (CLD-201) composed of adipose-derived mesenchymal stem cells loaded with oncolytic vaccinia virus. This patent strengthens the company’s robust intellectual property portfolio as Calidi plans to initiate a clinical trial in the second half of 2024. Calidi has shown preclinically the potential of SuperNova to shield the viral payload from the immune system allowing for its delivery to tumor sites.

Upcoming Anticipated Milestones

-

1H 2024: Interim clinical update from CLD-101 Phase 1 trial in collaboration with City of Hope for recurrent high-grade glioma patients

-

1H 2024: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients

-

2H 2024: First patient dosed in CLD-201 Phase 1 trial

Fourth Quarter 2023 Financial Results

The company reported a net loss of $8.2 million, or $0.23 per share, for the three months ended December 31, 2023, compared to a net loss of $7.8 million, or $0.90 per share, for the same period in 2022.

Research and development expenses were $4.0 million for the three months ended December 31, 2023, compared to $2.3 million for the comparable period in 2022 respectively.

General and administrative expenses were $5.9 million for the three months ended December 31, 2023, compared to $2.4 million for the comparable period in 2022, respectively.

Full Year 2023 Financial Results

The company reported a net loss of $

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UNITED

STATES

SECURITIES

AND EXCHANGE COMMISSION

Washington,

D.C. 20549

FORM

8-K

CURRENT

REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): February 7, 2024

CALIDI

BIOTHERAPEUTICS, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-40789

86-2967193

(State or other jurisdiction

of incorporation)

(Commission

File Number)

(I.R.S.

Employer

Identification No.)

4475 Executive Drive, Suite 200,

San Diego, California

92121

(Address of principal executive offices)

(Zip Code)

(858) 794-9600

(Registrant’s telephone number, including area code)

N/A

(Former name or former address, if changed since last report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Title of Each Class

Trading Symbol(s)

Name of Each Exchange on Which Registered

Common stock, par value $0.0001 per share

CLDI

NYSE

American LLC

Warrants, each whole warrant exercisable for one share of common stock

CLDI

WS

NYSE

American LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☒

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition.

In connection with the filing of Amendment No. 1 to Registration Statement on Form S-1 (Registration No. 333-276741) with the Securities and Exchange Commission on February 7, 2024 (the “Registration Statement”), we provided the following financial update relating to the financial statements for the quarter and year ended December 31, 2023:

Based upon preliminary estimates and information available to us as of the date of the Registration Statement, we expect to report that we had approximately $1.9 million of cash and cash equivalents, $27.4 million cash used in operations and $3.4 million in aggregate principal amount of indebtedness, each as of December 31, 2023. We have not yet completed our quarter-end financial close process for the quarter ended December 31, 2023. This estimate of our cash and cash equivalents as of December 31, 2023 is preliminary, has not been audited and is subject to change upon completion of our financial statement closing procedures. Additional information and disclosure would be required for a more complete understanding of our financial position and results of operations as of December 31, 2023. Our independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to this preliminary result and, accordingly, does not express an opinion or any other form of assurance about it.

Forward-Looking

Statements

The projections constituting the performance estimates involve risks and uncertainties, the outcome of which cannot be foreseen at this time and, therefore, actual results may vary materially from these forecasts. In this regard, the statements include projections and other “forward-looking statements” relating to our business, that are often identified using “believes,” “expects” or similar expressions. Forward-looking statements involve several estimates, assumptions, risks, and other uncertainties that may cause actual results to be materially different from those anticipated, believed, estimated, expected, etc. Therefore, actual results could differ from those projected due to numerous factors and uncertainties. Although we believe that the expectations, opinions, projections, and comments reflected in these forward-looking statements are reasonable, we can give no assurance that such statements will prove to be correct, and that our actual results of ‎operations, financial condition and performance will not differ materially from the ‎results of operations, financial condition and performance reflected or implied

EX-99.1

2 ex99-1.htm

Exhibit 99.1

Calidi Biotherapeutics Reports Third Quarter 2023 Operating and Financial Results

Announced first patient dosed by collaborator City of Hope in a Phase 1 clinical trial evaluating CLD-101 in recurrent high-grade glioma patients

Presented new preclinical data highlighting CLD-201 (SuperNova) platform technology at SITC 2023

Strengthened leadership with key appointments to management team and Board of Directors

San Diego, Calif., November 14, 2023 --(BUSINESS WIRE)-- Calidi Biotherapeutics, Inc. (NYSE American: CLDI or “Calidi”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, reports its financial results for the third quarter 2023 and reviews recent business highlights.

“We are highly encouraged by our clinical progress, highlighted by our partner City of Hope dosing the first patient in June this year in a Phase 1 clinical trial evaluating CLD-101, our NeuroNova platform, in high-grade glioma patients,” said Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics. “Our CLD-201 program, which we believe represents the future of immunotherapy as a novel allogeneic approach, continues to advance closer to the clinic, supported by promising preclinical data presented at the 2023 SITC annual meeting. With access to the public markets and recent key leadership and Board appointments, we feel well positioned to deliver on the promise of our novel programs and look forward to sharing interim results from our ongoing CLD-101 study in recurrent high-grade glioma patients in the first half of next year.”

Third Quarter 2023 and Recent Corporate Developments

● Presented updated CLD-201 (SuperNova) data demonstrating inhibition of tumor growth and the induction of robust anti-tumor immunity in preclinical models at the Society for Immunotherapy of Cancer’s (SITC) 38th Annual Meeting. The poster presentation exhibited CLD-201’s greater resistance to inactivation compared to unprotected CAL1 virus, significant inhibition of the growth of tumors even at very low doses, and the induction of robust anti-tumor immunity. The poster also detailed the clinical readiness of the product and plans to launch a Phase 1 study in 2024.

● Appointed Andrew Jackson to the role of Chief Financial Officer. Mr. Jackson most recently served as Chief Financial Officer of Eterna Therapeutics and brings 25 years of corporate finance experience with success in publicly traded life science companies and venture capital-backed startups. The company also announced the appointment of Alan Stewart, previously a Calidi advisor, to the Board of Directors. Mr. Stewart brings extensive experience in finance and public company governance.

● Closed business combination transaction and commenced trading on the NYSE American on September 13, 2023. In conjunction with the transaction closing, Calidi entered into a forward purchase agreement with a consortium of funds for up to $10 million.

● Announced City of Hope, in partnership with Calidi, dosed the first patient in June 2023 in a Phase 1 clinical trial evaluating CLD-101 (NeuroNova) for the treatment of recurrent high-grade gliomas. The trial seeks to determine the safety, immunogenicity, and preliminary clinical efficacy of treatment with multiple intracerebral doses of CLD-101.

Upcoming Anticipated Milestones

● 4Q 2023: First patient dosed in CLD-101 Phase 1 trial in collaboration with Northwestern University for newly diagnosed high-grade glioma patients

● 1H 2024: Interim clinical results from CLD-101 Phase 1 trial in collaboration with City of Hope for recurrent high-grade glioma patients

● 1H 2024: First patient dosed in CLD-201 Phase 1 trial

Third Quarter Financial Results

The company reported a net loss of $2.0 million, or $0.14 per share, for the three months ended September 30, 2023, compared to a net loss of $5.4 million, or $0.63 per share, for the same period in 2022.

Research and development expenses were $3.3 million for the three months ended September 30, 2023, compared to $1.9 million for the comparable period in 2022, an increase of $1.4 million. The increase in research and development spend primarily reflects an increase in lab expenses for preclinical and clinical candidates of $0.7 million, an increase in salaries and benefits due to higher headcount of $0.5 million, and an increase in rent expense related to the San Diego Lease of $0.2 million.

General and administrative expenses were $4.0 million for the three months ended September 30, 2023, compared to $5.0 million for the comparable period in 2022, a decrease of $1.0 million. The decrease was primarily related to a decrease in transaction costs of $1.8 million, partially offset by an increase in salaries and benefits of $0.5 million, director and consulting costs of $0.2 million, and accounting related services of $0.1 million.

The company had approximately $10.1 million in cash and $0.2 million in restricted cas