UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2025 Delaware 86-2967193 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification Number) 4475 Executive Drive, Suite 200, San Diego, California 92121 (Address of principal executive offices) (Zip Code) (858) 794-9600 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 1 ...

Announced partnership with Australian CRO to accelerate initiation of CLD-401 clinical trialThe 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 2026Partnered with Matica Bio around the GMP manufacturing of CLD-401Presented new data on in situ T-cell engagers (TCEs) at 2026 AACR-IO conferenceRaised $6.5 million in public offering ...

SAN DIEGO, March 24, 2026 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE American: CLDI) (“Calidi” or the “Company”), a biotechnology company pioneering the development of targeted genetic medicines, today announced a partnership 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 ...

Core Viewpoint - Calidi Biotherapeutics is advancing its proprietary RedTail platform and its lead candidate CLD-401, which targets metastatic tumors and aims to enhance the delivery of genetic medicines [1][6]. Group 1: Company Overview - Calidi Biotherapeutics is a biotechnology company focused on developing targeted therapies for delivering genetic medicines to distal sites of disease [6]. - The RedTail platform utilizes an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites, shielding the virus from immune clearance [6]. Group 2: Product Development - CLD-401 is the first lead candidate from the RedTail platform, currently in IND-enabling studies, targeting non-small cell lung cancer, head and neck cancer, and other tumor types with high unmet medical need [7]. - The company anticipates submitting an Investigational New Drug (IND) application for CLD-401 by the end of 2026 [5]. Group 3: Manufacturing and FDA Interaction - Calidi presented its proprietary manufacturing process for CLD-401 at the BioProcessing Summit, emphasizing its scalability and high-yield capabilities [3]. - The manufacturing process maintains the integrity of the CD55 over-expressing envelope, which is crucial for systemic delivery and preventing immune recognition [3]. - Feedback from the FDA supports the company's manufacturing and analytical approaches, indicating a positive outlook for clinical development [4][5]. Group 4: Strategic Partnerships and Future Plans - The company is actively pursuing strategic partnerships to accelerate clinical development and broaden the impact of its RedTail platform [5]. - Calidi continues to expand the functionality of the RedTail platform, including incorporating T-cell engagers in solid tumors [7].

Core Viewpoint - Calidi Biotherapeutics, Inc. has successfully closed a public offering, raising approximately $6.0 million in gross proceeds, which will support its ongoing development of targeted genetic medicines [1][2]. Group 1: Offering Details - The company sold a total of 12,094,631 shares of common stock and associated warrants, including the full exercise of the underwriters' option for an additional 1,575,000 shares [2]. - The Series J, K, and L warrants each have an initial exercise price of $0.50 per share, with varying terms of five years, one year, and six months from issuance respectively [5]. Group 2: Company Overview - Calidi Biotherapeutics is focused on developing targeted therapies that deliver genetic medicines to specific disease sites, utilizing its proprietary Redtail platform [7]. - The lead candidate, CLD-401, is currently in IND-enabling studies and targets non-small cell lung cancer and other high unmet medical need tumor types [8].

Core Viewpoint - Calidi Biotherapeutics, Inc. has announced a public offering of 10,519,631 units, aiming to raise approximately $5.2 million for working capital and general corporate purposes [3][5]. Offering Details - Each unit consists of one share of common stock (or a pre-funded warrant), along with three types of warrants: a 6-month warrant, a 12-month warrant, and a 5-year warrant [1][6]. - The offering price is set at $0.50 per unit, with pre-funded units priced at the public offering price minus a nominal exercise price of $0.001 per share [3][6]. - The underwriter, Ladenburg Thalmann & Co. Inc., has a 45-day option to purchase up to an additional 1,575,000 shares or warrants to cover over-allotments [4]. Financial Implications - The gross proceeds from the offering are expected to be approximately $5.2 million before deducting underwriting discounts and commissions [3]. - The company has also agreed to amend existing warrants held by investors to reduce the exercise price to $0.50 per share upon closing of the offering [7]. Company Overview - Calidi Biotherapeutics is focused on developing targeted genetic medicines, utilizing its proprietary Redtail platform, which features an engineered enveloped oncolytic virus for systemic delivery to metastatic sites [10][11]. - The lead candidate, CLD-401, is currently in IND-enabling studies and targets non-small cell lung cancer and other high unmet medical need tumor types [11].

Core Insights - Calidi Biotherapeutics is presenting data on its innovative RedTail platform for targeted genetic medicines at the AACR Immuno-Oncology conference, focusing on its application in solid tumors [1][3] Group 1: RedTail Platform - The RedTail platform is designed for systemic delivery of virotherapy, targeting tumors and remodeling the tumor microenvironment (TME) to enhance therapeutic efficacy [2][5] - CLD-401, the lead candidate from the RedTail platform, is engineered to express high levels of IL-15 superagonist (IL-15 SA), which activates T-cells within the TME [2][6] Group 2: Clinical Development - Data presented indicates that RedTail can express both a functional BiTE and IL-15 SA, facilitating T-cell activation and TME alteration simultaneously, potentially overcoming previous limitations of BiTEs in solid tumors [3][4] - Calidi is conducting IND-enabling studies for CLD-401, targeting non-small cell lung cancer, head and neck cancer, and other high unmet medical need tumor types, with plans to submit an Investigational New Drug (IND) application by the end of 2026 [4][6] Group 3: Company Overview - Calidi Biotherapeutics is focused on developing targeted therapies that deliver genetic medicines to metastatic disease sites, utilizing an engineered enveloped oncolytic virus to shield from immune clearance [5][6] - The company is actively pursuing strategic partnerships to enhance clinical development and expand the impact of its RedTail platform [4]

Core Insights - Calidi Biotherapeutics is set to present data on its innovative use of BiTEs in solid tumors through its RedTail platform at the AACR Immuno-Oncology conference from February 18-21, 2026 [1] Company Overview - Calidi Biotherapeutics is a biotechnology company focused on developing targeted genetic medicines, utilizing its proprietary RedTail platform for systemic delivery to metastatic sites [5] - The RedTail platform employs an engineered enveloped oncolytic virus designed to evade immune clearance, allowing effective delivery of genetic medicines to tumor sites [5] Product Development - The lead candidate from the RedTail platform, CLD-401, is engineered to express high levels of IL-15 superagonist, which activates T-cells within the tumor microenvironment [2][3] - CLD-401 is currently in IND-enabling studies and targets non-small cell lung cancer, head and neck cancer, and other tumor types with significant unmet medical needs [6] - The company plans to submit an Investigational New Drug (IND) application for CLD-401 by the end of 2026 [4] Technological Advancements - The RedTail platform has shown the ability to remodel the tumor microenvironment and induce T-cell activation, which is crucial for overcoming the limitations of BiTEs in solid tumors [3] - The platform allows for the simultaneous expression of multiple tumor-localized payloads, enhancing the potential for effective treatment [3] Strategic Initiatives - Calidi is actively pursuing strategic partnerships to accelerate the clinical development of its RedTail platform and broaden its impact in the biotechnology sector [4]

Drug Development - Calidi plans to file an IND in Q4 2026 for its first RedTail lead candidate, CLD-401, targeting metastatic disease with high concentrations of IL-15 superagonist[5]. - Calidi presented new preclinical data at ASCO on May 30, 2025, demonstrating enhanced biological efficacy of CLD-401 in immunocompetent tumor models[6]. - The Phase I study for CLD-401 is expected to include a basket of solid tumors, such as non-small cell lung cancer and triple-negative breast cancer[9]. - Calidi anticipates proof-of-concept data for the RedTail platform to deliver tumor-localized BiTEs alongside T-cell amplifiers, addressing previous efficacy limitations in solid tumors[9]. - Calidi expects to present proof-of-concept data for non-oncology indications, leveraging selective viral replication in proliferative cells[13]. Financial Performance - The company reduced term debt and notes payable by $3.1 million in 2025, from $3.8 million at December 31, 2024, to $0.7 million at December 31, 2025[9]. - G&A expenses were reduced by $2.3 million in the first nine months of 2025 compared to the same period in 2024[9]. Strategic Initiatives - The company aims to explore new payloads for inflammatory and immune diseases, targeting other cell types via envelope engineering[13]. - Calidi's RedTail platform is designed to avoid immune clearance and deliver genetic medicines effectively to metastatic sites[10]. - The management team was strengthened with the appointment of a new CEO and CMO, both with extensive biopharmaceutical experience[7].

Core Insights - Calidi Biotherapeutics, Inc. has successfully executed its 2025 priorities and is set to file an IND application for its lead candidate CLD-401 by the end of 2026 [2][4][9] 2025 Accomplishments - The company demonstrated the effectiveness of its RedTail platform in preventing immune clearance and specifically targeting tumor cells, achieving comparable genetic medicine expression levels to localized dosing while avoiding systemic exposure [2][5] - CLD-401, the first lead candidate, is designed to deliver high concentrations of IL-15 superagonist to the tumor microenvironment in patients with metastatic disease [4][9] - New preclinical data presented at ASCO and SITC showed enhanced biological efficacy of CLD-401 in immunocompetent tumor models, confirming its ability to replicate in tumor cells and avoid immune clearance [5][6] - The management team was strengthened with the appointment of Eric Poma, PhD, as CEO and Guy Travis Clifton, MD, as CMO, both bringing extensive biopharmaceutical experience [5][8] Financial Performance - Calidi reduced its term debt and notes payable by $3.1 million in 2025, decreasing from $3.8 million at the end of 2024 to $0.7 million at the end of 2025 [8] - General and administrative expenses were reduced by $2.3 million in the first nine months of 2025 compared to the same period in 2024 [8] 2026 Anticipated Milestones - The company plans to conduct a Phase I study for CLD-401 targeting non-small cell lung cancer, triple-negative breast cancer, and head and neck cancer, with proof-of-concept data expected early in the trial [4][9] - Calidi aims to present data demonstrating the versatility of the RedTail platform for delivering tumor-localized BiTEs alongside T-cell amplifiers, addressing previous efficacy challenges in solid tumors [4][9] - The company is exploring new payloads for inflammatory and immune diseases, targeting other cell types through envelope engineering [4][9]