Product 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 delivered to the tumor microenvironment [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, triple-negative breast cancer, and head and neck cancer [9]. - Calidi anticipates proof-of-concept data early in Phase I, with the initial dose cohort expected to be in the therapeutic range [9]. - The company aims to present proof of concept data for the RedTail platform's applicability in non-oncology indications [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]. - General and administrative 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 RedTail platform allows for the simultaneous delivery of tumor-localized BiTEs alongside T-cell amplifiers, addressing previous limitations in solid tumors [9]. - The company is exploring new payloads for inflammatory and immune diseases, targeting other cell types via envelope engineering [13]. - Calidi's management team was bolstered with the hiring of a new CEO and CMO, bringing extensive biopharmaceutical experience [7].

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED SEPTEMBER 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40789 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of incorporation or organizati ...

Exhibit 99.1 Calidi Biotherapeutics Reports Third Quarter 2025 Financial Results and Recent Operational Highlights 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 ex ...

As filed with the Securities and Exchange Commission on August 15, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2967193 (I.R.S. Employer Identification No.) 4475 Executive ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2025 (858) 794-9600 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40789 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of incorporation or ...

Exhibit 99.1 Calidi Biotherapeutics Reports Second Quarter 2025 Financial Results and Recent Operational Highlights 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 extr ...

Exhibit 99.1 Calidi Biotherapeutics Reports First Quarter 2025 Financial Results and Recent Operational Highlights 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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTERLY PERIOD ENDED MARCH 31, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number 001-40789 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of incorporation or organization) ...

Exhibit 99.1 Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights 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 thre ...

☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K Commission File Number: 001-40789 CALIDI BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware 86-2967193 (State or other jurisdiction of (I.R.S. Employer incorporation or or ...