On August 13, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported financial and operating results for the three months ended June 30, 2026, and reviewed recent business highlights.
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"Throughout the second quarter, Calidi continued to advance its RedTail platform and redefine the potential of oncolytic viruses and genetic medicine," said Eric Poma, Ph.D., Calidi Biotherapeutics CEO. "We anticipate CLD-401, the lead drug candidate from our RedTail platform, entering the clinic during the first quarter of 2027. In addition, we have expanded what the RedTail platform can do with our new approach of in situ T-cell engagers."
Second Quarter 2026 and Recent Business Developments
In the pre-IND meeting, the FDA and Calidi agreed on key aspects of the CMC and non-clinical programs, and the FDA provided feedback on the overall design for the proposed first-in-human clinical study. This pre-IND (Type B) interaction builds upon the engagement and alignment achieved through early scientific advice as part of a Type D interaction with the FDA.
Presented preclinical data at the 2026 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting on CLD-501, the lead compound from Calidi’s in situ TCE approach. CLD-501 is a systemically delivered virotherapy designed to selectively target tumors and simultaneously enable the high-level in situ expression of a TROP-2 TCE and IL-15 superagonist (IL-15 SA). The Company also presented preclinical data on CLD-401, its lead program. CLD-401 is a systemically delivered virotherapy designed to selectively target tumors and enable high-level expression of IL-15 SA, a known T- and NK-cell activator, driving profound immune changes in the tumor microenvironment, including the recruitment and activation of NK, NK-T, and gamma delta (γδ) T-cells that lead to a robust therapeutic response in immunocompetent animal models.
Strengthened its Board of Directors with the addition of Corsee Sanders, Ph.D. Dr. Sanders served as strategic advisor to Celgene’s Chief Medical Officer following Celgene’s acquisition of Juno, where she was Executive Vice President of Development Operations. She also served as Transition Advisor to Bristol Myers Squibb following its acquisition of Celgene. Dr. Sanders held numerous leadership positions over the course of 23 years at Genentech/Roche, including Senior Vice President, Global Head of Clinical Operations and Industry Collaboration.
Reduced general and administrative expenses by $1.5 million, or 48%, in the second quarter of 2026 compared with the same period in 2025. The Company will continue its tight focus on expense management to ensure sufficient capital to advance its pipeline.
Second Quarter 2026 Financial Results
Calidi reported a net loss attributable to common stockholders of $4.2 million, or $2.94 per share, for the second quarter of 2026, compared with a net loss attributable to common stockholders of $5.7 million, or $31.75 per share, for the same period in 2025. Prior-period share and per-share amounts have been adjusted to reflect the Company’s 1-for-16 reverse stock split completed in July 2026.
Research and development expenses were $2.6 million for the second quarter of 2026, unchanged from the second quarter of 2025.
General and administrative expenses were $1.6 million for the second quarter of 2026, compared with $3.1 million for the comparable period in 2025.
The Company had $4.1 million in cash and $0.2 million in restricted cash as of June 30, 2026, compared with $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.
(Press release, Calidi Biotherapeutics, AUG 13, 2026, View Source [SID1234670092])