On May 14, 2026 Calidi Biotherapeutics Inc. (NYSE American: CLDI) ("Calidi" or the "Company"), a biotechnology company pioneering the development of targeted genetic medicines, reported its first quarter 2026 operating and financial results and reviewed recent business highlights.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
"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) (Free AACR Whitepaper) annual meeting in San Diego, California. Data at AACR (Free AACR Whitepaper) 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 (Free AACR Whitepaper) 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) (Free ASGCT Whitepaper) 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 period in 2025.
Research and development expenses were $2.6 million for the three months ended March 31, 2026, compared to $2.4 million for the comparable period in 2025.
General and administrative expenses were $1.6 million for the three months ended March 31, 2026, compared to $2.6 million for the comparable period in 2025.
The Company had approximately $6.6 million in cash and $0.2 million in restricted cash as of March 31, 2026, compared to $5.6 million in cash and $0.2 million in restricted cash as of December 31, 2025.
(Press release, Calidi Biotherapeutics, MAY 14, 2026, View Source [SID1234665746])