GAAP earnings per share of $(1.99) for Q2 2025 missed analyst estimates by $0.07.
Net loss attributable to common stockholders (GAAP) narrowed to $5.7 million for Q2 2025, down from $7.4 million in the same period of 2024.
Cash on the balance sheet was $5.3 million as of June 30, 2025.
Calidi Biotherapeutics (NYSEMKT:CLDI), a biotechnology company developing stem cell-based and enveloped virus platforms for cancer therapy, released its second quarter 2025 results on August 8, 2025. The most notable news was a net loss attributable to common stockholders of $5.7 million (GAAP), or $(1.99) per share (GAAP), slightly worse than analyst expectations of $(1.92) per share (GAAP). Despite narrowing losses compared to the prior year and continued progress in its pipeline, the period highlighted persistent funding needs and a significant reduction in available cash. The quarter showed incremental operational improvements but underscored ongoing development-stage risks typical of clinical-stage biotech firms.
Metric | Q2 2025 | Q2 2025 Estimate | Q2 2024 | Y/Y Change |
---|---|---|---|---|
EPS (GAAP) | $(1.99) | $(1.92) | $(16.75) | N/A |
Net Loss Attributable to Common Stockholders | $(5.7 million) | $(7.4 million) | 23.0% decrease | |
Research and Development Expense | $2.6 million | $2.2 million | 18.2% | |
General and Administrative Expense | $3.1 million | $3.6 million | (13.9%) | |
Cash (End of Period) | $5.3 million | $9.6 million(as of Dec 31, 2024) | (44.8%) |
Source: Analyst estimates for the quarter provided by FactSet.
Calidi Biotherapeutics is focused on developing novel cancer treatments using stem cell-based delivery systems and enveloped virus platforms. The company's strategy is to leverage allogeneic stem cells, which are donor-derived and can be used for any patient, to enhance the effectiveness of oncolytic viruses. This approach is designed to shield therapeutic viruses from immune clearance, improve their delivery to tumor sites, and trigger immune system attacks against cancer.
In recent quarters, the company has focused on advancing preclinical and early-phase clinical assets, such as its RedTail enveloped virus system and proprietary stem cell delivery technologies, including the NeuroNova and SuperNova platforms. Success factors for Calidi include demonstrating robust safety and efficacy data in clinical trials, securing regulatory clearances, expanding its intellectual property portfolio, and maintaining adequate funding to support research and development activities.
During the period, Calidi Biotherapeutics' operating expenses were split between investment in research and development and efforts to manage general and administrative costs. Research and development spending increased to $2.6 million for Q2 2025, while general and administrative costs (GAAP) decreased to $3.1 million, showing ongoing cost discipline outside of core research activities. The overall net loss attributable to common stockholders (GAAP) improved from the same period in the prior year, down to $5.7 million from $7.4 million.
The company ended the quarter with $5.3 million in cash, a significant decrease from $9.6 million as of December 31, 2024. This change reflects continued cash burn required for ongoing research and development and operational outflows. To support its operations, Calidi raised $4.6 million in new capital during the quarter, bringing total gross proceeds for 2025 to $15.7 million. Despite these capital raises, the lower cash balance as of June 30, 2025 ($5.3 million, compared to $9.6 million as of December 31, 2024) signals a short operating runway and points to a reliance on additional external funding as product development progresses.
On the product development front, Calidi made key strides with its RedTail platform, an enveloped virus technology for systemic cancer therapy. New preclinical data presented at a major oncology conference indicated that the RedTail system effectively delivers an IL-15 superagonist payload to tumor sites, while engineered features help evade immune system detection. The company targets an Investigational New Drug (IND) filing for its lead RedTail product, CLD-401, by the end of 2026, signaling a long window before entering clinical trials. In parallel, Calidi secured Fast Track Designation from the U.S. Food and Drug Administration for CLD-201, its allogeneic stem cell-based immunotherapy for soft tissue sarcomas. This regulatory milestone can accelerate the development and review process, and the IND for a Phase 1 trial of CLD-201 was successfully opened in the first quarter of 2025.
No revenue was recorded during this period, which is expected for a pre-commercial, clinical-stage biotech. Limited operational milestones beyond preclinical and regulatory advancements were reported, and there was no mention of new clinical trial data, patient enrollment updates, or advanced strategic partnerships. The company did report notable changes in its senior leadership, appointing a new Chief Executive Officer and Chief Medical Officer with substantial experience in the biopharmaceutical sector.
Calidi’s management did not offer quantitative financial guidance for the upcoming quarter or for the full fiscal year. The leadership continues to focus on progressing its core therapeutic platforms, targeting future milestones such as the IND filing for CLD-401 by the end of 2026 and ongoing clinical work with CLD-201. Investors and observers should watch for updates on clinical trial enrollment, manufacturing advances, further regulatory milestones, and funding as the company’s cash position remains a point of risk.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
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