8-K: Calidi Biotherapeutics Reports Positive 2024 Financial Results and Advances Clinical Programs

Calidi Biotherapeutics announced its fourth quarter and full-year 2024 financial results, highlighting progress in its clinical programs and a reduction in net losses.

Summary

• Calidi Biotherapeutics reported its fourth quarter and full-year 2024 financial results.
• The company is making progress on its systemic asset CLD-400, its solid tumor asset CLD-201, and its CLD-101 program treating high-grade glioma.
• A single dose of a tumor-selective triple knockout (3KO) RT virus genetically engineered to encode a specific immune-boosting payload increased the antitumor immune response in preclinical models.
• In March 2025, Calidi filed an IND for a company sponsored, open label dose escalation trial of CLD-201 in adult patients with solid tumors.
• In February 2025, Northwestern University hospital started recruiting for the CLD-101 Phase 1 clinical trial in patients with newly diagnosed high-grade glioma.
• The company reported a net loss attributable to common stockholders of $4.1 million, or $0.27 per share, for the three months ended December 31, 2024, compared to a net loss of $8.2 million, or $0.23 per share, for the same period in 2023.
• Research and development expenses were $1.8 million for the three months ended December 31, 2024, compared to $4.0 million for the comparable period in 2023.
• General and administrative expenses were $2.2 million for the three months ended December 31, 2024, compared to $5.9 million for the comparable period in 2023.
• The company reported a net loss attributable to common stockholders of $23.8 million, or $2.97 per share, for the year ended December 31, 2024, compared to a net loss of $29.2 million, or $17.33 per share, for the year ended December 31, 2023.
• Research and development expenses were $8.9 million for the year ended December 31, 2024, compared to $13.0 million for the year ended December 31, 2023.
• General and administrative expenses were $12.9 million for the year ended December 31, 2024, compared to $16.0 million for the year ended December 31, 2023.
• The company had approximately $9.6 million in cash and $0.2 million in restricted cash as of December 31, 2024, compared to $1.9 million in cash and $0.2 million in restricted cash as of December 31, 2023.

Sentiment

Score: 7

Explanation: The sentiment is moderately positive due to the improved financial results and progress in clinical trials, but the company still faces risks and uncertainties.

Positives

• The company's net loss decreased from $29.2 million in 2023 to $23.8 million in 2024.
• Research and development expenses decreased from $13.0 million in 2023 to $8.9 million in 2024.
• General and administrative expenses decreased from $16.0 million in 2023 to $12.9 million in 2024.
• The company's cash position improved significantly, from $1.9 million in 2023 to $9.6 million in 2024.
• Calidi filed an IND for CLD-201, advancing its solid tumor program.
• Clinical trials for CLD-101 are progressing with patient recruitment at Northwestern University and City of Hope.

Negatives

• The company continues to operate at a net loss, reporting a loss of $23.8 million for the full year 2024.
• The company is reliant on clinical trials and regulatory approvals for future success.

Risks

• The company may not be able to raise sufficient capital to support its current and anticipated clinical trials.
• Early results of clinical trials do not necessarily predict final results.
• Calidi may not receive FDA approval for some or all of its therapeutic candidates.

Future Outlook

The company anticipates revealing payload and lead candidate information on the CLD-400 systemic platform in Q2 2025, dosing the first patient in the CLD-101 Phase 1 trial in collaboration with Northwestern University in Q2 2025, and dosing the first patient in the CLD-201 Phase 1 trial in Q3 2025.

Management Comments

• Allan Camaisa, CEO and Chairman of the Board of Calidi Biotherapeutics, stated that Calidi continues to make great progress on all three of their platforms.
• Allan Camaisa believes that the company's multi-modal mechanism of action is a game changer in treating multiple deadly cancers.

Industry Context

Calidi Biotherapeutics is operating in the competitive immuno-oncology space, focusing on novel stem cell-based platforms and oncolytic viruses. Companies like Amgen (with its oncolytic virus Imlygic), BioNTech (developing mRNA-based cancer therapies), and Adaptimmune (specializing in T-cell therapies) are key players in this field. Calidi's approach of using stem cells to deliver oncolytic viruses differentiates it from some competitors, but it also faces the challenges of clinical development and regulatory approval common to the industry.

Comparison to Industry Standards

• Calidi's net loss per share of $2.97 for 2024 is within the range of other clinical-stage biotech companies, but it's important to consider their cash burn rate and runway.
• For example, companies like Celldex Therapeutics and Gritstone Bio, which are also focused on cancer immunotherapies, have similar financial profiles in terms of R&D spending and net losses.
• The $9.6 million in cash on hand provides Calidi with a limited runway, and they will likely need to raise additional capital to fund their clinical programs.
• The $12 million CIRM grant for the CLD-101 program is a significant achievement and demonstrates the potential of their approach.
• The fact that Northwestern University and City of Hope are conducting trials with Calidi's therapies is a positive sign, as these are reputable institutions with expertise in cancer research.

Stakeholder Impact

• Shareholders will be encouraged by the improved financial results and clinical progress.
• Employees may feel more secure due to the improved cash position.
• Patients with high-grade gliomas and solid tumors may benefit from the company's clinical programs.

Next Steps

• Reveal payload and lead candidate information on CLD-400 systemic platform in Q2 2025.
• Dose the first patient in CLD-101 Phase 1 trial in collaboration with Northwestern University in Q2 2025.
• Dose the first patient in CLD-201 Phase 1 trial in Q3 2025.

Key Dates

Keywords

Calidi Biotherapeutics, CLDI, Financial Results, Clinical Trials, Immunotherapy, Oncolytic Virus, High-Grade Glioma, Solid Tumors, CLD-101, CLD-201, CLD-400, IND Filing, Phase 1 Trial, Cancer Treatment, Biotechnology