Calidi Biotherapeutics(US:CLDI)2025-11-13 21:46Financial Performance - The company reported a net loss of $5.2 million and $16.0 million for the three and nine months ended September 30, 2025, respectively, with an accumulated deficit of $137.6 million[227]. - The company has incurred significant operating losses since inception and has raised capital primarily through private sales of common stock and other securities[226]. - Net loss for Q3 2025 was $5.2 million, a 2% increase from $5.1 million in Q3 2024[253]. - The company reported a net loss of $16,000,000 for the nine months ended September 30, 2025, reduced by non-cash items including $1,700,000 in stock-based compensation[276]. Revenue and Funding - The company has not generated any revenue from product sales and expects to incur significant and increasing expenses for the foreseeable future as it advances its product candidates through development[229]. - The company anticipates needing substantial additional funding to support ongoing operations and growth strategy[230]. - The company raised approximately $4.6 million from the exercise of existing warrants as part of a Warrant Inducement Offer[235]. - The company received approximately $12.7 million from public offerings of its securities during the nine months ended September 30, 2025[263]. - Net cash provided by financing activities for the nine months ended September 30, 2025, was $17,119,000, up 20% from $14,259,000 in 2024[279]. Expenses - Research and development expenses for Q3 2025 were $2.4 million, an increase of 10% from $2.2 million in Q3 2024[254]. - General and administrative expenses for Q3 2025 were $2.7 million, a decrease of 13% from $3.1 million in Q3 2024[255]. - Total operating expenses for Q3 2025 were $5.0 million, a decrease of 3% from $5.2 million in Q3 2024[253]. - Research and development expenses for the nine months ended September 30, 2025, were $7.4 million, a 4% increase from $7.1 million in the same period of 2024[258]. - General and administrative expenses for the nine months ended September 30, 2025, were $8.4 million, a decrease of 21% from $10.7 million in the same period of 2024[259]. - Total operating expenses for the nine months ended September 30, 2025, were $15.8 million, an 11% decrease from $17.8 million in the same period of 2024[257]. Cash and Debt - As of September 30, 2025, the company had a cash balance of $10.4 million and restricted cash of $0.2 million[262]. - As of September 30, 2025, Calidi's total debt amounted to $1,072,000, with long-term debt net of current portion at $600,000[266]. - Calidi had outstanding warrants to purchase 5,026,613 shares of Common Stock as of September 30, 2025[268]. - For the nine months ended September 30, 2025, net cash used in operating activities was $16,249,000, an increase of 14% compared to $14,271,000 for the same period in 2024[275]. Product Development - The company plans to file an IND for a Phase I trial for CLD-401, the first compound from the RedTail platform, by the end of 2026[220]. - The RedTail platform is designed for systemic delivery of oncolytic viruses and has shown enhanced biological efficacy in animal models compared to previous platforms[224]. - The company has been granted Fast Track Designation for its investigational drug candidate CLD-201 for the treatment of soft tissue sarcoma[222]. - The company expects to incur significant commercialization expenses if marketing approval is obtained for current or future product candidates[281]. - Calidi's existing cash is insufficient to complete the development of its product candidates, necessitating further funding[284]. Regulatory and Compliance - The company is classified as an "emerging growth company" (EGC) and can delay the adoption of certain accounting standards until they apply to private companies, remaining an EGC until the earliest of December 31, 2026, or achieving total annual gross revenues of $1.235 billion or more[294][295]. - The company qualifies as a "smaller reporting company," with a market value of stock held by non-affiliates plus proposed gross proceeds from the offering being less than $700 million and annual revenue being less than $100 million during the most recently completed fiscal year[296]. - The company will present only two years of audited financial statements and will avail itself of exemptions from certain reporting requirements, including auditor's attestation reports on internal control over financial reporting[297][298]. - The company does not expect any recently issued accounting standards to have a material impact on its financial statements or operations[299]. Market Risk - The company is not currently exposed to significant market risk related to changes in interest rates, as it does not have cash equivalents or interest-bearing investments[291]. - The company has no significant exposure to foreign currency exchange rate fluctuations at present, although it operates through subsidiaries in Europe and Australia[292]. Other Considerations - The company has entered into license agreements that may require contingent payments under certain conditions, but does not currently expect to incur these payments[271]. - The company does not believe that inflation had a material effect on its business, financial condition, or results of operations during the three and nine months ended September 30, 2025 and 2024[293].