Calidi Biotherapeutics(US:CLDI)2025-05-14 20:45Financial Performance - The net loss for the three months ended March 31, 2025, was $5.1 million, with an accumulated deficit of $126.7 million as of the same date[242]. - The company has not generated any revenue from product sales and expects to incur significant and increasing expenses for the foreseeable future[241][244]. - The company has incurred significant operating losses since inception, primarily funded through private sales of common stock and convertible promissory notes[241]. - The net loss for Q1 2025 was $5.1 million, a reduction of 30% compared to a net loss of $7.2 million in Q1 2024[267]. - Research and development expenses for Q1 2025 were $2.4 million, a decrease of 12% from $2.7 million in Q1 2024[269]. - General and administrative expenses for Q1 2025 were $2.6 million, down 34% from $4.0 million in Q1 2024[270]. - Total operating expenses decreased by 25% to $5.1 million in Q1 2025 from $6.8 million in Q1 2024[267]. - Net cash used in operating activities was $7.1 million for the three months ended March 31, 2025, compared to $3.8 million for the same period in 2024, representing an increase of 86%[291][292]. - The company reported a net loss of $5.1 million for the three months ended March 31, 2025, a decrease from a net loss of $7.2 million in the same period of 2024[291][292]. - The total cash and restricted cash increased by $970,000 in the three months ended March 31, 2025, compared to a decrease of $806,000 in the same period of 2024, indicating a turnaround in cash flow[290]. Funding and Financial Position - The company anticipates needing substantial additional funding to support operations and pursue growth strategies, with potential financing through public or private equity offerings and debt financings[246]. - The company raised gross proceeds of $4.3 million from a public offering of 5,000,000 shares at $0.85 per share on January 10, 2025[275]. - The company entered into a Securities Purchase Agreement on March 28, 2025, resulting in gross proceeds of approximately $3.9 million[283]. - The company increased the maximum aggregate offering amount under the At The Market Offering Agreement from $5.1 million to $11.2 million on February 4, 2025[280]. - The company anticipates an increase in general and administrative expenses as it expands to support growth in research and development activities[262]. - The company raised substantial doubt about its ability to continue as a going concern due to insufficient cash on hand to support operations for at least one year[247]. - The company has concluded that it does not have sufficient cash on hand to support current operations for at least one year from the date of the financial statements issued, raising substantial doubt about its ability to continue as a going concern[297]. - The company anticipates that existing cash will not be sufficient to complete the development of product candidates CLD-101, CLD-201, and CLD-400, requiring further funding[298]. - The company plans to finance cash needs through public or private equity offerings, debt financings, or potential collaboration agreements, which may dilute ownership interests[299]. Research and Development - The FDA approved the IND application for CLD-201 (SuperNova™) in April 2025, with plans to commence a Phase 1 clinical trial by the end of 2025[237]. - A Phase 1b/2 clinical trial for CLD-101 (NeuroNova™) targeting newly diagnosed high-grade gliomas is dependent on the resumption of funding from National Cancer Institute grants, which were frozen in March 2025[235]. - The preclinical program CLD-400 (RTNova) is focused on targeting lung cancer and metastatic solid tumors, showing early signs of resistance to human humoral immunity[240]. - The company has engaged in early discovery research involving Adult Allogeneic Adipose-derived (AAA) stem cells for various therapeutic applications[238]. Management and Governance - Eric Poma, Ph.D., was appointed as CEO effective April 22, 2025, following the resignation of Allan Camaisa[251]. Market and Economic Conditions - The company is not currently exposed to significant market risk related to changes in interest rates or foreign currency exchange rates, but future operations may be subject to such fluctuations[306][307]. - Inflation has not had a material effect on the company's business, financial condition, or results of operations during the three months ended March 31, 2025, and 2024[308]. - The company is currently not exposed to significant market risk related to foreign currency exchange rates, but may face fluctuations in the future due to operations in Europe and Australia[307]. Regulatory and Reporting Status - The company qualifies as an "emerging growth company" (EGC) under the JOBS Act, allowing it to delay the adoption of certain accounting standards until they apply to private companies[309]. - The company is classified as a "smaller reporting company," with a market value of stock held by non-affiliates less than $700 million and annual revenue below $100 million in the most recently completed fiscal year[311]. - The company may continue to rely on exemptions from certain disclosure requirements as a smaller reporting company, including presenting only two years of audited financial statements[312]. - The company will avail itself of exemptions from providing an auditor's attestation report on internal control over financial reporting and reduced disclosure about executive compensation[313]. - Recent accounting standards are not expected to have a material impact on the company's financial statements or operations[314].