Calidi Biotherapeutics(CLDI) - 2025 Q2 - Quarterly Report

PART I - FINANCIAL INFORMATION This section presents the unaudited financial statements and management's analysis for the quarter ended June 30, 2025, along with market risk and control disclosures Item 1. Condensed Consolidated Financial Statements (unaudited) This section presents the unaudited financial statements for the quarter ended June 30, 2025, highlighting a net loss, accumulated deficit, and substantial doubt about the company's going concern ability Condensed Consolidated Balance Sheets This section provides a snapshot of the company's financial position, detailing assets, liabilities, and equity as of June 30, 2025, and December 31, 2024 Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2025 | December 31, 2024 | | :--- | :--- | :--- | | Assets | | | | Cash | $5,279 | $9,591 | | Total current assets | $6,049 | $10,227 | | Total Assets | $9,351 | $14,182 | | Liabilities & Equity | | | | Total current liabilities | $5,353 | $9,496 | | Total Liabilities | $7,275 | $12,214 | | Accumulated deficit | $(132,416) | $(121,715) | | Total Equity | $2,076 | $1,968 | Condensed Consolidated Statements of Operations This section outlines the company's financial performance, detailing revenues, expenses, and net loss for the three and six months ended June 30, 2025 Condensed Consolidated Statements of Operations Highlights (in thousands) | Metric | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $(2,593) | $(2,167) | $(5,018) | $(4,910) | | General and administrative | $(3,071) | $(3,605) | $(5,708) | $(7,614) | | Loss from operations | $(5,664) | $(5,772) | $(10,726) | $(12,524) | | Net Loss | $(5,761) | $(5,767) | $(10,823) | $(12,992) | | Net loss per share | $(1.99) | $(16.75) | $(4.17) | $(39.61) | Condensed Consolidated Statements of Cash Flows This section details the cash inflows and outflows from operating, investing, and financing activities for the six months ended June 30, 2025 Condensed Consolidated Statements of Cash Flows Highlights (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | | Net cash used in operating activities | $(12,011) | $(9,325) | | Net cash used in investing activities | $(64) | $(5) | | Net cash provided by financing activities | $7,639 | $8,213 | | Net decrease in cash | $(4,430) | $(1,113) | Notes to Condensed Consolidated Financial Statements This section provides critical disclosures regarding the company's business, significant events, going concern status, and legal proceedings - The company is a clinical-stage biotechnology firm developing genetic medicines and genetically-engineered oncolytic viruses[28] - On August 4, 2025, the company executed a 1-for-12 reverse stock split, with all share and per-share data retroactively adjusted[10][32] - Due to recurring losses, an accumulated deficit of $132.4 million, and negative operating cash flows, management has concluded there is substantial doubt about the company's ability to continue as a going concern[35][36] - The company is involved in several legal proceedings, including a lawsuit with its former Chief Accounting Officer and a securities fraud complaint, with uncertain outcomes[178][184] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's analysis of the company's financial condition, operational results, and liquidity, emphasizing its clinical-stage biotech focus and going concern challenges Company Overview This section introduces Calidi as a clinical-stage biotechnology company developing genetic medicines and oncolytic viruses across three distinct platforms - Calidi is a clinical-stage biotechnology company developing genetic medicines and proprietary genetically-engineered oncolytic viruses through three platforms: RedTail, SuperNova, and NeuroNova[215] - The RedTail platform is designed for systemic administration to target metastatic tumor sites, with the first compound, CLD-401, expected to enter a Phase I trial by the end of 2026[215][218] - In July 2025, the FDA granted Fast Track Designation to CLD-201, an investigational drug candidate from the SuperNova platform, for the treatment of soft tissue sarcoma[217] Results of Operations This section analyzes the company's financial performance, focusing on changes in research and development, general and administrative expenses, and net loss Comparison of Operating Results (in thousands) | Metric | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (%) | | :--- | :--- | :--- | :--- | | Research and development | $(5,018) | $(4,910) | 2% | | General and administrative | $(5,708) | $(7,614) | (25)% | | Loss from operations | $(10,726) | $(12,524) | (14)% | | Net loss | $(10,823) | $(12,992) | (17)% | - The $1.9 million decrease in general and administrative expenses for the first six months of 2025 was primarily driven by reductions in legal fees ($0.6 million), salaries and benefits ($0.4 million), and insurance expenses ($0.3 million)[256] Liquidity and Capital Resources This section discusses the company's cash position, capital raising activities, and its ability to meet future operational needs - As of June 30, 2025, the company had a cash balance of $5.3 million and has concluded there is substantial doubt about its ability to continue as a going concern for at least one year without additional funding[259][278] - During the first six months of 2025, the company raised approximately $10.1 million in proceeds from public offerings and a registered direct offering[260] - Subsequent to the quarter end, in July 2025, the company raised an additional $4.6 million in gross proceeds through a warrant inducement offer[261] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, Calidi is not required to provide detailed market risk disclosures - The company is a smaller reporting company and is not required to provide the information under this item[296] - The company is not currently exposed to significant market risk from interest rates as its debt is primarily fixed-rate[287] Item 4. Controls and Procedures Management, including the CEO and CFO, evaluated the company's disclosure controls and procedures and concluded they were effective at a reasonable assurance level as of June 30, 2025 - Based on an evaluation, the Chief Executive Officer and Chief Financial Officer concluded that the company's disclosure controls and procedures were effective at a reasonable assurance level as of June 30, 2025[298] - There were no changes in the company's internal control over financial reporting during the quarter ended June 30, 2025, that materially affected, or were reasonably likely to materially affect, its internal controls[299] PART II - OTHER INFORMATION This section provides additional information including legal proceedings, risk factors, equity sales, defaults, mine safety, other disclosures, and a list of exhibits Item 1. Legal Proceedings The company refers to its Form 10-K for the year ended December 31, 2024, for information on legal proceedings and states that no other material legal proceedings occurred during the quarter ended June 30, 2025 - The company is not currently party to any other material legal proceedings that occurred during the quarter ended June 30, 2025, beyond those discussed in its 2024 Form 10-K[301] Item 1A. Risk Factors The company reports no material changes from the risk factors previously disclosed in its Annual Report on Form 10-K for the year ended December 31, 2024 - There have been no material changes from the risk factors previously disclosed in the Company's Annual Report on Form 10-K for the year ended December 31, 2024[302] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company reports no unregistered sales of equity securities during the period - The company had no unregistered sales of equity securities during the reporting period[303] Item 3. Defaults Upon Senior Securities The company reports no defaults upon senior securities - None[304] Item 4. Mine Safety Disclosures This item is not applicable to the company - Not applicable[305] Item 5. Other Information The company states that no director or officer adopted or terminated a Rule 10b5-1 trading arrangement during the quarter - During the quarter ended June 30, 2025, no director or officer of the Company adopted or terminated a Rule 10b5-1 trading arrangement[306] Item 6. Exhibits This section lists the exhibits filed with the Form 10-Q, including an amendment to the Certificate of Incorporation, a form of Series H Common Warrant, a form of Inducement Letter, and various officer certifications - The report includes exhibits such as an amendment to the Certificate of Incorporation, a form of Series H Common Warrant, a form of Inducement Letter, and officer certifications required by the Sarbanes-Oxley Act[307][308]