Core Insights - Calidi Biotherapeutics, Inc. is advancing its first therapeutic candidate, CLD-401, from its RedTail platform, which focuses on targeted genetic medicines for cancer treatment [1][5] - CLD-401 is designed to target metastatic sites, replicate in tumor cells, and induce immune responses through the expression of IL-15 superagonist [2][3] - The company plans to submit an Investigational New Drug (IND) application for CLD-401 by the end of 2026 and is seeking strategic partnerships to enhance clinical development [3][5] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company based in San Diego, California, specializing in the development of targeted therapies for cancer [5] - The RedTail platform utilizes an engineered enveloped oncolytic virus for systemic delivery to metastatic sites, aiming to evade immune clearance and effectively deliver genetic medicines [4][5] Product Details - CLD-401 targets non-small cell lung cancer, head and neck cancer, and other tumor types with significant unmet medical needs [5] - The therapeutic candidate is currently undergoing IND-enabling studies, with a focus on achieving durable tumor clearance through innovative mechanisms [4][5] Upcoming Events - CLD-401 will be presented at the SITC 40th Anniversary Annual Meeting scheduled for November 7-9, 2025, with a specific presentation on its efficacy in tumor delivery and immune response activation [4]

Core Insights - Calidi Biotherapeutics, Inc. has formed a Scientific Advisory Board (SAB) to enhance the development of its RedTail platform and advance its lead candidate CLD-401 into clinical trials [1][2][4] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted genetic medicines using its proprietary RedTail platform, which employs an engineered enveloped oncolytic virus for systemic delivery to metastatic sites [18][19] Scientific Advisory Board Formation - The SAB consists of leading industry and academic researchers with extensive experience in drug development, aimed at guiding the efficient development of CLD-401 [1][4] - Founding members include: - Mace L. Rothenberg, MD, with over 30 years in drug development and a history of leading clinical development at Pfizer [4][6] - Dmitriy Zamarin, MD, PhD, a leader in virotherapy for cancer and a member of the Icahn Genomics Institute [7][9] - John Wrangle, MD, MPH, an expert in IL-15-based treatment for metastatic cancer [10][12] - David T. Curiel, MD, PhD, recognized for his work in cancer immunotherapy and virotherapy [14][16] RedTail Platform and CLD-401 - The RedTail platform utilizes a genetically engineered vaccinia virus designed to overexpress CD55, allowing for targeted delivery of genetic medicine to disease sites while avoiding immune clearance [2][3] - CLD-401 is designed to target metastatic sites, replicate in tumor cells, and induce immune responses through the expression of IL-15 superagonist in the tumor microenvironment [3][19]

Core Insights - Calidi Biotherapeutics, Inc. is participating in the second annual Oncology Venture, Innovation, and Partnering Summit on September 29-30, 2025, in Boston, MA [1] - CEO Eric Poma will discuss the intersection of science and capital in cancer treatment development during a fireside chat on September 30, 2025 [2] - The company's proprietary RedTail platform is designed to deliver genetic medicines to metastatic sites while protecting the virus from immune clearance [4] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on targeted therapies for delivering genetic medicines to distal disease sites [4] - The RedTail platform features an engineered enveloped oncolytic virus aimed at systemic delivery and targeting metastatic sites [4] - The lead candidate from the RedTail platform is currently in IND-enabling studies, targeting non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [5]

Core Insights - Calidi Biotherapeutics, Inc. is participating in the H.C. Wainwright 27th Annual Global Investment Conference from September 8 to 10, 2025, in New York [1] - CEO Eric Poma will present on the RedTail platform, which aims to deliver genetic medicines to metastatic sites while evading immune clearance [2] - The RedTail platform is designed to target non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [5] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted therapies for delivering genetic medicines to distal disease sites [4] - The proprietary RedTail platform utilizes an engineered enveloped oncolytic virus for systemic delivery and targeting of metastatic sites [4] - The company is headquartered in San Diego, California [6]

Core Viewpoint - Calidi Biotherapeutics, Inc. has successfully closed a public offering, raising gross proceeds of $6.9 million, which includes the full exercise of the underwriters' over-allotment option [1][2]. Group 1: Offering Details - The company sold a total of 1,922,764 common stock units, each consisting of one share of common stock and one Series I warrant, and 1,528,000 pre-funded warrant units, each consisting of one pre-funded warrant and one Series I warrant [2]. - The price per Common Stock Unit was set at $2.00, while the Pre-Funded Unit was priced at $1.999 [2]. - The Series I warrants have an exercise price of $2.00 per share, are exercisable upon issuance, and will expire five years from issuance [2]. Group 2: Management and Regulatory Information - Ladenburg Thalmann & Co. Inc. served as the sole book-running manager for the offering, with Laidlaw & Company (U.K.) Ltd. acting as a co-manager [3]. - The securities were offered under a registration statement on Form S-1, which was declared effective by the SEC on August 20, 2025 [4]. Group 3: Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted therapies that can deliver genetic medicines to distal disease sites [6]. - The company's proprietary Redtail platform utilizes an engineered enveloped oncolytic virus designed for systemic delivery and targeting of metastatic sites, aiming to enhance the effectiveness of virotherapy [6]. - The lead candidate from the Redtail platform is currently in IND-enabling studies and targets non-small cell lung cancer, ovarian cancer, and other tumor types with significant unmet medical needs [7].

Core Viewpoint - Calidi Biotherapeutics, Inc. has successfully priced a public offering to raise $6 million, indicating strong interest from both existing and new investors despite challenging market conditions [1][2]. Group 1: Offering Details - The offering consists of 1,472,764 common stock units priced at $2.00 each, and 1,528,000 pre-funded warrant units priced at $1.999 each [2]. - Each common stock unit includes one share of common stock and one Series I warrant, while each pre-funded unit includes one pre-funded warrant and one Series I warrant [2]. - The Series I warrants have an exercise price of $2.00 per share and are exercisable upon issuance, expiring five years from issuance [2]. Group 2: Underwriting and Closing - Ladenburg Thalmann & Co. Inc. is the sole book-running manager for the offering, with Laidlaw & Company (U.K.) Ltd. acting as a co-manager [3]. - The underwriters have a 45-day option to purchase an additional 450,000 shares of common stock and/or warrants at the public offering price [3]. - The offering is expected to close on or about August 21, 2025, pending customary closing conditions [3]. Group 3: Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies for delivering genetic medicines to disease sites [6]. - The company's proprietary Redtail platform utilizes an engineered enveloped oncolytic virus for systemic delivery to metastatic sites, aiming to enhance the effectiveness of virotherapy [6]. - The lead candidate from the Redtail platform is currently in IND-enabling studies, targeting non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [7].

As filed with the Securities and Exchange Commission on August 15, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) Approximate date of commencement of proposed sale to the public: As soon as practicable after this Registration Statement is declared ...

As filed with the Securities and Exchange Commission on August 15, 2025 Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Calidi Biotherapeutics, Inc. (Exact name of registrant as specified in its charter) (State or other jurisdiction of incorporation or organization) (Primary Standard Industrial Classification Code Number) Delaware 2834 86-2967193 (I.R.S. Employer Identification No.) 4475 Executive ...

[PART I - FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) 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)](index=5&type=section&id=Item%201.%20Condensed%20Consolidated%20Financial%20Statements%20(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](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) 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](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) 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](index=10&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) 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](index=11&type=section&id=Notes%20to%20Condensed%20Consolidated%20Financial%20Statements) 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](index=28&type=chunk) - On August 4, 2025, the company executed a **1-for-12 reverse stock split**, with all share and per-share data retroactively adjusted[10](index=10&type=chunk)[32](index=32&type=chunk) - 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](index=35&type=chunk)[36](index=36&type=chunk) - 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](index=178&type=chunk)[184](index=184&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=44&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) 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](index=44&type=section&id=Company%20Overview) 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](index=215&type=chunk) - 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](index=215&type=chunk)[218](index=218&type=chunk) - 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](index=217&type=chunk) [Results of Operations](index=50&type=section&id=Results%20of%20Operations) 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](index=256&type=chunk) [Liquidity and Capital Resources](index=51&type=section&id=Liquidity%20and%20Capital%20Resources) 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](index=259&type=chunk)[278](index=278&type=chunk) - 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](index=260&type=chunk) - 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](index=261&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=57&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) 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](index=296&type=chunk) - The company is not currently exposed to significant market risk from interest rates as its debt is primarily fixed-rate[287](index=287&type=chunk) [Item 4. Controls and Procedures](index=58&type=section&id=Item%204.%20Controls%20and%20Procedures) 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](index=298&type=chunk) - 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](index=299&type=chunk) [PART II - OTHER INFORMATION](index=59&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) 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](index=59&type=section&id=Item%201.%20Legal%20Proceedings) 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](index=301&type=chunk) [Item 1A. Risk Factors](index=59&type=section&id=Item%201A.%20Risk%20Factors) 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](index=302&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=59&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) 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](index=303&type=chunk) [Item 3. Defaults Upon Senior Securities](index=59&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None[304](index=304&type=chunk) [Item 4. Mine Safety Disclosures](index=59&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[305](index=305&type=chunk) [Item 5. Other Information](index=59&type=section&id=Item%205.%20Other%20Information) 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](index=306&type=chunk) [Item 6. Exhibits](index=59&type=section&id=Item%206.%20Exhibits) 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](index=307&type=chunk)[308](index=308&type=chunk)

Core Insights - Calidi Biotherapeutics reported a net loss of $5.7 million for Q2 2025, slightly worse than analyst expectations of $(1.92) per share, indicating ongoing funding needs and cash reduction despite operational improvements [1][2][5] Financial Performance - The company recorded an EPS (GAAP) of $(1.99), compared to $(16.75) in Q2 2024, showing a significant year-over-year improvement [2] - Net loss attributable to common stockholders decreased by 23% from $7.4 million in Q2 2024 to $5.7 million in Q2 2025 [2][5] - Research and Development expenses increased to $2.6 million, while General and Administrative expenses decreased to $3.1 million, reflecting cost discipline [2][5] - Cash at the end of the period was $5.3 million, down 44.8% from $9.6 million as of December 31, 2024, indicating a need for additional funding [2][6] Business Overview - Calidi Biotherapeutics focuses on developing cancer treatments using stem cell-based delivery systems and enveloped virus platforms, aiming to enhance the effectiveness of oncolytic viruses [3] - The company is advancing preclinical and early-phase clinical assets, including the RedTail enveloped virus system and proprietary stem cell delivery technologies [4] Product Development - Key advancements were made with the RedTail platform, which effectively delivers an IL-15 superagonist payload to tumor sites, with an IND filing for CLD-401 targeted by the end of 2026 [7] - The company received Fast Track Designation from the U.S. FDA for CLD-201, its allogeneic stem cell-based immunotherapy for soft tissue sarcomas, with an IND for a Phase 1 trial opened in Q1 2025 [8] Leadership Changes - Notable changes in senior leadership occurred, with the appointment of a new Chief Executive Officer and Chief Medical Officer, both with substantial biopharmaceutical experience [9] Future Outlook - Management did not provide quantitative financial guidance but emphasized the focus on progressing core therapeutic platforms and upcoming milestones [10]