Core Insights - Calidi Biotherapeutics is hosting a webinar on November 19, 2025, to discuss its innovative approach to precision genetic medicine using the RedTail platform [1][2] - The RedTail platform is designed to deliver genetic medicines to metastatic tumor sites while avoiding immune detection, showcasing promising preclinical data [2][3] - The oncology market is projected to exceed $560 billion by 2033, presenting significant growth opportunities for Calidi [3] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies for delivering genetic medicines to distal disease sites [1][6] - The proprietary RedTail platform utilizes an engineered enveloped oncolytic virus for systemic delivery, aiming to effectively reach tumor sites and induce tumor lysis [6][7] - The lead candidate from the RedTail platform targets non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [7] Financial Position - The third quarter 2025 earnings report indicated a strengthened balance sheet with reduced debt and an increased cash balance, alongside a decrease in general and administrative spending [3]

Financial 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].

Financial Performance - Calidi Biotherapeutics reported a net loss of $5.2 million for Q3 2025, compared to a net loss of $5.1 million in Q3 2024, with a total net loss attributable to shareholders increasing to $10.8 million due to a non-cash charge for deemed dividend on warrants[7]. - The net loss per share for Q3 2025 was $2.21, a significant decrease from $7.75 in the same period of 2024[8][19]. Expenses - Research and development expenses were $2.4 million in Q3 2025, up from $2.2 million in Q3 2024, while general and administrative expenses decreased to $2.7 million from $3.1 million year-over-year[8]. - Total current liabilities decreased to $5.2 million as of September 30, 2025, from $9.5 million as of December 31, 2024[17]. Cash and Funding - The company raised $6.9 million in gross proceeds through an underwritten public offering, increasing total gross proceeds raised in 2025 to $23.0 million[5][13]. - As of September 30, 2025, Calidi had approximately $10.4 million in cash, compared to $9.6 million as of December 31, 2024[9]. Product Development - The lead candidate, CLD-401, is advancing to clinical trials and aims to target non-small cell lung cancer and ovarian cancer[3][11]. - The RedTail platform demonstrated the ability to effectively express genetic medicines at tumor sites in preclinical models, with results presented at the Society of Immunotherapy for Cancer (SITC) meeting[6]. - The company established a new Scientific Advisory Board to support the development of CLD-401 and advance the RedTail platform for systemic delivery of targeted genetic medicine[5][6]. Assets - Total assets as of September 30, 2025, were $14.0 million, slightly down from $14.2 million at the end of 2024[17].

Core Insights - Calidi Biotherapeutics is making significant progress in developing targeted therapies for delivering genetic medicines to metastatic tumor sites, with its lead candidate CLD-401 advancing to clinical trials [2][4][5] Financial Results - For Q3 2025, Calidi reported a net loss of $5.2 million, slightly higher than the $5.1 million loss in Q3 2024. The total net loss attributable to shareholders increased to $10.8 million due to a non-cash charge for deemed dividends on warrants [6][15] - The net loss per share for Q3 2025 was $2.21, compared to $7.75 in the same period of 2024 [6][15] - Research and development expenses were $2.4 million in Q3 2025, up from $2.2 million in Q3 2024, while general and administrative expenses decreased to $2.7 million from $3.1 million [7][15] - As of September 30, 2025, the company had approximately $10.4 million in cash, an increase from $9.6 million at the end of 2024 [8][14] Corporate Developments - Calidi established a new Scientific Advisory Board (SAB) to support the development of CLD-401 and the RedTail platform, featuring esteemed members with extensive experience in drug development and cancer treatment [4][5] - The company presented new preclinical data at the Society of Immunotherapy for Cancer (SITC) annual meeting, demonstrating the effectiveness of the RedTail platform in delivering genetic medicines specifically to tumor sites while avoiding systemic exposure [4][5] - Calidi raised $6.9 million in gross proceeds through a public offering, increasing total gross proceeds raised in 2025 to $23.0 million, which strengthens the company's financial position [4][5]

Core Insights - Calidi Biotherapeutics, Inc. presented new data on its first therapeutic candidate, CLD-401, at the Society of Immunotherapy for Cancer Annual Meeting, highlighting its innovative approach in targeted genetic medicines [1][4]. Group 1: Product Development - CLD-401 is designed as a tumor-tropic oncolytic virus that targets metastatic sites, replicates only in tumor cells, and induces immune responses through the expression of IL-15 superagonist in the tumor microenvironment [2][3]. - The data from syngeneic murine models indicate that the RedTail platform can evade immune clearance and effectively deliver genetic medicines at tumor sites, achieving concentrations similar to localized dosing while minimizing systemic exposure [3]. Group 2: Clinical Trials and Future Plans - Calidi is currently conducting IND-enabling studies for CLD-401 and plans to submit an Investigational New Drug application by the end of 2026 [4][7]. - The company is actively seeking strategic partnerships to enhance clinical development and expand the impact of its RedTail platform [4]. Group 3: Expert Insights - During an investor day, experts including Dr. Dimitri Zamarin and Dr. John Wrangle discussed the potential and differentiation of CLD-401 and the RedTail platform, emphasizing its promise in the field of virotherapy [5].

Core Insights - Calidi Biotherapeutics, Inc. is hosting an investor event at the Society of Immunotherapy for Cancer (SITC) Annual Meeting to discuss its RedTail platform and lead candidate CLD-401 [1][2] - The company is conducting IND-enabling studies for CLD-401, targeting non-small cell lung cancer, head and neck cancer, and other high unmet medical need tumor types, with an IND application expected by the end of 2026 [2][4] Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted genetic medicines using its proprietary RedTail platform, which utilizes an engineered enveloped oncolytic virus for systemic delivery to metastatic sites [3][4] - The RedTail platform aims to shield the virus from immune clearance, allowing effective virotherapy to reach tumor sites and deliver potent genetic medicines [3] Event Details - The investor presentation will take place on November 7 from 8:30 AM to 9:30 AM at the Gaylord National Hotel and Convention Center in National Harbor, Maryland, and will be live-streamed [2] - Key speakers at the event include Eric Poma, PhD, CEO of Calidi, and other experts from the Scientific Advisory Board [2][6]

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]