Core Viewpoint - Calidi Biotherapeutics, Inc. announced a reverse stock split at a ratio of 1-for-12 to optimize market dynamics and broaden investor appeal, effective August 5, 2025 [1][2]. Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies that deliver genetic medicines to disease sites, utilizing its proprietary Redtail platform [6][7]. - The Redtail platform is designed to create viral vectors that evade immune detection, allowing for effective delivery of virotherapy to tumor sites [6]. Reverse Stock Split Details - The reverse stock split will consolidate every twelve pre-split shares into one post-split share, with fractional shares rounded up to the nearest whole share at the participant level [3][4]. - The split was approved by stockholders on July 9, 2025, and by the Board of Directors on July 11, 2025 [2]. - The new CUSIP number for the common stock will be 320703 408 following the split [1]. Stockholder Information - Registered stockholders with book-entry shares will not need to take action to receive post-split shares, while those with shares in certificate form will receive instructions for exchanging their certificates [5].

Company Overview - Calidi Biotherapeutics Inc. is a clinical-stage immuno-oncology company focused on developing proprietary technology to enhance the immune system's ability to fight cancer [5] - The company utilizes allogeneic stem cells to deliver oncolytic viruses for various oncology indications, including high-grade gliomas and solid tumors [5] - Calidi's innovative platforms aim to protect, amplify, and potentiate oncolytic viruses, potentially improving efficacy and patient safety [5] Industry Context - Approximately 20 million people are diagnosed with cancer each year, with nearly 10 million deaths globally, a figure expected to rise significantly by 2050 [3] - The American Cancer Society projects that annual cancer diagnoses will reach 35 million by 2050, highlighting the urgent need for more effective therapies [3] - The demand for innovation in cancer treatment presents significant market opportunities for companies like Calidi Biotherapeutics [3][4] Technological Approach - Calidi Biotherapeutics is developing a next-generation platform that delivers genetic medicines directly to primary and metastatic tumors using engineered viruses [4] - The company's dual approach aims to treat or prevent metastatic disease, positioning it among leading biotech innovators [4]

Core Viewpoint - Calidi Biotherapeutics has entered into a definitive agreement for the immediate exercise of existing warrants, which will generate approximately $4.6 million in gross proceeds to advance its clinical programs and operational expenses [1][3]. Group 1: Warrants and Financial Details - The company will exercise certain outstanding Series A, B-1, C-1, D, E, and F Warrants to purchase up to 6,595,000 shares of common stock at a reduced exercise price of $0.70 [1]. - Ladenburg Thalmann & Co, Inc. is acting as the exclusive placement agent for this offering [2]. - The new warrants will also allow for the purchase of 6,595,000 shares at the same exercise price of $0.70, with a term of five and a half years [2]. Group 2: Use of Proceeds - The net proceeds from the offering will be used to advance clinical and pre-clinical programs, as well as for ongoing operating expenses and working capital [3]. Group 3: Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted therapies that deliver genetic medicines to disease sites [6]. - The company's proprietary Redtail platform is designed to create viral vectors that evade immune detection, allowing for effective delivery of virotherapy to tumor sites [6]. - The lead candidate from the Redtail platform targets non-small cell lung cancer, ovarian cancer, and other high unmet medical need tumor types [7].

Company Overview - Calidi Biotherapeutics Inc. is a clinical-stage immuno-oncology company focused on developing innovative cancer treatments through the precise delivery of genetic medicines to both primary tumors and metastatic sites [3][4] - The company utilizes proprietary stem cell-based platforms that can carry oncolytic viruses, aiming to enhance the efficacy and safety of cancer therapies [4] Industry Context - An estimated 20 million people are diagnosed with cancer annually, with nearly 10 million deaths each year worldwide, and these figures are projected to rise significantly [2] - The American Cancer Society anticipates that by 2050, 35 million people will be diagnosed with cancer each year, highlighting the urgent need for new and effective cancer drugs [2] Technology and Innovation - Calidi's platform employs engineered viruses to target cancer sites in the body, delivering potent genetic medicines that could potentially revolutionize cancer treatment [3] - The dual approach of using allogeneic stem cells and oncolytic viruses aims to treat or prevent metastatic disease, addressing significant unmet needs in oncology [4]

Core Viewpoint - Calidi Biotherapeutics is undergoing significant transformation in leadership, focus, and financial management, aiming to advance its innovative oncology therapies, particularly the RedTail platform, which shows promise in delivering genetic medicines to metastatic cancer sites [1][3][7]. Company Developments - The appointment of Eric Poma as CEO in April 2025 marks a new leadership direction, with a focus on advancing therapeutic approaches in oncology [2]. - Dr. Guy Travis Clifton has been appointed as Chief Medical Officer, enhancing the company's expertise in clinical program advancement and regulatory strategy [2]. R&D Pipeline Progress - The RedTail platform is highlighted as a key focus, utilizing an engineered enveloped virus for systemic delivery of genetic medicines to metastatic cancer sites, representing over a decade of research [3][9]. - Recent preclinical data indicates that RedTail demonstrates potent tumor-selective targeting and improved anti-tumor immune modulation, differentiating it in the oncology market [4]. Strategic Partnerships - The company is actively seeking partnerships with leading biopharmaceutical firms to accelerate the development and commercialization of therapies, which could enhance market reach and shareholder value [4]. Future Milestones - The roadmap for the next 18 months includes completing IND-enabling studies for the lead candidate CLD-401, with an IND filing anticipated by the end of 2026 [5]. - An IND for the SuperNova virotherapy (CLD-201) was opened in April 2025, with Phase I trials expected to start by the end of 2025 [6]. Financial Management - As of Q1 2025, the company reported approximately $10.6 million in cash, with efforts to reduce costs and lower the burn rate while retiring most of its debt [7].

Core Insights - Calidi Biotherapeutics Inc. is a clinical-stage biotechnology company focused on developing systemic oncolytic targeted immunotherapies, with its lead candidate CLD-401 presented at the ASCO Annual Meeting [1][2] Group 1: Technology and Innovation - Calidi has developed an enveloped form of its proprietary oncolytic virus that shows greater resistance to immune clearance, enhancing systemic delivery and efficacy in pre-clinical models [2] - The novel genetic modification in CLD-401 incorporates a chimeric CD55 receptor into the virus envelope, which inhibits complement-mediated clearance, improving the virus's stability in circulation [2][4] - The RedTail platform allows for the delivery of genetic payloads directly into the tumor microenvironment, with CLD-401 expressing an IL-15 superagonist to activate and expand natural killer (NK) cells and CD8+ T cells [3][4] Group 2: Strategic Development - Calidi is conducting IND-enabling studies for CLD-401 and plans to submit an Investigational New Drug (IND) application in the second half of 2026 [4] - The company is actively seeking strategic partnerships to accelerate clinical development and enhance the impact of its RedTail platform [4][6] - The lead candidate targets non-small cell lung cancer, ovarian cancer, and other tumor types with high unmet medical needs [7]

Core Viewpoint - Calidi Biotherapeutics, Inc. (CLDI) has experienced a downtrend, losing 14% over the past two weeks, but a hammer chart pattern suggests a potential trend reversal due to increased buying interest [1][2]. Technical Analysis - The hammer chart pattern indicates a possible bottom in the stock price, suggesting that selling pressure may be exhausting [2][5]. - A hammer pattern forms when there is a small candle body with a long lower wick, signaling that bulls may be regaining control after a downtrend [4][5]. - This pattern can occur across various timeframes and is utilized by both short-term and long-term investors [5]. Fundamental Analysis - There has been a positive trend in earnings estimate revisions for CLDI, which is a bullish indicator [7]. - The consensus EPS estimate for the current year has increased by 48.9% over the last 30 days, indicating analysts' optimism about the company's earnings potential [8]. - CLDI holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks, which typically outperform the market [9].

Financial Performance - The company reported a net loss of $5.0 million, or $0.18 per share, for Q1 2025, a decrease from a net loss of $7.2 million, or $2.03 per share, in Q1 2024[7]. - General and administrative expenses decreased to $2.6 million in Q1 2025 from $4.0 million in Q1 2024[8]. - Research and development expenses were $2.4 million for Q1 2025, down from $2.7 million in the same period of 2024[7]. Cash and Assets - The company had approximately $10.6 million in cash as of March 31, 2025, compared to $9.6 million as of December 31, 2024[8]. - Total assets increased to $15.1 million as of March 31, 2025, compared to $14.2 million as of December 31, 2024[16]. - Total current liabilities decreased to $5.4 million as of March 31, 2025, from $9.5 million as of December 31, 2024[16]. Leadership and Development - The company appointed Eric Poma, PhD, as CEO, who has over 30 years of experience in the biopharmaceutical industry[6]. - The FDA cleared the IND application for CLD-201, which targets solid tumors, including breast cancer and head & neck cancer[10]. - The lead candidate from the Redtail platform is currently in IND-enabling studies, focusing on non-small cell lung cancer and ovarian cancer[11]. - New preclinical data on the Redtail platform was presented at the AACR Annual Meeting, highlighting the IL15 superagonist as the first payload for tumor delivery[10].

Financial 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].

Core Insights - Calidi Biotherapeutics Inc. reported its first quarter 2025 operating and financial results, highlighting advancements in its systemic oncolytic targeted immunotherapy platform, Redtail [1][3] Company Developments - The management team has been strengthened with the appointment of Eric Poma, PhD, as CEO and Guy Travis Clifton, MD, as Chief Medical Officer, both bringing extensive biopharmaceutical experience [4][5] - The company selected IL15-superagonist as the first payload for its lead candidate using the Redtail platform, with an Investigational New Drug (IND) filing expected in the second half of 2026 [4] - The FDA cleared the IND application for CLD-201, an allogeneic stem cell-based immunotherapy targeting solid tumors, including breast cancer, head & neck cancer, and soft tissue sarcoma [4][6] Financial Performance - For Q1 2025, Calidi reported a net loss of $5.0 million, or $0.18 per share, an improvement from a net loss of $7.2 million, or $2.03 per share, in Q1 2024 [7][15] - Research and development expenses decreased to $2.4 million in Q1 2025 from $2.7 million in the same period in 2024 [7] - General and administrative expenses also declined to $2.6 million in Q1 2025 from $4.0 million in Q1 2024 [8] Cash Position - As of March 31, 2025, the company had approximately $10.6 million in cash, an increase from $9.6 million as of December 31, 2024 [8][13]