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Calidi Biotherapeutics Announces Closing of $3.9 Million Registered Direct Offering and Concurrent Private Placement
Newsfilter· 2025-03-31 20:30
Core Viewpoint - Calidi Biotherapeutics, Inc. has successfully closed a registered direct offering and a concurrent private placement, raising approximately $3.9 million to support its clinical programs and working capital needs [4]. Group 1: Offering Details - The company issued and sold 3,325,000 shares of common stock and pre-funded warrants to purchase up to 2,728,000 shares [1]. - The combined offering price for each share of common stock and accompanying warrants was $0.65, with pre-funded warrants priced at $0.649 [2]. - The Series G warrants have an exercise price of $0.6954 per share and are exercisable six months from issuance, expiring seven and a half years after the initial exercise date [2]. Group 2: Use of Proceeds - Calidi intends to utilize the net proceeds from the offerings for working capital, general corporate purposes, and to advance its pre-clinical and clinical programs [4]. Group 3: Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted immunotherapies using proprietary technology to enhance the immune system's ability to fight cancer [8]. - The company employs novel stem cell-based platforms to deliver oncolytic viruses for various oncology indications, including high-grade gliomas and solid tumors [8].
Calidi Biotherapeutics Reports Fourth Quarter and Full-Year 2024 Financial Results and Recent Operational Highlights
Newsfilter· 2025-03-31 20:10
Core Insights - Calidi Biotherapeutics Inc. reported significant advancements in its clinical-stage biotechnology platforms, focusing on targeted immunotherapies for various cancers [2][4][7] Financial Results - For Q4 2024, the company reported a net loss of $4.1 million, or $0.27 per share, an improvement from a net loss of $8.2 million, or $0.23 per share in Q4 2023 [4] - Research and development expenses decreased to $1.8 million in Q4 2024 from $4.0 million in Q4 2023 [5] - General and administrative expenses also saw a reduction, totaling $2.2 million in Q4 2024 compared to $5.9 million in the same period of 2023 [5] - For the full year 2024, the net loss attributable to common stockholders was $23.8 million, or $2.97 per share, down from a net loss of $29.2 million, or $17.33 per share in 2023 [9] - Total research and development expenses for 2024 were $8.9 million, a decrease from $13.0 million in 2023 [9] - General and administrative expenses for the year were $12.9 million, down from $16.0 million in 2023 [10] - As of December 31, 2024, the company had approximately $9.6 million in cash, an increase from $1.9 million at the end of 2023 [10] Clinical Developments - The company has made progress in its clinical trials, including the filing of an IND for CLD-201 to treat multiple solid tumors and the advancement of CLD-101 in Phase 1 trials for high-grade glioma [2][7][8] - A total of 14 patients have been enrolled in the Phase 1 trial for recurrent high-grade glioma, supported by a $12 million award from the California Institute for Regenerative Medicine [8] - Upcoming milestones include the first patient dosing in the CLD-101 Phase 1 trial and the CLD-201 Phase 1 trial expected in Q2 and Q3 2025, respectively [8] Company Overview - Calidi Biotherapeutics is focused on developing immuno-oncology therapies utilizing proprietary technology to enhance the immune system's ability to fight cancer [11] - The company employs stem cell-based platforms to deliver oncolytic viruses for treating various oncology indications, including high-grade gliomas and solid tumors [11]
Calidi Biotherapeutics Announces Pricing of $3.9 Million Registered Direct Offering and Concurrent Private Placement
GlobeNewswire· 2025-03-28 13:00
Core Points - Calidi Biotherapeutics, Inc. has entered into a definitive securities purchase agreement for the sale of 3,325,000 shares of common stock at $0.65 per share, with an option for the investor to purchase pre-funded warrants for up to 2,728,000 shares at $0.649 each [1][3] - The company will also issue series G warrants in a concurrent private placement, allowing the purchase of up to 6,053,000 shares at an exercise price of $0.6954, exercisable six months after issuance [3][7] - The gross proceeds from both offerings are expected to be approximately $3.9 million, which will be used for working capital and to advance pre-clinical and clinical programs [5][6] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted immunotherapies using proprietary technology to enhance the immune system's ability to fight cancer [9] - The company utilizes allogeneic stem cells to deliver oncolytic viruses for various oncology indications, including high-grade gliomas and solid tumors, aiming to improve efficacy and patient safety [9]
Calidi Biotherapeutics and City of Hope Provide Update on a Phase 1 Clinical Trial with CLD-101 Virotherapy in Patients with Recurrent High-Grade Glioma
GlobeNewswire· 2025-03-26 12:00
Core Viewpoint - Calidi Biotherapeutics and City of Hope are advancing a phase 1 clinical trial for CLD-101, a novel virotherapy targeting recurrent high-grade glioma, with initial results showing safety and tolerability in participants [1][2][3] Group 1: Clinical Trial Details - The phase 1 trial, conducted by City of Hope, is evaluating the safety and feasibility of administering up to four weekly intracerebral doses of CLD-101 [2] - So far, 14 participants have been treated, and all treatments have been well tolerated, with enrollment continuing for the highest treatment schedule [2][3] Group 2: Key Personnel and Funding - Dr. Jana Portnow, co-director of City of Hope's Brain Tumor Program, is optimistic about the results, particularly from cohort 4 of the trial [3] - The study has received a $12 million award from the California Institute for Regenerative Medicine to support its development [4] Group 3: Company Background - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on using stem cell technology to deliver oncolytic virus payloads to cancer sites [5][7] - The company has licensed its technology from the University of Chicago, with City of Hope and the University of Alabama also involved [5] Group 4: City of Hope Overview - City of Hope is one of the largest cancer research and treatment organizations in the U.S., recognized for its comprehensive cancer care and research [8][9]
Calidi Biotherapeutics Announces Demonstrated Ability To Deliver Transient Gene Therapy (Payload) To Tumors Using Systemic Platform
GlobeNewswire· 2025-03-10 12:00
Core Insights - Calidi Biotherapeutics Inc. announced promising preclinical results for its systemic RTNova platform, which successfully delivers transient gene therapy payloads to targeted tumors and has shown efficacy in killing over 60 different tumor cell lines [1][2] Group 1: RTNova Platform - The RTNova platform addresses challenges in treating advanced-stage metastatic cancers, particularly when intratumoral administration is not feasible, by using a modified vaccinia virus strain that targets distant tumors while being protected in the bloodstream [2][3] - The platform's mechanism includes direct tumor killing and robust activation of antitumor immune responses, potentially revolutionizing cancer treatment approaches [4] Group 2: Immunological Impact - New data revealed that a single dose of a tumor-selective triple knockout (3KO) RT virus with a specific immunotherapeutic payload significantly altered the tumor microenvironment, increasing leukocyte infiltration to 80% for 3KO RT and 92% for 3KO RT with the payload, compared to 46% for the untreated group [3] - These changes in immune composition led to the complete eradication of certain tumors in preclinical models, confirming the production of immunomodulated payloads specifically at tumor sites [3] Group 3: Future Potential - The CEO of Calidi expressed excitement about the breakthrough, indicating that the systemic platform can also act as a viral vector to express therapeutic genes in target tumors, which may lead to multiple asset developments for various indications and potential partnership opportunities [4] - Calidi Biotherapeutics is focused on utilizing potent allogeneic stem cells to carry oncolytic viruses for multiple oncology indications, including high-grade gliomas and solid tumors, enhancing efficacy and patient safety [5]
Calidi Biotherapeutics Announces Commencement of Recruitment for Multiple Dose CLD-101 Trial in Patients with Newly Diagnosed High Grade Glioma at Northwestern University Hospital
GlobeNewswire· 2025-02-24 13:00
Core Viewpoint - Calidi Biotherapeutics is advancing its clinical trial for CLD-101, an immunotherapy product targeting high-grade glioma, with recruitment starting at Northwestern University/Northwestern Memorial Hospital [1][3]. Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted antitumor virotherapies, utilizing allogeneic neural stem cells loaded with oncolytic adenovirus CRAd-S-pk7 [2][7]. - The company aims to enhance the immune system's ability to fight cancer through its proprietary technology and stem cell-based platforms [7]. Clinical Trial Details - The CLD-101 clinical trial is a Phase 1B/2 study that will involve multiple doses of the treatment in newly diagnosed patients, building on previous promising results from a Phase 1 trial [3][4]. - The trial is physician-led and sponsored by the National Cancer Institute (NCI), with prominent experts Dr. Maciej Lesniak and Dr. Roger Stupp leading the study [3][4][5]. - The trial has received funding from the NIH/NCI SPORE, indicating strong institutional support for this pioneering research [4]. Expected Outcomes - The trial aims to improve therapeutic efficacy and patient outcomes compared to previous studies, with the potential for transformative implications in the treatment of brain tumors [6]. - If successful, the results could lead to significant advancements in the treatment of glioblastoma and other solid tumors, as the company develops a portfolio of products targeting these conditions [6].
Join Calidi Biotherapeutics' Exclusive Live Investor Webinar and Q&A Session on February 5
GlobeNewswire News Room· 2025-01-29 13:00
Core Viewpoint - Calidi Biotherapeutics Inc. is hosting a webinar to discuss its innovative cell-based delivery platforms for cancer treatment, highlighting its lead programs targeting various types of tumors [1][2]. Company Overview - Calidi Biotherapeutics is a clinical-stage biotechnology company focused on developing targeted antitumor virotherapies using proprietary technology to enhance the immune system's ability to fight cancer [4]. - The company utilizes allogeneic stem cells to deliver oncolytic viruses, aiming to improve efficacy and patient safety in treating high-grade gliomas and solid tumors [4]. Webinar Details - The webinar is scheduled for February 5, 2025, at 4:15 p.m. ET, featuring insights from CFO Andrew Jackson and CSO Antonio F. Santidrian [1][2]. - Attendees will receive an overview of Calidi's lead programs, including CLD-400 for metastatic cancers, CLD-201 for advanced solid tumors, and CLD-101 for high-grade glioma, followed by a live Q&A session [2]. Registration Information - Interested participants can register for the free webinar through a provided link and submit questions in advance [3].
Calidi Biotherapeutics Announces Bolstered Cash Balance and Termination of its Standby Equity Purchase Agreement
GlobeNewswire News Room· 2025-01-28 13:00
Core Viewpoint - Calidi Biotherapeutics has successfully strengthened its financial position through recent fundraising efforts, allowing the company to terminate its Standby Equity Purchase Agreement, which is seen as a strategic move to enhance shareholder value and focus on clinical goals [1][4]. Financial Position - As of December 31, 2024, Calidi reported an ending cash balance of approximately $9.6 million [1]. - In the fourth quarter of 2024, the company secured $9.5 million in gross proceeds from two public offerings, along with $2.0 million from warrant exercises and $3.1 million from its At-The-Market facility [3]. - A subsequent public offering in January 2025 raised an additional $4.25 million in gross proceeds [3]. Financing Strategy - The termination of the Standby Equity Purchase Agreement (SEPA) was a significant milestone in Calidi's financing strategy, allowing the company to avoid potential stock overhang and focus on operational goals [4]. - The SEPA, which was executed in December 2023, allowed Calidi the option to sell up to $25 million of common stock over three years, but the company did not exercise this option [2]. Clinical Development - Calidi is advancing its innovative virotherapy platforms, with recent milestones including the acceptance of an abstract for its systemic platform at the American Association for Cancer Research Annual Meeting in April 2025 [4]. - The company received IND clearance from the FDA for a Phase 1b/2 trial of CLD-101 targeting high-grade gliomas, with plans to begin patient enrollment in the first quarter of 2025 [4]. Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted antitumor virotherapies using proprietary stem cell-based platforms [5]. - The company's technology aims to enhance the immune system's ability to fight cancer, particularly in high-grade gliomas and solid tumors [5].
Calidi Biotherapeutics Announces Presentation of New Data of Systemic Virotherapy RTNova Platform at the AACR Annual Meeting in April 2025
GlobeNewswire· 2025-01-13 13:00
Core Insights - Calidi Biotherapeutics has announced the acceptance of its abstract for presentation at the AACR Annual Meeting, highlighting its commitment to advancing systemic enveloped virotherapy for metastatic cancers [1][2] - The proprietary RTNova systemic platform aims to address challenges in treating advanced-stage metastatic cancers by enabling targeted delivery to multiple tumor sites while evading rapid elimination by the immune system [2][3] - The company is also preparing to submit an abstract for the ASCO Annual Meeting in June 2025, focusing on selecting a lead clinical candidate for RTNova [4] Company Overview - Calidi Biotherapeutics is a clinical-stage immuno-oncology company that utilizes proprietary technology to enhance the immune system's ability to combat cancer [5] - The company employs novel stem cell-based platforms that can carry oncolytic viruses for various oncology indications, including high-grade gliomas and solid tumors [5] - Calidi's dual approach includes both systemic enveloped virotherapies and localized cell-based virotherapies, aiming to treat or prevent metastatic disease [5]
Calidi Biotherapeutics Announces Closing of $4.25 Million Public Offering of Common Stock
Newsfilter· 2025-01-10 21:30
Company Overview - Calidi Biotherapeutics Inc. is a clinical-stage biotechnology company focused on developing targeted antitumor virotherapies [3] - The company utilizes proprietary technology to enhance the immune system's ability to fight cancer, specifically through stem cell-based platforms that carry oncolytic viruses [3] Recent Financial Activity - Calidi announced the closing of a public offering of 5,000,000 shares of common stock at a price of $0.85 per share, resulting in gross proceeds of approximately $4.25 million [1] - The offering was facilitated by Ladenburg Thalmann & Co. Inc. as the exclusive placement agent [1] Regulatory Information - The public offering was conducted under registration statements on Form S-3, which were declared effective by the SEC on October 10, 2024 [2] - A final prospectus related to the offering was filed with the SEC on January 10, 2025, and is available on the SEC's website [2]