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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(CLDI) - 2024 Q4 - Annual Results
2025-03-31 20:59
Financial Performance and Capital Raising - In Q4 2024, Calidi Biotherapeutics raised $9.5 million in gross proceeds from two public offerings, $2.0 million from warrant exercises, and $3.1 million from its at-the-market program[6] - A subsequent public offering in January 2025 raised an additional $4.25 million in gross proceeds[6] - The total capital raised has strengthened the company's cash position, allowing it to meet capital requirements without reliance on the Standby Equity Purchase Agreement (SEPA)[6] - The SEPA, which allowed the company to issue and sell up to $25.0 million of its common stock, was terminated effective January 23, 2025, with no outstanding borrowings or fees due[4][5] Financial Reporting and Estimates - The preliminary financial information provided is subject to further internal review and may differ from final results due to ongoing closing procedures[8][10] - Management's estimates are based on preliminary information and may change as actual results are compiled[9][10] Forward-Looking Statements and Risks - Forward-looking statements regarding future financial performance are subject to risks and uncertainties that could cause actual results to differ materially[11] - The company operates in a competitive environment, and new risks may emerge that could impact forward-looking statements[11] - The company has no obligation to update forward-looking statements unless required by law[12] Press Release and Communication - The press release regarding the bolstered cash balance and termination of the SEPA was issued on January 28, 2025[13]
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]
Calidi Biotherapeutics Announces Pricing of $4.25 Million Public Offering of Common Stock
Newsfilter· 2025-01-10 13:30
Group 1 - Calidi Biotherapeutics, Inc. has priced its public offering of 5,000,000 shares of common stock at $0.85 per share, with expected gross proceeds of approximately $4.25 million before fees and expenses [1][2] - The offering is being conducted under a shelf registration statement declared effective by the SEC on October 10, 2024, and will be made only by means of a written prospectus [3] - The company intends to use the net proceeds from the offering for working capital and general corporate purposes [2] Group 2 - Calidi Biotherapeutics is a clinical-stage immuno-oncology company focused on developing targeted immunotherapies using proprietary technology that enhances the immune system's ability to fight cancer [5] - The company utilizes allogeneic stem cells to deliver oncolytic viruses for treating various oncology indications, including high-grade gliomas and solid tumors [5] - Calidi's dual approach aims to treat or prevent metastatic disease through its preclinical off-the-shelf enveloped virotherapies [5]
Calidi Biotherapeutics Announces Closing of $7.5 Million Public Offering of Common Stock
GlobeNewswire News Room· 2024-11-15 21:05
SAN DIEGO, Nov. 15, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the closing of its previously announced public offering of 4,437,869 shares of common stock at $1.69 per share for gross proceeds of approximately $7.5 million. Ladenburg Thalmann & Co. Inc. acted as the exclusive placement agent for this offering. The securities described above publi ...
Calidi Biotherapeutics Announces Pricing of $7.5 Million Public Offering of Common Stock
GlobeNewswire News Room· 2024-11-14 13:30
SAN DIEGO, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it has priced its public offering of 4,437,869 shares of the Company’s common stock at a price of $1.69 per share. The closing of the offering is expected to occur on or about November 15, 2024, subject to the satisfaction of customary closing conditions. Ladenburg Thal ...
Calidi Biotherapeutics Announces Proposed Public Offering
GlobeNewswire News Room· 2024-11-13 21:33
SAN DIEGO, Nov. 13, 2024 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics, Inc. (NYSE AMERICAN: CLDI) (“Calidi” or the “Company”), a clinical-stage biotechnology company developing a new generation of targeted immunotherapies, today announced that it intends to offer to sell shares of its common stock (and/or pre-funded warrants (“Pre-Funded Warrants”) in lieu thereof) in an public offering. All of the shares of common stock (and/or Pre-funded Warrants) are to be sold by the Company. Ladenburg Thalmann & Co. Inc. ...