SAN DIEGO, April 17, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE American: CLDI) (“Calidi”), a clinical-stage biotechnology company pioneering targeted antitumor virotherapies, announced today that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for CLD-201. This investigational, allogeneic stem cell-based immunotherapy is set to advance into clinical development for the treatment of solid tumors in adults, focusing on breast cancer, head ...

SAN DIEGO, April 10, 2025 (GLOBE NEWSWIRE) -- Calidi Biotherapeutics Inc. (NYSE:CLDI) ("Calidi"), a clinical-stage biotechnology company developing a new generation of targeted antitumor virotherapies, today announced the appointment of Guy Travis Clifton, MD as Chief Medical Officer, Consultant and Advisor. "With our recently filed IND for a company sponsored, dose escalation trial of CLD-201 in adult patients with solid tumors, Dr. Clifton's oncology and advisory experience will be invaluable to us and ou ...

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]

Financial Performance - The company has incurred an accumulated deficit of approximately $121.7 million as of December 31, 2024, with net losses of approximately $22.2 million and $29.2 million for the years ended December 31, 2024 and 2023, respectively [242]. - The company has not generated any revenue from product sales to date and does not expect to do so in the foreseeable future [247]. - The company has experienced recurring losses from operations since inception, raising substantial doubt about its ability to continue as a going concern [395]. Research and Development - Research and development expenses are expected to significantly increase due to the commencement and continuation of clinical trials for product candidates [243]. - The company intends to initiate a Phase 1b or Phase 2 clinical trial for its lead product candidate CLD-101 for newly diagnosed high-grade glioma (HGG) [255]. - The company plans to apply for an Investigational New Drug application (IND) for its product candidate CLD-201, which utilizes allogeneic adipose-derived mesenchymal stem cell [255]. - The company may develop product candidates in combination with other therapies, exposing it to additional risks related to those therapies [282]. - The company is committed to pay up to $10 million in clinical trial costs for CLD-101 for newly diagnosed HGG and recurrent HGG, with contingent consideration of up to $18.7 million based on development milestones achieved [262]. Regulatory Challenges - The success of the company is highly dependent on obtaining regulatory approval for CLD-101 for newly diagnosed HGG and recurrent HGG, as well as CLD-201 and CLD-400 [264]. - The company faces significant challenges in obtaining regulatory approval for its product candidates due to their novel approach using allogeneic neural stem cells and oncolytic viruses [276]. - The regulatory approval pathway for the company's product candidates may be complex, lengthy, and expensive, with no guarantee of approval [278]. - The company may experience delays in clinical trials or regulatory approvals due to heightened safety and contagion rules for live, gene-modified viruses [280]. - The design and conduct of the company's clinical trials differ from previously conducted trials, posing substantial risks for satisfactory outcomes [281]. Market and Competition - The commercial success of adenovirus-based product candidates, including CLD-101 for newly diagnosed and recurrent HGG, depends on public acceptance of immuno-oncology therapies [285]. - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may have greater resources and expertise [297]. - The commercial success of product candidates will depend on their efficacy, safety, convenience, and pricing compared to competitors [301]. - The company may face competition from biosimilars if its products are approved, leading to increased competitive pressure [338]. Funding and Capital Requirements - Future capital requirements may increase significantly due to the scope and costs of product discovery, preclinical and clinical development [256]. - The company may need to raise substantial additional funding to continue its product development programs and operations [255]. - The company may need to sell additional shares or issue debt to meet cash payment obligations, which could delay or reduce development and commercialization activities [263]. - The company may need to curtail clinical and research initiatives if it fails to secure additional capital, potentially delaying its business plans [396]. Compliance and Legal Risks - The company is subject to ongoing legislative and enforcement scrutiny regarding drug pricing practices, which may impact its pricing strategies [345]. - The company must comply with strict advertising and promotion regulations, and failure to do so could result in substantial fines and damage to reputation [330]. - The company is subject to various anti-corruption laws, including the FCPA, which prohibit bribery and could lead to significant penalties if violated [407]. - Compliance with federal and state healthcare laws is critical, as violations could result in substantial penalties and adversely affect the company's financial condition [410]. Operational Challenges - The company lacks a sales and marketing infrastructure, which may hinder the commercialization of current or future product candidates [352]. - The company may face challenges in establishing effective sales and marketing capabilities, which could delay drug launches and increase commercialization expenses [354]. - The company is highly dependent on the expertise of its executive officers and key personnel, making recruitment and retention critical to its success [385]. - The company identified material weaknesses in internal controls over financial reporting, particularly in accounting for derivatives and cash flow statements [400]. External Factors - The change in presidential administration in 2025 introduces uncertainty regarding potential modifications to FDA requirements, which could materially affect business operations and financial condition [308]. - Legislative changes, such as the ACA, could impose additional costs and competition from biosimilars, affecting the company's profitability [342]. - Changes in U.S. and international trade policies, including tariffs, may negatively impact the company's business and operating results [381]. - Unstable global economic conditions could adversely affect the company's financial condition, stock price, and results of operations [382].

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].

Fourth Quarter 2024 Financial Results The company reported a net loss attributable to common stockholders of $4.1 million, or $0.27 per share, for the three months ended December 31, 2024, compared to a net loss attributable to common stockholders of $8.2 million, or $0.23 per share, for the same period in 2023. Research and development expenses were $1.8 million for the three months ended December 31, 2024, compared to $4.0 million for the comparable period in 2023, respectively. General and administrative ...

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]

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]

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]

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].