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About Calidi Biotherapeutics Inc.
Calidi Biotherapeutics Inc. (NYSE American: CLDI) is a clinical-stage biotechnology company at the forefront of immuno-oncology, leveraging cutting-edge stem cell-based platforms to revolutionize cancer treatment. Headquartered in San Diego, California, Calidi specializes in developing proprietary technologies that utilize potent allogeneic stem cells to deliver and enhance the efficacy of oncolytic viruses, targeting a range of oncology indications, including high-grade gliomas and solid tumors.
Innovative Stem Cell-Based Platforms
Calidi's core innovation lies in its unique, off-the-shelf, universal cell-based delivery platforms. These platforms are designed to protect, amplify, and potentiate oncolytic viruses, significantly improving therapeutic outcomes while ensuring patient safety. The company's dual approach includes localized therapies, such as its CLD-101 platform for high-grade gliomas, and systemic therapies, like RTNova, which targets metastatic cancers. By addressing both localized and advanced-stage cancers, Calidi aims to overcome critical challenges in oncology, including the rapid immune clearance of virotherapies and limited therapeutic targeting.
Clinical and Preclinical Programs
Calidi is advancing a robust pipeline of clinical-stage and preclinical candidates. Its CLD-101 platform, utilizing neural stem cells loaded with oncolytic adenoviruses, is undergoing Phase 1b/2 trials for high-grade glioma at Northwestern University. Early studies have demonstrated safety, feasibility, and promising anti-tumor immune responses, paving the way for transformative outcomes in brain cancer treatment. The RTNova platform, on the other hand, represents a breakthrough in systemic virotherapy, leveraging extracellular enveloped viruses (EEVs) to target multiple metastatic tumor sites while avoiding rapid immune clearance.
Regenerative Medicine and Beyond
In addition to oncology, Calidi is exploring the potential of its stem cell technologies in regenerative medicine through its Nova Cell subsidiary. This strategic expansion taps into the growing global demand for stem cell therapies, targeting applications in cosmetics, orthopedics, autoimmune diseases, and more. With a proprietary cell expansion method and specialized media, Calidi's approach offers significant scalability advantages over conventional mesenchymal stem cell lines.
Position in the Competitive Landscape
Operating within the rapidly evolving biotech industry, Calidi differentiates itself through its proprietary stem cell-based delivery platforms and dual therapeutic strategies. While competitors in the immuno-oncology space also focus on oncolytic virotherapies, Calidi's integration of stem cell technology enhances the safety, efficacy, and scalability of its treatments, positioning it as a potential leader in this niche. The company's strong intellectual property portfolio and strategic collaborations further bolster its competitive edge.
Commitment to Innovation and Patient Outcomes
Calidi Biotherapeutics is committed to addressing some of the most challenging cancers and unmet medical needs. Through its innovative platforms and ongoing clinical trials, the company aims to redefine how cancer is treated, offering hope to patients with limited therapeutic options. By combining scientific rigor with a focus on scalability and safety, Calidi is poised to make significant contributions to the fields of oncology and regenerative medicine.
Calidi Biotherapeutics (NYSE American: CLDI) has announced a significant leadership transition, with Eric Poma, Ph.D. succeeding Allan Camaisa as CEO and Board Director, effective April 22, 2025. Camaisa will remain on the Board.
Dr. Poma brings over 30 years of biopharmaceutical industry experience, notably as CEO of Molecular Templates where he raised $250+ million in equity financing and secured $150+ million through strategic agreements with Takeda, Vertex, and BMS. His background includes roles at Innovive Pharmaceuticals, Imclone Systems, and as a Healthcare & Biotechnology Analyst.
The transition comes as Calidi, a clinical-stage biotechnology company, advances its systemic enveloped virotherapy platform, including preparations for a dose escalation trial of CLD-201 in adult patients with solid tumors. The company continues development of its CLD-400, CLD-101, and CLD-201 programs.
Calidi Biotherapeutics (NYSE American: CLDI) announces an exclusive live investor webinar scheduled for April 24, 2025, at 4:15 p.m. ET. The event will feature presentations by newly appointed Chief Medical Officer Dr. Guy Travis Clifton and CFO Andrew Jackson.
Dr. Clifton, a surgical oncologist and U.S. Army Colonel with 17 years of experience in oncology drug development, will discuss Calidi's stem cell-based delivery platforms for enhanced cancer treatment. The webinar will highlight the company's progression following FDA clearance of their IND application for CLD-201, an allogeneic stem cell-based immunotherapy for solid tumors, focusing on breast cancer, head & neck cancer, and soft tissue sarcoma.
The presentation will also cover other lead programs including CLD-400 (RTNova) for metastatic and lung cancer, and CLD-101 for high-grade gliomas. A Q&A session will follow the presentation.
Calidi Biotherapeutics (NYSE American: CLDI) has received FDA clearance for its Investigational New Drug (IND) application for CLD-201, an allogeneic stem cell-based immunotherapy targeting solid tumors in adults. The therapy will focus on treating breast cancer, head & neck cancer, and soft tissue sarcoma.
The IND application included preclinical data showing CLD-201's potential to evade viral inactivation by the patient's immune system and effectively target cancer cells. The innovative treatment combines adipose tissue-derived stem cells with oncolytic vaccinia virus, representing a unique approach in cancer therapy.
Upcoming clinical trials will evaluate the safety, tolerability, and preliminary efficacy of CLD-201 in patients with these difficult-to-treat tumors, addressing significant unmet medical needs.
Calidi Biotherapeutics (NYSE: CLDI) has appointed Dr. Guy Travis Clifton as Chief Medical Officer, Consultant and Advisor. This announcement comes as the company advances its targeted antitumor virotherapies through clinical development.
Dr. Clifton brings over 17 years of experience in drug development, early phase trials, and cancer immunotherapy. He previously served as CMO at Parthenon Therapeutics/Incendia Therapeutics and has been a practicing surgical oncologist in the US Army since 2013. His expertise includes advising over 20 companies and authoring more than 80 peer-reviewed publications.
The appointment aligns with Calidi's recent IND filing for a dose escalation trial of CLD-201 in adult patients with solid tumors. The company is developing two platforms: a systemic approach using extracellular enveloped viruses to target metastatic tumors, and an intratumoral approach using stem cells to protect and enhance virotherapy potency.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has successfully closed its previously announced registered direct offering and concurrent private placement, raising $3.9 million in gross proceeds. The transaction includes:
- 3,325,000 shares of common stock
- Pre-funded warrants for 2,728,000 shares at $0.001 exercise price
- Series G warrants for 6,053,000 shares at $0.6954 exercise price
The combined offering price was set at $0.65 per share. The Series G warrants will be exercisable after six months and expire seven and a half years following the initial exercise date. Ladenburg Thalmann & Co. Inc. served as the exclusive placement agent. The company plans to use the proceeds for working capital, general corporate purposes, and advancing its pre-clinical and clinical programs.
Calidi Biotherapeutics (NYSE: CLDI) reported its Q4 and full-year 2024 financial results, highlighting significant progress across its three therapeutic platforms. The company demonstrated success in delivering gene therapy payload to tumors using its systemic antitumor virotherapy platform.
Key developments include: filing an IND for CLD-201 Phase 1 trial for multiple solid tumors in March 2025, advancing recruitment for a Phase 1 trial at Northwestern University for newly diagnosed high-grade glioma patients, and enrolling 14 patients in a City of Hope Phase 1 trial for recurrent high-grade glioma.
Financial results show a Q4 2024 net loss of $4.1 million ($0.27 per share), compared to $8.2 million in Q4 2023. Full-year 2024 net loss was $23.8 million ($2.97 per share). The company ended 2024 with $9.6 million in cash.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has announced a $3.9 million financing through a registered direct offering and concurrent private placement. The company will sell 3,325,000 shares of common stock at $0.65 per share and pre-funded warrants for up to 2,728,000 shares at $0.649 per warrant to a single institutional investor.
The deal includes series G warrants in a private placement to purchase up to 6,053,000 shares at $0.6954 per share, exercisable after six months with a 7.5-year term. Ladenburg Thalmann & Co. Inc. is serving as the exclusive placement agent. The closing is expected around March 31, 2025.
The clinical-stage biotechnology company plans to use the proceeds for working capital, general corporate purposes, and advancing its pre-clinical and clinical programs in targeted immunotherapies.
Calidi Biotherapeutics (NYSE: CLDI) and City of Hope have reported progress on their Phase 1 clinical trial evaluating CLD-101, a neural stem cell-based oncolytic virotherapy for recurrent high-grade glioma. The trial, which is the first to assess a multiple-dose regimen of this novel treatment, has successfully treated 14 participants with up to four weekly intracerebral doses.
The study, supported by a $12 million award from the California Institute for Regenerative Medicine (CIRM), is currently enrolling participants for the highest treatment schedule. Dr. Jana Portnow, co-director of City of Hope's Brain Tumor Program and principal investigator, reported that all treatments have been well-tolerated.
The trial has expanded to include Northwestern University Feinberg School of Medicine and Stanford University Hospitals. The technology, licensed from the University of Chicago on behalf of City of Hope and University of Alabama, aims to improve clinical outcomes using stem cell technology to deliver oncolytic virus payloads to cancer sites.
Calidi Biotherapeutics (NYSE: CLDI) has announced promising preclinical results for its systemic RTNova platform, demonstrating successful delivery of transient gene therapy payloads to targeted tumors. The company's tumor-specific virotherapy has shown effectiveness in killing over 60 different tumor cell lines.
The platform utilizes an innovative vaccinia virus strain with human cell membrane protection, designed to treat advanced-stage metastatic cancers, particularly when intratumoral administration isn't feasible. New data reveals that a single dose of their tumor-selective triple knockout (3KO) RT virus with a specific immunotherapeutic payload significantly altered the tumor microenvironment, achieving 80% leukocyte infiltration for 3KO RT and 92% with the payload, compared to 46% in untreated cases.
The treatment demonstrated complete tumor eradication in certain preclinical models, combining direct tumor killing with robust antitumor immune responses. This breakthrough enables potential development of multiple assets for various indications and opens doors for partnership opportunities.
Calidi Biotherapeutics (NYSE:CLDI) will be featured on Bloomberg TV's RedChip Small Stocks, Big Money™ show on March 1, 2025, at 7 p.m. ET. During the interview, CFO Andrew Jackson discusses the company's oncolytic virotherapy (OV) platforms for cancer treatment.
The company's technology utilizes stem cells to protect, amplify, and enhance oncolytic viruses for targeting cancer cells. Their pipeline includes CLD-101, currently in Phase 1/1b trials with upcoming Phase 1b/2 study, and CLD-201 targeting Phase 1 initiation in 2025. The company estimates its addressable U.S. market at $13-15 billion.
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