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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), a clinical-stage biotechnology company focused on targeted antitumor virotherapies, has completed its previously announced public offering. The company sold 5,000,000 shares of common stock at $0.85 per share, raising gross proceeds of approximately $4.25 million.
Ladenburg Thalmann & Co. Inc. served as the exclusive placement agent for the offering, which was conducted under an effective Form S-3 registration statement. The final prospectus was filed with the SEC on January 10, 2025, and is available through the SEC's website and Ladenburg Thalmann & Co. Inc.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has announced the pricing of its public offering of 5,000,000 shares of common stock at $0.85 per share, expecting to raise gross proceeds of approximately $4.25 million. The offering is expected to close on January 10, 2025, with Ladenburg Thalmann & Co. Inc. acting as exclusive placement agent.
The company plans to use the net proceeds for working capital and general corporate purposes. The offering is being made through a shelf registration statement on Form S-3, which was declared effective by the SEC on October 10, 2024.
Calidi is a clinical-stage biotechnology company developing targeted immunotherapies, with proprietary technology focused on arming the immune system to fight cancer through stem cell-based platforms carrying oncolytic viruses for multiple oncology indications.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI), a clinical-stage biotechnology company focused on targeted immunotherapies, has announced plans for a public offering of common stock and pre-funded warrants. The offering will be conducted through Ladenburg Thalmann & Co. Inc. as the exclusive placement agent.
The company intends to use the proceeds for working capital and general corporate purposes. The securities will be offered through a shelf registration statement on Form S-3 that was declared effective by the SEC on October 10, 2024. The final size, terms, and completion of the offering are subject to market conditions.
A preliminary prospectus supplement and accompanying prospectus will be filed with the SEC, providing detailed information about the offering terms.
Calidi Biotherapeutics presented data at IOVC and SITC conferences showcasing their RTNova™ systemic enveloped virotherapy technology for targeting metastatic lung cancer. The technology utilizes a tumor-selective vaccinia virus engineered to produce extracellular enveloped viruses (EEVs), designed to target multiple metastatic tumor sites while avoiding immune system clearance.
The data demonstrated RTNova's therapeutic potential in an advanced lung metastasis model, both as a monotherapy and as a viral vector for delivering therapeutic payloads. The technology shows promise in killing and transforming tumor microenvironments across multiple sites, potentially offering new treatment options for previously untreatable metastatic diseases.
Calidi Biotherapeutics (NYSE American: CLDI), a clinical-stage biotechnology company focused on targeted antitumor virotherapies, has completed its previously announced public offering of 4,437,869 shares of common stock. The shares were priced at $1.69 per share, generating gross proceeds of approximately $7.5 million. Ladenburg Thalmann & Co. Inc. served as the exclusive placement agent for the offering, which was conducted under an effective Form S-3 registration statement.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has announced the pricing of its public offering of 4,437,869 shares of common stock at $1.69 per share, expecting to raise approximately $7.5 million in gross proceeds. The offering is expected to close around November 15, 2024. Ladenburg Thalmann & Co. Inc. is serving as the exclusive placement agent. The company plans to use the net proceeds for working capital, general corporate purposes, and pre-clinical and clinical trials. The offering is being made through a shelf registration statement that was declared effective on October 10, 2024.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI), a clinical-stage biotechnology company, has announced its intention to conduct a public offering of common stock and pre-funded warrants. The offering will be managed by Ladenburg Thalmann & Co. Inc. as the exclusive placement agent. The company plans to use the net proceeds for working capital and general corporate purposes. The securities are being offered through a shelf registration statement that was declared effective on October 10, 2024. The final size, terms, and completion of the offering are subject to market conditions.
Calidi Biotherapeutics (NYSE: CLDI) reported Q3 2024 financial results and key developments. The FDA cleared Northwestern University's IND application for NeuroNova (CLD-101), with Phase 1b/2 clinical trials in high-grade glioma expected to begin in early 2025. The company presented data on RTNova (CLD-400), their systemic antitumor virotherapy platform, at multiple conferences. Financially, Calidi reported a net loss of $5.1 million ($0.65 per share) compared to $2.0 million ($1.41 per share) in Q3 2023. The company raised $2 million through a registered direct offering and had $1.9 million in cash as of September 30, 2024.
Nexalin Technology (Nasdaq:NXL) and Calidi Biotherapeutics will be featured on Bloomberg TV's RedChip Small Stocks, Big Money show on October 26, 2024, at 7 p.m. ET. Nexalin's CEO Mark White will discuss their non-invasive neurostimulation technology for mental health treatment, including the Gen-3 HALO Clarity device, targeting a market projected to reach $537 billion by 2030. The technology addresses conditions like insomnia, PTSD, and traumatic brain injuries. Calidi's Chief Business Officer Stephen Thesing will present their oncolytic virotherapy developments for cancer treatment, featuring both systemic and localized approaches with engineered viruses protected by cell-based technologies.
Calidi Biotherapeutics (NYSE: CLDI) announces upcoming presentations of data supporting RTNova, their systemic antitumor virotherapy platform, at three major scientific conferences. The presentations will take place at the International Oncolytic Virotherapy Conference in Rotterdam (Oct 27-30), Immuno US 2024 in San Diego (Oct 28-30), and the Society for Immunotherapy of Cancer Annual Meeting in Houston (Nov 6-10).
RTNova is designed to target multiple tumor sites while evading the humoral immune system, offering potential treatment for previously untreatable metastatic diseases. The platform works by killing tumor cells and modifying the tumor immune microenvironment. Dr. Antonio Santidrian and Dr. Duong Nguyen will lead the presentations, sharing insights on this innovative therapeutic approach.
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