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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 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.
Calidi Biotherapeutics (NYSE AMERICAN: CLDI) has announced a $2 million registered direct offering and concurrent private placement. The company will sell 2,050,000 common stock shares at $1.00 per share, along with series E and F warrants to purchase up to 2,050,000 shares each at $1.13 per share. Series E warrants have a one-year term while Series F warrants extend to five years, both exercisable after six months. Ladenburg Thalmann & Co. Inc. is serving as exclusive placement agent. The proceeds will support working capital, general corporate purposes, and pre-clinical and clinical trials. The closing is expected around October 24, 2024.
Calidi Biotherapeutics, Inc. (NYSE American: CLDI), a clinical-stage biotechnology company, has announced that NYSE Regulation staff has decided to initiate delisting proceedings for the company's warrants (ticker symbol CLDI WS) from the NYSE American. The warrants, each exercisable for 1/10th of a common stock share at $115.00 per whole share, will be suspended from trading immediately.
The delisting decision is based on Section 1001 of the NYSE American Company Guide, citing the warrants' low trading price as unsuitable for listing. Calidi's common stock (CLDI) will continue to trade on the NYSE American. The company has the right to appeal this decision to the Listings Qualifications Panel. Upon completion of all procedures, including any potential appeal, the NYSE American will apply to the SEC for the official delisting of Calidi's warrants.
RedChip Companies will air interviews with Calidi Biotherapeutics (NYSE American:CLDI) and Gorilla Technology Group (Nasdaq:GRRR) on the RedChip Small Stocks, Big Money™ show on Bloomberg TV on October 19 at 7 p.m. ET. The show reaches an estimated 73 million homes across the U.S.
Calidi Biotherapeutics is pioneering oncolytic virotherapy (OV) for cancer treatment. Their approach uses engineered viruses to target cancer cells and stimulate immune response. Calidi's cell-based technologies protect OVs from immune system elimination, potentially increasing efficacy.
Gorilla Technology, with 22 years of experience and 29 global patents, specializes in digital transformation solutions. Their technologies include edge AI, big data analytics, and IoT security, serving sectors like government and manufacturing. Gorilla has buy ratings from three analysts with a mean price target of $29.50.
Calidi Biotherapeutics (NYSE American: CLDI) announced FDA clearance of Northwestern University's IND application for CLD-101, a novel stem-cell based platform delivering oncolytic viruses to tumors. A Phase 1b/2 clinical trial for newly diagnosed high-grade glioma is expected to start in late 2024 at Northwestern University. The trial will evaluate safety and feasibility of multiple CLD-101 doses in addition to standard treatments.
A previous Phase 1 study at Northwestern showed promising results, with median progression-free survival of 9.05 months and overall survival of 18.4 months. CLD-101 is also being evaluated in a Phase 1 trial for recurrent high-grade glioma at City of Hope, with interim data expected in the first half of 2025. City of Hope received a $5.3 million grant from CIRM to support CLD-101 studies in ovarian cancer.
Calidi Biotherapeutics Inc. (NYSEAM: CLDI) reported its Q2 2024 financial results and recent business highlights. Key developments include:
1. Launched Nova Cell subsidiary with a $2 million investment from Dr. Ronald Rigor to advance AAA stem cell programs.
2. Strengthened team with appointments of Dr. George E. Peoples to the Board of Directors and Dr. Mark Gilbert to the Medical Advisory Board.
3. Received a new U.S. patent for SuperNova technology, enhancing the CLD-201 program.
4. Reported a net loss of $5.8 million ($1.40 per share) for Q2 2024, compared to $12.5 million ($14.24 per share) in Q2 2023.
5. R&D expenses were $2.2 million, down from $3.2 million in Q2 2023.
6. Cash position of $0.8 million as of June 30, 2024.
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