Welcome to our dedicated page for Calidi Biotherapeutics news (Ticker: CLDI), a resource for investors and traders seeking the latest updates and insights on Calidi Biotherapeutics stock.
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 $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.
RedChip Companies will air interviews with GreenPower Motor Company Inc. (Nasdaq:GP) and Calidi Biotherapeutics, Inc. on Bloomberg TV on August 3, 2024, at 7 p.m. ET. Fraser Atkinson, CEO of GreenPower, will provide a corporate update on the show. GreenPower is a leading manufacturer of all-electric, zero-emission medium and heavy-duty vehicles for various sectors including cargo, delivery, shuttle, transit, and school buses.
The company has delivered over 700 vehicles to date and maintains a significant order book. GreenPower's competitive positioning, sales growth, and market dynamics highlight its potential for sustained growth in the EV industry. The interview will be accessible online through a provided link.
Calidi Biotherapeutics (NYSE American: CLDI) has launched a new subsidiary, Nova Cell, Inc., and secured a $3 million investment from Dr. Ronald Rigor. The investment includes $2 million for Nova Cell and $1 million for Calidi's oncology pipeline. Nova Cell will focus on advancing Calidi's Adult Adipose Allogeneic (AAA) stem cell programs for regenerative medicine applications.
Dr. Rigor, a Board-Certified Dermatologist and Stem Cell Therapy expert, joins Calidi's Scientific and Medical Advisory Board. He receives exclusive rights to use AAA stem cells and Calidi's CLD-201 product in the Philippines. Nova Cell aims to tap into the global stem cell therapy market, projected to reach $31.4 billion by 2030. The company plans to begin generating revenue by supplying AAA stem cells to Dr. Rigor's patients in 2025.
Calidi Biotherapeutics (NYSE American: CLDI) has been granted U.S. Patent No. 12,036,278 for its SuperNova technology platform. This patent, titled 'Smallpox Vaccine for Cancer Treatment,' covers methods and compositions related to cancer immunotherapy, specifically combining smallpox vaccines with various stem cell types.
The patent strengthens Calidi's intellectual property portfolio and supports the advancement of its CLD-201 program into clinical trials. It broadens previously allowed claims to include 21 smallpox vaccine virus strains and 19 different stem cell types. The SuperNova platform aims to shield viral payloads from the immune system, enhancing delivery to tumor sites and improving the therapeutic efficacy of oncolytic viruses.
Calidi plans to submit an IND to initiate a first-in-human clinical trial of this off-the-shelf allogeneic therapy, focusing on patients with advanced solid tumors.
Calidi Biotherapeutics (NYSE American: CLDI) has appointed Dr. Mark Gilbert, scientist emeritus at the National Institutes of Health (NIH), to its Medical Advisory Board. Dr. Gilbert, former Chief of the Neuro-Oncology Branch at NIH, brings extensive experience in brain tumor research and clinical trials. His addition expands the board to eight members, joining other renowned oncologists and scientists.
Dr. Gilbert expressed interest in Calidi's SNV1 and NNV1 therapies, noting their potential to address rare cancers affecting about 25% of cancer patients. Calidi's CEO, Allan Camaisa, highlighted Dr. Gilbert's expertise in developing multi-institutional studies and partnerships with national centers of excellence, which could advance Calidi's research efforts.
Calidi Biotherapeutics (NYSE American: CLDI) will implement a 1-for-10 reverse stock split, effective July 15, 2024. The stock will trade on a split-adjusted basis under the same ticker, CLDI. This decision, approved by shareholders on June 6, 2024, aims to reduce outstanding shares to one-tenth of the pre-split amount.
No fractional shares will be issued; fractional entitlements will be rounded up. The split will adjust equity awards, warrants, and exercise prices accordingly. Shareholders with book-entry or brokerage accounts need not take action, while those with certificate shares will receive instructions from Computershare.
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