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Tevogen Bio Holdings Inc. (Nasdaq: TVGN) is a clinical-stage specialty immunotherapy company, leveraging the power of CD8+ cytotoxic T lymphocytes (CTLs) to develop off-the-shelf, precision T cell therapies aimed at treating infectious diseases, cancers, and neurological disorders. Founded in 2020, Tevogen Bio has made significant strides in a short period, thanks to its highly cost-efficient business model and rapid technological advancements.
Tevogen Bio's core technology, ExacTcell™, harnesses the natural capabilities of CTLs to target and eliminate disease-causing cells. This platform is genetically unmodified, ensuring an allogeneic approach that is both flexible and scalable. The company's commitment to innovation is further exemplified by its integration of artificial intelligence to optimize the development of these therapies.
One of Tevogen Bio’s leading products, TVGN 489, focuses on treating COVID-19 and Long COVID. The company has reported positive safety data from its proof-of-concept clinical trials and is preparing for subsequent phases. TVGN 489 targets multiple proteins of SARS-CoV-2, maintaining effectiveness across various strains, including the highly mutated FLiRT variants.
Tevogen Bio's oncology pipeline is also noteworthy. Their CTLs are being explored for use in virally driven cancers such as cervical cancer caused by the Human Papilloma Virus (HPV). This strategy could provide a less invasive alternative to current surgical methods and potentially enhance the efficacy of combined treatments.
Financially, Tevogen Bio is backed by notable investors who have shown strong confidence in its commercial potential. Recent agreements have secured up to $50 million in financing, aimed at bolstering research and development, expanding clinical trials, and enhancing manufacturing capabilities. The company has successfully eliminated $94.9 million in balance sheet liabilities through strategic conversions of promissory notes into common stock.
Leadership at Tevogen Bio consists of experienced industry professionals and distinguished scientists dedicated to advancing personalized therapeutic solutions. Their vision is to ensure patient accessibility to advanced treatments through innovative business models and sustainable practices.
On July 10, 2024, Dr. Neal Flomenberg and Dr. Lori Grosso of Tevogen Bio discussed their genetically unmodified, off-the-shelf T cell technology on Nasdaq’s Live From MarketSite with Kristina Ayanian. The ExacTcell™ platform aims to address cost and patient accessibility challenges in treating cancer, infectious diseases, and neurological disorders. Unlike genetically modified autologous T cells, ExacTcell produced hundreds of doses from a single donor in a successful phase I clinical trial, showing no dose-limiting toxicities. Dr. Flomenberg expressed the goal of making T cell immunotherapy a routine, outpatient treatment. The results were published in Blood Advances, highlighting the potential of Tevogen’s innovative approach.
Ryan Saadi, CEO of Tevogen Bio (Nasdaq: TVGN), congratulates Marc Benioff, CEO of Salesforce, on receiving the Yale Legend in Leadership Award. The award, established 35 years ago, celebrates CEOs who exemplify leadership. Saadi, a Yale alumnus and a member of the Yale School of Public Health Leadership Council, emphasizes the alignment of corporate success with social responsibility. He attended the bi-annual CEO Summit alongside other notable business leaders from companies like Palo Alto Networks, Xerox, Verizon, Bank of America, Disney, General Motors, Coca-Cola, and many more, reflecting a shared commitment to integrating business and social prosperity.
Tevogen Bio, a clinical-stage specialty immunotherapy biotech company, filed a Registration Statement on Form S-1 on June 21, 2024. This filing is aimed at registering previously disclosed shares of common stock and the resale of shares and warrants by existing securityholders. Importantly, it does not involve any newly issued dilutive securities.
The filing includes shares underlying warrants issued in 2021 with an exercise price of $11.50 and earnout shares tied to a stock price threshold of $15.00 per share, previously registered in a Form S-4 filing. This registration statement has not yet been declared effective by the SEC.
Tevogen Bio announced positive Phase I clinical trial results for TVGN 489, an investigational SARS-CoV-2 specific T cell immunotherapy, published in Blood Advances. The study involved 12 high-risk patients receiving TVGN 489 and 18 receiving standard care. Notably, TVGN 489 was well-tolerated, with 88% or greater viral elimination by day 4, and over 99% by day 14. No disease progression or Long COVID was observed in the treatment group. The persistence of donor-derived T-cells was seen through the 6-month follow-up, suggesting potential long-term benefits. Tevogen plans to further test the efficacy and safety of TVGN 489 in later stage trials.
Tevogen Bio (Nasdaq: TVGN), a clinical-stage biotech firm, is pioneering off-the-shelf, genetically unmodified T cell therapies in oncology, neurology, and virology. At the Longwood Spring MIT Conference, Mittul Mehta, Chief Information Officer and Head of Tevogen.AI, discussed the transformative potential of Tevogen's T cell technology. Key highlights include the company's efforts to mainstream T cell therapy, reduce manufacturing costs, and eliminate side effects associated with CAR-T therapies. Mehta emphasized Tevogen's capability to produce hundreds of doses from a single donor and its strategy to develop T cell therapies for large patient populations, including those affected by Long COVID and multiple sclerosis. The company's approach focuses on speed, cost efficiency, and innovative pricing strategies, positioning Tevogen as a model for the industry.
Tevogen Bio Holdings (Nasdaq: TVGN) will join the Russell 3000® Index following the 2024 Russell US Indexes annual reconstitution, effective July 1. This inclusion reflects Tevogen's market capitalization among the 4,000 largest U.S. stocks as of April 30. Membership in the Russell 3000® Index entails automatic inclusion in the Russell 1000® or Russell 2000® Index, enhancing visibility among investment managers. Tevogen Bio focuses on developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology. CEO Dr. Ryan Saadi anticipates this will benefit both patients and investors.
Tevogen Bio (Nasdaq: TVGN) has secured up to $50 million in financing to boost its R&D and clinical development. The deal includes a $36 million line of credit and a potential $14 million private placement. The financing will support the development of TVGN 489 from Tevogen's ExacTcell™ technology platform and enhance its IP portfolio.
Tevogen recently eliminated $94.9 million in liabilities, positioning itself strategically for growth. The line of credit allows monthly draws up to $1 million at a low interest rate, payable in cash or stock. The private placement activates at a $10 per share threshold, discounted by 30%.
CEO Dr. Ryan Saadi emphasized the importance of this financing for expanding R&D and making personalized T cell therapies more accessible.
Tevogen Bio Holdings, a clinical-stage immunotherapy firm (Nasdaq: TVGN), held its inaugural post-public listing social engagement on May 31, 2024. The event, attended by elected officials, first responders, and U.S. Congress members, aimed to discuss the company's innovative business model and treatments using CD8+ cytotoxic T lymphocytes for diseases like cancer and neurological disorders. The gathering included mayors from various NJ towns, U.S. Congressmen Josh Gottheimer and Robert Menendez, and first responders like Matthew Caliente and Robert Ferreiro. CEO Dr. Ryan Saadi emphasized the societal value of Tevogen's business model and thanked attendees, particularly the patients who shared their experiences.
Tevogen Bio, a clinical-stage specialty immunotherapy company, hosted its first post-public listing social engagement on May 31, 2024. The event, attended by patients, first responders, elected officials, and U.S. Congress members, highlighted the company's efforts in developing CD8+ cytotoxic T cell therapies for infectious diseases, cancers, and neurological disorders. Key attendees included several New Jersey mayors, U.S. Congressmen Josh Gottheimer and Robert Menendez, and first responder representatives. The discussion focused on understanding patient needs and exploring how Tevogen's model could reduce healthcare costs and improve outcomes.
Tevogen Bio has announced that its investigational immunotherapy, TVGN 489, remains effective against FLiRT strains of SARS-CoV-2, the dominant COVID-19 variants. TVGN 489, a Cytotoxic CD8+ T lymphocyte treatment, targets multiple conserved peptides across SARS-CoV-2 proteins, maintaining efficacy despite mutations. A phase I trial showed significant clinical improvement in high-risk patients, with virus reduction over 99% within 14 days and no significant adverse events. Tevogen plans further trials to assess TVGN 489's ongoing efficacy.