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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.
Tevogen Bio, a clinical-stage biotech company developing T cell therapeutics, recently met with U.S. Congress members to advocate for Long COVID patients and showcase their achievements. The company's CEO, Ryan Saadi, presented Tevogen's ExacTcell™ technology as a potential solution to the Long COVID crisis. Tevogen's lead product, TVGN 489, an off-the-shelf T cell therapeutic for acute SARS-CoV-2 infections, advanced from discovery to clinical phase within 18 months.
Key achievements include: founding in June 2020, obtaining 3 U.S. patents by 2022, being valued at $4.2 billion in 2022, announcing positive clinical trial results for TVGN 489 in 2023, introducing Tevogen.AI, and going public on Nasdaq in February 2024. The company's CFO, Kirti Desai, emphasized the significant market value of Tevogen's intellectual property assets, which include granted patents and pending applications in various countries.
Tevogen Bio Holdings Inc. (Nasdaq: TVGN) has secured a $6 million Series C Preferred Stock investment from The Patel Family, LLP. The agreement includes:
- 7.5% annual dividend, accruing and payable quarterly
- Convertible to common stock after 6 months
- Callable by Tevogen after 5 years
- Non-voting and no mandatory redemption
- Dividends cease after 10 years if outstanding
The investment will be completed in two closings: $4 million on August 30, 2024, and $2 million on September 16, 2024. This long-term partnership reflects confidence in Tevogen's innovative approach to precision T cell therapies and its leadership team.
Tevogen Bio Holdings Inc. (Nasdaq: TVGN) has reported its Q2 2024 financial results. Key highlights include:
- $5.1 million net cash used in operating activities for H1 2024
- $33.0 million in non-cash expenses, including $30.5 million in stock-based compensation
- $8.6 million in operating expenses for Q2 2024
- $2.4 million in current assets as of June 30, 2024
- $2.8 million received from Series A-1 Preferred Stock financing, with $3.0 million expected in Q3 2024
Tevogen has eliminated doubt about its ability to continue as a going concern, citing sufficient cash for at least 12 months of operations. The company also repurchased all outstanding Series B preferred shares at a fair value of $3.6 million, with no cash consideration.
Tevogen Bio (Nasdaq: TVGN) congratulates Professor Sten Vermund, Chairperson of its Innovation and Public Health Advisory Board, on his appointment as dean of the USF Health College of Public Health, effective January 1, 2025. Dr. Vermund will continue his role as President of the Global Virus Network (GVN), a nonprofit coalition of virologists from over 80 centers in 40 countries. The GVN focuses on combating future pandemic threats through research and development of drugs, vaccines, and treatments.
Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio, expressed pride in Dr. Vermund's appointment, highlighting his contributions to public health. Dr. Vermund cited exciting opportunities at USF, a public institution innovating at many levels, as a reason for his move from Yale School of Public Health.
Tevogen Bio Holdings Inc. (Nasdaq: TVGN) has filed a Registration Statement on Form S-1, which became effective on August 2, 2024. The company's CEO, Ryan Saadi, clarified that this registration does not involve any new issuance of dilutive securities. Instead, it pertains to the registration of earnout shares and shares underlying outstanding warrants, as well as the resale of existing shares and warrants.
Dr. Saadi expressed confidence in Tevogen's growth strategy and emphasized their commitment to providing affordable and accessible therapies. He noted that the company's recent $50 million financing, completed in July, is expected to fund existing operations into the future. The warrants have an exercise price of $11.50 per share, while the earnout shares require Tevogen's stock to reach a threshold price of $15.00 per share over a specified period to trigger issuance.
Tevogen Bio has released a letter to stockholders highlighting recent achievements and growth plans, including the consideration of a potential share buyback. Their lead product, TVGN 489, a Cytotoxic CD8+ T lymphocyte (CTL) immunotherapy for acute COVID-19 in cancer patients, has shown promising Phase I clinical trial results. Additionally, Tevogen Bio is advancing treatments for virally induced cancers, with candidates TVGN 920, TVGN 960, and TVGN 930. The company has also made significant strides with Tevogen.AI in enhancing drug discovery through predictive modeling. In response to recent stock performance, Tevogen Bio is exploring options such as a share repurchase to enhance shareholder value.
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.
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