Tevogen Bio Reports 2023 Financials and Upcoming Goals

Tevogen Bio Inc., a clinical-stage specialty immunotherapy biotech firm, has recently unveiled its financial results for the full year 2023 along with significant business developments and future operational goals. The company, which trades on Nasdaq under the ticker TVGN, focuses on developing off-the-shelf, genetically unmodified T cell therapeutics targeting oncology, neurology, and virology.

Dr. Ryan Saadi, the Founder and CEO of Tevogen Bio, emphasized the company's mission to save lives by advancing their ExacTcell™ technology platform. Within just 18 months, Tevogen was able to move its first clinical product, an allogeneic target-specific cytotoxic CD8+ T lymphocyte (CTL), from conceptualization to clinical trials. Dr. Saadi also highlighted the company’s commitment to exploring TVGN 489 for the treatment of Long COVID, a priority echoed by numerous patients and their families.

Tevogen Bio is currently in negotiations to acquire manufacturing facilities capable of both clinical and commercial production of drug candidates emerging from its ExacTcell technology platform. These new facilities would bolster the production of TVGN 489 and support future clinical trials aimed at treating virally induced cancers and multiple sclerosis. Additionally, the acquisition is expected to enhance Tevogen’s research and development capabilities and foster new product innovation.

In January, Tevogen Bio announced positive proof-of-concept (POC) clinical trial results for TVGN 489, designed for high-risk patients. The trial’s primary endpoints focused on safety, and no dose-limiting toxicities or significant adverse events were observed across any of the four dosage levels. Unlike other cell therapy platforms such as CAR T, Tevogen Bio’s ExacTcell platform uniquely targets antigens found solely on diseased cells, making it suitable for outpatient settings. This platform can yield hundreds of doses per production lot, offering potential pricing flexibility and broader access.

Lori Grosso, Tevogen Bio’s Clinical Development Lead, pointed out the urgent need for novel treatments for immunocompromised COVID-19 patients. Grosso noted that the new manufacturing facilities would support their FDA approval application and expedite the commencement of new clinical trials for TVGN 489.

Tevogen Bio is also exploring various funding options to support its growth plans over the upcoming year, which include initiating in-house manufacturing, conducting clinical trials, and covering other operational expenses. Tapan Shah, Head of Investor Relations and Corporate Development, remarked on the company’s unique position, having achieved clinical success while retaining equity control and securing favorable financing terms.

The financials for Tevogen Bio in 2023 showed operating expenses amounting to $8.8 million. As of the end of the year, converting promissory notes to common stock helped remove $94.9 million in pro forma balance sheet liabilities, leaving total pro forma liabilities at $5.4 million.

Tevogen Bio specializes in harnessing CD8+ cytotoxic T lymphocytes to create off-the-shelf, precision T cell therapies for treating infectious diseases, cancers, and neurological disorders. Their leadership team is composed of industry veterans with extensive experience in drug development and global product launches. Tevogen Bio maintains positive safety data from its proof-of-concept clinical trial and owns key intellectual properties, including several patents related to artificial intelligence.

The company’s leadership believes that the future of medicine lies in accessible personalized therapeutics and that innovative business models are essential for sustaining medical advancements.