Tevogen Bio values TVGN-489 therapy at $9-11 billion

Tevogen Bio Holdings Inc. (NASDAQ: TVGN) announced its TVGN-489 allogeneic T cell therapy has a risk-adjusted net present value of $9 billion to $11 billion, according to a company statement. The therapy represents the first clinical product from the company's ExacTcell platform.

TVGN-489 is being developed to treat SARS-CoV-2 infection in high-risk patients and Long-COVID cases with persistent viral reservoirs. The valuation reflects projected revenue potential in the United States only and excludes the broader ExacTcell technology platform value.

A Phase I proof-of-concept trial published in Blood Advances showed the therapy was well tolerated in high-risk ambulatory patients, with 50% being immunocompromised. Patients received a single infusion across four dose levels without dose-limiting toxicities, infusion reactions, cytokine release syndrome, or graft-versus-host disease.

Trial results showed nasal PCR testing indicated at least 88% viral elimination by day four in 92% of patients, with more than 99% elimination in all patients by day 14. Treatment arm patients demonstrated faster symptom improvement compared to observational arm patients. No disease progression, recurrent COVID-19, or Long-COVID cases occurred in the treatment group during six months of follow-up.

"Two cancer patients were able to proceed to stem cell transplant just 15 and 28 days after receiving TVGN-489," said Neal Flomenberg, chief scientific officer. "Neither patient experienced reactivation or any complications from COVID-19 during or after transplant."

The therapy's target epitopes remain unaffected by viral mutations, including the current XFG SARS-CoV-2 variant. TVGN-489 cells were detected in patients through six months, indicating persistence and durability.

Tevogen previously shared five-year cumulative revenue projections for TVGN-489 from its oncology and specialty care units in October 2024. The company plans to provide additional valuation updates on internally developed assets and its product pipeline.

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