WARREN, N.J., Sept. 08, 2025 (GLOBE NEWSWIRE) — Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today shared the risk-adjusted net present value (rNPV) estimate of $9 billion to $11 billion for TVGN-489, an allogeneic precision T cell therapy and the first clinical-stage product from its proprietary ExacTcell™ platform. TVGN-489 is being developed for the treatment of SARS-CoV-2 infection in high-risk vulnerable patients and for Long-COVID in patients with evidence of a persistent viral reservoir.
Clinical Trial Key Findings (Phase I Proof-of-Concept, published in Blood Advances):
- High-risk ambulatory patients (50% immunocompromised) received a single infusion of TVGN-489 across four escalating dose levels.
- TVGN-489 was well tolerated; no dose-limiting toxicities, infusion reactions, cytokine release syndrome, or graft-versus-host disease were observed.
- Treatment arm patients showed faster and more consistent symptom improvement and earlier resolution compared to observational arm patients.
- Nasal PCR testing showed ≥88% viral elimination by Day 4 in 92% of patients, and >99% elimination in 100% of patients by Day 14.
- No disease progression, recurrent COVID-19, or cases of Long-COVID were observed in the treatment arm during six months of follow-up.
- TVGN-489 did not impair endogenous humoral or cellular immune responses.
- TVGN-489 CTLs were detected in patients through six months, supporting persistence and durability
- TVGN-489’s target epitopes remain unaffected by viral mutations, including the current XFG SARS-CoV-2 variant.
“Two cancer patients were able to proceed to stem cell transplant just 15 and 28 days after receiving TVGN-489, a procedure that effectively eliminates the patient’s immune system and requires months for recovery. Remarkably, neither patient experienced reactivation or any complications from COVID-19 during or after transplant. These results strongly suggest that TVGN-489 eradicates the virus both promptly and thoroughly, without evidence of rebound,” said Neal Flomenberg, M.D., Chief Scientific Officer of Tevogen Bio.
In October 2024, Tevogen shared TVGN 489’s cumulative revenue projections for five years from the Company’s oncology and specialty care units. The rNPV for this internally developed asset as of that date was between $9 billion and $11 billion. This valuation reflects US only revenue potential for the product and does not represent the value of the broader ExacTcell™ technology platform.
The Company intends to continue providing additional valuation updates on its internally developed assets, including its product pipeline and other assets.
Forward Looking Statements
This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; expectations regarding future growth; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.
Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; risks related to the ability to develop, license or acquire new therapeutics; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K.
You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.
Contacts
Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com
