Tevogen Values TVGN-489 at $9–$11 Billion rNPV, Its First Clinical Product From the Proprietary ExacTcell™ Allogeneic T Cell Platform
Tevogen (Nasdaq: TVGN) has announced a risk-adjusted net present value (rNPV) of $9-11 billion for TVGN-489, its first clinical-stage allogeneic precision T cell therapy from the ExacTcell™ platform. The therapy targets SARS-CoV-2 infection in high-risk patients and Long-COVID cases.
Phase I clinical trial results published in Blood Advances demonstrated significant efficacy: 92% of patients showed ≥88% viral elimination by Day 4, and 100% achieved >99% elimination by Day 14. The treatment showed excellent safety with no major adverse events and maintained effectiveness against viral mutations, including the XFG variant.
Notably, two cancer patients successfully underwent stem cell transplants shortly after TVGN-489 treatment without COVID-19 complications, suggesting thorough viral eradication. The valuation reflects US-only revenue potential and excludes the broader ExacTcell™ platform value.
Tevogen (Nasdaq: TVGN) ha comunicato un valore attuale netto corretto per il rischio (rNPV) di $9-11 miliardi per TVGN-489, la sua prima terapia T cellulare allogenica di precisione in fase clinica derivata dalla piattaforma ExacTcell™. Il trattamento è indirizzato all'infezione da SARS‑CoV‑2 in pazienti ad alto rischio e nei casi di Long‑COVID.
I risultati della fase I, pubblicati su Blood Advances, hanno mostrato un'efficacia significativa: il 92% dei pazienti ha registrato ≥88% di riduzione virale entro il giorno 4 e il 100% ha raggiunto >99% di eliminazione virale entro il giorno 14. La terapia ha evidenziato un ottimo profilo di sicurezza senza eventi avversi gravi e ha mantenuto efficacia contro le varianti virali, inclusa la variante XFG.
In modo rilevante, due pazienti oncologici hanno effettuato con successo trapianti di cellule staminali poco dopo il trattamento con TVGN-489 senza complicazioni da COVID‑19, suggerendo un'eradicazione virale completa. La valutazione riflette il potenziale di ricavi solo negli USA ed esclude il valore più ampio della piattaforma ExacTcell™.
Tevogen (Nasdaq: TVGN) ha anunciado un valor actual neto ajustado por riesgo (rNPV) de $9-11 mil millones para TVGN-489, su primera terapia T celular alogénica de precisión en etapa clínica de la plataforma ExacTcell™. La terapia está dirigida a la infección por SARS‑CoV‑2 en pacientes de alto riesgo y casos de Long‑COVID.
Los resultados del ensayo clínico de fase I publicados en Blood Advances mostraron una eficacia notable: el 92% de los pacientes presentó ≥88% de eliminación viral para el día 4, y el 100% alcanzó >99% de eliminación para el día 14. El tratamiento mostró un excelente perfil de seguridad sin eventos adversos graves y mantuvo eficacia frente a mutaciones virales, incluida la variante XFG.
Cabe destacar que dos pacientes oncológicos se sometieron con éxito a trasplantes de células madre poco después del tratamiento con TVGN-489 sin complicaciones por COVID‑19, lo que sugiere una erradicación viral completa. La valoración refleja el potencial de ingresos solo en EE. UU. y excluye el valor más amplio de la plataforma ExacTcell™.
Tevogen (Nasdaq: TVGN)는 ExacTcell™ 플랫폼에서 개발한 임상 단계의 첫 동종 정밀 T세포 치료제 TVGN-489의 위험조정 현재가치(rNPV)를 $9-11 billion으로 발표했습니다. 이 치료제는 고위험 환자와 롱코로나(Long‑COVID) 사례의 SARS‑CoV‑2 감염을 표적으로 합니다.
Blood Advances에 발표된 1상 임상시험 결과는 유의한 효능을 보였습니다: 환자의 92%가 4일차에 ≥88%의 바이러스 제거를 보였고, 14일차에는 100%가 >99% 제거를 달성했습니다. 치료는 중대한 이상반응 없이 안전성이 우수했고, XFG 변이를 포함한 바이러스 변이에도 효과를 유지했습니다.
특히 두 명의 암 환자가 TVGN-489 치료 직후 골수(줄기세포) 이식을 성공적으로 받았으며 COVID‑19 관련 합병증이 없어 철저한 바이러스 제거를 시사합니다. 이 평가액은 미국 내 매출 잠재력만을 반영하며 ExacTcell™ 플랫폼의 광범위한 가치는 제외되어 있습니다.
Tevogen (Nasdaq: TVGN) a annoncé une valeur actuelle nette ajustée au risque (rNPV) de $9–11 milliards pour TVGN‑489, sa première thérapie T cellulaire allogénique de précision en phase clinique issue de la plateforme ExacTcell™. Le traitement cible l'infection à SARS‑CoV‑2 chez les patients à haut risque et les cas de Long‑COVID.
Les résultats de l'essai clinique de phase I publiés dans Blood Advances ont montré une efficacité marquée : 92% des patients ont présenté ≥88% d'élimination virale au jour 4, et 100% ont atteint >99% d'élimination au jour 14. Le traitement a démontré une excellente tolérance sans événements indésirables graves et a conservé son efficacité contre les mutations virales, y compris la variante XFG.
Notamment, deux patients atteints de cancer ont subi avec succès des greffes de cellules souches peu après le traitement par TVGN‑489 sans complications liées au COVID‑19, suggérant une éradication virale complète. L'évaluation reflète le potentiel de revenus aux seuls États‑Unis et n'inclut pas la valeur plus large de la plateforme ExacTcell™.
Tevogen (Nasdaq: TVGN) hat einen risikoadjustierten Barwert (rNPV) von $9–11 Milliarden für TVGN-489 angegeben, seine erste klinische, allogene Präzisions‑T‑Zelltherapie aus der ExacTcell™-Plattform. Die Therapie zielt auf SARS‑CoV‑2‑Infektionen bei Hochrisikopatienten und Long‑COVID‑Fällen ab.
Ergebnisse der Phase‑I‑Studie, veröffentlicht in Blood Advances, zeigten eine deutliche Wirksamkeit: 92% der Patienten wiesen bis Tag 4 eine ≥88%ige Virusreduktion auf, und bis Tag 14 erreichten 100% eine >99%ige Eliminierung. Die Behandlung zeigte eine sehr gute Sicherheit ohne schwere Nebenwirkungen und behielt Wirksamkeit gegenüber Virusmutationen, einschließlich der XFG‑Variante, bei.
Bemerkenswert ist, dass zwei Krebspatienten kurz nach der TVGN‑489‑Behandlung erfolgreich Stammzelltransplantationen erhielten, ohne COVID‑19‑Komplikationen, was auf eine vollständige Viruseradikation hindeutet. Die Bewertung basiert nur auf US‑Umsatzpotenzial und schließt den breiteren Wert der ExacTcell™‑Plattform aus.
- Phase I trial showed strong efficacy with ≥88% viral elimination in 92% of patients by Day 4
- Excellent safety profile with no major adverse events or complications
- Significant market potential with $9-11 billion rNPV valuation for US market alone
- Demonstrated effectiveness against viral mutations, including current XFG variant
- Successful treatment of immunocompromised patients, including pre-transplant cases
- Valuation limited to US market only, excluding global potential
- Early-stage clinical development (Phase I only)
- Additional capital may be needed to execute business plan
- Potential regulatory and development risks highlighted in forward-looking statements
Insights
Tevogen's TVGN-489 valuation of $9-11B based on promising clinical data represents significant potential but remains speculative until commercialization.
Tevogen has assigned a substantial
The Phase I proof-of-concept data published in Blood Advances shows several encouraging signals. The therapy demonstrated a clean safety profile with no dose-limiting toxicities or serious adverse events like cytokine release syndrome or GVHD across four dose escalation cohorts. Efficacy signals included rapid viral clearance with
Two particularly noteworthy cases involved cancer patients who received stem cell transplants shortly after TVGN-489 treatment without COVID-19 reactivation, suggesting potential viral eradication. This could be especially valuable for immunocompromised populations.
However, investors should note this valuation represents risk-adjusted future revenue potential in the US only, not current market value. The
The press release indicates the therapy may have applications in both acute COVID-19 for high-risk patients and Long-COVID with viral reservoirs, potentially expanding its market. The company also notes that TVGN-489's target epitopes remain unaffected by viral mutations, including current variants, which would be a significant advantage if maintained.
This valuation represents Tevogen's first clinical product from their proprietary ExacTcell™ platform, suggesting the company believes the underlying technology has broader applications beyond this single product.
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
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 in92% of patients, and >99% elimination in100% 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
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
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