Tevogen Bio Plans to Expand Specialty Care Pipeline to Include Patients 65+, Building on Previous Forecast of Nearly $1 Billion in Launch-Year; Updated rNPV to Follow

Rhea-AI Summary

Tevogen Bio (NASDAQ: TVGN) has announced plans to expand its TVGN 489's target population to include patients aged 65 and older. This expansion builds upon the company's previously forecasted launch-year revenue of nearly $1 billion for its specialty care pipeline, with a five-year cumulative estimate of $18-22 billion. The company plans to provide an updated forecast and risk-adjusted net present value (rNPV) to reflect this expansion. The announcement comes as the U.S. reports cases of the new COVID variant NB.1.8.1. Tevogen's ExacTcell™ platform supports an expanded pipeline targeting various patient populations, including those with B cell hematologic cancer, other cancers, rheumatoid arthritis, psoriatic arthritis, Long COVID, and now the 65+ age group.

Positive

• Expansion to 65+ age group significantly increases market potential
• Strong existing revenue forecast of ~$1B in launch year
• Impressive 5-year cumulative revenue estimate of $18-22B
• Diversified pipeline addressing multiple patient populations
• Timely expansion amid emergence of new COVID variant NB.1.8.1

Negative

• Additional capital may be needed to execute business plan
• Revenue projections are forward-looking and not guaranteed
• Faces regulatory approval uncertainties and development risks
• Limited operating history as mentioned in risk factors

Insights

Biotech Investment Analyst

Tevogen expands TVGN 489 to elderly patients, potentially increasing its nearly $1B projected launch revenue.

Tevogen Bio's announcement to expand TVGN 489's target population to include patients 65+ represents a significant market opportunity expansion. Their previous revenue projection of $1 billion for launch year and $18-22 billion cumulative five-year estimate was already substantial, but did not include this elderly demographic.

The timing of this expansion appears strategic, coinciding with reports of a new COVID variant (NB.1.8.1) believed to be more contagious. This suggests Tevogen is positioning TVGN 489 to address emerging viral threats, particularly for vulnerable populations.

The company's ExacTcell™ platform supports multiple targeted applications of TVGN 489, primarily focused on SARS-CoV-2 infection in immunocompromised populations (cancer patients, rheumatoid arthritis patients) and Long COVID treatment. Adding the 65+ demographic is particularly notable as this population faces higher COVID-19 complication risks and represents a substantial market segment.

While the company promises updated financial forecasts and rNPV calculations to reflect this expansion, investors should note these are forward-looking projections subject to significant execution risks. The press release lacks specific clinical data supporting efficacy in this expanded population or regulatory milestones achieved. The company's limited operating history and need for additional capital (mentioned in forward-looking statements) further underscore execution risks despite the promising market opportunity.

WARREN, N.J., May 23, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced a planned expansion of TVGN 489’s target population to include patients 65 and older. As previously reported in October 2024, the top-line revenue forecast for the specialty care pipeline was projected at nearly $1 billion in its launch year, with a cumulative five-year estimate ranging between $18 billion and $22 billion. This anticipated expansion aims to broaden the market potential of Tevogen’s specialty pharmaceuticals. An updated forecast and the risk adjusted net present value (rNPV) will be provided to reflect the inclusion of the 65+ patient population.

Tevogen Bio’s Chief Commercial Officer, Sadiq Khan, MBA, with over three decades of commercial leadership, including experience at Sanofi-Aventis, commented, “As the U.S. begins reporting cases of the new COVID variant NB.1.8.1, previously identified in China, which is believed to be more contagious, we have prioritized expansion of clinical manufacturing capacity to addressing significant unmet medical needs.”  

Supported by Tevogen’s ExacTcell™ platform, the expanded pipeline is outlined below:

• TVGN 489:
  • Treatment of SARS-CoV-2 infection in patients with B cell hematologic cancer
    [part of Tevogen Bio Oncology forecast]
  • Treatment of SARS-CoV-2 infection in patients with other cancers
    [part of Tevogen Bio Oncology forecast]
  • SARS-CoV-2 infection in patients under treatment for rheumatoid arthritis
  • SARS-CoV-2 infection in patients under treatment for and psoriatic arthritis
  • Treatment of Long COVID [part of Tevogen Bio Specialty Care forecast]
  • SARS-CoV-2 infection in patients aged 65 and older [to be added to Tevogen Bio Specialty Care forecast]
    

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

FAQ

What is TVGN's projected revenue for the launch year of its specialty care pipeline?

Tevogen Bio projects nearly $1 billion in revenue for the launch year of its specialty care pipeline, with a five-year cumulative estimate between $18-22 billion.

How is Tevogen Bio (TVGN) expanding its TVGN 489 target population?

Tevogen Bio is expanding TVGN 489's target population to include patients aged 65 and older, in addition to its existing focus on cancer patients and those with specific conditions.

What conditions does Tevogen Bio's TVGN 489 pipeline target?

TVGN 489 targets SARS-CoV-2 infection in patients with B cell hematologic cancer, other cancers, rheumatoid arthritis, psoriatic arthritis, Long COVID, and now patients aged 65+.

Who is leading Tevogen Bio's commercial strategy?

Sadiq Khan, MBA, serves as Tevogen Bio's Chief Commercial Officer, bringing over three decades of commercial leadership experience, including from Sanofi-Aventis.

What is the new COVID variant mentioned in Tevogen Bio's announcement?

The announcement references the NB.1.8.1 variant, previously identified in China, which is believed to be more contagious and has begun appearing in U.S. cases.