Tevogen Bio Reports Nasdaq Listing Compliance as CEO Reaffirms His Commitment in Bridging the Information Gap About the Company

Rhea-AI Summary

Tevogen Bio (Nasdaq: TVGN) has regained compliance with Nasdaq's minimum bid price requirement without implementing a reverse stock split. The company maintained a closing bid price above $1.00 for 10 consecutive trading days, reaching $3.05 on October 25, 2024. CEO Ryan Saadi emphasized the company's commitment to preserving shareholder value through efficient financing strategies.

The clinical-stage biotech, developing off-the-shelf T cell therapeutics, forecasts $1 billion in oncology revenue for 2026 launch year, with a 5-year estimate of $10-14 billion. Their Specialty Care division projects similar launch year revenue with a 5-year estimate of $18-22 billion. The company recently joined Microsoft for Startups with their Tevogen.AI initiative.

Positive

• Regained Nasdaq compliance without dilutive reverse stock split
• Stock price increased from below $1.00 to $3.05
• Projected oncology revenue of $1B in 2026 launch year
• Estimated 5-year oncology revenue of $10-14B
• Projected specialty care revenue of $1B in launch year
• Estimated 5-year specialty care revenue of $18-22B
• Independent valuation of $4.2B as highest valued biotech unicorn of 2022
• Positive clinical trial results for TVGN 489 with no significant adverse events

Negative

• None.

Insights

Financial Analyst

The regaining of Nasdaq compliance without a reverse stock split is a significant achievement, demonstrating organic share price strength. The stock's rise to $3.05 from below $1.00 indicates substantial market confidence. The company's ambitious revenue forecasts of $1 billion for launch year 2026 and $10-14 billion cumulative 5-year estimate for Oncology, plus $18-22 billion for Specialty Care, warrant attention.

The $4.2 billion independent valuation as a biotech unicorn, combined with positive clinical trial results and strategic AI initiatives through Microsoft partnership, suggests strong fundamentals. However, investors should note these are forward-looking projections and actual performance may vary significantly. The focus on minimizing dilution while maintaining growth is particularly appealing for long-term shareholders.

Medical Research Analyst

The successful proof-of-concept clinical trial for TVGN 489, showing no dose-limiting toxicities and effective viral load reduction in high-risk SARS-CoV-2 patients, validates their ExacTcellTM platform technology. The expansion into HPV-related cervical lesions treatment demonstrates platform versatility. Their approach of using off-the-shelf, genetically unmodified T cell therapeutics could offer cost and manufacturing advantages over current cell therapies.

The intellectual property portfolio, including 3 granted U.S. patents and multiple pending applications, provides strong protection for their technology. The integration of AI through Tevogen.AI could potentially accelerate development timelines and reduce costs, critical factors in the competitive cell therapy landscape.

• Regained compliance without effecting a reverse stock split
• Tevogen Bio CEO reaffirms his commitment to preserve shareholder value

WARREN, N.J., Oct. 29, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech developing off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, announced today that on October 28, 2024, it received written notice from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company has regained compliance with the minimum bid price requirement (the “Minimum Bid Price Requirement”), as set forth in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Global Market.

Tevogen was notified by Nasdaq on June 14, 2024, that it was not in compliance with the Minimum Bid Price Requirement because its common stock had failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. In order to regain compliance with the Minimum Bid Price Requirement, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved during the period between October 14, 2024, to October 25, 2024. The Company’s closing price was $3.05 on October 25, 2024. Tevogen did not effect a reverse stock split of its common stock.

“Founders must navigate the need for capital to fuel growth with a vigilant eye on avoiding equity dilution. Since inception, Tevogen Bio’s financing strategy has confirmed our business philosophy of preserving shareholder value through speed and cost,” commented Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio.

Recent Announcements:

• Tevogen announces efforts on pipeline development including developing cell therapies designed to eradicate post procedure HPV in women with precancerous cervical lesions
• Tevogen Oncology top-line revenue forecast of $1 billion in launch year of 2026 and cumulative 5-year estimate between $10 billion and $14 billion
• Tevogen Specialty Care top-line revenue forecast of nearly $1 billion in launch year and cumulative 5-year estimate between $18 billion and $22 billion
• Tevogen’s artificial intelligence effort, Tevogen.AI, has joined Microsoft (Nasdaq: MSFT) for Startups

Key Achievements:

• In June of 2020, Tevogen Bio is founded and launched its proprietary ExacTcell^TM technology, designed to create accessible and disease-specific cellular immunotherapies.
• Tevogen Bio is granted 3 U.S. patents by 2022; there are currently 9 additional patents pending, including 2 for Artificial Intelligence, and 12 international applications filed.
• Tevogen Bio is recognized as the highest valued biotech unicorn of 2022, with an independent $4.2 billion valuation.
• By 2023, positive proof-of-concept clinical trial results are announced for TVGN 489, Tevogen Bio’s allogeneic CD8+ T cell therapy for high-risk SARS-CoV-2 patients. No dose-limiting toxicities or significant adverse events were reported, and secondary endpoints show rapid reduction of viral load, highlighting the potential of the therapy.
• Tevogen.AI is introduced to create artificial intelligence solutions for greater patient accessibility and quicker innovation while decreasing operating cost. Recently, Tevogen.AI has joined the Microsoft for Startups program gaining access to experts and resources from a world-leading AI company.
• On February 15, 2024, Tevogen Bio celebrates its public debut by ringing the Nasdaq Opening Bell, marking its first day of trading on the public market.
• Tevogen Bio is now included in the Russell 3000® Index, reflecting its growing presence and impact in the biotech industry.
  

About Tevogen Bio

Tevogen is a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders, aiming to address the significant unmet needs of large patient populations. Tevogen Leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents, nine pending US and twelve ex-US pending patents, two of which are related to artificial intelligence.

Tevogen is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen’s leadership believes that accessible personalized therapeutics are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation.

Forward Looking Statements

This press release contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen’s ability to develop additional product candidates, including through use of Tevogen’s ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen’s future clinical trials; and Tevogen’s ability to generate revenue in the future. 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; the effect of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”) on Tevogen’s business relationships, operating results, and business generally; the outcome of any legal proceedings that may be instituted against Tevogen; 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; costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; 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; the ability to develop, license or acquire new therapeutics; that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; 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 and subsequent filings with the SEC.

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 was Tevogen Bio's (TVGNW) stock price on October 25, 2024?

Tevogen Bio's closing stock price was $3.05 on October 25, 2024.

How did Tevogen Bio (TVGNW) regain Nasdaq compliance in October 2024?

Tevogen Bio maintained a minimum closing bid price of $1.00 or more for 10 consecutive trading days between October 14-25, 2024, without implementing a reverse stock split.

What are Tevogen Bio's (TVGNW) revenue projections for 2026?

Tevogen Bio projects $1 billion in oncology revenue and nearly $1 billion in specialty care revenue for the 2026 launch year.

When did Tevogen Bio (TVGNW) start trading on Nasdaq?

Tevogen Bio began trading on Nasdaq on February 15, 2024, marked by ringing the Nasdaq Opening Bell.