Tevogen Bio Announces Full Year 2023 Financial Results and Upcoming Operational Objectives

Rhea-AI Summary

Tevogen Bio announced its full-year 2023 financial results, highlighted its ExacTcell platform success, and upcoming operational objectives. The company aims to acquire a cell therapy manufacturing facility, expand clinical trials, and address Long COVID treatment. Tevogen Bio reported positive POC results for TVGN 489, showcasing safety and efficacy. The company is in discussions to secure manufacturing facilities, bolster research and development capabilities, and seek FDA approval for new clinical trials. Tevogen Bio is evaluating funding options to support growth plans, emphasizing favorable financing terms and equity control. Operating expenses for 2023 were $8.8 million, with significant liabilities converted to common stock.

Positive

• Tevogen Bio announced successful completion of the ExacTcell platform for additional clinical trials, highlighting positive POC results for TVGN 489 with no adverse events observed.

• The company aims to acquire cell therapy manufacturing facilities, enhance research and development capabilities, and innovate new product development hubs.

• Tevogen Bio is exploring funding options to support ambitious growth plans, including in-house manufacturing, clinical trials, and operational expenses.

Negative

• Operating expenses for Tevogen Bio Inc in 2023 were $8.8 million, indicating significant financial outlay.

• Despite positive clinical trial results, potential risks and challenges in securing FDA approval for new clinical trials may persist.

• While Tevogen Bio secured favorable financing terms and equity control, further funding challenges and dilution risks may arise with aggressive growth plans.

Insights

Financial Analyst

Reviewing Tevogen Bio's financial results reveals a strategic positioning that is likely to intrigue investors with an eye for the biotech space. The operating expenses totaled $8.8 million for the full year 2023, a figure that merits consideration given the company's clinical-stage nature and its investment into R&D and potential manufacturing facilities. The conversion of promissory notes into common stock, reducing pro forma balance sheet liabilities by $94.9 million, significantly strengthens the company's financial structure and underlines a proactive management approach to capitalization. This move, coupled with favorable financing terms mentioned, suggests a robust financial strategy that could provide leverage in negotiating future funding. It's essential, however, for investors to gauge the burn rate against the clinical development timelines and potential revenues from the ExacTcell platform, considering how liquidity will support the transition from research to potential revenue generation.

Medical Research Analyst

Tevogen’s commitment to advancing its ExacTcell technology is notable, focusing on unmet medical needs like Long COVID, which remain a concern despite the pandemic's trajectory. The platform's design, targeting antigens exclusive to diseased cells, potentially offers an advantage over CAR T therapies, traditionally more invasive and costly. The scalability hinted at by the expected yield of hundreds of doses per lot could disrupt the economics of cell therapy, previously hindered by high costs and complex logistics. Investors will do well to monitor the FDA approval process and subsequent clinical trial designs, as these developments are important indicators of the therapy's viability and market potential. The focus on ambulatory settings for administering their therapies could signal a strategic thrust towards greater patient accessibility and market penetration.

Market Research Analyst

Tevogen's potential expansion into in-house manufacturing capabilities signifies a move towards vertical integration, which may offer long-term cost efficiencies and agility in drug supply chains—a vital consideration in the biotechnology field. As Tevogen eyes manufacturing facilities with clinical and commercial capabilities, it is positioning itself not just for the current clinical trials but also for prospective market demands for its therapies. The biotech market often rewards companies that streamline operations and reduce dependency on third parties, which this acquisition could achieve. Furthermore, positive POC clinical trial results contribute to the company's credibility and may boost investor confidence. Yet, it is essential for investors to be aware of the risk associated with expansion and to assess the potential return on investment against the sizable upfront and ongoing operational costs associated with manufacturing facilities.

• Acquire cell therapy manufacturing facility with clinical and commercial capabilities
  
• Further ExacTcell platform for additional clinical trials based on successful completion of POC
• Highlight full year financial results and clarify key financial items
  

WARREN, N.J., May 01, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings Inc. (“Tevogen” or “Tevogen Bio”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, announced financial results for full year 2023, business highlights, and upcoming operational objectives.

“Saving lives remains our duty, and to that end, we remain committed to furthering our ExacTcell™ technology platform by moving Tevogen’s allogeneic cytotoxic CD8+ T lymphocytes (CTLs) into the next phase of clinical trials” said Dr. Ryan Saadi, Founder and Chief Executive Officer of Tevogen Bio. “Moving the first clinical product of Tevogen’s ExacTcell platform, an allogeneic target specific CTL, from inception to clinical trial in just 18 months validates Tevogen’s unique business model. I would also like to assure numerous Long COVID patients and their families who have contacted us that exploring the therapeutic potential of TVGN 489 for Long COVID remains my personal priority.” 

Tevogen Bio is in discussions to acquire cell therapy manufacturing facilities that are expected to provide Tevogen Bio with the capability for both clinical and commercial manufacturing of drug candidates from its ExacTcell technology platform. These facilities would support manufacturing for TVGN 489’s continued development, as well as provide the potential for future clinical trials for virally induced cancers and multiple sclerosis. In addition to manufacturing capability, these facilities are also expected to enhance Tevogen Bio’s research and development capabilities and serve as new product innovation hubs.

In January, Tevogen Bio announced positive POC clinical trial results for TVGN 489 for treatment of high-risk patients. The primary study endpoints were related to safety and there were no dose-limiting toxicities or significant adverse events related to TVGN 489 observed in any patient at any of the four dose levels. Unlike CAR T platforms, Tevogen Bio’s ExacTcell platform targets antigens present only on diseased cells and is designed for an ambulatory setting. The expected yield per lot is in hundreds of doses, providing pricing flexibility for greater access.

“Patients who are immune compromised continue to need novel treatments for COVID-19. We have completed the design of a new clinical trial of TVGN 489 to address the unmet need of this population. The manufacturing facilities are expected to support our application for FDA approval and expedite the commencement of that trial” said Lori Grosso, Clinical Development Lead of Tevogen Bio.

Tevogen Bio is evaluating several funding options to support its ambitious growth plans over the next 12 months to initiate in-house manufacturing, clinical trials, and other operational expenses. “Tevogen finds itself in a unique position by achieving clinical success while retaining equity control by executive management. In addition, it’s atypical for a start up to have received such company-favorable financing terms as Tevogen has. We will explore funding options that are similarly favorable” said Tapan Shah, Head of Investor Relations and Corporate Development of Tevogen Bio.

For full year 2023, the operating expenses for Tevogen Bio Inc were $8.8 million. As previously announced, as of December 31, 2023, the conversion of promissory notes into common stock removed $94.9 million in pro forma balance sheet liabilities; the remaining pro forma total liabilities were $5.4 million.

Tevogen Bio SEC Filings

Form 8-K/A (Current Report filed April 29, 2024)

Form 10-K (Annual Report filed April 29, 2024)

About Tevogen Bio

Tevogen Bio 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 and twelve pending patents, two of which are related to artificial intelligence.

Tevogen Bio is driven by a team of highly experienced industry leaders and distinguished scientists with drug development and global product launch experience. Tevogen Bio’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: 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, Tevogen’s manufacturing plans, Tevogen’s future financing and the terms thereof, and Tevogen’s ability to commercialize products in the future. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “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.

These factors include, but are not limited to: (i) 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; (ii) the challenges in negotiating and completing the acquisition of manufacturing facilities, and the risk that the Company may not be able to complete the acquisition of manufacturing facilities; (iii) that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; (iv) the outcome of any legal proceedings that may be instituted against Tevogen related to the Business Combination; (v) changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; (vi) the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; (vii) the risk that Tevogen may not be able to develop and maintain effective internal controls; (viii) costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; (ix) 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, (ix) the ability of Tevogen to grow and manage growth economically and hire and retain key employees; (x) 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; (xi) the ability to develop, license or acquire new therapeutics; (xii) the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; (xiii) uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; (xiv) risks related to regulatory review, and approval and commercial development; (xv) risks associated with intellectual property protection; (xvi) Tevogen’s limited operating history; and (xvii) those factors discussed in Tevogen’s filings with the SEC, including 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 were the operating expenses for Tevogen Bio Inc in 2023?

Operating expenses for Tevogen Bio Inc in 2023 were $8.8 million.

What positive results were reported for TVGN 489 in clinical trials?

Positive POC results for TVGN 489 were reported in clinical trials, showing safety and efficacy with no adverse events at any dose level.

What upcoming objectives did Tevogen Bio announce?

Tevogen Bio announced plans to acquire cell therapy manufacturing facilities, expand clinical trials, and address Long COVID treatment.

How is Tevogen Bio planning to support its growth plans?

Tevogen Bio is evaluating funding options to support its growth plans, including in-house manufacturing, clinical trials, and operational expenses.

What financial liabilities were converted to common stock for Tevogen Bio?

As of December 31, 2023, $94.9 million in pro forma balance sheet liabilities were converted to common stock for Tevogen Bio.