10-K: Tevogen Bio Reports 2025 Annual Results, Advances Cell Therapy Pipeline

Tevogen Bio Holdings Inc. reported a net loss of $26.3 million for 2025, alongside positive Phase 1 clinical trial results for TVGN 489 and ongoing development of its ExacTcell technology.

Summary

• Reported a net loss of $26.3 million for the year ended December 31, 2025, compared to a net loss of $13.7 million in 2024.
• Cash on hand was $0.6 million as of December 31, 2025, down from $1.3 million in 2024.
• Research and development expenses decreased to $11.1 million in 2025 from $31.0 million in 2024, primarily due to lower non-cash stock-based compensation.
• General and administrative expenses decreased to $15.0 million in 2025 from $22.5 million in 2024, also driven by lower non-cash stock-based compensation and legal/professional fees.
• Adjusted loss from operations (excluding stock-based compensation) improved to $9.9 million in 2025 from $12.8 million in 2024.
• Completed a Phase 1 proof-of-concept clinical trial for TVGN 489 for high-risk adult COVID-19 patients, observing no dose-limiting toxicities or significant adverse events.
• TVGN 489 Phase 1 trial showed rapid reduction of viral load and did not prevent development of patients' own anti-COVID-19 immunity; no progression of infection, reinfection, or Long COVID reported during six-month follow-up.
• Planning a pivotal trial for TVGN 489 in COVID-19 patients with B cell malignancies, targeting the six most common HLA types (60-65% of the population).
• Launched Tevogen.AI initiative to leverage artificial intelligence for drug development, laboratory optimization, and clinical trials, with patents filed for AI algorithms.
• Secured $7.0 million in additional committed grant funding from KRHP LLC and has $18.0 million remaining available under a loan agreement with The Patel Family, LLP.
• Regained compliance with Nasdaq's minimum bid price requirement following a 1-for-50 reverse stock split effective March 6, 2026.
• Identified a material weakness in internal control over financial reporting related to an insufficient risk assessment process, though one prior material weakness was remediated.

Sentiment

Score: 6

Explanation: StockSavvy.ai views this filing as cautiously optimistic. While the company shows promising clinical data for TVGN 489 and strategic advancements in AI, the significant financial losses and ongoing need for substantial capital, coupled with internal control weaknesses and high ownership concentration, present considerable risks for investors.

Positives

• TVGN 489 Phase 1 proof-of-concept trial demonstrated a strong safety profile with no dose-limiting toxicities or significant treatment-related adverse events.
• Secondary endpoints for TVGN 489 showed rapid reduction of COVID-19 viral load and preservation of patients' natural T cell and antibody immunity.
• None of the TVGN 489 treated patients reported progression of infection, reinfection, or development of Long COVID during the six-month follow-up period, suggesting potential for prevention.
• Laboratory evidence showed persistence of infused TVGN 489 cells for at least six months after treatment, which is a significant finding in T cell therapy.
• TVGN 489 targets have shown high retention (over 95%) in studied SARS-CoV-2 variants, indicating less susceptibility to viral mutations compared to monoclonal antibodies.
• The company has a pipeline of product candidates beyond TVGN 489, targeting HPV-related cancers (TVGN 920, TVGN 960), chronic hepatitis B (TVGN 116), and EBV-associated diseases like MS and lymphomas (TVGN 601, TVGN 930).
• The Tevogen.AI initiative aims to accelerate drug development and optimize processes using AI, with patents filed for AI-driven target identification.
• Adjusted loss from operations (excluding stock-based compensation) decreased from $12.8 million in 2024 to $9.9 million in 2025, indicating improved operational efficiency.
• Secured an additional $7.0 million in committed grant funding from KRHP LLC and has $18.0 million available under a loan agreement, providing liquidity for the next 12 months.
• Regained compliance with Nasdaq's minimum bid price requirement after a reverse stock split.

Negatives

• Reported a net loss of $26.3 million for 2025, an increase from $13.7 million in 2024, primarily due to the absence of a large non-cash gain from convertible promissory notes in the prior year.
• Cash on hand decreased to $0.6 million as of December 31, 2025, from $1.3 million in 2024, indicating continued cash burn.
• The company has a limited operating history, no products approved for commercial sale, and has never generated revenue from product sales.
• Will require substantial additional financing beyond current commitments to achieve business objectives and fund operations, which may not be available on acceptable terms or at all.
• Identified a material weakness in internal control over financial reporting related to an insufficient risk assessment process, which could impair the ability to produce accurate and timely financial statements.
• The company previously failed to timely file certain periodic reports with the SEC, posing risks to financing access and potential enforcement actions.
• The price of common stock and warrants has been and is likely to continue to be volatile, with a recent 1-for-50 reverse stock split implemented to maintain Nasdaq listing compliance.
• The company is highly dependent on its key personnel, and the loss of any could adversely impact objectives.
• Significant control over the company is held by executive officers, directors, and principal stockholders (81% beneficially owned, Dr. Ryan Saadi 62%), limiting influence of other shareholders.

Risks

• Limited operating history, no approved products, no product sales revenue, and a history of significant losses, with expectations of continued losses for the foreseeable future.
• Reliance on an additional $7.0 million of grant funding not yet received to meet liquidity needs.
• Requirement for substantial additional financing to achieve business objectives, which may not be available on acceptable terms or at all, potentially forcing delays or termination of development.
• The regulatory landscape for cellular therapy product candidates is rigorous, complex, uncertain, and subject to change, potentially leading to heightened scrutiny and delays.
• Limited experience designing and implementing preclinical and clinical trials, which are complex, expensive, time-consuming, and involve uncertain outcomes.
• Risk of being unable to develop, receive regulatory approval for, and commercialize product candidates.
• Potential for substantial delays and disruptions in the development of product candidates, including regulatory delays or rejections (e.g., FDA requiring additional trials before pivotal studies).
• Initial results and results of earlier trials may not be predictive of future results, and small sample sizes (like the TVGN 489 Phase 1) may be less reliable.
• Changes in product candidate manufacturing or formulation may result in additional costs or delays.
• ExacTcell technology is unproven and may not result in marketable products.
• Risk of failing to demonstrate safety and efficacy of product candidates, or identification of serious adverse or unacceptable side effects during development or post-approval.
• Difficulties in enrolling patients in clinical trials, which could delay or adversely affect development activities.
• Disruptions at government agencies (e.g., FDA) due to funding shortages or policy changes could hinder product development and commercialization.
• Commercial success depends on attaining significant market acceptance among physicians, patients, healthcare payors, and the medical community.
• Regulated biologics may be subject to biosimilar competition, potentially shortening exclusivity periods and impacting revenues.
• Incidence and prevalence of target patient populations are based on estimates and third-party sources, which may be inaccurate.
• Extensive ongoing regulatory requirements and review after regulatory approval, leading to significant additional expense and potential future difficulties.
• Inability to establish sales and marketing capabilities or enter into agreements with third parties to market and sell product candidates.
• Failure to comply with or adapt to changes in data protection, privacy, and similar laws could materially and adversely harm the business.
• Increasing use of AI could lead to liability, breaches of data security and privacy laws, or reputational damage, and the regulatory landscape for AI is immature.
• Internal computer systems, or those used by contractors, may fail or suffer security breaches.
• Coverage and reimbursement may be limited or unavailable in certain market segments, making it difficult to sell products profitably.
• Healthcare reform measures may negatively impact the ability to sell product candidates profitably.
• Risk of violating federal and state healthcare fraud and abuse laws, false claims laws, and health information privacy and security laws.
• Failure to comply with environmental, health, and safety laws and regulations.
• Manufacture of cell therapies is subject to a multitude of manufacturing risks, including contamination, equipment failure, and compliance with cGMP/GTP regulations.
• Efforts to establish manufacturing capabilities will involve significant time and expense and may not be successful.
• Dependence on third-party suppliers for key materials, with risks of loss or inability to supply adequate materials.
• Reliance on third parties to conduct preclinical studies and clinical trials, with risks of non-compliance, delays, or compromised data quality.
• Inability to obtain and maintain sufficient patent protection for product candidates or ExacTcell, allowing competitors to commercialize similar products.
• Patent protection could be reduced or eliminated for non-compliance with patent agency requirements.
• Inability to protect intellectual property rights throughout the world, especially in countries with weaker IP laws.
• Changes in patent law could diminish the value of patents in general.
• Involvement in lawsuits to protect or enforce intellectual property, which could be expensive, time-consuming, and unsuccessful.
• Issued patents covering product candidates could be found invalid or unenforceable if challenged in court.
• Third parties may initiate legal proceedings alleging infringement of their intellectual property rights.
• Others may claim an ownership interest in the company's intellectual property.
• Inability to protect the confidentiality of proprietary information, adversely affecting technology and product value.
• Claims asserting employees, consultants, or advisors have wrongfully used or disclosed alleged trade secrets of former employers.
• Inadequate protection of trademarks and trade names, hindering brand recognition.
• High dependence on key personnel, with intense competition for skilled individuals.
• Substantial competition from major pharmaceutical, specialty pharmaceutical, and biotechnology companies, as well as academic institutions and AI technology companies.
• Need to grow the size of the organization, which may lead to difficulties in managing growth.
• Failure to realize the benefits of any acquisitions, strategic alliances, or similar arrangements.
• Product liability lawsuits could cause substantial liabilities and limit commercialization.
• Ability to use net operating loss carryforwards may be subject to limitations due to ownership changes.
• Volatility in the price of common stock and warrants, with potential for significant fluctuations.
• Risk of delisting from Nasdaq if continued listing requirements are not met.
• Potential future delays in filing periodic reports with the SEC, impairing access to financing and potentially leading to enforcement action.
• May not have funds necessary to satisfy future obligations under preferred stock terms, creating uncertainty regarding capital raising and liquidity.
• Increased costs and management time devoted to compliance initiatives and corporate governance as a public company.
• Potential issuance of additional shares of common stock or other equity securities without shareholder approval, leading to dilution.
• As an emerging growth company and smaller reporting company, certain exemptions from disclosure requirements may make securities less attractive to investors.
• Management team has limited experience managing a public company.
• Lack of or adverse changes in research coverage by securities or industry analysts.
• Risk of securities litigation or stockholder activism.
• Potential for write-downs, write-offs, restructuring, or impairment charges.
• Material weaknesses in internal control over financial reporting could impair the ability to produce accurate and timely financial statements.

Future Outlook

The company plans to advance the clinical development of TVGN 489 for COVID-19 and Long COVID, including launching a pivotal trial in COVID-19 patients with B cell malignancies. It also intends to leverage its ExacTcell technology for additional indications in virology, oncology, and other conditions, and to develop manufacturing capabilities, potentially through acquisitions. The Tevogen.AI initiative will continue to explore AI-powered target detection and optimization of drug development. The company expects to incur significant expenses and operating losses for the foreseeable future as it progresses product candidates through development and prepares for potential commercialization.

Management Comments

• We believe that sustainability and commercial success in the forthcoming era of medicine will rely on ensuring patient accessibility through advanced science, innovative business models and engagement throughout various stages of the drug development and commercialization lifecycle.
• We believe the full potential of T cell therapies remains largely untapped, and aspire to be the first biotechnology company offering commercially attractive, economically viable, and cost-effective personalized T cell therapies.
• Our confidence in ExacTcell is reflected in our development pipeline, which has been carefully tailored to address the unmet needs of patient populations grappling with life-threatening viral diseases, cancers, and other disorders.
• We believe these findings validate our initiative to develop off-the-shelf T cell therapies for outpatient administration, targeting diseases that affect large patient populations for the very first time.
• We believe that TVGN 489 targets are less susceptible to viral mutations due to their small size than monoclonal antibody targets and less susceptible to drug resistance than antivirals.
• We believe our proprietary approach to manufacturing TVGN 489 may allow us to monitor the sequences of emerging variants and, if necessary, to proactively adjust or fine tune our products to ensure that they continue to recognize and treat current and future variants of this and other viruses.
• We believe based on precedential industry examples, including in areas with high unmet needs or strong early phase clinical trial results, that we may be able to commence pivotal trials of TVGN 489 on the basis of the results of our completed Phase 1 trial.
• We believe that the safety and the clinical benefit data from our completed Phase 1 clinical trial in ambulatory, high-risk adult patients should be sufficient to serve as the basis for later-stage and potentially pivotal trials in these patient groups as well as for the prevention of Long COVID.
• We believe that our ExacTcell approach also presents a novel and highly specific technique to combating virally induced cancers with T cell therapy.
• We believe that our approach has the potential to eventually bring the benefits of cell therapies to first-line options in oncology, as well as to create products that may overcome current limitations of checkpoint inhibitors.
• We believe that our cash balance, net proceeds of $0.9 million received pursuant to the Sales Agreement subsequent to December 31, 2025, amounts available under the Loan Agreement, which allows us to draw down term loans of $1.0 million per month over the remaining 18 months of the draw period, and the remaining commitment for a $7.0 million grant from KRHP will allow us to have adequate cash and financial resources to operate for at least the next 12 months from the date of issuance of our consolidated financial statements.

Industry Context

StockSavvy.ai notes that Tevogen Bio operates in the highly competitive and rapidly evolving cell therapy sector, characterized by significant R&D investment and intellectual property pursuit. The company's focus on 'off-the-shelf' allogeneic T cell therapies, particularly for infectious diseases like COVID-19 and various cancers, positions it against both established pharmaceutical giants and emerging biotech firms. The emphasis on genetically unmodified CD8+ CTLs and the ExacTcell technology represents a differentiated approach compared to genetically engineered CAR-T platforms, which have faced recent safety concerns (e.g., FDA's black box warning for T-cell malignancies). The Tevogen.AI initiative aligns with a broader industry trend of leveraging artificial intelligence to accelerate drug discovery and development, a critical area for efficiency and innovation in biotech.

Comparison to Industry Standards

• Tevogen's TVGN 489, an allogeneic, off-the-shelf T cell therapy, contrasts with autologous CAR-T platforms (e.g., Novartis' Kymriah, Gilead's Yescarta) which use a patient's own genetically modified cells, often requiring lengthy manufacturing and pre-infusion chemotherapy, and are associated with severe adverse events like cytokine release syndrome and neurotoxicity, as well as recent FDA black box warnings for T-cell malignancies.
• Unlike most monoclonal antibodies (e.g., those previously granted EUAs for COVID-19, many of which were withdrawn due to viral mutations), TVGN 489 targets multiple precise peptides across the SARS-CoV-2 genome, demonstrating over 95% target retention against variants through March 2026, suggesting greater durability against viral evolution.
• Compared to existing antiviral agents for COVID-19 like Pfizer's Paxlovid (nirmatrelvir with ritonavir) and Gilead's Veklury (remdesivir), TVGN 489 aims to address unmet needs in immunocompromised and high-risk elderly patients, where current antivirals have limitations (e.g., Paxlovid's drug-drug interactions and rebound effect, Remdesivir's intravenous administration requirement).
• Tevogen's approach of using naturally occurring, genetically unmodified CTLs from healthy donors aims to avoid the high incidence of adverse events seen with CAR-T platforms, a claim supported by the Phase 1 trial's safety data.
• The company's ability to produce hundreds of doses from a single donor for off-the-shelf use contrasts with the individualized, time-consuming manufacturing of autologous CAR-T therapies, potentially offering faster administration and lower costs.
• In the virus-specific T cell therapy space, Tevogen competes with companies like Atara Biotherapeutics (Ebvallo, ATA188) and AlloVir (formerly focused on viral diseases). Atara's Ebvallo received European approval for EBV-related cancer but was declined by the FDA in the U.S. in January 2026. Atara also paused development of ATA188 for MS after a Phase 2 trial failed efficacy endpoints, highlighting the challenges in this field. Tevogen's multi-target approach for EBV (TVGN 601, TVGN 930) and single HLA specificity for precise dosage control differentiate it from ATA188's broader HLA allele targeting.
• AlloVir, which merged with Kalaris Therapeutics, Inc., previously conducted a Phase 1b trial for an allogeneic COVID-19 product but did not continue clinical development, with one patient experiencing recurrence and death, underscoring the high risks in this therapeutic area.

Corporate Governance

Legal Proceedings

• Not currently a party to any material pending legal proceedings.

Related Party Transactions

• The Patel Family, LLP is an investor in Series A, Series A-1 (committed), and Series C Preferred Stock, and is the lender for an unsecured line of credit facility of up to $36.0 million.
• KRHP LLC, an affiliate of The Patel Family, LLP, provided grants of $2.0 million and $1.0 million in January and August 2025, respectively, and committed an additional $7.0 million in grant funding.
• Dr. Ryan Saadi, Chief Executive Officer, provided a capital contribution of $500,000 on June 30, 2025.
• Dr. Manmohan Patel of The Patel Family LLP was granted 120,000 RSUs in December 2024 for advisory services.
• The wife of the CEO and Mehtaphoric Consulting Inc. (controlled by the CFO's daughter) received Performance-Based RSUs in January 2023 for advisory and IT services, with compensation cost recognized in 2024 upon achievement of the performance condition.

Stakeholder Impact

• **Shareholders**: Potential for significant dilution from future equity offerings and conversion of preferred stock/warrants. High ownership concentration by insiders (81%) limits influence of other shareholders. Volatility in stock price and risk of delisting from Nasdaq are concerns. Positive clinical data and strategic initiatives could drive long-term value if successful.
• **Patients**: Potential for novel, off-the-shelf T cell therapies for unmet needs in infectious diseases (COVID-19, Long COVID, Hepatitis B), cancers (HPV-related, EBV-associated lymphomas), and neurological disorders (MS). The safety profile of TVGN 489 in Phase 1 is encouraging.
• **Employees**: Continued investment in R&D and expansion plans suggest potential for growth and hiring. Stock-based compensation is a key element of retention strategy. However, the company's financial position and need for additional capital could pose risks to job security if funding is not secured.
• **Creditors**: The company has significant accounts payable and accrued expenses. While management believes it has sufficient liquidity for 12 months, reliance on future funding and the default on notes payable to Polar Multi-Strategy Master Fund (though non-cash) indicate financial risk.
• **Regulatory Bodies**: The company is subject to rigorous and evolving regulatory scrutiny, particularly for novel cell therapies and AI use. Compliance with FDA, cGMP, and data integrity requirements is critical for product approval and commercialization.

Next Steps

• Launch a pivotal trial of TVGN 489 in COVID-19 patients with B cell malignancies, treating patients with the six most common HLA types.
• Consider a Phase 2 treatment trial examining the safety and efficacy of TVGN 489 in individuals with Long COVID.
• Continue leveraging ExacTcell technology to develop therapies for additional indications in virology, oncology, and other conditions (e.g., HPV-related diseases, chronic hepatitis B, EBV-associated lymphomas and MS).
• Continue investigative work to identify effective peptide targets for HPV and EBV.
• Develop manufacturing capabilities for clinical and commercial supply, potentially through acquiring or constructing a manufacturing and R&D facility.
• Explore options to work with partners to augment the study and treatment of patients and the impact of product candidates.
• Pursue strategic alliances, collaborations, and business combinations, including a letter of intent to acquire a greater than 50% economic ownership stake in a company with a CRO.
• Continue to deploy artificial intelligence-powered target detection to accelerate product development pace through the Tevogen.AI initiative.
• Continue curating a highly refined dataset across 14 isolates to train future machine learning and predictive artificial intelligence foundational models.
• Create an interface called PredicTcell to suggest viable T cell receptor designs.
• Seek FDA's Regenerative Medicine Advanced Therapy (RMAT) designation for TVGN 489.
• Address the material weakness in internal control over financial reporting by potentially hiring additional accounting personnel and enhancing risk assessment procedures.

Key Dates

Recommendation

Tevogen Bio presents a high-risk, high-reward investment profile. The positive Phase 1 clinical data for TVGN 489, particularly its safety and potential efficacy against COVID-19 and Long COVID, coupled with a promising pipeline and strategic AI initiatives, offers significant long-term upside. However, the company remains pre-revenue, heavily reliant on external financing, and faces substantial execution risks in clinical development, manufacturing scale-up, and regulatory approval. The increased net loss (though due to non-cash accounting), tight cash position, and identified material weakness in internal controls warrant caution. A 'hold' recommendation acknowledges the compelling scientific potential while recognizing the significant financial and operational hurdles that must be overcome before a clear path to profitability is established. Investors should monitor progress on pivotal trials, manufacturing capabilities, and capital raises closely.

Keywords

Tevogen Bio, TVGN, Cell Therapy, Immunotherapy, CD8+ CTLs, Off-the-shelf, Allogeneic T cell therapy, ExacTcell, COVID-19 treatment, Long COVID, Cancer therapy, Infectious diseases, Biotechnology, Clinical-stage, Phase 1 trial, Pivotal trial, SARS-CoV-2, HLA-A*02:01, Tevogen.AI, Artificial Intelligence in biotech, Drug development, Biologics, FDA approval, RMAT designation, Intellectual property, Patents, Nasdaq listing, Financial reporting, Internal controls, Capital raise, Patel Family, KRHP LLC