10q10k10q10k.net

What changed in Tevogen Bio Holdings Inc.'s 10-K — 2024 vs 2025

vs

Paragraph-level year-over-year comparison of Tevogen Bio Holdings Inc.'s 2024 and 2025 10-K annual filings, covering the Business, Risk Factors, Legal Proceedings, Cybersecurity, MD&A and Market Risk sections. Every new, removed and edited paragraph is highlighted side-by-side so you can see exactly what management changed in the 2025 report.

+327 added−261 removedSource: 10-K (2025-12-31) vs 10-K (2024-12-31)

Top changes in Tevogen Bio Holdings Inc.'s 2025 10-K

327 paragraphs added · 261 removed · 241 edited across 6 sections

Item 1. Business

Business — how the company describes what it does

122 edited+17 added−10 removed303 unchanged
Biggest changeAt this stage, however, we cannot be certain whether we will be permitted to move from a Phase 1 trial directly to a pivotal trial until FDA reviews and concurs with or rejects our proposed plans, and FDA may require us to conduct further trials to generate additional safety and efficacy data.
Biggest changeAt this stage, however, we cannot be certain whether we will be permitted to move from a Phase 1 trial directly to a pivotal trial until FDA reviews and concurs with or rejects our proposed plans, and FDA may require us to conduct further trials to generate additional safety and efficacy data. 19 As development of TVGN 489 continues, we may also seek FDA’s RMAT designation for TVGN 489, which as explained in “Regulatory Environment - Expedited Development and Review Programs” below, is intended to facilitate efficient development and expedited review or potentially, the FDA Commissioner’s National Priority Voucher pilot program, which the FDA is exploring as a pathway to reduce review times, even as compared to other priority review programs, for candidates meeting certain criteria.
These actions could include the suspension or termination of clinical trials by FDA, FDA’s refusal to approve pending applications or supplemental applications, suspension or withdrawal of an approval, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by FDA, the Department of Justice (“DOJ”), and other governmental entities. 25 An applicant seeking approval to market and distribute a biologic in the United States must typically undertake the following: ● completion of non-clinical laboratory tests and studies performed in accordance with FDA’s Good Laboratory Practice (“GLP”) regulations; ● manufacture, labeling and distribution of investigational drugs in compliance with FDA’s current Good Manufacturing Practice (“cGMP”) requirements; ● submission to FDA of an Investigational New Drug application (“IND”), which must become effective before clinical trials may begin and must be updated annually and when significant changes are made; ● approval by an Investigational Review Board (“IRB”) for each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practice (“GCP”) requirements to establish the safety, purity, and potency of the proposed biological product candidate for its intended purpose; ● after completion of all pivotal clinical trials, preparation of and submission to FDA of a Biologics License Application (“BLA”) requesting marketing approval, which includes providing sufficient evidence to establish the efficacy, safety, purity, and potency of the proposed biological product for its intended use, including from results of nonclinical testing and clinical trials; ● satisfactory completion of an FDA advisory committee review, when appropriate, as may be requested by FDA to assist with its review; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or certain components thereof, are produced to assess compliance with cGMP and data integrity requirements to assure that the facilities, methods, and controls are adequate to preserve the biological product’s identity, strength, quality, and purity and, if applicable, FDA’s Good Tissue practice (“GTP”) requirements for certain human cellular and tissue products; ● satisfactory completion of FDA inspections of selected clinical investigation sites to assure compliance with GCP requirements and the integrity of the clinical data; ● satisfactory completion of an FDA sponsor GCP inspection, often conducted at the applicant’s headquarters facility; ● payment of user fees (unless there is a waiver, exemption, or reduction) under the Prescription Drug User Fee Act (“PDUFA”) for the relevant year; ● FDA’s review and approval of the BLA to permit commercial marketing of the licensed biologic for particular indications for use in the United States; and ● compliance with post-approval requirements, including the potential requirements to implement a Risk Evaluation and Mitigation Strategies (“REMS”), to report adverse events and biological product deviations, and to complete any post-approval studies such as confirmatory trials or pediatric studies.
These actions could include the suspension or termination of clinical trials by FDA, FDA’s refusal to approve pending applications or supplemental applications, suspension or withdrawal of an approval, issuance of warning or untitled letters, product recalls, product seizures, total or partial suspension of production or distribution, import detention, injunctions, fines, refusals of government contracts, restitution, disgorgement of profits, or civil or criminal investigations and penalties brought by FDA, the Department of Justice (“DOJ”), and other governmental entities. 26 An applicant seeking approval to market and distribute a biologic in the United States must typically undertake the following: ● completion of non-clinical laboratory tests and studies performed in accordance with FDA’s Good Laboratory Practice (“GLP”) regulations; ● manufacture, labeling and distribution of investigational drugs in compliance with FDA’s current Good Manufacturing Practice (“cGMP”) requirements; ● submission to FDA of an Investigational New Drug application (“IND”), which must become effective before clinical trials may begin and must be updated annually and when significant changes are made; ● approval by an Investigational Review Board (“IRB”) for each clinical site before each clinical trial may be initiated; ● performance of adequate and well-controlled human clinical trials in accordance with FDA’s Good Clinical Practice (“GCP”) requirements to establish the safety, purity, and potency of the proposed biological product candidate for its intended purpose; ● after completion of all pivotal clinical trials, preparation of and submission to FDA of a Biologics License Application (“BLA”) requesting marketing approval, which includes providing sufficient evidence to establish the efficacy, safety, purity, and potency of the proposed biological product for its intended use, including from results of nonclinical testing and clinical trials; ● satisfactory completion of an FDA advisory committee review, when appropriate, as may be requested by FDA to assist with its review; ● satisfactory completion of one or more FDA inspections of the manufacturing facility or facilities at which the proposed product, or certain components thereof, are produced to assess compliance with cGMP and data integrity requirements to assure that the facilities, methods, and controls are adequate to preserve the biological product’s identity, strength, quality, and purity and, if applicable, FDA’s Good Tissue practice (“GTP”) requirements for certain human cellular and tissue products; ● satisfactory completion of FDA inspections of selected clinical investigation sites to assure compliance with GCP requirements and the integrity of the clinical data; ● satisfactory completion of an FDA sponsor GCP inspection, often conducted at the applicant’s headquarters facility; ● payment of user fees (unless there is a waiver, exemption, or reduction) under the Prescription Drug User Fee Act (“PDUFA”) for the relevant year; ● FDA’s review and approval of the BLA to permit commercial marketing of the licensed biologic for particular indications for use in the United States; and ● compliance with post-approval requirements, including the potential requirements to implement a Risk Evaluation and Mitigation Strategies (“REMS”), to report adverse events and biological product deviations, and to complete any post-approval studies such as confirmatory trials or pediatric studies.
T-cells, in contrast, recognize small peptide breakdown products of proteins and are only affected if the mutation is directly within the target peptide. More broadly, known companies developing virus-specific T cell therapies include Atara Biotherapeutics (“Atara Bio”), whose Ebvallo (tabelecleucel) has received approval in Europe for treating a rare hematologic cancer caused by EBV. AlloVir, Inc.
T-cells, in contrast, recognize small peptide breakdown products of proteins and are only affected if the mutation is directly within the target peptide. More broadly, known companies developing virus-specific T cell therapies include Atara Biotherapeutics, Inc. (“Atara Bio”), whose Ebvallo (tabelecleucel) has received approval in Europe for treating a rare hematologic cancer caused by EBV.
TVGN 489 cells are derived from healthy donors who recovered from a prior COVID-19 infection, and TVGN 489 is active against multiple, precise targets spread across the SARS-CoV-2 genome. 11 In January 2023, we completed a Phase 1 proof-of-concept trial of TVGN 489 for the treatment of ambulatory high-risk adult COVID-19 patients.
TVGN 489 cells are derived from healthy donors who recovered from a prior COVID-19 infection, and TVGN 489 is active against multiple, precise targets spread across the SARS-CoV-2 genome. In January 2023, we completed a Phase 1 proof-of-concept trial of TVGN 489 for the treatment of ambulatory high-risk adult COVID-19 patients.
Our efforts to develop manufacturing capability are currently focused on finding a manufacturing and research and development facility, including through collaboration with a potential facility development partner. 20 Our Commercialization Plans If approved, we plan to globally commercialize TVGN 489 and our other product candidates aimed at serving a large patient population suffering from infectious diseases, cancer, and other disorders.
Our efforts to develop manufacturing capability are currently focused on finding a manufacturing and research and development facility, including through collaboration with a potential facility development partner. Our Commercialization Plans If approved, we plan to globally commercialize TVGN 489 and our other product candidates aimed at serving a large patient population suffering from infectious diseases, cancer, and other disorders.
FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions and usually has followed such recommendations. 29 After FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its components will be produced, FDA may issue an approval letter or a Complete Response Letter (“CRL”).
FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions and usually has followed such recommendations. After FDA evaluates a BLA and conducts inspections of manufacturing facilities where the investigational product and/or its components will be produced, FDA may issue an approval letter or a Complete Response Letter (“CRL”).
Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. 33 The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.
Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to provide adequate coverage and reimbursement.
Secondary endpoints showed a rapid reduction of viral load and that infusion of TVGN 489 did not prevent the development of the patients’ own T cell-related (cellular) or antibody-related (humoral) anti-COVID-19 immunity. None of the patients reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period.
Secondary endpoints showed a rapid reduction of viral load and that infusion of TVGN 489 did not prevent the development of the patients’ own T cell-related (cellular) or antibody-related (humoral) anti-COVID-19 immunity. None of the treated patients reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period.
However, making these types of changes to TVGN 489 may require additional regulatory approvals, and there is no guarantee that we will receive such approvals. 14 TVGN 489 is also designed to be fast acting, as the cells are fully mature and crafted to be primed to act as soon as they find their way to infected cells.
However, making these types of changes to TVGN 489 may require additional regulatory approvals, and there is no guarantee that we will receive such approvals. TVGN 489 is also designed to be fast acting, as the cells are fully mature and crafted to be primed to act as soon as they find their way to infected cells.
These clinical observations were mirrored by laboratory evidence of the persistence of infused TVGN 489 cells for at least six months after treatment. 17 Persistence of infused therapeutic cells remains a significant issue in the T cell therapy space, leading to challenges in controlling viral infections, preventing viral recurrence, and managing cancer relapse.
These clinical observations were mirrored by laboratory evidence of the persistence of infused TVGN 489 cells for at least six months after treatment. Persistence of infused therapeutic cells remains a significant issue in the T cell therapy space, leading to challenges in controlling viral infections, preventing viral recurrence, and managing cancer relapse.
Saadi has also served as a Voting Member of the CMS Medicare Evidence Development & Coverage Advisory Committee, which provides independent guidance and expert advice to CMS on clinical topics. Kirti Desai has served as our Chief Financial Officer since February 2024, and served as Chief Financial Officer of Tevogen Bio beginning in June 2020. Mr.
Saadi has also served as a Voting Member of the CMS Medicare Evidence Development & Coverage Advisory Committee, which provides independent guidance and expert advice to CMS on clinical topics. 38 Kirti Desai has served as our Chief Financial Officer since February 2024, and served as Chief Financial Officer of Tevogen Bio beginning in June 2020. Mr.
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. 36 Privacy We may also be subject to federal, state, national and international laws and regulations governing the privacy and security of health-related and other personal data we collect and maintain (e.g., Section 5 of the Federal Trade Commission Act (the “FTC Act”), the California Consumer Privacy Act, as amended by the California Privacy Rights Act (the “CCPA”), and the European Union’s (“EU”) General Data Protection Regulation).
At the state level, legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. 37 Privacy We may also be subject to federal, state, national and international laws and regulations governing the privacy and security of health-related and other personal data we collect and maintain (e.g., Section 5 of the Federal Trade Commission Act (the “FTC Act”), the California Consumer Privacy Act, as amended by the California Privacy Rights Act (the “CCPA”), and the European Union’s (“EU”) General Data Protection Regulation).
We expect these circumstances to continue, which could adversely impact long-term community-level protective immunity. In addition, we believe that the expiration of the U.S. federal Public Health Emergency and U.S. government funding for COVID-19 testing, and treatment could lead to higher pricing for diagnostics and therapeutics.
We expect these circumstances to continue, which could adversely impact long-term community-level protective immunity. In addition, we believe that the expiration of the U.S. federal Public Health Emergency and U.S. government funding for COVID-19 testing, surveillance, and treatment could lead to higher pricing for diagnostics and therapeutics.
Patients on the interventional arm had a higher median number of comorbid conditions, a higher incidence of immune compromise, and a higher number of patients who were unvaccinated or failed to respond to vaccination versus patients on the observational arm. 16 Each patient in the treatment arm received a single intravenous infusion of TVGN 489 within four days of diagnosis.
Patients on the interventional arm had a higher median number of comorbid conditions, a higher incidence of immune compromise, and a higher number of patients who were unvaccinated or failed to respond to vaccination versus patients on the observational arm. Each patient in the treatment arm received a single intravenous infusion of TVGN 489 within four days of diagnosis.
In other words, observations indicate that TVGN 489 did not prevent the body from responding to the infection and generating its own CTLs and antibodies to COVID-19. All treatment arm patients reported returning to their baseline level of health without COVID-19 symptoms within 14 days of treatment.
In other words, observations indicate that TVGN 489 did not prevent the body from responding to the infection and generating its own CTLs and antibodies to COVID-19. 17 All treatment arm patients reported returning to their baseline level of health without COVID-19 symptoms within 14 days of treatment.
However, we cannot be certain whether FDA will require us to conduct a separate prevention trial until FDA reviews and concurs with or rejects our proposed plans. Recent studies have indicated that there is not an HLA class I-based predisposition to Long COVID.
However, we cannot be certain whether FDA will require us to conduct a separate prevention trial until FDA reviews and concurs with or rejects our proposed plans. Studies have indicated that there is not an HLA class I-based predisposition to Long COVID.
We believe that as with other viral infections, the availability of both a preventative strategy and a treatment strategy is important to reduce incidence and impact of disease and is investigating peptide candidates for HPV to further the development of TVGN 920 and TVGN 960.
We believe that as with other viral infections, the availability of both a preventative strategy and a treatment strategy is important to reduce incidence and impact of disease and we are investigating peptide candidates for HPV to further the development of TVGN 920 and TVGN 960.
Our confidence in ExacTcell is reflected in our development pipeline, which has been carefully tailored to address the unmet needs of large patient populations grappling with life-threatening viral diseases, cancers, and other disorders.
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.
Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life. 28 BLA Submission and Review Assuming successful completion of all required clinical testing in accordance with all applicable regulatory requirements, an applicant may submit a BLA requesting licensing to market the biologic for one or more indications in the United States.
Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the drug candidate does not undergo unacceptable deterioration over its shelf life. 29 BLA Submission and Review Assuming successful completion of all required clinical testing in accordance with all applicable regulatory requirements, an applicant may submit a BLA requesting licensing to market the biologic for one or more indications in the United States.
Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D to close the coverage gap in most Medicare drug plans, commonly referred to as the donut hole (this existing coverage gap program will be sunset by the Inflation Reduction Act beginning in 2025 and replaced with a new manufacturer discount program).
Further, the Bipartisan Budget Act of 2018, among other things, amended the ACA to increase from 50 percent to 70 percent the point-of-sale discount that is owed by pharmaceutical manufacturers who participate in Medicare Part D to close the coverage gap in most Medicare drug plans, commonly referred to as the donut hole (this existing coverage gap program is sunset by the Inflation Reduction Act beginning in 2025 and replaced with a new manufacturer discount program).
In addition, the Prescription Drug Marketing Act and its implementing regulations and state laws limit the distribution of prescription pharmaceutical product samples, and the DSCSA imposes requirements to ensure accountability in distribution and to identify and remove prescription drug and biological products that may be counterfeit, stolen, contaminated, or otherwise harmful from the market. 31 Expedited Development and Review Programs FDA offers a number of expedited development and review programs for qualifying product candidates.
In addition, the Prescription Drug Marketing Act and its implementing regulations and state laws limit the distribution of prescription pharmaceutical product samples, and the DSCSA imposes requirements to ensure accountability in distribution and to identify and remove prescription drug and biological products that may be counterfeit, stolen, contaminated, or otherwise harmful from the market. 32 Expedited Development and Review Programs FDA offers a number of expedited development and review programs for qualifying product candidates.
Commercialization of any treatments we develop will be affected by the level of competition from original and biosimilars products and the availability of reimbursement from government and other third-party payors. 23 Our ability to commercialize our proprietary cell products could be significantly and adversely affected if our competitors develop and commercialize products that are more effective, have a better safety profile, are more convenient or are less expensive than our products.
Commercialization of any treatments we develop will be affected by the level of competition from original and biosimilars products and the availability of reimbursement from government and other third-party payors. 24 Our ability to commercialize our proprietary cell products could be significantly and adversely affected if our competitors develop and commercialize products that are more effective, have a better safety profile, are more convenient or are less expensive than our products.
Treatment of these individuals is an area of unmet need that we believe TVGN 489 therapy has the opportunity to fill. These target populations also include COVID-19 patients with a non-B-cell cancer indication, elderly and infirm acute COVID-19 patients, and those with immune suppression due solid organ or hematopoietic transplantation or autoimmunity or its treatment.
Treatment of these individuals is an area of unmet need that we believe TVGN 489 therapy has the opportunity to fill. These target populations also include COVID-19 patients with a non-B-cell cancer indication, elderly and infirm acute COVID-19 patients, and those with immune suppression due to solid organ or hematopoietic transplantation or autoimmunity or treatment of these conditions.
Khan also acted as Founder and Chief Strategist for Pharmique Health LLC, where he advised corporations on strategic commercial planning and other matters. Previously, Mr. Khan co-founded Tegelix Therapeutics, a now-defunct pharmaceutical company, and held various regional and global commercialization and alliance management roles at Hoechst Marion Roussel, Aventis, and then Sanofi-Aventis. 38
Khan also acted as Founder and Chief Strategist for Pharmique Health LLC, where he advised corporations on strategic commercial planning and other matters. Previously, Mr. Khan co-founded Tegelix Therapeutics, a now-defunct pharmaceutical company, and held various regional and global commercialization and alliance management roles at Hoechst Marion Roussel, Aventis, and then Sanofi-Aventis. 39
In our Phase 1 clinical trial for TVGN 489, following infusion, peripheral blood of five patients was collected at various timepoints throughout the six-month follow-up period. These samples were sent to Adaptive Biotechnologies (“Adaptive”) to evaluate the persistence of infused TVGN 489 in the patients following treatment, and Adaptive conducted analyses by sequencing protein chains of TCRs in the samples.
In our Phase 1 clinical trial for TVGN 489, following infusion, peripheral blood of six patients was collected at various timepoints throughout the follow-up period. These samples were sent to Adaptive Biotechnologies (“Adaptive”) to evaluate the persistence of infused TVGN 489 in the patients following treatment, and Adaptive conducted analyses by sequencing protein chains of TCRs in the samples.
It is impossible to predict whether further legislative changes will be enacted or whether FDA regulations, guidance, policies, or interpretations will change, and the effects of any such changes. 26 Preclinical and Clinical Development Before an applicant can begin testing the potential product candidate in human subjects, the applicant must first conduct preclinical studies.
It is impossible to predict whether further legislative changes will be enacted or whether FDA regulations, guidance, policies, or interpretations will change, and the effects of any such changes. 27 Preclinical and Clinical Development Before an applicant can begin testing the potential product candidate in human subjects, the applicant must first conduct preclinical studies.
CD8+ T cells work in conjunction with HLA-class I molecules, and CD4+ T cells work in conjunction with HLA-class II molecules. Currently available cell-based immunotherapy approaches include genetically unmodified T cells applied to the treatment of viruses early after transplant and genetically modified chimeric antigen receptor (“CAR”) T cells used to treat a selected subset of malignancies.
CD8+ T cells work in conjunction with HLA-class I molecules, and CD4+ T cells work in conjunction with HLA-class II molecules. 9 Currently available allogeneic cell-based immunotherapy approaches include genetically unmodified T cells applied to the treatment of viruses early after transplant and genetically modified chimeric antigen receptor (“CAR”) T cells used to treat a selected subset of malignancies.
These treatments may also require lifelong monitoring for the development and treatment of infections due to eradication of normal parts of the immune system along with the cancer. In November 2023, FDA announced that it had “received reports of T-cell malignancies” in patients who received certain autologous CAR T cell immunotherapies.
These treatments may also require lifelong monitoring for the development and treatment of infections due to eradication of normal parts of the immune system along with the cancer. 10 In November 2023, FDA announced that it had “received reports of T-cell malignancies” in patients who received certain CAR T cell immunotherapies.
The IRA also creates a drug price negotiation program under which the prices for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026.
The IRA also created a drug price negotiation program under which the prices for Medicare units of certain high Medicare spend drugs and biologicals without generic or biosimilar competition will be capped by reference to, among other things, a specified non-federal average manufacturer price starting in 2026.
A Phase 2 treatment trial examining the safety and efficacy of TVGN 489 in individuals with Long COVID is currently under development. ● Leveraging our ExacTcell technology to develop therapies for additional indications . In addition to TVGN 489, we are leveraging our ExacTcell technology to advance product candidates in virology, oncology, and other conditions.
A Phase 2 treatment trial examining the safety and efficacy of TVGN 489 in individuals with Long COVID is currently under consideration. ● Leveraging our ExacTcell technology to develop therapies for additional indications . In addition to TVGN 489, we are leveraging our ExacTcell technology to advance product candidates in virology, oncology, and other conditions.
Interim patent extensions are not available for a product candidate for which a BLA has not been submitted. 32 Biosimilars and Marketing Exclusivities The BPCIA created an abbreviated approval pathway for biological product candidates shown to be highly similar to or interchangeable with an FDA licensed biological product.
Interim patent extensions are not available for a product candidate for which a BLA has not been submitted. 33 Biosimilars and Marketing Exclusivities The BPCIA created an abbreviated approval pathway for biological product candidates shown to be highly similar to or interchangeable with an FDA licensed biological product.
In addition, the IRA establishes a Medicare Part B inflation rebate scheme effective January 2023 and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.
In addition, the IRA established a Medicare Part B inflation rebate scheme effective January 2023 and a Medicare Part D inflation rebate scheme effective October 2022, under which, generally speaking, manufacturers will owe rebates if the price of a Part B or Part D drug increases faster than the pace of inflation.
We also believe that ExacTcell can enable us to deliver products faster, at a greater scale, and at lower cost than future competing cell therapies, if any. 8 ExacTcell focuses on the selection and expansion of naturally occurring, genetically unmodified CD8+ CTLs to target multiple, distinct, preselected antigens present only on virus-infected or malignant cells and to kill those cells.
We also believe that ExacTcell can enable us to deliver products faster, at a greater scale, and at lower cost than future competing cell therapies, if any. 8 ExacTcell focuses on the selection and expansion of naturally occurring, genetically unmodified CD8+ CTLs to target multiple, distinct, preselected antigenic peptides present only on virus-infected or malignant cells and to kill those cells.
Analysis of COVID-19 viral load showed that the patients were early in their COVID-19 disease course. Patients were treated with TVGN 489 at one of four dose levels: 1 x 10 5 /kg; 3 x 10 5 /kg; 1 x 10 6 /kg; or 3 x 10 6 /kg.
Analysis of COVID-19 viral load showed that the patients were early in their COVID-19 disease course at the time of treatment. Patients were treated with TVGN 489 at one of four dose levels: 1 x 10 5 /kg; 3 x 10 5 /kg; 1 x 10 6 /kg; or 3 x 10 6 /kg.
Our strategy is to target large patient populations for each pipeline product. Key elements of our strategy to advance toward this goal include the following: ● Advancing the clinical development of TVGN 489 for the treatment of COVID-19 and Long COVID .
Our strategy is to target large or underserved patient populations for each pipeline product. Key elements of our strategy to advance toward this goal include the following: ● Advancing the clinical development of TVGN 489 for the treatment of COVID-19 and Long COVID .
This protocol is in a very early stage of development. 19 Other Discovery Programs, Product Candidates and Indications In addition to TVGN 489, we have several product candidates under early-stage development in virology, neurology, and oncology using our ExacTcell technology.
This protocol is in a very early stage of development. 20 Other Discovery Programs, Product Candidates and Indications In addition to TVGN 489, we have several product candidates under early-stage development in virology, neurology, and oncology using our ExacTcell technology.
As of February 24, 2025, our U.S. intellectual property portfolio includes three U.S. patents relating to TVGN 489 for the treatment of COVID-19, nine pending U.S. patent applications, including two patent applications relating to the treatment of COVID-19, six relating to the treatment of other viruses or cancer, and one related to artificial intelligence-driven T cell target identification and receptor engagement, as well as thirteen ex-U.S. patent applications, including applications in Australia, Canada, Europe, Japan, Qatar, United Arab Emirates, and the Patent Cooperation Treaty (PCT) directed at viral specific T cells, methods of treating and preventing viral infections, methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of viral infections, and systems for predicting immunologically active peptides with machine learning models, which have anticipated expiration dates through December 16, 2044.
As of March 27, 2026, our U.S. intellectual property portfolio includes three U.S. patents relating to TVGN 489 for the treatment of COVID-19, nine pending U.S. patent applications, including two patent applications relating to the treatment of COVID-19, six relating to the treatment of other viruses or cancer, and one related to artificial intelligence-driven T cell target identification and receptor engagement, as well as thirteen ex-U.S. patent applications, including applications in Australia, Canada, Europe, Japan, Qatar, United Arab Emirates, and the Patent Cooperation Treaty (PCT) directed at viral specific T cells, methods of treating and preventing viral infections, methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of viral infections, and systems for predicting immunologically active peptides with machine learning models, which have anticipated expiration dates through December 16, 2044.
While recent press releases from Invivyd confirm continued activity of Pemivibart against circulating strains of SARS-CoV-2, third-party research showed that inhibitory concentrations needed for neutralization of the JN.1 sublineages increased for Pemivibart, and that activity was substantially adversely impacted by the currently highest circulating variant at the time of the research.
While press releases from Invivyd confirmed continued activity of Pemivibart against circulating strains of SARS-CoV-2, third-party research showed that inhibitory concentrations needed for neutralization of the JN.1 sublineages increased for Pemivibart, and that activity was substantially adversely impacted by the currently highest circulating variant at the time of the research.
In addition, we own a registered trademark for “Tevogen Bio” (and design), and have applied for a registered trademark protection for “ExacTcell” and “Tevogen.AI” (and logo) with the USPTO. 24 Human Capital Resources Our success depends on our ability to attract and retain highly qualified management and personnel.
In addition, we own a registered trademark for “Tevogen Bio” (and design), and have applied for a registered trademark protection for “AdapTcell”, “ExacTcell”, “PredicTcell”, and “Tevogen.AI” (and logo) with the USPTO. Human Capital Resources Our success depends on our ability to attract and retain highly qualified management and personnel.
As of March 21, 2025, we had 18 full-time and no part-time employees. We value a work culture that encourages employees, contractors, and vendors to contribute their unique and diverse perspectives, to harness optimism and creativity, and to be ready to learn and develop solutions towards a common and greater purpose of developing accessible immunotherapies.
As of March 27, 2026, we had 18 full-time and no part-time employees. We value a work culture that encourages employees, contractors, and vendors to contribute their unique and diverse perspectives, to harness optimism and creativity, and to be ready to learn and develop solutions towards a common and greater purpose of developing accessible immunotherapies.
This is in significant contrast with the target loss of anti-spike monoclonal antibody therapies, which has led to the withdrawal of emergency use authorizations (“EUAs”) that had been granted during the now-expired COVID-19 National Public Health Emergency. COVID-19 variants have demonstrated how this virus is able to escape our immune system through mutation.
This is in significant contrast with the target loss of anti-spike monoclonal antibody therapies, which has led to the withdrawal of EUAs that had been granted during the now-expired COVID-19 National Public Health Emergency. 14 COVID-19 variants have demonstrated how this virus is able to escape our immune system through mutation.
Information About Our Executive Officers The table below sets forth certain information concerning our executive officers serving as of the filing of this Annual Report : Name Age Current Position Dr. Ryan Saadi 60 Chief Executive Officer, Chairperson and Director Kirti Desai 68 Chief Financial Officer Dr.
Information About Our Executive Officers The table below sets forth certain information concerning our executive officers serving as of the filing of this Annual Report: Name Age Current Position Dr. Ryan Saadi 61 Chief Executive Officer, Chairperson and Director Kirti Desai 69 Chief Financial Officer Dr.
We have observed TVGN 489’s targets to be generally retained, in nearly all cases at greater than a 95% level of retention, in the genome of all of the isolates of SARS-CoV-2 variants that we have studied to date.
TVGN 489’s targets have also persisted in studied COVID-19 variants. We have observed TVGN 489’s targets to be generally retained, in nearly all cases at greater than a 95% level of retention, in the genome of all of the isolates of SARS-CoV-2 variants that we have studied to date.
EBV is a common virus that infects over 90% of the world’s adult population, according to the World Health Organization (the “WHO”), and is mainly transmitted through saliva, but also through other body fluids such as blood and semen. EBV is the leading cause of infectious mononucleosis, and infects B-cells, a type of immune cell.
EBV is a common virus that infects over 90% of the world’s adult population, according to the WHO, and is mainly transmitted through saliva, but also through other body fluids such as blood and semen. EBV is the leading cause of infectious mononucleosis, and infects B-cells, a type of immune cell.
Our efforts to develop manufacturing capability are currently focused on acquiring a manufacturing and research and development facility, including through collaboration with a potential facility development partner. ● Forming strategic alliances and collaborating with partners to augment our capabilities .
Our efforts to develop manufacturing capability are currently focused on acquiring a manufacturing and research and development facility, including through collaboration with a potential facility development partner. ● Forming strategic alliances, collaborating with partners, and entering into business combinations to augment our capabilities .
The convenience of “off-the-shelf” – manufactured and stored for immediate use – therapy has the potential to offer timely and cost-efficient therapeutics by potentially eliminating the need for specialized medical facilities, unlike existing platforms.
The convenience of “off-the-shelf” – pre-manufactured and ready-to-use - therapy has the potential to offer timely and cost-efficient therapeutics by potentially eliminating the need for specialized medical facilities, unlike existing platforms.
Although a vaccine for HPV exists, the National Cancer Institute estimates that as of 2022, only 58.6% of adolescents between the ages of 13 and 15 had received the recommended doses, estimated vaccination among older populations is lower, and the COVID pandemic has shown that significant portions of the population will avoid vaccination.
Although a vaccine for HPV exists, the National Cancer Institute estimates that as of 2023, only 57.3% of adolescents between the ages of 13 and 15 had received the recommended doses, estimated vaccination among older populations is lower, and the COVID pandemic has shown that significant portions of the population will avoid vaccination.
Cancer cells may not always express an ideal T cell target on their own. However, it is possible to coat a cancer cell with a well-recognized target peptide using monoclonal antibodies or liposomes. We believe this would allow our target specific CTLs to then attack the cancer cells.
Non-viral (sporadic) cancers may not always express an ideal T cell target on their own. However, it is possible to coat this sort of cancer cell with a well-recognized target peptide using monoclonal antibodies or liposomes. We believe this would allow our target specific CTLs to then attack the cancer cells.
CD8+ CTLs in ExacTcell-based products target multiple and distinct antigens, with the aim to circumvent the impact of mutations in viruses and cancer cells, which can render existing treatments focused on a single target ineffective.
CD8+ CTLs in ExacTcell-based products target multiple and distinct antigens, with the aim to circumvent the impact of mutations in viruses and virally driven as well as sporadic cancer cells, which can render existing treatments focused on a single target ineffective.
Neal Flomenberg 71 Chief Scientific Officer and Global R&D Lead Sadiq Khan 63 Chief Commercial Officer 37 Dr. Ryan Saadi has served as our Chief Executive Officer and Chairperson since February 2024, and served as Chief Executive Officer and Chairperson of Tevogen Bio beginning in June 2020. Dr.
Neal Flomenberg 72 Chief Scientific Officer and Global R&D Lead Sadiq Khan 64 Chief Commercial Officer Dr. Ryan Saadi has served as our Chief Executive Officer and Chairperson since February 2024, and served as Chief Executive Officer and Chairperson of Tevogen Bio beginning in June 2020. Dr.
As evidence of this, despite selection of T cell targets in 2020, more than 95% of the targets for the HLA-A*02:01 TVGN 489 product targets have remained intact through the first quarter of 2025.
As evidence of this, despite selection of T cell targets in 2020, more than 95% of the targets for the HLA-A*02:01 TVGN 489 product targets have remained intact through March 2026.
Both drugs also present challenges for subsets of patients. Paxlovid is associated with many drug-drug interactions, resulting in the need to temporarily stop ongoing medications or seek alternative therapy and thereby making it difficult for some patients to take. This is especially true for patients on multiple medications, which is often true of high-risk patients requiring anti-COVID-19 treatment.
Paxlovid is associated with many drug-drug interactions, resulting in the need to temporarily stop ongoing medications or seek alternative therapy and thereby making it difficult for some patients to take. This is especially true for patients taking multiple medications, which is often true of high-risk patients requiring anti-COVID-19 treatment.
Our senior leadership team is composed of accomplished scientists and biopharmaceutical leaders. The team brings together diverse experience across the entire life sciences spectrum, including biotechnology, pharmaceuticals, hospitals, public and private insurance, education, and health policy. Additionally, our team holds substantial expertise in drug development, global product launches, and commercialization and ensuring patient access across a range of therapeutic areas.
The team brings together diverse experience across the entire life sciences spectrum, including biotechnology, pharmaceuticals, hospitals, public and private insurance, education, and health policy. Additionally, our team holds substantial expertise in drug development, global product launches, and commercialization and ensuring patient access across a range of therapeutic areas.
Increased mortality, hospitalization, and incidence of Long COVID are higher in patients with B cell malignancies due to inadequate vaccination response and the immunosuppressive consequences of treatment received for B cell cancers.
Increased mortality, hospitalization, and persistence of COVID-19 infection are higher in patients with B cell malignancies due to inadequate vaccination response and the immunosuppressive consequences of treatment received for B cell cancers.
Many states have analogous laws and regulations, such as: state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to certain healthcare providers; laws that require drug manufacturers to report information related to clinical trials or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; laws that restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; and laws and local ordinances that require identification or licensing of sales representatives.
Like the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. 35 Many states have analogous laws and regulations, such as: state anti-kickback and false claims laws that may apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by non-governmental third-party payors, including private insurers; laws that require pharmaceutical companies to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government or otherwise restrict payments that may be made to certain healthcare providers; laws that require drug manufacturers to report information related to clinical trials or information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures; laws that restrict the ability of manufacturers to offer co-pay support to patients for certain prescription drugs; and laws and local ordinances that require identification or licensing of sales representatives.
In addition, although the federal False Claims Act is a civil statute, False Claims Act violations may also implicate various federal criminal statutes. 34 The healthcare fraud provisions of The Health Insurance Portability and Accountability Act (“HIPAA”) prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
The healthcare fraud provisions of The Health Insurance Portability and Accountability Act (“HIPAA”) prohibit knowingly and willfully executing, or attempting to execute, a scheme to defraud any healthcare benefit program, including private third-party payors, knowingly and willfully embezzling or stealing from a healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services.
We believe that the U.S. opportunity for our key pipeline products includes: ● TVGN 489: Approximately 750,000 patients with B cell hematologic cancer, 2,175,000 addressable patients with other cancers, including lung, breast, colon, pancreatic and liver, and 18 million addressable patients with Long COVID. ● TVGN 920: Approximately 5.5 million patients with high-risk HPV infections, of which 200,000 are diagnosed with high grade dysplasia per year. ● TVGN 930: Approximately 92,000 patients with the main EBV-associated lymphomas. ● TVGN 960: Approximately 110,000 patients with HPV-related mouth and throat cancer. ● TVGN 601: Approximately 1 million patients with EBV-related multiple sclerosis. ● TVGN 116: Approximately 500,000 to 1 million patients with high-risk chronic Hepatitis B for prevention of liver cancer.
Essential commercial capabilities, such as market analytics, pricing, and commercial operations functions, are continuously being developed as we progress toward the later-stage development of TVGN 489. 21 We believe that the U.S. opportunity for our key pipeline products includes: ● TVGN 489: Approximately 750,000 patients with B cell hematologic cancer, 2,175,000 addressable patients with other cancers, including lung, breast, colon, pancreatic and liver, and 18 million addressable patients with Long COVID. ● TVGN 920: Approximately 5.5 million patients with high-risk HPV infections, of which 200,000 are diagnosed with high grade dysplasia per year. ● TVGN 930: Approximately 92,000 patients with the main EBV-associated lymphomas. ● TVGN 960: Approximately 110,000 patients with HPV-related mouth and throat cancer. ● TVGN 601: Approximately 1 million patients with EBV-related multiple sclerosis. ● TVGN 116: Approximately 500,000 to 1 million patients with high-risk chronic Hepatitis B for prevention of liver cancer.
As a result, our competitors may discover, develop, license, or commercialize products before or more successfully than we do. TVGN 489 is being developed to fill the critical gaps that exist in COVID-19 therapeutics for the immunocompromised, the high-risk elderly, and Long COVID. Only one product has been FDA approved to date for treatment of COVID-19 in the immunocompromised population.
As a result, our competitors may discover, develop, license, or commercialize products before or more successfully than we do. TVGN 489 is being developed to fill the critical gaps that exist in COVID-19 therapeutics for the immunocompromised, the high-risk elderly, and Long COVID.
A large number of Americans remain highly vulnerable to COVID-19 infection, including immunocompromised and elderly patients. For example, the rate of hospitalization in cancer patients with COVID-19 infection remains high, specifically for those under active chemotherapy or immunosuppression. There is therefore a high unmet need to have an effective treatment available for these populations.
For example, the rate of hospitalization in cancer patients with COVID-19 infection remains high, specifically for those under active chemotherapy or immunosuppression. There is therefore a high unmet need to have an effective treatment available for these populations.
All patients in the interventional arm of our Phase 1 clinical trial noted improved symptoms within two to three days, which is shorter than the average noted by patients in the observational arm, and 83% of patients in the interventional arm had negative nasal swab polymerase chain reaction tests and there was a 99% viral load reduction in all patients within 14 days.
All patients in the interventional arm of our Phase 1 clinical trial noted improved symptoms within two to three days, which is shorter than the average noted by patients in the observational arm, and there was a ≥ 99% viral load reduction in all patients by PCR within 14 days.
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 across the development lifecycle and healthcare system.
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 also intend to explore options to work with partners to augment the study and treatment of patients and the impact of our product candidates, including medical professionals, healthcare professional networks, pharmacy benefit managers, insurance companies, and artificial intelligence companies.
We also intend to explore options to work with partners to augment the study and treatment of patients and the impact of our product candidates, including medical professionals, healthcare professional networks, pharmacy benefit managers, insurance companies, and artificial intelligence companies. In addition, from time to time we enter into letters of intent to explore potential acquisitions.
According to the WHO, HPV is responsible for 99% of cervical cancers. Mouth and throat cancers are more diverse, but the WHO estimates that about 70% of oropharyngeal cancers are due to HPV.
According to the World Health Organization (the “WHO”), HPV is responsible for 99% of cervical cancers. Mouth and throat cancers are more diverse, but the WHO estimates that in the U.S., about 60% to 70% of oropharyngeal cancers are due to HPV.
There are nonetheless ongoing efforts to develop additional anti-COVID monoclonal antibodies for treatment and prevention of COVID-19 infection. For example, in March 2024, Invivyd received an EUA of its product, Pemgarda (pemivibart), a broadly neutralizing monoclonal antibody used for COVID-19 prevention in immunocompromised individuals who have not either been exposed to or developed active COVID infection.
For example, in March 2024, Invivyd, Inc. received an EUA of its product, Pemgarda (pemivibart), a broadly neutralizing monoclonal antibody used for COVID-19 prevention in immunocompromised individuals who have not either been exposed to or developed active COVID infection.
TVGN 489 COVID-19 Reactive CD8+ T Cells Detected Throughout the Six-Month Follow Up Period Expansion and persistence of allogeneic T cells has been associated with disease control in many settings.
Taken together, we believe this data shows the persistence of TVGN 489 cells six months after administration. 18 TVGN 489 COVID-19 Reactive CD8+ T Cells Detected Throughout the Six-Month Follow Up Period Expansion and persistence of allogeneic T cells has been associated with disease control in many settings.
(“AlloVir”) is another company developing allogeneic T cell therapies for viral diseases. Neither Atara Bio nor AlloVir has an active development program for the treatment of COVID-19. AlloVir conducted a Phase 1b trial of an allogeneic, partially HLA-matched product candidate in COVID-19 and reported results of the trial in 2021 but has not continued clinical development.
Neither Atara Bio nor Kalaris has an active development program for the treatment of COVID-19. AlloVir conducted a Phase 1b trial of an allogeneic, partially HLA-matched product candidate in COVID-19 and reported results of the trial in 2021 but did not continue clinical development.
We believe our allogeneic, precision T cell technology, ExacTcell TM , represents a significant scientific breakthrough with the potential to mainstream cell therapy with a new class of off-the-shelf – manufactured and stored for immediate use – T cell therapies with diverse applications across virology, oncology, and other areas.
We believe our precision T cell technology, ExacTcell TM , represents a significant scientific breakthrough with the potential to mainstream cell therapy with a new class of off-the-shelf – pre-manufactured and ready-to-use – allogeneic T cell therapies with diverse applications across virology, oncology, and other areas. Allogeneic therapeutics are intended to be infused into individuals other than the original donor.
Identification of appropriate COVID-19 peptide targets for additional HLA molecules remains ongoing, and we plan to continue this testing until we are confident that between 90% and 95% of the COVID-19 infected population could be treated based on our research. We believe generating these CTLs can provide treatment for SARS-CoV-2 or, with the appropriate targets, for other viral infections.
Identification of appropriate COVID-19 peptide targets for additional HLA molecules remains ongoing, and we plan to continue this testing until we are confident that between 90% and 95% of the COVID-19 infected population could be treated based on our research.
Although the number of daily reported cases and deaths has declined, the emergence of more transmissible variants has led to spikes in cases and mortality, and variants are expected to continue to evolve over time. 12 The current COVID-19 landscape is also characterized by continued vaccine hesitancy among a significant portion of the population, unequal access to vaccines and treatment, lack of response in some immunocompromised and other high-risk groups, and breakthrough cases among the vaccinated due in part to increased immune evasion by current and emerging variants and the relatively short duration of protection by booster shots.
The current COVID-19 landscape is also characterized by continued vaccine hesitancy among a significant portion of the population, unequal access to vaccines and treatment, lack of response in some immunocompromised and other high-risk groups, and breakthrough cases among the vaccinated due in part to increased immune evasion by current and emerging variants and the relatively short duration of protection by booster shots.
ExacTcell CTLs are not genetically altered in the manufacturing process and although they expand during manufacture, this is the expected response of a T-lymphocyte when encountering its target antigen.
In contrast, CTLs generated using the ExacTcell technology come from a healthy donor with a normal immune system. ExacTcell CTLs are not genetically altered in the manufacturing process and although they expand during manufacture, this is the expected response of a T-lymphocyte when encountering its target antigen.
The only significant finding was a reduced rate of hospitalization in the CCP treatment group versus the non-treated group, with zero hospitalizations out of 59 patients versus five out of 58. In both of these studies, CCP was dosed multiple times. This therapy is an FDA licensed treatment through a blood donation center and is not marketed.
The only significant finding was a reduced rate of hospitalization in the CCP treatment group versus the non-treated group, with zero hospitalizations out of 59 patients versus five out of 58. In both of these studies, CCP was dosed multiple times.
Our First Product Candidate Our first product candidate, TVGN 489, is an off-the-shelf, allogeneic cytotoxic CD8+ T cell therapy designed to fill a critical remaining gap in COVID-19 therapeutic solutions for the immunocompromised and the high-risk elderly, who remain at substantial risk for poor outcomes, with potential applications in both treatment and prevention of Long COVID.
We expect efforts to produce second generation products based on this process may begin shortly after and if initial regulatory approval of the first-generation product is obtained. 11 Our First Product Candidate Our first product candidate, TVGN 489, is an off-the-shelf, allogeneic cytotoxic CD8+ T cell therapy designed to fill a critical remaining gap in COVID-19 therapeutic solutions for the immunocompromised and the high-risk elderly, who remain at substantial risk for poor outcomes, with potential applications in both treatment and prevention of Long COVID.
These both produce pores in the target cell’s membrane and also trigger a process known as apoptosis, or programmed cell death, which is built into all our cells.
These both produce pores in the target cell’s membrane and also trigger a process known as apoptosis, or programmed cell death, which is built into all our cells. Then, once the infected cells die, new, healthy cells are able to grow in their place.
However, the evidence of their prolonged persistence provides us with encouragement for future applications of the ExacTcell technology, particularly in oncology. 18 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 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.
Clinical Development for COVID-19 Patients FDA permitted our IND for TVGN 489 to proceed in May 2021, and we began enrolling patients in the Phase 1 proof-of-concept trial of TVGN 489 for the treatment of high-risk ambulatory adult COVID-19 patients in October 2021.
Modifications to the ExacTcell platform have increased the content of active CTLs to over 80% on a consistent basis. 16 Clinical Development for COVID-19 Patients FDA permitted our IND for TVGN 489 to proceed in May 2021, and we began enrolling patients in the Phase 1 proof-of-concept trial of TVGN 489 for the treatment of high-risk ambulatory adult COVID-19 patients in October 2021.
Having multiple targets within a product also blunts the impact of any one mutation. 9 Due to the targeted nature of the cells ExacTcell can produce, we also believe we may be able to avoid some of the unwanted corollary effects observed in other T cell immunotherapies.
Due to the targeted nature of the cells ExacTcell can produce, we also believe we may be able to avoid some of the unwanted corollary effects observed in other T cell immunotherapies.
Whether the prolonged persistence of the CTLs used in this study is of benefit in the treatment of COVID-19, Long COVID, or alternate future viral or oncologic targets for these CTLs merits further examination.
Whether the prolonged persistence of the CTLs used in this study is of benefit in the treatment of COVID-19, Long COVID, or alternate future viral or oncologic targets for these CTLs merits further examination. However, the evidence of their prolonged persistence provides us with encouragement for future applications of the ExacTcell technology, particularly in oncology.
We use a technique known as tetramer staining to assess whether T cells recognized these target peptides, assessed cytotoxicity against individual peptide-pulsed and non-pulsed targets, and selected final peptides for use in TVGN 489 on that basis.
Discovery and Preclinical Data Our approach to identifying CTL targets starts with computer-based prediction and then tests candidate peptides functionally with T cells. We use a technique known as tetramer staining to assess whether T cells recognized these target peptides, assessed cytotoxicity against individual peptide-pulsed and non-pulsed targets, and selected final peptides for use in TVGN 489 on that basis.
Requirements with respect to data integrity include, among other things, controls ensuring complete and secure data; activities documented at the time of performance; audit trail functionality; authorized access and limitations; validated computer systems; and review of records for accuracy, completeness, and compliance with established standards. 30 Post-approval changes to the manufacturing process are strictly regulated, and, depending on the significance of the change, may require FDA approval before being implemented.
Requirements with respect to data integrity include, among other things, controls ensuring complete and secure data; activities documented at the time of performance; audit trail functionality; authorized access and limitations; validated computer systems; and review of records for accuracy, completeness, and compliance with established standards.
In January 2024, FDA required a class-wide black box warning be added to the label of these CAR T products regarding this risk. Currently approved autologous CAR-T platforms utilize the patient’s own T cells to manufacture their products.
In January 2024, FDA required a class-wide black box warning be added to the label of these CAR T products regarding this risk, and continues to recommend long-term monitoring. Currently approved autologous CAR-T platforms utilize the patient’s own T cells to manufacture their products. These cells have previously been exposed to cancer therapy and are genetically altered and subsequently expanded.

… 69 more changes not shown on this page.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

67 edited+28 added−3 removed506 unchanged
Biggest changeOur future capital requirements depend on many factors, including: ● the scope, progress, timing, results, and costs of researching and developing TVGN 489 and our other product candidates, including product candidates developed with our ExacTcell technology, and of conducting preclinical studies and clinical trials; ● the timing of, and the costs involved in, obtaining marketing approval for TVGN 489 and any future product candidates we develop, if clinical trials are successful; ● the costs of manufacturing TVGN 489 and any future product candidates for preclinical studies and clinical trials and in preparation for marketing approval and commercialization; ● the costs of commercialization activities, including marketing, sales, and distribution costs, for TVGN 489 and any future product candidates we develop if any of these product candidates are approved for sale; ● our ability to establish and maintain strategic collaborations, licensing, or other arrangements on favorable terms, if at all; ● the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending, and enforcing patent claims, including litigation costs and the outcome of any such litigation; ● the timing, receipt, and amount of sales of, or royalties on, our future products, if any; and ● the emergence of competing therapies and other developments in the markets we intend to address. 40 Until we can generate sufficient product and royalty revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements.
Biggest changeBecause the designs and outcomes of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development of and commercialize any product candidate we develop. 41 Our future capital requirements depend on many factors, including: ● the scope, progress, timing, results, and costs of researching and developing TVGN 489 and our other product candidates, including product candidates developed with our ExacTcell technology, and of conducting preclinical studies and clinical trials; ● the timing of, and the costs involved in, obtaining marketing approval for TVGN 489 and any future product candidates we develop, if clinical trials are successful; ● the costs of manufacturing TVGN 489 and any future product candidates for preclinical studies and clinical trials and in preparation for marketing approval and commercialization; ● the costs of commercialization activities, including marketing, sales, and distribution costs, for TVGN 489 and any future product candidates we develop if any of these product candidates are approved for sale; ● our ability to establish and maintain strategic collaborations, licensing, or other arrangements on favorable terms, if at all; ● the costs involved in preparing, filing, prosecuting, maintaining, expanding, defending, and enforcing patent claims, including litigation costs and the outcome of any such litigation; ● the timing, receipt, and amount of sales of, or royalties on, our future products, if any; and ● the emergence of competing therapies and other developments in the markets we intend to address.
Because these programs, particularly our pipeline of allogeneic T cell product candidates that are developed from donors, represent a novel approach to immunotherapy for the treatment of virus-infected cells in order to produce T cell immunity, developing and commercializing our product candidates subjects us to a number of challenges, including: ● obtaining regulatory approval from FDA, which has relatively limited experience with regulating the development and commercialization of T cell immunotherapies; ● developing and deploying consistent and reliable processes for procuring blood from consenting third-party donors, isolating T cells from the blood of such donors, activating the isolated T cells against specific antigens, characterizing and storing the resulting activated T cells for future therapeutic use, selecting and delivering a sufficient supply and breadth of appropriate human leukocyte antigen-matched (“HLA-matched”) cells from among the available T cell lines, and finally infusing these activated T cells into patients to eliminate virus-infected cells in the patient and induce anti-disease benefit; 41 ● relying on healthcare provider site availability and accessibility to patients for receipt of T cell infusions; ● utilizing these product candidates in combination with other therapies currently used to treat patients in our target population, which may increase the risk of adverse side effects; ● educating medical personnel regarding the potential side effect profile of each of our product candidates, particularly those that may be unique to our allogeneic T cell therapy product candidates; ● understanding and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to manufacture product in a reliable and consistent manner; ● developing processes for the safe administration of these products, including long-term follow-up and registries, as applicable, for all patients who receive these product candidates; ● manufacturing our product candidates to our specifications and in a timely manner to support our clinical trials and, if approved, commercialization; ● sourcing clinical and, if approved by FDA, commercial supplies for the materials used to manufacture and process these product candidates that are free from viruses and other pathogens that may increase the risk of adverse side effects; ● developing a manufacturing process and distribution network that can provide a stable supply with a cost of goods that allows for an attractive return on investment; ● establishing sales and marketing capabilities ahead of and after obtaining any regulatory approval to gain market acceptance, and obtaining adequate coverage, reimbursement and pricing by third-party payors and government authorities; and ● developing therapies for types of diseases beyond those initially addressed by our current product candidates.
Because these programs, particularly our pipeline of allogeneic T cell product candidates that are developed from donors, represent a novel approach to immunotherapy for the treatment of virus-infected cells in order to produce T cell immunity, developing and commercializing our product candidates subjects us to a number of challenges, including: ● obtaining regulatory approval from FDA, which has relatively limited experience with regulating the development and commercialization of T cell immunotherapies; ● developing and deploying consistent and reliable processes for procuring blood from consenting third-party donors, isolating T cells from the blood of such donors, activating the isolated T cells against specific antigens, characterizing and storing the resulting activated T cells for future therapeutic use, selecting and delivering a sufficient supply and breadth of appropriate human leukocyte antigen-matched (“HLA-matched”) cells from among the available T cell lines, and finally infusing these activated T cells into patients to eliminate virus-infected cells in the patient and induce anti-disease benefit; ● relying on healthcare provider site availability and accessibility to patients for receipt of T cell infusions; ● utilizing these product candidates in combination with other therapies currently used to treat patients in our target population, which may increase the risk of adverse side effects; ● educating medical personnel regarding the potential side effect profile of each of our product candidates, particularly those that may be unique to our allogeneic T cell therapy product candidates; ● understanding and addressing variability in the quality of a donor’s T cells, which could ultimately affect our ability to manufacture product in a reliable and consistent manner; ● developing processes for the safe administration of these products, including long-term follow-up and registries, as applicable, for all patients who receive these product candidates; ● manufacturing our product candidates to our specifications and in a timely manner to support our clinical trials and, if approved, commercialization; ● sourcing clinical and, if approved by FDA, commercial supplies for the materials used to manufacture and process these product candidates that are free from viruses and other pathogens that may increase the risk of adverse side effects; ● developing a manufacturing process and distribution network that can provide a stable supply with a cost of goods that allows for an attractive return on investment; ● establishing sales and marketing capabilities ahead of and after obtaining any regulatory approval to gain market acceptance, and obtaining adequate coverage, reimbursement and pricing by third-party payors and government authorities; and ● developing therapies for types of diseases beyond those initially addressed by our current product candidates.
These laws, described in further detail in “ Regulatory Environment – Healthcare Regulation – Other Healthcare Laws and Compliance Requirements ,” include: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; ● the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government; 58 ● HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which imposes specified requirements relating to the privacy, security, and transmission of individually identifiable health information; ● the U.S. federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS information related to direct or indirect payments and other transfers of value to physicians and teaching hospitals (and certain other practitioners), as well as ownership and investment interests held in the Company by physicians and their immediate family members; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including governmental and private payors, laws that require manufacturers to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources, state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state laws governing the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same scope or application, thus complicating compliance efforts.
These laws, described in further detail in “ Regulatory Environment - Healthcare Regulation - Other Healthcare Laws and Compliance Requirements ,” include: ● the federal Anti-Kickback Statute, which prohibits, among other things, persons from knowingly and willfully soliciting, receiving, offering, or paying remuneration, directly or indirectly, to induce, or in return for, the purchase or recommendation of an item or service reimbursable under a federal healthcare program, such as the Medicare and Medicaid programs; ● the federal civil False Claims Act, which prohibits, among other things, individuals or entities from knowingly presenting, or causing to be presented, a false or fraudulent claim for payment of government funds, or knowingly making, using or causing to be made or used, a false record or statement material to an obligation to pay money to the government or knowingly concealing or knowingly and improperly avoiding, decreasing or concealing an obligation to pay money to the federal government; 59 ● HIPAA, which created new federal criminal statutes that prohibit executing a scheme to defraud any healthcare benefit program and making false statements relating to healthcare matters; ● HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, and its implementing regulations, which imposes specified requirements relating to the privacy, security, and transmission of individually identifiable health information; ● the U.S. federal Physician Payment Sunshine Act, which requires manufacturers of drugs, devices, biologics, and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) to report annually to the CMS information related to direct or indirect payments and other transfers of value to physicians and teaching hospitals (and certain other practitioners), as well as ownership and investment interests held in the Company by physicians and their immediate family members; and ● state law equivalents of each of the above federal laws, such as anti-kickback and false claims laws that may apply to items or services reimbursed by any third-party payor, including governmental and private payors, laws that require manufacturers to comply with the pharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government, or otherwise restrict payments that may be made to healthcare providers and other potential referral sources, state laws that require drug manufacturers to report information related to payments and other transfers of value to physicians and other healthcare providers or marketing expenditures, and state laws governing the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways and may not have the same scope or application, thus complicating compliance efforts.
Market acceptance of any of our product candidates for which we receive approval depends on a number of factors, including: ● the efficacy and safety of the product candidates as demonstrated in clinical trials; ● the clinical indications and patient populations for which the product candidate is approved; ● acceptance by physicians and patients of the drug as a safe and effective treatment; ● the administrative and logistical burden of treating patients, including the availability and accessibility of healthcare provider sites for administering infusions to patients; ● the adoption of novel cellular therapies by physicians, hospitals, and third-party payors; ● the potential and perceived advantages of product candidates over alternative treatments; ● the safety of product candidates seen in a broader patient group, including its use outside the approved indications should physicians choose to prescribe for such uses; ● any restrictions on use together with other medications; ● the prevalence and severity of any side effects; ● FDA’s product labeling or package insert requirements; ● the timing of market introduction of our products as well as competitive products; ● the development of manufacturing and distribution processes for our product candidates; ● the cost of treatment in relation to alternative treatments; ● the availability of coverage and adequate reimbursement from, and our ability to negotiate pricing with, third-party payors, providers, and government authorities; ● relative convenience and ease of administration; and ● the effectiveness of our sales and marketing efforts. 53 We expect the product candidates we develop will be regulated biologics and therefore they may be subject to biosimilar competition.
Market acceptance of any of our product candidates for which we receive approval depends on a number of factors, including: ● the efficacy and safety of the product candidates as demonstrated in clinical trials; ● the clinical indications and patient populations for which the product candidate is approved; ● acceptance by physicians and patients of the drug as a safe and effective treatment; ● the administrative and logistical burden of treating patients, including the availability and accessibility of healthcare provider sites for administering infusions to patients; ● the adoption of novel cellular therapies by physicians, hospitals, and third-party payors; ● the potential and perceived advantages of product candidates over alternative treatments; ● the safety of product candidates seen in a broader patient group, including its use outside the approved indications should physicians choose to prescribe for such uses; ● any restrictions on use together with other medications; ● the prevalence and severity of any side effects; ● FDA’s product labeling or package insert requirements; ● the timing of market introduction of our products as well as competitive products; ● the development of manufacturing and distribution processes for our product candidates; ● the cost of treatment in relation to alternative treatments; ● the availability of coverage and adequate reimbursement from, and our ability to negotiate pricing with, third-party payors, providers, and government authorities; ● relative convenience and ease of administration; and ● the effectiveness of our sales and marketing efforts. 54 We expect the product candidates we develop will be regulated biologics and therefore they may be subject to biosimilar competition.
Our ability to generate future revenue from product sales depends heavily on our, or our potential future collaborators’, success in: ● completing preclinical studies and clinical trials of our product candidates; ● seeking and obtaining marketing approvals for any product candidates that we or our collaborators develop; ● receiving authorization of investigational new drug applications INDs for future product candidates; 39 ● identifying and developing new product candidates; ● manufacturing cGMP supply of our product candidates for clinical trials and, if approved, commercial sales; ● launching and commercializing products for which we obtain marketing approval by establishing a marketing, sales, distribution, and medical affairs infrastructure or, alternatively, collaborating with a commercialization partner; ● achieving coverage and adequate reimbursement by hospitals and third-party payors, including governmental authorities, such as Medicare and Medicaid, private insurers, and managed care organizations, for product candidates, if approved, that we or our collaborators develop; ● obtaining market acceptance of product candidates, if approved, that we develop as viable treatment options; ● addressing any competing technological and market developments; ● negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter and performing our obligations under such arrangements; ● maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; ● defending against third-party interference or infringement claims, if any; and ● attracting, hiring, and retaining qualified personnel.
Our ability to generate future revenue from product sales depends heavily on our, or our potential future collaborators’, success in: ● completing preclinical studies and clinical trials of our product candidates; ● seeking and obtaining marketing approvals for any product candidates that we or our collaborators develop; ● receiving authorization of investigational new drug applications INDs for future product candidates; 40 ● identifying and developing new product candidates; ● manufacturing cGMP supply of our product candidates for clinical trials and, if approved, commercial sales; ● launching and commercializing products for which we obtain marketing approval by establishing a marketing, sales, distribution, and medical affairs infrastructure or, alternatively, collaborating with a commercialization partner; ● achieving coverage and adequate reimbursement by hospitals and third-party payors, including governmental authorities, such as Medicare and Medicaid, private insurers, and managed care organizations, for product candidates, if approved, that we or our collaborators develop; ● obtaining market acceptance of product candidates, if approved, that we develop as viable treatment options; ● addressing any competing technological and market developments; ● negotiating favorable terms in any collaboration, licensing, or other arrangements into which we may enter and performing our obligations under such arrangements; ● maintaining, protecting, and expanding our portfolio of intellectual property rights, including patents, trade secrets and know-how; ● defending against third-party interference or infringement claims, if any; and ● attracting, hiring, and retaining qualified personnel.
We may experience delays in completing planned clinical trials for a variety of reasons, including the following: ● the extensive research and development required because our product candidates are based on new technologies; ● the availability of financial resources to commence and complete the planned trials; ● reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● FDA or independent IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● recruiting suitable patients to participate in a trial or sufficient patients to complete a trial; ● having patients complete a trial or return for post-treatment follow-up; 44 ● clinical trial sites deviating from trial protocol or dropping out of a trial, which may require that we add new clinical trial sites or investigators; ● manufacturing the necessary product for use in the clinical trials; ● clinical trials of any product candidate may fail to show safety, purity, or potency, or may produce negative or inconclusive results, which may cause us to decide, or regulators to require us, to conduct additional nonclinical trials or clinical trials or which may cause us to decide to abandon product candidate development programs; ● any of our product candidates could cause undesirable side effects that could result in significant negative consequences, including the inability to enter clinical development or receive regulatory approval; and/or ● competition from other clinical trial programs for similar indications and clinical trial patients.
We may experience delays in completing planned clinical trials for a variety of reasons, including the following: ● the extensive research and development required because our product candidates are based on new technologies; ● the availability of financial resources to commence and complete the planned trials; ● reaching agreement on acceptable terms with prospective clinical research organizations (“CROs”) and clinical trial sites, the terms of which can be subject to extensive negotiation and may vary significantly among different CROs and trial sites; ● FDA or independent IRBs may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; ● recruiting suitable patients to participate in a trial or sufficient patients to complete a trial; ● having patients complete a trial or return for post-treatment follow-up; 45 ● clinical trial sites deviating from trial protocol or dropping out of a trial, which may require that we add new clinical trial sites or investigators; ● manufacturing the necessary product for use in the clinical trials; ● clinical trials of any product candidate may fail to show safety, purity, or potency, or may produce negative or inconclusive results, which may cause us to decide, or regulators to require us, to conduct additional nonclinical trials or clinical trials or which may cause us to decide to abandon product candidate development programs; ● any of our product candidates could cause undesirable side effects that could result in significant negative consequences, including the inability to enter clinical development or receive regulatory approval; and/or ● competition from other clinical trial programs for similar indications and clinical trial patients.
Potential future collaborations involving our product candidates may pose the following risks to us: ● collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; 62 ● collaborators may not properly enforce, maintain, or defend our intellectual property rights or may use our proprietary information in a way that gives rise to actual or threatened litigation or that could jeopardize or invalidate our intellectual property or proprietary information, exposing us to potential litigation or other intellectual property proceedings; ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; ● disputes may arise between a collaborator and us that cause the delay or termination of the research, development, or commercialization of the product candidate, or that result in costly litigation or arbitration that diverts management attention and resources; ● collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such products; ● if a present or future collaborator were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished, or terminated; and ● collaboration agreements may restrict our right to independently pursue new product candidates.
Potential future collaborations involving our product candidates may pose the following risks to us: ● collaborators may have significant discretion in determining the efforts and resources that they will apply to these collaborations; ● collaborators could independently develop, or develop with third parties, products that compete directly or indirectly with our products or product candidates; 63 ● collaborators may not properly enforce, maintain, or defend our intellectual property rights or may use our proprietary information in a way that gives rise to actual or threatened litigation or that could jeopardize or invalidate our intellectual property or proprietary information, exposing us to potential litigation or other intellectual property proceedings; ● collaborators may infringe the intellectual property rights of third parties, which may expose us to litigation and potential liability; ● disputes may arise between a collaborator and us that cause the delay or termination of the research, development, or commercialization of the product candidate, or that result in costly litigation or arbitration that diverts management attention and resources; ● collaborators with marketing and distribution rights to one or more of our product candidates that achieve regulatory approval may not commit sufficient resources to the marketing and distribution of such products; ● if a present or future collaborator were to be involved in a business combination, the continued pursuit and emphasis on our product development or commercialization program under such collaboration could be delayed, diminished, or terminated; and ● collaboration agreements may restrict our right to independently pursue new product candidates.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients; ● the number and location of participating clinical sites or patients; ● the design of the trial; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; ● the availability of competing commercially available therapies and other competing drug candidates’ clinical trials; ● our ability to obtain and maintain patient informed consents for participation in our clinical trials; ● the risk that patients enrolled in clinical trials will drop out of the trials before completion; and/or ● factors outside of our control, including as a result of business interruptions resulting from natural disasters and public health emergencies, such as the coronavirus. 50 We may experience difficulties in patient enrollment in our future clinical trials for a variety of reasons.
The enrollment of patients depends on many factors, including: ● the patient eligibility criteria defined in the protocol; ● the nature and size of the patient population required for analysis of the trial’s primary endpoints and the process for identifying patients; ● the number and location of participating clinical sites or patients; ● the design of the trial; ● our ability to recruit clinical trial investigators with the appropriate competencies and experience; ● clinicians’ and patients’ perceptions as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new products that may be approved for the indications we are investigating; ● the availability of competing commercially available therapies and other competing drug candidates’ clinical trials; ● our ability to obtain and maintain patient informed consents for participation in our clinical trials; ● the risk that patients enrolled in clinical trials will drop out of the trials before completion; and/or ● factors outside of our control, including as a result of business interruptions resulting from natural disasters and public health emergencies, such as the coronavirus. 51 We may experience difficulties in patient enrollment in our future clinical trials for a variety of reasons.
Additionally, such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect its relationships with service providers and make it more difficult to attract and retain qualified personnel. Also, we may be required to incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters.
Additionally, such securities litigation and stockholder activism could give rise to perceived uncertainties as to our future, adversely affect our relationships with service providers and make it more difficult to attract and retain qualified personnel. Also, we may be required to incur significant legal fees and other expenses related to any securities litigation and activist stockholder matters.
Many factors may have a material adverse effect on the market price of our securities, including, but not limited to: ● the commencement, enrollment, delay, or results of our ongoing or future clinical trials, or changes in the development status of our product candidates; ● our decision to initiate, not to initiate, or to terminate a clinical trial; ● unanticipated serious safety concerns related to the use of our product candidates; ● any delay in our regulatory filings for our product candidates and any adverse or perceived adverse development with respect to the applicable regulatory authority’s review of such filings; ● regulatory actions, including failure to receive regulatory approval, with respect to our product candidates or our competitors’ products or product candidates; ● our failure to commercialize our products; ● our failure to utilize AI technologies in the development of our product candidates; 72 ● the success of competitive products or technologies; ● announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations, capital commitments, significant development milestones, or product approvals; ● our failure to obtain new commercial partners; ● our failure to obtain adequate manufacturing capacity or product supply for any approved product or inability to do so at acceptable cost; ● our failure to achieve expected product sales and profitability; ● regulatory or legal developments applicable to our product candidates; ● the level of expenses related to our product candidates or clinical development programs; ● significant lawsuits, including without limitation patent or stockholder litigation; ● the impact of the incidence and development of COVID-19 on our business and product candidates; ● any changes in our Board of Directors (the “Board”) or senior management; ● actual or anticipated fluctuations in our cash position or operating results; ● changes in financial estimates or recommendations by securities analysts; ● fluctuations in the valuation or financial results of companies perceived by investors to be comparable to us; ● inconsistent trading volume levels of our shares; ● announcement or expectation of additional financing efforts; ● sales of Common Stock by us, our executive officers or directors, or our stockholders; ● fluctuations and market conditions in the U.S. equity markets generally and in the biotechnology sector; ● general economic, political and social conditions; and ● other events or factors, many of which are beyond our control, or unrelated to our operating performance or prospects.
Many factors may have a material adverse effect on the market price of our securities, including, but not limited to: ● the commencement, enrollment, delay, or results of our ongoing or future clinical trials, or changes in the development status of our product candidates; ● our decision to initiate, not to initiate, or to terminate a clinical trial; ● unanticipated serious safety concerns related to the use of our product candidates; ● any delay in our regulatory filings for our product candidates and any adverse or perceived adverse development with respect to the applicable regulatory authority’s review of such filings; ● regulatory actions, including failure to receive regulatory approval, with respect to our product candidates or our competitors’ products or product candidates; ● our failure to commercialize our products; ● our failure to utilize AI technologies in the development of our product candidates; 73 ● the success of competitive products or technologies; ● announcements by us or our competitors of significant acquisitions, strategic collaborations, joint ventures, collaborations, capital commitments, significant development milestones, or product approvals; ● our failure to obtain new commercial partners; ● our failure to obtain adequate manufacturing capacity or product supply for any approved product or inability to do so at acceptable cost; ● our failure to achieve expected product sales and profitability; ● regulatory or legal developments applicable to our product candidates; ● the level of expenses related to our product candidates or clinical development programs; ● significant lawsuits, including without limitation patent or stockholder litigation; ● the impact of the incidence and development of COVID-19 on our business and product candidates; ● any changes in our Board of Directors (the “Board”) or senior management; ● actual or anticipated fluctuations in our cash position or operating results; ● changes in financial estimates or recommendations by securities analysts; ● fluctuations in the valuation or financial results of companies perceived by investors to be comparable to us; ● inconsistent trading volume levels of our shares; ● announcement or expectation of additional financing efforts; ● sales of Common Stock by us, our executive officers or directors, or our stockholders, including under our Sales Agreement; ● fluctuations and market conditions in the U.S. equity markets generally and in the biotechnology sector; ● general economic, political and social conditions; and ● other events or factors, many of which are beyond our control, or unrelated to our operating performance or prospects.
The actual timing of these milestones can vary significantly compared to our estimates, in some cases for reasons beyond our control, including with respect to challenges related to enrollment, manufacturing, and our reliance on third parties to conduct, supervise or monitor some or all aspects of our clinical trials. 51 Disruptions at FDA and other government agencies, such as those that may be caused by funding shortages, could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
The actual timing of these milestones can vary significantly compared to our estimates, in some cases for reasons beyond our control, including with respect to challenges related to enrollment, manufacturing, and our reliance on third parties to conduct, supervise or monitor some or all aspects of our clinical trials. 52 Disruptions at FDA and other government agencies, such as those that may be caused by funding shortages, could hinder their ability to hire, retain or deploy key leadership and other personnel, or otherwise prevent new or modified products from being developed, approved, or commercialized in a timely manner or at all, which could negatively impact our business.
We have the ability to redeem outstanding public warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of Common Stock equals or exceeds $18.00 per share (as adjusted for stock splits, stock capitalizations, reorganizations, recapitalizations and the like for certain issuances of public shares and equity-linked securities for capital raising purposes in connection with the closing of its initial business combination) for any 20 trading days within a 30 trading-day period ending on the third trading day prior to the date we send the notice of redemption to the warrant holders.
We have the ability to redeem outstanding public warrants at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of Common Stock equals or exceeds $900.00 per share (as adjusted for stock splits, stock capitalizations, reorganizations, recapitalizations and the like for certain issuances of public shares and equity-linked securities for capital raising purposes in connection with the closing of its initial business combination) for any 20 trading days within a 30 trading-day period ending on the third trading day prior to the date we send the notice of redemption to the warrant holders.
If we do not accurately evaluate the commercial potential or target market for a particular future product candidate, we may relinquish valuable rights to those future product candidates through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product candidates. 47 Interim and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit, validation, and verification procedures that could result in material changes in the final data.
If we do not accurately evaluate the commercial potential or target market for a particular future product candidate, we may relinquish valuable rights to those future product candidates through collaboration, licensing, or other royalty arrangements in cases in which it would have been more advantageous for us to retain sole development and commercialization rights to such future product candidates. 48 Interim and preliminary results from our clinical trials that we announce or publish from time to time may change as more patient data become available and are subject to audit, validation, and verification procedures that could result in material changes in the final data.
Any performance failure on the part of our suppliers could delay the development and potential commercialization of our product candidates, including limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect on our business. 61 If the third parties we rely on to help conduct our preclinical studies and clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize TVGN 489 and any future product candidates we develop, and our business could be materially harmed.
Any performance failure on the part of our suppliers could delay the development and potential commercialization of our product candidates, including limiting supplies necessary for clinical trials and regulatory approvals, which would have a material adverse effect on our business. 62 If the third parties we rely on to help conduct our preclinical studies and clinical trials do not successfully carry out their contractual duties, comply with regulatory requirements, or meet expected deadlines, we may not be able to obtain marketing approval for or commercialize TVGN 489 and any future product candidates we develop, and our business could be materially harmed.
Our business and operations could be negatively affected we become subject to any securities litigation or stockholder activism, which could cause us to incur significant expense, hinder execution of business and growth strategy and impact its stock price.
Our business and operations could be negatively affected if we become subject to any securities litigation or stockholder activism, which could cause us to incur significant expense, hinder execution of business and growth strategy and impact its stock price.
If FDA become aware of new safety information after approval of any of our product candidates, they may require labeling changes or establishment of a REMS, impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. 54 In addition, manufacturers of cell therapies and their facilities are subject to initial and continual review and periodic inspections by FDA for compliance with cGMP, GCP, GLP, GTP and other regulations.
If FDA become aware of new safety information after approval of any of our product candidates, they may require labeling changes or establishment of a REMS, impose significant restrictions on a product’s indicated uses or marketing or impose ongoing requirements for potentially costly post-approval studies or post-market surveillance. 55 In addition, manufacturers of cell therapies and their facilities are subject to initial and continual review and periodic inspections by FDA for compliance with cGMP, GCP, GLP, GTP and other regulations.
Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is a covered benefit under its health plan, safe, effective, and medically necessary, appropriate for the specific patient, cost-effective, and neither experimental nor investigational. 56 Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products.
Reimbursement by a third-party payor may depend upon a number of factors, including, but not limited to, the third-party payor’s determination that use of a product is a covered benefit under its health plan, safe, effective, and medically necessary, appropriate for the specific patient, cost-effective, and neither experimental nor investigational. 57 Obtaining coverage and reimbursement of a product from a government or other third-party payor is a time consuming and costly process that could require us to provide to the payor supporting scientific, clinical and cost-effectiveness data for the use of our products.
If regulatory authorities do not approve these other biological products or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the biologics we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval of or market any such product candidate. 52 The use artificial intelligence in our business may require us to spend material resources and presents risks that could adversely impact our business, including by posing security and other risks to our confidential and/or proprietary information.
If regulatory authorities do not approve these other biological products or revoke their approval of, or if safety, efficacy, manufacturing, or supply issues arise with, the biologics we choose to evaluate in combination with any product candidate we develop, we may be unable to obtain approval of or market any such product candidate. 53 The use artificial intelligence in our business may require us to spend material resources and presents risks that could adversely impact our business, including by posing security and other risks to our confidential and/or proprietary information.
Regardless of merit or eventual outcome, liability claims may result in: ● decreased demand for any product candidate we may develop; ● withdrawal of trial participants; 71 ● termination of clinical trial sites or entire trial programs; ● injury to our reputation and significant negative media attention; ● initiation of investigations by regulators; ● significant time and costs to defend the related litigation; ● substantial monetary awards to trial subjects or patients; ● diversion of management and scientific resources from our business operations; and ● the inability to commercialize any product candidates that we may develop.
Regardless of merit or eventual outcome, liability claims may result in: ● decreased demand for any product candidate we may develop; ● withdrawal of trial participants; 72 ● termination of clinical trial sites or entire trial programs; ● injury to our reputation and significant negative media attention; ● initiation of investigations by regulators; ● significant time and costs to defend the related litigation; ● substantial monetary awards to trial subjects or patients; ● diversion of management and scientific resources from our business operations; and ● the inability to commercialize any product candidates that we may develop.
Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained. 46 We may never receive regenerative medicine advanced therapy (“RMAT”) designation for TVGN 489 or any other product candidate, and receiving this designation may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that such product candidates will receive marketing approval.
Such policy or regulatory changes could impose additional requirements upon us that could delay our ability to obtain approvals, increase the costs of compliance or restrict our ability to maintain any marketing authorizations we may have obtained. 47 We may never receive regenerative medicine advanced therapy (“RMAT”) designation for TVGN 489 or any other product candidate, and receiving this designation may not lead to a faster development or regulatory review or approval process, and will not increase the likelihood that such product candidates will receive marketing approval.
Additionally, any potential failure to timely file future periodic reports could result in investors not receiving access to current or timely information regarding our business and operations with which to make investment decisions. 73 We may not have the funds necessary to satisfy our future obligations under the terms of our Preferred Stock and uncertainties with respect to our obligations under the terms of our Preferred Stock could materially and adversely affect our ability to raise capital, our liquidity position, our ability to operate our business and execute our business strategy, and the trading volatility and price of our securities.
Additionally, any potential failure to timely file future periodic reports could result in investors not receiving access to current or timely information regarding our business and operations with which to make investment decisions. 75 We may not have the funds necessary to satisfy our future obligations under the terms of our Preferred Stock and uncertainties with respect to our obligations under the terms of our Preferred Stock could materially and adversely affect our ability to raise capital, our liquidity position, our ability to operate our business and execute our business strategy, and the trading volatility and price of our securities.
These new obligations and constituents require significant attention from our senior management and could divert their attention away from the day-to-day management of our business, which could harm our business, financial condition, and results of operations. 75 If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendation regarding our Common Stock or if our results of operations do not meet their expectations, including projections in those reports that differ from our actual results, our share price and trading volume could decline.
These new obligations and constituents require significant attention from our senior management and could divert their attention away from the day-to-day management of our business, which could harm our business, financial condition, and results of operations. 77 If securities or industry analysts do not publish research or reports about our business, if they adversely change their recommendation regarding our Common Stock or if our results of operations do not meet their expectations, including projections in those reports that differ from our actual results, our share price and trading volume could decline.
Without a sufficiently scaled, appropriately timed, and trained internal commercial organization or the support of a third party to perform sales and marketing functions, we may be unable to compete successfully against these more established companies. 55 Data protection, privacy and similar laws restrict access, use, and disclosure of information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.
Without a sufficiently scaled, appropriately timed, and trained internal commercial organization or the support of a third party to perform sales and marketing functions, we may be unable to compete successfully against these more established companies. 56 Data protection, privacy and similar laws restrict access, use, and disclosure of information, and failure to comply with or adapt to changes in these laws could materially and adversely harm our business.
In such circumstances, we may be unable to conduct certain research and development programs, unable to adequately manage our clinical trials and development of our product candidates, and unable to adequately address our management needs. 70 As a result of these factors, these competitors may obtain regulatory approval of their products before we are able to, which could result in our competitors obtaining a head start and establishing a frontrunner position before we are ready to commercialize and will limit our ability to develop or commercialize our product candidates.
In such circumstances, we may be unable to conduct certain research and development programs, unable to adequately manage our clinical trials and development of our product candidates, and unable to adequately address our management needs. 71 As a result of these factors, these competitors may obtain regulatory approval of their products before we are able to, which could result in our competitors obtaining a head start and establishing a frontrunner position before we are ready to commercialize and will limit our ability to develop or commercialize our product candidates.
If any of our current or future product candidates fail to demonstrate safety and efficacy in clinical trials or do not gain marketing approval, we will not be able to generate revenue and our business will be harmed. 49 FDA or an IRB may also require that we suspend, discontinue, or limit our clinical trials based on safety information, or that we conduct additional preclinical studies regarding the safety and efficacy of our product candidates that we have not planned or anticipated.
If any of our current or future product candidates fail to demonstrate safety and efficacy in clinical trials or do not gain marketing approval, we will not be able to generate revenue and our business will be harmed. 50 FDA or an IRB may also require that we suspend, discontinue, or limit our clinical trials based on safety information, or that we conduct additional preclinical studies regarding the safety and efficacy of our product candidates that we have not planned or anticipated.
The inability to recruit, or the loss of services of certain executives, key employees, consultants, or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our business, financial condition, results of operations and growth prospects. 69 We may face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
The inability to recruit, or the loss of services of certain executives, key employees, consultants, or advisors, may impede the progress of our research, development and commercialization objectives and have a material adverse effect on our business, financial condition, results of operations and growth prospects. 70 We may face substantial competition, which may result in others discovering, developing, or commercializing products before or more successfully than we do.
However, trade secrets can be difficult to protect, and some courts inside and outside the United States are less willing or unwilling to protect trade secrets. 66 Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business and financial condition.
However, trade secrets can be difficult to protect, and some courts inside and outside the United States are less willing or unwilling to protect trade secrets. 67 Third parties may initiate legal proceedings alleging that we are infringing their intellectual property rights, the outcome of which would be uncertain and could have a material adverse effect on the success of our business and financial condition.
In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country. 57 The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other third-party payors fail to provide coverage and adequate reimbursement. We expect downward pressure on pharmaceutical pricing to continue.
In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within a country. 58 The marketability of any product candidates for which we receive regulatory approval for commercial sale may suffer if government and other third-party payors fail to provide coverage and adequate reimbursement. We expect downward pressure on pharmaceutical pricing to continue.
Additionally, the terms of the Preferred Stock and our Loan Agreement may negatively impact our ability to raise additional capital through equity or debt financings, due to the potential substantial dilution to our stockholders that could occur as a result of the conversion of our convertible Preferred Stock or our issuance of shares under the Loan Agreement and due to the other terms of our Preferred Stock and the Loan Agreement, or may negatively affect our ability to obtain favorable or acceptable terms in connection with any such financing.
Additionally, the terms of our Preferred Stock, our Loan Agreement, and our Sales Agreement may negatively impact our ability to raise additional capital through equity or debt financings, due to the potential substantial dilution to our stockholders that could occur as a result of the conversion of our convertible Preferred Stock or our issuance of shares under the Loan Agreement or Sales Agreement and due to the other terms of our Preferred Stock and such agreements, or may negatively affect our ability to obtain favorable or acceptable terms in connection with any such financing.
We do not have any products that are approved for commercial sale, and we may never be able to develop or commercialize marketable products. 43 Our ability to generate revenue from our product candidates, which could take years to develop, if it ever does, will depend heavily on the successful development, regulatory approval, and eventual commercialization of our product candidates.
We do not have any products that are approved for commercial sale, and we may never be able to develop or commercialize marketable products. 44 Our ability to generate revenue from our product candidates, which could take years to develop, if it ever does, will depend heavily on the successful development, regulatory approval, and eventual commercialization of our product candidates.
If and when finalized, this and other guidance documents, as well as other new FDA regulations and requirements, could present substantial and increasing costs for our compliance. 42 As an organization, we have limited experience designing and implementing preclinical and clinical trials, which is a complex, expensive, and time-consuming process and involves uncertain outcomes, and we have never conducted pivotal clinical trials.
If and when finalized, this and other guidance documents, as well as other new FDA regulations and requirements, could present substantial and increasing costs for our compliance. 43 As an organization, we have limited experience designing and implementing preclinical and clinical trials, which is a complex, expensive, and time-consuming process and involves uncertain outcomes, and we have never conducted pivotal clinical trials.
In addition, compliance with such laws may require increased costs to us or may dictate that wet not offer certain types of services in the future. Increasing use of AI could give rise to liability, breaches of data security and privacy laws, or reputational damage. AI-based solutions, including generative AI, are increasingly being used in the biopharmaceutical industry.
In addition, compliance with such laws may require increased costs to us or may dictate that we not offer certain types of services in the future. Increasing use of AI could give rise to liability, breaches of data security and privacy laws, or reputational damage. AI-based solutions, including generative AI, are increasingly being used in the biopharmaceutical industry.
There are limited numbers of CMOs that operate under cGMP regulations and that are capable of manufacturing cell therapies, and transferring manufacturing processes and know-how is complex and may require utilization of new or different processes to meet the specific requirements of a given facility. 60 Cell therapy manufacturing is susceptible to product loss due to contamination, equipment failure, and vendor or operator error.
There are limited numbers of CMOs that operate under cGMP regulations and that are capable of manufacturing cell therapies, and transferring manufacturing processes and know-how is complex and may require utilization of new or different processes to meet the specific requirements of a given facility. 61 Cell therapy manufacturing is susceptible to product loss due to contamination, equipment failure, and vendor or operator error.
For example, we will not be eligible to register the offer and sale of our securities using a short-form registration statement on Form S-3 until we have timely filed all periodic reports required under the Exchange Act for a period of twelve calendar months and any portion of a month immediately preceding the filing of such registration statement.
For example, we will not be eligible to register the offer and sale of our securities using a short-form registration statement on Form S-3 unless we have timely filed all periodic reports required under the Exchange Act for a period of twelve calendar months and any portion of a month immediately preceding the filing of such registration statement.
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations. 68 Intellectual property rights do not necessarily address all potential threats.
Our efforts to enforce or protect our proprietary rights related to trademarks, trade secrets, domain names, copyrights or other intellectual property may be ineffective and could result in substantial costs and diversion of resources and could adversely impact our financial condition or results of operations. 69 Intellectual property rights do not necessarily address all potential threats.
As restrictions on resale end and any registration statements we file for the resale of such shares are available for use, the market price of our Common Stock could decline if the holders of previously restricted shares sell them or are perceived by the market as intending to sell them. 77 Our directors, executive officers, and principal stockholders, and Dr.
As restrictions on resale end and any registration statements we file for the resale of such shares are available for use, the market price of our Common Stock could decline if the holders of previously restricted shares sell them or are perceived by the market as intending to sell them. 79 Our directors, executive officers, and principal stockholders, and Dr.
Ryan Saadi in particular, have substantial control over our Company, which could limit your ability to influence the outcome of key transactions, including a change of control. Our executive officers, directors, and principal stockholders and their affiliates beneficially own approximately 90% of the outstanding shares of Common Stock and our Chief Executive Officer, Dr.
Ryan Saadi in particular, have substantial control over our Company, which could limit your ability to influence the outcome of key transactions, including a change of control. Our executive officers, directors, and principal stockholders and their affiliates beneficially own approximately 81% of the outstanding shares of Common Stock and our Chief Executive Officer, Dr.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations or prospects. 67 If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected. Trade secrets and know-how can be difficult to protect.
Any of the foregoing could have a material adverse effect on our business, financial condition, results of operations or prospects. 68 If we are unable to protect the confidentiality of our proprietary information, the value of our technology and products could be adversely affected. Trade secrets and know-how can be difficult to protect.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates or result in the development of our product candidates stopping early. 45 The FDA regulatory approval process is lengthy and time-consuming and may lead to significant delays in the clinical development and regulatory approval of our product candidates.
In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical trials may also ultimately lead to the denial of regulatory approval of our product candidates or result in the development of our product candidates stopping early. 46 The FDA regulatory approval process is lengthy and time-consuming and may lead to significant delays in the clinical development and regulatory approval of our product candidates.
In addition, there have been a significant number of business combinations among large pharmaceutical and biotechnology companies that have resulted in a reduced number of potential future collaborators. 63 We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all.
In addition, there have been a significant number of business combinations among large pharmaceutical and biotechnology companies that have resulted in a reduced number of potential future collaborators. 64 We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. 65 In addition, many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
Uncertainties resulting from the initiation and continuation of patent litigation or other proceedings could have a material adverse effect on our ability to compete in the marketplace. 66 In addition, many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions.
A decline in the value of our Company could also cause you to lose all or part of your investment. We are relying in part on an additional $8.0 million of grant funding that we have not yet received to meet our liquidity needs.
A decline in the value of our Company could also cause you to lose all or part of your investment. We are relying in part on an additional $7.0 million of grant funding that we have not yet received to meet our liquidity needs.
Ryan Saadi, beneficially owns approximately 70% of the outstanding shares of Common Stock. As a result, these stockholders exercise a significant level of control over all matters requiring stockholder approval, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions.
Ryan Saadi, beneficially owns approximately 62% of the outstanding shares of Common Stock. As a result, these stockholders exercise a significant level of control over all matters requiring stockholder approval, including the election of directors and the approval of mergers, acquisitions or other extraordinary transactions.
If any of these risks materialize, this could have a material adverse effect on our financial condition and results of operations and could contribute to negative market perceptions about our securities. 76 We have identified material weaknesses in our internal control over financial reporting.
If any of these risks materialize, this could have a material adverse effect on our financial condition and results of operations and could contribute to negative market perceptions about our securities. 78 We have identified material weaknesses in our internal control over financial reporting.
In such an event, potential competitors might be able to enter the market and this circumstance could have a material adverse effect on our business. 64 We may not be able to protect our intellectual property rights throughout the world.
In such an event, potential competitors might be able to enter the market and this circumstance could have a material adverse effect on our business. 65 We may not be able to protect our intellectual property rights throughout the world.
We may also be subject to federal, state, and foreign laws governing the privacy and security of identifiable patient information. 59 The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform.
We may also be subject to federal, state, and foreign laws governing the privacy and security of identifiable patient information. 60 The scope and enforcement of each of these laws is uncertain and subject to rapid change in the current environment of healthcare reform.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We may issue additional shares of our Common Stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of your shares.
This could result in continuing uncertainty regarding compliance matters and higher costs necessitated by ongoing revisions to disclosure and governance practices. We have issued and in the future may issue additional shares of our Common Stock or other equity securities without your approval, which would dilute your ownership interests and may depress the market price of your shares.
If the material weaknesses are not remediated, or if we generally fail to establish and maintain effective internal controls appropriate for a public company, we may be unable to produce timely and accurate financial statements, and we may conclude that our internal control over financial reporting is not effective, which could adversely impact our investors’ confidence and our stock price.
If the material weakness is not remediated, or if we generally fail to establish and maintain effective internal controls appropriate for a public company, we may be unable to produce timely and accurate financial statements, and we may conclude that our internal control over financial reporting is not effective, which could adversely impact our investors’ confidence and our stock price.
Such results could negatively impact our business, financial condition, results of operations and prospects. 48 Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
Such results could negatively impact our business, financial condition, results of operations and prospects. 49 Changes in methods of product candidate manufacturing or formulation may result in additional costs or delay.
Further, its stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.
Further, our stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.
The price per share at which the additional shares or securities convertible or exchangeable into public shares, will be sold in future transactions may be higher or lower than the price per share paid by investors in this offering.
The price per share at which the additional shares or securities convertible or exchangeable into public shares, will be sold in future transactions may be higher or lower than the price per share paid by other investors.
If any of the above should occur, our stockholders, including investors who purchased public shares in this offering, will experience additional dilution, and any such issuances may result in downward pressure on the price of our Common Stock. 74 The issuance of additional shares of Common Stock or other equity securities of equal or senior rank could have the following effects: ● your proportionate ownership interest in Tevogen will decrease; ● the relative voting strength of each previously outstanding share of Common Stock may be diminished; or ● the market price of your shares of Common Stock may decline.
If any of the above should occur, our stockholders will experience additional dilution, and any such issuances may result in downward pressure on the price of our Common Stock. 76 The issuance of additional shares of Common Stock or other equity securities of equal or senior rank could have the following effects: ● your proportionate ownership interest in Tevogen will decrease; ● the relative voting strength of each previously outstanding share of Common Stock may be diminished; or ● the market price of your shares of Common Stock may decline.
Although we continue to evaluate steps to remediate these material weaknesses, the material weaknesses will not be considered remediated until our plan has been fully implemented, the applicable controls are fully operational for a sufficient period of time, and we have concluded, through testing, that the newly implemented and enhanced controls are operating effectively.
Although we have remediated one material weakness as of December 31, 2025 and we continue to evaluate steps to remediate the remaining material weakness, the material weakness will not be considered remediated until our plan has been fully implemented, the applicable controls are fully operational for a sufficient period of time, and we have concluded, through testing, that the newly implemented and enhanced controls are operating effectively.
To address these material weaknesses, we intend to hire additional accounting personnel with appropriate expertise in accounting and reporting under U.S. generally accepted accounting principles (“GAAP”) and SEC regulations in order to better align with segregation of duties and perform appropriate risk assessment procedures to evaluate risks of material misstatement.
To address the material weakness, we intend to hire additional accounting personnel with appropriate expertise in accounting and reporting under U.S. generally accepted accounting principles (“GAAP”) and SEC regulations in order to perform appropriate risk assessment procedures to evaluate risks of material misstatement.
We are not currently taking advantage of these exemptions. However, for so long as we qualify as a “controlled company,” we maintain the option to rely on some or all of these exemptions.
We currently take advantage of certain of these exemptions. For so long as we qualify as a “controlled company,” we maintain the option to rely on some or all of these exemptions.
The realization of any of the above risks or any of a broad range of other risks, including those described in this “ Risk Factors ” section, could have a dramatic and material adverse impact on the market price of our Common Stock following the business combination. We have previously failed to timely file certain periodic reports with the SEC.
The realization of any of the above risks or any of a broad range of other risks, including those described in this “ Risk Factors ” section, could have a dramatic and material adverse impact on the market price of our Common Stock following the business combination.
We expect to spend substantial amounts of cash to continue the preclinical and clinical development of our current and future programs. If we receive marketing approval for any product candidates, including TVGN 489, we will require significant additional amounts of cash in order to launch and commercialize such product candidates. In addition, other unanticipated costs may arise.
If we receive marketing approval for any product candidates, including TVGN 489, we will require significant additional amounts of cash in order to launch and commercialize such product candidates. In addition, other unanticipated costs may arise.
Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, amounts available under the Loan Agreement, and an additional $8.0 million of grant funding we expect to receive in the second quarter of 2025 from KRHP LLC, a New Jersey limited liability company (“KRHP”).
Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, amounts available under the Loan Agreement (as defined below), proceeds from sales of Common Stock under our Sales Agreement with A.G.P./Alliance Global Partners (the “Sales Agreement”), and an additional $7.0 million of grant funding we expect to receive in 2026 from KRHP LLC, a New Jersey limited liability company (“KRHP”).
If we are unable to obtain additional financing on favorable terms when needed, we may be required to delay, limit, reduce, or terminate preclinical studies, clinical trials, or other research and development activities or one or more of our development programs.
If we are unable to obtain additional financing on favorable terms when needed, we may be required to delay, limit, reduce, or terminate preclinical studies, clinical trials, or other research and development activities or one or more of our development programs. 42 Risks Related to Development, Regulatory Review, and Product Approval The regulatory landscape that applies to cellular therapy product candidates is rigorous, complex, uncertain, and subject to change.
Additionally, RMAT designation can be revoked if the criteria for eligibility cease to be met as clinical data emerges. Our business is highly dependent on our first product candidate, TVGN 489, and we must conduct clinical testing before we can obtain regulatory approval and begin commercialization of any of our product candidates.
Our business is highly dependent on our first product candidate, TVGN 489, and we must conduct clinical testing before we can obtain regulatory approval and begin commercialization of any of our product candidates.
We are relying in part on the additional grant funding to help meet our liquidity needs. Even if we receive all of such proceeds, we will still need additional capital to fully implement our business, operating, and development plans. At this time, we have not secured any additional financing.
Even if we receive all of such proceeds, we will still need more capital to fully implement our business, operating, and development plans, in addition to proceeds from sales of Common Stock under our Sales Agreement. At this time, we have not secured any additional financing.
The additional shares or other securities convertible into or exchangeable for our public shares may be offered at price that may not be the same as the price per share in this offering.
The additional shares or other securities convertible into or exchangeable for our public shares may be offered at prices that may not be the same as the price per share paid by other investors. Investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
In January 2025, we received a grant of $2.0 million from KRHP to further our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers. KRHP also committed to provide an additional $8.0 million of grant funding to the Company to be used towards the Company’s ongoing operational expenses.
In January 2025, we received a grant of $2.0 million from KRHP to further our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers. In August 2025, we received a grant of $1.0 million from KRHP to advance Tevogen.AI.
Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of our product candidates. We face an inherent risk of product liability exposure related to the testing of our product candidates in human trials and may face greater risk if we commercialize any products that we develop.
We face an inherent risk of product liability exposure related to the testing of our product candidates in human trials and may face greater risk if we commercialize any products that we develop. Product liability claims may be brought against us by subjects enrolled in our trials, patients, healthcare providers or others using, administering, or selling our products.
Potential future delays in the filing of our reports with the SEC pose significant risks to our business, and could materially and adversely affect our financial condition and results of operations.
You may be unable to sell your securities unless a market can be established or sustained. We have previously failed to timely file certain periodic reports with the SEC. Potential future delays in the filing of our reports with the SEC pose significant risks to our business, and could materially and adversely affect our financial condition and results of operations.
We will require substantial additional financing to pursue our business objectives, which may not be available on acceptable terms, or at all. A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations.
We will require substantial additional financing to pursue our business objectives and to fund our operations, which may not be available on acceptable terms, or at all.
Product liability claims may be brought against us by subjects enrolled in our trials, patients, healthcare providers or others using, administering, or selling our products. If we cannot successfully defend ourselves against such claims, we could incur substantial liabilities.
If we cannot successfully defend ourselves against such claims, we could incur substantial liabilities.
Removed
Because the designs and outcomes of our planned and anticipated clinical trials are highly uncertain, we cannot reasonably estimate the actual amounts necessary to successfully complete the development of and commercialize any product candidate we develop.
Added
KRHP also committed to provide an additional $7.0 million of grant funding to the Company to be used towards the Company’s ongoing operational expenses. We are relying in part on the additional grant funding to help meet our liquidity needs.
Removed
Risks Related to Development, Regulatory Review, and Product Approval The regulatory landscape that applies to cellular therapy product candidates is rigorous, complex, uncertain, and subject to change.
Added
A failure to obtain this necessary capital when needed could force us to delay, limit, reduce or terminate our product development, commercialization efforts or other operations and affect our future viability as an ongoing business.
Removed
We may sell shares or other securities in any other offering at a price per share that is less than the price per share paid by the investors in this offering, and investors purchasing shares or other securities in the future could have rights superior to existing stockholders.
Added
We expect to spend substantial amounts of cash to continue the preclinical and clinical development of our current and future immunotherapy programs, to fund our Tevogen.AI artificial intelligence initiative, and to pursue other potential business objectives.
Added
Until we can generate sufficient product and royalty revenue to finance our cash requirements, which we may never do, we expect to finance our future cash needs through a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, and licensing arrangements.
Added
As a result of our cash balance, as well as our history of operating losses and negative cash flows from operations combined with our anticipated use of cash to, among other things, fund the preclinical and clinical development of our products, identify and develop new product candidates, and seek approval for TVGN 489 and our other product candidates and any other product candidates we develop, we will require substantial additional financing to pursue our business objectives and fund our operations.
Added
Our future viability as an ongoing business is dependent on our ability to generate cash from operating activities or to raise additional capital to finance our operations. As reflected in our balance sheets, we have significant accounts payable, accrued expenses and other liabilities.
Added
Proceeds from any capital-raising transactions may be used to reduce our accounts payable accrued expenses and other liabilities. However, there can be no assurance that we will raise sufficient funds to eliminate such amounts.
Added
Additionally, RMAT designation can be revoked if the criteria for eligibility cease to be met as clinical data emerges. We may also seek other accelerated approval pathways for our product candidates, which face some of the same risks as seeking RMAT designation, and may not be successful or actually result in expedited review or approval.
Added
One of these programs is the FDA Commissioner’s National Priority Voucher pilot program, which additionally is new and has only seen 18 products receive vouchers and one product see FDA approval as of December 2025, therefore presenting additional unknown risks.
Added
We may not realize the benefits of any acquisitions, strategic alliances, or similar arrangements that we enter into.

… 18 more changes not shown on this page.

Item 1C. Cybersecurity

Cybersecurity — threats and controls disclosure

2 edited+0 added−0 removed12 unchanged
Biggest changeAs of the date of this Annual Report, we are no t aware of any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially affected our business strategy, results of operations, or financial condition or are reasonably likely to have such a material effect .
Biggest changeAs of the date of this Annual Report, we are not aware of any risks from cybersecurity threats, including as a result of any previous cybersecurity incidents, that have materially affected our business strategy, results of operations, or financial condition or are reasonably likely to have such a material effect.
This program includes a number of safeguards, such as: multi-factor authentication; monitoring internal and cloud-based systems for threats; email filters; cybersecurity awareness training; limitation on the use of third-party devices; conditional access rules; and regular evaluations of our cybersecurity program. 78 We use a risk-based approach with respect to our use and oversight of third-party service providers and vendors, tailoring processes according to the nature and sensitivity of the data accessed, processed, or stored by such third-party service provider.
This program includes a number of safeguards, such as: multi-factor authentication; monitoring internal and cloud-based systems for threats; email filters; cybersecurity awareness training; limitation on the use of third-party devices; conditional access rules; and regular evaluations of our cybersecurity program. 80 We use a risk-based approach with respect to our use and oversight of third-party service providers and vendors, tailoring processes according to the nature and sensitivity of the data accessed, processed, or stored by such third-party service provider.

Item 2. Properties

Properties — owned and leased real estate

2 edited+0 added−0 removed0 unchanged
Biggest changeWe also have two research and development facilities located in Philadelphia: our 3,620 square foot research and development center under a lease that expires June 30, 2025; and a shared facility with laboratory space dedicated to us that is focused on preclinical and pharmacodynamic activities.
Biggest changeWe also have one research and development facility located in Philadelphia, which is a shared facility with laboratory space dedicated to us that is focused on preclinical and pharmacodynamic activities.
Item 2. Properties. Our corporate headquarters are located in Warren, New Jersey, and consist of 6,708 square feet dedicated to corporate, operational, and pre-commercial activities under a lease that expires February 14, 2026.
Item 2. Properties. Our corporate headquarters are located in Warren Township, New Jersey, and consist of 13,242 square feet dedicated to corporate, operational, and pre-commercial activities under a lease that expires February 28, 2033.

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

2 edited+0 added−0 removed1 unchanged
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our common stock and public warrants began trading on Nasdaq under the symbols “TVGN” and “TVGNW.” As of March 21, 2025, there were approximately 90 holders of record of our common stock and 183,893,433 shares of common stock outstanding.
Biggest changeItem 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities Our Common Stock and public warrants began trading on Nasdaq under the symbols “TVGN” and “TVGNW.” As of March 27, 2026, there were approximately 36 holders of record of our Common Stock and 4,164,205 shares of Common Stock outstanding.
We are unable to estimate the total number of stockholders represented by these record holders, as many of our shares are held by brokers and other institutions on behalf of our stockholders. We have never paid cash dividends on our capital stock and we do not anticipate paying any cash dividends in the foreseeable future.
We are unable to estimate the total number of stockholders represented by these record holders, as many of our shares are held by brokers and other institutions on behalf of our stockholders. We have never paid cash dividends on our capital stock and we do not anticipate paying any regular cash dividends in the foreseeable future.

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

46 edited+41 added−7 removed74 unchanged
Biggest changeIn addition, KRHP has committed to provide an additional $8.0 million of grant funding to the Company to be used towards the Company’s ongoing operational expenses. The grant funding will be used to satisfy the Company’s obligations as they come due through March 31, 2026. The Company does not plan to initiate a clinical trial until additional funding is received.
Biggest changeIn August 2025, we received a grant of $1.0 million from KRHP to advance Tevogen.AI. KRHP is affiliated with the Patel Family. KRHP also committed to provide an additional $7.0 million of grant funding to us to be used towards our ongoing operational expenses.
Our future capital requirements will depend on many factors, including: ● the progress, costs, and results of our planned clinical trials of TVGN 489 and other planned and future clinical trials; ● the scope, progress, costs, and results of our pre-clinical testing and clinical trials of TVGN 489 for additional combinations, targets, and indications; ● the number of and development requirements for additional indications for TVGN 489 or for any other product candidates; 88 ● our ability to scale up our manufacturing processes and capabilities to support clinical trials of TVGN 489 and other product candidates we are developing and may develop in the future; ● the costs, timing, and outcome of regulatory review of TVGN 489 and other product candidates we are developing and may develop in the future; ● potential changes in the regulatory environment and enforcement rules; ● our ability to establish and maintain strategic collaboration, licensing, or other arrangements and the financial terms of such arrangements; ● the costs and timing of future commercialization activities, including product manufacturing, sales, marketing, and distribution, for TVGN 489 and other product candidates we are developing and may develop in the future for which we may receive marketing approval; ● our ability to obtain and maintain acceptance of any approved products by patients, the medical community, and third-party payors; ● the amount and timing of revenue, if any, received from commercial sales of TVGN 489 and any other product candidates we are developing or develop in the future for which we receive marketing approval; ● potential changes in pharmaceutical pricing and reimbursement infrastructure; ● the availability of raw materials for use in production of our product candidates; and ● the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending any intellectual property-related claims.
Our future capital requirements will depend on many factors, including: ● the progress, costs, and results of our planned clinical trials of TVGN 489 and other planned and future clinical trials; ● the scope, progress, costs, and results of our pre-clinical testing and clinical trials of TVGN 489 for additional combinations, targets, and indications; ● the number of and development requirements for additional indications for TVGN 489 or for any other product candidates; 90 ● our ability to scale up our manufacturing processes and capabilities to support clinical trials of TVGN 489 and other product candidates we are developing and may develop in the future; ● the costs, timing, and outcome of regulatory review of TVGN 489 and other product candidates we are developing and may develop in the future; ● potential changes in the regulatory environment and enforcement rules; ● our ability to establish and maintain strategic collaboration, licensing, or other arrangements and the financial terms of such arrangements; ● the costs and timing of future commercialization activities, including product manufacturing, sales, marketing, and distribution, for TVGN 489 and other product candidates we are developing and may develop in the future for which we may receive marketing approval; ● our ability to obtain and maintain acceptance of any approved products by patients, the medical community, and third-party payors; ● the amount and timing of revenue, if any, received from commercial sales of TVGN 489 and any other product candidates we are developing or develop in the future for which we receive marketing approval; ● potential changes in pharmaceutical pricing and reimbursement infrastructure; ● the availability of raw materials for use in production of our product candidates; and ● the costs and timing of preparing, filing, and prosecuting patent applications, maintaining and enforcing our intellectual property and proprietary rights, and defending any intellectual property-related claims.
Operating Expenses Research and Development Expenses Research and development expenses consist primarily of costs incurred for our research activities, including staffing, discovery efforts, preclinical studies, and clinical development of TVGN 489, and preclinical studies of other product candidates, and include: ● acquisition of supplies and equipment and leasing lab spaces; ● expenses incurred to conduct the necessary pre-clinical studies required by FDA to obtain the regulatory approval necessary to conduct TVGN 489 clinical trials; ● salaries, benefits, and other related costs for personnel engaged in research and development functions; ● costs of funding research performed by third parties, including pursuant to agreements with CROs, and investigative site costs to conduct our pre-clinical studies and clinical trials; ● manufacturing costs, including expenses incurred under agreements with CMOs, including manufacturing scale-up expenses, and the cost of acquiring and manufacturing pre-clinical study and clinical trial materials; ● costs of outside consultants, including their fees, stock-based compensation, and related travel expenses; ● costs of laboratory supplies and acquiring materials for pre-clinical studies and clinical trials; and ● facility-related expenses, which include direct depreciation costs of equipment and expenses for rent and maintenance of facilities and other operating costs. 82 Research and development activities are central to the biotechnology business model.
Operating Expenses Research and Development Expenses Research and development expenses consist primarily of costs incurred for our research activities, including staffing, discovery efforts, preclinical studies, and clinical development of TVGN 489, and preclinical studies of other product candidates, and include: ● acquisition of supplies and equipment and leasing lab spaces; ● expenses incurred to conduct the necessary pre-clinical studies required by FDA to obtain the regulatory approval necessary to conduct TVGN 489 clinical trials; ● salaries, benefits, and other related costs for personnel engaged in research and development functions; ● costs of funding research performed by third parties, including pursuant to agreements with CROs, and investigative site costs to conduct our pre-clinical studies and clinical trials; ● manufacturing costs, including expenses incurred under agreements with CMOs, including manufacturing scale-up expenses, and the cost of acquiring and manufacturing pre-clinical study and clinical trial materials; ● costs of outside consultants, including their fees, stock-based compensation, and related travel expenses; ● costs of laboratory supplies and acquiring materials for pre-clinical studies and clinical trials; and ● facility-related expenses, which include direct depreciation costs of equipment and expenses for rent and maintenance of facilities and other operating costs. 84 Research and development activities are central to the biotechnology business model.
Cash Flows from Financing Activities During the year ended December 31, 2024, we received $12.3 million of net cash from financing activities attributable to $2.0 million in proceeds from the sale of Series A Preferred Stock, $6.0 million in proceeds from the sale of Series C Preferred Stock, $3.0 million of non-refundable prepaid proceeds towards the anticipated issuance of Series A-1 Preferred Stock, $1.0 million drawn under the Loan Agreement, and $0.2 million of cash in connection with the Merger.
During the year ended December 31, 2024, we received $12.3 million of net cash from financing activities attributable to $2.0 million in proceeds from the sale of Series A Preferred Stock, $6.0 million in proceeds from the sale of Series C Preferred Stock, $3.0 million of non-refundable prepaid proceeds towards the anticipated issuance of Series A-1 Preferred Stock, $1.0 million drawn under the Loan Agreement, and $0.2 million of cash in connection with the Merger.
Increased costs associated with being a public company will also include expenses related to services associated with maintaining compliance with SEC and Nasdaq requirements, insurance, and investor relations costs. If any of our current or future product candidates obtains marketing approval, we expect that we would incur significantly increased expenses associated with sales and marketing efforts.
Increased costs associated with being a public company also include expenses related to services associated with maintaining compliance with SEC and Nasdaq requirements, insurance, and investor relations costs. If any of our current or future product candidates obtains marketing approval, we expect that we would incur significantly increased expenses associated with sales and marketing efforts.
Examples of estimated accrued research and development expenses include fees paid to: ● vendors in connection with preclinical and clinical development activities; ● CROs in connection with clinical trials; and ● CMOs in connection with the process development and scale-up activities and the production of preclinical and clinical trial materials. 90 Costs for clinical trials and manufacturing activities are recognized based on an evaluation of our vendors’ progress towards completion of specific tasks, using data such as participant enrollment, clinical site activations, or information provided to us by our vendors regarding their actual costs incurred.
Examples of estimated accrued research and development expenses include fees paid to: ● vendors in connection with preclinical and clinical development activities; ● CROs in connection with clinical trials; and ● CMOs in connection with the process development and scale-up activities and the production of preclinical and clinical trial materials. 92 Costs for clinical trials and manufacturing activities are recognized based on an evaluation of our vendors’ progress towards completion of specific tasks, using data such as participant enrollment, clinical site activations, or information provided to us by our vendors regarding their actual costs incurred.
The Loan Agreement also contains a contingent option for the Patel Family to purchase at least $14.0 million of our Common Stock plus up to the then-remaining available amount under the Facility, in a future private placement if the ten-day trailing volume weighted average price per share of the Common Stock (the “Trailing VWAP”) reaches $10.00 per share.
The Loan Agreement also contains a contingent option for the Patel Family to purchase at least $14.0 million of our Common Stock plus up to the then-remaining available amount under the Facility, in a future private placement if the ten-day trailing volume weighted average price per share of the Common Stock (the “Trailing VWAP”) reaches $500.00 per share.
The MCS methodology simulates our future stock price to estimate if and when the Trailing VWAP will reach $10.00 per share, and discounts the resulting payoff back to each valuation date using a present value factor. Significant assumptions used in determining the fair value of these options include volatility and discount rate.
The MCS methodology simulates our future stock price to estimate if and when the Trailing VWAP will reach $500.00 per share, and discounts the resulting payoff back to each valuation date using a present value factor. Significant assumptions used in determining the fair value of these options include volatility and discount rate.
The Optional PIPE would be priced at a 30% discount to the Trailing VWAP on the date such price first reaches at least $10.00 per share (the “Threshold Price Date”) and will be exercisable by the Patel Family by written notice within three business days after we have notified the Patel Family of the Threshold Price Date (the date of such notice, the “Threshold Price Notice Date”).
The Optional PIPE would be priced at a 30% discount to the Trailing VWAP on the date such price first reaches at least $500.00 per share (the “Threshold Price Date”) and will be exercisable by the Patel Family by written notice within three business days after we have notified the Patel Family of the Threshold Price Date (the date of such notice, the “Threshold Price Notice Date”).
We anticipate that product commercialization may take several years, and we expect to spend a significant amount in development costs. 83 General and Administrative Expenses General and administrative expenses primarily consist of personnel expenses, which include salaries, benefits, and stock-based long term incentive compensation for employees.
We anticipate that product commercialization may take several years, and we expect to spend a significant amount in development costs. 85 General and Administrative Expenses General and administrative expenses primarily consist of personnel expenses, which include salaries, benefits, and stock-based long term incentive compensation for employees.
To date, we have not yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from the sale of convertible promissory notes and preferred stock, funds drawn on the Loan Agreement, and grant funding.
To date, we have not yet commercialized any products or generated any revenue from product sales and have financed our operations primarily with proceeds from the sale of convertible promissory notes and preferred stock, funds drawn on the Loan Agreement, grant funding, and proceeds from sales of Common Stock under the Sales Agreement.
We used a Monte Carlo Simulation (“MCS”) valuation methodology to determine the fair value of the freestanding $14 million purchase option and embedded purchase option associated with the Loan Agreement at inception and as of December 31, 2024.
We used a Monte Carlo Simulation (“MCS”) valuation methodology to determine the fair value of the freestanding $14 million purchase option and embedded purchase option associated with the Loan Agreement at inception and as of December 31, 2025.
On August 21, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor agreed to purchase shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million. 87 On June 6, 2024, we entered into the Loan Agreement, pursuant to which the Patel Family agreed to provide to us up to the Maximum Loan Amount of $36.0 million under the Facility.
On August 21, 2024, we entered into a securities purchase agreement with an investor pursuant to which the investor purchased shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million. 89 On June 6, 2024, we entered into the Loan Agreement, pursuant to which the Patel Family agreed to provide to us up to the Maximum Loan Amount of $36.0 million under the Facility.
We may repay or prepay any amount of outstanding principal balance under the Facility at our election in cash or in shares of Common Stock with an effective purchase price of the greater of $1.50 per share and the 10-day trailing volume weighted average price of the Common Stock (the “Trailing VWAP”) as of the trading day prior to payment, subject to certain requirements related to resale registration.
We may repay or prepay any amount of outstanding principal balance under the Facility at our election in cash or in shares of Common Stock with an effective purchase price of the greater of $75.00 per share and the 10-day trailing volume weighted average price of the Common Stock (the “Trailing VWAP”) as of the trading day prior to payment, subject to certain requirements related to resale registration.
Recent Accounting Pronouncements See Note 3 to our consolidated financial statements found in this Annual Report for a description of recent accounting pronouncements applicable to our financial statements. 91
Recent Accounting Pronouncements See Note 3 to our consolidated financial statements found in this Annual Report for a description of recent accounting pronouncements applicable to our financial statements. 93
The change was primarily a result of the increase in the underlying estimated fair value of our Common Stock during the year ended December 31, 2023 compared to a decrease in the underlying estimated fair value of our Common Stock from January 1, 2024 to the settlement of the convertible promissory notes upon the Closing.
The non-cash gain in the year ended December 31, 2024, was primarily a result of the increase in the underlying estimated fair value of our Common Stock during the year ended December 31, 2023 compared to a decrease in the underlying estimated fair value of our Common Stock from January 1, 2024 to the settlement of the convertible promissory notes upon the Closing.
Interest Expense, Net We recognized $0.2 million and $1.2 million in interest expense for the years ended December 31, 2024 and 2023, respectively, which was attributable primarily to the outstanding principal balance associated with our convertible promissory notes that converted into Common Stock in connection with the Closing.
Interest Expense, Net We recognized $0.2 million in interest expense for the years ended December 31, 2025 and 2024, respectively, which was attributable primarily to the outstanding balance on the Facility and the outstanding principal balance associated with our convertible promissory notes that converted into Common Stock in connection with the Closing, respectively.
Interest will be payable in shares of Common Stock with an effective purchase price of $1.50 per share, and each draw will mature 48 months after the Deposit Date. Prepayment will be permitted without penalty.
Interest will be payable in shares of Common Stock with an effective purchase price of $75.00 per share, and each draw will mature 48 months after the Deposit Date. Prepayment will be permitted without penalty.
Pursuant to the terms of the Loan Agreement, we also issued to the Patel Family 1,000,000 shares of Common Stock as a commitment fee (the “Commitment Shares”), subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares of Common Stock in the event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date (as defined in the Loan Agreement) in the event we have satisfied all applicable closing conditions. 81 In addition, in January 2025, we received a grant of $2.0 million from KRHP to further our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers.
Pursuant to the terms of the Loan Agreement, we also issued to the Patel Family 20,000 shares of Common Stock as a commitment fee (the “Commitment Shares”), subject to forfeiture by the Patel Family of the Commitment Shares or an equal number of shares of Common Stock in the event the Patel Family fails to (i) make a deposit under the Facility when due or (ii) pay the purchase price for the Optional PIPE within 30 days after the Threshold Price Notice Date (as defined in the Loan Agreement) in the event we have satisfied all applicable closing conditions. 83 In January 2025, we received a grant of $2.0 million from KRHP LLC, a New Jersey limited liability company (“KRHP”), to further our development of off-the-shelf, genetically unmodified precision T cell therapeutics to treat infectious diseases and cancers.
Significant assumptions used in determining the fair value of convertible promissory notes include volatility, discount rate, and probability of a future liquidity event. In February 2024, concurrent with the Merger, we converted our outstanding convertible promissory notes into 10,337,419 shares of Common Stock.
Significant assumptions used in determining the fair value of convertible promissory notes include volatility, discount rate, and probability of a future liquidity event. In February 2024, concurrent with the Merger, we converted our outstanding convertible promissory notes into 206,748 shares of Common Stock.
As of December 31, 2024, we had cash of $1.3 million. On February 14, 2024, we entered into a securities purchase agreement with The Patel Family, LLP (the “Patel Family”) pursuant to which the Patel Family purchased 500 shares of our Series A Preferred Stock for an aggregate purchase price of $2.0 million.
On February 14, 2024, we entered into a securities purchase agreement with The Patel Family, LLP (the “Patel Family”) pursuant to which the Patel Family purchased 500 shares of our Series A Preferred Stock for an aggregate purchase price of $2.0 million.
For more information about the Loan Agreement, see “— Liquidity and Capital Resources—Funding Requirements ” below. Income Tax Provision Since inception, we have incurred significant net losses. As of December 31, 2024, we had net operating loss carryforwards (“NOLs”) for federal and state income tax purposes of $25.6 million and $27.8 million, respectively.
For more information about the Loan Agreement, see “- Liquidity and Capital Resources-Funding Requirements ” below. Income Tax Provision Since inception, we have incurred significant net losses. As of December 31, 2025, we had net operating loss carryforwards (“NOLs”) for federal and state income tax purposes of $43.1 million and $45.4 million, respectively.
Our utilization of our NOLs may be subject to a substantial annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, respectively, as well as similar state provisions. 84 Results of Operations Comparison of the years ended December 31, 2024 and 2023 The following table summarizes our results of operations for the years ended December 31, 2024 and 2023: Year ended December 31, 2024 2023 Operating expenses: Research and development $ 31,033,276 $ 4,403,526 General and administrative 22,531,212 4,439,499 Total operating expenses 53,564,488 8,843,025 Loss from operations (53,564,488 ) (8,843,025 ) Interest expense, net (184,037 ) (1,206,352 ) Merger transaction costs (7,499,353 ) — Change in fair value of warrants (58,180 ) — Change in fair value of convertible promissory notes 48,468,678 (50,428,303 ) Loss on issuance of commitment shares (890,000 ) — Net loss $ (13,727,380 ) $ (60,477,680 ) Research and Development Expenses We do not track our internal research and development costs on a program-by-program basis.
Our utilization of our NOLs may be subject to a substantial annual limitation in the event of certain cumulative changes in the ownership interest of significant stockholders over a three-year period in excess of 50%, as defined under Sections 382 and 383 of the Internal Revenue Code of 1986, as amended, respectively, as well as similar state provisions. 86 Results of Operations Comparison of the years ended December 31, 2025 and 2024 The following table summarizes our results of operations for the years ended December 31, 2025 and 2024: Year ended December 31, 2025 2024 Operating expenses: Research and development $ 11,111,586 $ 31,033,276 General and administrative 15,028,929 22,531,212 Total operating expenses 26,140,515 53,564,488 Loss from operations (26,140,515 ) (53,564,488 ) Interest expense, net (195,618 ) (184,037 ) Merger transaction costs - (7,499,353 ) Change in fair value of warrants 60,701 (58,180 ) Change in fair value of convertible promissory notes - 48,468,678 Loss on issuance of commitment shares - (890,000 ) Net loss $ (26,275,432 ) $ (13,727,380 ) Research and Development Expenses We do not track our internal research and development costs on a program-by-program basis.
In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below. As of December 31, 2024, we had drawn $1.0 million with a remaining $30.0 million available for future financing over the remaining 30 months.
In June 2024, we entered into the Loan Agreement, which provided up to $36.0 million of term loans that can be drawn in $1.0 million increments each month over thirty-six months, as described below.
We regularly evaluate different strategies to obtain funding for operations for subsequent periods. These strategies may include but are not limited to private placements of securities, licensing and/or marketing arrangements, partnerships with other pharmaceutical or biotechnology companies, and public offerings of securities.
The Company does not plan to initiate a clinical trial until additional funding is received. We regularly evaluate different strategies to obtain funding for operations for subsequent periods. These strategies may include but are not limited to private placements of securities, licensing and/or marketing arrangements, partnerships with other pharmaceutical or biotechnology companies, and public offerings of securities.
Funding Requirements Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, including the funding we have received from the sale of our Series A and Series C Preferred Stock and the funding we expect to receive from the sale of our Series A-1 Preferred Stock, our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described below, and the $8.0 million of grant funding that KRHP has committed to provide to be used towards the Company’s ongoing operational expenses.
Funding Requirements Our primary sources of funds to meet our near-term liquidity and capital requirements include cash on hand, our access to an unsecured line of credit (limited to a $1.0 million monthly draw) under the Loan Agreement described below, potential future sales of Common Stock under the Sales Agreement, and the $7.0 million of grant funding that KRHP has committed to provide to be used towards the Company’s ongoing operational expenses.
On August 21, 2024, we entered into a securities purchase agreement with the Patel Family, pursuant to which the investor purchased 600 shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million.
As of the date of this Annual Report, a payment date for the remaining $3.0 million has not been set. On August 21, 2024, we entered into a securities purchase agreement with the Patel Family, pursuant to which the investor purchased 600 shares of our Series C Preferred Stock for an aggregate purchase price of $6.0 million.
We believe that our cash balance and amounts available under the Loan Agreement, which allows us to draw down term loans of $1.0 million per month over thirty-six months, 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 included in this Annual Report.
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 included in this Annual Report.
Based on cash on hand as of the date of this Annual Report of approximately $1.3 million, the amounts available under our Loan Agreement, and the $8.0 million of additional committed grant funding from KRHP, we have concluded that we have sufficient cash to fund our operations for at least the next 12 months from the issuance date of our consolidated financial statements.
Based on cash on hand as of the date of this Annual Report of approximately $0.6 million, net proceeds of $0.9 million received from sales of Common Stock under the Sales Agreement subsequent to December 31, 2025, combined with the amounts available under our Loan Agreement, and the $7.0 million of additional committed grant funding from KRHP, we have concluded that we have sufficient cash to fund our operations for at least the next 12 months from the issuance date of our consolidated financial statements.
During the year ended December 31, 2023, we used $8.2 million of net cash in operating activities.
During the year ended December 31, 2024, we used $12.0 million of net cash in operating activities.
The following table summarizes our research and development expenses for the years ended December 31, 2024 and 2023: Year ended December 31, 2024 2023 Personnel costs $ 466,955 $ 2,263,711 Stock-based compensation 27,012,127 - Other clinical and pre-clinical development expenses 2,584,651 1,226,402 Facilities and other expenses 969,543 913,413 Total research and development expenses $ 31,033,276 $ 4,403,526 Research and development expenses for the year ended December 31, 2024 were $31.0 million, compared to $4.4 million for the year ended December 31, 2024.
The following table summarizes our research and development expenses for the years ended December 31, 2025 and 2024: Year ended December 31, 2025 2024 Personnel costs $ 2,285,015 $ 466,955 Stock-based compensation 7,329,355 27,012,127 Other clinical and pre-clinical development expenses 583,777 2,584,651 Facilities and other expenses 913,439 969,543 Total research and development expenses $ 11,111,586 $ 31,033,276 Research and development expenses for the year ended December 31, 2025 were $11.1 million, compared to $31.0 million for the year ended December 31, 2024.
Cash used in operating activities reflected our net loss of $13.7 million offset by $1.7 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation expense, reductions in the operating right of use (“ROU”) assets, non-cash interest on the convertible promissory notes, and the net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.
Cash used in operating activities reflected our net loss of $13.7 million offset by $1.7 million in non-cash stock-based compensation expense, depreciation expense, and the net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.
There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement. As of December 31, 2024, we have drawn an aggregate of $1.0 million under the Loan Agreement.
There is no assurance as to the amount of proceeds we will ultimately receive under the Loan Agreement.
As our patents were developed internally, historical expenditures related to their development were all expensed as incurred per GAAP. We believe these patents have significant value as the basis of our product pipeline. Our continued investment in our pipeline highlights our belief in future commercial viability of these products.
We believe these patents have significant value as the basis of our product pipeline. Our continued investment in our pipeline highlights our belief in future commercial viability of these products.
General and Administrative Expenses The following table summarizes our general and administrative expenses for the years ended December 31, 2024 and 2023: Year ended December 31, 2024 2023 Personnel costs $ 1,725,326 $ 1,095,468 Stock-based compensation 13,752,010 - Legal and professional fees 6,636,232 2,616,925 Facilities and other expenses 417,644 727,106 Total general and administrative expenses $ 22,531,212 $ 4,439,499 85 General and administrative expenses for the year ended December 31, 2024 were $22.5 million compared to $4.4 million for the year ended December 31, 2023.
General and Administrative Expenses The following table summarizes our general and administrative expenses for the years ended December 31, 2025 and 2024: Year ended December 31, 2025 2024 Personnel costs $ 1,984,144 $ 1,725,326 Stock-based compensation 8,893,506 13,752,010 Legal and professional fees 3,753,997 6,636,232 Facilities and other expenses 397,282 417,644 Total general and administrative expenses $ 15,028,929 $ 22,531,212 87 General and administrative expenses for the year ended December 31, 2025 were $15.0 million compared to $22.5 million for the year ended December 31, 2024.
Change in Fair Value of Convertible Promissory Notes We recognized a non-cash gain of $48.5 million and a non-cash loss of $50.4 million for the change in fair value of the convertible promissory notes for the years ended December 31, 2024 and 2023, respectively.
Change in Fair Value of Convertible Promissory Notes There was no non-cash gain or loss recognized in the year ended December 31, 2025 in relation to our convertible promissory notes. We recognized a non-cash gain of $48.5 million for the change in fair value of the convertible promissory notes for the year ended December 31, 2024.
Cash used in operating activities reflected our net loss of $60.5 million offset by $52.0 million of non-cash charges related to the change in the fair value of the convertible promissory notes, depreciation expense, reductions in the ROU assets, non-cash interest on the convertible promissory notes, and a $0.3 million net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.
Cash used in operating activities reflected our net loss of $26.3 million offset by non-cash stock-based compensation expense, depreciation expense, and the net change in our operating assets and liabilities attributable to the timing of our payments to our vendors for research and development activities.
We expect to devote considerable financial resources to our ongoing and planned activities, particularly as we conduct our planned clinical trials of TVGN 489 and other product candidates.
See “— Liquidity and Capital Resources—Sources of Liquidity ” above for more information on amounts sold under the Sales Agreement. We expect to devote considerable financial resources to our ongoing and planned activities, particularly as we conduct our planned clinical trials of TVGN 489 and other product candidates.
Cash Flows from Investing Activities During the years ended December 31, 2024 and 2023, we used $0.0 million and $0.1 million respectively, for the purchase of property and equipment.
Cash Flows from Investing Activities During the year ended December 31, 2025, we used $0.1 million of net cash in investing activities attributable to $0.1 million in purchases of property and equipment. During the year ended December 31, 2024, we did not have any cash flows from investing activities.
As of December 31, 2024, we had cash of $1.3 million.
As of December 31, 2025, we had cash of approximately $0.6 million.
We expect to receive an additional $8.0 million grant from KRHP during the second quarter of 2025. 86 Cash Flows The following table summarizes our cash flows for the years ended December 31, 2024 and 2023: Year ended December 31, 2024 2023 Cash provided by (used in) Operating activities $ (11,998,730 ) $ (8,171,118 ) Investing activities - (133,000 ) Financing activities 12,229,328 3,872,250 Net change in cash $ 230,598 $ (4,431,868 ) Cash Flows from Operating Activities During the year ended December 31, 2024, we used $12.0 million of net cash in operating activities.
After deducting total expenses of approximately $140,000, including commission to the Agent of approximately $125,000, net proceeds to the Company were approximately $4.9 million. 88 Cash Flows The following table summarizes our cash flows for the years ended December 31, 2025 and 2024: Year ended December 31, 2025 2024 Cash provided by (used in) Operating activities $ (12,328,577 ) $ (11,998,730 ) Investing activities (64,439 ) - Financing activities 11,662,393 12,229,328 Net change in cash $ (730,623 ) $ 230,598 Cash Flows from Operating Activities During the year ended December 31, 2025, we used $12.3 million of net cash in operating activities.
To date, we have not generated any revenue. Our net loss for the years ended December 31, 2024 and 2023 was $13.7 million and $60.5 million, respectively.
To date, we have not generated any revenue. Our net loss for the years ended December 31, 2025 and 2024 was $26.3 million and $13.7 million, respectively. Net loss for the year ended December 31, 2025 was primarily attributable to non-cash, stock-based compensation expense, salaries and outside services. As of December 31, 2025, we had cash of $0.6 million.
(3) Reflects obligations to settle outstanding balances on our Loan Agreement, if paid in cash at time of settlement, as well as accrued interest. 89 The commitment amounts in the table above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum, or variable price provisions, and the approximate timing of the actions under the contracts.
The Company continually evaluates its liquidity position and may seek to refinance or restructure certain obligations as they come due. 91 The commitment amounts above are associated with contracts that are enforceable and legally binding and that specify all significant terms, including fixed or minimum services to be used, fixed, minimum, or variable price provisions, and the approximate timing of the actions under the contracts.
None of the patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period. 80 Our commercial success depends in part on our ability to obtain and maintain patent and other protection for our products and methods, preserve the confidentiality of our trade secrets, operate without infringing, misappropriating, or otherwise violating the valid, enforceable proprietary rights of others, and prevent others from infringing, misappropriating, or otherwise violating our proprietary rights.
In addition, through our Tevogen.AI artificial intelligence initiative, we are focused on harnessing the potential of AI to expedite drug development, optimize laboratory processes and clinical trials, unravel complex biological data, improve patient outcomes, and pass on related savings to patients. 82 Our commercial success depends in part on our ability to obtain and maintain patent and other protection for our products and methods, preserve the confidentiality of our trade secrets, operate without infringing, misappropriating, or otherwise violating the valid, enforceable proprietary rights of others, and prevent others from infringing, misappropriating, or otherwise violating our proprietary rights.
During the year ended December 31, 2023, we received $4.0 million of net cash from financing activities attributable to the proceeds from the convertible promissory notes, less $0.1 million related to payments of deferred transaction costs.
Cash Flows from Financing Activities During the year ended December 31, 2025, we received $11.7 million of net cash from financing activities attributable to $3.4 million in draws on the Loan Agreement, $3.0 million attributable to KRHP grants, $500,000 in capital contributions from Dr. Saadi, and $4.9 million in proceeds pursuant to the Sales Agreement, net of offering costs.
Loss on Issuance of Commitment Shares We incurred losses on the issuance of Commitment Shares during the year ended December 31, 2024, associated with the Loan Agreement. Liquidity and Capital Resources Sources of Liquidity As of December 31, 2024, we had $1.3 million in cash, as compared to $1.1 million in cash as of December 31, 2023.
Loss on Issuance of Commitment Shares We incurred losses on the issuance of Commitment Shares during the year ended December 31, 2024, associated with the Loan Agreement. Non-GAAP Presentation of Loss from Operations Since inception, we have incurred substantial operating losses, primarily driven by non-cash stock-based compensation expense, which does not directly impact our cash position or operating liquidity.
Removed
Net loss for the year ended December 31, 2024 was primarily attributable to a $53.6 million loss from operations that primarily resulted from non-cash, stock-based compensation expense recognized with the liquidity event condition contained in certain stock awards was satisfied upon the closing of the Business Combination as well as $7.5 million in transaction costs in connection with the Business Combination, partially offset by the change in fair value of convertible promissory notes of $48.5 million.
Added
None of the patients who participated in the trial reported progression of infection, reinfection, or the development of Long COVID during the six-month follow-up period.
Removed
The increase was primarily attributable to an increase in stock-based compensation due to stock compensation expense related to the restricted stock units (“RSUs”) granted to Dr. Saadi on the Closing Date.
Added
We continue to build our intellectual property portfolio and seek to protect our proprietary position by, among other things, filing patent applications. Our patent estate includes patents and patent applications with claims relating to our product candidates, methods of use, and methods of preparing the product candidates.
Removed
The increase was primarily attributable to stock-based compensation expense of $13.8 million, of which $7.7 million was recognized as a non-cash stock-based compensation expense from certain stock-based awards that continue to vest through satisfaction of service conditions subsequent to the satisfaction of the liquidity condition upon the Closing, and $2.3 million was recognized as restricted stock compensation expense related to the RSUs granted.
Added
To date, our U.S. intellectual property portfolio includes three U.S. patents relating to TVGN 489 for the treatment of COVID-19, nine pending U.S. patent applications, including two patent applications relating to the treatment of COVID-19, six relating to the treatment of other viruses or cancer, and one related to artificial intelligence-driven T cell target identification and receptor engagement, as well as thirteen ex-U.S. patent applications, including applications in Australia, Canada, Europe, Japan, Qatar, the United Arab Emirates, and the Patent Cooperation Treaty directed at viral specific T cells, methods of treating and preventing viral infections, methods for developing CD3+CD+ cells against multiple viral epitopes for the treatment of viral infections, and systems for predicting immunologically active peptides with machine learning models, which have anticipated expiration dates through December 16, 2044.
Removed
The increase of $0.6 million in personnel costs was primarily attributable to an increase in headcount and an increase in premium for our director and officer insurance policy. The increase of $4.0 million in legal and professional fees was primarily attributable to the additional services incurred as a result of the Merger.
Added
In the United States, our three issued utility patents, all of which will expire on December 9, 2040, are U.S. Patent No. 11,191,827 covering methods of treating COVID-19 infection using COVID-19 peptide specific CTLs; U.S. Patent No. 11,207,401 covering COVID-19 peptide-specific CTLs; and U.S. Patent No. 11,219,684 covering methods of manufacturing COVID-19 peptide specific CTLs.
Removed
We drew an additional $1.0 million on February 10, 2025. In addition, in January 2025, we received a grant of $2.0 million from KRHP.
Added
A pending utility patent application in the United States directed at viral specific T cells and methods of treating and preventing viral infections has an anticipated expiration of December 9, 2041.
Removed
Contractual Obligations and Commitments The following table summarizes our contractual obligations and commitments as of December 31, 2024: Total Less than 1 Year 1 to 3 Years Contractual obligations: Operating lease commitments (1) $ 244,446 $ 230,471 $ 13,975 Notes payable (2) 1,651,000 1,651,000 - Loan Agreement repayment (3) 1,028,270 28,270 1,000,000 Total contractual obligations $ 2,923,716 $ 1,909,741 $ 1,013,975 (1) Reflects obligations pursuant to our office and laboratory leases in Philadelphia, Pennsylvania and Warren, New Jersey.
Added
In addition, we own a registered trademark protection for “Tevogen Bio” (and design), and have applied for registered trademark protection for “ExacTcell” and “Tevogen AI” with the United States Patent and Trademark Office. We determine strategy for claim scope for our patent applications on a case-by-case basis, taking into account advice of counsel and our business model and needs.
Removed
(2) Reflects notes payable obligations assumed as part of the Merger.
Added
We file patents containing claims for protection of useful applications of our proprietary technologies and any product candidates, including new applications or uses we discover for existing technologies and product candidates, based on our assessment of their strategic value.
Added
We continuously reassess the number and type of patent applications, as well as our pending and issued patent claims, to ensure maximum coverage and value are obtained for our processes and compositions, given existing patent office rules and regulations. As our patents were developed internally, historical expenditures related to their development were all expensed as incurred per GAAP.
Added
In addition, in June 2025, we received a capital contribution of $500,000 from Ryan Saadi, our Chairman and Chief Executive Officer.
Added
On July 3, 2025, we entered into a Sales Agreement (the “Sales Agreement”) with A.G.P./Alliance Global Partners (the “Agent”), pursuant to which we may issue and sell from time to time up to $50,000,000 of Common Stock through the Agent as the Company’s sales agent.
Added
Sales of the Company’s Common Stock through the Agent, if any, will be made by any method that is deemed to be an “at-the-market” equity offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, pursuant to the Company’s effective shelf registration statement on Form S-3 (File No. 333-288218) filed on June 20, 2025 with the Securities and Exchange Commission and declared effective on June 26, 2025, the base prospectus filed as part of such registration statement, and the prospectus supplement dated July 3, 2025.
Added
On March 3, 2026, we filed a Certificate of Amendment to our Certificate of Incorporation (the “Certificate of Amendment”) with the Secretary of State of the State of Delaware to effect a 1-for-50 reverse stock split of our Common Stock (the “Reverse Stock Split”), which was effective as of March 6, 2026 (the “Effective Date”).
Added
The Common Stock began trading on Nasdaq on a post-split basis at the open of business on the Effective Date.
Added
Change in Fair Value of Warrants As the result of the Merger, the Company accounts for its warrants originally sold as part of Semper Paratus’s initial public offering (the “IPO”) in accordance with ASC 815, Derivatives and Hedging Contracts in Entity’s Own Equity (“ASC 815”) and ASC 480, Distinguishing Liabilities from Equity (“ASC 480”).
Added
The assessment considers whether the warrants are freestanding financial instruments and meet the definition of a liability pursuant to ASC 480 and meet all of the conditions for equity classification under ASC 815, including whether the warrants are indexed to the Company’s own shares of Common Stock, among other conditions.
Added
This assessment, which requires the use of professional judgment, is conducted at the time of warrant issuance and as of each subsequent quarterly period end date while the warrants are outstanding.
Added
For issued or modified warrants that meet all of the criteria for equity classification, the warrants are required to be recorded as a component of additional paid-in capital at the time of issuance.
Added
For issued or modified warrants that do not meet all the criteria for equity classification, the warrants are required to be recorded at their initial fair value on the date of issuance, and each balance sheet date thereafter until settlement.
Added
Changes in the estimated fair value of the warrants are recognized as a non-cash loss on the consolidated statements of operations.
Added
Under these standards, the Company’s private placement warrants sold at the time of the IPO do not meet the criteria for equity classification and must be recorded as liabilities while the public warrants sold in connection with the IPO do meet the criteria for equity classification and must be recorded as equity.
Added
The decrease was primarily attributable to lower non-cash stock-based compensation expense.
Added
The decrease was primarily attributable to lower legal and professional fees and non-cash stock-based compensation expense.
Added
Change in Fair Value of Warrants We recognized a gain on change in fair value of derivative warrant liabilities of $60,701 during the year ended December 31, 2025 and a loss of $58,180 during the year ended December 31, 2024.
Added
The change in value during these periods was largely attributable to the changes in the price of underlying Common Stock and risk-free rates and decreases to the time until expiration of the warrants.
Added
Other significant contributors to our operating losses have included legal and professional fees, clinical and pre-clinical development expenses, other personnel expenses, and facilities expenses.
Added
To enhance investors’ understanding of our historical results, we present below adjusted loss from operations, which is a non-GAAP measure that we define as loss from operations, calculated in accordance with GAAP, adjusted to exclude stock-based compensation expense.
Added
We believe adjusted loss from operations provides additional insight into the underlying capital efficiency of our business and helps investors evaluate our long-term operating performance by illustrating that a significant portion of our reported losses represents equity-based compensation expense rather than cash expenditures.

… 14 more changes not shown on this page.