Board Change • May 20
High number of new and inexperienced directors There are 5 new directors who have joined the board in the last 3 years. The company's board is composed of: 5 new directors. 6 experienced directors. No highly experienced directors. Member of Advisory Board Sten Vermund is the most experienced director on the board, commencing their role in 2022. The following issues are considered to be risks according to the Simply Wall St Risk Model: Lack of board continuity. Lack of experienced directors. 공시 • May 13
Tevogen Bio Holdings Inc. announced that it expects to receive $3 million in funding from The Patel Family, LLP. Tevogen Bio Holdings Inc. entered into a securities purchase agreement for a private investment to issue 375,000 prefunded warrants at an issue price of $8 for the proceeds of $3,000,000 on May 12, 2026. The Patel Family, LLP will participate in the transaction. The PIPE financing is expected to close on or about May 13, 2026. . 공시 • Apr 28
Tevogen Bio Holdings Inc Announces Near Completion of Predictcell Training and Debuts Internal Application Portal Tevogen Bio Holdings Inc. announced continued progress within its artificial intelligence initiative, Tevogen.AI, including the near completion of its PredicTcell training algorithm and early steps toward commercial readiness. PredicTcell, Tevogen.AI’s proprietary machine learning model designed to identify immunologically active peptides, is approaching the final stages of its training phase. The model has been trained on one of the industry’s largest curated peptide datasets, with feature expansion now exceeding 180 parameters, contributing to an approximate 10% improvement in precision. As development progresses, the Company has begun evaluating potential co-development partnerships to support broader application of the platform. These efforts are grounded in addressing a fundamental challenge in drug development, high-confidence target identification, which this day often requires significant wet lab validation. By leveraging advanced predictive modeling, Tevogen.AI aims to reduce development timelines, material costs, and overall experimental burden. To support this transition, Tevogen.AI has developed an initial version of an internal application and portal designed to serve the PredicTcell model in a scalable and user-friendly environment. This system is intended to streamline internal workflows while also serving as the foundation for a potential future customer-facing platform. PredicTcell Interface Preview. Screenshot of the initial version of an internal application and portal designed to serve the PredicTcell model. 공시 • Apr 23
Tevogen Bio Holdings Inc. Receives Non-Compliance Letter from Nasdaq On April 16, 2026, Tevogen Bio Holdings Inc. (the Company") received a letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the Company no longer meets Nasdaq's $50 million minimum market value for listed securities requirement pursuant to Nasdaq Listing Rule 5450(b)(2)(A) (the MVLS Requirement") for continued listing on the Nasdaq Global Market based on Nasdaq's review of the market value of the Company's listed securities for the previous 30 consecutive business days. In addition, on April 17, 2026, the Company received a letter from the Staff notifying the Company that the Company no longer meets Nasdaq's $15 million minimum market value of publicly held shares requirement under Nasdaq Listing Rule 5450(b)(2&3)(C) (the MVPHS Requirement", and together with the MVLS Requirement, the Requirements") based on Nasdaq's review of the market value of the Company's publicly held shares for the previous 30 consecutive business days. The notifications have no immediate effect on the Company's listing or trading on the Nasdaq Global Market. Nasdaq has provided the Company a period of 180 calendar days to regain compliance with each Requirement, or until October 13, 2026 for the MVLS Requirement (the MVLS Compliance Date") and October 14, 2026 for the MVPHS Requirement (the MVPHS Compliance Date" and, together with the MVLS Compliance Date, the Compliance Dates"). If, at any time before the applicable Compliance Date, the Company's market value of listed securities closes at $50 million or more or the Company's market value of publicly held shares closes at $15 million or more for a minimum of 10 consecutive business days and up to generally not more than 20 consecutive business days, the Staff will provide written notification to the Company that it has regained compliance with the applicable Requirement. The Company intends to actively monitor the market value of its listed securities and publicly held shares. The Company may evaluate and consider available options for regaining compliance with the Requirements, as well as applying for a transfer to The Nasdaq Capital Market. However, there can be no assurance that the Company will take any specific action or be able to regain compliance with either Requirement or otherwise maintain compliance with Nasdaq listing rules. 공시 • Mar 13
Tevogen Bio Holdings Inc. Reports Advancements In PredicTcell Beta And Expands Proprietary AI Infrastructure Tevogen Bio Holdings Inc. announced performance advancements for its artificial intelligence platform, operated through Tevogen.AI. Tevogen.AI was built to solve a critical challenge in drug development: identifying biological targets which are most likely to work in patients, before entering costly clinical trials. Over the past year, the Company has built a proprietary database of more than 655 million peptide sequences derived from approximately 24 million proteins, representing nearly 16 billion data points across multiple disease areas. This database is continuously enriched using analysis of 37 million scientific publications. In recent beta testing of its PredicTcell model, Tevogen reported: Recall improved from 87% to 92% (the model is finding more of the right targets), Precision improved from 40% to 48% (fewer incorrect predictions), Higher overall accuracy scores, Increased true positives and reduced missed targets, Dramatically expanded training sample size. These results allow the model to improve in identifying which immune targets are likely to succeed. The current version, trained on 1.8 million data points, is nearly 20 times more robust than the initial model, reflecting rapid scale and learning acceleration. This development builds on Tevogen.AI’s published international patent application (WO 2025/129197), which outlines novel machine learning systems for predicting immunologically active peptides, a critical step in developing targeted therapies for cancers and infectious diseases. Tevogen.AI now operates three production AI agents that: Continuously evaluate 14 active peptide candidates, Monitor newly published scientific literature, Integrate wet lab results back into the AI system. This creates a continuous learning loop between AI predictions and biological validation, strengthening future performance. As predictive accuracy continues to improve, Tevogen intends to explore partnerships with pharmaceutical companies to advance select peptide candidates for production and development. 공시 • Mar 05
Tevogen Announces Reverse Stock Split to Regain Compliance with Minimum Bid Price Requirement for Continued Listing on the Nasdaq Global Market Tevogen Bio Holdings Inc. announced that its Board of Directors (the “Board”) has approved a reverse stock split of its common stock at a ratio of 50 for 1. Stockholders previously approved the reverse stock split on February 19, 2026, and provided the Board with discretion to determine the final reverse stock split ratio. The reverse stock split is being conducted to regain compliance with the $1.00 minimum bid price requirement for continued listing on the Nasdaq Global Market (“Nasdaq”) and is expected to become effective at 12:01 a.m. on March 6, 2026 (the “Effective Date”). The Company’s common stock is expected to begin trading on Nasdaq on a split-adjusted basis as of the beginning of trading on March 6, 2026, under the same symbol, “TVGN”, and a new CUSIP number, 88165K 200. 공시 • Nov 06
Tevogen Bio Holdings Inc. Reports Major Clinical Milestone: Expands Hla Coverage of Its Investigational Precision T Cell Therapy for Acute and Long Covid Tevogen Bio Holdings Inc. announced a clinical milestone in the evolution of its proprietary ExacTcell™? platform: completion of T cell target identification for an additional five human leukocyte antigen (HLA) restrictions. This advancement significantly broadens the accessibility of Tevogen's investigational precision T cell therapies by extending therapeutic reach beyond the single HLA-A02:01 restriction used in the Company's initial proof-of-concept (POC) clinical trial, the results of which were published in Blood Advances. That study demonstrated the safety and feasibility of Tevogen's third-party cytotoxic T lymphocyte (CTL) therapy, TVGN 489, in high-risk patients with COVID-19. HLA type varies widely among individuals and population groups. HLA-A-A02:01 was selected for the proof-of-concept trial because it is one of the most common HLA types in the United States, present in approximately 25% of the population. Collectively, the identification of five additional HLA targets will allow the manufacture of CTLs which would extend treatment to approximately 65% of the US population, bolstering coverage for minority populations with less common HLA types. 공시 • Oct 16
Tevogen Bio Holdings Inc. Updates on TVGN 489 Following Growing Long COVID Patient Interest Tevogen Bio Holdings Inc. issued an update regarding growing public interest in its investigational precision T cell therapy, TVGN 489, under development for COVID-19 and Long COVID. The Company's dose-finding clinical trial of TVGN 489 demonstrated a favorable safety profile and provided valuable insights for the next phase of development. The results were peer-reviewed and published in Blood Advances, the journal of the American Society of Hematology. While TVGN 489 is not yet available for broader clinical use, Tevogen is actively preparing for the next stage of development. The Company intends to collaborate with government initiatives, Long COVID patient organizations, and major healthcare providers to expedite development and maximize patient access once regulatory pathways allow. In recognition of the high volume of patient inquiries, Tevogen has established a dedicated communication channel for Long COVID updates at <URL> which will be used to share verified information as it becomes available. Tevogen continues to maximize capital efficiency, maintains access to financing to support growth, and remains focused on sustainable advancement toward commercialization. 공시 • Sep 27
Tevogen Bio Holdings Inc. Receives Non-Compliance Letter Regarding from Nasdaq Regarding Minimum Bid Price Listing Requirement On September 23, 2025, Tevogen Bio Holdings Inc. (the Company") received a letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the Company no longer meets Nasdaq's $1.00 per share minimum bid price requirement pursuant to Nasdaq Listing Rule 5450(a)(1) (the Bid Price Requirement") for continued listing on Nasdaq based on the closing bid price for the Company's common stock, par value $0.0001 per share (the Common Stock"), for the previous 30 consecutive business days. The notification received has no immediate effect on the Company's listing or trading on the Nasdaq Global Market. The Company has been provided a period of 180 calendar days, or until March 23, 2026 (the Compliance Date"), to regain compliance with the Bid Price Requirement. If, at any time before the Compliance Date, the bid price for the Common Stock closes at $1.00 or more for a minimum of 10 consecutive business days and up to generally not more than 20 consecutive business days, the Staff will provide written notification to the Company that it has regained compliance with the Bid Price Requirement. If the Company does not regain compliance with the Bid Price Requirement by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period. To qualify, the Company will be required to transfer to the Nasdaq Capital Market and meet the continued listing requirement for market value of its publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the second 180 calendar day compliance period. The Company intends to actively monitor the closing bid price of the Common Stock in addition to its ongoing monitoring of the market integrity of the Common Stock. The Company may evaluate and consider available options to regain compliance with the Bid Price Requirement. However, there can be no assurance that the Company will take any specific action or otherwise be able to regain compliance with the Bid Price Requirement or otherwise maintain compliance with Nasdaq listing rules. 공시 • Sep 09
Tevogen Bio Holdings Inc. Values TVGN-489 at $9 $11 Billion rNPV, Its First Clinical Product from the Proprietary ExacTcell™? Allogeneic T Cell Platform Tevogen Bio Holdings Inc. shared the risk-adjusted net present value (rNPV) estimate of $9 billion to $11 billion for TVGN-489, an allogeneic precision T cell therapy and the first clinical-stage product from its proprietary ExacTcell™? platform. TVGN-489 is being developed for the treatment of SARS-CoV-2 infection in high-risk vulnerable patients and for Long-COVID in patients with evidence of a persistent viral reservoir. Clinical Trial Key Findings (Phase I Proof-of-Concept, published in Blood Advances): High-risk ambulatory patients (50% immunocompromised) received a single infusion of TVGN-489 across four escalating dose levels. TVGN-489 was well tolerated; no dose-limiting toxicities, infusion reactions, cytokine release syndrome, or graft-versus-host disease were observed. Treatment arm patients showed faster and more consistent symptom improvement and earlier resolution compared to observational arm patients. Nasal PCR testing showed 88% viral elimination by Day 4 in 92% of patients, and >99% elimination in 100% of patients by Day 14. The rNPV for this internally developed asset as of that date was between $9 billion and $11 billion. This valuation reflects US only revenue potential for the product and does not represent the value of the broader ExacTcell™? technology platform. The Company intends to continue providing additional valuation updates on its internally developed assets, including its product pipeline and other assets. 공시 • Sep 04
Tevogen Bio Holdings Inc. Underscores the Importance of Precision Immunotherapies, Including TVGN 489 for Vulnerable Individuals Infected with SARS-CoV-2 Tevogen Bio Holdings Inc. highlighted the continuing need for SARS-CoV-2 treatments for individuals with weakened immune systems, who are at the highest risk of complications from the virus. TVGN 489, the Company's investigational allogeneic SARS-CoV- 2-specific Cytotoxic CD8+ T lymphocyte (CTL) immunotherapy is developed using the ExacTcell platform. It is designed to fortify anti-SARS-CoV-2 immunity in these individuals and directly eliminate the virus. The CTLs are directed against the entire viral genome rather than single protein. Publication of positive POC/dose finding clinical trial data of TVGN 489 is available through Blood Advances: Clinical Trial Key Findings: The treatment arm, which included high-risk patients and half of whom were immunocompromised, received a single infusion of TVGN 489. As a secondary end point, treated patients demonstrated faster and more consistent symptom resolution, compared to patients in the standard of care comparative arm. In the treatment arm, viral elimination reached >99% in all patients by day +14; no disease progression or Long COVID was observed in the treatment arm. TVGN 489 was well-tolerated at all four dose levels and did not impair endogenous immune responses. 공시 • Jul 19
Tevogen.Ai Receives International Patent Publication for Ai Technology Predicting Immunologically Active Peptides Tevogen announced that the International Bureau of the World Intellectual Property Organization (WIPO) has published its international patent application (Publication No. WO 2025/129197) titled, "Systems and methods for Predicting Immunologically Active Peptides with Machine Learning Models." This patent covers technology developed by Tevogen.AI that leverages machine learning algorithms, powered by Microsoft and Databricks intended to rapidly and accurately identify peptides with strong immune system interactions. Identifying these peptides is critical in developing targeted therapies for a variety of diseases, including cancers and infectious diseases. Traditional methods for identifying immunologically active peptides often face significant limitations, such as overlooking critical human genetic diversity factors like age, sex, race, and ethnicity. Tevogen.AI's proprietary approach may overcome these challenges by: Efficiently screening and ranking potential peptides based on their immunological activity. Eliminating peptides likely to be ineffective due to self-tolerance or human genome overlap. Continuously refining predictions using real-world data to train and enhance machine learning models. 공시 • Jul 17
Tevogen.Ai Targets Faster Time-To-Market with Ai-Powered Patient Matching Following PredicTcell Alpha Launch Tevogen Bio Holdings Inc. announced that following the completion and deployment of the alpha version of PredicTcell, a proprietary AI-driven target discovery platform, the Company now plans to expand Tevogen.AI to include patient data against identified targets. Supported by Microsoft and Databricks, Tevogen.AI aims to rapidly analyze electronic health records and real-world patient data, to identify potential clinical trial participants based on medical historical, demographics, and clinical profiles. This approach could bridge target identification from the PredicTcell™? model with real-world patient data to enhance and support Tevogen Bio's ExacTcell™? pipeline development. Harnessing AI-driven patient matching and predictive analytics, Tevogen. AI aims to address challenges within clinical trials around patient identification, enhancing patient outcomes, expediting therapeutic approvals, and providing a foundation for commercial success and investment growth. This approach could position Tevogen to deliver sustained value to patients and shareholders alike. 공시 • Jul 04
Tevogen Bio Holdings Inc. has filed a Follow-on Equity Offering in the amount of $50 million. Tevogen Bio Holdings Inc. has filed a Follow-on Equity Offering in the amount of $50 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering 공시 • Jun 18
Tevogen Updates on Development of EBV-Specific T Cell Therapy with Support from AI-Powered Target Discovery Tevogen provided an update on its ongoing development of a cytotoxic T lymphocyte (CTL) therapy targeting Epstein-Barr virus (EBV)-associated lymphomas. Computer-based selection of EBV peptides is currently underway as part of Tevogen's preparation for a potential clinical trial using EBV-specific CTLs manufactured using the Company's proprietary ExacTcell™? technology. ExacTcell enables precision-engineered T cells with a high degree of specificity and scalability. In parallel, Tevogen's R&D laboratory has initiated confirmation studies to validate CTL responses to the selected viral peptides. Tevogen Bio's scientific and clinical teams are working closely with Tevogen.AI, the Company's artificial intelligence initiative, to co-develop an advanced peptide selection strategy. This collaboration aims to accelerate the identification of immunologically active targets across the EBV genome and further strengthen Tevogen's therapeutic precision. Tevogen Bio will continue to share updates as the EBV research progresses through its preclinical evaluation phase. 공시 • May 24
Tevogen Bio Holdings Inc. Plans to Expand Specialty Care Pipeline to Include Patients 65+ Patient Population Tevogen Bio Holdings Inc. announced a planned expansion of TVGN 489's target population to include patients 65 and older. As previously reported in October 2024, the top-line revenue forecast for the specialty care pipeline was projected at nearly $1 billion in its launch year, with a cumulative five-year estimate ranging between $18 billion and $22 billion. This anticipated expansion aims to broaden the market potential of Tevogen's specialty pharmaceuticals. An updated forecast and the risk adjusted net present value (rNPV) will be provided to reflect the inclusion of the 65+ patient population. Supported by Tevogen's ExacTcell™? platform, the expanded pipeline is outlined below: TVGN 489: Treatment of SARS-CoV-2 infection in patients with B cell hematologic cancer. Treatment of SARS-Co V-2 infection in patients with other cancers. SARS-CoV- 2 infection in patients under treatment for rheumatoid arthritis; SARS-CoV-1 infection in patients under treatment for and psoriatic arthritis; Treatment of Long COVID [part of Tevogen Bio Specialty Care forecast; SARS-CoV -2 infection in patients aged 65 and older [to be added to Tevogen Bio Specialty care forecast). SARS-CoV-3 infection in patients aged 65 and old [to be added to TeVogen Bio Specialty Care forecast). 공시 • Apr 28
Tevogen Bio Holdings Inc., Annual General Meeting, Jun 23, 2025 Tevogen Bio Holdings Inc., Annual General Meeting, Jun 23, 2025. 공시 • Apr 09
Tevogen Bio Holdings Inc. Announces AI X Bio Philadelphia Event Showcasing Philadelphia's Leading AI Biotechs Tevogen announced that Mittul Mehta, Chief Information Officer and Head of Tevogen.AI, presented at AI x Bio Philly, a premier event highlighting the convergence of artificial intelligence and life sciences in the Philadelphia region. Hosted by BioBuzz, BitsInBio, Atria, and Zetta, AI x Bio Philly brought together innovators, entrepreneurs, and investors for an evening of demos, discussion, and insight into how AI is shaping the future of biotechnology. joined by Irene Rombell, CEO of BioCurie, David Latshaw II, PhD, CEO of BioPhy AI and Nathan Buchbinder, CSO and co-founder of Proscia, Mehta spoke during the AI Demos and Presentations session. 공시 • Apr 02
Tevogen Bio Holdings Inc. announced delayed annual 10-K filing On 04/01/2025, Tevogen Bio Holdings Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. 공시 • Mar 26
Tevogen Bio Appoints David E. Banko as Global Head of Government Affairs and Patient Access Tevogen Bio announced the appointment of David E. Banko, CPA, a leading expert with three decades of industry experience in market access and health policy, to its leadership team as Global Head of Government Affairs and Patient Access. In this critical role, Mr. Banko will spearhead market access strategies in collaboration with R&D across Tevogen’s growing product portfolio in oncology, virology, neurology, and rheumatology to advance and support commercial readiness. His primary focus will be advancing patient access to the Company’s therapies under development, engaging with government and private payers, and ensuring Health Technology Assessment (HTA) readiness. These initiatives are core to Tevogen’s commercialization strategies, including securing appropriate coding, coverage, and provider reimbursement at launch. Mr. Banko will also lead policy engagement with the current administration to align on shared goals of improving patient accessibility and affordability of emerging medical innovations. Mr. Banko brings 30+ years of experience across pharma, medical devices, diagnostics, and hospital finance, with past roles at Cordis Corp, a former Johnson & Johnson company, and B. Braun Medical Inc. An expert in securing and enhancing market access for innovative technologies, he has successfully leveraged clinical evidence to shape Medicare’s national coverage policies, championed strategic global pricing, and developed initiatives that empower hospitals and physicians to advance the adoption of FDA-approved emerging breakthrough technologies. 공시 • Mar 11
Tevogen Bio Announces Unique T Cell Vaccine Under Development and Files Patent with the USPTO Tevogen Bio announced the filing of a new patent with the U.S. Patent and Trademark Office (USPTO) for its under-development T cell vaccine. Unlike many vaccines that primarily induce a B cell response, Tevogen Bio’s design aims to leverage the Company’s proprietary Tevogen.AI-powered PredicTcell technology to identify peptides which stimulate a T cell response. A key differentiator of this vaccine is its ability to target the entire viral genome, much like the Company’s lead product candidate, TVGN 489. This strategy helps mitigate the risk posed by mutations that might otherwise evade immune detection when only one protein or segment of the virus is targeted. The development of this vaccine leverages Tevogen Bio’s established technology and will not impact previously announced launch year topline forecasts of $1 billion each for Tevogen Bio Oncology and Specialty Care. 공시 • Dec 20
Tevogen Bio Strengthens Robust Ip Portfolio with Filing of Predictive Ai Patent Tevogen Bio filed for an additional patent, “Systems And Methods For Predicting Immunologically Active Peptides With Machine Learning Models”, as part of its developing intellectual property portfolio. 공시 • Nov 16
Tevogen Bio Holdings Inc. announced delayed 10-Q filing On 11/15/2024, Tevogen Bio Holdings Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. 공시 • Oct 31
Tevogen Bio Regains Compliance with Nasdaq Minimum Bid Price Requirement Tevogen Bio Holdings Inc. announced that on October 28, 2024, it received written notice from the Listing Qualifications Staff of the Nasdaq Stock Market LLC (“Nasdaq”) stating that the Company has regained compliance with the minimum bid price requirement (the “Minimum Bid Price Requirement”), as set in Nasdaq Listing Rule 5550(a)(2) for continued listing on The Nasdaq Global Market. Tevogen was notified by Nasdaq on June 14, 2024, that it was not in compliance with the Minimum Bid Price Requirement because its common stock had failed to maintain a minimum bid price of $1.00 for 30 consecutive business days. In order to regain compliance with the Minimum Bid Price Requirement, the Company was required to maintain a minimum closing bid price of $1.00 or more for at least 10 consecutive trading days, which was achieved during the period between October 14, 2024, to October 25, 2024. The Company’s closing price was $3.05 on October 25, 2024. Tevogen did not effect a reverse stock split of its common stock. “Founders must navigate the need for capital to fuel growth with a vigilant eye on avoiding equity dilution. Since inception, Tevogen Bio’s financing strategy has confirmed our business philosophy of preserving shareholder value through speed and cost,” commented Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio. 공시 • Oct 28
Tevogen Bio Provides Additional Guidance on Introduction of T Cell Therapy for Oncology and Specialty Care Therapeutic Areas Tevogen Bio provided additional guidance on the first clinical product of the company's proprietary ExacTcell™? technology, TVGN 489, designed to treat SARS-CoV-2 infections in immunocompromised oncology patients, and a subgroup of patients with post-acute sequencing of SARS-CoV- 2 (PASC). Tevogen Bio's recently shared forecast reflects its business plan of market entry by the end of 2026. Tevogen leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents and numerous pending patents, two of which are related to artificial intelligence. Tevogen is driven by a team of experienced industry leaders and scientists with drug development and global product launch experience. Tevogen's leadership believes that accessible therapeutics are the next forefront of medicine, and that disruptive business models are required to sustain medical innovation. Tevogen's development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen's ability to develop additional product candidates, including through use of Tevogen's ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen's future clinical trials; and Tevogen's ability to generate revenue in the future. 공시 • Oct 16
Tevogen Bio Holdings Inc. Takes Lead in Developing Cell Therapies Designed to Eradicate Post Procedure Human Papilloma Virus in Women with Precancerous Cervical Lesions Tevogen Bio elaborated on developing TVGN 920, a T cell therapy for the treatment of HPV in women with precancerous cervical lesions. The investigational product, TVGN 920, will be manufactured utilizing Tevogen’s proprietary ExacTcell technology, in which genetically unmodified, allogeneic cytotoxic CD8+ CTLs with precise targets across the HPV genome, will be tested in safety and feasibility studies. Tevogen aims to evaluate the potential of TVGN 920 in treating HPV, a known trigger of cervical cancer, which often persists in women following treatment for high-grade cervical lesions. The goal is to prevent recurrent lesions that could eventually lead to cervical cancer and eradicate HPV infection to prevent transmission of the virus. 공시 • Oct 09
Tevogen Bio Holdings Inc. Reissues Previously Announces Results from its Proof-of-Concept Clinical Trial Designed to Evaluate the Safety and Feasibility of TVGN 489 Tevogen Bio reissues its previously announced topline results from its Proof-of-Concept clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company’s first clinical product utilizing the internally developed ExacTcell™ technology, for the treatment of acute high-risk SARS-CoV-2 patients. TVGN 489 is a genetically unmodified, off-the-shelf, allogeneic cytotoxic CD8+ T lymphocyte product with precise targets across the SARS-CoV-2 genome, not just the Spike protein. To date, TVGN 489 targets, identified early in the pandemic, persist in the most recent SARS-CoV-2 variants. The open label comparative trial was conducted at Thomas Jefferson University Hospital in Philadelphia to assess the safety and feasibility of TVGN 489 when given at one of four escalating doses. Twelve ambulatory patients with newly diagnosed SARS-CoV-2 infection who were at higher risk for infection-related complications due to advanced age or CDC-defined comorbid conditions such as heart, lung, liver, and kidney disease, hypertension, diabetes, cancer, or obesity were treated on the trial. Eighteen patients, who also met these criteria but did not receive TVGN 489 because of lack of HLA matching, were enrolled on an observational arm in the study and treated with standard of care including monoclonal antibodies. The treated patients had between 2 to 5 comorbidities each and 6 out of 12 (50%) were immunocompromised due to treatment for cancer or autoimmune disease. Multiple SARS-CoV-2 variants were detected in the group. Safety endpoints included infusion reactions, grade 4 adverse events, GVHD, marrow aplasia, neurotoxicity and CRS. Safety endpoints were reviewed after each dose level and confirmed by an independent Data and Safety Monitoring Committee at Jefferson and by both internal and external Medical Monitors who provided permission to escalate to the next dose level. Based on the data in Table 1, safety was confirmed with the minimum required number of patients per dosing level. In addition to safety endpoints, endpoints measuring the reduction of viral load and the presence of cellular and humoral anti-SARS-CoV-2 responses after treatment were also met. Enrollment was completed in nine months, and six-month follow-up for all patients concluded on January 19, 2023. In the treatment arm, no patient experienced progression of their SARS-CoV-2 infection and all patients returned to their baseline level of health within 14 days of treatment. There were no incidences of COVID-19 reinfection or Long COVID observed in any treated patient through the 6-month follow-up period. While patients in the treatment group experienced COVID-19 symptom relief in a rapid, consistent timeframe as self-reported and confirmed by the investigators, patients on the observation arm showed improvement in a less consistent, and in some cases, longer time frame. 공시 • Aug 23
Tevogen Bio Holdings Inc. announced that it expects to receive $6 million in funding from The Patel Family, LLP Tevogen Bio Holdings Inc. announced that it has entered into a definitive agreement with new investor, The Patel Family, LLP to issue Series C Preferred Stock for the aggregate gross proceeds of $6,000,000 on August 22, 2024. The shares of Series C Preferred Stock will have a 7.5% dividend per year, accruing and payable quarterly. The Series C Preferred Stock is convertible into shares of common stock after 6 months at the election of the holder, and callable by Tevogen for redemption after 5 years at Tevogen’s election. The Series C Preferred Stock does not have any mandatory redemption and is non-voting. Dividends will cease to accrue after 10 years if the Series C Preferred Stock remains outstanding at that time. The purchase agreement for the Series C Preferred Stock provides for two closings, one on August 30, 2024, for $4 million, and one on September 16, 2024, for $2 million. 공시 • Jun 25
Tevogen Bio Holdings Inc. Announces Publication of Positive Phase I Clinical Trial Results for TVGN 489 in Blood Advances Tevogen Bio Holdings Inc. reported publication of its phase I clinical trial data of TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy by the journal Blood Advances. Key Observations: Interventional arm patients, totaling twelve high-risk individuals, 50% of whom were immunocompromised, and 40% of whom were immunocompromised due to preexisting cancers, received a single infusion of one of four escalating doses of TVGN 489, a product containing 68.5% SARS-CoV-2-specific CD8+ CTLs/total cells. Symptom improvement and resolution in treatment arm patients were compared to an observational group of eighteen patients who received standard care, making a total of 30 study participants. TVGN 489 was well-tolerated at all four doses tested. Nasal swab PCR data showed 88% or greater viral elimination in 92% of patients by day +4 and > 99% viral elimination in all patients by day +14. No progression of disease or the development of Long COVID was observed in the treatment group, despite the prevalence of immunocompromised patients. TVGN 489 did not interfere with the development of endogenous anti-SARS-CoV-2 humoral or cellular responses. T-cell receptor beta (TCRß) analysis comparing TVGN 489 responses derived from the CTL donor versus recipients showed persistence of donor-derived CTLs through the end of the 6-month follow-up period. An unanticipated finding was the persistence of the TVG-489 CTLs in all patients tested through the end of the 6-month follow-up period. 공시 • Jun 23
Tevogen Bio Holdings Inc. Receives A Letter from Nasdaq Regarding Minimum Bid Price Requirement On June 14, 2024, Tevogen Bio Holdings Inc. received a letter from the Listing Qualifications Department (the Staff") of The Nasdaq Stock Market LLC (Nasdaq") notifying the Company that the Company no longer meets Nasdaq's $1.00 per share minimum bid price requirement pursuant to Nasdaq Listing Rule 5450(a)(1) (the Bid Price Requirement") for continued listing on Nasdaq based on the closing bid price for the Common Stock, for the previous 35 consecutive business days. The notification received has no immediate effect on the Company's listing or trading on The Nasdaq Global Market. The Company has been provided a period of 180 calendar days, or until December 11, 2024 (the Compliance Date"), to regain compliance with the Bid Price Requirement. If, at any time before the Compliance Date, the bid price for the Common Stock closes at $1.00 or more for a minimum of 10 consecutive business days, the Staff will provide written notification to the Company that it has regained compliance with the Bid Price Requirement. If the Company does not regain compliance with the Bid Price Requirement by the Compliance Date, the Company may be eligible for an additional 180 calendar day compliance period. To qualify, the Company will be required to transfer to the Nasdaq Capital Market and meet the continued listing requirement for market value of its publicly held shares and all other initial listing standards for the Nasdaq Capital Market, with the exception of the Bid Price Requirement, and will need to provide written notice of its intention to cure the deficiency during the second 180 calendar day compliance period. The Company intends to actively monitor the closing bid price of the Common Stock and may, if appropriate, evaluate available options to regain compliance with the Bid Price Requirement. However, there can be no assurance that the Company will be able to regain compliance with the Bid Price Requirement or will otherwise maintain compliance with Nasdaq listing rules. 공시 • Jun 08
Tevogen Bio Confirms Ongoing Efficacy of Tvgn 489, Its Investigational Allogeneic Off-The-Shelf Immunotherapy, Against Dominant Flirt Strains of Sars-Cov-2 Tevogen Bio Holdings Inc. announced TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy for treatment of COVID-19 in high-risk patients and Long COVID, retains activity against the currently dominant and highly mutated FLiRT strains of SARS-CoV-2 based on a review of this variant’s protein sequences. Named FLiRT to reflect amino acid changes occurring in the spike protein, these Omicron subvariants are descendent from JN.1, the previously dominant strain in the US. TVGN 489 contains Cytotoxic T lymphocytes that recognize multiple SARS-CoV-2 proteins, or peptides. TVGN 489’s peptide targets have been preserved in all previously studied COVID strains. Continuing surveillance by Tevogen Bio of SARS-CoV-2 variants, show that 95% of these CTLs remain active against FLiRT variants, including KP.2, the current dominant strain. In January 2023, Tevogen reported positive phase I study results in which high-risk patients with the delta, omicron 1, and omicron 2 variants of COVID-19 received TVGN 489, manufactured for the trial in May of 2021. In addition to no dose-limiting toxicities or significant treatment-related adverse events being observed in the treatment arm, all patients, regardless of variant, experienced prompt clinical improvement and a reduced amount of virus in their nasal swabs (>99 to 100% in all patients) within 14 days. “These findings will be further assessed in planned later-stage trials and TVGN 489 will continue to be monitored for target preservation in emerging SARS-CoV-2 variants,” said Dr Dolores Grosso, DNP, Tevogen’s Global Clinical Development Lead. TVGN 489 is manufactured using the ExacTcell™ platform in which numerous peptides from across a viral genome are selected as targets for the CTLs, mitigating reductions in cytotoxicity from the loss of one target from mutation. In the case of SARS-CoV-2, the entire COVID-19 genome as opposed to just the Spike protein is targeted. The preservation of T-cell targets across nearly five years of viral evolution avoids the need to make frequent changes to the formulation of TVGN 489 and stands in contrast to the loss of monoclonal antibody targets, which has happened far more rapidly in a number of cases. 공시 • May 18
Tevogen Bio Holdings Inc. announced delayed 10-Q filing On 05/16/2024, Tevogen Bio Holdings Inc. announced that they will be unable to file their next 10-Q by the deadline required by the SEC. 공시 • Apr 03
Tevogen Bio Holdings Inc. announced delayed annual 10-K filing On 04/02/2024, Tevogen Bio Holdings Inc. announced that they will be unable to file their next 10-K by the deadline required by the SEC. 공시 • Mar 28
Tevogen Bio Holdings Inc. announced that it expects to receive $6 million in funding Tevogen Bio Holdings Inc. announced that it has entered into a securities purchase agreement with an existing investor pursuant to which the investor agreed to purchase shares of newly designated Series A-1 Preferred Stock of the Company in lieu of Series A Preferred Stock that the investor earlier agreed to purchase, for an aggregate purchase price of $6,000,000 on March 27, 2024. The shares of Series A-1 Preferred Stock will be issued in the first quarter and will be convertible at a conversion price of $10 as opposed to the $4 conversion price of the Series A Preferred Stock, into a total of 600,000 shares of the Company’s common stock at the election of the holder. The Series A-1 Preferred Stock is subject to a call right providing the Company the right to call the stock if the volume weighted average price of the common stock for the 20 days prior to delivery of the call notice is greater than $5.00 per share and there is an effective resale registration statement on file covering the underlying common stock. The Series A-1 Preferred Stock is non-voting, has no mandatory redemption, carries an annual 5% cumulative dividend, increasing by 2% each year, with a cap of 12% per year. 공시 • Feb 22
Tevogen Bio Holdings Inc. Prepares to Launch Crucial Genetic Predisposition Study in Preparation to Investigate the Potential of TVGN 489 to Address Critical Unmet Need for Long COVID Treatment Tevogen Bio Holdings Inc. announced that it's ExacTcell platform was developed to harness the killing ability of naturally occurring cytotoxic T lymphocytes (CTLs), against viral and malignant targets. TVGN 489, a CTL therapy produced by the ExactTcell platform, contains CTLs recognizing multiple protein targets across the SARS-CoV-2 genome. These cells were well tolerated in a completed proof of concept clinical trial in high-risk patients with acute COVID-19, with later stage studies planned in this area. Tevogen plans to assess whether TVGN 489 cells can rapidly eliminate symptoms of Long Covid. Specific HLA types may be associated with more or less protection against a particular infection. Prior to launching the Long COVID clinical trial, Tevogen seeks to address whether Long COVID occurs more commonly with certain HLA types and less commonly with others, or whether Long COVID occurs randomly in the population regardless of HLA. This effort will help Tevogen generate CTL products recognizing the HLA types that are most commonly associated with Long Covid, if a relationship between Long Covid and HLA type is identified, with the goal of allowing a Long COVID treatment trial to be designed and completed expeditiously. Board Change • Feb 16
No independent directors Following the recent departure of a director, there are no independent directors on the board. The company's board is composed of: No independent directors. 6 non-independent directors. Member of Advisory Board Afshin Beheshti was the last director to join the board, commencing their role in 2024. The company's lack of independent directors is a risk according to the Simply Wall St Risk Model.