Tevogen Bio Leadership Meets Members of U.S. Congress to Advocate for Long COVID Patients and Highlights Achievements and Assets as a Blueprint for Biotech Innovation
Tevogen Bio, a clinical-stage biotech company developing T cell therapeutics, recently met with U.S. Congress members to advocate for Long COVID patients and showcase their achievements. The company's CEO, Ryan Saadi, presented Tevogen's ExacTcell™ technology as a potential solution to the Long COVID crisis. Tevogen's lead product, TVGN 489, an off-the-shelf T cell therapeutic for acute SARS-CoV-2 infections, advanced from discovery to clinical phase within 18 months.
Key achievements include: founding in June 2020, obtaining 3 U.S. patents by 2022, being valued at $4.2 billion in 2022, announcing positive clinical trial results for TVGN 489 in 2023, introducing Tevogen.AI, and going public on Nasdaq in February 2024. The company's CFO, Kirti Desai, emphasized the significant market value of Tevogen's intellectual property assets, which include granted patents and pending applications in various countries.
Tevogen Bio, una compagnia biotech in fase clinica che sviluppa terapie a base di cellule T, ha recentemente incontrato membri del Congresso statunitense per sostenere i pazienti affetti da Long COVID e mostrare i propri successi. Il CEO dell'azienda, Ryan Saadi, ha presentato la tecnologia ExacTcell™ di Tevogen come una potenziale soluzione alla crisi del Long COVID. Il prodotto di punta di Tevogen, TVGN 489, una terapia a base di cellule T pronta all'uso per le infezioni acute da SARS-CoV-2, è avanzato dalla scoperta alla fase clinica in 18 mesi.
I risultati chiave includono: la fondazione nel giugno 2020, l'ottenimento di 3 brevetti negli Stati Uniti entro il 2022, una valutazione di 4,2 miliardi di dollari nel 2022, l'annuncio di risultati positivi nei trial clinici per TVGN 489 nel 2023, l'introduzione di Tevogen.AI e la quotazione in Nasdaq a febbraio 2024. Il CFO dell'azienda, Kirti Desai, ha sottolineato il significativo valore di mercato dei beni di proprietà intellettuale di Tevogen, che includono brevetti concessi e domande pendenti in vari paesi.
Tevogen Bio, una empresa biotecnológica en etapa clínica que desarrolla terapias con células T, se reunió recientemente con miembros del Congreso de EE. UU. para abogar por los pacientes de Long COVID y mostrar sus logros. El CEO de la compañía, Ryan Saadi, presentó la tecnología ExacTcell™ de Tevogen como una solución potencial a la crisis del Long COVID. El producto estrella de Tevogen, TVGN 489, una terapia con células T lista para usar para infecciones agudas por SARS-CoV-2, avanzó desde el descubrimiento hasta la fase clínica en 18 meses.
Los logros clave incluyen: la fundación en junio de 2020, la obtención de 3 patentes en EE. UU. para 2022, una valoración de 4.2 mil millones de dólares en 2022, la publicación de resultados clínicos positivos para TVGN 489 en 2023, la introducción de Tevogen.AI y su salida a bolsa en Nasdaq en febrero de 2024. El CFO de la empresa, Kirti Desai, enfatizó el significativo valor de mercado de los activos de propiedad intelectual de Tevogen, que incluyen patentes otorgadas y solicitudes pendientes en varios países.
Tevogen Bio는 T세포 치료제를 개발하는 임상 단계의 생명공학 회사로, 최근 미국 의회 의원들과 만나 롱 COVID 환자들을 지지하고 그들의 성과를 보여주었습니다. 회사의 CEO인 Ryan Saadi는 롱 COVID 위기에 대한 잠재적 해결책으로 Tevogen의 ExacTcell™ 기술을 소개했습니다. Tevogen의 주력 제품인 TVGN 489는 SARS-CoV-2 감염에 대한 즉시 사용할 수 있는 T세포 치료제로, 18개월 만에 발견에서 임상 단계로 발전했습니다.
주요 성과는 2020년 6월 설립, 2022년까지 3개의 미국 특허 획득, 2022년 42억 달러의 가치 평가, 2023년에 TVGN 489에 대한 긍정적인 임상 시험 결과 발표, Tevogen.AI의 도입, 그리고 2024년 2월 Nasdaq에 상장된 것입니다. 회사의 CFO인 Kirti Desai는 Tevogen의 지적 재산 자산의 상당한 시장 가치를 강조했으며, 이는 여러 국가에서 부여된 특허와 보류 중인 신청서를 포함합니다.
Tevogen Bio, une entreprise biopharmaceutique en phase clinique développant des thérapies par cellules T, a récemment rencontré des membres du Congrès américain pour plaider en faveur des patients atteints de Long COVID et présenter ses réalisations. Le PDG de l'entreprise, Ryan Saadi, a présenté la technologie ExacTcell™ de Tevogen comme une solution potentielle à la crise du Long COVID. Le produit phare de Tevogen, TVGN 489, une thérapie par cellules T prête à l'emploi pour les infections aiguës par SARS-CoV-2, est passé de la découverte à la phase clinique en 18 mois.
Les principales réalisations comprennent : la fondation en juin 2020, l'obtention de 3 brevets américains d'ici 2022, une valorisation à 4,2 milliards de dollars en 2022, l'annonce de résultats positifs d'essais cliniques pour TVGN 489 en 2023, l'introduction de Tevogen.AI et l'entrée en bourse sur le Nasdaq en février 2024. Le CFO de l'entreprise, Kirti Desai, a souligné la valeur de marché significative des actifs de propriété intellectuelle de Tevogen, qui incluent des brevets accordés et des demandes en cours dans divers pays.
Tevogen Bio, ein biopharmazeutisches Unternehmen in der klinischen Phase, das T-Zell-Therapien entwickelt, traf sich kürzlich mit Mitgliedern des US-Kongresses, um für Patienten mit Long COVID zu werben und ihre Erfolge vorzuzeigen. Der CEO des Unternehmens, Ryan Saadi, präsentierte die ExacTcell™-Technologie von Tevogen als potenzielle Lösung für die Long COVID-Krise. Das Hauptprodukt von Tevogen, TVGN 489, eine sofort verfügbare T-Zell-Therapie bei akuten SARS-CoV-2-Infektionen, schritt innerhalb von 18 Monaten von der Entdeckung in die klinische Phase.
Zu den wichtigsten Leistungen gehören: die Gründung im Juni 2020, die Erlangung von 3 US-Patenten bis 2022, eine Bewertung von 4,2 Milliarden US-Dollar im Jahr 2022, die Bekanntgabe positiver Ergebnisse klinischer Studien zu TVGN 489 im Jahr 2023, die Einführung von Tevogen.AI und der Börsengang an der Nasdaq im Februar 2024. Der CFO des Unternehmens, Kirti Desai, betonte den erheblichen Marktwert der geistigen Eigentumswerte von Tevogen, zu denen erteilte Patente und anhängige Anmeldungen in verschiedenen Ländern gehören.
- Rapid advancement of lead product TVGN 489 from discovery to clinical phase in 18 months
- Granted 3 U.S. patents by 2022, with 9 additional patents pending and 12 international applications
- Valued at $4.2 billion in 2022, recognized as the highest valued biotech unicorn
- Positive proof-of-concept clinical trial results for TVGN 489 with no dose-limiting toxicities
- Inclusion in the Russell 3000® Index, reflecting growing industry presence
- Introduction of Tevogen.AI and joining Microsoft for Startups program
- Public debut on Nasdaq in February 2024
- Potential undervaluation of intellectual property assets in financial statements due to US GAAP rules
Insights
Tevogen Bio's recent meeting with Congress highlights its strategic positioning in the Long COVID and infectious disease treatment space. The company's ExacTcell™ technology and lead candidate TVGN 489 show promise, particularly for vulnerable populations. Key achievements include:
- Rapid progression from inception to clinical phase for TVGN 489
- Positive proof-of-concept results for TVGN 489
- Robust IP portfolio with 3 granted patents and multiple pending applications
- Integration of AI through Tevogen.AI and Microsoft partnership
- Inclusion in the Russell 3000® Index
The company's $4.2 billion valuation as a biotech unicorn in 2022 suggests significant market confidence. However, the CFO's statement about undervalued IP assets on the balance sheet indicates potential for future value realization. The company's focus on cost-efficient innovation and addressing unmet medical needs could position it well in the competitive biotech landscape.
Tevogen Bio's intellectual property portfolio is a critical asset that may be undervalued in current financial statements due to GAAP limitations. Key IP highlights:
- 3 granted U.S. patents for COVID-19 specific T-cells and treatment methods
- 9 additional pending patents, including 2 for AI applications
- 12 international patent applications
- PCT applications for virus-specific T-cells and methods for developing CD3+CD8+ cells against multiple viral epitopes
- Provisional applications for AI-driven target detection and product development
The breadth of Tevogen's IP coverage, spanning T cell therapeutics, AI applications and potential cancer treatments, creates a strong foundation for future value creation and market exclusivity. The company's commitment to expanding its IP portfolio, particularly in emerging areas like AI in biotechnology, could provide significant competitive advantages and licensing opportunities in the future.
WARREN, N.J., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen” or “Tevogen Bio Holdings Inc.”) (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech developing off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, shared the company’s ambition to address the Long COVID crisis as its leadership met with Congress on Capitol Hill last week.
“It was an honor to meet with congressional teams in Washington, D.C., to address the urgent challenge of Long COVID and present Tevogen Bio’s proprietary ExacTcell™ technology as a promising solution to this escalating crisis, which is impacting both individual patients and the broader economy," said Ryan Saadi, MD, MPH, founder and CEO of Tevogen Bio. He continued, "We are pleased with our rapid progress and notable achievements, including our precision T cell technology, recently published clinical trial results, and our robust intellectual property portfolio, all of which are critical milestones in our efforts to develop lifesaving immunotherapies for large patient populations."
Within 18 months of its inception, Tevogen Bio advanced its lead product candidate, TVGN 489, a genetically unmodified, off-the-shelf investigational T cell therapeutic for acute SARS-CoV-2 infections, from discovery to the clinical phase. Tevogen Bio’s leadership highlights its unique business model, which is both faster and cost-efficient, potentially serving as a blueprint to drive sustainable innovation and maintain the U.S.'s competitive edge in the biotech sector. With the ongoing unmet need for effective treatments of acute SARS-CoV-2 in vulnerable populations, such as the immunocompromised, those undergoing cancer treatment, or suffering from Long COVID, Tevogen Bio believes TVGN 489 has the potential to be a breakthrough solution.
Key Achievements:
- In June of 2020, Tevogen Bio is founded and launched its proprietary ExacTcell technology, designed to create accessible and disease-specific cellular immunotherapies.
- Tevogen Bio is granted 3 U.S. patents by 2022; there are currently 9 additional patents pending, including 2 for Artificial Intelligence, and 12 international applications filed.
- Tevogen Bio is recognized as the highest valued biotech unicorn of 2022, with an independent
$4.2 billion valuation. - By 2023, positive proof-of-concept clinical trial results are announced for TVGN 489, Tevogen Bio’s allogeneic CD8+ T cell therapy for high-risk SARS-CoV-2 patients. No dose-limiting toxicities or significant adverse events were reported, and secondary endpoints show rapid reduction of viral load, highlighting the potential of the therapy.
- Tevogen.AI is introduced to create artificial intelligence solutions for greater patient accessibility and quicker innovation while decreasing operating cost. Recently, Tevogen.AI has joined the Microsoft for Startups program gaining access to experts and resources from a world-leading AI company.
- On February 15, 2024, Tevogen Bio celebrates its public debut by ringing the Nasdaq Opening Bell, marking its first day of trading on the public market.
- Tevogen Bio is now included in the Russell 3000® Index, reflecting its growing presence and impact in the biotech industry.
Kirti Desai, CFO of Tevogen Bio, highlights, “We believe Tevogen's intellectual property assets, including 3 granted patents, have significant market value that is not currently reflected in the financial statements of the company. US GAAP rules relating to valuation of intangible assets do not permit the company to write up the internally developed intangible assets to its fair market value. We believe that a proper assessment of the company's enterprise value should include consideration of its intellectual property assets.”
Intellectual Property:
Tevogen Bio received two granted patents in December 2021 and one in January 2022 from the United States Patent and Trademark Office (USPTO) for Covid-19 Peptide Specific T-Cells and Methods of Treating and Preventing Covid-19.
In June 2022, a Patent Cooperation Treaty (PCT) application covering Virus Specific T-Cells and Methods of Treating and Preventing Viral Infections was published. This application entered the National Stage in the US, Australia, Canada, Europe, Hong Kong, and Japan.
- Publication Number WO 2022/125746
In February 2023, a PCT application covering Methods for Developing CD3+CD8+ Cells Against Multiple Viral Epitopes for Treatment of Viral Infections Including Variants Evolving to Escape Previous Immunity was published. This application entered the National Stage in the US, Australia, Canada, Europe, Japan, Qatar, Saudi Arabia, and United Arab Emirates.
- Publication Number WO 2023/009770
Tevogen Bio also had two provisional patent applications in place as of December 2023 for its approach to leveraging artificial intelligence in expediting target detection to accelerate product development:
- AI Algorithm to Predict Immunologically Active HLA-Peptide Complexes
- AI Algorithms to Predict T Cell Receptor Engagement to Specific HLA+ Peptide Complexes
As of September 2024, applications have also been filed for Antigen-Specific T Cell Receptor Engineered T Cells (TCR-T) And Methods of Treating Cancer as well as Tumor Cell Expression of Viral Antigen by Targeting With Stealth Liposome Or Antibody And Subsequent Elimination With Viral Specific CTLs.
Tevogen’s leadership believes the overall value of the company is connected to both its intellectual property portfolio and the progress of its clinical and preclinical programs. The leadership plans to provide shareholders with an update on the fair market value of these assets as soon as they become available.
About Tevogen Bio
Tevogen is a clinical-stage specialty immunotherapy company harnessing CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified T cell therapeutics to treat infectious disease and cancers, aiming to address the significant unmet needs of large patient populations. Tevogen leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents and 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 personalized therapeutics are the next frontier of medicine, and that disruptive business models are required to sustain medical innovation.
Forward Looking Statements
This press release contains certain forward-looking statements, including without limitation statements relating to: expectations regarding the healthcare and biopharmaceutical industries; Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases, cancer and neurological disorders, including TVGN 489 for the treatment of COVID-19 and Long COVID; Tevogen’s ability to develop additional product candidates, including through use of Tevogen’s ExacTcell platform; the anticipated benefits of ExacTcell; expectations regarding Tevogen’s future clinical trials; and Tevogen’s ability to generate revenue in the future. Forward-looking statements can sometimes be identified by words such as “may,” “could,” “would,” “expect,” “anticipate,” “possible,” “potential,” “goal,” “opportunity,” “project,” “believe,” “future,” and similar words and expressions or their opposites. These statements are based on management’s expectations, assumptions, estimates, projections and beliefs as of the date of this press release and are subject to a number of factors that involve known and unknown risks, delays, uncertainties and other factors not under the company’s control that may cause actual results, performance or achievements of the company to be materially different from the results, performance or other expectations expressed or implied by these forward-looking statements.
Factors that could cause actual results, performance, or achievements to differ from those expressed or implied by forward-looking statements include, but are not limited to: that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the effect of the recent business combination with Semper Paratus Acquisition Corporation (the “Business Combination”) on Tevogen’s business relationships, operating results, and business generally; the outcome of any legal proceedings that may be instituted against Tevogen; changes in the markets in which Tevogen competes, including with respect to its competitive landscape, technology evolution, or regulatory changes; changes in domestic and global general economic conditions; the risk that Tevogen may not be able to execute its growth strategies or may experience difficulties in managing its growth and expanding operations; the risk that Tevogen may not be able to develop and maintain effective internal controls; costs related to the Business Combination and the failure to realize anticipated benefits of the Business Combination; the failure to achieve Tevogen’s commercialization and development plans and identify and realize additional opportunities, which may be affected by, among other things, competition, the ability of Tevogen to grow and manage growth economically and hire and retain key employees; the risk that Tevogen may fail to keep pace with rapid technological developments to provide new and innovative products and services or make substantial investments in unsuccessful new products and services; the ability to develop, license or acquire new therapeutics; that Tevogen will need to raise additional capital to execute its business plan, which may not be available on acceptable terms or at all; the risk of regulatory lawsuits or proceedings relating to Tevogen’s business; uncertainties inherent in the execution, cost, and completion of preclinical studies and clinical trials; risks related to regulatory review, approval and commercial development; risks associated with intellectual property protection; Tevogen’s limited operating history; and those factors discussed or incorporated by reference in Tevogen’s Annual Report on Form 10-K and subsequent filings with the SEC.
You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. Tevogen undertakes no obligation to update any forward-looking statements, except as required by applicable law.
Contacts
Tevogen Bio Communications
T: 1 877 TEVOGEN, Ext 701
Communications@Tevogen.com
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