Tevogen Bio Signs Letter of Intent With CD8 Technology to Build Up to a $50 Million R&D and Manufacturing Facility; No Impact on Shareholder Equity
Tevogen Bio (Nasdaq: TVGN) has signed a Letter of Intent with CD8 Technology to establish a $50 million R&D and manufacturing facility. The facility will support pre-clinical research and GMP manufacturing capabilities, with staffing provided by Tevogen. This strategic move aims to overcome capital and time barriers typically associated with building GMP capabilities at scale, potentially accelerating research and manufacturing processes. The company emphasizes that this arrangement will have no impact on shareholder equity while supporting their growth agenda.
Tevogen Bio (Nasdaq: TVGN) ha firmato una Lettera di Intenti con CD8 Technology per stabilire un impianto di ricerca e produzione da 50 milioni di dollari. L'impianto supporterà la ricerca preclinica e le capacità di produzione GMP, con il personale fornito da Tevogen. Questa mossa strategica mira a superare le barriere di capitale e di tempo tipicamente associate alla costruzione di capacità GMP su larga scala, accelerando potenzialmente i processi di ricerca e produzione. L'azienda sottolinea che questo accordo non avrà impatto sulla capitale degli azionisti, supportando al contempo la loro agenda di crescita.
Tevogen Bio (Nasdaq: TVGN) ha firmado una Carta de Intención con CD8 Technology para establecer una instalación de I+D y fabricación de 50 millones de dólares. La instalación respaldará la investigación preclínica y las capacidades de fabricación GMP, con personal proporcionado por Tevogen. Este movimiento estratégico tiene como objetivo superar las barreras de capital y tiempo que normalmente están asociadas con la construcción de capacidades GMP a gran escala, lo que podría acelerar los procesos de investigación y fabricación. La compañía enfatiza que este acuerdo no tendrá impacto en el capital de los accionistas al mismo tiempo que apoya su agenda de crecimiento.
Tevogen Bio (Nasdaq: TVGN)가 CD8 Technology와 5000만 달러 규모의 연구개발 및 제조 시설을 설립하기 위한 의향서를 체결했습니다. 이 시설은 전임상 연구 및 GMP 제조 능력을 지원하며, 직원은 Tevogen이 제공할 것입니다. 이 전략적 움직임은 대규모 GMP 능력을 구축하는 데 일반적으로 수반되는 자본 및 시간 장벽을 극복하여 연구 및 제조 프로세스를 가속화할 수 있습니다. 회사는 이 합의가 주주 자본에 영향을 미치지 않으면서 성장 계획을 지원할 것이라고 강조합니다.
Tevogen Bio (Nasdaq: TVGN) a signé une Lettre d'Intention avec CD8 Technology pour établir une installation de R&D et de fabrication de 50 millions de dollars. Cette installation soutiendra la recherche préclinique et les capacités de fabrication GMP, avec un personnel fourni par Tevogen. Ce mouvement stratégique vise à surmonter les barrières de capital et de temps généralement associées à la construction de capacités GMP à grande échelle, ce qui pourrait accélérer les processus de recherche et de fabrication. L'entreprise souligne que cet accord n'affectera pas les capitaux propres des actionnaires tout en soutenant son agenda de croissance.
Tevogen Bio (Nasdaq: TVGN) hat ein Letter of Intent mit CD8 Technology unterzeichnet, um eine Forschungs- und Produktionsstätte im Wert von 50 Millionen Dollar einzurichten. Die Einrichtung wird die präklinische Forschung und die GMP-Herstellungskapazitäten unterstützen, wobei das Personal von Tevogen bereitgestellt wird. Dieser strategische Schritt zielt darauf ab, Kapital- und Zeitbarrieren zu überwinden, die normalerweise mit dem Aufbau von GMP-Fähigkeiten in großem Umfang verbunden sind, und könnte die Forschungs- und Produktionsprozesse beschleunigen. Das Unternehmen betont, dass diese Vereinbarung keine Auswirkungen auf das Eigenkapital der Aktionäre hat und gleichzeitig seine Wachstumsagenda unterstützt.
- Strategic expansion of R&D and manufacturing capabilities without impacting shareholder equity
- Access to $50 million facility without direct capital investment
- Potential acceleration of research and manufacturing processes
- None.
Insights
The
The facility's dual purpose for pre-clinical research and GMP manufacturing suggests operational cost efficiencies and vertical integration benefits. However, investors should note that this is currently just a Letter of Intent and final terms, timeline and actual implementation details are yet to be confirmed. The impact on future operational expenses and potential lease obligations will be key metrics to monitor once the definitive agreement is reached.
The proposed GMP manufacturing facility represents a significant strategic advantage in the competitive cell therapy space. Having dedicated manufacturing capabilities is important for cell therapy companies, as it provides better control over production processes, reduces reliance on contract manufacturers and potentially lowers long-term production costs. The facility's dual R&D and manufacturing capability is particularly valuable for optimizing the translation from research to commercial production.
The turn-key approach could significantly reduce the typical 2-3 year timeline usually required to build and validate a GMP facility from scratch. This accelerated timeline could provide Tevogen with a competitive advantage in bringing their T cell therapeutics to market more quickly. The facility's focus on off-the-shelf T cell therapeutics suggests potential for scalable manufacturing, which is essential for commercial viability in the cell therapy market.
- CD8 Technology Services, LLC (“CD8 Technology”) to provide turn-key facility for Tevogen Bio
- Reinforces Tevogen Bio’s commitment to preserving shareholder value
- Expected to further enhance Tevogen Bio’s ambitious growth agenda
WARREN, N.J., Oct. 29, 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, took significant steps toward expanding R&D and manufacturing capabilities.
The proposed facility is intended to support both pre-clinical research and GMP manufacturing capabilities, staffed by Tevogen.
“By overcoming significant capital and time barriers of entry needed to build GMP capabilities at scale, this venture is expected to significantly expedite both research and manufacturing,” said Ryan Saadi, CEO of Tevogen Bio. “This facility will be instrumental in advancing our mission to bring innovative solutions to market with speed and cost efficiency.”
About Tevogen Bio
Tevogen is a clinical-stage specialty immunotherapy company harnessing one of nature’s most powerful immunological weapons, CD8+ cytotoxic T lymphocytes, to develop off-the-shelf, genetically unmodified precision T cell therapies for the treatment of infectious diseases, cancers, and neurological disorders, aiming to address the significant unmet needs of large patient populations. Tevogen Leadership believes that sustainability and commercial success in the current era of healthcare rely on ensuring patient accessibility through advanced science and innovative business models. Tevogen has reported positive safety data from its proof-of-concept clinical trial, and its key intellectual property assets are wholly owned by the company, not subject to any third-party licensing agreements. These assets include three granted patents, nine pending US and twelve ex-US pending patents, two of which are related to artificial intelligence.
Tevogen is driven by a team of highly experienced industry leaders and distinguished 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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