Tevogen Bio Finalizes Agreement for Company’s Own Cell Therapy Production Facility
Tevogen Bio (TVGN) has signed an agreement with CD 8 Technology Services for developing a turn-key facility supporting in-house pre-clinical research and GMP cell therapy production capabilities. The agreement has an initial 12-month term with automatic renewal.
The facility will be primarily staffed and operated by Tevogen Bio, marking a strategic move to accelerate development timelines, maintain operational agility, and control costs. The company expects this agreement to help overcome typical capital barriers in building GMP capabilities at scale.
The agreement formalizes a previously announced letter of intent with CD8, a company associated with Dr. Manmohan Patel, who owns over 5% of Tevogen's common stock. Specific details including scope of work, costs, and timelines will be outlined in future work orders.
Tevogen Bio (TVGN) ha firmato un accordo con CD 8 Technology Services per sviluppare una struttura chiavi in mano che supporti la ricerca pre-clinica interna e le capacità di produzione di terapie cellulari GMP. L'accordo ha una durata iniziale di 12 mesi con rinnovo automatico.
La struttura sarà principalmente gestita e operata da Tevogen Bio, rappresentando una mossa strategica per accelerare i tempi di sviluppo, mantenere l'agilità operativa e controllare i costi. L'azienda prevede che questo accordo aiuterà a superare le tipiche barriere di capitale nella costruzione di capacità GMP su larga scala.
L'accordo formalizza una lettera di intenti precedentemente annunciata con CD8, una società associata al dott. Manmohan Patel, che possiede oltre il 5% del capitale comune di Tevogen. Dettagli specifici, inclusi ambito di lavoro, costi e tempistiche, saranno definiti in futuri ordini di lavoro.
Tevogen Bio (TVGN) ha firmado un acuerdo con CD 8 Technology Services para desarrollar una instalación llave en mano que apoye la investigación preclínica interna y las capacidades de producción de terapias celulares GMP. El acuerdo tiene una duración inicial de 12 meses con renovación automática.
La instalación será principalmente operada y gestionada por Tevogen Bio, marcando un movimiento estratégico para acelerar los plazos de desarrollo, mantener la agilidad operativa y controlar los costos. La empresa espera que este acuerdo ayude a superar las barreras típicas de capital para construir capacidades GMP a gran escala.
El acuerdo formaliza una carta de intenciones previamente anunciada con CD8, una empresa asociada con el Dr. Manmohan Patel, quien posee más del 5% de las acciones comunes de Tevogen. Los detalles específicos, incluyendo el alcance del trabajo, costos y plazos, se definirán en futuras órdenes de trabajo.
Tevogen Bio (TVGN)는 CD 8 Technology Services와 협력하여 자체 전임상 연구 및 GMP 세포 치료제 생산 역량을 지원하는 턴키 시설을 개발하기 위한 계약을 체결했습니다. 이 계약은 초기 12개월 기간이며 자동 갱신됩니다.
이 시설은 주로 Tevogen Bio가 운영 및 관리할 예정이며, 이는 개발 일정 가속화, 운영 유연성 유지, 비용 통제라는 전략적 움직임을 의미합니다. 회사는 이 계약이 대규모 GMP 역량 구축 시 일반적인 자본 장벽을 극복하는 데 도움이 될 것으로 기대합니다.
이 계약은 이전에 발표된 CD8과의 의향서(LOI)를 공식화한 것으로, CD8은 Tevogen의 보통주 5% 이상을 보유한 Manmohan Patel 박사와 관련된 회사입니다. 업무 범위, 비용, 일정 등 구체적인 세부 사항은 향후 작업 지시서에 명시될 예정입니다.
Tevogen Bio (TVGN) a signé un accord avec CD 8 Technology Services pour développer une installation clé en main soutenant la recherche préclinique interne et les capacités de production de thérapies cellulaires GMP. L'accord a une durée initiale de 12 mois avec renouvellement automatique.
L'installation sera principalement exploitée et gérée par Tevogen Bio, marquant une démarche stratégique pour accélérer les délais de développement, maintenir l'agilité opérationnelle et contrôler les coûts. L'entreprise prévoit que cet accord aidera à surmonter les barrières financières typiques à la construction de capacités GMP à grande échelle.
L'accord formalise une lettre d'intention annoncée précédemment avec CD8, une société associée au Dr Manmohan Patel, qui détient plus de 5 % des actions ordinaires de Tevogen. Les détails spécifiques, y compris le périmètre des travaux, les coûts et les délais, seront précisés dans de futurs ordres de travail.
Tevogen Bio (TVGN) hat eine Vereinbarung mit CD 8 Technology Services unterzeichnet, um eine schlüsselfertige Einrichtung zur Unterstützung der internen präklinischen Forschung und der GMP-Zelltherapieproduktion zu entwickeln. Die Vereinbarung hat eine anfängliche Laufzeit von 12 Monaten mit automatischer Verlängerung.
Die Einrichtung wird hauptsächlich von Tevogen Bio betrieben und besetzt, was einen strategischen Schritt darstellt, um Entwicklungszeiten zu verkürzen, operative Flexibilität zu erhalten und Kosten zu kontrollieren. Das Unternehmen erwartet, dass diese Vereinbarung hilft, die typischen Kapitalbarrieren beim Aufbau von GMP-Kapazitäten im großen Maßstab zu überwinden.
Die Vereinbarung formalisierte eine zuvor angekündigte Absichtserklärung mit CD8, einem Unternehmen, das mit Dr. Manmohan Patel verbunden ist, der über 5 % der Stammaktien von Tevogen besitzt. Konkrete Details wie Arbeitsumfang, Kosten und Zeitpläne werden in zukünftigen Arbeitsaufträgen festgelegt.
- Agreement enables in-house production capabilities without significant upfront capital investment
- Strategic move to accelerate development timelines and control costs
- Expansion of infrastructure for advancing CD8+ T cell therapeutics pipeline
- Related party transaction with 5% stakeholder raises potential conflict of interest concerns
- Specific costs and timeline details not yet determined
- Additional capital may be needed to execute business plan
Insights
Tevogen's in-house cell therapy facility agreement marks strategic operational independence while avoiding typical capital-intensive outlays, though related party concerns exist.
This agreement represents a significant strategic inflection point for Tevogen Bio's manufacturing capabilities. By establishing in-house GMP cell therapy production, Tevogen is addressing one of the most significant operational bottlenecks in cell therapy development - manufacturing infrastructure.
The structure appears designed to circumvent the enormous capital expenditures typically required for cell therapy facilities, which often exceed
For context, cell therapy manufacturing requires highly specialized facilities with tightly controlled environments, extensive quality systems, and skilled personnel. Building such capabilities in-house offers several competitive advantages:
- Accelerated development timelines through elimination of CMO scheduling constraints
- Direct quality oversight throughout the manufacturing process
- Protection of proprietary manufacturing know-how
- Cost control through elimination of third-party margins
However, the related-party nature of this transaction (with CD8 associated with a
This vertical integration move aligns with industry trends, as cell therapy developers increasingly recognize manufacturing as a critical competitive differentiator rather than merely a technical function. The ability to avoid massive upfront capital requirements while gaining manufacturing independence could significantly strengthen Tevogen's strategic position if executed properly.
Tevogen secures potential manufacturing capability with capital outlay through related-party agreement, maintaining financial forecasts but lacking critical details.
The announced agreement represents a capital-efficient approach to securing manufacturing infrastructure, potentially allowing Tevogen to overcome the substantial barriers to entry typically associated with cell therapy production facilities. This strategic move addresses a critical operational need while apparently preserving the company's cash position.
From a financial perspective, the most notable aspect is how this agreement appears structured to minimize upfront capital expenditure - typically a major financial hurdle for biotech companies. Traditional GMP facility construction can consume
Several financial considerations merit investor attention:
- The related-party nature of this transaction (with CD8 connected to a
5%+ shareholder) raises governance questions that will require transparency in the forthcoming work orders - The statement that this aligns with "previously announced topline forecasts" suggests this arrangement was already incorporated into financial projections
- The automatic renewal provision creates an ongoing financial obligation that requires careful evaluation
- The critical details regarding financial terms are deferred to future work orders
The CEO's comment about "exploring additional ways to recognize our real, long-term shareholders" is intriguing but ambiguous - potentially suggesting future capital allocation decisions favorable to long-term holders.
Without specific financial terms disclosed, investors cannot fully evaluate the economic impact of this agreement. While the strategic rationale for in-house manufacturing is sound, the value creation potential depends entirely on the yet-undisclosed financial structure. The company's ability to maintain financial flexibility while securing manufacturing capabilities will be critical to its long-term capital efficiency.
- The agreement would facilitate providing Tevogen Bio with in-house cell therapy production capabilities
- Formalized agreement aligns with previously announced topline forecasts
WARREN, N.J., April 17, 2025 (GLOBE NEWSWIRE) -- Tevogen Bio (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), today announced it has entered into an agreement with CD 8 Technology Services LLC (“CD8”) for the development and/or acquisition of a turn-key facility that is intended to support both in-house pre-clinical research and GMP cell therapy production capabilities.
Tevogen Bio will provide the primary staff and operations for the facility, which is a key component of the company’s long-term strategy to accelerate development timelines, maintain operational agility, and control cost. Tevogen Bio believes that this agreement should allow the Company to overcome significant capital barriers of entry that are typically faced in building GMP capabilities at scale. The agreement has an initial term of 12 months and will automatically renew and aligns with the previously announced topline forecasts.
“This milestone represents a significant step forward in Tevogen Bio’s infrastructure expansion to support the advancement of its pipeline of off-the-shelf, genetically unmodified CD8+ T cell therapeutics,” commented Ryan Saadi, MD, MPH, Founder and CEO of Tevogen Bio. “In addition, as we continue executing our mission to help patients, we’re also exploring additional ways to recognize our real, long-term shareholders.”
CD8 is associated with Dr. Manmohan Patel, who beneficially owns more than
Forward Looking Statements
This press release contains certain forward-looking statements, including without limitation statements relating to: Tevogen’s plans for its research and manufacturing capabilities; Tevogen’s ability to build GMP capabilities at scale; the prospective benefits of the agreement with CD8; expectations regarding future product revenues; expectations regarding the healthcare and biopharmaceutical industries; and Tevogen’s development of, the potential benefits of, and patient access to its product candidates for the treatment of infectious diseases and cancer. 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; 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; 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; risks related to the ability to develop, license or acquire new therapeutics; 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.
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
FAQ
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