Financial Performance - Tevogen Bio reported a net loss of $10.4 million for the three months ended March 31, 2025, compared to a net loss of $11.3 million for the same period in 2024, primarily due to non-cash stock-based compensation expenses [136]. - The net loss for the three months ended March 31, 2025, was $10.4 million, compared to a net loss of $11.3 million for the same period in 2024 [156]. - Research and development expenses for the three months ended March 31, 2025, were $3.2 million, a decrease of 84.7% from $20.8 million for the same period in 2024 [157]. - General and administrative expenses for the three months ended March 31, 2025, were $7.2 million, down 17.7% from $8.7 million in the same period in 2024 [158]. - Cash used in operating activities for the three months ended March 31, 2025, was $3.3 million, compared to $2.2 million for the same period in 2024 [165][166]. Cash and Funding - As of March 31, 2025, Tevogen Bio had an accumulated deficit of $123.8 million and cash reserves of $2.0 million [136]. - As of March 31, 2025, the company had $2.0 million in cash, an increase from $1.3 million as of December 31, 2024 [163]. - The company raised aggregate gross proceeds of $24.0 million from the sale of convertible promissory notes since January 2021 [163]. - The company has drawn $3.0 million from a Loan Agreement with a remaining $27.0 million available for future financing [163]. - The company expects to utilize $8.0 million in grant funding from KRHP for ongoing operational expenses through March 31, 2026 [176]. - The company is exploring various funding strategies, including private placements and partnerships, to support operations [177]. Clinical Development - The first clinical product, TVGN 489, has completed a Phase 1 proof-of-concept trial with no dose-limiting toxicities observed, and secondary endpoints showed a rapid reduction in viral load [126]. - The company aims to commercialize TVGN 489 and other product candidates, expecting to incur expenses related to expanding research and development capabilities and building manufacturing infrastructure [141]. - The company plans to conduct clinical trials for TVGN 489 and other product candidates, which will require considerable financial resources [172]. - The company anticipates increased expenses related to commercialization if marketing approval for TVGN 489 is obtained [174]. Patent and Technology - Tevogen Bio's patent portfolio includes three issued U.S. patents related to TVGN 489, all expiring on December 9, 2040, and nine pending U.S. patent applications [130][131]. - Tevogen Bio's ExacTcell technology is designed to develop off-the-shelf T cell therapies with applications in infectious diseases and cancers [124]. Future Expectations - The company has not generated any revenue to date and does not expect to do so until marketing approval is obtained for its product candidates [141]. - The company expects general and administrative expenses to increase in the future to support ongoing research and development and potential commercialization efforts [149]. - The company expects to incur costs associated with operating as a public company, necessitating additional funding [174]. Obligations and Agreements - Total contractual obligations as of March 31, 2025, amount to $4,846,712, with $1,846,712 due within one year [179]. - The company has committed to a securities purchase agreement with the Patel Family for $6.0 million in Series C Preferred Stock [170]. - The company has not yet received $3.0 million of the $6.0 million purchase price for Series A-1 Preferred Stock [170]. - The company has entered into a Loan Agreement allowing for monthly draws of up to $1.0 million over 27 months, with a maximum loan amount of $36.0 million [171]. - The company has drawn an aggregate of $3.0 million under the Loan Agreement as of March 31, 2025, with an additional $0.5 million drawn in April 2025 [171].

Group 1 - Tevogen Bio Holdings Inc. has received inquiries from shareholders about transferring shares to the Direct Registration System (DRS) following a recent press release [1] - The company will provide step-by-step guidance next week for shareholders to register their shares directly with the transfer agent, Continental Stock Transfer & Trust [2] - Several of Tevogen's largest shareholders have chosen to hold their shares via DRS, indicating their confidence in this method of ownership [2]

Core Viewpoint - Tevogen Bio Holdings Inc. has signed a letter of intent with CD8 Technology Services LLC to establish a facility that will support its cell therapy manufacturing, emphasizing the importance of in-house manufacturing for operational efficiency and highlighting significant insider ownership at 74% [1]. Company Summary - Tevogen's CEO, Ryan Saadi, stated that in-house manufacturing is critical for operational efficiency [1]. - The company has a notable insider ownership of 74%, indicating a strong commitment to business discipline [1]. Industry Context - The agreement with CD8 is expected to enhance Tevogen's research and manufacturing capabilities, particularly in building GMP (Good Manufacturing Practice) capabilities at scale [2]. - The company aims to develop product candidates for treating infectious diseases and cancer, which aligns with trends in the healthcare and biopharmaceutical industries [2].

Core Viewpoint - Tevogen Bio Holdings Inc. informs shareholders about the differences between holding shares in Direct Registration System (DRS) accounts versus brokerage accounts, highlighting the benefits and drawbacks of each option [1]. Group 1: DRS Accounts - DRS accounts allow shares to be registered directly in the shareholder's name, providing direct control over the shares [2]. - Holding shares in DRS accounts may result in reduced transaction and account maintenance costs for shareholders [2]. Group 2: Brokerage Accounts - Brokerage accounts may offer greater access to investment tools and facilitate quicker selling of shares compared to DRS accounts [2]. - Investors may incur costs associated with transferring shares in and out of brokerage accounts [2]. Group 3: Additional Information - For further details regarding the differences between DRS and brokerage accounts, shareholders are encouraged to contact the Company's transfer agent, Continental Stock Transfer & Trust [3].

Reflects business philosophy of commercial success through patient accessibilityRecently executed agreement with CD 8 Technology Services LLC providing up to $50 million for Company’s dedicated R&D and manufacturing facility; no impact on shareholder equity WARREN, N.J., April 28, 2025 (GLOBE NEWSWIRE) -- Tevogen (“Tevogen Bio Holdings Inc.” or “Company”) (Nasdaq: TVGN), reaffirms its top-line revenue forecast for its oncology pipeline, projecting $1 billion in revenue in its launch year and a cumulative 5- ...

Core Viewpoint - Tevogen Bio Holdings Inc. will hold its 2025 annual meeting of stockholders via live webcast on June 23, 2025, where stockholders will vote on the re-election of two directors and the ratification of the independent accounting firm [1] Group 1 - Stockholders of record as of April 30, 2025, are encouraged to participate in the voting process, with proxy materials to be distributed in accordance with SEC regulations [2] - The Company plans to disclose the voting results on a Form 8-K after the Annual Meeting [3] - A proxy statement will be filed with the SEC, which stockholders are urged to read carefully as it will contain important information about the Company and the Annual Meeting [4] Group 2 - Stockholders can obtain free copies of the proxy statement and other SEC filings from the SEC's website or the Company's Investor Relations page [5] - The Company and its directors and executive officers may be considered participants in the proxy solicitation, with relevant information to be included in the proxy statement [6]

Core Insights - Tevogen Bio has entered into an agreement with CD8 Technology Services for the development and/or acquisition of a turn-key facility to support pre-clinical research and GMP cell therapy production capabilities [1][2] - The agreement aims to accelerate development timelines, maintain operational agility, and control costs, addressing capital barriers typically faced in building GMP capabilities at scale [2][3] - The initial term of the agreement is 12 months, with automatic renewal, aligning with previously announced topline forecasts [2][6] Company Strategy - Tevogen Bio will provide primary staff and operations for the new facility, which is a significant step in expanding its infrastructure to support its pipeline of off-the-shelf, genetically unmodified CD8+ T cell therapeutics [3] - The agreement formalizes a previously announced letter of intent and is associated with Dr. Manmohan Patel, who owns more than 5% of the company's common stock [3] Future Outlook - Specific details regarding the facility, including scope of work, costs, and timelines, will be outlined in future work orders [3][6] - The agreement is expected to facilitate in-house cell therapy production capabilities, aligning with the company's long-term strategic goals [6]

Core Insights - Tevogen Bio has entered into an agreement with CD8 Technology Services LLC to develop a turn-key facility for in-house pre-clinical research and GMP cell therapy production capabilities [2][3] - The agreement is part of Tevogen Bio's long-term strategy to enhance development timelines, maintain operational flexibility, and control costs [3] - This milestone is seen as a significant step in expanding Tevogen Bio's infrastructure to support its pipeline of off-the-shelf, genetically unmodified CD8+ T cell therapeutics [4] Agreement Details - The agreement has an initial term of 12 months and will automatically renew, aligning with previously announced topline forecasts [3] - Tevogen Bio will provide the primary staff and operations for the facility, which is expected to help overcome capital barriers typically faced in building GMP capabilities at scale [3][4] - Specific details regarding the facility, including scope of work, costs, and timelines, will be outlined in future work orders [4] Leadership Commentary - Ryan Saadi, CEO of Tevogen Bio, emphasized the importance of this agreement in advancing the company's mission to help patients and in recognizing long-term shareholders [4]

Core Insights - Tevogen Bio Holdings Inc. has commissioned Databricks, Inc. to enhance the development of its AI-driven target prediction model, PredicTcell, aimed at precision immunotherapy [1][2] - The collaboration will focus on modeling immunologically active HLA+ peptide complexes and predicting T cell receptor (TCR) engagement, utilizing the ExacTcell™ platform [2] - This initiative represents a significant step in Tevogen's AI strategy, which is designed to transform precision medicine [3] Company Overview - Tevogen is dedicated to providing innovative and affordable healthcare solutions, operating through three strategic pillars: Tevogen Bio, Tevogen.AI, and Tevogen Generics [3] - Tevogen Bio focuses on genetically unmodified precision T cell therapies, while Tevogen.AI leverages AI for drug discovery and healthcare optimization [3] - The company possesses all key intellectual property and is led by a team with extensive experience in drug development and global product launches [3] Strategic Partnerships - Databricks will supply a dedicated data engineering team and expertise in data and AI systems to support the development of PredicTcell [2][6] - Microsoft Research is also contributing digital infrastructure and AI expertise to bolster the initiative [6]

Group 1 - Tevogen Bio Holdings Inc. will have its CEO, Dr. Ryan Saadi, participate in BioNJ's Fifteenth Annual Bio Partnering Conference, focusing on strategies for adapting to market volatility [1][2] - The conference aims to foster strategic partnerships and drive funding within the biopharmaceutical industry, ultimately advancing medical innovation [2][3] - Dr. Saadi emphasized the importance of addressing market volatility and its impact on patient outcomes, aligning with Tevogen Bio's mission to enhance accessibility to lifesaving treatments [3] Group 2 - The conference will feature a dynamic agenda including 1:1 partnering sessions, company pitch presentations, and extensive networking opportunities designed for growth and collaboration [3] - BioNJ President and CEO Debbie Hart expressed excitement for the panel discussion, highlighting the potential for attendees to gain actionable insights [3]