Core Insights - Tevogen Bio Holdings Inc. has been recognized by Yale University for its commitment to health equity and the leadership of its Founder and CEO, Dr. Ryan Saadi [2] - The company operates with a lean, capital-efficient business model, fully owning its core intellectual property to minimize costs and complexity in developing CD8+ T cell therapies [3] - Dr. Saadi emphasized that affordability and accessibility are foundational to Tevogen's operations, achieving significant milestones with lower capital expenditure compared to industry norms [4] Business Model and Strategy - Tevogen's business model is designed to withstand market pressures through a capital-efficient structure, focusing on off-the-shelf, genetically unmodified therapies [3] - The company has avoided the typical billion-dollar burn rate seen in the industry, maintaining a lean cash run rate while preserving equity [4] - Tevogen aims to deliver innovative therapies that not only improve patient outcomes but also achieve commercial success at a lower cost [4] Recognition and Impact - The recognition from Yale highlights the impact of Tevogen's mission on making healthcare more affordable and accessible [2] - Dr. Saadi's vision is acknowledged as a significant contribution to the healthcare landscape, reinforcing the company's commitment to health equity [2][4]

Core Viewpoint - Tevogen Bio Holdings Inc. has reported a significant increase in institutional ownership of its common stock, indicating growing confidence from long-term investors in the company's scientific and operational progress [2][3]. Institutional Ownership Update - As of June 30, 2025, institutional ownership of Tevogen common stock rose by 24% compared to March 31, 2025, following a 60% increase in the first quarter [2]. - The number of institutional holders increased from 51 to 55, with 72% of these holders either increasing or maintaining their positions [2]. Key Contributors - Major contributors to the second quarter growth in institutional ownership were Morgan Stanley and BlackRock, which collectively increased their holdings by 80% [2]. Management Commentary - The Head of Investor Relations at Tevogen stated that the increase in institutional ownership is a positive sign, reflecting the company's scientific advancements and operational milestones, such as positive clinical data and progress towards internal GMP cell manufacturing capabilities [3].

Core Insights - Tevogen Bio Holdings Inc. has been recognized in BINJE's BEST Health Care 2025 for its commitment to health equity and innovation in sustainable biopharma [1][2] - The company's focus is on developing affordable and safe T cell therapies for acute viral infections and cancers, utilizing its proprietary ExacTcell™ platform [2] Company Overview - Tevogen Bio is dedicated to advancing health equity by ensuring access to life-saving medications through a sustainable biopharma model [2] - The company operates a lean, capital-efficient structure that avoids licensing overhead by fully owning its core intellectual property [2] - Tevogen's CD8+ T cell therapies are designed to reduce manufacturing complexity and costs, aligning with U.S. healthcare priorities [2] Technological Advancements - The launch of Tevogen.AI aims to accelerate therapeutic discovery and development through advanced algorithms and partnerships with Microsoft and Databricks [2] Recognition and Community - Tevogen expresses gratitude to BINJE and congratulates other honorees in the health care sector for their achievements [3]

Core Insights - Tevogen Bio Holdings Inc. has been recognized in BINJE's BEST Health Care 2025 for its commitment to health equity and innovation in sustainable biopharma [1][2] - The company's focus is on developing affordable T cell therapies for acute viral infections and cancers, utilizing its proprietary ExacTcell™ platform [2] Company Overview - Tevogen Bio is dedicated to advancing health equity by ensuring access to life-saving medications through a sustainable biopharma model [2] - The company operates a lean, capital-efficient structure that avoids licensing overhead by fully owning its core intellectual property [2] - Tevogen's CD8+ T cell therapies are designed to reduce manufacturing complexity and costs, aligning with U.S. healthcare priorities [2] Technological Advancements - The launch of Tevogen.AI aims to accelerate therapeutic discovery and development through advanced algorithms and partnerships with Microsoft and Databricks [2] Recognition and Community - Tevogen expresses gratitude to BINJE and congratulates other honorees in the health care sector for their achievements [3]

Core Viewpoint - Tevogen Bio Holdings Inc. has secured a financing agreement of up to $50 million, which includes a $36 million line of credit and a potential $14 million private placement, following the elimination of $94.9 million in liabilities, aimed at supporting its R&D efforts and expanding its intellectual property portfolio [1][2][3]. Financing Details - The financing structure consists of a $36 million line of credit, allowing access to $1 million per month at an interest rate of the lower of the daily SOFR plus 2.0% or 7.0%, with a maturity of four years after each draw [3]. - The $14 million private placement can be executed at the counterparty's option once the share price reaches $10, priced at a 30% discount to that price [4]. Business Model and R&D Focus - Tevogen's innovative business model is designed to enhance research and development, particularly for its initial product, TVGN 489, derived from the ExacTcell™ technology platform [2]. - The company currently holds three granted US patents and has nine pending US patent applications, along with twelve ex-US patent applications, indicating a strong intellectual property position [2][6]. Leadership and Vision - Tevogen is led by a team of experienced industry leaders and scientists, emphasizing the importance of accessible personalized therapeutics as the next frontier in medicine [7]. - The company aims to provide affordable and accessible personalized T cell therapies to address significant unmet needs in large patient populations [5][6].

Core Viewpoint - Tevogen Bio Holdings Inc. reported improved operational efficiency and reduced losses in its financial results for Q2 2025, indicating a positive trajectory towards anticipated revenue by the end of 2026 [1][2][3]. Financial Performance - For the three months ended June 30, 2025, the loss from operations was $5.4 million, a decrease from $8.6 million in the same period of 2024 [2][7]. - The net loss for the quarter was $5.5 million, compared to $9.7 million in Q2 2024, reflecting a significant improvement in financial performance [2][7]. Operational Strategy - The company is focused on maximizing capital efficiency and has access to sufficient financing to support its growth plans [3][7]. - Tevogen is in the process of establishing its own GMP manufacturing facility, which is a strategic move to enhance production control and accelerate product development timelines [4][7]. Market Position and Future Outlook - Tevogen acknowledges the limited growth in the market but emphasizes that it is building infrastructure, advancing AI, and strengthening internal capabilities [3][7]. - The company is exploring options to address its current limited tradable float to better meet investor demand [3][7].

Core Viewpoint - Tevogen Bio Holdings Inc. announced a donation of 10,000 shares by its Founder and CEO, Dr. Ryan Saadi, to the Warren Township Honorary Policemen's Benevolent Association, highlighting the company's commitment to community support and public service [1][3]. Company Summary - Tevogen Bio Holdings Inc. is involved in the biopharmaceutical industry, focusing on the development of products for the treatment of infectious diseases and cancer [4]. - The company operates under SEC Rule 144, ensuring compliance in the donation process, and Dr. Saadi will not benefit financially from the share disposal [3]. Community Engagement - The Warren Township P.B.A. Local 235 is a non-profit organization that supports local schools, community events, and charitable causes, including assistance for families of fallen and injured police officers [2]. - Dr. Saadi emphasized the importance of the P.B.A. in strengthening community bonds with law enforcement, reflecting the company's values of social responsibility [3].

Core Viewpoint - Tevogen Bio Holdings Inc. announced a significant donation of 10,000 shares by its Founder and CEO, Dr. Ryan Saadi, to the Warren Township Honorary Policemen's Benevolent Association, highlighting the company's commitment to community support and public service [1][3]. Company Summary - Tevogen Bio Holdings Inc. is actively involved in community engagement through charitable contributions, as demonstrated by Dr. Saadi's donation to a local non-profit organization [1][2]. - The donation aligns with SEC Rule 144, ensuring compliance in the disposal of securities, and Dr. Saadi will not benefit financially from this transaction [3]. Industry Context - The Warren Township P.B.A. Local 235 focuses on supporting local schools, community events, and charitable causes, which fosters a strong relationship between law enforcement and the community [2].

Company Overview - Tevogen Bio Holdings Inc. announced a donation of 10,000 shares by its Founder and CEO, Dr. Ryan Saadi, to the Opportunity Project, a nonprofit organization focused on supporting individuals with brain injuries [1][2] - The Opportunity Project has been operational since 1993 and has served over 600 individuals and their families, providing programs aimed at fostering independence and community reintegration [1] Community Engagement - Dr. Saadi expressed admiration for the Opportunity Project's impact on the community and emphasized a shared commitment to supporting local initiatives [2] - The donation was made in compliance with SEC Rule 144, ensuring that Dr. Saadi will not benefit financially from the sale of the donated shares [2]

Part I - Financial Information [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited).) The unaudited consolidated financial statements for the six months ended June 30, 2025, report a net loss of $15.9 million, a significant shift from prior year's net income, with a $9.5 million stockholders' deficit and operations sustained by financing [Consolidated Financial Statements](index=4&type=section&id=Consolidated%20Financial%20Statements) As of June 30, 2025, the balance sheet shows $4.3 million in assets, $13.8 million in liabilities, and a $9.5 million stockholders' deficit, with a $15.9 million net loss and $6.5 million net cash used in operations for the six months ended June 30, 2025 Consolidated Balance Sheet Summary (Unaudited) | Metric | June 30, 2025 ($) | December 31, 2024 ($) | | :--- | :--- | :--- | | Cash | $685,229 | $1,282,995 | | Total Assets | $4,269,136 | $3,461,675 | | Total Liabilities | $13,753,878 | $10,135,680 | | Total Stockholders' Deficit | $(9,484,742) | $(6,674,005) | Consolidated Statement of Operations Summary (Unaudited) | Metric | Three Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2025 ($) | | :--- | :--- | :--- | | Research and Development | $2,699,991 | $5,895,059 | | General and Administrative | $2,744,545 | $9,905,824 | | Net Loss | $(5,503,979) | $(15,871,040) | | Net Loss Per Share (Basic & Diluted) | $(0.03) | $(0.09) | Consolidated Statement of Cash Flows Summary (Unaudited) | Metric | Six Months Ended June 30, 2025 ($) | Six Months Ended June 30, 2024 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | $(6,497,766) | $(5,146,335) | | Net cash provided by financing activities | $5,900,000 | $5,229,328 | | Net (decrease) increase in cash | $(597,766) | $82,993 | [Notes to the Unaudited Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Unaudited%20Consolidated%20Financial%20Statements) The notes detail the company's clinical-stage immunotherapy business, liquidity position, significant related-party transactions including a $36 million loan facility, and subsequent events like an at-the-market equity offering - The company is a clinical-stage immunotherapy company using its ExacTcell platform to develop T cell therapies, with its lead product, TVGN 489 for COVID-19, having completed a Phase 1 trial, and is also developing its Tevogen.AI initiative[21](index=21&type=chunk)[22](index=22&type=chunk) - Management believes existing cash, recent financing proceeds, and available credit/grant funding will be sufficient to operate for **at least the next 12 months**, but the company does not plan to initiate new clinical trials until additional funding is secured[27](index=27&type=chunk) - In June 2024, the company entered into a Loan Agreement with The Patel Family, a related party, for a line of credit up to **$36 million**, of which **$4.4 million** had been drawn as of June 30, 2025, with **$24 million** remaining available[59](index=59&type=chunk) - Subsequent to the quarter end, the company initiated an "at-the-market" equity offering of up to **$50 million**, selling approximately **2.3 million shares** for net proceeds of **$2.53 million** between July 3 and August 13, 2025[120](index=120&type=chunk)[121](index=121&type=chunk) - The company has significant related-party transactions, including preferred stock sales, the primary loan agreement, and grants with entities affiliated with The Patel Family[104](index=104&type=chunk)[105](index=105&type=chunk)[108](index=108&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=24&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses the company's pre-revenue status, Q2 2025 operating expense decrease due to lower stock-based compensation, and liquidity, noting sufficient cash for 12 months but additional capital needed for new clinical trials [Overview](index=25&type=section&id=Overview) Tevogen is a clinical-stage immunotherapy company developing T cell therapies with its ExacTcell platform, reporting a $5.4 million net loss for Q2 2025 and no revenue - The company's strategy is to develop off-the-shelf CD8+ cytotoxic T lymphocyte (CTL) therapies for infectious diseases, cancers, and other disorders using its ExacTcell technology[128](index=128&type=chunk)[129](index=129&type=chunk) - The first clinical product, TVGN 489, has completed a **Phase 1 trial** for high-risk COVID-19 patients, showing no dose-limiting toxicities and meeting secondary endpoints[131](index=131&type=chunk) - The company is also leveraging its Tevogen.AI initiative to expedite drug development and optimize clinical trials[132](index=132&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Operating results show Q2 2025 R&D and G&A expenses decreased due to lower stock-based compensation, leading to a $15.9 million net loss for the six-month period compared to a $1.6 million net income in 2024 Comparison of Operating Results (Three Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research & Development | $2.7M | $4.1M | ($1.4M) | | General & Administrative | $2.7M | $4.5M | ($1.8M) | | Net Loss | ($5.5M) | ($9.7M) | $4.2M | Comparison of Operating Results (Six Months Ended June 30) | Metric | 2025 ($) | 2024 ($) | Change ($) | | :--- | :--- | :--- | :--- | | Research & Development | $5.9M | $24.9M | ($19.0M) | | General & Administrative | $9.9M | $13.2M | ($3.3M) | | Net (Loss) Income | ($15.9M) | $1.6M | ($17.5M) | - The primary reason for the decrease in operating expenses in 2025 compared to 2024 was **significantly lower non-cash stock-based compensation expense**[163](index=163&type=chunk)[168](index=168&type=chunk)[169](index=169&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2025, the company had $0.7 million in cash, funded by preferred stock sales, a $36 million loan facility, grants, and a subsequent $2.53 million at-the-market offering, sufficient for 12 months of operations but not new clinical trials - The company is financing operations through a combination of preferred stock sales, a loan agreement, grant funding, and an at-the-market equity offering[176](index=176&type=chunk)[177](index=177&type=chunk) - Management has concluded that cash on hand, combined with available loan and grant commitments and proceeds from the Sales Agreement, is sufficient to fund operations for **at least the next 12 months**[148](index=148&type=chunk)[190](index=190&type=chunk) - The company does not plan to initiate a new clinical trial until additional funding is received[190](index=190&type=chunk) Contractual Obligations as of June 30, 2025 | Obligation Type | Total ($) | Less than 1 Year ($) | 1 – 3 Years ($) | More than 3 Years ($) | | :--- | :--- | :--- | :--- | :--- | | Operating lease commitments | $2,512,670 | $327,740 | $983,219 | $1,201,711 | | Notes payable | $1,651,000 | $1,651,000 | - | - | | Loan Agreement repayment | $4,462,614 | $62,614 | - | $4,400,000 | | **Total** | **$8,626,284** | **$2,041,354** | **$983,219** | **$5,601,712** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=38&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk.) As a smaller reporting company, Tevogen is exempt from providing quantitative and qualitative disclosures about market risk - As a **smaller reporting company**, Tevogen is not required to provide information regarding quantitative and qualitative disclosures about market risk[200](index=200&type=chunk) [Item 4. Controls and Procedures](index=38&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that disclosure controls and procedures were ineffective as of June 30, 2025, due to material weaknesses in internal control over financial reporting - Management concluded that the company's disclosure controls and procedures were **not effective** as of the end of the period covered by the report[201](index=201&type=chunk) - The ineffectiveness is attributed to **material weaknesses** in the company's internal control over financial reporting[201](index=201&type=chunk) Part II - Other Information [Item 1. Legal Proceedings](index=39&type=section&id=Item%201.%20Legal%20Proceedings.) The company reports no material legal proceedings are currently pending - As of the filing date, the company is **not involved in any material legal proceedings**[204](index=204&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors.) The company's risk factors, detailed in its Annual Report, emphasize the critical need for substantial additional financing, as failure to secure it could jeopardize development and commercialization efforts - The company requires **substantial additional financing** to pursue its business objectives, and failure to obtain it could force delays or termination of product development[207](index=207&type=chunk) - The company's **future viability** is dependent on its ability to generate cash from operations or raise additional capital[210](index=210&type=chunk) - Raising additional capital may not be available on acceptable terms, if at all, and could result in **significant dilution** to existing stockholders or **restrictive covenants**[213](index=213&type=chunk)[215](index=215&type=chunk) [Item 5. Other Information](index=40&type=section&id=Item%205.%20Other%20Information.) No directors or officers adopted or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the three months ended June 30, 2025 - During the second quarter of 2025, **no directors or officers adopted or terminated any Rule 10b5-1 or non-Rule 10b5-1 trading arrangements**[216](index=216&type=chunk) [Item 6. Exhibits](index=41&type=section&id=Item%206.%20Exhibits.) This section provides an index of exhibits filed with the Form 10-Q, including CEO/CFO certifications and the Sales Agreement - The report includes a list of filed exhibits, such as **CEO/CFO certifications** required by the Sarbanes-Oxley Act and **interactive data files (XBRL)**[219](index=219&type=chunk)