WARREN, N.J., Oct. 17, 2024 (GLOBE NEWSWIRE) -- HMP Partners and The Patel Family LLP, leading investors in innovative healthcare ventures, congratulate Tevogen Bio ("Tevogen" or "Tevogen Bio Holdings Inc.") (Nasdaq: TVGN) and founding CEO Dr. Ryan Saadi for being honored with prestigious proclamation by the Township of Warren, New Jersey, in recognition of their Nobel Prize nomination for pioneering business model to alleviate health inequality through breakthrough life-saving medical innovations. Warren T ...

Approximately one in three women remain HPV positive after cervical procedures for precancerous lesions. Tens of thousands of women in the US each year are diagnosed with high-grade cervical precancerous lesions. These high-grade cervical lesions can reoccur, requiring more treatment, and potentially lead to cervical cancer. Nearly all cervical cancer and high-grade cervical lesions are associated with HPV which promotes cancer formation. The primary risk factor for the recurrence of high-grade cervical les ...

WARREN, N.J., Oct. 11, 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, plans to share its $1B+ revenue potential, a reflection of the company's novel business approach. "In the current market reality, Tevogen Bio's unique, faster, and cost-efficient drug development model has the potential to serve as a ...

Developing therapeutic products that not only treat cancer but also enable oncology patients to maintain uninterrupted therapy. Expanding its pipeline to include non-oncology products, an opportunistic approach aimed at maximizing ROI from its ExacTcell™ technology. WARREN, N.J., Oct. 11, 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 ...

The primary study endpoints were related to safety. No dose-limiting toxicities or significant adverse events related to TVGN 489, including Cytokine Release Syndrome, were observed in any patient at any dose level. Endpoints measuring the reduction of viral load and the presence of cellular and humoral antiCOVID-19 responses after treatment were met. Fifty percent (50%) of treatment arm patients were immunocompromised versus six percent (6%) of observational arm patients. Treatment arm patients were infect ...

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 L ...

WARREN, N.J., Aug. 15, 2024 (GLOBE NEWSWIRE) -- In a release issued under the same headline earlier today by Tevogen Bio Inc (Nasdaq: TVGN), please note that paragraph two has been updated. The corrected release follows: Tevogen Bio Holdings Inc. ("Tevogen" or "Tevogen Bio") (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, has announced financial results for the fiscal quarter e ...

WARREN, N.J., Aug. 15, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holdings Inc. ("Tevogen" or "Tevogen Bio") (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, has announced financial results for the fiscal quarter ending June 30, 2024, and filed its quarterly report on Form 10-Q with the Securities and Exchange Commission. Tevogen's reported $5.1 million net cash used in operating acti ...

[Part I – Financial Information](index=4&type=section&id=Part%20I%20%E2%80%93%20Financial%20Information) This section covers the company's unaudited financial statements, management's analysis, market risk, and internal controls [Item 1. Financial Statements (Unaudited)](index=4&type=section&id=Item%201.%20Financial%20Statements%20%28Unaudited%29) This section presents Tevogen Bio Holdings Inc.'s unaudited consolidated financial statements and related notes as of June 30, 2024 Consolidated Balance Sheet Highlights (Unaudited) | Balance Sheet Item | June 30, 2024 ($) | Dec 31, 2023 ($) | | :--- | :--- | :--- | | Cash | 1,135,390 | 1,052,397 | | Total Assets | 3,310,259 | 5,505,503 | | Accounts Payable | 6,666,229 | 3,418,378 | | Total Liabilities | 10,944,156 | 99,934,400 | | Total Stockholders' Deficit | (7,633,897) | (94,428,897) | Consolidated Statement of Operations Highlights (Unaudited) | Metric | Three Months Ended June 30, 2024 ($) | Three Months Ended June 30, 2023 ($) | Six Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2023 ($) | | :--- | :--- | :--- | :--- | :--- | | Research and Development | 4,124,450 | 1,031,393 | 24,936,032 | 2,378,566 | | General and Administrative | 4,474,577 | 1,153,073 | 13,179,719 | 2,130,182 | | Loss from Operations | (8,599,027) | (2,184,466) | (38,115,751) | (4,508,748) | | Net Income (Loss) | (9,663,447) | (22,184,353) | 1,601,395 | (52,940,497) | | Net Income (Loss) Per Share, Basic | (0.04) | (0.18) | 0.03 | (0.44) | Consolidated Statement of Cash Flows Highlights (Unaudited) | Cash Flow Activity | Six Months Ended June 30, 2024 ($) | Six Months Ended June 30, 2023 ($) | | :--- | :--- | :--- | | Net cash used in operating activities | (5,146,335) | (4,394,654) | | Net cash used in investing activities | — | (133,000) | | Net cash provided by financing activities | 5,229,328 | 2,500,000 | | Net increase (decrease) in cash | 82,993 | (2,027,654) | [Note 1. Nature of Business](index=9&type=section&id=Note%201.%20Nature%20of%20Business) Tevogen is a clinical-stage immunotherapy company focused on developing off-the-shelf T cell therapies, which completed a reverse recapitalization merger on February 14, 2024 - The company's lead product, **TVGN 489 for COVID-19**, has completed a Phase 1 proof-of-concept trial[13](index=13&type=chunk) - On **February 14, 2024**, Tevogen Bio Inc. merged with Semper Paratus Acquisition Corporation, with Tevogen Bio as the accounting acquirer in a reverse recapitalization, forming Tevogen Bio Holdings Inc[14](index=14&type=chunk)[15](index=15&type=chunk) [Note 2. Development-Stage Risks and Liquidity](index=9&type=section&id=Note%202.%20Development-Stage%20Risks%20and%20Liquidity) The company has an accumulated deficit of **$98.1 million** as of June 30, 2024, but a new **$36 million** loan agreement is expected to provide liquidity for the next 12 months - The company had an accumulated deficit of **$98,056,342** as of **June 30, 2024**, and anticipates incurring additional losses[17](index=17&type=chunk) - A Loan Agreement in **June 2024** allows the company to draw **$1 million per month** for **36 months**, totaling **$36 million**, providing adequate liquidity for the next 12 months[17](index=17&type=chunk) [Note 7. Debt](index=16&type=section&id=Note%207.%20Debt) The company secured a **$36 million** unsecured line of credit from a related party and is in default on **$1.65 million** in merger-assumed notes payable - The company secured an unsecured line of credit for up to **$36 million**, drawable in **$1 million** monthly increments over **36 months**, with interest payable in common stock at **$1.50 per share**[42](index=42&type=chunk) - The company is in default on **$1.65 million** of notes payable to Polar Multi-Strategy Master Fund, assumed in the merger and due within five business days of the transaction[46](index=46&type=chunk) [Note 8. Stock-Based Compensation](index=17&type=section&id=Note%208.%20Stock-Based%20Compensation) Following the merger, the company adopted a new incentive plan, recognizing substantial stock-based compensation, including an **$87.3 million** RSU grant to the CEO Stock-Based Compensation Expense | Period | Research and Development ($) | General and Administrative ($) | Total ($) | | :--- | :--- | :--- | :--- | | Three months ended June 30, 2024 | 3,010,944 | 1,131,276 | 4,142,220 | | Six months ended June 30, 2024 | 22,746,840 | 7,728,629 | 30,475,469 | - As of **June 30, 2024**, **$83,988,402** of unrecognized compensation cost related to the CEO's Restricted Stock remains, to be expensed over **9.6 years**[50](index=50&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=22&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, operating results, liquidity, and capital resources, including the ExacTcell platform and TVGN 489 [Overview](index=26&type=section&id=Overview) Tevogen is a clinical-stage immunotherapy company developing off-the-shelf T cell therapies, with its lead product TVGN 489 for COVID-19 showing positive Phase 1 results - The company's **ExacTcell platform** develops allogeneic, precision T cell therapies for virology, oncology, and neurology[76](index=76&type=chunk) - The Phase 1 trial for **TVGN 489** showed no dose-limiting toxicities, rapid viral load reduction, and cell persistence for at least **six months**, with a pivotal trial planned for COVID-19 patients with B cell malignancies[78](index=78&type=chunk) [Results of Operations](index=30&type=section&id=Results%20of%20Operations) Operating expenses significantly increased due to non-cash stock-based compensation and merger-related fees, while net income for the six-month period was driven by a non-cash gain on convertible notes - For **Q2 2024**, R&D expenses increased to **$4.1 million** from **$1.0 million** in **Q2 2023**, largely due to **$3.0 million** in stock-based compensation[100](index=100&type=chunk) - For **Q2 2024**, G&A expenses rose to **$4.5 million** from **$1.2 million** in **Q2 2023**, driven by a **$2.0 million** increase in legal/professional fees and **$1.1 million** in stock-based compensation[101](index=101&type=chunk) - For the **six months ended June 30, 2024**, the company reported net income of **$1.6 million**, primarily due to a **$48.5 million** non-cash gain on convertible promissory notes, offsetting a **$38.1 million** operating loss and **$7.5 million** in merger costs[105](index=105&type=chunk)[109](index=109&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) As of **June 30, 2024**, the company had **$1.1 million** in cash, with a new **$36 million** loan agreement providing liquidity for the next 12 months, though additional funding is needed for new clinical trials - As of **June 30, 2024**, the company had **$1.1 million** in cash and an accumulated deficit of **$98.1 million**[111](index=111&type=chunk) - The company entered a Loan Agreement in **June 2024** for an unsecured line of credit of up to **$36 million**, drawable monthly, serving as a primary source of near-term liquidity[117](index=117&type=chunk) - Management concluded there is adequate cash for at least the next **12 months**, but new clinical trials will not commence until additional funding is secured[122](index=122&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=37&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 exempt from providing quantitative and qualitative disclosures about market risk[135](index=135&type=chunk) [Item 4. Controls and Procedures](index=39&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were not effective as of **June 30, 2024**, due to material weaknesses in internal control over financial reporting - The principal executive and financial officers concluded that disclosure controls and procedures were not effective due to material weaknesses in internal control over financial reporting[136](index=136&type=chunk) [Part II – Other Information](index=40&type=section&id=Part%20II%20%E2%80%93%20Other%20Information) This section provides updates on legal proceedings, risk factors, other information, and exhibits filed with the report [Item 1. Legal Proceedings](index=40&type=section&id=Item%201.%20Legal%20Proceedings) The company reports no material legal proceedings currently pending - As of the report date, the company is not involved in any material legal proceedings[139](index=139&type=chunk) [Item 1A. Risk Factors](index=40&type=section&id=Item%201A.%20Risk%20Factors) This section updates risk factors, including Nasdaq non-compliance for minimum bid price and risks associated with untimely SEC filings - On **June 14, 2024**, the company received a Nasdaq notification for non-compliance with the minimum bid price requirement, as its common stock closed below **$1.00** for **35 consecutive business days**[141](index=141&type=chunk) - The company has until **December 11, 2024**, to regain compliance with Nasdaq's minimum bid price rule[142](index=142&type=chunk) - The company previously failed to timely file its Annual Report on Form **10-K for FY 2023** and Form **10-Q for Q1 2024**, potentially impairing financing access and leading to SEC enforcement[145](index=145&type=chunk) [Item 5. Other Information](index=41&type=section&id=Item%205.%20Other%20Information) No Rule 10b5-1 trading arrangements were adopted or terminated, and the company filed a Certificate of Elimination for Series B Preferred Stock on **August 9, 2024** - On **August 9, 2024**, the Company filed a Certificate of Elimination to remove the designation of Series B Preferred Stock, as no shares were outstanding[147](index=147&type=chunk) [Item 6. Exhibits](index=42&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form **10-Q**, including the Certificate of Elimination of Series B Preferred Stock and CEO/CFO certifications - Key exhibits filed include the Certificate of Elimination of Series B Preferred Stock, the Loan Agreement with The Patel Family, LLP, and Sarbanes-Oxley Act certifications by the CEO and CFO[150](index=150&type=chunk) [Signatures](index=43&type=section&id=Signatures) This section contains the required signatures for the report

WARREN, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- Tevogen Bio Holding Inc. ("Tevogen" or "Tevogen Bio") (Nasdaq: TVGN), a clinical-stage specialty immunotherapy biotech pioneer developing off-the-shelf, genetically unmodified T cell therapeutics in oncology, neurology, and virology, congratulates Professor Sten Vermund, MD, PhD, Chairperson of Tevogen Bio's Innovation and Public Health Advisory Board, on being named as the dean of the USF Health College of Public Health, effective January 1, 2025. In addition ...