The Albany Gazette - Tharimmune Issues Comprehensive Corporate Update including Lead TH104 as Critical National Security Solution Against Weaponized Fentanyl and TH023 Poised to Revolutionize Oral Antibody Delivery

RED BANK, NJ / ACCESS Newswire / August 4, 2025 / Tharimmune, Inc. (Nasdaq:THAR) ("Tharimmune" or the "Company"), a clinical-stage biotechnology company dedicated to developing innovative therapeutic candidates for inflammation, immunology, and critical unmet medical needs, today issued a comprehensive corporate update highlighting significant advancements across its pipeline. The update underscores the rapid progression of TH104 as a lead asset addressing critical national security risks posed by weaponized fentanyl, and the transformative potential of TH023 in pioneering oral antibody delivery for widespread inflammatory conditions.

The Company has strengthened its financial position by successfully completing several equity financings and securing approximately $5.47 million in gross proceeds before deducting placement and legal fees, during the latter part of the second quarter and continuing into the third quarter of this year. The capital infusion underscores the strong confidence from existing investors, whose continued commitment reflects a clear recognition of the Company's strategic vision and pipeline potential. We believe these proceeds will strategically accelerate the advancement of TH104, recognizing its paramount importance as a swiftly progressing national security asset, in addition to supporting general corporate purposes vital for the Company's continued growth and operational efficiency.

"Over the past year, Tharimmune has achieved considerable milestones, particularly in advancing our lead candidate TH104 to a potential NDA with clear direction from FDA on a pathway while demonstrating preclinical success with our oral antibody program, TH023," stated Sireesh Appajosyula, Chief Executive Officer of Tharimmune. "Our strategic focus on high-impact solutions, from protecting military and first responders to redefining treatment paradigms for chronic inflammatory diseases, reflects our unwavering commitment to patient well-being and shareholder value."

TH104: A National Security Solution Against Weaponized Fentanyl and High-Potency Opioids

Tharimmune's lead asset, TH104, a buccal film formulation of nalmefene, has rapidly advanced with a regulatory pathway to address the escalating national security threat posed by weaponized fentanyl and other high-potency opioids like fentanyl.

Addressing an Important National Security Threat: The U.S. government has increasingly recognized fentanyl and its related compounds as significant national security threats due to their extreme potency and potential for mass casualty incidents if weaponized. Incidents such as the 2002 Moscow theater hostage crisis, where aerosolized synthetic opioids were reportedly used, tragically demonstrated the devastating potential of such agents. In this critical context, Tharimmune explicitly positions TH104 as a direct response to this growing threat, aligning with the urgent need for specialized prophylactic medical countermeasures highlighted in recent U.S. Strategic National Stockpile (SNS) market assessments.

Superiority and Convenience over Current Solutions: While existing solutions like naloxone auto-injectors are vital for emergency reversal, they often have a relatively short half-life (e.g., naloxone has a half-life of approximately 60-90 minutes to 2 hours). This can necessitate repeated dosing, particularly with longer-acting or highly potent synthetic opioids like fentanyl, which can have a significantly longer half-life (around 8 hours). TH104, which utilizes nalmefene, offers a crucial advantage with a significantly longer plasma half-life of approximately 8 to 11 hours. This extended duration of action means TH104 provides sustained protection, potentially reducing the need for continuous monitoring and potential multiple redosing in a high-risk environment. Furthermore, TH104's buccal film formulation allows for rapid and convenient administration, a critical benefit for military personnel and chemical incident responders who may be wearing full protective gear, where intramuscular injections can be impractical or delayed.

Positive FDA Feedback and Expedited Pathway: In a pivotal development, Tharimmune previously announced positive feedback from the FDA regarding the New Drug Application (NDA) path for TH104. Crucially, the FDA confirmed that no additional clinical trials appear to be necessary prior to a 505(b)(2) NDA submission for TH104's proposed indication: "Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders Entering an Area Contaminated with High-Potency Opioids." This expedited pathway allows Tharimmune to leverage existing extensive safety and efficacy data for nalmefene, combined with the Company's human pharmacokinetic data, enabling an "in silico" (computer simulation) submission model, significantly accelerating its potential availability.

Robust Clinical Data and Metabolic Profile: Positive Phase 1 clinical data for TH104, presented at prominent conferences including Digestive Disease Week (DDW) and the European Association for the Study of the Liver (EASL) International Liver Congress in May 2025, highlights its distinct pharmacokinetic and metabolic profile. The data demonstrated that buccal administration achieves systemic exposure to nalmefene with reliable and predictable absorption and delayed phase 1 metabolism, potentially offering advantages for individuals with impaired liver function as potential added benefit. This scientific validation underpins TH104's suitability as a critical medical countermeasure.

Strengthened Expertise in National Security: Tharimmune has strategically fortified its leadership to advance TH104's national security mission. James Gordon Liddy (CDR US Navy SEAL (Ret)), a renowned counter-terrorism and critical infrastructure expert, has been appointed to the Board of Directors and serves as a Key Strategic Advisor. His unparalleled expertise in national security and preparedness, including his role in designing and coordinating policy for the Global War on Terrorism and architecting the Navy's Anti-Terrorism Force Protection Plan, provides invaluable guidance for the development and potential deployment of TH104 within national security frameworks.

The Promise of Oral Antibody Delivery

The administration of monoclonal antibodies (mAb), while highly effective for a range of chronic diseases, has historically been limited to intravenous (IV) infusions or subcutaneous injections. These parenteral routes often necessitate frequent clinic visits, specialized medical personnel for administration, and can be painful or inconvenient for patients, impacting adherence to long-term therapy. The development of an effective oral delivery method for antibodies would truly be a "game-changer," revolutionizing patient access, convenience, and quality of life by transforming a complex, clinic-bound procedure into a simple, at-home pill. Overcoming the formidable physiological barriers of the gastrointestinal tract - including harsh pH environments, enzymatic degradation, and limited permeability for large molecules - has been a persistent challenge in biopharmaceutical development. We believe Tharimmune's TH023 program is at the forefront of addressing this critical unmet need.

TH023: Pioneering Oral Antibody Delivery for Inflammatory Conditions

Tharimmune is developing TH023, a novel oral monoclonal antibody targeting Tumor Necrosis Factor-alpha (TNF-alpha), licensed through Intract Pharma (UK), which could potentially revolutionize the delivery of biologic therapies for a wide array of inflammatory conditions.

Preclinical Validation: In an advancement for oral antibody delivery, Tharimmune in the past year announced positive preclinical results for TH023. Leveraging a proprietary protease enzyme stabilized platform (Soteria^®), preclinical studies in a murine model successfully demonstrated oral delivery of infliximab, achieving serum concentrations significantly higher than standard therapeutic levels. The studies confirmed enzymatic protection and successful in vivo delivery to both local colonic tissue and systemic circulation, highlighting its potential for treating both local gastrointestinal diseases (like Inflammatory Bowel Disease) and systemic inflammatory conditions. This proprietary formulation showed superior tissue penetration compared to traditional permeation enhancers, underscoring the innovative nature of TH023.

Revolutionizing Patient Care and Market Potential: This program originated from a strategic global licensing agreement with Intract Pharma for INT-023 (now TH023) in September 2024. Traditionally, TNF-alpha inhibitors like infliximab (Remicade^®) are administered via intravenous infusions or subcutaneous injections, which may be burdensome for patients. TH023 aims to overcome these challenges, offering a convenient oral pill form that could dramatically improve patient compliance, quality of life, and reduce healthcare system burdens. With the global infliximab market in the multibillions, an oral formulation represents a substantial commercial opportunity by providing a differentiated, patient-preferred option that broadens access and potentially lowers overall treatment costs.

Future Development: Building on these promising preclinical results, Tharimmune plans to optimize TH023's formulation and dosing regimen and prepare for a first-in-human clinical trial within the next 12 months, marking a significant step towards bringing this transformative therapy to patients.

Strengthening Corporate Governance and Leadership for Accelerated Growth

Tharimmune has strategically enhanced its leadership and governance structure to support its ambitious pipeline advancements and future growth.

Key Executive and Board Appointments: In addition to the strategic advisory role and Board appointment of James Gordon Liddy, Tharimmune has appointed Sireesh Appajosyula as Chief Executive Officer, leveraging his extensive experience in corporate development and operations. Vincent LoPriore, with decades of financial and investment banking experience, has been appointed Executive Chairman of the Board, further solidifying strategic oversight. The Board has also been strengthened by the appointments of Clay Kahler, bringing entrepreneurial leadership and expertise in life sciences manufacturing and clinical innovation, and Gary Stetz, a seasoned financial executive with extensive experience in accounting, finance, and corporate governance. These appointments collectively enhance the company's operational, financial, and strategic capabilities as it advances its critical programs.

Tharimmune remains dedicated to leveraging its innovative platforms to address high unmet medical needs and drive significant value for patients and shareholders alike.

About Tharimmune, Inc.

Tharimmune is a clinical-stage biotechnology company developing a diverse portfolio of therapeutic candidates in immunology, inflammation and oncology. Its lead clinical asset, TH104, is being developed for a specific indication via a 505(b)2 pathway for respiratory and/or nervous system depression in military personnel and chemical incident responders who may encounter environments contaminated with high-potency opioids. The expanded pipeline includes other indications for TH104, such as chronic pruritus in primary biliary cholangitis and TH023, a new approach to treating autoimmune diseases along with an early-stage multispecific biologic platform targeting unique epitopes against multiple solid tumors through its proprietary EpiClick^™ Technology. The Company has a license agreement with OmniAb, Inc. to access their antibody discovery technology for targeting specified disease markers. Tharimmune continues to position itself as a leader in patient-centered innovation while working to deliver long-term value for shareholders. For more information, visit: www.tharimmune.com.

Forward Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. All statements, other than statements of historical facts, contained in this press release, including statements regarding the timing and design of Tharimmune's future Phase 2 trial, Tharimmune's strategy, future operations, future financial position, projected costs, prospects, plans and objectives of management, are forward-looking statements. The words "anticipate," "believe," "continue," "could," "depends," "estimate," "expect," "intend," "may," "ongoing," "plan," "potential," "predict," "project," "target," "should," "will," "would," and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. The Company may not actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements, and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions and expectations disclosed in these forward-looking statements. Factors that may cause such differences, include, but are not limited to, those discussed under Risk Factors set forth in our Annual Report on Form 10-K for the year ended December 31, 2024 and other periodic reports filed by the Company from time to time with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views as of the date of this release. Subsequent events and developments may cause the Company's views to change; however, the Company does not undertake and specifically disclaims any obligation to update or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by applicable law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date of this release.

Contacts:

Tharimmune, Inc.
[email protected]

SOURCE: Tharimmune Inc.

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