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

Rhea-AI Summary

Tharimmune (NASDAQ:THAR) provided a comprehensive corporate update highlighting two key programs and recent financing. The company raised $5.47 million in equity financing during Q2/Q3 2025.

Their lead asset TH104, a buccal film formulation of nalmefene, is being developed as a critical national security solution against weaponized fentanyl. The FDA has confirmed no additional clinical trials are needed before NDA submission via the 505(b)(2) pathway. The drug offers advantages over existing solutions with a longer half-life of 8-11 hours.

The company's second program, TH023, is developing an oral formulation of infliximab (TNF-alpha inhibitor) for inflammatory conditions. Preclinical studies have demonstrated successful oral delivery achieving significant therapeutic levels. The company plans to initiate first-in-human trials within 12 months.

Positive

• None.

Negative

• First-in-human trials for TH023 still 12 months away
• Significant competition in the TNF-alpha inhibitor market
• Additional capital likely needed for clinical development

Insights

Biotechnology Investment Analyst

Tharimmune secures $5.47M funding to advance TH104 for fentanyl protection and TH023 for oral antibody delivery, though both remain pre-commercial.

Tharimmune's $5.47 million financing provides critical runway for its dual-program strategy, though investors should recognize both assets remain in early development stages. TH104, their lead candidate, has received favorable FDA feedback with a potential 505(b)(2) pathway that could accelerate approval without additional clinical trials—a significant regulatory advantage. The positioning of TH104 as a national security countermeasure against weaponized fentanyl represents a specialized market opportunity with potential government procurement rather than traditional commercial channels.

The company's secondary program, TH023, tackles the long-standing challenge of oral antibody delivery—specifically for TNF-alpha inhibitors like infliximab. While still preclinical, their murine studies demonstrated successful oral delivery achieving therapeutic serum concentrations, potentially addressing a multi-billion dollar market opportunity. However, successful translation to humans remains uncertain with clinical trials at least 12 months away.

From a financial perspective, the $5.47 million raise came from existing investors, which provides validation but suggests limited new institutional interest. The funds will primarily accelerate TH104's development, recognizing its more advanced regulatory position. The cash infusion is modest relative to typical biotech development costs, potentially necessitating additional financing rounds before reaching commercialization for either asset.

The company has strategically positioned itself at the intersection of national security and innovative drug delivery technology, though both avenues face significant execution risks before generating revenue.

National Security and Defense Consultant

TH104's development as a fentanyl countermeasure addresses legitimate security concerns, but faces regulatory and deployment challenges before government adoption.

Tharimmune's TH104 addresses a genuine and evolving national security threat. Weaponized fentanyl represents a credible concern for military personnel and first responders, as demonstrated by historical incidents like the 2002 Moscow theater crisis. The company correctly identifies the limitations of current countermeasures like naloxone, which has a relatively short half-life of 60-90 minutes compared to fentanyl's persistence of approximately 8 hours in the body.

TH104's potential advantages are technically sound: nalmefene's 8-11 hour half-life provides extended protection against opioid exposure, while the buccal film administration offers practical field deployment advantages for personnel in protective gear where injections are problematic. This addresses a critical gap in current preparedness.

The FDA's apparent willingness to consider an expedited 505(b)(2) pathway without additional clinical trials signals regulatory recognition of this need. However, the specific indication being sought—"Temporary Prophylaxis of Respiratory and/or Nervous System Depression in Military Personnel and Chemical Incident Responders"—suggests a highly specialized application rather than broad commercial potential.

The appointment of James Gordon Liddy (CDR US Navy SEAL Ret.) brings credible national security expertise to guide potential government adoption. His background in counterterrorism and critical infrastructure protection provides the company with valuable insights into procurement channels and deployment requirements for specialized countermeasures of this nature.

While the threat is legitimate and the approach scientifically sound, procurement will ultimately depend on government prioritization of this specific countermeasure versus competing national security investments.

-Company closes approximately $5.47 million in equity financing in 2Q/3Q25
-TH104 potentially fills a critical National Security Need against Weaponized Fentanyl
-TH023 may fulfill the promise of delivering a safe and effective oral antibody medication against inflammation
-Company Strengthens Operational Leadership, Corporate Governance and Accounting

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.
ir@tharimmune.com

SOURCE: Tharimmune Inc.

View the original press release on ACCESS Newswire

FAQ

What is Tharimmune's (THAR) TH104 drug candidate and its potential national security application?

TH104 is a buccal film formulation of nalmefene being developed as a countermeasure against weaponized fentanyl for military personnel and first responders. It offers 8-11 hours of protection compared to shorter-acting alternatives.

How much funding did Tharimmune (THAR) raise in Q2/Q3 2025?

Tharimmune raised approximately $5.47 million in gross proceeds through equity financing during the latter part of Q2 and into Q3 2025.

What are the advantages of Tharimmune's TH023 oral antibody delivery system?

TH023 aims to deliver infliximab orally instead of through traditional injections or infusions, potentially improving patient compliance and reducing healthcare costs. Preclinical studies showed successful delivery to both local colonic tissue and systemic circulation.

What is the regulatory pathway for Tharimmune's TH104?

The FDA has confirmed that no additional clinical trials are necessary before submitting a 505(b)(2) NDA for TH104's proposed indication for temporary prophylaxis against high-potency opioids.

When will Tharimmune begin human trials for TH023?

Tharimmune plans to initiate first-in-human clinical trials for TH023 within the next 12 months, following optimization of formulation and dosing regimen.