Tharimmune Appoints Renowned Counter-Terrorism and Critical Infrastructure Expert James Gordon Liddy (CDR US Navy SEAL (Ret)) as Key Strategic Advisor Against Weaponized Fentanyl and Other High-Potency Opioids Following Positive FDA Feedback
- FDA feedback indicates no additional clinical trials needed before NDA submission for TH104
- Strategic advisor appointment brings valuable expertise in counter-terrorism and national security
- 505(b)(2) pathway allows leveraging existing data, potentially accelerating development timeline
- None.
Insights
Positive FDA feedback on TH104's 505(b)(2) pathway significantly accelerates Tharimmune's timeline to market for their opioid prophylactic countermeasure.
The FDA's feedback that no additional clinical trials appear necessary before NDA submission represents a significant regulatory milestone for Tharimmune's TH104 program. The 505(b)(2) pathway allows them to leverage existing data, potentially saving years of development time and millions in clinical trial costs.
This regulatory approach is particularly well-suited for repurposed compounds targeting new indications, suggesting TH104 likely utilizes an established molecule with known safety profiles. The prophylactic indication for opioid exposure represents a specialized market niche with limited competition but critical national security implications.
The timing aligns with increased government concern about weaponized fentanyl threats, potentially positioning Tharimmune to secure government contracts if TH104 demonstrates efficacy. Notably, the company appears to be bypassing traditional Phase 2/3 efficacy trials, suggesting they've compiled sufficient existing evidence or are leveraging the FDA's flexibility for countermeasures against chemical threats.
Liddy's appointment strategically complements this regulatory progress by providing expertise in the deployment frameworks where TH104 would ultimately be utilized. His background suggests Tharimmune is preparing for potential government procurement processes that typically follow regulatory approval for defense-oriented medical countermeasures.
The regulatory feedback significantly derisks the development pathway, though manufacturing scale-up and specific labeling requirements for this specialized application may still present challenges before commercialization.
Liddy's appointment signals Tharimmune's strategic positioning for government contracts addressing critical opioid countermeasure gaps in military and first responder protection.
The appointment of CDR Liddy represents more than a typical advisory role – it's a strategic move to integrate defense sector expertise into Tharimmune's commercialization strategy. Liddy's background in counterterrorism and critical infrastructure protection directly addresses the specialized deployment scenarios for TH104.
Weaponized fentanyl represents a growing asymmetric threat that traditional protective equipment struggles to counter effectively. The 2002 Moscow theater hostage crisis demonstrated how aerosolized opioids can be deployed with devastating effects, highlighting a capability gap that has concerned defense planners for decades.
Liddy's experience architecting the Navy's Anti-Terrorism Force Protection Plan and DoD's Anti-terrorism directive positions him to guide TH104's integration into existing military and first responder protocols. His specialized knowledge in CBRNE (Chemical, Biological, Radiological, Nuclear, and Explosive) threats from his studies at the Uniformed Services Medical School is directly relevant to the deployment contexts for an opioid prophylactic.
The timing is particularly significant given increased focus on protecting critical infrastructure and personnel against non-traditional threats. TH104 addresses a specific tactical vulnerability where personnel may need to operate in environments with potential opioid exposure while maintaining full cognitive and physical capabilities.
This appointment signals Tharimmune's intent to position their product within national security frameworks rather than traditional pharmaceutical markets, targeting specialized government procurement channels where efficacy against specific threat profiles often outweighs cost considerations.
BRIDGEWATER, NJ / ACCESS Newswire / May 19, 2025 / Tharimmune, Inc. (Nasdaq:THAR), a clinical-stage biopharmaceutical company focused on developing innovative therapeutics, today announced the appointment of James Gordon Liddy (CDR US Navy SEAL (Ret)) as a strategic advisor. Mr. Liddy, an internationally recognized expert on counterterrorism and critical infrastructure protection, will provide invaluable guidance as Tharimmune advances the development of TH104, its lead program for temporary prophylaxis against respiratory and/or central nervous system depression in military personnel and chemical incident responders exposed to high-potency opioids, including potential weaponized agents like fentanyl.
Mr. Liddy brings a distinguished career and unparalleled expertise in national security and preparedness to Tharimmune. As the Senior Advisor to the Director for Strategy, Policy and Initiatives for the Office of the Assistant Secretary of Defense for Special Operations and Low Intensity Conflict, and previously the Chief of Plans and Policy for the United States Special Operations Command's Washington Office, he played a pivotal role in designing and coordinating policy, operational plans, and strategic initiatives for the Global War on Terrorism. His experience as a member of a highly classified national security program further underscores his deep understanding of the threats facing the nation.
Notably, CDR Liddy's tenure as the Combating Terrorism and Special Operations Officer for the Chief of Naval Operations saw him as the principal architect for the Navy's Anti-Terrorism Force Protection Plan and the leader of the Navy's elite Antiterrorism Assessment Team (Red Cell). He also spearheaded the creation of DoD's Anti-terrorism and Force Protection Plan DoD Directive 20012.H, demonstrating his capability to develop and implement critical protective measures at the highest levels of government.
Tharimmune recently announced positive feedback from the U.S. Food and Drug Administration (FDA) regarding the advancement of TH104 for the prophylaxis indication against ultrapotent opioid exposure. The FDA indicated that no additional clinical trials appear to be necessary prior to a 505(b)(2) New Drug Application (NDA) submission, allowing Tharimmune to leverage existing data and focus on this critical unmet need for military personnel and first responders.
"We are honored to welcome James Gordon Liddy to our team as a strategic advisor," said Vincent LoPriore, Executive Chairman of Tharimmune. "His extensive background in counter-terrorism, critical infrastructure protection, and the development of national security strategies aligns perfectly with our mission to advance TH104 as a crucial medical countermeasure against the threat of weaponized opioids. Mr. Liddy's insights and guidance will be invaluable as we work to bring this potentially life-saving prophylaxis to those on the front lines."
Mr. Liddy's deep expertise in threat assessment, preparedness, and response planning will provide Tharimmune with unique strategic perspectives as the company navigates the development and potential deployment of TH104 within national security frameworks. His understanding of the operational environments faced by military personnel and chemical incident responders, as well as the critical need for effective countermeasures, will be instrumental in shaping Tharimmune's approach.
"I am impressed with Tharimmune's commitment to addressing the serious national security threat posed by high-potency opioids, including weaponized fentanyl," said James Gordon Liddy. "The potential of TH104 to provide a temporary prophylactic solution is significant. I look forward to contributing my experience to help guide Tharimmune's strategy and accelerate the availability of this important medical countermeasure to protect our servicemen and women and first responders."
Mr. Liddy holds a Masters Degree from the John Hopkins University School of Advanced International Studies (SAIS) and has completed the Information Operations Curriculum at the National Defense University. He is also a Doctoral student in Complex Emergency and Disaster Management at Tulane University, with a Graduate CBRNE sub-specialty curriculum from the Uniformed Services Medical School, Bethesda MD. He is also the co-author of the New York Times bestseller, FIGHT BACK, Tackling Terrorism Liddy Style.
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
Alliance Advisors IR
Tirth T. Patel
tpatel@allianceadvisors.com
212-201-6614
SOURCE: Tharimmune Inc.
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