PharmaTher provides update following FDA approval of ketamine

PharmaTher (PHRRF) provided a corporate update highlighting commercial readiness for ketamine and an ambitious regulatory program aimed at advancing KETARx for rare disorders. With the recent FDA approval of KETARx for surgical pain management, PharmaTher is executing a progressive plan to establish category leadership in the U.S. while advancing additional indications via the efficient 505(b)(2) pathway-particularly in rare disorders, where orphan-drug incentives and real-world evidence can accelerate timelines. Building on the momentum of FDA approval, PharmaTher is actively implementing a comprehensive commercialization strategy for KETARx in the U.S. market. This strategy, designed for sustainable growth, prioritizes both strategic partnerships and robust self-launch capabilities to ensure broad market access and capitalize on the significant opportunities within surgical and diagnostic anesthesia, while providing freedom to expand to exclusive new indications. Partnership pathway: PharmaTher is in advanced discussions with specialty pharmaceutical partners with commercial expertise in pain management and injectables. The Company anticipates a definitive agreement on or before Q4-2025 to accelerate U.S. and select international launches. Dual-track launch readiness: If a definitive agreement does not materialize on that timeline, PharmaTher will self-launch, leveraging established manufacturing and commercial partners. Channel build-out underway: Active discussions with leading and specialty drug wholesalers to supply hospitals, specialty clinics, government institutions, and clinical research. Furthermore, the Company is in separate, promising initial discussions on potential development partnerships for its ketamine-based clinical stage programs, including for Parkinson’s disease, further expanding PharmaTher’s pipeline and future revenue streams. PharmaTher is strategically pursuing additional FDA approvals for KETARx to address rare disorders. Leveraging recent FDA drug approval initiatives for rare diseases, the Company’s robust orphan drug portfolio, and the successful FDA approval of KETARx the Company intends to submit literature-based New Drug Applications. This will be accomplished via the expedited 505(b)(2) pathway, which utilizes existing data to potentially accelerate approval timelines and require limited to no new efficacy-based studies. PharmaTher holds five FDA orphan drug designations for ketamine, each representing a distinct opportunity for market exclusivity and significant patient impact: Amyotrophic lateral sclerosis; Complex Regional Pain Syndrome; Status Epilepticus; Ischemia/reperfusion injury during solid organ transplantation; Rett Syndrome. Following a meeting with the FDA regarding a potential New Drug Application for ketamine in Complex Regional Pain Syndrome via the 505(b)(2) pathway and further consultation with its regulatory advisors, PharmaTher now has a better understanding of the FDA’s approval requirements. The Company is therefore gathering relevant clinical data and securing exclusive rights to this essential data to support an NDA for a narrowly defined, short-term use of ketamine for CRPS. The Chemistry, Manufacturing, and Controls section of this NDA will be strongly supported by the recently approved ketamine product, KETARx. The Company expects to submit this NDA to the FDA by the end of Q4-2025, with hopes for a Prescription Drug User Fee Act date by Q4-2026. With orphan drug designation for CRPS, KETARx would qualify for substantial benefits and incentives, including seven years of marketing exclusivity, potential tax credits, exemption of post-approval fees, and the waiver of the FDA New Drug Application filing fee of approximately $2.4 million – significantly enhancing the value for this program. Additionally, PharmaTher plans to submit another NDA for KETARx to treat a different rare disorder by Q1-2026; details will be released closer to the filing to maintain competitive advantage. The Company currently has no plans to pursue non-orphan/rare indications for KETARx. PharmaTher is strategically focused on advancing ketamine for rare disorders under the FDA’s 505(b)(2) pathway with Orphan Drug Designation, which provides seven years of market exclusivity, fee waivers, and other regulatory incentives. Unlike common indications, where reliance solely on published literature would not secure market exclusivity and any new label expansion would ultimately flow to all ketamine ANDA holders, such as PharmaTher, orphan indications offer a durable competitive advantage. By targeting rare disorders with high unmet medical need, PharmaTher is positioned to create meaningful exclusivity, protect market share, and unlock long-term value for patients and shareholders.