Pharmather Holdings hoping for big things from KETARx

Mr. Fabio Chianelli reports PHARMATHER PROVIDES CORPORATE UPDATE FOLLOWING FDA APPROVAL OF KETAMINE (KETARX) Pharmather Holdings Ltd. is providing a corporate update highlighting commercial readiness for ketamine (KETARx) and an ambitious regulatory program aimed at advancing KETARx for rare disorders. Fabio Chianelli, founder and chief executive officer of Pharmather, stated: "With FDA approval for KETARx secured, our immediate priority is market entry, underpinned by a strong and efficient operational framework. We are also committed to broadening its therapeutic applications. Our strategy involves establishing a high-integrity ketamine franchise through a two-pronged approach: initially focusing on surgical and diagnostic anesthesia, then expanding into rare disorders leveraging ketamine's proven efficacy and safety and the FDA's increasing openness to real-world evidence and published data for drug approvals of rare disorders." With the recent Food and Drug Administration approval of KETARx for surgical pain management (anesthesia and sedation for surgical and diagnostic procedures), Pharmather is executing a progressive plan to establish category leadership in the United States while advancing additional indications via the efficient 505(b)(2) pathway -- particularly in rare disorders, where orphan-drug incentives and real-world evidence (RWE) can accelerate timelines. Ketamine: a transformative opportunity Numerous positive trends for ketamine are converging to offer unprecedented growth opportunities in both the near and medium terms, positioning Pharmather at the forefront of ketamine's evolution: Large addressable market: global ketamine injectable market projected to expand from $725-million (2024) to $3.42-billion (2034); Sizeable, durable demand: approximately 50 million to 55 million U.S. surgical procedures and 23 million to 24 million diagnostic procedures annually utilize anesthesia/sedation-high-value access points for KETARx2-7; Growing macro factors: The increasing number of surgical and diagnostic procedures requiring anesthesia, driven by an aging population, rising chronic diseases and novel surgical techniques, creates a robust demand for KETARx; Clinical advantages: Ketamine's well-known physiological and opioid-sparing profile; Quality and supply security: quality and labelling concerns with compounded ketamine and potential supply blocks from the FDA underscore the need for FDA-approved, standardized products like KETARx; Expanding reimbursement landscape: broader medical community acceptance and growing coverage in psychiatry and pain expand ketamine's long-term utility; Favourable regulatory environment: FDA increasing openness to real-world evidence and published data -- especially for rare diseases -- supports a fast-follower strategy under 505(b)(2) pathway; Commercialization: fast-track to U.S. market leadership. 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 the fourth quarter of 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 under way: 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. Capitalizing on new FDA initiatives for orphan drugs: a pipeline of exclusive opportunities 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 (NDA). 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 (approved on 08/03/2021); Complex Regional Pain Syndrome (approved on 10/12/2021); Status Epilepticus (approved on 01/31/2022); Ischemia/reperfusion injury during solid organ transplantation (approved on 12/14/2022); Rett Syndrome (approved on 02/01/2023). Lead NDA program: complex regional pain syndrome Following a meeting with the FDA regarding a potential new drug application (NDA) for ketamine in complex regional pain syndrome (CRPS) 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 (CMC) 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 (PDUFA) 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 postapproval 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 the first quarter of 2026; details will be released closer to the filing to maintain competitive advantage. No plans for seeking FDA approval for non-orphan/rare indications for ketamine 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 (that is, depression), 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. The company will continue to provide timely updates on its commercial and regulatory progress, inviting shareholders, prospective investors and partners. About Pharmather Holdings Ltd. Pharmather Holdings is focused on unlocking the pharmaceutical potential of KETARx, an FDA-approved ketamine product for anesthesia and sedation in surgical and diagnostic procedures, while pursuing additional indications-particularly rare disorders, via the 505(b)(2) pathway. The company's strategy combines regulatory efficiency, manufacturing quality and commercial execution to deliver durable, capital-efficient growth. We seek Safe Harbor.