As filed with the U.S. Securities and Exchange Commission on November 17, 2025. Registration No. 333- UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM F-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 Biodexa Pharmaceuticals PLC (Exact name of registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) England and Wales 2834 Not Applicable (Primary Standard Industrial Classification Code Number) (IRS Employer Identification No. ...

Core Viewpoint - PharmaTher Holdings Ltd. has received a U.S. patent for the use of ketamine in treating Amyotrophic Lateral Sclerosis (ALS), significantly enhancing its intellectual property portfolio and clinical development program [1][2][3] Company Overview - PharmaTher is focused on unlocking the pharmaceutical potential of ketamine, particularly for severe neurological disorders [1][3][8] - The company aims to address unmet medical needs in various fields, including surgery, pain, mental health, and neurological conditions [8] Patent and Regulatory Designations - The newly granted U.S. Patent No. 12,128,012, expiring on May 14, 2041, provides long-term protection for the specific method of using ketamine to treat ALS [7] - The company holds an Orphan Drug Designation (ODD) from the FDA, which offers seven years of market exclusivity post-approval, tax credits for clinical trials, exemption from FDA application fees, and regulatory guidance [7] Market Opportunity - The ALS treatment market is projected to exceed USD $1.04 billion by 2030, driven by high unmet needs and a dedicated patient advocacy community [7] - Approximately 5,000 new ALS cases are diagnosed annually in the U.S., with an estimated 30,000 individuals currently living with the disease [7] Strategic Positioning - The combination of the new patent and FDA ODD creates a strong strategic advantage for PharmaTher, allowing the company to advance its clinical program and pursue strategic partnerships [6][7] - The company is positioned to deliver potentially life-altering therapies to patients with urgent medical needs [6][3]

Summary of Avadel Pharmaceuticals (AVDL) 2025 Conference Call Company Overview - **Company**: Avadel Pharmaceuticals - **Lead Product**: LUMRIZE, a next-generation oxybate for treating hypersomnia, specifically narcolepsy [5][6] Key Points and Arguments Transformation and Growth - Avadel has transitioned from a generic hospital business to a high-growth biopharmaceutical company over the past five years [5] - LUMRIZE has been on the market for two years, with significant progress in patient acquisition and revenue growth [6] Milestones and Future Plans - The company aims to achieve market leadership in narcolepsy and is focused on lifecycle management and pipeline expansion [6] - Enrollment in a Phase 3 trial for LUMRIZE in idiopathic hypersomnia is expected to be completed by the end of the year, with readout anticipated in early next year [6][7] - LUMRIZE has received orphan drug designation from the FDA for idiopathic hypersomnia, which is crucial for regulatory approval [7][60] Market Opportunity - The total addressable market for LUMRIZE is estimated at upwards of 50,000 potential patients, sourced from various segments including current oxybate users and new patients [22][23] - The company has reached a critical mass of approximately 2,800 patients on therapy, with over 2,000 being reimbursed [28] Financial Performance - Avadel reported a 50% growth in net patient additions in Q1 2025 compared to Q4 2024 [20] - The company has achieved three consecutive quarters of adjusted positive operating income, with operating expenses down 3% year-over-year [26] Competitive Landscape - Avadel is confident in LUMRIZE's position against competitors, particularly in the new-to-oxybate segment, where it is gaining market share [36][48] - The company believes that oxybates will continue to play a significant role in treatment, even with the emergence of orexin-based therapies [51][52] Litigation and Regulatory Matters - Avadel is involved in ongoing litigation, including an antitrust case and patent disputes, with a jury trial scheduled for November 2025 [56][58] - The company is pursuing total recovery exceeding $1 billion due to market delays caused by patent issues [56] Additional Important Insights - The company has implemented comprehensive patient support initiatives to reduce discontinuation rates, particularly among new patients [39][40] - There is a focus on improving patient experience and treatment adherence, which is expected to further enhance growth [41][42] - The management is optimistic about the future trajectory of LUMRIZE, citing strong demand and positive clinical outcomes from real-world evidence studies [18][19] This summary encapsulates the critical aspects of Avadel Pharmaceuticals' conference call, highlighting the company's strategic direction, market potential, financial performance, and ongoing legal challenges.