InMed Pharmaceuticals(INM) - 2025 Q4 - Annual Report

PART I This part covers the company's business, risk factors, and other foundational disclosures Special Note Regarding Forward-Looking Statements This section highlights that the Annual Report contains forward-looking statements subject to risks and uncertainties - The report contains forward-looking statements and information, which are subject to risks and uncertainties that could cause actual results to differ materially from those anticipated[16] - Key risk factors include the company's ability to stem operating losses, obtain additional financing, effectively research and commercialize drug candidates, optimize manufacturing approaches, and successfully navigate regulatory processes[16][17] - New risks regularly emerge, and management cannot predict all factors that could cause actual results to differ, emphasizing the need for readers not to place undue reliance on forward-looking statements[18] ITEM 1. BUSINESS InMed Pharmaceuticals develops small molecule drug candidates for unmet medical needs and commercializes rare cannabinoids via BayMedica - InMed Pharmaceuticals Inc. is a pharmaceutical company developing proprietary small molecule drug candidates targeting CB1 and CB2 receptors for diseases with high unmet medical needs[19] - Through its subsidiary BayMedica, the company also develops and sells bulk rare cannabinoids as ingredients for the health and wellness sector[19] - The current pharmaceutical pipeline includes INM-901 for Alzheimer's disease, INM-089 for dry Age-Related Macular Degeneration, and INM-755 for Epidermolysis Bullosa[20] Overview InMed is a pharmaceutical company developing small molecule drug candidates targeting CB1 and CB2 receptors - InMed is a pharmaceutical company developing small molecule drug candidates that are preferential signaling ligands of CB1 and CB2 receptors, targeting diseases with high unmet medical needs[19] - The company's pipeline includes INM-901 for Alzheimer's disease, INM-089 for dry Age-Related Macular Degeneration, and INM-755 for Epidermolysis Bullosa[20][22][23][24] - BayMedica, a wholly-owned subsidiary, specializes in B2B commercialization of bulk rare, non-intoxicating cannabinoids for the Health and Wellness sector, utilizing chemical synthesis, biosynthesis, and the proprietary IntegraSyn approach[19][25] Corporate Information InMed Pharmaceuticals Inc. was incorporated in British Columbia, Canada, in 1981, with offices in Vancouver - InMed Pharmaceuticals Inc. was incorporated in British Columbia, Canada, on May 19, 1981, and changed its name to the current one on October 6, 2014[26] - The principal executive offices are located in Vancouver, BC, Canada[26] Employees and Human Capital The company's management team comprises experienced executives, with 13 full-time employees as of September 2025 - The management team consists of highly experienced pharmaceutical and biotechnology executives with 20-30+ years of industry experience[27] - As of September 12, 2025, the company had 13 full-time employees and utilized several consultants[27] - Compensation programs include competitive salaries, stock options, and annual bonuses to attract and retain talented employees in a competitive industry[28] Our Business Strategy The company aims to develop a pipeline of prescription drug candidates and expand its health and wellness product portfolio - The company's goal is to develop a pipeline of prescription-based Product Candidates for diseases with high unmet medical needs[30] - The strategy includes advancing drug candidates through preclinical and clinical development, expanding the portfolio of health and wellness products, and developing cost-effective manufacturing processes[32][33] - Commercialization strategies for Product Candidates may involve 'go-it-alone' efforts, out-licensing, or co-promotion agreements, with INM-755's advancement contingent on partnerships[31] Our Strengths Key strengths include an experienced team, a robust pharmaceutical pipeline, diverse manufacturing, and early-mover status - Key strengths include an experienced executive team and board, a robust pharmaceutical pipeline (INM-901 for Alzheimer's, INM-088/089 for ocular diseases, INM-755 for dermatology), and multiple manufacturing approaches (chemical synthesis, biosynthesis, IntegraSyn)[34][35][36] - The company holds an early-mover status as a B2B supplier of non-intoxicating rare cannabinoids to the health and wellness sector[37] - A diverse portfolio of patent applications covers a spectrum of commercial opportunities, bolstered by the acquisition of BayMedica[38] Research and Development Pipeline of Therapeutic Drug Candidates This section details the company's therapeutic drug candidate pipeline, including INM-901, INM-089, and INM-755 INM-901 for the Treatment of Alzheimer's Disease ("AD") INM-901 is a small molecule drug candidate for Alzheimer's, showing neuroprotective effects in preclinical studies - INM-901 is a proprietary small molecule drug candidate for Alzheimer's disease, demonstrating neuroprotective effects, reduced neuroinflammation, enhanced neuronal function, and improved cognitive function and memory in preclinical studies[40][66][68][70] - It acts as a preferential signaling agonist for CB1 and CB2 receptors and impacts the PPAR signaling pathway, offering a multi-factorial approach to AD treatment[22][71] - As a small molecule, INM-901 can safely cross the blood-brain barrier and may offer advantages like oral administration, good bioavailability, and low-cost manufacturing compared to antibody therapies[41][42][58][73] INM-089 for the Treatment of Age-related Macular Degeneration ("AMD") INM-089 is a small molecule dual CB1/CB2 agonist for dry AMD, showing neuroprotection in preclinical studies - INM-089 is a proprietary small molecule dual CB1/CB2 agonist for dry AMD, demonstrating neuroprotection of photoreceptors, improved retinal pigment epithelium integrity, and reduced extracellular autofluorescent deposits in preclinical studies[87][101][103][108] - The company has selected an intravitreal (IVT) formulation for INM-089, successfully delivered in preclinical studies, as it is the established method for effective drug delivery to the back of the eye[115][116] - Dry AMD is the most common form of AMD, affecting 80-90% of cases, and current FDA-approved complement inhibitors for advanced stages only slow progression and do not improve eyesight, highlighting a significant unmet medical need[84][90][94][96][98] INM-755 for the Treatment of Epidermolysis Bullosa ('EB') INM-755 cream for Epidermolysis Bullosa demonstrated safety in Phase 1 and anti-itch activity in Phase 2 - INM-755 (cannabinol) cream is a proprietary topical product candidate for Epidermolysis Bullosa (EB), an orphan disease with no definitive cure, targeting wound healing, infection, pain, inflammation, and itch[118] - Phase 1 clinical trials (755-101-HV and 755-102-HV) demonstrated INM-755 cream was safe and well-tolerated on both intact and induced epidermal wounds[120][129][132] - Phase 2 clinical trial (755-201-EB) results showed a positive indication of enhanced anti-itch activity, with 66.7% of assessed patients experiencing clinically meaningful improvement in chronic non-wound itch[125] - Continued development of INM-755 is contingent on R&D and commercial partnerships, with potential expansion beyond EB to broader chronic itch indications[126