Financial Performance - Sales for the three months ended September 30, 2025, were $1,120,121, a decrease of 11.4% compared to $1,264,638 for the same period in 2024[14]. - Gross profit for the quarter was $403,159, down from $493,413 in the prior year, indicating a decline of approximately 18.3%[14]. - The net loss for the period was $1,726,899, compared to a net loss of $1,677,868 in the prior year, reflecting an increase in loss of approximately 2.9%[14]. - For the three months ended September 30, 2025, InMed Pharmaceuticals reported a net loss of $1,726,899, compared to a net loss of $1,677,868 for the same period in 2024, indicating a year-over-year increase in losses of approximately 2.9%[18]. - Total cash used in operating activities for the three months ended September 30, 2025, was $1,607,616, a decrease of 12% compared to $1,826,810 for the same period in 2024[18]. - The company recognized total expenses from share-based payment transactions of $20,205 for the three months ended September 30, 2025, compared to $28,964 for the same period in 2024[76]. Assets and Liabilities - Total current assets decreased to $10,799,967 as of September 30, 2025, down from $12,867,279 as of June 30, 2025, representing a decline of approximately 16%[13]. - Cash and cash equivalents decreased to $9,331,077 as of September 30, 2025, down from $11,075,871 as of June 30, 2025, a reduction of about 15.7%[13]. - Total liabilities decreased to $1,770,462 as of September 30, 2025, from $2,145,545 as of June 30, 2025, a decline of approximately 17.5%[13]. - Shareholders' equity decreased to $11,590,623 as of September 30, 2025, down from $13,434,495 as of June 30, 2025, representing a decrease of about 13.7%[13]. - As of September 30, 2025, the Company reported total inventories of $890,807, a decrease from $961,173 as of June 30, 2025, with a write-down due to obsolescence amounting to $208,737[61]. - Accounts payable and accrued liabilities totaled $1,130,219 as of September 30, 2025, down from $1,404,283 as of June 30, 2025[64]. Funding and Financial Challenges - The company has an accumulated deficit of approximately $119 million as of September 30, 2025, reflecting ongoing financial challenges since inception[23]. - InMed expects its cash and cash equivalents will be sufficient to fund operations into the fourth quarter of calendar 2026, contingent on the timing of BayMedica revenues from bulk rare cannabinoids sales[24]. - The company has indicated substantial doubt about its ability to continue as a going concern within one year from the issuance of the financial statements, primarily due to recurring losses and negative cash flows[26]. - InMed is actively seeking additional funding through equity and debt financings, collaborations, and strategic transactions to support its operations[25]. Research and Development - Research and development expenses were $581,612 for the quarter, a decrease of 16.9% from $700,145 in the same quarter of 2024[14]. - The company continues to focus on optimizing proprietary manufacturing approaches and technologies to enhance production efficiency and product viability[8]. Shareholder Information - The company issued 602,000 common shares during the quarter, resulting in an increase in common shares outstanding to 2,604,186[16]. - The Company completed a Private Placement on June 26, 2025, raising approximately $5.0 million from the sale of 1,952,363 common shares at a price of $2.561 per share[67]. - As of September 30, 2025, the Company had 3,939,210 warrants outstanding with a weighted average exercise price of $48.43, down from 4,541,210 at the beginning of the period[73]. - The unrecognized compensation cost related to unvested options was $50,055, expected to be recognized over a weighted-average vesting period of approximately 1.13 years[77]. Segment Information - The company has two operating segments: Pharma, focused on drug development, and Commercial, focused on manufacturing technologies for cannabinoids[56]. - The company reported total sales of $1,120,121 in the Commercial segment for the three months ended September 30, 2025, a decrease from $1,264,638 in the same period of 2024[83]. - Total assets in the Pharma segment decreased from $13.7 million as of June 30, 2025, to $11.4 million as of September 30, 2025[82]. Intangible Assets and Amortization - The Company has intangible assets totaling $2,927,420 as of September 30, 2025, with accumulated amortization of $1,347,851, resulting in net intangible assets of $1,579,569[62]. - The Company expects to incur amortization expense of approximately $162,746 annually over the next five years for its intangible assets[63]. Lease Obligations - The company is committed to minimum lease payments totaling $668,267, with a present value of lease liabilities at $640,243 as of September 30, 2025[78]. - BayMedica is obligated to pay $1,295,759 over three years for a lease extension in South San Francisco, California[79].

Core Insights - InMed Pharmaceuticals has appointed Mr. John Bathery to its Board of Directors, effective immediately, to enhance its strategic capabilities in drug development [1][2][4] - Mr. Bathery has over 30 years of experience in the pharmaceutical industry, with a strong background in corporate development and strategic partnerships, having managed transactions exceeding $60 billion [2][3] - The company is advancing its INM-901 program for Alzheimer's disease and INM-089 program for Age-related Macular Degeneration towards clinical readiness [3] Company Overview - InMed Pharmaceuticals focuses on developing proprietary small molecule drug candidates targeting diseases with high unmet medical needs, including Alzheimer's and ocular conditions [5] - The company has a pipeline consisting of three separate programs aimed at treating Alzheimer's, ocular, and dermatological indications [5] Leadership Changes - Mr. Bryan Baldasare will not stand for re-election at the upcoming Annual General Meeting due to increasing professional obligations [3] - Andrew Hull, Chairman of the Board, expressed confidence in Mr. Bathery's expertise to drive the company's growth and strategic collaborations [4]

Core Insights - InMed Pharmaceuticals has appointed Mr. Neil Klompas to its Board of Directors, effective immediately, enhancing its leadership team with his extensive experience in healthcare and biotechnology [1][4]. Company Overview - InMed Pharmaceuticals is focused on developing proprietary small molecule drug candidates targeting diseases with high unmet medical needs, specifically in the areas of Alzheimer's, ocular, and dermatological indications [5]. Leadership Experience - Mr. Klompas has over 30 years of experience in the healthcare and biotechnology sectors, having served as President and COO at Zymeworks Inc., where he played a crucial role in scaling the company to a multi-billion-dollar entity [2][3]. - He has a strong background in financial and operational roles, including leading Zymeworks' successful IPO in 2017 [2]. Strategic Vision - Mr. Klompas expressed enthusiasm about joining InMed, particularly regarding the promising data for INM-901, which targets Alzheimer's disease through a multi-pathway approach [4]. - The company aims to advance its innovative pipeline and strategic growth initiatives under his guidance [4][8].

Core Insights - InMed Pharmaceuticals reported its financial results for the fiscal year ending June 30, 2025, highlighting advancements in its pharmaceutical pipeline, particularly with INM-901 for Alzheimer's disease [1][3][4] - The company has strengthened its balance sheet, with cash reserves of $11.1 million to support ongoing pharmaceutical development programs into the fourth quarter of calendar year 2026 [4][17] Financial Performance - For the fiscal year ended June 30, 2025, InMed recorded a net loss of $8.2 million, compared to a net loss of $7.7 million in the previous year [15][19] - Research and development expenses decreased to $2.9 million from $3.2 million year-over-year, while general and administrative expenses increased to $6.6 million from $5.8 million [15][16] - BayMedica, InMed's commercial subsidiary, achieved sales of $4.9 million, representing an 8% increase from the previous year [11][16] Pharmaceutical Development Programs - INM-901 is advancing as a potential treatment for Alzheimer's disease, targeting multiple biological pathways and demonstrating significant reductions in neuroinflammation [3][5][13] - The company is also developing INM-089 for dry age-related macular degeneration, with promising preclinical results and a selected intravitreal formulation [10][4] Research and Development Highlights - INM-901 showed statistically significant improvements in cognitive function and behavioral outcomes in preclinical studies, presented at the Alzheimer's Association International Conference [6][3] - The drug can be administered orally while achieving therapeutic brain levels comparable to intraperitoneal injection, offering advantages over current approved products [7][3] Strategic Initiatives - InMed plans to advance its Alzheimer's program in fiscal 2026, focusing on Chemistry, Manufacturing, and Controls (CMC) activities and preparing for a pre-IND meeting [9][4] - The company has expanded its scientific advisory board and filed an additional international patent application for INM-901 [14][3]

[PART I](index=4&type=section&id=Part%20I) This part covers the company's business, risk factors, and other foundational disclosures [Special Note Regarding Forward-Looking Statements](index=4&type=section&id=Special%20Note%20Regarding%20Forward-Looking%20Statements) 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](index=16&type=chunk) - 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](index=16&type=chunk)[17](index=17&type=chunk) - 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](index=18&type=chunk) [ITEM 1. BUSINESS](index=6&type=section&id=Item%201.%20Business) 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](index=19&type=chunk) - Through its subsidiary BayMedica, the company also develops and sells bulk rare cannabinoids as ingredients for the health and wellness sector[19](index=19&type=chunk) - 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](index=20&type=chunk) [Overview](index=6&type=section&id=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](index=19&type=chunk) - 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](index=20&type=chunk)[22](index=22&type=chunk)[23](index=23&type=chunk)[24](index=24&type=chunk) - 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](index=19&type=chunk)[25](index=25&type=chunk) [Corporate Information](index=8&type=section&id=Corporate%20Information) 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](index=26&type=chunk) - The principal executive offices are located in Vancouver, BC, Canada[26](index=26&type=chunk) [Employees and Human Capital](index=8&type=section&id=Employees%20and%20Human%20Capital) 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](index=27&type=chunk) - As of September 12, 2025, the company had **13 full-time employees** and utilized several consultants[27](index=27&type=chunk) - Compensation programs include competitive salaries, stock options, and annual bonuses to attract and retain talented employees in a competitive industry[28](index=28&type=chunk) [Our Business Strategy](index=9&type=section&id=Our%20Business%20Strategy) 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](index=30&type=chunk) - 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](index=32&type=chunk)[33](index=33&type=chunk) - 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](index=31&type=chunk) [Our Strengths](index=10&type=section&id=Our%20Strengths) 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](index=34&type=chunk)[35](index=35&type=chunk)[36](index=36&type=chunk) - The company holds an early-mover status as a B2B supplier of non-intoxicating rare cannabinoids to the health and wellness sector[37](index=37&type=chunk) - A diverse portfolio of patent applications covers a spectrum of commercial opportunities, bolstered by the acquisition of BayMedica[38](index=38&type=chunk) [Research and Development Pipeline of Therapeutic Drug Candidates](index=10&type=section&id=Research%20and%20Development%20Pipeline%20of%20Therapeutic%20Drug%20Candidates) 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")](index=10&type=section&id=INM-901%20for%20the%20Treatment%20of%20Alzheimer%27s%20Disease%20(%22AD%22)) 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](index=40&type=chunk)[66](index=66&type=chunk)[68](index=68&type=chunk)[70](index=70&type=chunk) - 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](index=22&type=chunk)[71](index=71&type=chunk) - 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](index=41&type=chunk)[42](index=42&type=chunk)[58](index=58&type=chunk)[73](index=73&type=chunk) [INM-089 for the Treatment of Age-related Macular Degeneration ("AMD")](index=19&type=section&id=INM-089%20for%20the%20Treatment%20of%20Age-related%20Macular%20Degeneration%20(%22AMD%22)) 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](index=87&type=chunk)[101](index=101&type=chunk)[103](index=103&type=chunk)[108](index=108&type=chunk) - 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](index=115&type=chunk)[116](index=116&type=chunk) - 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](index=84&type=chunk)[90](index=90&type=chunk)[94](index=94&type=chunk)[96](index=96&type=chunk)[98](index=98&type=chunk) [INM-755 for the Treatment of Epidermolysis Bullosa ('EB')](index=27&type=section&id=INM-755%20for%20the%20Treatment%20of%20Epidermolysis%20Bullosa%20('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](index=118&type=chunk) - 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](index=120&type=chunk)[129](index=129&type=chunk)[132](index=132&type=chunk) - 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](index=125&type=chunk) - Continued development of INM-755 is contingent on R&D and commercial partnerships, with potential expansion beyond EB to broader chronic itch indications[126

InMed Pharmaceuticals Conference Call Summary Company Overview - InMed Pharmaceuticals is a pharmaceutical drug development company focused on a proprietary pipeline of small molecule drug candidates targeting the endocannabinoid system, specifically CB1 and CB2 receptors [2][3] - The company has two main segments: drug development activities and a commercial entity, BayMedica, which manufactures rare, non-intoxicating cannabinoids for the health and wellness market [3][24] Drug Development Pipeline Alzheimer's Disease (INM-901) - INM-901 is a preferential signaling agonist for CB1 and CB2 pathways, addressing a high unmet medical need in Alzheimer's disease [5][12] - Early in vitro and extensive long-term in vivo studies in a 5X FAD mouse model showed statistically significant improvements in behavioral tests for treated diseased mice compared to untreated ones [7][11] - Key findings from studies include: - Reduction in amyloid beta load [8][15] - Decrease in neuroinflammation [9][14] - Neuroprotection of neurons [10][11] - Increased neurogenesis and neuritogenesis [10][11] - The compound can cross the blood-brain barrier and can be formulated as an oral medication [12][13] - Next steps include further studies on stress responses and cellular growth, and a pre-IND meeting with the FDA planned for next year [16][27] Dry Age-Related Macular Degeneration (INM-089) - INM-089 targets dry age-related macular degeneration, affecting nearly 200 million people globally, with a high unmet medical need [17][18] - Early studies indicate that INM-089 improves the thickness of the retinal layer, suggesting potential vision improvement [18] - The drug also provides neuroprotection to retinal ganglion cells [19] - A pre-IND meeting is also planned for this program [19][27] Epidermolysis Bullosa (INM-755) - INM-755 is a CBN cream showing strong anti-itch effects for patients with epidermolysis bullosa, a genetic skin condition [20][22] - The phase two study demonstrated meaningful anti-itch activity, but the company is seeking partnerships to advance it into phase three trials due to resource constraints [23] Commercial Operations (BayMedica) - BayMedica manufactures rare, non-intoxicating cannabinoids, generating approximately $5 million per year in profitable revenue despite pricing pressures [24] - The company has maintained sales levels while increasing the number of kilograms sold over the past 18 months [24] Financial Overview - Estimated cash balance at the end of June was $9.2 million, with a market cap around $10 million [25][26] - The company has a cash runway into the fourth quarter of 2026 and is exploring non-dilutive funding opportunities [28] Key Value Drivers - Focus on advancing INM-901 and INM-089 towards IND filings and human clinical trials [26][28] - Engagement with the FDA through pre-IND meetings to ensure clarity on regulatory expectations [29] Conclusion - InMed Pharmaceuticals is positioned with promising drug candidates in Alzheimer's disease and dry age-related macular degeneration, alongside a profitable commercial operation in cannabinoid manufacturing. The company is actively seeking partnerships and preparing for regulatory engagements to advance its drug development pipeline [27][30]

Core Viewpoint - InMed Pharmaceuticals Inc. is set to present updates on its drug development pipeline, particularly focusing on its lead program INM-901 for Alzheimer's treatment, at the Life Sciences Virtual Investor Forum on September 18, 2025 [1][4]. Group 1: Event Details - The presentation will be conducted by Eric A. Adams, the CEO of InMed, and will take place at 2:00 PM ET on September 18, 2025 [2]. - Investors can register for the event and are encouraged to schedule one-on-one meetings with the company from September 18-23 [2]. - An archived webcast of the presentation will be available for those unable to attend live [2]. Group 2: Company Overview - InMed Pharmaceuticals focuses on developing proprietary small molecule drug candidates targeting diseases with high unmet medical needs, specifically through its pipeline targeting CB1/CB2 receptors [5]. - The company's pipeline includes three programs aimed at treating Alzheimer's, ocular, and dermatological conditions [5]. Group 3: Investor Engagement - Virtual Investor Conferences (VIC) provides a platform for companies to engage with investors in real-time, enhancing communication and access to information [6]. - VIC aims to replicate the experience of an on-site investor conference, allowing for targeted one-on-one meetings and dynamic presentations [6].

Core Viewpoint - InMed Pharmaceuticals will participate in the H.C. Wainwright 27th Annual Global Investment Conference from September 8-10, 2025, in New York, where the management team will conduct one-on-one meetings with investors and present updates on their drug development pipeline [1][2]. Group 1: Company Overview - InMed Pharmaceuticals is focused on developing proprietary small molecule drug candidates targeting diseases with high unmet medical needs, including Alzheimer's, ocular, and dermatological conditions [3]. - The company's leading pharmaceutical program, INM-901, is aimed at treating Alzheimer's disease and has recently presented data at the Alzheimer's Association International Conference (AAIC) 2025 [2][3]. Group 2: Conference Details - The H.C. Wainwright 27th Annual Global Investment Conference will feature a corporate presentation from InMed, which will be available online for 90 days [3]. - The conference provides an opportunity for InMed's management to engage directly with investors through one-on-one meetings [1].

As filed with the Securities and Exchange Commission on July 31, 2025 Registration No. 333-288594 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 PRE-EFFECTIVE AMENDMENT NO.1 TO FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 INMED PHARMACEUTICALS INC. (Exact name of registrant as specified in its charter) British Columbia 2834 98-1428279 (State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification Number) Classification Code Number) S ...

Core Insights - InMed Pharmaceuticals is presenting new preclinical data on its drug candidate INM-901 at the Alzheimer's Association International Conference (AAIC) 2025, focusing on its potential in treating Alzheimer's disease [1][5]. Group 1: Study Findings - The study evaluates INM-901 using a long-term 5xFAD mouse model, showing improvements in cognitive function, anxiety-related behavior, and sensory responsiveness [3]. - Treatment with INM-901 resulted in a significant reduction in inflammatory biomarkers, indicating a dose-dependent therapeutic effect in neuroinflammation [6]. - Behavioral improvements were observed, with cognitive function and anxiety-related behavior approaching normal levels following treatment with INM-901 [12]. Group 2: Mechanisms of Action - INM-901 targets multiple biological pathways associated with Alzheimer's disease, demonstrating anti-inflammatory action and neuroprotection by significantly reducing amyloid-beta-induced cell death [12]. - The drug promotes neurite outgrowth, enhancing neuronal connectivity and function, which aligns with observed improvements in cognition and memory [12]. - Molecular validation through mRNA data supports the behavioral findings, indicating a comprehensive therapeutic potential for INM-901 in Alzheimer's pathology [12]. Group 3: Conference Details - The AAIC 2025 will take place from July 27-31, 2025, in Toronto, Canada, serving as a premier global event for advancing research in dementia and cognitive health [5][8].