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].

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].

Alzheimer's Disease Burden and Current Treatments - Alzheimer's accounts for 60-80% of dementia cases[6] - It affects 6.9 million Americans[6] - Alzheimer's is the 5th leading cause of death for those aged 65+[6] - The U.S annual financial impact of Alzheimer's and other dementias is $360 billion[6] - Current treatments primarily target amyloid-beta plaques but have limitations, including limited therapeutic effects and side effects[14, 15] INM-901: A Multifactorial Approach - INM-901 is an orally available small molecule drug candidate that can cross the blood-brain barrier[8, 21, 48] - It acts as a preferential signaling agonist for CB1/CB2 receptors and impacts the PPAR signaling pathway[8, 18, 21] - In vitro studies show INM-901 demonstrates neuroprotective effects and increased neurite outgrowth, signifying enhanced neuronal function[8, 27, 28, 29, 32] - Preclinical in vivo studies suggest INM-901 improves behavior and cognitive function, reduces neuroinflammation, and enhances neuronal function[8, 39, 42, 44] - Molecular data indicates INM-901 reduces pro-inflammatory genes and elevates neuronal function genes[42]

Core Viewpoint - InMed Pharmaceuticals has announced new preclinical data indicating that its drug candidate INM-901 significantly reduces neuroinflammation in ex vivo models, supporting its potential as a therapeutic option for Alzheimer's disease [1][5]. Group 1: Study Findings - The study evaluated INM-901 in an ex vivo model of lipopolysaccharide (LPS)-induced inflammation, showing that INM-901 treatment can reduce pro-inflammatory cytokines such as IL-6, IL-1β, IL-2, and KC/Gro, and the inflammasome marker NLRP3 [2][7]. - INM-901 demonstrated a statistically significant reduction in levels of NLRP3 and IL-1β, which are implicated in the pathogenesis of Alzheimer's disease and other neuroinflammatory conditions [8][4]. - The results suggest that INM-901's effects on neuroinflammation are independent of amyloid beta or tau pathology, indicating its potential to treat a broader range of dementia-related diseases [8][4]. Group 2: Implications for Alzheimer's Disease - The study highlights INM-901 as a promising therapeutic candidate for Alzheimer's disease, with plans for further preclinical studies and IND-enabling studies to follow [5][9]. - NLRP3-driven inflammation is recognized as a key contributor to neurodegenerative disease progression, and INM-901's ability to reduce this inflammation could have significant implications for treating Alzheimer's and other neurodegenerative diseases [4][8]. Group 3: Drug Characteristics - INM-901 is a proprietary small molecule drug candidate with multiple mechanisms of action, including neuroprotective effects and the ability to improve cognitive function and memory [14][9]. - The drug can be administered orally, achieving therapeutic levels in the brain comparable to those obtained through intraperitoneal injection, which may offer advantages over currently approved products [14].

Core Viewpoint - InMed Pharmaceuticals reported its financial results for the third quarter of fiscal year 2025, highlighting advancements in its drug development pipeline, particularly INM-901 for Alzheimer's disease and INM-089 for dry age-related macular degeneration, while also addressing financial performance and operational challenges [1][2]. Financial Performance - For the three months ended March 31, 2025, InMed reported a net loss of $2.12 million, an increase from a net loss of $1.72 million in the same period the previous year, primarily due to higher research and development expenses [6][9]. - General and administrative expenses decreased to $1.33 million from $3.75 million year-over-year, attributed to lower accounting fees and share-based payments [10]. - As of March 31, 2025, the company's cash, cash equivalents, and short-term investments totaled $4.68 million, down from $6.57 million at June 30, 2024, indicating a need for additional funding sources [11]. Revenue Generation - BayMedica's commercial business generated revenues of $1.26 million for the three months ended March 31, 2025, reflecting an 8% increase from $1.18 million in the same period last year, driven by expanded marketing efforts and increased demand for cannabinoid products [12]. - Despite stable revenues, gross margins declined due to competitive pricing pressures and increased sales of lower-margin products [12]. Drug Development Updates - INM-901 is under development for Alzheimer's disease, targeting neuroinflammation through multiple biological pathways, with positive preclinical data indicating its potential to significantly reduce neuroinflammation [3][4]. - INM-089 is being developed for dry age-related macular degeneration, showing promise in preserving retinal function and improving retinal structure in preclinical studies [6][8]. Future Outlook - The company expects its cash reserves to be sufficient to fund operations into the third quarter of calendar year 2025, contingent on the timing of commercial revenues and operating expenses [11]. - InMed plans to seek additional funding through equity and debt financings, collaborations, and other strategic transactions to support its pharmaceutical pipeline [11].