InMed Pharmaceuticals Reports Full Year Fiscal 2025 Financial Results and Provides Business UpdateSeptember 23, 2025 8:30 AM EDT | Source: InMed PharmaceuticalsAdvances INM-901 program, addressing multiple key biological pathways implicated in Alzheimer's disease pathologyFurther develops INM-089 demonstrating neuroprotection in the treatment of dry Age-related Macular DegenerationCash of $11.1M to support pharmaceutical developments into the fourth quarter of calendar year 2026Vancouver, Brit ...

[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]

Company invites individual and institutional investors, as well as advisors and analysts, to attend online at VirtualInvestorConferences.com VANCOUVER, British Columbia, Sept. 16, 2025 (GLOBE NEWSWIRE) -- InMed Pharmaceuticals Inc. (NASDAQ: INM) (“InMed” or the “Company”), a pharmaceutical company focused on developing a pipeline of proprietary small molecule drug candidates for diseases with high unmet medical needs, today announced that Eric A. Adams, InMed’s CEO, will present live at the Life Sciences Vi ...

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].

Financial Performance - For the three months ended March 31, 2025, sales increased to $1,261,578, up 7.6% from $1,172,601 in the same period of 2024[17] - Gross profit for the nine months ended March 31, 2025, was $1,129,932, a significant increase of 78.1% compared to $634,842 for the same period in 2024[17] - The net loss for the nine months ended March 31, 2025, was $6,373,822, compared to a net loss of $5,737,879 for the same period in 2024, indicating a 11.1% increase in losses[17] - The company reported a basic and diluted net loss per share of $1.94 for the three months ended March 31, 2025, compared to $3.58 for the same period in 2024[17] - The 'BayMedica Commercial' segment reported sales of $3,637,923 for the nine months ended March 31, 2025, an increase from $3,314,663 in the same period of 2024[112] Assets and Liabilities - As of March 31, 2025, total assets decreased to $9,279,834 from $11,822,782 as of June 30, 2024, representing a decline of approximately 21.5%[15] - Total liabilities decreased to $2,258,309 as of March 31, 2025, from $2,616,673 as of June 30, 2024, a reduction of approximately 13.7%[15] - Shareholders' equity decreased to $7,021,525 as of March 31, 2025, from $9,206,109 as of June 30, 2024, reflecting a decline of approximately 23.8%[15] - Cash and cash equivalents decreased to $4,679,826 as of March 31, 2025, down from $6,571,610 at the beginning of the period, a decline of 28.8%[20] - As of March 31, 2025, total inventories amounted to $813,970, a decrease from $1,244,324 as of June 30, 2024, reflecting lower demand and pricing pressure[84] Research and Development - Research and development expenses rose to $2,741,200 for the nine months ended March 31, 2025, compared to $2,558,648 in the prior year, reflecting an increase of 7.1%[17] - Research and development costs are expensed as incurred, with no specific figures provided for the current period[71] Funding and Capital - The Company raised $4,361,220 from private placements during the nine months ended March 31, 2025, compared to $5,216,193 in the same period of 2024[20] - The Company expects to continue seeking additional funding through equity and debt financings, collaborations, and strategic transactions[28] - The Company has an uninsured cash balance of $2.5 million as of March 31, 2025, which may exceed insurable limits[43] - The Company’s liquidity condition raises substantial doubt about its ability to continue as a going concern, necessitating additional capital to finance operations[29] Customer Concentration - Customer A and Customer B accounted for 25% and 37% of revenues, respectively, for the three months ended March 31, 2025, indicating increased customer concentration risk compared to the previous year[45] Legal and Compliance - The Company received a letter from the Licensor on April 29, 2025, indicating the intention to commence arbitration proceedings regarding the Patent License Agreement[123] - The Company has not recognized any liabilities related to indemnification obligations due to the minimal fair value of these obligations[118] Stock and Equity - The Company issued 313,242 Common Shares for gross proceeds of approximately $1.9 million during the nine months ended March 31, 2025[93] - The Company entered into a Standby Equity Purchase Agreement (SEPA) to sell up to $10 million in Common Shares over a 36-month period, with a limit of 19.99% of outstanding shares unless pricing conditions are met[94] - The Company granted 28,700 stock options to employees and external directors on December 20, 2024, with an exercise price of $4.14[101] - As of March 31, 2025, the Company had 61,864 stock options outstanding, with a weighted average exercise price of $32.41[104] Miscellaneous - The Company recorded deferred offering costs of $25,000 for the nine months ended March 31, 2025, related to ongoing financing efforts[46] - The Company has a total undiscounted operating lease liability of $898,599 as of March 31, 2025[107] - The Company has made a one-time payment to UBC under the Collaborative Research Agreement, with one such payment already completed[115] - No payments have been required to be made to UBC under the Technology Assignment Agreement to date[114] - The Company has not experienced any triggering events for repayment under the Contribution Agreement with NRC-IRAP as of March 31, 2025[116]