Core Viewpoint - InMed Pharmaceuticals reported its financial results for the second quarter of fiscal year 2026, highlighting progress in its drug development pipeline, particularly in neuroinflammation treatments for Alzheimer's disease and dry age-related macular degeneration [1][3]. Business Update - Pharmaceutical Development Programs - INM-901 is advancing as a potential treatment for Alzheimer's disease, focusing on modulating neuroinflammation. Recent pharmacokinetic studies in large animals showed robust bioavailability and no adverse effects, supporting its progression to human clinical trials [3][4]. - INM-089 is under investigation for treating dry age-related macular degeneration, with successful preclinical studies demonstrating significant improvements in disease models [5]. Financial Commentary - BayMedica's commercial business generated revenues of $0.8 million for the three months ending December 31, 2025, a 26% decrease from $1.1 million in the same period last year, primarily due to pending changes in U.S. legislation [6]. - Research and development expenses were $0.6 million for the quarter, down from $0.9 million year-over-year, attributed to reduced spending on external contractors and research supplies [7]. - General and administrative expenses were $1.6 million for the quarter, slightly down from $1.7 million in the previous year [8]. - As of December 31, 2025, the company had cash and short-term investments totaling $7.0 million, down from $11.1 million on June 30, 2025, with expectations to fund operations into the fourth quarter of calendar year 2026 [9]. Legislative Impact - The U.S. congressional legislation H.R. 5371, if enacted, could negatively impact BayMedica's commercial business by prohibiting certain aspects of its operations related to rare cannabinoids [10]. - BayMedica is exploring alternative options but has not set a timetable for decisions regarding its commercial business, which may include divesting or pivoting operations [11].

Financial Performance - Total sales for the three months ended December 31, 2025, were $820,188, a decrease of 26.2% compared to $1,111,707 for the same period in 2024[18]. - Gross profit for the six months ended December 31, 2025, was $587,353, down 38.4% from $954,307 in 2024[18]. - The net loss for the three months ended December 31, 2025, was $2,028,223, compared to a net loss of $2,575,024 for the same period in 2024[18]. - For the six months ended December 31, 2025, the net loss was approximately $3.8 million, compared to a net loss of $4.3 million for the same period in 2024, representing a decrease of about 11.5%[22]. - Net loss for the three months ended December 31, 2025, was $2,028,223, compared to a net loss of $2,575,024 for the same period in 2024, representing a 21.3% improvement[95]. - For the six months ended December 31, 2025, total sales were $1,940,309, down 18.3% from $2,376,345 in the same period of 2024[95]. - Research and development expenses for the three months ended December 31, 2025, were $630,636, a reduction of 29.6% from $895,176 in 2024[18]. - Research and development expenses for the six months ended December 31, 2025, were $1,212,248, a decrease of 24.1% compared to $1,595,321 in the same period of 2024[95]. Cash and Assets - Cash and cash equivalents decreased to $6,954,834 as of December 31, 2025, from $11,075,871 as of June 30, 2025[16]. - Cash and cash equivalents as of December 31, 2025, were $6,954,834, an increase from $5,583,039 as of June 30, 2025[95]. - Total assets decreased to $11,191,484 as of December 31, 2025, from $15,580,040 as of June 30, 2025[16]. - Total cash used in operating activities for the six months ended December 31, 2025, was approximately $3.98 million, compared to $4.33 million for the same period in 2024, indicating improved cash management[22]. - The company expects its cash and cash equivalents will be sufficient to fund operations into the fourth quarter of calendar 2026, depending on revenue realization from BayMedica[28]. Liabilities and Deficits - Total liabilities decreased to $1,603,820 as of December 31, 2025, from $2,145,545 as of June 30, 2025[16]. - The company reported an accumulated deficit of $120,993,014 as of December 31, 2025[16]. - As of December 31, 2025, the accumulated deficit reached approximately $121.0 million, reflecting ongoing financial challenges[27]. - The company has substantial doubt about its ability to continue as a going concern within one year from the issuance of the financial statements[30]. Funding and Capital - The company has raised capital primarily through the sale of common shares, with a private placement generating $1.03 million in 2024[27]. - The company plans to seek additional funding through equity financings, debt financings, or collaborations, but may face challenges in obtaining financing on acceptable terms[29]. - The Company completed a Private Placement on June 26, 2025, issuing 1,952,363 common shares at a price of $2.561 per share, resulting in gross proceeds of approximately $5.0 million[75]. - The Company issued 1,208,336 Common Shares for gross proceeds of approximately $6.2 million during the year ended June 30, 2025, after offsetting $0.4 million in related fees[80]. Inventory and Expenses - The company reported an inventory write-down of $70,000 during the six months ended December 31, 2025, indicating potential issues with inventory management[22]. - The Company recorded an inventory write-down of $70,000 due to net realizable value during the three and six months ended December 31, 2025, compared to no write-down in the same period of 2024[69]. - Total inventories as of December 31, 2025, amounted to $947,898, with a total inventory reserve of $278,737[68]. - The company incurred share-based compensation expenses of approximately $45,469 for the six months ended December 31, 2025, down from $52,123 in the same period of 2024[22]. - Total expenses from share-based payment transactions for the three months ended December 31, 2025, were $25,564, with $16,829 allocated to general and administrative expenses[87]. Customer Concentration - Customer concentration risk for the three months ended December 31, 2025, shows that Customer A accounts for 30% of revenues, while Customer B accounts for 22%[43]. - As of December 31, 2025, accounts receivable concentration risk indicates that Customer F represents 37% and Customer G represents 32% of total accounts receivable[43]. Other Agreements and Legal Matters - The company has entered into a technology license agreement with a third party, which includes annual royalty payments contingent on net sales of products made using the licensed process[103]. - The company is currently involved in arbitration proceedings regarding a technology license agreement, which could have a material adverse impact on its business and financial condition[107]. - The company has not recognized any liabilities related to indemnification obligations, believing the fair value of these obligations is minimal[102].

Core Insights - Premarket trading is showing notable activity with significant price movements indicating potential investment opportunities before the market opens [1] Premarket Gainers - WhiteFiber, Inc. (WYFI) is up 21% at $17.35 [3] - Rising Dragon Acquisition Corp. (RDAC) is up 21% at $12.63 [3] - Julong Holding Limited (JLHL) is up 13% at $3.45 [3] - Linkhome Holdings Inc. (LHAI) is up 11% at $12.50 [3] - A SPAC III Acquisition Corp. (ASPC) is up 9% at $13.09 [3] - Intuitive Machines, Inc. (LUNR) is up 7% at $11.61 [3] - Ascent Solar Technologies, Inc. (ASTI) is up 7% at $3.31 [3] - Bitmine Immersion Technologies, Inc. (BMNR) is up 6% at $30.39 [3] - Velo3D, Inc. (VELO) is up 5% at $12.10 [3] - Gain Therapeutics, Inc. (GANX) is up 4% at $2.36 [3] Premarket Losers - cbdMD, Inc. (YCBD) is down 17% at $1.60 [4] - Mega Fortune Company Limited (MGRT) is down 16% at $7.33 [4] - Cassava Sciences, Inc. (SAVA) is down 14% at $2.43 [4] - NIKE, Inc. (NKE) is down 10% at $59.01 [4] - InMed Pharmaceuticals Inc. (INM) is down 6% at $1.21 [4] - Datacentrex, Inc. (DTCX) is down 5% at $3.23 [4] - Abundia Global Impact Group Inc (AGIG) is down 5% at $1.50 [4] - PSQ Holdings, Inc. (PSQH) is down 5% at $1.00 [4] - Paranovus Entertainment Technology Ltd. (PAVS) is down 4% at $2.34 [4] - Worksport Ltd. (WKSP) is down 4% at $2.09 [4]

Group 1 - InMed Pharmaceuticals held its 2025 Annual General Meeting of Shareholders, chaired by CEO Eric Adams [1][2] - The meeting included a sworn declaration confirming that all materials were mailed to security holders as of October 22, 2025 [3]

Core Viewpoint - InMed Pharmaceuticals is facing potential negative impacts on its subsidiary BayMedica due to the recently signed H.R. 5371 Act, which may prohibit certain aspects of BayMedica's commercial business if enforced in its current form [3][5]. Group 1: Impact of the Act - The Act could materially affect BayMedica's inventory of rare, non-intoxicating cannabinoids, which may be prohibited under the new legislation set to take effect on November 12, 2026 [3][5]. - InMed is currently evaluating alternative supply chain options to ensure regulatory compliance for BayMedica [3][6]. - The company acknowledges uncertainty regarding whether the sections of the Act impacting BayMedica will ultimately be enforced or amended before the effective date [5]. Group 2: Commitment to Core Programs - Despite the potential challenges posed by the Act, InMed remains focused on its core pharmaceutical drug development programs, which are not affected by the new legislation [4]. - The company continues to advance its drug candidates, including INM-901 for Alzheimer's disease and INM-089 for age-related macular degeneration [4]. Group 3: Ongoing Operations - BayMedica is continuing its normal business operations while evaluating the potential impact of the Act, with no set timetable for concluding its evaluation or making definitive decisions on alternative options [6].

InMed Pharmaceuticals Conference Call Summary Company Overview - **Company Name**: InMed Pharmaceuticals (NasdaqCM: INM) - **Industry**: Pharmaceutical drug development - **Focus**: Proprietary small molecule drug candidates targeting CB1 and CB2 receptors [2][3] Key Drug Development Programs 1. **INM-901 for Alzheimer's Disease** - Target: Alzheimer's disease affecting up to 7.2 million Americans [5] - Preclinical data shows: - Statistically significant reduction in neuroinflammation [6] - Improvement in neuron growth and cognitive functions [7] - Ability to cross the blood-brain barrier [6] - Multiple mechanisms of action including neuroprotection and reduction of amyloid beta [8][10] - Long-term studies indicate improved behavior and cognition in animal models [11] 2. **INM-089 for Dry Age-Related Macular Degeneration (AMD)** - Target: Dry AMD affecting approximately 19.8 million Americans [16] - Mechanism: Preserves retinal function and heals damaged photoreceptor cells [17][18] - Delivery method: Injection into the eye [18] 3. **INM-755 for Epidermolysis Bullosa (EB)** - Focus: Cannabinol cream for chronic itch in EB patients [19] - Phase two clinical trial showed 66% of patients experienced clinically meaningful improvement in chronic itch [20] Financial Overview - **Cash Position**: $9.3 million as of September 30, providing approximately one year of runway [25] - **Market Capitalization**: Approximately $5.6 million [25] - **Shares Outstanding**: 4.2 million, fully diluted 6.7 million [25] Strategic Initiatives - Seeking partnerships for funding phase three trials, particularly for INM-755 [21] - Continuing to explore strategic partnerships to expedite drug development [22][23] - Focus on advancing INM-901 and INM-089 towards IND filings [26] Future Catalysts - Identifying strategic partners for drug development [30] - Presenting positive data at scientific conferences to attract interest [31] - Continued progress in preclinical studies for both INM-901 and INM-089 [32] Additional Insights - The company emphasizes the importance of addressing neuroinflammation in Alzheimer's and other diseases [12][28] - The leadership team is experienced in drug development, which is seen as a key strength [3][24] - The company maintains a clean balance sheet with no debt, allowing for focused investment in R&D [25]

Core Insights - InMed Pharmaceuticals Inc. shares experienced a significant increase of 21.98% in after-hours trading, reaching a price of $1.50 after closing at $1.23, which was a decline of 15.75% during the regular session [1]. Group 1: Study Milestones - The company announced the successful completion of pharmacokinetic studies in large animal models for its Alzheimer's disease candidate INM-901, marking the first preclinical study to administer the oral formulation in large animals [2]. - The studies demonstrated strong bioavailability in in vivo models over a seven-day period, achieving therapeutic systemic exposure levels for INM-901 [3]. Group 2: Regulatory Path Forward - InMed has completed additional chemistry, manufacturing, and controls development to scale production for Investigational New Drug-enabling studies. The company plans to conduct dose-ranging studies, a pre-IND meeting with the FDA, and Good Laboratory Practice-enabling studies to support its IND submission [4]. Group 3: Financial Position and Stock Performance - As of September 30, the company reported $9.3 million in cash, sufficient to fund operations into the fourth quarter of 2026. However, InMed's stock has declined by 74.38% year-to-date, trading within a 52-week range of $1.23 to $8.27, with a market capitalization of $3.45 million [5].

Core Insights - InMed Pharmaceuticals has successfully completed pharmacokinetic studies in large animal models for its Alzheimer's disease candidate INM-901, marking a significant step towards human clinical trials [1][2][3] Pharmacokinetic Study Results - The oral formulation of INM-901 demonstrated robust bioavailability over a seven-day dosing period, achieving therapeutic levels of systemic exposure, which supports its potential use in treating neurodegenerative disorders like Alzheimer's disease [3][4] - Neurological assessments showed no adverse neural or behavioral effects, reinforcing the compound's favorable safety profile [4][6] Development and Regulatory Preparation - InMed has advanced its chemistry, manufacturing, and controls (CMC) development to scale up the manufacturing process of INM-901 in preparation for Investigational New Drug (IND)-enabling studies and regulatory interactions with the FDA [5][10] - The company is preparing for a pre-IND meeting with the FDA and conducting dose-ranging studies in two species to support IND submission [9][10] Company Overview - InMed Pharmaceuticals focuses on developing proprietary small-molecule drug candidates targeting CB1/CB2 receptors, with a pipeline that includes programs for Alzheimer's, ocular, and dermatological indications [11]

Group 1 - The article does not provide any specific content or key points related to a company or industry [1]

Core Viewpoint - InMed Pharmaceuticals reported its financial results for the first quarter of fiscal year 2026, highlighting advancements in its lead program INM-901 for Alzheimer's disease and a solid financial position with $9.3 million in cash [1][3][11]. Financial Performance - The company generated revenues of $1.1 million for the three months ending September 30, 2025, down 11% from $1.3 million in the same period last year, primarily due to pricing adjustments [7][8]. - Research and development expenses decreased to $0.6 million from $0.7 million year-over-year, attributed to reduced spending on external contractors and compensation [9]. - General and administrative expenses remained stable at $1.5 million for both periods [10]. - The net loss for the period was $1.7 million, compared to a loss of $1.7 million in the previous year, with a net loss per share of $0.44 [13]. Business Update - INM-901 is advancing as a potential treatment for Alzheimer's disease, with ongoing IND-enabling activities and plans for a pre-IND meeting with the FDA [3][5]. - The company presented findings on INM-901 at the 2025 Alzheimer's Association International Conference, showcasing its therapeutic potential [4]. - INM-089 is under investigation for treating dry age-related macular degeneration, with preclinical studies showing significant improvements [6]. Cash Position - As of September 30, 2025, InMed had cash and cash equivalents of $9.3 million, down from $11.1 million at the end of June 2025, but expected to be sufficient to fund operations into the fourth quarter of calendar year 2026 [11].