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InMed Reports Third Quarter Fiscal 2025 Financial Results and Provides Business Update
Newsfile· 2025-05-12 22:00
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].
InMed Pharmaceuticals(INM) - 2025 Q3 - Quarterly Report
2025-05-12 21:27
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]
InMed Reports Second Quarter Fiscal 2025 Financial Results and Provides Business Update
Newsfile· 2025-02-12 23:54
Core Viewpoint - InMed Pharmaceuticals reported its financial results for the second quarter of fiscal year 2025, highlighting progress in its pharmaceutical pipeline and commercial operations, particularly with drug candidates INM-901 and INM-089 [1][3]. Financial Performance - For the three months ended December 31, 2024, InMed reported a net loss of $2.6 million, an increase from a net loss of $1.5 million in the same period the previous year, primarily due to higher research and development expenses [8]. - Pharmaceutical research and development and patent expenses were $1 million for the quarter, up from $0.6 million in the same period last year, attributed to increased external contractor costs and patent fees [9]. - General and administrative expenses rose to $1.6 million from $1.4 million year-over-year, driven by higher consulting, legal, and personnel expenses [10]. - As of December 31, 2024, the company's cash and short-term investments totaled $3.5 million, down from $6.6 million at June 30, 2024, but expected to be sufficient to fund operations through the second quarter of 2025 [11]. Business Development - INM-901, a drug candidate for Alzheimer's disease, showed promising results in reducing neuroinflammatory markers in preclinical studies, positioning it as a novel treatment approach [4][3]. - The selection of an intravitreal formulation for INM-089 marks a significant advancement in the treatment of dry Age-related Macular Degeneration (AMD), enhancing delivery options for the drug [6][7]. - BayMedica, a commercial business unit of InMed, generated revenues of $1.1 million for the quarter, a 10% decrease from the previous year, but achieved a net income of $0.23 million, reflecting a 189% improvement due to reduced operational expenses [12]. Corporate Governance - At the 2024 Annual General Meeting, shareholders withheld the election of Ms. Janet Grove to the Board of Directors, leading to her resignation, and the Board is now seeking an independent director to fill the vacancy [13]. Additional Information - InMed Pharmaceuticals focuses on developing proprietary small molecule drug candidates targeting various medical conditions, including Alzheimer's and ocular diseases [21].
InMed Pharmaceuticals(INM) - 2025 Q2 - Quarterly Report
2025-02-12 22:30
Financial Performance - For the six months ended December 31, 2024, the company reported a net loss of approximately $4.3 million, compared to a net loss of $4.0 million for the same period in 2023, indicating a year-over-year increase in losses of about 7.5%[29]. - Sales for the three months ended December 31, 2024, were $1.1 million, a decrease of approximately 10.3% compared to $1.2 million for the same period in 2023[19]. - Gross profit for the six months ended December 31, 2024, was $954,307, which is an increase of approximately 176.5% compared to $345,384 for the same period in 2023[19]. - The company incurred total operating expenses of $4.9 million for the six months ended December 31, 2024, compared to $4.7 million for the same period in 2023, reflecting an increase of approximately 6%[19]. - The company reported a net loss of $2,575,024 for the three months ended December 31, 2024, compared to a net loss of $1,478,185 for the same period in 2023[108]. Assets and Liabilities - Total current assets decreased from $8.7 million as of June 30, 2024, to $5.5 million as of December 31, 2024, reflecting a decline of approximately 37.5%[17]. - The company's cash and cash equivalents decreased from $6.6 million as of June 30, 2024, to $3.4 million as of December 31, 2024, a reduction of about 48%[17]. - The total liabilities decreased from $2.6 million as of June 30, 2024, to $2.3 million as of December 31, 2024, a decline of about 11.3%[17]. - The Company held $1,031,568 in cash equivalents as of December 31, 2024, down from $1,939,482 as of June 30, 2024, indicating a significant decrease in liquidity[41]. - As of December 31, 2024, the uninsured cash balance was $0.9 million, indicating potential exposure to credit risk[46]. Revenue Concentration - Customer A contributed 34% of revenues for the three months ended December 31, 2024, while Customer B contributed 33%, highlighting a high concentration of revenue from a few customers[48]. Research and Development - Research and development expenses for the three months ended December 31, 2024, increased to $1.1 million, up from $609,791 in the same period of 2023, representing an increase of approximately 74%[19]. - Research and development costs are expensed in the periods incurred, reflecting the Company's ongoing commitment to innovation and development[70]. Going Concern and Liquidity - The Company has substantial doubt about its ability to continue as a going concern for the next year due to liquidity concerns[32]. - The company expects its cash and cash equivalents, along with anticipated financing proceeds, to be sufficient to fund operations through the end of the second quarter of calendar 2025[30]. Stock and Equity - A reverse stock split of 20-to-1 was executed on November 14, 2024, affecting all Common Shares and related securities[35]. - The Company issued 243,547 Common Shares for gross proceeds of approximately $1.4 million during the six months ended December 31, 2024[91]. - The company has not issued any Common Shares under the Standby Equity Purchase Agreement as of December 31, 2024, which allows for up to $10 million in sales[92]. - As of December 31, 2024, the company had 509,580 outstanding warrants with a weighted average exercise price of $30.18, down from 544,280 warrants at $20.40 as of June 30, 2024[95]. Intangible Assets - The Company has intangible assets totaling $2,927,420 as of December 31, 2024, with accumulated amortization of $1,226,209[85]. - Amortization expense on intangible assets for the three months ended December 31, 2024, was $42,820, compared to $40,993 for the same period in 2023[87]. - The Company expects to incur amortization expense on intangible assets over the next five years totaling $1,701,211[87]. - The Company has not recognized any impairment losses on intangible assets during the three and six months ended December 31, 2024 and 2023[53]. Legal Matters - BayMedica has paid $300,000 for minimum payments due under the Patent License Agreement as of June 30, 2023[116]. - On February 10, 2023, BayMedica received a letter alleging a breach of the Patent License Agreement, which was disputed by the company[116]. - As of July 18, 2024, the Licensor again alleged breach of the Patent License Agreement, with BayMedica asserting no funds are owed[118]. - BayMedica intends to vigorously defend its position if a lawsuit is initiated regarding the Patent License Agreement[119]. - During Q4 2024, legal services rendered by Norton Rose Fulbright amounted to $194,428, compared to $116,951 in Q4 2023[120]. Shareholder Matters - At the 2024 AGM, shareholders withheld the election of Ms. Janet Grove, leading to her resignation from the Board[123].
InMed Announces INM-089 Intravitreal Formulation in the Treatment of Dry Age-Related Macular Degeneration
Newsfile· 2025-02-03 12:30
Core Viewpoint - InMed Pharmaceuticals has selected an intravitreal formulation for its drug candidate INM-089, aimed at treating dry age-related macular degeneration (AMD), highlighting its potential as an effective therapeutic approach for this condition [1][2]. Company Developments - InMed's proprietary intravitreal (IVT) formulation of INM-089 has shown successful delivery in preclinical studies, achieving doses up to 10 times the calculated safety margin relative to the therapeutic dose level [2][6]. - The company has completed a series of dose-ranging in vivo studies to guide the selection of appropriate doses for pivotal preclinical toxicology studies [3]. Industry Context - AMD is a prevalent progressive eye disease affecting an estimated 196 million people globally, with dry AMD accounting for approximately 80% of cases [5]. - There is a significant unmet medical need for effective treatments for dry AMD, particularly as it impacts about 12.6% of Americans aged 40 and older [5].
InMed Pharmaceuticals Announces Granting of Patent for Novel Compounds
Newsfile· 2025-01-22 12:30
Core Viewpoint - InMed Pharmaceuticals has been granted an international Patent Cooperation Treaty (PCT) patent for its proprietary small molecule drug candidates aimed at treating diseases with high unmet medical needs, including Alzheimer's disease and dry age-related macular degeneration [1][2][3] Patent Details - The patent titled "Cannabinoid analogs and methods for their preparation" protects several proprietary small molecule compounds and their preparation methods, with a 20-year term starting from its issuance in Mexico [2][5] - This patent strengthens InMed's intellectual property portfolio, ensuring protection for innovative cannabinoid analogs designed for various therapeutic applications, including neurological disorders and inflammation [2][3] - The PCT application is pending in several jurisdictions, including the U.S., Europe, and Japan, indicating a strategic approach to global patent protection [2][3] Company Overview - InMed Pharmaceuticals focuses on developing a pipeline of proprietary small molecule drug candidates targeting CB1/CB2 receptors, with programs in Alzheimer's, ocular, and dermatological indications [7] - The company has a total of 14 patent families covering compositions, formulations, manufacturing processes, and methods of use, highlighting its commitment to expanding its patent portfolio [3][4]
InMed's INM-901 Demonstrates Statistically Significant Reduction in Neuroinflammation in a Long-Term Preclinical Alzheimer's Disease Study
Newsfile· 2025-01-21 12:30
Core Viewpoint - InMed Pharmaceuticals' INM-901 shows statistically significant reduction in neuroinflammation in a long-term preclinical study for Alzheimer's Disease, indicating its potential as a promising drug candidate [1][2][6]. Group 1: Study Results - INM-901 demonstrated a reduction in several neuroinflammation markers in an amyloid-induced Alzheimer's disease model, suggesting its ability to lower neuroinflammation [2][3]. - The study showed a statistically significant reduction in pro-inflammatory cytokines such as TNF-α, IL-1ß, and INF-γ, which are associated with Alzheimer's disease [4][7]. - A significant reduction in the neurodegeneration biomarker neurofilament light chain (NfL) was observed in the high dose treated group, indicating decreased cellular damage [4][3]. Group 2: Mechanisms of Action - INM-901 is believed to have multiple mechanisms of action, including engagement with CB1/CB2 receptors and PPAR, which are important in neuroprotection and inflammation modulation [6][11]. - The drug's ability to reduce key neuroinflammatory genes such as GFAP, CD-33, and TLR-2 was supported by mRNA assessments, further validating the study's findings [4][3]. Group 3: Future Directions - The company is conducting further molecular analyses to better define the mechanisms of action and potential role of INM-901 in Alzheimer's treatment [2][5]. - Additional evaluations will focus on neuritogenesis and neuroprotection, assessing markers for neuronal differentiation and cellular growth/survival [10][11].
InMed Enters Into Standby Equity Purchase Agreement
Newsfile· 2024-12-17 21:56
Core Viewpoint - InMed Pharmaceuticals has entered into a Standby Equity Purchase Agreement (SEPA) with YA II PN, LTD to sell up to $10 million in common shares over a 36-month period, aimed at supporting its pharmaceutical development initiatives [2][3]. Financing Strategy - The SEPA is described as a key component of the company's financing strategy, providing flexibility and an extended runway for accelerating pharmaceutical programs and business development [3]. - The company can raise capital on an as-needed basis, allowing control over the timing and amount of capital raised [3]. Share Issuance Details - The total number of common shares that can be issued under the SEPA is limited to 19.99% of the outstanding shares as of the effective date, unless certain pricing conditions are met [3]. - The issuance is also subject to a limitation where the investor and its affiliates cannot own more than 9.99% of the total shares [3]. Pricing Mechanism - Common shares sold to the investor will be priced at 97% of the market price during a specified three-day pricing period [4]. - The company retains the right to set a minimum acceptable price for these share issuances [4]. Company Overview - InMed Pharmaceuticals focuses on developing proprietary small molecule drug candidates targeting CB1/CB2 receptors, with programs aimed at treating Alzheimer's, ocular, and dermatological conditions [6].
InMed Announces Publication of Study on Anti-Inflammation by Modulation of Endocannabinoid System
Newsfile· 2024-11-19 12:30
Core Viewpoint - InMed Pharmaceuticals has published a peer-reviewed study demonstrating the anti-inflammatory effects of cannabinol (CBN) through modulation of the endocannabinoid system, indicating its potential therapeutic applications for inflammatory skin diseases [2][4]. Company Overview - InMed Pharmaceuticals is focused on developing proprietary small molecule drug candidates targeting CB1/CB2 receptors, with a pipeline that includes programs for Alzheimer's disease, ocular conditions, and dermatological indications [6]. Study Findings - The study, conducted in collaboration with Dr. Mauro Maccarrone, found that CBN can prevent keratinocyte inflammation via TRPV1, express mitogen-activated protein kinases, modulate endocannabinoid-regulating enzymes, increase CB1 expression, and alter cytokine release by reducing pro-inflammatory cytokines (IL-8, IL-12, IL-31) while increasing the anti-inflammatory cytokine IL-10 [3][4]. - The anti-inflammatory activity of CBN suggests its potential to regulate epidermal functions and provide protective roles in the skin [4]. Expert Commentary - Dr. Mauro Maccarrone highlighted the significance of the study in providing scientific evidence for CBN's anti-inflammatory properties, supporting its therapeutic and cosmetic applications in treating inflammatory skin conditions [4]. - Dr. Eric Hsu emphasized the importance of understanding the endocannabinoid system in the context of various diseases and how rare cannabinoids may modulate inflammation [4].
InMed Reports First Quarter Fiscal 2025 Financial Results and Provides Business Update
Newsfile· 2024-11-14 21:45
Core Viewpoint - InMed Pharmaceuticals reported positive progress in its pharmaceutical programs, particularly with its Alzheimer's treatment candidate INM-901, and announced financial results for the first quarter of fiscal 2025, highlighting a commitment to enhancing shareholder value through strategic opportunities and operational improvements [3][4]. Financial Results - For the first quarter ended September 30, 2024, InMed reported revenues of $1.3 million from its BayMedica commercial business, a 40% increase from $0.9 million in the same period last year [8]. - The company recorded a net loss of $1.68 million for the quarter, compared to a net loss of $2.54 million in the same period of the previous year, indicating an improvement in financial performance [13]. - Research and development expenses decreased to $0.8 million from $1.3 million year-over-year, primarily due to reduced spending on external contractors and patent fees [9]. - As of September 30, 2024, the company had cash and cash equivalents of $5.6 million, down from $6.6 million at the end of the previous quarter [10]. Pharmaceutical Development Programs - INM-901, targeting Alzheimer's disease, showed robust progress with positive behavioral data from long-term preclinical studies, achieving statistical significance in certain criteria [3][4]. - The drug can be administered orally, achieving therapeutic levels in the brain comparable to intraperitoneal injection, which is significant for its development [4]. - Next steps for INM-901 include further molecular analyses to characterize its mechanisms of action, with data read-out expected in calendar Q4 2024 [5]. - INM-089, aimed at treating dry Age-related Macular Degeneration (AMD), is progressing with additional in vivo preclinical studies and ongoing Chemistry, Manufacturing, and Controls (CMC) activities [6]. Corporate Actions - The company implemented a reverse stock split effective November 14, 2024, to regain compliance with Nasdaq listing requirements, reflecting its commitment to maintaining a major exchange listing [3].