Core Insights - Stonegate Capital Partners has updated its coverage on Incannex Healthcare Inc. (NASDAQ: IXHL) for Q2 2025, highlighting a decrease in R&D costs and a strategic financing agreement [1][6]. Financial Performance - Incannex reported R&D costs of $1.4 million in Q2 2025, down from $2.6 million in the same period last year, primarily due to the completion of the IHL-42X clinical trial and resource reallocation [1]. - The company recovered 68.3% of R&D costs through a tax incentive amounting to $0.956 million [1]. - The net loss for the quarter was $5.9 million, compared to $5.2 million in the same period of the previous year [1]. Strategic Developments - Incannex secured a strategic financing agreement with Arena Investors, which includes a $50 million equity line of credit (ELOC) [6]. - The IHL-42X study yielded positive top-line results, confirming the bioavailability of the drug components [6]. Valuation Insights - A probability adjusted discounted cash flow (DCF) model estimates the share valuation range for Incannex at $5.08 to $5.96, with a midpoint of $5.50 [6].

Business Focus - The company is focused on developing combination medicines for chronic conditions such as obstructive sleep apnea (OSA), rheumatoid arthritis, and generalized anxiety disorder[109]. Clinical Trials - Positive topline results from a pharmacokinetics study of IHL-42X showed bioavailability and no serious adverse events reported, with 57.4% of subjects experiencing treatment-emergent adverse events (TEAEs) during the fasted period[110]. - The Australian Phase 2 clinical trial for IHL-675A in rheumatoid arthritis has been paused due to slower than anticipated patient recruitment, with plans to reallocate resources to a larger U.S. Phase 2 study[111]. Financing Activities - An equity line of credit Purchase Agreement was entered into with Arena Global for up to $50 million, with shares priced at 96% of the daily volume weighted average price[113]. - A Securities Purchase Agreement was established with Arena Investors for convertible debentures totaling up to $10 million, with a 10% original issue discount[114]. - The first tranche of the convertible debenture financing closed for $3.33 million, with a payment-in-kind interest rate of 5% and a maturity date of April 14, 2026[115]. - A Facility Agreement with FC Credit provides a term loan facility of up to $4.7 million, with an initial drawdown of approximately $4.6 million at an interest rate of 14.5% per annum[121]. Tax Incentives - The Research and Development Tax Incentive program in Australia offers a tax rebate of 48.5% for eligible R&D expenses, allowing companies to recoup nearly half of their spending[122]. Revenue and Expenses - Revenue from customers for the three months ended December 31, 2024, was $12,000, a 100% increase compared to the same period in 2023[123]. - Total operating expenses decreased by $2.967 million (37%) for the three months ended December 31, 2024, compared to the same period in 2023[123]. - Research and development expenses decreased by $1.2 million (46%) for the three months ended December 31, 2024, primarily due to the completion of the IHL-42X clinical trial[128]. - General and administrative expenses decreased by $1.7 million (33%) for the three months ended December 31, 2024, compared to the same period in 2023[135]. - Benefit from R&D tax incentive decreased by $2.0 million (65%) for the three months ended December 31, 2024, due to a lower estimate of the receivable[139]. - Comprehensive loss for the three months ended December 31, 2024, was $6.308 million, compared to a loss of $4.314 million in the same period in 2023[123]. - Research and development expenses for the six months ended December 31, 2024, decreased by $1.1 million (21%) compared to the same period in 2023[129]. - Total comprehensive losses for the six months ended December 31, 2024, were $11.4 million, compared to $5.6 million for the same period in 2023, indicating a significant increase in losses[146]. - Net losses for the six months ended December 31, 2024, were $5.9 million, a decrease from $11.3 million for the same period in 2023[146]. Cash Flow and Assets - Cash and cash equivalents as of December 31, 2024, were $2.1 million, down $3.8 million from $5.9 million as of June 30, 2024[148]. - Net cash used in operating activities for the six months ended December 31, 2024, was $7.9 million, an increase of $0.1 million compared to $7.8 million for the same period in 2023[151]. - Net cash provided by financing activities increased by $4.1 million for the six months ended December 31, 2024, due to the issuance of the FC Credit Facility Agreement and the First Tranche Debenture[154]. - Current assets exceeded current liabilities by $4.7 million as of December 31, 2024, a decrease of $5.9 million compared to $10.6 million as of June 30, 2024[149]. - The company experienced a decrease in cash flows from investing activities, with net cash used of $8,000 for the six months ended December 31, 2024, compared to $280,000 for the same period in 2023[151]. Future Outlook - The company anticipates a substantial increase in general and administrative expenses in the future as operations expand[137]. - The company expects to incur substantial and increasing losses in the future as it expands R&D activities[145]. - The accumulated deficit as of December 31, 2024, was $122.0 million[146]. - The company has raised concerns about its ability to continue as a going concern for at least one year from the issuance date of the financial statements due to negative cash flows[147].

Core Insights - Incannex Healthcare Inc. has appointed Dr. Alison Wimms as an advisor to its newly formed IHL-42X Obstructive Sleep Apnea Clinical Advisory Board, representing ResMed [1][3] - Dr. Wimms brings over 20 years of experience in sleep medicine and research, holding a Ph.D. in Medicine and a Master of Medicine in Sleep Medicine from the University of Sydney [2] - The formation of the advisory board and Dr. Wimms' appointment highlight Incannex's commitment to innovation in treating obstructive sleep apnea (OSA) and improving patient outcomes [3] Company Overview - Incannex is focused on developing combination medicines targeting chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder [6] - The company's lead clinical programs include IHL-42X, an oral fixed-dose combination of acetazolamide and dronabinol, currently in Phase 2/3 clinical studies for OSA [4][6] - IHL-42X has shown promising results in a prior Australian Phase 2 trial, reducing the Apnea-Hypopnea Index (AHI) by an average of 51% at the lowest dose [4] Clinical Development - The global Phase 2/3 clinical trial, named RePOSA, is evaluating IHL-42X in OSA patients who are non-compliant, intolerant, or naïve to positive airway pressure devices [4] - The Phase 2 portion of the trial is being conducted in the United States, with an anticipated top-line readout expected in the first half of 2025 [4] ResMed Overview - ResMed is a pioneer in innovative solutions for chronic diseases, including sleep apnea and COPD, utilizing digital health technologies and cloud-connected medical devices [5] - The company aims to improve quality of life and reduce healthcare costs through its comprehensive out-of-hospital software platforms [5]

Company Overview - Incannex Healthcare Inc. is a clinical-stage biopharmaceutical company focused on developing combination medicines targeting chronic conditions, including obstructive sleep apnea (OSA) [6] - The company is advancing novel oral fixed-dose treatments based on evidence-based innovation, with lead programs including IHL-42X, IHL-675A, and PSX-001 [6] Appointment of Dr. Alison Wimms - Dr. Alison Wimms has been appointed as an advisor to Incannex's newly formed IHL-42X OSA Clinical Advisory Board, representing ResMed [1][3] - Dr. Wimms brings over 20 years of experience in the sleep medicine industry and holds a Ph.D. in Medicine, a Master of Medicine in Sleep Medicine, and a Bachelor of Science from the University of Sydney [2] IHL-42X Clinical Development - IHL-42X is an oral fixed-dose combination of acetazolamide and dronabinol, currently in Phase 2/3 clinical studies for OSA treatment [4] - The drug targets two physiological pathways associated with intermittent hypoxia and hypercapnia, which are characteristic of OSA [4] - In a prior Australian Phase 2 trial, IHL-42X reduced the Apnea-Hypopnea Index (AHI) by an average of 51% relative to baseline at the lowest dose [4] - The ongoing global Phase 2/3 'RePOSA' clinical trial is evaluating IHL-42X in individuals with OSA who are non-compliant, intolerant, or naïve to positive airway pressure devices, with a top-line readout expected in the first half of 2025 [4]

Demonstrated bioavailability of IHL-42X, Incannex’s proprietary combination formulation, confirming delivery of both dronabinol and acetazolamideAchieved similar PK and equivalent total drug exposure levels of IHL-42X and the reference listed drugs (RLD) for dronabinol and acetazolamide, building a scientific bridge to established safety and toxicology data with the potential to support a future FDA 505(b)(2) new drug application (NDA)Pharmacokinetic results for IHL-42X will inform analysis of anticipated P ...

Stonegate Updates Coverage on Incannex Healthcare Inc. (IXHL) 1Q 2025December 02, 2024 4:48 PM EST | Source: Reportable, Inc. Dallas, Texas--(Newsfile Corp. - December 2, 2024) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners updates their coverage on Incannex Healthcare Inc.  (NASDAQ: IXHL). During 1Q 2025 the Company reported research and development costs of $2.9M, an increase of $0.3M from 1Q24. We expect R&D costs to continue to climb as the Company focuses on getting ...

Revenue and Loss - Revenue from customers for the three months ended September 30, 2024, was $74,000, compared to $0 in the same period of 2023[83] - Loss from operations for the three months ended September 30, 2024, was $6,254,000, an increase of $1,362,000, or 28%, from $4,892,000 in 2023[83] - Comprehensive loss for the three months ended September 30, 2024, was $5,081,000, an increase of $3,845,000, or 311%, from $1,236,000 in 2023[83] - Total comprehensive losses were $5.1 million for the three months ended September 30, 2024, compared to $1.2 million for the same period in 2023[101] Expenses - Research and development expenses increased by $288,000, or 11%, to $2,896,000 for the three months ended September 30, 2024, compared to $2,608,000 in 2023[83] - General and administrative expenses rose by $1,148,000, or 50%, to $3,432,000 for the three months ended September 30, 2024, compared to $2,284,000 in 2023[83] - Total operating expenses increased by $1,436,000, or 29%, to $6,328,000 for the three months ended September 30, 2024, compared to $4,892,000 in 2023[83] - General and administrative expenses increased by $1.1 million for the three months ended September 30, 2024, compared to the same period in 2023, primarily due to increased salaries and legal costs[94] - Research and development expenses are expected to increase substantially due to ongoing and planned clinical and preclinical development activities[89] - The company anticipates increased accounting, audit, legal, and compliance expenses as it prepares for potential commercialization of its drug candidates[95] Tax Credits - Benefit from R&D tax credit decreased by $3,286,000, or 80%, to $811,000 for the three months ended September 30, 2024, compared to $4,097,000 in 2023[83] - The benefit from R&D tax credit decreased by $3.3 million for the three months ended September 30, 2024, compared to the same period in 2023[98] Cash and Assets - As of September 30, 2024, the company had cash and cash equivalents of $3.6 million, a decrease of $2.2 million from $5.9 million as of June 30, 2024[102] - Net cash used in operating activities was $5.7 million for the three months ended September 30, 2024, a decrease of $3.5 million compared to the same period in 2023[105] - Current assets exceed current liabilities by $6.0 million as of September 30, 2024, a decrease of $4.6 million from June 30, 2024[103] - Cash used in investing activities was $221,000 for the three months ended September 30, 2024, with no spending on property, plant, and equipment[106] Financing Activities - The company entered into an equity line of credit Purchase Agreement with Arena Global for up to $50 million[71] - The company completed the first tranche of a secured convertible debenture for $3,333,333 at an aggregate purchase price of $3 million[77] - The company received approximately $4.6 million as the initial drawdown from a term loan facility of up to $4.7 million[81] Accumulated Deficit - The accumulated deficit as of September 30, 2024, was $116.1 million[101]

NEW YORK and MELBOURNE, Australia, Nov. 14, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today reported fiscal first quarter financial results and provided business highlights for the quarter ended September 30, 2024. “The first quarter reflects ongoing progress for Incannex, building on the momentum of a transformative year. Our co ...

NEW YORK and MELBOURNE, Australia, Oct. 24, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with chronic diseases and significant unmet medical needs, today announced the appointment of Lou Barbato, M.D., as Chief Medical Officer (CMO) effective immediately. Dr. Barbato’s drug development experience includes senior clinical development and operational roles at Jazz Pharmaceuticals, AbbVie, Bio ...

Dallas, Texas--(Newsfile Corp. - October 2, 2024) - Incannex Healthcare Inc. (NASDAQ: IXHL): Stonegate Capital Partners initiates their coverage on Incannex Healthcare Inc. (NASDAQ: IXHL) To view the full announcement, including downloadable images, bios, and more, click here. Key Takeaways: Advancing proprietary, synthetic first and best-in-class cannabinoid and psychedelic-assisted therapeutics Conducting FDA phase 2/3 trial, IHL-42X, for the treatment of Obstructive Sleep Apnea (OSA) IHL-42X pivotal phas ...