Capital structure streamlined and potential dilution from Series A Warrants eliminated ahead of key Phase 2 clinical milestonesNEW YORK and MELBOURNE, Australia, June 12, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company advancing combination drug therapies for high-impact indications, announces it has successfully canceled all remaining Series A Warrants pursuant to its letter agreements with the holders of the Series ...

NEW YORK and MELBOURNE, Australia, June 03, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL) (“Incannex” or the “Company”), a clinical-stage biopharmaceutical company leading the way in developing oral combination medicines, today announced the recent appointment of four distinguished experts to its IHL-42X Obstructive Sleep Apnea (OSA) Clinical Advisory Board: Scott A. Sands, Ph.D., Associate Professor of Medicine at Harvard Medical School and Director of the Sleep Apnea Translational Physi ...

NEW YORK and MELBOURNE, Australia, May 29, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage pharmaceutical company developing novel combination therapies, today announced that the Phase 3 component of the RePOSA clinical trial will proceed. The U.S. Food and Drug Administration (FDA) previously reviewed and authorized the protocol to proceed under the Company’s Investigational New Drug (IND) application. The study will evaluate the efficacy and safety of IHL-42X, Incannex’s ...

Core Insights - Incannex Healthcare Inc. (NASDAQ: IXHL) reported a reduction in R&D expenses to $2.74 million in Q3 2025 from $3.28 million in the same quarter of the previous year, indicating effective cost containment measures [1] - SG&A expenses decreased significantly to $2.27 million from $4.14 million year-over-year, driven by strategic cost-saving initiatives [1] - The net loss for the quarter was reduced to $3.97 million from $6.03 million year-over-year, supported by improved operational efficiencies [1] - Cash and cash equivalents increased to $6.7 million from $2.1 million at the end of Q2 2024, attributed to recent financing activities and R&D tax incentive payments [1] Financial Management - IXHL plans to issue approximately $24.7 million worth of shares to repurchase all outstanding Series A Warrants, representing 347.2 million shares that could be dilutive, showcasing management's proactive approach to capital management [7] - The company secured $12.5 million in private placement funding, priced at-the-market [7] - A probability adjusted DCF model estimates a share valuation range of $5.30 to $5.94, with a midpoint of $5.61 [7]

MELBOURNE, Australia and NEW YORK, May 28, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), a clinical-stage biopharmaceutical company advancing combination drug therapies for high- impact indications, today announced that it has entered into a binding agreement to cancel the remaining 172 million Series A Warrants issued under a previous financing arrangement contingent upon Incannex paying the Series A Warrant holders a cancellation payment of up to $12.2 million. When combined with the e ...

Core Insights - Incannex Healthcare Inc. successfully completed a capital raise of $16.7 million through its at-the-market facility, with $12.5 million allocated to cancel up to 50.4% of Series A Warrants previously issued [1][2][3] - The cancellation of these warrants significantly reduces potential future dilution, as up to 5,841,038 warrants are eligible for cancellation, which could have led to the issuance of up to 175.2 million additional shares [2][3] - The initiative reflects the company's commitment to responsible capital management and enhancing shareholder value ahead of the Phase 2 results for its lead product, IHL-42X [3] Company Overview - Incannex is a clinical-stage biopharmaceutical company focused on developing combination drug therapies targeting chronic conditions such as obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [7] - The lead product, IHL-42X, is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally [5][6] - IHL-42X has shown promising results in prior trials, reducing the Apnea-Hypopnea Index by an average of 51% at the lowest dosage [6]

Core Viewpoint - Incannex Healthcare Inc. has entered into agreements allowing for a potential reduction of up to 50.4% of the shares of common stock underlying its Series A Warrants, which could mitigate dilution for stockholders [1][4]. Agreements and Financial Details - The Letter Agreements grant Incannex the discretion to utilize its at-the-market sales agreement with A.G.P/Alliance Global Partners, with the first approximately $12.5 million of net proceeds earmarked for paying holders of Series A Warrants to cancel up to 5,833,333 shares [2]. - The Series A Warrants are currently not exercisable pending stockholder approval, which is sought at a special meeting scheduled for May 27, 2025 [3]. Product Development - IHL-42X, Incannex's lead product, is an oral fixed-dose combination designed to treat obstructive sleep apnea (OSA) and is currently in the RePOSA Phase 2/3 clinical trial, expected to enroll over 560 patients globally [5][6]. - Previous trials indicated that IHL-42X reduced the Apnea-Hypopnea Index (AHI) by an average of 51% at the lowest dosage compared to baseline [6]. Company Overview - Incannex is focused on developing combination medicines targeting chronic conditions, including OSA, rheumatoid arthritis, and generalized anxiety disorder, with three clinical-stage product candidates [7]. - The company aims to address disorders with limited or no approved treatment options, leveraging evidence-based innovation and streamlined operations [7].

Core Viewpoint - Incannex Healthcare Inc. is making significant progress in its IHL-42X development program for treating obstructive sleep apnea (OSA), with key milestones expected in the near future [2]. Operational Highlights - The company secured $12.5 million in private placement funding to support the ongoing IHL-42X Phase 2/3 clinical program [7]. - An OSA Clinical Advisory Board was formed, with Dr. Alison Wimms appointed to enhance collaboration and clinical development efforts [7]. - More than 120 patients have been dosed across 11 clinical trial sites in the Phase 2 portion of the RePOSA study [7]. Clinical Highlights - IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide, currently in the RePOSA Phase 2/3 clinical trial, which aims to enroll over 560 patients globally [6]. - The trial is evaluating two doses of IHL-42X compared to placebo over a four-week treatment period, with topline data expected in July 2025 [7][8]. - Positive topline results from a pharmacokinetics and safety study confirmed the bioavailability of both active components in IHL-42X [7]. Financial Results - General and Administrative (G&A) expenses for the three months ended March 31, 2025, were $2.27 million, down from $4.14 million in the same period of 2024 [7]. - Research and Development (R&D) expenses for the same period totaled $2.74 million, compared to $3.28 million in 2024 [7]. - The net loss for the three-month period ended March 31, 2025, was $3.97 million, a decrease from $6.03 million in the prior year [7].

Drug Development - The company is developing innovative medicines for serious chronic diseases, with lead drug candidates IHL-42X, PSX-001, and IHL-675A currently in Phase 2/3 and Phase 2 clinical developments [109]. - The company is focused on addressing significant unmet medical needs with its drug candidates targeting conditions with limited treatment options [109]. - The company expects substantial increases in R&D expenses as it moves drug candidates into later stages of development [126]. Financial Agreements - An equity line of credit Purchase Agreement was entered into on September 6, 2024, allowing for the purchase of up to $50 million of common stock at a price of 96% of the daily volume weighted average price [110]. - The company issued secured convertible debentures under a Purchase Agreement with a total principal amount of up to $10 million, with a 10% original issue discount [111]. - The first tranche of the convertible debenture was completed on October 17, 2024, for a principal amount of $3,333,333, with net proceeds of $2,877,588 after expenses [115][116]. - A Facility Agreement was established on October 9, 2024, providing a term loan facility of up to $4.7 million, with an initial drawdown of approximately $4.6 million [118]. - The Loan Facility has a term of 12 months and an interest rate of 14.5% per annum, payable monthly [118]. - The company issued a five-year warrant for 585,000 shares of common stock with an exercise price of $1.66 per share as part of the equity line of credit agreement [110]. Financial Performance - Revenue from customers for the three months ended March 31, 2025, was $86,000, representing a 100% increase compared to the same period in 2024 [121]. - Research and development expenses decreased by $0.5 million (17%) for the three months ended March 31, 2025, compared to the same period in 2024 [124]. - General and administrative expenses decreased by $1.9 million (45%) for the three months ended March 31, 2025, compared to the same period in 2024 [131]. - Total operating expenses decreased by $2.4 million (33%) for the three months ended March 31, 2025, compared to the same period in 2024 [121]. - The benefit from R&D tax incentive decreased by $0.9 million (68%) for the three months ended March 31, 2025, compared to the same period in 2024 [136]. - Comprehensive loss for the three months ended March 31, 2025, was $4.1 million, a decrease of $2.8 million (41%) compared to the same period in 2024 [144]. - Total comprehensive losses for the nine months ended March 31, 2025, were $16.2 million, compared to $12.4 million for the same period in 2024 [144]. - As of March 31, 2025, the accumulated deficit was $126.0 million [145]. - Cash and cash equivalents as of March 31, 2025, were $6.7 million [145]. - For the nine months ended March 31, 2025, net cash used in operating activities was $11.0 million, a decrease of $1.2 million compared to the same period in 2024 [146]. - As of March 31, 2025, cash and cash equivalents increased to $6.7 million from $5.9 million as of June 30, 2024, representing an increase of $0.8 million [146]. - Current assets exceeded current liabilities by $8.2 million as of March 31, 2025, a decrease of $2.4 million compared to $10.6 million as of June 30, 2024 [146]. - Net cash provided by financing activities was $11.8 million for the nine months ended March 31, 2025, compared to no cash provided in the same period in 2024 [150]. - Cash used in investing activities decreased by $0.3 million for the nine months ended March 31, 2025, due to reduced spending on property, plant, and equipment [149]. Research and Development - Research and development costs are expensed as incurred, including salaries, benefits, and clinical trial costs [154]. - The company recognizes R&D tax credits in Australia as other income once compliance with grant conditions is met [158]. - The difference between accrued costs and actual costs incurred for R&D activities has not been material [157]. - The company did not have any off-balance sheet arrangements during the periods presented [147]. - Management's estimates and assumptions are based on historical experience and known trends, which may differ from actual results under different conditions [151].

Core Viewpoint - Incannex Healthcare Inc. has announced a private placement to raise approximately $12.5 million to support its clinical programs, particularly the IHL-42X Phase 2/3 study for obstructive sleep apnea [2][4]. Group 1: Offering Details - Incannex has entered into agreements for the purchase and sale of 11,574,090 shares at a price of $1.08 per share, along with Series A Warrants to purchase an equal number of shares at an initial exercise price of $2.16 per share [2][4]. - The Series A Warrants will be exercisable following stockholder approval and will expire 2.5 years after issuance [3][4]. - The transaction is expected to close around March 10, 2025, pending customary closing conditions [5]. Group 2: Use of Proceeds - The net proceeds from the offering will be utilized to fund ongoing clinical trials, including the completion and topline readout of the U.S. Phase 2 study of IHL-42X, and its expansion into Phase 3 [4]. - Additional uses of the proceeds include repayment of outstanding convertible debentures, working capital, and general corporate purposes [4]. Group 3: Company Overview - Incannex is focused on developing combination medicines targeting chronic conditions such as obstructive sleep apnea, rheumatoid arthritis, and generalized anxiety disorder [8]. - The company's lead clinical programs include IHL-42X, an oral fixed-dose combination designed for obstructive sleep apnea, and other innovative treatments for inflammatory conditions and anxiety disorders [8].