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 ...

Announced strategic financing with Arena Investors, providing access to up to $59.0 million USD in gross proceeds to Incannex Announced positive top-line results from our Phase 2 proof-of-concept clinical trial of PSX-001, known as the PsiGAD1 study, in which synthetic psilocybin in combination with psychotherapy was observed to significantly reduce anxiety scores and to be well tolerated in patients with generalised anxiety disorder (GAD) Commenced dosing in the RePOSA Phase 2/3 clinical trial of IHL-42X, ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ______ to ______ Commission file number: 001-41106 Incannex Healthcare Inc. (Exact name of registrant as specified in its charter) | --- | |--------------------------- ...

Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as well as safety and quality of the investigational drug product. PsiGAD2, short for Psilocybin for Generalised Anxiety Disorder trial two, follows the PsiGAD1 proof of concept trial, which demonstrated a 12.8 point reduction in the Hamilton Anxiety Rating Sacle (HAM-A) score from baseline in the psilocybin treatment group. NEW YORK and MELBOURNE, Austra ...

Approval from FDA to proceed with 94 patient Phase 2 clinical trial received following review of IND dossier containing information on the clinical trial, as well as safety and quality of the investigational drug product. PsiGAD2, short for Psilocybin for Generalised Anxiety Disorder trial two, follows the PsiGAD1 proof of concept trial, which demonstrated a 12.8 point reduction in the Hamilton Anxiety Rating Sacle (HAM-A) score from baseline in the psilocybin treatment group. NEW YORK and MELBOURNE, Austra ...

IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone. bioavailability/bioequivalence ('BA/BE') clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan. Analysis of data underway, however, no serious adverse events were reported. Phase 2/3 FDA IND-enabling RePOSA clinical trial continues after dosing commenced i ...

IHL-42X is a fixed dose combination drug targeting obstructive sleep apnea (OSA), a medical condition with no available registered pharmaceutical treatment for millions of sufferers in the USA alone. bioavailability/bioequivalence ('BA/BE') clinical trial assessed the pharmacokinetics and tolerability of IHL-42X consistent with FDA development plan. Analysis of data underway, however, no serious adverse events were reported. Phase 2/3 FDA IND-enabling RePOSA clinical trial continues after dosing commenced i ...