Incannex Healthcare Inc. (Nasdaq: IXHL) has announced its fiscal full-year financial results and provided key business updates, highlighting advancements in its clinical programs and strategic financial moves. The company is focused on developing innovative medicines for chronic diseases with unmet needs.
Clinical Trial Progress
Incannex reported positive top-line results from its Phase 2 proof-of-concept clinical trial, PsiGAD1, evaluating PSX-001, a synthetic psilocybin combined with psychotherapy, for generalized anxiety disorder (GAD). The trial demonstrated a significant reduction in anxiety scores among patients, with a 9.2-point improvement over placebo (p<0.0001). The company also received FDA clearance for PsiGAD2, a Phase 2b clinical trial of PSX-001, expected to enroll approximately 94 patients in the U.S. and UK.
"The past year has been transformative for Incannex," said Joel Latham, Incannex’s President and Chief Executive Officer. "These achievements demonstrate our commitment to advancing new oral cannabinoids and psychedelic treatments."
IHL-42X for Obstructive Sleep Apnea
Dosing has commenced in the RePOSA Phase 2/3 clinical trial of IHL-42X, an oral fixed-dose combination of dronabinol and acetazolamide, for obstructive sleep apnea (OSA). The trial is designed to assess the safety and efficacy of IHL-42X in OSA patients who are intolerant, non-compliant, or naïve to positive airway pressure. Incannex plans to recruit 560 subjects, with top-line data from the Phase 2 portion expected in the first half of 2025.
IHL-675A for Rheumatoid Arthritis
An Australian Phase 2 clinical trial of IHL-675A has been initiated for patients with rheumatoid arthritis (RA). IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate, designed to target different pathways to alleviate inflammation. The trial plans to include approximately 128 subjects, with top-line data expected in the second half of 2025.
Financial Highlights
Incannex announced strategic financing with Arena Investors, potentially providing up to $59.0 million USD in gross proceeds. These funds will support ongoing clinical trials and general corporate purposes. General and administrative expenses for the year ended June 30, 2024, were $17.2 million USD, compared to $8.0 million USD in 2023, due to the redomiciliation to the United States and Nasdaq listing. Research and development expenses increased to $12.9 million USD from $6.3 million USD due to increased clinical research activities. The net loss for the period was $18.5 million USD, compared to $48.8 million USD in the previous year. Cash and cash equivalents were $5.9 million USD as of June 30, 2024.
About PSX-001
PSX-001 is Incannex’s oral synthetic psilocybin drug candidate, administered with psychotherapy, for patients with moderate-to-severe GAD. In the PsiGAD1 trial, 44% of subjects in the psilocybin group showed a clinically meaningful improvement of at least 50% in anxiety score from baseline, a response rate more than four times higher than the placebo group.
About IHL-42X
IHL-42X is an oral fixed-dose combination of dronabinol and acetazolamide designed to act synergistically, targeting physiological pathways associated with intermittent hypoxia and hypercapnia that characterize OSA. In a Phase 2 trial, IHL-42X reduced the apnea-hypopnea index and was well-tolerated in OSA patients.
About IHL-675A
IHL-675A is an oral drug candidate for inflammatory conditions, initially focusing on RA. It combines cannabidiol and hydroxychloroquine sulfate to target different pathways, acting synergistically to alleviate inflammation. A Phase 2 trial is ongoing, enrolling 128 subjects with pain and reduced function, regardless of current treatment regimen.
