Incannex Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates
-- 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, an
oral investigational treatment for patients with obstructive sleep apnea
-- Received Investigational New Drug $(IND.AU)$ application clearance from the
U.S. Food and Drug Administration (FDA) to initiate PsiGAD2, a Phase 2
clinical trial of PSX-001
-- Successfully completed redomiciliation to the United States and listing
shares of Incannex common stock on Nasdaq under the ticker "IXHL" in late
2023
NEW YORK and MELBOURNE, Australia, Sept. 30, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage biopharmaceutical company developing innovative medicines for people with serious chronic diseases and significant unmet medical needs, today reported fiscal full year financial results and provided business updates.
"The past year has been transformative for Incannex as we successfully completed our transition to the Nasdaq as a company domiciled in the United States, reported positive top-line data from our proof-of-concept clinical trial of PSX-001, known as PsiGAD1, and initiated dosing in our Phase 2/3 IHL-42X RePOSA trial. These achievements demonstrate our commitment to advancing new oral cannabinoids and psychedelic treatments. With our recent strategic financing and clinical trials underway for three programs, we are excited to share updates later this year," said Joel Latham, Incannex's President and Chief Executive Officer. "We are grateful to all of the physicians, investigators and patients involved in our U.S. and Australian clinical trials for their support of our investigational synthetic cannabinoid and psilocybin-based therapeutic programs."
Operational Highlights
-- Announced strategic financings with Arena Investors, which may provide up
to $59.0 million USD in gross proceeds to Incannex through a $50 million
USD equity line of credit and the sale in future closings of convertible
debentures with an aggregate principal amount of up to $9.0 million USD.
Incannex intends to use the proceeds from this strategic financing to
support the ongoing clinical trials of its drug candidates, and for
working capital and other general corporate purposes. Drawdown of the
capital will be determined according to the Incannex's strategic needs.
-- Announced the opening of Clarion Clinics, one of the first
psychedelic-assisted psychotherapy clinics in Australia, which will serve
as a model for potential future sites. Incannex believes this first
clinic will provide real-world experience in treating mental health
patients utilizing psychedelic-assisted psychotherapy. Assuming
regulatory approval of PSX-001, the Clarion Clinics model has the
potential to provide insight into the potential commercialization of
PSX-001.
-- Completed the redomiciliation of Incannex from Australia to the United
States, effective November 28, 2023 and listing our common stock on the
Nasdaq Global Market under the ticker "IXHL." With no material changes to
its operations, Incannex believes this will provide access to a broader
set of investors, streamline financial reporting comparably with industry
peers, and provide greater flexibility in accessing capital.
Clinical Highlights
-- Commenced dosing in the RePOSA Phase 2/3 clinical trial of IHL-42X, an
oral fixed dose combination of dronabinol and acetazolamide for the
treatment of patients with obstructive sleep apnea (OSA). RePOSA, a
randomized, double-blind trial, is designed to assess the safety and
efficacy of IHL-42X in patients with OSA who are intolerant,
non-compliant, or naïve to positive airway pressure. The Phase 2
portion of this clinical trial is being conducted in the United States,
and the expanded Phase 3 portion will include sites in the United Kingdom
and European Union. Incannex plans to recruit 560 subjects, with an
estimated 355 participants in the active study arms, and anticipates
reporting top-line data from the Phase 2 portion of this clinical trial
in the first half of 2025.
-- Completed dosing of 115 subjects in a bioavailability/bioequivalence
(BA/BE) clinical trial conducted in Australia assessing the
pharmacokinetics and tolerability of IHL-42X, our drug product for the
treatment of obstructive sleep apnea. Data analysis is underway, with no
serious adverse events reported to date. Incannex expects to release
top-line results from this BA/BE clinical trial in 2024.
-- Announced positive results from its proof-of-concept Australian Phase 2
clinical trial, PsiGAD1, of PSX-001. In the PsiGAD2 trial the combination
of an oral synthetic psilocybin with psychotherapy was observed to
significantly reduced anxiety scores and was well tolerated in patients
with generalized anxiety disorder (GAD). The reduction in HAM-A from
baseline, the trial's primary endpoint, in the psilocybin group was 12.8
points from baseline, representing a 9.2-point improvement over
psychotherapy with placebo (p<0.0001).
-- Received IND clearance from the FDA to initiate PsiGAD2, a Phase 2b
clinical trial of PSX-001 evaluating change in the HAM-A anxiety score,
and other measures of efficacy and safety at sites in the U.S. and UK.
The trial is expected to include approximately 94 patients, including
those currently treated with selective serotonin reuptake inhibitors
(SSRIs), who meet the study inclusion and exclusion criteria.
-- Initiated dosing in an Australian Phase 2 clinical trial of IHL-675A for
patients with rheumatoid arthritis $(RA)$. IHL-675A is an oral fixed dose
combination of cannabidiol and hydroxychloroquine sulfate designed to
target two different pathways, acting synergistically to alleviate
inflammation. The trial is planned to include approximately 128 subjects.
Incannex anticipates reporting top-line data in the second half of 2025.
Financial Results
-- General and Administration (G&A) expenses for the twelve months ended
June 30, 2024 were $17.2 million USD, as compared to $8.0 million USD for
the twelve months ended June 30, 2023, due to associated completed the
redomicilation to the United States, listing of common stock on Nasdaq,
and expanded U.S. operations.
-- Research and development (R&D) expenses were for $12.9 million USD for
the twelve months ended June 30, 2024 compared to $6.3 million USD for
the twelve months ended June 30, 2023, due to increased clinical research
activities.
-- Net loss for the twelve-month period ended June 30, 2024 was $18.5
million USD, as compared to $48.8 million USD for the twelve months ended
June 30, 2023.
-- Cash and cash equivalents were $5.9 million USD as of June 30, 2024,
compared to $22.1 million USD as of June 30, 2023.
About IHL-42X
IHL-42X is Incannex's oral fixed dose combination of dronabinol and acetazolamide designed to act synergistically, targeting two different physiological pathways associated with the intermittent hypoxia $(IH)$ and hypercapnia that characterize OSA. In a proof-of-concept Australian Phase 2 clinical trial, IHL-42X was observed to reduce the apnea hypopnea index and be well tolerated in OSA patients. An ongoing pivotal Phase 2/3 clinical trial investigating the safety and efficacy of IHL-42X is underway with the Phase 2 portion conducted in the U.S., the expanded Phase 3 portion will also include the UK and EU. Top-line results from an ongoing pharmacokinetic and safety study in Australia are expected in late 2024. The top-line readout from the U.S. Phase 2 portion of the pivotal Phase 2/3 trial is anticipated in the first half of 2025.
About PSX-001
PSX-001 is Incannex's oral synthetic psilocybin drug candidate, administered in combination with psychotherapy, for patients diagnosed with moderate-to-severe GAD. In the Australian Phase 2 proof-of-concept PsiGad1 clinical trial, PSX-001 was observed to reduce anxiety scores and was well tolerated in GAD patients. In this trial, 44% of subjects in the psilocybin group were observed to show a clinically meaningful improvement of at least 50% subjects in anxiety score from baseline; a 'response rate' more than four times higher than that of the placebo group. The FDA has cleared Incannex's IND application for PsiGAD2 to conduct a U.S. Phase 2b clinical trial, which is expected to include approximately 94 patients with GAD, including those currently treated with selective serotonin reuptake inhibitors (SSRIs), who meet the study inclusion and exclusion criteria. Incannex anticipates reporting full data results from PsiGAD1 trial in the first half of 2025.
About IHL-675A
(MORE TO FOLLOW) Dow Jones Newswires
September 30, 2024 16:01 ET (20:01 GMT)
Comments