Full Press Release Details
Healthcare Inc. Reports Fiscal Full Year 2024 Financial Results and Business Updates
YORK and MELBOURNE, Australia, September 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.
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."
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.
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.
is an oral drug candidate currently in an ongoing Australian Phase 2 trial for the treatment of inflammatory conditions, with an initial
focus on 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. IHL-675A was observed to be well-tolerated and bioavailable in an Australian
Phase 1 trial. IHL-675A was also observed to reduce inflammatory markers and disease scores across multiple animal inflammatory disease
models and in vitro assays in preclinical evaluation. A Phase 2 trial investigating the safety and efficacy of IHL-675A in RA patients
is ongoing, enrolling 128 subjects with pain and reduced function regardless of current treatment regimen. Top-line data from this Phase
2 trial is anticipated in the second half of 2025.
Incannex Healthcare Inc.
is a clinical-stage biopharmaceutical company focused on developing innovative medicines for patients living with serious chronic diseases
and significant unmet needs. The company is advancing oral synthetic cannabinoid and psilocybin drug candidates targeting sleep apnea,
anxiety, and inflammatory diseases. Incannex's lead programs include IHL-42X, an oral fixed dose combination of dronabinol and
acetazolamide, designed to act synergistically in the treatment of OSA, in a global Phase 2/3 study for the treatment of obstructive
sleep apnea, PSX-001 in a Phase 2 trial conducted in the U.S. and UK to assess the combination of an oral synthetic psilocybin treatment
with psychotherapy for patients with generalized anxiety disorder, and IHL-675A, an oral fixed dose combination of cannabidiol and hydroxychloroquine
sulfate, acting synergistically to alleviate inflammation, in an Australian Phase 2 trial. Each of these programs target indications
that have limited, inadequate, or no approved pharmaceutical treatment options.
press release contains "forward-looking statements" within the meaning of the "safe harbor" provisions of the U.S.
Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements in this press release include statements about,
among other things: Incannex's business strategy, future operations; Incannex's ability to execute on its objectives, prospects,
or plans, the benefits of the redomiciliation and the Nasdaq common stock listing, future closings of the strategic financings with Arena,
which are subject to conditions and may not occur, evaluations and judgments regarding Incannex's research and development efforts,
including any implications that the results of earlier clinical trials will be representative or consistent with later clinical trials
or final results; the expected timing of enrollment for these trials and the availability of data or results of these trials, and the
potential benefits, safety or of Incannex's drug candidates. Forward-looking statements are statements other than historical facts
and relate to future events or circumstances or Incannex's future performance, and they are based on management's current
assumptions, expectations, and beliefs concerning future developments and their potential effect on Incannex's business. These
forward-looking statements are subject to a number of risks and uncertainties, which may cause the forward-looking events and circumstances
described in this press release to not occur, and actual results to differ materially and adversely from those described in or implied
by the forward-looking statements. These risks and uncertainties include, among others: the continued availability of financing; Incannex's
ability to raise capital to fund continuing operations and to complete capital raising transactions; the impact of any infringement actions
or other litigation brought against Incannex; the success of Incannex's development efforts, including Incannex's ability
to progress its drug candidates through clinical trials on the timelines expected; competition from other providers and products; that
the market for its drug candidates may not grow at the rates anticipated or at all; Incannex's compliance with the various evolving
and complex laws and regulations applicable to its business and its industry; and Incannex's ability to protect its proprietary
technology and intellectual property; and other factors relating to Incannex's industry, its operations and results of operations.
The forward-looking statements made in this press release speak only as of the date of this press release, and Incannex assumes no obligation
to update publicly any such forward-looking statements to reflect actual results or to changes in expectations, except as otherwise required
by law. Incannex's reports filed with the U.S. Securities and Exchange Commission (SEC) including its annual report on Form
10-K for the fiscal year ended June 30, 2024, filed with the SEC on September 30, 2024, and the other reports it
files from time to time, including subsequently filed annual, quarterly and current reports, are made available on Incannex's website
upon their filing with the SEC. These reports contain more information about Incannex, its business and the risks affecting its
business, as well as its results of operations for the periods covered by the financial results included in this press release.
Edison Group for Incannex
thousands, except share and per share amounts)
in U.S. Dollars, unless otherwise stated)
| June 30, 2024 | June 30, 2023 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 5,858 | $ | 22,120 | ||||
| Prepaid expenses and other assets | 507 | 877 | ||||||
| R&D tax incentive receivable | 9,837 | - | ||||||
| Total current assets | 16,202 | 22,997 | ||||||
| Property, plant and equipment, net | 472 | 294 | ||||||
| Operating lease right-of-use assets | 373 | 492 | ||||||
| Total assets | $ | 17,047 | $ | 23,783 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 612 | $ | 1748 | ||||
| Accrued expenses and other current liabilities | 4,845 | 689 | ||||||
| Operating lease liabilities, current | 163 | 113 | ||||||
| Total current liabilities | 5,620 | 2,550 | ||||||
| Operating lease liabilities, non-current | 210 | 408 | ||||||
| Total liabilities | 5,830 | 2,958 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.0001 par value - 100,000,000 shares authorized; 15,873,113 and 15,873,113 shares issued and outstanding at June 30, 2024 and 2023, respectively | 2 | 2 | ||||||
| Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized; no shares issued or outstanding at June 30, 2024 and 2023, respectively | - | - | ||||||
| Additional paid-in capital | 125,218 | 116,290 | ||||||
| Accumulated deficit | (110,671 | ) | (92,212 | ) | ||||
| Foreign currency translation reserve | (3,332 | ) | (3,255 | ) | ||||
| Total shareholders' equity | 11,217 | 20,825 | ||||||
| Total liabilities and stockholders' equity | $ | 17,047 | $ | 23,783 |
Statements of Operations and Comprehensive Loss
thousands, except share and per share amounts)
in U.S. Dollars, unless otherwise stated)
| June 30, 2024 | June 30, 2023 | |||||||
| Revenue from customers | 12 | - | ||||||
| Operating expenses: | ||||||||
| Research and development | (12,879 | ) | (6,309 | ) | ||||
| Acquisition of in-process research and development | - | (35,347 | ) | |||||
| General and administrative | (17,174 | ) | (8,012 | ) | ||||
| Total operating expenses | (30,053 | ) | (49,668 | ) | ||||
| Loss from operations | (30,041 | ) | (49,668 | ) | ||||
| Other income, net: | ||||||||
| R&D tax incentive | 11,434 | 683 | ||||||
| Foreign exchange expense | (28 | ) | (67 | ) | ||||
| Interest income | 206 | 241 | ||||||
| Total other income, net | 11,612 | 857 | ||||||
| Loss before income tax expense | (18,429 | ) | (48,811 | ) | ||||
| Income tax expense | (30 | ) | - | |||||
| Net loss | $ | (18,459 | ) | $ | (48,811 | ) | ||
| Other comprehensive loss: | ||||||||
| Currency translation adjustment, net of tax | (77 | ) | (2,292 | ) | ||||
| Total comprehensive loss | $ | (18,536 | ) | $ | (51,103 | ) | ||
| Net loss per share: Basic and diluted | $ | (1.15 | ) | (3.32 | ) | |||
| Weighted average number of shares outstanding, basic and diluted | 16,164,338 | 15,384,704 |