Full Press Release Details
Incannex Healthcare Inc. Reports Fiscal Second Quarter 2025 Financial
Results and Business Updates
YORK and MELBOURNE, Australia, February 14, 2025 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (Nasdaq: IXHL), (Incannex), a clinical-stage
biopharmaceutical company leading the way in developing oral combination medicines, today reported fiscal second quarter financial results
and provided business highlights for the quarter ended December 31, 2024.
with obstructive sleep apnea need new and convenient therapeutic options to manage this serious, chronic and life-threatening disease.
We are enthusiastic about the potential for IHL-42X, an oral, once-daily treatment that uniquely targets physiological pathways responsible
for the airway obstruction characteristic of OSA. We achieved a key milestone for our OSA program, reporting positive top-line results
from a pharmacokinetics (PK) and safety study of IHL-42X, conducted alongside our global Phase 2/3 RePOSA study," said Joel Latham,
Incannex's President and Chief Executive Officer.
"Our new OSA clinical advisory board brings
together leading scientific and industry experts, and we are pleased to welcome Dr. Alison Wimms, representing ResMed, a recognized leader
in the sleep medicine field. The OSA advisory board will provide valuable insights and guidance for our ongoing global IHL-42X Phase 2/3
RePOSA clinical trial. Looking ahead, we are committed to executing our clinical programs and are energized by the upcoming catalysts,
including the top-line readout from the U.S. Phase 2 portion of the IHL-42X trial expected in the first half of 2025."
The RePOSA Global Phase 2/3 clinical
trial is progressing well, with strong recruitment and enrollment at the U.S. sites. Building on the positive momentum and continued interest
in patient recruitment, the trial design includes expansion to both U.K. and U.S. sites for the Phase 3 trial. Additionally, we have successfully
completed manufacturing of the IHL-42X clinical supply needed to initiate Phase 3.
an oral fixed-dose combination of acetazolamide and dronabinol, is currently in Phase 2/3 clinical studies for the treatment of obstructive
sleep apnea (OSA). Designed to act synergistically, IHL-42X uniquely targets two physiological pathways associated with the intermittent
hypoxia (IH) and hypercapnia that characterize OSA. In a prior Australian Phase 2 clinical trial, IHL-42X was shown to reduce the Apnea-Hypopnea
Index (AHI) in all dosage strengths, with the lowest dose reducing AHI by an average of 51 percent relative to baseline. RePOSA,
a global Phase 2/3 clinical trial is underway, evaluating IHL-42X in individuals with OSA who are either non-compliant, intolerant, or
na ve to positive airway pressure devices, including CPAP, with the Phase 2 portion conducted in the United States. The expanded
Phase 3 portion will include sites in the United Kingdom and European Union. A topline readout from the U.S. Phase 2 portion is anticipated
in the first half of 2025.
IHL-675A is an oral fixed-dose combination of
cannabidiol and hydroxychloroquine sulfate designed to target two distinct pathways, while acting synergistically to alleviate inflammation.
IHL-675A was observed to be well tolerated and bioavailable in an Australian Phase 1 clinical 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.
Moving forward the company plans to focus resources on a larger U.S. Phase 2 study, where an expedited regulatory pathway may be available,
enrolling patients with rheumatoid arthritis (RA).
PSX-001 is Incannex's oral synthetic psilocybin
drug candidate, administered in combination with psychotherapy, for patients diagnosed with moderate-to-severe Generalized Anxiety Disorder
(GAD). In the Australian Phase 2 "PsiGAD1" clinical trial, PSX-001 was observed to reduce anxiety scores and be well-tolerated
in GAD patients. Forty-four percent of the subjects in the psilocybin group exhibited a clinically meaningful improvement of at least
50% in anxiety score from baseline; a response rate' more than four times higher than that of the placebo group. Incannex plans
to submit full results from the PsiGAD1 Phase 2 trial for publication in a peer-reviewed scientific journal. The "PsiGAD2" Phase
2 trial is expected to recruit 94 patients with GAD, including those currently treated with selective serotonin reuptake inhibitors (SSRIs),
who meet the study inclusion and exclusion criteria in the United States and United Kingdom.
About Incannex Healthcare Inc.
Incannex is leading the way in developing combination
medicines that target the underlying biological pathways associated with chronic conditions, including obstructive sleep apnea, rheumatoid
arthritis and generalized anxiety disorder. The company is advancing novel oral fix-dosed treatments and therapeutic regimens based on
evidence-based innovation. Incannex's lead Phase 2/3 and Phase 2 clinical programs include IHL-42X, an oral fixed-dose combination of
dronabinol and acetazolamide, designed to act synergistically in the treatment of obstructive sleep apnea; IHL-675A, an oral fixed-dose
combination of cannabidiol and hydroxychloroquine sulfate, acting synergistically to alleviate inflammatory conditions, such as rheumatoid
arthritis, and PSX-001, an oral synthetic psilocybin treatment in combination with psychotherapy, for the treatment of generalized anxiety
disorder. Incannex's programs target disorders that have limited, inadequate, or no approved pharmaceutical treatment options.
Forward Looking Statements
This 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 skills and experience of the newly appointed
officer of Incannex and expectations with respect to his future contributions to the Company and statements, 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. For additional information on Incannex, please visit our website at www.incannex.com.
Edison Group for Incannex
INCANNEX HEALTHCARE INC.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share amounts)
in U.S. Dollars, unless otherwise stated)
| December 31, 2024 | June 30, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 2,098 | $ | 5,858 | ||||
| Prepaid expenses and other assets | 417 | 507 | ||||||
| Assets pledged as security for short-term debt | 1,383 | - | ||||||
| Research and Development ("R&D") tax incentive receivable | 6,606 | 9,837 | ||||||
| Total current assets | 10,504 | 16,202 | ||||||
| Property, plant and equipment, net | 273 | 472 | ||||||
| Operating lease right-of-use assets | 329 | 373 | ||||||
| Total assets | $ | 11,106 | $ | 17,047 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 845 | $ | 612 | ||||
| Accrued expenses and other current liabilities | 3,435 | 4,845 | ||||||
| Short-term debt | 1,383 | - | ||||||
| Operating lease liabilities, current | 177 | 163 | ||||||
| Total current liabilities | 5,840 | 5,620 | ||||||
| Operating lease liabilities, non-current | 152 | 210 | ||||||
| Long-term debt | 2,385 | - | ||||||
| Warrant liabilities | 1,286 | - | ||||||
| Convertible rights | 478 | - | ||||||
| Total liabilities | 10,141 | 5,830 | ||||||
| Commitments and contingencies (Note 8) | ||||||||
| Stockholders' equity: | ||||||||
| Common stock, $0.0001 par value - shares 100,000,000 authorized; 17,785,235 and 17,642,832 shares issued and outstanding at December 31, 2024 and June 30, 2024 respectively | 2 | 2 | ||||||
| Preferred stock, $0.0001 par value per share, 10,000,000 shares authorized; no shares issued or outstanding at December 31, 2024 and June 30, 2024, respectively | - | - | ||||||
| Additional paid-in capital | 126,354 | 125,218 | ||||||
| Accumulated deficit | (121,984 | ) | (110,671 | ) | ||||
| Foreign currency translation reserve | (3,407 | ) | (3,332 | ) | ||||
| Total stockholders' equity | 965 | 11,217 | ||||||
| Total liabilities and stockholders' equity | $ | 11,106 | $ | 17,047 |
INCANNEX HEALTHCARE INC.
Condensed Consolidated Statements of Operations
and Comprehensive Loss
(in thousands, except share and per share amounts)
in U.S. Dollars, unless otherwise stated)
| For the three months ended December 31, | For the 6 months ended December 31, | |||||||||||||||
| 2024 | 2023 | 2024 | 2023 | |||||||||||||
| Revenue from customers | 12 | - | 86 | - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (1,414 | ) | (2,638 | ) | (4,310 | ) | (5,247 | ) | ||||||||
| General and administrative | (3,602 | ) | (5,345 | ) | (7,034 | ) | (7,629 | ) | ||||||||
| Total operating expenses | (5,016 | ) | (7,983 | ) | (11,344 | ) | (12,876 | ) | ||||||||
| Loss from operations | (5,004 | ) | (7,983 | ) | (11,258 | ) | (12,876 | ) | ||||||||
| Other income, net: | - | - | ||||||||||||||
| R&D tax incentive | 956 | 2,727 | 1,767 | 6,824 | ||||||||||||
| Foreign exchange gains/(losses) | (326 | ) | (5 | ) | (331 | ) | (6 | ) | ||||||||
| Interest income | 28 | 20 | 57 | 90 | ||||||||||||
| Interest expense | (171 | ) | - | (171 | ) | - | ||||||||||
| Change in fair value of convertible rights | (179 | ) | - | (179 | ) | - | ||||||||||
| Change in fair value of warrant liabilities | (103 | ) | - | (103 | ) | - | ||||||||||
| ELOC commitment fee | (1,095 | ) | - | (1,095 | ) | - | ||||||||||
| Total other income, net | (890 | ) | 2,742 | (55 | ) | 6,908 | ||||||||||
| Loss before income tax expense | (5,894 | ) | (5,241 | ) | (11,313 | ) | (5,968 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net loss | $ | (5,894 | ) | $ | (5,241 | ) | $ | (11,313 | ) | $ | (5,968 | ) | ||||
| Other comprehensive income/(loss): | - | |||||||||||||||
| Currency translation adjustment, net of tax | (414 | ) | 927 | (75 | ) | 418 | ||||||||||
| Total comprehensive loss | $ | (6,308 | ) | $ | (4,314 | ) | $ | (11,388 | ) | $ | (5,550 | ) | ||||
| Net loss per share: Basic and diluted | $ | (0.33 | ) | $ | (0.33 | ) | $ | (0.65 | ) | $ | (0.38 | ) | ||||
| Weighted average number of shares outstanding, basic and diluted | 17,624,422 | 15,873,113 | 17,563,200 | 15,873,113 |