Full Press Release Details
Incannex Healthcare Inc. Reports Fiscal Third Quarter 2025 Financial
Results and Business Updates
NEW YORK and MELBOURNE, Australia, May 15, 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 March 31, 2025.
"The third quarter of 2025 represents a
pivotal period of progress for Incannex as we continue to execute on our IHL-42X development program," said Joel Latham, President
and CEO of Incannex. "With the rapid completion of Phase 2 enrollment in the Phase 2/3 RePOSA, recent positive and confirmatory
PK and safety clinical results, and the addition of expert sleep medicine clinical advisory leadership, we are well-positioned to deliver
on key upcoming milestones and to advance IHL-42X as a potential treatment for millions of underserved patients living with OSA."
Operational Highlights
IHL-42X is designed to treat OSA by targeting
its underlying pathophysiology. An oral fixed-dose combination of dronabinol and acetazolamide, IHL-42X is currently advancing through
the RePOSA Phase 2/3 clinical trial, which is expected to enroll more 560 patients at sites worldwide.
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. A topline readout from the U.S. Phase 2 portion is anticipated in July 2025.
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 three clinical-stage product candidates based on evidence-based innovation,
and supported by streamlined operations. Incannex's lead clinical program, IHL-42X, is an oral fixed-dose combination of dronabinol and
acetazolamide designed to target underlying mechanisms and act synergistically in the treatment of obstructive sleep apnea. In a Phase
2 development program, IHL-675A is an oral fixed-dose combination of cannabidiol and hydroxychloroquine sulfate designed to act synergistically
to alleviate inflammatory conditions, such as rheumatoid arthritis. Approved for Phase 2 clinical development, PSX-001 is an oral synthetic
psilocybin treatment for the treatment of generalized anxiety disorder. Incannex's programs target disorders that have limited, inadequate,
or no approved pharmaceutical treatment options. For additional information on Incannex, please visit our website at www.incannex.com.
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)
| March 31, 2025 | June 30, 2024 | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 6,711 | $ | 5,858 | ||||
| Prepaid expenses and other assets | 416 | 507 | ||||||
| Assets pledged as security for short-term debt | 1,397 | - | ||||||
| Research and Development ("R&D") tax incentive receivable | 7,105 | 9,837 | ||||||
| Total current assets | 15,629 | 16,202 | ||||||
| Property, plant and equipment, net | 277 | 472 | ||||||
| Operating lease right-of-use assets | 291 | 373 | ||||||
| Total assets | $ | 16,197 | $ | 17,047 | ||||
| Liabilities and stockholders' equity | ||||||||
| Current liabilities: | ||||||||
| Trade and other payables | $ | 1,067 | $ | 612 | ||||
| Accrued expenses and other current liabilities | 4,718 | 4,845 | ||||||
| Short-term debt | 1,397 | - | ||||||
| Operating lease liabilities, current | 186 | 163 | ||||||
| Total current liabilities | 7,368 | 5,620 | ||||||
| Operating lease liabilities, non-current | 104 | 210 | ||||||
| Long-term debt | - | - | ||||||
| Warrant liabilities | 1,322 | - | ||||||
| Convertible rights | - | - | ||||||
| Total liabilities | 8,794 | 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 | 136,849 | 125,218 | ||||||
| Accumulated deficit | (125,953 | ) | (110,671 | ) | ||||
| Foreign currency translation reserve | (3,495 | ) | (3,332 | ) | ||||
| Total stockholders' equity | 7,403 | 11,217 | ||||||
| Total liabilities and stockholders' equity | $ | 16,197 | $ | 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 9-months ended March 31, | For the 3-months ended March 31, | |||||||||||||||
| 2025 | 2024 | 2025 | 2024 | |||||||||||||
| Revenue from customers | 86 | - | - | - | ||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | (7,045 | ) | (8,520 | ) | (2,735 | ) | (3,277 | ) | ||||||||
| General and administrative | (9,302 | ) | (11,777 | ) | (2,268 | ) | (4,138 | ) | ||||||||
| Total operating expenses | (16,347 | ) | (20,297 | ) | (5,003 | ) | (7,415 | ) | ||||||||
| Loss from operations | (16,261 | ) | (20,297 | ) | (5,003 | ) | (7,415 | ) | ||||||||
| Other income/(expense), net: | - | - | - | - | ||||||||||||
| R&D tax incentive | 2,188 | 8,150 | 421 | 1,320 | ||||||||||||
| Foreign exchange income/(expense) | (290 | ) | (17 | ) | 41 | (11 | ) | |||||||||
| Interest expense | (303 | ) | - | (132 | ) | |||||||||||
| Interest income | 60 | 166 | 4 | 75 | ||||||||||||
| Change in fair value of convertible rights | (179 | ) | - | - | - | |||||||||||
| Change in fair value of warrant liabilities | 1,721 | - | 1,824 | - | ||||||||||||
| Warrant issuance costs | (129 | ) | (129 | ) | ||||||||||||
| Loss on extinguishment | (994 | ) | - | (994 | ) | - | ||||||||||
| Other expenses | (1,095 | ) | - | - | - | |||||||||||
| Total other income/(expense), net | 979 | 8,299 | 1,035 | 1,384 | ||||||||||||
| Loss before income tax expense | (15,282 | ) | (11,998 | ) | (3,968 | ) | (6,031 | ) | ||||||||
| Income tax expense | - | - | - | - | ||||||||||||
| Net loss | $ | (15,282 | ) | $ | (11,998 | ) | $ | (3,968 | ) | $ | (6,031 | ) | ||||
| Other comprehensive income/(loss): | - | |||||||||||||||
| Currency translation adjustment, net of tax | (163 | ) | (403 | ) | (88 | ) | (820 | ) | ||||||||
| Total comprehensive income/(loss) | $ | (15,445 | ) | $ | (12,401 | ) | $ | (4,056 | ) | $ | (6,851 | ) | ||||
| Net loss per share: Basic and diluted | $ | (0.84 | ) | $ | (0.76 | ) | $ | (0.20 | ) | $ | (0.38 | ) | ||||
| Weighted average number of shares outstanding, basic and diluted | 18,238,863 | 15,873,113 | 19,632,539 | 15,873,113 |