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Incannex Healthcare Limited ABN 93 096 635 246 Appendix 4E For the year ended 30 June 2023 Information for ASX under listing rule 4.3A Reporting Period: 30 June 2023 Comparative Period: 30 June 2022 2.0 Results for annou

Key Takeaway: Incannex Healthcare Limited published its annual report for the year ending June 30, 2023, revealing a substantial loss of approximately $19.98 million, compared to $14.9 million the previous year. Despite financial losses, the company highlighted major advancements in its clinical trial programs, including successful results from the IHL-42X trial for obstructive sleep apnoea and progress in its cannabinoid therapy IHL-675A. Furthermore, the company has received FDA approval to open its Investigational New Drug file, paving the way for a pivotal Phase 2/3 trial. The report also notes the expected completion of a Phase 2 clinical trial for psilocybin-assisted therapy for generalized anxiety disorder in early 2024.

Market Sentiment Analysis

POSITIVE FACTORS

  • Incannex has multiple clinical trials underway that may lead to significant breakthroughs.
  • The IHL-42X trial showed promising results in treating obstructive sleep apnoea.
  • The successful opening of the Investigational New Drug file with the FDA is a major step for the company.
  • Partnerships with Monash University enhance Incannex's capabilities in the psychedelic therapy sector.

CONCERNS & RISKS

  • The company reported a loss from ordinary activities after tax of nearly $20 million, an increase from the previous year.
  • No dividends were paid, declared, or proposed for the financial year 2023, indicating potential cash flow issues.

Full Press Release Details

Incannex Healthcare Limited
year ended 30 June 2023
Information for ASX under listing rule 4.3A
Reporting Period: 30 June 2023
Comparative Period: 30 June 2022
30-Jun-23 30-Jun-22 Amount change Percentage change
$ $ $ %
Revenues from ordinary activities - - - nmf
30-Jun-23 30-Jun-22 Amount change Percentage change
$ $ $ %
Loss from ordinary activities after tax (19,979,558 ) (14,903,909 ) (5,075,649 ) 34
30-Jun-23 30-Jun-22 Amount change Percentage change
$ $ $ %
Loss from ordinary activities after tax (19,979,558 ) (14,903,909 ) (5,075,649 ) 34
No dividends have been paid, declared or proposed
in respect of the year ended 30 June 2023 (2022: Nil).
Results for the year
Refer to the attached financial statements and review
of operations in the Directors' Report for an explanation of the results for the year.
Statement of profit and loss and other comprehensive income
Refer to attached financial statements.
Statement of financial position
Refer to attached financial statements.
Statement of changes in equity
Refer to attached financial statements.
Statement of cash flows
Refer to attached financial statements.
Details of dividends and distribution payments
Dividend and distribution reinvestment
Net tangible asset per security
Net tangible asset per ordinary security 30-Jun-23 30-Jun-22
Net tangible assets 31,411,440 35,869,075
Number of shares on issue at reporting date 1,587,010,366 1,292,334,028
Net tangible asset per ordinary security 1.98 cents 2.78 cents
The net tangibles asset backing per security of 1.98
cents presented above is inclusive of right-of-use assets and lease liabilities. The net tangible asset per security, at 30 June 2023,
would reduce to 1.93 cents (2022: no change) if right-of use assets were excluded, and lease liabilities were included in the calculation.
The consolidated financial statements include the financial
statements of Incannex Healthcare Limited ( IHL') and its wholly owned subsidiaries Incannex Pty Ltd ( IXPL')
and Psychennex Pty Ltd ( PXPL'). IXPL is incorporated in Australia and IHL owns 100% of the issued ordinary shares in IXPL
(2022: 100%). PXPL is incorporated in Australia and IHL owns 100% of the issued ordinary shares in PXPL (2022: 100%).
Joint ventures and associates
Commentary on results
The figures in this report are based on the attached Financial
Report which is audited.
The independent audit report is not subject to any modified
opinion, emphasis of matter or other matter paragraph.
Melbourne, Victoria, 30 August 2023
Incannex Healthcare Limited
Annual Financial Report
For the year ended 30 June 2023
Incannex Healthcare Limited
Page
Corporate Information 1
Chairman's Letter 2
Directors' Report 4
Business Activities and Outlook 6
Remuneration Report 27
Auditor's Independence Declaration 34
Statement of Comprehensive Income 35
Statement of Financial Position 36
Statement of Changes In Equity 37
Statement of Cash Flows 38
Notes to the Financial Statements 39
Directors' Declaration 63
Independent Auditor's Report 64
Corporate Governance Statement 71
Securities Exchange Information 78
Incannex Healthcare Limited
CORPORATE INFORMATION
Incannex Healthcare Limited
Mr Joel Latham (Managing Director & CEO)
Valentine (Non-Executive Chairman)
Mr Peter Widdows (Non-Executive Director)
Dr George Anastassov (Non-Executive Director)
Robert B. Clark (Non-Executive Director) (Appointed 17/08/2022)
Level 23, South Tower Rialto
Melbourne Victoria 3000
Principal Place of Business
Docklands Victoria 3008
Level 5 126 Phillip Street
Phone: +61 2 9698 5414
Level 6, 10 Eagle St
Brisbane 4000, Queensland
Securities Exchange Listing
ASX Limited (Australian Securities Exchange)
Exchange: Melbourne Victoria
Incannex Healthcare Limited
On behalf of the Board of Directors,
I am pleased to present the Annual Report of Incannex Healthcare Limited ("Incannex" or "IHL") for the financial
year ended 30 June 2023.
The hard work of our team throughout
the year elucidated major opportunities to advance our diversified product development pipeline despite challenging capital market conditions
for the broader biotech sector.
Financial decisions that Incannex
made in 2021 and 2022 to ensure that the Company remained well funded has ensured that we are able to continue our extensive research
and development plans unabated.
Operationally we've witnessed
amazing progress in the clinical development of our portfolio of drug candidate assets. Most biotech companies only have one lead candidate,
however, we have three major efficacy trials underway over three different drugs or therapies that have the potential to influence patient
treatment protocols and unlock significant shareholder value upon the release of positive trial results.
In our IHL-42X program to treat
obstructive sleep apnoea, our phase 2 proof of concept trial demonstrated that the main symptom measure of sleep apnea was more than halved
on average for the participants in this trial, truly outstanding results.
After considerable work by the broader
team throughout the year, Incannex has successfully opened its Investigational New Drug file after approval from the US Food and Drug
Administration, truly a landmark achievement for the company. Incannex is now at the point whereby we will imminently undertake a major
multi- site phase 2/3 pivotal clinical trial to assess IHL-42X for potential registration and marketing approval in the United States.
It was also another important year
of development for IHL-675A, our multi-use cannabinoid drug candidate for inflammatory disorders. Various pre-clinical assessments of
IHL-675A have demonstrated a superior response to inflammation to CBD administer alone, which is highly encouraging to us from a marketability
and economic perspective.
Successful clinical results in
the Phase 1 trial for IHL-675A were precursory to the extensive multi-site Phase 2 trial that was commenced in February to assess IHL-675A
for use in the treatment of pain and function in patients with rheumatoid arthritis.
IHL-675A comprises cannabidiol and
hydroxychloroquine. Both compounds are currently used to treat arthritis. By conducting studies on our unique proprietary combination
formulation, we intend to open a major new market for prescribing health professionals to help the growing population of sufferers of
rheumatoid arthritis.
With the benefit of our partnership
with Monash University, Incannex has proved itself to be a sophisticated and advanced participant in the global psychedelic therapy sector.
The PsiGAD phase 2 clinical trial assessing the use of our psilocybin assisted psychotherapy treatment protocol for generalised anxiety
disorder nears completion with the final readout of results expected in Q1 of 2024.
Psychedelic therapies continue
to garner attention from all walks of life and we are delighted to have established Clarion Clinics as the first dedicated clinic in Australia

Frequently Asked Questions

What were Incannex's revenues for the fiscal year 2023?

Incannex reported no revenues from ordinary activities for the year ended 30 June 2023.

How much was the loss after tax for Incannex in 2023?

The loss from ordinary activities after tax for Incannex was $19,979,558 in 2023.

Have any dividends been declared for 2023?

No dividends have been paid, declared, or proposed for the year ended 30 June 2023.

What is the net tangible asset per security for 2023?

The net tangible asset per ordinary security for Incannex was 1.98 cents as of 30 June 2023.

Which major trials are underway at Incannex?

Incannex has three major efficacy trials in progress across different drug candidates.

Last updated: Sep 1, 2023