UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 6-K

 

 

Report of Foreign Private Issuer

Pursuant to Rule 13a-16 or 15d-16

under the Securities Exchange Act of 1934

 

For the month of March 2022

 

Commission File Number: 001-41106

 

 

Incannex Healthcare Limited

(Exact name of Registrant as specified in its charter)

 

 

not applicable

(Translation of Registrant’s name into English)

 

Australia

(Jurisdiction of incorporation or organization)

 

Joel Latham

Chief Executive Officer and Managing Director

Level 39, Rialto South Tower
525 Collins Street

Melbourne 3000

Australia

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F:

 

Form 20-F ☒ Form 40-F ☐

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):

 

Yes ☐  No ☒

 

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):

 

Yes ☐  No ☒

 

 

 

INFORMATION CONTAINED IN THIS REPORT ON FORM 6-K

 

On February 28, 2022, Incannex Healthcare Limited filed its half-year report for the six months ended December 31, 2021, with the Australian Securities Exchange, a copy of which half year report is attached to this Form 6-K as Exhibit 99.1.

 

On March 10, 2022, Incannex Healthcare Limited filed with the Australian Securities Exchange an announcement captioned “Incannex observes substantial reduction in AHI in preliminary results of clinical trial assessing IHL-42X in patients with OSA; proceeds to pivotal studies”, which announcement is attached hereto as Exhibit 99.2.

 

On March 16, 2022, Incannex Healthcare Limited filed an application (Appendix 2A) for quotation of additional securities on the Australian Securities Exchange, which Appendix 2A is attached hereto as Exhibit 99.3.

 

 

Signatures

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

	Incannex Healthcare Limited
Date: March 21, 2022	By:	/s/ Joel Latham
	Name:	Joel Latham
	Title:	Chief Executive Officer and Managing Director

 

 

INDEX TO EXHIBITS

 

Exhibit No.
99.1	Half-year report for the six months ended December 31, 2021
99.2	ASX Announcement, dated March 10, 2022
99.3	Appendix 2A, dated March 16, 2022

 

 

3

Exhibit 99.1

  

 

 

 

 

 

INCANNEX HEALTHCARE LIMITED

 

ABN 93 096 635 246

 

(and controlled entities)

 

 

 

 

HALF-YEAR INFORMATION

 

FOR THE SIX MONTHS ENDED 31 DECEMBER 2021

 

PROVIDED TO THE ASX UNDER LISTING RULE 4.2A.3

 

 

Appendix 4D

Half Year Report for the six months to 31 December 2021

 

INCANNEX HEALTHCARE LIMITED

ABN 93 096 635 246

 

1.	Reporting period

 

Report for the half year ended:	31 December 2021
Previous corresponding periods:	Financial year ended 30 June 2021 Half-year ended 31 December 2020

 

2.	Results for announcement to the market

 

Description		31-Dec-21				31-Dec-20				Change
Item 2.1 - Revenue from ordinary activities			-			$	1,177,163			Down 100%
Item 2.2 - Profit/(Loss) from ordinary activities		$	(5,244,874	)		$	(3,821,439	)		Down 37%
Item 2.3 - Net Profit/(Loss) attributable to members		$	(5,244,874	)		$	(3,821,439	)		Down 37%

 

Item 2.4 – Dividends – no dividends for the period have been paid or declared (FY21: nil)

 

3.	Net tangible asset value: +1.61cps (30-Jun-2021: +0.80cps)

 

4.	Details of entities over which control has been gained or lost during the period: Nil

 

5.	Dividends: No dividends have been declared of paid during the period

 

5.	Details of dividend or distribution reinvestment plans in operation are described below: Nil

 

6.	Details of associates and joint venture entities: Nil

 

7.	The financial information provided in this Appendix 4D is based on the half-year condensed financial report which accompanies this report.

 

9.	The financial report has been independently reviewed and is not subject to any qualified independent review statement.

 

 

 

 

 

 

 

 

 

Incannex Healthcare Limited

 

ABN 93 096 635 246

 

Interim Financial Report

 

for the half-year ended 31 December 2021

 

 

TABLE OF CONTENTS

 

Corporate Directory	3
Directors’ Report	4
Auditor’s Independence Declaration	6
Condensed Consolidated Statement of Comprehensive Income	7
Condensed Consolidated Statement of Financial Position	8
Condensed Consolidated Statement of Cash Flows	9
Condensed Consolidated Statement of Changes in Equity	10
Notes to the Consolidated Financial Statements	11
Directors’ Declaration	18
Independent Auditor’s Review Report	19

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

CORPORATE DIRECTORY

 

BOARD OF DIRECTORS

 

Mr Troy Valentine – Non-executive Chairman

Mr Peter Widdows – Non-executive Director

Dr Sud Agarwal – Non-Executive Director

Mr Joel Latham – Managing Director

 

COMPANY SECRETARY

 

Madhukar Bhalla

 

REGISTERED OFFICE

 

Level 35, 525 Collins Street Melbourne VIC 3000

 

AUDITORS

 

HLB Mann Judd (WA Partnership)

Level 4, 130 Stirling Street, Perth WA 6000

 

SHARE REGISTRY

 

AUTOMIC REGISTRY SERVICES

Level 5, 126 Phillip Street, SYDNEY, NSW, AUSTRALIA, 2000

 

LAWYER

 

Thomson Geer

Level 35, 525 Collins Street, Melbourne VIC 3000

 

BANKER

 

Westpac Banking Group

 

SECURITIES EXCHANGE LISTING

 

ASX code: “IHL”

 

Australian Securities Exchange

Level 4, North Tower Rialto, 525 Collins Street, Melbourne VIC 3000

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

DIRECTORS’ REPORT

 

Your directors submit the interim financial report of the consolidated entity, comprising Incannex Healthcare Limited (“the Company” or “IHL”) and its controlled entities (collectively “the Group”) for the half-year ended 31 December 2021. To comply with the provisions of the Corporations Act 2001, the directors report as follows:

 

DIRECTORS

 

The names of directors who held office during or since the end of the interim period and until the date of this report are noted below. All directors were in office for the entire period.

 

	●	Mr Troy Valentine (Chairman)

	●	Mr Peter Widdows

	●	Dr Sud Agarwal

●

Mr Joel Latham

 

PRINCIPAL ACTIVITIES

 

The Group continued research and development of its medicinal cannabinoid compounds. On 20 November 2020 the Group also established a separate business to research and develop the use of psychedelic medicine and therapies for the treatment of mental health disorders.

 

REVIEW OF OPERATIONS

 

Results

 

The consolidated loss for the half-year after tax was A$5,244,874 (2020: loss of A$3,821,439). During this period, the Group worked towards implementing separate strategies for its two business segments.

 

Medicinal Cannabis

 

The Company continued to advance its novel drug development programs using combination cannabinoid compounds to treat unmet medical conditions. Three proprietary drug formulations are being applied to five indications: (i) obstructive sleep apnoea; (ii) traumatic brain injury (concussion); (iii) rheumatoid arthritis; (iv) lung inflammation; and (v) inflammatory bowel disease.

 

Psychedelic Medicine and Therapies

 

The Company advanced its research and development program for the application of psylocibin combined with psychotherapy to treat general anxiety disorder. During the December 2021 half year, the Company received approval to proceed to a phase 2 clinical trial from the Monash University Human Research Ethics Committee. IHL also held a pre-IND meeting with the United States Food and Drug Administration (FDA) regarding its psilocybin clinical trial program. Other psychedelic therapy clinical programs are also being considered by the Company.

 

Capital Management

 

The Group raised A$16,129,282 in new capital (before costs) during the period through the exercise of options – significantly enhancing its working capital position – refer to note 7 for further detail.

 

Other than the above items, and in the period between the end of the half-year and the date of this report there has not arisen any other item, transaction or event of a material or unusual nature likely, in the opinion of the directors of the Company, to significantly affect the operations of the Group, the results of those operations, or the state of affairs of the Group, in future financial years.

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

DIRECTORS’ REPORT

 

AUDITOR’S INDEPENDENCE DECLARATION

 

Section 307C of the Corporations Act 2001 requires our auditors, HLB Mann Judd, to provide the directors of the Company with an Independence Declaration in relation to the review of the interim financial report. This Independence Declaration is set out on the next page and forms part of this Directors’ Report for the half-year ended 31 December 2021.

 

This report is signed in accordance with a resolution of the Board of Directors made pursuant to s306(3) of the Corporations Act 2001.

 

/s/ Troy Valentine
Troy Valentine
Non-executive Chairman
Melbourne

 

28 February 2022

 

 

 

 

AUDITOR’S INDEPENDENCE DECLARATION

 

As lead auditor for the review of the consolidated financial report of Incannex Healthcare Limited for the half-year ended 31 December 2021, I declare that to the best of my knowledge and belief, there have been no contraventions of:

 

a)

the auditor independence requirements of the Corporations Act 2001 in relation to the review; and

 

b)

any applicable code of professional conduct in relation to the review.

 

		/s/ L Di Giallonardo
Perth, Western Australia		L Di Giallonardo
28 February 2022		Partner

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

CONDENSED CONSOLIDATED STATEMENT OF COMPREHENSIVE INCOME

FOR THE HALF-YEAR ENDED 31 DECEMBER 2021

 

				Consolidated
		Note		31 December 2021				30 December 20201
								(restated)
				$				$
Sales		2(a)			-				1,177,163
Cost of sales					(174,294	)			(537,939	)
					(174,294	)			639,224
Other income		2(b)			783,288				52,078
Administration expenses					(130,591	)			(454,664	)
Advertising and investor relations					(847,967	)			(227,532	)
Bad debt expense					(134,626	)			-
Compliance, legal and regulatory					(1,368,561	)			(89,065	)
Research and development costs					(2,401,520	)			(2,039,147	)
Occupancy expenses					(53,341	)			(61,992	)
Salaries and employee benefit expense					(871,753	)			(327,920	)
Share based payment expense		5			(45,509	)			(1,312,421	)
Loss before tax					(5,244,874	)			(3,821,439	)
Income tax benefit (expense)					-				-
Net loss for the period					(5,244,874	)			(3,821,439	)
Other comprehensive income					-				-
Total comprehensive loss for the period					(5,244,874	)			(3,821,439	)
Earnings per share		3
Basic loss per share (cents per share)					(0.47	)			(0.42	)
Diluted loss per share (cents per share)					(0.47	)			(0.42	)

 

1.

Reclassified and remeasured amounts due to restatement from error in prior year – see note 11 for explanation

 

The accompanying notes form part of these financial statements

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

CONDENSED CONSOLIDATED STATEMENT OF FINANCIAL POSITION

AS AT 31 DECEMBER 2021

 

				Consolidated
		Note		31 December 2021				30 June 20211
								(restated)
Assets				$				$
Current assets
Cash and cash equivalents					19,770,505				9,123,617
Trade and other receivables					178,495				169,088
Other financial assets					69,554				36,090
Total current assets					20,018,554				9,328,795
Total assets					20,018,554				9,328,795
Liabilities
Current liabilities
Trade and other payables					547,782				755,049
Total current liabilities					547,782				755,049
Total liabilities					547,782				755,049
Net assets					19,470,772				8,573,746
Equity
Issued capital		7			61,948,498				45,852,107
Reserves					6,658,151				6,612,641
Accumulated losses					(49,135,876	)			(43,891,002	)
Total equity					19,470,772				8,573,746

 

1.

Reclassified and remeasured amounts due to restatement from error in prior year – see note 11 for explanation

 

The accompanying notes form part of these financial statements

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS

FOR THE HALF-YEAR ENDED 31 DECEMBER 2021

 

		Consolidated
		31 December 2021				31 December 2020
		$				$
Cash flows from operating activities
Receipts from customers			-				1,318,121
Payment to suppliers and employees			(6,151,612	)			(4,235,483	)
R&D tax refund			782,383				-
Interest received			1,002				52,078
Net cash used in operating activities			(5,368,227	)			(2,865,284	)
Cash flows from financing activities
Proceeds from share issues			16,129,282				11,200,178
Share issue costs paid			(32,891	)			(97,976	)
Net cash provided by financing activities			16,096,391				11,102,203
Net increase in cash and cash equivalents			10,728,164				8,236,918
Cash and cash equivalents at beginning of period			9,123,617				3,603,390
Effect of exchange rate fluctuations on cash held			(81,276	)			-
Cash and cash equivalents at end of period			19,770,505				11,840,308

 

The accompanying notes form part of these financial statements

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN EQUITY

FOR THE HALF-YEAR ENDED 31 DECEMBER 2021

 

Consolidated		Issued Capital				Reserves				Accumulated Losses				Total Equity
		$				$				$				$
Balance at 1 July 2020			34,192,043				1,490,588				(32,518,203	)			3,164,428
Loss for the period1 (restated)			-				-				(3,821,439	)			(3,821,439	)
Other comprehensive income			-				-				-				-
Total comprehensive loss for the period			-				-				(3,821,439	)			(3,821,439	)
Shares issued on exercise of options			11,199,678				-				-				11,199,678
Options granted			-				262,652				-				262,652
Share based payments			-				380,371				-				380,371
Share issue costs			(315,237	)			-				-				(315,237	)
Balance at 31 December 2020			45,076,484				2,133,611				(36,339,642	)			10,870,453

 

Consolidated		Issued Capital				Reserves				Accumulated Losses				Total Equity
		$				$				$				$
Balance at 1 July 20211 (restated)			45,852,107				6,612,641				(43,891,002	)			8,573,746
Loss for the period			-				-				(5,244,874	)			(5,244,874	)
Other comprehensive income			-				-				-				-
Total comprehensive loss for the period			-				-				(5,244,874	)			(5,244,874	)
Shares issued on exercise of options			16,129,282				-				-				16,129,282
Options granted			-				-				-				-
Share based payments			-				45,509				-				45,509
Share issue costs			(32,891	)			-				-				(32,891	)
Balance at 31 December 2021			61,948,498				6,658,151				(49,135,876	)			19,470,772

 

1.

Reclassified and remeasured amounts due to restatement from error in prior year – see note 11 for explanation

 

The accompanying notes form part of these financial statements

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTES TO THE CONSOLIDATED FINANCIAL STATEMENTS

FOR THE HALF-YEAR ENDED 31 DECEMBER 2021

 

NOTE 1: STATEMENT OF SIGNIFICANT ACCOUNTING POLICIES

 

(a) Basis of preparation

 

The condensed interim consolidated financial statements (the interim financial statements) are general purpose interim financial statements and have been have prepared in accordance with the requirements of the Corporations Act 2001, applicable accounting standards including AASB 134 Interim Financial Reporting, Accounting Interpretations and other authoritative pronouncements of the Australian Accounting Standards Board (‘AASB’). Compliance with AASB 134 ensures compliance with IAS 34 ‘Interim Financial Reporting’.

 

The interim financial statements comprise the condensed interim financial statements for the Group. For the purposes of preparing the interim financial statements, the Group is a for-profit entity.

 

The interim financial statements do not include full disclosures of the type normally included in the full financial report. Therefore, it cannot be expected to provide as full an understanding of the financial performance, financial position and cash flows of the Group as in the full financial report. It is recommended interim financial statements be read in conjunction with the full financial report for the year ended 30 June 2021 and any public announcements made by Incannex Healthcare Limited and its subsidiaries during the half-year in accordance with continuous disclosure requirements arising under the Corporations Act 2001 and the ASX Listing Rules.

 

The accounting policies and methods of computation adopted are consistent with those of the previous financial year and corresponding half-year except for the impact of the new standards and interpretations effective 1 July 2021 as outlined below. These accounting policies are consistent with Australian Accounting Standards and with International Financial Reporting Standards. To ensure comparability with current year disclosures, some presentation changes have been made to comparative information.

 

The interim financial statements have been prepared on a historical cost basis, except for the revaluation of certain financial instruments to fair value. Cost is based on the fair value of the consideration given in exchange for assets.

 

The Group is domiciled in Australia and all amounts are presented in Australian dollars, unless otherwise noted.

 

For the purpose of preparing the interim financial statements, the half-year has been treated as a discrete reporting period.

 

(b) Adoption of new and revised standards

 

New Standards and Interpretations applicable for the half year ended 31 December 2021 In the period ended 31 December 2021, the Directors have reviewed all of the new and revised Standards and Interpretations issued by the AASB that are relevant to the Group and effective for the current reporting period. As a result of this review, the Directors have determined that there is no material impact of the new and revised Standards and Interpretations on the Group and, therefore, no material change is necessary to Group accounting policies.

 

Standards and Interpretations in issue not yet adopted

 

The Directors have also reviewed all of the new and revised Standards and Interpretations in issue not yet adopted for the period ended 31 December 2021. As a result of this review the Directors have determined that there is no material impact of the Standards and Interpretations in issue not yet adopted on the Group and, therefore, no change is necessary to Group accounting policies.

 

(c) Statement of compliance

 

The interim financial statements were authorised for issue on 28 February 2022.

 

The interim financial statements comply with Australian Accounting Standards, which include Australian equivalents to International Financial Reporting Standards (AIFRS). Compliance with AIFRS ensures that the financial report, comprising the interim financial statements and notes thereto, complies with International Financial Reporting Standards (IFRS).

 

(d) Significant accounting estimates and judgements

 

The preparation of the interim financial statements requires management to make judgments, estimates and assumptions that affect the application of accounting policies and the reported amounts of assets, liabilities, income and expense. Actual results may differ from these estimates.

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTE 1: STATEMENT OF SIGNIFICANT ACCOUNTING POLICIES (continued)

 

The judgements, estimates and assumptions applied in the interim financial statements, including the key sources of estimation uncertainty were the same as those applied in the Group’s last annual financial statements for the year ended 30 June 2021.

 

(e) Going concern

 

The financial report has been prepared on the going concern basis, which contemplates continuity of normal business activities and the realisation of assets and settlements of liabilities in the ordinary course of business.

 

NOTE 2: REVENUE

 

(a) Revenue (point in time)

 

		31 December 2021 $				31 December 2020 $
Sales of cannabinoid oils			—				1,177,163
Total sales revenue			—				1,177,163

 

(b) Other income

 

Revenue from other contractual arrangements			—				50,171
Interest			905				1,907
Refundable R&D tax offset			782,383				—
Total other income			783,288				52,078

 

NOTE 3: LOSS PER SHARE

 

Basic loss per share has been calculated using the loss attributable to shareholders of the Parent Company and the weighted average number of ordinary shares on issue.

 

		31 December 2021				31 December 2020
Weighted average number of shares			1,147,811,124				902,054,732

 

NOTE 4: SEGMENT REPORTING

 

AASB 8 Operating Segments requires operating segments to be identified on the basis of internal reports about components of the Group that are regularly reviewed by the Chief Operating Decision Maker in order to allocate resources to the segment and to assess its performance.

 

The Group’s operating segments have been determined with reference to the monthly management accounts used by the Chief Operating Decision maker to make decisions regarding the Group’s operations and allocation of working capital. Due to the size and nature of the Group, the Board as a whole has been determined as the Chief Operating Decision Maker.

 

Based on the quantitative thresholds included in AASB 8, for the current reporting period, the Group has two reportable segments, being (1) distribution of medicinal cannabis products; and (2), development of psychedelic medicines and therapies - and currently one geographical segment, namely Australia.

 

The revenues and results of these segments of the Group as a whole are set out in the condensed statement of comprehensive income and the assets and liabilities of the Group as a whole are set out in the condensed statement of financial position.

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTE 4: SEGMENT REPORTING (continued)

 

A summary of revenue and expenses for the period and assets and liabilities at the end of the period for each segment is shown below:

 

		6 months ended 31 December 2021
		Medicinal Cannabis $				Psychedelic Medicine $				Unallocated $				Consolidated $
Sales revenue			—				—				—
Cost of sales			(174,294	)			—				—				(174,294	)
Other revenue			97				—				783,191				783,288
Other expenses			(2,161,705	)			(280,045	)			(3,412,118	)			(5,853,868	)
Loss before tax			(2,335,902	)			(280,045	)			(2,628,927	)			(5,244,874	)
Segment assets			697,073				7,374				19,314,107				20,018,554
Segment liabilities			(155,467	)			(11,000	)			(381,315	)			(547,782	)

 

		6 months ended 31 December 2020
		Medicinal Cannabis $				Psychedelic Medicine $				Unallocated $				Consolidated $
Sales revenue			1,177,163				—				—				1,177,163
Cost of sales			(537,939	)			—				—				(537,939	)
Other revenue			6				—				52,072				52,078
Other expenses			(2,157,611	)			(90,000	)			(2,265,130	)			(4,512,741	)
Loss before tax			(1,518,381	)			(90,000	)			(2,213,058	)			(3,821,439	)
Segment assets			774,229				—				11,406,723				12,180,952
Segment liabilities			(119,141	)			—				(259,308	)			(378,449	)

 

NOTE 5: SHARE BASED PAYMENTS

 

Securities on Issue at 30 June 2021

 

As at 30 June 2021, the Group had a number of securities on issue that had either not completed all of their vesting conditions or had not yet reached their performance hurdles (or both). These included:

 

a.

583,333 ordinary shares approved by shareholders on 26 June 2020. These vest upon continuing employment with the Company by the CEO on 30 June 2022. $13,924 was expensed for these options during FY21, with $6,962 expensed during the current period. $6,962 will be expensed in the second half of FY22;

  

b.

1,968,412 ordinary shares approved by shareholders on 1 July 2020. Half of these vest upon continuing employment with the Company by the CEO on 30 June 2022 and the other half on 30 June 2023. $39,999 was expensed for these options during FY21, with $19,999 expensed during the current period. $19,999 will be expensed in the second half of FY22, and $16,017 will be expensed in FY23;

 

c.

750,000 options with a strike price of $0.05 (expiring on 30 June 2027) were issued after approval by shareholders on 26 June 2020. 750,000 of these vest upon continued employment with the Company by the CEO until 30 June 2022. $13,801 was expensed for these options during FY21, with $6,901 expensed during the current period. $6,900 will be expensed in the second half of FY22;

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTE 5: SHARE BASED PAYMENTS (continued)

 

d.

1,500,000 options with a strike price of $0.05 (750,000 expiring on 30 June 2025 and 750,000 expiring on 30 June 2026) were issued after approval by shareholders on 1 July 2020. 750,000 of these vest upon continued employment with the Company by the CEO until 30 June 2022 and 30 June 2023 respectively. $23,295 was expensed for these options during FY21, with $11,647 expensed during the current period. $11,648 will be expensed in the second half of FY22 and $9,645 will be expensed in FY23.

 

Description		Being expensed:
		During FY21				This period first half of FY22				Remainder of FY22				FY23 and after
CEO ordinary shares (2020 package)			13,924				6,962				6,962				—
CEO unlisted options (2020 package)			13,801				6,901				6,900				—
CEO ordinary shares (2021 package)			39,998				19,999				19,999				16,017
CEO unlisted options (2021 package)			23,295				11,647				11,648				9,645
Share Based Payments expense							45,509

 

New Securities Issued During Period

 

No new securities were issued during the period.

 

Valuation assumptions

 

OPTIONS

 

The fair value of the equity-settled share options granted is estimated as at the grant date using a Black- Scholes option model (for all $0.05 options) taking into account the terms and conditions upon which the options were granted.

 

Expiry date		30-Jun-25				30-Jun-26				30-Jun-27
Number			750,000				750,000				750,000
Exercise price		$	0.05			$	0.05			$	0.05
Dividend yield			0	%			0	%			0	%
Expected volatility			100	%			100	%			92	%
Risk-free interest rate			2	%			2	%			0.58	%
Expected life of option			4				5				6
Grant date share price		$	0.049			$	0.049			$	0.048

 

The expected life of the options is based on historical data and is not necessarily indicative of exercise patterns that may occur. The expected volatility reflects the assumption that the historical volatility is indicative of future trends, which may also not necessarily be the actual outcome.

 

SHARES

 

Ordinary shares issued have been valued based on the market price of the shares on grant date.

 

NOTE 6: DIVIDENDS

 

No dividend for the period has been declared or paid (2020: nil).

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTE 7: ISSUED CAPITAL

 

(a) Issued capital

 

 

		31 December 2021 $				30 June 20211 (restated) $
Ordinary shares			61,948,498				45,852,107
Total ordinary shares			61,948,498				45,852,107

 

1.

Reclassified and remeasured amounts due to restatement from error in prior year – see note 11 for explanation

 

(b)  Ordinary shares — movements during years

 

		6 months ended 31 December 2021 No.				Year ended 30 June 2021 No.
At beginning of year			1,068,411,224				748,654,489
Issues of new shares – share based payments			—				2,952,619
Conversion of performance rights			—				30,303,593
Exercise of options			140,116,779				286,500,523
Total ordinary shares			1,208,528,003				1,068,411,224

 

NOTE 8: CONTINGENCIES

 

There has been no change in contingent liabilities since the last annual reporting date.

 

NOTE 9: FINANCIAL INSTRUMENTS

 

The Group has a number of financial instruments which are not measured at fair value in the statement of financial position.

 

The Directors consider that the carrying amounts of current receivables, current payables and current borrowings are considered to be a reasonable approximation of their fair values.

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTE 10: RELATED PARTY DISCLOSURES

 

Directors’ holdings in securities

 

31 December 2021		Options				Performance Shares and Rights				Ordinary Shares
Mr Troy Valentine			—				—				33,851,198
Mr Peter Widdows			—				—				16,573,685
Dr Sud Agarwal*			—				—				107,303,093
Mr Joel Latham			4,500,000				—				18,148,414

 

31 December 2020		Options				Performance Shares and Rights				Ordinary Shares
Mr Troy Valentine			7,116,950				1,500,000				23,734,248
Mr Peter Widdows			657,895				1,500,000				15,915,799
Dr Sud Agarwal *			200,000,000				14,037,265				54,266,328
Mr Joel Latham			4,700,000				5,000,000				17,948,414

 

*

Options and shares reported for Dr Sud Agarwal include those owned by Cannvalate Pty Ltd – an entity of which Dr Agarwal is a significant shareholder, the CEO and a director.

 

NOTE 11: RESTATEMENT OF FINANCIAL STATEMENTS

 

Restatement due to error in a prior period

 

It was identified in the current period that the accounting for share options issued to consultants and advisors as share-based payments during the year 30 June 2021 were recorded using the incorrect vesting dates. As such, this was an error in the financial report for the year ended 30 June 2021.

 

Details of the restated accounts appear below:

 

Statement of Financial Position		Reported at 30 June 2021				Effect of Error				Restated 30 June 2021
		$				$				$
ASSETS
Total assets			9,328,795				—				9,328,795
LIABILITIES
Total liabilities			755,049				—				755,049
NET ASSETS			8,573,746				—				8,573,746
EQUITY
Issued capital			45,938,576				(86,469	)			45,852,107
Reserves			3,316,963				3,295,678				6,612,641
Accumulated losses			(40,681,793	)			(3,209,209	)			(43,891,002	)
TOTAL EQUITY			8,573,746				—				8,573,746

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

NOTE 11: RESTATEMENT OF FINANCIAL STATEMENTS (continued)

 

Statement of Comprehensive Income		Reported for the 6 Months to 31 December 2020				Effect of Error				Restated 6 Months to 31 December 2020
		$				$				$
Share based payment expense			(380,371	)			(932,050	)			(1,312,421	)
Loss before tax			(2,889,389	)			(932,050	)			(3,821,439	)
Net loss for the period			(2,889,389	)			(932,050	)			(3,821,439	)
Total comprehensive loss for the period			(2,889,389	)			(932,050	)			(3,821,439	)
Earnings per share
Basic loss per share (cents per share)			(0.32	)			(0.10	)			(0.42	)
Diluted loss per share (cents per share)			(0.32	)			(0.10	)			(0.42	)

 

NOTE 12: SIGNIFICANT EVENTS AFTER BALANCE DATE

 

On 25 February 2022, the Company’s securities were listed for trading on the Nasdaq, in New York. No further significant events have occurred since the end of the half year.

 

 

Incannex Healthcare Limited

Interim Financial Report 31 December 2021

 

DIRECTORS’ DECLARATION

 

In the opinion of the directors of Incannex Healthcare Limited (‘the Company’):

 

1.

The attached financial statements and notes thereto are in accordance with the Corporations Act 2001 including:

 

a.

complying with Accounting Standards, the Corporations Regulations 2001 and other mandatory professional reporting requirements; and

 

b.

giving a true and fair view of the Group’s financial position as at 31 December 2021 and of its performance for the half-year then ended; and

 

2.

There are reasonable grounds to believe that the Company will be able to pay its debts as and when they become due and payable.

 

This declaration is signed in accordance with a resolution of the Board of Directors made pursuant to s.303(5) of the Corporations Act 2001.

 

/s/ Troy Valentine
Troy Valentine
Non-executive Chairman
Melbourne

 

 

28 February 2022

 

 

 

 

INDEPENDENT AUDITOR’S REVIEW REPORT

To the members of Incannex Healthcare Limited

 

Report on the Condensed Half-Year Financial Report

 

Conclusion

 

We have reviewed the accompanying half-year financial report of Incannex Healthcare Limited (“the company”) which comprises the condensed consolidated statement of financial position as at 31 December 2021, the condensed consolidated statement of comprehensive income, the condensed consolidated statement of changes in equity and the condensed consolidated statement of cash flows for the half-year ended on that date, notes comprising a summary of significant accounting policies and other explanatory information, and the directors’ declaration, for the group comprising the company and the entities it controlled at the half-year end or from time to time during the half- year.

 

Based on our review, which is not an audit, we have not become aware of any matter that makes us believe that the half-year financial report of Incannex Healthcare Limited does not comply with the Corporations Act 2001 including:

 

(a)	giving a true and fair view of the group’s financial position as at 31 December 2021 and of its performance for the half-year ended on that date; and

 

(b)	complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001.

 

Basis for conclusion

 

We conducted our review in accordance with ASRE 2410 Review of a Financial Report Performed by the Independent Auditor of the Entity. Our responsibilities are further described in the Auditor’s responsibilities for the review of the financial report section of our report. We are independent of the company in accordance with the auditor independence requirements of the Corporations Act 2001 and the ethical requirements of the Accounting Professional and Ethical Standards Board’s APES 110 Code of Ethics for Professional Accountants (including Independence Standards) (the Code) that are relevant to our audit of the annual financial report in Australia. We have also fulfilled our other ethical responsibilities in accordance with the Code.

 

Responsibility of the directors for the financial report

 

The directors of the company are responsible for the preparation of the half-year financial report that gives a true and fair view in accordance with Australian Accounting Standards and the Corporations Act 2001 and for such internal control as the directors determine is necessary to enable the preparation of the half-year financial report that gives a true and fair view and is free from material misstatement, whether due to fraud or error.

 

 

 

 

 

Auditor’s responsibility for the review of the financial report

 

Our responsibility is to express a conclusion on the half-year financial report based on our review. ASRE 2410 requires us to conclude whether we have become aware of any matter that makes us believe that the half-year financial report is not in accordance with the Corporations Act 2001 including giving a true and fair view of the group’s financial position as at 31 December 2021 and its performance for the half-year ended on that date, and complying with Accounting Standard AASB 134 Interim Financial Reporting and the Corporations Regulations 2001.

 

A review of a half-year financial report consists of making enquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review is substantially less in scope than an audit conducted in accordance with Australian Auditing Standards and consequently does not enable us to obtain assurance that we would become aware of all significant matters that might be identified in an audit. Accordingly, we do not express an audit opinion.

 

Independence

 

In conducting our review, we have complied with the independence requirements of the Corporations Act 2001.

 

/s/ HLB Mann Judd		/s/ L Di Giallonardo
HLB Mann Judd		L Di Giallonardo
Chartered Accountants		Partner
Perth, Western Australia 28 February 2022

 

 

20

 

 

Exhibit 99.2

 

Date: March 10, 2022 Public Announcement (NASDAQ: IXHL) (ASX: IHL)

 

Incannex observes substantial reduction in AHI in preliminary results of clinical trial assessing
IHL-42X in patients with OSA; proceeds to pivotal studies

 

Highlights:

 

●

20% of trial participants experienced a reduction in AHI of greater than 80%

 

●

60% of trial participants experienced a reduction in AHI of greater than 50%

 

●

Average of low, mid and high-dose IHL-42X reduced AHI in trial participants by 44.4%

 

●

IHL-42X was observed to be well tolerated in the clinical trial

 

●

IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life

 

●

The Company has been granted a pre-IND meeting with FDA on May 11, 2022 (U.S. EST)

 

●

Planning commences for pivotal clinical trials to commence after opening an IND with FDA.

 

Melbourne, Australia, March 10, 2022 – Incannex Healthcare Limited (Nasdaq: IXHL) (ASX: IHL), (‘Incannex’ or the ‘Company’) a clinical-stage pharmaceutical company developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for unmet medical needs, today announced the completion of a preliminary analysis of data from its phase 2, proof-of-concept clinical trial investigating novel cannabinoid combination product, IHL-42X, for the treatment of obstructive sleep apnoea (‘OSA’).

 

The clinical trial assessed three doses of IHL-42X at reducing the apnoea hypopnoea index (‘AHI’), the main diagnostic and monitoring criteria for OSA, compared to placebo in patients who suffered from the disease. Trial participants received each of the three doses of IHL-42X and placebo across four seven-day treatment periods, separated by one week washout periods. At the end of each treatment period, they attended the clinic for an overnight sleep study where AHI was determined, along with other measures of sleep quality, quality of life and drug safety. The study was conducted at the University of Western Australia Centre for Sleep Science and The Alfred Hospital.

 

A total of eleven participants were recruited to the study and ten participants completed treatment periods. The crossover design of the study permitted Incannex to generate high quality data with a reduced participant number compared to a conventional parallel arm study. Each participant serves as their own internal control and inter-participant variation is eliminated. The study included ten placebo treatment periods and twenty-six IHL-42X treatment periods totalling thirty-six AHI data points that were compared to baseline.

 

Incannex has undertaken preliminary analysis of the study data comparing the AHI during treatment with IHL-42X across all three dose levels or placebo to baseline. At baseline, the average AHI was 42.84. For all IHL-42X treatment periods (using low, mid, and high doses), the average AHI was 23.81, a 44.4 % reduction (p-value 0.0067) compared to baseline AHI. During placebo treatment periods, the average AHI was 40.08, a 6.4 % reduction (p-value 0.75) compared to baseline. 60% of participants experienced a reduction in AHI of greater than 50% and a resulting AHI of less than 20 during at least one treatment period of one dose strength of IHL-42X. 20% of participants experienced a reduction in AHI of greater than 80% relative to baseline during at least one treatment period of one dose strength of IHL-42X.

 

 

Date: March 10, 2022 Public Announcement (NASDAQ: IXHL) (ASX: IHL)

 

Specific data from the study, including which IHL-42X doses were received by which patient and when, remain blinded. Patient response to specific IHL-42X doses (low, mid, and high) and the secondary endpoints continue to be analysed by contract research organisation, Novotech, and will only be released to Incannex upon the completion of the analysis as per usual clinical trial processes. This will include a comparison between IHL-42X doses for each patient, which increases the power of the analysis, and provides a more robust differentiation of dose strengths. The full clinical study report is anticipated in Q2 2022.

 

Preliminary analysis also revealed that IHL-42X was observed to be well tolerated in the clinical trial. All treatment associated adverse events were consistent with what has been reported for constituent components of IHL-42X in historic studies.

 

Chief Scientific Officer of Incannex Healthcare, Dr. Mark Bleackley, said; “We are delighted that IHL-42X has demonstrated efficacy and good safety characteristics in our preliminary assessment of data from the proof-of-concept trial. The average reduction in AHI calculated across low, mid, and high-dose IHL-42X has met our expectations for what would constitute a valuable product for the treatment of obstructive sleep apnoea. IHL-42X has the potential to reduce disease severity, resulting in improved sleep quality, multiple major health benefits and increased quality of life. We look forward to the further analysis of the study data by Novotech, which will include identification of which dose strength performed best.”

 

As announced on December 20, 2021, Incannex is preparing for a pre-IND meeting with the U.S. Food and Drug Administration (‘FDA’) on the future development plan for IHL-42X. The Company and its medical and scientific advisors have been granted a meeting via teleconference on May 11, 2022 (U.S. EST). This meeting will provide guidance on what data is required to open an Investigational New Drug (IND) application with FDA for IHL-42X for treatment of OSA and the design of a larger pivotal phase 2 clinical trial with trial sites in the United States.

 

About Obstructive Sleep Apnoea

 

OSA is the most common sleep-related breathing disorder, and it causes people to repeatedly stop and start breathing for elongated intervals during sleep. It is a major public health problem and IHL-42X represents a significant commercial opportunity for Incannex as there are no approved pharmacotherapy treatments available to patients at the present time.

 

OSA is a serious medical condition that increases the risk of numerous health complications¹. Drops in blood oxygen levels that occur during OSA increase blood pressure and strain the cardiovascular system. Many people with OSA develop high blood pressure (hypertension), which can increase the risk of heart disease. The more severe the OSA, the greater the risk of coronary artery disease, heart attacks, heart failure and strokes.

 

People with OSA often have severe daytime drowsiness, fatigue, and irritability due to lack of restorative sleep at night, which are observed causes of workplace accidents. Those diagnosed with OSA are also at higher risk of memory problems, headaches, mood swings and depression.

 

The current standard of care is a continuous positive airway pressure (‘CPAP’) machine, however, patient compliance to CPAP is low due to discomfort and claustrophobia resulting from pressurized air being pumped into the mouth during sleep. Incannex anticipates greatly improved treatment compliance and outcomes from a pharmaceutical product, which could be IHL-42X subject to further clinical assessment and approval from regulators. Regardless of the discomfort caused by CPAP, the global annual market for OSA detection and treatment using CPAP and other breathing aids is approximately US$10 billion per annum and growing².

 

OSA is highly prevalent, affecting approximately 30 million adults in the United States alone. It is estimated that the annual economic burden of undiagnosed sleep apnoea among U.S. adults is approximately US$149.6 billion per annum. These costs include US$86.9 billion in lost productivity, US$26.2 billion in motor vehicle accidents and US$6.5 billion in workplace accidents³.

 

1

https://www.mayoclinic.org/diseases-conditions/obstructive-sleep-apnea/symptoms-causes/syc-20352090

2

https://www.fortunebusinessinsights.com/industry-reports/sleep-apnea-devices-market-100708

3

https://aasm.org/resources/pdf/sleep-apnea-economic-crisis.pdf

 

END

 

 

Date: March 10, 2022 Public Announcement (NASDAQ: IXHL) (ASX: IHL)

 

About Incannex Healthcare Limited

 

Incannex is a clinical stage pharmaceutical development company that is developing unique medicinal cannabis pharmaceutical products and psychedelic medicine therapies for the treatment of anxiety disorders, obstructive sleep apnoea (OSA), traumatic brain injury (TBI)/concussion, lung inflammation (ARDS, COPD, asthma, bronchitis), rheumatoid arthritis and inflammatory bowel disease. U.S. FDA approval and registration, subject to ongoing clinical success, is being pursued for each drug and therapy under development. Each indication represents major global markets and currently have no, or limited, existing registered pharmacotherapy (drug) treatments available to the public. IHL has a strong patent filing strategy in place as it develops its products and therapies in conjunction with its medical and scientific advisory board and partners.

Website: www.incannex.com.au

Investors: investors@incannex.com.au

 

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. These forward-looking statements are made as of the date they were first issued and were based on current expectations and estimates, as well as the beliefs and assumptions of management. The forward-looking statements included in this press release represent Incannex’s views as of the date of this press release. Incannex anticipates that subsequent events and developments may cause its views to change. Incannex undertakes no intention or obligation to update or revise any forward-looking statements, whether as of a result of new information, future events or otherwise. These forward-looking statements should not be relied upon as representing Incannex’s views as of any date after the date of this press release.

 

Contact Information

 

Incannex Healthcare Limited

Mr Joel Latham

Managing Director and Chief Executive Officer

+61 409 840 786

joel@incannex.com.au

 

US IR Contact

Rx Communications Group

Michael Miller

+1-917-633-6086

mmiller@rxir.com

 

 

Exhibit 99.3

 

+Rule 2.8, 3.10.3A to 3.10.3D

 

Appendix 2A

 

Application for quotation of +securities

 

Part 1 – Entity and announcement details

 

Question no		Question		Answer
1.1		We (the entity here named) apply for +quotation of the following +securities and agree to the matters set out in Appendix 2A of the ASX Listing Rules.1		Incannex Healthcare Limited
1.2		Registration type and number		ABN 93 096 635 246
1.3		ASX issuer code		IHL
1.4		This announcement is		A new announcement
1.5		*Date of this announcement		16 March 2022

 

Part 2 – Type of issue

 

Question No.		Question		Answer
2.1		The +securities to be quoted are:		Securities issued as a result of options being exercised
2.1a		*Have the +securities to be quoted been issued yet?		Yes
2.1a.1		*What was their date of issue?		14 March 2022
2.2c.1		Please state the number and type of options that were exercised or other +convertible securities that were converted (including their ASX security code)		● 500,000 unquoted options - $0.15 strike price - expiring 20 Nov 2023
				●  1,350,000 unquoted options - $0.20 strike price – expiring 20 Nov 2023
2.2c.2		And the date the options were exercised or other +convertible securities were converted		14 March 2022
2.2c.3		Is this all of the options or other +convertible securities on issue of that type (ie have all of those options now been exercised or have all of those convertible securities now been converted)?		No
2.2c.4		The right of the holder of the options or other +convertible securities to receive the +underlying securities is being satisfied by:		An issue of new +securities
2.2c.5		The underlying securities being received by the holder are:		Intended to be, but are not yet, quoted by ASX
2.2c.6		Were the options being exercised or other +convertible securities being converted issued under an +employee incentive scheme?		No
2.2c.7		Are any of the options being exercised or other +convertible securities being converted held by +key management personnel (KMP) or an +associate?		No
2.2c.7.a		Provide details of the KMP or +associates who are exercising options or converting convertible securities.		Not applicable
2.4		The +securities to be quoted are:		Additional +securities in a class that is already quoted on ASX (“existing class”)

 

1

Appendix 2A of the Listing Rules includes a warranty that an offer of the securities for sale within 12 months after their issue will not require disclosure under section 707(3) or 1012C(6) of the Corporations Act. If you are in any doubt as to the application of, or the entity’s capacity to give, this warranty, please see ASIC Regulatory Guide 173 Disclosure for on-sale of securities and other financial products and consult your legal adviser.

 

+ See chapter 19 for defined terms
5 June 2021	Page 1

 

 

Appendix 2A

Application for quotation of +securities

 

Part 3B

– number and type of +securities to be quoted (existing class) where issue has not previously been notified to ASX in an Appendix 3B

 

Question No.		Question		Answer
3B.1		ASX security code & description		IHL ordinary shares (“IHL”)
3B.2		Number of +securities to be quoted		1,850,000
3B.3a		Will the +securities to be quoted rank equally in all respects from their issue date with the existing issued +securities in that class?		Yes

 

Part 4 – Issued capital following quotation

 

Following the quotation of the +securities the subject of this application, the issued capital of the entity will comprise:

 

4.1

*Quoted +securities (total number of each +class of +securities quoted on ASX following the +quotation of the +securities the subject of this application)

 

ASX security code and description		Total number of +securities on issue
“IHL” – Ordinary fully paid shares		1,210,378,003

 

4.2

*Unquoted +securities (total number of each +class of +securities issued but not quoted on ASX):

 

ASX security code and description		Total number of +securities on issue
A. Options – Strike $0.05 - Expiry 30-Jun-2025 B. Options – Strike $0.05 - Expiry 30-Jun-2026 C. Options – Strike $0.05 - Expiry 30-Jun-2027 D. Options – Strike $0.15 – Expiry 20/11/2023 E.  Options – Strike $0.20 – Expiry 20/11/2023 F.  Options – Strike $0.25 – Expiry 20/11/2023		A. 1,500,000 B. 1,500,000 C. 1,500,000 D. 9,500,000 E. 8,650,000 F. 20,000,000

 

 

Introduced 01/12/19; amended 31/01/20; 05/06/21

 

 

See chapter 19 for defined terms
5 June 2021	Page 2