MELBOURNE, Australia and NEW YORK, May 07, 2024 (GLOBE NEWSWIRE) -- Incannex Healthcare Inc. (NASDAQ:IXHL), (Incannex or the Company), a leading cannabinoid and psychedelic medicine biotechnology company, is pleased to announce the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development of CannQuit-O for treatment of Opioid Use Disorder (OUD). The pre-IND teleconference included representatives from various divisions of ...

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=6&type=section&id=Item%201.%20Financial%20Statements) This section presents the company's unaudited consolidated financial statements and accompanying explanatory notes [Consolidated Balance Sheets](index=6&type=section&id=Consolidated%20Balance%20Sheets) Financial Position (in thousands USD) | Metric | Dec 31, 2023 | Jun 30, 2023 | | :-------------------------------- | :----------- | :----------- | | Cash and cash equivalents | $14,554 | $22,120 | | Total current assets | $21,332 | $22,997 | | Total assets | $22,359 | $23,783 | | Total current liabilities | $3,186 | $2,550 | | Total liabilities | $3,487 | $2,958 | | Total stockholders' equity | $18,872 | $20,825 | - Cash and cash equivalents decreased by **$7.57 million**, and total stockholders' equity decreased by **$1.95 million** from June 30, 2023, to December 31, 2023, while total liabilities increased by **$0.53 million**[16](index=16&type=chunk) [Consolidated Statements of Operations and Comprehensive Loss](index=7&type=section&id=Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) Operating Results (in thousands USD) | Metric | 3 Months Ended Dec 31, 2023 | 3 Months Ended Dec 31, 2022 | 6 Months Ended Dec 31, 2023 | 6 Months Ended Dec 31, 2022 | | :----------------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | :-------------------------- | | Research and development | $2,638 | $1,549 | $5,247 | $2,959 | | General and administrative | $5,345 | $2,090 | $7,629 | $3,521 | | Total operating expenses | $7,983 | $3,639 | $12,876 | $41,827 | | Loss from operations | $(7,983) | $(3,639) | $(12,876) | $(41,827) | | R&D tax incentive | $2,727 | $666 | $6,824 | $680 | | Net loss | $(5,241) | $(2,918) | $(5,968) | $(41,066) | | Net loss per share (Basic and diluted) | $(0.33) | $0.05 | $(0.38) | $(2.76) | - For the three months ended December 31, 2023, total operating expenses increased by **119.3% YoY**, driven by higher R&D and G&A expenses, and net loss increased by **79.6% YoY**[19](index=19&type=chunk) - For the six months ended December 31, 2023, total operating expenses decreased by **69.2% YoY**, and net loss significantly decreased by **85.5% YoY**, primarily due to the absence of a prior-year acquisition expense[19](index=19&type=chunk) - The R&D tax incentive saw substantial increases of **309%** for the three-month period and **903.5%** for the six-month period, significantly offsetting losses[19](index=19&type=chunk) [Consolidated Statements of Stockholders' Equity (Deficit)](index=8&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Equity%20(Deficit)) Stockholders' Equity (in thousands USD) | Metric | Dec 31, 2023 | Sep 30, 2023 | Jun 30, 2023 | Dec 31, 2022 | Jun 30, 2022 | | :-------------------------- | :----------- | :----------- | :----------- | :----------- | :----------- | | Common stock (Amount) | $2 | $2 | $2 | $2 | $1 | | Additional paid-in capital | $119,887 | $116,491 | $116,290 | $115,169 | $69,074 | | Accumulated deficit | $(98,179) | $(92,938) | $(92,212) | $(84,467) | $(43,401) | | Foreign currency translation reserve | $(2,838) | $(3,765) | $(3,255) | $(2,790) | $(963) | | Total stockholders' equity | $18,872 | $19,790 | $20,825 | $27,914 | $24,711 | - Total stockholders' equity decreased from **$20.83 million** at June 30, 2023, to **$18.87 million** at December 31, 2023, primarily due to net losses[22](index=22&type=chunk)[25](index=25&type=chunk) - Additional paid-in capital increased by **$3.6 million** from June 30, 2023, to December 31, 2023, mainly due to share-based compensation[22](index=22&type=chunk)[25](index=25&type=chunk) - The accumulated deficit increased by **$5.97 million** from June 30, 2023, to December 31, 2023, reflecting the net loss for the period[22](index=22&type=chunk)[25](index=25&type=chunk) [Consolidated Statements of Cash Flows](index=10&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows) Cash Flow Summary (in thousands USD) | Metric | 6 Months Ended Dec 31, 2023 | 6 Months Ended Dec 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(7,852) | $(5,437) | | Net cash used in investing activities | $(280) | $(113) | | Net cash provided by financing activities | $0 | $8,280 | | Net (decrease)/increase in cash | $(8,132) | $2,730 | | Cash and cash equivalents at end of period | $14,555 | $28,065 | - Net cash used in operating activities increased by **$2.42 million (44.5%)** for the six months ended December 31, 2023, compared to the prior year period[28](index=28&type=chunk) - Net cash provided by financing activities decreased to **$0** in 2023 from **$8.28 million** in 2022, indicating no new equity issuances for funding[28](index=28&type=chunk) - Overall, cash and cash equivalents decreased by **$8.13 million**, resulting in an ending balance of **$14.56 million** as of December 31, 2023[28](index=28&type=chunk) [Notes to Unaudited Consolidated Financial Statements](index=11&type=section&id=Notes%20to%20Unaudited%20Consolidated%20Financial%20Statements) [Note 1 – Re-domiciliation and Business](index=11&type=section&id=Note%201%20%E2%80%93%20Re-domiciliation%20and%20Business) - Incannex Healthcare Inc (Delaware) acquired Incannex Healthcare Limited (Australia) in November 2023, making the Australian entity a wholly-owned subsidiary[31](index=31&type=chunk) - The share exchange ratio was **1 share of Incannex Healthcare Inc common stock for every 100 ordinary shares** of the Australian entity[33](index=33&type=chunk) - Issued and outstanding common stock shares in the financial statements are retrospectively adjusted to reflect the **100:1 exchange ratio** as if it occurred on July 1, 2022[34](index=34&type=chunk) [Note 2 – Basis of Presentation and Summary of Significant Accounting Policies](index=11&type=section&id=Note%202%20%E2%80%93%20Basis%20of%20Presentation%20and%20Summary%20of%20Significant%20Accounting%20Policies) - Following re-domiciliation, the company transitioned from IFRS to **US GAAP**, applying US GAAP retrospectively for all prior periods presented[37](index=37&type=chunk) - The company's consolidated financial statements include Incannex Healthcare Inc and its wholly-owned subsidiaries, with all intercompany balances and transactions eliminated[40](index=40&type=chunk) - Significant estimates include valuation of equity-based instruments, accrued R&D expense, and R&D tax credit[42](index=42&type=chunk) - The company faces risks common to the biopharmaceutical industry, including financing, regulatory approval, and competition[43](index=43&type=chunk) - Research and development costs are expensed as incurred, including salaries, supplies, clinical trials, and manufacturing costs[57](index=57&type=chunk) USD:AUD Exchange Rate | Date | Exchange Rate | | :--- | :------------ | | Dec 31, 2023 (Balance Sheet) | 0.6840 | | Jun 30, 2023 (Balance Sheet) | 0.6630 | | Dec 31, 2023 (Average for period) | 0.6526 | | Jun 30, 2023 (Average for period) | 0.6764 | [Note 3 – Prepaid expenses and other current assets](index=18&type=section&id=Note%203%20%E2%80%93%20Prepaid%20expenses%20and%20other%20current%20assets) Prepaid Expenses and Other Current Assets (in thousands USD) | Item | Dec 31, 2023 | Jun 30, 2023 | | :------------------------ | :----------- | :----------- | | Prepayments | $1,188 | $686 | | R&D tax credit recoverable | $5,337 | $0 | | GST recoverable | $253 | $191 | | **Total** | **$6,778** | **$877** | - The R&D tax credit recoverable increased from **$0 to $5.34 million**, contributing to a substantial increase in total other assets[78](index=78&type=chunk) [Note 4 – Property, Plant and Equipment, net](index=18&type=section&id=Note%204%20%E2%80%93%20Property,%20Plant%20and%20Equipment,%20net) Property, Plant and Equipment, net (in thousands USD) | Item | Dec 31, 2023 | Jun 30, 2023 | | :-------------------------------- | :----------- | :----------- | | Furniture, fittings and equipment | $195 | $157 | | Assets under construction | $412 | $160 | | Total property, plant and equipment, gross | $607 | $317 | | Accumulated depreciation and amortization | $(48) | $(23) | | **Total property, plant and equipment, net** | **$559** | **$294** | - Net property, plant, and equipment increased by **$0.265 million (90.1%)** from June 30, 2023, to December 31, 2023, primarily due to an increase in assets under construction[80](index=80&type=chunk) [Note 5 – Trade and other payables, accrued expenses and other current liabilities](index=18&type=section&id=Note%205%20%E2%80%93%20Trade%20and%20other%20payables,%20accrued%20expenses%20and%20other%20current%20liabilities) Current Liabilities (in thousands USD) | Item | Dec 31, 2023 | Jun 30, 2023 | | :------------------------------------------------- | :----------- | :----------- | | Trade payables | $1,952 | $1,748 | | Accrued expenses | $734 | $426 | | Employee leave entitlements | $331 | $263 | | **Total Trade and other payables, accrued expenses and other current liabilities** | **$3,017** | **$2,437** | - Total current liabilities increased by **$0.58 million (23.8%)** from June 30, 2023, to December 31, 2023, mainly due to increases in trade payables and accrued expenses[81](index=81&type=chunk) [Note 6 – Leases](index=19&type=section&id=Note%206%20%E2%80%93%20Leases) - In fiscal 2023, the Group entered into three new lease agreements for its corporate head office, Melbourne office, and Clarion Clinic site[82](index=82&type=chunk) Lease Metrics (as of Dec 31, 2023) | Metric | Value | | :-------------------- | :---- | | Weighted-average remaining lease term | 1.48 years | | Discount rate | 9.18% | | Operating lease cost (6 months ended Dec 31, 2023) | $79 thousand | | Cash paid for operating lease liabilities (6 months ended Dec 31, 2023) | $73 thousand | Future Minimum Lease Payments (in thousands USD) | Period | Amount | | :----------- | :----- | | June 30, 2024 | $103 | | June 30, 2025 | $214 | | June 30, 2026 | $208 | | June 30, 2027 | $50 | | June 30, 2028 | $34 | | **Total minimum lease payments** | **$609** | | Less amount representing interest | $(139) | | **Total operating lease liabilities** | **$470** | [Note 7 – Commitments and contingencies](index=20&type=section&id=Note%207%20%E2%80%93%20Commitments%20and%20contingencies) - The company records loss contingencies when probable and estimable, and discloses material contingencies when reasonably possible[85](index=85&type=chunk) - Management does not believe there are any current legal or tax actions that would have a material impact on the company's financial position[85](index=85&type=chunk) [Note 8 – Stockholder's equity/Issued capital](index=20&type=section&id=Note%208%20%E2%80%93%20Stockholder's%20equity/Issued%20capital) - Post-re-domiciliation, the company has **100,000,000 authorized shares** of common stock with a par value of **$0.0001 per share**[86](index=86&type=chunk) - As of December 31, 2023, there were **15,873,113 shares** of common stock outstanding[88](index=88&type=chunk) - In the prior period, the company raised **$8.83 million** from a share placement and issued shares for the acquisition of APIRx Pharmaceuticals[88](index=88&type=chunk)[89](index=89&type=chunk) [Note 9 – Additional paid-in capital](index=21&type=section&id=Note%209%20%E2%80%93%20Additional%20paid-in%20capital) Additional Paid-in Capital (in thousands USD) | Item | Dec 31, 2023 | Dec 31, 2022 | | :------------------------------------ | :----------- | :----------- | | Opening balance | $116,294 | $69,075 | | Equity instruments issued to management and directors | $3,598 | $2,150 | | Share placements | - | $8,830 | | Asset acquisition shares issued | - | $34,171 | | **At December 31** | **$119,892** | **$116,298** | - Additional paid-in capital increased by **$3.6 million** from December 31, 2022, to December 31, 2023, primarily due to equity instruments issued to management and directors[90](index=90&type=chunk) - Prior period activities included **$8.83 million** from share placements and **$34.17 million** from asset acquisition shares issued[90](index=90&type=chunk)[91](index=91&type=chunk) [Note 10 – General and Administration expenses](index=22&type=section&id=Note%2010%20%E2%80%93%20General%20and%20Administration%20expenses) General and Administration Expenses (in thousands USD) | Item | Dec 31, 2023 | Dec 31, 2022 | Change ($) | Change (%) | | :------------------------------ | :----------- | :----------- | :--------- | :--------- | | Salaries, and other employee benefits | $4,825 | $2,142 | $2,683 | 125.2% | | Compliance, legal and regulatory | $1,573 | $695 | $878 | 126.3% | | Advertising and investor relations | $705 | $427 | $278 | 65.1% | | Occupancy expenses | $153 | $35 | $118 | 337.1% | | Other administration expenses | $349 | $188 | $161 | 85.6% | | **Total general and administration expenses** | **$7,629** | **$3,521** | **$4,108** | **116.7%** | - Total G&A expenses more than doubled, increasing by **$4.11 million (116.7%)** for the six months ended December 31, 2023, primarily due to higher salaries and legal costs[93](index=93&type=chunk) [Note 11 – Share-based payments](index=22&type=section&id=Note%2011%20%E2%80%93%20Share-based%20payments) Share-based Compensation Expense (in thousands USD) | Item | Dec 31, 2023 | Dec 31, 2022 | | :-------------------------------- | :----------- | :----------- | | General and administrative | $3,471 | $1,100 | | **Total share-based compensation expense** | **$3,471** | **$1,100** | - Share-based compensation expense increased by **$2.37 million (215.5%)** for the six months ended December 31, 2023[94](index=94&type=chunk) - As of December 31, 2023, there were **1,739,215 unvested restricted shares** outstanding with a fair value of **$1,006k**[95](index=95&type=chunk) - As of December 31, 2023, there were **284,008 stock options outstanding** with a weighted average exercise price of **$36.37**[97](index=97&type=chunk) - Unrecognized compensation cost related to unvested share options was **$411 thousand**, expected to be recognized over **1.08 years**[98](index=98&type=chunk) [Note 12 – Income Tax](index=24&type=section&id=Note%2012%20%E2%80%93%20Income%20Tax) - The company reported an accounting loss before tax of **$(5,805) thousand** for the six months ended December 31, 2023[100](index=100&type=chunk) - Due to a history of operating losses, the company has a valuation allowance against its deferred tax assets, with **$6,485 thousand** in net unrecognized tax benefit[100](index=100&type=chunk) [Note 13 – Loss per share](index=24&type=section&id=Note%2013%20%E2%80%93%20Loss%20per%20share) Net Loss Per Share (Basic and Diluted) | Metric | Dec 31, 2023 | Dec 31, 2022 | | :------------------------------------------------- | :----------- | :----------- | | Basic loss per share (cents) | 37.60 | 275.58 | | Basic loss per share (USD) | $0.38 | $2.76 | | Total comprehensive loss for the year (in thousands) | $5,968 | $41,066 | | Weighted average number of common stocks | 15,873,113 | 14,901,631 | - Basic and diluted loss per share are the same because potential common stocks are anti-dilutive due to net losses[101](index=101&type=chunk) [Note 14 – Related Party Transactions](index=24&type=section&id=Note%2014%20%E2%80%93%20Related%20Party%20Transactions) - Related party transactions are conducted on commercial terms[102](index=102&type=chunk) - No amounts were payable to related parties as of December 31, 2023, and June 30, 2023[103](index=103&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=25&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial performance, liquidity, capital resources, and operational results [Overview](index=25&type=section&id=Overview) - The company is an early-stage development enterprise with drug candidates, incurring net losses since inception[107](index=107&type=chunk) - Operations are primarily funded by equity securities sales, option exercises, R&D tax grants, and interest income[107](index=107&type=chunk) - The company anticipates being entitled to a **43.5% refundable tax offset** for eligible R&D activities from the Australian government[108](index=108&type=chunk) [Results of Operations](index=25&type=section&id=Results%20of%20Operations) [Research and development](index=27&type=section&id=Research%20and%20development) - R&D expenses increased by **$1.1 million (71%)** for the three months ended December 31, 2023, due to clinical research and product development[111](index=111&type=chunk) - R&D expenses increased by **$2.3 million (77%)** for the six months ended December 31, 2023, driven by new clinical trials[112](index=112&type=chunk) [Acquisition of in-process research and development](index=27&type=section&id=Acquisition%20of%20in-process%20research%20and%20development) - No acquisition of in-process R&D expense was recorded for the three or six months ended December 31, 2023[109](index=109&type=chunk) - A **$35.3 million expense** was recorded in the six months ended December 31, 2022, related to the APIRx Pharmaceutical USA, LLC acquisition[109](index=109&type=chunk)[113](index=113&type=chunk) [General and Administrative](index=27&type=section&id=General%20and%20Administrative) - G&A expenses increased by **$3.3 million (156%)** for the three months ended December 31, 2023, mainly due to a **$3.1 million** increase in salaries and employee benefits[114](index=114&type=chunk) - G&A expenses increased by **$4.1 million (117%)** for the six months ended December 31, 2023, driven by a **$2.7 million** increase in salaries and a **$0.9 million** increase in legal costs[115](index=115&type=chunk) [Benefit from R&D tax credit](index=27&type=section&id=Benefit%20from%20R&D%20tax%20credit) - The R&D tax credit increased by **$2.1 million (308%)** for the three months ended December 31, 2023[116](index=116&type=chunk) - The R&D tax credit increased by **$6.1 million (904%)** for the six months ended December 31, 2023[117](index=117&type=chunk) - The increase is attributed to higher tax credits received from the Australian Taxation Office due to increased research and clinical trials activities[116](index=116&type=chunk)[117](index=117&type=chunk) [Foreign exchange losses and Interest Income](index=27&type=section&id=Foreign%20exchange%20losses%20and%20Interest%20Income) - Foreign exchange losses and interest income decreased by **$40 thousand** for the three months ended December 31, 2023, due to lower interest income and increased currency exchange losses[118](index=118&type=chunk) - Foreign exchange losses and interest income increased by **$3 thousand** for the six months ended December 31, 2023, due to higher interest income partially offset by foreign exchange losses[119](index=119&type=chunk) [Currency translation adjustment, net of tax](index=28&type=section&id=Currency%20translation%20adjustment,%20net%20of%20tax) - The currency translation adjustment, net of tax, decreased by **$2.8 million** for the three months ended December 31, 2023[120](index=120&type=chunk) - The currency translation adjustment, net of tax, decreased by **$2.2 million** for the six months ended December 31, 2023[121](index=121&type=chunk) - The decrease is attributed to currency translation from the Australian dollar (functional currency) to the US dollar (reporting currency)[120](index=120&type=chunk)[121](index=121&type=chunk) [Liquidity and Capital Resources](index=28&type=section&id=Liquidity%20and%20Capital%20Resources) - Operations are mainly financed through equity securities issuance and interest earned from cash on term deposit[122](index=122&type=chunk) - As of December 31, 2023, cash was **$14.5 million**, anticipated to be sufficient until at least December 2024[123](index=123&type=chunk) - Substantial additional funds will be required for long-term goals, as significant revenue is not expected until regulatory approval[125](index=125&type=chunk) - The company's capital risk management objective is to balance current working capital against R&D programs and corporate overheads[124](index=124&type=chunk) [Cash Flows](index=29&type=section&id=Cash%20Flows) Cash Flow Summary (in thousands USD) | Metric | 6 Months Ended Dec 31, 2023 | 6 Months Ended Dec 31, 2022 | | :-------------------------------- | :-------------------------- | :-------------------------- | | Net cash used in operating activities | $(7,852) | $(5,437) | | Net cash used in investing activities | $(280) | $(113) | | Net cash provided by financing activities | $0 | $8,280 | | **Net increase in cash** | **$(8,132)** | **$2,730** | [Cash flows from operating activities](index=29&type=section&id=Cash%20flows%20from%20operating%20activities) - Cash used in operating activities increased by **$2.4 million** for the six months ended December 31, 2023[129](index=129&type=chunk) - This increase was primarily due to a **$5.66 million** increase in prepaid expenses and other current assets, partially offset by positive changes in payables and share-based compensation[129](index=129&type=chunk) [Cash flows from investing activities](index=29&type=section&id=Cash%20flows%20from%20investing%20activities) - Cash used in investing activities increased by **$167 thousand** for the six months ended December 31, 2023[130](index=130&type=chunk) - This increase was due to increased purchases of equipment to conduct clinical trials[130](index=130&type=chunk) [Cash flows from financing activities](index=29&type=section&id=Cash%20flows%20from%20financing%20activities) - Cash provided by financing activities decreased to **$0** for the six months ended December 31, 2023, from **$8.28 million** in the prior year[131](index=131&type=chunk) - This decrease was due to a decrease in the proceeds from issuances of common stock[131](index=131&type=chunk) [Critical Accounting Policies and Estimates](index=29&type=section&id=Critical%20Accounting%20Policies%20and%20Estimates) [Stock Based Compensation](index=29&type=section&id=Stock%20Based%20Compensation) - Compensation expense for stock options is recorded based on the fair market value of the awards on the date of grant and amortized over the vesting period[133](index=133&type=chunk) - The company uses a binomial option pricing model to estimate the fair value of share options and other equity-based compensation[133](index=133&type=chunk) [Income Taxes](index=30&type=section&id=Income%20Taxes) - Income taxes are accounted for using the liability method, recognizing deferred tax assets and liabilities for temporary differences[134](index=134&type=chunk) - A valuation allowance is established for deferred tax assets if realization is not "more likely than not"[134](index=134&type=chunk) [Emerging Growth Company Status](index=30&type=section&id=Emerging%20Growth%20Company%20Status) - The company is an "emerging growth company" as defined in the JOBS Act[136](index=136&type=chunk) - The company elected to use the extended transition period for new or revised accounting standards[137](index=137&type=chunk) [Fully Diluted Share Capital](index=30&type=section&id=Fully%20Diluted%20Share%20Capital) Fully Diluted Share Capital (as of Dec 31, 2023) | Item | Number of Shares of Common Stock Equivalents | | :--------------------- | :------------------------------------------- | | Shares of Common Stock | 15,873,113 | | Restricted Stock | 2,316,715 | | Warrants | 1,978,346 | | **Total** | **20,168,174** | [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=31&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a "smaller reporting company," the company is permitted to omit the information typically required for this item - The company is exempt from providing detailed market risk disclosures due to its "smaller reporting company" status[139](index=139&type=chunk) [Item 4. Controls and Procedures](index=31&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded that disclosure controls and procedures were effective as of December 31, 2023 [Evaluation of Disclosure Controls and Procedures](index=31&type=section&id=Evaluation%20of%20Disclosure%20Controls%20and%20Procedures) - Management, with CEO and CFO participation, concluded that disclosure controls and procedures were effective as of December 31, 2023[140](index=140&type=chunk) [Changes in Internal Control over Financial Reporting](index=31&type=section&id=Changes%20in%20Internal%20Control%20over%20Financial%20Reporting) - No changes in internal control over financial reporting occurred during the quarter that materially affected or are reasonably likely to materially affect internal controls[141](index=141&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=32&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently involved in any material legal or arbitration proceedings - The company is not involved in any legal or arbitration proceedings that could materially affect its financial position or profitability[144](index=144&type=chunk) [Item 1A. Risk Factors](index=32&type=section&id=Item%201A.%20Risk%20Factors) This section outlines key risks and uncertainties by referencing other detailed company filings - Key risks and uncertainties are discussed in Item 3D "Risk Factors" of the 2023 Annual Report on Form 20-F and in Part II, Item 1A of this Quarterly Report[145](index=145&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=32&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) This section details unregistered equity sales related to the re-domiciliation, which were exempt from registration - The re-domiciliation involved an exchange of securities, with ratios of **1:100 for ordinary shares**, **1:100 for options**, and **1:4 for ADSs**[148](index=148&type=chunk) - These issuances were exempt from registration under Section 3(a)(10) of the Securities Act of 1933[147](index=147&type=chunk) - No proceeds were used from these unregistered sales of equity securities[147](index=147&type=chunk) [Item 3. Defaults upon Senior Securities](index=33&type=section&id=Item%203.%20Defaults%20upon%20Senior%20Securities) This item is not applicable to the company - This item is not applicable[149](index=149&type=chunk) [Item 4. Mine Safety Disclosures](index=33&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - This item is not applicable[150](index=150&type=chunk) [Item 5. Other Information](index=33&type=section&id=Item%205.%20Other%20Information) There is no other information to report under this item - No other information to report[150](index=150&type=chunk) [Item 6. Exhibits](index=33&type=section&id=Item%206.%20Exhibits) This section provides a list of exhibits filed with the Quarterly Report - The exhibit list includes various corporate documents, employment and research agreements, and required certifications[151](index=151&type=chunk)[154](index=154&type=chunk) [SIGNATURES](index=35&type=section&id=SIGNATURES) - The report was signed by the Chief Executive Officer and Chief Financial Officer on February 14, 2024[157](index=157&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2023 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...

(Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended June 30, 2022 OR UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 20-F ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE ...