Announcement PDF ABN 16 165 160 841 ASX RELEASE 27 November 2024 Appendix 4D and Financial Report Half Year ended 30 September 2024 Amplia Therapeutics Limited (ASX: ATX) (“Amplia” or the “Company”) announces its Appendix 4D and Financial Report for the Half Year ended 30 September 2024. This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics. Investor Contact: Dr Chris Burns Chief Executive Officer chris@ampliatx.com Media Contact: H^CK Director, Haley Chartres haley@hck.digital +61 423 139 163 About Amplia Therapeutics Limited Amplia Therapeutics Limited is an Australian pharmaceutical company advancing a pipeline of Focal Adhesion Kinase (FAK) inhibitors for cancer and fibrosis. FAK is an increasingly important target in the field of cancer and Amplia has a particular development focus in fibrotic cancers such as pancreatic and ovarian cancer. FAK also plays a significant role in a number of chronic diseases, such as idiopathic pulmonary fibrosis (IPF). For more information visit www.ampliatx.com and follow Amplia on Twitter (@ampliatx), Threads (@ampliatx) and LinkedIn. Level 7, 350 Queen Street, Melbourne VIC 3000 Email info@ampliatx.com www.ampliatx.com Amplia Therapeutics Limited Appendix 4D Half-year report 1. Company details Name of entity: ACN: Reporting period: Previous period: Amplia Therapeutics Limited 165 160 841 For the half-year ended 30 September 2024 For the half-year ended 30 September 2023 2. Results for announcement to the market $ Revenues from ordinary activities and other income down 41% to 1,491,536 Loss from ordinary activities after tax attributable to the owners of Amplia Therapeutics Limited up 149% to (2,814,163) Loss for the half-year attributable to the owners of Amplia Therapeutics Limited 149% to (2,814,163) up Dividends The Directors have resolved that no dividend will be paid this half year. Comments The loss for the Group after providing for income tax for the half-year ended 30 September 2024 amounted to $2,814,163 (30 September 2023: $1,129,243). 3. Net tangible assets Reporting period Cents Net tangible assets per ordinary security 4. Control gained over entities Not applicable. 5. Loss of control over entities Not applicable. 6. Dividends Current period There were no dividends paid, recommended or declared during the current financial period. Previous period There were no dividends paid, recommended or declared during the previous financial period. 7. Dividend reinvestment plans Not applicable. 1.8 Previous period Cents 1.8 Amplia Therapeutics Limited Appendix 4D Half-year report 8. Details of associates and joint venture entities Not applicable. 9. Foreign entities Details of origin of accounting standards used in compiling the report: Not applicable. 10. Audit qualification or review Details of audit/review dispute or qualification (if any): The financial statements were subject to a review by the auditors and the review report is attached as part of the Half Year Report. 11. Attachments Details of attachments (if any): The Half Year Report of Amplia Therapeutics Limited for the half-year ended 30 September 2024 is attached. 12. Signed Signed ___________________________ Warwick Tong Non-Executive Chairman Date: 27 November 2024 HALF-YEAR REPORT 30 September 2024 1 FIGHT C Amplia Therapeutics Ltd Amplia Therapeutics Limited Corporate directory 30 September 2024 Directors Dr. Warwick Tong (Non-Executive Chairman) Dr. Robert Peach (Non-Executive Director) Dr. Christopher Burns (CEO and Managing Director) Mrs. Jane Bell (Non-Executive Director) Company secretary Mr. Andrew J. Cooke Registered office Level 17, 350 Queen Street Melbourne VIC 3000 Australia Share register Computershare Investor Services Pty Limited Level 3, 60 Carrington Street Sydney NSW 2000 Australia Telephone: 1300 556 161 (within Australia) + 61 3 9415 4000 (outside Australia) Website: www.investorcentre.com/contact Auditor Grant Thornton Audit Pty Ltd Australia Stock exchange listing Amplia Therapeutics Limited shares are listed on the Australian Securities Exchange (ASX code: ATX) Website www.ampliatx.com 1 Amplia Therapeutics Limited Contents 30 September 2024 Directors' report Auditor's independence declaration Consolidated statement of profit or loss and other comprehensive income Consolidated statement of financial position Consolidated statement of changes in equity Consolidated statement of cash flows Notes to the consolidated financial statements Directors' declaration Independent auditor's review report to the members of Amplia Therapeutics Limited 2 3 8 9 10 11 12 13 19 20 Amplia Therapeutics Limited Directors' report 30 September 2024 The Directors present their report, together with the financial statements, on the consolidated entity (referred to hereafter as the 'Group') consisting of Amplia Therapeutics Limited (referred to hereafter as the 'Company' or 'parent entity') and the entities it controlled at the end of, or during, the half-year ended 30 September 2024. Directors The names of the Directors in office at any time during or since the period are: Name and independence status Period of office and special responsibilities Appointed as Non-Executive Director on 4 May 2018 and Chair since 25 Warwick Tong Independent Non-Executive Director and Chair May 2018. Member of the Audit & Risk Committee and the Remuneration Committee. Robert Peach Independent Non-Executive Director Appointed as Non-Executive Director on 2 September 2015 and is Chair of the Remuneration Committee and a member of the Audit & Risk Committee. Christopher Burns CEO and Managing Director Appointed as Non-Executive Director on 4 May 2018. Appointed Chief Executive Officer and Managing Director starting 5 December 2022. Jane Bell Independent Non-Executive Director Appointed as Non-Executive Director on 12 April 2021 and is also Chair of the Audit & Risk Committee a member of the Remuneration Committee. Principal activities The principal activity of the Company is development of its Focal Adhesion Kinase (FAK) inhibiting drug candidates Narmafotinib (AMP945) and AMP886. These assets represent highly attractive compounds for clinical development possessing excellent potency and selectivity in biological assay systems; good pharmacokinetics, bioavailability and drug-like properties; promising efficacy in a range of preclinical studies; and, appropriate chemical properties for manufacturing scaleup and long-term stability. The Company is focused on the development of these drug candidates for potential use in multiple indications in oncology (e.g. pancreatic cancer) and chronic fibrotic diseases. Financial update The loss for the Group after providing for income tax for the half-year period ended 30 September 2024 amounted to $2,814,163 (30 September 2023: $1,129,243). Total current assets at the beginning of the period amounted to $6,753,225 with cash and cash equivalents totalled $3,385,310. At 30 September 2024, total current assets had decreased to $6,154,117. Of this amount, $4,558,412 was represented by cash and cash equivalents and $1,394,916 was represented by the R&D tax incentive receivable. Total liabilities at the beginning of the period amounted to $3,426,799. This decreased to $1,429,578 at the end of the period. Review of operations The strategic priority for the Company over the reporting period has been the efficient prosecution of the Phase 2a portion of the ACCENT trial in pancreatic cancer. The ACCENT clinical trial explores the safety, tolerability, and efficacy of the Company’s FAK inhibitor narmafotinib, in combination with the chemotherapy drugs gemcitabine and Abraxane®, in newly diagnosed patients with advanced pancreatic cancer. The Phase 2a stage of the ACCENT trial is open at six sites in Australia and at five hospitals in the Republic of Korea. Dosing patient began in January this year and recruitment of the first cohort of 26 patients was completed in early July. This trial the first of the is being conducted using the Simon’s two-stage design, chosen because it can result in efficient determination of whether narmafotinib has sufficient promise to warrant further development. In the ACCENT trial, the first stage consists of efficacy assessment in a group of 26 patients where a confirmed complete or partial response in six (6) patients is considered sufficiently promising to warrant continuation of the trial. 3 Amplia Therapeutics Limited Directors' report 30 September 2024 At the end of July we reported that three (3) patients had recorded confirmed partial responses (PRs), meaning that a 30% or greater reduction in the overall size of tumour lesions had been observed and maintained for 2 months or more, with no new tumour lesions apparent. A further three (3) confirmed partial responses were reported by the end of September, indicating that the desired activity threshold of six (6) confirmed PRs had been achieved. The second stage of the Phase 2a trial, recruitment of an additional 24 patients, began in October with enrolment expected to be completed by end of Q1 2025. The trial size of 50 patients in total was determined based on previous pancreatic cancer trials using gemcitabine and Abraxane and from which a statistically meaningful benefit from the narmafotinib combination can be determined. In April we presented a poster at the annual meeting of the American Association of Cancer Research with updated analysis of data from the ACCENT Phase 1b trial. This data was subsequently published in the abstracts for the annual meeting of the American Society of Clinical Oncology meeting in May. During that conference, the inaugural meeting of the Company’s Clinical Advisory Board (CAB) was also held to discuss the ACCENT trial progress, as well as strategy and plans for additional trials of narmafotinib in pancreatic cancer. The CAB consists of five world-class clinical oncologists, with expertise in pancreatic cancer from Australia, the US and Canada. In August we announced that the European Patent Office and the Japan Patent Office, had independently notified the Company that a key patent describing the specific chemical form of narmafotinib in development had been granted in their respective jurisdictions. This patent extends patent protection over the drug to 2040 (and potentially beyond). Patent office review in other countries, including Australia and the US, is underway. In September we announced that the United States Food and Drug Administration (FDA) had granted Fast Track Designation to narmafotinib for the treatment of advanced pancreatic cancer. Fast Track Designation is available to drugs that may provide an advantage over current therapies in the treatment of serious conditions and is designed to speed the development of these drugs. This designation allows the Company to have increased opportunities to interact with the FDA through meetings and written communication. Material Business Risks The current and future performance of the Company may be affected by changing circumstances, uncertainties, and risks specific to the Company and the Company’s business activities, as well as general risks. (a) Clinical development risk The nature of clinical drug development has inherent risks, with many drug candidates entering clinical trial failing to be successfully developed into marketable products. The Company is currently undertaking a clinical trial with its lead drug narmafotinib in advanced pancreatic cancer patients. Clinical trials have many associated risks which may impact commercial potential and therefore future profitability. Such trials may fail to recruit patients at a sufficient rate, and a slower than expected recruitment will mean slower than expected data points so a longer period incurring overheads and personnel costs. Clinical trialling may reveal drug candidates to be unsafe or poorly tolerated in the patient population being tested. The drugs may also be shown to be only modestly effective, thereby limiting commercial potential, or ineffective. Any of these outcomes will likely have a significant adverse effect on the Company, the value of its securities and the future commercial development of its drug candidates, including narmafotinib. Clinical trials might also potentially expose the Company to product liability claims in the event its products in development have unexpected effects on clinical subjects. (b) Regulatory approvals The Company may be unable to secure and maintain necessary approvals from regulatory agencies and institutional bodies (clinics and hospitals) to conduct its clinical trials. Using funds raised in the Offer, the Company plans to initiate a Phase 2 clinical trial (as an Investigator Initiated Trial) in advanced ovarian cancer patients. There is no assurance that regulatory bodies and local ethics committees will approve the Company’s plans to recruit these patients. (c) Regulatory and reimbursement approvals The research, development, manufacture, marketing and sale of products developed by the Company are subject to varying degrees of regulation by a number of government authorities in Australia and overseas. Pharmaceutical products under development, such as drug candidate narmafotinib, must undergo a comprehensive and highly regulated development and review process before receiving approval for marketing. The process includes the provision of clinical data relating to the quality, safety and efficacy of the products for their proposed use. There is no guarantee that such regulatory approvals will be granted. Products may also be submitted for cost reimbursement approval. The availability and timing of that reimbursement approval may have an impact upon the uptake and profitability of products in some jurisdictions. There is no guarantee that such approvals will be granted. 4 Amplia Therapeutics Limited Directors' report 30 September 2024 (d) Chemistry, manufacturing and controls The ACCENT clinical trial currently underway requires supply of narmafotinib drug product (capsules). There are risks to production of drug substance in a timely manner should supply chains be affected. There are also risks associated with shipment, storage and handling of drug product that may render the material unavailable or inappropriate for clinical usage. For clinical trial sites in South Korea, supplies of the chemotherapies gemcitabine and Abraxane are also required. There are risks in the supply, shipment, storage and handling of drug product that may delay delivery or render the material unavailable or inappropriate for clinical usage. (e) Commercialisation of products and potential market failure The Company has not yet commercialised any products and as yet has no revenues. The Company is also dependent on commercially attractive markets remaining available to it during the commercialisation phase and there is a risk that, once developed and ready for sale, commercial sales may not be achieved. Furthermore, any products developed by the Company may prove to be uneconomical to market or compete with alternative products marketed by third parties, or not be as attractive or efficacious as alternative treatments. (f) Competition The biotechnology and pharmaceutical industries are intensely competitive and subject to rapid and significant change. A number of companies, both in Australia and abroad, may be pursuing the development of products that target the same markets and/or diseases that the Company is targeting. The Company’s products may compete with existing products that are already available to customers. The Company may face competition from parties who have substantially greater resources than the Company. Competing products may be superior to the Company’s products, which would adversely impact the commercial viability of the Company’s products. (g) Dependence upon key personnel The Company’s ability to attract and retain personnel will have a direct impact on its ability to deliver its project commitments. The Company depends on the talent and experience of its personnel as an important asset. There may be a negative impact on the Company if any of its key personnel leave. It may be difficult to replace them, or to do so in a timely manner or at comparable expense. Additionally, any key personnel of the Company who leave to work for a competitor may adversely impact the Company. Additionally, increases in recruitment fees, wages and contractor costs may adversely impact upon the financial performance of the Company. (h) Research & Development (R&D) Tax Incentive Rebates The Company is currently entitled to receive an R&D rebate on part of its expenditure in research and development. There is a risk that the Australian Government may make material changes to the rebate scheme, which may adversely impact the funding available to the Company to fund its operations. In order to obtain an R&D rebate on that part of its expenditure that is incurred out of Australia the Company must first gain approval for that expenditure from the Australian Government. Such an approval is called an Advanced Finding. The Company has received Advanced Findings for R&D work which is planned for its lead assets narmafotinib and AMP886. (i) Growth There is a risk that the Company may be unable to manage its future growth successfully. The ability to hire and retain skilled personnel as outlined above may be a significant obstacle to growth. (j) Commercial partners The Company’s growth strategy may be impacted if it is unable to find suitable commercialisation partners. The Company's due diligence processes may not be successful and a commercial partnership may not perform to the level expected. (k) Intellectual Property The Company’s ability to commercialise any product depends upon its ability to protect its intellectual property and any improvements to it. The intellectual property may not be capable of being legally protected, it may be the subject of unauthorised disclosure or be unlawfully infringed, or the Company may incur substantial costs in asserting or defending its intellectual property rights. 5 Amplia Therapeutics Limited Directors' report 30 September 2024 (l) Revenues and Profitability The Company does not currently generate revenue from product sales nor are revenues anticipated in the short to medium term. The Company’s ability to achieve both revenues and profitability is dependent on a number of factors, including its ability to complete successful clinical trials, obtain regulatory approval for its products and successfully commercialise those products. There is no guarantee that the Company’s products (including the drug narmafotinib) will be commercially successful. (m) Economic General economic conditions, movements in financial markets, interest and inflation rates and currency exchange rates may have an adverse effect on the Company's business and production activities, as well as on its ability to fund those activities. (n) Market Conditions Share market conditions may affect the value of the Company's quoted shares (and options to acquire quoted shares) regardless of the Company's operating performance. Share market conditions are affected by many factors such as: (a) (b) (c) (d) (e) (f) general economic outlook; introduction of tax reform or other new legislation; interest rates and inflation rates; changes in investor sentiment toward particular market sectors; the demand for, and supply of, capital; and terrorism or other hostilities. The market price of securities can fall as well as rise and may be subject to varied and unpredictable influences on the market for equities in general and pharmaceutical stocks in particular. Neither the Company nor the Directors warrant the future performance of the Company or any return on an investment in the Company. (o) Litigation There is a risk that the Company may in future be the subject of or required to commence litigation. There is, however, no litigation, mediation, conciliation or administrative proceeding taking place, pending or threatened against the Company. (p) Tax risks Changes to the rate of taxes imposed on the Company (including in overseas jurisdictions in which the Company operates now or in the future) or tax legislation generally may affect the Company and its shareholders. In addition, an interpretation of Australian tax laws by the Australian Taxation Office that differs to the Company’s interpretation may lead to an increase in the Company’s tax liabilities and a reduction in shareholder returns. Personal tax liabilities are the responsibility of each individual investor. The Company is not responsible either for tax or tax penalties incurred by investors. (q) Additional capital requirements The Company's capital requirements depend on numerous factors. The Company may require further financing in addition to amounts raised under the capital raising. Any additional equity financing will dilute shareholdings, and debt financing, if available, may involve restrictions on financing and operating activities. If the Company is unable to obtain additional financing as needed, it may be required to reduce the scope of its operations, its production levels, or scale back its research and development and/or clinical trials as the case may be. There is no guarantee that the Company will be able to secure any additional funding or be able to secure funding on terms favourable to the Company. Significant changes in the state of affairs During the period the Company completed the following equity issues: ● On 15 May 2024, the Company issued 77,602,838 shares at $0.55 per share to eligible shareholders through rights issues raising $4.27 million before costs. ● On 17 July 2024, the Company issued 1,821,508 shares at $0.062 per share to employees in relation to bonus entitlements for FY24. ● On 19 July 2024, the Company issued 781,250 shares which had a value of $0.064 per share to corporate advisors in lieu of cash for services. ● On 26 August 2024, the Company issued 586,321 shares at $0.062 per share to Chris Burns in relation to his short-term incentive entitlement for FY24. This issue was approved by shareholders at the Annual General Meeting held on 26 August 2024. There were no other significant changes in the state of affairs of the Company during the financial half-year. 6 Amplia Therapeutics Limited Directors' report 30 September 2024 Matters subsequent to the end of the financial half-year On 30 October 2024, the Company announced the interim data on the Phase 2a ACCENT trial. Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed Partial Responses (PRs) having been recorded along with four (4) unconfirmed PRs and five (5) Stable Diseases (SDs). With the six (6) confirmed PRs obtained, recruitment reopened for the final stage of the trial. On 30 October 2024, the Company announced a capital raise of up to $13.0 million by issuing shares at $0.115 per share with three (3) free attaching options for every four (4) new shares purchased. The attaching options will have an exercise price of $0.1725 and will expire 31 October 2027 and were subject to shareholder approval. On 7 November 2024, the Company issued a placement of 83,444,931 shares raising $9.6 million before costs. The placement issue is being followed by a 1 for 6.45 pro-rata accelerated non-renounceable entitlement offer to eligible shareholders to raise the remaining funds. No other matter or circumstance has arisen since 30 September 2024 that has significantly affected, or may significantly affect the Group's operations, the results of those operations, or the Group's state of affairs in future financial years. Auditor's independence declaration A copy of the auditor's independence declaration as required under section 307C of the Corporations Act 2001 is set out immediately after this Directors' report. This report is made in accordance with a resolution of Directors, pursuant to section 306(3)(a) of the Corporations Act 2001. On behalf of the Directors ___________________________ Warwick Tong Non-Executive Chairman 27 November 2024 7 Grant Thornton Audit Pty Ltd Level 22 Tower 5 Collins Square 727 Collins Street Melbourne VIC 3008 GPO Box 4736 Melbourne VIC 3001 T +61 3 8320 2222 Auditor’s Independence Declaration To the Directors of Amplia Therapeutics Limited In accordance with the requirements of section 307C of the Corporations Act 2001, as lead auditor for the review of Amplia Therapeutics Limited for the half-year ended 30 September 2024, I declare that, to the best of my knowledge and belief, there have been: a no contraventions of the auditor independence requirements of the Corporations Act 2001 in relation to the review; and b no contraventions of any applicable code of professional conduct in relation to the review. Grant Thornton Audit Pty Ltd Chartered Accountants J D Vasiliou Partner – Audit & Assurance Melbourne, 27 November 2024 www.grantthornton.com.au ACN-130 913 594 Grant Thornton Audit Pty Ltd ACN 130 913 594 a subsidiary or related entity of Grant Thornton Australia Limited ABN 41 127 556 389 ACN 127 556 389. ‘Grant Thornton’ refers to the brand under which the Grant Thornton member firms provide assurance, tax and advisory services to their clients and/or refers to one or more member firms, as the context requires. Grant Thornton Australia Limited is a member firm of Grant Thornton International Ltd (GTIL). GTIL and the member firms are not a worldwide partnership. GTIL and each member firm is a separate legal entity. Services are delivered by the member firms. GTIL does not provide services to clients. GTIL and its member firms are not agents of, and do not obligate one another and are not liable for one another’s acts or omissions. 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Amplia Therapeutics Limited Consolidated statement of profit or loss and other comprehensive income For the half-year ended 30 September 2024 30 September 2024 $ 30 September 2023 $ 1,394,916 12,000 84,620 1,491,536 2,448,397 78,551 2,526,948 Expenses Research & development expenses Administrative & general expenses Share based compensation Patent & associated expenses Depreciation and amortisation expense Total expenses (2,800,243) (1,269,110) (66,736) (71,023) (43,361) (4,250,473) (2,193,791) (1,215,140) (46,263) (111,416) (42,949) (3,609,559) Operating loss (2,758,937) (1,082,611) Interest expense (55,226) (46,632) (2,814,163) (1,129,243) - - (2,814,163) (1,129,243) - - (2,814,163) (1,129,243) Cents Cents Note Revenue and other income R&D tax incentive Government grants Interest income Total revenue and other income 5 Loss before income tax expense Income tax expense Loss after income tax expense for the half-year attributable to the owners of Amplia Therapeutics Limited Other comprehensive income for the half-year, net of tax Total comprehensive loss for the half-year attributable to the owners of Amplia Therapeutics Limited Basic earnings per share Diluted earnings per share 12 12 (1.11) (1.11) (0.58) (0.58) The above consolidated statement of profit or loss and other comprehensive income should be read in conjunction with the accompanying notes 9 Amplia Therapeutics Limited Consolidated statement of financial position As at 30 September 2024 Note 30 September 2024 $ 31 March 2024 $ Assets Current assets Cash and cash equivalents R&D tax incentive receivable Prepayments Other assets Total current assets 4,558,412 1,394,916 112,317 88,472 6,154,117 3,385,310 3,177,718 74,177 116,020 6,753,225 7,499 50,448 7,937,932 53,034 8,048,913 12,634 88,284 7,937,932 53,034 8,091,884 14,203,030 14,845,108 1,313,440 54,987 45,751 1,414,178 1,790,299 1,491,849 80,826 40,471 3,403,445 15,400 15,400 13,893 9,461 23,354 Total liabilities 1,429,578 3,426,799 Net assets 12,773,452 11,418,309 6 Non-current assets Property, plant and equipment Right-of-use assets Intangibles Other assets Total non-current assets 7 Total assets Liabilities Current liabilities Accounts payable & accrued liabilities Borrowings Lease liabilities Provisions Total current liabilities 8 Non-current liabilities Lease liabilities Provisions Total non-current liabilities Equity Issued capital Reserves Accumulated losses 9 10 Total equity 155,628,077 151,529,215 (1,074,394) (1,096,539) (141,780,231) (139,014,367) 12,773,452 11,418,309 The above consolidated statement of financial position should be read in conjunction with the accompanying notes 10 Amplia Therapeutics Limited Consolidated statement of changes in equity For the half-year ended 30 September 2024 Issued capital $ Balance at 1 April 2023 Share option reserve $ Foreign currency translation reserve $ Accumulated losses Total equity $ $ 151,528,974 849,586 Loss after income tax expense for the half-year Other comprehensive income for the half-year, net of tax - - - (1,129,243) (1,129,243) - - - - - Total comprehensive loss for the half-year - - - (1,129,243) (1,129,243) 69 46,263 - - - 46,263 69 - (198,260) - 198,260 - 151,529,043 697,589 (1,818,617) (135,655,400) 14,752,615 Transactions with owners in their capacity as owners: Share-based payments Issue of shares on exercise of options Expiry of options previously recorded as sharebased payments Balance at 30 September 2023 Issued capital $ Balance at 1 April 2024 Share option reserve $ (1,818,617) (134,724,417) Foreign currency translation reserve $ 15,835,526 Accumulated losses Total equity $ $ 151,529,215 722,078 Loss after income tax expense for the half-year Other comprehe