Announcement PDF ABN 16 165 160 841 ASX RELEASE 30 May 2024 Annual Report – Year Ended 31 March 2024 Amplia Therapeutics Limited (ASX: ATX) today releases its Appendix 4E Preliminary Final Report YE 31 March 2024 and its 2024 Annual Report. This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics. - End 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 immunology and Amplia has a particular development focus in fibrotic cancers such as pancreatic 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) and LinkedIn. Level 17, 350 Queen Street, Melbourne VIC 3000 Email info@ampliatx.com www.ampliatx.com Amplia Therapeutics Limited Appendix 4E Preliminary final report 1. Company details Name of entity: ABN: Reporting period: Previous period: Amplia Therapeutics Limited 16 165 160 841 For the year ended 31 March 2024 For the year ended 31 March 2023 2. Results for announcement to the market $ Revenues and other income from ordinary activities up 257% to 4,597,843 Loss from ordinary activities after tax attributable to the owners of Amplia Therapeutics Limited down 28% to (4,503,453) Loss for the year attributable to the owners of Amplia Therapeutics Limited down 28% to (4,503,453) Dividends The Directors have resolved that no dividend will be paid during this current financial year. Comments The loss for the Group after providing for income tax amounted to $4,503,453 (31 March 2023: $6,242,435). 3. Net tangible assets Reporting period Cents Previous period Cents 1.8 4.1 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. Amplia Therapeutics Limited Appendix 4E Preliminary final 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 have been audited and an unmodified opinion has been issued. 11. Attachments Details of attachments (if any): The Annual Report of Amplia Therapeutics Limited for the year ended 31 March 2024 is attached. 12. Signed Signed ___________________________ Warwick Tong Non-Executive Chairman Date: 30 May 2024 ANNUAL REPORT 1 FIGHT C 2023-2024 Amplia Therapeutics Ltd Amplia Therapeutics recognises and respects First Nations People and welcomes the work of all those who strive for health equality in Australia. 2 Contents Letter from the Chairman ..................................................... 4 CEO’s Message ...................................................................... 6 Meet the Team ................................................................... 8 Company Snapshot ......................................................... 10 Year in Review ................................................................... 12 ACCENT Trial in pancreatic cancer ................................. 14 ACCENT Trial: Phase 1b results .......................................... 16 ACCENT Trial: Phase 2a launched ........................................... 18 In Conversation with COO, Dr Rhiannon Jones .......................... 20 Narmafotinib shows promise in preclinical studies .......................... 22 Our Values ............................................................................................................. 24 Financial Report ................................................................................................................. 25 Letter from the Chairman Dear Shareholders, On behalf of your Board it is my pleasure to share the Amplia 2024 Annual Report. I would like to take this opportunity to thank you, our shareholders, for your ongoing support of the Company as we progress our pipeline of FAK inhibitors for the treatment of cancer and fibrotic diseases. This year we completed the Phase 1b stage of the ACCENT trial of our lead asset narmafotinib (AMP945) in pancreatic cancer, and initiated the Phase 2a, dose-expansion stage of the trial. We were very encouraged by the analysis of data from the patient cohort in the Phase 1b trial. Narmafotinib was well tolerated and in these patients with advanced disease showed promising early signs of efficacy. The Phase 2a stage of the ACCENT trial, using the dose selected in the Phase 1b stage, is now recruiting patients in both Australia and South Korea. The Korean drug regulator approved the Company’s application to conduct the trial in Korea in December 2023 and sites opened in January 2024. The Korean healthcare and clinical trial systems are world-class and we are grateful for the support of the trial sites, and our other partners in Korea, for contributing to the ACCENT trial in pancreatic cancer. Developing a new drug is a complex, multi-disciplinary undertaking and requires a high-functioning, experienced and committed team. We are extremely proud of the team for driving our Company’s FAK inhibitor programs forward to achieve our preclinical and clinical goals. A notable achievement was successfully submitting an Investigational New Drug (IND) application with the US Food and Drug Administration (FDA) in December 2023. Amplia was notified in January 2024 that the application was successful and that the proposed trial of narmafotinib in the US for pancreatic cancer, could now be undertaken. The Board and Management are focused on corporate strategies that harness the huge potential of our pipeline of FAK inhibitors. Sentiment for biotech remains somewhat weak with investors - but we remain confident that the Company’s assets and approach will lead to significant and positive growth. Promising clinical data with competitive FAK inhibitors in development overseas further validates FAK inhibition as an approach for the treatment of cancer, in turn reducing perceived development risk. The excellent safety and tolerability data for narmafotinib helps position our lead asset as the preferred agent for combination studies in pancreatic cancer and other solid tumour indications, thereby expanding clinical and commercial optionality. Now eighteen months into his role as CEO and MD, Dr Chris Burns has provided leadership and oversight to position Amplia’s key projects in a very competitive position in the coming year. As always, I thank my Board colleagues for their thoughtful insights, guidance and positive collaboration. Amplia has made great progress over the past year, and we look forward in the coming months to data from the ACCENT trial, together with additional opportunities provided by the open IND in the USA, and strong preclinical data in other cancer indications. Warwick Tong Independent Non-Executive Chair 4 “ Developing a new drug is a complex, multi-disciplinary undertaking and requires a high-functioning, experienced and committed team. We are extremely proud of the Amplia Therapeutics team for driving our Company’s FAK inhibitor programs forward to achieve both clinical and preclinical goals INDEPENDENT NON-EXECUTIVE CHAIR WARWICK TONG CEO’s Message This past year has been highly significant for Amplia Therapeutics. We have delivered upon a number of important milestones for the Company and continue to drive these activities to key readouts and value inflections. Our primary focus has been progressing our lead asset narmafotinib in oncology indications, and specifically in the treatment of solid tumours, to position the drug as the preferred agent for combination with targeted therapies or chemotherapy. Narmafotinib is a highly potent and selective inhibitor of focal adhesion kinase (FAK) currently undergoing a Phase 1b/2a trial in advanced pancreatic cancer patients – the ACCENT trial. Most importantly, we completed the Phase 1b, dose-escalation stage of the trial identifying a well-tolerated dose of the drug for progression into the Phase 2a stage of the trial. The Phase 2a stage, which is still ongoing, opened in November 2023 at our existing six trial sites in Australia. In December 2023 we received notification from the Korean medicines regulator that approval had been granted to open the trial in Korea. We had previously identified five sites in Korea, and these sites are now also recruiting patients. We look forward to reporting interim data on the trial in Q3 of 2024 once 26 patients have been recruited and activity of the drug determined. In January, we reported that our Investigational New Drug (IND) application to the US Food and Drug Administration (FDA) had been successful, thereby allowing us to conduct a clinical trial of narmafotinib in the USA. The IND application involved cataloguing and summarising all data obtained for narmafotinib since its discovery at the Cancer Therapeutics CRC in Melbourne, along with preclinical efficacy data from our academic collaborators, through to the formal safety, toxicology and clinical data generated at Amplia. Once completed, the final application dossier came to well over 10,000 pages – a truly herculean effort by the team! A successful IND application represents a major achievement for a small biotech company given the rigorous review undertaken by the FDA. The potential for FAK inhibitors in the treatment of cancer is receiving increasing attention and focus from the biotech and pharma community worldwide, driven in part by positive data reported by us and other companies developing FAK inhibitors. In particular, the US biotech Verastem, who are developing the first-generation FAK inhibitor defactinib, disclosed data in June 2023 from a clinical trial in an uncommon form of ovarian cancer showing that addition of defactinib to another targeted therapy significantly enhanced therapeutic response. These findings, which crucially validate FAK inhibition as an approach to enhance the activity of other drugs, have led to Verastem seeking accelerated approval for the drug combination in this subset of patients from the FDA. Our own preclinical data in ovarian cancer, generated in collaboration with academics at UC San Diego, is focused on high grade ovarian cancer (representing ~90% of all ovarian cancer diagnoses) and supports the potential of narmafotinib in treatment of this challenging disease. Discussions are ongoing with clinical experts in Australia and the USA on clinical trial pathways. The small team at Amplia work diligently to progress our drug programs in the most efficient and timecritical manner possible. Much of this work happens out-of-sight, such as managing drug production and supply; writing and reviewing study reports; and the ongoing monitoring of clinical data and trial sites. I thank the Amplia team for their dedicated efforts, together with our partners and collaborators. Lastly, I wish to thank you, our Shareholders and investors: the important work we are undertaking is only possible with your support. Dr Christopher Burns CEO & MD 6 “ Our primary focus over this last year has been progressing our lead asset narmafotinib in oncology indications, and specifically in the treatment of solid tumours, to position the drug as the preferred agent for combination with targeted therapies or chemotherapy. CEO & MD, DR CHRISTOPHER BURNS Meet the Team Board of Directors WARWICK TONG MB ChB MPP GAICD Non-Executive Chairman of the Board Warwick is a NZ trained physician with more than 25 years’ experience in the Pharmaceutical and Biotechnology industry. Dr Tong was appointed as a Non-Executive Director on 4th of May 2018 and Chairman on 25th May 2018. Dr Tong is also a member of the Audit Committee. CHRISTOPHER BURNS B.Sc. (Hons) PhD GAICD Chief Executive Officer and Managing Director Chris is an experienced drug discovery leader having worked in various roles in pharma, biotech and academia for 30 years. Dr Burns was originally appointed as a Non-Executive Director on 4th May 2018 and was subsequently appointed as Chief Executive Officer and Managing Director on 5th December 2022. ROBERT PEACH PhD Independent Non-Executive Director Dr Peach has over 25 years of drug discovery and development experience in the Pharmaceutical and Biotechnology industry. Dr Peach was appointed as an Independent Non-Executive Director on 2nd September 2015 and is a member of the Remuneration Committee. JANE BELL AM, BEc, LLB, LLM (Lond), FAICD Independent Non-Executive Director Jane is a banking and finance lawyer and non-executive director with more than 30 years’ experience in leading law firms, financial services and corporate treasury operations in Melbourne, London, Toronto, San Francisco and Brisbane. Ms Bell was appointed as an Independent Non-Executive Director on 12th April 2021 and is Chair of the Audit and Risk Committee. 8 Meet the Team Executive Team Scientific Advisers CHRISTOPHER BURNS BSc (Hons) PhD, GAICD Chief Executive Officer and Managing Director PROFESSOR MARGARET FRAME OBE, PhD FAK Biology Adviser RHIANNON JONES BSc (Hons) PhD, GAICD Chief Operating Officer PROFESSOR PAUL TIMPSON PhD FAK Biology Adviser TIM LUSCOMBE BCom, CA, GIA(Cert) Chief Financial Officer DR MARK DEVLIN BSc (Hons) PhD GradD Drug Dev MBA Scientific Adviser ANDREW J. COOKE LL.B Company Secretary CHARLOTTE MULDER BVSc (Hons), MBA Director Early Clinical Development TERRIE-ANNE COCK PhD Director Translational Science ADRIAN SULISTIO B Eng (Hons), B. Com, PhD Manager Product Development NICOLE KRUGER BSc Director Clinical Operations Clinical Advisers DR JOSE IGLESIAS MD Clinical Adviser (Oncology) DR JASON LICKLITER MBBS, FRACP Medical Adviser Company Snapshot Amplia’s pipeline drugs were originally discovered by the Cancer Therapeutics CRC, an Australian industry/academic collaboration that included leading cancer and drug discovery researchers at Australia’s top cancer research institutes. Amplia was established to advance these promising drugs into clinical development and commercialisation.​ Amplia Therapeutics Limited (ASX: ATX) is an Australian, clinical-stage, drug development company focused on the development of two potent, orally-available inhibitors of Focal Adhesion Kinase (FAK) for the treatment of cancer and fibrotic diseases.​ Our Technology Amplia Therapeutics is currently focused on the clinical development of two highly-promising drug candidates targeting Focal Adhesion Kinase (FAK). FAK inhibitors have been described as a ‘heavy punch’ to cancer, showing promising potential when used in combination with existing ‘standard of care’ therapies in the treatment of solid cancers. Our FAK inhibitors affect both the cancer cells themselves and the surrounding tissue, making tumours more vulnerable and responsive to currently used, and developmental, treatments. Pipeline Drug Target Indication Preclinical IND enabling Phase 1 Phase 2 Late Phase Status FAK Pancreatic Cancer (+Gemcitabine/Abraxane® ) ACCENT Enrolling Pancreatic Cancer (+FOLFIRINOX ) IND approved Ovarian Cancer In planning ONCOLOGY Narmafotinib (AMP945) Other solid tumours AMP886 FAK/VEGFR3/FLT3 Solid tumours FAK Idiopathic Pulmonary Fibrosis FIBROTIC DISEASE Narmafotinib (AMP945) Other fibrotic diseases TOPICAL Narmafotinib (AMP945) FAK Scar Reduction POC developed next 12 months 10 Focus on Oncology Focal Adhesion Kinase (FAK) is upregulated in many cancers where it supports cell survival and drives cell growth and migration. In addition, it is directly involved in several important biological processes in the tumour microenvironment i.e. the region surrounding the tumour; including the formation of new fibrotic tissue and generation of an immunosuppressed environment. When cancers become established in the body, they often use these processes to improve their own survival. Amplia’s Cancer Program is directed at using its FAK inhibitors to block FAK activity in the cancer cells as well as the surrounding tissue, thereby blocking the above processes and making the tumours more susceptible to chemotherapy. Amplia’s lead drug candidate, narmafotinib, is a highly selective and potent FAK inhibitor that has shown promising results in preclinical studies for the treatment of pancreatic and ovarian cancers. Ovarian Cancer Pancreatic Cancer Pancreatic cancer is a difficult to treat cancer, with a low survival rate, typically detected late in disease progression. There were an estimated 4,500 diagnoses in Australia in 2023 and the estimated 5 year survival rate is 13%. Amplia has demonstrated the efficacy of narmafotinib in preclinical models of pancreatic cancer and is now undertaking a Phase 2 clinical trial in advanced pancreatic cancer in Australia and South Korea. Amplia has orphan drug designation and an open IND for a trial in pancreatic cancer from the US FDA. 11 Over 315,000 women develop ovarian cancer annually and high grade serous ovarian cancer (HGSOC) accounts for ≥90% of cases. HGSOC has poor prognosis with a 10-year survival rate of 15%. Platinum-based chemotherapy is the standard-of-care (SOC) treatment, however, nearly all recurrent HGSOC develop platinum-resistance limiting treatment options. Year in Review Amplia Therapeutics has made notable progress throughout the past year. The ACCENT clinical trial has remained the primary focus, however exciting preclinical advances combined with important international engagement has resulted in the achievement of significant clinical and regulatory milestones for the Company. ACCENT Clinical Trial Preclinical Advances Throughout the year, Amplia Therapeutics has focused on advancing the clinical development of its lead drug, narmafotinib, in the ongoing ACCENT trial for pancreatic cancer. The Company successfully completed the Phase 1b dose-escalation stage, identifying a safe and well-tolerated dose that demonstrates sufficient efficacy in blocking the FAK enzyme. Preliminary results from this phase showed a promising disease control rate of 93%, exceeding historical averages for patients receiving standard chemotherapy alone. (For more detailed coverage of the ACCENT Trial, turn to page 14) Amplia also reached some compelling milestones in preclinical research. The Company discovered that narmafotinib enhances the activity of the widelyused chemotherapy FOLFIRINOX in preclinical models of pancreatic cancer. This finding positions narmafotinib as a potential key player in combination therapies for pancreatic cancer, globally. Amplia is seeking patent protection for the use of narmafotinib with FOLFIRINOX and similar regimens. International Reach Future Outlook Amplia expanded its clinical reach by obtaining approval from the Korean Ministry of Food and Drug Safety to conduct the ACCENT trial in advanced pancreatic cancer patients in Korea. The Phase 2a trial commenced in January 2024, with eleven patients dosed by March. (Read more about our work in Korea on page 18). To strengthen the Company’s financial position, Amplia secured a non-dilutive loan from Director Dr. Robert Peach, ensuring a more favorable cash runway for the Company. In a significant regulatory milestone, the Company received clearance from the US FDA for its Investigational New Drug (IND) application for a trial of narmafotinib, in combination with FOLFIRINOX, in pancreatic cancer patients in the US. This success underscores the quality of the preclinical data amassed for the drug. Amplia also secured a grant from AusIndustry’s Entrepreneur’s Programme to collaborate with CSIRO in developing novel formulations of its FAK inhibitors for topical applications in scar reduction and wound healing. This research is based on scientific publications highlighting the efficacy of FAK inhibitors in preclinical models of scarring and wound repair. Finally, in a step towards global recognition, the World Health Organization approved narmafotinib as the International Nonproprietary Name for AMP945. 12 In addition to pancreatic cancer, Amplia is also exploring the potential of narmafotinib in other indications. Promising preclinical data presented at an international conference on Ovarian Cancer showed the drug’s potential in treating drug-resistant high-grade serous ovarian cancer. (Read more about preclinical data in Ovarian cancer on page 22). ASX announcements April 2023 Dose Escalation Approved in ACCENT Clinical Trial of AMP945 April 2023 First Patient Recruited to Cohort 3 of ACCENT Trial April 2023 ACCENT Trial Recruitment Progress May 2023 Amplia receives grant to collaborate with CSIRO May 2023 AMP945 and FOLFIRINOX active in model of Pancreatic Cancer June 2023 AMP945 International Nonproprietary Name Narmafotinib August 2023 ACCENT Trial Recruitment Update September 2023 New Chief Financial Officer Mr Tim Luscombe September 2023 AACR Pancreatic Cancer Conference Presentation October 2023 AACR Ovarian Cancer Conference Presentation October 2023 Amplia Receives R&D Tax Rebate Totalling $ 2.4 Million October 2023 Promising Clinical Data 1b ACCENT Trial in Pancreatic Cancer December 2023 Approval to Initiate Phase2 Pancreatic Cancer Trial in Korea January 2024 Amplia Reports First Patient Dosing In Phase 2a Accent Trial January 2024 FDA Clearance Amplia’s IND for Pancreatic Cancer Trial in US March 2024 Update on ACCENT Trial in Pancreatic Cancer 13 ACCENT Trial in pancreatic cancer Since the launch of the ACCENT trial in August 2022, Amplia has made encouraging progress. Here’s an overview of the purpose of the trial, and where things are at now. What is the ACCENT Trial? Amplia is testing its FAK inhibitor narmafotinib (AMP945) in a Phase 1b/2a clinical trial in advanced pancreatic cancer patients, called the ACCENT trial. ACCENT = AMP945 Combined Chemotherapy ENhancementT Narmafotinib is being added to the standard-of-care chemotherapy for advanced pancreatic cancer in Australia, a combination of two drugs called gemcitabine (a generic drug originally marketed as Gemzar®) and nab-paclitaxel (Abraxane®). The trial is an open-label trial meaning all patients receive the experimental treatment and there is no control arm. Clinical data from the trial will be compared against published data from previous trials where gemcitabine and nab-paclitaxel have been studied in the identical patient population. Newly diagnosed patients who have advanced disease are able to participate in the trial. • For the Phase 1b stage of the trial this includes patients who have either locally advanced disease that is non-resectable (i.e. cannot be removed by surgery) or that is metastatic (spread to other parts of the body). • For the Phase 2a stage of the trial only patients with metastatic disease are included. Phase 1b The Phase 1b stage of the trial seeks to identify a dose of narmafotinib that is well tolerated by patients when given in combination with gemcitabine and nab-paclitaxel. Groups of 3 patients are tested with the drug combination and the safety assessed after one complete treatment cycle (28 days of dosing). If no issues are identified, the trial’s safety committee approves moving to the next dose. This process continues until a dose is identified that provides sufficient circulating drug levels determined to be effective (based on modeling of drug exposure) whilst remaining safe for the patients. Phase 2a The Phase 2a stage of the trial is focused on testing the optimal dose identified from the Phase 1b studies for efficacy. The efficacy measures use an international standard called RECIST (Response Evaluation Criteria in Solid Tumors) that provides an objective measurement of tumour burden in response to treatment. The primary readout from the trial is Objective Response Rate (ORR). Secondary endpoints are Duration on Trial (DOT), Progression Free Survival (PFS) and Overall Survival (OS). Finally, Amplia is conducting a preliminary biomarker assessment to determine whether specific proteins in the blood correlate with response to treatment. 14 The Company is adopting a common trial design called a Simon’s Two-Stage Design where the objective is to establish whether the proportion of responses to the drug is sufficient to warrant testing in a larger patient group. Analysis of the trial and anticipated response rates by a contracted team of expert biostatisticians identified that a clinical response (partial or complete response) in six or more patients out of 26 would be sufficient to continue enrollment of a further 24 patients. In total, there would be 50 patients in the trial, sufficient to generate statistically meaningful response data. These data will then be compared to published data for historical trials of combined gemcitabine and nab-paclitaxel in an equivalent patient population. ACCENT Trial Phase 1b results show early promise, dose identified In October, Amplia announced promising early results from the Phase 1b portion of the ACCENT clinical trial. The Phase 1b portion of the trial was designed to determine a safe and effective dose of narmafotinib. The trial used a dose-escalation design, with ascending doses of narmafotinib provided to pancreatic cancer patients in combination with the standard-of-care chemotherapy regime of gemcitabine combined with nab-paclitaxel. The study successfully identified a 400 mg daily dose of narmafotinib providing sufficient circulating drug levels to significantly block the activity of the FAK enzyme. Importantly, this dose was shown to be safe and well-tolerated by patients in the trial. While the Phase 1b trial was not specifically designed to assess efficacy, an initial analysis of data obtained from the 14 patients dosed in this Phase 1b trial, updated in March this year, was very encouraging. Not only was the drug well tolerated, with mild to moderate fatigue being the only adverse event seen in more than one patient likely related to narmafotinib, there were promising early indications of efficacy. Six patients recorded a partial response as best response, while the remaining eight recorded stable disease as best response. These data compare very favourably against historical response rates for patients treated with gemcitabine and nab-paclitaxel alone. In addition, nine patients stayed on trial for more than five (5) months, with two patients being on trial for over 10 months. Importantly, there was a clear dose-response effect with patients on the higher dose of narmafotinib having better responses and increased time on the trial. ACCENT Gemcitabine + Abraxane Best Overall Response (n=14) Best Overall Response* (n=431) Complete Response (CR) 0 (0%) <1% Partial response (PR) 6 (36%) 23% Stable Disease (SD) 8 (57%) 27% Disease Control Rate (DCR) (=CR+PR+SD) 14 (100%) 50% Progressive Disease (PD) 0 (0%) 20% Not Evaluable 0 (0%) 30% Classification 16 “ Completion of the Phase 1b stage of the trial is an important milestone for the ACCENT trial and the preliminary efficacy signals we have seen to date are very encouraging. Having identified a safe and well tolerated dose of narmafotinib, the team is now focused on executing the next phase of the trial as quickly and efficiently as possible. CEO & MD, DR CHRISTOPHER BURNS ACCENT Trial Phase 2a launched in Australia and Korea Amplia has initiated the Phase 2a portion of the ACCENT clinical trial, with active recruitment of patients across six sites in Australia and five sites in South Korea. The decision to expand the trial into Korea was based on the country’s reputation for world-class clinical research facilities, robust patient recruitment rates in pancreatic cancer trials, and a shared standard of care with Australia. This strategic move aims to accelerate the evaluation of narmafotinib’s potential to improve outcomes for patients with this challenging disease. As of March 2024, 11 patients have been dosed in the Phase 2a trial, with seven in Australia and four in Korea. An interim analysis of efficacy, scheduled for Q3 2024, will assess the treatment’s effectiveness. If six or more partial or complete responses are observed among the initial 26 patients, the trial will proceed to enroll an additional 24 patients, bringing the total to 50. Building relationships in Korea In December, Amplia received approval from the Korean Ministry of Food and Drug Safety (MFDS) for Phase 2a of the ACCENT trial to be conducted across five preselected trial sites in South Korea. This was the culmination of extensive work undertaken by the Amplia team, working closely with Korean regulators to achieve this important milestone. Extending the Phase 2a trial to Korea was a strategic decision for Amplia. Both Australia and Korea boast world-class clinical research facilities, renowned for their high standards, advanced infrastructure, and successful patient recruitment in pancreatic cancer trials. This, combined with the shared standard of care between the two countries, which differs from that in the US and some European nations, made Korea an ideal location to further evaluate the efficacy of narmafotinib. Amplia continues to strengthen its relationships with Korea, with regular visits to clinical sites, and attendance at import