Announcement PDF RAD RADIOPHARM THERANOSTICS Annual Report: Year Ended 30 June 2024 Radiopharm Theranostics Limited ABN 57 647 877 889 Annual Report - 30 June 2024 Corporate directory Review of operations and activities Directors' report Directors and company secretary Principal activities Dividends Review of operations Significant changes in the state of affairs Events since the end of the financial year Likely developments and expected results of operations Environmental regulation Information on directors Company secretary Meetings of directors Audited Remuneration report Shares under option Insurance of officers and indemnities Proceedings on behalf of the company Non-audit services Auditor's independence declaration Rounding of amounts Corporate governance statement Financial statements Independent auditor's report to the members Shareholder information 1 4 12 12 12 12 12 12 13 13 13 14 16 17 18 32 32 33 33 34 34 35 36 101 106 Radiopharm Theranostics Limited Corporate directory Directors Mr Paul Hopper Executive Chairman Mr Riccardo Canevari CEO and Managing Director Mr Phillip Hains (appointed 26 March 2024) Executive Director Mr Ian Turner Non-Executive Director Ms Hester Larkin Non-Executive Director Dr Leila Alland Non-Executive Director Secretary Mr Phillip Hains Mr Nathan Jong Principal registered office in Australia Level 3, 62 Lygon Street Carlton VIC 3053 Australia Telephone: +61 (0)3 9824 5254 Facsimile: +61 (0)3 9822 7735 Share and debenture register Automic Pty Ltd Level 5, 126 Phillip Street Sydney NSW 2000 +61 (0)2 9698 5414 Auditor Grant Thornton Audit Pty Ltd Collins Square Tower 5, 727 Collins Street Melbourne VIC 3008 Telephone: +61 (0)3 8320 2222 Solicitors McCullough Robertson Level 11, Central Plaza Two 66 Eagle Street Brisbane QLD 4000 Telephone: +61 (0)7 3233 8888 Bankers National Australia Bank 330 Collins Street Melbourne VIC 3000 Stock exchange listings Radiopharm Theranostics Limited shares are listed on the Australian Securities Exchange (ASX: RAD) Website www.radiopharmtheranostics.com Radiopharm Theranostics Limited 1 Executive Chairman’s Letter Dear Fellow Shareholders, It is with pleasure that I present to you the 2024 Annual Report for Radiopharm Theranostics (RAD), marking a year of notable transformation and achievement for our company. Over the past year, we have achieved milestones across our clinical programs, significantly strengthened our financial position, and continued our push to be a recognised player in the burgeoning field of radiopharmaceuticals. First and foremost, we were recently pleased to announce the successful completion of our A$70 million capital raising effort, a landmark achievement that positions RAD for substantial growth and advancement. This funding round included a strategic investment from the world’s largest radiopharmaceutical player, Nasdaq listed, Lantheus Holdings, Inc. This support underscores the confidence in our highly prospective portfolio of assets. The associated placement attracted solid interest from leading international institutional investors and specialist healthcare funds, such that our share register is now 75% institutional owned. This again reflects the confidence in our assets and the RAD business strategy. This capital infusion is expected to fully support our ongoing clinical initiatives through 2026, ensuring robust progress across our pipeline and solidifying our position in a sector which is attracting widespread investor and Big Pharma interest. Throughout the year, we achieved noteworthy advancements across our clinical programs including dosing first patients across two clinical trials, granting of the IND for our brain mets program, and completion of CMC manufacturing in two programs, demonstrating the commitment of the team to driving the assets into the clinic. Our Phase 1 clinical trial for RAD 301 pancreatic cancer, targeting αvβ6 integrin in Pancreatic Ductal Adenocarcinoma (PDAC), commenced at the Montefiore Medical Center, Albert Einstein College of Medicine, NY, USA. This study aims to evaluate the safety and dosimetry of RAD 301, building on the encouraging results previously obtained in compassionate use and investigator-initiated studies. At the European Molecular Imaging Meeting (EMIM) in Portugal, our academic collaborators presented encouraging preclinical and clinical data that support the potential of our RAD 301 programs to detect and treatαvβ6-integrin expressing cancers, including pancreatic, non small cell lung, and head and neck cancers. These presentations showed our commitment to advancing precision medicine through innovative radiopharmaceutical solutions. Furthermore, our RAD 204 program, a therapeutic targeting Programmed Death-Ligand 1 (PDL1) in Non-Small Cell Lung Cancer (NSCLC), saw the dosing of its first patient in a Phase 1 clinical trial at Wollongong Hospital, and other Centres in Australia are now being opened. This milestone represents a solid step forward in exploring the therapeutic potential of our proprietary nanobody approach in combating advanced NSCLC. Radiopharm Theranostics Limited 2 We are ready to submit our Her-2 nanobody therapeutic program for Ethics approval to start a Phase 1 trialin Australia in which several Centres will participate. Our joint venture partnership with MD Anderson Cancer Centre continues to make good progress and our plans to have the key therqpeutic molecule targeting B7H3 in a Phase 1 clinical trial in 2025, remains on-track. Post balance date, we increased RAD’s shareholding in the MD Anderson joint-venture to 75%. The global interest in radiopharmaceuticals continues to grow, driven by the promising clinical outcomes, subsequent approvals and the potential of targeted therapies to revolutionize cancer treatment. Our work in leveraging six targeting agents, across five therapeutic and two imaging programs, to develop next-generation radiotherapeutics, has garnered investor and medical attention within the scientific community and industry stakeholders alike. As we look ahead, RAD is poised to build upon these achievements and capitalise on the recent momentum gained from our successful capital raising. We remain committed to advancing our pipeline, pursuing regulatory milestones, and delivering innovative solutions that have the potential to transform cancer care globally. I wish to thank our CEO, Riccardo Canevari for his tireless work efforts & experienced guidance, across all aspects of the Company’s operations over the past year. I also extend my thanks to our dedicated team, whose commitment and expertise have been instrumental in driving our progress. I also thank our shareholders, new and existing, for their continued support and confidence in our vision. In closing, I am confident that RAD is well-positioned for renewed growth and success, driven by our dedication to innovation, scientific excellence, and improving patient outcomes. Yours sincerely, Paul Hopper Executive Chairman Radiopharm Theranostics Limited 3 Review of Operations and Activities Year ended: 30 June 2024 Radiopharm Theranostics Limited is developing a world‐class platform of radiopharmaceutical and products for both diagnostic and therapeutic uses. Company’s pipeline includes 5 therapeutics and 2 imaging molecules. FINANCIAL REVIEW The group reported a loss for the year ended 30 June 2024 of $47,949,119 (30 June 2023: $34,611,194). This increased loss compared to the comparative period is due to the increase in clinical trial and research activities undertaken by the group during the year and increase fair value movements in contingent consideration. The group’s net assets decreased to $27,353,286 (30 June 2023: 45,579,425). This is primarily due to amortisation and sale of intangible assets, and increase trade and other payables which is due to the increased progress of the group’s research and development activities in the year. As at 30 June 2024, the group had cash reserves of $18,575,040 (30 June 2023: $11,699,066). CLINICAL PROGRESS OPERATING REVIEW First participant dosed in Phase 1 pancreatic imaging study of RAD 301 The Phase 1 clinical trial for 68Ga-Trivehexin (RAD 301) commenced in February. The trial, involving nine participants, aims to assess the safety and dosimetry of RAD 301, a diagnostic radiopharmaceutical targeting αvβ6 integrin in Pancreatic Ductal Adenocarcinoma (PDAC) patients. The trial is being conducted at the Montefiore Medical Center, Albert Eistein College of Medicine, NY, USA. Radiopharm previously received a “safe to proceed” letter from the US Food and Drug Administration (FDA) for an amended IND (Investigational New Drug) to open a Phase 1 clinical trial of 68GaTrivehexin (RAD 301) in New York City. 99 patients have previously been imaged with RAD 301 under compassionate use or Investigator-Initiated Study without safety issues. Radiopharm Theranostics Limited 4 First patient dosed with PD-L1 nanobody in Phase 1 therapeutic Non-Small Cell Lung Cancer trial Subsequent to the end of the period, Radiopharm announced the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer. The open-label Phase 1 study, entitled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is a First-InHuman dose escalation trial of 177Lu-RAD 204, and is designed to evaluate the safety and preliminary efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC. The study is currently being conducted in Australia at Wollongong Hospital (NSW), Princess Alexandra Hospital (QLD), and Hollywood Private Hospital (WA), with the support of GenesisCare CRO. Radiopharm received Human Research Ethics Committee (HREC) approval for the study in October 2023. Multiple positive data release for RAD 301 During the period Radiopharm announced promising preclinical and clinical data from its academic collaborators that support the potential for RAD 301 programs to become important new diagnostic and therapeutic modfalities. The data were presented at the 2024 European Molecular Imaging Meeting (EMIM) in Porto, Portugal. The technologies were featured across three different presentations at the event. The first presentation, led by Prof. Susanne Kossatz from the Technical University of Munich, showcased a lung cancer mouse model study. This research demonstrated that succinylated gelatin significantly reduces kidney uptake of αvβ6-integrin targeted therapies and diagnostics compared to traditional methods. This reduction in kidney uptake is crucial for minimising radiation exposure to the kidneys during radiopharmaceutical treatments. The findings suggest that succinylated gelatin could enhance the safety and effectiveness of Radiopharm’s RAD 302 αvβ6-integrin targeting agentto treat multiple cancer types. The second presentation involved a clinical study with 33 patients comparing [18F]FDG PET/CT with 68Ga-Trivehexin (RAD 301) for detecting αvβ6-integrin expressing cancers. The study revealed that RAD 301 offers a superior Tumor to Background Ratio in Pancreatic Ductal Adenocarcinoma (PDAC) and Head and Neck Squamous Cell Carcinoma (HNSCC), highlighting its potential as an important imaging biomarker and candidate for αvβ6-integrin radiotherapeutic treatment selection. Additionally, Ms. Nora Schmid from the Technical University of Munich conducted a comprehensive immunohistochemistry analysis on over 3200 specimens from Radiopharm Theranostics Limited 5 approximately 1400 patients, covering fourteen αvβ6-integrin expressing carcinomas, including PDAC, NSCLC, HNSCC, and prevalent female cancers such as Cervical, TripleNegative Breast, Endometrial, and Ovarian Cancer. The analysis revealed high expression levels of αvβ6-integrin across these cancers, underscoring its significance as a target with broad therapeutic potential. Pilot study in prostate cancer validates RAD’s development of first-in- class Terbium-161 radioptherapeutics In February, results from a pilot study were reported demonstrating the potential superiority of Terbium-161 (TB-161) over Lutetium-177 (Lu-177) in treating metastatic castration-resistant prostate cancer. The study, involving six patients, showed that Tb-161-PSMA-617 delivered a significantly higher tumor-absorbed dose than Lu-177PSMA-617. These data support Radiopharm's strategy for the development of nextgeneration Tb-161 radiotherapeutics for advanced cancers. Radiopharm has partnered with TerThera to secure a supply of Tb-161, making it the first public company to access this isotope for clinical development of its assets, starting with the planned development of RAD 402 to treat advanced prostate cancer. Radiopharm executed an expanded supply agreement with TerThera for the provision of Terbium-161 (Tb-161). BOARD & MANAGEMENT CHANGES At the beginning of the financial year, Radiopharm announced the appointment of accomplished biotech and pharma industry leader Dr Sherin Al-Safadi to the position of Vice President Medical and Corporate Affairs. Prior to joining Radiopharm, Dr Al-Safadif held the role of Vice-President – Medical Affairs at POINT Biopharma, where she assembled and headed up a medical affairs division and led the strategic and tactical planning for Phase III support and launch preparation of radiopharmaceuticals. She also provided strategic input and leadership for business development and licensing opportunities. During March, Dr Michael Baker resigned from his position as Non-Executive Director of Radiopharm to focus on his other business interests. Dr Baker served on Radiopharm’s Board since February 2021. Following the resignation, the Board appointed Phillip Hains as an Australian resident Director to fill a casual vacancy. Phillip is the Company’s CFO and Joint Company Secretary. Radiopharm Theranostics Limited 6 FUNDING ACTIVITIES In June, Radiopharm announced the successful completion of a A$70 million placement (Placement), marking a pivotal milestone for the company. Very significantly, this capital raising included a strategic investment from Lantheus Holdings, Inc., a leader in the global radiopharmaceutical industry. Lantheus committed A$7.5 million at a price of A$0.05 per share (a 47% premium to the last closing price prior to the Placement). Additionally, Lantheus holds an option to further invest another A$7.5 million within the next six months. As part of the agreement Lantheus also secured rights to two early preclinical assets through a US$2 million upfront payment. In addition to the Lantheus investment, the Placement raised an additional A$62.5 million, with these new shares offered at A$0.04 each, representing an 18% premium to the closing price prior to the Placement. This fundraising effort attracted participation from leading international institutional investors, including specialist healthcare investors from the US. The Placement is expected to fully support Radiopharm’s current clinical programs until the end of 2026, ensuring a robust pipeline of development. Executive Chair Paul Hopper is also participated in the Placement with a personal investment of A$3 million. Radiopharm Theranostics has subsequently announced that all resolutions concerning the capital raising, at its Extraordinary General Meeting (EGM) on 14 August 2024, were approved. This includes the A$70 million capital raising and A$7.5 million investment by Lantheus Holdings. As part of these broader funding arrangements outlined above, subsequent to the end of the period Radiopharm notified Lind Global Fund II, LP (Lind) of the Company’s intent to exercise its right to terminate the Share Subscription Agreement and Share Purchase Agreement between Radiopharm and Lind. The abovementioned agreement with Lind was announced in February, in order to provide initial funding of A$1.5m and total funding of up to A$12.5m. In November, the Company received A$4,851,839 from the Australian Government’s R&D tax incentive program, which offers a refundable tax offset of up to 43.5% for eligible activities. On 31 October 2023, the company launched a non-renounceable entitlement offer to raise approximately $10 million, allowing eligible shareholders to subscribe for new shares at $0.07 each. The offer concluded in December, raising approximately $2.1 million through valid applications for around 30 million new shares. On 24 January 2024, additional valid applications for approximately 24 million new shares were received under the shortfall of the entitlement offer, raising approximately $1.7 million. Radiopharm Theranostics Limited 7 In February it was also announced that Radiopharm received $1.9 million from Radium Capital under a funding facility secured against its anticipated FY24 Research and Development Tax Incentive (RDTI). OTHER SUBSEQUENT EVENTS FDA IND “Safe to Proceed” letter received for Phase 2b imaging trial in brain metastases Radiopharm received a “safe to proceed” letter from the US FDA after submission of an Investigational New Drug (IND) application for its imaging agent, F18-Pivalate (RAD 101), aimed at detecting and characterizing brain metastases. This approval allows the company to proceed with a Phase 2b multi-center clinical trial. F18-Pivalate targets fatty acid synthetase, which is overexpressed in brain tumours, providing a novel approach for imaging brain metastases. The first patient is expected to be dosed in Q4 2024, with full enrollment anticipated by 2025. Radiopharm Theranostics targets Nasdaq listing by end of 2024 The Company has announced plans to secure a secondary listing on the Nasdaq Capital Market by the end of 2024. This follows a delay in the process due to market conditions. The listing involves the issuance of American Depositary Shares (ADS), each representing 200 ordinary shares, under the ticker RADX. The Nasdaq listing aims to broaden Radiopharm’s investor base and enhance shareholder value. RAD increases ownership in Radiopharm Ventures to 75% Radiopharm increased its ownership in Radiopharm Ventures, LLC, a joint venture with MD Anderson Cancer Center, from 51% to 75%. This follows progress in developing its lead candidate, a B7H3 monoclonal antibody for cancer treatment, which is nearing Phase I clinical trials set for mid 2025. Additionally, two other preclinical assets have shown promising results. Radiopharm committed an additional USD $4 million to support future clinical and preclinical efforts. Appointment of Dr Dimitris Voliotis as Chief Medical Officer Radiopharm has appointed Dr Dimitris Voliotis as Chief Medical Officer (CMO). Dr Voliotis brings nearly 20 years of experience in the pharmaceutical and biotechnology sectors, with a focus on radiopharmaceuticals and oncology. He has overseen multiple drug approvals in various oncology indications and has held leadership roles at multiple companies including Convergent Therapeutics, Zentalis Pharmaceuticals, Eisai and Bayer. For and behalf of the company, Riccardo Canevari CEO and Managing Director Radiopharm Theranostics Limited 8 Material Risk Report This forms part of the review of operations which forms part of the directors report. Additional Information with regards to Risk Management and Key Risks There are various internal and external risks that may have a material impact on the Group’s future financial performance. The Group has processes in place to identify materials risks and to manage these effectively. The Board takes a proactive approach to risk management. The Board has oversight of the Audit & Risk Committee which is responsible for ensuring that risks, and opportunities are identified in a timely manner and that the Group’s objectives and activities are aligned with the risks and opportunities identified by the Board. The Audit & Risk Committee periodically receives updates on and provides feedback to Management on the identification of risks and the progress/effectiveness of risk mitigation strategies. Material risks that could adversely impact the Group’s financial prospects are outlined below. These risks do not represent an exhaustive list of the risks Radiopharm is exposed to, nor are they in order of significance. Clinical Trial Risk The ability of the Group to commercialise its intellectual property is dependent on receiving approvals to conduct future clinical trials. Given the nature of the Group's activities, there is a risk that the clinical trials may not be successful. If the Group does not receive approval for clinical trials, or the clinical trials are not successful, this will impact on the Group's ability to commercialise its intellectual property. The Group mitigates this risk by having highly qualified and skilled personnel and consultants where required conducting clinical trials and liaising with regulatory and licensing authorities. Dependence upon key personnel Radiopharm depends on the talent and experience of its personnel as its primary asset. There may be a negative impact on Radiopharm if any of its key personnel leave. It may be difficult to replace them, or to do so in a timely manner or at a comparable expense. The Group mitigates this risk by ensuring key personnel are remunerated commensurate to the value they provide Radiopharm and also invested in the success of Radiopharm through the issuance of short and long term incentives. Competition The Biotechnology and Pharmaceutical industries are intensely competitive and subject to rapid and significant technological change. A number of companies, both in Australia and abroad, may be pursing the development of products that target the same markets that Radiopharm is targeting. The Company’s products may compete with existing alternative treatments that are already available to customers. In addition, a number of companies, both in Australia and abroad, may be pursuing the development of products that target the same conditions that the Group is targeting. Radiopharm Theranostics Limited 9 The Group mitigates this risk by completing extensive assessments periodically of their competitors and their progress to ensure that Radiopharm has a competitive advantage where possible. Requirements to raise additional funds The Group may be required to raise additional equity or debt capital in the future. As there is no assurance a raise will be successful when required, the group may need to reprioritise its operations. The Group mitigates this risk by closely monitoring their cash and cash equivalents and engaging in investment/funding opportunities as required. Risk of delay and continuity of operations Radiopharm may experience delay in achieving a number of critical milestones, including securing commercial partners, completion of clinical trials, obtaining regulatory approvals, manufacturing, product launch and sales. Any material delays may impact adversely upon the group including the timing of any revenues under milestone or sales payments. The Group mitigates this risk by closely managing timelines of critical milestones and actively engages with potential commercial partners and regulators. In addition, the Group is ensuring that all FDA and regulatory advice is carefully reviewed and implemented accordingly. Manufacturing Manufacturing processes may result in product batches not meeting minimum specifications, raw material components not being sourced to specification. The manufacturing process may encounter process issues not previously identified and controlled, and there may be non-controllable disruptions to the operations of the products, contract manufacturers. These factors may lead to delay or nonsupply of product and/or adverse regulatory outcomes. The Group mitigates this risk by working very closely with its suppliers to ensure scheduling fits forecast requirements and that the manufacturing processes are actively managed. New suppliers are subject to due diligence processes and key relationships are developed with regulatory agencies to support the Group in the event of supply chain disruption. Taxation Changes to the rate of taxes imposed on the Group (including overseas jurisdictions in which Radiopharm operates now or in the future) or tax legislation generally may affect Radiopharm and its shareholders. In addition, an interpretation of Australian tax laws by the Australian Taxation Office that differs to the Group’s interpretation may lead to an increase in the Group’s tax liabilities and a reduction in shareholder returns. Personal tax liabilities are the responsibility of each individual investor. Radiopharm is not responsible either for tax or tax penalties incurred by investors. Accounting Standards Australian accounting standards are set by the Australian Accounting Standards Board (AASB) and are outside the director’s and Radiopharm’s control. Changes to accounting standards issued by AASB could materially adversely affect the financial performance and position reported in Radiopharm’s financial statements. Radiopharm Theranostics Limited 10 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. Radiopharm Theranostics Limited 11 Radiopharm Theranostics Limited Directors' report 30 June 2024 Your directors present their report on the consolidated entity consisting of Radiopharm Theranostics Limited and the entities it controlled (Radiopharm Theranostics (USA) Inc and Radiopharm Ventures LLC) at the end of, or during, the year ended 30 June 2024. Throughout the report, the consolidated entity is referred to as the group. Directors and company secretary The following persons held office as directors of Radiopharm Theranostics Limited during the financial year and up to the date of this report, except where otherwise stated: Mr Paul Hopper, Executive Chairman Mr Riccardo Canevari, CEO and Managing Director Mr Phillip Hains, Executive Director (appointed 26 March 2024) Dr Michael Baker, Non-Executive Director (resigned 26 March 2024) Mr Ian Turner, Non-Executive Director Ms Hester Larkin, Non-Executive Director Dr Leila Alland, Non-Executive Director The following persons held office as company secretary of Radiopharm Theranostics Limited during the whole of the financial year and up to the date of this report, except where otherwise stated: Mr Phillip Hains Mr Nathan Jong Principal activities Radiopharm Theranostics Limited is an Australian research and development group. The aim of the group is focused on the development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical need. Lead products under development by the group are Nano-mAbs and AVB6 Integrin. Dividends No dividends were declared or paid to members for the year ended 30 June 2024 (2023: none). The directors do not recommend that a dividend be paid in respect of the financial year. Review of operations Information on the operations and financial position of the group and its business strategies and prospects is set out in the review of operations and activities, which forms part of this directors' report, on pages 4 to 11 of this Annual report. Significant changes in the state of affairs On 25 June 2024, Radiopharm announced they had completed a A$70 million two tranche placement which comprises of the following: - Tranche 1: A$23.9 million of placement shares issued on 1 July 2024 comprising of 97 million shares; - Tranche 2: A$46.1 million of placement shares issued in August and September after receiving shareholder approval; and - 781 million options exercisable at A$0.06. In addition, Radiopharm has agreed to transfer two of its early preclinical assets to Lantheus for A$3.0 million, pursuant to a separate transfer and development agreement. In the opinion of the directors, there were no other significant changes in the state of affairs of the group that occurred during the year. Radiopharm Theranostics Limited 12 Radiopharm Theranostics Limited Directors' report 30 June 2024 (continued) Events since the end of the financial year On 2 July 2024, the group announced that they ended the share subscription agreement and share purchase agreement with Lind Partners effective immediately. On 5 August 2024 Radiopharm announced they had received US$2 million from Lantheus Holdings Inc in accordance with the preclinical asset transfer and development agreement announced on 20 June 2024. On 14 August, the group completed a Extraordinary General Meeting which approved the issue of 1,115 million shares raising A$46.1 million, issue of 772 million options exercisable at $0.06 and expiring in 2 years from settlement and issue 150 million unlisted options exercisable at $0.05 and expiring in February 2025. On 20 August 2024 the group announced the appointment of Dr Dimitris Voliotis as their Chief Medical Officer. On 26 August 2024, Radiopharm announced they had increased their ownership in Radiopharm Ventures to 75%. To support the further advancement of the trails and to increase the ownership, Radiopharm has committed an additional US$4.0 million to the joint venture to cover future preclinical and clinical expenses. No other matter or circumstance has occurred subsequent to year end that has significantly affected, or may significantly affect, the operations of the group, the results of those operations or the state of affairs of the group or economic entity in subsequent financial years. Likely developments and expected results of operations The group aims to create value for shareholders through researching, developing and commercialising Radio