Announcement PDF RAD RADIOPHARM THERANOSTICS Annual Report Year Ended 30 June 2025 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, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☐ SHELL COMPANY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Date of event requiring this shell company report _________ Commission file number 001-41621 Radiopharm Theranostics Limited (Exact name of Registrant as specified in its charter) n/a (translation of Registrant’s name into English) Australia (Jurisdiction of incorporation or organization) Level 3, 62 Lygon Street Carlton VIC 3053 Australia (Address of principal executive offices) Riccardo Canevari, Chief Executive Officer Level 3, 62 Lygon Street Carlton VIC 3053 Australia Phone: +61 3 9824 5254 E-mail: rc@radiopharmtheranostics.com (Name, Telephone, E-mail and/or Facsimile number and Address of Company Contact Person) Securities registered or to be registered pursuant to Section 12(b) of the Act: Title of each class Ordinary Shares, as represented by American Depositary Shares Trading Symbol(s) RADX Securities registered or to be registered pursuant to Section 12(g) of the Act. None Securities for which there is a reporting obligation pursuant to Section 15(d) of the Act. None Name of each exchange on which registered The Nasdaq Stock Market LLC The number of ordinary shares outstanding as of June 30, 2025 was 2,364,949,502. Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. ☐ Yes ☒ No If this report is an annual or transition report, indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934. ☐ Yes ☒ No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. ☒ Yes ☐ No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). ☒ Yes ☐ No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or an emerging growth company. See definition of “large accelerated filer,” “accelerated filer,” and “emerging growth company” in Rule 12b-2 of the Exchange Act. Large accelerated filer ☐ Accelerated filer ☐ Non-accelerated filer ☒ Emerging growth company ☒ If an emerging growth company that prepares its financial statements in accordance with U.S. GAAP, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐ Indicate by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. ☐ If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐ Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐ Indicate by check mark which basis of accounting the registrant has used to prepare the financial statements included in this filing: U.S. GAAP ☐ International Financial Reporting Standards as issued by the International Accounting Standards Board ☒ Other ☐ If “Other” has been checked in response to the previous question, indicate by check mark which financial statement item the registrant has elected to follow. ☐ Item 17 ☐ Item 18 If this is an annual report, indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). ☐ Yes ☒ No TABLE OF CONTENTS PART I Item 1. Item 2. Item 3. Item 4. Item 4a. Item 5. Item 6. Item 7. Item 8. Item 9. Item 10. Item 11. Item 12. PART II Item 13. Item 14. Item 15. Item 16. Item 16a. Item 16b. Item 16c. Item 16d. Item 16e. Item 16f. Item 16g. Item 16h. Item 16I. Item 16J. Item 16K. PART III Item 17. Item 18. Item 19. Identity of Directors, Senior Management and Advisers Offer Statistics and Expected Timetable Key Information Information on the Company Unresolved Staff Comments Operating and Financial Review and Prospects Directors, Senior Management and Employees Major Shareholders and Related Party Transactions Financial Information The Offer and Listing Additional Information Quantitative and Qualitative Disclosures about Market Risk Description of Securities Other Than Equity Securities Defaults, Dividend Arrearages and Delinquencies Material Modifications to the Rights of Security Holders and Use of Proceeds Controls and Procedures Reserved Audit Committee Financial Expert Code of Ethics Principal Accountant Fees and Services Exemptions from the Listing Standards for Audit Committees Purchases of Equity Securities by the Issuer and Affiliated Purchasers Change in Registrant’s Certifying Accountant Corporate Governance Mine Safety Disclosure Disclosure Regarding Foreign Jurisdictions that Prevent Inspections. Insider trading policies Cybersecurity Financial Statements Financial Statements Exhibits i 1 1 1 1 26 47 47 54 69 70 71 72 88 88 90 90 90 90 90 90 90 91 91 91 91 91 92 92 92 92 93 93 93 94 GENERAL INFORMATION Radiopharm Theranostics Limited was incorporated under the laws of the Commonwealth of Australia in February 2021. Our ordinary shares are listed on the ASX under the symbol “RAD”. We filed a registration statement on Form 20-F with respect to our ordinary shares, as represented by American Depositary Shares, or ADSs, with the U.S. Securities and Exchange Commission, that was declared effective on November 27, 2024. Our ADSs, each of which represents 300 of our ordinary shares, are listed on the Nasdaq Capital Market under the symbol “RADX”. Deutsche Bank Trust Company Americas acts as our depositary and registers and delivers our ADSs. Except where the context otherwise requires or where otherwise indicated, the terms “we,” “us,” “our”, “Radiopharm” and the “Company” mean Radiopharm Theranostics Limited and its subsidiaries, unless otherwise indicated. FINANCIAL AND OTHER INFORMATION Our consolidated financial statements appearing in this Annual Report on Form 20-F are prepared in Australian dollars and in accordance with the International Financial Reporting Standards, or IFRS, as issued by the International Accounting Standards Board, or IASB. Our consolidated financial statements appearing in this Annual Report on Form 20-F comply with both the IFRS and Australian Accounting Standards. In this Annual Report, all references to “U.S. dollars” or “US$” are to the currency of the United States and all references to “Australian dollars” or “$” or “A$” are to the currency of Australia. In this Annual Report, “fiscal year” refers to the period between July 1 and June 30 of the following year. For instance, the term “fiscal 2025” refers to our fiscal year ending June 30, 2025. Statements made in this Annual Report on Form 20-F concerning the contents of any contract, agreement or other document are summaries of such contracts, agreements or documents and are not complete descriptions of all of their terms. If we filed any of these documents as an exhibit to this Annual Report or to any registration statement that we previously filed, you may read the document itself for a complete description of its terms. SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS Except for the historical information contained in this Annual Report on Form 20-F, the statements contained in this Annual Report on Form 20-F are “forward-looking statements” which reflect our current view with respect to future events and financial results. We urge you to consider that statements which use the terms “anticipate,” “believe,” “do not believe,” “expect,” “plan,” “intend,” “estimate,” and similar expressions are intended to identify forward-looking statements and these forward-looking statements, include, without limitation, any statements relating to: ● our product development and business strategy, including the potential size of the markets for our products and future development and/or expansion of our products and therapies in our markets; ● our current and future research and development activities, including clinical testing and manufacturing and related costs and timing; ● sufficiency of our cash resources; ● our ability to commercialize products and generate product revenues; ● our ability to raise additional funding when needed; ● any statements concerning anticipated regulatory activities or licensing or collaborative arrangements, including our ability to obtain regulatory clearances; ● our research and development expenses; ● our operations and intellectual property risks; ● our ability to remain compliant with the Australian Securities Exchange (“ASX”) and Nasdaq’s continued listing standards; and ● any statement of assumptions underlying any of the foregoing. We remind investors that forward-looking statements are merely predictions and therefore inherently subject to uncertainties and other factors and involve known and unknown risks that could cause the actual results, performance, levels of activity, our achievements or industry results, to be materially different from any future results, performance, levels of activity, or our achievements expressed or implied by such forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by applicable law, including the securities laws of the United States, we undertake no obligation to publicly release any update or revision to any forward-looking statements to reflect new information, future events or circumstances, or otherwise after the date hereof. Please see the Risk Factors section that appears in “Item 3. Key Information – D. Risk Factors.” ii PART I ITEM 1. IDENTITY OF DIRECTORS, SENIOR MANAGEMENT AND ADVISERS Not applicable. ITEM 2. OFFER STATISTICS AND EXPECTED TIMETABLE Not applicable. ITEM 3. KEY INFORMATION A. [Reserved] B. Capitalization Not applicable. C. Reasons for the Offer and Use of Proceeds Not applicable. D. Risk Factors The following risks relate specifically to our business and should be considered carefully. Our business, financial condition and results of operations could be adversely affected by any of the following risks. As a result, the trading price of our ordinary shares and our American Depositary Shares, or ADSs, could decline and the holders of our ADSs could lose part or all of their investment. Risks Related to Our Business ● We have a history of operating losses and may not achieve or maintain profitability in the future. ● Our research and development activities could be adversely impacted if our sources of funding and revenue are insufficient. ● We currently have no source of product revenue and may never become profitable. ● We will require additional financing and may be unable to raise sufficient capital, which could have a material impact on our research and development programs or commercialization of our drug candidates. ● We may find it difficult to enroll patients in our clinical trials, and patients could discontinue their participation in clinical trials, which could delay or prevent clinical trials and make those trials more expensive to undertake. ● Any failure to implement our business strategy could negatively impact our business, financial condition and results of operations. ● Positive results from preclinical studies of our drug candidates ae not necessarily predictive of the results of our planned clinical trials of our drug candidates. ● Ongoing and future clinical trials of drug candidates may not show sufficient safety and efficacy to obtain requisite regulatory approvals for commercial sale. ● If we do not obtain the necessary regulatory approvals, we will be unable to commercialize our drug candidates. 1 ● Even if our drug candidates receive regulatory approval it may still face development and regulatory difficulties that may delay or impair future sales of drug candidates. ● We have limited manufacturing experience with our drug candidates. ● To the extent we rely significantly on contractors, we will be exposed to risks related to the business and operational conditions of our contractors. ● We depend on, and will continue to depend on, collaboration and strategic alliances with third partners. To the extent we are able to enter into collaborative arrangements or strategic alliances, we will be exposed to risks related to those collaborations and alliances. ● Because we rely on third party manufacturing and supply partners, our supply of research and development, preclinical and clinical development materials may become limited or interrupted or may not be of satisfactory quantity or quality. ● Our research and development efforts will be jeopardized if we are unable to retain key management personnel and cultivate key academic and scientific collaborations. ● We may encounter difficulties in managing our growth, which could negatively impact our operations. ● Future potential sales of our drug candidates may suffer if they are not accepted in the marketplace by physicians, patients and the medical community. ● We face competition from entities that may develop drug candidates for our target disease indications, including companies developing novel treatments and technology platforms based on modalities and technology similar to ours. ● If healthcare insurers and other organizations do not pay for our drug candidates or impose limits on reimbursement, our future business may suffer. ● We could become exposed to product liability claims that could harm our business. ● The outbreak of a pandemic could adversely impact our business, including our non-clinical studies and clinical trials. Risks Related to Intellectual Property ● Our success depends on our ability to protect our intellectual property and out proprietary technology. ● Intellectual property rights of third parties could adversely affect our ability to commercialize our drug candidates such that we could be required to litigate with or obtain licenses from third parties in order to develop or market our drug candidates. ● Our reliance on third parties requires us to share our trade secrets, which increases the possibility that a competitor will discover them or that our trade secrets will be misappropriated or disclosed. ● Obtaining and maintaining our patent protection depends on compliance with various procedural, document submission, fee payment and other requirements imposed by governmental patent agencies, and our patent protection could be reduced or eliminated for non-compliance with these requirements. ● We may become involved in lawsuits to protect and defend our patents or other intellectual property, which could be expensive, time consuming and unsuccessful. ● Confidentiality and invention assignment agreements with our employees, advisors and consultants may not adequately prevent disclosure of trade secrets and protect other proprietary information. ● Intellectual property rights do not address all potential threats to our competitive advantage. 2 ● We may face difficulties with protecting our intellectual property in certain jurisdictions, which may diminish the value of our intellectual property rights in those jurisdictions. ● Changes in patent law could diminish the value of patents in general, thereby impairing our ability to protect our drug candidates and any future drug candidates. ● Price controls may be imposed in non-U.S. markets, which may negatively affect our future profitability. Risks Relating to Ownership of the ADS ● The trading price of the ADSs may be volatile, and purchasers of the ADSs could incur substantial losses. ● If we are or become a passive foreign investment company (“PFIC”), then that would subject our U.S. shareholders to adverse tax rules. ● The requirements of being a public company may strain our resources and divert management’s attention. ● We could become subject to the auditor attestation requirement under the Sarbanes-Oxley Act even if we have little or no revenue, thus imposing significant cost and administrative burden on us. ● Our issuance of additional ordinary shares in connection with financings, acquisitions, investments, or otherwise will dilute all other ADS holders. ● As long as we remain subject to the rules of the ASX, we may be unable to conduct certain types of capital raisings without shareholder approval if such capital raising would result in an equity issuance above regulatory thresholds and, consequently, we could be unable to obtain financing sufficient to sustain our business if we are unsuccessful in soliciting requisite shareholder approvals. ● We are subject to risks associated with currency fluctuations, and changes in foreign currency exchange rates could impact our results of operations. ● Our ADS holders are not shareholders and do not have shareholder rights. ● Our ADS holders do not have the same rights to receive dividends or other distributions as our shareholders. ● There are circumstances where it may be unlawful or impractical to make distributions to the holders of our ADSs. ● ADS holders may not be entitled to a jury trial with respect to claims arising under the deposit agreement, which could augur less favorable results to the plaintiff(s) in any such action. ● The exclusive jurisdiction and arbitration provided for in the deposit agreement may discourage claims or limit the ability of the ADS holders to bring a claim. 3 Risks Relating to Our Location In Australia ● Australian takeover laws may discourage takeover offers being made for us or may discourage the acquisition of large numbers of our shares. ● Holders of our ordinary shares or ADSs may have difficulty in effecting service of process in the United States or enforcing judgments obtained in the United States. ● As a foreign private issuer whose ADSs are listed on the Nasdaq Capital Market, we may follow certain home country corporate governance practices instead of certain Nasdaq requirements. ● As a foreign private issuer, we are exempt from a number of rules under the U.S. securities laws and are subject to lower disclosure requirements under U.S. law compared to a U.S. company. ● Any loss of our foreign private issuer status in the future could result in significant additional cost. ● U.S. investors may have difficulty enforcing civil liabilities against our company, our directors or members of senior management and the experts named in this Annual Report. ● Our quorum requirements to vote at a shareholders meeting and our voting procedures may not protect our shareholders’ interests. Risks Related to Our Business We have a history of operating losses and may not achieve or maintain profitability in the future. We have experienced significant recurring operating losses and negative cash flows from operating activities since inception. For example, for the year ended June 30, 2025, we had a total comprehensive loss of A$37.88 million and negative cash flows from operating activities of approximately A$36.65 million. As of June 30, 2025, we had accumulated losses of A$145.73 million. We are a clinical-stage radiotherapeutics company that focuses on the development of radiopharmaceutical products for diagnostic and therapeutic uses in areas of high unmet medical need. The success of any product development is uncertain. We expect to continue to incur losses from operations for the foreseeable future and expect the costs of drug development to increase in the future as more patients are recruited to our clinical trials. In particular, we expect to continue to incur significant losses in the development of our clinical trials and drug candidates. Because of the numerous risks and uncertainties associated with the development, manufacturing, sales and marketing of our drug candidates, we may experience larger than expected future losses and may never become profitable. 4 Moreover, there is a substantial risk that we, or our development partners, may not be able to complete the development of our current drug candidates or develop other pharmaceutical products. It is possible that none of them will be successfully commercialized, which would prevent us from ever achieving profitability. The group’s ongoing viability and ability to continue as a going concern depends on its capacity to meet debts and commitments as they fall due. Based on current budget forecast assumptions, the group is in a position to meet future commitments in the current business cycle and pay its debts as and when they fall due. Furthermore, the group is able to progress its research and development programs for at least the next 12 months. In addition, the group has the ability to employ cash management strategies such as delaying or reducing some operating activities and raise further capital subject to maintaining an active listing on the NASDAQ exchange as well as compliance with the group’s obligations under ASX Listing Rule 7.1. The group’s track record of successful capital raises provides confidence in their ability to secure funding if required. Our research and development activities could be adversely impacted if our sources of funding and revenue are insufficient. We anticipate that as the costs related to the development of our clinical trials will increase, we will require additional funds to achieve our longterm goals of commercialization and further development of our drug candidates. In addition, we will require funds to pursue regulatory applications, defend intellectual property rights, contract manufacturing capacity, potentially develop marketing and sales capabilities and fund operating expenses. We intend to seek such additional funding through public or private financings and/or through licensing of our assets or other arrangements with corporate partners. However, such financing, licensing opportunities or other arrangements may not be available from any sources on acceptable terms, or at all. Any shortfall in funding could result in us having to curtail or cease our research and development activities, thereby harming our business, financial condition and results of operations. In addition, because of the numerous risks and uncertainties associated with the development of our drug candidates, we are unable to predict the timing or amount of increased research and development costs, or when, or if, we will be able to achieve or maintain profitability. Our costs could significantly increase beyond current expectations if the applicable regulatory authorities require further studies in addition to those currently anticipated. In any case, even if our drug candidates are approved for commercial sale, we anticipate incurring significant costs associated with the commercial launch of such drug candidates and there can be no guarantee that we will ever generate significant revenues. We currently have no source of product revenue and may never become profitable. Our drug candidates have not been approved for commercial sale. We expect it to be several years before they are approved, if ever, and we are able to commence sales of our drug candidates. To date, we have not generated any revenue from the licensing or commercialization of our drug candidates and do not expect to receive revenue from them for a number of years, if ever. We will not be able to generate product revenue unless and until our current drug candidates or any future drug candidates, alone or with future partners, successfully completes clinical trials, receives regulatory approval and is successfully commercialized. Although we may seek to obtain revenue from collaboration or licensing agreements with third parties, we currently have no such agreements that could provide us with material, ongoing future revenue and we may never enter into any such agreements. 5 We will require additional financing and may be unable to raise sufficient capital, which could have a material impact on our research and development programs or commercialization of our drug candidates. We have historically devoted most of our financial resources to research and development, including pre-clinical and clinical development activities. To date, we have financed a significant amount of our operations through equity financings. The amount of our future net losses will depend, in part, on the rate of our future expenditures and our ability to obtain funding through equity or debt financings or strategic collaborations. The amount of such future net losses, as well as the possibility of future profitability, will also depend on our success in developing and commercializing products that generate significant revenue. Our failure to become and remain profitable would depress the value of our ADSs and could impair our ability to raise capital, expand our business, maintain our research and development efforts, diversify our product offerings or even continue our operations. We anticipate that our expenses will increase substantially for the foreseeable future if, and as, we: ● continue our research and preclinical and clinical development of our drug candidates; ● expand the scope of our current proposed clinical studies for our drug candidates; ● initiate additional preclinical, clinical or other studies for our drug candidates; ● change or add additional manufacturers or suppliers; ● seek regulatory and marketing approvals for our drug candidates that successfully complete clinical studies; ● seek to identify and validate additional drug candidates; ● acquire or in-license other drug candidates and technologies; ● maintain, protect and expand our intellectual property portfolio; ● attract and retain skilled personnel; ● create additional infrastructure to support our operations as a publicly quoted company and our product development and planned future commercialization efforts; ● add an internal sales force; and ● experience any delays or encounter issues with any of the above. Until our drug candidates become commercially available, we will need to obtain additional funding in connection with the further development of our drug candidates. Our ability to obtain additional financing will be subject to a number of factors, including market conditions, our operating performance and investor sentiment. As such, additional financing may not be available to us when needed, on acceptable terms, or at all. If we are unable to raise capital when needed or on attractive terms, we could be forced to delay, reduce or eliminate our research and development programs or any future commercialization efforts or obtain funds by entering agreements on unattractive terms. Furthermore, any additional equity fundraising in the capital markets may be dilutive for shareholders and any debt-based funding may bind us to restrictive covenants and curb our operating activities and ability to pay potential future dividends even when profitable. We cannot guarantee that future financing will be available in sufficient amounts or on acceptable terms, if at all. If we are unable to raise additional capital in sufficient amounts or on acceptable terms, we will be prevented from pursuing research and development efforts. This could harm our business, operating results and financial condition and cause the price of our ADSs to fall. If we are unable to secure sufficient capital to fund our operations, then we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to third parties to develop and market drug candidates that we would otherwise prefer to develop and market ourselves. For example, strategic collaborations could require us to share commercial rights to our drug candidates with third parties in ways that we do not intend currently or on terms that may not be favorable to us. Moreover, we could also be required to relinquish valuable rights to our technologies, future revenue streams, research programs or drug candidates or grant licenses on terms that may not be favorable to us. 6 We may find it difficult to enroll patients in our clinical trials, and patients could discontinue their participation in clinical trials, which could delay or prevent clinical trials and make those trials more expensive to undertake. Identifying and qualifying patients to participate in current and any future clinical trials of our drug candidates is critical to our success. The timing of our