Core Insights - The Phase 2b clinical trial for RAD101 has reached a 50% patient enrollment milestone, indicating progress towards demonstrating its clinical benefits in differentiating tumor recurrence from radiation necrosis in brain metastasis patients [2][6] - Early patient data shows significant and selective tumor uptake in brain metastases, aligning with previous Phase 2a results, which may lead to a global Phase 3 registrational trial if confirmed [3][7] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][9] - The company is listed on ASX (RAD) and NASDAQ (RADX), with a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumor cancers, including lung, breast, and brain metastases [9] Clinical Trial Details - The Phase 2b trial is a multicenter, open-label study evaluating the diagnostic performance of 18F-RAD101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [6] - The primary objective is to assess the concordance between 18F-RAD101 positive lesions and those identified through conventional imaging methods [6] Product Information - RAD101 is a novel imaging small molecule targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [2][7] - The product has received FDA Fast Track Designation to help distinguish between recurrent disease and treatment effects in brain metastases [5]

Core Insights - Radiopharm Theranostics has completed enrollment for the second cohort in the Phase 1 trial of 177Lu-RAD204, which targets PD-L1 positive advanced cancers, marking a significant milestone for the company [1][2] - The Data and Safety Monitoring Committee has approved advancing to a higher dose of 90mCi for the third cohort of patients [2] - The trial aims to evaluate the safety, tolerability, biodistribution, radiation dosimetry, and preliminary anti-tumor activities of 177Lu-RAD204 in patients with metastatic solid tumors [2][3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][5] - The company is listed on both ASX (RAD) and NASDAQ (RADX) and has a diverse pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [5] - The company’s technology platform spans peptides, small molecules, and monoclonal antibodies for cancer treatment [5] Product Details - 177Lu-RAD204 is a single-domain monoclonal antibody that targets PD-L1, which is overexpressed in many solid tumors, making it a promising therapeutic target [3][4] - Previous Phase 1 imaging data indicated that the diagnostic compound is safe and has acceptable dosimetry in NSCLC patients [3]

Core Insights - The Depositary Receipts Virtual Investor Conference ("dbVIC") was held on November 4th, 2025, and the presentations are now available for online viewing [1][2] - The company presentations will be accessible 24/7 for a duration of 90 days, allowing investors, advisors, and analysts to download materials [2] Company Presentations - The following companies presented at the conference: - HUTCHMED (China) Limited (AIM: HCM, NASDAQ: HCM, HKEX: 13) - First Pacific Company Ltd (HKEX: 142, OTC: FPAFY) - Viomi Technology Co., Ltd (NASDAQ: VIOT) - Epiroc AB (Nasdaq Stockholm: EPIA, OTC: EPOAY) - Yiren Digital Ltd. (NYSE: YRD) - Belite Bio, Inc (NASDAQ: BLTE) - Deutsche Lufthansa AG (FRA: LHA, OTCQX: DLAKY) - Lotus Technology Inc (NASDAQ: LOT) - 51Talk Online Education Group (NYSE American: COE) - Radiopharm Theranostics Ltd (Nasdaq: RADX; ASX: RAD) - Repsol S.A (BME: REP, OTCQX: REPYY) [3] About Virtual Investor Conferences - Virtual Investor Conferences (VIC) is recognized as the leading proprietary investor conference series, providing an interactive platform for publicly traded companies to present directly to investors [4] - VIC offers a real-time investor engagement solution, designed to enhance investor access and replicate the components of an on-site investor conference [5]

Summary of Radiopharm Theranostics Conference Call Company Overview - **Company Name**: Radiopharm Theranostics - **Ticker Symbols**: ASX (Australia), NASDAQ: RADX - **Founded**: 2021 in Australia - **Core Business**: Radiopharmaceutical imaging and therapies - **Management Team**: Primarily U.S.-based, located on the East Coast - **Public Listing**: Dual-listed on ASX and NASDAQ since December 2024 [2][4] Key Business Strategies - **Differentiation**: Focus on unique mechanisms of action in radiopharmaceuticals, avoiding common targets like PSMA, SSTR2, and FAP [3] - **Clinical Development**: Four therapeutic molecules and one imaging molecule currently in clinical stages [2][5] - **Supply Chain**: Established a secure and redundant supply chain, with strategic partnerships [4] Strategic Partnerships - **Lantheus**: Co-development agreement and largest shareholder (12% stake) [4] - **MD Anderson Cancer Center**: Joint venture for developing new radiopharmaceuticals [4][21] Product Pipeline - **RAD101**: Imaging agent for brain metastasis, currently in Phase IIB trials with 12 out of 30 patients enrolled. Expected completion by Q1 2026 [5][6][10] - **RAD204**: Therapeutic targeting PD-L1, in dose escalation trials, with promising early results [6][15] - **RAD202**: Therapeutic targeting HER2, also in dose escalation trials, showing significant tumor uptake [18][19] - **B7-H3**: Emerging mechanism for multiple solid tumors, IND approval received, expected to start Phase I soon [8][9] - **KLK3**: Prostate cancer drug using Tb-161 isotope, expected to start Phase I soon [9] Market Potential - **RAD101 Market Assessment**: Estimated total addressable market of $500 million to $700 million in the U.S. alone, with a projected market share of 94% due to lack of competition in brain metastasis imaging [26][27] - **Patient Population**: 300,000 new patients diagnosed annually with brain metastasis [10] Financials and Capital Raise - **Recent Capital Raise**: Conducted to extend cash runway into Q1 2027, following a previous raise in June 2024 [5][20] - **Cash Position**: Current cash runway is eight months, prompting the recent capital raise [20][27] Clinical Trial Updates - **RAD101**: Primary endpoint focuses on concordance with MRI, with secondary endpoints assessing additional lesion detection [23] - **RAD204 and RAD202**: Expected readouts in mid-2026 and end of 2026, respectively [25] Conclusion - **Outlook**: Positive early signals from clinical trials, with a strong focus on expanding the use of radiopharmaceuticals in oncology [25]

Core Insights - Radiopharm Theranostics is advancing its clinical programs with promising early data from multiple trials, indicating strong potential for its radiopharmaceutical pipeline [1][2][3] Clinical Trials and Data - Preliminary data from the Phase 2b trial of RAD 101 shows uptake in brain metastases from solid tumors, with topline results expected by H1 2026 [1][6] - The Phase 1 trial of RAD 202 (HER2) has shown higher than expected tumor uptake, with data from the second cohort anticipated by year-end 2025 [1][10] - RAD 204 (PD-L1) has demonstrated promising tumor uptake and stable disease in two out of three patients at the first dose level [5][11] - RAD 301 is being evaluated in a Phase 1 imaging trial for pancreatic cancer, with initial data supporting a move to a Phase 2 trial [8][12] Regulatory and Designation Updates - RAD 101 has received FDA Fast Track Designation to expedite its review process for patients with cerebral metastases [3] - RAD 301 has received Orphan Drug Designation from the FDA, highlighting its potential in treating pancreatic ductal adenocarcinoma [8] Company Strategy and Future Plans - The company plans to initiate Phase 1 trials for RV01 and RAD402 by year-end 2025, expanding its clinical portfolio to include four therapeutic candidates and two imaging agents [2] - The strategic execution of the company remains strong, with a focus on advancing multiple trials and achieving significant milestones [2][9]

Core Points - Radiopharm Theranostics Limited has successfully raised approximately A$35 million through a private placement of new shares at A$0.03 per share, with significant participation from institutional investors including Lantheus Holdings, Inc. [1][5][6] - The company will also conduct a Share Purchase Plan (SPP) to raise an additional A$5 million for existing eligible shareholders, maintaining the same terms as the placement [3][6]. Placement Details - The placement involves the issuance of approximately 1,167 million new fully paid ordinary shares, with Lantheus investing A$7.6 million, increasing its shareholding to 14.5% [5][6]. - Each placement subscriber will receive one free attaching option for every share subscribed, with an exercise price of A$0.039 and an expiration date of October 31, 2027 [2][10]. Use of Funds - The funds raised will be allocated as follows: A$6 million for drug manufacturing, A$34 million for clinical trials, and A$19 million for administration and working capital, extending the funding runway into 2027 [4][7][6]. Shareholder Approval - The second tranche of the placement, amounting to A$22.5 million, will require shareholder approval at an upcoming Extraordinary General Meeting (EGM) anticipated in early December 2025 [9][10].

NASDAQ: RADX / ASX: RAD CLINICAL UPDATE AND CAPITAL RAISING OCTOBER 20th , 2025 For personal use only Notice & Disclaimer The information in this presentation does not constitute personal investment advice. The presentation is not intended to be comprehensive or provide all information required by investors to make an informed decision on any investment in Radiopharm Theranostics Ltd ACN 647 877 889 (Company). In preparing this presentation, the Company did not take into account the investment objectives, f ...

Core Insights - The company has received a positive recommendation from the Data Safety and Monitoring Committee (DSMC) to advance its clinical-stage radiotherapeutic asset, 177Lu-RAD202 (RAD202), to the next dose level of 75mCi in the Phase 1 'HEAT' clinical trial for patients with HER2-positive advanced solid tumors [1][2]. Group 1: Clinical Trial Progress - The Phase 1 'HEAT' trial is progressing rapidly, with initial dosing starting in June and the first cohort completed swiftly [2]. - The DSMC confirmed positive safety, pharmacokinetic, and biodistribution data from the first cohort treated with 30mCi of Lu177-RAD202, allowing the study to continue without modifications [2]. - The second cohort of patients is expected to be enrolled by Q4 2025 [2]. Group 2: Product Information - RAD202 is a proprietary single domain monoclonal antibody targeting HER2-positive expression in advanced solid tumors, which are prevalent in breast cancer and other solid tumors [4]. - Previous diagnostic studies have shown RAD202's clinical proof-of-concept, along with positive safety and biodistribution results [4]. Group 3: Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [5]. - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and three Phase 1 trials across various solid tumor cancers [5].

Summary of Radiopharm Theranostics Webinar Company and Industry Overview - **Company**: Radiopharm Theranostics (NasdaqCM:RADX) - **Industry**: Medical diagnostics and therapeutics, specifically focusing on brain metastases from solid tumors Key Points and Arguments 1. **Unmet Medical Need**: There is a significant unmet medical need for patients with suspected rare metastases from solid tumors, particularly brain metastases, which are five times more common than primary brain tumors [2][10][41] 2. **Current Treatment Landscape**: Advances in systemic treatments have improved patient survival, leading to an increase in brain metastases. The brain is a sanctuary site for cancer, making it difficult for systemic treatments to penetrate [10][11] 3. **Stereotactic Radiosurgery (SRS)**: SRS is highlighted as a precise treatment for brain metastases, allowing for targeted radiation that minimizes damage to surrounding healthy tissue. The Lexell Gamma Knife is noted as the gold standard for this treatment [13][14][15] 4. **Challenges in Diagnosis**: Current imaging methods, particularly MRI, are insufficient for accurately distinguishing between tumor progression and radiation necrosis, leading to clinical uncertainty [23][52] 5. **Introduction of RET 101**: Radiopharm's agent, RET 101, is a small molecule targeting fatty acid synthase, which is crucial for the survival of brain cancer cells. This agent aims to improve diagnostic accuracy and address the unmet medical need in detecting recurrent brain metastases [30][32][34] 6. **Clinical Trials**: The company is conducting a Phase 2b study with promising early results, showing high tracer uptake in patients with brain metastases. The study aims to differentiate between pretreated and treatment-naive patients [45][50] 7. **Market Potential**: The potential market for RET 101 is significant, with estimates suggesting it could become one of the largest imaging agents, with potential annual sales exceeding $500 million in the U.S. alone [62][63] 8. **Future Development Plans**: Radiopharm plans to initiate a Phase 3 trial in 2026, with the goal of submitting for FDA approval by 2028. The company is open to partnerships to expedite this process [60][61][89] Additional Important Content 1. **Expert Insights**: Dr. Ramji Rajendran, a key opinion leader, emphasized the importance of early detection and treatment of brain metastases, noting that patients often face poor quality of life due to neurological decline [70][71] 2. **Patient Statistics**: Approximately 300,000 new cases of brain metastases are diagnosed annually in the U.S., indicating a substantial patient population that could benefit from improved diagnostic tools [31][57] 3. **Comparison with Other Imaging Agents**: RET 101 is positioned as a unique offering in the market, with no direct competitors currently in clinical development for imaging brain metastases [89] 4. **Clinical Collaboration**: The ongoing collaboration with Imperial College London has provided valuable preclinical data supporting the efficacy of RET 101 [38][49] This summary encapsulates the critical insights and developments discussed during the webinar, highlighting the potential impact of Radiopharm Theranostics' innovations in the field of brain metastases treatment and diagnostics.

Financial Performance - For the year ended June 30, 2025, the company reported a total comprehensive loss of A$37.88 million and negative cash flows from operating activities of approximately A$36.65 million[34]. - As of June 30, 2025, the company had accumulated losses of A$145.73 million[34]. - The company expects to continue incurring significant losses in the development of clinical trials and drug candidates[36]. - The company has historically financed operations primarily through equity financings, and future net losses will depend on the rate of expenditures and ability to obtain funding[43]. Revenue Generation Challenges - The company currently has no source of product revenue and does not expect to generate revenue from its drug candidates for several years, if ever[42]. - The company may need to delay, limit, or terminate product development if sufficient capital is not secured, potentially impacting its ability to commercialize drug candidates[46]. - Market acceptance of drug candidates is uncertain, and lack of acceptance could adversely affect potential revenues[74]. - Successful commercialization depends on securing reimbursement from government and private health insurers, which may not be sufficient for competitive marketing[81]. Clinical Development Risks - The company anticipates that the costs related to the development of clinical trials will increase, necessitating additional funds for commercialization and further development of drug candidates[40]. - The development and commercialization of drug candidates face numerous risks, including potential delays in clinical trials and regulatory approvals[49]. - Positive results from preclinical studies do not guarantee success in clinical trials, with many companies experiencing setbacks despite initial positive outcomes[51]. - Phase I and II clinical trials primarily test safety rather than efficacy, and success in early trials does not ensure positive results in later trials[52]. - The company may face difficulties in enrolling patients in clinical trials, which could delay trials and increase costs[48]. Funding and Financial Viability - The company is exploring additional funding through public or private financings and licensing arrangements, but such opportunities may not be available on acceptable terms[40]. - The company’s ongoing viability depends on its ability to meet debts and commitments, with a forecast indicating it can progress research and development programs for at least the next 12 months[39]. - The company may face increased compliance costs due to the auditor attestation requirement under the Sarbanes-Oxley Act once it ceases to be classified as an emerging growth company[119]. - The company may raise capital through equity financings in the future, which could lead to significant dilution of ADS holders' ownership interests[124]. Intellectual Property and Regulatory Risks - The company must protect its intellectual property rights to maintain competitive advantages, as failure to do so could adversely affect commercialization[87]. - Patent applications may face challenges that could reduce the scope or validity of the company's intellectual property rights[91]. - The company may incur significant expenses and distractions from litigation related to intellectual property claims, impacting financial resources[102]. - Regulatory approvals are not guaranteed, and failure to obtain them would prevent the company from generating revenue from its drug candidates[55]. Competitive Landscape - The competitive landscape includes multinational pharmaceutical companies and specialized biotechnology firms developing similar drug candidates[75]. - The company faces significant competition from multinational pharmaceutical and specialized biotechnology companies with greater resources and experience[77]. - Competitive products may render the company's drug candidates obsolete or non-competitive before recovering development costs[78]. - The company may experience adverse impacts on business due to government control over pharmaceutical pricing, particularly in Australia and potentially in the U.S.[80]. Corporate Governance and Shareholder Rights - As a foreign private issuer, the company is exempt from certain U.S. securities laws and has lower disclosure requirements compared to U.S. public companies[146]. - Holders of American Depositary Shares (ADSs) do not have the same voting rights as shareholders and must provide instructions to the depositary to vote[131]. - The deposit agreement governing the ADSs includes a jury trial waiver provision, which may limit the ability of ADS holders to bring claims in a judicial forum[135]. - The deposit agreement provides for exclusive jurisdiction in New York, which may discourage claims or limit the ability of ADS holders to bring a claim[139]. Recent Developments and Acquisitions - The company acquired Pharma15 Corporation in March 2023, agreeing to pay a contingent consideration of $2.3 million, which can be satisfied through the issuance of up to 47,000,000 ordinary shares[122]. - In March 2025, the company signed an amendment with Diaprost and Fredax to increase the payment of Milestone Event 4 to $12,500,000, with $11,750,000 payable in cash and $750,000 in shares, resulting in shareholder dilution[123]. - In June 2024, Radiopharm entered into an equity agreement with Lantheus Omega, purchasing 149,625,180 ordinary shares for A$7.5 million[166]. - Radiopharm aims to pursue FDA approval for all drug candidates currently in development, with plans to seek marketing approval in multiple regions including the EU and Japan[175]. Clinical Trials and Product Development - The Phase I trial for RAD202, targeting HER2 breast and gastric cancer, is set to enroll 21 patients and is anticipated to complete in the first half of 2026[193]. - The Phase I trial for RAD204, targeting non-small cell lung cancer, is expected to recruit 27 patients and complete by the second half of 2026[194]. - The Phase IIb trial for RAD101, targeting brain metastases, is expected to enroll 30 patients and complete by the first quarter of 2026[197]. - The Phase III trial for RAD102, targeting brain tumors, is planned to enroll 150 patients, starting in the second half of 2026 and completing by the end of 2027[198]. - The clinical data gathered outside the United States may not be accepted by the FDA, potentially requiring additional trials in the U.S. or elsewhere[214].