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.

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Summary of Radiopharm Theranostics (RADX) Update / Briefing Company and Industry Overview - **Company**: Radiopharm Theranostics (RADX) - **Industry**: Prostate cancer treatment and radiopharmaceuticals Key Points and Arguments 1. **Prostate Cancer Treatment Landscape**: - Significant advancements in prostate cancer treatments, particularly with radiotherapy options like radium-223 combined with enzalutamide and targeted therapies such as PSMA radiotherapeutics like Pluvicto [3][4] - Pluvicto has shown efficacy in prostate cancer patients both before and after chemotherapy, as evidenced by the PSMA-4 and VISION trials [3] 2. **Unmet Medical Needs**: - Despite advancements, there remains a substantial medical need for new therapies, especially targeted radiotherapy, as all patients receiving PSMA-targeting treatments will eventually relapse [4] 3. **Introduction of Betabart**: - Betabart, a monoclonal antibody targeting B7-H3, is being developed as a new treatment option. It has a modified half-life to reduce side effects while maintaining strong target affinity [4][5] - The upcoming study will enroll patients with various tumors, including those with prostate cancer who have previously received Pluvicto [5] 4. **KLK3 Targeting**: - KLK3 (PSA) is identified as a promising new target for prostate cancer therapy, with a focus on its specific expression in prostate tissues compared to PSMA, which is expressed in multiple organs [7][8] - The KLK3-targeted study is set to begin in Australia early next year [8] 5. **Preclinical Data**: - Preclinical studies show that KLK2 and KLK3 are highly specific to prostate tissues, with KLK3 exhibiting higher expression levels than KLK2 [9][19] - The therapeutic efficacy of KLK2-targeted therapies has been demonstrated in advanced mouse models, showing significant tumor reduction [13][14] 6. **Mechanism of Action**: - The therapeutic approach exploits the upregulation of androgen receptors (AR) in response to DNA damage, which increases the expression of KLK2 and KLK3, enhancing the targeting efficacy over time [16][29] 7. **Comparison with Other Therapies**: - KLK3-targeted therapies are positioned as a more advanced approach compared to KLK2, with a higher expression level and a more extensive research background [20][29] - The antibody developed for KLK3 is designed to avoid targeting PSA in circulation, focusing instead on the free form of PSA in tissues [28] 8. **Clinical Development Plans**: - RAD402 (KLK3 targeting molecule) is expected to enter clinical studies in Australia before the end of the year, alongside RV-01 (B7-H3 targeting molecule) in the U.S. [48] Additional Important Content - **Market Potential**: - The arrival of radiopharmaceuticals has significantly changed the metastatic prostate cancer treatment landscape, with improved patient survival rates [45] - There is a recognition that existing treatments like Pluvicto are not perfect, indicating a need for further scientific advancements [46] - **Future Directions**: - The company is exploring new targets and approaches to enhance treatment efficacy and patient outcomes in metastatic prostate cancer [46][47] - **Community Engagement**: - The webinars have attracted significant interest, indicating a strong community engagement and support for ongoing research and development in prostate cancer therapies [45]

Summary of Radiopharm Theranostics (RADX) Update / Briefing August 26, 2025 Company and Industry Overview - **Company**: Radiopharm Theranostics (RADX) - **Industry**: Oncology, specifically focusing on prostate cancer treatment and radiopharmaceutical therapies Key Points and Arguments 1. **Prostate Cancer Treatment Landscape**: The treatment of prostate cancer has evolved significantly, moving from traditional methods like surgery and chemotherapy to incorporating genetics, molecular imaging, and targeted therapies, including immunotherapy and radiopharmaceuticals [11][12][30] 2. **B7-H3 as a Target**: B7-H3 is highlighted as a promising new target for prostate cancer treatment, being highly expressed in various tumors, including 93% of castrate-resistant prostate cancer cases. This makes it a viable alternative to PSMA-targeted therapies, especially in cases where PSMA expression is low [39][41][43] 3. **Need for New Therapies**: There is a critical need for more effective therapies for metastatic castration-resistant prostate cancer, as current treatments often provide limited survival benefits [18][30] 4. **NCCN Guidelines**: The National Comprehensive Cancer Network (NCCN) guidelines are discussed, emphasizing the importance of treatment sequencing and the variety of options available based on prior therapies [19][20] 5. **Theranostics Concept**: The concept of theranostics is introduced, where ligands are designed to bind to specific cancer cell targets, allowing for both diagnosis and treatment using radiopharmaceuticals [24][25] 6. **Clinical Trials and FDA Approvals**: The presentation mentions several clinical trials demonstrating survival benefits from new therapies, including the FDA approval of Plavicto (lutetium-177) for prostate cancer treatment [27][28][51] 7. **BetaBART Development**: The development of BetaBART, a humanized monoclonal antibody targeting the four Ig isoform of B7-H3, is presented as a novel approach in radioimmunotherapy, with plans for a Phase 1 trial in 2025 [51][66] 8. **Competitive Landscape**: The competitive landscape for B7-H3 targeting is discussed, noting that while there are other modalities like ADCs and CAR T-cell therapies, the unique properties of BetaBART provide a competitive advantage [75][78][87] 9. **Immunological Memory**: Evidence of secondary immune memory from prior treatments suggests that BetaBART may not only target tumors but also enhance the immune response against them [64][66] 10. **Market Potential**: The potential market for B7-H3 targeting therapies is significant, with opportunities extending beyond prostate cancer to other solid tumors [46][51] Other Important but Overlooked Content 1. **Challenges with Current Therapies**: The limitations of existing therapies, including the need for better options post-Plavicto treatment, are emphasized, highlighting the urgency for innovation in this space [30][102] 2. **Mechanism of Action**: The mechanism of action for BetaBART is discussed, focusing on its ability to selectively target the four Ig isoform of B7-H3 while minimizing off-target effects and toxicity [49][66] 3. **Future Directions**: The discussion includes the need for randomized control groups in future trials to better assess the efficacy of new treatments [31] This summary encapsulates the critical insights from the briefing, focusing on the advancements in prostate cancer treatment, the significance of B7-H3 as a target, and the innovative approaches being developed by Radiopharm Theranostics.

Core Insights - Radiopharm Theranostics is advancing its clinical pipeline with significant milestones, including FDA Fast Track Designation for RAD101 and clearance for higher dosing of RAD204 [3][5][6] - The company confirmed a cash runway extending through mid-2026, with a year-end cash balance of $29.12 million, up from $18.58 million the previous year [10][12] Program and Business Updates - RAD204, a nanobody targeting PD-L1, is on track for higher dosing at 60mCi of Lu177, with enrollment for the second cohort expected to complete soon [6] - RAD202, targeting HER2, has initiated its Phase 1 HEAT trial, with preliminary data anticipated by the end of 2025 [6] - The company has established supply agreements for key radioisotopes, enhancing its clinical trial capabilities [3][12] Financial Update - For the fiscal year ending June 30, 2025, net cash outflows from operating activities totaled $36.67 million, primarily due to research and development expenditures [10][12] - The company received $4.58 million for research and development tax incentives for the 2024 financial year [12]