drugset / Press release

RAD Presentation July 2026

2026-07-23 · Radiopharm Theranostics, Ltd · original radiopharmtheranostics.com ↗

ASX: RAD | NASDAQ: RADX July 2026 A Multi-Asset, First-in-Class Radiopharmaceutical Platform Clinical-stage oncology radiopharmaceuticals — diagnostics and therapeutics 1 Notice & Disclaimer 2 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, financial situation and particular needs of any particular investor. Further advice should be obtained from a professional investment adviser before taking any action on any information dealt with in the presentation. Those acting upon any information without advice do so entirely at their own risk. Whilst this presentation is based on information from sources which are considered reliable, no representation or warranty, express or implied, is made or given by or on behalf of the Company, any of its directors, or any other person about the accuracy, completeness or fairness of the information or opinions contained in this presentation. No responsibility or liability is accepted by any of them for that information or those opinions or for any errors, omissions, misstatements (negligent or otherwise) or for any communication written or otherwise, contained or referred to in this presentation. Neither the Company nor any of its directors, officers, employees, advisers, associated persons or subsidiaries are liable for any direct, indirect or consequential loss or damage suffered by any person as a result of relying upon any statement in this presentation or any document supplied with this presentation, or by any future communications in connection with those documents and all of those losses and damages are expressly disclaimed. Certain statements contained in this presentation, including, without limitation, statements containing the words “believes,” “plans,” “expects,” “anticipates,” and words of similar import, constitute “forward- looking statements.” Such forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, the following: the risk that our clinical trials will be delayed and not completed on a timely basis; the risk that the results from the clinical trials are not as favourable as we anticipate; the risk that our clinical trials will be more costly than anticipated; and the risk that applicable regulatory authorities may ask for additional data, information or studies to be completed or provided prior to their approval of our products. Given these uncertainties, undue reliance should not be placed on such forward-looking statements. The Company disclaims any obligation to update any such factors or to publicly announce the results of any revisions to any of the forward-looking statements contained herein to reflect future events or developments except as required by law. This presentation is not a prospectus or other disclosure document under the Corporations Act 2001 (Cth) and will not be lodged with the Australian Securities and Investments Commission. This presentation is for information purposes only and is not an invitation or offer of securities for subscription, purchase or sale in any jurisdiction. The distribution of this presentation (including electronically) outside Australia is restricted by law. If you come into possession of this presentation, you should observe such restrictions as any non- compliance with these restrictions could contravene applicable securities laws (see the section captioned ‘International offer restrictions’). In particular, this document does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States. The New Shares, Attaching Options and shares underlying the Attaching Options have not been, and will not be, registered under the US Securities Act of 1933 and may not be offered or sold in the United States except in transactions registered under the US Securities Act or in transactions exempt from, or not subject to, the registration requirements of the US Securities Act and applicable US state securities laws. Any opinions expressed reflect the Company’s position at the date of this presentation and are subject to change. Company Pipeline in Clinical Stage First two programs reporting strong clinical data. Additional upside from the other three Phase I trials PROGRAM INDICATION ISOTOPE PHASE I PHASE II PHASE III CATALYSTS PD-L1+ solid tumors 177Lu Clinical activity reported July 2026 Dose-escalation completion Q4 2026 – Q1 2027 HER2+ solid tumors 177Lu Dose-escalation completion H1 2027 RAD402 KLK3 (prostate cancer) 161Tb Dose-escalation completion H2 2027 RV01 B7-H3 (solid tumors) 177Lu Dose-escalation completion H2 2027 RAD101 Imaging — brain mets 18F Positive Phase 2b read-out July 2026 ¹⁷⁷Lu, lutetium-177; ¹⁶¹Tb, terbium-161; ¹⁸F, fluorine-18; B7-H3, B7 homolog 3; HER2, human epidermal growth factor receptor 2; KLK3, kallikrein-3; PD-L1, programmed death ligand-1. RAD202 RAD204 3 One Phase IIb imaging lead (RAD101) and four Phase I therapeutics across validated oncology targets. Pharma Partnership Window KEY CATALYSTS & MILESTONES Consistent clinical & regulatory delivery since mid-2025, with multiple value-driving catalysts approaching from mid-2026 into 2027 Achieved milestones sourced from Radiopharm Theranostics ASX and GlobeNewswire announcements (Jul 2025 - Apr 2026); upcoming timing reflects management expectations and is indicative. Phase IIb topline readout (Jul 2026) not yet reported. Achieved Milestones Upcoming Milestones RAD101 Phase IIb 1st interim: 92% MRI concordance (11/12) Dec 2025 RV-01 first patients dosed (Phase 1/2a) Feb 2026 RAD101 Phase IIb 2nd interim: 90% MRI concordance (18/20) Mar 2026 Siemens Healthineers supply pact for planned US Phase III Apr 2026 RAD101 Phase IIb readout (final 30- patient cohort) Jul 2026 FDA Phase III protocol alignment meeting Sep 2026 RAD101 Phase III registrational trial starts Q4 2026 Partnering / monetisation discussions advance Q4 2026 1H 2027 RAD204 Efficacy data released RAD402 first patients dosed (Phase 1/2a) Mar 2026 RAD204 Phase I read out RAD202 Phase I read out RAD202 Expected Efficacy data released Q4 2026 4 5 RAD 101 DIAGNOSTIC Imaging lead asset — RAD 101 First-in-class PET imaging agent for brain metastases T H E A G E N T FASN Tumor target Pivalate Targeting molecule ¹⁸F PET isotope Short-chain fatty-acid analogue Brain-metastasis indication Fatty acid synthase (FASN) — a validated target Targets the FASN fatty-acid metabolism pathway Detects recurrence after stereotactic radiosurgery (SRS) Addresses a major diagnostic gap in neuro-oncology High unmet need in early relapse detection FDA Fast Track Phase 2b Positive Read-out First-in-class PET imaging for post-SRS brain-metastasis recurrence — no direct competitor. FASN, fatty acid synthase; ¹⁸F, fluorine-18; PET, positron emission tomography; SRS, stereotactic radiosurgery. RAD 101 DIAGNOSTIC Imaging lead asset — RAD101 First-in-class PET tracer to advance to Phase 3 — near-term value and optionality T H E N E E D High unmet need - SoC MRI falls short Early identification of recurrent brain metastases is urgent need in suspected relapse after SRS. T H E M A R K E T 300,000 ~300,000 new brain-metastasis patients post-SRS each year (US) — with no direct competitor in this imaging sector. T H E A S S ET First-in-class PET tracer RAD101 (¹⁸F-pivalate) is a FASN-targeted PET tracer designed to close this diagnostic gap. T H E D A T A Phase 3 preparation started Company-sponsored Phase 2b (US, N=30); Positive Phase IIb data Islam S, et al. EJNMMI 2025. doi.org/10.1007/s00259-025-07118-0. FASN, fatty acid synthase; MRI, magnetic resonance imaging; PE T, positron emission tomography; SoC, standard of care; SRS, stereotactic radiosurgery; SUV, standardized uptake value. 6 RAD 101 DIAGNOSTIC RAD101 Phase IIb — primary endpoint readout Primary endpoint met — high concordance with MRI. P R I M A R Y E N D P O I N T Concordance with MRI SUCCESSFULLY ACHIEVED 93% 28 / 30 patients concordant SECONDARY ENDPOINT · INTERIM ANALYSIS SPECIFICITY PENDING Not yet available Read-out expected Q4 2026 Primary endpoint met — 93% concordance with MRI · full sensitivity and specificity read-out expected Q4 2026. MRI, magnetic resonance imaging. 7 SENSITIVITY INTERIM 86% 12 / 14 patients *3/30 Patient data not yet available RAD 101 DIAGNOSTIC RAD101 - Next steps to Phase 3 A clear, de-risked path to a Phase 3 start in Q4 2026 M I L E S T O N E S May 2026 Advisory Board Supportive of Phase 3 Sep 2026 FDA protocol meeting Align on trial design Q4 2026 Phase 3 start Ready to initiate Trial design N=150–200 patients · primary endpoints: sensitivity & specificity Supply & logistics US radiolabeling & distribution outsourced to a global leader — contract signed with Siemens PETNET Partnering opportunity assessment — contract signed with a radiopharma specialist in M&A 8 9 RAD 101 DIAGNOSTIC Why RAD101 will be adopted Four reasons RAD101 fits — and wins — in post-treatment neuro-oncology imaging. T H E N E E D Clear unmet need MRI is frequently equivocal in post-treatment brain metastases. T H E F I T Fits existing workflow PET is already standard — no new infrastructure required. T H E M O M E N T High-value decision point Resolves the critical post-SRS recurrence question. T H E W H I T E S P A C E No direct competitor First-in-class PET agent for this indication. Clear unmet need · fits existing PET workflow · high-value decision point · no direct competitor. MRI, magnetic resonance imaging; PET, positron emission tomography; SRS, stereotactic radiosurgery. RAD 204 THERAPEUTIC RAD204— First-in-class PD-L1 targeted radiotherapy Validated immuno-oncology target First-in-class PD-L1 targeted 177Lu radiotherapy POTEN TIA L POSITION IN G LEAD INDICATION Post-IO NSCLC High unmet-need setting after immunotherapy EXPANSION Multiple solid tumors Across PD-L1–expressing tumor types Expands a proven IO target into a new therapeutic modality IO, immuno-oncology; NSCLC, non-small cell lung cancer; PD-L1, programmed death ligand-1; 177Lu, lutetium-177. 10 RAD 204 THERAPEUTIC RAD204: early efficacy signal First patient dosed at Cohort 3 (90 mCi) — dose escalation ongoing under a Bayesian (BOIN) design TRIAL DESIGN PRIMARY OBJECTIVES • Safety & tolerability of ¹⁷⁷Lu-RAD204 • Recommended Phase 2 dose STUDY DESIGN • BOIN dose-finding design • Population: prior PD-L1+ (>1%) metastatic disease Phase I — Treatment (dose escalation) 30 mCi 1.1 GBq DL1 Completed · 3 pts 60 mCi 2.2 GBq DL2 Completed · 3 pts 90 mCi 3.3 GBq DL3 2/3 recruited 120 mCi (tbd) 4.4 GBq DL4 Planned DL1–DL2: Tumor uptake confirmed; favorable safety profile, no DLT. DL3: Early clinical signal (see next slide). BOIN, Bayesian optimal interval; DL, dose level; GBq, gigabecquerel; mCi, millicurie; PD-L1, programmed death ligand-1; tbd, to be determined. 11 RAD 204 THERAPEUTIC RAD204: early clinical activity First patient at 90 mCi achieved a confirmed RECIST Partial Response with durable (7+ months) tumor shrinkage Partial Response RECIST Confirmed (Pt #7) 7+ months PFS No evidence of progression DOSE LEVEL #3 · 90 mCi (3.3 GBq) · NSCLC Patient #7 NSCLC · No DLT PARTIAL RESPONSE Safety No DLT Kidney dose* 8.1 Gy (cumulative, 4 doses) PFS 7+ months, no progression Completed 4 doses. Tumor shrinkage by cycle (dose) -19% D1 -43% D2 -43% D3 -35% D4 *FDA guidance = 23 Gy (under discussion). 12 Patient #8 NSCLC · No DLT STABLE DISEASE Safety No DLT Kidney dose* 2.5 Gy (cumulative, 2 doses) PFS 2+ months, no progression 2 doses received, continuing to dose #3 Tumor shrinkage by cycle (dose) -7% D1 2+ months PFS No evidence of progression Stable disease Positive trend in tumor reduction (Pt #8) Patient #9 (to complete dose level #3) - NSCLC · In screening- to be dosed in August RAD 204 THERAPEUTIC Baseline October ‘25 1st dose November ‘25 2nd dose January ‘26 3rd dose March ‘26 Patient #7 — first patient treated at 90 mCi Durable confirmed RECIST partial response across multiple cycles NSCLC — progressed after multiple prior therapies • External-beam radiotherapy • Chemotherapy (carboplatin, taxane) • PD-L1 checkpoint inhibitor Expected PFS 4–6 months Treated with RAD204 at 90 mCi Confirmed RECIST PR 43% tumor-size reduction PFS 7 months & ongoing SPECT/CT — Complete Response RLL primary at IM, C1–C3 SUVmax 2.71 → 1.14 → 0.93 → 0 / nd CORONAL CT · RLL PRIMARY 13 RAD204 Investment Case RAD 204 THERAPEUTIC PD-L1 is the largest and most validated immuno-oncology target Targeted radiotherapy introduces a new principle combining two synergistic mechanisms of action Addressable market (US, post-IO NSCLC) 40,000–65,000 patients per year Platform enables continued optimization across the pipeline ✓ Early clinical signal already observed at dose level #3 ✓ First-in-class: no radiopharma competitors identified 14 RAD 202 THERAPEUTIC RAD202: Cohort #3 expected to complete by September Evidence of tumor radiation at Dose Level 3 (130 mCi) Completing by September 3 patients dosed in Cohort #3 No DLT to date Safety assessment ongoing Next dose: 200 mCi Escalation planned DOSE LEVEL 3 · 130 mCi (4.8 GBq) #8 Patient #8 Colorectal PD Safety No DLT Kidney (at risk) 10 Gy · avg 2 doses Tumor uptake 2.4 Gy · avg 2 doses RECIST — Stable disease 3 mo (dose 1+2); progressive disease before 3rd dose. #9 Patient #9 Breast ONGOING, SD Safety Assessment ongoing Kidney (at risk) 11 Gy · 1 dose Tumor uptake 9.8 Gy · 1 dose RECIST Stable Disease Unchanged after 1st dose; continuing to Dose 2 (Jul 14). #10 Patient #10 Breast ONGOING Safety Assessment ongoing Kidney (at risk) 5.8 Gy Tumor uptake 12.3 Gy RECIST — Continuing to Dose 2 (Aug 4). High uptake of the drug in the patients DLT, dose-limiting toxicity; Gy, gray; mCi, millicurie; RECIST, Response Evaluation Criteria in Solid Tumours 16 ! SUMMARY A multi-asset radiopharmaceutical platform — a Phase III-ready imaging lead plus four clinical-stage therapeutics. RAD 101 Successful Phase 2b trial in Brain Mets Advancing to single registrational Phase 3 No Competition Attractive asset for M&A PIPELINE UPSIDE RAD 202 has very promising tumor uptake RAD 402 & RV01 trials are enrolling fast, with read-out in 2027 No dose-limiting toxicities reported RAD 204 Strong signal of Clinical Efficacy reported in Phase I, Dose Level 3 No dose-limiting toxicity reported No Competitor identified Very Large total addressable market 2026 CATALYSTS 2027 CATALYSTS 17 Thank You w w w . r a d i o p h a r m t h e r a n o s t i c s . c o m 1818

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