Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Investor Presentation (June 2024)
50 slides from Radiopharm Theranostics's investor presentation, Jun 25, 2024
Slide 1: Lantheus Strategic Investment and Capital Raising
For personal use only Lantheus Strategic Investment and Capital Raising June 2024 Not for release to US wire services or distribution in the United R A DIO States P H A R M TH E R A N O STIC S L TD 20 24 1
Slide 2: Important Notice and Disclaimer
IMPORTANT NOTICE AND 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
Slide 3: RAD is at the cutting edge of radiopharmaceuticals
RAD IS AT THE CUTTING EDGE OF RADIOPHARMACEUTICALS, A TRANSFORMATIVE MODALITY WITHIN CANCER TREATMENT 1 Differentiated Within Radiopharmaceuticals • Clinical-stage company with deep pipeline of radiotherapeutic assets pursuing novel targets, leveraging insights from ADCs, using innovative targeting
Slide 4: Lantheus Strategic Investment
LANTHEUS STRATEGIC INVESTMENT Lantheus Holdings Inc (LNTH.NASDAQ, market cap approximately US$5.5Bn) is a global leader in the development, manufacture and commercialisation of diagnostic and therapeutic radiopharmaceutical products with offices in Massachusetts, New Jersey, For personal use only Ca
Slide 5: Case Study: Lantheus Strategic Investment in Perspective Therapeutics
CASE STUDY: LANTHEUS STRATEGIC INVESTMENT IN PERSPECTIVE THERAPEUTICS • On 9th January 2024, Lantheus announced it had entered into multiple strategic agreements with Perspective Therapeutics, Inc. (NYSE:CATX)* For personal use only • Perspective is a clinical stage radiopharmaceutical company with
Slide 6: Growing Interest in Radiopharma Deal Space (2018 to Present)
GROWING INTEREST IN RADIOPHARMA DEAL SPACE (2018 TO PRESENT) Selected Recent Strategic Agreements Selected Recent M&A Transactions • Mariana acquired by Novartis for US$1.0B (May ‘24) For personal use only • Lantheus/Perspective (‘24) - $61MM upfront/investment • Fusion Pharmaceuticals acquired by A
Slide 7: Radiopharmaceuticals Deliver Radiation Directly to Cancer Cells
RADIOPHARMACEUTICALS DELIVER RADIATION DIRECTLY TO CANCER CELLS Building Blocks of Considerations Radiopharmaceuticals For personal use only Targeting Molecule Serum half-life, immunogenicity, tumor uptake (high affinity small and retention, plasma clearance (especially via molecule, peptide or rena
Slide 8: Expanding Radiopharmaceutical Targets and Indications
EXPANDING RADIOPHARMACEUTICAL TARGETS AND INDICATIONS Novel Radiopharmaceutical Targets With Validated Biology beyond PSMA, SSTR2, FAPI For personal use only PD-L1, HER2, (nanobodies); αVβ6 Integrin (peptide), fatty acid synthase (small molecule) Tuned Isotope Selection Lu177 (beta), Ac225 (alpha),
Slide 9: Clinical Pipeline (Nanobodies, Peptide, Small Molecule)
CLINICAL PIPELINE (Nanobodies, Peptide, Small Molecule) TARGET & PROGRAM INDICATION Dx/Tx ISOTOPE PRECLINICAL PHASE I PHASE II NOTES MOLECULE PD-L1 NON-SMALL CELL RAD204 Therapy Lu177 Phase 1 enrolling in Australia, NCT06305962 For personal use only LUNG CANCER (Nanobody) HER 2 BREAST / Ethics appro
Slide 10: Preclinical Assets
PRECLINICAL ASSETS TARGET & PROGRAM INDICATION Dx/Tx ISOTOPE PRECLINICAL PHASE I PHASE II NOTES MOLECULE For personal use only KLK3 CMC production ongoing, BioD study ongoing RAD402 (mAb) PROSTATE Therapy Tb161 (Phase 1 in 2025 depending on financials) JV with MD Anderson TARGET & PROGRAM INDICATION
Slide 11: Fully Funded To Achieve Upcoming Milestones
Fully Funded To Achieve Upcoming Milestones, which is anticipated to include Four Read-Outs 1H 2024 2H 2024 1H 2025 2H 2025 1H 2026 For personal use only TARGET & PROGRAM INDICATION Dx/Tx ISOTOPE MOLECULE PD-L1 NON-SMALL CELL RAD204 (Nanobody) LUNG CANCER Therapy Lu177 P1 in Aus read-out HER 2 BREAS
Slide 12: Key Management Team
KEY MANAGEMENT TEAM For personal use only Paul Hopper Riccardo Canevari Vittorio Puppo Dr. Sherin Al-Safadi Vimal Patel Executive Chairman Chief Executive Officer Chief Operating Officer VP, Medical Affairs VP, CMC • Founder of Radiopharm • Radiopharm Theranostics • Has served as Chief • Served in t
Slide 13: Clinical Pipeline
For personal use only CLINICAL PIPELINE (Nanobodies, Peptide, Small Molecule) R A DIO P H A R M TH E R A N O STIC S L TD 20 24 13
Slide 14: RAD Therapeutic: PD-L1 Nanobody
RAD 204 Therapeutic: PD-L1 NANOBODY PD-L1 NANOMAB For personal use only Single domain monoclonal antibody (Sd mAb) PD-L1 Immune Checkpoint Protein Overexpression mediates evasion of immune LINKER responses by cancer cells CANCER CELL Blockade by antibodies leads to tumour TARGET TARGETING RADIOACTIV
Slide 15: PD-L1 Nanobody: Clinical Development & Regulatory Strategy
RAD 204 Therapeutic: PD-L1 NANOBODY CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Human pharmacokinetic and biodistribution validated with imaging agent (positive Phase I in 16 pts) For personal use only • Phase I therapeutic dose escalation trial in Australia started • Phase II combo therapy trial w
Slide 16: RAD (NM-01) Does Not Interfere With ICI Binding
RAD 204 (NM-01) Does Not Interfere With ICI Binding - Combination Potential Binding kinetics at different doses with Biodistribution of [99mTC]-NM-01 in mice or without the presence of atezolizumab For personal use only 180 Human PD-L1 130 Kd = 0.8 nM Resp. Diff 80 30 (20) 0 200 400 600 800 1000 Bio
Slide 17: RAD - Imaging with 99mTc
RAD 204 - Imaging with 99mTc Favorable Biodistribution and Diagnostic Characteristics in NSCLC For personal use only Time–activity curves for organs with highest Presence of intra-patient heterogeneity in PD-L1 expression between primary 99mTc-RAD204 uptake tumor and nodal malignancies • PI FIH stud
Slide 18: RAD Trial Design
RAD 204 TRIAL DESIGN 177Lu-anti-PD-L1 single domain Ab in metastatic non-small cell lung cancer • Primary Objectives (Phase 1, Treatment): For personal use only • To assess the safety and tolerability of 177Lu-RAD204tr Phase 0 Dose Level1 Dose (mCi) Dose (GBq) (Imaging • To determine the recommended
Slide 19: RAD Therapeutic: HER-2 Nanobody
RAD 202 Therapeutic: HER-2 NANOBODY HER-2 NANOMAB For personal use only Single domain monoclonal antibody (Sd mAb) HER-2 pathway validated in Oncology. Overexpression in Breast Cancer and LINKER CANCER CELL Gastroesophageal cancers TARGET TARGETING RADIOACTIVE HER2 MOLECULE ISOTOPE 99Tc to SEE Sd mA
Slide 20: HER-2 Nanobody: Clinical Development & Regulatory Strategy
RAD 202 Therapeutic: HER-2 NANOBODY CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Human pharmacokinetic and biodistribution proven with imaging agent (positive Phase I in 10pts in 2021, followed by For personal use only IIT in Germany in additional 6 pts. • 99mTc-labeled single-domain antibody for SP
Slide 21: RAD202 - 99mTc SPECT Imaging of Breast Cancer Patients
RAD202 - 99mTc SPECT Imaging of Breast Cancer Patients to Determine HER2 Status Favorable Biodistribution and Diagnostic Characteristics For personal use only Varied uptake of 99mTc-RAD202 in primary and metastatic lesions (CT – top) and SPECT/CT (bottom), demonstrating heterogeneity of HER2 express
Slide 22: RAD - Trial Design (HEAT Trial)
RAD 202 - TRIAL DESIGN HEAT Trial (HER2 Antibody Therapy with Lutetium-177) in patients with HER2+ advanced solid tumors • Primary Objectives (Phase 1, Treatment): For personal use only • To assess the safety and tolerability of 177Lu-RAD202tr • To determine the recommended dose(s) of future Phase 0
Slide 23: RAD 301/302: Imaging and Therapy for Pancreatic Cancer
RAD 301/302 : Imaging and Therapy for Pancreatic Cancer For personal use only TRIVEHEXIN RGD peptide (arginylglycylaspartic acid) Integrin αvβ6 receptor antagonist Design features include hydrophilicity to reduce non- specific uptake into undesired organs and increase LINKER CANCER CELL clearance in
Slide 24: RAD Imaging: Ga68-Integrin αVβ6 Development & Regulatory Strategy
RAD 301 Imaging: Ga68-Integrin αVβ6 CLINICAL DEVELOPMENT & REGULATORY STRATEGY • 66 patients already dosed under compassionate use (No drug-related adverse events reported) For personal use only • 33 patients dosed under Investigator Initiated Research (presented at EANM 9/2023) • IND approved Phase
Slide 25: RAD301 Clinical Development (Imaging)
RAD301 Clinical Development (Imaging) 68Ga-trivehexin PET/MRI Imaging Patients with 68Ga-trivehexin PET/CT Imaging vs F18-FDG Pancreatic Tumors • Selective detection of αvβ6 integrin-expressing tumour lesions in • Selective detection of αvβ6 integrin-expressing tumor lesions in patients with PDAC pa
Slide 26: Multi-Indication Potential Beyond Pancreatic Cancer
MULTI-INDICATION POTENTIAL BEYOND PANCREATIC CANCER Expression of αvβ6-integrin in High expression case studies For personal use only human cancers NSCLC (103 cases, 291 specimens) ESCC (100 cases, 306 specimens) R A DIO P H A R M TH E R A N O STIC S L TD 20 24 26
Slide 27: RAD Therapeutic: Lu177-Integrin αVβ6 Development Strategy
RAD 302 Therapeutic: Lu177-Integrin αVβ6 CLINICAL DEVELOPMENT & REGULATORY STRATEGY For personal use only • GMP peptide production ongoing • GLP Tox and Biodistribution study planned in 2024 • IND submission in H2 2024 • Next step: Phase I dose escalation basket trial (multiple indications) planned
Slide 28: RAD 101: Imaging and Therapy for Brain Metastases
RAD 101: Imaging and Therapy for Brain Metastases F18-PIVALATE For personal use only Selectively targets fatty acid synthase which is overexpressed in tumours but not normal brain cells LINKER CANCER CELL TARGET TARGETING RADIOACTIVE Fatty acid MOLECULE ISOTOPE oxidation 18F to SEE pivalate 131I / 1
Slide 29: RAD Imaging: F18-Pivalate Development & Regulatory Strategy
RAD 101 Imaging: F18-PIVALATE CLINICAL DEVELOPMENT & REGULATORY STRATEGY For personal use only • Ongoing Tech transfer from UK to USA. IND approval after Tech transfer finalized • 24 months to complete late-stage development (Phase IIb + Phase III) • Only 1 expected competitor: Axumin (Bracco) curre
Slide 30: RAD Delivers Positive Phase II Data in Brain Metastasis Trial
F18-pivalate PET showed high uptake RAD 101 Delivers Positive Phase II RESULTS independent of origin of primary Data in Brain Metastasis Trial tumour Indicates that pivalate can be used to detect & monitor cerebral metastases RAD101 Phase IIa Clinical Trial: For personal use only • Patients without
Slide 31: RAD Trial Design: Phase IIb Imaging Study
RAD 101 TRIAL DESIGN Phase IIb Imaging Study in participants with suspected recurrent brain metastases from solid tumors • Primary Objective: Concordance between RAD101 positive lesions and those seen in conventional imaging For personal use only (MRI with gadolinium) in participants with suspected
Slide 32: Capital Raising
For personal use only CAPITAL RAISING R A DIO P H A R M TH E R A N O STIC S L TD 20 24 32
Slide 33: Capital Raising Overview
CAPITAL RAISING OVERVIEW Company has raised approximately A$70.0m via a two-tranche placement • A$70.0m placement comprising: ‒ A$23.9m placement under the Company’s available placement capacity under ASX Listing Rules 7.1 and 7.1A (“Tranche 1”); For personal use only ‒ A$46.1m subject to the Compan
Slide 34: Capital Raising and Use of Funds
CAPITAL RAISING AND USE OF FUNDS Company undertook a capital raising of approximately A$70.0m, which it expects will fully fund its current clinical programs until the end of 2026 For personal use only PRO-FORMA FUNDING A$M CAPITAL RAISE USE OF FUNDS A$M Existing Cash Balance1 $2.9 Drug Manufacturin
Slide 35: Offer Timetable
OFFER TIMETABLE Indicative capital raising timetable1 Date (AEST2) For personal use only Trading halt to complete capital raise Thursday, 20th June 2024 Capital Raising announced and trading halt lifted Tuesday, 25th June 2024 Settlement of Tranche 1 Placement Friday, 28th June 2024 Allotment of Tra
Slide 36: Appendix 1: Preclinical Portfolio
For personal use only APPENDIX 1: PRECLINICAL PORTFOLIO R A DIO P H A R M TH E R A N O STIC S L TD 20 24 36
Slide 37: RAD 402: KLK3 (PSA) Targeting mAb
RAD 402: KLK3 (PSA) TARGETING mAb Exquisite Anatomical & Disease Specificity Targeting Prostate Kallikrein Versus Traditional Prostate Cancer Targets For personal use only • hu5A10 is a humanized IgG1 that internalize prostate cells by specifically binding to catalytically active PSA/KLK3 (not found
Slide 38: RAD 402: Tumor-Specific Uptake
RAD 402: Tumor-Specific Uptake Biodistribution & Blocking Study of [89Zr]hu5A10 in Two [89Zr]hu5A10-PET in Cynomolgus Monkeys Subcutaneous Prostate Cancer Xenograft Models (Crab-Eating Macaque) For personal use only KLK3 expression: MDAPCa2b > LNCaP-AR Showcases robust uptake and low uptake in healt
Slide 39: RV 01: First and Only Selective B7H3 Radiopharmaceutical in Development
RV 01: FIRST AND ONLY SELECTIVE B7H3 RADIOPHARMACEUTICAL IN DEVELOPMENT ® BETABART Isoform-Selective Targeting of 4Ig-B7-H3 for PET Imaging and Beta-Radioligand Therapy For personal use only ® LINKER CANCER CELL TARGET TARGETING RADIOACTIVE 4Ig-B7H3 MOLECULE ISOTOPE 177Lu Betabart A soluble 2Ig-B7H3
Slide 40: B7H3 Pathway Highly Attractive Pan-Tumor Target
B7H3 PATHWAY HIGHLY ATTRACTIVE PAN-TUMOR TARGET For personal use only Loo, D. et. al. Clinical Cancer Research (2012). R A DIO P H A R M TH E R A N O STIC S L TD 20 24 40
Slide 41: Fc Mutations Designed to Accelerate Blood Clearance
FC MUTATIONS DESIGNED TO DISRUPT F(C)RN AND F(C)GR RECEPTOR BINDING TO ACCELERATE BLOOD CLEARANCE AND DECREASE MARROW BINDING BETABART For personal use only BLOOD CLEARANCE OF BETABART IN HUMANS (ESTIMATED) (Allometric Scaling of Blood Clearance of Predecessor Antibody MIL33B from Murine Dynamic PET
Slide 42: Therapeutic Efficacy: 56% Survival With Single Injection
THERAPEUTIC EFFICACY: 56% SURVIVAL WITH SINGLE INJECTION For personal use only 100 CT26 hB7H3 100uCi90Y-DOTA-MIL33B I.V. (n = 15) CT26 Vector 100uCi 90Y-DOTA-MIL33B I.V. (n = 9) 90 CT26 hB7H3 Saline I.V. (n = 23) 80 CT26 hB7H3 nothing (n = 20) 70 Percent Survival 60 50 40 * *** ** 30 20 10 0 (* p =
Slide 43: Clinical Development & Regulatory Strategy
CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Preclinical models validated selective targeting of tumor cells • Significant tumor reduction and increased survival in the animal models For personal use only • GMP CMC production ongoing. GMP batch in Q3 2024 • GLP TOX and Biodistribution studies in Q3
Slide 44: Appendix 2: Risk Factors
For personal use only Appendix 2: Risk Factors R A DIO P H A R M TH E R A N O STIC S L TD 20 24 44
Slide 45: Key Specific Risks Associated with Radiopharm's Business
Key specific risks associated with Radiopharm’s business Pipeline product in Radiopharm’s ability to achieve profitability is dependent on a number of factors, including its ability to complete successful clinical development and not trials, obtain regulatory approval for its products and successful
Slide 46: Key Specific Risks Associated with Radiopharm's Business
Key specific risks associated with Radiopharm’s business Radiopharm may pursue collaborative arrangements with pharmaceutical and life science companies, academic institutions or other For personal use only Arrangements with partners to complete the development and commercialisation of its products.
Slide 47: Appendix 3: Foreign Offer Restrictions
For personal use only Appendix 3: Foreign Offer Restrictions R A DIO P H A R M TH E R A N O STIC S L TD 20 24 47
Slide 48: Offer Jurisdictions & Disclaimers
OFFER JURISDICTIONS & DISCLAIMERS This document does not constitute an offer of new ordinary shares (“New Shares”) and free-attaching options (“Options”) of the Company in any jurisdiction in which it would be unlawful. In particular, this document may not be distributed to any person, and the New S
Slide 49: Offer Jurisdictions & Disclaimers (Cont.)
OFFER JURISDICTIONS & DISCLAIMERS (CONT.) New Zealand (Cont.) The New Shares and Options are not being offered or sold in New Zealand (or allotted with a view to being offered for sale in New Zealand) other than to a person who: • is an investment business within the meaning of clause 37 of Schedule
Slide 50: Offer Jurisdictions & Disclaimers (Cont.)
OFFER JURISDICTIONS & DISCLAIMERS (CONT.) United Kingdom (Cont.) The New Shares and Options may not be offered or sold in the United Kingdom by means of this document or any other document, except in circumstances that do not require the publication of a prospectus under section 86(1) of the FSMA. T
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