Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Investor Presentation (January 2024)
23 slides from Radiopharm Theranostics's investor presentation, Jan 24, 2024
Slide 1: Company Presentation – January 2024
For personal use only Company Presentation – January 2024 R A DIO 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: Radiopharmaceuticals Deliver Radiation Directly to Cancer Cells
RADIOPHARMACEUTICALS DELIVER RADIATION DIRECTLY TO CANCER CELLS Building Blocks of Radiopharmaceuticals For personal use only TARGETING MOLECULE High affinity, specific to cancer cells small molecule, peptide or antibody RADIOACTIVE ISOTOPE CANCER Imaging Isotope to SEE the cancer cells CELL TARGET
Slide 4: FDA-Approved Radiopharmaceutical Drugs Beating Expectations
FDA-APPROVED RADIOPHARMACEUTICAL DRUGS BEATING EXPECTATIONS Prostate Cancer Imaging Prostate Cancer Therapy Recent M&A Combined analysts’ peak BMS/RAYZEBIO (‘23) – For personal use only Analysts’ peak sales sales consensus for: $4.1B acquisition consensus for: Pylarify, Illucix Pluvicto ~$1,5B in
Slide 5: Company Vision & Strategy
COMPANY VISION & STRATEGY SUCCESSFULLY FIGHT CANCER THROUGH INNOVATIVE RADIOPHARMACEUTICAL THERAPIES Public Company (RAD : ASX) created in mid 2021 • Lean organization of 10 FTEs with low resource allocation to G&A • Expanded partnerships and strategic alliances For personal use only • AUD$ 82m rais
Slide 6: Expanded Partnerships & Strategic Alliances
EXPANDED PARTNERSHIPS & STRATEGIC ALLIANCES - UNIQUE BUSINESS MODEL: LOW CAPITAL INTENSITY, FLEXIBLE RESOURCE ALLOCATION For personal use only Lu177 Ac225 Tb161 ISOTOPES PIPELINE PHARMA DEVELOPMENT CMO / CDMO PRECLINICAL CLINICAL R A DIO P H A R M TH E R A N O STIC S L TD 20 24 6
Slide 7: 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 8: Clinical Development Priorities
CLINICAL DEVELOPMENT PRIORITIES MOLECULE & RAD CODE INDICATION Dx/Tx ISOTOPE PRECLINICAL PHASE I PHASE II PHASE III NOTES TARGET For personal use only Phase 1 enrolling in the USA RAD301 Imaging Ga68 READ-OUT by Q2 2024 TRIVEHEXIN PANCREATIC (αVβ6 Integrin) CANCER GMP production to be completed by Q
Slide 9: Trivehexin: Imaging and Therapy for Pancreatic Cancer
TRIVEHEXIN: Imaging and Therapy for Pancreatic Cancer TRIVEHEXIN For personal use only RGD peptide (arginylglycylaspartic acid) Integrin αvβ6 receptor antagonist Marker for tumour invasion and metastatic LINKER growth CANCER CELL TARGET Expression correlates with decreased survival in TARGETING RADI
Slide 10: RAD Imaging: Ga68-Trivehexin Clinical Development & Regulatory Strategy
RAD 301 Imaging: Ga68-TRIVEHEXIN CLINICAL DEVELOPMENT & REGULATORY STRATEGY • 66 patients already dosed under compassionate use (solid safety profile) For personal use only • 33 patients dosed under Investigator Initiated Research (presented at EANM 9/2023) • IND approved Phase I started, followed b
Slide 11: RAD301 Clinical Development Began
RAD301 Clinical Development Began Results Indicate that RAD301 can be used to detect Under German Medical Drug Act, and monitor pancreatic cancer supported by European partner • Rapid and specific accumulation in many target PDAC TRIMT primary lesions and metastases For personal use only • Low backg
Slide 12: RAD301 Clinical Development: Investigator Initiated Trial
RAD301 Clinical Development: Results Indicate that RAD301 shows incremental Investigator Initiated Trial at value over F18-FDG in PDAC & HNSCC Fortis Medical Center, supported • Favorable tumour-to-background contrast vs F18-FDG by TRIMT • Sharper images and negligible uptake in the surrounding For
Slide 13: Trivehexin Imaging: Projected Revenue Opportunities
TRIVEHEXIN Imaging: PROJECTED REVENUE OPPORTUNITIES Eligible New Revenue For personal use only Cancer New US Cases Price Patients Per Opportunity Per Type Per Annum Per Dose Annum Annum Imaging 124,000 Pancreatic Source: SEER database 99,000 USD $5,000 USD 240m US incidence Cancer Source: Bell Potte
Slide 14: RAD Therapeutic: Lu177-Trivehexin Clinical Development & Regulatory Strategy
RAD 302 Therapeutic: Lu177-TRIVEHEXIN CLINICAL DEVELOPMENT & REGULATORY STRATEGY For personal use only • GMP peptide production ongoing • GLP Tox and Biodistribution study by mid-2024 • IND submission and approval in H2 • Phase I dose escalation basket trial (multiple indications) to be started by y
Slide 15: Nanobody PD-L1: Imaging and Therapy for Lung Cancer
NANOBODY PD-L1: IMAGING AND THERAPY FOR LUNG CANCER 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 TARG
Slide 16: RAD Therapeutic: Nanomab PD-L1 Clinical Development & Regulatory Strategy
RAD 204 Therapeutic: NANOMAB PD-L1 CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Human pharmacokinetic and Biodistribution validated with Imaging agent (positive Phase I in 16pts) For personal use only • Phase I therapeutic dose escalation in Australia started • Phase II combo therapy trial with chec
Slide 17: Pivalate: Imaging and Therapy for Brain Metastases
PIVALATE: Imaging and Therapy for Brain Metastases F18-PIVALATE For personal use only Selectively targets fatty acid synthetase which is overexpressed in tumours but not normal brain cells LINKER CANCER CELL TARGET TARGETING RADIOACTIVE Fatty acid MOLECULE ISOTOPE synthetase 18F to SEE pivalate 131I
Slide 18: RAD Imaging: F18-Pivalate Clinical 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 • 21 months to complete late-stage development (Phase IIb + Phase III) • ~30 months to anticipated NDA Approval and first
Slide 19: Pivalate Delivers Positive Phase II Data in Brain Metastasis Trial
F18-pivalate PET showed high uptake Pivalate 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 20: Pivalate: Imaging Projected Revenue Opportunities
PIVALATE: IMAGING PROJECTED REVENUE OPPORTUNITIES Eligible New Revenue For personal use only Cancer New US Cases Price Patients Per Opportunity Per Type Per Annum Per Dose Annum Annum Imaging 300,000 88,000 USD $4,730 USD 364m Brain Metastasis Source: SEER database US incidence Source: Jones Group a
Slide 21: Inflection Points in 2024: Imaging Trial Read-outs; Advancing Therapeutic Molecules
INFLECTION POINTS IN 2024: 2 IMAGING TRIAL READ-OUTS; ADVANCING THERAPEUTIC MOLECULES MOLECULE & PHASE RAD CODE TARGET INDICATION Dx/Tx ISOTOPE PRECLINICAL PHASE I 2a/2b 2024 EVENTS For personal use only RAD301 Imaging Ga68 PHASE I READ-OUT by Q2 TRIVEHEXIN PANCREATIC (αVβ6 Integrin) CANCER RAD302 T
Slide 22: Potential for Significant Shareholder Value Creation
POTENTIAL FOR SIGNIFICANT SHAREHOLDER VALUE CREATION SOME RELEVANT PEER-TO-PEER COMPARISON For personal use only Public Public Public Private Private FDA INDs or other Regulatory approval 3 3 4 3 - for clinical trials (EU, AUS, UK…) Phase I imaging ongoing 1 1 - - Phase II Imaging ongoing 1 - 2 - Ph
Slide 23: For personal use only
For personal use only R A DIO P H A R M TH E R A N O STIC S L TD 20 22 C O N FIDE N TIA L | 23
Radiopharm Theranostics — Investor Presentation (January 2024) on 6ix