Radiopharm Theranostics Limited · ASX:RAD
Radiopharm Theranostics — Bell Potter Healthcare Conference 2023
25 slides from Radiopharm Theranostics's conference presentation, Nov 15, 2023
Slide 1: Bell Potter Healthcare Conference
For personal use only BELL POTTER HEALTHCARE CONFERENCE 15 November 2023 R A DIO P H A R M TH E R A N O STIC S L TD 20 23 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 Therapy Directly to Cancer Cells
RADIOPHARMACEUTICALS DELIVER RADIATION THERAPY 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
Slide 4: Sector Excitement Driven by FDA-Approved Radiopharmaceutical Drugs
SECTOR EXCITEMENT DRIVEN BY FDA-APPROVED RADIOPHARMACEUTICAL DRUGS BEATING EXPECTATIONS Prostate Cancer Imaging Prostate Cancer Therapeutic Combined analysts’ peak For personal use only Analysts’ peak sales sales consensus for: consensus for: Pylarify, Illucix Pluvicto ~$1,5B in 2024 $3.0B in 2029 F
Slide 5: Company Vision & Strategy
COMPANY VISION & STRATEGY SUCCESSFULLY FIGHT CANCER THROUGH INNOVATIVE RADIOPHARMACEUTICAL THERAPIES Unique Business Model • High resource allocation to R&D • Low resource allocation to G&A – small team of 11 FTE. For personal use only • Expanded partnerships and strategic alliances Intellectual Pro
Slide 6: Expanded Partnerships & Strategic Alliances
EXPANDED PARTNERSHIPS & STRATEGIC ALLIANCES - UNIQUE BUSINESS MODEL: LOW CAPITAL INTENSITY, FLEXIBLE RESOURCE ALLOCATION For personal use only Lu177 Ac225 Tb161 ISOTOPES PIPELINE PHARMA DEVELOPMENT CMO / CDMO PRECLINICAL CLINICAL R A DIO P H A R M TH E R A N O STIC S L TD 20 23 6
Slide 7: Transition from Preclinical to Clinical Stage Company in Only Two Years
TRANSITION FROM PRECLINICAL TO CLINCAL STAGE COMPANY IN ONLY TWO YEARS Company IPO AUS$ 50m incorporation in ASX:RAD In-licensed Australia & For personal use only Created 4 technologies 2021 capital raise management team highly AUS$ 20m and BoD differentiated 7/2021 11/2021 In-licensed Joint Venture
Slide 8: Portfolio Priorities – Two Imaging & Two Therapeutics
PORTFOLIO PRIORITIES – Two Imaging & Two Therapeutics RAD MOLECULE & INDICATION ISOTOPE PRECLINICAL PHASE I PHASE IIA PHASE IIB PHASE III NOTES For personal use only CODE TARGET IMAGING Pivalate Phase 2b first patient expected in Q4 RAD101 BRAIN METS F18 IND approval after USA Tech transfer (Fatty A
Slide 9: RAD Imaging: F18-Pivalate
RAD 101 Imaging: F18-PIVALATE 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 pivalate 18F BRAND VISION: BECOME THE LEADING
Slide 10: 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 11: RAD100 Program: Pivalate Positive Phase II Results
RAD100 PROGRAM F18-pivalate PET showed high uptake Pivalate Delivers Positive Phase II RESULTS regardless of origin of primary tumour Data in Brain Metastasis Trial Indicates that pivalate can be used to detect & monitor cerebral metastases RAD101 Phase IIa Clinical Trial: For personal use only • Pa
Slide 12: RAD Imaging: Ga68-Trivehexin
RAD300 PROGRAM RAD 301 Imaging: Ga68-TRIVEHEXIN 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 RADIOACTIV
Slide 13: 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 Pilot Study (presented at EANM 9/2023) • IND approved Phase I start imminent, followed by registratio
Slide 14: RAD301 Clinical Development Began Under German Medical Drug Act
RAD300 PROGRAM 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 o
Slide 15: RAD301 Investigator Initiated Trial at Fortis Medical Center
RAD300 PROGRAM 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 practically no uptake in t
Slide 16: Two Imaging Assets: Projected Revenue Opportunities
TWO IMAGING ASSETS: 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
Slide 17: RAD Therapeutic: Nanomab PD-L1
RAD200 PROGRAM RAD 204 Therapeutic: NANOMAB PD-L1 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 TARGET
Slide 18: Nanomab PD-L1 Clinical Development & Regulatory Strategy
RAD 204 Therapeutic: NANOMAB PD-L1 CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Human pharmacokinetic and Biodistribution proven with Imaging agent (positive Phase I in 16pts in 2019 For personal use only • Strategic Collaboration with Lantheus for the PDL-1 Imaging agent • Phase I therapeutic dose
Slide 19: RAD Therapeutic: Nanomab HER-2
RAD 202 Therapeutic: NANOMAB HER-2 HER 2 NANOMAB Single domain monoclonal antibody (Sd mAb) For personal use only HER 2 pathway proven in Oncology Overexpression in Breast Cancer and LINKER Gastroesophageal cancers CANCER CELL TARGET TARGETING RADIOACTIVE HER2 MOLECULE ISOTOPE 99Tc to SEE Sd mAb 177
Slide 20: Nanomab HER-2 Clinical Development & Regulatory Strategy
RAD 202 Therapeutic: NANOMAB HER-2 CLINICAL DEVELOPMENT & REGULATORY STRATEGY • Human pharmacokinetic and Biodistribution proven with Imaging agent (positive Phase I in 10pts in For personal use only 2021, follow by IIT in Germany in additional 6 pts. • Phase I therapeutic dose escalation in USA (ap
Slide 21: Two Read Outs by Mid 2024
TRANSITION FROM PRECLINICAL TO CLINICAL STAGE COMPANY WITH 4 MOLECULES - 2 READ OUTS BY MID 2024 - For personal use only Phase 2b √ Phase 1 √ READ OUT 1st Patient READ OUT Pivalate 1stPatient Phase I RAD301 1st Patient 1st Patient Ethics FDA IND Phase I Phase 2b RAD202 Committee IND approval Phase I
Slide 22: Summary
SUMMARY FOUR PRIORITY ASSETS LEADING THE ISOTOPE SUPPLY CHAIN SECURED WITH ONGOING COMPANY TRANSFORMATION MULTIPLE CONTRACTS SIGNED FOR Lu177, For personal use only TO CLINICAL STAGE COMPANY Ac225, Tb161 ACHIEVEMENT OF MULTIPLE INFLECTION POINTS: RAD 101 Phase 2b read out RAD 301 Phase 1 read out RA
Slide 23: Key Management Team
KEY MANAGEMENT TEAM For personal use only Paul Hopper Riccardo Canevari Vittorio Puppo Dr. Antje Wegener Dr. Sherin Al-Safadi Executive Chairman Chief Executive Officer Chief Operating Officer VP, Clinical Development VP, Medical Affairs • Founder of Radiopharm • Radiopharm Theranostics • Has served
Slide 24: Glowing Radiopharma Deal Space (2018 to Present)
GLOWING RADIOPHARMA DEAL SPACE (2018 TO PRESENT) HIGHLIGHTS GROWING STRATEGIC AND INVESTOR INTEREST Selected Recent Strategic Agreements Selected Recent Financing Deals For personal use only • POINT/LLY (‘23) - $1.4B acquisition • RayzeBio IPO nets $269.8MM IPO (’23) • Roche/Genentech/PeptiDream (‘2
Slide 25: Contact Us
For personal use only CONTACT US Riccardo Canevari Paul Hopper CEO & MANAGING DIRECTOR Executive Chairman Radiopharm Theranostics Limited Radiopharm Theranostics Limited T +1 862 309 0293 T +61 406 671 515 E rc@radiopharmtheranostic.com E paulhopper@lifescienceportfolio.com W www.radiopharmtheranost
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