Oncoinvent Asa · OSL:ONCIN
Oncoinvent Asa — Investor Presentation (November 2024)
41 slides from Oncoinvent Asa's investor presentation, Nov 13, 2024
Slide 1: Oncoinvent - Innovative alpha-emitting therapy
Oncoinvent Innovative alpha-emitting therapy
Slide 2: Disclaimer (I/II)
DISCLAIMER Disclaimer (I/II) THIS DOCUMENT IS NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO OR FROM THE UNITED STATES OF AMERICA, ITS TERRITORIES OR POSSESSIONS, JAPAN, AUSTRALIA, CANADA, HONG KONG OR SOUTH AFRICA OR TO ANY RESIDENT THEREOF, OR
Slide 3: Disclaimer (II/II)
DISCLAIMER Disclaimer (II/II) This Presentation contains information obtained from third parties. Such information has been accurately reproduced and, as far as the Company is aware and able to ascertain from the information published by that third party, no facts have been omitted that would render
Slide 4: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 4
Slide 5: Oncoinvent at a glance
EXECUTIVE SUMMARY Oncoinvent at a glance 1 Clinical-stage radiopharmaceutical company focused on treating peritoneal metastases 1 2 Lead drug candidate is based on radioactive 224Ra and is currently in phase 2 clinical trials 2 3 3 safety profile and encouraging efficacy signals from two phase 1/2a
Slide 6: Peritoneal metastases - urgent need for novel treatments
EXECUTIVE SUMMARY Peritoneal metastases - urgent need for novel treatments • Peritoneal metastases are confined to the peritoneum - the membrane covering the abdominal cavity and organs – creating a ‘closed compartment’ • Peritoneal metastases arise from many different primary cancers, amongst other
Slide 7: Radspherin - innovative alpha emitting therapy targeted to and retained in the peritoneum
EXECUTIVE SUMMARY Radspherin® - innovative alpha emitting therapy targeted to and retained in the peritoneum Radspherin® How does it work? Clinical development • Novel formulation combining alpha- • Delivering high dose of lethal radioactivity to cancer cells in the Ovarian cancer emitting 224Ra wit
Slide 8: Peritoneal metastases represent a significant market opportunity
EXECUTIVE SUMMARY Peritoneal metastases represent a significant market opportunity Adds perfectly to existing patient flow Limited competition High addressable patient number • Surgery is and will remain the cornerstone • Distinguished by its unique mechanism of • Total treatments per year targeted
Slide 9: Radiopharmaceuticals have significant potential to become next generation of cancer treatments
EXECUTIVE SUMMARY Radiopharmaceuticals have significant potential to become next generation of cancer treatments Emergence of modern radiotherapy The promise of radiopharmaceuticals • Simple, proven MOA1) to kill cancer cells directly through DNA • Radiopharmaceuticals use a radioactive element to d
Slide 10: Radiopharma sector concentrated in two indications; Oncoinvent pursues peritoneal metastases
EXECUTIVE SUMMARY While the radiopharma sector is largely concentrated in two indications, Oncoinvent pursues peritoneal metastases Snapshot of the Radiopharma Landscape 224Ra 212Pb 225Ac 177Lu Other Commentary metastases Peritoneal • Majority of drug candidates are crowded in two indications – pros
Slide 11: Radiopharmaceutical expertise at all levels
EXECUTIVE SUMMARY Radiopharmaceutical expertise at all levels Management Scientific founders Board of Directors 11
Slide 12: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 12
Slide 13: Pipeline in one product - broad clinical application
UNMET MEDICAL NEED AND TREATMENT CONCEPT Pipeline in one product - broad clinical application Extraperitoneal Intraperitoneal metastases metastases Lung cancer Cholangiocarcinoma Breast cancer Gastric cancer • Peritoneal metastases arise from many Malignant melanoma Pancreatic cancer different cance
Slide 14: The main cause of death in ovarian cancer
UNMET MEDICAL NEED AND TREATMENT CONCEPT The main cause of death in ovarian cancer • Despite a comprehensive treatment approach, the majority of patients experience disease recurrence • Ovarian cancer rarely metastasize hematogenously, recurrences almost exclusively confined to the peritoneum • Need
Slide 15: Radspherin - innovative alpha emitting therapy targeted to and retained in the peritoneum
UNMET MEDICAL NEED AND TREATMENT CONCEPT Radspherin® - innovative alpha emitting therapy targeted to and retained in the peritoneum • Each vial consists of >1 billion CaCO3 microparticles labelled with alpha-emitting 224Ra • Ready-to-use, single dose delivered directly to the peritoneum • Shelf life
Slide 16: Eliminating residual micro metastases after surgery
UNMET MEDICAL NEED AND TREATMENT CONCEPT Eliminating residual micro metastases after surgery • Administration 1-3 days post-operative through a catheter placed at surgery • The microparticles retain radiation in the abdominal cavity, minimizing off-target exposure • Alpha radiation has a very short
Slide 17: Potent alpha-radiation dose delivered in the immediate post-operative treatment window
UNMET MEDICAL NEED AND TREATMENT CONCEPT Potent alpha-radiation dose delivered in the immediate post-operative treatment window 224Ra 3.63 d α • Radium-224 half life 3.6 days 220Rn • Decay of radium-224 to stable lead-208 via shorter- 55.6 s lived daughters α 216Po • The amount of lead resulting fro
Slide 18: Maximized dose to the target intraperitoneal tumors versus non-target sites
UNMET MEDICAL NEED AND TREATMENT CONCEPT Maximized dose to the target intraperitoneal tumors versus non-target sites Bypasses Retains Increases Reduces Prolongs the need of biological radioactivity in the the radionuclide the radionuclide the residence time of the targeting and systemic peritoneal c
Slide 19: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 19
Slide 20: Radspherin - in development for two lead indications
CLINICAL DEVELOPMENT PROGRAM Radspherin® - in development for two lead indications Patients undergoing surgical resection for peritoneal metastases Ovarian cancer Colorectal cancer Phase 1: after surgical treatment of platinum-sensitive Phase 1/2a: after surgery and HIPEC in patients with recurrence
Slide 21: Clinical development plan
CLINICAL DEVELOPMENT PROGRAM Colorectal cancer Ovarian cancer Clinical development plan 2024 2025 2026 2027 2028 Ovarian N=21 5 -year follow-up for survival Ph 1/2a Colorectal N=47 Ovarian N=60/30 Ph 2 Colorectal N = 60/30 TBD Ovarian Ph 3 Colorectal = Interim read-out = Final results 21
Slide 22: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 22
Slide 23: Safety profile validated in two phase 1/2a studies treating 68 patients
PHASE 1/2A RESULTS Colorectal cancer Ovarian cancer Safety profile validated in two phase 1/2a studies treating 68 patients • No dose limiting toxicity Well tolerated and safe to use • Only two out of 40 serious adverse events reported as possibly related to Radspherin* • 80% of radiation dose retai
Slide 24: Microparticle retention limits off-target organ exposure
PHASE 1/2A RESULTS Microparticle retention limits off-target organ exposure • Absorbed doses below 1 Gy* for all organs measured • Highest absorbed doses to organs at risk for osteogenic cells, followed by liver, bone marrow and kidneys • No signs of hematological, kidney or liver toxicity observed
Slide 25: Encouraging signal of efficacy in phase 1 in ovarian cancer
PHASE 1/2A RESULTS Ovarian cancer Encouraging signal of efficacy in phase 1 in ovarian cancer 12 months data from patients receiving 7 MBq dose vs historical recurrence-free rate Key results summary (RAD 18-001) – 10 patients Historical recurrence-free rate 90%* ~75% Overall Overall recurrence-free
Slide 26: Peritoneal control in colorectal cancer
PHASE 1/2A RESULTS Colorectal cancer Peritoneal control in colorectal cancer Peritoneal recurrence after surgery halves life expectancy vs non-peritoneal recurrence (21 vs 43 months) 18 months data from 20 of 36 patients receiving 7 MBq dose vs historical recurrence-free rates Peritoneal recurrence-
Slide 27: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 27
Slide 28: Phase 2 study in ovarian cancer - enrollment started
PHASE 2 PROGRAM Ovarian cancer Phase 2 study in ovarian cancer – enrollment started PFS Patients with primary pPFS SoC+ Radspherin Assessment OS advanced HRD negative Safety run-in Randomised (60 patients) every 3 months TFST ovarian cancer with (6-12 cohort 2:1 up to 24 TSST peritoneal metastases p
Slide 29: Phase 2 study in colorectal cancer - IND and CTAs in place
PHASE 2 PROGRAM Colorectal cancer Phase 2 study in colorectal cancer – IND and CTAs in place PFS pPFS SoC + Radspherin® OS Patients with peritoneal Biomarkers metastasis from colorectal (60 patients) Assessment every 3 CEA, CA19-9, CA125 months up to 24 cancer eligible for 2:1 months, including QoL
Slide 30: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 30
Slide 31: High addressable patient numbers with unmet need
MARKET POTENTIAL High addressable patient numbers with unmet need Ovarian cancer USA Europe Total Colorectal cancer USA Europe Total Patient diagnosed (100%) 22,000 63,000 85,000 Patient diagnosed stage IV (100%) 39,000 113,000 152,000 Peritoneal metastasis (70%) 15,000 44,000 59,000 Peritoneal meta
Slide 32: A multi billion USD market opportunity
MARKET POTENTIAL A multi billion USD market opportunity • Targeted patient population: Up to 65,000 eligible patients per year • Average pricing assumption: $100,000 per treatment (conservative vs. benchmarks) • The total addressable market in the US and Europe, for two cancer types in US and EU onl
Slide 33: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 33
Slide 34: In-house production at GMP facility
MANUFACTURING AND SUPPLY In-house production at GMP facility Oncoinvent has in-house GMP 224Ra produced from 228Th, which Microparticles and finished goods production capability has multiple sources produced in-house Current GMP facility supplies phase 2, outsourcing and scale-up required for phase
Slide 35: Radspherin production process
MANUFACTURING AND SUPPLY Radspherin® production process Overview of the Radspherin® production process Raw material input Combination Final product Elution of the alpha- emitter radium-224 Thorium-228 generator column Radium-224 Labeling of radium-224 to microparticles Pre-made calcium carbonate mic
Slide 36: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 36
Slide 37: Radspherin - solid multilayer intellectual property protection
INTELLECTUAL PROPERTY Radspherin® - solid multilayer intellectual property protection Radspherin® composition of matter & use • Granted in US, EU, China, Japan and additional countries • Patent expiry 2035 (2036 in some countries) with an option for 5 years extension Radspherin® formulation • Filed
Slide 38: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 38
Slide 39: A unique radiopharmaceutical opportunity
SUMMARY A unique radiopharmaceutical opportunity 1 High unmet need and limited competition 1 2 Tailored therapy for peritoneal metastases 2 3 3 Targeting by proximity – a clearly differentiated radiopharmaceutical asset 4 4 Compatible with established treatment regimes - adds well to existing patien
Slide 40: Agenda
AGENDA I. Executive summary 4 II. Unmet medical need and Radspherin® treatment concept 12 III. Clinical development program 19 IV. Phase 1/2a results 22 V. Phase 2 program 27 VI. Market potential 30 VII. Manufacturing and supply 33 VIII. Intellectual property 36 IX. Summary 38 X. Appendix 40 40
Slide 41: Significant headroom for further acquisitions in radiopharma
APPENDIX Despite strong M&A activity within the radiopharma sector there is still significant headroom for further acquisitions Summary of M&A Activity Overview of Radiopharma Exposure Commercial Late-Stage Early-Stage Preclinical $4,1 Pluvicto, Lutathera Lu-NeoB, 225Ac-PSMA-617, FAP-2286 MC-339 $3,