Oncoinvent Asa · OSL:ONCIN
Oncoinvent Asa — Investor Presentation (June 2021)
50 slides from Oncoinvent Asa's investor presentation, June 2021
Slide 1: Oncoinvent Company presentation June 2021
Oncoinvent Company presentation June 2021 Jan A. Alfheim CEO
Slide 2: Disclaimer
Disclaimer This presentation and its appendices (collectively the "Presentation") has been produced by Oncoinvent AS (the "Company") with assistance from Arctic Securities AS and DNB Markets, part of DNB Bank ASA (the "Managers"), solely for information purposes in connection with a contemplated off
Slide 3: Disclaimer
Disclaimer The Presentation is not intended for distribution to, or use by, any person in any jurisdiction where such distribution or use would be contrary to local laws and regulations. By accepting these materials, each Recipient represents and warrants that it is able to receive them without cont
Slide 4: Summary of Risk Factors (i/ii)
Summary of Risk Factors (i/ii) • Investing in the shares (the "Shares") of the Company involves inherent risks. Before deciding whether or not to invest in the Shares, a prospective investor should consider carefully all of the information set forth in this Presentation and otherwise available. • Be
Slide 5: Summary of Risk Factors (ii/ii)
Summary of Risk Factors (ii/ii) RISKS RELATED TO FINANCING • The Company is in a development phase and dependent on capital contributions from existing shareholders and new investors to fund its operations • The Company's results will be exposed to exchange rate risks RISKS RELATED TO THE SHARES • T
Slide 6: Presenting Team
Presenting Team Jan Alan Alfheim Tore Kvam CEO CFO 6
Slide 7: Growth in the Field of Targeted Radiotherapeutics
Growth in the Field of Targeted Radiotherapeutics High and increasing activity on the backdrop of recent breakthroughs Selected recent deals and transactions Number of deals per year 46 45 43 • Listed at NASDAQ June 2020 • Four compounds in pipeline 42 with USD 708m post-money with one in phase 1 34
Slide 8: Targeted Radiopharmaceuticals Existing Medicine / in Late-Stage Development
Targeted Radiopharmaceuticals Existing Medicine / in Late-Stage Development Positioning targeted radiopharmaceuticals Existing medicines and contrast agents Tc-99m imaging1 ✓ Positioned to serve important unmet needs Lutathera ✓ Enables visualization of organ and tissue structure In development ✓ De
Slide 9: Table of Contents
TABLE OF CONTENTS 1 Introduction to Oncoinvent 2 Radspherin® & pipeline 3 Manufacturing, financials and organization 4 Appendix
Slide 10: A Global Leader in Alpha-Emitting Radiotherapeutics
A Global Leader in Alpha-Emitting Radiotherapeutics Oncoinvent is advancing a pipeline of radiopharmaceutical products across a variety of solid cancers that leverages robust internal R&D and manufacturing capabilities to enable a clinical supply of radioisotopes 10
Slide 11: Oncoinvent Background
Oncoinvent Background Building on experience from serial-innovators within the oncology space 2010 33 41 founded FTEs Industrial Ph.D. students Professor of clinical Dr. Roy H. Larsen, Ph.D. oncology Øyvind S. Bruland Founders with a combined 60 + years of Oncoinvent is the 3rd company founded and R
Slide 12: Key Achievements to Date
Key Achievements to Date 2010 • Oncoinvent AS founded Novel radiopharmaceutical platform technology with ✓ the potential to develop multiple products for 2015 • Radspherin® patent application filed treatment of a variety of solid cancers Effective execution of phase 1 with good patient • NOK 18m rai
Slide 13: Table of Contents
TABLE OF CONTENTS 1 Introduction to Oncoinvent 2 Radspherin® & pipeline 3 Manufacturing, financials and organization 4 Appendix
Slide 14: Oncoinvent's Promising Development Pipeline
Oncoinvent’s Promising Development Pipeline Discovery Preclinical Phase 1 Description Target Peritoneal carcinomatosis RAD-18-001: Radspherin® Alpha-emitting from ovarian cancer radioactive microspheres designed for treatment of metastatic cancers in Peritoneal carcinomatosis RAD-18-002: Radspherin®
Slide 15: Radspherin – Overview
Radspherin® – Overview De-risked1 radiopharmaceutical-based innovative therapy for cancer patients Radspherin® overview Designed for precise and safe impact Strong product distribution results to date Patient 012 (7 MBq) – “whole body” 0 Serious adverse events to date Specifically designed to safely
Slide 16: Radspherin is Targeting Indications with a High Unmet Medical Need
Radspherin® is Targeting Indications with a High Unmet Medical Need… 1st indication – peritoneal carcinomatosis High unmet medical need with poor survival rates • Treatment of peritoneal carcinomatosis (PC) originating from ovarian cancer, colorectal Five-year survival rates in ovarian cancer cancer
Slide 17: …and with a Large Market Potential
…and with a Large Market Potential Radspherin® is targeting devastating diseases with large market potential Incidence and mortality1 Potential patient populations for Radspherin®2 Large and growing target market In Northern America and Europe, numbers from 2020 In Northern America and Europe, numbe
Slide 18: Radspherin Mechanism of Action
Radspherin® Mechanism of Action Effect of destructive ionizing radiation from alpha particles on cancer cell DNA Alpha particles are a high Linear Energy Transfer (LET) form of radiation and 1 are capable of breaking both strands of DNA in cancer cells Alpha particles Beta particles Beta particles a
Slide 19: Safety Benefits from Using Alpha Emitters versus Beta Emitters
Safety Benefits from Using Alpha Emitters versus Beta Emitters Less penetration into healthy tissue by alpha particles • Alpha particles penetrate the distance of 5 – 10 cell diameters (100 micrometers) while Beta particles penetrate up to 12 millimeters Paper Plexiglass Lead • The risk of damage an
Slide 20: Demonstrated Effectiveness in Preventing Ascites and Extending Survival
Demonstrated Effectiveness in Preventing Ascites and Extending Survival ID8 ovarian cancer model ES-2 ovarian cancer murine model treated with Radspherin® Treatment start ✓ Promising early signs of efficacy Survival Untreated mouse with ascites ✓ Improved effect at higher doses Time after cell inocu
Slide 21: A Successful Distribution of Radspherin in the Peritoneal Cavity Observed
A Successful Distribution of Radspherin® in the Peritoneal Cavity Observed Planar scintigraphy – anteriorly: 20 minutes acquisition time ✓ A successful distribution of Radspherin® in the peritoneal cavity is necessary to obtain an effective irradiation of the micrometastatic cancer cells 3h post-inj
Slide 22: Clinical Development Plan
Clinical Development Plan Clinical No. of Indication stage patients 2020 2021 2022 2023 2024 2025 Commentary RAD-18-001: Radspherin® RAD-18-001 study Peritoneal carcinomatosis from ovarian cancer • Recruitment targeted for Ongoing clinical Phase Phase1I 45 completion Q3 2021 studies RAD-18-002: Rads
Slide 23: Two Signals of Efficacy to be Measured in Phase 2A
Two Signals of Efficacy to be Measured in Phase 2A Median time to progression Rate of progression • A measurement of how long patients remain disease free • A measurement of the number of patients that remain disease free at different time points until the anticipated median time • In comparison to
Slide 24: Table of Contents
TABLE OF CONTENTS 1 Introduction to Oncoinvent 2 Radspherin® & pipeline 3 Manufacturing, financials and organization 4 Appendix
Slide 25: Internal Production and R&D Facilities
Internal Production and R&D Facilities Oslo, Norway ✓ Class B production facility ✓ GMP certificate from the Norwegian Medical Agency ✓ Well equipped R&D Labs allow for development of new radioisotopes and targeting agents in-house ✓ In total 580 m2 facility 25
Slide 26: Projected Cash Burn (2022-23)
Projected Cash Burn (2022-23) Cash burn 2022-23 NOKm Oncoinvent expects expenses of roughly NOK 191m up to end-23’ • Established a competent organization with a strong R&D focus Income -25.0 • In-house production to deliver GMP material for clinical trials • Sufficient production capacity for the tw
Slide 27: Management Team
Management Team Jan Alan Alfheim, MSc, MBA Tore Kvam Anne-Kirsti Aksnes, PhD CEO CFO VP of Clinical Operations (start 1. August) >30 years’ experience within pharmaceutical Life-long experience from working within >25 years of clinical development experience, & radiopharmaceutical industries, former
Slide 28: Board of Directors
Board of Directors Roy Hartvig Larsen, PhD Ludvik Sandnes Chairman and co-founder Board member Long experience within drug development and business. He was the main >40 years’ experience from international corporate finance, asset founder of Algeta and Nordic Nanovector and has served in various sen
Slide 29: Shareholder Overview
Shareholder Overview Shareholder Shares % Comments Sciencons AS 3 207 223 22.4 % • Strong shareholders of both specialized funds Geveran Trading Co. Ltd. 1 098 000 7.7 % and family offices Hadean Capital 760 000 5.3 % • Entrepreneurs still active in company with Roy H. Larsen 678 000 4.7 % significa
Slide 30: Multiple Inflection Points Expected Over 2021/22
Multiple Inflection Points Expected Over 2021/22 2021 2022 2023 2024 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 1st interim report with Amendment to start First efficacy signals from Results of phase 2A safety data from dose phase 2A study phase 1 study available clinical trial available range fin
Slide 31: Investment Highlights
Investment Highlights 1 Locally delivered, minimally invasive, transformative lead product candidate - Radspherin® 2 Radspherin® has an attractive product profile that is highly complementary to current cancer treatment paradigm 3 De-risked1 portfolio of radiopharmaceutical-based innovative therapie
Slide 32: Table of Contents
TABLE OF CONTENTS 1 Introduction to Oncoinvent 2 Radspherin® & pipeline 3 Manufacturing, financials and organization 4 Appendix
Slide 33: Promising Indications of an Efficient Distribution of Radspherin
Promising Indications of an Efficient Distribution of Radspherin® Images from phase 1 study: Day 1-2 post-injection of Radspherin® Day 1: Day 2: No aggregate correlation to “hot spot” Patient 5 002-study (2MBq) ✓ Images show that Radspherin® may redistribute in the peritoneal cavity, that small part
Slide 34: Established Radioisotope Network
Established Radioisotope Network Ra-224 Commercial Clinical & Preclinical Th 228 Suppliers Standardization Production • Radium Hospital, Oslo Norway • National Institute for Standards • Institute for Energy Technology, • Oak Ridge National Laboratory, and Technology, Maryland USA Kjeller Norway Tenn
Slide 35: Targeted Radiotherapeutics are seen as the New Cancer Treatment Method
Targeted Radiotherapeutics are seen as the New Cancer Treatment Method “Old method” ~ Radiation therapy “New method” ~ Targeted therapeutics • Delivering beams of radiation from outside the body to • Compound is injected, infused, inhaled, or ingested, Significant scientific highlights kill tumors i
Slide 36: Radspherin: The Active Component – the Radionuclide Ra-224
Radspherin®: The Active Component – the Radionuclide Ra-224 Unique raw material and characteristics • Radspherin® is based on Ra-224, which is produced from Th-228 • Ra-224 has unique characteristics ✓ Efficient production: • Large quantities that enables efficient production • Long shelf-life of ra
Slide 37: Robust Preclinical Proof of Concept Demonstrated
Robust Preclinical Proof of Concept Demonstrated Description Illustrative overview of results • x program of preclinical studies completed, aiming to evaluate • Robust Radspherin®’s characteristics in mouse models Background • Tumor inhibition and survival benefit measured in three ovarian cancer mo
Slide 38: Radspherin First-In-Human Phase 1 Study Design
Radspherin® First-In-Human Phase 1 Study Design Dose escalation phase Repeated injection phase Expansion cohort phase 1 MBq 2 MBq 4 MBq 7 MBq • Dose range selected from preclinical data Repeated injection cohort of 3 subjects Expansion cohort of 6 subjects • No DLTs1 observed at any dose level in •
Slide 39: Robust Safety Profile Seen to Date
Robust Safety Profile Seen to Date Robust safety profile seen to date with minor side effects reported ✓ No Serious Adverse Events (SAE) seen • No DLTs1 observed at any dose level • No SAE’s deemed related to Radspherin observed to date in both phase 1 trials ✓ Clinically relevant dose determined •
Slide 40: Pipeline Potential (OI-3 and OI-1)
Pipeline Potential (OI-3 and OI-1) Product concept Indication • Product concept: Targeted radiotherapy based on OI-3 and OI-1 • Potential first tumor targets for a OI-3 targeted alpha antibodies with an alpha emitter radiotherapeutic • OI-3 targets CD146, a cell adhesion molecule, has been • gliomas
Slide 41: Phase 2A Study in Ovarian Cancer
Phase 2A Study in Ovarian Cancer Background and rationale Study design • A phase 2A study to evaluate the efficacy and safety of Radspherin® in subjects with Phase 2A study in ovarian cancer subjects with peritoneal peritoneal carcinomatosis from ovarian cancer following cytoreductive surgery (CRS)
Slide 42: Phase 2A Study in Colorectal Cancer
Phase 2A Study in Colorectal Cancer Background and rationale Study design • A phase 2A study to evaluate the efficacy and safety of Radspherin® in subjects with Phase 2A study in colorectal carcinoma subjects with peritoneal carcinomatosis from colorectal carcinoma following hyperthermic peritoneal
Slide 43: Risk Factors
OnNCO Invent Risk Factors
Slide 44: Risk Factors (i/vi)
Risk Factors (i/vi) Investing in the shares of the Company (the "Shares") involves inherent risks. Before making an investment decision, prospective investors should carefully consider all information set forth in the Presentation and which is otherwise available, including, but not limited to, hist
Slide 45: Risk Factors (ii/vi)
Risk Factors (ii/vi) 1.3 The Company is exposed to commercial risk, including successful market penetration There is an inherent risk that the Company's product candidates, despite having obtained necessary authorizations and approvals in relevant markets, will not succeed in achieving a sufficientl
Slide 46: Risk Factors (iii/vi)
Risk Factors (iii/vi) 1.8 The Company is reliant on the sourcing of particular types of isotopes for its production The Company has established own production of isotopes for its clinical trials. However, the Company does not have sufficient capacity to produce a sufficient quantity of isotopes for
Slide 47: Risk Factors (iv/vi)
Risk Factors (iv/vi) 1.14 The Company's processing of personal data is subject to complex and evolving laws and regulations regarding data protection and privacy The Company's processing of personal data is subject to complex and evolving laws and regulations regarding data protection and privacy (t
Slide 48: Risk Factors (v/vi)
Risk Factors (v/vi) 3.2 The price of the Shares may fluctuate significantly The market price of the Shares could be subject to significant fluctuations in response to actual or anticipated variations in the development of the Company's product candidates, particularly the progress of the clinical tr
Slide 49: Risk Factors (vi/vi)
Risk Factors (vi/vi) 3.8 Shareholders outside of Norway are subject to exchange rate risk The Shares are priced in NOK, and any future payments of dividends on the Shares will be made in NOK. Exchange rate movements of NOK will therefore affect the value of these dividends and distributions for inve
Slide 50: On~o
On~o Invent