Oncoinvent ASA · OSL:ONCIN
Oncoinvent ASA — Investor Presentation (September 2022)
22 slides from Oncoinvent ASA's investor presentation, Sep 22, 2022
Slide 1: Company Presentation
Company Presentation 22. September 2022 Jan A. Alfheim CEO 1
Slide 2: A Global Leader in Alpha-Emitting Radiotherapeutics
DRAFT 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 2
Slide 3: Oncoinvent organisation
Oncoinvent organisation Admin Process 14 % development/production 22 % QA 5% • Represents over 140 years of experience Regulatory 5% in developing and manufacturing of radiopharmaceuticals • Clinical and preclinical R&D represents Clinical 8% 76% of workforce Quality Control 24 % R&D 22 % 3
Slide 4: Radspherin®
Radspherin® De-risked1 radiopharmaceutical-based innovative therapy for cancer patients Radspherin® description Designed for precise and safe impact Strong biodistribution results to date Patient 012 (7 MBq) – “whole body” 0 Serious adverse events to date in clinical studies Specifically designed to
Slide 5: Targeting Indications with a High Unmet Medical Need
Targeting Indications with a High Unmet Medical Need Peritoneal Carcinomatosis Poor survival rates • One of the most serious complications of gastrointestinal and Five-year survival rates in ovarian cancer gynecological malignancies and patients suffering from PC have 90% very poor outcomes 70% 39%
Slide 6: Radspherin clinical trial status
Radspherin® clinical trial status RAD-18-002 (colorectal cancer) • Preliminary safety data presented at ASCO in June • Preliminary efficacy signal at 12 months noted • Phase 2A started 25th of August • Both clinical sites (Radium Hospital and Uppsala) are ready to begin enrollment 6
Slide 7: RAD-18-002 safety data presented at ASCO 2022
RAD-18-002 safety data presented at ASCO 2022 Principal Investigator, Dr. Stein G. Larsen, M.D. presented the preliminary safety results from RAD-18-002 at ASCO in Chicago June 4, 2022 7
Slide 8: 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 seen • No dose limiting toxicities observed at any dose level • No SAE’s observed to date in both phase 1 trials ✓ Clinically relevant dose determined • 7 MBq dose deter
Slide 9: Historical recurrence rates in CRC patients
Historical recurrence rates in CRC patients 60 50 40 30 52,1 53,9 41,0 20 10 0 OUS CRS+ HIPEC 10 MONTHS, N= 119 PRODIGE 7 CRS+HIPEC 12 MONTHS, N=133 PRODIGE 7 CRS ALONE 12 MONTHS, N= 132 OUS CRS+ HIPEC: Recurrence rate at 10 months in a historical cohort at Oslo University Hospital (OUS), the Norweg
Slide 10: RAD-18-002 signal of efficacy at 12 months
RAD-18-002 signal of efficacy at 12 months • Far fewer patients enrolled in RAD-18-002 have relapsed in comparison to historical controls • All patients from phase 1 will reach 12 month time point by end of September (2 of 12 patients at 7 MBq dose have not yet been entered into clinical database) •
Slide 11: Radspherin clinical trial status
Radspherin® clinical trial status RAD-18-001 (ovarian cancer) • 2nd patient has been recruited to the 7 MBq dose level • Seeking patients at both clinical sites (Radium Hospital & KU Leuven) for 7 MBq dose level • Will start phase 2A expansion cohort after completion of dose range finding study • Wi
Slide 12: Radspherin clinical trial status – RAD-18-001 (continued)
Radspherin® clinical trial status – RAD-18-001 (continued) • Safety profile same as seen in RAD-18-002 • Too early to observe any signal of efficacy • Current status for patients enrolled in RAD-18-011: • 12 month timepoint reached for most patients enrolled in study to date CONFIDENTIAL 12
Slide 13: Radspherin Clinical Development Plan
Radspherin ® Clinical Development Plan Indication 2022 2023 2024 2025 2026 Ovarian cancer Recurrent Phase 1/2a 12 mo (n=13) 12 mo (n=37) + population 18mo(n=15) Primary Pivotal lead-in Pivotal population Colorectal Phase 1/2a 12 mo 15 mo 18 mo 12 mo (n=53)+ (n=23) (n=23) (n=23) 18mo (n=23) Phase 2 P
Slide 14: Oncoinvent's Vibrant and Promising Development Pipeline
Oncoinvent’s Vibrant and Promising Development Pipeline Discovery Preclinical Phase I 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:
Slide 15: OI-3, targeting CD146
OI-3, targeting CD146 CD146 is an adhesion molecule that plays important roles in angiogenesis, cancer metastasis, and immune response. It exists as a monomer or dimer on the cell surface. AA98 is a monoclonal antibody that binds to CD146, which abrogates the activation of CD146-mediated signaling p
Slide 16: CD146 - function and tumor expression
CD146 - function and tumor expression CD146 has been shown to be actively involved in various processes, such as development, signalling transduction, cell migration, mesenchymal stem cells differentiation, endothelial signalling, angiogenesis and immune response. CD146 is found to be upregulated in
Slide 17: OI-3, targeting CD146
OI-3, targeting CD146 • Expression: • Publications and expression databases show increased expression during disease development of mesothelioma, glioblastoma, ovarian cancer. • Internalisation: • Publication support internalization of CD146 binding antibodies. Our microscopy data show internalizati
Slide 18: Internalization of OI-3
Internalization of OI-3 Time % OI-3-Al488 Cell Antibody point internalized 45 min 14,4 45 min 23,4 Cetuximab 4h 31,2 4h 45,2 OHS 45 min 37,7 OI-3-Al488 followed by 45 min 49,1 OI-3 stripping of surface 4h 50,2 bound 4h 51,6 Assay with lead-212 labeled antibodies Microscopy, 2 h incubation 18
Slide 19: Last private placement of USD 25 M
Last private placement of USD 25 M • The proceeds will allow company to move both Radspherin clinical studies into phase 2a • The objective is to collect sufficient proof of concept efficacy data to design effective pivotal studies • The proceeds will also allow the start of development of a targete
Slide 20: Financial status Q2-2022
Financial status Q2-2022 KEY FIGURES (AMOUNTS IN NOK thousand) 2nd QUARTER 2022 2021 2022 YTD 2021 FULL YEAR 2021 • EBITDA result in Q2-2022 of minus TOTAL REVENUES AND OTHER INCOME 302 951 302 1 273 11 083 NOK 20.1 mill. (~USD 2.2 mill.) Payroll and related expenses -7 912 -7 748 -19 751 -15 943 -3
Slide 21: Anticipated Milestones for 2022
Anticipated Milestones for 2022 • Publication of safety results from phase 1 colorectal study at ASCO • Emergence of an efficacy signal from phase 1 • Selection of new targeted radiopharmaceutical agent to start preclinical testing • Initiation of phase 2a programs • Development of a multi-dose prod
Slide 22: On~o
On~o Invent