Molecure Sa · GPW:MOC
Molecure Sa — Investor Presentation (April 2023)
26 slides from Molecure Sa's investor presentation, Apr 5, 2023
Slide 1: Fate can be altered
“Our goal is to become a leading biotechnology company, globally recognized for discovering and developing breakthrough small molecule drugs acting on unexplored protein and novel mRNA targets to help patients in need of innovative therapeutic solutions” Fate can be altered April 5, 2023
Slide 2: Disclaimer
Molecure SA (”MOC") and its Board and employees make no warranties or assurances regarding the accuracy or completeness of any representations or other materials contained herein. The information and data contained herein reflect the current conditions and assessments of the market situation as at t
Slide 3: Presenting Team
Presenting Team Marcin Szumowski Zbigniew Zasłona Chairman of the Board & CEO Chief Scientific Officer Samson Fung Sławomir Broniarek Chief Medical Officer Chief Financial Officer 05/04/2023 3
Slide 4: 2022 | Two clinical assets enter Molecure's pipeline
2022 | Two clinical assets enter Molecure’s pipeline Revision of pipeline priorities OATD-01: preparations for a Phase II Proof-of-concept (PoC) clinical trial OATD-02: regulatory approval and start of a Phase I clinical trial in solid tumor patients Progress in the deubiquitinase (DUB) platform Fur
Slide 5: Balanced pipeline
Balanced pipeline Current status Clinical Candidate 2023 estimate Selection Molecular Target Lead In Vivo Preclinical Regulatory Target Indications Validation Optimization POC Development Process Phase I Phase II Hit-to-lead PROTEIN TARGETS OATD-01 Sarcoidosis, other OATD-01 OATD-01 CHIT1 ILDs 2ND G
Slide 6: OATD-01
OATD-01 05/04/2023 6
Slide 7: OATD-01 | on track to enter Phase II
OATD-01 | on track to enter Phase II Preparations for Phase II clinical Grant application for the Phase II trial in patients with pulmonary clinical trial to ABM** for a total sarcoidosis amount of PLN 49m submitted (PLN 24.5m grant funding) Ph I studies in human volunteers performed (129 subjects A
Slide 8: OATD-01 | Phase II clinical trial plan
OATD-01 | Phase II clinical trial plan Double-blind, randomized, placebo-controlled multi-center study to assess the safety and efficacy of an oral inhibitor of CHIT1 (OATD-01) in patients with active pulmonary sarcoidosis H1 202 IND & CTA FDA & EMA *FPFV *LPLV *CSR Submission approvals Q2 2023 Q2-Q
Slide 9: OATD-02
OATD-02 05/04/2023 9
Slide 10: OATD-02 | administered to the first patient
OATD-02 | administered to the first patient Phase I clinical trial *FPFV *LPLV *CSR Sites initiation Patient screening approval Nov 2022 Jan-Feb 2023 Feb 2023 Mar 2023 H2 2024 H2 2024 Design: Open-label single-arm dose-escalation Patient population (30-40 patients): Relapsed/refractory advanced mono
Slide 11: OATD-02 | dosing scheme
OATD-02 | dosing scheme Sixth cohort o Six main doses (2.5-30 mg) each 4 weeks. Min. 3-6 patients o After each cohort the decision is taken by Sponsor with Fifth cohort help of Safety Review Committee to continue the study. Min. 3-9 patients 30 mg o Only one patient can be enrolled at the time. Four
Slide 12: DUBs platform
DUBs platform 05/04/2023 12
Slide 13: USP7 inhibitor - a T cell modifier with proven anti-cancer potential
USP7 inhibitor - a T cell modifier with proven anti-cancer potential Validated translational Significant anticancer efficacy as potential monotherapy and in combinations Current focus in the program: Mechanism of action involves optimalization of drug-like activation of T cells properties of a lead
Slide 14: USP7i developed as a tumor-agnostic therapy
USP7i developed as a tumor-agnostic therapy B16F10 melanoma E0771 breast A20 lymphoma CT26 colon Vehicle 1000 2500 Vehicle 2000 Vehicle Vehicle (mm3, median with IQR) OAT-4828 (mm3, median with IQR) (mm3, median with IQR) 2000 OAT-4828 (25 mg/kg) (mm3, median with IQR) 1000 (100 mg/kg, PO, BID) 800
Slide 15: USP21 inhibitors developed as inhibitors of tumor metabolism
USP21 inhibitors developed as inhibitors of tumor metabolism Clinical Candidate Selection Current status Target Lead In Vivo Validation Preclinical Hit-to-lead Optimization POC Development 2023 estimate USP21 o Launched in August 2021 o Hit molecule found as a starting point for the development of a
Slide 16: Undisclosed signaling pathway crucial to fibrosis (UoM license)
Undisclosed signaling pathway crucial to fibrosis (UoM license) Clinical Candidate Selection Current status Target Lead In Vivo Validation Preclinical Hit-to-lead Optimization POC Development 2023 estimate Undisclosed License Agreement with o Launched in March 2022 o The medicinal chemistry team foc
Slide 17: mRNA platform
mRNA platform 05/04/2023 17
Slide 18: mRNA platform | discovering medicines of the future
mRNA platform | discovering medicines of the future We are here Docking (virtual 3D screening) Optimized In silico Druggable 3D Docking Active NMR* In silico Small Validation structure Lead Sequence Secondary structure Small SHAPE- molecule of the compound structures CryoEM* of RNA (virtual (wet lab
Slide 19: Financials
Financials 05/04/2023 19
Slide 20: Financial Results
Financial Results PLN m 2022 2021 Assets & Liabilities changes (PLN m) Revenue 1.64 1.46 Grants 1.61 1.17 25,64 Other 0.03 0.29 36,45 4,53 1,78 Cost incl: 18.22 15.23 General & Adm & Projects* 12.78 9.28 151,58 138,03 Early stage programs 4.46 0.52 Motivation program 0.44 2.84 Commercialisation cost
Slide 21: R&D expenses and CAPEX
R&D expenses and CAPEX PLN m 2022 2021 Grant funding R&D expenses incl.: 25.64 10.10 PLN 20m in current grants Arginase program 10.19 2.67 Cash position (Mar 2023) Chitinase program 8.72 4.78 >PLN 53m Deubiquitinases & UoM 6.73 2.65 Lab equipment infrastructure** 3.22 1.98 Financing secured other CA
Slide 22: Grants
Grants Submitted to ABM** (Feb 23), NIH** (Mar 20) Planned to PARP** (Apr) ABM ABM PARP OATD-01 Undisclosed* mRNA platform PLN 49/24.5m PLN 43/29.7m PLN 46/29m NIH PARP OATD-01 USP21 USD 2.2m PLN 57/40m In total Submitted 5 applications PLN 203/133m (over the next 6 years) *project aiming at an undi
Slide 23: 2023-2025 plans
2023-2025 plans 05/04/2023 23
Slide 24: Potential news flow until Q4 2023
Potential news flow until Q4 2023 Q2: decisions on one or two ABM grant applications Q2: FDA approval obtained for OATD-01 Q2-Q3: continued progress in OATD-02 dose escalation Q3: decisions on the NIH grant for OATD-01 & FENG grants Q3: First Patient Dosed in OATD-01 clinical trial Q4: nomination of
Slide 25: Molecure 3-year outlook
Molecure 3-year outlook Potential milestones targeted by 2025 Protein Targets RNA Platform BD/Financial/Operational 2023-2024 o Two clinical assets in PhI/II o In vitro PoC reached for o At least one clinical stage multi center clinical trials in 2-3 high value mRNA program partnered in patients tar
Slide 26: Thank you
Thank you Q&A 05/04/2023 26