Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Investor Presentation (February 2025)
20 slides from Faron Pharmaceuticals Oy's investor presentation, February 2025
Slide 1: Activate Your Body to Deactivate Cancer
ACTIVATE YOUR BODY TO DEACTIVATE CANCER February 2025
Slide 2: Corporate Disclaimer
Corporate Disclaimer The contents of this presentation have not been approved by an authorized person within the meaning of Section 21 of the Financial Services and Markets Act 2000 (as amended) ("FSMA"). Reliance on the contents of this presentation for the purpose of engaging in any investment act
Slide 3: Harnessing the Power of Macrophages to Conquer Immune Resistance
Harnessing the Power of Macrophages to Conquer Immune Resistance Faron is developing an approach to sensitize treatment resistant cancers to the Standard of Care ✓ Clever-1 is a master immunosuppressive receptor on macrophages which supports tumour growth and metastases ✓ Bexmarilimab (BEX), first-i
Slide 4: Bexmarilimab MoA
Bexmarilimab MoA Best-in-class Macrophage Reprogrammer 4 FEB-2025
Slide 5: An Overview of the Target
An Overview of the Target Clever-1 (Common Lymphatic Endothelial and Vascular Endothelial Receptor-1) Clever-1 • A scavenger receptor expressed by leukemic myeloid cells and immunosuppressive macrophage populations1 • Involved in receptor-mediated endocytosis and recycling of altered and normal self
Slide 6: Clever-1 is highly expressed by malignant cells in many hard-to-treat blood cancers
Clever-1 is highly expressed by malignant cells in many hard-to-treat blood cancers BCL/TCL High expression of Clever-1 B-ALL especially in MDS & AML T- ALL MM MDS CML Clever-1 (STAB1) expression in primary samples from different hematological AML FAB AML malignancies and normal myeloid cells M3 T-L
Slide 7: Efficacy in r/r MDS
Efficacy in r/r MDS Phase I/II BEXMAB Study - Bexmarilimab + Azacitidine 7 FEB-2025
Slide 8: Patient population and safety
Patient population and safety Bex + Aza is well tolerated Patient Baseline Characteristics r/r MDS, n (%) Event count Subject n count n (%*) Age (years); median (range) 72.5 (52-84) ECOG PS 0 7 (35) TEAEs, total 184 19 (95) 1 13 (65) IPSS-R Intermediate (>3 − ≤4.5 points) 2 (10) Grade ≥3 58 14 (70)
Slide 9: Phase 2 Efficacy in r/r MDS
Phase 2 Efficacy in r/r MDS ≥50% Reduction of BM Blasts in 55% of r/r MDS patients Waterfall plot showing best change in BM blast% vs. baseline. >5% BM lasts at baseline in 12/20 patients. *actual change 250% (left) and 107% (right) 9 FEB-2025 Data cut 25Nov2024
Slide 10: Objective Response in 80% of r/r MDS Patients
Objective Response in 80% of r/r MDS Patients 1 mg/kg 3 mg/kg 6 mg/kg Swimmer plot showing best response to BEX + AZA (IWG2018 criteria) and treatment duration in r/r MDS patients • Remission (CR/PR/mCR) achieved in 14/20 (70%) patients • mTP53: ORR 56% (5/9 patients) • Ven + HMA pre-treated: ORR 63
Slide 11: HR MDS Market Dynamics & Competitive Landscape
HR MDS Market Dynamics & Competitive Landscape 11 FEB-2025
Slide 12: The market opportunity in r/r MDS
The market opportunity in r/r MDS MDS represents a significant growing market with an un-tapped area especially in r/r MDS MDS market growth r/r MDS patient journey2) Estimated worldwide indication sales by year (USDbn)1) 180-510k MDS Patients in the US & EU3) ! 50% 50% As a new, well tolerated effe
Slide 13: Current Phase 2 Results with Bexmarilimab
Current Phase 2 Results with Bexmarilimab Bexmarilimab has proven it can overcome treatment resistance Objective Response Rate (ORR)4) Current options Bex + Aza 80% Old, toxic and poorly effective 1 treatments1) 1 Well tolerated Overall median survival Overall median survival 2 5.6 months2) 2 13.4 m
Slide 14: Market Dynamics and Competitive Landscape in MDS
Market Dynamics and Competitive Landscape in MDS Risk/benefit ratio is outstanding with Bex, and key to approval and commercial up-take • Vibecotamab (CD3-CD123 T-cell engager) in r/r MDS (ASH 2024 abstract #1007): • N = 16 r/r MDS patients treated: ORR 56%, 0% CR+PR, mCR with limited hematological
Slide 15: Development Plan in HR MDS and Outlook into the Future
Development Plan in HR MDS and Outlook into the Future 15 FEB-2025
Slide 16: Development Plan for HR MDS per FDA Guidance
Development Plan for HR MDS per FDA Guidance 2024 2025 2026 2027 H1 H2 H1 H2 H1 H2 H1 H2 Phase II Phase 3 & BLA Full P1/P2 Full P1/P2 Readout Survival Analysis Phase 2 Dose optimization (n=32) r/r MDS r/r MDS Accelerated MDS FDA FDA EOP2 FDA Pre-AA Approval r/r MDS AA Fast Track Meeting Meeting Subm
Slide 17: Outlook into 2025
Outlook into 2025 Full Phase 2 readouts, regulatory interactions, and combo data with anti-PD-1 ➢ Jan 2025 Phase 2 enrollment completed ➢ End of Q1 2025 full Phase 2 response rate readout (r/r) ➢ End of Q2 2025 FDA EOP2 meeting and Breakthrough Designation possibility ➢ End of Q3 2025 Phase 2 durati
Slide 18: Management
Management World leading science and oncology drug development from Finland Juho Jalkanen Maija Hollmén Yrjö Wichmann Petri Bono CEO CSO CFO CMO Turku, Finland 24 2007 Global Headquarters Employees Year Founded 18 FEB-2025
Slide 19: Scientific Advisory Board
Scientific Advisory Board Further depth and experience Scientific Advisors Toni Choueiri, MD, FASCO Naval G. Daver, MD Professor Professor Harvard, USA MD Anderson, CCC Tom Powles, MBBS, MRCP, MD Mika Kontro, MD, PhD Professor Adjunct Professor Barts Cancer Center, London HUS, CCC Amer Zeidan, MD, M
Slide 20: Thank You
Thank You 20 FEB-2025
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