Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — JPMorgan Healthcare Conference 2024
23 slides from Faron Pharmaceuticals Oy's conference presentation, Jan 11, 2024
Slide 1: A CLEVER Approach to Fight Cancer
A CLEVER Approach to Fight Cancer Faron Pharmaceuticals Dr. Markku Jalkanen, CEO January 11th, 2024 London AIM: FARN Helsinki First North: FARON
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: Investment Highlights
Investment Highlights A CLEVER Approach to Fight Cancer via Re-programming Macrophages and Myeloid Cells Bexmarilimab (Bex) is a humanized anti-Clever-1 antibody, which by a novel mode of action primes the immune system to attack tumors Bex is potentially applicable to a wide range of hematologic di
Slide 4: Bex: Proven anti-Clever-1 mechanism of action
Bex: Proven anti-Clever-1 mechanism of action An innovative approach to hematological malignancies and solid tumors Clever-1 Clever-1+ macrophages “Do not show me” After Clever-1 blocking “Show me” bexmarilimab Bexmarilimab Clever-1 is an immunosuppressive receptor on macrophages that helps cancer e
Slide 5: Proof of Principle for Modulating Tumor Microenvironment (TME)
Proof of Principle for Modulating Tumor Microenvironment (TME) Phase 1/2 First-in-Human MATINS Trial Highlights In the MATINS Phase 1/2 trial BEX as a single agent demonstrated proof of principle for anti-Clever- 1 in 10 different cancer types in ~200 patients Targeting Clever-1 with bex is well tol
Slide 6: Clever-1 is highly expressed by malignant blast cells in AML and MDS
Clever-1 is highly expressed by malignant blast cells in AML and MDS B-ALL BCL/TCL Patients with higher-risk MDS, in whom azacitidine (HMA-agent) treatment T- ALL MM has failed, have a poor MDS CML prognosis and low AML probability of response to FAB M3 AML T-Lymphoid salvage treatments CLL HEMAP da
Slide 7: Targeting Clever-1 in Myeloid Malignancies
Targeting Clever-1 in Myeloid Malignacies PoC Bex in combination with SOC in hematological malignancies – HR MDS and r/r AML Bexmarilimab increases HLA-DR expression by monocyte-like cells and improves azacytidine-induced HLA-DR in a subset od patient samples. Data from AML bone marrow ex vivo cultu
Slide 8: Higher-Risk MDS Patient Journey
Higher-Risk MDS Patient Journey ”HMA or nothing” – significant unmet need with 85% of patients not eligible for intensive therapy and left with limited treatment options HR-MDS 15% 85% Eligible for Intensive Not Eligible for Therapy Intensive Therapy 5% Good Transplant Not a Good Transplant Candidat
Slide 9: BEXMAB Phase 1/2 Study Evaluating Bex with SoC in Myeloid Malignancies
BEXMAB Phase 1/2 Study Evaluating Bex with SoC in Myeloid Malignancies Expect to dose patients in Phase 2 in January 2024 Phase 1 Findings 36 patients treated in doublet/triplet with 3 dose levels have been evaluated • Highest immune activation, as observed in the accumulation of activated immune ce
Slide 10: Adding Bexmarilimab to SoC is Well Tolerated
Adding Bexmarilimab to SoC is Well Tolerated No DLTs have been reported and most AEs are of Grade 1/2 All 1.0mg/kg 3.0mg/kg 6.0mg/kg (n=28) % (n=7) % (n=11) % (n=10) % AEs n Any TRAE 12 (43) 3 (43) 4 (36) 5 (50) Any Grade 244 Pyrexia 3 (11) 1 (14) 0 2 (20) ≥ Grade 3 81 Blood TSH increased 2 (8
Slide 11: Bex Increases Bone Marrow Immune Activation
Bex Increases Bone Marrow Immune Activation CD8 T and NK cell numbers increase from screening to end-Cycle 3 in Bex-Aza patients CD8 T cells % from baseline Target engagement in the bone marrow of HR MDS patients MDS 80 (relative to baseline) 60 % binding Upregulation of Antigen-presentation molecul
Slide 12: Objective Responses Observed in ~50% of Patients Across Indications
Objective Responses Observed in ~50% of Patients Across Indications Swimmer plot of doublet patients at 1.0, 3.0, and 6.0 mg/kg bexmarilimab combined with azacitidine (n=27). Readout November 18, 2023. Data released December 11, 2023 at ASH Responses are deep and durable with 7/10 MDS patients achie
Slide 13: High ORR achieved in both frontline HR MDS and HMA-failed MDS patients
High ORR achieved in both frontline HR MDS and HMA-failed MDS patients With a median overall survival in refractory MDS of just 4-6 months and no viable treatment options, patients now surpassing anticipated survival rates and maintaining remission TP53 Allo-HSCT TP53 Number CR mCR PR/HI-P n All MDS
Slide 14: Significant Bone Marrow Blast Reduction in HR MDS Patients Treated with Bex + Aza
Significant Bone Marrow Blast Reduction in HR MDS Patients Treated with Bex + Aza Durable cancer blast eradication * *Hematological improvement without remission, transformed into AML 14 I NON-CONFIDENTIAL
Slide 15: Exceptional Data in Patients with High Unmet Medical Need
Exceptional Data in Patients with High Unmet Medical Need Conclusions of BEXMAB Patients with high-risk MDS who have failed HMA face a poor prognosis and a low probability to respond to salvage therapy Remarkable and durable responses observed in combination with azacitidine in MDS 13/28 patients wi
Slide 16: Bexmarilimab has the Potential to Establish a New Standard of Care in Myeloid Malignancies
Bexmarilimab has the Potential to Establish a New Standard of Care in Myeloid Malignancies Bexmarilimab is a humanized monoclonal antibody to Clever-1 which reprograms myeloid blasts Mechanism of Action and primes the immune system to attack tumor cells Bexmarilimab is well-tolerated in combination
Slide 17: Accelerated Development Plan for HMA-failed HR MDS
Accelerated Development Plan for HMA-failed HR MDS Frontline HR MDS and r/r AML development plans explored separately 2023 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Phase 1 Phase 2 Confirmatory & BLA FDA Advice on: continue single arm for AA* (Plan A) or start a randomized trial
Slide 18: Outlook for the Next 12 Months
Outlook for the Next 12 Months Clinical development Bexmab Q1 2024 Phase 2 initiation on HMA-failed MDS Q2 2024 Initial Phase 2 data read out Q2 2024 Durability analysis of Phase 1 frontline HR MDS, HMA-failed MDS patients and r/r AML Q4 2024 Full Phase 2 data read out Regulatory interactions for ad
Slide 19: Bexmarilimab Pipeline
Bexmarilimab Pipeline Phase of Development Next Steps/Near-Term Programs Indication Preclinical Phase 1 Phase 2 Phase 3 Milestones Hematological malignancies Phase 2 readouts in Q2 HMA Failed MDS BEXMAB Trial and Q4 2024 Waiting for dose from project Frontline HR MDS SOC + BEX bexmarilimab Optimus p
Slide 20: Corporate Summary
Corporate Summary Potential to Establish New Standard of Care in Myeloid Malignancies Faron’s Lead Asset Validated Platform Position Milestones Proven anti-Clever-1 dual mechanism ✓ Proof of principle for anti-Clever-1 Potential for future expansion into a BEXMAB Phase 1/2 readouts in 2Q of action –
Slide 21: An Overview of Faron
An Overview of Faron Management Team Markku Jalkanen, PhD Maija Hollmén, PhD James O’Brien, MBA, CPA Birge Berns, MD Juho Jalkanen, MD, PhD, MSc Founder & CEO Founder & CSO CFO CMO Founder & COO Boston, MA / Turku, Finland 35+ 2007 Global Headquarters Employees Year Founded 21 I NON-CONFIDENTIAL
Slide 22: Experienced Leadership
Experienced Leadership Scientific Advisors Sirpa Jalkanen, MD PhD Jonathan Knowles, PhD Tyler Curiel, MD, MPH Naval G. Daver, MD Mika Kontro, MD, PhD Cristophe Massard, MD, PhD David Adams, MD Academician Professor Professor Professor Adjunct Professor Professor Professor Board of Directors Transact
Slide 23: Thank You
Thank You
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