Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Investor Presentation (August 2023)
26 slides from Faron Pharmaceuticals Oy's investor presentation, August 2023
Slide 1: A CLEVER Approach to Fight Cancer
A CLEVER Approach to Fight Cancer Faron Pharmaceuticals Corporate Presentation August 2023 London A IM: FA RN Helsinki First North: FA RON Faron Pharmaceuticals | Non-Confidential Information
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: Overcoming Resistance in Cancer
Overcoming Resistance in Cancer Immune Activation in Hematological and Solid Tumors Interferon signaling is critical for successful outcome of current cancer therapies Lead asset bexmarilimab (bex) is a Clever-1 antibody that reprograms immunosuppressive M2 macrophages into immune-stimulating M1 mac
Slide 4: Harnessing the Power of Macrophages to Conquer Immune Resistance
Harnessing the Power of Macrophages to Conquer Immune Resistance CLEVER approach to sensitizing cancers to standard of care Bexmarilimab is a humanized monoclonal antibody to Clever-1 and primes the immune system to attack tumors Clever-1 is an immunosuppressive receptor on macrophages allowing tumo
Slide 5: Bexmarilimab Mode of Action
Bexmarilimab Mode of Action Macrophage checkpoint to control cancer growth Clever-1 Clever-1+ macrophages “Do Not Show Me” After Clever-1 inhibition “Show Me” bexmarilimab Bexmarilimab Clever-1 is an immunosuppressive receptor on macrophages that helps cancer evade the immune system Bex primes immun
Slide 6: Bexmarilimab-induced macrophage activation: MATINS trial summary
Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors: the Phase I/II first-in-human MATINS trial summary Highlights ● Targeting Clever-1 with bexmarilimab is well tolerated ● Bexmarilimab monotherapy showed to achieve disease control in late-stage cancer patients ● L
Slide 7: Dual Mode of Action in Hematological Malignancies
Dual Mode of Action in Hematological Malignancies Clever-1 expressed on monocytes and myeloid leukemia cells and is abundant in AML Binds directly Activates monocytes to leukemic in circulation bexmarilimab cells and lowers viability Ylitalo et al (2023) Presented AACR AML in Austin 7 FARON PHARMACE
Slide 8: Increase in Antigen Presentation and T Cell Activity Observed
Increase in Antigen Presentation and T Cell Activity Observed Bexmarilimab treatment results in immune activation in bone marrow at tested dose levels* Increase of T and NK cells in the BM of patients during Upregulation of antigen-presentation treatment across dose levels molecules on blasts during
Slide 9: External Scientific Validation
External Scientific Validation One Clever Macrophage Checkpoint “…we still need to move the bar in those patient populations, increase response rates while maintaining safety… I think this will be something to really look at with the bexmarilimab drug… if we don't see cumulative myelosuppression, th
Slide 10: Pipeline Overview
Pipeline Overview Harnessing the Power of the Immune System Phase of Development Next Steps/Near-Term Programs Indication Preclinical Phase I Phase II Phase III Milestones Cancer Therapeutics Piloted BEXMAB and BEXCOMBO Solid tumors MATINS Trial development; ESMO 2023 abstract submitted bexmarilimab
Slide 11: BEXMAB Phase I/II Study Evaluating Bexmarilimab with SoC
BEXMAB Phase I/II Study Evaluating Bexmarilimab with SoC Enrichment cohorts of DOUBLET ongoing Dose Finding (Phase I) Efficacy Evaluation (Phase II) POPULATION DOUBLET MDS MDS Phase 2 azacitidine + doses r/r AML r/r AML bexmarilimab MDS failing on HMA based therapy MDS HMA failure POPULATION TRIPLET
Slide 12: Bexmarilimab Combinations Well Tolerated
Bexmarilimab Combinations Well Tolerated BEXMAB Phase I/II Study DOUBLET COHORTS (1, 3, 6 mg/kg Q1W) Treatment-Related Adverse Events Patients n (%) Conclusions: N=96 (Adverse Events) N=15 Any grade 8 (8) • No dose limiting toxicities (DLT) Grade 3 1 (1) • Majority of AE grade 1-2 Grade 5 1 (1)
Slide 13: Three Objective Responses Observed in the Latest Dosing Cohort
Three Objective Responses Observed in the Latest Dosing Cohort BEXMAB Doublet, 6 mg/kg dosing cohort, data cut-off July 12, 2023 Updated BEXMAB data supports advancement to Phase II in H2 2023 6 mg/kg SD SD 6 mg/kg SD SD SD Malignancy MDS 6 mg/kg mCR mCR mCR MDS-HMA r/r AML 6 mg/kg mCR 6 mg/kg CR CR
Slide 14: Responses Observed Across Indications and Dose Levels
Responses Observed Across Indications and Dose Levels BEXMAB Doublet cohorts, data cut-of July 12, 2023 Eight of 15 objective responses (ORs) observed across the three dosing doublet cohorts Complete blood 1 mg/kg SD SD PR CRi PR PR SD SD count recovery C6 1 mg/kg SD SD IDH2 mutation, transfered to
Slide 15: Reduction of Bone Marrow Blasts in Majority of Patients
Reduction of Bone Marrow Blasts in Majority of Patients BEXMAB Doublet cohorts, data cut-off July 12, 2023 Malignancy 200 Best Change in Bone Marrow Blasts (%) MDS MDS-HMA r/r AML 100 0 -100 1.0 mg/kg 3.0 mg/kg 1.0 mg/kg 1.0 mg/kg 3.0 mg/kg 3.0 mg/kg 1.0 mg/kg 6.0 mg/kg 6.0 mg/kg 3.0 mg/kg 1.0 mg/kg
Slide 16: Putting BEXMAB Efficacy into Context of SoC
Putting BEXMAB Efficacy into Context of SoC Encouraging Efficacy Signals Across All Patient Cohorts DOUBLET COHORTS azacytidine + bexmarilimab MDS MDS r/r AML Frontline HMA failure SoC Responses CR 17% OR 10% CR/CRi 14% SoC OS 9 – 24 months 5-6 months 9 months Success bar for BEXMAB CR 25% OR 20% CR
Slide 17: Encouraging Data in Patients with High Unmet Medical Need
Encouraging Data in Patients with High Unmet Medical Need Conclusions AML and MDS remain diseases of unmet medical need, especially in relapsed settings Bexmarilimab is well-tolerated in combination with standards of care: azacitidine and azacitidine/venetoclax Encouraging and durable responses obse
Slide 18: BEXMAB – Accelerated Development Plan for r/r AML/MDS HMA
BEXMAB – Accelerated Development Plan for r/r AML/MDS HMA Aiming to File BLA H1 2025 2023 2024 2025 2026 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 Q1 Q2 Phase II – Dose Phase II/III Phase I – Dose Escalation BLA & Confirmatory Optimization Efficacy MDS with failure Expansion HMA-F MDS RDE1 Confirmatory Tr
Slide 19: Goal to Improve Standard of Care – Potential in Solid Tumors
Goal to Improve Standard of Care – Potential in Solid Tumors Addressing lack of benefit in ~70-80% checkpoint inhibitor (CPI) treated patients IMMUNE SUPPRESSION IMMUNE ACTIVATION Inhibited immune activation Ignites innate immune response against cancer cells. against cancer cells Upregulates T cell
Slide 20: De-risked Safety Profile (MATINS Phase I/II Single Agent Study)
De-risked Safety Profile (MATINS Phase I/II Single Agent Study) Well-tolerated therapy in over 200 patients with advanced solid cancers Treatment Related Adverse Events Patients (n, %) Phase 1/2 dose study to assess safety, tolerability Any Grade 94 (45) and efficacy of single agent bexmarilimab in
Slide 21: Strategy to Identify Biomarkers for Patient Selection
Strategy to Identify Biomarkers for Patient Selection Can a single standard blood test identify patients that will benefit from bexmarilimab? Landmark Landmark OS Survival Overall Patients achieving disease control have significantly lower levels of Landmark OS n=138 proinflammatory markers 1.0 0.8
Slide 22: Three-Fold Longer Survival for Patients Achieving Disease Control
Three-Fold Longer Survival for Patients Achieving Disease Control Survival benefit most likely attributed to bexmarilimab-induced IFN gamma increase Overall Survival IFN-ɣ mean +- SE (138 MATINS patients*) Median Overall Survival All Part I and II patients with currently Patients with disease contro
Slide 23: BEXCOMBO Phase II Study Evaluating Bexmarilimab with PD-1 Blockade
BEXCOMBO Phase II Study Evaluating Bexmarilimab with PD-1 Blockade Aiming at improving SoC PD-1 response rates Patient Population Treatment Potential Expansion Cohorts HNSCC n= 15-40 Advanced HNSCC, UCC and bex SoC PD-1 + bexmarilimab NSCLC. 1st line setting UCC n= 15-40 NSCLC n= 15-40 • Targeting i
Slide 24: An Overview of Faron
An Overview of Faron Management Team James O’Brien, MBA, Juho Jalkanen, MD, Markku Jalkanen, PhD Maija Hollmén, PhD Marie-Louise Fjällskog, MD, PhD CPA PhD, MSc Founder & CEO Founder & CSO CMO CFO Founder & COO Boston, MA / Turku, Finland 35+ 2007 Global Headquarters Employees Year Founded 24 FARON
Slide 25: Experienced Leadership
Experienced Leadership Scientific Advisors Jonathan Knowles, Cristophe Massard, Sirpa Jalkanen, MD PhD Tyler Curiel, MD, MPH Naval G. Daver, MD Mika Kontro, MD, PhD David Adams, MD PhD MD, PhD Academician Professor Professor Professor Adjunct Professor Professor Professor Board of Directors Transact
Slide 26: Thank You
Thank You
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