Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — H1 2023 Earnings Presentation
22 slides from Faron Pharmaceuticals Oy's earnings presentation, Aug 29, 2023
Slide 1: Faron Pharmaceuticals H1-2023 Presentation
A CLEVER Approach to Fight Cancer Faron Pharmaceuticals H1-2023 Presentation 29 August 2023 CEO Markku Jalkanen CFO James (Jim) O´Brien 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: 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 3 FARON P
Slide 4: H1 2023 Financial Results
H1 2023 Financial Results Overview • Cash balances of EUR 6.3 million at June 30, 2023 (2022: EUR 9.9 million). The company raised EUR 6.6 million at the end of June that had not been settled until July 2023. The company entered the third quarter with EUR 12.8 million and has funds sufficient to sup
Slide 5: 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 6: 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 7: 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 8: Bexmarilimab-induced macrophage activation leads to treatment benefit in solid tumors
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 9: 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 9 FARON PHARMACE
Slide 10: 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 11: 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 12: 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 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 1.0 mg/kg 6.0 mg/kg 6.0 mg/kg 3.0 mg/kg 1.0 mg/kg 3.0 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: Why is bexmarilimab-azacitidine superior to SoC in AML & MDS?
Why is the combination of bexmarilimab-azacitidine superior to SoC in AML & MDS? Immune activation and reducing the viability of cancer cells 1) In myeloid malignancies (AML & MDS), bexmarilimab converts the abundant immunosuppressive precursor macrophages (monocytes) back to immune activators both
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: 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 21: Future outlook for the next 12 months
Future outlook for the next 12 months Clinical pipeline Corporate 1) Continuation of US readiness and team build A. BEXMAB 2) Intensifying partnering discussions 1) Completion of dose escalation and readout 3) Enhancing market access and support of enrichment cohorts (Q4-2023) 2) Dose selection for
Slide 22: Thank You
Thank You
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