Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Investor Presentation (June 2022)
36 slides from Faron Pharmaceuticals Oy's investor presentation, Jun 16, 2022
Slide 1: Faron Corporation Presentation
Faron Corporation Presentation June 2022 | Investor Presentation 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 The contents of this presentation have not been independently verified. The contents of this meaning of Section 21 of the Financial Services and Markets Act 2000 (as amended) ("FSMA"). pr
Slide 3: Faron at a Glance
Faron at a Glance Faron Pharmaceuticals Ltd. Helsinki’s Nasdaq First North Growth Market (FARON) Exchanges London’s Alternative Investment Market (AIM) (FARN) Market Cap €143.3 M1 (~$151 M) Headquarters, Turku, Finland Faron Locations Faron USA, Boston, MA Faron Europe, Zürich, Switzerland # of Empl
Slide 4: Highly Experienced Leadership Team
Highly Experienced Leadership Team Management Board of Directors Markku Jalkanen; PhD Frank Armstrong; MD Founder and CEO Non-Executive Chairman Toni Hänninen; MBA Markku Jalkanen; PhD CFO Founder and CEO Greg B. Brown; MD Marie-Louise Fjaellskog; MD, PhD Non-Exec Director CMO Juho Jalkanen; MD, PhD
Slide 5: The Science Behind The Company
The Science Behind The Company Scientific Founders Scientific Advisory Board Professor Jonathan Knowles; PhD Pr Christophe Massard; MD, PhD Professor David Adams; MD Academician* Sirpa Jalkanen; MD PhD Adjunct Professor Maija Hollmen; PhD Founder & Founder & Professor Tyler Curiel; Member of the SAB
Slide 6: Harness the Power of the Immune System
Harness the Power of the Immune System Modulating the immune system is key to tackling cancer and inflammation Programs Indication Phase of Development Anticipated (Target) (TRIAL NAME) Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Immuno-Oncology Solid Tumors (MATINS) ▪ Additional data release
Slide 7: Bexmarilimab (anti-CLEVER-1 mAb)
Bexmarilimab (anti-CLEVER-1 mAb) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 8: Bexmarilimab Opportunity
Bexmarilimab Opportunity Benefiting those who are resistant to checkpoint inhibition (CPI) The adoption of CPIs has occurred very quickly due to • Approximately 200,000 patients fail on anti-PD-1 their success in improving overall survival, despite poor response rates1 treatment each year within the
Slide 9: Bexmarilimab Ignites Immune Activation – Turning Cold Tumors Hotter
a Bexmarilimab Ignites Immune Activation – Turning Cold Tumors Hotter Patients with high IFN-ɣ have longer affect of PD-1 blockade Landmark Overall Survival Landmark with Bex -treatment OS n=138 Kaplan-Meier Curves 1.0 are representative of a 0.8 hypothesis and should not be considered Survival (Pro
Slide 10: The CLEVER-1 Positive Macrophage
The CLEVER-1 Positive Macrophage Hides tumor to avoid recognition by immune system CLEVER-1 “Hide-Me” Signal • A large glycoprotein receptor that is expressed on the surface of immunosuppressive macrophages 2 • Scavenger receptor known to bind to wide range of ligands, central to tissue homoeostasis
Slide 11: MATINS Updated Safety Part I and II
MATINS Updated Safety Part I and II Well tolerated therapy with clear clinical indications of immune activation Treatment Related Adverse Events Patients (%) Immune related side effects Any grade 84 (44) As expected with active immunotherapy, immune related Grade 3 11 (6) side effects were seen: Gra
Slide 12: MATINS Efficacy Data Part II
MATINS Efficacy Data Part II Clinical benefit in up to 30-40% of patients who failed several prior lines of therapy Tumor reductions were observed in several patients Confirmed Responses (RECIST) n (%) Complete response (CR) 0 (0) Partial Response (PR) 1 (1) Stable Disease (SD) 18 (16) Progressive D
Slide 13: Survival Advantage for Patients Experiencing Clinical Benefit
Survival Advantage for Patients Experiencing Clinical Benefit Long term survival possible for late-stage, heavily pre-treated patients • Similar time to failure on prior therapy indicates that BEX drives the survival benefit, not patient selection Time to Failure on Prior Therapy Prior Therapy time
Slide 14: MATINS Strategy to Identify Biomarkers for Patient Selection
MATINS Strategy to Identify Biomarkers for Patient Selection Readily available, inexpensive blood tests can identify patients most likely to benefit from BEX Patients achieving disease control have significantly Models using two or four proinflammatory markers are lower levels of proinflammatory mar
Slide 15: Excellent Survival in Patients Experiencing Clinical Benefit
Excellent Survival in Patients Experiencing Clinical Benefit Cancer specific survival in Phase I/II MATINS trial 12-Month Overall Survival Patients Who Experienced Patients Who Did Not Tumor Types Clinical Benefit Experience Clinical Benefit Melanoma and 100% 0% Cholangiocarcinoma All 10 Cohorts 65%
Slide 16: Bexmarilimab Continued Clinical Development After MATINS
Bexmarilimab Continued Clinical Development After MATINS Currently in dose optimization in six countries (11 sites) MATINS Trial Dose Finding (Part I) Initial Expansion (Part II) Dose Optimization Expansion into Pivotal STUDY Completed Completed Ongoing - 2022 Planned FDA meeting – Q4/22 Candidate c
Slide 17: Key Findings from MATINS Trial
Key Findings from MATINS Trial These findings pave the way for final study designs ➢ Clinical benefit observed as a monotherapy in last line cancer patients • Significant extension of overall survival among responders • Several tumor cohorts have shown 30-40% clinical benefit rates ➢ Biomarkers may
Slide 18: Bexmarilimab Broader Clinical Development Plan
Bexmarilimab Broader Clinical Development Plan Evidence based clinical trials to allow for registration 2021 2022 2023 2024 2025 The MATINS Phase I/II Trial 1,2 Planned Randomized Phase II/III Single Agent 2 meeting BEXMAB: Ph I/II AML & MDS 1,2 Phase I NSCLC in 1st line with PD-1 inhibitor 2,3,4 BE
Slide 19: On-going and Up-coming Trials with Bex
On-going and Up-coming Trials with Bex | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 20: BEXMAB
BEXMAB Rationale for treating AML/MDS with BEX in combination with standard of care (SoC) • High unmet medical need - 10% survival five years after relapse. Clever-1 expression • Azacitidine (AZA) and venetoclax are SOC therapies in AML. • CLEVER-1 expression is high in AML and associated with resis
Slide 21: BEXMAB
BEXMAB Evaluating BEX in combination with standard of care in AML, CMML and MDS Dose Finding (Phase I) Efficacy Evaluation (Phase II) Myelodysplastic syndrome (MDS) CMML-2 with indication for AZA Relapsed acute myeloid leukemia (AML) Azacitidine+ Phase II BEX dose CMML/MDS failing on HMA based thera
Slide 22: BEXCOMBO
BEXCOMBO Rationale for adding BEX to PD-1 blockade in solid tumors Patients with high IFN-ɣ have longer effect of PD-1 blockade* • Most patients (70-80%) do not respond to single agent PD-1 blockade. Progression free survival • High baseline level of IFN-ɣ indicates that the immune system is already
Slide 23: BEXCOMBO Planned Study Run by Faron
BEXCOMBO Planned Study Run by Faron Phase II (efficacy) study Patient Population Treatment Initial Cohort • Advanced indications with CLEVER-1 expression where PD-1 blockade is SoC 1-2nd line setting with modest ORR PD-1 blockade SoC + HNSCC, n= 15-40 BEX RP2D HNS • PD-1 blockade naïve • 1st (-2nd)
Slide 24: Bexmarilimab – The Future of Immunotherapy
Bexmarilimab – The Future of Immunotherapy 30% - 40% clinical benefit achieved in heavily pre-treated, last-line cancer patients across 1 multiple indications Highly favorable safety profile compared to current immunotherapy treatments 2 suggesting combination therapy will be well tolerated Clear bi
Slide 25: A CLEVER Antibody with a Lot of Potential
A CLEVER Antibody with a Lot of Potential Benchmarks and competitor landscape Significant licensing and M&A activity in the macrophage field recently • Pre-clinical/early clinical deals (TREM2, LILRB2) ranging from $100 – 200 million up-fronts and billion-dollar milestones • With Phase II data Gilea
Slide 26: Traumakine (Intravenous Interferon beta-1a)
Traumakine (Intravenous Interferon beta-1a) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 27: Inducing CD73 for Organ Protection
Inducing CD73 for Organ Protection An effective pharmacotherapy for producing anti-inflammatory, adenosine Pro-inflammatory Anti-inflammatory Capillary Alveolus ATP AMP Adenosine Capillary CO2 O2 Alveolus Protein-rich fluid Normal CO2 O2 Red O2 CO 2 blood cells Red blood cells AMP Leukocyte CD39 CD7
Slide 28: Phase 2 INFORAAA Study in Multi-Organ Failure
Phase 2 INFORAAA Study in Multi-Organ Failure 100% survival and renal protective when a CD73 response is achieved Equally, patients who responded to CD73 had a Up-regulation of CD73 reduces inflammation and reduction in Renal SOFA leading to better prevents vascular outcomes from a patient standpoin
Slide 29: Traumakine – Novel Approach to Organ Protection
Traumakine – Novel Approach to Organ Protection ARDS is a major social and economic burden Indications expected to benefit from Traumakine use • Acute Respiratory Distress • Cytokine Storm and 30%-40% Syndrome (ARDS) Release Syndrome MORTALITY2 • Viral Pandemics (COVID-19, • Major Cardiovascular MER
Slide 30: Haematokine (A0C3 Inhibitor)
Haematokine (A0C3 Inhibitor) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 31: The Unmet Need
The Unmet Need Chemotherapy Induced Neutropenia (CIN) • The total estimated number of chemotherapy patients Chemotherapy patients is around 650K in the US each year Annually in the US 650K • More than 70% are at high (35%) or intermediate (37%) risk for developing CIN • Covid changed the guidelines:
Slide 32: Expansion of Haematopoietic Stem Cells By Regulating AOC3 Activity
Expansion of Haematopoietic Stem Cells By Regulating AOC3 Activity AOC3 is highly expressed on bone marrow vasculature and induced by chemo • Blocking enzymatic activity of AOC3 inhibits reactive oxygen species within haemopoietic stem cells leading to more HSC production ex vivo in human tissue and
Slide 33: Targeting AOC3/VAP-1 for Stem Cell Expansion and Anti-Tumour Activity
Targeting AOC3/VAP-1 for Stem Cell Expansion and Anti-Tumour Activity Benefitting both solid tumors and hematological malignancies Haematokine’s Benefit Easier transplantation for older and impaired patients suffering from MDS and AML Planning to reduce the 20% mortality post transplantation in haem
Slide 34: Haematokine – for Suppressed Bone Marrow
Haematokine – for Suppressed Bone Marrow Well tolerated therapy that could provide a 1 permanent solution to a costly problem First-in-class asset Well known target; confirmed target with a wealth of 2 literature and understanding Safety Established Established Target, Novel Use Large potential as a
Slide 35: Harnessing the Power of Our Immune System to Tackle Cancer and Inflammation
Harnessing the Power of Our Immune System to Tackle Cancer and Inflammation Bexmarilimab can bring the promise of immunotherapy to patients who are not 1 currently benefiting from approved IO treatment options Accelerated bexmarilimab development strategy with studies across solid tumors 2 and hemat
Slide 36: Thank You
Thank You | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
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