Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Shareholder Meeting (March 2023)
27 slides from Faron Pharmaceuticals Oy's shareholder meeting presentation, Mar 24, 2023
Slide 1: AGM Presentation
AGM Presentation 24 March 2023 CEO Markku Jalkanen CFO Toni Hänninen 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: Year 2022 in Brief
Year 2022 in Brief The Year of Transformation ➢Post COVID-19 pandemic the Company re-activated US expansion ➢The appointment of the new CMO transformed pipeline, especially the bexmarilimab program ➢Successful financing rounds in difficult market conditions allowed further personel development (17 n
Slide 4: 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 I Phase II Phase III Key Milestones Immuno-Oncology Solid tumors (MATINS) First-in-human ▪ Pre-I
Slide 5: Key 2022 Financial and Corporate Information
Key 2022 Financial and Corporate Information Including post period • Cash balances on December 31, 2022 of EUR 7.0 million (2021: EUR 6.9 million) • Loss for the period for the financial year ended December 31, 2022 was EUR 28.7 million (2021: EUR 21.2 million) • Net assets on December 31, 2022 were
Slide 6: Highly Experienced Team
Highly Experienced Team Combining tightly the original science and distinguished clinical investigators Scientific Founder Management Board of Directors Scientific Advisory Board Markku Jalkanen Frank Armstrong, MD Academician & Professor Sirpa PhD Non-Executive Professor Jonathan Jalkanen, MD PhD F
Slide 7: "A CLEVER Way to Treat Cancer"
”A CLEVER Way to Treat Cancer” Outsmarting tumor cells Faron Pharmaceuticals | Non-Confidential Information
Slide 8: The Potential of Bexmarilimab
The Potential of Bexmarilimab Removing therapeutic resistance by ignition of host immunity The Rationale • Bone marrow-born immunosuppressive monocytes and macrophages (myeloid cells) can generate tumor environment helping cancer cells to hide patient’s immune system (“Do not show me” -signal) The S
Slide 9: Bexmarilimab Mode of Action
Bexmarilimab Mode of Action A macrophage checkpoint to control cancer growth CLEVER-1+ macrophages “Do Not Show Me” After CLEVER-1 inhibition “Show Me” Bexmarilimab 9 Faron Pharmaceuticals | Non-Confidential Information
Slide 10: Bexmarilimab Clinical Program Progress
Bexmarilimab Clinical Program Progress MATINS laid the groundwork, BEXMAB in progress and BEXCOMBO eyed First-in-human MATINS study has laid the basis for multiple routes to market: • Bexmarilimab is well-tolerated in 250+ advanced solid cancer patients • Bexmarilimab dosing and biomarker enrichment
Slide 11: Bexmarilimab Modes of Action to Kill Leukemia Cells
Bexmarilimab Modes of Action to Kill Leukemia Cells Limiting oxidative phosphorylation reduces cell viability and results in cancer cell death MOA 1: MOA 2: Activation of circulating CLEVER-1 blockade monocytes to produce cytotoxic down regulates T cells against leukemia cells energy production (AML
Slide 12: CLEVER-1 in Hematological Malignancies
CLEVER-1 in Hematological Malignancies Chuang et al. (Oncotarget, 2015) studied 158 patients with cytogenetically normal (CN) AML and identify STAB1 (CLEVER-1 mRNA) to be amongst 11 genes differentially expressed in patients with poor response to induction chemotherapy. Lin et al. (Molecular Therapy
Slide 13: BEXMAB Study
BEXMAB Study Phase I/II study of bexmarilimab on top of SoC in myeloid malignancies Dose Finding (Phase I) Efficacy Evaluation (Phase II) • Myelodysplastic syndrome (MDS)/Chronic myelomonocytic leukemia (CMML)-2 Azacitidine+ Selected indications RP2D • Relapsed/refractory acute myeloid leukemia BEX
Slide 14: Responses Observed Across Indications in Doublet
Responses Observed Across Indications in Doublet CRi (r/r AML), PR (MDS HMA), CR (MDS) PI decision to move to IDH trial Fatal non-related SAE (neutropenic infection) DOUBLET TRIPLET 14 Faron Pharmaceuticals | Non-Confidential Information
Slide 15: Efficacy Example Observed in Myeloid Blast Disappearance
Efficacy Example Observed in Myeloid Blast Disappearance 1.0 mg/kg bexmarilimab Q1W plus azacitidine This patient is a prior azacitidine failure (relapsed/refractory AML) The patient also showed normalised leukocyte blood population indicating bone marrow recovery Courtesy of Mika Kontro, PI, HUS, F
Slide 16: Bexmarilimab Clinical Program Progress
Bexmarilimab Clinical Program Progress MATINS laid the basis, BEXMAB in progress, BEXCOMBO Ready, MATINS Ph III in future First-in-human MATINS study has laid the basis for multiple routes to market: • Bexmarilimab is well-tolerated in 250+ advanced solid cancer patients • Bexmarilimab dosing and bi
Slide 17: MATINS: Phase I/II First-in-human Trial
MATINS: Phase I/II First-in-human Trial An extensive evaluation of bexmarilimab in advanced solid tumors Dose Finding (Part I) Initial Expansion (Part II) Dose Optimization Pivotal Study Completed Completed Completing Biomarker driven single- agent approach with OS as Breast Cancer (ER+) Indications
Slide 18: Summary of Single Agent Bexmarilimab in Solid Tumors
Summary of Single Agent Bexmarilimab in Solid Tumors FDA PIND/EOP2 meeting request sent • Bexmarilimab is well-tolerated • More than 250 cancer patients treated • Mostly grade 1/2 events; immune related AEs managed with steroids • Translational data show immune activation • Conversion towards a more
Slide 19: Three-Fold Longer Survival for Patients Achieving Disease Control
Three-Fold Longer Survival for Patients Achieving Disease Control Attributed to bexmarilimab-induced IFN-ɣ increase Patients treated with bexmarilimab achieve an immune response (increase in IFN-ɣ) leading to a significant survival benefit. Overall Survival (all melanoma, gastric and bile duct) Medi
Slide 20: Overall Survival in Select Indications of Phase I/II MATINS Trial
Overall Survival in Select Indications of Phase I/II MATINS Trial Bile duct cancer: candidate for further single agent development Bile duct cancer No clinical benefit Response to bexmarilimab treatment Clinical benefit 20 Faron Pharmaceuticals | Non-Confidential Information
Slide 21: Percentage of CLEVER-1+ Cells Associated with Clinical Benefit from Bex
Percentage of CLEVER-1+ Cells Associated with Clinical Benefit from Bex Immunohistochemistry (IHC) staining data from MATINS Phase I/II study Number of samples Score n (%) median % p- (range) value Clever-1 78 (100) Whole tumor 78 (100) 15 (1-55) non-DCR 71 (91) 15 (1-55) NS DCR 7 (9) 20 (13-35) Str
Slide 22: Bexmarilimab ignites the suppressive tumor microenvironment
Bexmarilimab ignites the suppressive tumor microenvironment to support antitumor responses We have demonstrated in patient samples that bexmarilimab leads to a reduction of M2- like, therapeutic-resistant macrophages. We have also seen an increase in antigen presentation, leading to an increase in I
Slide 23: BEXCOMBO: Rationale for adding bexmarilimab to PD-1 blockade
BEXCOMBO Rationale for adding bexmarilimab to PD-1 blockade in solid tumors Patients with high IFN-ɣ have longer affect 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-γ indicates that the immune system i
Slide 24: 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 HNSCC, n= 15-40HNS 1-2nd line setting with modest ORR PD-1 blockade SoC + • PD-1 blockade naïve BEX RP2D • 1st (-2nd) l
Slide 25: Faron Has a New and Absolutely Unique Cancer Drug
Faron Has a New and Absolutely Unique Cancer Drug BEXMARILIMAB 1. We have shown that the drug is well tolerated and not toxic like chemos, in more than 200 cancer patients with no other treatement option left and facing death. 2. For the above patients, we have shown that 1 out of 3 patients with ga
Slide 26: Near term pipeline related news flow
Near term pipeline related news flow Important value inflection points, especially from BEXMAB study March • KeyStone symposium (poster on macrophage activation after bexmarilimab treatment) April • FDA feedback on MATINS data and last line single-agent registrational study • AACR, additional MATIN
Slide 27: Thank You
Thank You Further information: - www.faron.com - first.family@faron.com 27 Faron Pharmaceuticals | Non-Confidential Information
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