Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — H1 2021 Earnings Presentation
32 slides from Faron Pharmaceuticals Oy's earnings presentation, Aug 26, 2021
Slide 1: H1-2021 Presentation
H1-2021 Presentation 26 th August 2021 | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 2: Corporate Disclaimer
Corporate Disclaimer The contents of this presentation have not been approved by an authorised 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 is Focused on Building the Future of Immunotherapy
Faron is Focused on Building the Future of Immunotherapy A unique macrophage focused therapy targeting CLEVER-1 with demonstrated 1 single agent activity in multiple advanced solid tumors 30%+ clinical benefit positions macrophage-targeting Bexmarilimab to 2 change the treatment paradigm in difficul
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 Phase of Development Anticipated Indication(s) (Target) Preclinical Phase 1 Phase 2 Phase 3 Key Milestones Immuno-Oncology Additional data to be presented at ESMO Solid Tumors (M
Slide 5: Pipeline Highligths
Pipeline Highligths H1-2021 and post period • Bexmarilimab demonstrates compelling antitumor activity in multiple advanced solid tumor types in the completed Part I and ongoing Part II of the MATINS study • Strongest results were observed in cutaneous melanoma, gastric cancer, cholangiocarcinoma, an
Slide 6: Financial Highlights
Financial Highlights 1 January – 30 June 2021 (unaudited) • Cash balances of €7.0 million at 30 June 2021 (2020: €11.6 million). • Operating loss of €10.4 million for the six months ended 30 June 2021 (2020: €7.1 million). The increase mainly driven by an additional €3.5m million in R&D expenses due
Slide 7: Bexmarilimab (anti-CLEVER-1 mAb)
Bexmarilimab (anti-CLEVER-1 mAb) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 8: A CLEVER Antibody: Outsmarting Cancer with Early Signs of Efficacy
A CLEVER Antibody: Outsmarting Cancer with Early Signs of Efficacy A unique macrophage focused therapy targeting CLEVER-1 1 with demonstrated single agent activity in multiple advanced solid tumors Favorable safety profile enables extensive combinations with 2 checkpoint inhibitors Opportunity to tr
Slide 9: Bexmarilimab Opportunity
Bexmarilimab Opportunity Benefiting those who do not respond to checkpoint inhibition CPIs were among the first drugs to significantly impact survival in metastatic melanoma and lung cancer, which were in-curable before The adoption of CPIs has occurred very quickly due to their success this in impr
Slide 10: Macrophages: The Next Breakthrough in Oncology
Macrophages: The Next Breakthrough in Oncology A poorly understood, but promising area of IO 1 Why Macrophages? Macrophages make up nearly 50% of cancer mass 7 • Macrophages promote tumor growth and metastases M2, but not M1 macrophages play a central role in promoting proliferation, colony formatio
Slide 11: CDx (Companion Diagnostics) for Clever-1 Detection in Tissue Samples
CDx (Companion Diagnostics) for Clever-1 Detection in Tissue Samples Significant milestone achieved • Clone identification and initial characterization • Protocol • Accuracy, Precision, Sensitivity, Specificity -> Laboratory Developed Test (LDT) is working, and clinical trial testing & feasibi
Slide 12: The Most Promising Macrophage Strategy: Reprogramming
The Most Promising Macrophage Strategy: Reprogramming 1 Novel and diverse antibody with broad applicability Bexmarilimab CLEVER-1 Bexmarilimab is a humanised anti-CLEVER-1 IgG4 antibody currently in clinical trials • A large glycoprotein receptor that is expressed on the for solid tumors and expandi
Slide 13: CLEVER-1: a Master T Cell Suppressor
CLEVER-1: a Master T Cell Suppressor Tackling both immunosuppressive macrophages and soluble protein that inactivates T-cells Advanced cancer patients have elevated levels of Bexmarilimab CLEVER-1 macrophages and the soluble form Bexmarilimab inhibits soluble CLEVER-1 from interfering with the immun
Slide 14: Inhibition of CLEVER-1 Leads to Responses in Refractory Mice Models
Inhibition of CLEVER-1 Leads to Responses in Refractory Mice Models Macrophages are central to tumor growth and survival Silencing the STAB1 gene for CLEVER-1 shows a dramatic improvement in AML cell lines * * * 500 LLC 1 400 2 300 * * mm3 200 100 Tumors cannot grow in mice that do not have 00 5 10
Slide 15: Bexmarilimab's Ability to Turn Cold Tumors Hot
Bexmarilimab’s Ability to Turn Cold Tumors Hot 23% of immune suppressed cancer patients show an IFNy response during dose finding Robust T-Cell Restoration of Pro-Inflammatory Mice 1 MATINS patient 2 Activation 2 IFNy Response 2 Pre- Wild Type Treatment IFNy Post- CLEVER KO Treatment Cytotoxic granz
Slide 16: MATINS Trial Design and Rationale
MATINS Trial Design and Rationale A first-in-human study in advanced solid tumors with high levels of macrophages Design Biology Milestones Macrophages are central for changing the Open-label Phase 1/2 adaptive clinical treatment paradigm in IO 1 trial in selected metastatic or inoperable solid tumo
Slide 17: A Dramatic Turnaround for Last Line Patients
A Dramatic Turnaround for Last Line Patients Overall survival in all MATINS patients Patients who are at the end of life have a significant survival benefit • In all comers, last line, unoptimized setting patients with cutaneous melanoma, gastric cancer, cholangiocarcinoma and hepatocellular carcino
Slide 18: MATINS Phase I/II Top Line Data
MATINS Phase I/II Top Line Data Safety and efficacy data from over 140 patients Top Line Efficacy Data Subsequent expansion and dose confirmation cohorts Response in based on the responses seen in first 10 target lesion (%) patients/indications include: Gastric cancer, cutaneous melanoma, cholangioc
Slide 19: Soluble CLEVER-1: a Master Regulator of T Cell Activation
Soluble CLEVER-1: a Master Regulator of T Cell Activation Bexmarilimab treatment downregulates major checkpoints PD-1 Levels in Patients What makes Bexmarilimab different? CD4 Cells Dosing Unique macrophage focused therapy to show signs of survival benefit in multiple advanced cancer types as a mo
Slide 20: Indications Chosen for MATINS Expansion
Indications Chosen for MATINS Expansion Response Rates, Patient Populations and Annual Incidence Standard of Care and Bexmarilimab benefit in Refractory Annual Incidence 1 Refractory Population Population 10,11,12 USA: 98,000 5EU: 77,500 CPIs as standard of care at 1stL 30% Cutaneous Melanoma Japan:
Slide 21: Bexmarilimab Clinical Development Plan in Solid Tumors
Bexmarilimab Clinical Development Plan in Solid Tumors Following the well-established path of other immuno-oncology drugs Today FDA Exploring meeting Pivotal Expansion BLA Dose Confirmation indications & doses Once Bexmarilimab has shown a potential therapeutic One or two doses will go into benefit
Slide 22: Bexmarilimab Clinical Development Plan
Bexmarilimab Clinical Development Plan Evidence based clinical trials to allow for registration 2021 2022 2023 2024 Sites Involved The MATINS Platform Trial 1,2 Comprehensive Cancer Centre Gastric Melanoma Solid tumors Cholangiocarcinoma Hepatocellular carcinoma Neo-adjuvant study in multiple indica
Slide 23: HOT or COLD Tumor - Can RENACOL Answer That?
HOT or COLD Tumor - Can RENACOL Answer That? Testing neoadjuvant bexmarilimab treatment in localized renal cell and colon carcinoma Target: Localized renal cell and colon carcinoma prior surgical tumor removal Dosing: Single dosing 1-10 mg/kg (with option to go up 30 or 100 mg/kg) two weeks prior su
Slide 24: Faron is Focused on Building the Future of Immunotherapy
Faron is Focused on Building the Future of Immunotherapy A unique macrophage focused therapy targeting CLEVER-1 with demonstrated 1 single agent activity in multiple advanced solid tumors 30%+ clinical benefit positions macrophage-targeting Bexmarilimab to 2 change the treatment paradigm in difficul
Slide 25: Traumakine (Intravenous IFN beta-1a)
Traumakine (Intravenous IFN beta-1a) | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 26: Interferon Beta Induces CD73 for Organ Protection
Interferon Beta Induces 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 Capi
Slide 27: HIBISCUS: A Phase 2/3 Co-funded by the Department of Defence
HIBISCUS: A Phase 2/3 Co-funded by the Department of Defence Supporting Hospitalised COVID-19 Patients to prevent ARDS and admission to the ICU Phase 2 Phase 3 Interim Analysis Traumakine better than Adjust dexamethasone powering according to interim results Require No and continue Mechanical Random
Slide 28: Corporate Highlights
Corporate Highlights | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 29: A push towards approval
A push towards approval 1 Single agent activity in multiple solid tumors which are refractory to standard of care 2 We see a significant clinical benefit in an all comers setting 3 HCC 1st line recent SOC with 75% refractory to combo treatment 4 2nd Line Melanoma is forecast to be 1 Bn by 2026 from
Slide 30: Multiple Near-Term Catalysts For Bexmarilimab
Multiple Near-Term Catalysts For Bexmarilimab Discovery of Soluble CLEVER CMC Commercial Scale Preparation Topline data from MATINS Phase 1 Dramatic Survival Benefit was seen in responding patients Selection of Expansion Cohorts (Gastric, Melanoma and Cholangiocarcinoma) Key Intellectual
Slide 31: And Across Entire Pipeline
And Across Entire Pipeline CMC Commercial Scale Preparation HIBISCUS first patient dosed Traumakine Interim analysis Poster Presentation at Military Health System Research Symposium REMAP-CAP Interim Readout Organ protection data release with the DoD Ongoing pre-clinical studies with h
Slide 32: Thank you
Thank you | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
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