Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Shareholder Meeting (April 2021)
35 slides from Faron Pharmaceuticals Oy's shareholder meeting presentation, Apr 23, 2021
Slide 1: Faron AGM presentation
Faron AGM presentation 23 APRIL 2021 CEO Markku Jalkanen and CFO Toni Hänninen | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
Slide 2: Disclaimer
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"). presentation
Slide 3: Harnessing the Power of the Immune System
Harnessing the Power of the Immune System Our approach is focused on activating, suppressing and maintaining the immune system Immuno-Oncology & Infectious Disease Clevegen® (bexmarilimab) CLEVER-1 regulates tissue immune status Organ Protection Traumakine® (interferon-beta) CD73 controls capillary
Slide 4: Our Pipeline
Our Pipeline Building the future of immunotherapy Therapeutic Space Program Indications Preclinical Phase I Phase II Phase III Partner Solid tumors MATINS Immuno- Clevegen NSCLC1 MATINS-05 LUNG Bexmarilimab Oncology FP-1305-antibody Hematological MATINAML malignancies REMAP–CAP ARDS2 & COVID-19 HIBI
Slide 5: Key 2020 events
Key 2020 events Including post period • Bexmarilimab Phase I/II MATINS study showing early clinical benefits in six hard-to-treat solid cancers • Significant survival benefit observed among responders • More frequent and higher dosing to be investigated in MATINS + combination studies planned • Incr
Slide 6: Vuoden 2020 keskeisiä tapahtumia
Vuoden 2020 keskeisiä tapahtumia Sisältää myös vuoden 2021 tapahtumat ennen tilinpäätösjulkaisua • Bexmarilimab faasi I/II MATINS-tutkimus osoittanut aikaisen vaiheen tehohyödyn vaikeasti hoidettavissa pitkälle edenneissä syövissä • Hoitoon reagoivien potilaiden elinajan odote kasvanut merkittävästi
Slide 7: Key financial and corporate information
Key financial and corporate information Including post period • Cash balances on 31 December 2020 of €4.1 million (2019: €7.1 million) • Loss for the period for the financial year ended 31 December 2020 was €16.9 million (2019: €13.3 million) • Net assets on 31 December 2020 were €-1.8 million (2019
Slide 8: Avainluvut ja Pääkohdat
Avainluvut ja Pääkohdat Sisältäen tilikauden jälkeisiä tapahtumia • Rahavarat 31. joulukuuta 2020: €4,1 miljoonaa (2019: €7,1 miljoonaa) • Tilikauden tappio 31. joulukuuta 2020 oli €16,9 miljoonaa (2019: €13,3 miljoonaa) • Oma pääoma 31. joulukuuta 2020 oli €-1,8 miljoonaa (2019: €1,6 miljoonaa) • F
Slide 9: Macrophage-Guided Immunotherapy
Macrophage-Guided Immunotherapy | Investor Presentation 9 Faron Pharmaceuticals | Non-Confidential Information
Slide 10: The Revolution of Checkpoint Inhibitors (CPIs) to Treat Cancer
The Revolution of Checkpoint Inhibitors (CPIs) to Treat Cancer CPI market estimated to become $56.5 billion by 2025 Responder 13% Not eligible Eligible Non- Responder 56% 44% 87% The adoption of CPIs has occurred very quickly due to their success compared to older drugs, despite poor response rates.
Slide 11: The Desperate Search to Improve Survival Further
The Desperate Search to Improve Survival Further Macrophages are considered a key barrier to unlock the next level Why Macrophages? • Macrophages promote tumor growth and metastases • Macrophages create a highly immunosuppressive environment • Continued evidence shows that macrophages are key in Bex
Slide 12: CLEVER-1 Expression is Predictive of Survival, Therapeutic Response, & T-Cell Dysfunction
CLEVER-1 Expression is Predictive of Survival, Therapeutic Response, & T-Cell Dysfunction1 Kaplan Meier of Clever-1 (STAB1) mRNA expression TCGA-PANCAN TCGA Among all cancer patients Among immunotherapy treated patients All immunotherapy treated patients OS (months) OS (months) Not responding to IO
Slide 13: Blocking CLEVER-1 Leads to Tumor Rejection
Blocking CLEVER-1 Leads to Tumor Rejection Single agent activity in checkpoint refractory mice models LLC1 (lung) Macrophage COLD HOT CLEVER-1 Wild Type Lyz2-Cre/STAB1fl/fl deficiency mm3 significantly impairs the * progression of solid tumors1 E0771 (mammary) Wild Macro Blocking of CLEVER-1 leads t
Slide 14: The New Unlock Agent to Regain Immunity; bexmarilimab
The New Unlock Agent to Regain Immunity; bexmarilimab Tackling both immuno-suppressive macrophages and soluble protein that inactivates T-cells CLEVER-1+ ‹ AUC 0.79 P<0.0001 macrophages After CLEVER-1 inhibition Level of active sCLEVER-1 during Bex treatment Ç‹ • Advanced MATINS cancer patients have
Slide 15: Soluble Clever-1: A Remote Controller of Cytotoxic T-cells
Soluble Clever-1: A Remote Controller of Cytotoxic T-cells Inhibiting the immunological synapse blocks the benefit of CPI such as anti-PD-1(L1) 15 | 04.23.21 Faron Pharmaceuticals | Non-Confidential Information
Slide 16: MATINS; Phase I/II Trial Design and Timelines
MATINS; Phase I/II Trial Design and Timelines Adaptive design enabling pivotal data generation Part I Part II Part III The adaptive design of the MATINS trial Dose Finding Initial Expansion Confirmatory Completed Ongoing Q3’2021–Q4’2022 1 Expand into promising Ovarian indications quickly Key Metrics
Slide 17: CLEVER-1; a Master Regulator of Immunity
CLEVER-1; a Master Regulator of Immunity Clevegen treatment downregulates all major checkpoints and increases CD8+ effector populations T Cell Populations EFF = Effector EM = Effector memory CM = Central memory CD8+ EFF Cells Treg = T regulatory * P < 0.05 ** P < 0.01 *** P < 0.001 * P < 0.05 Immuno
Slide 18: MATINS Phase I/II; 30-Patient Part I Safety Data Overview
MATINS Phase I/II; 30-Patient Part I Safety Data Overview Topline Safety Data Highlights from Part I Treatment-related adverse events Grade 1-2 Grade 3-4 Dose-finding conducted in highly pretreated patients (n=66 events total) [ n (%) ] [ n (%) ] with advanced solid tumors that are refractory to ICI
Slide 19: Single Agent Efficacy in Last-Line Checkpoint Refractory Patients
Single Agent Efficacy in Last-Line Checkpoint Refractory Patients (MATINS Part I patients) Pre-dose 30 weeks Week (Post Treatment) 0 from pre-treatment (%) Change in Tumour Size MSI- -10 0 5 10 15 20 25 30 35 40 negative -20 CRC -30 -40 -50 -60 Week (Post Treatment) Pre-dose 6 weeks 0 from pre-treat
Slide 20: Up to date Survival Data from Part II of the MATINS trial
Up to date Survival Data from Part II of the MATINS trial Significant survival benefit seen in patients that seem to be responsive to bexmarilimab Progression-free survival (PFS) with previous treatment Overall survival (OS) of patients with before entering MATINS bexmarilimab benefit Treatment bene
Slide 21: Next Stages of Development
Next Stages of Development Targeting Myeloid Cells; Poorly understood area of IO1 Ongoing Myeloid Trials which are CLEVER-1 is uniquely set to change paradigms Modulating Myeloid Cell Function2 (total=63) This is a first–in-class target with promising results have been achieved CCL2 while investigat
Slide 22: Bexmarilimab Clinical Development Plan
Bexmarilimab Clinical Development Plan Flexible trial designs enables multiple routes to market 2021 2022 2023 2024 2025 MATINS Part II1 MATINS Part III1,2 Pivotal trials in CPI refractory settings can provide Solid tumours massive market opportunities without competition NSCLC in combination with a
Slide 23: Clevegen: A Clever Antibody, with a Lot of Potential
Clevegen: A Clever Antibody, with a Lot of Potential A monotherapy which provides a permanent immune 1 stimulation in difficult-to-treat cancer types Positive safety data; bringing benefits in comparison First-in-class asset 2 to currently available checkpoint inhibitors Rapid phenotypical change Pr
Slide 24: HAEMATOKINE® Hematopoietic Stem Cell Expansion
HAEMATOKINE® Hematopoietic Stem Cell Expansion | Investor Presentation 24 Faron Pharmaceuticals | Non-Confidential Information
Slide 25: Targeting Amine Oxidase Copper Containing 3
Targeting Amine Oxidase Copper Containing 3 A different approach to a poorly utilised target Tradition blocking adhesion approach Why Target AOC3? Small molecule AOC3 inhibitor • Faron’s founders pioneered the discovery of the AOC3 and have nearly 30 years of knowledge of the target1 • Faron is deve
Slide 26: Expansion of Haematopoietic Stem Cell By Regulating AOC3 Activity
Expansion of Haematopoietic Stem Cell By Regulating AOC3 Activity AOC3 is highly expressed on bone marrow vasculature • Blocking enzymatic activity of AOC3 inhibits reactive oxygen species within haemopoietic stem cells leading to more HSC production ex vivo in human tissue and in vivo in mice after
Slide 27: CD73 & Organ Protection
CD73 & Organ Protection | Investor Presentation 27 Faron Pharmaceuticals | Non-Confidential Information
Slide 28: 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 Capillary leakage
Slide 29: ARDS Phase I/II Proof of Concept Trial Results: Significant Reduction in Mortality
ARDS Phase I/II Proof of Concept Trial RESULTS: Significant Reduction in Mortality Reduction in ICU stay from 28 to 16 days, less need for dialysis between groups Traumakine® treated (n=37, APACHE II of 22) P = 0.01 (28 day) Control group, standard treatment (n=59, APACHE II of 23) Carried out in 8
Slide 30: Phase III Trial (INTEREST Study) Key Learnings
Phase III Trial (INTEREST Study) Key Learnings Post hoc analysis shows that concomitant steroid use blocks Interferon beta-1a activity and increases mortality risk by 7x4 INTEREST Study Result 1,2 Post-Hoc Analysis of INTEREST 3,4 Active vs Placebo IFN beta-1a Treatment Arm n=301 (296 dosed) n=144 (
Slide 31: HIBISCUS: A Phase II/III Supported by the Department of Defense
HIBISCUS: A Phase II/III Supported by the Department of Defense Supporting hospitalised COVID-19 patients to prevent entrance to the ICU and/or death Phase II Phase III Trial End Interim analysis Final analysis Traumakine indicatively Was Traumakine better than Continue enrolment superior to placebo
Slide 32: Traumakine – Novel Approach to Organ Protection
Traumakine – Novel Approach to Organ Protection Now supported by US Department of Defense 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 Pande
Slide 33: Traumakine; Route to Market
Traumakine; Route to Market Simultaneous ongoing pivotal trials supported by medical agencies and academic networks Worldwide patient's 2021 2022 2023 2024 2025 potential per annum4 REMAP-CAP & Faron (Phase 3)1 3 000 000 HIBISCUS (Phase 2/3)2 AKI (Phase 1/2)3 17 500 000 CAR therapy induced CRS3 450
Slide 34: 2021 Set to be a Year of Significant Pipeline Progress
2021 Set to be a Year of Significant Pipeline Progress • Top line data from MATINS trial Part II Bexmarilimab • • Determination of final dosage and frequency Selection of first pivotal cohort from MATINS • Initiation of combination, neoadjuvant and haematological malignancies trials Haematokine
Slide 35: Thank you
Thank you | Investor Presentation Faron Pharmaceuticals | Non-Confidential Information
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