Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Shareholder Meeting (May 2017)
33 slides from Faron Pharmaceuticals Oy's shareholder meeting presentation, May 16, 2017
Slide 1: Conquering ARDS and Cancer Immunity
CONQUERING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND CANCER IMMUNITY Faron Pharmaceuticals CEO Review / Annual General Meeting 16 May 2017 1
Slide 2: Disclaimer
DISCLAIMER The contents of this presentation have not been approved by an authorised 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 activity may
Slide 3: Introduction to Faron (LSE: FARN)
INTRODUCTION TO FARON (LSE: FARN) Late stage clinical development pipeline targeting significant unmet medical needs • Successful IPO on London AIM in November 2015 – Raised £23 million to date with €11.5 million cash as at 31 December 2016 and €5.8 million raised on 1 March 2017 • Lead drug Traumak
Slide 4: Endothelial barrier is everything
16.5.2017 ENDOTHELIAL BARRIER IS EVERYTHING Faron pipeline is based on endothelial receptors involved in regulation of immune responses and vascular dysfunctions CD73 controls capillary Clever-1 regulates leakage and escalation of tissue immune status inflammation AOC3 escalates inflammation and vas
Slide 5: Pipeline targets significant unmet medical needs
PIPELINE TARGETS SIGNIFICANT UNMET MEDICAL NEEDS 16.5.2017 May 2017 5
Slide 6: Executive Directors & Senior Management Team
EXECUTIVE DIRECTORS & SENIOR MANAGEMENT TEAM Experienced team shortlisted for leading industry award EXECUTIVE DIRECTORS Dr Markku Jalkanen, Chief Executive Officer & Founder • Over 25 years’ experience in biomedical research, biotech development and the biopharmaceutical industry • Former CEO of Bi
Slide 7: Annual Results 2016
ANNUAL RESULTS 2016 Building global pipeline and presence in London equity markets
Slide 8: 2016 Operational Highlights
2016 OPERATIONAL HIGHLIGHTS Including post period end highlights Traumakine® • Pivotal, pan-European, Phase III INTEREST trial for the treatment of Acute Respiratory Distress Syndrome (“ARDS”), has continued to progress as planned • Initiated filing of a clinical trial application (CTA) for the use
Slide 9: 2016 Financial Highlights
2016 FINANCIAL HIGHLIGHTS Including post period end highlights • Raised €9.3 million (net €8.5 million) by issuing 3,200,000 new ordinary shares at 250p per share to fund: • Traumakine US safety trials (INTRUST) • Clevegen pre-clinical and clinical development to Phase I/II • Further R&D and operati
Slide 10: Income Statement
INCOME STATEMENT Revenues and income from IFN-beta sales and EU Traumakine grant, respectively EUR 000s FY 2016 FY 2015 Revenues 1 153 520 Cost of Sales - (25) GROSS PROFIT 1 153 496 Administrative expenses (2 161) (3 061) Research and development expenses (9 592) (3 971) Other operating income 1 74
Slide 11: Balance Sheet
BALANCE SHEET This balance sheet does not include the €5.8 million financing round in March 2017 EUR 000s FY 2016 FY 2015 Property, plant and equipment 21 28 Intangible assets 933 1 001 NON-CURRENT ASSETS 954 1 029 Inventories 1 451 649 Trade and other receivables 3 404 2 074 Cash and cash equivalen
Slide 12: Traumakine: Interferon-beta treatment of ARDS and other ischaemic reperfusion injuries
INTERFERON-BETA TREATMENT OF ARDS AND OTHER ISCHAEMIC REPERFUSION INJURIES TRAUMAKINE®
Slide 13: Acute Respiratory Distress Syndrome – Potentially Significant Opportunity
ACUTE RESPIRATORY DISTRESS SYNDROME – POTENTIALLY SIGNIFICANT OPPORTUNITY* Orphan lung disease with no available drug treatment ARDS is a rare disease characterised by vascular leakage and inflammation of the lungs and acute but persistent loss of lung function Causes include: pneumonia (bacteria/vi
Slide 14: Traumakine Mode of Action
16.5.2017 TRAUMAKINE MODE OF ACTION Prevention of lung capillary leakage and escalation of inflammation Normal Expression The first proprietary intra- venous formulation of interferon-beta to provide a precise daily dosing of 10 µg for six consecutive days Abnormal Expression following ARDS diagnosi
Slide 15: Compelling Phase I/II Trial Results
COMPELLING PHASE I/II TRIAL RESULTS Data published below comparable to Japanese clinical trial Reduction in ICU stay from 28 to 16 days, saving money and improving ICU capacity Primary endpoint: significant drop in mortality* A B 100 Traumakine® treated (n=37, APACHE II of 22) Phase I/II trial showe
Slide 16: INTEREST - Pan-European Phase III Trial at Completion
INTEREST - PAN-EUROPEAN PHASE III TRIAL AT COMPLETION Targeting Conditional MA in Europe 2017-18 and Progressing as Planned • Randomised, double-blind, 300 moderate/severe ARDS patients in seven countries across 60 hospital sites • Seeking a reduction of all-cause mortality and days on ventilator •
Slide 17: Expected Development Status for Traumakine in ARDS
EXPECTED DEVELOPMENT STATUS FOR TRAUMAKINE IN ARDS Currently in pivotal stage in Europe and Japan, with further expansion of territories Pan-European Phase III INTEREST - FPCLI002 (ongoing) • A phase III double-blind, randomised, parallel-group comparison of efficacy and safety of FP-1201-lyo and pl
Slide 18: Traumakine Phase III Trials – Road to Commercialisation
TRAUMAKINE PHASE III TRIALS – ROAD TO COMMERCIALISATION Trials phased according to regions – enables a cost controlled approach Conditional MAA filing if overwhelmingly Post-approval pharmacovigilance positive Phase III/1 results cohort trial Phase I/II 1 INTEREST 2 Phase IV MAA (completed) (on goin
Slide 19: Development Status for Traumakine in RAAA
DEVELOPMENT STATUS FOR TRAUMAKINE IN RAAA Moving beyond ARDS Ruptured Abdominal Aortic Aneurysm (RAAA) • Abdominal aortic aneurysms (AAAs) is a potentially life-threatening condition that results from the degeneration of the arterial wall • The most common complication of AAA is a rupture, which is
Slide 20: Establishing Strong IP & Exclusivity
16.5.2017 ESTABLISHING STRONG IP & EXCLUSIVITY Protecting the exclusivity of Traumakine in ARDS and other indications Intellectual Property • New use of IFN-beta in ischemic conditions - Exclusivity through 2025 – 26 in all major territories • Prevention of multi organ failure - Exclusivity through
Slide 21: Clevegen: Novel technologies to control immune suppression
NOVEL TECHNOLOGIES TO CONTROL IMMUNE SUPPRESSION IN VARIOUS CONDITIONS CLEVEGEN®
Slide 22: Control of Immune Reaction
CONTROL OF IMMUNE REACTION Ability to balance immune activation and suppression 1. Immune activation is our first line of defense against any foreign element (e.g. infections, foreign molecules, transformed cells) 2. Immune suppression is an elementary part of our immune balance as it controls the m
Slide 23: M2 Macrophages at Sites of Immune Suppression
M2 MACROPHAGES AT SITES OF IMMUNE SUPPRESSION The M2 involvement controls key physiological and pathological processes M2 macrophages are present Clever-1 positive macrophages Clever-1 positive M2 when pathogens want to hide are induced by pregnancy and macrophages promote tumour host immune system
Slide 24: Cancer Immunotherapy Based on Type II Macrophage (M2) Elimination
CANCER IMMUNOTHERAPY BASED ON TYPE II MACROPHAGE (M2) ELIMINATION Clevegen limits the function of tumour associated type II macrophages ( M2 TAM), a known immunosuppressive cell group in tumours Circulation CURRENT LANDSCAPE Bone marrow Activation of T-cells Stem cell Monocyte (eACT), $2.0+ billion
Slide 25: Macrophage Dependent Cancer Immunotherapy
MACROPHAGE DEPENDENT CANCER IMMUNOTHERAPY May 2017 25
Slide 26: Current Clevegen Development Pathway
CURRENT CLEVEGEN DEVELOPMENT PATHWAY 1 2 3 4 5 Antibody GMP Protocol Research humani- Phase I/II Phase II sation production design Completed Completed In progress In progress 2017-2019 2019-2021 1 Faron has excellent IP-coverage on Clever-1 target and function blocking antibodies Faron has carried o
Slide 27: Hepatocellular Carcinoma (HCC)
HEPATOCELLULAR CARCINOMA (HCC) Maximize treatment success with right target group 1. High presence of type M2 macrophages predict poor prognostic outcome • Low presence of CD86+ TAMs (M1) and high presence of CD206+ TAMs (M2) correlate well with aggressive HCC and poor survival outcome (Dong et al.,
Slide 28: TIET-Technology (Tumour Immunity Enabling Technology)
TIET-TECHNOLOGY (TUMOUR IMMUNITY ENABLING TECHNOLOGY) Provides stand-alone or immune combination therapies to combat cancer Conversion of the local tumour environment from immune suppressive to immune activated by Clevegen: • Targets unique immune switch molecule Clever1 • Binds to specific propriet
Slide 29: Upcoming Potential News Flow
UPCOMING POTENTIAL NEWS FLOW INTEREST trial read out is the next important value inflection point Traumakine® • ARDS Pan-European Phase III INTEREST efficacy results expected H2-2017 • Initiation of US ARDS safety study expected in H2-2017 (subject to pre-IND DFA meeting mid- 2017) • Additional comm
Slide 30: Summary
SUMMARY • Phase III asset in lead drug, Traumakine, currently undergoing trial in Acute Respiratory Distress Syndrome (ARDS), results expected H2-2017 • De-risked drug candidate due to known API with safety & tolerance understood • Strong Phase II data showed 81% reduction in ARDS mortality, Phase I
Slide 31: Faron Pharmaceuticals
FARON Pharmaceuticals
Slide 32: Non-Executive Directors
NON-EXECUTIVE DIRECTORS Dr Frank Armstrong, Non-Executive Chairman • Significant industry experience at big pharma including Bayer and Zeneca as well as CEO roles with five biotechnology companies (public and private). Also holds several Chairmanships and Non-Executive positions • Member of the Scie
Slide 33: Proposed Board Changes for Shareholder Approval
16.5.2017 PROPOSED BOARD CHANGES FOR SHAREHOLDER APPROVAL Dr. Gregory B. Brown and Mr. John Poulos Dr. Gregory B. Brown, Non-Executive Director (proposed) • More than 35 years of experience in healthcare and investment • Former General Partner at Paul Capital Partners in New York, Co-Head of Investm
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