Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Shareholder Meeting (May 2016)
24 slides from Faron Pharmaceuticals Oy's shareholder meeting presentation, May 26, 2016
Slide 1: Conquering Acute Respiratory Distress Syndrome (ARDS) and Cancer Immunity
CONQUERING ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) AND CANCER IMMUNITY Faron Pharmaceu-cals Oy/Ltd CEO Review / Annual General Mee-ng 26 May 2016 1
Slide 2: Disclaimer
DISCLAIMER The contents of this presentaAon have not been approved by an authorised person within the meaning of SecAon 21 of the Financial Services and Markets Act 2000 (as amended) ("FSMA"). Reliance on the contents of this presentaAon for the purpose of engaging in any investment acAvity may expo
Slide 3: Introduction to Faron
INTRODUCTION TO FARON Late Stage Clinical Development Pipeline Targe-ng Significant Unmet Medical Needs • Successful IPO November 2015, raising €14.2 million (£10 million) • Lead drug Traumakine® in Phase III INTEREST trial in Acute Respiratory Distress Syndrome (ARDS) Ø Generated strong results in
Slide 4: Executive Directors & Senior Management Team
EXECUTIVE DIRECTORS & SENIOR MANAGEMENT TEAM Experienced Team with Successful Track Record in Drug Development EXECUTIVE D IRECTORS Dr Markku Jalkanen, Chief ExecuAve Officer & Founder • Over 25 years’ experience in biomedical research, biotech development and the biopharmaceu-cal industry • Former CE
Slide 5: Non-Executive Directors
NON-‐EXECUTIVE DIRECTORS Dr Frank Armstrong, Non-‐ExecuAve 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-‐Execu-ve posi-ons • Member of the Sci
Slide 6: Annual Results 2015
ANNUAL RESULTS 2015 Total New Equity Raised in 2015 was €19.3 Million
Slide 7: Key Operational Highlights
KEY OPERATIONAL HIGHLIGHTS Traumakine® • First pa-ent recruited in Phase III INTEREST trial following a successful regulatory establishment of the 55 ICU sites in seven European countries • Entered into agreements with A&B (HK) Company Limited and CMS Pharma Co. Ltd in mainland China, Hong Kong, Mac
Slide 8: Key Financial Highlights
KEY FINANCIAL HIGHLIGHTS Investments in High Priority Lead Projects – Traumakine® and Clevegen® • Successful AIM IPO raising €14.2 million • €5.1 million pre-‐IPO funding from A&B (HK) Company Limited in conjunc-on with Traumakine agreement for Greater China • Total equity raised of €19.3 million (
Slide 9: Income Statement
INCOME STATEMENT EUR 000s FY 2015 FY 2014 Revenues 520 906 Cost of Sales (25) (425) GROSS PROFIT 496 481 Administra-ve expenses (3 061) (349) Research and development expenses (3 971) (1 471) Other opera-ng income 701 111 OPERATING RESULT (5 835) (1 228) NET FINANCIAL COSTS (311) (130) Loss before i
Slide 10: Balance Sheet
BALANCE SHEET EUR 000s FY 2015 FY 2014 Property, plant and equipment 28 0 Intangible assets 1 001 1 184 NON-‐CURRENT ASSETS 1 029 1 184 Inventories 649 699 Trade and other receivables 2 074 40 Cash and cash equivalents 11 068 242 CURRENT ASSETS 13 791 980 TOTAL ASSETS 14 821 2 165 CURRENT LIABILITI
Slide 11: Post-Period End Highlights
27.5.16 POST-‐PERIOD END HIGHLIGHTS Focus on Commercial Success of Traumakine® • January 2016, Faron announced posi-ve results from the Phase II Japanese study for Traumakine conducted by Maruishi Pharmaceu-cal Co., Ltd. • March 2016, Faron announced a patent applica-on to further strengthen protec
Slide 12: Acute Respiratory Distress Syndrome (ARDS) Traumakine
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) Traumakine®
Slide 13: INTEREST - Pan-European Phase III Trial Ongoing
INTEREST -‐ PAN-‐EUROPEAN PHASE III TRIAL ONGOING Targe-ng Condi-onal MA in Europe 2017-‐18 and Progressing as Planned • Randomised, double-‐blinded, 300 moderate/severe ARDS pa-ents in seven countries across 55 hospital sites • Seeking a reduc-on of all-‐cause mortality and days on ven-lator •
Slide 14: Traumakine Phase III Trials - Road to Commercialisation
TRAUMAKINE® PHASE III TRIALS – ROAD TO COMMERCIALISATION Trials Phased According to Regions – Enables a Cost Controlled Approach Condi-onal MAA filing if overwhelmingly Post-‐approval pharmacovigilance posi-ve Phase III/1 results cohort trial Phase I/II 1 2 Phase IV Phase III/1 MAA (completed) Size
Slide 15: Third Party Validation Through Partnership Agreements
THIRD PARTY VALIDATION THROUGH PARTNERSHIP AGREEMENTS Two Territorial Agreements with Milestone Revenue, Equity & Development Funding • Japanese specialty pharma company with core focus on cri-cal care medicines • Japanese rights to Traumakine in return for €5.0 million in milestones and revenues •
Slide 16: Traumakine Summary
TRAUMAKINE® SUMMARY • Most advanced treatment globally in development for ARDS • Life saving treatment with no significant compe-tors in development • Compelling data from Phase I/II trial was published in The Lancet Respiratory Medicine • Strong market posi-on with clear regulatory pathway Ø Europe
Slide 17: Cancer Immunotherapy Clevegen
CANCER IMMUNOTHERAPY Clevegen®
Slide 18: Macrophages
MACROPHAGES Two Types of Macrophages, An--‐tumour M1s and Pro-‐tumour Type M2s How macrophages are produced and their role in adapAve immunity Bone marrow Blood Tissue Role in adapAve immunity • As scavengers, macrophages rid the body of worn-‐out cells and other debris • Macrophages are among th
Slide 19: Cancer Immunotherapy Based on TAM Elimination
CANCER IMMUNOTHERAPY BASED ON TAM ELIMINATION Promising Approaches to Intervene in Tumour Immune Suppression Clevegen® limits funcAon of tumour acAvated macrophages (TAM), a known immunosuppressive cell group in tumours CirculaAon Bone marrow Kite Pharma: Juno Therapeu-cs: Ac-va-on of T-‐cells Ac-v
Slide 20: Macrophage M2 to M1 Conversion Is an Important Immune Checkpoint Event
27.5.16 MACROPHAGE M2 àM1 CONVERSION IS AN IMPORTANT IMMUNE CHECKPOINT EVENT 20
Slide 21: Current Clevegen Development Pathway Supported with €1.5 Million Non-Dilutive Loan from Tekes
CURRENT CLEVEGEN® DEVELOPMENT PATHWAY SUPPORTED WITH €1.5 MILLION NON-‐DILUTIVE LOAN FROM TEKES 1 2 3 AnAbody GMP Primate Full size Research humani -‐ Phase I/II saAon producAon tox study Phase II Completed Completed In progress Not iniAated Not iniAated Not iniAated 1 Faron has excellent IP-‐cov
Slide 22: TIET-Technology (Tumour Immunity Enabling Technology)
TIET-‐TECHNOLOGY (TUMOUR IMMUNITY ENABLING TECHNOLOGY) Provides stand-‐alone or immune combina-on therapies to combat cancer Conversion of the local tumour environment from immune suppressive to immune acAvated by Clevegen: • Targets unique immune checkpoint molecule Clever-‐1 • Binds to specific
Slide 23: Summary
SUMMARY • Drug development company with a strong pipeline, targe-ng significant unmet medical needs • Lead drug Traumakine is the most advanced treatment globally in development for ARDS • Strong market posi-on with clear regulatory pathway • Valida-ng Traumakine deals from Maruishi (Japan) and CMS (
Slide 24: Footnotes
FARON Pharmaceuticals
Faron Pharmaceuticals Oy — Shareholder Meeting (May 2016) on 6ix