Faron Pharmaceuticals Oy · LSE:FARN
Faron Pharmaceuticals Oy — Shareholder Meeting (May 2019)
26 slides from Faron Pharmaceuticals Oy's shareholder meeting presentation, May 28, 2019
Slide 1: Full year 2018 results, Annual General Meeting 28 May 2019
Faron Pharmaceuticals (LSE: FARN) Full year 2018 results Annual General Meeting 28 MAY 2019 CEO Markku Jalkanen 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: We see barriers as opportunities
WE SEE BARRIERS AS OPPORTUNITIES Faron’s pipeline is based on receptors involved in regulation of immune responses and vascular dysfunctions Immuno-Oncology ARDS & Organ protection Clevegen® Traumakine® Clever-1 regulates CD73 controls capillary tissue immune status leakage and escalation of inflamm
Slide 4: Faron pipeline
FARON PIPELINE * * Subject to regulatory discussions and approvals and partnering discussions 4
Slide 5: Key pipeline highlights
KEY PIPELINE HIGHLIGHTS Traumakine • Corticosteroid interference identified both in European and Japanese phase III studies • Japanese results inline with INTEREST study • Corticosteroid resistant polymorphism identified with good Traumakine efficacy • Advanced interim read out for INFORAAA expected
Slide 6: Key financial & corporate highlights
KEY FINANCIAL & CORPORATE HIGHLIGHTS (including Post Period-end) Financial ❑ Raised £15m in February 2018 ❑ Extensive cash saving program applied post negative INTEREST study results ❑ Cash balance of €4.1m on 31 December 2018 and €4.9m on 31 March 2019 ❑ Operating loss of €20.1m (2017: €21.1m) ❑ Ne
Slide 7: Interferon-beta treatment of ARDS and other ischaemic reperfusion injuries
INTERFERON-BETA TREATMENT OF ARDS AND OTHER ISCHAEMIC REPERFUSION INJURIES
Slide 8: Acute respiratory distress syndrome (ARDS): the burden of ARDS
ACUTE RESPIRATORY DISTRESS SYNDROME (ARDS) It’s what you die of in influenza, pneumonia, sepsis, and major trauma ARDS is an inflammatory lung injury leading to vascular leakage filling the lungs with fluid – “drowning within” The burden of ARDS • Over 300,000 cases annually in EU & US, and 3 millio
Slide 9: Phase I/II proof of concept trial results
PHASE I/II PROOF OF CONCEPT TRIAL RESULTS Reduction in ICU stay from 28 to 16 days, less need for dialysis between groups Primary endpoint: significant drop in mortality* Traumakine® treated (n=37, APACHE II of 22) Mortality 8% P = 0.01 (28 day) Control group, standard treatment (n=59, APACHE II of
Slide 10: Phase III INTEREST trial: design & results
PHASE III INTEREST TRIAL: DESIGN & RESULTS Multi center, double blind, 1:1 randomized, pan-European trial1,2 N=301 (296 dosed) FP-1201-lyo 10 Eligible patients μg • ≥18 years All-cause All-cause Primary FDA • Receiving Dosing regimen analysis: required mortality mortality mechanical IV once daily al
Slide 11: Concomitant corticosteroid use increases mortality
CONCOMITANT CORTICOSTEROID USE INCREASES MORTALITY Post hoc analysis of INTEREST trial data base of the active arm Logrank p<0.0001
Slide 12: Steroids block Traumakine induced CD73 up-regulation
STEROIDS BLOCK TRAUMAKINE INDUCED CD73 UP-REGULATION Testing human lung tissue ex vivo samples proves steroid interference of Traumakine action Interferon-beta induced lung capillary CD73 upregulation Interferon-beta (DS) induced lung capillary CD73 upregulation is as published previously in Belling
Slide 13: Corticosteroids inhibit IFN beta-1a induced nuclear translocation of IRF9
29.5.2019 CORTICOSTEROIDS INHIBIT IFN BETA-1A INDUCED NUCLEAR TRANSLOCATION OF IRF9 IN HUMAN LUNG ENDOTHELIAL CELLS IRF9 deficiency leads to death in childhood influenza Without the overlapping use of hydrocortisone IFN beta-1a activates its nuclear response element by its main transcription factor
Slide 14: Future Traumakine steps
FUTURE TRAUMAKINE STEPS Traumakine • Design of the new phase III study CALIBER based on INTEREST data post hoc analysis • Seek scientific advise for CALIBER study from regulatory authorities • Initiate preparations for the global CALIBER study • CALIBER initiation post external funding • Continue in
Slide 15: Turn on your immunity
Turn on your immunity Footnotes 15
Slide 16: 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 (eACT), acquired by Stem cell Monocyte Act
Slide 17: Clevegen mode of action in cancer fight
CLEVEGEN® MODE OF ACTION IN CANCER FIGHT Footnotes 17
Slide 18: Clevegen development pathway
CLEVEGEN® DEVELOPMENT PATHWAY 1 2 3 4 5 Antibody GMP MATINS: MATINS: Research humani- CTA filing production part 1 parts 2–3 sation Completed Completed Completed Completed 2018–2019 2019–2021 1 Excellent IP coverage on Clever-1 target and function blocking antibodies The product is an anti-Clever-1
Slide 19: MATINS study structure
MATINS STUDY STRUCTURE Escalate the dose to tolerated dose & observe biomarkers; learn as you go Part II initial expansion with Part I (dose finding) selected cohorts Part III expansion* Dose escalation HCC n=10 4 dose levels Initially n=2–5 at each PDAC n=10 dose level Patients with Clever-1 total
Slide 20: Presently available mean surrogate marker data from MATINS patients (n=5)
29.5.2019 PRESENTLY AVAILABLE MEAN SURROGATE MARKER DATA* FROM MATINS PATIENTS (N=5) Trial has progressed to 3mg/kg with no serious drug related adverse events observed First patient now dosed also in UK at The Royal Marsden Hospital with similar response Blood cell Prior dose Post dose Post dose Po
Slide 21: Strong immune switch post Clevegen administration
STRONG IMMUNE SWITCH POST CLEVEGEN ADMINISTRATION Blood immune cell changes in partial responder subject Regulatory T-cells CD4-cells CD8-cells 200% 200% 200% % of CD4+CD25+ cells (% from % from predose % from predose 150% 150% 150% 100% 100% 100% predose) 50% 50% 50% 0% 0% 0% Pre C1D2 C1D15Pre C2Pr
Slide 22: Clevegen - the immune switch: observations so far
Cancer cell Turn on your Observations so far immunity • Unique target • Profound CD8 CD8 immunological effect where wanted • Does not affect Clever-1 healthy tissue • Extensive IP coverage Cancer cell Clevegen - the immune M2 M1 • Liquid biopsy switch antibody possibility • Does not lead to T cell e
Slide 23: Performance of the humanized antibody in man
PERFORMANCE OF THE HUMANIZED ANTIBODY IN MAN Concept proven in vivo in man – Re-activation of the host immune response 01 Jan 2019 18 Mar 2019 First responder results from MATINS trial 23
Slide 24: Clevegen value drivers
CLEVEGEN VALUE DRIVERS Potential as stand-alone or in combination to combat cancer Novel mode of action to remove immune suppression around tumours • Targets unique immune switch molecule Clever-1 on the surface of tumour associated type 2 macrophages (TAM-2) • No expected abnormalities following in
Slide 25: Next Clevegen steps
NEXT CLEVEGEN STEPS Clevegen • Complete part I of the MATINS trial to optimise dosing • Expand study sites in Europe and US for part II (expansion cohort) • Continue MATINS data analysis to understand early responder signal from the surrogate markers • Amend protocol to define optimal cohort populat
Slide 26: Thank You
Thank You “Our world is built on biology. Once we begin to understand our biology, it then becomes a technology” Footnotes
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