Vicore Pharma AB. Audiocast, October 2, Presentation by Per Jansson, CEO and Ulrike Muscha Steckelings, CSO

Transcription

1 Vicore Pharma AB Audiocast, October 2, Presentation by Per Jansson, CEO and Ulrike Muscha Steckelings, CSO

2 FORWARD-LOOKING STATEMENTS This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and depend on circumstances that will occur in the future and which, by their nature, will have an impact on Vicore Pharma s business, financial condition and results of operations. The terms anticipates, assumes, believes, can, could, estimates, expects, forecasts, intends, may, might, plans, should, projects, will, would or, in each case, their negative, or other variations or comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a particular projection is realized. Factors that could cause these differences include, but are not limited to, implementation of Vicore Pharma s strategy and its ability to further grow, risks associated with the development and/or approval of Vicore Pharma s products candidates, ongoing clinical trials and expected trial results, the ability to commercialize C21, technology changes and new products in Vicore Pharma s potential market and industry, the ability to develop new products and enhance existing products, the impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors. No assurance can be given that such expectations will prove to have been correct. Vicore Pharma disclaims any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. 2

3 VICORE PHARMA OVERVIEW (VICO) Vicore Pharma is a development-stage biotech company focused on serving patients with unmet medical needs in orphan fibrotic diseases. Vicore Pharma s business strategy is to lead the development of drugs based on stimulating the AT2 receptor in the Renin-Angiotensin-System. Financial highlights Listed on NASDAQ OMX First North (ticker: VICO) Market cap: approx. USD 65m (August 2017) Closed SEK 56m (USD 6.2m) directed share issue to institutional investors in Feb Lead drug candidate: C21 First in class AT2 receptor agonist Stimulates the angiotensin AT2 receptor Induces endogenous healing and repair mechanisms Orphan Drug Status for Idiopathic Pulmonary Fibrosis (IPF) in the EU and USA Next step; Phase IIa study for IPF 3

4 RECENT KEY MILESTONES 2017 January: ODD IPF (USA) February: Directed share issue 56 MSEK announced March: BioMAP study with C21 study shows excellent results on fibrosis August: Phase I extension study top-line data reported October: Phase I extension study in-depth data reported 2016 April: June: August: Start of Phase I studies Phase I SAD completed ODD IPF (EU) November: Phase I MAD completed 4

5 5 Results from the Phase I, randomised, double-blind, placebo-controlled study in healthy, obese male volunteers to investigate the safety, tolerability, pharmacokinetics and possible pharmacodynamic effects of multiple oral doses of Compound 21 (C21)

6 Aim: to perform an exploratory study in healthy volunteers with compromised metabolic parameters due to obesity in order to get an indication, whether C21 has detectable pharmacodynamic effect in humans 6

7 MEN Double-blind, randomised, placebo-controlled study performed at CRST/University of Turku, Finland, PI: Prof. Mika Scheinin Healthy, obese male volunteers (BMI kg/m 2, body weight < 140 kg, WHR >0.90) Dose 100 mg (oral solution; once daily application) 8 subjects on drug, 8 subjects on matching placebo C21 / placebo application 8:00 8:00 8:00 8:00 8:00 8:00 8:00 8:00 day 1 day 2 day 3 day 4 day 5 day 6 day 7 day 8 Collection of plasma samples (day 1 and 8) 8:00 9:30 11:00 13:00 C21 / placebo meal 7

8 Methods of analysis Routine laboratory parameters at Turku University Hospital University of Turku / Professor M. Scheinin s lab (mainly ELISA) University of Turku / Professor S. Jalkanen s lab (multiplex ELISA) Nightingale Health (metabolomics / NMR; > 220 markers) 8

9 Comparisons are always between day 1 and 8 not between different time points on the same day Day 1 8:00 9:30 11:00 13:00 Day 8 8:00 9:30 11:00 13:00 C21 meal C21 meal 9

10 Results most effects were seen on lipoprotein level 10

11 Results Overview of pattern of biomarkers significant beneficial effect of C21 (decrease in VLDL/LDL or increase in HDL) (p<0.05) borderline significant beneficial effect of C21 (p<0.1) fp-chol fp-chol-hdl fp-chol-ldl 11

12 Results Overview of pattern of biomarkers Decrease in VLDL and LDL measured independently at 3 different time points over the day (8-10 markers; results from 2 independent labs) fp-chol fp-chol-hdl fp-chol-ldl 12

13 Results Overview of pattern of biomarkers Example: placebo * C21 fp-chol fp-chol-hdl fp-chol-ldl 13

14 Results Overview of pattern of biomarkers Example: When looking at individual time points over the day, on day 1, all mean LDL values in the C21 group are higher than in the placebo group; on day 8, all mean values in the C21 group are lower than in the placebo group Day 1 Day 8 fp-chol fp-chol-hdl fp-chol-ldl placebo C21 14

15 Results Overview of pattern of biomarkers Smaller post-prandial increase in VLDL (10 markers) fp-chol fp-chol-hdl fp-chol-ldl 15

16 Results Overview of pattern of biomarkers Prevention of decrease in HDL (as seen in placebo group) measured independently at 4 different time points over the day (8-10 markers; results from 2 independent labs) fp-chol fp-chol-hdl fp-chol-ldl 16

17 Results Overview of pattern of biomarkers Example: * placebo C21 fp-chol fp-chol-hdl fp-chol-ldl 17

18 Results Overview of pattern of biomarkers Example: When looking at individual time points over the day, on day 1, all mean HDL values in the C21 group are lower than in the placebo group; on day 8, all mean values in the C21 group are higher than in the placebo group Day 1 Day 8 fp-chol fp-chol-hdl fp-chol-ldl placebo C21 18

19 Conclusions There were no safety or tolerability issues whatsoever in this group of metabolically compromised subjects receiving 100mg doses of C21, which was also the highest dose tested in the non-obese cohort of the Phase I / MAD study. The pattern and consistency of the findings strongly support a pharmacodynamic effect of C21 in humans C21 affects the plasma levels of various lipoproteins (VLDL, LDL, HDL) in a beneficial and clinically relevant way The selected dose (100 mg once daily) seems to be effective 19

20 20 QUESTIONS AND ANSWERS