Asarina Pharma AB (publ) — Shareholder Meeting (May 2020)
18 slides from Asarina Pharma AB (publ)'s shareholder meeting presentation, May 5, 2020
Slide 1: Asarina Pharma Annual General Meeting
ASARINA PHARMA Remain in control of your life Annual General Meeting 5 May 2020 Peter Nordkild, CEO 1
Slide 2: Disclaimer
Disclaimer • The shares of Asarina Pharma (”Asarina”) are traded on NASDAQ First North in Stockholm (ticker: ”ASAP”) • This presentation may contain specific forward-looking statements, relating to Asarina´s future business, development and economic performance e.g. statements including terms like ”
Slide 3: Introduction
Introduction • Due to the Covid-19 restrictions, Asarina management is unable to physically attend the 2019 Annual General Meeting • The CEO and the CFO will participate by video and will be available to answer questions • The following slides include the presentation by Peter Nordkild of the curren
Slide 4: Asarina – highlights May 2020
Asarina – highlights May 2020 • PMDD: No statistical difference in clinical endpoints between placebo and Sepranolone in phase IIb study - Strong safety profile for Sepranolone confirmed - Additional data analysis – unlikely to change overall result • Menstrual migraine: 75% of patients recruited in
Slide 5: PMDD - phase IIb results
» ASARINA PHARMA PMDD - phase IIb results
Slide 6: Phase IIb study design in PMDD
A randomised, double-blind, placebo-controlled, parallel-group, multicentre study investigating the efficacy and safety of Sepranolone (UC1010) in patients with PMDD 2 cycles 3 cycles 1 cycle baseline / diagnosis treatment follow-up Sepranolone dose 10 mg Advertisement PMDD Randomisation Sepranolone
Slide 7: Phase IIb Clinical Study: Treatment effect
Phase IIb Clinical Study ~) ASARINA Treatment effect PHARMA * Late luteal phase symptom scores in the ITT population (N=192) a. DRSP points 90 80 BActive Baseline 70 W Active treatment 60 Placebo Baseline O Placebo treatment 50 40 30 20 : | : a Total symptoms Sum21 Cardinal symptoms Impairment score
Slide 8: Phase IIb Clinical Study: Treatment effect
Phase IIb Clinical Study » ASARINA Treatment effect PHARMA . Improvement in late luteal phase symptom scores from baseline in the ITT population (N=192) Sepranolone Sepranolone Difference Active vs. Placebo 10mg 16mg Active-Placebo| Placebo Total symptoms (Sum21) 30.5#22.2 30.0+20.2 27.9+21.4 2.4421
Slide 9: Phase IIb Clinical Study: Treatment effect
Phase IIb Clinical Study » ASARINA Treatment effect PHARMA * Improvement in late luteal phase symptom scores in the ITT population (N=192) DRSP points 6 W Active treatment O Placebo treatment 5 4 Tullureblt < ay eo) A aes $ @ & Q > > i) o> we << < a) wt & e wP oe FSF SF S&F §& F&F ES F SF S s Se Pr
Slide 10: Phase IIb Clinical Study: Adverse events
Phase IIb Clinical Study gy ASARINA Adverse events PHARMA * No treatment related Serious Adverse Events has been reported * In total 236 probably/possibly related Adverse Events were reported - The vast majority were mild and transient, none was severe - No single type of general adverse event occur
Slide 11: Menstrual Migraine - phase IIa study
Menstrual Migraine - phase IIa study 11
Slide 12: Menstrual Migraine: Phase IIa (APH204)
Menstrual Migraine: Phase IIa (APH204) • 7 study sites: 3 in Finland, 4 in Sweden • 86 women to be randomized • Study includes a baseline/diagnostic phase of 3 menstrual cycles, followed by 3 cycles of sepranolone/placebo • Daily eDiary ratings • Due to COVID-19 related recruitment restrictions, est
Slide 13: APH204 Population status
APH204 Population status baseline / diagnosis 3 cycles treatment follow-up Subjects enrolled: 86 Screen failures: 21 Randomized: 33 • Approx. 20% screen failure Started T1: rate • Compliance: 80% of days Withdrawn: 1 need to be completed in eDiary Started T2: • Once started treatment cycles – 1 with
Slide 14: Tourette - phase IIa study
» ASARINA PHARMA Tourette - phase Ila study
Slide 15: Efficacy on par with Haldol and Finasteride
Efficacy on par with Haldol and Finasteride Spatial confinement 1.50 Vehicle (SC) P<0.0001 P<0.00001 1.25 Sepranolone (10 mg/kg, SC) P<0.00001 # Tics/min P<0.00001 Haloperidol (0.3 mg/kg, IP) 1.00 NS Finasteride (25 mg/kg, IP) 0.75 NS 0.50 NS 0.25 0.00 WT D1CT-7 Source of Variation % of total variat
Slide 16: Phase IIa study in Tourette
Phase IIa study in Tourette Sepranolone 1 month 3 months treatment 30-60d screening 1 month baseline follow-up Non drug treatment • A randomized parallel group Phase IIa study in drug naive adolescent and adult patients with TS • ~30 male and female TS patients, age 12-45, randomized 2:1 to sepranol
Slide 17: Near term value inflection points
Near term value inflection points 2020 2021 2022 Tourette Orphan APH205 study Initiation Phase designation initiation in IIb trial MM Tourette Menstrual Top line Migraine results Tourette Top last patient Menstrual Line data last dose Migraine H1- 2021 Q4 - 2020 Q4 - 2020 Q2 - 2021 Q1 - 2022 Q1-2 -
Slide 18: Thank you, questions?
» ASARINA PHARMA THANK YOU QUESTIONS?