Slide 1: AP1189 - A new medicine to treat inflammatory diseases
AP1189 - A new medicine to treat inflammatory diseases Thomas Jonassen, CSO Jeppe Øvlesen, CEO Sedermeradagen Malmø 2018
Slide 2: In a Nutshell
IN A NUTSHELL AP1189 – a melanocortin receptor agonist to reduce inflammation and “boost” healing ➔ First indication: active inflammatory joint diseases (rheumatoid and psoriatic arthritis) ➔ Opportunity: additional indications based on Mode of Action (ACTH-like properties) Current market for arthri
Slide 3: The Share (Ticker SYNACT)
THE SHARE (Ticker SYNACT) • Listed at Aktietorget in July 2016 • Introduction price at 6.40 SEK per share • Current (Maj 2018) app. 13.50 per Share • Market cap (Maj 2018) of app. 160 MSEK • Right issue of 2 257 718 shares – subscribed with 196% - closed yesterday • Lock up for 12 months (Management
Slide 4: Experienced Team
EXPERIENCED TEAM Jeppe Øvli Øvlesen, MBA Torbjørn Bjerke, MD CEO Chairman, Board of Directors > 15 years of CEO experience Co-founder and Chairman in TXP Pharma Investor and founding Board Member > 25 years track record from Pharma industry as at a number of Biotech/Medtech Head R&D and
Slide 5: Melanocortin Therapy – Recent Deals
MELANOCORTIN THERAPY – RECENT DEALS Specialized programs focused on peptide derived therapy 2012 2013 2014 2015 2017 Action TXP Questor Merck Palatins Pharma´s Pharma´s including cortico- Recynda AP214 peptide Acthar gel tropin program program program products (Phase 3) Phase 2 Deal value: Deal valu
Slide 6: AP1189 – Development Overview
AP1189 - DEVELOPMENT OVERVIEW 2017 2018 2019 Start of clinical phase I study • Report phase I study • Report phase IIa study (healthy) • Start of clinical phase IIa study • Evaluate potential in additional Planning for clinical phase IIa indications study (patients) • Continued preclinical studi
Slide 7: AP1189 – In Clinical Development for Active Joint Disease
AP1189 – IN CLINICAL DEVELOPMENT FOR ACTIVE JOINT DISEASE Broadening indication from flares in PsA to active inflammatory joint disease, both RA and PsA Both RA and PsA treatment markets are dominated by high priced biologics – room for novel oral entrants The RA and PsA market reached global sa
Slide 8: Rheumatoid and psoriatic arthritis have overlapping characteristics
AP1189 – IN CLINICAL DEVELOPMENT FOR ACTIVE JOINT DISEASE Rheumatoid and psoriatic arthritis have overlapping characteristics autoimmune diseases where the immune system ”wrongly” attacks joint tissues similar symptoms with swelling, pain, stiffness and in severe cases joint destructions avail
Slide 9: Resolution of Inflammation – A New Therapeutic Frontier
RESOLUTION OF INFLAMMATION - A NEW THERAPEUTIC FRONTIER AP1189 Inhibits the inflammatory response - + AP1189 Stimulates the resolution phase Resolution therapy holds promise to correct overshooting/ongoing inflammation typical of many pathological settings 9
Slide 10: Treatment Effects in Disease Models
AP1189 – TREATMENT EFFECTS IN DISEASE MODELS Increases clearance of apoptotic cells Efficacious in arthritis model in mice (joint inflammation) ➜ Stimulates resolution of inflammation Control AP1189 White blood cells/mouse (x106) AP1189 (1mg/kg i.p.) Reduced joint swelling Reduced disease activity T
Slide 11: AP1189 – In Clinical Phase I
AP1189 - IN CLINICAL PHASE I Clinical Phase I study is ongoing Plasma levels after single dose • Single dose completed in 64 healthy volunteers • Well tolerated up to dose levels where peak exposures reached > 10 times the efficacious concentrations • Data support once daily dosing • Newly developed
Slide 12: AP1189 – Positioning as an Add-on in Active Joint Disease
AP1189 – POSITIONING AS AN ADD-ON IN ACTIVE JOINT DISEASE • Patients with active joint disease are treated with methotrexate (MTX) • Approx. 40% have inadequate response • Next line treatments are more efficacious, but often have side effects • Even with expensive injectable biologics, up to 30% sti
Slide 13: AP1189 – Development Overview
AP1189 - DEVELOPMENT OVERVIEW 2017 2018 2019 Start of clinical phase I study • Report phase I study • Report phase IIa study (healthy) • Start of clinical phase IIa study • Evaluate potential in additional Planning for clinical phase IIa indications study (patients) • Continued preclinical studi
Slide 14: Melanocortin Derived Therapy – AP1189 Opportunity in ACTH Space
MELANOCORTIN DERIVED THERAPY - AP1189 OPPORTUNITY IN ACTH SPACE ACTH based therapy • ACTH has potent effects in autoimmune and inflammatory disorders via: 1. Melanocortin receptor activation (non- selective) Preclinical studies 2. Release of steroid hormones ongoing to evaluate other • Limited to di
Slide 15: The Opportunity – 2018/2019
THE OPPORTUNITY – 2018/2019 • New Share issue facilitates broader approach • Increased market potential by broadening the indication from flares in PsA to active inflammatory joint diseases in both RA and PsA (2015 sales: 19.5 and 4.53 billion USD, respectively) • Complete an expanded Phase lla (cli
Slide 16: CEO, Jeppe Øvlesen
CEO, Jeppe Øvlesen joo@synactpharma.com Tel.: + 45 2844 7567 CFO, Henrik Stage hs@synactpharma.com Tel.: + 45 4026 0900 www.synactpharma.com
Slide 17: Erbjudandet i sammandrag
ERBJUDANDET I SAMMANDRAG Teckningstid: Teckningstid: 19 april – 8 maj 2018. Teckningskurs: Teckningskurs: 9,90 SEK per aktie. Emissionsvolym: Emissionsvolym Cirka 22,4 MSEK. Antal aktier innan nyemissionen: nyemissionen 12 417 449 stycken. Marknadsplats: Marknadsplats: AktieTorget. Värdering (pre- (