Slide 1: SynAct Pharma AB (publ)
SynAct Pharma AB (publ) Transforming the treatment of severe inflammatory diseases Stockholm, October 2020
Slide 2: Forward-looking statements
Forward- Forward-looking statements The information in this presentation (the “Information”) contains forward-looking statements related to Synact Pharma AB (the “Company”). All statements other than statements of historical facts included in the Information are forward-looking statements. Forward-l
Slide 3: SynAct Pharma – Investment Highlights
SynAct Pharma – Investment Highlights Facts and Figures Focus on developing a novel treatment concept for inflammatory and autoimmune Founded in 2013 diseases by targeting the melanocortin system Listed on Spotlight exchange since 2016 High unmet need in inflammatory diseases for therapeutics th
Slide 4: SynAct Pharma – Experienced Management
SynAct Pharma – Experienced Management Jeppe Øvli Øvlesen, MBA – CEO Torbjørn Bjerke, MD – Chairman >20 years of CEO experience >25 years track record from Pharma Founding Board Member of more than industry as Head R&D and CEO 10 biotech/medtech companies (private & public) Co-founder of TXP
Slide 5: SynAct Pharma – Pipeline Overview
SynAct Pharma – Pipeline Overview Next Asset Indication Preclinical Phase I Phase IIa Phase IIb Phase III milestone 2Q21 final Rheumatoid Arthritis readout 2H21 final Nephrotic Syndrome readout AP1189 COVID-19-induced acute 2Q21 final respiratory distress syndrome readout Psoriatic Arthritis* Pharma
Slide 6: Resolution in Inflammation – The New Frontier
Resolution in Inflammation – The New Frontier The Inflammatory Response AP1189 inhibits the AP1189 stimulates inflammatory response the resolution phase Inflammatory response effectively controlled in extent and 1 time – protects tissues and limits damage - + 2 Pathways activated to safely terminate
Slide 7: The Melanocortin System and its Role in Inflammation
The Melanocortin System and its Role in Inflammation Melanocortin Receptor Family Melanocortin is activated in inflammatory diseases MC1R MC2R MC3R Pro-inflammatory stimulus Apoptotic body MC4R MC5R Steroidal dependent effects Steroidal independent effects Discovery of the family of 5 melanocortin r
Slide 8: AP1189 – First-in-class biased MCR agonist in Phase II development
AP1189 – First- First-in- in-class biased MCR agonist in Phase II development 1 AP1189 X MC1 receptor activation in transfected cells First-in-class biased melanocortin receptor type 1 and 3 agonist The compound stimulates resolution of inflammation The compound has shown treatment effects in
Slide 9: Current melanocortin-derived therapy and AP1189's differentiation
Current melanocortin- melanocortin-derived therapy and AP1189’s differentiation Melanocortin- Melanocortin-derived therapies address high unmet needs Current melanocortin-derived therapy is unspecific and associated with treatment limiting side effects Criteria for melanocortin- Despite the unwa
Slide 10: AP1189 - Phase II Development in Rheumatoid Arthritis
AP1189 - Phase II Development in Rheumatoid Arthritis Positioning as add- add-on Therapy in Active Joint Disease
Slide 11: Rheumatoid Arthritis
Rheumatoid Arthritis Patients with inadequate response 1% Global population affected 40% to current treatments Expected global market size in Biologics patients with inadequate $30b 30% 2025 response AP1189 has potential to attenuate RA symptoms , decrease time to resolution, and reduce need for cor
Slide 12: AP1189's fit in the Rheumatoid Arthritis Treatment Paradigm
AP1189’s fit in the Rheumatoid Arthritis Treatment Paradigm 1st line 2nd line AP1189 Biologic / JAK inhibitors Moderate Potential to delay (CDAI 10-22) or additional DMARD to severe Corticosteroids (CDAI ≥22) Methotrexate Time Current guidelines recomments to go to 2nd line treatment if methotrexate
Slide 13: AP1189 Demonstrates Efficacy in Arthritis Models
AP1189 Demonstrates Efficacy in Arthritis Models Collagen-induced arthritis K/BxN-induced arthritis Combination Treatment with (30mg/kg, p.o.) (25/50mg/kg, i.p.) Methotrexate Cumulated disease score 100% Proportion with severe clinical signs (%) Clinical score (0-12) 80% * 80% * 60% 50% 50% 40% Onse
Slide 14: AP1189 – Phase IIa Trial in Rheumatoid Arthritis
AP1189 – Phase IIa Trial in Rheumatoid Arthritis Phase IIa trial design Blinded observations reported to date Part 1 Part 2 Cohort 1 AP1189 50/100mg 2:1 randomization 2:1 randomization AP1189 50mg Interim analysis Final analysis Placebo Cohort 2 AP1189 100mg Placebo Placebo 4 weeks 4 weeks Key inclu
Slide 15: AP1189 – Phase II Development in Nephrotic Syndrome
AP1189 – Phase II Development in Nephrotic Syndrome Positioning as alternative to immuno- immuno-suppressive Therapy
Slide 16: Nephrotic Syndrome
Nephrotic Syndrome Unmet Need c.150k Prevalence across US and EU Limited clinical guidelines exist for the proper management of Nephrotic Syndrome Management consists of therapeutic treatment with diuretics, ACE inhibitors, anti-infectives, lipid-lowering agents, and immunosuppressants Limited T
Slide 17: MC1R-mediated pathways activated in Nephrotic Syndrome
MC1R- MC1R-mediated pathways activated in Nephrotic Syndrome MC1R & Nephrotic Syndrome MC1R expression is increased in nephrotic syndrome, both in rat models and in humans MC1R agonism induced protection of podocytes from stress fiber loss Actin stabilization through the MC1R consisted of ERK1
Slide 18: AP1189's fit in the Nephrotic Syndrome Treatment Paradigm
AP1189’s fit in the Nephrotic Syndrome Treatment Paradigm 1st line 2nd line 2-3 months AP1189 Potential to delay Corticosteroids ACE inhibitors, lipid-lowering agents, etc. & other ISTs Time Current clinical practice is to go to 2nd line treatment if continued proteinuria is present following 6 mont
Slide 19: AP1189 Shows Benefits in Models of Nephritis
AP1189 Shows Benefits in Models of Nephritis Vehicle (n=12) Membranous nephropathy rat model (passive Heymann Nephritis) AP1189 (n=12) Creatinine Clearance (ml/min/g KW) Albumin excretion rate Reduction in AER (day 14-42) 1,0 8.000 4.000 0,8 † umol/24 hrs umol/24 hrs umol/24 hrs 6.000 3.000 0,6 * 0,
Slide 20: AP1189 – Phase IIa Trial in Nephrotic Syndrome
AP1189 – Phase IIa Trial in Nephrotic Syndrome ACE – inhibitor treatment 2:1 randomization Final analysis AP1189 100mg Follow up Placebo Follow up 4 weeks 4 weeks 24 hour urine 24 hour urine 24 hour urine collection collection collection Key inclusion criteria: Primary endpoint: Change in 24 hour pr
Slide 21: AP1189 – COVID-19 Patients at risk of developing ARDS
AP1189 – COVID- COVID-19 Patients at risk of developing Acute Respiratory Distress Syndrome (ARDS)
Slide 22: The Melanocortin System and its Role in Inflammation
The Melanocortin System and its Role in Inflammation Macrophages play a role in COVID-19 hyper-inflammation AP1189 targets key pathways in hyper-inflammation COVID-19 infection is associated with severe pneumonia that if left untreated AP1189 induces inflammatory resolution by reducing pro-inflammat
Slide 23: COVID-19: Disease development and AP1189's fit in treatment
COVID- COVID-19: Disease development and AP1189’s fit in treatment Stage I Stage II Stage III Early Infection Pulmonary Phase Hyperinflammation Phase IIA IIB Severity of Illness Viral Response Phase Patient Inflammation Phase Time Course Treatment Options Fever, dry cough, headache, diarrhea 23 Shor
Slide 24: AP1189 as an add-on therapy in COVID-19 infected patients
AP1189 as an add-on therapy in COVID-19 infected patients Open label Analysis Interim (n=6) AP1189 100mg QD Up to 2 weeks 2:1 randomization Final analysis AP1189 100mg QD n = 54 Placebo Up to 2 weeks Key inclusion criteria: Key secondary endpoints: Positive COVID-19 infection Rate of ICU admissi
Slide 25: Summary
SYNACT [J PHARMA Summary
Slide 26: SynAct Pharma Investment Highlights
SynAct Pharma Investment Highlights Investment highlights Expected news flow Focus on developing a novel treatment concept for inflammatory and autoimmune diseases by targeting the melanocortin system Q4 2020 Interim Phase IIa data Part 1 RA Initiation of Phase IIa Part 2 RA High unmet need in i
Slide 27: Contact
Chairman Dr. Torbjørn Bjerke tb@synactpharma.com CEO, Jeppe Øvlesen joo@synactpharma.com Tel.: + 45 2844 7567 CFO, Henrik Stage hs@synactpharma.com Tel.: + 45 4026 0900 CSO, Thomas Jonassen tj@synactpharma.com Tel.: + 45 4015 6669 www.synactpharma.com 27