Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Investor Presentation (December 2021)
37 slides from Synact Pharma Ab's investor presentation, Dec 7, 2021
Slide 1: SynAct Pharma AB: Resolving Inflammation Through Melanocortin Biology
SynAct Pharma AB Resolving Inflammation Through Melanocortin Biology December 2021
Slide 2: Forward Looking Statements
Forward Looking Statements Certain information set forth in this presentation contains “forward-looking information”, including “future-oriented financial information” and “financial outlook”, under applicable securities laws (collectively referred to herein as forward-looking statements). Except fo
Slide 3: SynAct Pharma – Highlights
SynAct Pharma – Highlights ▪ SynAct Pharma is focused on the development of novel and first-in-class Facts and figures agonists that target the melanocortin system ▪ There is high unmet need in autoimmune and inflammatory diseases for Founded in 2013 efficacious and safe therapies – current therapie
Slide 4: SynAct Pharma – Pipeline overview
SynAct Pharma – Pipeline overview Next Asset Indication Preclinical Phase I Phase IIa Phase IIb Phase III milestone IND filing with Rheumatoid arthritis FDA Ongoing Phase IIa Nephrotic syndrome being re- designed AP1189 Initiate Virus-induced respiratory confirmatory insufficiency trial Next indicat
Slide 5: Inflammation Resolution can correct dysregulated inflammation without inducing immunosuppression
Inflammation Resolution can correct dysregulated inflammation without inducing immunosuppression The inflammatory response 1 Inflammatory response effectively controlled in extent and time – protects tissues and limits damage 2 Pathways activated to safely terminate the inflammatory response and pro
Slide 6: AP1189: A First-in-Class Selective Melanocortin Receptor 1 and 3 Agonist
AP1189: A First-in-Class Selective Melanocortin Receptor 1 and 3 Agonist MC1R MC2R MC3R MC4R MC5R Steroid dependent effects Targeted by AP1189 ▪ AP1189 was designed to activate melanocortin receptors 1 and 3 ▪ AP1189 exbibits anti-inflammatory activity through stimulation of (MC1R and MC3R), which a
Slide 7: IP Strategy to Safeguard AP1189 through 2042
SynAct Pharma Has Executed an IP Strategy to Safeguard AP1189 through 2042 with Several Layers of Protection AP1189 Patent Portfolio with focus on RA1 IP Strategy 2025 2026 2027 2028 2029 2030 2031 2032 2033 2034 2035 2036 2037 2038 2039 2040 2041 2042 2043 2044 2045 ▪ Critical composition of matter
Slide 8: AP1189 – Rheumatoid Arthritis
AP1189 – Rheumatoid Arthritis Immune Resolution without Immunosuppression
Slide 9: AP1189 has potential to safely treat and attenuate RA symptoms
AP1189 has potential to safely treat and attenuate RA symptoms and decrease time to inflammation resolution Patients with inadequate response 1% Global population affected1 40% to current treatments4 Expected global market size in Patients with inadequate response €27b 30% 20252 to biologics4 Treate
Slide 10: The current treatment paradigm for RA leaves significant potential for new therapies
The current treatment paradigm for RA leaves significant potential for new meaningful therapies RA diagnosis Unmet need in the RA treatment paradigm DMARD monotherapy (typically methotrexate) ▪ Rheumatologists tend to treat aggressively with the variety of treatment options available, but RA treatme
Slide 11: Phase IIa BEGIN study in patients with early RA
Phase IIa BEGIN study in patients with early RA with severe disease activity Part 1 Part 2 AP1189 50 mg + MTX 1:1:1 randomisation AP1189 50 mg + MTX 2:1 randomisation Analysis of Part 1 Analysis of Part 2 (for each cohort) Placebo + MTX AP1189 100 mg + MTX AP1189 100 mg + MTX Placebo + MTX Placebo +
Slide 12: Phase IIa BEGIN: Change in Clinical Disease Activity Index (CDAI)
Phase IIa BEGIN: Change in Clinical Disease Activity Index (CDAI) Mean change in CDAI from baseline to Week 4 Proportion of subjects with a change in CDAI score from severe (CDAI > 22) to moderate (CDAI ≤ 22) at Week 4 vs. baseline -40 70 -6 65 62% 60 -8 Change in CDAI score 55 52% Percentage (%) -1
Slide 13: Phase IIa BEGIN: Change in ACR20/50/70
Phase IIa BEGIN: Change in ACR20/50/70 Proportion of subjects achieving a minimum 20/50/70% improvement in disease activity after 4 weeks of treatment compared with baseline 60 50 48 40 Percentage (%) 31 30 23 20 18,2 9,1 10 6,7 3,5 3,3 0 0 ACR20 ACR50 ACR70 Placebo (n=30) AP1189 50 mg (n=29) AP1189
Slide 14: Phase IIa BEGIN: AP1189 reduced patient fatigue and pain
Phase IIa BEGIN: AP1189 reduced patient fatigue and pain Mean improvement in Fatigue (FACIT Score) Mean reduction in pain (VAS-score) -0,6 10 9 -0,8 8 8 -1 -0,9 7 -1,2 5,9 -1,2 6 -1,4 5 4,8 -1,6 4 -1,8 3 -1,8 2 -2 Placebo (n=30) AP1189 50 mg (n=29) AP1189 100 mg (n=33) Placebo (n=30) AP1189 50 mg (n
Slide 15: Phase IIa BEGIN: AP1189 demonstrated a benign safety profile
Phase IIa BEGIN: AP1189 demonstrated a benign safety profile Placebo (n=32) AP1189 50 mg (n=31) AP1189 100 mg (n=35) Total (n=98) Serious Adverse Events, n (%) 0 (0%) 0 (0%) 0 (0%) 0 (0%) AEs, n reported from baseline 21 38 27 86 AE severity (mild/moderate/severe) 18/2/1 26/12/0 22/5/0 66/19/1 Disco
Slide 16: Phase IIa BEGIN: Conclusions
Phase IIa BEGIN: Conclusions ▪ In this 4 week study, patients treated once daily with 100 mg AP1189 achieved a statistically significantly greater reduction in mean CDAI as compared with placebo ▪ Change in disease activity from severe to moderate was numerically higher in groups treated with AP1189
Slide 17: Rheumatologists express high degree of interest in AP1189
Rheumatologists express high degree of interest in AP1189 based on the BEGIN Part 1 data Rheumatologist interest to use AP1189 on a scale of 1 to 10 ▪ Rheumatologists reacted very favourably to the product 10 profile for AP1189 based on Part 1 data from BEGIN 9 ▪ US respondents were familiar with me
Slide 18: AP1189 in Virus-induced Respiratory Insufficiency
AP1189 in Virus-induced Respiratory Insufficiency Leveraging AP1189’s MoA to Treat Viral-Induced Pulmonary Hyperinflammation
Slide 19: AP1189's MoA on macrophages can resolve hyper-inflammation of the lungs
Virus-induced Respiratory Insufficiency: AP1189’s MoA on macrophages can resolve hyper-inflammation of the lungs AP1189 targets key pathways in hyper-inflammation G GM-CSF, granulocyte-macrophage colony-stimulating factor; IL-6, interleukin 6; MoA, mechanism of action; SARS-CoV-2, severe acute respi
Slide 20: COVID-19: AP1189's anti-inflammatory properties provide strong rationale
COVID-19: AP1189’s anti-inflammatory properties provide strong rationale to explore its potential utilization in COVID-19 infections Stage I Stage II Stage III Early infection Pulmonary phase Hyperinflammation phase IIA IIB Severity of illness Viral response phase Patient inflammation phase Time cou
Slide 21: RESOVIR-1: AP1189 versus placebo in patients with COVID-19
RESOVIR-1: AP1189 versus placebo in patients with COVID-19 with respiratory insufficiency 2:1 randomisation Interim analysis Final analysis Open label AP1189 100 mg QD (n=54) (n=6) AP1189 100 mg QD Placebo Up to 2 weeks Up to 2 weeks Key inclusion criteria Key secondary endpoints ▪ Positive COVID-19
Slide 22: RESOVIR-1: Greater proportion achieving respiratory recovery faster
RESOVIR-1: Treatment with AP1189 resulted in a greater proportion of patients achieving respiratory recovery at a faster pace Average respiratory recovery time* Cumulative respiratory recovery by Day 4* 12 60 10 50 9,9 50% Proportion of patients (%) 8 40 Days (n) 6 34% 30 5,9 4 20 2 10 0 0 AP1189 al
Slide 23: RESOVIR-1: Patients discharged from hospital faster
RESOVIR-1: Patients treated with AP1189 were discharged from hospital faster than those receiving placebo Hospital discharge by Day 4 Average hospital discharge time 50 14 45 12 40 41% 11,2 Proportion of patients (%) 35 10 30 8 Days (n) 7,9 25 6 20 15 4 10 2 5 0% 0 0 AP1189 all (n=42) Placebo (n=18)
Slide 24: RESOVIR-1: AP1189 Continued to Demonstrate a Well-Tolerated Profile
RESOVIR-1: AP1189 Continued to Demonstrate a Well-Tolerated Profile Observed safety profile ▪ The overall frequency of adverse events was higher in the AP1189-treated than the placebo-treated group ▪ Reported adverse events: ▪ Nausea ▪ Vomiting ▪ Dyspepsia ▪ Diarrhoea ▪ Cough ▪ Increase in transamin
Slide 25: RESOVIR-1: Conclusions
RESOVIR-1: Conclusions Conclusions ▪ Significantly reduced time to respiratory recovery by 4 days compared with placebo ▪ Reduced time to discharge from hospital by c. 3 days compared to placebo ▪ Facilitated early discharge from hospital with 33% of all AP1189-treated patients discharged following
Slide 26: AP1189 can target Viral-Induced Respiratory Insufficiency in and beyond COVID-19
AP1189’s broad anti-inflammatory mechanism can target Viral- Induced Respiratory Insufficiency in and beyond COVID-19 COVID-19 21 US COVID-19 cases per 100,000 population require hospitalization1 Up to $54,000 hospital costs and almost $200,000 hospital charges per hospitalized patient (2020)2 Respi
Slide 27: Leadership
SYNACT JJ PHARMA Leadership
Slide 28: SynAct Pharma – Experienced Management
SynAct Pharma – Experienced Management Jeppe Øvli Øvlesen, MBA – CEO Henrik Stage, MSc – CFO ▪ >20 years of CEO experience ▪ >25 years’ experience in biotech and ▪ Founding Board Member of more than financial industry 10 biotech/medtech companies ▪ Former CEO and CFO at Santaris ▪ Co-founder of TXP
Slide 29: SynAct Pharma – Board of Directors
SynAct Pharma – Board of Directors Torbjørn Bjerke, MD – Chairman Thomas Jonassen, MD – Board Member, Founder ▪ >25 years track record from pharma ▪ Associate Professor, KU in Denmark industry as Head, R&D and CEO ▪ Visiting Professor, WHRI, UK (private and public), BD ▪ Co-founder of TXP Pharma and
Slide 30: Summary
SYNACT JJ PHARMA Summary
Slide 31: Investment highlights and upcoming news flow
SynAct Pharma – Investment highlights and upcoming news flow ▪ Initiate Phase IIb programme Focus on developing a novel treatment for inflammatory and autoimmune diseases targeting the melanocortin system RA Several near-term value inflection points from Phase II development and other corporate acti
Slide 32: ▪ Chairman, Dr Torbjørn Bjerke ▪ CSO, Dr Thomas Jonassen ▪ CEO, Jeppe Øvlesen
▪ Chairman, Dr Torbjørn Bjerke ▪ CSO, Dr Thomas Jonassen ▪ tbj@synactpharma.com ▪ tj@synactpharma.com ▪ Tel: + 46 727444158 ▪ Tel: + 45 40156669 ▪ CEO, Jeppe Øvlesen ▪ CMO, Dr Anders Dyhr Toft ▪ joo@synactpharma.com ▪ adt@synactpharma.com ▪ Tel: + 45 28447567 ▪ Tel: + 45 40817076 32
Slide 33: Appendix
SYNACT JJ PHARMA Appendix
Slide 34: Safety Concerns With JAK Inhibitors Create an Opportunity for AP1189
Safety Concerns That Have Arisen With JAK Inhibitors Create a Tangible Opportunity for AP1189 in RA Recent developments with JAK inhibitors ▪ Based on a review of a large randomized clinical trial, the FDA has concluded that there is an increased risk of serious cardiovascular-related events such as
Slide 35: Phase IIa BEGIN: Baseline Characteristics
Phase IIa BEGIN: Baseline Characteristics Placebo (n=34) AP1189 50 mg (n=35) AP1189 100 mg (n=36) Female, % 79.4 77.1 77.8 Age (years) Mean±SD 56.4±13.1 56.4±13.1 55.3±13.9 Median (range) 61 (26–78) 57 (28–79) 56.5 (27–77) 18–64 years/65–84 years (%) 73.5/26.5 71.4/28.5 72.2/27.8 Race, White/Asian/O
Slide 36: Rheumatologists Describe Two Target Patient Segments for AP1189
Rheumatologists Describe Two Target Patient Segments for AP1189 Segment Description 7 MM segment size ▪ Patients who experience multiple flares per year (>4) ▪ ~15% of patients1 Frequently flaring ▪ Typically experience low disease activity between flares ▪ >2m flares/year2 ▪ Can be receiving long-t
Slide 37: RESOVIR-1: Lower rates of mechanical ventilation and Acute Kidney Injury
RESOVIR-1: AP1189 treatment resulted in lower rates of both mechanical ventilation and development of Acute Kidney Injury Mechanical ventilation up to Day 28 Acute kidney injury up to Day 28 25 40 35 20 33% 30 Proportion of patients (%) Proportion of patients (%) 17% 25 15 20 19% 10 15 10 7% 5 5 0 0
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