Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Investor Presentation (March 2023)
45 slides from Synact Pharma Ab's investor presentation, March 2023
Slide 1: SynAct Pharma AB
INFLAMMATION RESOLUTION SynAct Pharma AB Treating Inflammation through Resolution Therapy
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: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 4: SynAct Pharma – In Brief
SynAct Pharma – In Brief ▪ SynAct Pharma is a clinical stage biotechnology company focused on resolving inflammation through melanocortin biology to treat inflammatory and autoimmune diseases ▪ Oral small molecule, AP1189, is currently in active Phase 2 development for rheumatoid arthritis (RA) and
Slide 5: SynAct acquired TXP Pharma adding complementary peptide-based melanocortin assets
SynAct acquired TXP Pharma adding a portfolio of complimentary peptide-based melanocortin assets AP1189 TXP Peptides Being developed as an Being developed for: Once daily oral therapy for: ▪ TXP-11: Intravenous administration ▪ Early severe RA (P2b) for organ protection in major surgery ▪ DMARD-IR R
Slide 6: SynAct Pharma – Pipeline overview
SynAct Pharma – Pipeline overview Asset Indication Pre-clinical Phase I Phase IIa Phase IIb Phase III Rheumatoid Arthritis Severe treatment-naïve with MTX Rheumatoid Arthritis DMARD-IR AP1189 Nephrotic syndrome (iMN) Virus- Induced Respiratory Insufficiency Prevention of organ failures in TXP-11 com
Slide 7: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 8: What is inflammation?
What is inflammation? ▪ Inflammation is the immune system’s way of responding to infections or injuries. Normally an inflammatory response is self-limiting. The immune system will “deactivate” itself and the inflammation will be resolved after the invading pathogen has been removed or the injury has
Slide 9: SynAct compounds provide anti-inflammatory and pro-resolving activity
SynAct compounds provides anti-inflammatory and pro-resolving activity SynAct compounds SynAct compounds inhibits the stimulates the inflammatory response resolution phase The inflammatory response 1 Inflammatory response effectively controlled in extent and - + time – protects tissues and limits da
Slide 10: Selective melanocortin agonists with anti-inflammatory and pro-resolution activity
SynAct is developing selective melanocortin agonists with both anti-inflammatory and pro-inflammation resolution activity MC1R MC2R MC3R MC4R MC5R Steroid dependent effects Targeted by AP1189 and TXP-11 ▪ Selective stimulation of melanocortin receptors 1 and 3 (MC1R ▪ AP1189 exbibits anti-inflammato
Slide 11: Lead Program AP1189 – A once-daily oral selective melanocortin agonist
Lead Program AP1189 – A once-daily oral selective melanocortin agonist Administration at disease induction in peritonitis1 • AP1189 selectively stimulates MC1R and MC3R, the MCRs responsible for direct immunomodulatory effects • Importantly AP1189 does not stimulate cortisol release AP1189 inhibits
Slide 12: AP1189 well tolerated in Phase 1 and 2a with once daily PK profile
AP1189 was well tolerated in Phase 1 and Phase 2a studies with pharmacokinetic profile supporting once daily dosing • Initial clinical development, Phase 1 and Phase 2a, performed with suspension for once daily oral administration was overall well tolerated, no signs of immunosuppression or dose lim
Slide 13: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 14: RA affects about 1% of the global population
RA affects about 1% of the global population, and while there are several classes of approved therapies remission can remain elusive DMARD patients do not 1% Global population affected 70% achieve remission and require therapy escalation Biologics patients do not achieve $30b Expected global market
Slide 15: RA is a large prevalent disease with a significant incident population
RA is a large prevalent disease but also has a significant incident population • Commercially, biologic market players are focused on a mix of patient and class share stealing and retention strategies both within and between classes – some biologic usage in naïve patients but limited • In contrast,
Slide 16: RA market drivers will change product mix amongst advanced therapies
Reference Code: GDHC209PIDR Published: December 2020 Healthcare RA market drivers will change product mix amongst advanced therapies Figure 31 depicts the sales of RA drugs in the 8MM, by class, in 2019 and 2029. Figure 31: Global (8MM) Sales Forecast for RA, by Class, in 2019 and 2029 • The RA mark
Slide 17: RA market drivers will increase pricing pressure for advanced therapies
11.2.2 Key Events RA market drivers will increase pricing pressure for advanced therapies Table 34 lists the key events that GlobalData expects to impact the sales of products for the treatment of RA in the US from 2019‒2029. Table 34: Key Events Impacting Sales for RA in the US, 2019– 2029 • The ta
Slide 18: AP1189 significant treatment effects in severe treatment-naïve RA in BEGIN P2a
AP1189 demonstrated significant treatment effects in patients with severe treatment-naïve RA in the 4-week BEGIN P2a clinical trial Phase 2a study in treatment naive RA patients with high disease activity (CDAI >22 at randomization) in combination with MTX with 4 weeks treatment Mean change in CDAI
Slide 19: Meaningful improvements in DAS28 (CRP) and FACIT-Fatigue scores
Meaningful improvements were also seen in DAS28 (CRP) and FACIT-Fatigue Scores 80 Responders going from severe to at 10 Mean change in FACIT-Fatigue score least moderate (>5.1 to <5.1 at 1-mo) 70 9 68 8 60 8 Mean Change in Score 61.1 50 7 Percentage (%) 40 5.9 6 36.8 4.8 30 5 20 4 10 3 0 2 Placebo (
Slide 20: AP1189 ACR20 scores in range of JAK inhibitors
100mg AP1189 ACR20 scores are in the range of the JAK inhibitors in P3 MTX-Naïve trials - Response rates should increase over time with 3-mo dosing as seen with JAKs and biologics 90 1-mo actual and 3-mo proj. ACR20 Rates Range of 80 3-mo JAK data (75-80%) 70 Range of 60 1-mo JAK data ACR20 (%) (58-
Slide 21: Emerging AP1189 clinical profile supports continued RA development
The emerging AP1189 clinical profile supports continued RA development for patients where DMARD therapy is insufficient DMARD-insufficient RA Positioning Emerging AP1189 Clinical profile Severely Active Treatment Naïve: • Severe or highly active disease activity is the dominating poor • Once-Daily O
Slide 22: US rheumatologists interested in AP1189 for DMARD-IR
High volume US rheumatologists expressed a high degree of interest in AP1189 for DMARD-IR patients US Rheum Interest in AP1189 in DMARD-IR The combination of efficacy, safety, 10 tolerability and oral convenience positions 8 AP1189 well for DMARD-IR 6 4 8.9 9 Recent FDA labelling actions with RA JAK
Slide 23: AP1189 potential to become a foundational therapy in and beyond RA
AP1189 has the potential to become a foundational therapy in and beyond RA External Black Boxed Product Indications or Internal Warnings • 7/10 of the top RA brands were originally external programs that were 1 Humira External • Serious Infections 9 acquired through business development highlighting
Slide 24: Additional P2 RA studies with data readouts in 2023
SynAct is currently conducting 2 additional P2 RA studies with AP1189 with data readouts in 2023 EXPAND – 3-mo P2b trial in severe treatment-naïve RA patients H2-22 H1-23 H2-23 Patients ▪ Severe treatment-naïve (CDAI>22) min 6 s/t joints, RF(+) Groups & Size ▪ 2 groups of 60: 1) 100mg* AP1189, 2) Pl
Slide 25: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 26: MCRs widely distributed in the kidney
MCRs are widely distributed in the kidney and provide both direct protective actions as well as provide immunomodulation and anti-inflammatory benefits Melanocortins can both directly protect MCRs are widely expressed in renal parenchymal cells1 Gong Glomerular cells and provide immunomodulation 2 P
Slide 27: Proteinuria is a significant global health issue
Given the impact upon kidney disease progression, proteinuria is a significant global health issue Proteinuric Patients at High or Very High Risk of CKD Progression • There are an estimated 40M CKD patients with 14.0 13.3 moderate or severe proteinuria who are at a high China or very high risk of di
Slide 28: AP1189 is effective in pre-clinical nephritis models
AP1189 is effective in pre-clinical nephritis models 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
Slide 29: Ongoing CS-003 Phase 2a trial in iMN
Ongoing study: CS-003 study – 12 weeks explorative Phase 2a trial in idiopathic membranous nephropathy (iMN) with severe proteinuria ACE – inhibitor treatment 2:1 randomization Final analysis AP1189 100mg Follow up Placebo Follow up 3 Months 1 Month • Dosing is ongoing following approval of major am
Slide 30: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 31: RESOVIR-1: AP1189 versus placebo in hospitalized COVID-19 patients
RESOVIR-1: AP1189 versus placebo in hospitalized patients with COVID-19 suffering from 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 endpoi
Slide 32: RESOVIR-1: Greater proportion achieving respiratory recovery quicker than placebo
RESOVIR-1: Treatment with AP1189 resulted in a greater proportion of patients achieving respiratory recovery quicker than placebo Average respiratory recovery time* Cumulative respiratory recovery by Day 4* 12 60 10 50 9.9 50% Proportion of patients (%) 8 40 Days (n) 34% 6 30 5.9 4 20 2 10 0 0 AP118
Slide 33: AP1189 can target viral induced respiratory insufficiency beyond COVID-19
AP1189’s broad anti-inflammatory and pro-resolution 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 pat
Slide 34: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 35: Peptides to Target High Unmet Needs and High Value Opportunities
Peptides to Target High Unmet Needs and High Value Opportunities Evidence for Targeting With Melanocortin Therapeutic Area Development Strategy agonists ▪ αMSH has demonstrated organ protective effects in ▪ Short-term dosing, IV administration and ability for several models of systemic inflammation
Slide 36: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 37: Postoperative Organ Dysfunction and Failure is a Significant Source of Mortality and Cost
Postoperative Organ Dysfunction and Failure is a Significant Source of In-Hospital Mortality and Healthcare System Cost 2 Postoperative Organ Dysfunction/Failure and Associated In-Hospital Mortality From a German National ICU Registry Postoperative Organ Dysfunction and Failure Surgery Status Pulmon
Slide 38: TXP-11: Cardiac Surgery Associated with Major Postoperative Complications
TXP-11: Cardiac Surgery in particular is associated with Major Postoperative Complications and High Rates of Organ Failure Major Cardiac Surgery Complications and There Involvement in In-Hospital Mortality 900 35% Major Surgical Complications Associated With Cardiac Surgery1 Count of Majopr Complica
Slide 39: TXP-11: Use in On-Pump Cardiac Surgery Presents a Significant Opportunity
TXP-11: Use in On-Pump Cardiac Surgery Presents a Significant Opportunity With Room For Expansion into Transplant and Major Abdominal Surgery Estimated Estimated 20201 On-PumpProcedures 2021 On-Pump Procedures11 On-Pump cardiac Surgeries are Growing in US and EU1 CABG Valve ▪ There were more than 35
Slide 40: TXP-11 advancing to Phase 1 in H1 2024
TXP-11 is advancing to Phase 1 clinical development in H1 2024 – Targeting organ dysfunction following major CV Surgery Treatment X effect in model of acute peritonitis TXP-11 ▪ Lead candidate in novel class of melanocortin receptor agonists with increased stability and efficacy compared to native m
Slide 41: Agenda
INFLAMMATION RESOLUTION ▪ Introduction to SynAct Pharma 4 ▪ Inflammation, resolution and AP1189 8 ▪ AP1189 – Rheumatoid Arthritis (RA) program 14 ▪ AP1189 – Nephrotic syndrome (iMN) program 26 ▪ AP1189 – Virus induced respiratory insufficiency program 31 ▪ TXP peptide melanocortin agonists 35 ▪ TXP1
Slide 42: SynAct Pharma – Experienced Management Team
SynAct Pharma – Experienced Management Team Jeppe Øvli Øvlesen, MBA – CEO Patrik Renblad, MSc – CFO ▪ Over 20 years of experience as CEO of various ▪ Over 20 years of experience within various companies financial roles in the pharmaceutical industry ▪ Founding Board Member of more than 10 ▪ Former H
Slide 43: SynAct Pharma – Board of Directors
SynAct Pharma – Board of Directors Torbjørn Bjerke, MD PhD – Chairman Marina Bozilenko, BA, MA – Independent Board Member ▪ Over 25 years of experience within private and ▪ Over 30 years of investment banking and other public pharmaceutical companies as Executive healthcare industry experience VP, R
Slide 44: SynAct Pharma – In Summary
SynAct Pharma – In Summary ▪ SynAct Pharma is a clinical stage biotechnology company focused on resolving inflammation through melanocortin biology to treat inflammatory and autoimmune diseases ▪ Oral small molecule, AP1189, is currently in active Phase 2 development for rheumatoid arthritis and nep
Slide 45: Thank you
INFLAMMATION RESOLUTION Thank you