Synact Pharma Ab · OMXSTO:SYNACT
Synact Pharma Ab — Q2 2023 Earnings Presentation
19 slides from Synact Pharma Ab's earnings presentation, Aug 4, 2023
Slide 1: SynAct Pharma AB Q2 Report
INFLAMMATION RESOLUTION SynAct Pharma AB Q2 Report April-June 2023 August 4, 2023 Torbjörn Bjerke, MD, CEO Thomas Jonassen, MD, CSO Björn Westberg CFO
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: RA affects about 1% of the global population, and remission remains elusive
RA affects about 1% of the global population, and while there are several classes of approved therapies remission 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 size
Slide 4: Treatment naïve RA patients present with high activity and poor prognostic indicators
Treatment naïve RA patients present with high activity and other poor prognostic indicators almost 50% of the time Highly-Active Naïve: • Studied in BEGIN and EXPAND studies • Highly active disease is the dominating Present without high Present with high poor prognostic indicator (PPI) in ACR and ac
Slide 5: DMARDs are time-tested 1st-line RA therapies but many patients do not respond
DMARDs are time-tested 1st-line RA therapies but the majority of treated patients will not achieve a durable response on DMARD monotherapy DMARD-IR: • This is the patient population being studied in RESOLVE Later IR 6-12 Mo • Up to 50% of 1st DMARD Tx will not 16% achieve low disease activity and 70
Slide 6: Resomelagon demonstrated significant treatment effects in the BEGIN P2a trial
Resomelagon (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 c
Slide 7: The emerging resomelagon clinical profile supports continued RA development
The emerging resomelagon clinical profile supports continued RA development for potential broad utility Resomelagon Emerging Severe Tx- Naïve DMARD-IR Clinical Profile Once-Daily Oral Dosing • Oral convenience key for early patients • Oral convenience key for early patients Simple one-daily oral tab
Slide 8: DMARD insufficient positioning targets a higher volume commercially attractive space
DMARD insufficient positioning targets a higher volume commercially attractive space not well served by current therapies These lines of therapy are established by clinical practice, step-therapy indications and access restrictions Humira, Enbrel, Cimzia, MTX, sulfasalazine, Actemra, Orencia, Rituxa
Slide 9: US high-volume rheumatologists stated strong interest and high intent to use
US high-volume rheumatologists stated a strong interest and high intent to use in both DMARD-IR and anti-TNF-IR RA patients Rheum Interest in AP1189 for DMARD-IR 100% 80% “Oh man. I'd love to use this up front. I'd love to use it right after 60% methotrexate. I'd love to use it before. I'd love to s
Slide 10: Update on pipeline
INFLAMMATION RESOLUTION Update on pipeline
Slide 11: 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 Resomelagon (AP1189) Nephrotic syndrome (iMN) Virus- Induced Respiratory Insufficiency Prevention of organ failures
Slide 12: EXPAND study: P2b study in treatment naive RA patients
EXPAND STUDY P2b study in treatment naive RA patients. Dosing completed in July 2023 - Patient Population: ▪ Previous treatment naïve, eligible for Resomelagon (AP1189) 100* mg, combination with MTX initiation of DMARD treatment (MTX) ▪ CDAI >22 at baseline – min of 6 swollen Placebo, combination wi
Slide 13: RESOLVE Study - Adaptive P2 trial design in DMARD-IR patients
RESOLVE Study - Adaptive P2 trial design in DMARD-IR patients Dosing in part A will be completed in August – Conducted under an US-IND in US and Europe Part A – 4 weeks dosing Part B – 12 weeks dosing 3 dose levels of Resomelagon (AP1189) cont. MTX Up to 3 dose levels of Resomelagon (AP1189), cont.
Slide 14: Resomelagon - Beyond RA - interest in additional rheumatology diseases
Resomelagon (AP1189) - Beyond RA – Rheumatologists express significant Interest for development in additional rheumatology diseases Additional rheumatology diseases-of-interest for Resomelagon (AP1189) Psoriatic arthritis Psoriatic Arthritis 11 **Use may depend on if Product X improves both dermal s
Slide 15: Financial summary
INFLAMMATION RESOLUTION Financial summary
Slide 16: Financial summary
Financial summary Operating activities (SEK m) 23-Q2 22Q2 23-H1 22-H1 R&D costs -29.0 -14.3 -72.6 -27.8 • Higher R&D costs due to more study activities vs LY G&A costs -14.5 -12.1 -29.1 -20.9 • G&A 2023 is affected by one-offs EBIT -43.5 -26.4 -101.7 -48.7 Financial position (SEK m) 30/06/23 30/06/2
Slide 17: Upcoming news flow and closing remarks
INFLAMMATION RESOLUTION Upcoming news flow and closing remarks
Slide 18: Upcoming news flow
Upcoming news flow Q3 2023 Q4 2023 H1 2024 September: Topline October: Topline Initiation of Resolve results from Expand results from Part A Part B Resolve Initiation of Phase I More results from TXP-11 Expand More pipeline updates More results from Part A Resolve I N F L A M M A T I O N R E S O L U
Slide 19: Thank you
INFLAMMATION RESOLUTION Thank you