Ars Pharmaceuticals, Inc. · NASDAQ:SPRY
Ars Pharmaceuticals — Silverback Therapeutics — Corporate Update (March 2022)
18 slides from Ars Pharmaceuticals's corporate update, Mar 31, 2022
Slide 1: Update on Strategic Priorities
Update on Strategic Priorities March 31, 2022
Slide 2: Forward-looking statements and disclaimers
Forward-looking statements and disclaimers Any reproduction or distribution of this presentation, in whole or in part, or the disclosure of any of its contents is prohibited. This presentation includes certain forward-looking statements that involve risks and uncertainties that could cause actual re
Slide 3: Today’s Participants and Agenda
Today’s Participants and Agenda Laura Shawver, PhD Chief Executive Officer Agenda ▪ Executive summary Valerie Odegard, PhD ▪ Update on SBT6050 and SBT6290 President, Chief Scientific Officer ▪ Review of SBT8230 in chronic HBV ▪ Milestones and next steps Naomi Hunder, MD Chief Medical Officer Jonatha
Slide 4: Executive Summary
Executive Summary ▪ Strategic realignment to focus resources on SBT8230 for chronic hepatitis B virus (cHBV) and discovery pipeline by discontinuing SBT6050 and SBT6290 clinical oncology programs ▪ Anticipated milestones: » 4Q’22 - Submit the Phase 1 regulatory application for SBT8230 » 4Q’22 - Prov
Slide 5: Update on SBT6050-101
SILVERBACK’ THERAPEUTICS Upda
Slide 6: Study schema: phase 1/1b dose escalation and expansion study
Study schema: phase 1/1b dose escalation and expansion study as a single agent and in combination with PD-1 inhibitors Part 1: monotherapy dose escalation Part 2: monotherapy tumor specific cohorts SBT6050 SC injection Q2W SBT6050 SC injection Q2W HER2-expressing (IHC 2+ or 3+) or HER2-amplified adv
Slide 7: Further development of SBT6050 challenged by limited monotherapy activity and cytokine-related AEs
Further development of SBT6050 challenged by limited monotherapy activity and cytokine-related AEs in combination with pembrolizumab Part 1: monotherapy Part 3: pembrolizumab combination » 0.6 mg/kg was found to be the maximum tolerated dose » At SBT6050 doses above 0.3 mg/kg, 4 of 6 patients had gr
Slide 8: Silverback to discontinue SBT6050 and SBT6290 oncology programs
Silverback to discontinue SBT6050 and SBT6290 oncology programs ▪ SBT6050 was administered to 58 patients as monotherapy and in combination with a checkpoint inhibitor at dose levels ranging from 0.15 mg/kg through 1.2 mg/kg with the length of patient experience ranging from 2 weeks through 41 weeks
Slide 9: Review of SBT8230
SILVERBACK’ THERAPEUTICS
Slide 10: SBT8230 activity differentiated from SBT6050 and SBT6290
SBT8230's profound liver-localized exposure and anti-viral SBT8230 activity are differentiated from SBT6050 and SBT6290 ▪ TLR8 biology in cHBV clinically validated through Gilead’s selgantolimod ASGR1-TLR8 ▪ SBT8230 mAb is highly specific to ASGR1, which is restricted to liver ▪ Combinable with RNAi
Slide 11: SBT8230 is designed to drive an anti-viral immune response in an ASGR1- and FcgR-dependent manner
SBT8230 is designed to drive an anti-viral immune response in an ASGR1- and FcgR-dependent manner 11
Slide 12: SBT8230-S reduces HBsAg and drives seroconversion in AAV-HBV mouse model
SBT8230-S reduces Hepatitis B surface antigen (HBsAg) and drives seroconversion in AAV-HBV mouse model ASGR1-S lowered average plasma viral DNA titers 2.5 logs 12
Slide 13: SBT8230 demonstrates highly efficient liver uptake
SBT8230 demonstrates highly efficient liver uptake SBT8230 concentration in NHP liver vs serum 100000 SBT8230 concentration (ng/g) 10000 1000 >300-fold higher 100 exposure in liver 10 Liver 1 Serum 0.1 0 1 2 3 4 5 6 7 Days Post Dose 13
Slide 14: Highly efficient liver uptake of SBT8230 in NHP leads to robust liver-localized PD effects
Highly efficient liver uptake of SBT8230 in NHP leads to robust liver-localized PD effects Gene expression changes in liver and serum assessed by RNAseq IL-6 IP-10 MCP-1 70 6 20 Fold Change vs Fold Change vs Fold Change vs Pre-Treatment 60 Pre-Treatment Pre-Treatment 50 15 4 40 10 30 20 2 5 10 0 0 0
Slide 15: SBT8230 has far lower serum exposure than SBT6050
SBT8230 has far lower serum exposure than SBT6050 due to its efficient localization to liver SBT6050 vs SBT8230 serum PK ▪ In non-clinical studies, SBT8230 confers a distinctly different peripheral exposure and tolerability profile than observed with SBT6050 and SBT6290 ▪ Based on NHP serum and live
Slide 16: Phase 1/1b study design includes SAD in healthy volunteers, followed by repeat dosing in cHBV patients
Phase 1/1b study design includes SAD in healthy volunteers, followed by repeat dosing in cHBV patients, virally suppressed on NRTI therapy Part 1: Single Ascending Dose (Randomized, Placebo-controlled) – Healthy volunteers • Healthy volunteers • Single dose SC Dose level 1 Dose level 2 Dose level 3
Slide 17: Advancing a pipeline of systemically delivered, tissue-targeted programs
Advancing a pipeline of systemically delivered, tissue-targeted programs Target / Program Indication(s) Preclinical Studies Phase 1 Phase 2 Anticipated Milestones Payload • 4Q 2022 – Phase 1 regulatory submission ASGR1 SBT8230 cHBV • 1H 2023 – Open enrollment for Phase 1 SAD study in healthy TLR8 Ag
Slide 18: SILVERBACK’
SILVERBACK’ THERAPEUTICS
Silverback Therapeutics — Corporate Update (March 2022) on 6ix