Slide 1: Ensovibep Clinical Results Call – EMPATHY Part A
Ensovibep Clinical Results Call 1 EMPATHY Part A January 2022 Mol ec ul ar Pa r t ne rs A G, S w itz er l and (SIX: MOLN, NASDAQ: MOLN)
Slide 2: Disclaimer
D i scla i mer 2 This presentation contains forward looking statements. Any statements contained in this presentation that do not describe historical facts may constitute forward - looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995, as amended, includi
Slide 3: Ensovibep: Advancement of COVID-19 Clinical Program
Ensovibep: 3 Advancement of COVID - 19 Clinical Program
Slide 4: Structure and Features of Ensovibep Neutralizing the SARS-CoV-2 Spike Protein
4 Structure and Features of Ensovibep Neutralizing the SARS - CoV - 2 Spike Protein • High potency : high binding affinity and avidity leads to one of the highest anti - viral potencies reported to date • Pan - variant activity : cooperative binding of different sites allows blocking of all describe
Slide 5: Ensovibep: Clinical Development Overview
Ensovibep: Clinical Development Overview • Empathy study (top - line analysis): • Randomized 407 pts in Part A • Mild or moderate symptoms • Rapid antigen test positive • Un - vaccinated and vaccinated patients • Met primary endpoint: • Significant reduction in viral load x • Clinically relevant sec
Slide 6: EMPATHY Phase 2 Part A Clinical Design and Endpoints
EMPATHY Phase Part A (Phase 2) Clinical Design and Endpoints 6 Primary E ndpoint • Time - weighted change from baseline (measured at Day 3, Day 5, and Day 8) in log 10 SARS - CoV - 2 viral load in nasopharyngeal swabs through Day 8 Key S ec onda r y Endpoints • Proportion of patients with hospitaliz
Slide 7: EUA Submission Supported by Reductions in Hospitalization, ER Visit or Death
EUA Submission Supported by Secondary End Point in Reductions in Hospitalization and or ER Visit or Death 7 Patients with hospitalization and/or ER visit related to COVID - 19 or death 1.0% 1.0% 0.7% 1.0% 2.0% 0.0% 0.7% 3.0% 2.0% 600 mg (n=100) 225 mg (n=100) 75 mg (n=101) All doses (n=301) Placebo
Slide 8: Topline Results Show Significant Reductions in Viral Load, Hospitalization and Death
Topline Results Show Significant Reductions in Viral Load, Risk of Hospitalization and Death, and Faster Time to Recovery 8 • Statistically significant reduction of viral load from baseline, through Day 8 over placebo for all doses (primary endpoint) • Fewer hospitalization and/or ER visits related
Slide 9: Cooperative Target Engagement Leads to Super Affinity
Cooperative Target Engagement Leads to Super Affinity DARPin #1; 1 hour off - rate DARPin #2; 1 hour off - rate DARPin #3; 1 hour off - rate Multi - DARPin #1 - #2 - #3; >10 hours off rate sub pM target binding T i me (s) 9 Time (s) Response (RU) Respo n se (RU) Time (s) Respo n se (RU) Time (s) Res
Slide 10: Ensovibep Retains Full Activity Against Omicron
Ensovibep Retains Full Activity Against Omicron 1 2 0 1 0 0 80 60 40 20 0 Wild Type Relative infection (%) 0 10 - 1 1 0 0 1 0 1 1 0 2 1 0 3 1 0 4 1 0 5 n o v i r u s Concentration (ng/ml) 1 2 0 1 0 0 80 60 40 20 0 O mic r o n Relative infection (%) 0 10 - 1 1 0 0 1 0 1 1 0 2 1 0 3 1 0 4 1 0 5 n o v
Slide 11: Ensovibep Retains Full Activity Against Omicron – Table
Ensovibep Retains Full Activity Against Omicron – Table Wild Type Omicron (Q493R) Compound IC 50 (ng/mL) IC 50 (ng/mL) fold change to wt Ensovibep 1.6 2.2 1.4 REGN10933 3.2 >1000 >100 REGN10987 3.3 >1000 >100 LY - CoV555 13 >1000 >100 LY - CoV016 6.4 >1000 >100 S309 23 72 3.1 AZD8895 0.6 415 >100 AZ
Slide 12: Ensovibep: Tri-Specific Antiviral for COVID-19
Ensovibep: T ri - Specific An t i v iral for COVID - 19 DARPin A d v antage Target P a t i ent D i sease B i o l ogy • Viral entry dependent on viral spike protein binding to ACE2 receptor • Spike protein is a trimer with three identical subunits • Multiple variants evolving mutations in the spike p
Slide 13: Ensovibep Upcoming Milestones
Ensovibep Upcoming Milestones 13 • EMPATHY (Novartis / MP) • 407 patients enrolled, Part A results - positive • EUA submission expected early 2022 • Discussion with appropriate federal agencies regarding supplies of ensovibep • Part B initiate (N≥1,700) • Large - scale commercial manufacturing estab
Slide 14: Acknowledgments
A c kn o w ledgments Covid Project Team (Novartis & Molecular Partners) Spiez Laboratory – Federal Office of Civil Protection (FOCP) Group of Olivier Engler CHUV Lausanne - Sylvia Rothenberger’s group, for performing PsV and authentic virus assays. University Utrecht Group of Berend - Jan Bosch for
Slide 15: Ensovibep – Summary of EMPATHY Results
Ensovibep – Summary of EMPATHY Results 15 • EMPATHY Phase 2b met its primary endpoint • A statistically significant dose - response signal of ensovibep based on change in viral load from baseline, through Day 8 • Clinically relevant secondary endpoints: Combined risk reduction (hospitalization, ER v
Slide 16: Licensing Agreement with Novartis and Financial Guidance Update
Licensing Agreement with Novartis and Financial Guidance Update 16 Summary and Terms
Slide 17: Novartis Deal Terms and Updated Financial Guidance
Novartis Deal Terms and Updated Financial Guidance • Novartis has informed Molecular Partners that it will exercise option for in - licensing of ensovibep • Completion of in - licensing will trigger CHF 150 m milestone payment • CHF 60 m previously received at signing of option agreement ( 20 m cash
Slide 18: Summary
Summar y : • Positive EMPATHY results represent a potential immediate and impactful solution in a constantly evolving pandemic • Statistically significant reduction in viral load, reduction in risk of hospitalization and death, and time to recovery. • Continued evidence of 'pan - variant’ activity a
Slide 19: Pipeline
19 Pipeline O ncology Discovery Oncology O phth a lmolog y Infectious disease Pipeline CANDIDATE / FOCUS RESEARCH PRECLINICAL PHASE 1 PHASE 2 PHASE 3 RIGHTS Ensovibep – Covid Next Gen Covid Future VoC* Cov id ambulatory – E mpathy AMG506 / MP0310 FAP x 4 - 1BB Solid tumors MP0317 FAP x CD40 Solid tu
Slide 20: Questions?
20 Questions?