Molecular Partners AG · SIX:MOLN
Molecular Partners — Investor Presentation (May 2019)
41 slides from Molecular Partners's investor presentation, May 9, 2019
Slide 1: Molecular Partners: Building Tomorrow's Breakthroughs
Molecular Partners: Building Tomorrow’s Breakthroughs Corporate Presentation Molecular Partners AG, Switzerland (SIX: MOLN) May 9, 2019 1
Slide 2: A Swiss Biotech developing innovative protein drugs
Molecular Partners: A Swiss Biotech developing innovative protein drugs DARPin® platform as source of mono/multi-specific protein drugs DARPin® Rapid cycle of innovation to test novel therapeutic design ENGINE Validation in >1.8k patients treated to date (mainly Abicipar) Abicipar: Phase 3 in wet AM
Slide 3: Experienced Management Team & Board of Directors
Experienced Management Team & Board of Directors Dr. Patrick Amstutz, CEO Bill Burns, Chairman Former CEO of Roche Pharmaceuticals Co-founder, former CBO & COO Former board member of Roche, Genentech, Member of the Board of Directors Chugai Pharmaceuticals, Shire PhD in molecular biology f
Slide 4: Investment Case
Investment Case DARPin® Engine: Source for candidates with novel therapeutic designs Advanced and balanced DARPin® Portfolio –Abicipar on track for market launch in nAMD in 2020 –MP0250 in P2 pioneering a new MoA in MM, P2 in NSCLC & MP0274 in P1 –Research is delivering candidates with highly in
Slide 5: DARPin Proteins: Nature's Choice for Multi-Specific Binding
DARPin® Proteins: Nature’s Choice for Multi-Specific Binding Monoclonal antibodies DARPin® protein(s) Paratope Paratope DARPin® domain SCALE 15 kDa 150 kDa Multi-DARPin® product candidate • High affinity and specificity • Low immunogenicity potential • Tunable half life • Large size: 150 kDa • Small
Slide 6: DARPin Engine: Selecting Novel Therapeutic Designs
DARPin® Engine: Selecting Novel Therapeutic Designs to Match Desired Function Opening novel Therapeutic Selecting the «optimal» DARPin® module selection Design Space Therapeutic Design DARPin® Library with 1012 modules Target(s) Identified DARPin® modules Multi-DARPin® product candidates Therapeutic
Slide 7: A Balanced and Robust Portfolio
A Balanced and Robust Portfolio Product Indication/ Commercial Preclinical Phase 1 Phase 2 Phase 3 Candidates Focus Rights MP0250 Multiple Myeloma, PI combo Oncology MP0250 Multiple Myeloma, IMiD study Source of Product Candidates MP0250 EGFR-mutated NSCLC DARPin® Engine: MP0274 HER2 positive MP0310
Slide 8: Innovation & Differentiation
Tree of Evolution of DARPin® Approaches Next level of immune Local cell targeting Agonists MHC-peptides Innovation & Differentiation FAP x CD40 Direct Tumor Increasing level of MP0310 Cell Killers MP0274 MP0250 Mono-Specifics Dual Abicipar: Local activity, Antagonists high affinity binding DARPin® P
Slide 9: Oncology Deep Dive: MP0250, MP0274, MP0310, Research
Oncology Deep Dive: MP0250, MP0274, MP0310, Research 9
Slide 10: MP0250: Our First Multi-DARPin Product Candidate
MP0250 MP0250: Our First Multi-DARPin® Product Candidate HSA HGF VEGF HSA DARPin® DARPin® DARPin® DARPin® Upregulation of escape Medical need: Agents that block Medical Need: Some tumors develop adaptive pathways after SOC escape pathways to SOC resistance to SOC by up-regulating VEGF and HGF MoA: M
Slide 11: MP0250: Potential to Treat Several Indications
MP0250 MP0250: Potential to Treat Several Indications MM and EGFR-mut NSCLC selected initially Head and neck Nasopharyngeal squamous cell Gastric cancer EGFR-mutated NSCLC Renal cancer Multiple myeloma Anal cancer Hepatocellular INCIDENCE:1 carcinoma <50,000 Colorectal cancer 50,000 – 100,000 >100,0
Slide 12: Unmet Medical Need in Multiple Myeloma
MP0250 Unmet Medical Need in Multiple Myeloma (MM) Dynamic activation of the HGF pathway during disease progression1. HGF is highly overexpressed in bone marrow biopsies of multiple myeloma patients Newly diagnosed On partial remission Relapsed MET receptor Activated -c- 28% 2% 89% Bone marrow 6/8 t
Slide 13: Testing how MP0250 can revert Adaptive Resistance in MM
MP0250 Testing how MP0250 can revert Adaptive Resistance in MM Illustrative course of disease of a MM patient1 IMiD PI PI or or + PI IMiD MP0250 our «initial» trial 1) Hajek, R. Strategies for the Treatment of Multiple Myeloma in 2013: Moving Toward the Cure. In “Multiple Myeloma: A Quick Reflection
Slide 14: MP0250 Phase 2 Study in MM: Promising Signs of Efficacy
MP0250 MP0250 Phase 2 Study in MM: Promising Signs of Efficacy1) Case A Patient population: Patients with MM with Cohort 1 ≥ 2 prior lines of treatment, including IMiD and PI, and no response or early relapse Treatment regimen: Velcade®/Dexamethasone plus MP0250 8 of 18 patients on 8mg/kg dose
Slide 15: 1st Case Study: Patient A
1st Case Study: Patient A (4th line, coming from PI) Female 63y, MM IgG kappa diagnosed in May 2016 Prior MM Therapy: PD 6 mths –1st Line: Cyclo/Thal/Dex; Best Response: SD –2nd Line: Bor/Dex; Best Response: SD 5 mths –3rd Line: Bor/Len/Dex: PD SD Best response 3 mths Current Treatment: 4th li
Slide 16: 2nd Case Study: Patient C
2nd Case Study: Patient C (6th line, coming from Dara) Female 66y, MM IgG kappa diagnosed in Sep 2014 Prior MM Therapy: PD –1st Line: Cyclo/Thal/Dex; Best Response: PR –2nd Line: Bor/Dox/Dex; Best Response: SD –3rd Line: Len/Dex; Best Response: SD SD –4th Line: Len/Cyclo/Dex; Best Response: PR B
Slide 17: MP0250 Positioning in MM and Our Planned Trials
MP0250 MP0250 Positioning in MM and Our «planned» Trials Multiple myeloma: n >100,0001 n 30,0001 2nd most common blood cancer 1st Line 2nd 3rd 4th Therapy Line Line Line Global market value of PI MM treatment: IMiD PI or or + $13 billion 75% PI IMiD MP0250 + + expected to exceed mAb mAb IMiD + $20
Slide 18: Unmet Need in EGFR-mutated NSCLC
MP0250 Unmet Need in EGFR-mutated NSCLC HGF up-regulation/ No targeted drug approved cMET pathway activation for patients progressing on Tagrisso® EGFR- T790 - other - mutations treatment – high unmet medical need mutation mutation cMET- amplification ~10% Phase 2 ongoing in the US – on partial
Slide 19: MP0274: Killing HER2+ Cells by New MoA
MP0274 MP0274: Killing HER2+ Cells by New MoA Her2 «Open» HSA HER2 HER2 HSA DARPin® DARPin® A DARPin® B DARPin® MP0274 Medical need: despite good antibody-based Bi-paratopic DARPin® HER2+ treatments, eventually patients progress Novel mode of action: MP0274 is an allosteric inhibitor blocking HER2-
Slide 20: MP0274 is a Highly Potent Tumor Cell Killer
MP0274 MP0274 is a Highly Potent Tumor Cell Killer Tumor Cell Apoptosis Tumor Cell Killing BT474 BT474 100 100 100 MP0274 MP0274 Ado-trastuzumab 80 80 80 emtansine (Kadcyla®) 60 % Killing 60 60 40 40 40 Trastuzumab/ 20 Pertuzumab 20 20 (Herceptin®/ Perjeta®) 0 00 0 0 100 101 102 103 100 10 0 11 110
Slide 21: Our Vision to Expand the Therapeutic Window
MP0310 Our Vision to Expand the Therapeutic Window FAP x CD40 Through Tumor-Localized Immune Modulation healthy cells Current IO therapeutics that activate the immune system tumor cells (agonists) throughout the body show systemic side effects that can limit the activated effective dosing T cell Tum
Slide 22: DARPin Toolbox: Tumor-Localized Immune Modulators
MP0310 DARPin® Toolbox: Tumor-Localized Immune Modulators Tumor-localized immune modulators – overcoming the limitation of systemic side effects Immune Modulator OX-40 4-1BB CD40 Other Targets Solid Tumor TAA x 4-1BB TAA* Localizer Tumor FAP x 4-1BB Stromal FAP x CD40 MP0310 Antigen Hematologic TAA
Slide 23: MP0310 (FAP x 4-1BB): Activating T-cells in the Tumor
MP0310 MP0310 (FAP x 4-1BB): Activating T-cells in the Tumor Immune modulator Localizer Half-life extender MP0310 DARPin® modules + + 4-1BB FAP HSA Illustrative graphic DARPin® DARPin® DARPin® Medical need: most current 4-1BB agonists activate T-cells and NK cells systemically and are limited by sid
Slide 24: Combined Therapy with MP0310 and TAA x CD3 Bi-Specific
MP0310 Combined Therapy with MP0310 and TAA x CD3 Bi-Specific Results in Significant Increase of Intratumoral CD8+ T Cells FAP-Mediated Tumor Tumor growth inhibition Accumulation of MP0310 PBMC humanized HT-29 xenograft model Intratumoral CD8 T cells HT-29-T-implanted NSG mice 2000 Mean tumor volume
Slide 25: Peptide-MHCs – DARPin approach for inaccessible targets
Engage Peptide-MHCs – DARPin® approach for «inaccessible» targets Antibody-based approaches: Limited success with mAbs, BiTEs, CAR-T cell, etc. to target pMHC complexes Extra-cellular targets Intra-cellular targets MHC peptide Soluble T cell receptor approaches: limited by biophysical characteristic
Slide 26: Program Deep Dive: Abicipar
Program Deep Dive: Abicipar 26
Slide 27: Abicipar has Potential to be First Fixed 12 Week anti-VEGF
Abicipar Abicipar has Potential to be First Fixed 12 Week anti-VEGF Choroidal Neovascularization Medical Need: Current anti-VEGFs in wet-AMD are mostly dosed monthly or extended to bi-monthly, leading to high burden for patients and under-dosing in real-world settings OCT MoA: Abicipar is the only l
Slide 28: Phase 3 Efficacy Results (SEQUOIA study, 1yr data)
Abicipar Phase 3 Efficacy Results (SEQUOIA study, 1yr data) Secondary Endpoint: Change in BCVA From Baseline Abicipar Q8 and Q12 in SEQUOIA Non-Inferior to Ranibizumab Primary Endpoint: STABLE VISION Abicipar Q8 and Q12 Non-Inferior to Ranibizumab Q4 Secondary Endpoint: Change in CRT similar across
Slide 29: Allergan confirmed timelines for planned BLA filing and launch
Abicipar Allergan confirmed timelines for planned BLA filing to FDA in H1 2019 and for targeted market launch in 2020 Primary and secondary endpoints of Phase 3 trials support abicipar potential to become the first fixed 12-week anti VEGF in nAMD – Reduce patient burden from injections and allow f
Slide 30: Partnerships
MOLECULAR partners Partnerships
Slide 31: Leveraging our DARPin Engine via Partners
Leveraging our DARPin® Engine via Partners Strategy: Broaden and accelerate our activities & cross-finance our proprietary pipeline Partnership to leverage the DARPin® Partnership to test MP0310 in combination with candidates in ophthalmology (no cost share) selected Amgen IO drug candidates (cost s
Slide 32: Outlook & Conclusions
MOLECULAR partners Outlook & Conclusions
Slide 33: Investment Case
Investment Case DARPin® Engine: Source for candidates with novel therapeutic designs Advanced and balanced DARPin® Portfolio –Abicipar on track for market launch in nAMD in 2020 –MP0250 in P2 pioneering a new MoA in MM, P2 in NSCLC & MP0274 in P1 –Research is delivering candidates with highly in
Slide 34: Expected Catalysts 2019 and Beyond
Expected Catalysts 2019 and Beyond 2019 2020 Abicipar BLA filing planned (H1)* nAMD Launch MAPLE: data of further optimized material DME: P3 start* MP0250 Additional data: ongoing P2 MM trial Interim P2 data: PI-combo trial Start of P2 PI and IMiD-combo trial in MM** Interim P2 data:
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Slide 36: Appendix
MOLECULAR partners Appendix
Slide 37: Key Figures FY2018
Key Figures FY2018 (CHF million, except per share and FTE data) FY 2018 FY 2017 change Revenues 10.4 20.0 (9.6) Total expenses1 (47.8) (45.9) (2.0) Operating result – EBIT (37.4) (25.8) (11.6) Net financial result 0.4 0.4 0.0 Net result (37.0) (25.4) (11.6) Basic net result per share (in CHF) (1.75)
Slide 38: Financial Guidance for Full-Year 2019
Financial Guidance for Full-Year 2019 • Total expenses of CHF 60-70 million, of which around CHF 6 million non-cash effective costs • Capital expenditures of ca. CHF 2 million • No guidance on net cash flow; timelines and potential milestones payments with partnerships not disclosed • Guidance subje
Slide 39: Shareholder Structure
Shareholder Structure Shareholder structure as of December 31, 2018 Highlights VC holdings halved vs. end 2016 to 23% 23%* Listed on SIX Swiss Exchange (SIX: MOLN) 59% Included in key indices: SPI, SPI Extra, SXI Life Sciences and SXI Bio+Medtech 18%* 21,228,593 shares outstanding Ca. CHF
Slide 40: Disclaimer
Disclaimer This presentation is not an offer to sell or a solicitation of offers to purchase or subscribe for shares of Molecular Partners AG, nor shall it or any part of it nor the fact of its distribution form the basis of, or be relied on in connection with, any contract or investment decision. T
Slide 41: Molecular Partners AG contact and IR agenda
Molecular Partners AG Wagistrasse 14 8952 Zürich-Schlieren Switzerland www.molecularpartners.com T +41 44 755 77 00 IR Agenda August 27, 2019 Publication of Half-year Results 2019 (unaudited) October 30, 2019 Publication of Q3 Interim Management Statement 41
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