Gossamer Bio, Inc. · NASDAQ:GOSS
Gossamer Bio — Investor Presentation (May 2019)
38 slides from Gossamer Bio's investor presentation, May 14, 2019
Slide 1: Confidential Corporate Presentation
Confidential Corporate Presentation Exhibit 99.2
Slide 2: Forward Looking Statement
Forward Looking Statement This presentation contains forward-looking statements. All statements other than statements of historical facts contained in this presentation, including statements regarding our future results of operations and financial position, business strategy, prospective products, p
Slide 3: Building The Next Generation Biotechnology Company
Building The Next Generation Biotechnology Company Our Mission: Apply proven R&D expertise to drive efficient clinical development to deliver innovative, patient-focused new medicines for underserved therapeutic areas 4 assets in clinical development, targeting various indications with clear unmet m
Slide 4: Foundation of Immunology and Translational Discovery and Developmental Expertise
Foundation of Immunology and Translational Discovery and Developmental Expertise Deep Therapeutic Area Expertise Leads to Centers of Excellence Discover orthogonal pathways in areas of emerging biology Address 1st and 2nd resistance to checkpoint inhibitors Gastroenterology: Develop gut-targeted the
Slide 5: Experienced Leadership Team at the Helm
Bryan Giraudo Chief Financial Officer Christian Waage EVP and General Counsel Sheila Gujrathi, MD Chief Executive Officer Luisa Salter-Cid, PhD Chief Scientific Officer Experienced Leadership Team at the Helm Jakob Dupont, MD Chief Medical Officer Board of Directors Faheem Hasnain Executive Chairman
Slide 6: Robust Pipeline with Five Clinical Programs
PROGRAM CLASS (Route of Admin.) INDICATION RESEARCH PRE-CLINICAL PHASE 1 PHASE 2 PHASE 3 RIGHTS GB001 DP2 Antagonist (Oral) Moderate-to-Severe Eosinophilic Asthma Worldwide (except Japan) GB001 DP2 Antagonist (Oral) Chronic Rhinosinusitis (with and without nasal polyps) Worldwide (except Japan) GB00
Slide 7: GB001 DP2 Antagonist
GB001 DP2 Antagonist Asthma and Other Allergic Conditions, including Chronic Rhinosinusitis (CRS) and Chronic Spontaneous Urticaria (CSU)
Slide 8: GB001: Oral Therapy with Potential to Disrupt Treatment Paradigms in Allergic Disease
GB001: Oral Therapy with Potential to Disrupt Treatment Paradigms in Allergic Disease CRS = Chronic Rhinosinusitis; CSU = chronic spontaneous urticaria. As of December 31st, 2018. Includes assumption of maximum 5 years of patent term extension. Corresponding patent(s) and patent application(s) with
Slide 9: Role and Biology of the DP2 Pathway in Type 2 Inflammation
Role and Biology of the DP2 Pathway in Type 2 Inflammation Sources: Domingo, Respiratory Research 2018; Singh, Clinical Pharmacology: Advances and Applications 2017; Farne, Expert Opinion on Emerging Drugs 2016; Stone, J Allergy Clin Immunol 2010; Saunders, Sci Transl. Med. 2019. PGD2 DP2 PGD2 TH2 D
Slide 10: Japanese Phase 2 Study Demonstrated Significant Improvements in Time-to-First Asthma Worsening
Japanese Phase 2 Study Demonstrated Statistically Significant Improvements in Time-to-First Asthma Worsening pbo vs 5 mg pbo vs 20 mg p-value (log-rank test) 0.088 P<0.001 Hazard Ratio (95% CI)* 0.59 (0.32, 1.07) 0.29 (0.14, 0.58) 100 90 80 70 60 50 40 30 20 10 0 Asthma Worsening Rate (%) 0 14 28 42
Slide 11: Beyond Eos: Potential for Target Market Expansion
Beyond Eos: Potential for Target Market Expansion Subjects in High FeNO and Eos. Subgroups Mean (Standard Error) reduction in FeNO (ppb) Mean Reduction in FeNO at Day 28 Background Fractional exhaled nitric oxide (FeNO) is a marker of airway inflammation. FeNO is elevated in eosinophilic inflammatio
Slide 12: Potential for Market Positioning Prior to Biologics in Asthma
Potential for Market Asthma Positioning Prior to Biologics Intermittent & Mild Moderate Severe Severe Low Dose Inhaled CS Asthma Controllers LTRA montelukast/generics Anti-IL-4 / IL-13 Dupixent® (dupilumab) Anti- IL-5 & IL5R Nucala®, Cinquar®, Fasenra® Anti-IgE Xolair® (omalizumab) 3 4 5 Global INit
Slide 13: LEDA Study: Phase 2b Study Design
LEDA Study: Phase 2b Study Design Allows for Efficient Transition to Phase 3 Patient Population 480 adult mod.-to-severe eosinophilic asthmatics (eosinophil counts ≥ to 250 cells/μL) Treatment 60mg, 40mg, 20 mg or placebo, oral administration (QD) on top of background therapy Duration of Treatment 2
Slide 14: CRS and CSU Represent High-Value Indications with a Strong Strategic Fit
CRS and CSU Represent High-Value Indications with a Strong Strategic Fit A subtype of CRS is thought to occur secondary to chronic inflammation involving eosinophil activation DP2 implicated in pathophysiology, including nasal polyps formation Mast cell driven disease Eosinophil infiltration in lesi
Slide 15: TITAN Study: Phase 2 Proof of Concept in CRS
TITAN Study: Phase 2 Proof of Concept in CRS With and Without Nasal Polyps Patient Population ~64 adult patients with CRS with nasal polyps; ~36 adult patients with CRS without polyps Treatment 40mg or placebo, oral administration (QD), on top of intra-nasal steroids Duration of Treatment 16 weeks E
Slide 16: Phase 2 Proof of Concept in Chronic Spontaneous Urticaria
Phase 2 Proof of Concept in Chronic Spontaneous Urticaria Patient Population 70 adult patients with Chronic Spontaneous Urticaria refractory to H1 antihistamines Treatment 40mg or placebo, oral administration (QD) on top of standard doses of H1 antihistamines Duration of Treatment 12 weeks Endpoint
Slide 17: GB002 PDGF Receptor Kinase Inhibitor
GB002 PDGF Receptor Kinase Inhibitor Pulmonary Arterial Hypertension (PAH)
Slide 18: GB002: Potential To Be the First Treatment for PAH with Disease-Modifying Effects
PAH underlying pathology driven by abnormal cell proliferation related to lung small blood vessels Activated PDGF receptor induces cellular proliferation and is known to be upregulated in PAH Kinase inhibition was shown to be clinically significant in Phase 3 PAH trial of imatinib (Gleevec), with sy
Slide 19: PDGF Pathway Drives Pulmonary Arteriolar Remodeling in PAH
PDGF Pathway Drives Pulmonary Arteriolar Remodeling – an Underlying Problem in PAH PAH Endothelial Cell Myofibroblast PDGF PDGFRß PDGFRα PDGFR Inhibitor: Anti-proliferative effect BMPR2 dysregulation can lead to endothelial changes to smooth muscle like cells PDGFR inhibition modulates BMPR2 in pulm
Slide 20: GB002 Improves Hemodynamics and Reverses Vascular Remodeling in Animal Models
GB002 inhibits both PDGF α and β, and inhibited and reversed cell overgrowth in lung blood vessels in PAH in a rat model Rat model replicates many features of human PAH, including the abnormal cell proliferation that can block the small vessels of the lung GB002 Improves Hemodynamics and Reverses Va
Slide 21: Imatinib Demonstrated Clinical Proof of Principle for Targeting PDGF in PAH
Imatinib Demonstrated Clinical Proof of Principle for Targeting PDGF in PAH in the Phase 3 IMPRES Trial Source: Circulation, March 2013. Imatinib mesylate, as add-on therapy in PAH patients who remain inadequately treated on at least two PAH-specific drugs, improves exercise capacity and hemodynamic
Slide 22: GB002 Could Provide a Much Needed Treatment Option for High Risk PAH Patients
GB002 Could Provide a Much Needed Treatment Option for High Risk PAH Patients Mild (FC1) Moderate (FC2) Moderate-Severe (FC3) Severe (FC4) PAH Therapies PDEV Inh/SGC ETAR Antagonist Early Combination Prostanoid* GB002 (PDGFR Inhibitor) ETAR = endothelin receptor type A; FC = Functional Class; PDEV =
Slide 23: Planned Phase 1b Study in Pulmonary Arterial Hypertension
Planned Phase 1b Study in Pulmonary Arterial Hypertension A Phase 1b, signal seeking, placebo-controlled, dose-ranging study to evaluate the safety and pharmacokinetic profile of GB002 in adult patients with PAH Status: Anticipated Patient Screening in 2Q 2019 Patient Population Adult PAH patients T
Slide 24: GB004 HIF-1α Stabilizer
GB004 Hypoxia Inducible Factor 1α (HIF-1α) Stabilizer Inflammatory Bowel Disease (IBD), including Ulcerative Colitis (UC) and Crohn’s Disease (CD)
Slide 25: GB004: Gut-targeted HIF Stabilizer with Potential to Deliver Superior Efficacy for IBD
Designed to restore epithelial barrier function, in addition to immunomodulatory effects High degree of hypoxia in inflamed gut due to vascular disruption and chronic inflammation HIF-1α stabilization restores epithelial barrier function and exerts innate immunomodulatory effects, which is expected
Slide 26: Mechanism of PHD Inhibitor to Restore Epithelial Barrier Function
Adapted from Pasparakis et al. (2015) Nature. GB004 Restoration of epithelial barrier function 1 Luminal Microbes GB004 Immunomodulation 2 T cell IBD represents a state of chronic tissue injury HIFs play an important role in protecting cells in times of stress and low oxygen levels GB004 inhibits PH
Slide 27: Oral GB004 Demonstrates Restitution of the Epithelial Barrier in Colitis Model
Oral GB004 Demonstrates Restitution of the Epithelial Barrier and Effects on Mucosal Healing in TNBS-Induced Colitis Model Vehicle in Cyclodextrin TNBS + Cyclodextrin TNBS + Dexamethasone TNBS + GB004 in Cyclodextrin TNBS + GB004 in HCl GB004 * p<0.01 compared to all other groups ** p<0.025 compared
Slide 28: GB004 Represents a New, Potentially Transformative Approach in UC
GB004 Represents a New, Potentially Transformative Approach in UC Mild Moderate Severe Aminosalicylates UC Treatments Steroids, immune suppressants Biologic Oral / Topical White space for safe, effective oral therapy Immune Suppressant Orals: JAK inhibitors, S1P1R modulators Xeljanz Biologics: anti-
Slide 29: Planned GB004 Phase 1b in Ulcerative Colitis
Planned GB004 Phase 1b in Ulcerative Colitis to Allow for PK Assessment in Patients and Potential Initial Assessment of Biological Effect Patient Population Adult patients with active ulcerative colitis, who have had an inadequate response or intolerance to 5-ASA or steroids; mild disease or greater
Slide 30: GB1275 CD11b Modulator Solid Tumors
GB1275 CD11b Modulator Solid Tumors
Slide 31: GB1275: Opportunity to Improve Response to Cancer Therapy
Disrupts multiple immunosuppressive myeloid cell subsets, including MDSCs and TAMs Efficacy observed as single agent and synergistically in combination with chemotherapy and immuno-oncology therapies Preclinical data suggest differentiation from other approaches targeting immunosuppressive mechanism
Slide 32: MDSCs and M2 Macrophages Generate an Immunosuppressive Tumor Microenvironment
MDSCs and M2 Macrophages Generate an Immunosuppressive Tumor Microenvironment and Hinder Response to IO Agents Adapted from R&D Systems Mac1 = CD18/CD11b Integrin CD11b expressed on myeloid cells Monocytes Neutrophils MDSCs Tumor associated macrophages Targeting MDSCs or M2 macrophages is one of the
Slide 33: GB1275 Pre-clinical Data: Single Agent and Combination Activity
GB1275 Pre-clinical Data: Single Agent and Combination Activity GB1275 (60 mg/kg, PO, BID) D10 tumor FACS profiling Vehicle ADH-503 CD103+ DCs CD8+ CTLs GB1275 Tumor Biopsy: Biomarker Data Single Agent GB1275 in Pancreatic Cancer Mouse Model Survival: Control vs GB1275 Survival: GB1275 + Chemo Combi
Slide 34: Planned Phase 1/2 Study of GB1275 In Select Solid Tumor Indications
GB1275 Planned Phase 1/2 Study of GB1275 In Select Solid Tumor Indications PDAC = pancreatic ductal adenocarcinoma; CRC = colorectal cancer; MSS = micro-satellite stable; Gem = gemcitabine; mPanc = metastatic pancreatic cancer; Gastric = gastric cancer. Targeting IO resistant tumor types including:
Slide 35: Financial Highlights and Milestones
Financial Highlights and Milestones
Slide 36: Financial Highlights
Financial Highlights Pro Forma Cash, Cash Equivalents and Marketable Securities (As of 3/31/19, including $11 million interest and securities receivable, pro forma for initial $30mm tranche of debt facility, announced 5/2/19) $523mm xx Debt (Initial tranche of $150 million debt facility, announced 5
Slide 37: Multiple Near-Term Expected Clinical Trial Initiations and Readouts
Legend GB004: Initiate UC Ph. 2 GB002: Ph. 1b PAH Read Out GB001: Asthma LEDA Ph. 2b Interim Multiple Near-Term Expected Clinical Trial Initiations and Readouts 2019 2021 Today Q2 Q3 Q4 Q12020 Q2 Q3 Q4 Q12021 Q2 Q3 Q4 Note: All trial bars and milestone flags are shown at the center of estimated timi
Slide 38: gossamerbio
gossamerbio