Geron Corporation · NASDAQ:GERN
Geron — BIO Investor Forum 2015
13 slides from Geron's conference presentation, Oct 21, 2015
Slide 1: BIO Investor Forum San Francisco
BIO Investor Forum San Francisco John Scarlett, M.D. President & CEO, Geron Corporation October 21, 2015
Slide 2: Forward-Looking Statements
Forward-Looking Statements Except for the historical information contained herein, this presentation contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Investors are cautioned that statements in this press releas
Slide 3: Geron Today
Geron Today Imetelstat: a novel and transformative oncology product candidate • First telomerase inhibitor in clinical development • Disease-modifying activity suggested by clinical data in ET (ASH 2012, EHA 2013) and MF (ASH 2013 and 2014) • Recent publication of data from both trials in the New En
Slide 4: Hematologic Malignancies
Hematologic Malignancies Arise from Malignant Progenitor Cell Clones in the Bone Marrow essential thrombocythemia (ET) polycythemia vera (PV) myelofibrosis (MF)1 platelets (abnormal) • ~3,000 cases diagnosed per year in the US red blood cells (abnormal) • ~13,000 people in the US living with MF • Dr
Slide 5: Transformative Potential of Imetelstat
Preliminary Clinical Efficacy Data Suggest Transformative Potential of Imetelstat Proof-of-concept study in essential thrombocythemia1 • Compelling and durable hematologic responses • Significant and durable molecular responses • Molecular responses suggest effect on underlying malignant progenitor
Slide 6: Myelosuppression is the Dose Limiting Toxicity
Preliminary Clinical Safety Data Indicate Myelosuppression is the Dose Limiting Toxicity Proof-of-concept study in essential thrombocythemia1 • Cytopenias most frequently reported adverse event • Mild-to-moderate non-hematologic adverse events (gastrointestinal events and fatigue) • Persistent low-g
Slide 7: Partnership with Janssen: Exclusive Worldwide Collaboration for Imetelstat
Partnership with Janssen Exclusive Worldwide Collaboration for Imetelstat First Stage Continuation Stage Phase 2 MF study Primary Phase 3: MF, MDS Phase 2: Additional exploratory indications analysis Phase 2,3: AML Phase 2 MDS study* • Janssen to execute Phase 2 MF and Phase 2 • Geron has Opt-In rig
Slide 8: Phase 2 Trial in Myelofibrosis (IMbark)
Phase 2 Trial in Myelofibrosis (IMbarkTM) An open label, single-blind study being conducted by Janssen Biotech, Inc. • Multi-center across US, Europe, and Asia • Objectives: Define proper dosing and confirm efficacy using current validated regulatory endpoints • Opened for enrollment in July 2015; f
Slide 9: IMbark Data Review Time Points
IMbarkTM Data Review Time Points Interim Review Primary Analysis Final Analysis • To assess the adequacy of one • To assess co-primary and • To perform final assessment of all or both of the initial dosing secondary endpoints endpoints regimens • To be conducted after all patients • To be conducted
Slide 10: IMbark Rationale for Study Design
IMbarkTM Rationale for Study Design Targets significant unmet medical need population Patient • No approved alternative therapies beyond Jakafi • Median survival reported to be approximately 6 months Population • 3-year discontinuation rate for Jakafi ~86% – Major reasons: loss of therapeutic effect
Slide 11: Myelodysplastic Syndromes (MDS)
Myelodysplastic Syndromes (MDS) Disease Characteristics • Most common myeloid malignancy Diverse group of clonal hematologic malignancies – ~12,000 cases diagnosed per year in the US with disordered and ineffective production of the – ~60,000 people in the US living with MDS myeloid lineage in the b
Slide 12: MDS: Chronic Anemia Remains an Unmet Need
Myelodysplastic Syndromes (MDS) Chronic Anemia Remains an Unmet Need Treatments for lower risk MDS patients with anemia are inadequate • Erythropoiesis stimulating agent (ESA): – Patients may experience a transient (median duration of ~2 years) improvement in anemia – Patients who do not respond or
Slide 13: Upcoming Events
Upcoming Events Data from MDS-RARS cohort from Mayo Clinic Pilot Study expected at the ASH Annual Meeting in December 2015 • A cohort of nine patients with subtype of MDS – refractory anemia with ring sideroblasts (RARS) • MDS-RARS: – primarily a lower risk subtype of MDS – characterized by anemia,