Slide 1: Q1 2023 Earnings Call
Q1 2023 Earnings Call May 11, 2023
Slide 2: Welcome and Introduction
Welcome and Introduction JOHN SCARLETT, M.D. OLIVIA BLOOM FAYE FELLER, M.D. ANIL KAPUR Chairman and EVP, Chief Financial Officer EVP, Chief Medical Officer EVP, Corporate Strategy and Chief Executive Officer Chief Commercial Officer 2
Slide 3: 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 such statements, include, witho
Slide 4: Agenda
Agenda 1. Introductory Remarks ▸ John Scarlett, M.D. 2. Regulatory, Clinical and Medical Affairs Updates ▸ Faye Feller, M.D. 3. Commercial Preparedness and LR MDS Market Opportunity Overview ▸ Anil Kapur 4. Financial Review ▸ Olivia Bloom 5. Concluding Remarks ▸ John Scarlett, M.D. 6. Q&A ▸ All 4
Slide 5: Introductory Remarks
Introductory Remarks John A. Scarlett, M.D. Chairman and CEO 5
Slide 6: Geron's Compelling Commercial Value Proposition
Geron’s Compelling Commercial Value Proposition Transforming the Treatment of Heme Malignancies • Imetelstat poised to become a highly differentiated standard of care in lower risk myelodysplastic syndromes (LR MDS) and relapsed/refractory myelofibrosis (R/R MF) patients ◦ LR MDS Ph3: Unprecedented
Slide 7: Regulatory, Clinical and Medical Affairs Updates
Regulatory, Clinical and Medical Affairs Updates Faye Feller, M.D. Executive Vice President, Chief Medical Officer 7
Slide 8: Regulatory Update: NDA expected to be submitted in June 2023
Regulatory Update: NDA expected to be submitted in June 2023 8
Slide 9: ASCO and EHA
ASCO and EHA 9
Slide 10: ASCO 2023 Oral Presentation: IMerge Phase 3
Abstract # 7004 ASCO 2023 Abstract Title: IMerge: Results from a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Imetelstat in Patients (pts) With Heavily Transfusion Dependent (TD) Non-Del(5q) Lower- Risk Myelodysplastic Syndromes (LR-MDS) Relapsed/Refractory (R/R) to Erythropoiesis
Slide 11: EHA 2023: Updated Continuous TI Durability in IMerge Phase 3
EHA 2023: EHA Oral Presentation – Abstract #S165 Updated Continuous TI Durability in IMerge Phase 3 Conclusions P<0.001 • Imetelstat showed 50.0 statistically significant and clinically 45.0 P<0.001 meaningful efficacy 39.8% P<0.001 with robust 8-wk, 16- 40.0 Represents 63.6% of wk, 24-wk, and 1-yr
Slide 12: EHA 2023: Disease-Modifying Potential of Imetelstat in IMerge Phase 3
EHA Oral Presentation – Abstract #S164 EHA 2023: Disease-Modifying Potential of Imetelstat in IMerge Phase 3 Conclusions VAF reductions were greater Genes frequently in patients treated with imetelstat vs placebo Correlation of reduction mutated in MDS of VAF and clinical SF3B1 TET2 DNMT3A ASXL1 res
Slide 13: EHA 2023: Patient-reported Fatigue in IMerge Phase 3
EHA Poster Presentation – Abstract #P732 EHA 2023: Patient-reported Fatigue in IMerge Phase 3 Conclusions • Imetelstat-treated • Overall, 50.0% of imetelstat-treated patients patients more likely to reported sustained meaningful improvement in have sustained fatigue versus 40.4% of placebo-treated m
Slide 14: EHA 2023: Collaborator Imetelstat Abstracts
EHA 2023: Collaborator Imetelstat Abstracts Modulation of the Immune Landscape The Telomerase Inhibitor Imetelstat in Lower-risk Myelodysplastic Differentially Targets JAK2V617F- Versus Syndromes with Imetelstat-induced CALR-mutant Myeloproliferative Neoplasm Transfusion Independency Cells and Inhib
Slide 15: IMpactMF: First and Only Phase 3 trial in the U.S. in MF with OS
IMpactMF: First and Only Phase 3 trial in the U.S. in MF with OS as Primary Endpoint • Significant excitement in A randomized (2:1) open-label, phase 3 study (N~320) of imetelstat vs best available therapy investigator and patient (BAT)* in intermediate-2 or high-risk MF relapsed/refractory to JAK i
Slide 16: Medical Affairs Team Supporting Potential LR MDS Launch
Medical Affairs Team Supporting Potential LR MDS Launch • Direct interaction with medical community • MDS disease state information and resources • Engagement with key professional medical societies • Completed initial hiring of medical affairs field team 16
Slide 17: Commercial Preparedness and LR MDS Market Opportunity Overview
Commercial Preparedness and LR MDS Market Opportunity Overview Anil Kapur Executive Vice President, Corporate Strategy and Chief Commercial Officer 17
Slide 18: Integrated Planning with Cross-Functional Execution to Achieve Imetelstat U.S. Launch Excellence
Integrated Planning with Cross-Functional Execution to Achieve Imetelstat U.S. Launch Excellence Objectives: Ensure broad reimbursement and deliver a seamless customer experience to all stakeholders Prepare Imetelstat Prepare the Market Prepare Geron REGULATORY SUBMISSIONS & TRADEMARK MARKET INSIGHT
Slide 19: Lower Risk MDS Patient Experience
Lower Risk MDS Patient Experience Frequent transfusions, transfusion dependence, poor quality of life, shortened survival Diagnosis Median age ~70 years Majority treated under Medicare Part B (US) Treat Symptomatic Anemia Lengthy Office Visits Typically blood transfusions, ESAs and in some cases wit
Slide 20: Treatment Landscape for LR MDS
Treatment Landscape for LR MDS • ~70% of MDS Continuing unmet need presents significant opportunity for imetelstat patients are classified as lower risk • Majority of the HR MDS Lower Risk MDS (~70%) patients with symptomatic anemia are treated with ESAs Complex presentations Symptomatic Anemia (~90
Slide 21: IMerge Phase 3 Data Received Favorably by Practicing Hematologists
IMerge Phase 3 Data Received Favorably by Practicing Hematologists across U.S./EU Key Markets Key attributes of imetelstat resonated strongly with community and academic hematologists Totality of Meaningful Durability Clinical Benefit of Response EFFICACY Compelling TI rates across RS 16- and 24-wee
Slide 22: Hematologists' Feedback Confirms Imetelstat Opportunity Across RS Subtypes
Hematologists’ Feedback Confirms Imetelstat Opportunity Across RS Subtypes and High Transfusion Burden Patients Imetelstat Strongly Prefered Treatment Physicians express a clear preference to use imetelstat first for their ESA R/R of Choice for All ESA R/R RS- Patients RS- patients, regardless of le
Slide 23: LR MDS Expected Future Market Evolution (U.S.)
LR MDS Expected Future Market Evolution (U.S.): Imetelstat likely to become new SOC in second line and provide an important new option for frontline ESA-ineligible patients Expected Second Line Usage Expected Second Line Usage Expected Frontline Usage ESA-experienced Reblozyl-experienced ESA-ineligi
Slide 24: Financial Review
Financial Review Olivia Bloom Executive Vice President and Chief Financial Officer 24
Slide 25: Financial Resources to Support Potential Commercial Launch of Imetelstat
Financial Resources to Support Potential Commercial Launch of Imetelstat ~$40M Up to ~$409M Financial resources $210M Q1 2023 operating Cash and marketable 2023 expected non-GAAP total expected to support expenses securities as of 3/31/23 operating expenses* projected level of operations through thi
Slide 26: Closing Remarks
Closing Remarks John A. Scarlett, M.D. Chairman and CEO 26
Slide 27: Q&A
Q&A 27
Slide 28: Thank you!
Thank you! Contact: Investor Relations info@geron.com
Slide 29: Appendix
Appendix 29
Slide 30: Total Addressable Market for LR MDS and R/R MF >$7B by 2033
Total Addressable Market (TAM) for LR MDS and R/R MF >$7B by 2033 (US/EU)* Establishing imetelstat as standard of care in LR MDS and R/R MF Potential LR MDS Patient Population Potential MF Patient Population ESA Ineligible (RS+ve / RS-ve) JAKi R/R ESA R/R RS+ve ESA R/R RS-ve Become part of SOC in LR
Slide 31: Planned Path to Commercialization
Planned Path to Commercialization 2025+ 2024 Continued Expansion in Other Heme Malignancies 2024 2023 Expansion in R/R MF • Milestones for additional indications and LR MDS Commercial • IMpactMF Ph3 interim combination trials Regulatory Submissions Launch in US and EU analysis for median based on Po
Slide 32: Non-GAAP Financial Measure
Non-GAAP Financial Measure Non-GAAP total operating expenses for fiscal year 2023 which excludes estimated non-cash items such as, stock-based compensation expense, amortization of debt discounts and issuance costs and depreciation and amortization. To supplement our financial results and guidance p
Slide 33: References
References Slide # Reference Slide # Reference Slide # Reference 6 IMerge Phase 3 TLR reported Jan 4, 2023 14 Chapuis, et al, EHA 2023 abstract (#S169); Olschok et al, EHA 2023 21 Geron Market Research, US/EU3 Jan 2023 Market Opportunity Assumptions: US: 50% of US+EU patient distribution, abstract (