Slide 1: Q1 2024 Earnings Call
Q1 2024 Earnings Call May 2, 2024
Slide 2: Welcome and Introduction
Welcome and Introduction JOHN SCARLETT, ANIL KAPUR FAYE FELLER, MICHELLE ANDREW J. M.D. M.D. ROBERTSON GRETHLEIN, PH.D. Chairman and EVP, Corporate EVP, Chief EVP, Chief EVP, Chief Chief Executive Officer Strategy and Medical Officer Operating Officer Financial Officer Chief Commercial Officer 2
Slide 3: Forward-Looking Statements
Forward-Looking Statements During the course of this presentation and question-and-answer session, there will be forward-looking statements regarding future events, performance, plans, expectations and other projections, including those relating to: • the therapeutic potential of and potential regul
Slide 4: Introductory Remarks
Introductory Remarks John A. Scarlett, M.D. Chairman and Chief Executive Officer 4
Slide 5: Poised for Successful Imetelstat U.S. Launch
Poised for Successful Imetelstat U.S. Launch* Imetelstat TD LR-MDS PDUFA date June 16, 2024* FDA ODAC voted 12 to 2 in favor of the clinical benefit/risk profile of imetelstat for TD LR-MDS* Imetelstat uniquely positioned to address underserved TD LR-MDS patient population Sales force integrated Apr
Slide 6: Commercial Update
Commercial Update Anil Kapur Executive Vice President, Corporate Strategy and Chief Commercial Officer 6
Slide 7: Path to Commercial Value Creation
Path to Commercial Value Creation Geron is well-positioned Imetelstat is highly Patent and market for a successful U.S. launch differentiated in the exclusivity in the U.S. upon potential approval TD LR-MDS market • Commercial team fully onboarded • Opportunity for imetelstat given • Orphan drug exc
Slide 8: Imetelstat Uniquely Positioned to Address Unmet Need in TD LR-MDS
We Believe Imetelstat is Uniquely Positioned to Address Unmet Need in TD LR-MDS HR-MDS Lower-Risk MDS (~70%) Significant Complex Symptomatic Anemia (~90%) potential presentations opportunity ESAs and for imetelstat: sEPO (>500 sEPO (>500 luspatercept are 1st line RS+ (~25%) mU/mL) RS- (~75%) mU/mL)
Slide 9: Hematologists Confirm Importance of Clinical Benefit Across LR-MDS Subgroups
Hematologists Confirm Importance of Clinical Benefit Potentially Achievable with Imetelstat Across LR-MDS Subgroups and Payors Recognize the Unmet Need in TD LR-MDS space* Achievement of RBC-TI and Rise in Physicians note durable RBC-TI and hemoglobin levels improvement are Hemoglobin Critical to De
Slide 10: Expectations for Imetelstat Uptake
Expectations for Imetelstat Uptake ESA-ineligible, ESA-failed RS- and RS+ high transfusion burden TD LR-MDS patients ~90% of Second-Line Patients Expected to be Either ESA or Luspatercept Experienced Expected Second- Expected Second- Expected Second- Expected Second- Line Usage Line Usage Line Usage
Slide 11: Launch-Critical Success Factors Build on Unique Product Profile
Launch-Critical Success Factors Build on Unique Product Profile & Unmet Need • Embrace clinical benefit achievable with imetelstat Supportive • Understand the context and management of cytopenias to optimize Prescribers patient experience and duration of therapy • Have a positive first experience us
Slide 12: Medical & Clinical Updates
Medical & Clinical Updates Faye Feller, M.D. Executive Vice President, Chief Medical Officer 12
Slide 13: FDA ODAC Votes 12 to 2 in Favor of Clinical Benefit/Risk Profile
MARCH 14, 2024: FDA ODAC Votes 12 to 2 in Favor of the Clinical Benefit/Risk Profile of Imetelstat for the Treatment of Transfusion-Dependent Anemia in Patients with Lower-Risk MDS CONFIDEN TI A L | 13
Slide 14: Central Themes from the ODAC Meeting
Hematologists, Advocates and Patients Participated in the ODAC Meeting Contextualized the disease and current treatments, expressing support for new treatment options in TD LR-MDS Anemia and transfusion dependence negatively impact patients’ and their families’ quality of life LR-MDS is a progressiv
Slide 15: Medical Affairs Launch Readiness
Medical Affairs Launch Readiness • Congresses • Publications • NCCN® Guidelines • Education • Medical Information • Field Medical Team 15
Slide 16: First and Only Phase 3 Trial in MF with Overall Survival as Primary Endpoint
First and Only Phase 3 Trial in MF with Overall Survival as Primary Endpoint Data monitoring committee recommended Planned analyses* study continue based on review of unblinded data in April 2024 • Interim Analysis expected in early 2026 when ~35% of the planned enrolled patients have died; alpha sp
Slide 17: Financial Review
Financial Review Michelle Robertson Executive Vice President and Chief Financial Officer 17
Slide 18: Financial Resources Support Planned U.S. Commercial Launch
Financial Resources Support Planned U.S. Commercial Launch $270M - ~$465M ~$56M $280M Cash and Expected Expect resources to marketable Q1 2024 range sustain operations securities as of operating of operating into 2Q 2026* 3/31/24 expenses expenses FY 2024 * Based on the Company’s current operating p
Slide 19: Closing Remarks
Closing Remarks John A. Scarlett, M.D. Chairman and Chief Executive Officer 19
Slide 20: Driving Geron's Transformation in 2024
Driving Geron’s Transformation in 2024 Differentiated product profile addressing unmet need We are committed Building momentum on the heels of positive to enhancing care ODAC meeting for patients with hematologic Well-prepared for U.S. imetelstat launch, if approved malignancies Continued execution
Slide 21: Q&A
Q&A 21
Slide 22: Thank you!
Thank you! Contact: investor@geron.com
Slide 23: Appendix: TAM (U.S./EU)
Appendix: TAM (U.S./EU) Potential LR MDS Patient Population Potential R/R MF Patient Population ESA Ineligible (RS+/RS-): ~4,000 ESA R/R RS+: ~8,000 JAKi treated: ~29,000 ESA R/R RS-: ~24,000 Become part of SOC in LR-MDS Expand as SOC in R/R MF >$7B (~$3.5B TAM 2031) (~$3.5B TAM 2031) by 2031 LR-MDS
Slide 24: Imetelstat LR-MDS patent and market exclusivity in the U.S.
Imetelstat LR-MDS patent and market exclusivity in the U.S. Patent Terms, Patent Term Extensions, Regulatory Exclusivities 12/27/25 12/27/30 3/15/2033 09/2037 1H ʻ24 LR MDS Data/Market Exclusivity1 1H ʻ29 1H ʻ24 LR MDS Orphan Drug Exclusivity2 1H ʻ31 COM Patent Term If PTE Applied to COM3 Methods of