Slide 1: Q2 2023 Earnings Call
Q2 2023 Earnings Call August 3, 2023
Slide 2: Welcome and Introduction
Welcome and Introduction JOHN SCARLETT, M.D. OLIVIA BLOOM FAYE FELLER, M.D. ANIL KAPUR Andrew J. Grethlein, Ph.D. Chairman and EVP, Chief Financial Officer EVP, Chief Medical Officer EVP, Corporate Strategy and EVP, Chief Operating Officer 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: Introductory Remarks
Introductory Remarks John A. Scarlett, M.D. Chairman and CEO 4
Slide 5: Key Q2 Achievements Drive Geron Toward Potential Launch
Key Q2 Achievements Drive Geron Toward Potential Launch Evolving Geron • Imetelstat New Drug Application in lower risk myelodysplastic from late-stage syndromes (LR MDS) submitted June 2023 clinical development • New IMerge Phase 3 data and analyses presented at ASCO and EHA company toward one with
Slide 6: Regulatory and Clinical Updates
Regulatory and Clinical Updates Faye Feller, M.D. Executive Vice President, Chief Medical Officer 6
Slide 7: Regulatory Updates
Regulatory Updates • LR MDS NDA Submitted June 2023 • Requested priority review from FDA • Expect to submit MAA in EU for LR MDS in Q4 2023 7
Slide 8: Imetelstat Expanded Access Protocol in LR MDS initiated June 2023
Imetelstat Expanded Access Protocol in LR MDS initiated June 2023 8
Slide 9: New IMerge Phase 3 Data and Analyses Presented at ASCO and EHA
New IMerge Phase 3 Data and Analyses Presented at ASCO and EHA 9
Slide 10: Presentations at ASCO and EHA
Presentations at ASCO and EHA Compelling Imetelstat Profile from IMerge Phase 3 Highly statistically significant (p<0.001) and clinically meaningful improvements for imetelstat-treated patients Durable transfusion versus placebo in 8-week TI, 16-week TI and 24-week TI independence (TI) & hemoglobin
Slide 11: 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 Actively enrolling global trial (>40% enrolled) • Sites planned across North America, South ClincialTrials.gov America, Europe, Australia and Asia (NCT0457615) Primary Endpoint: • Overall survival (OS) Planned analy
Slide 12: First Patient Dosed in IMpress Phase 2 in June 2023
First Patient Dosed in IMpress Phase 2 in June 2023 Investigator-led study of single agent imetelstat in post-HMA relapsed/refractory/intolerant AML and higher risk MDS 12
Slide 13: Commercial Updates
Commercial Updates Anil Kapur Executive Vice President, Corporate Strategy and Chief Commercial Officer 13
Slide 14: Academic and community hematologist feedback
Academic and IMerge Phase 3 risk/benefit profile received favorably community hematologist feedback across U.S. Imetelstat opportunity across ESA and EU indicates relapsed/refractory RS- and RS+ subgroups, as well as high transfusion burdened patients substantial imetelstat opportunity in LR MDS Ime
Slide 15: Financial Review
Financial Review Olivia Bloom Executive Vice President and Chief Financial Officer 15
Slide 16: Financial Resources to Support Potential Commercial Launch of Imetelstat
Financial Resources to Support Potential Commercial Launch of Imetelstat Up to ~$52M ~$400M $210M Financial resources Q2 2023 operating Cash and marketable 2023 expected non-GAAP total expected to support expenses securities as of 6/30/23 operating expenses* projected level of operations through the
Slide 17: Closing Remarks
Closing Remarks John A. Scarlett, M.D. Chairman and CEO 17
Slide 18: Q&A
Q&A 18
Slide 19: Thank you!
Thank you! Contact: Investor Relations info@geron.com
Slide 20: Appendix
Appendix 20
Slide 21: 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 22: References
References Slide # Reference 5, 10 Zeidan et al, ASCO 2023; Platzbecker et al, EHA 2023; Santini et al, EHA 2023; Sekeres et al, EHA 2023 11 IMpactMF clinical trial protocol 14 Geron Market Research, US/EU3 May 2023 22