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JanuChangingry, 2021 the course of hematologic malignancies
Geron Corporation
Nasdaq: GERN
Corporate Presentation January 2021
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 forward-looking statements, include, without limitation, those regarding: (i) the IMerge Phase 3 clinical trial in lower risk MDS (LR MDS) - that Geron expects to: (a) have top-line results in the second half of 2022, (b) file the NDA for LR MDS in 1H 2023, (c) file the MAA for LR MDS in 2H 2023, and (d) obtain regulatory approval for LR MDS in 2H 2023 for the U.S. and 1H 2024 for the EU; (ii) that Geron expects to have IMpactMF interim and final analyses in 2023-2024; (iii) that imetelstat has shown evidence of and has potential disease-modifying activity, e.g., its impact on malignant cells in LR MDS and improved survival in MF; (iv) that Geron expects that imetelstat has intellectual property and market exclusivity through 2033; (v) that the U.S. revenue potential for imetelstat could exceed: (a) $500 million for LR MDS patients without chromosomal 5q deletion (non-del(5q)), relapsed/refractory to ESAs prior to being treated with lenalidomide or hypomethylating agents (HMAs), and (b) $750 million for Int-2/HR MF patients who are refractory to JAKi treatment; (vi) that Geron expects its cash and investments as of 12/31/20 will be sufficient to fund operations through Phase 3 IMerge top-line results; and (vii) other statements that are not historical facts. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to the following: (a) whether Geron overcomes all the potential delays, added expense and other adverse impacts caused by the continuing and evolving effects of the COVID-19 pandemic, and overcomes the clinical, safety, efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to meet the expected timelines and planned milestones in (i) and (ii) above; (b) Geron's capital resources as of 12/31/2020 may not be sufficient to fund operations until the expected the Phase 3 IMerge top-line results in 2H 2022; (c) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (d) whether imetelstat is demonstrated to be safe and efficacious in clinical trials; (e) whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; (f) whether imetelstat actually demonstrates disease-modifying activity in patients; (g) imetelstat may not achieve the revenue potential in (v) above because Geron may not have the expertise to successfully market imetelstat, competition could cause imetelstat not to achieve the revenue potential in (v) above, and/or Geron may not have sufficient funds to successfully commercialize imetelstat; (h) if Geron and imetelstat are unable to maintain intellectual property and market exclusivity through 2033 and have freedom to operate, then imetelstat would likely not achieve the revenue potential in (v) above; (i) If Geron is unable to complete IMerge enrollment in the second quarter of 2021, then it is unlikely to have top-line results in the second half of 2022; and (j) if Geron is unable to raise substantial additional capital before the end of 2022, it may not be able to complete the IMpactMF clinical trial, begin the commercialization of imetelstat for MDS and/or pursue any additional clinical development of imetelstat. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained under the heading "Risk Factors" in Geron's quarterly report on Form 10-Q for the quarter ended September 30, 2020 filed with the Securities and Exchange Commission (SEC). Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
2
Geron's Vision Being Realized
Changing the course of hematologic malignancies by targeting telomerase with imetelstat
2020-2021
Strong evidence from
2022-2024
Top-line results for
Phase 3 LR MDS
expected
2015
Dual NEJM papers:
complete and partial responses in ET & MF
plus JAK and CALR
molecular responses, suggesting therapeutic activity in the malignant clones underlying the disease
2015-2016
Phase 2 trials
initiated Lower Risk MDS (LR MDS)
- Relapsed/Refractory MF (R/R MF)
2019-2020 | |
2017-2019 | Phase 3 registration |
trials started | |
Compelling Phase 2 | |
in LR MDS and | |
clinical results in | JAKi-refractory MF |
LR MDS & R/R MF | |
Meaningful and | |
durable transfusion | Clinical and |
independence in LR MDS | regulatory buildout |
and OS improvement vs. | |
historical controls and | |
RWD in R/R MF |
Phase 2 for disease
modification
Improvement in OS (MF) and marrow fibrosis (MF), and durable transfusion independence (LR MDS) correlate with reduction of mutation burden and cytogenetic abnormalities of malignant clones
NDA/MAA readiness & commercial transition begin
2H 2022
Imetelstat LR MDS launch
expected US (2023) EU (2024)
Interim and final
analyses for Phase 3 JAKi-Refractory MF expected
2023-2024
ET - essential thrombocythemia | JAK - janus kinas | |
LR MDS - lower risk myelodysplastic syndromes | CALR - calreticulin | |
R/R MF - myelofibrosis relapsed or refractory to JAK inhibitors | OS - overall survival | |
JAKi-refractory MF - JAK inhibitor refractory myelofibrosis | RWD - real world data | References on slide 31 |
3
Geron's Vision Being Realized
Our Mission
To Improve and Extend
Patient Lives by
Changing the Course of
Hematologic Malignancies
by Targeting Telomerase
Imetelstat in LR MDS and MF
- Imetelstat MOA provides highly differentiated product profile
- Evidence for disease modification has continued to strengthen in both LR MDS and MF
- Only drug in development to establish correlation of disease modification with durable transfusion independence (LR MDS) and improvement in survival (MF)
Geron Today
- Highly experienced development team with expertise in developing and commercializing therapeutics for hematologic malignancies
- NDA preparations and upgrades of supportive enterprise-level capabilities underway
- Beginning transition to commercial-stage company
- ~$260M in cash and investments at 12/31/20 expected to fund operations through Phase 3 LR MDS top-line results
Geron's Expected Future
- Top-lineresults Phase 3 LR MDS in 2H 2022
- Imetelstat LR MDS US launch in 2023
- Interim and final analyses for Phase 3 JAKi-Refractory MF in 2023-2024
- Intellectual property/market exclusivity through 2033
References on slide 31 | 4 |
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Geron Corporation published this content on 08 January 2021 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 08 January 2021 19:39:06 UTC