Corporate Presentation
Forward-Looking Statements and Safe Harbor
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, without limitation, those regarding: (i) that the Company is on target for successful transition to a commercial company in 2024; (ii) plans for approval and a
potential launch of imetelstat in TD LR-MDS in the U.S. by the end of the first half of 2024 and for the MAA review to be completed by the end of 2024, with potential EU approval and launch in 2025; (iii) that
imetelstat has showed unprecedented durability of transfusion independence across multiple MDS patient subgroups that are not addressed by currently available products, and is a differentiated first-in-class
investigational telomerase inhibitor; (iv) that for the Phase 3 IMpactMF in R/R MF, Geron expects to conduct an interim analysis in the first half of 2025 and the final analysis in the first half of 2026, together with
the assumptions used in making these estimates; (v) that the Company believes imetelstat has a potential total addressable market (TAM) in the US/EU of greater than $3.5B in TD LR-MDS and greater than $3.5B
in R/R MF in 2031; (vi) the status, plans and expected timing of the Company's clinical programs on its pipeline chart; (vii) that imetelstat has the potential to have disease-modifying activity in patients; (viii) the
Company's estimates and assumptions used in the calculations of percentages and numbers of patients in the treatment landscape for LR-MDS; (ix) that the Company expects imetelstat to be a highly
differentiated product in the TD LR-MDS commercial marketplace; (x) that there are unmet needs in TD LR-MDS and R/R MF potentially addressed with imetelstat treatment; (xi) the Company's market research
used to obtain the views of practicing hematologists of the IMerge Phase 3 data and the opportunity in TD LR-MDS patients, including the characteristics of imetelstat and the Phase 3 data that support the
expectation that imetelstat can become a compelling treatment option and standard of care with a significant market opportunity; (xii) that the Company is well-positioned for a successful launch of imetelstat, if
approved, and the Company's plans and expectations regarding launch preparations; (xiii) the Company's assumptions and expectations regarding the expected opportunity for imetelstat in R/R MF; (xiv) the
Company's estimates of cash and marketable securities and operating expenses as of December 31, 2023; (xv) the Company's projections and expectations regarding the sufficiency of its cash resources and
expected available resources to fund its projected operating requirements into Q3 2025, and the assumptions underlying such projections and expectations; (xvi) the Company's estimates and assumptions used in
the calculations of total addressable market (TAM); and (xvii) other statements that are not historical facts, constitute forward-looking statements. These forward-looking 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: (a) whether the FDA and
EMA may have issues with the NDA or MAA for imetelstat for TD LR-MDS that delay or prevent approval and a potential commercial launch; (b) whether we will be able to continue to develop imetelstat or
advance imetelstat to subsequent clinical trials, or that we will be able to receive regulatory approval for or successfully commercialize imetelstat, on a timely basis or at all; (c) whether imetelstat may cause, or
have attributed to it, adverse events that could further delay or prevent the commencement and/or completion of clinical trials, delay or prevent its regulatory approval, or limit its commercial potential; (d)
whether the IMpactMF Phase 3 trial for R/R MF has a positive outcome and demonstrates safety and effectiveness to the satisfaction of the FDA and international regulatory authorities, and whether our projected
rates for enrollment and death events differ from actual rates, which may cause the interim and final analyses to occur later than anticipated; (e) whether we overcome all of the enrollment, clinical, safety,
efficacy, technical, scientific, intellectual property, manufacturing and regulatory challenges in order to have the financial resources for, and to meet the expected timelines and planned milestones; (f) if imetelstat
is approved for marketing and commercialization, whether we are able to establish and maintain effective sales, marketing and distribution capabilities, obtain adequate coverage and third-party payor
reimbursement, and achieve adequate acceptance in the marketplace; (g) whether imetelstat actually demonstrates disease-modifying activity in patients; (h) whether there are failures in manufacturing or
supplying sufficient quantities of imetelstat that would delay, or not permit, the anticipated commercial launch or not enable ongoing or planned clinical trials; (i) whether we are able to obtain and maintain the
exclusivity terms and scopes provided by patent and patent term extensions, regulatory exclusivity, and have freedom to operate; (j) that we may be unable to successfully commercialize imetelstat due to
competitive products, or otherwise; (k) that we may decide to partner and not to commercialize independently in the U.S. or in Europe and other international markets; (I) whether we have sufficient resources to
satisfy our debt service obligations and to fund our planned operations; (m) that we may seek to raise substantial additional capital in order to complete the development and commercialization of imetelstat and
to meet all of the expected timelines and planned milestones, and that we may have difficulty in or be unable to do so; and (n) the impact of general economic, industry or political climate in the U.S. or
internationally and the effects of macroeconomic conditions on our business and business prospects, financial condition and results of operations. 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" or other similar headings
found in documents Geron files from time to time with the Securities and Exchange Commission (the "SEC"), including the Company's Report on Form 10-Q for the quarter ended September 30, 2023 and
subsequent filings. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are ma 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.
geron
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