GERON CORP (GERN) Business

ITEM 1.BUSINESS

Company Overview

We are a commercial-stage biopharmaceutical company aiming to change lives by changing the course of

blood cancer. Our first-in-class telomerase inhibitor, RYTELO® (imetelstat), harnesses Nobel Prize winning science in a

treatment that scientific evidence suggests reduces proliferation of malignant cells, allowing production of new healthy

cells, which we believe drives differentiated clinical benefits, potentially altering the underlying course and modifying the

disease of these hematologic malignancies.

We commercially launched RYTELO in the U.S. in June 2024 following its approval by the U.S. Food and

Drug Administration, or FDA, on June 6, 2024 for the treatment of adult patients with low- to intermediate-1 risk

myelodysplastic syndromes, or lower-risk MDS, with transfusion-dependent, or TD, anemia requiring four or more red

blood cell units over eight weeks who have not responded to or have lost response to or are ineligible for erythropoiesis-

stimulating agents, or ESAs. Lower-risk MDS is a progressive blood cancer with high unmet need, where many patients

with anemia become dependent on red blood cell transfusions, which can be associated with clinical consequences and

decreased quality of life. We believe that the results of our Phase 3 clinical trial, IMerge, in LR-MDS, favorable FDA label

and National Comprehensive Cancer Network, or NCCN®, Clinical Practice Guidelines in Oncology, or NCCN

Guidelines®, position RYTELO as a potential treatment that can compete for significant market segments in lower-risk

MDS, including second-line ESA ineligible patients regardless of prior treatment or RS status and first-line ESA ineligible

patients.

In March 2025, we received European Commission (EC) approval of RYTELO for the treatment of adults

with TD anemia due to lower-risk MDS without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had

an unsatisfactory response to or are ineligible for ESAs. RYTELO is the first and only telomerase inhibitor approved by the

EC, and the marketing authorization applies to all 27 European Union member states, and Iceland, Norway and

Liechtenstein. We are pursuing paths to make RYTELO available to eligible LR-MDS patients outside of the U.S.,

including in the EU. To enable paid access to patients outside the United States through approved Named Patient Programs

(NPPs), we have partnered with Tanner Pharma, a distributor with broad global reach to support patient access. To date,

our revenues pursuant to NPPs have been minimal.

In addition to lower-risk MDS, we are developing imetelstat for the treatment of other myeloid hematologic

malignancies. Our Phase 3 IMpactMF clinical trial is evaluating imetelstat in patients with intermediate-2 or high-risk

myelofibrosis, or MF, who have relapsed after or are refractory to treatment with a janus associate kinase inhibitor, or JAK

inhibitor, or relapsed/refractory MF, or R/R MF, with overall survival, or OS, as the primary endpoint. As of September

2025, the trial completed enrollment. Based on our current assumptions for event (death) rates in the trial, we expect the

interim analysis for OS in IMpactMF may occur in the second half of 2026 and the final analysis may occur in the second

half of 2028.

We believe that telomerase inhibition with imetelstat represents a novel mechanism of action with unique

benefits in hematologic malignancies and potentially in other tumor types.

Our Strategy

Our strategy is to maximize the value of our first-in-class telomerase inhibitor, RYTELO (imetelstat). This

includes maximizing the commercial opportunity for RYTELO in lower-risk MDS by investing in and executing on our

U.S. commercial efforts. We expect to deliver steady growth by executing across several key imperatives, including driving

new patient starts across all eligible lower-risk MDS population segments, particularly in second-line lower-risk MDS;

reinforcing with health care providers, or HCPs, the value of duration of treatment we have observed with RYTELO;

educating HCPs on appropriate management of patient safety with RYTELO; and leveraging strong payor access for

RYTELO. We are also pursing paths to bring RYTELO to eligible LR-MDS patients outside the United States including

the EU.

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We also plan to progress our development programs that could help identify potential additional indications

for imetelstat. This includes the Phase 3 IMpactMF trial, which, if positive and approved in label expansion, could

significantly increase the RYTELO commercial opportunity. Additionally, we plan to execute on our pipeline programs

and assess the data to understand the potential to develop imetelstat in additional hematologic malignancies and as a

potential combination therapy.

U.S. Commercialization of RYTELO

RYTELO is the first and only FDA approved telomerase inhibitor. The FDA label indicates that RYTELO

is approved for certain ESA ineligible or ESA relapsed/refractory lower-risk MDS patients, regardless of RS status.  The

MDS NCCN Guidelines® include imetelstat as a Category 1 preferred option treatment in second-line RS+/RS- ESA-

eligible patients regardless of prior treatment options and as a Category 2A treatment for first-line ESA-ineligible RS+/RS-

patients.  In October 2025, the MDS NCCN Guidelines® were updated to change from azacitadine to imetelstat as the

preferred option in first-line RS- ESA-ineligible patients.

Our commercial strategy is designed to ensure that RYTELO reaches eligible patients when they are most

likely to benefit.

Our commercial execution is focused on three core initiatives.

•First, targeted engagement with high-volume accounts that treat earlier-line patients.

•Second, we are investing in what we believe to be the most effective marketing channels.

This includes a strong emphasis on digital, non-personal promotion, and third-party

educational platforms designed to ensure consistent, high-quality messaging across multiple

touchpoints.

•Third, we are executing cross-functionally through effective account management

initiatives.

Our cross-functional customer-facing teams include over 60 key account managers, regional business

directors, regional marketers, regional access directors , and regional medical scientific directors. We offer a wide range of

resources to support access and affordability for eligible RYTELO patients, including our REACH4RYTELO® patient

support program, which provides a range of resources which are designed to support access and affordability to eligible

patients prescribed RYTELO.

Commercialization Plans for RYTELO Outside of the U.S.

In March 2025, we received European Commission approval, of RYTELO for the treatment of adults with

TD anemia due to lower-risk MDS. We are pursuing paths to make RYTELO available to eligible LR-MDS patients

outside of the U.S., including in the EU. We are preparing for the planned commercialization of RYTELO in select EU

markets in 2026. At this time, we do not plan to commercialize RYTELO independently in the EU (or in any other regions

outside of the U.S. where RYTELO may be approved for marketing in the future). Accordingly, we plan to work with

experienced third parties for the commercialization and marketing of RYTELO in the EU, including on critical path

activities for the planned launch of RYTELO in the EU, such as reimbursement, Health Technology Assessment, or HTA,

submissions, market access and distribution.To enable paid access to patients outside the United States through approved

Named Patient Programs (NPPs), we partnered with Tanner Pharma, a distributor with broad global reach to support

patient access.  To date, revenues pursuant to NPPs have been minimal.

Background of Telomerase Inhibition in Hematologic Malignancies and Imetelstat Development

In the human body, normal growth and maintenance of tissues occurs by cell division. However, most cells

are only able to divide a limited number of times, and this number of divisions is regulated by telomere length. Telomeres

are repetitions of a deoxyribonucleic acid, or DNA, sequence located at the ends of chromosomes. They act as protective

caps to maintain stability and integrity of the chromosomes, which contain the cell’s genetic material. Normally, every time

a cell divides, the telomeres shorten. Eventually, they shrink to a critically short length, and as a result, the cell either dies

by apoptosis or stops dividing and senesces.

Telomerase is a naturally occurring enzyme that maintains telomeres and prevents them from shortening

during cell division, such as stem cells that must remain immortalized to support normal health. Telomerase consists of at

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least two essential components: a ribonucleic acid, or RNA, template, which binds to the telomere, and a catalytic subunit

with reverse transcriptase activity, which adds a specific DNA sequence to the chromosome ends. The 2009 Nobel Prize

for Physiology or Medicine was awarded to Drs. Elizabeth H. Blackburn, Carol W. Greider and Jack Szostak, former

Geron collaborators, for the discovery of how chromosomes are protected by both telomeres and telomerase.

Telomerase is upregulated in many tumor cells and malignant stem and progenitor cells, enabling the

continued and uncontrolled proliferation of the malignant cells that drive tumor growth and progression. We believe that

inhibiting telomerase may be an attractive approach to treating cancer because it may limit the proliferative capacity of

malignant stem and progenitor cells, which are believed to be important drivers of tumor growth and progression. We and

others have observed in various in vitro, ex vivo and rodent tumor models that inhibiting telomerase: (a) results in telomere

shortening and (b) arrests uncontrolled malignant cell proliferation and tumor growth.

Many myeloid hematologic malignancies, such as essential thrombocythemia, or ET, MF and MDS, have

been shown to arise from malignant stem and progenitor cells that express higher telomerase activity and have shorter

telomeres when compared to normal healthy cells. In vitro studies have suggested that tumor cells with short telomeres

may be especially sensitive to the anti‑proliferative effects of inhibiting telomerase.

Imetelstat, our proprietary telomerase inhibitor which was discovered and developed at Geron, was

designed to inhibit telomerase in malignant cells with continuously upregulated telomerase.

Imetelstat is a lipid conjugated 13‑mer oligonucleotide that we designed to be complementary to and bind

with high affinity to the RNA template of telomerase, thereby directly inhibiting telomerase activity. Imetelstat does not act

as an antisense inhibitor of protein translation. The compound has a proprietary thio‑phosphoramidate backbone, which is

designed to provide resistance to the effect of cellular nucleases, thus conferring improved stability in plasma and tissues,

as well as improved binding affinity to its target. To improve the ability of imetelstat to penetrate cellular membranes, we

conjugated the oligonucleotide to a lipid group. Imetelstat’s IC50, or half maximal inhibitory concentration, is 3 – 9 nM in

cell free assays.

We believe that imetelstat may have the potential to suppress the proliferation of malignant stem and

progenitor cells while transiently affecting normal cells. Early clinical data from a Phase 2 trial of imetelstat in patients

with ET, or the ET Trial, and a pilot study of imetelstat in patients with MF conducted at Mayo Clinic, or the Pilot Study,

suggested that imetelstat inhibits the progenitor cells of the malignant clones believed to be responsible for the underlying

diseases in a relatively select manner, indicating potential disease-modifying activity. These data were published in two

separate articles in a September 2015 issue of The New England Journal of Medicine. In the Phase 2 IMbark study, an

association of survival improvement and reduction in variant allele frequency, or VAF, was observed for high-risk

imetelstat-treated MF patients, results which were published in Journal of Clinical Oncology in 2021. Additionally, in the

Phase 2/3 IMerge study, SF3B1 VAF reduction was associated with longest transfusion independence, or TI, and with 8-

week, 24-week and 1-year TI duration in imetelstat-treated lower-risk MDS patients. These results were published in The

Lancet and at the European Hematology Association, or EHA, annual meeting in 2023.

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Pipeline Chart

Lower-Risk Myelodysplastic Syndromes (MDS)

MDS is a group of blood disorders in which the proliferation of malignant progenitor cells produces

multiple malignant cell clones in the bone marrow resulting in disordered and ineffective production of the myeloid

lineage, which includes red blood cells, white blood cells and platelets. In MDS, bone marrow and peripheral blood cells

may have abnormal, or dysplastic, cell morphology. MDS is frequently characterized clinically by severe anemia, or low

red blood cell counts, and low hemoglobin. In addition, other peripheral cytopenias, or low numbers of white blood cells

and platelets, may cause life‑threatening infections and bleeding. Transformation to acute myeloid leukemia, or AML, is

reported to occur in up to 30% of MDS cases and results in poorer overall survival.

MDS is the most common of the myeloid malignancies. There are approximately 64,000 people in the U.S.

living with the disease and approximately 21,000 reported new cases of MDS in the U.S. every year, according to

Clarivate/DRG MDS Syndicated Report 2025. MDS is primarily a disease of the elderly, with median age at diagnosis

around 70 years. The majority of patients, approximately 70%, fall into what are considered to be the lower-risk groups at

diagnosis, according to the International Prognostic Scoring System, or IPSS, which assigns relative risk of progression to

AML and overall survival by taking into account the presence of a number of disease factors, such as cytopenias and

cytogenetics.

Chronic anemia is the predominant clinical problem in patients who have lower-risk MDS. The current

standard of care for the treatment of lower-risk MDS is the use of ESAs as supportive care, and more recently luspatercept

to improve upon disease-associated chronic anemia. The majority of patients who no longer respond to ESAs or other

available drug therapies become dependent on red blood cell transfusions due to low hemoglobin. Serial red blood cell

transfusions can lead to elevated levels of iron in the blood and other tissues, which the body has no normal way to

eliminate. Iron overload is a potentially dangerous condition. Published studies in patients with MDS have shown that iron

overload resulting from regular red blood cell transfusions is associated with a poorer overall survival and a higher risk of

developing AML.

Phase 3 IMerge Trial in Lower-Risk MDS

Our regulatory approval in the U.S. for certain patients with lower-risk MDS and our EMA submission are

each based on positive data from the IMerge Phase 3 clinical trial. The trial met its primary endpoint of ≥ 8-week red blood

cell transfusion independence rate and a key secondary endpoint of ≥ 24-week red blood cell transfusion independence rate,

demonstrating highly statistically significant (i.e., p0.001 for both) and clinically meaningful benefits with imetelstat

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treatment versus placebo. Furthermore, statistically significant and clinically meaningful efficacy results were observed in

the trial across key MDS patient subtypes, including patients who were ringed sideroblast positive, or RS positive, and

ringed sideroblast negative, or RS negative; patients with high (4-6 RBC units/8 weeks) and very high baseline transfusion

burden (6 RBC units/8 weeks); and patients classified as Low or Intermediate-1 risk according to the IPSS. The most

common Grade 3/4 adverse reactions were neutropenia (72%) and thrombocytopenia (65%), which lasted a median

duration of less than two weeks, and in more than 80% of patients were resolved to Grade 2 in under four weeks.

Myelofibrosis (MF)

MF, a type of myeloproliferative neoplasm, is a chronic blood cancer in which abnormal or malignant

precursor cells in the bone marrow proliferate rapidly, causing scar tissue, or fibrosis, to form. As a result, normal blood

production in the bone marrow is impaired and may shift to other organs, such as the spleen and liver, which can cause

them to enlarge substantially. People with MF may have abnormally low or high numbers of circulating RBCs, white blood

cells or platelets, and abnormally high numbers of immature cells in the blood or bone marrow. MF patients can also suffer

from debilitating constitutional symptoms, such as drenching night sweats, fatigue, severe itching, or pruritus, abdominal

pain, fever and bone pain.

Approximately 70% of MF patients are classified as having Intermediate‑2 or High-risk disease, as defined

by the Dynamic International Prognostic Scoring System Plus described in a 2011 Journal of Clinical Oncology article.

Drug therapies currently approved by the FDA and other regulatory authorities for treating these MF patients include JAK

inhibitors, ruxolitinib, fedratinib and momelotinib, as well as pacritinib, a kinase inhibitor. Currently, no drug therapy is

approved for those patients who fail or no longer respond to JAK inhibitor treatment.  A variety of best available therapies

are used in absence of an approved treatment for this patient population, and median survival is limited, representing a

significant unmet medical need.

Ongoing Phase 3 IMpactMF Trial in Relapsed/Refractory MF

Trial Design

IMpactMF, our Phase 3 clinical trial in relapsed/refractory MF, is an open label, 2:1 randomized, controlled

clinical trial designed to evaluate imetelstat (9.4 mg/kg administered by intravenous infusion over two hours every three

weeks) in approximately 320 patients. Patients relapsed after or refractory to a JAK inhibitor are defined as having an

inadequate spleen response or symptom response after treatment with a JAK inhibitor for at least six months, including an

optimal dose of a JAK inhibitor for at least two months. The best available therapy, or BAT, control arm of IMpactMF

excludes the use of JAK inhibitors. With respect to the trial design for IMpactMF, the FDA urged us to consider adding a

third dosing arm to assess a lower dose and/or a more frequent dosing schedule that might improve the planned trial’s

chance of success by identifying a less toxic regimen and/or more effective spleen response, one of the trial’s secondary

endpoints. Based on data from IMbark, which evaluated a low and high doses, we believe that testing a lower dose regimen

would likely result in a lower median OS, which is the trial’s primary endpoint, in the imetelstat treatment arm. We believe

existing data also suggest that lowering the dose would not result in a clinically meaningful reduction in toxicity. For these

reasons, we therefore determined not to add a third dosing arm to the trial design, and the FDA did not object to our

proposed imetelstat dose and schedule of 9.4 mg/kg every three weeks. Our belief may ultimately be incorrect. Therefore,

our failure to add a third dosing arm could result in a failure to maintain regulatory clearance from the FDA and similar

international regulatory authorities, could result in the trial’s failure, or could otherwise delay, limit or prevent marketing

approval of imetelstat for relapsed/refractory MF by the FDA or similar international regulatory authorities.

The primary efficacy endpoint for IMpactMF is OS. Key secondary endpoints include symptom response;

spleen response; progression free survival; complete remission, partial remission or clinical improvement, as defined by the

International Working Group for Myeloproliferative Neoplasms Research and Treatment criteria; duration of response;

safety; pharmacokinetics; and patient reported outcomes. There are IMpactMF sites across North America, South America,

Europe, Australia and Asia.

Current Status of IMpactMF

IMpactMF opened for patient screening and enrollment in December 2020. In September 2025, the trial

completed enrollment. Based on our current assumptions for event (death) rates in the trial, we expect the interim analysis

for OS in IMpactMF may occur in the second half of 2026 and the final analysis may occur in the second half of 2028.

Because these analyses are event-driven and it is uncertain whether actual rates for events will reflect current planning

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assumptions, the results may be available at different times than currently expected. At the interim analysis, if the pre-

specified statistical OS criterion is met, then we expect such data may potentially support the registration of imetelstat in

relapsed/refractory MF. Subject to protocol-specified stopping rules for futility, if the pre-specified OS criterion is not met

at the interim analysis, the trial will continue to the final analysis.

The timing and achievement of either or both of the planned analyses depend on numerous factors,

including blinded death rates, which have in the past been, and may continue to be, lower than our projections. In addition,

our ability to conduct and complete IMpactMF depends on whether we can obtain and maintain the relevant clearances

from regulatory authorities and other institutions to continue to conduct and complete the trial.

Improvement in Overall Survival and Potential Disease-Modifying Activity Observed in IMbark Phase 2

The IMbark Phase 2 clinical trial was designed to evaluate two dosing regimens of imetelstat (either 4.7

mg/kg or 9.4 mg/kg administered by intravenous infusion every three weeks) in patients with relapsed/refractory MF.

We previously reported efficacy and safety results from the IMbark Phase 2 clinical trial, including median

OS of 28.1 months for patients on the high dose arm of the study, which is almost twice the reported median OS of 14–16

months in medical literature. To evaluate this potential benefit, we conducted a post-hoc analysis of OS for patients treated

with imetelstat 9.4 mg/kg in IMbark compared to OS calculated from real world data, or RWD, collected at the Moffitt

Cancer Center for patients who had discontinued treatment with ruxolitinib, a JAK inhibitor, and who were subsequently

treated with BAT. To make a comparison between the IMbark data and RWD, a cohort from the real-world dataset was

identified that closely matched the IMbark patients, using guidelines for inclusion and exclusion criteria as defined in the

IMbark clinical protocol, such as platelet count and spleen size. Calculations from two propensity score analysis

approaches resulted in a median OS of 30.7 months for the imetelstat-treated patients from IMbark, which is more than

double the median OS of 12.0 months using RWD for patients treated with BAT. These analyses also showed a 65% – 67%

lower risk of death for the imetelstat-treated patients vs. BAT-treated patients. We believe these analyses suggest

potentially longer OS for imetelstat-treated relapsed/refractory MF patients in IMbark, compared to BAT in closely-

matched patients from RWD. However, comparative analyses between RWD and our clinical trial data have several

limitations. For instance, the analyses create a balance between treatment groups with respect to commonly available

covariates, but do not take into account the unmeasured and unknown covariates that may affect the outcomes of the

analyses. Potential biases are introduced by factors which include, for example, the selection of the patients included in the

analyses, misclassification in the matching process, the small sample size, and estimates that may not represent the

outcomes for the true treated patient population. For these and other reasons, such comparative analyses and any

conclusions from such analyses should be considered carefully and with caution, and should not be relied upon as

demonstrative or otherwise predictive or indicative of any current or potential future clinical trial results of imetelstat in

relapsed/refractory MF, including IMpactMF.

In IMbark, patients also experienced other positive clinical outcomes, including symptom improvement,

spleen reduction and bone marrow fibrosis improvement. In June 2020, we reported correlation analyses from IMbark that

showed a trend of longer OS in patients who achieved symptom response, spleen volume reductions and improved bone

marrow fibrosis, in a dose-dependent manner. Furthermore, the reductions in the variant allele frequency of key driver

mutations in MF and the improvement in bone marrow fibrosis observed in IMbark have also been correlated to the

improvement in OS. We believe the improvement in bone marrow fibrosis, potential survival benefit, molecular data and

correlations from IMbark provide strong evidence of the potential for disease modification with imetelstat, which we

believe would differentiate imetelstat from currently approved treatments for MF, if approved.

The safety results observed in IMbark were consistent with prior clinical trials of imetelstat in hematologic

malignancies, and no new safety signals were identified. In the 9.4 mg/kg arm, reversible and manageable Grade 3/4

thrombocytopenia and neutropenia were reported in 24/59 patients (41%) and 19/59 patients (32%), respectively, without

significant clinical consequences. 1/59 patients (2%) had Grade 3 febrile neutropenia. 3/59 patients (5%) had Grade 3/4

bleeding. 6/59 patients (10%) had Grade 3/4 infections. Furthermore, more than 70% of the observed Grade 3/4 cytopenias

resolved to Grade 2 or lower by laboratory assessment within four weeks.

FDA Fast Track Designation

Fast Track designation provides opportunities for frequent interactions with FDA review staff, as well as

eligibility for priority review, if relevant criteria are met, and rolling review. Fast Track designation is intended to facilitate

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and expedite development and review of an NDA to address unmet medical needs in the treatment of serious or life-

threatening conditions. However, Fast Track designation does not accelerate conduct of clinical trials or mean that the

regulatory requirements are less stringent, nor does it ensure that imetelstat will receive marketing approval or that

approval will be granted within any particular timeframe. In addition, the FDA may withdraw Fast Track designation if it

believes that the designation is no longer supported by data emerging from the imetelstat clinical development program.

In October 2017, the FDA granted Fast Track designation to imetelstat for the treatment of adult patients

with TD anemia due to lower-risk MDS who do not have a non-del 5q abnormality and who are refractory or resistant to

treatment with an ESA (i.e., the treatment population in IMerge Phase 3).

In September 2019, the FDA granted Fast Track designation to imetelstat for the treatment of adult patients

with Intermediate-2 or High-Risk MF whose disease has relapsed after or is refractory to JAK inhibitor treatment (i.e., the

treatment population in IMpactMF).

Potential Additional Indications

IMproveMF: Phase 1 Combination Clinical Trial in Frontline Myelofibrosis (Frontline MF)

We are also evaluating imetelstat as a combination therapy in the Phase 1 IMproveMF clinical trial as a

first-line treatment for patients with Intermediate-1, Intermediate-2 or High-Risk myelofibrosis. Based on the dose

escalation findings in Part 1 of the study, presented at the American Society of Hematology, or ASH, annual meeting in

December 2024, imetelstat 9.4 mg/kg dosed every four weeks with ruxolitinib was the selected dose for the dose expansion

Part 2 of the study, which is currently enrolling patients.

IMpress: Investigator-Led Phase 2 Clinical Trial in Higher Risk Myelodysplastic Syndromes (Higher Risk MDS) and

Acute Myeloid Leukemia (AML)

Imetelstat is also being studied in an investigator-led IMpress Phase 2 clinical trial in Intermediate-2 or

High-Risk myelodysplastic syndromes, or higher-risk MDS, and acute myeloid leukemia, or AML, patients that are

relapsed or refractory to hypomethylating agent, or HMA, treatment. Based on observations from an interim analysis from

the first cohort, presented at ASH in December 2024, the protocol was amended to a more frequent dosing schedule for a

second cohort of patients being enrolled and treated with this modified schedule as of August 2024. These data were

presented at ASH in December 2025.

IMAGINE: Investigator-Led Phase 1/2 Clinical Trial in Relapsed/RefractoryAML

We are enrolling a Phase 1/2 investigator-led study, called IMAGINE, in relapsed/refractory AML, using a

combination approach of imetelstat and azacitidine with or without venetoclax.

Research Programs

Next Generation Telomerase Inhibitor Discovery

We have initiated a discovery program to identify lead compounds as a potential next generation oral

telomerase inhibitor. If the leads we have identified are optimized, we may conduct preclinical experiments that may serve

as a basis for potential future clinical testing. Discovery research is an uncertain and unpredictable process. As such, the

timing and nature of any results from this discovery effort are difficult to forecast. If we optimize lead compounds from

this discovery program, we expect to provide an update on our efforts at that time.

Preclinical Lymphoid Hematologic Malignancies

Academic research data suggests that certain lymphoid hematologic malignancies have higher telomerase

activity and shorter telomeres when compared to normal healthy cells. Based on this scientific hypothesis, we conducted a

preclinical research project with MD Anderson Cancer Center to determine the potential application of imetelstat in

lymphoid hematologic malignancies. The project was completed, and preliminary results of the research project were

published in Blood in November 2022. Exploring the utility of imetelstat in lymphoid hematologic malignancies remains

an area of interest for us.

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Intellectual Property and Regulatory Exclusivity

Intellectual property, including patent protection, is very important to our business. We file patent

applications in the U.S. and other jurisdictions, and we also rely on trade secret protection and contractual arrangements to

protect aspects of our business. An enforceable patent with appropriate claim coverage can provide an advantage over

competitors who may seek to employ similar approaches to develop therapeutics, and so the future commercial success of

RYTELO (imetelstat), and therefore our future success, will be in part dependent on our intellectual property strategy.

Our intellectual property strategy includes the early development of a technology, such as imetelstat,

followed by rounds of increasingly focused innovation around a product opportunity, including identification and definition

of a specific product candidate and uses thereof, manufacturing processes, product formulation and methods of treatment

and administration. The result of this process is that products in development are often protected by several families of

patent filings that are filed at different times during the development process and cover different aspects of the product.

Consequently, earlier filed, broad technology patents will usually expire ahead of patents covering later developments, such

as product formulations and methods of treatment and administration, so that patent expirations on a product may span

several years. Patent coverage may also vary from country to country based on the scope of available patent protection.

There are also opportunities to obtain an extension of patent coverage for a product in certain jurisdictions, which adds

further complexity to the determination of patent life.

From time to time, we may endeavor to monitor worldwide patent filings by third parties that are relevant

to our business. Based on this monitoring, we may determine that an action is appropriate to protect our business interests.

Such actions may include negotiating patent licenses where appropriate, filing oppositions against a patent, filing a request

for post grant review against a patent or filing a request for the declaration of an interference with a patent application or

issued patent.

The information provided in this section should be reviewed in the context of the section entitled “Risks

Related to Protecting Our Intellectual Property” described in “Risk Factors” in Part I, Item 1A of this Report.

RYTELO (imetelstat)

Summary

RYTELO was developed internally by us, and we hold global commercial rights to it. We own issued

patents related to RYTELO in the U.S., Europe and other jurisdictions. Although composition of matter patents generally

provide the most comprehensive coverage of a therapeutic product such as RYTELO, subsequent patent filings directed to

other aspects of RYTELO may also provide additional patent coverage with later expiration dates. In addition, it may be

possible to obtain patent term extensions of some patents in some jurisdictions for claims covering RYTELO or relating to

RYTELO, such as methods of treatment with RYTELO, which could further extend the patent term.

We have issued patents in the U.S., Europe and other jurisdictions that provide patent coverage into 2033

(not including any patent term extension) pertaining to the treatment of MDS and MF with RYTELO.

In the U.S., our method of treatment patent rights for MDS and MF expire in March 2033 (not including

any patent term extension). We also hold an issued patent in the U.S. covering the composition of matter of RYTELO

(imetelstat) that that was set to expire in December 2025 according to its original patent term, including patent term

adjustment for delays at the USPTO. Now that we have received approval for RYTELO in the U.S., we have applied for

patent term extensions under the provisions of the Drug Price Competition and Patent Term Restoration Act of 1984 (as

amended), or the Hatch-Waxman Act, which, if granted, could extend the patent term of either our method of treatment

patent for MDS and MF or our composition of matter patent by up to five years (but not beyond 14 years from the date of

approval). Our composition of matter patent was granted interim patent term extension under the Hatch-Waxman Act,

which extends its expiration date to December 2026, while a decision is being rendered on the patient term extension

application.

In Europe and other countries, our patent rights for use in MDS and MF expire in November 2033 (not

including any patent term extension). Our composition of matter patent coverage expired in September 2024. We plan to

seek patent term extension under a Supplementary Protection Certificate, or SPC, as permitted under European Council, or

EC, Regulation No 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary

protection certificate of medicinal products (the Medicinal SPC Regulation), of one of our use patents, such as our patent

for use in MDS, in the European Economic Area, or the EEA, which could extend the patent term by up to five years.

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In the U.S., Europe, and other jurisdictions, we are also pursuing other patent rights relating to RYTELO

(imetelstat), such as methods of treatment of MDS in specific patient subpopulations, reagents useful in the manufacturing

processes for the drug, and other methods of treatment and kit claims, certain of which are co‑owned with other entities.

Patent Term Extension

Although we are in the process of seeking patent term extension for some of our issued patents covering

RYTELO, it is not possible to obtain patent term extension of any patents that expired prior to or are issued following

regulatory approval. For the patents for which we are seeking a patent term extension, we may not be granted any such

patent term extension and/or the applicable time period of such patent term extension could be less than we have projected.

In the U.S., patent term extension is available for a product that contains an active ingredient that has not previously been

approved.  The extension, which compensates for patent term lost during product development and FDA regulatory review

process, is generally equal to the sum of one-half the time between the effective date of an IND application and the

submission date of an NDA, and all of the time between the submission date of an NDA and the approval of that

application. Moreover, in some jurisdictions, including the U.S., such patent term extensions, if any, are available for only

one patent for a given product and the rights derived from such extension are limited to those claims which encompass the

product composition and treatment indications as approved by the relevant healthcare regulatory authority on or after the

regulatory review period on which the extension is based.  During the life of the patent term extension, however, its scope

of protection may expand to include any additional indications subsequently approved for the product and claimed by the

patent. Furthermore, some jurisdictions, including the U.S., allow the filing of patent term extension applications on

multiple patents, but ultimately the patent owner must select one patent to which the extension is applied.

In the U.S., now that we have received approval for RYTELO in certain patients with lower-risk MDS, we

may potentially extend the term of our composition of matter patent in the U.S. for a maximum of five years until

December 2030, subject to U.S. Patent and Trademark Office, or USPTO, approval. Alternatively, we may potentially

extend the term of our method of treatment for MDS claims in the U.S. until August 2037, subject to USPTO approval. As

we have previously disclosed, we expect to apply patent term extension, if granted, to our method of treatment patent, since

doing so extends the expiration date of the method of treatment patent to a later date than the composition of matter patent.

However, if we do not receive a patent term extension for our U.S. method of treatment patent for MDS, it will expire in

March 2033. Once our composition of matter patent expires in the U.S., we must rely on our method of treatment patent

and other patents and regulatory exclusivity for RYTELO in the U.S.

Similarly, in Europe, we are in the process of seeking to potentially extend the term of our patents in the

EEA for the use of RYTELO in MDS for a maximum of five years, from November 2033 until November 2038, subject to

the approval of the national patent offices, in accordance with the Medicinal SPC Regulation. Since our European

composition of matter patents expired in September 2024, we must rely on our use and other patents and, subject to

receiving approval from the EC, regulatory exclusivity for RYTELO in the EEA.

If we do not have sufficient patent life and regulatory exclusivity to protect RYTELO in the U.S. and

Europe, our financial results, business and business prospects, and future development of imetelstat could be materially and

adversely affected, which might cause us to cease operations.

Orphan Drug Designation and Market Exclusivity

United States

Some jurisdictions, including the U.S., may designate drugs or biologics for relatively small patient

populations as orphan drugs.  For a drug to qualify for orphan drug designation by the FDA, both the drug and the disease

or condition must meet certain criteria specified in the Orphan Drug Act, or ODA, and FDA’s implementing regulations.

Orphan drug designation is granted by the FDA’s Office of Orphan  Products Development in order to support

development of medicines for rare diseases or conditions, which generally are those that affect fewer than 200,000 people

in the U.S. or, if the disease or condition affects more than 200,000 individuals annually in the U.S., if there is no

reasonable expectation that the cost of developing and making the drug available in the U.S. would be recovered from sales

of such drug in the U.S. Orphan drug designation does not shorten the duration of the regulatory review process or lower

the approval standards, but can provide important benefits, including consultation with FDA. Orphan drug designation

qualifies the sponsor of the drug for various development incentives under the ODA, including certain tax credits for

qualified clinical testing and exemption from user fees.

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A drug granted approval for an orphan designated indication generally receives seven years of market

exclusivity, during which time the FDA generally may not approve any other application for the same drug for the same

use, with certain limited exceptions, including when the later product is shown to be clinically superior to the product with

exclusivity (and thus not the same). If there is a previously-approved product that is the same drug for the same indication,

orphan drug designation requires the sponsor to provide a plausible hypothesis of clinical superiority over the approved

product, whereas ODE requires the sponsor to actually demonstrate clinical superiority.  Clinical superiority can be

established by way of greater efficacy, greater safety, or making a major contribution to patient care.  Orphan drug

exclusivity does not prevent the FDA from approving a different drug for the same disease or condition, or the same drug

for a different use. The FDA can revoke a product’s orphan drug exclusivity under certain circumstances, including when

the product sponsor is unable to assure the availability of sufficient quantities of the product to meet patient needs. A later

product may also be approved during the exclusivity period if the orphan drug exclusivity holder consents to the approval

of that product.

A marketing application for a prescription drug product that has received orphan drug designation is not

subject to a prescription drug user fee unless the application includes an indication for a disease or condition other than the

rare disease or condition for which the drug was granted orphan drug designation. The granting of orphan drug designation

does not alter the standard regulatory requirements and process for obtaining marketing approval, including the

requirement that a drug’s effectiveness be established by substantial evidence, as demonstrated through adequate and

well‑controlled studies (and, as appropriate, confirmatory evidence).

In June 2015 and December 2015, the FDA granted orphan drug designation to imetelstat for the treatment

of MF and MDS, respectively, and following approval of RYTELO in June 2024, the FDA listed in its Approved Drug

Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, and its database for orphan-

drug designations and approvals, that RYTELO has orphan drug exclusivity, which is expected to provide orphan drug

exclusivity until June 2031 for its MDS indication, subject to our continuing compliance with the requirements to maintain

such orphan drug exclusivity.

In addition to orphan drug exclusivity, under the Hatch-Waxman Act, if a product is a “new chemical

entity” or NCE, which generally means that the active moiety has never before been previously approved by the FDA,

there is a period of five years from approval of the first indication during which the FDA may not accept for filing any

abbreviated new drug application, or ANDA, under section 505(j) of the Federal Food, Drug, and Cosmetic Act, or an

application under section 505(b)(2) of the statute for a drug with the same active moiety. An ANDA or 505(b)(2)

application may be submitted after four years, however, if the sponsor of the application makes a Paragraph IV

certification, which may trigger litigation and a 30-month stay of approval, as further described in the section titled "The

validity, scope and enforceability of any patents listed in the Orange Book that cover RYTELO or its methods of use can be

challenged by third parties and may not protect us from generic or innovator competition" under “Risk Factors” in Part I,

Item 1A of this Report. Our request for NCE exclusivity for RYTELO is pending review by the FDA. If the FDA were to

grant NCE exclusivity for RYTELO, NCE exclusivity would continue until June 2029.

The Hatch-Waxman Act also provides three years of marketing exclusivity for a product that is not an NCE

but that incorporates a change(such as a new indication, dosage form or strength) from the approved product with the same

moiety.  Such product may qualify for a three-year period of exclusivity if the NDA contains reports of new clinical

investigations (other than bioavailability studies) conducted or sponsored by the sponsor that were  necessary for approval

of the NDA. In that instance, the exclusivity period does not preclude filing or review of an ANDA or 505(b)(2)

application; rather, the FDA is precluded from granting final approval to the ANDA or 505(b)(2) application until three

years after approval of the Reference Listed Drug, or RLD. Additionally, the exclusivity applies only to the extent that any

subsequent ANDA or Section 505(b)(2) product that shares the conditions of approval that required submission of the

clinical data.

In the US, the exclusivity periods and patent-related protections described above also may be eligible for a

six-month extension of regulatory exclusivity, or pediatric exclusivity, pursuant to section 505A of the Federal Food, Drug,

and Cosmetic Act, if the sponsor submits pediatric data that “fairly respond” to a written request from FDA for such data;

however, we do not expect to receive pediatric exclusivity for RYTELO in the U.S.

Europe

In the EEA, a medicinal product containing a new active substance generally receives eight years of data

exclusivity, which prevents competitors from relying on the results of pre-clinical tests and of clinical trials when applying

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for a marketing authorization for a generic or biosimilar product, and an additional two years of market exclusivity, during

which competitors can apply for a marketing authorization by referencing the  marketing authorization holder's data but are

not allowed to place their product on the market until the end of this period, conferring a total of ten years of exclusivity for

the medicinal product.  The ten years of exclusivity can be extended to a maximum of eleven years if, during the first eight

years of those ten years, the marketing authorization holder obtains an authorization for one or more new therapeutic

indications which, during the scientific evaluation prior to their authorization, are held to bring a significant clinical benefit

in comparison with existing therapies. When RYTELO was granted marketing authorization by the EC for the treatment of

certain patients with lower-risk MDS on March 7, 2025, it was confirmed to contain a new active substance and so

RYTELO is entitled to  ten years of data exclusivity in the EEA from the time of approval.

In addition to data exclusivity, orphan drug designation by the EC provides regulatory and financial

incentives for companies to develop and market therapies that treat a life‑threatening or chronically debilitating condition

affecting no more than five in 10,000 persons in the EU (or if it is unlikely that marketing of the medicinal product would

generate sufficient returns to justify the investment needed for its development), and where no satisfactory treatment is

available, or, if such method exists, the medicine must be of significant benefit to those affected by the condition in

accordance with Regulation (EC) No 141/2000 (the EU Orphan Regulation). Orphan drug designation also entitles a party

to financial incentives such as reduction of fees or fee waivers, as well as protocol assistance from the EMA during the

product development phase, and direct access to the centralized authorization procedure. In addition, ten years of market

exclusivity is granted following receipt of marketing authorization as an orphan medicinal product, meaning that a

competing similar medicinal product for the same therapeutic indication in principle may not enter the market for a period

of 10 years following marketing authorization, subject to specific conditions. To benefit from market exclusivity, a

medicine must maintain its orphan designation at the time of marketing authorization. Each indication with an orphan

designation confers ten years' market exclusivity for the particular indication. This period may be reduced to six years if the

orphan drug designation criteria are no longer met, including where it is shown that the product is sufficiently profitable to

not justify maintenance of market exclusivity.

In December 2015 and July 2020, the EC granted orphan drug designation to imetelstat for the treatment of

MF and MDS, respectively. On March 7, 2025, the EC granted marketing authorization for RYTELO (imetelstat sodium)

as an orphan medicinal product and considered that imetelstat is a new active substance. RYTELO is indicated as

monotherapy for the treatment of adult patients with TD anemia due to very low, low or intermediate risk myelodysplastic

syndromes (MDS) without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory

response to or are ineligible for erythropoietin-based therapy. With the grant of the marketing authorization, RYTELO in

principle is currently entitled to maintain orphan market exclusivity in the EEA  in the approved indication for ten years

post-approval.

In addition, under the European Pediatric Regulation, if we fulfill our pediatric investigation plan agreed

upon with the EMA, we would be eligible to receive an additional two years of market exclusivity

under the European Pediatrics Regulation (Regulation (EC) No 1901/2006).

Prior Collaboration with Janssen Biotech, Inc.

Upon the effective date of termination of the license and collaboration agreement, or the Prior

Collaboration Agreement, with Janssen Biotech, Inc., or Janssen, on September 28, 2018, we regained global rights to

imetelstat and are continuing the development, commercialization and marketing of imetelstat on our own. In accordance

with the termination provisions of the Prior Collaboration Agreement, we have an exclusive worldwide license for

intellectual property developed under the Prior Collaboration Agreement for the further development, commercialization

and marketing of imetelstat, without any economic obligations to Janssen with respect to such license. Janssen has assigned

to us certain intellectual property developed by it under the Prior Collaboration Agreement. We now are responsible for the

costs of maintaining, prosecuting and litigating all imetelstat intellectual property that we own.

Licensing

We have no material license agreements. We have global rights to imetelstat, which was discovered and

developed at Geron.

Manufacturing

A typical sequence of steps in the manufacture of imetelstat drug product includes the following key

components:

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•starting materials, which are well‑defined raw materials that are used to make bulk drug

substance;

•bulk drug substance, which is the active pharmaceutical ingredient in a drug product that

provides pharmacological activity or other direct effect in the treatment of disease; and

•final drug product, which is the finished dosage form that contains the drug substance and is

supplied for patient treatment.

Since September 2018, we have engaged third‑party contract manufacturers and have established a supply

chain to manufacture and supply  imetelstat that meets applicable regulatory standards for current and potential commercial

uses and current and potential future clinical trials.

We do not have direct control over third‑party personnel or operations. These third‑party contract

manufacturers, and/or any other third parties that we may rely upon for the manufacture and/or supply of imetelstat,

typically complete their services on a proposal by proposal basis under master supply agreements and may need to make

substantial investments to enable sufficient capacity increases and cost reductions, and to implement those regulatory and

compliance standards necessary for commercial production and successful Phase 3 clinical trials. These third‑party contract

manufacturers, and/or any other third parties that we may rely upon for the manufacture and/or supply of imetelstat, may

not be able to achieve such capacity increases, cost reductions, or regulatory and compliance standards, and even if they do,

such achievements may not be at a commercially reasonable cost. We are responsible for establishing any long‑term

commitments or commercial supply agreements with any of the third‑party contract manufacturers for imetelstat. The

information provided in this section should be reviewed in the context of the section entitled “Risks Related to

Manufacturing RYTELO (Imetelstat)” under Part I, Item 1A, “Risk Factors” of this Report.

Competition

The pharmaceutical and biotechnology industries are characterized by intense and dynamic competition

with rapidly advancing technologies and a strong emphasis on proprietary products. While we believe our proprietary

oligonucleotide chemistry; experience with the biological mechanisms related to RYTELO, telomeres and telomerase;

clinical data to date indicating potential disease-modifying activity with RYTELO treatment; and knowledge and expertise

around the development of potential treatments for myeloid hematologic malignancies provide us with competitive

advantages, we face competition from many different sources, including major pharmaceutical, specialty pharmaceutical

and biotechnology companies, academic institutions, governmental agencies, and public and private research institutions.

RYTELO is competing with other products and therapies that currently exist, are being developed or will in the future be

developed, some of which we may not currently be aware of.

Competition in Lower-Risk MDS

The current standard of care for the treatment of lower-risk MDS is the use of ESAs as supportive care, and more

recently luspatercept to improve upon disease-associated chronic anemia. Historically, ESAs have been used as a mainstay

of treatment; once no longer effective, serial blood transfusions are often administered, which can cause organ damage due

to iron overload and result in poor outcomes and shorter survival. In recent years, considerable advancements have been

made in the treatment of LR-MDS with the approval of new therapies, expanding indications, and ongoing clinical

investigation of novel agents.

In lower-risk MDS, data from the IMerge Phase 3 clinical trial resulted in FDA approval of RYTELO in June

2024 and EC approval in March 2025 for the treatment of certain patients with lower-risk MDS. IMerge showed

meaningful and durable transfusion independence, activity across MDS patient subtypes, and potential disease-modifying

activity achievable with RYTELO treatment. We believe that these key features are differentiators compared to currently

approved products as well as investigational drugs currently in clinical development.

In lower-risk MDS, RYTELO competes against a number of currently existing therapies, including ESAs (Epoetin

alfa, Procrit; Darbepoetin alfa, Aranesp-Amgen) that are indicated for anemia; immunomodulators, such as Revlimid

(lenalidomide) by Celgene Corporation, or Celgene, a Bristol Myers Squibb, or BMS, company; hypomethylating agents,

such as Vidaza (azacitidine) by BMS and Dacogen (decitabine) by Otsuka America Pharmaceutical, Inc. and other

manufacturers in the U.S. and Janssen in the EU; Inqovi (oral combination of decitabine and cedazuridine) by Astex

Pharmaceuticals, Inc., or Astex, and Taiho Oncology; Tibsovo (ivosidenib), an IDH1 inhibitor, by Servier Pharmaceuticals,

LLC; and Reblozyl (luspatercept), a TGF-beta ligand trap, by BMS. In August 2023, luspatercept was approved for the

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treatment of anemia in ESA-naive adult patients with very low-to intermediate-risk MDS who may require regular RBC

transfusions.

Other therapies currently in Phase 3 development in lower-risk MDS include elritercept (KER-050), a

TGF-beta inhibitor, by Keros Therapeutics, Inc.; and Reblozyl (luspatercept) in non-transfusion-dependent lower-risk MDS

patients, by BMS.

In addition, there are multiple Phase 1 and Phase 2 clinical trials of other agents being developed for lower-

risk MDS, including but not limited to: LB‐100, a PP2A inhibitor by Lixte Biotechnology Holdings, Inc., and bemcentinib,

an AXL inhibitor by BerGenBio. Also, a lower dose of ASTX727, an oral formulation of decitabine and cedazuridine,

referred to as ASTX727 LD, by Astex; ASTX030, an oral formulation of azacitidine and cedazuridine, by Astex; R289, a

dual oral inhibitor of interleukin receptor-associated kinases 1 and 4, or IRAK1/4, by Rigel Pharmaceuticals, Inc.; and a

combination regimen of luspatercept and ESA.

Competition in Relapsed/Refractory MF

The current standard of care for the treatment of Intermediate-2 or High-risk MF is the use of JAK

inhibitors to address the patient’s symptoms. Once JAK inhibitors fail or are no longer effective, a variety of best available

therapies are used since there are no approved treatments for this patient population and median OS is limited.

In Intermediate-2 or High-risk relapsed/refractory MF, data from IMbark suggest potential disease-

modifying activity with RYTELO treatment and a potential meaningful improvement in OS, which is supported in a

comparison to real-world data.

If approved for commercial sale for the treatment of relapsed/refractory MF, RYTELO would compete

against currently approved JAK inhibitors: Jakafi (ruxolitinib) by Incyte Corporation, or Incyte, Inrebic (fedratinib) by

BMS, and OJJAARA (momelotinib) by GlaxoSmithKline plc, or GSK, which was approved in September 2023 for the

treatment of intermediate or high-risk MF, including primary MF or secondary MF (postpolycythemia vera and post-

essential thrombocytopenia), in adults with anemia; and Vonjo (pacritinib), by Sobi, Inc., which was approved in February

2022 for the treatment of adults with intermediate or high-risk primary or secondary MF with a platelet count below 50 ×

109/L. Other treatment modalities for MF include hydroxyurea for the management of splenomegaly, leukocytosis,

thrombocytosis and constitutional symptoms; splenectomy and splenic irradiation for the management of splenomegaly and

co-existing cytopenias; chemotherapy; and pegylated interferon. Drugs for the treatment of MF-associated anemia include

ESAs, androgens, danazol, corticosteroids, thalidomide and lenalidomide. In addition, luspatercept has been used to treat

MF-associated anemia, although the Phase 3 trial did not meet its primary endpoint for RBC-TI.

Other therapies currently in Phase 3 development in MF, some of which may obtain regulatory approval earlier

than RYTELO for MF, include  pelabresib (CPI-0610), a BET inhibitor, by  Novartis AG; and navtemadlin, an MDM2-

inhibitor, by Kartos Therapeutics, Inc. Other approaches for MF currently under investigation that could compete with

RYTELO in the future include luspatercept; zinpentraxin alfa (RG6354, formerly PRM-151), an anti-fibrosis antibody, by

F. Hoffmann-La Roche, Ltd.; INCB160058, a JAK2 inhibitor, by Incyte; AJ1-11095, a JAK2 inhibitor, by Ajax

Therapeutics, Inc.; SLT-5505, a pan-LOX inhibitor, by Syntara Limited; tasquinimod, an S100A9 inhibitor, by Active

Biotech AB; XPOVIO (selinexor), a nuclear export inhibitor, by Karyopharm Therapeutics, Inc.; TL-895, an oral tyrosine

kinase inhibitor, by Telios Pharma, Inc.; pelcitoclax (APG-1252), a dual BCL-2/BCL-XL inhibitor, by Ascentage Pharma;

DISC-0974, a monoclonal antibody against hemojuvelin (HJV) by DISC Management Inc.; elritercept (KER-050) in

combination with ruxolitinib, by Keros Therapeutics; CK0804, an allogeneic T-regulatory cell agent, by Cellenkos, Inc. in

collaboration with Incyte; nuvisertib (TP-3654), an oral PIM kinase inhibitor by Sumitomo Pharma Co., Ltd.; and a

mutated-CALR peptide vaccine, from the Icahn School of Medicine at Mount Sinai.

Government Regulation

Regulation by governmental authorities in the U.S. and other countries is a significant factor in the

development, manufacture, distribution and marketing of RYTELO (imetelstat). Imetelstat will require regulatory approval

by regulatory authorities prior to commercialization in any jurisdictions where it is not yet approved. In particular, potential

human therapeutic products, such as imetelstat, are subject to rigorous preclinical testing,  clinical testing and quality

standards by the FDA and similar regulatory authorities in European and other countries. Various  statutes and regulations

at  the federal and state level—as well as regulations and guidance at the international level—also govern or influence the

testing, manufacturing, safety reporting, labeling, storage, import, export, distribution, sale and recordkeeping related to

such products and their marketing. The process of obtaining these approvals and the subsequent compliance with

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appropriate statutes and regulations require the expenditure of substantial time and money, and there can be no guarantee

that approvals will be granted. Moreover, compliance with government regulations governing personal data and

information security requires the expenditure of substantial time and financial resources. The information provided in this

section should be reviewed in the context of the sections entitled “Risks Related to the Further Development of RYTELO

(Imetelstat)” and “Risks Related to Regulatory Approval of RYTELO” under Part I, Item 1A, “Risk Factors” of this

Report.

United States Food and Drug Administration Regulatory Approval Process

Prior to commencement of clinical trials of new pharmaceutical products in humans, government

authorities generally require the completion of laboratory studies as well as certain preclinical testing in animals to evaluate

the potential efficacy and safety of a product candidate, though, under the 2022 FDA Modernization Act 2.0, FDA has

begun to phase out the requirement for animal testing by incorporating new approval methodologies such as AI-based

computational models, organ-on-a-chip systems, and advanced in vitro assays. The results of animal testing or alternative

models are submitted to the FDA as part of an Investigational New Drug Application, or IND, which must become

effective before clinical testing in humans can begin. The FDA can place an IND on clinical hold at any time, which can

prevent the conduct of a clinical trial or all trials under an IND or it may be a partial hold (e.g., a hold on further

enrollment) until safety concerns or questions are addressed by the IND sponsor to the FDA’s satisfaction.

Typically, a clinical development program is lengthy and involves three phases. In Phase 1, clinical trials

are conducted with a small number of healthy volunteers or patients afflicted with a specific disease to assess safety and to

evaluate the metabolism, pharmacokinetics, and pharmacologic action of the drug in humans, and, if possible, to gain early

evidence on effectiveness. In Phase 2, clinical trials are typically well controlled, closely monitored, and conducted in a

relatively small number of patients, usually involving no more than several hundred subjects to evaluate the effectiveness

of the drug in patients to determine the common short-term side effects and risks associated with the drug.  Phase 2 trials

can be conducted comparing the investigational treatment to a comparator arm, or not. If used, a comparator arm often

includes standard of care therapy. Safety and efficacy data from Phase 2 clinical trials, even if favorable, may not provide

sufficient rationale for proceeding to a Phase 3 clinical trial. In Phase 3, clinical trials are typically large scale, multi‑center,

comparative trials conducted with patients with the disease or condition under study and are intended to gather sufficient

data to demonstrate the efficacy and safety required by the FDA. The FDA closely monitors the progress of each of the

three phases of clinical testing and may, at its discretion, re‑evaluate, alter, suspend, or terminate the trials. Human clinical

trials must be conducted in compliance with Good Clinical Practice, or GCP, regulations and applicable laws, with

informed consent from patients and the oversight of Institutional Review Boards for the protection of human subjects.

Drugs used in clinical trials must be manufactured, packaged and labeled in conformity with current Good Manufacturing

Practices, or cGMP, and applicable laws.

The results of the preclinical and clinical testing of drugs and complete manufacturing information are

submitted to the FDA in the form of an NDA for review and approval prior to commencement of commercial sales.

Submission of an NDA requires the payment of a substantial user fee to the FDA, which may be waived in certain cases. In

responding to an NDA submission, the FDA may approve the drug for commercialization, impose limitations on its

indications for use and labeling, including in the form of Risk Evaluation and Mitigation Strategies or may issue a complete

response letter explaining the reason the NDA cannot be approved in its present form. Even if an NDA is approved, its

sponsor and drug will continue to be  subject to ongoing and pervasive regulatory compliance requirements.

European Union and Other Regulatory Approval Process

Prior to initiating clinical trials in a region outside of the U.S., a clinical trial application must be submitted

and reviewed by the appropriate regulatory authority governing clinical trials in the country in which the trial will be

conducted. Whether or not FDA clearance or approval has been obtained, approval or authorization of a product by

comparable regulatory authorities in the EU and other countries is necessary prior to marketing the product in such

countries. The competent regulatory authorities may impose their own requirements and may refuse to grant an approval,

or may require additional data before granting it, even though the relevant product has been cleared or approved by the

FDA or another authority. As with the FDA, the regulatory authorities in the EU and other developed countries have

lengthy approval processes for pharmaceutical products. The process for gaining approval in particular countries varies, but

it generally follows a similar sequence to that described for FDA approval. In Europe, the EMA and the CHMP provide a

mechanism for EU member states to exchange information on all aspects of product licensing. The EU has established the

EMA for the evaluation of medical products, with a centralized procedure which is mandatory for orphan and oncology

products and which grants a single marketing authorization valid in all EU member states.

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Fraud and Abuse, and Transparency Laws and Regulations

We may also be subject to additional regulation and enforcement by the federal government and by

authorities in the states and foreign jurisdictions in which we conduct our business. These additional regulations could

affect our current and future arrangements with healthcare professionals, principal investigators, consultants, customers and

third‑party payors. Such laws include, without limitation, state and federal bribery/anti‑kickback, the False Claims Act,

privacy and data security laws, and healthcare professionals payment transparency laws.

The federal Anti‑Kickback Statute makes it illegal for any person or entity, including a prescription drug

manufacturer (or a party acting on its behalf) to knowingly and willfully, directly or indirectly, solicit, receive, offer, or pay

any remuneration that is intended to induce the referral of business, including the purchase, order, or lease of any good,

facility, item or service for which payment may be made under a federal healthcare program, such as Medicare, Medicaid

TRICARE, and the Veterans Health Care Program. The term “remuneration” has been broadly interpreted to include

anything of value. Several courts have interpreted the statute’s intent requirement to mean that if any one purpose of an

arrangement involving remuneration is to induce referrals, the Anti‑Kickback Statute has been violated. In addition, a

person or entity does not  need to have actual knowledge of the statute or specific intent to violate, in order to commit a

violation.

Federal civil and criminal false claims and false statement laws, including the federal civil False Claims Act

and its whistleblower or qui tam provisions (which permit private individuals to bring an action on behalf of the

government to enforce the civil False Claims Act), prohibit, among other things, any person or entity from knowingly

presenting, or causing to be presented, for payment to, or approval by, federal programs, including Medicare and Medicaid,

claims for items or services, including drugs, that are false or fraudulent or not provided as claimed. Entities can be held

liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example,

providing inaccurate billing or coding information to customers, promoting a product off‑label, or for providing medically

unnecessary services or items. In addition, a claim including items or services resulting from a violation of the federal Anti-

Kickback Statute constitutes a false or fraudulent claim for purposes of the federal civil False Claims Act. Criminal

prosecution is also possible for making or presenting a false, fictitious or fraudulent claim to the federal government.

The federal Health Insurance Portability and Accountability Act of 1996, or HIPAA, created criminal and

civil liability for, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud any

healthcare benefit program, including private third‑party payors, knowingly and willfully embezzling or stealing from a

healthcare benefit program, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and

willfully falsifying, concealing or covering up a material fact or making any materially false, fictitious or fraudulent

statement in connection with the delivery of or payment for healthcare benefits, items or services.

HIPAA, as amended by the Health Information Technology for Economic and Clinical Health Act, or

HITECH, and their implementing regulations, impose obligations, including mandatory contractual terms, with respect to

safeguarding the privacy, security, transmission and breach reporting of individually identifiable health information, upon

entities subject to the law, such as health plans, healthcare clearinghouses and certain healthcare providers and their

respective business associates and their subcontractors that perform services for them that involve individually identifiable

health information.

The federal Physician Payments Sunshine Act requires certain manufacturers of drugs, devices, biologics

and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance

Program to report annually to the Centers for Medicare & Medicaid Services, or CMS, information related to payments or

other transfers of value made to physicians (defined to include doctors, dentists, optometrists, podiatrists, and

chiropractors), other healthcare professionals (such as physicians assistants and nurse practitioners), and teaching hospitals,

and information related to ownership and investment interests held by physicians and their immediate family members.

Analogous state and foreign laws and regulations, such as state anti‑kickback and false claims laws, may

apply to sales or marketing arrangements and claims involving healthcare items or services reimbursed by

non‑governmental third-party payors, including private insurers. Additionally, we may be subject to state and foreign laws

that require pharmaceutical companies to comply with the pharmaceutical industry’s otherwise voluntary compliance

guidelines and certain industry compliance guidance documents. Further, we may be subject to state and foreign laws that

require drug manufacturers or other pharmaceutical companies to report information related to payments and other

transfers of value to physicians, other healthcare providers and healthcare entities, or marketing expenditures, as well as

state, foreign and local laws that require the registration of pharmaceutical sales representatives; state and foreign laws that

require the reporting of information related to drug pricing; and state, federal and foreign laws governing the privacy and

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security of personal data (including key-coded data and health information), including the European Union’s General Data

Protection Regulation, or EU GDPR, many of which differ from each other in significant ways, thus complicating

compliance efforts.

If our operations are found to be in violation of any of these or any other healthcare regulatory laws that

may apply to us, we may be subject to significant penalties, including the imposition of significant civil, criminal and

administrative penalties, damages, monetary fines, disgorgement, imprisonment, possible exclusion from participation in

Medicare, Medicaid and other federal healthcare programs, reputational harm, diminished profits and future earnings,

additional reporting requirements and oversight if we become subject to a corporate integrity agreement or similar

agreement to resolve allegations of non-compliance with these laws, and curtailment of our operations, any of which could

adversely affect our ability to operate our business and our results of operations. Defending against any such actions can be

costly, time-consuming and may require significant financial and personnel resources. Therefore, even if we are successful

in defending against any such actions that may be brought against us, our business may be impaired.

Data Privacy and Security

In the ordinary course of our business, we process personal or sensitive data. Accordingly, we are, or may

become, subject to numerous data privacy and security obligations, including federal, state, local, and foreign laws,

regulations, guidance, and industry standards related to data privacy and security. Efforts to ensure that our current and

future business arrangements will comply with applicable data privacy and data security laws and regulations will involve

substantial costs. For example, foreign data privacy and security laws (including but not limited to the EU GDPR and UK

GDPR) impose strict significant and complex compliance obligations on entities that are subject to those laws. As one

example, the EU GDPR applies to any company established in the EEA and to companies established outside the EEA that

process personal data in connection with the offering of goods or services to data subjects in the EEA or the monitoring of

the behavior of data subjects in the EEA. These obligations in the EU and UK include limiting the collection and

processing of personal data  to only what is necessary for specified, explicit, and legitimate purposes; requiring a legal

basis for personal data processing; requiring the appointment of a data protection officer in certain circumstances;

increasing transparency obligations to data subjects; requiring data protection impact assessments in certain circumstances;

limiting the duration for which personal data may be retained; increasing rights for data subjects formalizing a heightened

and codified standard for data subject consent, requiring the implementation and maintenance of technical and

organizational safeguards for personal data, mandating data breach notifications to relevant supervisory authority(ies), and

mandating the appointment of representatives in the UK and/or the EU in certain circumstances. Moreover, there have

recently been, and we expect that there will continue to be, new data privacy and security laws, regulations and industry

standards in the U.S. As one example, the California Consumer Privacy Act of 2018, or CCPA, imposes numerous

obligations on covered business. Although the CCPA exempts certain data (such as some data processed in the context of

clinical trials), the CCPA, to the extent applicable to our business and operations, may increase our compliance costs and

potential liability with respect to the personal data we maintain about California residents. The CCPA provides for civil

penalties and a private right of action for data breaches which may include an award of statutory damages. Failure, or

perceived failure, to comply with all applicable obligations could result in enforcement actions, fines, litigation, and other

consequences. See the section titled “We and third parties with whom we work are subject to stringent and changing U.S.

and foreign laws, regulations, rules, contractual obligations, industry standards, policies and other obligations related to

data privacy and security. Our (or the third parties with whom we work) actual or perceived failure to comply with such

obligations could lead to regulatory investigations or actions; litigation; fines and penalties; disruptions of our business

operations; reputational harm; loss of revenue and profits; and other adverse business impacts,” under “Risk Factors” in

Part I, Item 1A of this Report for additional information about the laws and regulations to which we may become subject

and about the risks to our business associated with such laws and regulations.

Coverage and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidate that

receives regulatory approval. In the U.S. and markets in other countries, sales of RYTELO will depend, in part, on the

extent to which third‑party payors provide coverage and establish adequate reimbursement levels.

In the U.S., third‑party payors include federal and state healthcare programs, government authorities,

private managed care providers, private health insurers, employer health plans, and other organizations. Decisions

regarding the extent of coverage and amount of reimbursement to be provided are made on a plan-by-plan basis.

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Reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s

determination that a product is safe, effective and medically necessary; appropriate for the specific patient; cost-effective;

supported by peer-reviewed medical journals; included in clinical practice guidelines; and neither cosmetic, experimental,

nor investigational. A third-party payor could also require that certain lines of therapy be completed or failed prior to

reimbursing our therapy. The principal decisions about reimbursement for new medicines are typically made by CMS.

CMS decides whether and to what extent products will be covered and reimbursed under Medicare and private payors tend

to follow CMS to a substantial degree. Third-party payors determine which products and procedures they will cover and

establish reimbursement levels. Third‑party payors are increasingly challenging the price, examining the medical necessity

and reviewing the cost‑effectiveness of medical drug products and medical services, in addition to questioning their safety

and efficacy. Such payors may limit coverage to specific drug products on an approved list, also known as a formulary,

which might not include all of the FDA‑approved drugs for a particular indication. We may need to conduct expensive

pharmacoeconomic studies in order to demonstrate the medical necessity and cost‑effectiveness of RYTELO, in addition to

the costs required to obtain the FDA approvals. Nonetheless, RYTELO may not be considered medically necessary or

cost‑effective. Moreover, the process for determining whether a third‑party payor will provide coverage for a drug product

may be separate from the process for setting the price of a drug product or for establishing the reimbursement rate that such

a payor will pay for the drug product. A payor’s decision to provide coverage for a drug product does not imply that an

adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a drug product

does not assure that other payors will also provide coverage for the drug product, as there is no uniform coverage and

reimbursement policy among third-party payors in the U.S. Adequate third‑party reimbursement may not be available to

enable us to maintain price levels sufficient to realize an appropriate return on our investment in RYTELO. Even if a third-

party payor covers a particular product or procedure, the resulting reimbursement payment rates may not be adequate.

Coverage policies and third-party payor reimbursement rates may change. Thus, even if favorable coverage and

reimbursement status is attained, less favorable coverage policies and reimbursement rates may be implemented in the

future. These third-party payors are increasingly reducing coverage and reimbursement for medical products, drugs and

services. In addition, the U.S. government, state legislatures and foreign governments have continued implementing cost-

containment programs, including price controls, restrictions on coverage and reimbursement and requirements for

substitution of generic products. Adoption of price controls and cost-containment measures, and adoption of more

restrictive policies in jurisdictions with existing controls and measures, could further limit sales of any product. Decreases

in third-party reimbursement for any product or a decision by a third-party payor not to cover a product could reduce

demand for the product and also have a material adverse effect on future sales.

Healthcare Reform

There has been increasing legislative and enforcement interest in the U.S. with respect to specialty drug

pricing practices. Specifically, there have been several recent U.S. Congressional inquiries, Presidential executive orders,

and federal and state legislative activity designed to, among other things, bring more transparency to drug pricing, review

the relationship between pricing and manufacturer patient programs, reduce the cost of drugs under Medicare, and reform

government program reimbursement methodologies for drugs. For example, the Inflation Reduction Act of 2022, or IRA,

which, among other things, (i) directs the Department of Health and Human Services, or HHS, to negotiate the price of

certain high-expenditure, single-source drugs and biologics covered under Medicare that have been on the market for at

least seven years (the “Medicare Drug Price Negotiation Program”), and subject drug manufacturers to civil monetary

penalties and a potential excise tax by offering a price that is not equal to or less than the negotiated “maximum fair price”

for such drugs and biologics under the law, and (ii) imposes rebates with respect to certain drugs and biologics covered

under Medicare Part B or Medicare Part D to penalize price increases that outpace inflation. The IRA permits HHS to

implement many of these provisions through guidance, as opposed to regulation, for the initial years. These provisions

began to take effect progressively in fiscal year 2023. The agreed upon prices of the first ten drugs that were subject to

price negotiations took effect on January 1, 2026, although the Medicare Drug Price Negotiation Program is currently

subject to legal challenges. In2025, HHS selected fifteen additional products covered under Part D for price negotiation and

announced “maximum fair prices” that will go into effect on January 1, 2027. Each subsequent year, more Part B and Part

D products will become subject to the Medicare Drug Price Negotiation Program. Further, on December 7, 2023, an

initiative was announced to evaluate whether the use of march-in authorities under the Bayh-Dole Act could impact the

price of or promote equitable access to prescription drugs. On December 8, 2023, the National Institute of Standards and

Technology published for comment a Draft Interagency Guidance Framework for Considering the Exercise of March-In

Rights, or the Draft Framework, which contemplated the price of a product as one of several factors an agency could use

when deciding to exercise march-in rights. The Bayh-Dole Act does not include product pricing as an express basis for

exercising march-in rights, and prior rulemaking initiatives have not adopted proposed regulatory revisions that would have

permitted the exercise of march-in rights on the basis of product pricing.  While march-in rights have not previously been

exercised, it is uncertain if that will continue if the Draft Framework ultimately is adopted. Additionally, at the state level,

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legislatures have increasingly passed legislation and implemented regulations designed to control pharmaceutical and

biological product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product

access and marketing cost disclosure and transparency measures, and, in some cases, to encourage importation from other

countries and bulk purchasing.

The U.S. and some foreign jurisdictions are considering or have enacted legislative and regulatory

proposals to contain healthcare costs, as well as to improve quality and expand access.  For example, the IRA also

eliminated the “donut hole” under the Medicare Part D program by significantly lowering the beneficiary maximum out-of-

pocket cost and creating a new manufacturer discount program. It is possible that the IRA will be subject to additional

judicial or Congressional challenges in the future. We expect that other healthcare reform measures that may be adopted in

the future may result in more rigorous coverage criteria and lower reimbursement, and additional downward pressure on

the price that may be charged for RYTELO. It is unclear how any such healthcare reform measures will impact the

pharmaceutical industry.

In addition, aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which

went into effect beginning on April 1, 2013 under provisions of the Budget Control Act of 2011 will stay in effect through

2032 unless additional Congressional action is taken.

Information About Our Executive Officers

The following table sets forth certain information with respect to our executive officers and other members

of management as of January 31, 2026:

Harout Semerjian has served as our President and Chief Executive Officer and member of our Board

since August, 2025.  Prior to joining the Company, Mr. Semerjian  served as President and Chief Executive Officer of

GlycoMimetics, Inc., a late-stage clinical biotechnology company subsequently combined with Crescent Biopharma, Inc.,

from August 2021 until February 2025. He also previously served on the board of directors of GlycoMimetics until

February 2025. Since October 2023, Mr. Semerjian has also served as a member of the board of directors at the

Biotechnology Innovation Organization. From June 2020 to July 2021, Mr. Semerjian served as an independent healthcare

consultant at Emerge Bio Consulting, advising private equity firms on healthcare investment projects. Mr. Semerjian

served as President and Chief Executive Officer of Immunomedics Inc., a biotechnology company specializing in antibody-

drug conjugates for cancer treatment, from April 2020 to May 2020, prior to its acquisition by Gilead Sciences, Inc. From

March 2018 to April 2020, Mr. Semerjian served as Executive Vice President, Chief Commercial Officer of Ipsen Pharma,

a global, pharmaceutical company focusing on areas of high unmet medical need, leading and executing Ipsen’s global

commercial strategy and functions across oncology, neurosciences and rare diseases. From February 2017 to February

2018, he served as President and Head of Ipsen’s Specialty Care International Region & Global Franchises. From 1994 to

January 2017, Mr. Semerjian held several commercial, marketing and sales positions of increasing responsibility within

Novartis Pharmaceuticals, a global pharmaceutical company, including serving as Senior Vice President and Global

Launch Leader for KISQALI®, in regional vice president hematology and oncology roles in the U.S., MENA and the

Nordics, and as global brand director for Gleevec®, as well as for Merck, a global pharmaceutical company, and Solvay, a

multinational chemical and materials company. Mr. Semerjian holds an MBA from Cornell University and Queen's

University in Canada, and a B.S. in Biology from Lebanese American University.

Michelle Robertson has served as our Executive Vice President, Chief Financial Officer and Treasurer

since September 2023. Prior to joining Geron, she served as the Chief Financial Officer and Treasurer of Editas Medicine,

Inc., a CRISPR genome editing company, from January 2020 to May 2023. Before that, she served as Chief Financial

Officer of Momenta Pharmaceuticals, Inc. from 2018 until 2020, when Momenta was acquired by Johnson & Johnson.

Prior to joining Momenta, Ms. Robertson held multiple commercial finance roles of increasing responsibility, including

Vice President, Oncology Finance for Baxalta Incorporated following its spin-off from Baxter International Inc., from 2015

to 2016; Head of Financial Planning and Analysis and Operations Excellence at Ironwood Pharmaceuticals, Inc. from 2012

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to 2015; and various finance and commercial operations roles at Genzyme Corporation (acquired by Sanofi). She also

currently serves as a member of the board of directors and as the chair of the audit committee for Verastem, Inc., a

publicly-traded biopharmaceutical company. Ms. Robertson received her B.S. in Finance and A.S. in Accounting and

Management from Bentley University.

Joseph Eid, M.D., has served as our Executive Vice President Research and Development since November

2024. Prior to joining Geron, Dr. Eid served as President, Research and Development for Dragonfly Therapeutics, Inc., a

clinical stage biopharmaceutical company, with overall responsibilities for Dragonfly's discovery and clinical research

strategy and execution, from February 2023 to March 2024. Before joining Dragonfly Dr. Eid served as Executive Vice

President, Chief Medical Officer at Luzsana Biotechnology, Inc., a pharmaceutical company and a subsidiary of Hengrui

Pharmaceuticals, from October 2021 to September 2022. Prior to his biotechnology leadership roles, Dr. Eid served as

Senior Vice President and Head, Global Medical Affairs for Bristol Myers Squibb, or BMS, from 2017 to 2021, where he

led global medical affairs across four therapeutic franchises. Prior to BMS, Dr. Eid spent nine years at Merck, first at

Merck Research Labs, where he led the first-in-human strategy of their global KEYTRUDA® program, and then at Merck

Global Human Health, where he built Merck's global oncology medical affairs team. Dr. Eid started his pharmaceutical

career at Hoffmann La Roche, where he was responsible for both early- and late-stage assets and led several clinical teams.

Prior to entering the biopharmaceutical industry, Dr. Eid was an Assistant Professor in the hematology department of

Robert Wood Johnson Medical School in New Jersey from 1999 to 2004 and as a volunteer, through 2019. Dr. Eid

received his M.D. from Saint Joseph University, Faculty of Medicine, and serves on ALSAC/St Jude Children’s Research

Hospital board, and on the board of Angle PLC, a liquid biopsy company.

Ahmed ElNawawi has served as our Executive Vice President, Chief Commercial Officer since October

2025. Prior to joining the Company, Mr. ElNawawi most recently served as Senior Vice President and U.S. Commercial

Head at Stemline Therapeutics, a wholly-owned subsidiary of the Menarini Group, from April 2022 until October 2025,

where he led the U.S. commercial organization spanning the sales, marketing, market access, commercial excellence, and

data analytics functions. Before joining Stemline, Mr. ElNawawi spent nearly two decades at Novartis Oncology, from

April 2004 until April 2022, in roles of increasing responsibility, including Oncology General Manager for Romania and

the Gulf region, Executive Director for U.S. Melanoma, and Global Indication Lead for both breast and lung cancer.

Earlier in his career, he held commercial and marketing positions in Egypt, the UAE, and Saudi Arabia with Merck and

Schering-Plough. He received an MBA from the University of Leicester and a B.S. in Clinical Pharmacy from Ain Shams

University in Cairo, Egypt.

Human Capital

Corporate Values

Fostering and maintaining a strong, healthy culture is a key strategic focus. We recognize and value the

unique strengths of each of our team members, and the impact and contributions of every employee.

Our core values are the foundational principles of our organization. These values reflect who we are, how

we work and the way our employees interact with one another, our partners, our communities, and our shareholders. They

are the essential tenets that guide our business decisions, govern our relationships, both internally and externally, and

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articulate what we stand for and who we are. These values dictate the ways in which we interact, work and communicate,

how we resolve conflicts and ultimately, how we strive to make Geron successful.

Our team of talented professionals is the foundation of our company and fuels our historical and

prospective achievements for patients. We consider the intellectual capital of our employees to be an essential driver of our

business and key to our future opportunities. As of December 31, 2025, we had 258 full‑time employees. However, in

December 2025, we announced a strategic restructuring plan that is intended to position us for long-term value creation and

improve our financial discipline. The restructuring plan will result in a reduction in headcount of approximately one-third

of our workforce. We anticipate that the restructuring plan will be substantially completed in the first quarter of 2026. See

Note 16 on Restructuring in Notes to Consolidated Financial Statements of this Report for additional information. Every

employee plays a vital role in furthering our business goals and advancing the development and delivery of our novel

medicine to patients.

In addition to our employee base, we have established, and expect to continue to establish, consulting

agreements with drug development professionals, clinicians, attorneys and regulatory experts with experience in numerous

fields, including clinical science, biostatistics, clinical operations, pharmacovigilance, quality, manufacturing and

regulatory affairs.

To succeed in our mission, we must attract, recruit, retain, develop and motivate qualified clinical,

nonclinical, commercial, scientific, manufacturing, regulatory, management and other personnel needed to support our

business and operations. As a biotechnology company with office locations in the San Francisco Bay Area and northern

New Jersey, and with remote employees throughout the U.S., we operate in a highly competitive industry and geographies

for employee talent. We maintain a comprehensive dashboard of measurements, including recruitment productivity,

employee engagement scores, total rewards benchmarking, participation rates and satisfaction scores for internal training,

turnover rates and exit interview results, to guide our human capital management efforts.

We believe that our ability to attract highly skilled and talented employees in a competitive labor market is

enhanced by nurturing our workplace culture, providing competitive compensation and benefits programs and supporting

employee career development and related management training. To that end, we continue to invest resources and energy

into being an employer of choice – attracting and engaging individuals who are innovative, curious, driven, diligent,

collaborative and of the highest integrity and ethics. Some of our key efforts in this area and management of our human

capital assets generally are described here.

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Compensation and Benefits

Our compensation philosophy is to provide pay and benefits that are competitive in the biotechnology and

pharmaceutical industry where we compete for talent. We monitor our compensation programs closely and review them

annually to provide what we consider a competitive mix of compensation and health, welfare and retirement benefits for all

our employees. Our compensation package for all employees includes market-competitive base salaries, eligibility for

annual performance bonuses or incentive compensation for field- based roles, and equity grants. Annual cash bonus

opportunity and equity compensation increase as a percentage of total compensation based on level of responsibility.

Actual bonus payouts for annual performance bonus are generally based on a combination of achievement of our annual

corporate goals and individual performance, with our CEO’s annual performance bonus being based entirely on the level of

achievement of our annual corporate goals. All regular-status, full-time employees are eligible to participate in our

comprehensive benefit program, pursuant to plan terms and conditions. Plan choices include medical, dental, vision, life

insurance, flexible spending accounts, short and long-term disability insurance, a 401(k) retirement savings plan with a

discretionary matching employer contribution, and an employee stock purchase plan. We also provide regular-status, full-

time employees with a generous time off program that includes vacation, sick, holiday, and paid leave for certain life

events.

Every year, we undertake a detailed review of our compensation by position and level and make

adjustments necessary to ensure that we continue to provide competitive compensation. We publish pay ranges in all job

postings for jobs as required by various states’ pay disclosure requirements.

Corporate Culture

We pride ourselves on an open culture that respects co-workers, values employees’ health and well-being

and fosters professional development. We support employee growth and development in a variety of ways, including with

group training, individual mentoring and coaching, conference attendance and tuition reimbursement. Our management

conducts annual employee engagement surveys and reports to our board of directors on human capital management topics,

including corporate culture, employee development and retention, and compensation and benefits. Similarly, our board of

directors regularly provides input on important decisions relating to these matters, including with respect to employee

compensation and benefits, talent retention and development.

During 2025, we furthered the development of our hybrid workforce program that provides a variety of

virtual and in-person collaboration opportunities, such as leadership training and coaching resources. Since 2021, we have

utilized a peer-centric employee recognition program to empower employees to champion our workplace culture and

values, and promote direct praise to peers. In addition, we have implemented a reward program that enables managers to

recognize employees who have demonstrated exceptional performance.

Corporate Responsibility Efforts

Our commitment to corporate responsibility is integrated throughout our business and informed by our

values and ambition to change lives by changing the course of blood cancer. To support lower-risk MDS patients eligible

for RYTELO, we have a patient support program called REACH4RYTELO that can help patients navigate access and

coverage. Our corporate responsibility initiatives reflect our commitment to making a difference for blood cancer patients

and health care providers who care for them through RYTELO. Our corporate responsibility priorities also reflect our

commitment to fostering a strong culture for employees and governing with integrity to advance our mission and create

value for stockholders. We review our corporate responsibility practices and disclosures on an ongoing basis.

Communication and Engagement

We believe that part of what sets us apart from other companies is our culture and, in particular, our focus

on providing timely and transparent communications and creating a strong sense of belonging and inclusiveness. We

engage in periodic in-office and in-person meetings and interactions, as well as in-office and in-person training and

development opportunities, to encourage cross-functional team-building and collaboration, in conjunction with which

many of our teams engage in group lunches and dinners. We held a summer contest that encouraged our employees to

share summer travel experiences and special events, building rapport and strengthening employee relationships, and we

conduct organizational and team-specific holiday events to promote connectivity among our employees. We share

information and news with employees through quarterly all-hands meetings, monthly newsletters to employees, social

media posts on our intranet and outward facing social media sites, such as LinkedIn, and regular employee chats with our

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Chief Executive Officer and other members of senior management. We survey our employees each year to measure their

level of engagement at the Company. Our employee engagement scores have remained relatively steady over the past three

years. These surveys provide rich feedback each year that helps us to continue to grow our culture and make Geron a great

place to work.

Health, Wellness and Safety

We offer benefits that promote our employees’ whole health and wellness, including reimbursement for

certain wellness costs, external support from our employee assistance programs and mental wellness services, which covers

therapy and/or coaching for our employees and their dependents, including high school and college-aged children.

None of our employees is subject to a collective bargaining agreement or represented by a trade or labor

union. We consider our relations with our employees to be good.

Corporate and Available Information

Geron Corporation was incorporated in the State of Delaware on November 28, 1990. Geron UK Limited

was incorporated in the United Kingdom on September 29, 2021. Geron Netherlands B.V. was incorporated in the

Netherlands on February 17, 2023. Our principal executive offices are located at 919 E. Hillsdale Blvd., Suite 250, Foster

City, CA 94404, and our telephone number is 650-473-7700. Our website address is http://www.geron.com.

We file or furnish electronically with the U.S. Securities and Exchange Commission, or the SEC, annual

reports on Form 10-K, quarterly reports on Form 10-Q, current reports on Form 8-K and amendments to those reports filed

or furnished pursuant to Section 13(a) or 15(d) of the Securities Exchange Act of 1934, as amended, or the Exchange Act.

We make copies of these reports available free of charge through the “SEC Filings” tab on the “Investors &

Media” page of our website as soon as reasonably practicable after we file or furnish them with the SEC.

Information contained on or accessible through our website is not incorporated into, and does not form a

part of, this Report or any other report or document we file with the SEC, and any references to our website are intended to

be inactive textual references only.