Skip to main content

GERON CORP

For the period ended Sep 30, 2026. Filed Nov 4, 2026.

View on SEC.gov

About this filing

A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2026 · Filed Nov 4, 2026

GERN$0.99+4.2%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2026-06-30; filed 2026-08-05.

0000886744-26-000037

Item 2. : Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-04.

0000886744-26-000041

Item 2. : Management’s Discussion and Analysis of Financial Condition and Results of Operations

The baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.

Compared 106 previous paragraphs and 107 current paragraphs.

71 unchanged; 32 reworded; 4 added; 0 removed; 3 previous and 0 current paragraphs rearranged.

Tables are not compared: 4 previous and 4 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.

A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.

Added paragraphs (4)

Current report

Effective November 1, 2026, we revised our returned goods policy to significantly limit the circumstances under which customers may return RYTELO. As a result, we reduced our estimated product returns reserve during the three months ended September 30, 2026, resulting in a reduction of gross-to-net deductions.

Current report

In September 2026, the Company entered into agreements with a third-party service provider to support the commercial launch of RYTELO in Germany and France. The arrangements include medical and commercial field personnel and related operational support, and have initial terms through December 31, 2028. The underlying agreements may be terminated for convenience by either party upon nine months’ prior written notice. During the notice period, monthly fees may not be less than the average monthly fees earned during the preceding 12 months. Upon termination, the Company may also be responsible for services performed through the termination date, approved noncancelable or nonrefundable commitments, certain vehicle lease termination charges, and applicable severance and employee-transition costs. After the initial term, agreements automatically renew for successive 12-month periods.

Current report

In September 2026, the Company entered into a new lease agreement for an office space in Parsippany, New Jersey. The new lease has an initial term of approximately eight and one-half years following commencement, with an option to extend the lease for an additional five years. Lease commencement is expected to occur upon substantial completion of certain landlord-funded improvements, which is currently expected in the first quarter of 2027. Concurrent with entering into the new lease, the Company entered into an agreement to terminate its existing lease for an office space in Parsippany, New Jersey. The existing lease will terminate, without a termination fee, upon substantial completion of the landlord’s work under the new lease. The new lease provides for initial annual base rent of approximately $0.4 million, subject to annual increases over the lease term.

Current report

In October 2019, we entered into an operating lease agreement for office space located in Foster City, California, or the Foster City Lease. The Foster City Lease commenced on March 10, 2020, and its initial term extends through June 2027, with an option to extend the lease for an additional five years. In October 2026, we notified the landlord that we do not intend to exercise the five-year renewal option. Accordingly, the Foster City Lease is expected to expire in June 2027 in accordance with its existing terms.
Reworded paragraphs (32)

Previous wording

In March 2025, we were granted marketing authorization by the European Commission, or EC, for RYTELO as a monotherapy for the treatment of adult patients with TD anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic, or non-del 5q, abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. We are preparing for the planned commercialization of RYTELO in select EU markets in 2026. At this time, we are working 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 U.S. through approved Named Patient Programs, or NPPs, in 2025, we partnered with Tanner Pharma, a distributor with broad global reach to support patient access. To date, product revenue pursuant to NPPs have been minimal.

Current wording

In March 2025, we were granted marketing authorization by the European Commission, or EC, for RYTELO as a monotherapy for the treatment of adult patients with TD anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic, or non-del 5q, abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy. To support the commercialization and marketing of RYTELO in the EU, we have engaged experienced third parties, including a commercialization partner, to assist with critical activities, including reimbursement, Health Technology Assessment, or HTA, submissions, market access and distribution, a contracted sales force and recording of sales. We have initiated a gated commercial launch in targeted European markets, with a commercialization partner and a related contracted sales force, with availability expected in Germany by the end of 2026 and in France in 2027. In addition, to enable paid access for patients outside the U.S. through approved Named Patient Programs, or NPPs, in 2025, we partnered with Tanner Pharma, a distributor with broad global reach. To date, product revenue generated through NPPs has been minimal.

Previous wording

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 with overall survival, or OS, as the primary endpoint. As of September 2025, the trial was fully enrolled. Based on our current planning 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.

Current wording

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. In addition to lower-risk MDS, we are developing imetelstat for the treatment of other myeloid hematologic malignancies, but there can be no assurance that we will obtain and maintain the necessary regulatory approvals to market RYTELO for any additional indications. In this regard, in October 2026, we announced our decision to discontinue our Phase 3 IMpactMF clinical trial 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. The decision to discontinue the Phase 3 IMpactMF trial was based on a recommendation from an independent Data Monitoring Committee, or DMC, following the DMC’s conclusion that the trial was unlikely to meet the primary endpoint of overall survival. No new safety signals that change the known safety profile of imetelstat or require additional safety monitoring were observed in the imetelstat arm of the Phase 3 IMpactMF. Given the discontinuation of the Phase 3 IMpactMF trial, we will be unable to pursue any regulatory approvals for the relapsed/refractory MF indication and we will otherwise not receive any return on, or recoup our investment in the relapsed/refractory MF indication. Moreover, the development of imetelstat for the treatment of other myeloid hematologic malignancies is in the early stages and we do not expect to receive any regulatory approvals to market RYTELO for any additional indications for a number of years, if ever. Accordingly, we will remain wholly dependent on the commercialization of RYTELO in lower-risk MDS for the foreseeable future.

Previous wording

Since our inception, we have primarily financed our operations through the sale of equity securities, draw downs on our debt facilities, cash generated from sales of RYTELO, interest income on our marketable securities, payments we received under the Royalty Pharma Agreement and our prior collaborative and licensing arrangements. As of June 30, 2026, we had approximately $326.9 million in cash, cash equivalents, restricted cash and marketable securities.

Current wording

Since our inception, we have primarily financed our operations through the sale of equity securities, draw downs on our debt facilities, cash generated from sales of RYTELO, interest income on our marketable securities, payments we received under the Royalty Pharma Agreement and our prior collaborative and licensing arrangements. As of September 30, 2026, we had approximately $339.4 million in cash, cash equivalents, restricted cash and marketable securities.

Previous wording

We began commercializing RYTELO in June 2024, and the commercial potential of and our ability to successfully commercialize RYTELO remains unproven. Our success in commercializing RYTELO will require, among other things, effective sales, marketing, manufacturing, distribution, information systems and pricing strategies, as well as compliance with applicable laws and regulations. Prior to our commercialization of RYTELO, substantially all of our revenues were generated from payments under prior collaboration agreements, and milestones, royalties and other revenues from our licensing arrangements. We reported a small profit for the year ended December 31, 2015, and we have not reported any profit since. We have incurred significant net losses since our inception in 1990, resulting principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations. As of June 30, 2026, we had an accumulated deficit of approximately $1.9 billion.

Current wording

We began commercializing RYTELO in June 2024, and the commercial potential of and our ability to successfully commercialize RYTELO in lower-risk MDS remains unproven. Our success in commercializing RYTELO will require, among other things, effective sales, marketing, manufacturing, distribution, information systems and pricing strategies, as well as compliance with applicable laws and regulations. Prior to our commercialization of RYTELO, substantially all of our revenues were generated from payments under prior collaboration agreements, and milestones, royalties and other revenues from our licensing arrangements. We reported a small profit for the year ended December 31, 2015, and we have not reported any profit since, with the exception of net income reported in the three months ended September 30, 2026. Our ability to maintain profitability is uncertain. We have incurred significant net losses since our inception in 1990, resulting principally from costs incurred in connection with our research and development activities and from general and administrative costs associated with our operations. As of September 30, 2026, we had an accumulated deficit of approximately $1.9 billion.

Previous wording

On November 1, 2024, we entered into a loan agreement, or the Pharmakon Loan Agreement, with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, which are investment funds managed by Pharmakon Advisors, LP, and BioPharma Credit PLC, as collateral agent. We drew the Tranche A Loan of $125.0 million on November 1, 2024, a portion of which was utilized to repay all outstanding indebtedness associated with the Hercules Loan Agreement. The Pharmakon Loan Agreement provided for two additional committed term loan tranches, which were no longer available as of August 1, 2026. The Term Loans mature on November 1, 2029. The Term Loans bear interest at a variable rate per annum equal to 5.75% plus three-month SOFR with a SOFR floor of 3.00%. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information on the Pharmakon Loan Agreement.

Current wording

On November 1, 2024, we entered into a loan agreement, or the Pharmakon Loan Agreement, with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, which are investment funds managed by Pharmakon Advisors, LP, and BioPharma Credit PLC, as collateral agent. We drew the Tranche A Loan of $125.0 million on November 1, 2024, a portion of which was utilized to repay all outstanding indebtedness associated with the Hercules Loan Agreement. The Tranche A Loan matures on November 1, 2029 and bears interest at a variable rate per annum equal to 5.75% plus three-month SOFR with a SOFR floor of 3.00%. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information on the Pharmakon Loan Agreement.

Previous wording

The significance of future losses, future revenues and any potential future profitability will depend primarily on the clinical and commercial success of RYTELO, our sole product. In this regard, our ability to generate meaningful revenue from product sales and achieve profitability is wholly dependent on our ability to successfully commercialize RYTELO in the U.S. for lower-risk MDS or to expand its indications of use. We have seen and may continue to see variability in RYTELO sales trends and resulting revenue.

Current wording

The significance of future losses, future revenues and any potential future profitability will depend primarily on the clinical and commercial success of RYTELO, our sole product. In this regard, our ability to generate meaningful revenue from product sales and achieve profitability is wholly dependent on our ability to successfully commercialize RYTELO for lower-risk MDS or to expand its indications of use. We have seen and may continue to see variability in RYTELO sales trends and resulting revenue.

Previous wording

Our commercial strategy is designed such that RYTELO reaches eligible patients when they are most likely to benefit. Our commercial execution is focused on targeted engagement with high-volume accounts that treat earlier-line patients, investment in non-personal promotion and third-party education to further consistent, high-quality messaging across multiple touchpoints, and cross-functional execution of effective account management. However, our strategy to drive sales growth and our ongoing commercialization efforts have not to date achieved and may not in the future achieve meaningful sales growth, which may require us to, among others, further adjust or amend our commercialization strategy and plans and incur significant expenses, and there can be no assurance that we will be able to grow RYTELO net product revenue in future periods. In particular, our strategy may not drive new patient starts across the breadth of the eligible patient population in RYTELO's approved indication, particularly across appropriate second-line patients in RYTELO's approved indication, in a timely manner or at all, or the duration of therapy could be shorter than we expect, each of which would limit RYTELO’s growth potential and could preclude or delay our ability to generate meaningful revenue from product sales and to achieve profitability.

Current wording

Our commercial strategy is designed such that RYTELO reaches eligible patients in its approved indication when they are most likely to benefit. Our commercial execution is focused on targeted engagement with high-volume accounts that treat earlier-line patients, investment in non-personal promotion and third-party education to further consistent, high-quality messaging across multiple touchpoints, and cross-functional execution of effective account management. However, our strategy to drive sales growth and our ongoing commercialization efforts have not to date achieved and may not in the future achieve meaningful sales growth, which may require us to, among others, further adjust or amend our commercialization strategy and plans and incur significant expenses, and there can be no assurance that we will be able to grow RYTELO net product revenue in future periods. In particular, our strategy may not drive new patient starts across the breadth of the eligible patient population in RYTELO's approved indication, particularly across appropriate second-line patients in RYTELO's approved indication, in a timely manner or at all, or the duration of therapy could be shorter than we expect, each of which would limit RYTELO’s growth potential and could preclude or delay our ability to generate meaningful revenue from product sales and to achieve sustained profitability.

Previous wording

In addition, in an effort to expand its indications of use, we are also developing RYTELO for the treatment of several myeloid hematologic malignancies that will continue to require additional time and significant investment in clinical trials to complete. We also expect to continue to seek regulatory approvals of RYTELO in jurisdictions outside of the U.S., such as our recent marketing authorization in the EU, and to establish arrangements with third parties to assist us in the commercialization of RYTELO in such jurisdictions. As a result, we expect research and development expenses and selling, general and administrative expenses to continue to be substantial as we continue to support the commercialization of RYTELO in the U.S. and further development of RYTELO, including the conduct and completion of our IMpactMF Phase 3 clinical trial, as well as our ongoing Phase 1 IMproveMF combination clinical trial in frontline MF, our Phase 2 investigator-led IMpress clinical trial in higher-risk MDS and acute myeloid leukemia, and our Phase 1/2 investigator-led IMAGINE clinical trial in relapsed/refractory acute myeloid leukemia, and as we pursue paths to make RYTELO available to eligible LR-MDS patients outside of the U.S., including in the EU.

Current wording

In addition, in an effort to expand its indications of use, we are also developing RYTELO for the treatment of several myeloid hematologic malignancies that will continue to require additional time and significant investment in clinical trials to complete. Moreover, we may continue to experience significant setbacks in advanced clinical trials, even after promising results in earlier trials, which often occur in later-stage clinical trials. For example, notwithstanding the improvement in overall survival and potential disease-modifying activity observed in our Phase 2 IMbark clinical trial, we recently announced our decision to discontinue our Phase 3 IMpactMF clinical trial following the DMC’s conclusion that the trial was unlikely to meet the primary endpoint of overall survival. As a result, we will be unable to expand RYTELO’s indication to use to the relapsed/refractory MF indication and we will otherwise not receive any return on or recoup our investment in the relapsed/refractory MF indication. We also expect to continue to seek regulatory approvals of RYTELO in lower-risk MDS in jurisdictions outside of the U.S., such as our recent marketing authorization in the EU, and to establish arrangements with third parties to assist us in the commercialization of RYTELO in such jurisdictions. In this regard, we have initiated a gated commercial launch in targeted European markets with a commercialization partner, with availability expected in Germany by the end of 2026 and in France in 2027. As a result of these current and planned activities, we expect research and development expenses and selling, general and administrative expenses to continue to be substantial as we continue to support the commercialization of RYTELO in the U.S. and the EU and the further development of RYTELO, including the conduct and completion of our Phase 1 IMproveMF combination clinical trial in frontline MF, our Phase 2 investigator-led IMpress clinical trial in higher-risk MDS and acute myeloid leukemia, and our Phase 1/2 investigator-led IMAGINE clinical trial in relapsed/refractory acute myeloid leukemia, and as we continue our efforts to make RYTELO available to eligible lower-risk MDS patients outside of the U.S., such as our recently-initiated gated commercial launch in targeted European markets.

Previous wording

Our critical accounting policies are described in Item 7, “Critical Accounting Policies and Estimates” in our 2025 Form 10-K. There have been no significant changes in our critical accounting policies and estimates during the three and six months ended June 30, 2026, as compared to the critical accounting policies and estimates disclosed in our 2025 Form 10-K.

Current wording

Our critical accounting policies are described in Item 7, “Critical Accounting Policies and Estimates” in our 2025 Form 10-K. There have been no significant changes in our critical accounting policies and estimates during the three and nine months ended September 30, 2026, as compared to the critical accounting policies and estimates disclosed in our 2025 Form 10-K.

Previous wording

Product revenue, net for the three and six months ended June 30, 2026, was approximately $57.5 million and $109.2 million, respectively, compared to $49.0 million and $88.4 million for the three and six months ended June 30, 2025, respectively. Product revenue, net increased by $8.5 million and $20.8 million during the three and six months ended June 30, 2026, respectively, compared to the same periods in 2025, primarily due to increased sales volumes and, to a lesser extent, a higher selling price, partially offset by higher gross-to-net adjustments. The increase in sales volume in both periods was primarily driven by a higher number of patients on therapy.

Current wording

Product revenue, net for the three and nine months ended September 30, 2026 was approximately $60.1 million and $169.4 million, respectively, compared to $47.2 million and $135.6 million for the three and nine months ended September 30, 2025, respectively. Product revenue, net increased by $12.9 million and $33.7 million during the three and nine months ended September 30, 2026, respectively, compared to the same periods in 2025, primarily due to increased sales volumes and, to a lesser extent, a higher selling price, partially offset by higher gross-to-net adjustments. The increase in sales volume in both periods was primarily driven by a higher number of accounts and patients on therapy.

Previous wording

Total gross-to-net adjustments for both the three and six months ended June 30, 2026 was 20.7% of gross product revenue, compared to 15.3% and 14.3% for the three and six months ended June 30, 2025, respectively. The increase in gross-to-net adjustments in both periods was driven by a greater proportion of sales made under governmental managed-care pricing programs and group purchasing organizations in addition to a greater volume of product returns. We expect total gross-to-net adjustments to be in the percentage range of low to mid-twenties of gross product revenue in the remaining quarters of 2026.

Current wording

Total gross-to-net adjustments for the three and nine months ended September 30, 2026 were 19.3% and 20.2% of gross product revenue, compared to 21.6% and 17.0% for the three and nine months ended September 30, 2025, respectively. The changes in gross-to-net adjustments as a percentage of revenue were driven by a greater proportion of sales made under governmental managed-care pricing programs and group purchasing organizations, partially offset by lower return provision due to the revised returned goods policy effective November 1, 2026. We expect total gross-to-net adjustments to be in the percentage range of low to mid-twenties of gross product revenue in the fourth quarter of 2026.

Previous wording

We recognized royalty revenues of less than $0.1 million and $0.1 million in the three and six months ended June 30, 2026, respectively, compared to less than $0.1 million and $0.2 million for the same periods in 2025, respectively. Royalty revenues in the three and six months ended June 30, 2026 and 2025 primarily reflect estimated royalties from sales of cell-based research products from our divested stem cell assets.

Current wording

We recognized royalty revenues of $0.1 million in both the three and nine months ended September 30, 2026, compared to $0.1 million and $0.3 million for the same periods in 2025, respectively. Royalty revenues in the three and nine months ended September 30, 2026 and 2025 primarily reflect estimated royalties from sales of cell-based research products from our divested stem cell assets.

Previous wording

Cost of goods sold was approximately $9.2 million and $10.9 million for the three and six months ended June 30, 2026, respectively, compared to $1.2 million and $2.4 million for the three and six months ended June 30, 2025, respectively, which consists of raw materials, third-party manufacturing costs to manufacture the raw materials into finished product, freight, and indirect overhead costs associated with the sale of RYTELO as well as inventory provisions and non-cash inventory write-offs for the applicable period. Cost of product sales increased in the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily due to non-cash inventory write-offs of $6.3 million during the second quarter of 2026.

Current wording

Cost of goods sold was approximately $6.1 million and $17.0 million for the three and nine months ended September 30, 2026, respectively, compared to $1.0 million and $3.4 million for the three and nine months ended September 30, 2025, respectively, which consists of raw materials, third-party manufacturing costs to manufacture the raw materials into finished product, freight, and indirect overhead costs associated with the sale of RYTELO as well as inventory provisions and non-cash inventory write-offs for the applicable period. Cost of goods sold increased in the three and nine months ended September 30, 2026, compared to the same periods in 2025, primarily due to higher sales and non-cash inventory write-offs of $4.8 million and $11.2 million, respectively.

Previous wording

Prior to receiving FDA approval for RYTELO in June 2024, we manufactured inventory to be sold upon commercialization and recorded the costs as research and development expense. As a result, a significant portion of the manufacturing costs related to the inventory manufactured prior to receiving FDA approval was partially expensed in a prior period and is therefore excluded from the cost of goods sold for the three and six months ended June 30, 2026 and

Current wording

Prior to receiving FDA approval for RYTELO in June 2024, we manufactured inventory to be sold upon commercialization and recorded the costs as research and development expense. As a result, a significant portion of the manufacturing costs related to the inventory manufactured prior to receiving FDA approval was partially expensed in a prior period and is therefore excluded from the cost of goods sold for the three and nine months ended September 30, 2026 and 2025. We estimate our cost of sales as a percentage of product revenue, net will continue to be positively impacted for at least the next 12 months as we sell through certain inventory that was partially expensed prior to FDA approval.

Previous wording

During the three and six months ended June 30, 2026 and 2025, our RYTELO (imetelstat) program and our research discovery program related to potential next generation telomerase inhibitors were the only research and development programs we supported. For these research and development programs, we incur direct external, personnel-related and other research and development costs. For the three and six months ended June 30, 2026 and 2025, research and development expenses consist of expenses incurred in developing and testing imetelstat and research related to potential next generation telomerase inhibitors. These expenses include, but are not limited to, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator-led clinical trials, raw materials to manufacture clinical trial supply, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting expenses, costs to maintain technology licenses and research-related overhead.

Current wording

During the three and nine months ended September 30, 2026 and 2025, our RYTELO (imetelstat) program and our research discovery program related to potential next generation telomerase inhibitors were the only research and development programs we supported. For these research and development programs, we incur direct external, personnel-related and other research and development costs. For the three and nine months ended September 30, 2026 and 2025, research and development expenses consist of expenses incurred in developing and testing imetelstat and research related to potential next generation telomerase inhibitors. These expenses include, but are not limited to, payroll and personnel expense, lab supplies, non-clinical studies, clinical trials, including support for investigator-led clinical trials, raw materials to manufacture clinical trial supply, manufacturing costs for research and clinical trial materials, sponsored research at other labs, consulting expenses, costs to maintain technology licenses and research-related overhead.

Previous wording

The increase in research and development expenses for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily a result of investments in supply chain development, partially offset by lower personnel-related expenses driven by a decrease in headcount as a result of the workforce reduction in December 2025.

Current wording

The decrease in research and development expenses for the three and nine months ended September 30, 2026, compared to the same periods in 2025, was primarily a result of lower personnel-related expenses driven by a decrease in headcount as a result of the workforce reduction in December 2025. In addition, the decrease in the three months ended September 30, 2026, compared to the same period in 2025, was driven by lower clinical and chemistry, manufacturing, and controls costs.

Previous wording

Selling, general and administrative expenses were $38.9 million and $74.3 million for the three and six months ended June 30, 2026, respectively, compared to $38.6 million and $78.6 million for the same periods in 2025. The change in selling, general and administrative expenses for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily due to lower general and administrative personnel-related expenses from decreased headcount as a result of the workforce reduction in December 2025, partially offset by additional investment in marketing programs and higher legal expenses.

Current wording

Selling, general and administrative expenses were $35.7 million and $110.0 million for the three and nine months ended September 30, 2026, respectively, compared to $39.0 million and $117.6 million for the same periods in 2025. The decrease in selling, general and administrative expenses for the three and nine months ended September 30, 2026, compared to the same periods in 2025, was primarily due to lower general and administrative personnel-related expenses from decreased headcount as a result of the workforce reduction in December 2025, partially offset by higher marketing costs due to continued investment in our RYTELO commercialization strategy and higher legal costs.

Previous wording

For the three and six months ended June 30, 2026, a credit of $0.2 million and $0.6 million, respectively, in restructuring charges was recognized, primarily due to lower‑than‑expected utilization of previously accrued amounts related to healthcare and related benefits. The credit was recorded in the condensed consolidated statement of operations as restructuring charges. The workforce reduction was substantially completed in the first quarter of 2026. There were no restructuring charges during the three and six months ended June 30, 2025.

Current wording

For the three and nine months ended September 30, 2026, a credit of $0.1 million and $0.6 million, respectively, in restructuring charges was recognized, primarily due to lower‑than‑expected utilization of previously accrued amounts related to healthcare and related benefits. The credit was recorded in the condensed consolidated statement of operations as restructuring charges. The workforce reduction was substantially completed in the first quarter of 2026. There were no restructuring charges during the three and nine months ended September 30, 2025.

Previous wording

Interest income was $3.0 million and $6.4 million, respectively, for the three and six months ended June 30, 2026, compared to $4.7 million and $9.8 million for the same periods in 2025. The decrease in interest income for the three and six months ended June 30, 2026, compared to the same periods in 2025, primarily reflects a decrease in interest rates between the periods and a smaller marketable securities portfolio. Interest earned in future periods will depend on the size of our marketable securities portfolio and prevailing interest rates.

Current wording

Interest income was $3.0 million and $9.4 million, respectively, for the three and nine months ended September 30, 2026, compared to $4.3 million and $14.1 million for the same periods in 2025. The decrease in interest income for the three and nine months ended September 30, 2026, compared to the same periods in 2025, primarily reflects a decrease in interest rates between the periods and a smaller marketable securities portfolio. Interest earned in future periods will depend on the size of our marketable securities portfolio and prevailing interest rates.

Previous wording

Interest expense was $7.1 million and $14.3 million, respectively, for the three and six months ended June 30, 2026, compared to $8.5 million and $16.7 million for the same periods in 2025. The decrease in interest expense for the three and six months ended June 30, 2026, compared to the same periods in 2025, was primarily due to lower average interest rates related to the Royalty Pharma Agreement and the Pharmakon Loan Agreement, which were entered into in November 2024. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information.

Current wording

Interest expense was $7.2 million and $21.5 million, respectively, for the three and nine months ended September 30, 2026, compared to $8.6 million and $25.4 million for the same periods in 2025. The decrease in interest expense for the three and nine months ended September 30, 2026, compared to the same periods in 2025, was primarily due to lower average interest rates related to the Royalty Pharma Agreement and the Pharmakon Loan Agreement, which were entered into in November 2024. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information.

Previous wording

Other income (expense), net was an expense of less than $0.1 million and $0.1 million, respectively, for the three and six months ended June 30, 2026, compared to $0.1 million for each of the three and six months ended June 30, 2025. Other income (expense), net primarily reflects realized losses on marketable securities and foreign currency transaction adjustments.

Current wording

Other income (expense), net was an expense of $0.3 million and $0.4 million, respectively, for the three and nine months ended September 30, 2026, compared to an expense of $0.2 million and $0.3 million for the same periods in 2025. Other income (expense), net primarily reflects realized losses on marketable securities and foreign currency transaction adjustments.

Previous wording

As of June 30, 2026, we had cash, restricted cash, cash equivalents, and marketable securities of $326.9 million, compared to $401.1 million at December 31, 2025. The decrease in cash, restricted cash, cash equivalents and marketable securities during the six months ended June 30, 2026 was primarily the net result of cash used in operations partially offset by the receipt of net cash proceeds from accounts receivable.

Current wording

As of September 30, 2026, we had cash, restricted cash, cash equivalents, and marketable securities of $339.4 million, compared to $401.1 million at December 31, 2025. The decrease in cash, restricted cash, cash equivalents and marketable securities during the nine months ended September 30, 2026 was primarily the net result of cash used in operations partially offset by the receipt of net cash proceeds from accounts receivable.

Previous wording

On November 1, 2024, we entered into the Pharmakon Loan Agreement. We drew the Tranche A Loan of $125.0 million on November 1, 2024, a portion of which was utilized to repay all outstanding indebtedness associated with the Hercules Loan Agreement. The Pharmakon Loan Agreement provided for two additional committed term loan tranches, each of which expired on July 30, 2026. The Term Loans mature on November 1, 2029. The Term Loans bear interest at a variable rate per annum equal to 5.75% plus three-month SOFR with a SOFR floor of 3.00%. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information on the Pharmakon Loan Agreement.

Current wording

On November 1, 2024, we entered into the Pharmakon Loan Agreement. We drew the Tranche A Loan of $125.0 million on November 1, 2024, a portion of which was utilized to repay all outstanding indebtedness associated with the Hercules Loan Agreement. The Tranche A Loan matures on November 1, 2029 and bears interest at a variable rate per annum equal to 5.75% plus three-month SOFR with a SOFR floor of 3.00%. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information on the Pharmakon Loan Agreement.

Previous wording

Successful drug development and commercialization requires significant amounts of capital. As of June 30, 2026, we had approxim ately $326.9 million in cash, cash equivalents, restricted cash and marketable securities. Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from sales of RYTELO, will be sufficient to fund our projected operating requirements for the foreseeable future. However, if we do not generate net revenues from commercial sales of RYTELO at the levels we anticipate, if we experience unforeseen events or choose to make other investments in our business, or our assumptions regarding our projected operating expenses are otherwise incorrect, we may require additional funding, which could include a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements or marketing and distribution arrangements, which may not be possible. For example, changes in our operations, such as increased development, manufacturing and clinical trial expenses, or our undertaking of additional programs, business activities, or entry into strategic transactions, including potential future acquisitions of products, technologies or businesses, may cause our operating expenses to increase, perhaps significantly, which could require us to raise additional funding. If adequate funds are not available to us when we need them, our RYTELO commercialization efforts may be adversely affected and we may be unable to pursue further development of imetelstat, which would severely harm our business and we might cease operations.

Current wording

Successful drug development and commercialization requires significant amounts of capital. As of September 30, 2026, we had approxim ately $339.4 million in cash, cash equivalents, restricted cash and marketable securities. Based on our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from sales of RYTELO, will be sufficient to fund our projected operating requirements for the foreseeable future. However, if we do not generate net revenues from commercial sales of RYTELO at the levels we anticipate, if we experience unforeseen events or choose to make other investments in our business, or our assumptions regarding our projected operating expenses are otherwise incorrect, we may require additional funding, which could include a combination of public or private equity offerings, debt financings, collaborations, strategic alliances, licensing arrangements or marketing and distribution arrangements, which may not be possible. For example, changes in our operations, such as increased development, manufacturing and clinical trial expenses, or our undertaking of additional programs, business activities, or entry into strategic transactions, including potential future acquisitions of products, technologies or businesses, may cause our operating expenses to increase, perhaps significantly, which could require us to raise additional funding. If adequate funds are not available to us when we need them, our RYTELO commercialization efforts may be adversely affected and we may be unable to pursue further development of imetelstat, which would severely harm our business and we might cease operations.

Previous wording

Despite receiving FDA approval of RYTELO in the U.S. in June 2024 and marketing authorization in the EU in March 2025, the outcome of any clinical activities and/or regulatory approval process is highly uncertain, and we cannot reasonably estimate whether our future development activities may succeed, whether we will obtain regulatory approval for RYTELO in any other jurisdictions or indications we are pursuing or may in the future pursue, or whether we will be able to effectively commercialize RYTELO in the U.S. or in the EU for lower-risk MDS or other potential jurisdictions or indications, if at all. We may never recoup our investment in any RYTELO development, which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations. In addition, our plans and timing expectations could be further delayed or interrupted by the effects of macroeconomic or other global conditions, including those resulting from further changes in tariffs and other trade restrictions, renegotiation of existing international trade agreements or further escalation of trade tensions, inflation, fluctuations in interest rates, prospects of a recession, government shutdowns, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts such as the ongoing Russia and Ukraine military conflict and the ongoing military conflict involving the U.S., Israel and Iran, pandemics or other health crises and supply chain and resource issues. Further, our future capital requirements are difficult to forecast and will depend on many factors, including:

Current wording

Despite receiving FDA approval of RYTELO in the U.S. in June 2024 and marketing authorization in the EU in March 2025, the outcome of any clinical activities and/or regulatory approval process is highly uncertain, and we cannot reasonably estimate whether our future development activities may succeed, whether we will obtain regulatory approval for RYTELO in any other jurisdictions or indications we are pursuing or may in the future pursue, or whether we will be able to effectively commercialize RYTELO in the U.S. or in the EU for lower-risk MDS or other potential jurisdictions or indications, if at all. We may never recoup our investment in any RYTELO development, which would adversely affect our financial condition and our business and business prospects, and might cause us to cease operations. In this regard, given our decision to discontinueour Phase 3 IMpactMF clinical trial, we will be unable to expand RYTELO’s indication to use to the relapsed/refractory MF indication and we will otherwise not receive any return on or recoup our investment in the relapsed/refractory MF indication. As a result, we will remain wholly dependent on the commercialization of RYTELO in lower-risk MDS for the foreseeable future. In addition, our plans and timing expectations could be further delayed or interrupted by the effects of macroeconomic or other global conditions, including those resulting from further changes in tariffs and other trade restrictions, renegotiation of existing international trade agreements or further escalation of trade tensions, inflation, fluctuations in interest rates, prospects of a recession, government shutdowns, bank failures and other disruptions to financial systems, civil or political unrest, military conflicts such as the ongoing Russia and Ukraine military conflict and the ongoing military conflict involving the U.S., Israel and Iran, pandemics or other health crises and supply chain and resource issues. Further, our future capital requirements are difficult to forecast and will depend on many factors, including:

Previous wording

•the scope, progress, timing, magnitude and costs of non-clinical and clinical development, manufacturing and commercialization of RYTELO, including commercialization in the U.S. and any commercialization in the EU for lower-risk MDS, or in any other jurisdictions or other indication we may pursue, subject to clearances and approvals by the FDA and similar international regulatory authorities;

Current wording

•the scope, progress, timing, magnitude and costs of non-clinical and clinical development, manufacturing and commercialization of RYTELO, including commercialization in the U.S. and in the EU for lower-risk MDS, or in any other jurisdictions or other indication we may pursue, subject to clearances and approvals by the FDA and similar international regulatory authorities;

Previous wording

In addition, we may seek additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Due to uncertainty in the general economic, market and political climate, we may determine that it is necessary or appropriate to raise additional funds proactively to meet longer-term anticipated operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, including pursuant to the 2026 Sales Agreement, our stockholders may be diluted, and the terms may include liquidation or other preferences that could materially and adversely affect the rights of our existing stockholders. In addition, we have borrowed, and in the future may borrow, additional capital from institutional and commercial banking sources to fund development and our future growth, including pursuant to our Pharmakon Loan Agreement or potentially pursuant to new arrangements with different lenders. We may borrow funds on terms under agreements, such as our Pharmakon Loan Agreement, that include restrictive covenants, including covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Moreover, if we raise additional funds through alliance, collaborative or licensing arrangements with third parties, we may have to relinquish valuable rights to RYTELO or our technologies or grant licenses on terms that are not favorable to us.

Current wording

In addition, we may seek additional capital due to market conditions or strategic considerations even if we believe we have sufficient funds for our current or future operating plans. Due to uncertainty in the general economic, market and political climate, we may determine that it is necessary or appropriate to raise additional funds proactively to meet longer-term anticipated operating plans. To the extent that we raise additional capital through the sale of equity or convertible debt securities, including pursuant to the 2026 Sales Agreement, our stockholders may be diluted, and the terms may include liquidation or other preferences that could materially and adversely affect the rights of our existing stockholders. In addition, we have borrowed, and in the future may borrow, additional capital from institutional and commercial banking sources to fund development and our future growth, including existing borrowings pursuant to our Pharmakon Loan Agreement or subsequent borrowing pursuant to new arrangements with different lenders. We may borrow funds on terms under agreements, such as our Pharmakon Loan Agreement, that include restrictive covenants, including covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. Moreover, if we raise additional funds through alliance, collaborative or licensing arrangements with third parties, we may have to relinquish valuable rights to RYTELO or our technologies or grant licenses on terms that are not favorable to us.

Previous wording

Net cash used in operations for the six months ended June 30, 2026 and 2025 was $78.7 million and $75.4 million, respectively. The increase in net cash used in operations for the six months ended June 30, 2026, compared to the same period in 2025, was primarily due to payments related to our workforce reduction and inventory purchases.

Current wording

Net cash used in operations for the nine months ended September 30, 2026 and 2025 was $68.5 million and $89.0 million, respectively. The decrease in net cash used in operations for the nine months ended September 30, 2026, compared to the same period in 2025, reflects a decrease in net loss, primarily due increased product revenue and lower personnel-related expenses as a result of the workforce reduction in December 2025, partially offset by net changes in operating assets and liabilities.

Previous wording

Net cash provided by investing activities for the six months ended June 30, 2026 and 2025 was $60.2 million and $72.8 million, respectively. The decrease in net cash provided by investing activities for the six months ended June 30, 2026, compared to the same period in 2025, primarily reflects decreased proceeds from the sale and maturities of marketable securities.

Current wording

Net cash provided by investing activities for the nine months ended September 30, 2026 and 2025 was $54.2 million and $86.1 million, respectively. The decrease in net cash provided by investing activities for the nine months ended September 30, 2026, compared to the same period in 2025, primarily reflects higher purchases of marketable securities and decreased proceeds from the sale and maturities of marketable securities.

Previous wording

Net cash provided by financing activities for the six months ended June 30, 2026 and 2025 was $3.8 million and $1.3 million, respectively. The increase in net cash provided by financing activities primarily reflects higher proceeds from issuances of common stock under our equity plans and proceeds from the exercise of warrants.

Current wording

Net cash provided by financing activities for the nine months ended September 30, 2026 and 2025 was $6.0 million and $1.9 million, respectively. The increase in net cash provided by financing activities primarily reflects higher proceeds from issuances of common stock under our equity plans and proceeds from the exercise of warrants.

Previous wording

We have engaged third‑party contract manufacturers to manufacture and supply additional quantities of RYTELO that meet applicable regulatory standards for current and potential future clinical trials and commercial uses. Related to those contract manufacturing agreements, we have binding commercial purchase commitments of approximately $10.2 million that can be cancelled, but would incur cancellation penalties, and approximately $37.3 million in agreed upon manufacturing commitments that can be adjusted based on commercial demand of RYTELO. We expect to utilize all related commercial purchase commitments.

Current wording

We have engaged third‑party contract manufacturers to manufacture and supply additional quantities of RYTELO that meet applicable regulatory standards for current and potential future clinical trials and commercial uses. Related to those contract manufacturing agreements, we have binding commercial purchase commitments of approximately $31.6 million that can be cancelled, but would incur cancellation penalties, and approximately $9.9 million in agreed upon manufacturing commitments that can be adjusted based on commercial demand of RYTELO. We expect to utilize all related commercial purchase commitments.

Previous wording

On November 1, 2024, we entered into the Pharmakon Loan Agreement, and in connection with this transaction, all obligations outstanding under the Hercules Loan Agreement were repaid in full on November 1, 2024, upon which the Hercules Loan Agreement was terminated. On January 5, 2026, the Pharmakon Loan Agreement was amended to extend the date for requesting the Tranche B Loan and Tranche C Loan, once available, from December 31, 2025 to July 30, 2026. Neither the Tranche B Loan nor the Tranche C Loan was drawn, and both are no longer available. The amendment also extended the Makewhole Date from November 1, 2026 to May 1, 2027. We expect our interest expense in future periods to reflect the continued amortization of debt discount and issuance costs associated with the Tranche A Loan under the Pharmakon Loan Agreement. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information on the Pharmakon Loan Agreement.

Current wording

On November 1, 2024, we entered into the Pharmakon Loan Agreement, and in connection with this transaction, all obligations outstanding under the Hercules Loan Agreement were repaid in full on November 1, 2024, upon which the Hercules Loan Agreement was terminated. We expect our interest expense in future periods to reflect the continued amortization of debt discount and issuance costs associated with the Tranche A Loan under the Pharmakon Loan Agreement. As of September 30, 2026, we had a long-term principal debt balance of $120.4 million related to the Pharmakon Loan Agreement. See Note 7 on Debt in Notes to Condensed Consolidated Financial Statements of this Report for additional information on the Pharmakon Loan Agreement.
Rearranged previous paragraphs (3)

Previous report — wording carried elsewhere

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.

Previous report — wording carried elsewhere

We estimate our cost of sales as a percentage of product revenue, net will continue to be positively impacted for at least the next 12 months as we sell through certain inventory that was partially expensed prior to FDA approval.

Previous report — wording carried elsewhere

As of June 30, 2026, we had a long-term principal debt balance of $120.1 million related to the Pharmakon Loan Agreement.