On May 7, 2025 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results for the first quarter of 2025 and recent business highlights (Press release, Geron, MAY 7, 2025, View Source [SID1234652640]).
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"We are confident in the long-term potential of RYTELO as an important therapeutic for eligible patients with lower-risk-MDS and are sharply focused on maximizing the U.S. commercial opportunity," said Dawn Carter Bir, Interim President and Chief Executive Officer of Geron. "We have received positive feedback from clinicians who have utilized RYTELO, supporting its strong therapeutic profile. We’ve identified specific opportunities and are making focused investments that we believe will strengthen the U.S. commercial trajectory. We expect our increased commercial investments to bolster uptake across a broader group of prescribers and drive long-term demand. We are also expanding our medical affairs efforts to support increased awareness and education. Looking ahead, our Phase 3 IMpactMF trial evaluating overall survival with imetelstat in patients with JAKi relapsed/refractory myelofibrosis (R/R MF), which we believe represents a tremendous expansion opportunity, is progressing well and the event-driven interim analysis is still expected in the second half of 2026."
Recent Business Highlights
Continued first year of U.S. commercialization of RYTELO, with net product revenue of $39.4 million in the first quarter of 2025. Demand for RYTELO in the 13-week period through the week ending March 28 increased 1% compared to the prior 13 weeks.
Received marketing authorization for RYTELO from the European Commission (EC) as a monotherapy for the treatment of adult patients with transfusion-dependent (TD) anemia due to very low, low, or intermediate risk myelodysplastic syndromes (lower-risk MDS or LR-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 (ESAs).
Launch planning is underway and Geron expects to commercialize RYTELO in select EU countries commencing in 2026.
Reached 85% enrollment in Phase 3 IMpactMF clinical trial evaluating imetelstat in patients with JAKi R/R MF. We continue to expect an interim analysis readout for overall survival in the second half of 2026 (when approximately 35% of patient events have occurred), and final analysis in the second half of 2028 (when approximately 50% of patient events have occurred).
The Company believes there is a significant market opportunity for imetelstat to treat JAKi R/R MF patients based on its unique mechanism of action, strong clinical data to date, and the substantial size of the addressable patient population, if the trial is positive and imetelstat is approved in this indication.
Clinical data from the Phase 2 study showed a strong signal regarding prolonged survival and resolution of bone marrow fibrosis in patients treated with imetelstat, suggesting the potential for disease modification.
First Quarter 2025 Financial Results
As of March 31, 2025, Geron had approximately $457.5 million in cash, cash equivalents, restricted cash and marketable securities, compared to $502.9 million as of December 31, 2024.
Net Loss
For the three months ended March 31, 2025, the Company reported a net loss of $19.8 million, or $0.03 per share, compared to $55.4 million, or $0.09 per share, for the three months ended March 31, 2024.
Revenues
Total product revenue, net for the three months ended March 31, 2025, was $39.4 million. There was no product revenue in the prior year period, as RYTELO was approved by the FDA in June 2024. The decline in net product revenue compared to the three months ended December 31, 2024, which was $47.5 million, was primarily due to inventory drawdown among RYTELO distributors from the fourth quarter of 2024 into the first quarter of 2025.
Total net revenue for the three months ended March 31, 2025, was $39.6 million, compared to $0.3 million for the same period in 2024. Total net revenue includes license fees and royalties in addition to any product revenue, net. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was approved by the FDA in June 2024.
Operating Expenses
Total operating expenses for the three months ended March 31, 2025, were $56.3 million, compared to $56.4 million for the same period in 2024.
Cost of goods sold was approximately $1.2 million for the three months ended March 31, 2025, which consisted of costs to manufacture and distribute RYTELO, compared to nil in the prior year period.
Research and development expenses for the three months ended March 31, 2025, were $15.1 million, compared to $29.4 million for the same period in 2024. The decrease was primarily due to the wind down of clinical trial costs associated with a decrease of activity in our Phase 3 IMerge MDS study after FDA approval of RYTELO in 2024, as well as manufacturing and quality costs that were capitalized in the current period now that RYTELO is approved, versus being expensed in the prior year period.
Selling, general and administrative expenses for the three months ended March 31, 2025, were $40.0 million, compared to $27.1 million for the same period in 2024. The increase in general and administrative expenses in 2025 as compared to 2024 primarily reflects higher personnel expenses related to increased headcount to support commercialization of RYTELO in the U.S.
Interest income was $5.2 million for the three months ended March 31, 2025, compared to $4.2 million for the same period in 2024. The increase in interest income in 2025 compared to 2024 primarily reflects a larger marketable securities portfolio, with the receipt of net cash proceeds from synthetic royalty and debt financings in November 2024. Interest earned in future periods will depend on the size of our marketable securities portfolio and prevailing interest rates.
Interest expense was $8.2 million for the three months ended March 31, 2025, compared to $3.4 million for the same period in 2024. The increase in interest expense primarily reflects $4.8 million in non-cash interest expense related to our synthetic royalty agreement and an increased principal debt balance under our loan agreement and a prior loan agreement, which was repaid in the fourth quarter of 2024. Interest expense reflects interest expense recognized under the synthetic royalty agreement, interest owed under the loan agreements, as well as amortization of associated debt issuance costs and debt discounts using the effective interest method and accrual for an end of term charge.
2025 Financial Guidance
For fiscal year 2025, the Company maintains its previously announced expectations of total operating expenses to be in the range of approximately $270 million to $285 million, which includes non-cash items such as stock-based compensation expense, amortization of debt discounts and issuance costs, and depreciation and amortization.
Based on the current operating plans and assumptions, the Company believes that existing cash, cash equivalents, and marketable securities, together with anticipated net revenues from U.S. sales of RYTELO, will be sufficient to fund projected operating requirements for the foreseeable future.
Conference Call
Geron will host a conference call at 8:00 a.m. ET on Wednesday, May 7, 2025, to discuss business updates and first quarter 2025 financial results.
A live webcast of the conference call and related presentation will be available on the Company’s website at www.geron.com/investors/events. An archive of the webcast will be available on the Company’s website for 30 days.
Participants may access the webcast by registering online using the following link, View Source
About RYTELO (imetelstat)
RYTELO is an oligonucleotide telomerase inhibitor approved in the U.S. for the treatment of adult patients with low-to-intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent 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 (ESAs). It is indicated to be administered as an intravenous infusion over two hours every four weeks.
In addition, RYTELO is approved in the European Union as a monotherapy for the treatment of adult patients with transfusion-dependent anemia due to very low, low or intermediate risk myelodysplastic syndromes without an isolated deletion 5q cytogenetic (non-del 5q) abnormality and who had an unsatisfactory response to or are ineligible for erythropoietin-based therapy.
RYTELO is a first-in-class treatment that works by inhibiting telomerase enzymatic activity. Telomeres are protective caps at the end of chromosomes that naturally shorten each time a cell divides. In LR-MDS, abnormal bone marrow cells often express the enzyme telomerase, which rebuilds those telomeres, allowing for uncontrolled cell division. Developed and exclusively owned by Geron, RYTELO is the first and only telomerase inhibitor approved by the U.S. Food and Drug Administration and the European Commission.