On August 8, 2024 Geron Corporation (Nasdaq: GERN), a commercial-stage biopharmaceutical company aiming to change lives by changing the course of blood cancer, reported financial results and business highlights for the second quarter of 2024 (Press release, Geron, AUG 8, 2024, View Source [SID1234645600]).
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"We are thrilled to have begun the launch of RYTELO, our first commercial product, in June, and are encouraged by the early success we are seeing and the reception from the medical community over these first six weeks," said John A. Scarlett, M.D., Geron’s Chairman and Chief Executive Officer. "Our field teams have mobilized efficiently and have already interacted with approximately 60% of our top decile 1-4 accounts across the community and academic settings. This has contributed to gratifying uptake – as of July 31, 2024, we estimate that approximately 160 patients have received RYTELO, which is encouraging given the very early stage of this launch. Further, the MDS NCCN Guidelines, which guide clinical decision-making, prescriber behavior and reimbursement decisions, were updated at the end of July to include RYTELO as a Category 1 and 2A treatment of symptomatic anemia in patients with lower-risk MDS. With the introduction of RYTELO as a new therapeutic option, we are seeing increasing dialogue among hematologists rethinking treatment approaches for eligible patients with lower-risk MDS with transfusion-dependent anemia, regardless of ring sideroblast status, and we believe that RYTELO can become part of the standard-of-care for these patients."
Business Highlights
Received approval on June 6, 2024 from the U.S. Food & Drug Administration (FDA) of RYTELO for the treatment of adult patients with low- to intermediate-1 risk myelodysplastic syndromes (LR-MDS) with transfusion-dependent (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 (ESAs).
Launched RYTELO commercially in the U.S., with both dosage strengths available for prescribers to order from specialty distributors as of June 27, 2024.
The National Comprehensive Cancer Network (NCCN) updated the MDS NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) to include RYTELO for the treatment of symptomatic anemia in patients with LR-MDS. For both RS+ and RS- patients, RYTELO has a Category 1 designation for second-line treatment regardless of first-line treatment and a Category 2A designation for first-line treatment of patients who are ESA ineligible (serum EPO >500 mU/mL).
Achieved approximately 70% enrollment in the Phase 3 IMpactMF trial of imetelstat as of August 2024, which has a primary endpoint of overall survival, in patients with myelofibrosis (MF) who are relapsed/refractory to JAK-inhibitors. As previously disclosed, based on the most recent planning assumptions for enrollment and death rates in the trial, an interim analysis is expected in early 2026 (when approximately 35% of planned enrolled patients have died) and final analysis is expected in early 2027 (when approximately 50% of planned enrolled patients have died).
Expanded the dose level 4 cohort (imetelstat 9.4 mg/kg) in the Part 1 dose-finding stage of the Phase 1 IMproveMF study evaluating imetelstat as a combination therapy with ruxolitinib in patients with frontline MF. This followed a unanimous decision by the study’s Safety Evaluation Team (SET), who in July 2024 reviewed data from the first three patients in the dose level 4 cohort and identified no dose-limiting toxicities.
Second Quarter 2024 Financial Results
As of June 30, 2024 the Company had approximately $430.4 million in cash, cash and equivalents and marketable securities.
Net Loss
For the three and six months ended June 30, 2024, the Company reported a net loss of $67.4 million, or $0.10 per share, and $122.8 million, or $0.19 per share, respectively, compared to $49.2 million, or $0.09 per share and $87.3 million, or $0.16 per share, respectively, for the three and six months ended June 30, 2023.
Revenues
Total product revenue, net for the three and six months ended June 30, 2024, was approximately $780,000.
Total net revenues for the three and six months ended June 30, 2024, were $882,000 and $1.2 million, compared to $29,000 and $50,000 for the same periods in 2023. The increase in revenue is due to product revenue from U.S. sales of RYTELO, which was available for prescribers to order from specialty distributors as of June 27, 2024.
Operating Expenses
Total operating expenses for the three and six months ended June 30, 2024 were $70.2 million and $126.7 million, compared to $52.0 million and $92.1 million for the same periods in 2023.
Cost of goods sold was approximately $17,000 for the three and six months ended June 30, 2024, which consisted of costs to manufacture and distribute RYTELO.
Research and development expenses for the three months and six months ended June 30, 2024 were $30.8 million and $60.2 million, respectively, and $35.5 million and $62.7 million, for the same periods in 2023. The decrease is primarily due to IMerge Phase 3 operations moving into the long-term follow-up stage.
Selling, general and administrative expenses for the three and six months ended June 30, 2024 were $39.4 million, and $66.5 million, respectively, and $16.5 million and $29.4 million for the same periods in 2023. The increase in selling, general and administrative expenses primarily reflects higher commercial launch expenses, increases in headcount and stock-based compensation expense recognized due to the vesting of performance-based stock options upon FDA approval of RYTELO.
Interest income was $5.3 million and $9.6 million for the three and six months ended June 30, 2024, compared to $4.7 million and $8.6 million for the same periods in 2023. The increase in interest income primarily reflects a larger marketable securities portfolio with the receipt of net cash proceeds from the underwritten offering completed in March 2024, as well as higher yields from recent marketable securities purchases.
Interest expense was $3.3 million and $6.8 million for the three and six months ended June 30, 2024, compared to $2.0 million and $3.9 million for the same periods in 2023. The increase in interest expense primarily reflects rising interest rates. Currently, we have $80.0 million in principal debt outstanding. Interest expense reflects interest owed under the loan agreement, 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.
2024 Financial Guidance
For fiscal year 2024, we expect total operating expenses to be in the range of approximately $270 million to $280 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 our current operating plans and assumptions, we believe that our existing cash, cash equivalents, and marketable securities, together with projected revenues from U.S. sales of RYTELO, will be sufficient to fund our projected operating requirements into the second quarter of 2026.
As of June 30, 2024, we had 220 full-time employees. We plan to grow to a total of approximately 230-260 employees by year-end 2024.
Conference Call
Geron will host a conference call at 8:00 a.m. ET on Thursday, August 8, 2024, to discuss business updates and second quarter 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 (imetelstat) is an FDA-approved oligonucleotide telomerase inhibitor 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.
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.
Geron aims to ensure broad access to RYTELO for eligible patients. Accordingly, our REACH4RYTELO Patient Support Program provides a range of resources that support access and affordability to eligible patients prescribed RYTELO.