Geron (NASDAQ:GERN) said it expects full-year net revenue from RYTELO to land in the mid-to-high end of its previously stated range, or approximately $230 million to $240 million, as the company continues to expand use of the telomerase inhibitor in lower-risk myelodysplastic syndromes, or MDS.
During the Cantor Healthcare Conference, Chief Executive Officer Harout Semerjian said Geron generated $57.5 million in net revenue during the second quarter, nearly $5 million above the preceding quarter. He said the company has now recorded three consecutive quarters of growth and reported that RYTELO revenue rose 24% in the first half of the year while operating expenses declined 4%.
Community Expansion and Earlier-Line Use
Semerjian said Geron’s commercial strategy has progressed from early engagement with academic medical centers toward greater penetration of community treatment settings. He said roughly 80% of lower-risk MDS patients are seen and treated in the community, particularly those in the second-line population targeted by RYTELO.
Geron is focusing on high-volume community accounts and on increasing use within accounts that have already adopted the treatment. Semerjian characterized this as a shift toward “depth” of use while the company continues to add new accounts.
The company is also seeking to move utilization toward earlier treatment lines. Semerjian said more than one-third of patients receiving RYTELO are now coming from earlier lines of therapy. He said Geron’s label and recently updated NCCN guidelines support use in the second-line setting, where the company believes its data are strongest and treatment duration may be longer than in later-line use.
While physicians may continue to use the therapy organically in later-line patients, Semerjian said Geron’s commercial efforts will center on second-line treatment.
European Strategy Under Review
Geron has global rights to RYTELO and has received European Medicines Agency approval. Semerjian said the company plans to update investors by the end of the year on its strategy for markets outside the United States, including Europe.
Potential approaches could include partnerships, targeted commercial activity or use of contract sales organizations, he said. Geron does not plan to pursue a traditional model of building large country-by-country commercial teams in Europe.
Semerjian said the company is weighing pricing and policy considerations, including the evolving most-favored-nation, or MFN, discussion. He said management intends to preserve its flexibility and avoid making decisions that could undermine the company financially while pursuing broader patient access.
“RYTELO needs to be everywhere in the world, helping patients around the world,” Semerjian said. “We don’t necessarily need to be everywhere in the world.”
Myelofibrosis Study Discussions Continue
Chief Medical Officer Joe Eid provided an update on Geron’s relapsed/refractory myelofibrosis study in patients who have failed JAK inhibitors. The trial, which completed enrollment in September of last year, uses overall survival as its primary endpoint.
Eid said Geron has been discussing the interim analysis with U.S. and European regulators to ensure the study’s framework reflects current regulatory expectations. The company is evaluating whether an interim result could potentially support a supplemental new drug application, though its previously communicated base case remains a final analysis in the second half of 2028.
The study could continue unchanged, reach a futility outcome or produce a positive result, Eid said. He added that Geron intends to complete regulatory discussions before any unblinding trigger is reached in order to preserve trial integrity.
The study permits certain control-arm patients to cross over to active treatment after a washout period and company review. Eid said the trial was designed with a buffer intended to prevent crossover from diluting the study’s statistical power.
Business Development and Capital Position
Semerjian said Geron had more than $320 million in cash and has not exercised the final two tranches of a $125 million Pharmakon debt facility. The company recently added a chief business officer and is building capabilities to evaluate potential partnerships and business-development opportunities.
While RYTELO growth remains Geron’s top priority, Semerjian said the company may consider assets that fit its existing commercial and medical infrastructure. He said Geron does not need multibillion-dollar peak-sales assets to support its strategy and believes its available capital provides flexibility if attractive opportunities emerge.
About Geron (NASDAQ:GERN)
Geron Corporation is a biopharmaceutical company focused on developing and commercializing treatments for myeloid hematologic malignancies, including certain bone marrow cancers. The company’s approach centers on imetelstat, a telomerase inhibitor designed to target malignant stem and progenitor cells.
Geron’s lead product, Rytelo (imetelstat), is approved in the United States for adults with lower-risk myelodysplastic syndromes who have transfusion-dependent anemia requiring or having failed treatment with erythropoiesis-stimulating agents.
