Geron NASDAQ: GERN executives used a presentation at the Needham Healthcare Conference to outline the company’s early commercial trajectory for its telomerase inhibitor imetelstat (marketed as RYTELO) in lower-risk myelodysplastic syndromes (MDS), provide updated views on physician adoption dynamics, and discuss the ongoing Phase 3 myelofibrosis (MF) program.
Commercial launch status and financial outlook
President and CEO Harout Semerjian described Geron as a “commercial-stage company focused in hematology-oncology,” noting that the company launched “the first telomerase inhibitor, imetelstat,” in the middle of 2024. He said the company is in the first two years of its launch phase in the U.S., anchored by the IMerge dataset in lower-risk MDS.
Semerjian said Geron reported $184 million of net revenue in 2025 and reiterated company guidance for $220 million to $240 million of net revenue in 2026. He attributed the company’s confidence in its outlook to a streamlined operating approach and what he characterized as a sharper focus on commercial activities that “move the needle,” including digital and non-personal promotion, regional meetings, and targeting high-volume accounts.
Semerjian also emphasized Geron’s balance sheet, stating the company has “$400 million on our balance sheet.”
Where RYTELO fits in lower-risk MDS treatment
Chief Medical Officer Joseph Eid, EVP and CMO, framed MDS as a “spectrum of disease,” describing high-risk MDS as being “very close to acute myelogenous leukemia” and noting that MDS is “a precursor to leukemic transformation.”
Eid reviewed a treatment landscape that has evolved from transfusion support to broader use of ESAs, luspatercept, and other therapies, including lenalidomide for 5q deletion and hypomethylating agents (HMAs) such as azacitidine and decitabine. He said the paradigm has shifted toward ESAs or luspatercept in first line, with luspatercept “making a move into capturing more of that first line.”
He added that “depending on whether it’s ESAs or luspatercept, the second line preferentially is now imetelstat,” citing NCCN guideline positioning that, in his description, pushes HMAs into “third line and beyond.” Eid also said imetelstat has applicability in first line within the label for patients who are ESA-ineligible, including those with EPO levels over 500 and high transfusion burden.
Physician experience: cytopenias, education, and line of therapy
Both executives said U.S. adoption has required significant education, in part because Semerjian stated that about 90% of patients in the pivotal IMerge trial were enrolled outside the U.S. Semerjian said Geron has been working to build awareness among U.S. hematologists about mechanism of action, durable response, and how to manage cytopenias.
Eid discussed data presented at ASH related to cytopenias, describing them as a predictable early treatment effect. He said cytopenias tend to occur within the first two to three cycles with “predictable recovery within two to four weeks in over 80% of patients” with lower levels of cytopenia. Eid said the company’s interpretation is that cytopenias are tied to the drug’s on-target activity against mutated MDS clones, and that patients with cytopenias “tend to be the ones that have the most durable, robust response.”
In discussing real-world management, Eid said that earlier in the launch, some patients were taken off imetelstat due to lack of physician familiarity with cytopenias. He said the company now emphasizes education and an analogy to lenalidomide in 5q deletion MDS, where cytopenias have also been correlated with response. Eid also said that in IMerge, the incidence of bleeding or infection on placebo was similar to that seen on imetelstat, which he described as minimal.
On treatment burden, Eid said that when growth factor support is used, it is typically “no more than one injection,” and he contrasted imetelstat’s effects with chemotherapy, saying imetelstat targets “the bad clones” rather than indiscriminately affecting all marrow cells.
Semerjian addressed the line-of-therapy mix, saying Geron disclosed in its full-year 2025 results that it believes 30% of business is coming from first-line and second-line patients, with 70% coming from third-line-plus. He characterized that later-line skew as common in early launches and said the company is focused on moving adoption toward the approved second-line setting, which he estimated at about 8,000 patients in the U.S.
Frontline sequencing and RS-negative dynamics
Eid discussed ring sideroblast (RS) status and physician decision-making, pointing to luspatercept performance differences in RS-negative patients as a factor in how clinicians may evaluate treatment options. He said physicians increasingly view imetelstat as a drug that can work across RS-positive and RS-negative settings and across mutation and transfusion-burden profiles, describing imetelstat as “more of a disease modifying agent.”
He also addressed sequencing between ESAs and luspatercept, describing ESAs as stimulating progenitors while luspatercept acts as an erythroid maturation agent. Eid said luspatercept has stronger comparative data versus ESAs in the same population, and he described ESAs as “not as effective post-luspatercept.” Semerjian said the shift of luspatercept into frontline use could create “tailwinds” for RYTELO in second line as patients still need additional options after frontline therapy.
Ex-U.S. commercialization and the Phase 3 myelofibrosis program
Semerjian said imetelstat is a wholly owned asset with worldwide rights and that Geron has EMA approval “as of last year,” but has not fully commercialized in Europe. He said the company is evaluating paths forward, including potential partnerships, and emphasized the importance of pricing strategy and “gated” decision-making. He also noted that many European centers enrolled imetelstat trial patients, creating what he described as a stronger base of familiarity among European physicians.
On the MF program, Eid described the ongoing IMpactMF Phase 3 trial as a 2:1 randomization of imetelstat versus best available therapy, with overall survival as the primary endpoint. He said the trial design was supported by Phase 2 EMBARK data, a randomized study of two imetelstat doses that showed benefit in symptom relief and overall survival, with the higher dose given every three weeks. Eid said the company expects to reach an interim analysis in the second half of the year, driven by death events, and suggested the Data Monitoring Committee will likely recommend continuing to the final analysis given the interim’s high statistical bar.
Eid also said that while the MF standard of care has expanded from one to multiple JAK inhibitors, he does not see evidence that any particular JAK inhibitor has improved survival, characterizing them instead as symptom-relief therapies. He said the IMpactMF study has taken longer partly because patients are living longer on trial, reflecting broader improvements in cancer supportive care.
About Geron NASDAQ: GERN
Geron Corporation NASDAQ: GERN is a clinical-stage biotechnology company dedicated to developing and commercializing novel treatments that target telomerase, an enzyme critical to cancer cell immortality. The company's research is focused on hematologic malignancies and solid tumors, with a pipeline designed to address diseases that have historically had limited therapeutic options.
The lead product candidate, imetelstat, is a first-in-class telomerase inhibitor currently in Phase II and Phase III clinical trials for myelofibrosis and myelodysplastic syndromes.
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