Geron Corporation reports recurring developments as a commercial-stage biopharmaceutical company focused on hematologic malignancies. Its first-in-class telomerase inhibitor RYTELO (imetelstat) is approved in the United States and European Union for certain adult patients with lower-risk myelodysplastic syndromes with transfusion-dependent anemia.
Company updates commonly cover RYTELO net product revenue, U.S. commercialization, financial results and guidance, and continued development of imetelstat in JAK-inhibitor relapsed or refractory myelofibrosis and other hematologic malignancies. Geron news also includes investor conference participation, Nasdaq inducement grants, board appointments, executive leadership changes, and restructuring-related business updates.
Geron Corporation (Nasdaq: GERN) announced that its CEO, John A. Scarlett, will present a company overview at the Stifel Virtual Healthcare Conference on November 17, 2020, at 2:40 p.m. ET. A live audio webcast of the presentation will be accessible on Geron’s website, with an archived version available for 30 days post-event. Geron focuses on developing imetelstat, a first-in-class telomerase inhibitor for hematologic myeloid malignancies. For more details, visit www.geron.com.
Geron Corporation (Nasdaq: GERN) reported a net loss of $19.7 million for Q3 2020, slightly higher than the $15.2 million lost in Q3 2019. Revenue for the third quarter was $108,000, compared to $131,000 for the same period last year. The company continues to advance its imetelstat program, despite COVID-19 related challenges that may delay trial enrollment. Geron has approximately $274 million in cash, expected to support operations until the end of 2022, and plans to begin two Phase 3 trials in early 2021.
Geron Corporation (Nasdaq: GERN) announced that ten abstracts related to imetelstat, its telomerase inhibitor, are accepted for presentation at the 62nd American Society of Hematology (ASH) Annual Meeting scheduled online from December 5-8, 2020. The abstracts highlight data from Phase 2 trials supporting ongoing Phase 3 studies in lower risk myelodysplastic syndromes (MDS) and myelofibrosis (MF). Notably, 42% of patients achieved red blood cell transfusion independence lasting over 20 months. The expected improvements in overall survival may mark significant advances in treating these conditions.
Geron Corporation (Nasdaq: GERN) will release its third quarter 2020 financial results on November 5, 2020, after market close. The results will be discussed in a conference call at 4:30 p.m. ET the same day. The press release will be available on the company’s website. A live webcast of the call will also be accessible, with archived options available for 30 days. Geron is focused on developing its telomerase inhibitor, imetelstat, for treating hematologic myeloid malignancies.
Geron Corporation (Nasdaq: GERN) announced the publication of positive data from the IMerge Phase 2 trial of imetelstat in the Journal of Clinical Oncology, highlighting its effectiveness for patients with lower risk myelodysplastic syndromes (MDS). The trial demonstrated a median transfusion independence duration of 21 months without new safety signals. These results support ongoing Phase 3 trials aimed at addressing anemia in MDS patients. The publication indicates increasing interest from the oncology community, enhancing the potential for future regulatory approval.
Geron Corporation (NASDAQ: GERN) announced a loan facility of up to $75 million with Hercules Capital and Silicon Valley Bank to support its development program for imetelstat. The financing provides non-dilutive resources for working capital and advancing two Phase 3 clinical trials: the ongoing IMerge trial for lower risk myelodysplastic syndromes and a planned trial for refractory myelofibrosis. The loan is structured in three tranches, with $25 million disbursed initially, and additional amounts contingent on achieving clinical milestones.
Geron Corporation (Nasdaq: GERN) announced a positive opinion from the EMA for its orphan drug designation of imetelstat for treating myelodysplastic syndromes (MDS). This designation could provide a 10-year marketing exclusivity in the EU post-approval. The ongoing IMerge Phase 3 clinical trial is set to enroll about 170 patients, with completion expected by Q1 2021 and results in H2 2022. Imetelstat has also received orphan drug status from the U.S. FDA. The company anticipates final approval by the European Commission by the end of July 2020.
Geron Corporation (NASDAQ: GERN) reported encouraging results from the IMerge Phase 2 clinical trial, showing a durable transfusion independence (TI) rate of 29% over one year for patients with lower risk myelodysplastic syndromes (MDS). The median duration of TI reached 20 months, and a 42% 8-week TI rate was noted. Additionally, analyses from the IMbark Phase 2 trial indicated potential improvements in overall survival and clinical benefits in patients with high-risk myelofibrosis. Ongoing Phase 3 trials aim to further evaluate imetelstat's efficacy.
Geron Corporation (Nasdaq: GERN) reported its Q1 2020 financial results, posting a net loss of $16.4 million, or $0.08 per share, compared to $10.1 million, or $0.05 per share, in Q1 2019. Revenues decreased slightly to $52,000 from $57,000. Operating expenses rose to $16.9 million, with R&D expenses increasing to $10.8 million due to higher clinical development costs. As of March 31, 2020, Geron held $133 million in cash and securities, bolstered by a recent $140 million public offering, providing operational funds into 2022. Revised guidance indicates a 2020 operating expense burn of $70 to $75 million due to COVID-19 measures.
Geron Corporation (Nasdaq: GERN) has successfully closed a public offering of 107,049,375 shares of common stock and 8,335,239 pre-funded warrants, along with warrants for 57,692,307 shares. The offering was priced at $1.30 per share and raised approximately $140 million in net proceeds. These funds will be utilized to support the ongoing IMerge Phase 3 clinical trial for lower-risk myelodysplastic syndromes and a planned Phase 3 trial for refractory myelofibrosis, alongside general corporate needs. The offering was managed by Stifel and MTS Health Partners.