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Geron Corporation (GERN) is a clinical-stage biopharmaceutical company dedicated to the development of first-in-class therapies for cancer. The company's cornerstone product candidate is Imetelstat, a novel telomerase inhibitor currently in clinical development. Telomerase is an enzyme that allows cancer cells to maintain telomere length, essential for limitless cellular replication.
Imetelstat is a potent, specific inhibitor of telomerase and holds promise for treating various hematologic myeloid malignancies. Based on clinical data obtained in late 2012, Geron is exploring the potential of Imetelstat to treat conditions such as myelofibrosis (MF), myelodysplastic syndromes (MDS), and acute myelogenous leukemia (AML).
Geron earns revenue through a mix of collaboration agreements, milestones, royalties, and licensing arrangements. The company is the exclusive developer of Imetelstat and possesses various rights to the drug. Operating as a single segment focused on oncology, Geron is committed to advancing its research to bring effective cancer treatments to market.
Stay updated with the latest news and developments from Geron Corporation to learn more about their groundbreaking research and progress in cancer treatment.
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.
Geron Corporation (Nasdaq: GERN) announced a public offering of 107,049,375 shares of common stock and pre-funded warrants, along with warrants for an additional 57,692,307 shares, priced at $1.30 each. The offering aims to generate approximately $150 million in gross proceeds to fund ongoing clinical trials and general corporate purposes. The offering is anticipated to close on or about May 27, 2020. This move follows Geron's focus on developing its telomerase inhibitor, imetelstat, in hematologic malignancies, amid standard market conditions.
Geron Corporation (Nasdaq: GERN) announced plans for an underwritten public offering of its common stock and accompanying warrants. The offering is subject to market conditions, and the final terms remain uncertain. Stifel and MTS Health Partners will manage the offering, following a previously filed shelf registration statement with the SEC. The company, focused on developing imetelstat for hematologic malignancies, emphasizes the need for additional capital to fund operations and warns of risks related to the offering's completion and market conditions.
Geron Corporation (Nasdaq: GERN) announced plans for a Phase 3 clinical trial in refractory myelofibrosis (MF) with overall survival as the primary endpoint, expected to start in Q1 2021. The trial will evaluate imetelstat in about 320 patients who are refractory to JAK inhibitors. Additionally, Geron aims to complete patient enrollment in the ongoing IMerge Phase 3 trial for lower risk myelodysplastic syndromes (MDS) by Q1 2021. The company revised its 2020 operating expenses guidance to $70-$75 million due to COVID-19 impacts and trial preparations.
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