This process is automatic. The increase in general and administrative expenses, compared to the same periods in 2018, primarily reflects higher corporate and patent legal costs and increased personnel-related expenses for additional headcount to support the development organization.
Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for both the treatment of patients with non-del(5q) lower risk MDS who are refractory or resistant to an erythropoiesis-stimulating agent and for patients with Intermediate-2 or High-risk MF whose disease has relapsed after or is refractory to janus kinase (JAK) inhibitor treatment.
Revenues for the three and nine months ended September 30, 2019 were $131,000 and $289,000, respectively, compared to $165,000 and $691,000 for the same periods in 2018. The Company develops telomerase inhibitor, imetelstat, and in hematologic myeloid malignancies. The trial is planned to be conducted at multiple medical centers globally, including North America, Europe, Middle East and Asia. 3 Sylvan Way Parsippany, NJ 07054 USA. Revenues for the three and nine months ended September 30, 2019 and 2018 included royalty and license fee revenues under various non-imetelstat license agreements. 919 E. Hillsdale Blvd Suite 250 Foster City, CA 94404 USA Tel: 650-473-7700 Fax: 650-473-7700 Email: info@geron.com.
Completed Transition of Imetelstat Program Back to Geron. Event details are available. Many key aspects from Part 1 of IMerge remain the same for the Phase 3, including the primary and secondary endpoints, the dose and schedule of imetelstat administration, the target patient population, and a majority of the clinical sites that participated in the Phase 2. A live, listen-only webcast will also be available on the Company’s website at www.geron.com/investors/events. For more information about Geron, visit www.geron.com. Please enable Cookies and reload the page. GERON CORPORATIONCONDENSED STATEMENTS OF OPERATIONS(UNAUDITED). The delivery and testing of materials under the Clinical Supply Agreement is expected to be completed by the end of December 2019 with payment to Janssen to occur in the first quarter of 2020. United States. Fast Track designation provides opportunities for frequent interactions with FDA review staff, including meetings to discuss the drug's development plan and to ensure the collection of appropriate data needed to support approval. Geron Corporation operates as a clinical stage biopharmaceutical company. In October, we announced the first patient dosed in the IMerge Phase 3 trial, and we are currently focused on patient recruitment and enrollment.
The FDA's Fast Track Program is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious conditions and supported by data that demonstrate the potential to address an unmet medical need. [])), +((!+[]+(!![])+!![]+!![]+!![]+!![]+!![]+[])+(!+[]+(!![])+!![]+!![]+!![]+!![]+!![]+!![]+!![])+(!+[]+(!![])+!![]+!![]+!![]+!![]+!![])+(!+[]-(!![]))+(!+[]-(!![]))+(!+[]+(!![])+!![])+(!+[]+(!![])+!![]+!![])+(!+[]+(!![])+!![])+(!+[]+(!![])+!![]+!![]+!![]+!![]+!![]))/+((!+[]+(!![])-[]+[])+(!+[]+(!![])+!![])+(!+[]+(!![])-[])+(!+[]+(!![])+!![]+!![]+!![])+(+!![])+(+!![])+(!+[]+(!![])+!![]+!![]+!![]+!![]+!![])+(!+[]+(!![])-[])+(!+[]+(!![])+!![]+!![]+!![]+!![]+!![]+!! Phase 2 data from Part 1 of IMerge reported earlier this year suggested meaningful and durable transfusion independence, as well as potential disease-modifying activity and transfusion independence across different MDS patient subgroups, potentially achievable with imetelstat treatment. The IMerge Phase 3 clinical trial is planned to enroll approximately 170 patients in a randomized, double-blind, placebo-controlled clinical trial to test the hypothesis that imetelstat improves the rate of red blood cell transfusion independence (TI). Geron serves customers in the State of California. The funds will support future development costs, including the IMerge Phase 3 clinical trial. View Company . Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. In the third quarter of 2019, the Company completed the transition of the imetelstat program from Janssen. Geron is a clinical-stage biopharmaceutical company focused on the development of a telomerase inhibitor, imetelstat, in hematologic myeloid malignancies.
A unique molecule targeting a hallmark of cancer. Additional information on the above risks and uncertainties and additional risks, uncertainties and factors that could cause actual results to differ materially from those in the forward-looking statements are contained in Geron’s periodic reports filed with the Securities and Exchange Commission under the heading “Risk Factors,” including Geron’s quarterly report on Form 10-Q for the quarter ended September 30, 2019.
Investor Relations. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that top-line results from the IMerge Phase 3 clinical trial will be available by mid-year 2022; (ii) that recently reported Phase 2 IMerge data suggested meaningful and durable transfusion independence, potential disease-modifying activity, and transfusion independence across different MDS patient subgroups potentially achievable with imetelstat treatment; (iii) Geron’s plan to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020 and to subsequently provide a decision regarding potential late-stage development of imetelstat in relapsed/refractory MF; (iv) that the IMerge Phase 3 clinical trial is planned to enroll approximately 170 patients and is planned to be conducted at multiple medical centers globally; (v) that the Company expects its 2019 operating expenses to be $80 to $85 million; (vi) that the Company expects delivery and testing of materials under the Clinical Supply Agreement to be completed by the end of 2019; (vii) that the Company expects to grow to 45 to 50 employees by year-end 2019; (viii) that imetelstat may have disease-modifying activity; and (ix) other statements that are not historical facts, constitute forward looking statements. Suite 2070
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United States, Geron Announces Ten Imetelstat Presentations at Upcoming American Society of Hematology Annual Meeting, BRITISH & AMERICAN INVESTMENT TRUST PLC: Half-year Report, Geron to Announce Third Quarter Financial Results on November 5, 2020, Geron Announces Publication of IMerge Phase 2 Data in Journal of Clinical Oncology, Geron Secures Loan Facility for Up to $75 Million, Geron Reports Inducement Grant Under Nasdaq Listing Rule 5635(c)(4), Geron to Present at the H.C. Wainwright Global Investment Conference, Visiongain publishes Global Stem Cell Technologies and Applications Market 2020-2030 report, Geron Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4), Geron Corporation Reports Second Quarter 2020 Financial Results and Current Events. Note 1: Derived from audited financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2018.
Except for the historical information contained herein, this press release contains forward-looking statements made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.
Geron is now the sponsor of both the IMbark and IMerge clinical trials in all countries. The increase in research and development expenses, compared to the same periods in 2018, primarily reflects costs for the transition of the imetelstat program, including resuming sponsorship of the ongoing imetelstat clinical trials; expenses for start-up activities for the IMerge Phase 3 clinical trial; and higher personnel-related costs for the expanding development team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
Early clinical data suggest imetelstat may have disease-modifying activity through the suppression of malignant progenitor cell clone proliferation, which allows potential recovery of normal hematopoiesis. 919 E Hillsdale Blvd #250. Suzanne MessereInvestor and Media Relationsinvestor@geron.commedia@geron.com. Menlo Park (HQ), CA. For fiscal year 2019, the Company expects total operating expenses to range from $80 to $85 million, of which approximately $20 to $25 million represents one-time costs that include imetelstat program transition activities from Janssen to Geron and purchase of drug product, drug substance and raw materials from Janssen to supply the IMerge Phase 3 trial and prepare for new drug manufacturing. Connecting decision makers to a dynamic network of information, people and ideas, Bloomberg quickly and accurately delivers business and financial information, news and insight around the world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