Geron Continues to Build Senior Leadership of Its Development Team
Vice President, Biometrics –
As Vice President, Biometrics, Dr. Wan will manage and lead biostatistics and statistical programming. This includes leading statistical strategy for clinical development; supporting clinical projects by implementing innovative approaches in designs and analyses plans; and providing statistical and programming deliverables for clinical programs and submissions, while ensuring compliance with regulatory guidance, standards and processes.
Vice President, Manufacturing –
As Vice President, Manufacturing, Mr. Murphy will lead the manufacturing function, which includes developing and executing a comprehensive global CMC strategy that encompasses manufacturing, process development, supply chain management, and technology transfer, across the product lifecycle of imetelstat from the planned Phase 3 clinical trial in lower risk myelodysplastic syndromes to potential new drug applications, and preparing for commercial manufacturing.
Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)
In connection with the commencement of employment, the Company has granted non-statutory stock options to purchase an aggregate of 976,600 shares of Geron common stock to the senior leadership announced today and two other new employees. The stock options were granted on
Imetelstat is a novel, first-in-class telomerase inhibitor exclusively owned by Geron and being developed in hematologic myeloid malignancies. 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. Ongoing clinical studies of imetelstat include a Phase 2/3 trial, called IMerge, in lower risk myelodysplastic syndromes (MDS) and a Phase 2 trial, called IMbark, in Intermediate-2 or High-risk myelofibrosis. Imetelstat has been granted Fast Track designation by the United States Food and Drug Administration for the treatment of patients with transfusion-dependent anemia due to lower risk MDS who are non-del(5q) and refractory or resistant to an erythroid stimulating agent.
Geron is a late-stage clinical biopharmaceutical company focused on the development and potential commercialization of a first-in-class telomerase inhibitor, imetelstat, in hematologic myeloid malignancies. For more information about Geron, visit www.geron.com.
Use of Forward-Looking Statements
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. Investors are cautioned that such statements, include, without limitation, those regarding: (i) that the Phase 3 clinical trial in lower risk myelodysplastic syndromes will be open for patient screening and enrollment by mid-year 2019; (ii) that imetelstat may have disease-modifying activity; and (iii) other statements that are not historical facts, constitute forward-looking statements. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. These risks and uncertainties, include, without limitation, risks and uncertainties related to: (i) whether the Company overcomes all the clinical, safety and efficacy, technical, scientific, manufacturing and regulatory challenges to enable the opening of the Phase 3 clinical trial in lower risk myelodysplastic syndromes for screening and enrollment by mid-year 2019; (ii) whether regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (iii) whether imetelstat is safe and efficacious, and whether any future efficacy or safety results may cause the benefit-risk profile of imetelstat to become unacceptable; and (iv) whether imetelstat demonstrates disease-modifying activity. 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 March 31, 2019. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made, and the facts and assumptions underlying the forward-looking statements may change. Except as required by law, Geron disclaims any obligation to update these forward-looking statements to reflect future information, events or circumstances.
Investor and Media Relations
Source: Geron Corporation