Geron Corp. (NASDAQ:GERN)
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3 Months : From Apr 2019 to Jul 2019
Geron Corporation (Nasdaq: GERN) today announced that it is continuing to build the senior leadership of its development team with the addition of a Vice President, Biometrics, and a Vice President, Manufacturing. Their oncology and drug development expertise will support Geron’s late-stage clinical development, including the planned opening of the Phase 3 clinical trial of imetelstat in lower risk myelodysplastic syndromes for screening and enrollment by mid-year 2019.
Vice President, Biometrics – Ying Wan, M.D., Ph.D.
Ying Wan, M.D., Ph.D., has more than 17 years of biometrics experience within oncology drug development. Prior to Geron, Dr. Wan was Director and Functional Leader, Oncology Statistics, Statistics & Decision Sciences at Janssen Research and Development, LLC (Janssen). Dr. Wan’s tenure at Janssen spanned 12 years with increasing responsibility where she led the statistical strategy for imetelstat and most recently, multiple solid tumor programs, across all stages of development, including Balversa. In addition, she provided statistical support for Imbruvica, Zytiga, Procrit, and other compounds. As the statistical leader for the imetelstat program at Janssen, she led the statistical strategy for study design and provided statistical expertise throughout the execution of both the IMerge Phase 2/3 and the IMbark Phase 2 clinical trials. Prior to Janssen, Dr. Wan was a Biometrician, Senior Statistician at Merck & Co., Inc. Dr. Wan holds an M.D. from Shanghai Medical College of Fudan University in Shanghai, China; an M.S. in nutrition science and an M.S. in statistics from Penn State University; and a Ph.D. in statistics from Temple University.
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 – Patrick Murphy
Patrick Murphy has an extensive leadership background in manufacturing and technical operations, and has guided over ten new investigational products from pilot to full-scale commercial production while ensuring both product and facility compliance with the regulations for the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA). Prior to joining Geron, Mr. Murphy was Vice President, Technical Operations at Omniox, Inc., where he was directly responsible for global chemistry, manufacturing and control (CMC) activities, including quality assurance, quality control and manufacturing. Prior to that role, Mr. Murphy held manufacturing leadership positions with Anthera Pharmaceuticals, Inc.; Versartis, Inc.; Solstice Neurosciences, Inc.; Acologix, Inc.; and Abgenix, Inc. Mr. Murphy began his career in biotechnology manufacturing and technical operations with Genentech, Inc., a Roche Company, with increased roles and responsibility over his 19-year tenure. Mr. Murphy has a B.S. in chemistry from State University of New York, Binghamton.
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 May 15, 2019 at an exercise price of $1.79 per share, which is equal to the closing price of Geron common stock on the date of grant. Each stock option granted has a 10-year term and vests over four years, with 12.5% of the shares underlying the option vesting on the six-month anniversary of commencement of employment and the remaining shares vesting over the following 42 months in equal installments of whole shares, subject to continued employment with Geron through the applicable vesting dates. Each stock option was granted as a material inducement to employment in accordance with Nasdaq Listing Rule 5635(c)(4) and is subject to the terms and conditions of a stock option agreement covering the grant and Geron’s 2018 Inducement Award Plan, which was adopted December 14, 2018 and provides for the granting of stock options to new employees.
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.
Suzanne MessereInvestor and Media Relationsinvestor@firstname.lastname@example.org