Geron Enhances Oncology Expertise to Advance Corporate Objectives
Vice President, Global Regulatory Affairs –
As Vice President, Global Regulatory Affairs, Ms. McBain will be responsible for global regulatory strategy development, oversight of regulatory submissions, and interactions with the
Ms. McBain is a well-respected industry veteran with more than 35 years of biopharmaceutical drug development experience, including more than 20 years of experience in regulatory affairs. Most recently, she was Senior Director, Global Regulatory Leader, Oncology at
Prior to Janssen, Ms. McBain established a successful consulting business working for multiple companies, including Janssen, and supported the European approval for DACOGEN during this time. Before that, Ms. McBain was the Head of Development, International Regulatory Affairs at Biogen, where she managed Tysabri through to approval. Ms. McBain began her career in drug development and regulatory affairs with
Ms. McBain holds a B.Sc. (Hons) in applied biology from North East London Polytechnic in
Vice President, Business Development –
As Vice President, Business Development, Ms. Bodarky will support Geron’s longer-term corporate objectives of partnering the ex-U.S. commercialization rights for imetelstat, as well as building a leading hematology-oncology franchise through the identification and potential acquisition or in-licensing of attractive oncology product candidates.
Ms. Bodarky has more than 25 years of corporate strategy, business development and licensing, marketing and corporate affairs experience within the biopharmaceutical industry. Most recently, she was President of
Ms. Bodarky has a B.S. from
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 1,100,000 shares of Geron common stock to Ms. McBain, Ms. Bodarky 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 consist of 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 Geron’s growing internal expertise will advance its current and longer-term corporate objectives; (ii) that Geron will conduct an End of Phase 2 meeting with the FDA for relapsed/refractory MF by the end of the first quarter of 2020; (iii) that the imetelstat program could potentially be commercialized; (iv) that Geron plans to partner the ex-U.S. commercialization rights for imetelstat; (v) that Geron will build a leading hematology-oncology franchise; (vi) that imetelstat may have disease-modifying activity; and (vii) 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 regulatory authorities permit the further development of imetelstat on a timely basis, or at all, without any clinical holds; (ii) 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; (iii) whether Geron is able to complete the required activities in order to conduct an End of Phase 2 meeting with the FDA by the end of the first quarter of 2020; (iv) whether imetelstat is approved by regulatory authorities for commercialization; (v) Geron’s potential inability to successfully retain or recruit key personnel to support its current and future corporate objectives or to otherwise successfully manage its growth; and (vi) 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