Geron Corporation (Nasdaq: GERN) today announced the appointments
of Sharon McBain as Vice President, Global Regulatory Affairs and
Lynn Bodarky as Vice President, Business Development. These
appointments further enhance the Company’s oncology expertise to
advance its current and longer-term corporate objectives.
Vice President, Global Regulatory Affairs – Sharon McBain
As Vice President, Global Regulatory Affairs, Ms. McBain will be
responsible for global regulatory strategy development, oversight
of regulatory submissions, and interactions with the U.S. Food and
Drug Administration (FDA), European Medicines Agency (EMA) and
other ex-U.S. health authorities. She will guide the strategic
regulatory direction of the imetelstat development program,
including assuming a leadership role in the achievement of the
Company’s objective to conduct an End of Phase 2 meeting with the
FDA by the end of the first quarter of 2020 for relapsed/refractory
myelofibrosis (MF).
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 Janssen Research and Development, LLC (Janssen) where
she led the global regulatory development strategy for
hematology-oncology drug candidates, including imetelstat. At
Janssen, she was responsible for procuring imetelstat’s orphan drug
designation in both lower risk myelodysplastic syndromes (MDS) and
relapsed/refractory MF, as well as securing FDA Fast Track
designation for imetelstat in lower risk MDS. She also provided
global regulatory expertise in order to evaluate a number of other
early-stage development assets as well as due diligence for
potential in-licensing opportunities. Outside of her project
responsibilities at Janssen, Ms. McBain initiated and led an
industry alliance working group with representatives from the
pharmaceutical industry and various health authorities to identify
and define surrogate endpoints for hematologic malignancy clinical
trials. She also led multiple advisory boards and has frequently
participated in expert panels organized by the FDA and the EMA on
this topic.
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 GlaxoSmithKline plc, and held various
positions of increasing responsibility throughout her 20-year
tenure, including serving as the Head of the Gastrointestinal
(GI)/Metabolic Therapy Area, where she led regulatory filings
resulting in approvals for multiple new
products.
Ms. McBain holds a B.Sc. (Hons) in applied biology from North
East London Polytechnic in Stratford, East London, Great
Britain.
Vice President, Business Development – Lynn Bodarky
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 LMB Consulting, LLC where she provided
corporate strategy and end-to-end business development advisory
services to biopharmaceutical companies. Prior to that, she was
Vice President, Business Development for Intrexon Corporation where
she was responsible for negotiating and structuring corporate
partnerships across therapeutic areas, including oncology. Ms.
Bodarky’s previous experience includes senior corporate strategy
and business development roles within the following organizations:
International Partnership for Microbicides; Pfizer Inc.; Progenics
Pharmaceuticals, Inc.; Pharmacia Corporation; and Merck & Co.,
Inc.
Ms. Bodarky has a B.S. from The Wharton School, University of
Pennsylvania and an M.B.A. from Columbia Business School, Columbia
University.
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 July
17, 2019 at an exercise price of $1.24 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.
About Imetelstat
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.
About Geron
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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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