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.
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 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.
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 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.
CONTACT:
Suzanne MessereInvestor and Media
Relationsinvestor@geron.commedia@geron.com
CG Capital877-889-1972
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