Geron Corporation (Nasdaq: GERN) today announced an expansion of
its leadership team with the appointment of a new chief medical
officer to support the Company’s clinical drug development efforts
in hematology-oncology.
“As we transition to a late-stage development company, we are
very pleased to welcome Dr. Aleksandra Rizo to Geron as Chief
Medical Officer,” said John A. Scarlett, M.D., Chairman and Chief
Executive Officer. “With Aleksandra’s prior experience as the
clinical lead for the imetelstat program for more than three years
at Janssen, as well as her wealth of leadership experience with
other hematology-oncology development projects at both Janssen and
Celgene, we believe she is uniquely suited to build and lead our
clinical development team.”
“I am excited to be joining Geron at this pivotal time,” said
Dr. Rizo. “I strongly believe that imetelstat has great promise in
hematology-oncology given my experience with the drug at Janssen
and the recent data reported at the ASH meeting in December, and
look forward to the initiation of imetelstat’s Phase 3 trial in
lower risk myelodysplastic syndromes.”
New Chief Medical Officer Appointed
Aleksandra Rizo, M.D., Ph.D., was appointed Chief Medical
Officer as of January 30, 2019 and will be a member of the
Company’s Executive Management Committee. Dr. Rizo will be
responsible for directing imetelstat’s clinical development
strategy, including designing a product development plan for
current and potential future indications. Functions under Dr.
Rizo’s oversight include clinical science, clinical operations,
data management, biostatistics, clinical pharmacology,
translational research and medical affairs.
Dr. Rizo has more than 10 years of experience in
hematology-oncology clinical development, leading teams through the
entire drug development process from Phase 1 through Phase 3
clinical trials and regulatory submissions. Most recently, she was
Executive Director, Strategy and Clinical Lead at Celgene
Corporation, working across the myeloid portfolio. While there, she
led submission activities and participated in strategic and
business development initiatives. Prior to that, Dr. Rizo was a
Senior Director, Compound Development Team Leader at Janssen
Research and Development, LLC (Janssen) for all Phase 1 myeloid
assets, and Global Clinical Leader for all late-stage myeloid
assets, including imetelstat from 2014-2018. In these roles, she
had oversight and leadership responsibilities for overall clinical
development strategy, study designs, execution and data
interpretation for all related programs. In addition, Dr. Rizo was
a core member of Janssen’s Hematology Strategy Team, and in this
role, participated and led diligence projects in hematology.
Previously, Dr. Rizo was Global Clinical Leader for the ibrutinib
mantle cell lymphoma (MCL) program and was responsible for all MCL
studies led by Janssen. During her initial tenure with Janssen, Dr.
Rizo worked on a variety of Velcade clinical trials in lymphoma and
multiple myeloma.
Dr. Rizo holds an M.D. from the University Ss Cyril and
Methodius, Skopje, Macedonia, where she also completed a residency
in internal medicine/hematology. She also has a Ph.D. in human
leukemic stem cell biology from the University of Groningen,
Groningen, Netherlands, and a Ph.D. in mouse stem cell biology from
the University of Tokyo, Tokyo, Japan.
Additional Office to be Opened in New
Jersey
The Company will open an additional office in northern New
Jersey in order to enhance its ability to attract talented
employees from local biopharmaceutical companies with late-stage
clinical drug development expertise, as well as provide support for
future global clinical trials. Other corporate functions also
expected to be managed from the New Jersey office include business
development and, assuming imetelstat is approved, future commercial
operations.
Other Executive Leadership Appointments and
Responsibilities
Andrew J. Grethlein, Ph.D., has been appointed Chief Operating
Officer and will be responsible for global regulatory affairs,
pharmacovigilance and drug safety, manufacturing, quality, program
management, human resources and information technology.
Melissa A. Kelly Behrs has been appointed Chief Business Officer
and will be responsible for business development, portfolio
management, alliance management, and strategic market assessment
and planning.
Stephen N. Rosenfield has been appointed Chief Legal Officer and
will be responsible for legal affairs, corporate compliance,
intellectual property and corporate governance.
Preliminary 2019 Financial Guidance
The Company expects its operating expenses to increase as it
assumes full responsibility for the development and potential
commercialization of imetelstat. For fiscal year 2019, the Company
expects its operating expense burn to range from $65 to $70
million, of which approximately $10 to $15 million represent
one-time costs, such as imetelstat program transition activities,
including the transfer of the investigational new drug (IND)
sponsorship from Janssen to Geron, and purchase of raw materials
and other supplies in preparation for new drug manufacturing. In
addition to the one-time costs, the preliminary 2019 operating
expense guidance includes costs for the expansion of
the internal development team, the global Phase 3 clinical
trial in lower risk myelodysplastic syndromes (MDS) and the opening
of a New Jersey office. According to current hiring plans, the
Company expects the total number of full-time employees to grow to
be approximately 30 to 40 by year-end 2019, with half being
research and development personnel. As of December 31, 2018, the
Company had approximately $182 million in cash and marketable
securities, which is expected to be sufficient to support its plans
to initiate the Phase 3 clinical trial of imetelstat in lower risk
MDS by mid-year 2019.
Inducement Grants Under Nasdaq Listing Rule
5635(c)(4)
In connection with the commencement of Dr. Rizo’s employment
with the Company, the Company granted her a non-statutory stock
option to purchase 750,000 shares of Geron common stock on January
30, 2019 which 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 Dr. Rizo’s continued employment with Geron. In addition,
Dr. Rizo was granted non-statutory stock options to purchase an
aggregate of 750,000 shares of Geron common stock on January 30,
2019 with vesting conditioned on the achievement of certain
regulatory milestones for imetelstat, subject to Dr. Rizo’s
continued employment with Geron on the vesting dates. All of Dr.
Rizo’s stock options have a 10-year term and an exercise price of
$1.03 per share, which is equal to the closing price of Geron
common stock on the date of grant. The stock options were granted
as a material inducement to Dr. Rizo’s employment in accordance
with Nasdaq Listing Rule 5635(c)(4) and are subject to the terms
and conditions of stock option agreements covering the grants 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 clinical stage 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 that the Phase 3
clinical trial in lower risk myelodysplastic syndromes will begin
by mid-year 2019, that the operating expense burn in 2019 will
range from $65-70 million, and 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, to enable patient screening and
enrollment of the Phase 3 clinical trial in lower risk
myelodysplastic syndromes to begin by mid-year 2019; (ii)
whether imetelstat is safe and efficacious, and whether any past or
future efficacy or safety results may cause the benefit-risk
profile of imetelstat to become unacceptable; (iii) whether the
transition of the imetelstat program from Janssen Biotech, Inc. to
the Company proceeds on a timely basis to enable the Phase 3
clinical trial in lower risk myelodysplastic syndromes to begin by
mid-year 2019; and (iv) whether any additional operating expenses
arise that are unknown at this time. 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 September 30, 2018. 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
Geron (NASDAQ:GERN)
Historical Stock Chart
From Apr 2024 to May 2024
Geron (NASDAQ:GERN)
Historical Stock Chart
From May 2023 to May 2024