Galera Appoints Mark J. Bachleda as Chief Commercial Officer and Jennifer Evans Stacey as Chief Legal and Compliance Officer
October 12 2021 - 7:00AM
Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage
biopharmaceutical company focused on developing and commercializing
a pipeline of novel, proprietary therapeutics that have the
potential to transform radiotherapy in cancer, today announced the
appointment of Mark J. Bachleda, Pharm.D., M.B.A., as Chief
Commercial Officer (CCO) and Jennifer Evans Stacey, Esq., as Chief
Legal and Compliance Officer (CLCO) and Secretary. Both executives
join Galera with over 25 years of leadership experience within the
biopharmaceutical industry.
“We are thrilled to welcome Mark and Jennifer to Galera at this
critical point in the Company’s growth,” said Mel Sorensen, M.D.,
Galera’s President and CEO. “As we begin to expand our focus toward
becoming a commercial-stage company, we will leverage our two new
colleagues’ executive-level experiences to continue shaping
Galera’s corporate and regulatory strategy. We look forward to
their invaluable contributions that will help position us to
achieve our mission of delivering novel therapies that improve
outcomes for patients with cancer undergoing radiotherapy.”
Prior to joining Galera, Mark served as Vice President &
U.S. Business Unit Head for Bristol Myers Squibb’s (BMS) CAR T cell
therapy franchise. At BMS, he was responsible for building core
U.S. commercial capabilities and the successful launch execution of
Breyanzi® and Abecma®. Prior to BMS, Mark was Vice President of
Sales at Juno Therapeutics, a biotechnology company acquired by
Celgene in 2018. Prior to Juno, Mark worked at Amgen for 15 years
in a variety of U.S. and international commercial operations roles.
His most recent role was General Manager of Amgen Czech Republic,
where he led an enterprise of 11 commercialized therapies including
launches of Kyprolis®, Blincyto®, and Repatha®. Mark is a
registered pharmacist and received his Pharm.D. degree from the
University of Illinois at Chicago. He completed a post-doctoral
fellowship in health policy and economics at Thomas Jefferson
University and earned M.B.A. degrees from both Columbia University
and the University of California, Berkeley.
“I am delighted to join Galera as the Company prepares for
potential commercialization of its lead asset, avasopasem,”
commented Mark J. Bachleda, Pharm.D., M.B.A. “In only a few years,
the Company has advanced avasopasem into a pivotal Phase 3 trial,
which has the potential to become the new standard of care for
severe oral mucositis in patients with head and neck cancer. I am
eager to collaborate with the Galera management team as we dedicate
our efforts to bringing this therapy to market and making it
available for cancer patients in need.”
Previously, Jennifer served as Vice President, General Counsel,
Secretary and Government Relations at The Wistar Institute, an
independent international biomedical research institution. During
her tenure, she drafted and negotiated license and equity
agreements to launch six start-ups that helped advance Wistar
technology. Prior to her role at Wistar, Jennifer was the Senior
Vice President, General Counsel, Human Resources and Secretary for
Antares Pharma, a publicly traded pharmaceuticals company. Before
that, Jennifer was Executive Vice President, General Counsel, Human
Resources and Secretary for Auxilium Pharmaceuticals, Inc., a
publicly traded biopharmaceutical company acquired by Endo
International plc. Jennifer earned her J.D. from the University of
Pennsylvania Law School and her A.B. from Princeton University.
“I am excited to partner with Galera’s driven and dynamic
management team to help advance the Company’s novel dismutase
mimetic product candidates through late-stage development,” said
Jennifer Evans Stacey, Esq. “Galera’s assets have the potential to
significantly improve quality of life for patients. I look forward
to leading the Company’s legal, compliance and human resources
divisions during this significant time.”
About Galera TherapeuticsGalera Therapeutics,
Inc. is a clinical-stage biopharmaceutical company focused on
developing and commercializing a pipeline of novel, proprietary
therapeutic candidates that have the potential to transform
radiotherapy in cancer. Galera’s lead product candidate is
avasopasem manganese (avasopasem, or GC4419), a selective small
molecule dismutase mimetic in late-stage development to reduce the
incidence and severity of radiotherapy-induced severe oral
mucositis (SOM) in patients with head and neck cancer. Avasopasem
is also in development for radiotherapy-induced esophagitis in
patients with lung cancer. Avasopasem has been granted FDA Fast
Track and Breakthrough Therapy designations for the reduction of
SOM induced by radiotherapy, with or without systemic therapy.
Galera’s second dismutase mimetic product candidate, GC4711, is in
clinical-stage development to augment the anti-cancer efficacy of
stereotactic body radiation therapy in patients with non-small cell
lung cancer and locally advanced pancreatic cancer. Galera is
headquartered in Malvern, PA. For more information, please visit
www.galeratx.com.
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. All statements
contained in this press release that do not relate to matters of
historical fact should be considered forward-looking statements,
including without limitation statements regarding: expectations
surrounding our growth and the continued advancement of our product
pipeline; the potential, safety, efficacy, and regulatory and
clinical development of Galera’s product candidates; plans for the
commercial launch of avasopasem; and expected contributions from
the newly hired executives. These forward-looking statements are
based on management’s current expectations. These statements are
neither promises nor guarantees, but involve known and unknown
risks, uncertainties and other important factors that may cause
Galera’s actual results, performance or achievements to be
materially different from any future results, performance or
achievements expressed or implied by the forward-looking
statements, including, but not limited to, the following: Galera’s
limited operating history; anticipating continued losses for the
foreseeable future; needing substantial funding and the ability to
raise capital; Galera’s dependence on avasopasem manganese
(GC4419); uncertainties inherent in the conduct of clinical trials;
difficulties or delays enrolling patients in clinical trials; the
FDA’s acceptance of data from clinical trials outside the United
States; undesirable side effects from Galera’s product candidates;
risks relating to the regulatory approval process; failure to
capitalize on more profitable product candidates or indications;
ability to receive or maintain Breakthrough Therapy Designation or
Fast Track Designation for product candidates; failure to obtain
regulatory approval of product candidates in the United States or
other jurisdictions; ongoing regulatory obligations and continued
regulatory review; risks related to commercialization; risks
related to competition; ability to retain key employees and manage
growth; risks related to intellectual property; inability to
maintain collaborations or the failure of these collaborations;
Galera’s reliance on third parties; the possibility of system
failures or security breaches; liability related to the privacy of
health information obtained from clinical trials and product
liability lawsuits; unfavorable pricing regulations, third-party
reimbursement practices or healthcare reform initiatives;
environmental, health and safety laws and regulations; the impact
of the COVID-19 pandemic on Galera’s business and operations,
including preclinical studies and clinical trials, and general
economic conditions; risks related to ownership of Galera’s common
stock; and significant costs as a result of operating as a public
company. These and other important factors discussed under the
caption “Risk Factors” in Galera’s Annual Report on Form 10-K for
the year ended December 31, 2020 filed with the U.S. Securities and
Exchange Commission (SEC) and Galera’s other filings with the SEC
could cause actual results to differ materially from those
indicated by the forward-looking statements made in this press
release. Any forward-looking statements speak only as of the date
of this press release and are based on information available to
Galera as of the date of this release, and Galera assumes no
obligation to, and does not intend to, update any forward-looking
statements, whether as a result of new information, future events
or otherwise.
Investor Contacts:Christopher DegnanGalera
Therapeutics, Inc.610-725-1500cdegnan@galeratx.com
William WindhamSolebury
Trout646-378-2946wwindham@soleburytrout.com
Media Contact:Zara LockshinSolebury
Trout646-378-2960zlockshin@soleburytrout.com
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