Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB), a commercial-stage biopharmaceutical company focused on the
development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer, announced today
that its Board of Directors has appointed Michael Rossi as
President and Chief Executive Officer (“CEO”) and a member of the
Board of Directors with an expected start date of November 6, 2023.
Mr. Rossi brings more than 30 years of experience in the
radiopharmaceutical industry, including building out and leading
the U.S. Business for Advanced Accellerators Applications (“AAA”),
a Novartis company, led the growth of Jubilant Radiopharm into a
vertically integrated radiopharmaceutical leader, and spent after
over a decade at GE Healthcare and, more recently, served as
President, Medical Group at Mirion Technologies, Inc. (“Mirion”).
In connection with Mr. Rossi’s appointment, Thomas Gad, who founded
Y-mAbs in 2015 and has served as President and Head of Business
Development and Strategy (since 2015) and Interim CEO (since 2022)
of the Company, will cease serving in those offices and assume the
roles of Vice Chairman of the Board of Directors and Chief Business
Officer of the Company, in each case effective as of Mr. Rossi’s
start date.
“Michael Rossi shares Y-mAbs’ belief that our
future is bright as we continue to commercialize DANYELZA
(naxitamab-gqgk) and build world-class capabilities working to
develop and commercialize new innovative treatments that improve
the lives of patients with cancer. Michael’s demonstrated ability
to build and scale global radiotherapeutic businesses, his
experience in large multi-faceted organizations, combined with deep
radiotherapeutic knowledge, provide the strategic and operational
expertise needed to lead Y-mAbs to the next level,” said Jim Healy,
M.D., Ph.D., Chairman of the Board. “We are extremely grateful for
Thomas’s successful leadership and dedication as Interim CEO. We
look forward to Thomas’s continued leadership in his new role as
Vice Chairman of the Board of Directors and Chief Business Officer
of Y-mAbs.”
Mr. Rossi said, “I have long admired Y-mAbs as a
leader in the development of transformative cancer therapies.
Y-mAbs is a pioneer in pretargeted radioimmunotherapy with its SADA
Technology and diverse pipeline of promising SADA programs, and a
science-driven, patient-first culture. I am honored to become
President and CEO and work with the experienced team to further
deliver on Y-mAbs’ mission to make a meaningful difference so that
people who have been diagnosed with cancer can live better
lives.”
“After our successful re-organization was
implemented and completed back in the first quarter of 2023, I am
excited to welcome Michael to the Y-mAbs team and look forward to
working closely with him as we continue to expand the commercial
footprint of DANYELZA, as well as bringing forward our novel SADA
constructs for cancer patients, with a continued focus on pediatric
patients as well,” said Thomas Gad.
About Michael Rossi
Michael Rossi has more than 30 years of
radiopharmaceutical, drug development, commercialization and people
leadership experience on a global scale, most recently as
President, Medical Group at Mirion. Before Mirion, Michael served
as the Head of Radioligand Imaging for AAA, a Novartis Company.
Michael also spent five years at Jubilant Pharma, where he served
in several different roles including President of Jubilant
Radiopharma, and brings experience from GE Healthcare, Tyco
Healthcare/Mallinckrodt and Syncor International. Michael earned a
Bachelor of Science in Pharmacy from the University of the Sciences
in Philadelphia and holds an Authorized Nuclear Pharmacist
Certification from Butler University. He has served on several
boards of directors and remains a Licensed Pharmacist in the state
of Pennsylvania.
About DANYELZA®
(naxitamab-gqgk)
DANYELZA® (naxitamab-gqgk) is indicated, in
combination with granulocyte-macrophage colony-stimulating factor
(“GM-CSF”), for the treatment of pediatric patients 1 year of age
and older and adult patients with relapsed or refractory high-risk
neuroblastoma in the bone or bone marrow who have demonstrated a
partial response, minor response, or stable disease to prior
therapy. This indication was approved in the United States by the
FDA under accelerated approval based on overall response rate and
duration of response. Continued approval for this indication is
contingent upon verification and description of clinical benefits
in a confirmatory trial. DANYELZA® includes a Boxed Warning for
serious infusion-related reactions, such as cardiac arrest and
anaphylaxis, and neurotoxicity, such as severe neuropathic pain and
transverse myelitis. See full Prescribing Information
(https://labeling.ymabs.com/danyelza) for complete Boxed Warning
and other important safety information.
About Y-mAbs
Y-mAbs is a commercial-stage biopharmaceutical
company focused on the development and commercialization of novel,
antibody-based therapeutic cancer products. In addition to
conventional antibodies, the Company’s technologies include
bispecific antibodies generated using the Y-BiClone platform and
the SADA platform. The Company’s broad and advanced product
pipeline includes one FDA-approved product, DANYELZA
(naxitamab-gqgk), which targets tumors that express GD2, and one
product candidate, omburtamab, which targets tumors that express
B7-H3.
Forward-Looking
StatementsStatements in this press release about future
expectations, plans and prospects, as well as any other statements
regarding matters that are not historical facts, may constitute
“forward-looking statements” within the meaning of Section 27A of
the Securities Act of 1933 and Section 21E of the Securities
Exchange Act of 1934. Such statements include, but are not limited
to, statements about the Company’s management and business model,
including the Company’s plans and strategies, development,
commercialization and product distribution plans, including the
Company’s ability to build world-class capabilities and develop and
commercialize new innovative treatments that improve the lives of
patients with cancer; expectations with respect to the Company’s
products and product candidates, including the potential of
DANYELZA and product candidates based on the SADA technology and
the potential benefits thereof, including with respect to expansion
of the commercial footprint of DANYELZA as well as bringing forward
novel SADA constructs for cancer patients; and other statements
that are not historical facts. Words such as ‘‘anticipate,’’
‘‘believe,’’ “contemplate,” ‘‘continue,’’ ‘‘could,’’ ‘‘estimate,’’
‘‘expect,’’ “hope,” ‘‘intend,’’ ‘‘may,’’ ‘‘might,’’ ‘‘plan,’’
‘‘potential,’’ ‘‘predict,’’ ‘‘project,’’ ‘‘should,’’ ‘‘target,’’
“will”, ‘‘would’’, “guidance,” and similar expressions are intended
to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. The
Company’s product candidates and related technologies are novel
approaches to cancer treatment that present significant challenges.
Actual results may differ materially from those indicated by such
forward-looking statements as a result of various factors,
including but not limited to: risks associated with the Company’s
financial condition and need for additional capital; the risks that
actual results of the Company’s restructuring plan and revised
business plan will not be as expected; risks associated with the
Company’s development work; cost and success of the Company’s
product development activities and clinical trials; the risks of
delay in the timing of the Company’s regulatory submissions or
failure to receive approval of the Company’s drug candidates; the
risks related to commercializing any approved pharmaceutical
product including the rate and degree of market acceptance of the
Company’s product candidates; development of the Company’s sales
and marketing capabilities and risks associated with failure to
obtain sufficient reimbursement for the Company’s products; the
risks related to the Company’s dependence on third parties
including for conduct of clinical testing and product manufacture;
the Company’s inability to enter into partnerships; the risks
related to government regulation; risks related to market approval,
risks associated with protection of the Company’s intellectual
property rights; risks related to employee matters and managing
growth; risks related to the Company’s common stock, risks
associated with macroeconomic conditions, including the conflict
between Russia and Ukraine and sanctions related thereto,
inflation, increased interest rates, uncertain global credit and
capital markets and disruptions in banking systems; and other risks
and uncertainties affecting the Company including those described
in the "Risk Factors" section included in the Company’s Annual
Report on Form 10-K for the fiscal year ended December 31, 2022,
the Company’s Quarterly Report on Form 10-Q for the quarter ended
March 31, 2023, the Company’s Quarterly Report on Form 10-Q for the
quarter ended June 30, 2023 and future filings and reports by the
Company. Any forward-looking statements contained in this press
release speak only as of the date hereof, and the Company
undertakes no obligation to update any forward-looking statement,
whether as a result of new information, future events or
otherwise.
DANYELZA®, OMBLASTYS® and Y-mAbs® are registered
trademarks of Y-mAbs Therapeutics, Inc.
Contact:
Courtney DuganVP, Head of Investor RelationsE: cdu@ymabs.com
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