Y-mAbs to Host Annual Research and Development Day in New York
December 06 2022 - 9:00AM
Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a commercial-stage biopharmaceutical company today announced
that it will host its annual Research and Development Day in New
York, NY on December 14, 2022, at 9:00 am ET. The event will
feature presentations of the Company, its clinical development, and
advanced product pipeline.
Company Presenters:
- Thomas Gad (Founder, President, and Interim Chief Executive
Officer at Y-mAbs Therapeutics) will give a corporate
presentation.
- Steen Lisby, M.D., DMSc, (SVP, Chief Scientific Officer at
Y-mAbs Therapeutics) will present pipeline news and an overview of
the investigational SADA technology platform (Liquid
Radiation™).
- Vignesh Rajah, MBBS, DCH, MRCP (UK) MBA, (SVP, Chief Medical
Officer at Y-mAbs Therapeutics), will present an update on the
potential DANYELZA® (naxitamab-gqgk) label expansion into
osteosarcoma.
A question-and-answer session will follow the formal
presentations. To register for the event, please click here.
About DANYELZA® (naxitamab-gqgk)In the United
States, 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 under accelerated approval by the U.S.
Federal Drug Administration based on overall response rate and
duration of response. Continued approval for this indication may be
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 for complete
Boxed Warning and other important safety information.
Researchers at Memorial Sloan Kettering Cancer Center (“MSK”)
developed DANYELZA, which is exclusively licensed by MSK to
Y-mAbs. MSK has institutional financial interests related to the
compound and Y-mAbs.
About Y-mAbsY-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 at the registration stage, OMBLASTYS®
(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 The Private Securities Litigation Reform Act
of 1995. Such statements include, but are not limited to,
statements about our business model and development,
commercialization and product distribution plans; current and
future clinical and pre-clinical studies and our research and
development programs; expectations related to the timing of the
initiation and completion of regulatory submissions; regulatory,
marketing and reimbursement approvals, including statements with
respect to our expectations with regards to the omburtamab program,
pipeline development programs, potential for DANYELZA territory
expansion, potential for DANYELZA label expansion, and advancement
of SADA; collaborations or strategic partnerships and the potential
benefits thereof; potential for receipt and sale of a PRV voucher
relating to omurtamab, if approved, and potential net proceeds
therefrom; expectations related to our anticipated cash runway and
the sufficiency of our cash resources; DANYELZA revenue guidance
and other guidance for 2022 and future years, and our financial
performance, including our estimates regarding revenues, expenses
and capital expenditure requirements; 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’’
“goal”, “aim”, and similar expressions are intended to identify
forward-looking statements, although not all forward-looking
statements contain these identifying words. Our 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 our financial condition and need for additional
capital; risks associated with our development work; cost and
success of our product development activities and clinical trials;
the risks of delay in the timing of our regulatory submissions or
failure to receive approval of our drug candidates; the risks
related to commercializing any approved pharmaceutical product,
including the rate and degree of market acceptance of our product
candidates; development of our sales and marketing capabilities and
risks associated with failure to obtain sufficient reimbursement
for our products; the risks related to our dependence on third
parties, including for conduct of clinical testing and product
manufacture; our inability to enter into partnerships; the risks
related to government regulation; risks related to market approval;
risks associated with protection of our intellectual property
rights; risks related to employee matters and managing growth;
risks related to our common stock; risks associated with the
COVID-19 pandemic; risks associated with the conflict between
Russia and Ukraine and sanctions related thereto, macroeconomic
conditions, including inflation and volatile global capital
markets; and other risks and uncertainties affecting the Company
including those described in the “Risk Factors” section included in
our Annual Report on Form 10-K for the year ended December 31, 2021
filed with the SEC and in our other SEC filings, including our
Quarterly Report on Form 10-Q for the quarters ended March 31,
2022, June 30, 2022, and September 30, 2022 filed with the SEC. 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:
Y-mAbs Therapeutics, Inc. 230 Park Avenue, Suite 3350New York,
NY 10169USA
+1 646 885 8505
E-mail: info@ymabs.com
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