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, today announced a
strategic restructuring plan designed to extend its cash runway and
prioritize resources on the commercialization and potential label
extension of DANYELZA and development of the SADA (Self-Assembly
DisAssembly (“SADA”) PRIT 2-STEP) technology platform. The Company
plans to discuss omburtamab at its upcoming Type A meeting with the
FDA; however, the Company has assumed a deprioritization of the
omburtamab program, including all indications, in designing its
restructuring plan and in its estimates for 2023. In addition, the
Company plans to deprioritize other pipeline programs, including
activities relating to GD2-GD3 Vaccine and CD33 bispecific antibody
constructs, as part of the restructuring plan.
“We believe that this restructuring of the
organization aligns our resources to efficiently leverage both the
DANYELZA franchise and support development activities for our
highly differentiated novel SADA platform, which we view as the key
near and long-term potential growth drivers of Y-mAbs. We believe
this sharpened focus should propel us through key anticipated
milestones, including continuation and potential expansion of the
commercialization of DANYELZA for neuroblastoma patients and
potential indication expansion,” said Thomas Gad, founder,
President, and Interim CEO. “We also look forward to potentially
dosing the first patient with GD2-SADA and generating data that we
believe could potentially represent a transformative therapeutic
option for patients based on the novel mechanism of action of our
SADA constructs. We also expect to submit the IND for CD38-SADA
targeting non-Hodgkin's lymphoma. We are excited for 2023 and aim
at further de-risking our SADA platform while continuing to grow
our top line revenue for DANYELZA in the U.S. and adding ex-U.S.
sales as we are excited about the potential launch in China after
SciClone Pharmaceuticals received an approval late last year.
Additionally, we anticipate a Type A meeting with the FDA in
January 2023 to discuss the future of omburtamab.”
Mr. Gad continued, “We expect the reduction in
our workforce and our revised business plan to result in a
reduction in operating expenses and extension of our cash runway
into Q1 2026. I want to extend my sincere appreciation and
gratitude to all of our colleagues for the work that has brought us
to this point, and for their dedication and service to Y-mAbs while
striving to develop new treatments for patients with cancer.”
Strategic Objectives for 2023 and Beyond
- Aiming to drive growth for our
commercial drug, DANYELZA in the US through market growth and
potential label expansion to target an estimated US market
opportunity of $400 million for high-risk neuroblastoma and
osteosarcoma alone
- Seeking initial validation of the
tumor binding capability of our novel SADA platform in solid tumors
in the GD2-SADA multicenter trial through the collection of imaging
data in patients with small-cell lung cancer, sarcoma, and
malignant melanoma
- Targeting an IND submission in Q2
2023 for CD38-SADA construct against non-Hodgkin's lymphoma to
potentially validate SADA in blood cancers
- Seeking partnerships based on the
SADA technology platform
- Discussing potential regulatory
pathway for omburtamab at Type A meeting with the FDA
2023 Financial Outlook
- The restructuring plan announced today is expected to result in
a reduction of Y-mAbs workforce by approximately 35% by the end of
May 2023
- Operating expenses, including restructuring costs which are
expected to be recognized in Q1 2023, are expected to decrease by
approximately 28% to $115-120 million, compared to previously
announced 2022 guidance for operating expenses of $162-167
million
- As a result of the estimated decrease in operating expenses, we
estimate that our cash and cash equivalents should support our
operations as currently planned, taking into account the
restructuring plan, into the first quarter of 2026
- The total cash burn for the 2023 fiscal year is expected to be
in the range of $50-55 million, which is based on an expected
2022 year-end cash position of approximately $106 million
- Estimated DANYELZA net product revenues for the 2023 fiscal
year are expected to be between $60-65 million, compared to
approximately $47-48 million expected for fiscal year 2022
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.
Preliminary Financial
Results
The preliminary financial results pertaining to
expected cash and cash equivalents as of December 31, 2022 and
DANYELZA net product revenues for fiscal year 2022 set forth above
are unaudited and based on management’s initial review of the
Company’s results as of and for the year ended December 31, 2022,
and are subject to revision based upon the Company’s year-end
closing procedures and the completion of the audit by the Company’s
external auditors of the Company’s December 31, 2022 financial
statements. Actual results may differ materially from these
preliminary results as a result of the completion of year-end
closing procedures, final adjustments, and other developments
arising between now and the time that the Company’s financial
results are finalized. In addition, these preliminary results are
not a comprehensive statement of the Company’s financial results as
of and for the year ended December 31, 2022, should not be viewed
as a substitute for complete financial statements prepared in
accordance with U.S. generally accepted accounting principles, and
are not necessarily indicative of the Company’s results for any
future period.
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 under accelerated approval
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.
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 at the registration-stage, OMBLASTYS®
(omburtamab), which targets tumors that express B7-H3.
Forward-Looking Statements
Statements 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,
including financial outlook for 2023, including estimated operating
expenses, total cash burn and DANYELZA product revenue and
sufficiency of cash resources, in addition to expected revenues,
operating expenses, and cash position for 2022, the restructuring,
including the reduction in workforce and revised business plan, and
the expected impacts, expenses and benefits thereof, including
potential cost-savings from the reduction in force, expected
reduction of operating expenses and any expectations with respect
to cost savings to be derived therefrom; implied and express
statements regarding the future of the Company’s business; the
Company’s plans and strategies, development, commercialization and
product distribution plans; expectations with respect to
omburtamab, including the anticipated Type A meeting with the FDA;
expectations with respect to our products and product candidates,
including potential territory and label expansion of DANYELZA and
the potential market opportunity related thereto and potential
benefits thereof, and the potential of the SADA Technology,
including the development of the first tumor binding dataset and
potential benefits thereof and potential partnership relating
thereto; expectations relating to key anticipated development
milestones, including potential expansion of international
commercialization efforts with respect to DANYELZA and the SADA
Technology, including anticipated collection of data in in GD2-SADA
multicenter trial against small-cell lung cancer, sarcoma, and
malignant melanoma and anticipated IND relating to the CD38-SADA
construct against non-hodgkin's lymphoma, and the timing thereof;
expectations that DANYELZA and the SADA technology represent
potential key near and long-term growth drivers; 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 satisfaction of conditions to
approvals; additional product candidates and technologies;
collaborations or strategic partnerships and the potential benefits
thereof; expectations related to the use of our cash and cash
equivalents, and the need for, timing and amount of any future
financing transaction; our financial performance, including our
estimates regarding revenues, expenses, capital expenditure
requirements, cash burn; 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’’
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; the
risks that actual results of our restructuring plan and revised
business plan will not be as expected; 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;
including inflation and uncertain global credit and 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, our Quarterly Reports on Firm 10-Q for the quarters ending
March 31, 2022, June 30, 2022 and September 30, 2022, and in our
other SEC filings. 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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