Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a late-stage clinical biopharmaceutical company focused on
the development and commercialization of novel, antibody-based
therapeutic products for the treatment of cancer, today reported
financial results for the first quarter 2020.
“We are very pleased with our first quarter 2020
financial results, especially seen in conjunction with the
completion of our naxitamab BLA submission to the FDA and the
notable progress we’ve made on our rolling BLA submission for
omburtamab, as well as the continued commercial ramp-up for the
potential launch of both compounds. After the balance sheet date,
we entered into an exclusive licensing agreement with MSK and MIT
for the SADA technology, which we believe may be a potential game
changer in therapeutic and diagnostic use of Liquid RadiationTM,”
stated Thomas Gad, Founder, Chairman, President and Head of
Business Development and Strategy.
Dr. Claus Moller, Chief Executive Officer,
continued, “We have worked hard to complete the submission of the
naxitamab BLA in March, and were excited to see the application go
in. The omburtamab BLA application process is well underway, and
after our recent pre-BLA meeting with the FDA, we have made good
progress on that submission. We expect to start submitting a
rolling BLA in May, with anticipated completion in June.”
First Quarter 2020 and Recent Corporate
Developments
- Subsequent to the end of the first
quarter, on April 24, 2020, Y-mAbs announced the appointment
of Laura J. Hamill to its Board of Directors.
- Also, subsequent to the end of the
first quarter, on April 15, 2020, Y-mAbs announced that it has
entered into an agreement with Memorial Sloan Kettering Cancer
Center and the Massachusetts Institute of Technology for a
worldwide exclusive license and research collaboration for the SADA
technology, a concept we refer to as Liquid RadiationTM.
- After the close of the first
quarter, on April 1, 2020, Y-mAbs announced that the Company
completed the submission of its rolling BLA submission to the FDA
for naxitamab on March 31, 2020.
- On February 26, 2020, Y-mAbs
announced a Pre-BLA meeting with the FDA for omburtamab.
Financial Results
Y-mAbs reported a net loss for the first quarter
of 2020 of $26.2 million, or $0.66 per basic and diluted share,
compared to a net loss of $15.9 million, or $0.47 per basic and
diluted share, reported for the first quarter of 2019.
Operating Expenses
Research and DevelopmentResearch and development
expenses were $18.6 million for the quarter ended March 31, 2020,
compared to $12.5 million for the quarter ended March 31, 2019, an
increase of $6.1 million. The increase in research and development
expenses primarily reflects the following:
- $2.8 million increase in outsourced
research and supplies to support the expansion of our product
development activities;
- $2.1 million increase in personnel
costs; and
- $0.9 million increase in outsourced
manufacturing for our two lead product candidates, naxitamab and
omburtamab.
General and AdministrationGeneral and
administrative expenses were $8.1 million for the quarter ended
March 31, 2020, compared to $3.7 million for the quarter ended
March 31, 2019, an increase of $4.4 million. Such increase in
general and administrative expenses primarily reflects the
following:
- $1.6 million increase in personnel
costs; and
- $1.6 million increase in commercial
infrastructure costs.
Cash and Cash Equivalents
The Company had approximately $185.8 million in
cash and cash equivalents as of March 31, 2020, compared to $207.1
million as of December 31, 2019. The decrease of $21.4 million was
primarily attributable to the increased costs of operation as the
Company completed its BLA submission for naxitamab and prepared the
upcoming submission of the rolling BLA for omburtamab, as wells as
build-up of the Company’s commercial infrastructure, and increased
personnel costs related to thesse activities.
Webcast and Conference Call
The Company will host a conference call on
Friday, May 8, 2020 at 9 am eastern time. To participate in the
call, please dial 855-327-6838 (domestic) or 604-235-2082
(international) and reference the access code 10009507. A webcast
will be available at:
http://public.viavid.com/index.php?id=139639
About Y-mAbs
Y-mAbs is a late-stage clinical
biopharmaceutical company focused on the development and
commercialization of novel, antibody-based therapeutic products for
the treatment of cancer. The Company has a broad and advanced
product pipeline, including two pivotal-stage product
candidates—naxitamab and omburtamab—which target tumors that
express GD2 and B7-H3, respectively.
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 and
development and commercialization plans; current and future
clinical and pre-clinical studies and our research and development
programs; regulatory, marketing and reimbursement approvals; rate
and degree of market acceptance and clinical utility as well as
pricing and reimbursement levels; retaining and hiring key
employees; our commercialization, marketing and manufacturing
capabilities and strategy; our intellectual property position and
strategy; 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; potential adverse affects on our business, financial
condition and results of operations from the global COVID-19
pandemic; developments relating to our competitors and our
industry; and other statements that are not historical facts. Words
such as ‘‘anticipate,’’ ‘‘believe,’’ “contemplate,” ‘‘continue,’’
‘‘could,’’ ‘‘estimate,’’ ‘‘expect,’’ ‘‘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; risks associated with
our development work; cost and success of our product development
activities and clinical trials; the risks of delay 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 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 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.
|
Y-MABS THERAPEUTICS, INC. |
Consolidated Balance Sheets |
(unaudited) |
(in thousands, except share data) |
|
|
|
|
|
|
|
March 31, |
|
December 31, |
|
2020 |
|
2019 |
ASSETS |
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
185,774 |
|
|
$ |
207,136 |
|
Other current assets |
|
4,062 |
|
|
|
4,819 |
|
Total current assets |
|
189,836 |
|
|
|
211,955 |
|
Property and equipment, net |
|
1,992 |
|
|
|
2,052 |
|
Operating lease right-of-use assets |
|
1,865 |
|
|
|
1,989 |
|
Other assets |
|
381 |
|
|
|
370 |
|
TOTAL ASSETS |
$ |
194,074 |
|
|
$ |
216,366 |
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
10,260 |
|
|
$ |
8,520 |
|
Accrued liabilities |
|
4,035 |
|
|
|
4,550 |
|
Operating lease liabilities, current portion |
|
548 |
|
|
|
516 |
|
Total current liabilities |
|
14,843 |
|
|
|
13,586 |
|
Accrued milestone and royalty payments |
|
1,901 |
|
|
|
1,921 |
|
Operating lease liabilities, long-term portion |
|
1,543 |
|
|
|
1,714 |
|
Other liabilities |
|
457 |
|
|
|
242 |
|
TOTAL LIABILITIES |
|
18,744 |
|
|
|
17,463 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized
at |
|
|
|
|
|
March 31, 2020 and December 31, 2019; none
issued at |
|
|
|
|
|
March 31, 2020 and December 31, 2019 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized
at |
|
|
|
|
|
March 31, 2020 and December 31, 2019;
39,757,623 and 39,728,416 |
|
|
|
|
|
shares issued at March 31, 2020 and
December 31, 2019, respectively |
|
4 |
|
|
|
4 |
|
Additional paid in capital |
|
367,293 |
|
|
|
364,712 |
|
Accumulated other comprehensive income |
|
75 |
|
|
|
50 |
|
Accumulated deficit |
|
(192,042 |
) |
|
|
(165,863 |
) |
TOTAL STOCKHOLDERS’ EQUITY |
|
175,330 |
|
|
|
198,903 |
|
|
|
|
|
|
|
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
194,074 |
|
|
$ |
216,366 |
|
|
|
|
|
|
|
Y-MABS THERAPEUTICS, INC. |
Consolidated Statements of Net Loss and Comprehensive
Loss |
(unaudited) |
(in thousands, except share and per share data) |
|
|
|
|
|
|
|
For the year ended March 31, |
|
2020 |
|
2019 |
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
Research and development |
$ |
18,622 |
|
|
$ |
12,511 |
|
General and administrative |
|
8,125 |
|
|
|
3,742 |
|
Total operating expenses |
|
26,747 |
|
|
|
16,253 |
|
Loss from operations |
|
(26,747 |
) |
|
|
(16,253 |
) |
|
|
|
|
|
|
OTHER INCOME/(EXPENSES) |
|
|
|
|
|
Interest and other income, net |
|
568 |
|
|
|
319 |
|
NET LOSS |
$ |
(26,179 |
) |
|
$ |
(15,934 |
) |
|
|
|
|
|
|
Other comprehensive income |
|
|
|
|
|
Foreign currency translation |
|
25 |
|
|
|
56 |
|
COMPREHENSIVE LOSS |
$ |
(26,154 |
) |
|
$ |
(15,878 |
) |
|
|
|
|
|
|
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(0.66 |
) |
|
$ |
(0.47 |
) |
Weighted average common shares outstanding, basic and diluted |
|
39,753,583 |
|
|
|
34,193,666 |
|
|
|
|
|
|
|
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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