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 second quarter 2020.
“We are very pleased with our second quarter
2020 financial results, especially seen in conjunction with the
recent completion of our omburtamab BLA submission to the FDA. We
are also very excited about the FDA’s acceptance of our naxitamab
BLA for priority review, and the continued commercial ramp-up for
our potential launch of both compounds in the U.S.,” stated Thomas
Gad, Founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer,
continued, “We also 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
Radiation™. We were very pleased to designate the first four SADA
constructs for preclinical development and hope to file the first
IND next year.”
Second Quarter 2020 and Recent Corporate
Developments
- Subsequent to the end of the second
quarter, on August 6, 2020, Y-mAbs announced the completion of the
submission of its omburtamab Biologics License Application to FDA
for the treatment of pediatric patients with CNS/leptomeningeal
metastasis from neuroblastoma
- Also, subsequent to the end of the
second quarter, on July 14, 2020, Y-mAbs announced an update on the
SADA technology and presented B7-H3 as a new preclinical SADA
construct
- On June 2, 2020, Y-mAbs announced
that the FDA had accepted the Biologics License Application for
Danyelza™ (naxitamab) for the treatment of neuroblastoma for
priority review
- On April 24, 2020, Y-mAbs announced
the appointment of Laura J. Hamill to its Board of Directors
- On April 15, 2020, Y-mAbs announced
that it had 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 Radiation™
- 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
Financial Results
Y-mAbs reported a net loss of $40.4 million, or
$1.01 per basic and diluted share, for the three months ended June
30, 2020, compared to a net loss of $18.0 million, or $0.53 per
basic and diluted share, reported for the three months ended June
30, 2019.
For the six months ended June 30, 2020, Y-mAbs
reported a net loss of $66.6 million, or $1.67 per basic and
diluted share, compared to the net loss of $34.0 million, or $0.99
per basic and diluted share, reported for the six months ended June
30, 2019.
Operating Expenses
Research and DevelopmentResearch and development
expenses were $30.1 million for the three months ended June 30,
2020, compared to $14.5 million for the three months ended June 30,
2019, an increase of $15.6 million. The increase in research and
development expenses primarily reflects the following:
- $13.3 million increase in
milestones and license fees due to the $2.0 million SADA upfront
payment, $10.7 million SADA stock grants accruals, and $0.6 million
for SADA milestone accrual; and
- $1.8 million increase in personnel costs.
Research and development expenses were $48.7
million for the six months ended June 30, 2020, compared to $27.0
million for the six months ended June 30, 2019, an increase of
$21.7 million. The increase in research and development expenses
primarily reflects the following:
- $13.3 million increase in
milestones and license fees due to the $2.0 million SADA upfront
payment, $10.7 million SADA stock grants accruals, and $0.6 million
for SADA milestone accrual;
- $3.9 million increase in personnel costs;
- $2.3 million increase in outsourced
research and supplies to support the expansion of our product
development activities; and
- $1.6 million increase in outsourced
manufacturing for our two lead product candidates, naxitamab and
omburtamab.
General and AdministrationGeneral and
administrative expenses were $10.4 million for the three months
ended June 30, 2020, compared to $4.1 million for the three months
ended June 30, 2019, an increase of $6.3 million. Such increase in
general and administrative expenses primarily reflects the
following:
- $3.5 million increase in commercial infrastructure costs;
- $1.9 million increase in personnel costs; and
- $0.9 million increase in business insurance and professional
fees.
General and administrative expenses were $18.5
million for the six months ended June 30, 2020, compared to $7.9
million for the six months ended June 30, 2019, an increase of
$10.6 million. Such increase in general and administrative expenses
primarily reflects the following:
- $5.5 million increase in commercial infrastructure costs;
- $3.6 million increase in personnel costs; and
- $1.5 million increase in business insurance and professional
fees.
Cash and Cash Equivalents
The Company had approximately $158.1 million in
cash and cash equivalents as of June 30, 2020, compared to $207.1
million as of December 31, 2019. The decrease of $49.0 million was
primarily attributable to the increased costs of operation as the
Company completed its BLA submission for naxitamab and advanced the
rolling BLA for omburtamab, as well as build-up of the Company’s
commercial infrastructure, and increased personnel costs related to
these activities.
Webcast and Conference Call
The Company will host a conference call on
Friday, August 7, 2020 at 9 am eastern time. To participate in the
call, please dial 877-407-0792 (domestic) or 201-689-8263
(international) and reference the access code 13705298. A webcast
will be available at:
http://public.viavid.com/index.php?id=140271
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; developments relating to our competitors and our
industry; and other statements that are not historical facts. Words
such as ‘‘anticipate,’’ “appear,” ‘‘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) |
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
2020 |
|
2019 |
ASSETS |
|
|
|
|
|
CURRENT
ASSETS |
|
|
|
|
|
Cash and cash equivalents |
$ |
158,059 |
|
|
$ |
207,136 |
|
Other current assets |
|
5,261 |
|
|
|
4,819 |
|
Total current assets |
|
163,320 |
|
|
|
211,955 |
|
Property and equipment, net |
|
1,894 |
|
|
|
2,052 |
|
Operating lease right-of-use assets |
|
1,758 |
|
|
|
1,989 |
|
Other assets |
|
357 |
|
|
|
370 |
|
TOTAL
ASSETS |
$ |
167,329 |
|
|
$ |
216,366 |
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
Accounts payable |
$ |
9,825 |
|
|
$ |
8,520 |
|
Accrued liabilities |
|
5,313 |
|
|
|
4,550 |
|
Operating lease liabilities, current portion |
|
569 |
|
|
|
516 |
|
Total current liabilities |
|
15,707 |
|
|
|
13,586 |
|
Accrued milestone and royalty payments |
|
2,486 |
|
|
|
1,921 |
|
Operating lease liabilities, long-term portion |
|
1,399 |
|
|
|
1,714 |
|
Other liabilities |
|
1,729 |
|
|
|
242 |
|
TOTAL
LIABILITIES |
|
21,321 |
|
|
|
17,463 |
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized
at |
|
|
|
|
|
June 30, 2020 and December 31, 2019; none
issued at |
|
|
|
|
|
June 30, 2020 and December 31, 2019 |
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized
at |
|
|
|
|
|
June 30, 2020 and December 31, 2019; 40,014,519
and 39,728,416 |
|
|
|
|
|
shares issued at June 30, 2020 and
December 31, 2019, respectively |
|
4 |
|
|
|
4 |
|
Additional paid in capital |
|
378,455 |
|
|
|
364,712 |
|
Accumulated other comprehensive income |
|
(16 |
) |
|
|
50 |
|
Accumulated deficit |
|
(232,435 |
) |
|
|
(165,863 |
) |
TOTAL
STOCKHOLDERS’ EQUITY |
|
146,008 |
|
|
|
198,903 |
|
|
|
|
|
|
|
TOTAL
LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ |
167,329 |
|
|
$ |
216,366 |
|
|
|
|
|
|
|
|
Y-MABS
THERAPEUTICS, INC. |
Consolidated
Statements of Net Loss and Comprehensive Loss |
(unaudited) |
(in thousands,
except share and per share data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended June 30 |
|
Six months ended June 30 |
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
|
|
|
|
|
|
|
OPERATING
EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
30,059 |
|
|
$ |
14,494 |
|
|
$ |
48,681 |
|
|
$ |
27,005 |
|
General and administrative |
|
10,393 |
|
|
|
4,140 |
|
|
|
18,519 |
|
|
|
7,882 |
|
Total
operating expenses |
|
40,452 |
|
|
|
18,634 |
|
|
|
67,200 |
|
|
|
34,887 |
|
Loss from
operations |
|
(40,452 |
) |
|
|
(18,634 |
) |
|
|
(67,200 |
) |
|
|
(34,887 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
OTHER
INCOME |
|
|
|
|
|
|
|
|
|
|
|
Interest and
other income, net |
|
60 |
|
|
|
598 |
|
|
|
628 |
|
|
|
917 |
|
NET
LOSS |
$ |
(40,392 |
) |
|
$ |
(18,036 |
) |
|
$ |
(66,572 |
) |
|
$ |
(33,970 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Other
comprehensive income |
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
(91 |
) |
|
|
(66 |
) |
|
|
(66 |
) |
|
|
(10 |
) |
COMPREHENSIVE LOSS |
$ |
(40,483 |
) |
|
$ |
(18,102 |
) |
|
$ |
(66,638 |
) |
|
$ |
(33,980 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share attributable to common stockholders, basic and diluted |
$ |
(1.01 |
) |
|
$ |
(0.53 |
) |
|
$ |
(1.67 |
) |
|
$ |
(0.99 |
) |
Weighted
average common shares outstanding, basic and diluted |
|
39,972,174 |
|
|
|
34,193,666 |
|
|
|
39,862,878 |
|
|
|
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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