Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq:
YMAB) a development-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 third quarter 2020.
“We are very pleased with our third quarter 2020
financial results, especially seen in conjunction with the upcoming
PDUFA date for naxitamab later this month, and the planned
resubmission of the omburtamab BLA. We believe that we are well
positioned to transform Y-mAbs to a commercial-stage company,”
stated Thomas Gad, founder, Chairman and President.
Dr. Claus Moller, Chief Executive Officer, continued, “We are
making good progress on the omburtamab BLA resubmission, and
concurrently we’ve continued to advance many of the earlier stage
programs in our pipeline. Nivatrotamab, our leading bispecific
antibody, recently received ODD and RPDD from the FDA and our two
INDs for 177Lu-omburtamab-DTPA in medulloblastoma and B7-H3
positive CNS/leptomeningeal metastasis in adults were recently
cleared by the FDA.”
Third Quarter
2020 and Recent Corporate
Developments
- Subsequent to the end of the third quarter, on October 26, 2020
Y-mAbs announced that the FDA has cleared the Company’s IND
for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive CNS
and Leptomeningeal Metastasis from tumors in adult patients
- Also subsequent to the end of the third quarter, on October 16,
2020, Y-mAbs announced updates on naxitamab and omburtamab data,
which were presented at the International Society of Pediatric
Oncology conference
- Also subsequent to the end of the third quarter, on October 14,
2020 Y-mAbs announced that the FDA has cleared the Company’s
Investigational New Drug application for 177Lu-omburtamab-DTPA
for the treatment of medulloblastoma, which is the most common type
of primary brain cancer in children
- Also subsequent to the end of the third quarter, on October 7,
2020, Y-mAbs announced that the FDA has granted Orphan Drug
Designation and Rare Pediatric Disease Designation for its leading
bispecific antibody product candidate nivatrotamab for the
treatment of neuroblastoma
- After the close of the third quarter, on October 5, 2020,
Y-mAbs announced that it had received a Refusal to File letter from
the FDA for the omburtamab BLA for the treatment of pediatric
patients with CNS/leptomeningeal metastasis from neuroblastoma.
Subsequently, Y-mAbs requested and received what it believes to
have been a positive Type A meeting with the FDA, and plans to work
in close dialog with the Agency to amend the BLA with the goal of
resubmitting by the end of 2020 or in early 2021. The BLA was
originally submitted in August 2020
- On July 14, 2020, Y-mAbs announced an update on the SADA
technology and presented B7-H3 as a new preclinical SADA construct
with potential use in prostate cancer
Financial Results
Y-mAbs reported a net loss of $32.8 million, or
($0.82) per basic and diluted share, for the three months ended
September 30, 2020, compared to a net loss of $23.9 million, or
($0.70) per basic and diluted share, reported for the three months
ended September 30, 2019.
For the nine months ended September 30, 2020,
Y-mAbs reported a net loss of $99.4 million, or ($2.49) per basic
and diluted share, compared to the net loss of $57.9 million, or
($1.69) per basic and diluted share, reported for the nine months
ended September 30, 2019.
Operating Expenses
Research and DevelopmentResearch and development
expenses were $21.0 million for the three months ended September
30, 2020, compared to $19.7 million for the three months ended
September 30, 2019, an increase of $1.3 million. The increase in
research and development expenses primarily reflects the
following:
- $2.4 million increase in personnel costs;
- $0.5 million increase in clinical trial expenses;
- $0.4 million increase in professional and consulting fees;
and
- $2.0 million offsetting decrease in outsourced manufacturing
cost
Research and development expenses were $69.7
million for the nine months ended September 30, 2020, compared to
$46.7 million for the nine months ended September 30, 2019, an
increase of $23.0 million. The increase in research and development
expenses primarily reflects the following:
- $13.3 million increase in milestones and license fees related
to the SADA upfront cash payment and stock issuances and accrued
milestones;
- $6.3 million increase in personnel costs; and
- $1.9 million increase in outsourced research and supplies to
support the expansion of our product development activities
General and AdministrationGeneral and
administrative expenses were $11.6 million for the three months
ended September 30, 2020, compared to $4.7 million for the three
months ended September 30, 2019, an increase of $6.9 million. Such
increase in general and administrative expenses primarily reflects
the following:
- $3.2 million increase in commercial infrastructure costs;
- $2.2 million increase in personnel costs; and
- $1.6 million increase in business insurance and professional
fees
General and administrative expenses were $30.2
million for the nine months ended September 30, 2020, compared to
$12.6 million for the nine months ended September 30, 2019, an
increase of $17.6 million. Such increase in general and
administrative expenses primarily reflects the following:
- $8.7 million increase in commercial infrastructure costs;
- $5.8 million increase in personnel costs; and
- $3.1 million increase in business insurance and professional
fees
Cash and
Cash Equivalents
The Company had approximately $131.3 million in
cash and cash equivalents as of September 30, 2020
Webcast and Conference Call
The Company will host a conference call on
Friday, November 6, 2020 at 9 a.m. Eastern Time. To participate in
the call, please dial 877-407-0792 (domestic) or 201-689-8263
(international) and reference the access code 13712633. A webcast
will be available at:
http://public.viavid.com/index.php?id=142256
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” is a registered trademark of Y-mAbs
Therapeutics, Inc.
Y-MABS THERAPEUTICS, INC. |
Consolidated Balance Sheets |
(unaudited) |
(in thousands, except share data) |
|
|
|
|
|
|
|
|
|
September 30, |
|
December 31, |
|
|
2020 |
|
2019 |
ASSETS |
|
|
|
|
|
|
CURRENT ASSETS |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
131,267 |
|
|
$ |
207,136 |
|
Other current assets |
|
|
1,942 |
|
|
|
4,819 |
|
Total current assets |
|
|
133,209 |
|
|
|
211,955 |
|
Property and equipment, net |
|
|
1,888 |
|
|
|
2,052 |
|
Operating lease right-of-use assets |
|
|
5,123 |
|
|
|
1,989 |
|
Other assets |
|
|
2,975 |
|
|
|
370 |
|
TOTAL ASSETS |
|
$ |
143,195 |
|
|
$ |
216,366 |
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS’
EQUITY |
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
Accounts payable |
|
$ |
10,320 |
|
|
$ |
8,520 |
|
Accrued liabilities |
|
|
7,570 |
|
|
|
4,550 |
|
Operating lease liabilities, current portion |
|
|
1,887 |
|
|
|
516 |
|
Total current liabilities |
|
|
19,777 |
|
|
|
13,586 |
|
Accrued milestone and royalty payments |
|
|
2,466 |
|
|
|
1,921 |
|
Operating lease liabilities, long-term portion |
|
|
2,517 |
|
|
|
1,714 |
|
Other liabilities |
|
|
1,923 |
|
|
|
242 |
|
TOTAL LIABILITIES |
|
|
26,683 |
|
|
|
17,463 |
|
|
|
|
|
|
|
|
STOCKHOLDERS’ EQUITY |
|
|
|
|
|
|
Preferred stock, $0.0001 par value, 5,500,000 shares authorized
at |
|
|
|
|
|
|
September 30, 2020 and December 31, 2019; none
issued at |
|
|
|
|
|
|
September 30, 2020 and December 31, 2019 |
|
|
— |
|
|
|
— |
|
Common stock, $0.0001 par value, 100,000,000 shares authorized
at |
|
|
|
|
|
|
September 30, 2020 and December 31, 2019;
40,472,435 and 39,728,416 |
|
|
|
|
|
shares issued at September 30, 2020 and
December 31, 2019, respectively |
|
4 |
|
|
|
4 |
|
Additional paid in capital |
|
|
381,803 |
|
|
|
364,712 |
|
Accumulated other comprehensive income / (loss) |
|
|
(28 |
) |
|
|
50 |
|
Accumulated deficit |
|
|
(265,267 |
) |
|
|
(165,863 |
) |
TOTAL STOCKHOLDERS’
EQUITY |
|
|
116,512 |
|
|
|
198,903 |
|
|
|
|
|
|
|
|
TOTAL LIABILITIES AND
STOCKHOLDERS’ EQUITY |
|
$ |
143,195 |
|
|
$ |
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 endedSeptember 30 |
|
Nine months endedSeptember 30 |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
|
|
|
|
|
|
|
|
OPERATING EXPENSES |
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
$ |
21,005 |
|
|
$ |
19,660 |
|
|
$ |
69,686 |
|
|
$ |
46,665 |
|
General and administrative |
|
|
|
11,636 |
|
|
|
4,699 |
|
|
|
30,155 |
|
|
|
12,581 |
|
Total operating expenses |
|
|
|
32,641 |
|
|
|
24,359 |
|
|
|
99,841 |
|
|
|
59,246 |
|
Loss from operations |
|
|
|
(32,641 |
) |
|
|
(24,359 |
) |
|
|
(99,841 |
) |
|
|
(59,246 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
OTHER INCOME |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest and other income,
net |
|
|
|
(191 |
) |
|
|
437 |
|
|
|
437 |
|
|
|
1,354 |
|
NET LOSS |
|
|
$ |
(32,832 |
) |
|
$ |
(23,922 |
) |
|
$ |
(99,404 |
) |
|
$ |
(57,892 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other comprehensive income /
(loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign currency translation |
|
|
|
(12 |
) |
|
|
134 |
|
|
|
(78 |
) |
|
|
124 |
|
COMPREHENSIVE LOSS |
|
|
$ |
(32,844 |
) |
|
$ |
(23,788 |
) |
|
$ |
(99,482 |
) |
|
$ |
(57,768 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
attributable to common stockholders, basic and diluted |
|
|
$ |
(0.82 |
) |
|
$ |
(0.70 |
) |
|
$ |
(2.49 |
) |
|
$ |
(1.69 |
) |
Weighted average common shares
outstanding, basic and diluted |
|
|
|
40,187,173 |
|
|
|
34,371,927 |
|
|
|
39,971,766 |
|
|
|
34,253,739 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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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