Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional therapeutics, today reported
financial results for the third quarter ended September 30,
2019.
“We recently presented data on our lead asset, ZW25, at two
major medical conferences that pave the way for
registration-enabling trials in second-line biliary tract cancer
(BTC) with single agent ZW25 and in first-line gastroesophageal
adenocarcinoma (GEA) with ZW25 in combination with chemotherapy,”
said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “These
clinical plans support our evaluation of ZW25’s broad potential in
earlier lines of therapy with the goal of establishing ZW25 as a
therapeutic option for a greater number of people with
HER2‑expressing cancers.”
Third Quarter 2019 Business Highlights and Recent
Developments
- Single Agent Data for ZW25 Presented at European Society for
Medical Oncology (ESMO) Congress Updated Phase 1 clinical data
continued to show that ZW25 monotherapy provides anti-tumor
activity and durable disease control across multiple tumor types in
heavily pretreated patients. Encouraging response rates in BTC
support the initiation of a registration-enabling Phase 2 trial
evaluating single agent ZW25 as a second-line treatment for
patients with HER2‑expressing BTC.
- ZW25 Chemotherapy Combination Data Presented at
AACR-NCI-EORTC International Conference on Molecular Targets and
Cancer Therapeutics Phase 1 clinical data demonstrated that the
addition of chemotherapy to ZW25 treatment may enhance anti-tumor
activity vs. ZW25 alone, and the combination therapy was tolerated
in heavily pretreated HER2‑expressing GEA patients. These data
further support the ongoing Phase 2 trial of ZW25 in combination
with standard of care chemotherapy in first-line GEA.
- Celgene Advances First Azymetric™ Bispecific Towards
the Clinic Celgene selected its first lead bispecific antibody
candidate built using Zymeworks’ Azymetric platform and exercised
its option to a commercial license for which Zymeworks received a
US$7.5 million payment.
Financial Results for the Quarter Ended September 30,
2019
Revenue for the three months ended September 30, 2019 was $7.9
million as compared to $2.1 million in the same period of 2018.
Revenue for the third quarter of 2019 includes $7.5 million
recognized upon Celgene’s exercise of its commercial license option
and $0.4 million in research and support payments from our
partners. Revenue in the same period in 2018 was primarily due to a
$2.0 million development milestone upon Lilly’s submission of an
IND application under a licensing agreement with Lilly.
For the three months ended September 30, 2019, research and
development expenses were $29.3 million as compared to $14.2
million in the same period of the prior year. The change was
primarily due to an increase in clinical trial activity and
associated manufacturing costs for ZW25, as well as an increase in
other research and discovery activities compared to the same period
in 2018. Research and development expenses included non-cash
stock-based compensation expense of $1.7 million from
equity-classified stock options and a $0.9 million expense related
to the non-cash mark-to-market revaluation of certain historical
liability-classified stock options.
For the three months ended September 30, 2019, general and
administrative expenses were $12.2 million as compared to $7.5
million in the same period in 2018, primarily due to an increase in
employee compensation expenses relating to non-cash stock-based
compensation, as well as increased head count in 2019 over 2018.
General and administrative expenses in 2019 included non-cash
stock-based compensation expense of $1.7 million from
equity-classified stock options and $2.8 million related to the
non-cash mark-to-market revaluation of certain historical
liability-classified stock options.
The net loss for the three months ended September 30, 2019, was
$30.5 million as compared to $18.8 million in the same period of
2018. This was primarily due to an increase in research and
development expenses associated with our lead therapeutic
candidates and other programs, as well as an increase in general
and administrative expenses in 2019. This increase was partially
offset by increased revenue from research and development
collaborations, interest and other income in 2019.
Zymeworks expects research and development expenditures to
increase over time in line with the advancement and expansion of
clinical development of our product candidates, as well as our
ongoing preclinical research activities. Additionally, Zymeworks
anticipates continuing to receive revenue from our existing and
future strategic partnerships, including technology access fees,
milestone-based payments and research support payments. However,
Zymeworks’ ability to receive these payments is dependent upon
either Zymeworks or our collaborators successfully completing
specified research and development activities.
As of September 30, 2019, Zymeworks had $335.1 million in cash
and cash equivalents and short-term investments.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the development of next-generation multifunctional
biotherapeutics. Zymeworks’ suite of therapeutic platforms and its
fully integrated drug development engine enable precise engineering
of highly differentiated product candidates. Zymeworks’ lead
clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody
currently in Phase 2 clinical development. Zymeworks’ second
clinical candidate, ZW49, is a bispecific antibody-drug conjugate
currently in Phase 1 clinical development and combines the unique
design and antibody framework of ZW25 with Zymeworks’ proprietary
ZymeLink™ cytotoxic payload. Zymeworks is also advancing a deep
preclinical pipeline in immuno-oncology and other therapeutic
areas. In addition, its therapeutic platforms are being leveraged
through strategic partnerships with nine biopharmaceutical
companies. For more information, visit www.zymeworks.com.
Cautionary Note Regarding Zymeworks’ Forward-Looking
Statements
This press release includes “forward-looking statements” within
the meaning of the U.S. Private Securities Litigation Reform Act of
1995 and “forward-looking information” within the meaning of
Canadian securities laws, or collectively, forward-looking
statements. Forward-looking statements in this news release
include, but are not limited to, statements that relate to plans to
initiate a registration-enabling trial for ZW25, increases in
research and development expenditures, planned advancement and
expansion of clinical development of Zymeworks’ product candidates,
anticipated continued receipt of revenue from existing and future
partners, and other information that is not historical information.
When used herein, words and phrases such as “enable”, “may”,
“expect”, “anticipate”, “advances”, “continue”, and similar
expressions are intended to identify forward-looking statements. In
addition, any statements or information that refer to expectations,
beliefs, plans, projections, objectives, performance or other
characterizations of future events or circumstances, including any
underlying assumptions, are forward-looking. All forward-looking
statements are based upon Zymeworks’ current expectations and
various assumptions. Zymeworks believes there is a reasonable basis
for its expectations and beliefs, but they are inherently
uncertain. Zymeworks may not realize its expectations, and its
beliefs may not prove correct. Actual results could differ
materially from those described or implied by such forward-looking
statements as a result of various factors, including, without
limitation, market conditions and the factors described under “Risk
Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its
quarter ended September 30, 2019 (a copy of which may be obtained
at www.sec.gov and www.sedar.com). Consequently, forward-looking
statements should be regarded solely as Zymeworks’ current plans,
estimates and beliefs. Investors should not place undue reliance on
forward-looking statements. Zymeworks cannot guarantee future
results, events, levels of activity, performance or achievements.
Zymeworks does not undertake and specifically declines any
obligation to update, republish, or revise any forward-looking
statements to reflect new information, future events or
circumstances or to reflect the occurrences of unanticipated
events, except as may be required by law.
ZYMEWORKS INC.
Condensed Interim Consolidated Statements of Loss
(Expressed in thousands of U.S. dollars except share and per
share data)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Revenue
Research and developmental
collaborations
$
7,860
$
2,054
$
27,667
$
24,094
Operating expenses:
Research and development
29,251
14,195
70,511
42,648
General and administrative
12,173
7,447
33,937
23,161
Impairment on acquired IPR&D
—
—
768
—
Total operating expenses
41,424
21,642
105,216
65,809
Loss from operations
(33,564
)
(19,588
)
(77,549
)
(41,715
)
Other income (expense), net
2,181
886
4,276
(2,288
)
Loss before income taxes
(31,383
)
(18,702
)
(73,273
)
(44,003
)
Income tax expense (recovery)
908
(49
)
80
(1,826
)
Net loss and comprehensive loss
$
(30,475
)
$
(18,751
)
$
(73,193
)
$
(45,829
)
Net loss per common share:
Basic
(0.70
)
(0.59
)
(2.03
)
(1.63
)
Diluted
(0.70
)
(0.59
)
(2.03
)
(1.63
)
Weighted-average common shares
outstanding:
Basic
43,445,379
31,959,206
36,143,113
28,119,872
Diluted
43,445,379
31,959,206
36,143,113
28,119,872
ZYMEWORKS INC.
Selected Condensed Consolidated Balance Sheet Data
(Expressed in thousands of U.S. dollars)
September 30, 2019
December 31,
2018
Cash, cash equivalents and short-term
investments
$ 335,103
$ 200,164
Working capital
294,622
174,383
Total assets
400,037
244,363
Accumulated deficit
(218,465)
(145,272)
Total shareholders’ equity
309,525
180,490
NON-GAAP FINANCIAL MEASURES
In addition to reporting financial information in accordance
with U.S. generally accepted accounting principles (“GAAP”) in this
press release, Zymeworks is also reporting normalized expenses and
normalized loss per share, which are non-GAAP financial measures.
Normalized expenses and normalized loss per share are not defined
by GAAP and should not be considered as alternatives to net loss,
net loss per share or any other indicator of Zymeworks’ performance
required to be reported under GAAP. In addition, Zymeworks’
definitions of normalized expenses and normalized loss per share
may not be comparable to similarly titled non-GAAP measures
presented by other companies. Investors and others are encouraged
to review Zymeworks’ financial information in its entirety and not
rely on a single financial measure. As defined by Zymeworks,
normalized expenses represent total research and development
expenses and general and administrative expenses adjusted for
non-cash stock-based compensation expenses for equity and
liability-classified equity instruments.
Normalized expenses are a non-GAAP measure that Zymeworks
believes is useful because it excludes those items that Zymeworks
believes are not representative of Zymeworks’ operating
expenses.
GAAP to Non-GAAP Reconciliations
(Expressed in thousands of U.S. dollars except share and per
share data)
(unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Research and development expenses
$ 29,251
$ 14,195
$ 70,511
$ 42,648
Stock based compensation for
equity-classified instruments
(1,690)
(691)
(4,324)
(1,724)
Stock based compensation for
liability-classified instruments
(888)
(496)
(2,856)
(1,966)
Normalized research and development
expenses (Non-GAAP basis)
$ 26,673
$ 13,008
$ 63,331
$ 38,958
General and administrative expenses
$ 12,173
$ 7,447
$ 33,937
$ 23,161
Stock based compensation for
equity-classified instruments
(1,721)
(1,093)
(4,791)
(2,758)
Stock based compensation for
liability-classified instruments
(2,781)
(1,304)
(8,908)
(5,342)
Normalized general and administrative
expenses (Non-GAAP basis)
$ 7,671
$ 5,050
$ 20,238
$ 15,061
Three Months Ended September
30,
Nine Months Ended September
30,
2019
2018
2019
2018
Net loss per common share – Basic
(0.70)
(0.59)
(2.03)
(1.63)
Stock based compensation for
equity-classified instruments
0.08
0.06
0.25
0.16
Stock based compensation for
liability-classified instruments
0.08
0.06
0.33
0.26
Normalized net loss per common share –
Basic (Non-GAAP basis)
(0.54)
(0.47)
(1.45)
(1.21)
Net loss per common share – Diluted
(0.70)
(0.59)
(2.03)
(1.63)
Stock based compensation for
equity-classified instruments
0.08
0.06
0.25
0.16
Stock based compensation for
liability-classified instruments
0.08
0.06
0.33
0.26
Normalized net loss per common share –
Diluted (Non-GAAP basis)
(0.54)
(0.47)
(1.45)
(1.21)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191105005313/en/
Zymeworks Inc.
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com
Tiffany Tolmie (604) 678-1388 ir@zymeworks.com
Media Inquiries: Kavita Shah, Ph.D. (604) 678-1388
info@zymeworks.com
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