Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today reported
financial results for the first quarter ended March 31, 2021.
This press release features multimedia. View
the full release here:
https://www.businesswire.com/news/home/20210505006039/en/
FDA cleared the IND for Zanidatamab's
first randomized Phase 3 trial in first line HER2-positive gastric
cancer. (Photo: Business Wire)
“As we look ahead over the next 12 months, Zymeworks is focused
on delivering several key clinical data presentations highlighting
the significant potential of zanidatamab and ZW49, as well as
driving continued value creation from our preclinical assets and
partnerships,” said Ali Tehrani, Ph.D., Zymeworks’ President &
CEO. “Recently, the FDA cleared the IND for zanidatamab's first
randomized Phase 3 trial in first line HER2-positive gastric
cancer, which represents a significant corporate milestone. This
will also be the second pivotal trial for zanidatamab, in addition
to our ongoing trial in refractory HER2-amplified biliary tract
cancer. We look forward to presenting the supportive Phase 2 data
at an upcoming medical meeting this year.”
First Quarter 2021 Business Highlights and Recent
Developments
- Zanidatamab Advances in Pivotal Trial in Biliary Tract
Cancer (BTC) Enrollment continues at sites across North and
South America, Europe, and Asia for the global, pivotal trial for
zanidatamab (a HER2-targeted bispecific antibody) monotherapy in
patients with previously treated HER2 gene-amplified BTC
(HERIZON-BTC-01). This trial was initiated based on encouraging
data, recently updated at the American Society of Clinical Oncology
(ASCO) Gastrointestinal Cancers Symposium in January, which
highlighted a 40% confirmed objective response rate for zanidatamab
monotherapy in BTC. Zanidatamab development is also supported by a
number of special designations in the U.S. and European Union,
including Breakthrough Therapy designation for BTC from the U.S.
Food and Drug Administration (FDA).
- FDA Clears Zanidatamab Phase 3 Pivotal Trial in First Line
HER2-positive Gastroesophageal Adenocarcinoma (GEA) Zymeworks
recently received clearance from the FDA for its first randomized
Phase 3 clinical trial for zanidatamab. HERIZON-GEA-01 is a
randomized, multicenter study of zanidatamab in combination with
chemotherapy with or without BeiGene’s PD-1-targeted antibody,
tislelizumab, as a first line treatment for patients with
HER2-positive unresectable locally advanced or metastatic GEA.
Supportive clinical data from an ongoing Phase 2 clinical trial
evaluating zanidatamab with chemotherapy in first line
HER2-positive GEA are expected to be presented at a medical
conference in the second half of the year.
- ZW49 Continues Enrollment in Dose-Escalation and Expansion
Cohorts In January, interim data was presented for ZW49, a
bispecific antibody-drug conjugate targeting HER2, which
demonstrated antitumor activity and a differentiated safety
profile. Specifically, there have been no dose limiting toxicities,
no treatment-related hematologic, pulmonary, or liver toxicity, and
no treatment-related deaths. Over 90% of treatment-related adverse
events have been mild or moderate in severity, with the most common
being keratitis, fatigue, and diarrhea, which have been reversible
and manageable in an outpatient setting. ZW49 has demonstrated
antitumor activity at all dose levels evaluated in the once every
three week regimen, including confirmed partial responses and
stable disease per RECIST 1.1. Dose escalation is continuing in
both the weekly and once every three week schedules and three
indication-specific expansion cohorts (HER2-positive breast cancer,
HER2-positive GEA, and a basket cohort of other HER2-positive
cancers) utilizing the 2.5 mg/kg once every three week regimen have
also been initiated. The objective of these studies is to identify
a recommended Phase 2 dose and schedule by the end of this
year.
- Preclinical Assets, Including New Therapeutic Platform,
ProTECT™, and Zanidatamab Mechanisms of Action Showcased at AACR
Annual Meeting Data presented at the American Association for
Cancer Research (AACR) in April highlighted preclinical data that
reveal new insights into the unique mechanisms of action of lead
clinical candidate, zanidatamab, introduce Zymeworks’ fourth
therapeutic platform, ProTECT™, and describe two new preclinical
assets focused on both the cytokine, IL-12, and the immune-oncology
target, 4-1BB.
- Expanded Commercial and Clinical Leadership As
zanidatamab advances in late-stage clinical development, Zymeworks
continues to build its clinical and commercial leadership team in
preparation for potential commercial launch. In January, James
Priour, former Senior Vice President, Commercial, was promoted to
Chief Commercial Officer and named to the Company’s Executive
Committee. The Commercial team also recruited Manny Duenas as Vice
President, Global Value & Access. The clinical team was
strengthened with the recent additions of Dr. Jonas Hylton as Vice
President, Medical and Scientific Affairs and Dr. Kaycia Wilde as
Vice President, Clinical Operations.
Financial Results for the Quarter Ended March 31,
2021
Revenue for the three months ended March 31, 2021 was $0.6
million compared to $8.3 million for the same period of 2020.
Revenue for the first quarter of 2021 related to research support
and other payments from our partners. Revenue for the same period
in 2020 included $5.0 million from BeiGene for a development
milestone and $3.3 million from our partners for research support,
drug supply and other payments.
For the three months ended March 31, 2021, research and
development expenses were $44.3 million compared to $36.9 million
for the same period of 2020. The increase was primarily due to
higher salaries and benefits expense from additional headcount and
an increase in lab and consulting expenses partly offset by
slightly lower third-party research and development program
expenses. For the three months ended March 31, 2021, research and
development expenses included non-cash stock-based compensation
expense of $4.3 million from equity-classified equity awards and a
$2.5 million recovery related to the non-cash mark-to-market
revaluation of certain historical liability classified equity
awards.
For the three months ended March 31, 2021, general and
administrative expenses were $1.3 million compared to $7.2 million
for the same period in 2020. The decrease was primarily due to a
$5.7 million increase in stock-based compensation recovery. For the
three months ended March 31, 2021, general and administrative
expenses included non-cash stock-based compensation expense of $4.2
million from equity-classified equity awards and a $13.0 million
recovery related to the non-cash mark-to-market revaluation of
certain historical liability-classified equity awards. Excluding
stock-based compensation, general and administrative expense
decreased by $0.2 million in the three months ended March 31, 2021
compared to the same period in 2020.
Net loss for the three months ended March 31, 2021 was $44.6
million compared to $31.1 million for the same period of 2020. This
was primarily due to the decrease in revenue and interest income
and increase in research and development expenses referred to
above, partially offset by lower general and administrative
expenses.
Zymeworks expects research and development expenditures to
increase over time in line with the advancement and expansion of
the Company’s clinical development of its product candidates, as
well as its ongoing preclinical research activities. Additionally,
Zymeworks anticipates continuing to receive revenue from its
existing and future strategic partnerships, including technology
access fees and milestone-based payments. However, Zymeworks’
ability to receive these payments is dependent upon either
Zymeworks or its collaborators successfully completing specified
research and development activities.
As of March 31, 2021, Zymeworks had $411.5 million in cash
resources consisting of cash, cash equivalents and short-term
investments. We anticipate this will enable us to fund our planned
operations into the second half of 2022 and potentially beyond.
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, zanidatamab (ZW25), is a novel Azymetric™
bispecific antibody which has been granted Breakthrough Therapy
designation by the FDA and is currently enrolling in a pivotal
clinical trial for refractory HER2-amplified biliary tract cancer
(HERIZON-BTC-01) as well as several Phase 2 clinical trials for
HER2-expressing gastroesophageal and breast cancers. Zymeworks’
second clinical candidate, ZW49, is a novel bispecific
HER2-targeting antibody-drug conjugate currently in Phase 1
clinical development and combines the unique design and antibody
framework of zanidatamab with Zymeworks’ proprietary ZymeLink™
linker and cytotoxin. Zymeworks is also advancing a deep
preclinical pipeline in oncology (including immuno-oncology agents)
and other therapeutic areas. In addition, its therapeutic platforms
are being leveraged through strategic partnerships with nine
biopharmaceutical companies. For additional information about
Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on
Twitter.
Cautionary Note Regarding 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
Zymeworks’ clinical and preclinical development of its product
candidates, related clinical trials and regulatory filings,
anticipated clinical data presentations, potential commercial
launch, expected increases in research and development
expenditures, anticipated continued receipt of revenue from
existing and future partners, and other information that is not
historical information. When used herein, words such as “plan”,
“expect”, “may”, “continue”, “anticipate”, “potential” 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 March 31, 2021 (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) (unaudited)
Three Months Ended March
31,
2021
2020
Revenue
Research and development
collaborations
$
644
$
8,269
Operating expenses:
Research and development
44,283
36,943
General and administrative
1,296
7,206
Total operating expenses
45,579
44,149
Loss from operations
(44,935)
(35,880)
Other income, net
870
5,119
Loss before income taxes
(44,065)
(30,761)
Income tax expense
(525)
(375)
Net loss and comprehensive loss
$
(44,590)
$
(31,136)
Net loss per common share:
Basic and diluted
$
(0.87)
$
(0.64)
Weighted-average common shares
outstanding:
Basic and diluted
51,367,663
48,686,718
ZYMEWORKS INC. Selected Condensed Consolidated Balance Sheet
Data (Expressed in thousands of U.S. dollars)
March 31, 2021
December 31,
2020
(unaudited)
Cash, cash equivalents, short-term
investments and certain long-term investments
$
411,474
$
451,557
Working capital
362,523
369,410
Total assets
490,059
538,376
Accumulated deficit
(515,851)
(471,261)
Total shareholders’ equity
377,145
409,922
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 March
31,
2021
2020
Research and development expenses
$
44,283
$
36,943
Stock-based compensation for equity
classified instruments
(4,336)
(2,016)
Stock-based compensation for liability
classified instruments
2,513
1,794
Normalized research and development
expenses (Non-GAAP basis)
$
42,460
$
36,721
General and administrative expenses
$
1,296
$
7,206
Stock-based compensation for equity
classified instruments
(4,192)
(2,228)
Stock-based compensation for liability
classified instruments
12,951
5,379
Normalized general and administrative
expenses (Non-GAAP basis)
$
10,055
$
10,357
Net loss per common share – Basic and
Diluted
$
(0.87)
$
(0.64)
Stock based compensation for equity
classified instruments
0.17
0.09
Stock based compensation for liability
classified instruments
(0.30)
(0.15)
Normalized net loss per common share –
Basic (Non-GAAP basis)
$
(1.00)
$
(0.70)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210505006039/en/
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com
Jack Spinks (604) 678-1388 ir@zymeworks.com
Media Inquiries: Mary Klem (604) 678-1388
media@zymeworks.com
Zymeworks (NYSE:ZYME)
Historical Stock Chart
From Mar 2024 to Apr 2024
Zymeworks (NYSE:ZYME)
Historical Stock Chart
From Apr 2023 to Apr 2024