- Last patient enrolled ahead of expectations in pivotal trial
evaluating zanidatamab as monotherapy in 2L biliary tract cancers
(BTC)
- Two zanidatamab data presentations at ASCO in June: 1L breast
cancer and 1L gastroesophageal adenocarcinoma (GEA)
- Presented topoisomerase 1 inhibitor (TOPO1i) antibody-drug
conjugate (ADC) platform at World ADC London highlighting
next-generation ADC capabilities and potential ADC candidates
- Completed licensing agreement with Atreca utilizing ZymeLink's
auristatin-based ADC platform
- ZW49 continues to progress towards anticipated data read-out in
2H22
- Will host conference call with Management today at 4:30 PM
ET
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today reported
financial results for the first quarter ended March 31, 2022.
“We are incredibly excited to celebrate the milestone of the
last patient enrolled for our pivotal study in second-line biliary
tract cancers, as well as the continued progression of multiple
zanidatamab clinical studies that we will be presenting over the
course of the year starting at ASCO in June,” said Kenneth
Galbraith, Chair & CEO. “The completion of enrollment in
HERIZON-BTC-01 is an important step forward in our efforts to
provide patients with a new HER2-targeted therapy for BTC with the
potential to improve on the current standard of care. We completed
this clinical milestone ahead of our previously guided timeline set
out in January, and hope to continue delivering on our corporate
goals and exceeding expectations as we move forward.”
First Quarter 2022 Business Highlights and Recent
Developments
- Completed Enrollment in HERIZON-BTC-01 Pivotal Trial in 2L
Biliary Tract Cancers (BTC) Enrollment was completed ahead of
schedule for the global, pivotal trial (HERIZON-BTC-01) evaluating
zanidatamab monotherapy in patients with previously-treated
advanced HER2-amplified BTC. The primary endpoint of this pivotal
trial is confirmed objective response rate as determined by
independent central review and we expect to finalize and present
top-line data by early 2023. We expect that full details of the
study will be presented at a major medical meeting in 2023.
- Unveiled Next-Generation TOPO1i ADC Platform Presentation The
presentation shown in March at World ADC London highlighted the
development of our next-generation TOPO1i ADC payload technology.
We anticipate sharing more information on potential therapeutic
candidates leveraging this TOPO1i platform at our R&D day in
the fourth quarter of this year as we advance towards our goal of
submitting two new Investigational New Drug applications by the end
of 2024.
- Completed Licensing Agreement with Atreca Utilizing
Auristatin-Based ADC Platform The technology licensing agreement
with Atreca provides further validation of our auristatin-based ADC
and technology platforms and showcases our ability to generate
continued non-dilutive funding opportunities.
- ZW49 Enrollment Continues to Advance Toward Anticipated Data
Readout in 2H22 Zymeworks’ second clinical-stage asset and first
biparatopic HER2-targeting antibody-drug conjugate, ZW49, has
completed enrollment of 30 patients in the expansion cohorts
targeting 2.5 mg/kg every three weeks. Additionally, the weekly
dosing regimen recently expanded enrollment in the 1.5 mg/kg cohort
and, in parallel, is now enrolling patients in the 1.75 mg/kg
escalation cohort. Enrollment continues to progress well and we
remain on target to submit data for presentation at a major medical
meeting expected to occur in the second half of this year.
Zanidatamab Update at 2022 American Society of Clinical
Oncology (ASCO) Annual Meeting
Zymeworks’ Asia-Pacific partner BeiGene will present data at the
upcoming ASCO meeting in June on the first-line treatment of
patients with HER2+ metastatic breast cancer using zanidatamab plus
chemotherapy and on the first-line treatment of patients with HER2+
metastatic GEA using zanidatamab in combination with chemotherapy
and tislelizumab. The outcomes of these treatments will be released
in abstract form on May 26th, and more detailed information will be
discussed at poster presentations on June 4th for first-line GEA
and on June 6th for first-line breast cancer. Both presentations
will provide further validation of zanidatamab’s clinical efficacy
and stand to strengthen its position as a leading biparatopic
HER2-targeting antibody. We plan to host a conference call to
present the clinical results and clinical development strategy for
zanidatamab after the ASCO Annual Meeting.
“We look forward to discussing these two important datasets at
the ASCO meeting, and how the results will help shape our future
development plans for zanidatamab,” said Neil Josephson, M.D.,
Chief Medical Officer. “This will be the first presentation of
clinical data with zanidatamab in the first-line treatment of
advanced or metastatic HER2-positive breast cancer. The GEA
presentation will contain new data from patients treated with
standard of care first-line chemotherapy combined with zanidatamab,
and the PD-1 inhibitor tislelizumab; a regimen that is being
evaluated in the ongoing phase 3 HERIZON-GEA-01 study. We also look
forward to additional opportunities available throughout 2022 to
provide progress updates and present additional clinical data to
support our global development program for zanidatamab."
Financial Results for the Quarter Ended March 31,
2022
Zymeworks’ revenue relates primarily to non-recurring upfront
fees, expansion payments or milestone payments from collaboration
and license agreements, which can vary in timing and amount from
period to period, as well as payments for research and development
support. Revenue for the three months ended March 31, 2022 was $1.9
million compared to $0.6 million for the same period of 2021.
Revenue for 2022 related to research support and other payments
from our partners including cost sharing arrangements. Revenue for
the same period in 2021 was also related to research support and
other payments from our partners.
Research and development expense increased by $18.2 million in
the three months ended March 31, 2022 compared to the same period
in 2021. Research and development expense in 2022 included non-cash
stock-based compensation recovery of $3.2 million, comprised of a
$2.7 million recovery from equity classified awards and a $0.5
million recovery related to the non-cash mark-to-market revaluation
of certain historical liability classified awards, as well as $5.5
million from restructuring expenses. Excluding stock-based
compensation expense and restructuring expenses, research and
development expense increased on a Non-GAAP basis by $17.7 million
in 2022 compared to 2021. The increase related primarily to higher
clinical trial expenses for zanidatamab, increased drug
manufacturing expenses, severance and other expenses incurred due
to the Company's restructuring program, partly offset by lower
clinical trial expense for ZW49.
We expect research and development expenditures to fluctuate
over time in line with the advancement, expansion and completion of
the clinical development of our product candidates, as well as our
ongoing preclinical research activities.
Excluding the impact of stock-based compensation and
restructuring expenses, general and administrative expense
increased on a Non-GAAP basis by $3.2 million in 2022 compared to
2021. This increase was primarily due to severance and other
expenses incurred due to the Company's restructuring program in
2022 as well as a non-recurring sales tax refund recognized in
2021, which offset expenses in the prior year.
Net loss for the three months ended March 31, 2022 was $72.6
million compared to $44.6 million for the same period of 2021. This
was primarily due to increase in research and development expenses
and general and administrative expenses referred to above.
"We continue to make progress upon our goal of improving our
financial position and have successfully completed the first steps
with the reduction in anticipated spending through prioritization
of R&D programs and the previously announced new equity
issuance closed in January," said Chris Astle, Ph.D., SVP and Chief
Financial Officer. "We remain committed to further improving our
cash position through non-dilutive capital and executing on the
framework laid out in January, and we look forward to reporting on
these initiatives in the coming months."
As of March 31, 2022, Zymeworks had $300.5 million in cash
resources consisting of cash, cash equivalents and short-term
investments. Based on our current operating plan, we believe that
our current cash resources, and proceeds from certain existing
collaboration payments we anticipate receiving, will enable us to
fund our planned operations into the second half of 2023 and
potentially beyond. Further, we continue to make good progress
towards our previously announced goal of executing on new
partnerships and collaborations in order to provide additional
non-dilutive sources of funding for our operations beyond 2023.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company
dedicated to the discovery, development and commercialization 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, is a
novel Azymetric™ HER2-targeted bispecific antibody currently being
evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials
globally as a targeted treatment option for patients with solid
tumors that express HER2. Zymeworks’ second clinical candidate,
ZW49, is a novel bispecific HER2‑targeted 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 global biopharmaceutical companies. For more
information on our ongoing clinical trials visit
www.zymeworksclinicaltrials.com. 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 press release
include, but are not limited to, statements that relate to
Zymeworks’ expectations regarding implementation of its corporate
goals, Zymeworks’ clinical development of its product candidates,
related clinical trials, anticipated clinical data presentations,
potential therapeutic effects of zanidatamab and its other product
candidates, expected financial performance and future financial
position, the commercial potential of technology platforms and
product candidates, anticipated continued receipt of revenue from
existing and future partners, Zymeworks’ preclinical pipeline,
anticipated sufficiency of cash resources and other potential
sources of cash to fund Zymeworks’ planned operations into the
second half of 2023 and potentially beyond, Zymeworks’ ability to
execute new collaborations and partnerships and other information
that is not historical information. When used herein, words such as
“plan”, “hope”, “believe”, “expect”, “may”, “continue”,
“anticipate”, “potential”, “will”, “progress”, “look forward”, 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: the impact of the COVID-19
pandemic on Zymeworks’ business, research and clinical development
plans and timelines and results of operations, including impact on
its clinical trial sites, collaborators, and contractors who act
for or on Zymeworks’ behalf, may be more severe and more prolonged
than currently anticipated; clinical trials may not demonstrate
safety and efficacy of any of Zymeworks’ or its collaborators’
product candidates; any of Zymeworks’ or its partners’ product
candidates may fail in development, may not receive required
regulatory approvals, or may be delayed to a point where they are
not commercially viable; regulatory agencies may impose additional
requirements or delay the initiation of clinical trials; the impact
of new or changing laws and regulations; market conditions;
Zymeworks’ assumptions regarding its financial condition or future
financial performance may be incorrect; Zymeworks may not recognize
the anticipated cost savings of its reduction in workforce;
inability to maintain or enter into new partnerships or strategic
collaborations; and the factors described under “Risk Factors” in
Zymeworks’ quarterly and annual reports filed with the Securities
and Exchange Commission, including its Quarterly Report on Form
10-Q for its quarter ended March 31, 2022, which the Company
anticipates filing on or about the date hereof (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 and Comprehensive Loss
(Expressed in thousands of U.S. dollars
except share and per share data) (unaudited)
Three Months Ended March
31,
2022
2021
Revenue
Research and development
collaborations
$
1,916
$
644
Operating expenses:
Research and development
62,510
44,283
General and administrative
12,092
1,296
Total operating expenses
74,602
45,579
Loss from operations
(72,686
)
(44,935
)
Other income (expense), net
(13
)
870
Loss before income taxes
(72,699
)
(44,065
)
Income tax recovery (expense)
74
(525
)
Net loss and comprehensive loss
$
(72,625
)
$
(44,590
)
Net loss per common share:
Basic
$
(1.18
)
$
(0.87
)
Diluted
$
(1.19
)
$
(0.87
)
Weighted-average common shares
outstanding:
Basic
61,367,368
51,367,663
Diluted
61,378,170
51,367,663
ZYMEWORKS INC.
Selected Condensed Consolidated Balance
Sheet Data
(Expressed in thousands of U.S.
dollars)
March 31, 2022
December 31,
2021
(unaudited)
Cash, cash equivalents and short-term
investments
$
300,534
$
252,608
Working capital
244,051
216,367
Total assets
429,977
389,132
Accumulated deficit
(755,729
)
(683,104
)
Total shareholders’ equity
282,444
249,094
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 adjusted expenses and
adjusted loss per share, which are non-GAAP financial measures.
Adjusted expenses and adjusted 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, other companies,
including companies in our industry, may calculate similarly titled
non-GAAP or adjusted measures differently or may use other measures
to evaluate their performance, all of which could reduce the
usefulness of our adjusted expenses measures as tools for
comparison. 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, adjusted
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 as well as expenses incurred in
relation the restructuring program implemented in 2022.
Adjusted expenses are a non-GAAP measure that Zymeworks believes
may be helpful to investors because they provide consistency and
comparability with past financial performance.
GAAP to Non-GAAP
Reconciliations
(Expressed in thousands of U.S. dollars
except share and per share data)
(unaudited)
Three Months Ended March
31,
2022
2021
Research and development expenses
$
62,510
$
44,283
Stock-based compensation recovery /
(expense) for equity classified instruments (*)
2,747
(4,336
)
Stock-based compensation recovery /
(expense) for liability classified instruments (*)
474
2,513
Restructuring expenses
(5,542
)
—
Adjusted research and development expenses
(Non-GAAP basis)
$
60,189
$
42,460
General and administrative expenses
$
12,092
$
1,296
Stock-based compensation recovery /
(expense) for equity classified instruments (*)
2,232
(4,192
)
Stock-based compensation recovery /
(expense) for liability classified instruments (*)
2,876
12,951
Restructuring expenses
(3,935
)
—
Adjusted general and administrative
expenses (Non-GAAP basis)
$
13,265
$
10,055
Net loss per common share – Basic
$
(1.18
)
$
(0.87
)
Stock-based compensation recovery
(0.13
)
(0.13
)
Restructuring expenses
0.15
—
Adjusted net loss per common share – Basic
(Non-GAAP basis)
$
(1.16
)
$
(1.00
)
Net loss per common share – Diluted
$
(1.19
)
$
(0.87
)
Stock-based compensation recovery
(0.13
)
(0.13
)
Restructuring expenses
0.15
—
Adjusted net loss per common share –
Diluted (Non-GAAP basis)
$
(1.17
)
$
(1.00
)
(*): Research and development expenses and general and
administrative expenses include stock-based compensation recovery
related to the restructuring of $5,516 and $4,865, respectively,
for the three months ended March 31, 2022.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220504005986/en/
Investor Inquiries: Jack Spinks (604) 678-1388 ir@zymeworks.com
Media Inquiries: Diana Papove (604) 678-1388
media@zymeworks.com
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