02.05.2024 22:05:08 - dpa-AFX: GNW-Adhoc: Zymeworks Provides Corporate Update and Reports First Quarter 2024 Financial Results

* Reported $420.5 million in cash resources as of March 31, 2024, which when
    combined with certain anticipated regulatory milestone payments provides
    projected cash runway into 2H 2027
  * Completion of rolling biologics license application (BLA) filing with the
    U.S. Food and Drug Administration (FDA) for zanidatamab as second-line

treatment for biliary tract cancers (BTC) in the United States (U.S.) by our
    partner, Jazz Pharmaceuticals
  * Expected initiation of a Phase 3 clinical trial for zanidatamab in the
    second half of 2024, for breast cancer patients who have progressed on
    trastuzumab deruxtecan (T-DXd), by our partner, Jazz Pharmaceuticals
  * Two planned investigational new drug (IND) and foreign equivalent
    submissions in 2024 for ZW191 and ZW171
  * Acceptance of an abstract for zanidatamab in BTC at the American Society of
    Clinical Oncology (ASCO) annual meeting submitted by our partner, Jazz
    Pharmaceuticals
  * Presentation of five abstracts at the American Association for Cancer
    Research (AACR) annual meeting highlight R&D pipeline
  * Will host conference call with management today at 4:30 p.m. Eastern Time
    (ET)

VANCOUVER, British Columbia, May 02, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc.
(Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse
pipeline of novel, multifunctional biotherapeutics to improve the standard of
care for difficult-to-treat diseases, today reported financial results for the
three months ended March 31, 2024 and provided a summary of recent business
highlights.
"We are very pleased to have presented five poster presentations at AACR, which
showcase Zymeworks' ability to apply key insights from our proprietary
technology and in-house expertise to optimize our product development candidates
for targets of significant interest," said Kenneth Galbraith, Chair and Chief
Executive Officer of Zymeworks. "As we prepare to enter multiple Phase 1 trials
in the coming 24 months, our commitment to advancing innovative solutions
remains evident, with more preclinical data for our early-stage pipeline to be
presented throughout 2024."
Mr. Galbraith continued, "Consistent with our previous disclosures, our
anticipated cash runway remains on track to support the development of our 5 by
5 product pipeline into the second half of 2027. While we approach milestones
that may result in further extension of this runway, we remain diligent in
efficiently managing our operating expenses as we continue to execute on the
strategic clinical development plans for our assets."
Recent Highlights and Current Developments
Zanidatamab Continues to Progress with Promising Developments
  * In March 2024, our partner Jazz announced their intention to initiate a
    Phase 3 clinical trial, EMPOWHER, in the second half of 2024 to evaluate
    zanidatamab plus chemotherapy or trastuzumab plus chemotherapy in patients

with HER2-positive breast cancer whose disease has progressed on previous T-
    DXd treatment.
  * In April 2024, our partner Jazz announced the completion of the rolling BLA
    submission to the FDA seeking accelerated approval for zanidatamab as a
    treatment for previously-treated, unresectable locally advanced, or
    metastatic HER2-positive BTC.
  * In April 2024, our partner Jazz announced their participation at the 2024
    ASCO annual meeting with an abstract for zanidatamab in BTC to be included

in a poster session, titled "Zanidatamab in previously-treated HER2+ BTC: OS
    and longer follow-up from the phase 2b HERIZON-BTC-01 study".
  * In May 2024, our partner Jazz guided that their plans to submit a marketing
    authorization application (MAA) to the European Medicines Agency (EMA) for
    zanidatamab in BTC are proceeding.

Progression of Research & Development Programs
  * Presentation of five posters at the AACR Annual Meeting in April. Posters
    included two presentations from our multispecific antibody therapeutics
    (MSAT) program:
     1. DLL3 TriTCE Co-Stim: A next generation trispecific T cell engager with
        integrated CD28 costimulation for the treatment of DLL3-expressing
        cancers (Abstract #6716)
     2. TriTCE Co-Stim: A next generation trispecific T cell engager platform
        with integrated CD28 costimulation, engineered to improve responses in
        the treatment of solid tumors (Abstract #6719)

and three posters from our antibody-drug conjugate (ADC) program:
     1. ZW191 - a FR?-targeting antibody-drug conjugate with strong preclinical
        activity across multiple FR?-expressing indications (Abstract #1862)

2. Screening novel format antibodies to design bispecific ADCs that address
        target heterogeneity (Abstract #2052)
     3. Development of three-dimensional cancer cell line spheroid models for
        the in vitro functional characterization of cytotoxic antibody-drug
        conjugates (Abstract #3127)
  * On track to submit two IND and foreign equivalent submissions for ZW191 and
    ZW171 in 2024 to commence recruitment in Phase 1 clinical studies.

"We're pleased to have multiple opportunities in 2024 to present our unique
development approach, which we believe places Zymeworks as a thought leader in
the antibody-drug conjugate and multispecific antibody space. Our R&D efforts
are focused on attractive targets, with the ability to use our proprietary
technology to develop next generation candidates with the potential to advance
new modalities that we have not previously seen in oncology, and beyond," stated
Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "We look forward to
showcasing how this technology and in-house expertise could be used to develop
candidates in other therapeutic areas such as blood cancers and autoimmune and
inflammatory diseases."
Board of Directors Addition
* On March 28, 2024, Zymeworks announced the appointment of Dr. Neil Gallagher
    to its board of directors, effective April 2, 2024. Dr. Gallagher was also
    appointed to serve as a member of the research and development committee of
    the board of directors. Dr. Gallagher is the sixth new director elected or
    appointed to the Board in the past 12 months.

Financial Results for the Three Months Ended March 31, 2024
Revenue was $10.0 million for the three months ended March 31, 2024 compared to
$35.6 million for the same period in 2023. Revenue for the three months ended
March 31, 2024 included $9.9 million for development support and drug supply
revenue from Jazz and $0.2 million from our partners for research support and
other payments. Revenue for the same period in 2023 included $34.4 million
revenue for development support and drug supply payments from Jazz and $1.2
million from our partners for research support and other payments. The decrease
in revenue from Jazz reflects the transfer of responsibility for certain
clinical trials regarding zanidatamab to Jazz pursuant to a stock and asset
purchase agreement with Jazz (as amended, the Transfer Agreement) and a
collaboration agreement with Jazz (as amended, the Amended Collaboration
Agreement), with such future costs to be borne by Jazz instead of being incurred
by us and reimbursed by Jazz.
Research and development expense was $32.0 million for the three months ended
March 31, 2024 compared to $45.9 million for the same period in 2023. The
decrease in research and development expense was primarily due to a decrease in
expenses for zanidatamab as a result of transfer of responsibility for this
program to Jazz per our Transfer Agreement and the Amended Jazz Collaboration
Agreement. This decrease, compared to the same period in 2023, was partially
offset by an increase in preclinical expenses, primarily with respect to
preclinical product candidates ZW171, ZW191 and ZW220. Salaries and benefits
expenses decreased compared to the same period in 2023, due to lower headcount
in 2024, which was partially offset by an increase in stock-based compensation
expense in 2024.
General and administrative expense was $15.8 million for the three months ended
March 31, 2024 compared to $16.9 million for the same period in 2023. The
decrease in general and administrative expense was primarily due to a decrease
in expenses related to external legal spend and insurance expenses compared to
the same period in 2023.
Other income, net increased by $1.9 million for the three months ended March 31,
2024 compared to the same period in 2023. Other income, net for 2024 included
$5.9 million in interest income and $0.3 million in net foreign exchange gain
and other miscellaneous income. Other income, net for the three months ended
March 31, 2023 included $4.8 million in interest income and a $0.5 million net
foreign exchange loss and other miscellaneous amounts. The increase in interest
income was driven by higher rates of return on our cash, cash equivalents and
marketable securities.
Income tax expense decreased by $1.3 million for the three months ended
March 31, 2024 compared to the same period in 2023, primarily due to a reduction
in U.S. taxes under the global intangible low-taxed income rules for the three
months ended March 31, 2024.
Net loss for the three months ended March 31, 2024 was $31.7 million compared to
$24.4 million loss for the same period in 2023. The increase in net loss was due
to decrease in revenue, which was partially offset by a decrease in operating
expenses and an increase in interest income. As of March 31, 2024, we had $420.5
million of cash resources consisting of cash, cash equivalents and marketable
securities, comprised of $114.8 million in cash and cash equivalents and $305.7
million in marketable securities. Based on current operating plans and receipt
of certain anticipated regulatory milestones, we expect our existing cash
resources as of March 31, 2024, when combined with certain anticipated
regulatory milestone payments, will enable us to fund planned operations into
the second half of 2027.
About Zymeworks Inc.
Zymeworks is a global biotechnology company committed to the discovery,
development, and commercialization of novel, multifunctional biotherapeutics.
Zymeworks' mission is to make a meaningful difference in the lives of people
impacted by difficult-to-treat cancers and other diseases. The Company's
complementary therapeutic platforms and fully integrated drug development engine
provide the flexibility and compatibility to precisely engineer and develop
highly differentiated antibody-based therapeutic candidates. Zymeworks
engineered and developed zanidatamab, a HER2-targeted bispecific antibody using
the Company's proprietary Azymetric(TM) technology. Zymeworks has entered into
separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals
Ireland Limited (Jazz), granting each exclusive rights to develop and
commercialize zanidatamab in different territories. Zanidatamab is currently
being evaluated in multiple global clinical trials as a potential best-in-class
treatment for patients with HER2-expressing cancers. A Biologics License
Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking
accelerated approval for the HER2-targeted bispecific antibody zanidatamab as a
treatment for previously treated, unresectable, locally advanced, or metastatic
HER2-positive biliary tract cancer (BTC) has been submitted by Zymeworks'
partner, Jazz. If approved, zanidatamab would be the first HER2-targeted
treatment specifically approved for BTC in the United States. Zymeworks is
rapidly advancing a deep pipeline of product candidates based on its experience
and capabilities in both antibody drug conjugates and multispecific antibody
therapeutics across multiple novel targets in indications that represent areas
of significant unmet medical need. In addition to Zymeworks' wholly owned
pipeline, its therapeutic platforms have been further leveraged through
strategic partnerships with global biopharmaceutical companies. For information
about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.
Cautionary Note Regarding Forward-Looking Statements
This press release includes "forward-looking statements" or information within
the meaning of the applicable securities legislation, including Section 27A of
the Securities Act of 1933, as amended, and Section 21E of the Securities
Exchange Act of 1934, as amended. Forward-looking statements in this press
release include, but are not limited to, statements that relate to Zymeworks'
expectations regarding implementation of its strategic priorities; the
anticipated benefits of the collaboration agreement with Jazz, including
Zymeworks' ability to receive any future milestone payments and royalties
thereunder; the potential addressable market of zanidatamab; the timing of and
results of interactions with regulators; Zymeworks' clinical development of its
product candidates and enrollment in its clinical trials; the timing and status
of ongoing and future studies and the related data; anticipated preclinical and
clinical data presentations; expectations regarding future regulatory filings
and approvals and the timing thereof; the timing of and results of interactions
with regulators; potential safety profile and therapeutic effects of zanidatamab
and Zymeworks' other product candidates; expected financial performance and
future financial position; the commercial potential of technology platforms and
product candidates; our ability to satisfy potential regulatory and commercial
milestones with existing and future partners; the timing and status of ongoing
and future studies and the release of data; anticipated continued receipt of
revenue from existing and future partners; Zymeworks' preclinical pipeline;
anticipated sufficiency of existing cash resources and certain anticipated
regulatory milestone payments to fund Zymeworks' planned operations into the
second half of 2027; Zymeworks' ability to execute new collaborations and
partnerships and other information that is not historical information. When used
herein, words such as "plan", "believe", "expect", "may", "continue",
"anticipate", "potential", "will", "progress", 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: 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; Zymeworks may not achieve milestones or receive additional
payments under its collaborations; regulatory agencies may impose additional
requirements or delay the initiation of clinical trials; the impact of new or
changing laws and regulations; market conditions; the impact of pandemics and
other health crises 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;
clinical trials may not demonstrate safety and efficacy of any of Zymeworks' or
its collaborators' product candidates; Zymeworks' assumptions and estimates
regarding its financial condition, future financial performance and estimated
cash runway may be incorrect; 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 (copies of which may be obtained at www.sec.gov and
www.sedar.com).
Although Zymeworks believes that such forward-looking statements are reasonable,
there can be no assurance they will prove to be correct. Investors should not
place undue reliance on forward-looking statements. The above assumptions, risks
and uncertainties are not exhaustive. Forward-looking statements are made as of
the date hereof and, except as may be required by law, Zymeworks undertakes no
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.
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,
                                               --------------------------------
                                                     2024             2023
                                               ---------------- ---------------

Revenue
Research and development collaborations $ 10,030 $ 35,578
Operating expenses:
 Research and development                             32,042           45,912
 General and administrative                           15,790           16,947
                                               ---------------- ---------------
 Total operating expenses                             47,832           62,859
                                               ---------------- ---------------
 Loss from operations                                (37,802 )        (27,281 )
 Other income, net                                     6,224            4,318
                                               ---------------- ---------------
 Loss before income taxes                            (31,578 )        (22,963 )
 Income tax expense                                      (75 )         (1,390 )
                                               ---------------- ---------------
 Net loss                                       $    (31,653 )   $    (24,353 )

Other comprehensive (loss) income:
Unrealized (loss) income on available for sale
 securities, net of tax of nil                        (1,121 )            720
                                               ---------------- ---------------
 Total other comprehensive (loss) income              (1,121 )            720
                                               ---------------- ---------------
 Comprehensive loss                             $    (32,774 )   $    (23,633 )
                                               ---------------- ---------------

Net loss per common share:
 Basic                                          $      (0.42 )   $      (0.36 )
 Diluted                                        $      (0.42 )   $      (0.37 )

Weighted-average common stock outstanding:
 Basic                                            76,214,833       66,739,308
 Diluted                                          76,248,158       66,742,030

ZYMEWORKS INC.
Condensed Consolidated Balance Sheet
(Expressed in thousands of U.S. dollars) (unaudited)
                                                                      December
                                                         March 31,      31,
                                                           2024         2023
                                                        ----------- -----------

Assets
Current assets:
Cash, cash equivalents and short-term marketable
 securities                                              $ 345,047   $  374,327
 Accounts receivable                                        30,949       19,477
 Other current assets                                       17,824       19,122
 Long-term marketable securities                            75,446       81,930
 Other long-term assets                                     84,486       86,024
                                                        ----------- -----------
 Total assets                                            $ 553,752   $  580,880
                                                        ----------- -----------

Liabilities
Current liabilities:
 Accounts payable and accrued expenses                   $  47,434   $   45,992
 Other current liabilities                                   9,456        9,771
 Long-term liabilities                                      58,863       60,311
                                                        ----------- -----------
 Total liabilities                                         115,753      116,074
 Stockholders' equity                                      437,999      464,806
                                                        ----------- -----------
 Total liabilities and stockholders' equity              $ 553,752   $  580,880
                                                        ----------- -----------

Contacts:
Investor Inquiries:
Shrinal Inamdar
Director, Investor Relations
(604) 678-1388?
ir@zymeworks.com (mailto:ir@zymeworks.com)
Media Inquiries:??
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388??
media@zymeworks.com (mailto:media@zymeworks.com)
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Name WKN Börse Kurs Datum/Zeit Diff. Diff. % Geld Brief Erster Schluss
ZYMEWORKS DL-,00001 A3DSSN Frankfurt 8,000 09.07.24 09:59:01 +0,100 +1,27% 8,000 8,400 8,000 7,900

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