- Provides updated key priorities and focus on enterprise value
framework
- Closing of Jazz Pharmaceuticals (Jazz) collaboration in fourth
quarter completes financial transformation initiatives originally
planned for 2022
- Announces additional financial guidance on expected cash
runway; provides unaudited cash and cash resources balance as of
December 31, 2022
- Announces recommended Phase 2 dose (RP2D) for zanidatamab
zovodotin (ZW49)
Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology
company developing novel, multifunctional biotherapeutics, today
announced updated key strategic priorities and provided updated
financial guidance for the 2023 calendar year.
“Since becoming Chair and CEO a year ago, the Company has made
tremendous progress with a renewed focus on priority R&D
programs and improved operational execution. During 2022, we
advanced our two ongoing pivotal clinical studies of zanidatamab,
presented important new data for both zanidatamab and zanidatamab
zovodotin (formerly ZW49) to inform additional clinical development
opportunities, advanced our preclinical product pipeline towards
two new Investigational New Drug applications (INDs) planned for
2024, and gained further insights from our legacy platform licenses
with our pharmaceutical partners as they advance product candidates
into and through clinical development,” stated Kenneth Galbraith,
Chair and Chief Executive Officer of Zymeworks.
“Through a series of financial initiatives successfully executed
during 2022, including the Jazz collaboration that closed in the
fourth quarter, we were able to transform our financial position to
ensure adequate funding of our planned operations over the next
several years as we continue to build a broad and exciting product
pipeline comprised of both antibody-drug conjugates (ADCs) and
multispecific antibody therapeutics.”
Key 2022 Accomplishments:
- Fully recruited the HERIZON-BTC-01 (NCT04466891) pivotal
clinical study for zanidatamab before mid-2022 and announced
positive topline data before the end of 2022;
- Recruitment of the HERIZON-GEA-01 (NCT05152147) pivotal
clinical study for zanidatamab is well under way;
- Through a series of publications and presentations, outlined
additional data from ongoing clinical studies supporting the
potential for further development efforts for zanidatamab beyond
biliary tract cancers (BTC) and gastroesophageal adenocarcinoma
(GEA);
- Presented Phase 1 clinical study data for zanidatamab zovodotin
and outlined the future clinical development path;
- Selected and advanced two new preclinical product candidates
(ZW191 and ZW171), that leverage Zymeworks’ novel, therapeutic
technology platforms, with planned Investigational New Drug (IND)
applications for both candidates in 2024;
- Presented an overview of our future scientific strategy to
build an innovative and differentiated product pipeline focused on
next-generation ADCs and multispecific antibody therapeutics as a
part of our early Research and Development day in October
2022;
- Completed commercialization partnership arrangements for
zanidatamab with closing of the Jazz collaboration agreement in the
fourth quarter;
- Completed redomicile to Delaware and a stock exchange listing
change from the New York Stock Exchange (NYSE) to The Nasdaq Stock
Market LLC (Nasdaq), better aligning Zymeworks with U.S.
shareholder base and peer companies in the biotechnology sector;
and
- Completed a new equity financing in January 2022 at a price per
common share of $8.00 resulting in gross proceeds of $115
million.
“2022 was an important year for Zymeworks and its shareholders,”
said Mr. Galbraith. “With the key accomplishments of 2022, we are
able to look forward to the future as we aim to make substantial
progress in 2023 and 2024 across all five of the key focus areas of
our enterprise value framework.”
Updated Financial Guidance
Zymeworks provided an update on its unaudited cash resources,
which consist of cash, cash equivalents, and marketable debt
securities. As of December 31, 2022, we had cash resources on hand
of approximately $490 million (unaudited), which excludes the
expected zanidatamab-related reimbursements pursuant to our
agreement with Jazz for R&D expenses incurred in the fourth
quarter of approximately $30 million.
During the fourth quarter of 2022, we received gross proceeds of
$375 million pursuant to the collaboration agreement with Jazz.
With a substantially improved financial position and reduced
cash burn rate, we are providing additional financial guidance to
allow for an improved understanding of our future planned spending.
Based on current operating plans, we expect a net operating cash
burn of between $90 million and $120 million for calendar year
2023, including planned capital expenditures of approximately $15
million.
Based on current operating plans, we expect to have cash
resources to fund research and development programs, as well as
operations, through at least the end of 2026, and potentially
beyond.
“Throughout the course of 2022, we worked diligently to improve
our financial situation. Today, we are pleased to share that we
have cash resources that should support our ongoing development
plans over the next several years,” said Chris Astle, Ph.D., SVP
and Chief Financial Officer at Zymeworks. “We now have the balance
sheet strength to both fund our current operating plans and be
opportunistic in evaluating additional R&D opportunities
internally and externally, while maintaining a strong financial
position. We will continue to be financially disciplined in order
to ensure that future spending is prioritized and allocated in
those areas expected to drive increases in enterprise value.”
Key 2023 and 2024 Priorities and Zymeworks’ Enterprise Value
Framework
“With a significantly improved financial position, Zymeworks is
now well positioned to build upon our key priorities and enhance
shareholder value through focusing on the five key areas of our
enterprise value framework,” said Neil Klompas, President and Chief
Operating Officer at Zymeworks. “As we look forward, we will be
focused on delivering substantial progress across the five key
areas of: our zanidatamab collaborations with Jazz and BeiGene, our
early R&D programs, further development of zanidatamab
zovodotin and our portfolio of legacy platform licensing
agreements.”
Zanidatamab Collaboration with Jazz Pharmaceuticals
The collaboration agreement with Jazz represents an important
component of our commercialization strategy for zanidatamab and our
financial strategy for expanding our product pipeline. To date, we
have received $375 million in proceeds from the Jazz collaboration
and are eligible for reimbursement for ongoing zanidatamab-related
costs expended after October 19, 2022. We remain eligible to
receive regulatory approval milestones of up to $525 million,
commercial milestones of up to $862.5 million, and royalties of
between 10% and 20% of future zanidatamab sales, pending regulatory
approval of zanidatamab. During 2023, we expect to report
additional clinical data from our ongoing Phase 2 study in
front-line GEA at the ASCO GI symposium on January 19th in San
Francisco and the full data set from our HERIZON-BTC-01 pivotal
clinical trial at a major medical meeting in the first half of
2023. In conjunction with Jazz, we look forward to providing
updates on progress towards regulatory filings, new clinical
studies, and future clinical data releases.
Zanidatamab Collaboration with BeiGene
Our collaboration agreements with BeiGene in the key Asia
Pacific (APAC) regions (excluding Japan) are important given the
high prevalence of BTC and GEA in the APAC region. To date, we have
received approximately $60 million in upfront payments and
milestone payments from the BeiGene collaboration as well as
certain co-development funding for zanidatamab clinical studies.
Through our collaboration with BeiGene on zanidatamab and
zanidatamab zovodotin, we remain eligible to receive up to $390
million in additional development and commercial milestones
together with tiered royalties of up to 20% of future product
sales, pending regulatory approval. In conjunction with BeiGene, we
look forward to providing updates on progress towards regulatory
filings in the APAC region, new clinical studies, and future
clinical data releases.
Research and Early Development Programs
Our current scientific strategy provides for a broad and
differentiated product pipeline of ADCs and multispecific antibody
therapeutics to be developed from our technology platforms with the
goal of five new INDs by 2027. We expect to submit INDs for our
lead preclinical programs (ZW191 and ZW171) in 2024. During 2023,
we expect to nominate an additional product candidate for
preclinical development with an expected IND filing in 2025. We
plan to continue actively presenting and publishing additional data
on our preclinical programs in 2023, with a focus on the AACR
meeting scheduled for the second quarter. We expect to evaluate and
complete additional multi-product collaborations and partnerships
in 2023 and 2024 to expand the breadth of our research and early
development programs. We plan to make additional investments during
2023 and 2024 in the size and capabilities of our research group in
order to enable the desired speed, quality, diversity, and novelty
in our future product pipeline. Further, we also plan to evaluate
external opportunities in adjacent research areas to expand our
focus beyond the current technology platforms.
Zanidatamab Zovodotin (ZW49)
Today, we announced that we will continue to develop zanidatamab
zovodotin using a dose of 2.5 mg/kg every three weeks (Q3W), and in
the next year expect to present additional data from our Phase 1
clinical study that support this RP2D. Since the presentation of
our Phase 1 data at the European Society of Medical Oncology (ESMO)
conference in September 2022, we have continued to enroll subjects
in our ongoing Phase 1 study to gather further data for zanidatamab
zovodotin monotherapy treated at the RP2D. During 2023, we expect
to evaluate zanidatamab zovodotin, as monotherapy and/or in
combination with the current respective standards of care, in four
different patient cohorts: (i) HER2-amplified non-small cell lung
cancer (NSCLC), (ii) HER2-expressing ovarian and endometrial
cancers, (iii) HER2-positive GEA, and (iv) HER2-amplified
colorectal cancer. We also expect to commence enrollment in studies
evaluating zanidatamab zovodotin in two different cohorts: (i) in
patients with HER2-positive breast cancer after progression on
T-Dxd, and (ii) in patients with HER2-low breast cancer.
These study cohorts will be undertaken with a planned expansion
of clinical study sites in North and South America, Europe, and
Asia Pacific regions. Based on our development efforts to date, we
believe that zanidatamab zovodotin represents a unique and
differentiated product candidate among the HER2 ADCs currently
under active development. We anticipate the results of these
planned clinical studies may provide the rationale for one or more
registrational studies of zanidatamab zovodotin, which we would
expect to undertake with a future collaboration partner.
Legacy Platform Licensing Portfolio
We continue to have active licensing arrangements with nine key
pharmaceutical and biotechnology partners, with four product
candidates currently in clinical development. To date, we have
received approximately $180 million in upfront and milestone
payments from these arrangements, excluding amounts received
related to zanidatamab or zanidatamab zovodotin. During 2023 and
2024, we expect to earn additional milestone payments under our
existing agreements as products continue to advance in development
as well as the potential for payments for expansion or extension of
existing agreements. We continue to evaluate the feasibility of
monetization of all or a portion of our rights to receive future
milestone payments and royalties under these legacy agreements.
Management Changes
In order to ensure appropriate focus on both supporting the
further development and commercialization of zanidatamab with our
partners, Jazz and BeiGene, as well as the expansion of our
early-stage product pipeline, the Company will be re-organizing its
current development group into two separate groups: one focused on
zanidatamab and one focused on the remainder of the product
portfolio, including zanidatamab zovodotin. In conjunction with the
internal re-organization, Dr. Neil Josephson, will be leaving the
Company.
The late-stage development group will focus on supporting the
further clinical development and commercialization of zanidatamab
by our partners in their respective regions. Based in our current
Seattle operational site, the late-stage development group will be
led by the current development management team, reporting to Neil
Klompas, President and COO.
The early-stage development group will be focused on the
clinical development of zanidatamab zovodotin, ZW171, ZW191, and
future product candidates. In order to ensure timely development
with a global perspective, the early-stage development group will
be regionally focused among new operational sites to cover the
Americas (California), Europe and MENA (Dublin) and Asia-Pacific
(Singapore).
In addition to the late-stage development group, the Company’s
Seattle site will retain responsibilities for global technical and
manufacturing operations.
The early-stage development group will be led by newly appointed
SVP, Early-Stage Development, Dr. Jeffrey Smith, to be based in the
Company’s Dublin offices. Dr. Smith has more than thirty years of
drug development experience working for pharmaceutical,
biotechnology and contract research organizations in Europe and
North America. He was formerly the co-founder and Chief Medical
Officer of Alder BioPharmaceuticals, based in Seattle, which was
acquired by Lundbeck in 2019 for approximately $2 billion. Dr.
Smith has an M.D. from the University of London.
In addition, the Company announced the promotions of Mark
Hollywood to Executive Vice President and Head of Technical and
Manufacturing Operations, and Daniel Dex to General Counsel and
Corporate Secretary.
“I wish to thank Dr. Josephson for his efforts and contributions
as Chief Medical Officer during my first year as CEO of Zymeworks.
I would like to welcome Jeff to the organization and congratulate
both Mark and Daniel on well-earned promotions within my leadership
team,” stated Mr. Galbraith. “I am confident that this new
organizational structure will ensure we can properly support our
partners’ efforts on the timely commercialization of zanidatamab
while also improving the speed of development of our growing
product pipeline.”
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 for people impacted by difficult-to-treat
cancers and other diseases. Zymeworks' 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 Zymeworks’ proprietary Azymetric™
technology. Zymeworks has entered into separate agreements with
BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited
(Jazz), granting each of BeiGene and Jazz with exclusive rights to
develop and commercialize zanidatamab in different territories.
Zanidatamab is currently being evaluated in global Phase 1, Phase
2, and pivotal clinical trials as a best-in-class treatment for
patients with HER2-expressing cancers. Zymeworks' next clinical
candidate, zanidatamab zovodotin (ZW49), is a HER2-targeted
bispecific antibody-drug conjugate (ADC) developed using Zymeworks’
proprietary Azymetric™ and ZymeLink™ Auristatin technologies.
Zanidatamab zovodotin is currently being evaluated in a Phase 1
clinical trial for patients with a variety of HER2-expressing
cancers. Zymeworks is also advancing a deep pipeline of product
candidates based on its experience and capabilities in both ADC and
multispecific antibody therapeutics (MSAT). 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 Twitter.
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, including those with respect to its pipeline and
R&D strategy; preliminary and unaudited estimates of its cash,
cash equivalents, and marketable debt securities; Zymeworks’
anticipated financial runway and funding of its current operations;
Zymeworks’ anticipated cash burn; Zymeworks’ estimated
reimbursements from collaboration partners; future financial
position; timing of milestones with respect to zanidatamab, ZW49
and other potential product candidates; potential therapeutic
effects and commercial potential of zanidatamab and Zymeworks'
other product candidates; the anticipated benefits of the
collaboration agreement with Jazz; the anticipated benefits of
Zymeworks’ agreements with BeiGene and its other collaborators;
Zymeworks' ability to receive additional payments pursuant to the
collaboration agreement, including any future milestone payments
and royalties; the commercial potential of zanidatamab and
Zymeworks' and Jazz's ability to obtain regulatory approval of and
successfully commercialize zanidatamab; the anticipated internal
re-organization and the expected timing and benefits thereof; the
timing of and results of the interactions with regulators,
including anticipated regulatory filings and the timing thereof;
current and future partnerships and strategic collaborations;
Zymeworks’ clinical development of its product candidates and
enrollment in its clinical trials; the timing and status of ongoing
and future clinical trials and studies and presentation of related
data; the ability to advance product candidates into later stages
of development; and other information that is not historical
information. When used herein, words such as "believe", "future",
"anticipate", "approximately", "will", "plans", "may", "potential",
“expect”, “should”, “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: Zymeworks’ assumptions
regarding its financial condition may be incorrect; 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 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; Zymeworks may
be unable 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 September 30, 2022 (a copy of which may
be obtained at www.sec.gov and www.sedar.com).
Furthermore, we are in the process of finalizing our financial
results for the fourth quarter and fiscal year 2022, and therefore
our finalized and audited results and final analysis of those
results are not yet available. The preliminary expectations
regarding year-end cash, cash equivalents, and marketable debt
securities are the responsibility of management, are subject to
management’s review and actual results could differ from
management’s expectations. The actual results are also subject to
audit by our independent registered public accounting firm and no
assurance is given by our independent registered public accounting
firm on such preliminary expectations. You should not draw any
conclusions as to any other financial results as of and for the
year ended December 31, 2022, based on the foregoing estimates.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230104005869/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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