Full Press Release Details
Zymeworks Provides Corporate Update on Key Strategic Priorities and Outlook for 2023
Vancouver, British Columbia (January 04, 2023) 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.
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:
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
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
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.
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,
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