Zymeworks Outlines Strategic Priorities and Outlook for 2024 and 2025
- Company well-positioned for further progress and broadening of R&D pipeline
- Cash resources of approximately
$455 millionas of December 31, 2023(unaudited)
- Expected cash runway, including proceeds from recent private placement, into 2H 2027
- Top-line data readout from the Phase 3 trial evaluating zanidatamab in HER2-positive gastroesophageal adenocarcinoma (GEA), HERIZON-GEA-01, expected in 2024
- Expected regulatory reviews ongoing during 2024 for zanidatamab in second-line biliary tract cancers (BTC) in
the United Statesand Chinawith our partners Jazz Pharmaceuticals and BeiGene
- Expected Investigational New Drug (IND) applications and first-in-human (FIH) studies for ZW171 and ZW191 candidates in 2024 and ZW220 and ZW251 in 2025
- Progression on ‘5 by 5’ portfolio and ADVANCE with R&D Day scheduled for Q4-24
- Additional leadership appointments announced separately today
- Company presentation on
Thursday, January 11, 2024at 08:15 a.m. Pacific Time(PT) at the J.P. Morgan 42nd Annual Healthcare Conference
"We begin 2024 in an exciting position, having met key objectives set for our programs in 2022 and 2023, including generating data supporting the clinical development of zanidatamab, identifying strong new preclinical product candidates and ensuring that we continue to have the financial resources and leadership necessary to support the Company’s strategic objectives,” said
“Our most important current R&D priority is to progress our differentiated portfolio of antibody-drug conjugates (ADCs) into clinical studies during 2024 and 2025, especially our potential best-in-class folate receptor-alpha-targeted ADC, ZW191, expected to enter FIH studies during 2024. Beyond ZW191, we are planning additional IND filings and FIH studies for ZW220 (NaPi2b) and ZW251 (GPC3) to commence in 2025. All three ADCs were designed with our moderate-potency, proprietary topoisomerase 1 inhibitor, ZD06519. Beyond ADCs, we look to make progress in our differentiated approach to next-generation multi-specific antibodies, starting with our planned IND filing and FIH studies in 2024 for ZW171, our 2+1 mesothelin-directed T-cell engager.”
“We were also able to strengthen our board of directors with the additions of
Key 2023 Accomplishments:
- Our partner, Jazz Pharmaceuticals, presented positive pivotal Phase 2b trial data (NCT04466891) evaluating zanidatamab in HER2-amplified BTC at the
American Society of Clinical Oncologyannual meeting and initiated rolling Biologics License Application (BLA) submission for accelerated approval in second-line BTC with completion expected in the first half of 2024;
- Our partner, Jazz Pharmaceuticals, gained alignment with FDA on the confirmatory trial evaluating zanidatamab in first-line metastatic BTC patients;
- Continued patient enrollment in the HERIZON-GEA-01 (NCT05152147) pivotal clinical study for zanidatamab in first-line HER2-positive GEA remains on track to announce top-line data during 2024;
- Nominated two new preclinical product candidates (ZW220 and ZW251) that leverage Zymeworks’ novel ADC technology platforms, with planned IND applications for both candidates in 2025;
- Through a series of publications and presentations, outlined additional preclinical data supporting the potential therapeutic benefit of IND candidates in our ‘5 by 5’ program (ZW171, ZW191, ZW220, and ZW251);
- Regained full development rights for zanidatamab zovodotin (ZW49) with plans to conduct a Phase 2 study in NSCLC in 2024;
- Strengthened board of directors through the addition of three new members,
Carlos Campoy, Dr. Nancy Davidson, and Derek Miller;
- Expanded the global footprint of our
Early-Stage Developmentteam into Dublin, California, and Singaporewhile retaining key talent and establishing fit-for-purpose facilities;
- Inclusion of common stock in
Russell3000 Index and Nasdaq Biotechnology Index (NBI) as a result of redomicile to Delawareand switch from NYSE to Nasdaq completed in 2022; and
$50 millionprivate placement to EcoR1 Capital, with proceeds expected to help extend cash runway into H2 2027.
“2023 was an important year for
Updated Financial Guidance
“Based on current operating plans and including the recent private placement with
Key 2024 and 2025 Priorities
Zanidatamab Development Collaborations
Our collaboration agreements with Jazz Pharmaceuticals (“Jazz”) and BeiGene, Ltd (“BeiGene”) represent important components of the commercialization strategy for zanidatamab and our strategy to continue to expand our future product pipeline.
Under our amended agreement with Jazz, we have received an aggregate of
During 2024, we look forward to providing further updates on our collaboration agreements and our progress towards regulatory filings and potential approvals, new clinical studies, and future data releases, including the anticipated announcement of top-line clinical data from the ongoing pivotal study, HERIZON-GEA-01, in first-line HER2-positive GEA.
Research and Early-Stage Development Programs
Our scientific strategy supports our goal to build a broad and differentiated product pipeline of ADCs and multispecific antibody therapeutics (MSATs) to be developed from our technology platforms, targeting five new INDs by 2026 (‘5 by 5’ program). We expect to submit INDs for ZW171 and ZW191 in 2024, and INDs for ZW220 and ZW251 in 2025. During 2024, we expect to nominate the final ‘5 by 5’ product candidate for preclinical development with an expected IND filing in 2026.
Zanidatamab zovodotin represents a unique and differentiated product candidate among the HER2 ADCs currently under active development. Based on our development efforts to date, we believe that zanidatamab zovodotin has the potential to become a novel treatment option for advanced HER2+ cancers, supporting further but limited clinical development. It will be evaluated in a planned Phase 2 study in HER2 over-expressing NSCLC patients in combination with a checkpoint inhibitor. We anticipate the results of this clinical study may provide the rationale for one or more registrational studies, which we would expect to undertake with a future collaboration partner.
We plan to continue to be active in presenting and publishing data from our preclinical and clinical programs in 2024 as well as evaluate opportunities beyond our ‘5 by 5’ program by leveraging our proprietary technologies to target additional therapeutic applications such as autoimmune and inflammatory diseases, bispecific biparatopic ADCs, dual-payload ADCs, multi-specific immune cell engagers and immune-oncology pursuant to our ADVANCE R&D strategy. An R&D Day to highlight our progress and future R&D strategy will be held in the fourth quarter of 2024.
Legacy Partnerships and Future Collaborations
We will also explore new opportunities for development collaborations in early-stage clinical programs, and plan to continue to evaluate the potential for additional multi-product collaborations and partnerships to broaden or accelerate our development plans.
J.P. Morgan Healthcare Conference Presentation and Webcast
Management will participate in the J.P. Morgan 42nd Annual Healthcare Conference taking place in
Zanidatamab is an investigational bispecific antibody that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. This unique design and increased binding results in multiple mechanisms of action, including dual HER2 signal blockade, removal of HER2 protein from the cell surface, and immune-mediated cytotoxicity leading to encouraging antitumor activity in patients. Zanidatamab is being developed in multiple clinical trials as a targeted treatment option for patients with solid tumors that express HER2. Zanidatamab is being developed by
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 securities; Zymeworks’ anticipated financial runway and funding of its current operations; Zymeworks’ estimated reimbursements from collaboration partners; future financial position; timing of milestones with respect to zanidatamab, zanidatamab zovodotin 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 its collaboration agreements, including any future milestone payments and royalties; the commercial potential of zanidatamab and Zymeworks’ and its partners’ ability to obtain regulatory approval of and successfully commercialize zanidatamab; 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’ 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; the timing of anticipated IND filings; 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.
Furthermore, we are in the process of finalizing our financial results for the fourth quarter and fiscal year 2023, 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 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
Director, Investor Relations
Senior Director, Corporate Communications
Source: Zymeworks Inc.