Zymeworks Outlines Strategic Priorities and Outlook for 2025 and 2026

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• Investigational new drug (IND) purposes for initiating first-in-human research for ZW220 and ZW251 in stable tumors anticipated in 2025
• IND purposes for initiating first-in-human research for ZW209 and ZW1528 anticipated in 2026
• Part 3 HERIZON-GEA-01 top-line outcomes for Ziihera® (zanidatamab-hrii) in first-line HER2-positive gastroesophageal adenocarcinoma (GEA) are anticipated 2Q-2025, with potential supplemental biologics license utility (sBLA) by Jazz Prescribed drugs later in 2025
• Potential regulatory choices in EU and China for approval of zanidatamab in second-line biliary tract most cancers (BTC) as early as 2Q-2025
• Money, money equivalents, and marketable securities of roughly $324 million (unaudited) as of December 31, 2024, which when mixed with sure anticipated regulatory milestone funds, present projected money runway into 2H-2027
• Firm well-positioned for additional progress and enlargement of R&D pipeline into autoimmune and inflammatory illnesses (AIID) and hematological cancers
• Firm to current on Thursday, January 16, 2024 at 08:15 a.m. PT on the J.P. Morgan Annual Healthcare Convention

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VANCOUVER, British Columbia, Jan. 08, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology firm creating a various pipeline of novel, multifunctional biotherapeutics to enhance the usual of take care of difficult-to-treat illnesses, together with most cancers, irritation, and autoimmune illness, at the moment supplied an replace on key strategic priorities for 2025 and 2026.

“2024 was a pivotal 12 months for Zymeworks, marked by the primary FDA approval of our internally developed product, zanidatamab, vital medical progress with our novel, antibody-based therapeutic candidates in stable tumors and developments in our rising preclinical pipeline,” mentioned Kenneth Galbraith, Chair and Chief Government Officer of Zymeworks. “With important R&D milestones achieved roughly eighteen months forward of our preliminary timelines, a powerful monetary place and the operational capabilities to advance a number of applications in stable tumors, hematological oncology, and autoimmune and inflammatory illnesses, we’re well-positioned to execute in opposition to our strategic priorities over the following two years, and proceed addressing potential therapy choices for among the most difficult and complicated illnesses.”

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Key 2024 Accomplishments:

• First-in-human world research initiated for ZW171, a 2+1 trivalent T cell engager concentrating on mesothelin-expressing stable tumors (NCT06523803);
• First-in-human world research initiated for ZW191, an antibody-drug conjugate (ADC) engineered to focus on folate receptor-⍺ using our novel proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD-06519 (NCT06555744);
• U.S. Meals and Drug Administration (FDA) granted accelerated approval of Ziihera® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the therapy of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line BTC;
• Nominated the fifth product within the Firm’s ‘5 by 5’ R&D program, ZW209, a novel DLL3-targeting trispecific T cell engager incorporating co-stimulation that leverages Zymeworks’ clinically validated expertise platform, AzymetricÔ, with a deliberate IND utility in 1H-2026;
• Nominated the primary product from our ADVANCE analysis technique, ZW1528, the Firm’s first improvement candidate in AIID, which demonstrates twin blockade of two complementary pathways of respiratory irritation and provides potential profit in mixed-type persistent obstructive pulmonary illness (COPD) with a deliberate IND utility in 2H-2026;
• By way of a sequence of publications and displays, outlined further preclinical information supporting the potential therapeutic advantage of medical applications and IND candidates in our stable tumor R&D portfolio (ZW171, ZW191, ZW220, ZW251 and ZW209) and our proprietary TOPO1i payload, ZD-06519;
• Strengthened our board of administrators by means of the addition of three new members, Dr. Alessandra Cesano, Dr. Neil Gallagher, and Mr. Scott Platshon;
• Strengthened our management group by means of the addition of Ms. Leone Patterson as Chief Enterprise and Monetary Officer; and
• Efficiently accomplished $30 million of share repurchases below the Firm’s Share Repurchase Program introduced in August 2024.

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2025 and 2026 Priorities and Anticipated Milestones

Medical Improvement of Wholly-Owned Stable Tumor Pipeline (‘5 by 5’)

• Advance ZW171 and ZW191 in stable tumors in ongoing Part 1 trials; and
• Proceed to drive the development of the broad and differentiated product pipeline of ADCs and multispecific antibody therapeutics (MSATs) developed pursuant to the ‘5 by 5’ R&D program, concentrating on completion of all 5 IND purposes by the tip of 1H-2026.

ADVANCE R&D Program

• Leverage Zymeworks’ proprietary platforms to develop our ADVANCE R&D technique and diversify our pipeline inside and past stable tumor indications with further therapeutic indications corresponding to AIID and hematological cancers;
• Submission of first IND utility in AIID anticipated in 2H-2026 for ZW1528, targeted in COPD sufferers;
• Proceed to drive product innovation with elevated novelty in targets, and distinctive mechanisms of motion by means of bispecific or biparatopic ADCs, dual-payload ADCs, multi-specific immune cell engagers and immune-oncology; and
• Proceed to actively share peer-reviewed publications and information throughout preclinical and medical applications.

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Ziihera® (zanidatamab-hrii)

• Our accomplice Jazz Prescribed drugs is predicted to report top-line outcomes from the Part 3 HERIZON-GEA-01 trial evaluating zanidatamab in HER2-positive GEA in 2Q-2025 with potential for submission for a sBLA in first-line GEA later in 2025;
• A BLA for zanidatamab in second-line BTC was accepted for evaluate by the Heart for Drug Analysis of the Nationwide Medical Merchandise Administration in China in 2024 and potential approval is anticipated as early as 2H-2025; and
• The European Medicines Company validated the advertising authorization utility for zanidatamab in second-line BTC in 2024 and potential approval is anticipated as early as 2Q-2025.

Up to date Money Runway Steerage

As of December 31, 2024, the Firm had money sources of roughly $324 million (unaudited), consisting of money, money equivalents, and marketable securities, not together with a $25 million milestone fee earned in 4Q-2024 from Jazz Prescribed drugs which is predicted to be acquired in 1Q-2025. Primarily based on present working plans and assuming receipt of sure anticipated regulatory milestones, we proceed to count on our current money sources, when mixed with such anticipated milestone funds, will allow us to fund deliberate operations into 2H-2027.

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J.P. Morgan Healthcare Convention Presentation and Webcast

Administration will take part within the J.P. Morgan Annual Healthcare Convention happening in San Francisco, California, from January 13-16, 2025, and current on January 16 at 8:15 am PT. The presentation and webcast shall be out there on Zymeworks’ web site.

About Zymeworks Inc.

Zymeworks is a worldwide clinical-stage biotechnology firm dedicated to the invention, improvement, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a significant distinction within the lives of individuals impacted by difficult-to-treat circumstances corresponding to most cancers, irritation, and autoimmune illness. The Firm’s complementary therapeutic platforms and totally built-in drug improvement engine present the flexibleness and compatibility to exactly engineer and develop extremely differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody utilizing the Firm’s proprietary Azymetric™ expertise. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Prescribed drugs Eire Restricted (Jazz Prescribed drugs), granting every unique rights to develop and commercialize zanidatamab in numerous territories. The U.S. FDA granted accelerated approval of Ziihera^® (zanidatamab-hrii) 50mg/mL for injection for intravenous use for the therapy of adults with previously-treated, unresectable or metastatic HER2-positive (IHC 3+) second-line biliary tract most cancers (BTC). Ziihera^® is the primary and solely twin HER2-targeted bispecific antibody permitted for HER2-positive BTC within the U.S. Zanidatamab is presently below regulatory evaluate within the EU and China for second-line BTC and is being evaluated in a number of world medical trials as a possible best-in-class therapy for sufferers with a number of HER2-expressing cancers. Zymeworks is quickly advancing a sturdy pipeline of wholly-owned product candidates, leveraging its experience in each antibody-drug conjugates and multispecific antibody therapeutics concentrating on novel pathways in areas of serious unmet medical want. Part 1 research for ZW171 and ZW191 are actually actively recruiting with investigational new drug purposes for ZW220 and ZW251 deliberate for 2025. Along with Zymeworks’ pipeline, its therapeutic platforms have been additional leveraged by means of strategic partnerships with world biopharmaceutical corporations. For details about Zymeworks, go to www.zymeworks.com and comply with @ZymeworksInc on X.

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Cautionary Be aware Relating to Ahead-Wanting Statements

This press launch contains “forward-looking statements” or info inside the which means of the relevant securities laws, together with Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Change Act of 1934, as amended. Ahead-looking statements on this press launch embrace, however usually are not restricted to, statements that relate to Zymeworks’ expectations relating to implementation of its strategic priorities, together with these with respect to its pipeline and R&D technique; preliminary and unaudited estimates of its money, money equivalents, and marketable securities; anticipated sufficiency of current money sources and sure anticipated regulatory milestone funds to fund Zymeworks’ deliberate operations into 2H-2027; future monetary place; timing of milestones with respect to zanidatamab and different product candidates; potential therapeutic results and business potential of zanidatamab and Zymeworks’ different product candidates; the anticipated advantages of the collaboration settlement with Jazz Prescribed drugs; the anticipated advantages of Zymeworks’ agreements with BeiGene and its different collaborators; Zymeworks’ means to obtain further funds pursuant to its collaboration agreements, together with any future milestone funds and royalties; the business potential of zanidatamab and Zymeworks’ and its companions’ means to acquire additional regulatory approval of and efficiently commercialize zanidatamab; the timing of and outcomes of the interactions with regulators, together with anticipated regulatory filings and the timing thereof; present and future partnerships and strategic collaborations; Zymeworks’ improvement of its product candidates and enrollment in its medical trials; the timing and standing of ongoing and future medical trials and research and presentation of associated information; the flexibility to advance product candidates into later levels of improvement; the timing of anticipated IND submissions; and different info that isn’t historic info. When used herein, phrases corresponding to “imagine”, “future”, “anticipate”, “roughly”, “will”, “plans”, “could”, “potential”, “count on”, “ought to”, “proceed”, and comparable expressions are supposed to determine forward-looking statements. As well as, any statements or info that seek advice from expectations, beliefs, plans, projections, goals, efficiency or different characterizations of future occasions or circumstances, together with any underlying assumptions, are forward-looking. All forward-looking statements are primarily based upon Zymeworks’ present expectations and varied assumptions. Zymeworks believes there’s a cheap foundation for its expectations and beliefs, however they’re inherently unsure. Zymeworks could not understand its expectations, and its beliefs could not show appropriate. Precise outcomes may differ materially from these described or implied by such forward-looking statements on account of varied elements, together with, with out limitation: Zymeworks’ assumptions and estimates relating to its monetary situation could also be incorrect; any of Zymeworks’ or its companions’ product candidates could fail in improvement, could not obtain required regulatory approvals, or could also be delayed to some extent the place they don’t seem to be commercially viable; Zymeworks could not obtain milestones or obtain further funds below its collaborations; regulatory companies could impose further necessities or delay the initiation of medical trials; the affect of latest or altering legal guidelines and laws; market circumstances; the affect of pandemics and different well being crises on Zymeworks’ enterprise, analysis and medical improvement plans and timelines and outcomes of operations, together with affect on its medical trial websites, collaborators, and contractors who act for or on Zymeworks’ behalf; zanidatamab will not be efficiently commercialized; medical trials and any future medical trials could not display security and efficacy of any of Zymeworks’ or its collaborators’ product candidates; Zymeworks could also be unable to take care of or enter into new partnerships or strategic collaborations; and the opposite dangers described below “Danger Components” in Zymeworks’ Quarterly Report on Type 10-Q for its quarter ended September 30, 2024 (a replica of which can be obtained at www.sec.gov and www.sedar.com).

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Moreover, we’re within the technique of finalizing our monetary outcomes for the fourth quarter and monetary 12 months 2024, and subsequently our finalized and audited outcomes and closing evaluation of these outcomes usually are not but out there. The preliminary expectations relating to year-end money, money equivalents, and marketable securities are the accountability of administration, are topic to administration’s evaluate and precise outcomes may differ from administration’s expectations. The precise outcomes are additionally topic to audit by our impartial registered public accounting agency and no assurance is given by our impartial registered public accounting agency on such preliminary expectations. You shouldn’t draw any conclusions as to some other monetary outcomes as of and for the 12 months ended December 31, 2024, primarily based on the foregoing estimates.

Though Zymeworks believes that such forward-looking statements are cheap, there may be no assurance they’ll show to be appropriate. Buyers shouldn’t place undue reliance on forward-looking statements. The above assumptions, dangers and uncertainties usually are not exhaustive. Ahead-looking statements are made as of the date hereof and, besides as could also be required by legislation, Zymeworks undertakes no obligation to replace, republish, or revise any forward-looking statements to replicate new info, future occasions or circumstances, or to replicate the occurrences of unanticipated occasions.

Investor inquiries:
Shrinal Inamdar
Senior Director, Investor Relations
(604) 678-1388
ir@zymeworks.com

Media inquiries:
Diana Papove
Senior Director, Company Communications
(604) 678-1388
media@zymeworks.com

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