Zymeworks (ZYME) Stock News, Apr-Aug 2025

Zymeworks (NASDAQ:ZYME) announced FDA clearance of its Investigational New Drug (IND) application for ZW251, a novel antibody-drug conjugate (ADC) targeting hepatocellular carcinoma (HCC). ZW251 is designed to target glypican-3 (GPC3), which is expressed in over 75% of HCC cases.

The drug represents Zymeworks' second ADC utilizing their proprietary topoisomerase 1 inhibitor payload. Preclinical studies demonstrated strong anti-tumor activity across various HCC models and favorable tolerability in non-human primates at doses up to 120 mg/kg. The company plans to initiate Phase 1 clinical trials in 2025.

Zymeworks (NASDAQ: ZYME), a clinical-stage biotechnology company, has scheduled its second quarter 2025 financial results announcement for August 7, 2025 after market close. The company will host a conference call and webcast at 4:30 PM ET on the same day to discuss the results and provide a corporate update.

Additionally, Zymeworks' management will participate in two upcoming investor conferences: the BTIG Virtual Biotechnology Conference on July 29 and the Stifel Biotech Summer Summit from August 11-13, featuring one-on-one meetings and fireside chat presentations.

Zymeworks (NASDAQ: ZYME) has received NMPA approval in China for zanidatamab, making it the first dual HER2-targeted bispecific antibody approved for HER2-positive biliary tract cancer in the region. The conditional approval triggers a $20 million milestone payment from BeOne Medicines, with potential for additional $144 million in development and commercial milestones. Zanidatamab was previously approved by the FDA in November 2024 and received positive CHMP opinion in Europe in April 2025. Under the partnership with BeOne Medicines, Zymeworks has already received $61 million in upfront and milestone payments and is eligible for tiered royalties up to 19.5% of net sales in BeOne's territories. The approval represents a significant advancement for patients with HER2-positive BTC, addressing an area of high unmet medical need.

Zymeworks (NASDAQ: ZYME) announced multiple presentations at upcoming medical conferences showcasing its oncology portfolio. The presentations will take place at the ASCO Annual Meeting (May 31-June 4, 2025) and ESMO Gynaecological Cancers Congress (June 19-21, 2025).

Key highlights include long-term outcomes and survival data for Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal cancer, demonstrating the potential of their Azymetric™ platform. Partner presentations from Jazz Pharmaceuticals, Johnson & Johnson, and Daiichi Sankyo will further validate their expertise in multispecific and bispecific antibodies.

The company will also present Trial-in-Progress posters for two clinical candidates: ZW171 (mesothelin x CD3 targeting bispecific T-cell engager) at ASCO and ZW191 (Folate Receptor α-targeting Antibody-Drug Conjugate) at ESMO-Gyn, with enrollment for both trials progressing as planned.

Zymeworks Inc. (NASDAQ: ZYME), a clinical-stage biotech company focused on developing novel biotherapeutics for cancer, inflammation, and autoimmune diseases, has announced its participation in three major upcoming investor conferences in June 2025:

• Jefferies Global Healthcare Conference on June 4 in New York - Management will conduct one-on-one meetings and a fireside chat at 2:35 pm ET
• Goldman Sachs Global Healthcare Conference on June 11 in Miami - Including one-on-one meetings and a fireside chat at 2:00 pm ET
• Citi European Healthcare Conference on June 17 in London - Management will participate in one-on-one meetings

Zymeworks (NASDAQ: ZYME) presented preclinical data for ZW1528, its novel IL-4Rα x IL-33 bispecific molecule targeting respiratory inflammation, at the American Thoracic Society International Conference. The data showed ZW1528's high-affinity binding to both IL-33 and IL-4Rα, effectively blocking IL-4, IL-13, and IL-33 signaling pathways. Key findings demonstrated efficacy in murine models of lung inflammation, extended pharmacokinetics, and biophysical stability at high concentration (150 mg/mL). The company expects to file regulatory submissions for Phase 1 studies in 2H-2026. Additionally, Zymeworks is developing ZW1572 for atopic dermatitis and plans further IND submissions for 2028 and beyond.

Zymeworks (NASDAQ: ZYME) reported its Q1 2025 financial results and corporate updates. The company presented six posters at AACR showcasing their multispecific T cell engager and antibody-drug conjugate platforms. They appointed Dr. Sabeen Mekan as SVP of Clinical Development. Financial highlights include $321.6M in cash resources (vs $324.2M in Dec 2024), with runway into 2H-2027. Q1 revenue was $27.1M (vs $10.0M in Q1 2024), including milestone payments from GSK ($14M) and Daiichi Sankyo ($3.1M). Net loss decreased to $22.6M from $31.7M year-over-year. Their partner Jazz reported $2.0M in Ziihera® sales, generating $0.2M in royalties for Zymeworks. The company continues to advance its pipeline in cancer, inflammation, and autoimmune diseases.

Zymeworks (NASDAQ: ZYME) presented six posters featuring new preclinical data at the 2025 AACR Annual Meeting, showcasing progress in their antibody-drug conjugate and T cell engager platforms. Key highlights include:

- ZW209: A novel T cell engager demonstrating durable activity in small cell lung cancer, with IND submission expected in 1H-2026

- ZW171: A mesothelin-targeting T cell engager in Phase 1 clinical study showing strong anti-tumor activity in lung, ovarian, and pancreatic cancers

- ZW327: A first-in-class Ly6E-targeting antibody-drug conjugate displaying robust anti-tumor activity across various cancer types

The company also presented findings on their biparatopic antibody-drug conjugates targeting PTK7 and developments in 3D tumor models for improved ADC screening.

Zymeworks Inc. (Nasdaq: ZYME) has appointed Dr. Sabeen Mekan as Senior Vice President of Clinical Development to lead the clinical development strategy for its oncology portfolio and global regulatory affairs. Dr. Mekan brings 18 years of experience in hematology and oncology across academic research, clinical practice, and biopharmaceutical industry development.

The company also announced organizational changes with Dr. Jeff Smith continuing as Executive Vice President & Chief Medical Officer, focusing on autoimmune and inflammatory disease R&D portfolio, while Barbara Schaeffler has been promoted to Senior Vice President of Clinical Development Operations.

Dr. Mekan's previous roles include Executive Director at Gilead Sciences, Senior Medical Director at Daiichi Sankyo, and Medical Director at Bristol-Myers Squibb. She will support Zymeworks' development of next-generation antibody-drug conjugates and multispecific antibody therapeutics for gynecological, thoracic, and digestive system cancers.