PresentationI would now like to turn the conference over to Dr. Sabeen Mekan, Senior Vice President of Clinical Development of FarmWorks. Dr. Mekan. Please go ahead.Thank you for standing by. This is the conference operator. Welcome to Zymeworks conference call to discuss initial results from the Phase I trial of ZW191. [Operator Instructions] The conference is being recorded. [Operator Instructions]Sabeen MekanSenior Vice President of Clinical Development Good afternoon. Thank you for joining our call disc ...

Summary of Zymeworks Conference Call on ZW191 Phase One Trial Results Company and Industry - **Company**: Zymeworks - **Industry**: Biotechnology, specifically focused on antibody-drug conjugates (ADCs) for cancer treatment Key Points and Arguments Overview of ZW191 - ZW191 is an antibody-drug conjugate designed to target folate receptor alpha, utilizing a novel IgG monoclonal antibody conjugated to a topoisomerase I inhibitor, ZD-06519, with a drug-to-antibody ratio of eight [4][5] - The design aims to enhance tumor penetration and deliver high payload levels, particularly in tumors with low folate receptor alpha expression [5] Phase One Trial Design - The trial focuses on three primary tumor types: platinum-resistant epithelial ovarian cancer, serous or endometrial cancer, and adenocarcinoma non-small cell lung cancer [8] - Patients had a performance status of zero or one and were heavily pretreated, with a median of three prior treatments [10][11] Patient Demographics - 41 patients were treated, with approximately 70% having metastatic platinum-resistant ovarian cancer, 20% endometrial cancer, and 10% non-small cell lung cancer [10] - The patient population included a mix of Asian and Caucasian participants, with a significant number being heavily pretreated [9][10] Safety Profile - The trial reported minimal grade 3 or greater treatment-related adverse events, with only seven patients experiencing such events [12] - No serious treatment-related adverse events or deaths were reported, indicating a favorable safety profile [12][18] Efficacy Results - Preliminary data showed significant anti-tumor activity, with a 50% partial response rate in patients with gynecological cancers at doses between 6.4 mg/kg and 9.6 mg/kg [16][18] - Notably, ZW191 demonstrated efficacy in patients with low or negative folate receptor alpha expression, contrasting with other ADCs that require high expression for efficacy [14][15][16] Next Steps in Development - The maximum tolerated dose was determined to be 11.2 mg/kg, with plans to proceed with dose optimization at 6.4 mg/kg and 9.6 mg/kg [20] - Enrollment for the next phase of the study is expected to begin soon, focusing on refining the balance between efficacy and safety [20][21] Strategic Partnerships and Future Plans - Zymeworks aims to explore strategic partnerships to accelerate development and expand global reach, particularly for ZW191 and other pipeline ADCs [21][22] - The company is also considering combination therapies with existing treatments, such as bevacizumab, to enhance efficacy in earlier lines of treatment [71][86] Additional Insights - The design of ZW191 allows for a broader therapeutic window, supporting further investigation in advanced solid tumors [19] - The company is also looking into other preclinical candidates targeting novel antigens, indicating a robust pipeline beyond ZW191 [22][91] Important but Overlooked Content - The trial's design allows for the inclusion of patients regardless of prior mirvetuximab treatment, which may increase enrollment as the drug gains approval globally [25][26] - The efficacy observed in patients with low folate receptor alpha expression highlights a significant advantage of ZW191 over existing therapies, potentially expanding the treatment landscape for these patients [28][31] - The discussion around the mechanism of resistance for folate receptor alpha-based ADCs suggests that the payload's stability and the linker chemistry play crucial roles in the observed safety and efficacy [65][66] This summary encapsulates the critical aspects of the conference call, focusing on the development and potential of ZW191 in the oncology landscape.

Core Insights - Zymeworks Inc. announced preliminary results from a Phase 1 study of ZW191, an antibody-drug conjugate targeting folate receptor-alpha, at the AACR-NCI-EORTC Conference [1][2] Study Results - The Phase 1 study enrolled 41 patients with heavily pretreated platinum-resistant ovarian cancer, metastatic endometrial cancer, and metastatic non-small cell lung cancer, with 85% of patients remaining on treatment [3] - The maximum tolerated dose was determined to be 11.2 mg/kg, with dose optimization planned for 6.4 mg/kg and 9.6 mg/kg, involving approximately 30 patients in each cohort [4] Efficacy and Safety - ZW191 demonstrated a 44% overall response rate (ORR) across all response-evaluable participants and a 53% ORR for doses between 6.4 mg/kg and 9.6 mg/kg [6] - In gynecological cancer participants, the ORR was 50% overall and 64% for doses ≥6.4 mg/kg, with responses observed starting at 3.2 mg/kg [6] - The safety profile was manageable, with low rates of dose modifications and no serious treatment-related adverse events reported [6] Technology and Mechanism - ZW191 is designed to target folate receptor-alpha, which is present in approximately 75% of high-grade serous ovarian carcinomas and 70% of lung adenocarcinomas, utilizing a proprietary payload to kill tumor cells [8] Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer and autoimmune diseases, with a robust pipeline and strategic partnerships [9]

VANCOUVER, British Columbia, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced that management will report its third quarter 2025 financial results after market close on November 6, 2025. Following the announcement, management will host a conference ...

Core Viewpoint - Momentum investing focuses on following a stock's recent price trends, aiming to buy high and sell higher, with the expectation that established trends will continue [1] Company Overview: Zymeworks Inc. (ZYME) - Zymeworks Inc. currently holds a Momentum Style Score of A, indicating strong momentum characteristics [3] - The company has a Zacks Rank of 2 (Buy), suggesting a favorable outlook compared to the market [4] Price Performance - ZYME shares have increased by 6.61% over the past week, while the Zacks Medical - Biomedical and Genetics industry has decreased by 0.34% during the same period [6] - Over the past month, ZYME's price has risen by 13.69%, outperforming the industry's 6.95% [6] - In the last quarter, ZYME shares rose by 26.47%, and over the past year, they increased by 36.17%, compared to the S&P 500's gains of 6.67% and 15.74%, respectively [7] Trading Volume - ZYME's average 20-day trading volume is 678,382 shares, which serves as a baseline for price-to-volume analysis [8] Earnings Outlook - In the past two months, three earnings estimates for ZYME have been revised upward, while none have been revised downward, improving the consensus estimate from -$0.99 to -$0.75 [10] - For the next fiscal year, three estimates have moved up, with one downward revision noted [10] Conclusion - Given the strong momentum indicators and positive earnings outlook, Zymeworks Inc. is positioned as a promising investment opportunity [12]

Core Insights - Zymeworks Inc. announced the acceptance of a poster presentation for preliminary results from a Phase 1 study of ZW191, an antibody-drug conjugate targeting folate receptor-α, at the AACR-NCI-EORTC Conference on Molecular Targets and Cancer Therapeutics [1][2] Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [5] - The company has a diverse pipeline, including the lead product candidate ZW191, which utilizes a proprietary payload, ZD06519, designed to target FRα, a protein found in various challenging cancers [2][4] Product Details - ZW191 targets folate receptor-α, which is expressed in approximately 75% of high-grade serous ovarian carcinomas and about 70% of lung adenocarcinomas [4] - The design of ZW191 supports its ability to internalize into FRα-expressing cells, potentially releasing the active topoisomerase-1 inhibitor to kill tumor cells [4][6] Clinical Development - The Phase 1 study of ZW191 is actively recruiting participants, with preliminary data expected to provide insights into its efficacy in treating advanced solid tumors, including ovarian cancer, endometrial cancer, and non-small cell lung cancer [6][7] - A live webcast will be held on October 23, 2025, to discuss the data presented, featuring the lead author and Zymeworks senior management [3]

Core Insights - Zymeworks Inc. has appointed Adam Schayowitz, Ph.D., MBA as Acting Chief Development Officer to enhance its R&D and business development efforts [1][2][3] Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing multifunctional biotherapeutics for challenging diseases such as cancer, inflammation, and autoimmune disorders [1][5] - The company has a diverse pipeline of product candidates, including zanidatamab, which has received multiple regulatory approvals [5][6] Leadership Appointment - Dr. Schayowitz will report to Kenneth Galbraith, the Chair & CEO, and will work closely with R&D and Business Development teams to advance the company's product candidates [2][3] - He brings nearly 20 years of experience in oncology drug development, having held leadership roles at Pfizer Oncology and other biotech firms [3][4] Strategic Focus - The company aims to strengthen partnerships and collaborations while advancing its R&D portfolio [4][5] - Recent milestones include investigational new drug clearance for ZW251 and expanded global approvals for zanidatamab, indicating a focus on execution across the development pipeline [3][5] Product Pipeline - Zymeworks is advancing a robust pipeline, with ZW191 in Phase 1 recruitment and ZW251 expected to enter clinical trials in 2025 [5][6] - Zanidatamab is the first dual HER2-targeted bispecific antibody approved for treating HER2-positive biliary tract cancer in the U.S., Europe, and China [5]

Financial Data and Key Metrics Changes - The company has approximately $500 million left in regulatory milestones and about $860 million in commercial milestones, with royalties ranging from 10% to 20% based on net sales [10][11][12] Business Line Data and Key Metrics Changes - The zanidatamab program is a significant focus, with upcoming Phase 3 study readouts expected in Q4, which could drive value for the company [6][10] - ZW171 has been discontinued due to on-target, off-tumor toxicity, reflecting the company's disciplined approach to capital allocation [14][16][17] Market Data and Key Metrics Changes - The competitive landscape for zanidatamab includes potential opportunities in breast cancer, with Jazz Pharmaceuticals exploring this area [11][12] - ZW191 is positioned as a strong contender in the folate receptor alpha ADC space, with a focus on differentiating its product through superior internalization and potency [20][21][22] Company Strategy and Development Direction - The company emphasizes a disciplined approach to capital allocation and decision-making regarding its pipeline programs, focusing on those with the highest potential for patient benefit [14][16] - The strategy includes exploring partnerships for various programs, particularly ZW191, to enhance development and market reach [30][39] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the upcoming data readouts and the potential for zanidatamab to capture significant market value, estimating a valuation of over $2 billion [12][13][45] - The company is preparing for multiple catalysts over the next 12 to 18 months, including clinical studies for ZW251 and ZW209 [45] Other Important Information - The ZW209 program, utilizing a tri-TCE platform, is expected to enter clinical trials in the first half of 2026, showcasing the company's commitment to advancing its innovative pipeline [34][45] - The company is also exploring early-stage pipeline opportunities, including novel targets and ADCs, to leverage its protein engineering capabilities [33][34] Q&A Session Summary Question: What is the significance of the upcoming zanidatamab readout? - The readout is expected to provide clarity on the differentiation of zanidatamab in the competitive landscape, particularly in gastroesophageal adenocarcinoma [6][7] Question: What are the financial implications of the zanidatamab program? - The company has significant regulatory and commercial milestones associated with zanidatamab, which could lead to substantial revenue through royalties and milestone payments [10][11] Question: What led to the discontinuation of ZW171? - The decision was based on a lack of efficacy and on-target, off-tumor toxicity, demonstrating the company's commitment to prudent capital allocation [14][16][17] Question: How does Zymeworks differentiate its ADCs? - The company focuses on the holistic design of ADCs, ensuring that the antibody is optimized for internalization and payload delivery, which sets it apart from competitors [20][21][22] Question: What are the next steps for ZW191? - The company is considering partnerships for ZW191 and exploring various tumor types for clinical trials, including ovarian and endometrial cancers [30][39]

Group 1 - The article discusses Zymeworks Inc. (NASDAQ: ZYME) and highlights its recent progress, particularly focusing on two key milestones related to its drug Zanidatamab [2] - The author operates the Biotech Analysis Central service, which provides in-depth analysis of various pharmaceutical companies and includes a model portfolio of small and mid-cap stocks [2] - The service offers a subscription model with a promotional two-week free trial and a discounted annual plan [1] Group 2 - The article does not provide specific financial data or performance metrics for Zymeworks Inc. or its products [4] - There are no disclosures regarding stock positions or business relationships with the companies mentioned, indicating an unbiased perspective [3]

Core Points - Zymeworks Inc. has decided to voluntarily discontinue the clinical development of ZW171, a T-cell engager targeting gynecological, thoracic, and digestive system cancers [1] - The decision was made after completing the planned cohorts of the dose escalation portion of the Phase 1 trial in patients with ovarian cancer and non-small cell lung cancer [2] - Zymeworks determined that further dose evaluation would unlikely support a benefit-risk profile consistent with the desired monotherapy target product profile [3] - While cytokine release syndrome was well-managed, dose-limiting toxicities were observed, consistent with mesothelin-related on-target off-tumor toxicity [4] - Ongoing participants in the Phase 1 trial will continue treatment at the discretion of their investigator, and those who have discontinued will continue safety follow-up as per the study protocol [4] - The company continues to advance its broader product pipeline, including ongoing trials for ZW191 and ZW251, with an IND filing for ZW209 planned for the first half of 2026 [5] - Following the announcement, ZYME stock decreased by 5%, trading at $14.07 [5]