Core Insights - Zymeworks Inc. is advancing its oncology programs with multiple presentations scheduled at major medical conferences, including ASCO and ESMO, highlighting its commitment to developing novel biotherapeutics for difficult-to-treat diseases [1][3][10] Oncology Programs - The company is particularly focused on zanidatamab, which is being presented at ASCO, showcasing long-term outcomes and survival data in HER2-positive gastroesophageal cancer [2][4][6] - Zymeworks' proprietary Azymetric™ platform is emphasized for its ability to develop clinically validated therapeutic antibodies, with zanidatamab being a key example [6][14] Upcoming Presentations - Zymeworks and its partners will present multiple abstracts at the ASCO Annual Meeting from May 31 to June 4, 2025, in Chicago, IL [3] - The ESMO Gynaecological Cancers Congress will also feature a trial-in-progress poster for ZW191, scheduled for June 19-21, 2025, in Vienna, Austria [10] Product Details - Ziihera (zanidatamab-hrii) is a bispecific HER2-directed antibody that has received accelerated approval from the FDA for treating advanced HER2-positive biliary tract cancer [18][34] - ZW171 is a bispecific antibody targeting mesothelin and CD3, designed to enhance T cell-mediated tumor cell killing, with promising preclinical data supporting its efficacy [15][34] - ZW191 is an antibody-drug conjugate targeting folate receptor-α, showing strong activity across various cancer models, including those with low levels of the target [16][17] Clinical Development - The company is actively recruiting for Phase 1 studies of ZW171 and ZW191, with plans for an investigational new drug application for ZW251 in mid-2025 [34] - Zymeworks has established partnerships with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab in different territories [33][34]

Financial Data and Key Metrics Changes - The company reported a net loss of $22.6 million for Q1 2025, a decrease from a net loss of $31.7 million in Q1 2024, primarily due to increased revenue [11] - Revenue for Q1 2025 was $27.1 million, significantly up from $10 million in Q1 2024, driven by milestone revenues and development support [11][12] - Operating expenses increased to $52.7 million in Q1 2025 from $47.3 million in Q1 2024, reflecting a 10% rise [12][13] Business Line Data and Key Metrics Changes - Milestone revenue included $14 million from GSK and $3.1 million from Daiichi Sankyo, contributing to the overall revenue growth [11] - Research and development expenses rose to $35.7 million in Q1 2025 from $32 million in Q1 2024, mainly due to increased costs associated with ZW251 and other preclinical research [12] Market Data and Key Metrics Changes - The company anticipates increased royalty revenue from the potential approval of zanadatumab for advanced HER2 positive biliary tract cancer, with a final decision expected soon [10] - The company is also looking forward to presenting data at several upcoming medical conferences, which may enhance its market presence [9] Company Strategy and Development Direction - The company emphasizes a disciplined approach to cash burn and pipeline management, focusing on evidence-based decisions tied to clinical validation [8] - The R&D strategy includes advancing a diverse pipeline of ADCs and T cell engagers, with a focus on unmet needs in oncology and immunology [36][40] - The company plans to submit an IND for ZW251 by mid-2025, marking a significant milestone in its development strategy [36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the dynamic biotech environment while delivering shareholder value [7][8] - The company remains well-capitalized with $321.6 million in cash and equivalents, projected to fund operations into the second half of 2027 [14][38] - Management highlighted the importance of clinical progress and disciplined capital allocation in creating long-term shareholder value [40] Other Important Information - The company presented six posters at the AACR annual meeting, showcasing advancements in its R&D pipeline [16][35] - The recent appointment of Dr. Sabine McCann as Senior VP of Clinical Development is expected to enhance the company's clinical strategy [37] Q&A Session Summary Question: What are the base case assumptions regarding milestone royalty revenues? - Management emphasized the importance of capital allocation and expressed excitement about the progress made by partners Jazz and Beijing, which could impact future revenues [44][46] Question: Can you provide details on the cytokine induction data for ZW209? - The design of ZW209 allows for localized T cell activation, which may limit cytokine release syndrome, presenting a favorable safety profile compared to other approaches [50][52] Question: How do you view the impact of ex-US patients in the Horizon GEA trial? - Management noted that there is generally no significant difference in efficacy across ethnicities, but they are monitoring the data closely [58][60] Question: What is the expectation for the KLK2 bispecific update at ASCO? - Management indicated that they are looking forward to the data presentation and highlighted the financial interest in the partnership with J&J [63][64] Question: How many internal programs can the company support? - The company can handle approximately five internal programs through phase one and about ten preclinical programs at any one time [87]

Core Insights - Zymeworks Inc. reported financial results for Q1 2025, highlighting a significant increase in revenue and ongoing advancements in its clinical pipeline [1][15][20] Recent Developments - The appointment of Dr. Sabeen Mekan as Senior Vice President of Clinical Development is expected to enhance Zymeworks' oncology portfolio and regulatory strategy [3] - Six posters were presented at the AACR annual meeting, showcasing progress in the company's T cell engager and antibody-drug conjugate platforms [4][5] Financial Performance - Revenue for Q1 2025 was $27.1 million, a substantial increase from $10.0 million in Q1 2024, driven by milestone revenues from GSK and Daiichi Sankyo [15] - Research and development expenses rose to $35.7 million in Q1 2025 from $32.0 million in Q1 2024, primarily due to increased activities related to ZW251 and ZW209 [16] - The net loss for Q1 2025 was $22.6 million, down from $31.7 million in the same period last year, attributed to higher revenues [20] Cash Position - As of March 31, 2025, Zymeworks had $321.6 million in cash resources, expected to fund operations into the second half of 2027 [21] Pipeline and Collaborations - Zymeworks is advancing multiple clinical candidates, including ZW171 and ZW191, with an investigational new drug application for ZW251 planned by mid-2025 [22] - The company has strategic partnerships with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab [22][8]

Core Viewpoint - Zymeworks Inc. has appointed Dr. Sabeen Mekan as Senior Vice President of Clinical Development, enhancing its leadership team to advance its clinical-stage oncology portfolio and diversify into autoimmune and inflammatory diseases [1][2]. Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel biotherapeutics for difficult-to-treat diseases, including cancer, inflammation, and autoimmune diseases [1][4]. - The company utilizes proprietary technologies to engineer and develop differentiated antibody-based therapeutic candidates, including zanidatamab, a HER2-targeted bispecific antibody [4][5]. Leadership Changes - Dr. Sabeen Mekan, with 18 years of experience in hematology and oncology, will play a crucial role in formulating the clinical development strategy for Zymeworks' oncology portfolio [2][3]. - Dr. Jeff Smith continues as Executive Vice President & Chief Medical Officer, focusing on R&D in autoimmune and inflammatory diseases [1][2]. - Barbara Schaeffler has been promoted to Senior Vice President, Clinical Development Operations, reporting to Dr. Smith [1]. Clinical Development Focus - The expanded clinical development team aims to enhance the focus on progressing Zymeworks' clinical-stage solid tumor portfolio while diversifying into autoimmune and inflammatory diseases [2]. - Dr. Mekan expressed commitment to addressing unmet needs in various cancer types through next-generation antibody-drug conjugates and multispecific antibody therapeutics [2][3]. Pipeline and Regulatory Progress - Zymeworks has received FDA accelerated approval for Ziihera® (zanidatamab-hrii) for treating adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer [4]. - The company is advancing a robust pipeline, with Phase 1 studies for ZW171 and ZW191 actively recruiting and an investigational new drug application for ZW251 planned for mid-2025 [5].

Core Viewpoint - Zymeworks Inc. is set to report its first quarter 2025 financial results on May 8, 2025, followed by a conference call and webcast to discuss the results and provide a corporate update [1][2] Company Overview - Zymeworks Inc. is a clinical-stage biotechnology company focused on developing novel, multifunctional biotherapeutics aimed at improving treatment for difficult-to-treat diseases such as cancer, inflammation, and autoimmune diseases [3] - The company utilizes its proprietary Azymetric™ technology to engineer and develop zanidatamab, a HER2-targeted bispecific antibody [3] - Zymeworks has exclusive agreements with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab in different regions [3] - The U.S. FDA has granted accelerated approval for Ziihera® (zanidatamab-hrii) for treating adults with previously-treated, unresectable or metastatic HER2-positive second-line biliary tract cancer, marking it as the first dual HER2-targeted bispecific antibody approved for this indication in the U.S. [3] - Zanidatamab is currently under regulatory review in the EU and China and is being evaluated in multiple global clinical trials for various HER2-expressing cancers [3] - Zymeworks is advancing a robust pipeline of product candidates, with ongoing Phase 1 studies for ZW171 and ZW191, and plans for an investigational new drug application for ZW251 in mid-2025 [3] - The company has established strategic partnerships with global biopharmaceutical companies to further leverage its therapeutic platforms [3]

Zymeworks Inc. (NASDAQ:ZYME) Q4 2024 Earnings Conference Call March 5, 2025 4:30 PM ET Company Participants Shrinal Inamdar - Director, Investor Relations Leone Patterson - Executive Vice President, Chief Business and Financial Officer Paul Moore - Chief Scientific Officer Kenneth Galbraith - Chair and Chief Executive Officer Conference Call Participants Stephen Willey - Stifel Yigal Nochomovitz - Citi Brian Cheng - JPMorgan Jonathan Miller - Evercore ISI Jay Olson - Oppenheimer & Co. Justin Zelin - BTIG Op ...