Business Strategy & Financial Performance - Zymeworks is transitioning to a revenue-generating organization with in-house R&D capabilities, focusing on royalty streams and strategic capital allocation for shareholder returns[6] - The company reported $103 million in revenues for 2025 as of September 30, 2025[31] - Zymeworks anticipates up to $440 million in near-term milestones from global GEA approvals for Ziihera[20, 31] - A $125 million share repurchase plan has been announced[4, 31] - Existing cash resources are expected to fund operations beyond 2028, assuming full execution of the share repurchase plan and anticipated regulatory milestone payments[2, 31, 82] Pipeline & Partnerships - Zymeworks received a $25 million regulatory milestone payment from Jazz for FDA approval of Ziihera for HER2+ (IHC 3+) BTC[4] - The company also received a $20 million milestone payment from BeOne for NMPA conditional approval of Ziihera for BTC[4] - Zymeworks recognized $25.2 million in partnership milestone payments[4] - Zymeworks has potential future milestone payments of up to $434 million from one partner and up to $1.1 billion from another, plus tiered royalties[22] Clinical Development - Initial clinical data from the Phase 1 trial of ZW191 showed a 64% overall response rate in gynecological cancers at doses ≥6.4mg/kg[42, 49] - ZW251, an ADC targeting GPC3, is in Phase 1 clinical trials for hepatocellular carcinoma (HCC)[4, 55]

Core Insights - Zymeworks Inc. has appointed Scott Platshon as Acting Chief Investment Officer to manage future cash flows from its healthcare assets and product candidates [1][2] - The company aims to build a diversified portfolio of revenue-generating assets following positive data from the Phase 3 HERIZON-GEA-01 trial for zanidatamab [4] - Zymeworks is focused on optimizing cash flows from its licensed products, including Ziihera® and pasritamig, while advancing its pipeline of biotherapeutics [6] Company Strategy - The appointment of Scott Platshon is part of a strategic initiative to actively manage and aggregate revenue-generating assets to enhance long-term shareholder returns [4] - Zymeworks is leveraging its financial foundation and collaborations to create a disciplined, high-return portfolio [5] - The company is advancing a robust pipeline of product candidates targeting significant unmet medical needs, utilizing its proprietary Azymetric™ technology [6] Leadership and Expertise - Scott Platshon has extensive experience in biotech investments, having worked at EcoR1 Capital since 2015 and served as a Partner since 2020 [4] - His role will involve close collaboration with Zymeworks' CEO Kenneth Galbraith to execute the company's healthcare asset aggregation strategy [2][4] - Platshon's background includes serving on the boards of other biotech companies, enhancing his capability to contribute to Zymeworks' strategic goals [4]

Core Insights - Zymeworks Inc. has announced a strategic initiative aimed at optimizing future cash flows from its licensed healthcare assets, particularly focusing on Ziihera® and pasritamig, to establish a profitable operating structure [1][2][5] Financial Opportunities - The company anticipates receiving up to $440 million in milestone payments related to Ziihera's regulatory approvals across various markets, including $250 million from the USA, $100 million from the EU, $75 million from Japan, and $15 million from China [3] - For pasritamig, Zymeworks is eligible for up to $434 million in milestone payments from Johnson & Johnson, along with a mid-single digit royalty on pasritamig sales [4] Strategic Direction - The company aims to transition from a traditional biotechnology model to a royalty-driven organization, leveraging in-house R&D capabilities while reinvesting proceeds from licensed products to foster growth [5][6] - Zymeworks plans to integrate partnerships and collaborations into its R&D operations to enhance funding for ongoing projects and reduce reliance on internal capital [8] Share Repurchase and Financial Position - The company has authorized a new share repurchase plan of $125 million, following the repurchase of approximately 4.4 million shares, representing about 6% of its outstanding shares [9][10] - As of September 30, 2025, Zymeworks reported cash and investments totaling $299.4 million, which, combined with anticipated milestone payments, is expected to fund operations beyond 2028 [11][12] Leadership and Governance - Recent governance enhancements, including the appointment of a new Acting Chief Investment Officer, are expected to strengthen the company's ability to execute its strategic initiatives [7]

Andrew Berens from Leerink Partners set a price target of $37 for NASDAQ:ZYME, indicating a potential increase of approximately 54.81%.Ziihera, developed in collaboration with Jazz Pharmaceuticals, shows significant improvement in treating HER2-positive gastroesophageal adenocarcinoma.ZYME's market capitalization stands at approximately $1.8 billion, with a trading volume of 11.1 million shares, reflecting increased investor interest.Zymeworks Inc. (NASDAQ:ZYME) is a biotechnology company focused on develop ...

Zymeworks Inc. ( ZYME ), as of today, represents a pretty compelling clinical-stage biotech opportunity. Shares jumped as much as 30% today on the back of news that its bispecific HER2-targeted antibody Ziihera has demonstrated positive Phase 3 results in first-line HER2-positive gastroesophagealI hold a Master’s degree in Cell Biology and began my career working for several years as a lab technician in a drug discovery clinic, where I gained extensive hands-on experience in cell culture, assay development, ...

Core Insights - Zymeworks Inc. (ZYME) has shown a significant clinical-stage biotech opportunity, with shares increasing by up to 30% following positive Phase 3 results for its bispecific HER2-targeted antibody Ziihera in first-line HER2-positive gastroesophageal cancer [1] Company Overview - Zymeworks is focused on developing innovative therapies, particularly in the oncology space, leveraging its bispecific antibody technology [1] - The positive Phase 3 results for Ziihera indicate potential for strong market performance and investor interest in the company's future developments [1] Market Implications - The surge in Zymeworks' stock price reflects investor confidence in the company's clinical advancements and the potential for Ziihera to capture market share in the HER2-positive cancer treatment segment [1] - The biotech sector is characterized by high volatility and potential for significant returns, particularly when breakthrough therapies are developed [1]

Core Insights - Zymeworks Inc. stock is experiencing a significant surge following the announcement of positive topline results from the Phase 3 HERIZON-GEA-01 trial for Ziihera in combination with chemotherapy [1][7] Group 1: Trial Results - The Phase 3 trial evaluated Ziihera (zanidatamab-hrii) as a first-line treatment for HER2-positive locally advanced or metastatic gastroesophageal adenocarcinoma, showing statistically significant improvements in progression-free survival (PFS) compared to the control arm [2] - Ziihera plus Tevimbra and chemotherapy demonstrated clinically meaningful and statistically significant improvements in overall survival (OS) [3] - A strong trend toward statistical significance in OS was observed for Ziihera plus chemotherapy compared to the control arm, with an additional OS interim analysis planned for mid-2026 [4] Group 2: Efficacy and Subgroup Analysis - Benefits in PFS and OS were noted in both PD-L1-positive and PD-L1-negative subgroups for the Ziihera plus Tevimbra and chemotherapy arm versus the control arm [5] - Improvements in key secondary endpoints, including objective response rate (ORR) and duration of response (DoR), were supportive of the primary efficacy endpoints [5] Group 3: Future Plans and Regulatory Actions - Jazz Pharmaceuticals plans to present the trial data at a major medical meeting in Q1 2026 and aims for publication in a peer-reviewed journal, along with rapid adoption in the National Comprehensive Cancer Network Guidelines [6] - A supplemental Biologics License Application is expected to be submitted in the first half of 2026 to support Ziihera as a first-line treatment for HER2+ locally advanced or metastatic GEA [6] Group 4: Market Reaction - Following the announcement, Zymeworks stock rose by 36.20% to $25.23, while Jazz Pharmaceuticals and BeOne Medicines also saw significant stock price increases of 20.45% and 3.37%, respectively [7]

Core Insights - Zymeworks Inc. announced positive topline results from the Phase 3 HERIZON-GEA-01 trial for Ziihera (zanidatamab-hrii) in combination with chemotherapy for HER2-positive gastroesophageal adenocarcinoma, indicating a significant advancement in treatment options for this patient population [1][5][6] Trial Results - Ziihera plus chemotherapy showed a clinically meaningful and statistically significant improvement in progression-free survival (PFS) compared to trastuzumab and chemotherapy [6][7] - Ziihera plus Tevimbra (tislelizumab) and chemotherapy demonstrated statistically significant improvements in overall survival (OS) and PFS versus the control arm [6][7] - The trial results support Ziihera's potential as the preferred HER2-targeted agent in first-line gastroesophageal adenocarcinoma [6][7] Safety Profile - The safety profile of Ziihera in combination with chemotherapy, with or without Tevimbra, was consistent with known safety profiles, with no new safety signals observed [3] Future Plans - Jazz Pharmaceuticals plans to submit the trial data for presentation at a major medical meeting in Q1 2026 and for publication in a peer-reviewed journal [4] - A supplemental Biologics License Application is expected to be submitted in the first half of 2026 to support Ziihera as a first-line treatment [5][6] Regulatory Designations - Zanidatamab has received Breakthrough Therapy designation and Fast Track designations from the FDA for various indications, including first-line gastroesophageal adenocarcinoma [9] Commercial Strategy - Zymeworks is eligible for additional regulatory and commercial milestones, as well as tiered royalties on net sales of Ziihera from Jazz and BeOne [8] - The company is advancing a robust pipeline of product candidates and leveraging strategic partnerships to enhance its market position [10]

Financial Data and Key Metrics Changes - Total revenue for Q3 2025 was $27.6 million, up from $16 million in Q3 2024, primarily due to a $25 million milestone from Janssen and $1 million in royalties from Jazz Pharmaceuticals and BeiGene [9][10]. - Overall operating expenses decreased slightly to $49.7 million in Q3 2025 from $50.2 million in Q3 2024, a reduction of 1% [10]. - Net loss improved to $19.6 million in Q3 2025 compared to a net loss of $29.9 million in Q3 2024, attributed to increased revenue [10][11]. - Cash, cash equivalents, and marketable securities totaled $299.4 million as of September 30, 2025, down from $324.2 million at the end of 2024 [11]. Business Line Data and Key Metrics Changes - The company recognized a $25 million development milestone from Jazz Pharmaceuticals related to the clinical progress of pacritimab, contributing significantly to revenue [6][9]. - Royalty revenues of $1 million were earned based on Ziihera net product sales by Jazz and BeiGene [8]. Market Data and Key Metrics Changes - The company continues to see strong momentum in its partnered programs, with Jazz presenting positive trial data at ESMO [5][6]. - The first patient has been dosed in the phase one clinical trial of ZW251, targeting GPC3 in hepatocellular carcinoma, indicating ongoing clinical development [4][17]. Company Strategy and Development Direction - The company aims to leverage partnerships to accelerate development and maintain control over R&D innovations while de-risking clinical developments [25][27]. - The focus remains on advancing programs with clear differentiation and strong scientific rationale, utilizing partnerships to offset development risks [27]. - The company is committed to disciplined capital allocation to drive sustainable long-term returns [9][25]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's outlook, citing the strength of the pipeline and the successful execution of clinical trials [8][11]. - The company anticipates that existing cash resources, combined with expected regulatory milestones, will fund operations into the second half of 2027 [11]. Other Important Information - The company completed share repurchases of $22.7 million under its previously authorized program, reflecting confidence in its outlook [8]. - The decision to discontinue the development of ZW171 was made to prioritize programs with clearer paths to patient benefit [20][21]. Q&A Session Summary Question: Thoughts on the update in the PFS analysis for Horizon GEA 01 - Management aligned with Jazz's regulatory strategy regarding the readout of Horizon GEA 01 and did not provide additional comments [30]. Question: Implications of ZW191 data for GPC3 and potential development strategies - Management expressed intrigue regarding the GPC3 construct and emphasized the importance of safety in the hepatocellular carcinoma population [31][33]. Question: Insights on GPC3 payload and preclinical efficacy expectations - Management noted that while topo1 is not standard for liver cancer, there is precedent for its use, and they believe their ADC can deliver effective treatment [38][44]. Question: Confidence in GPC3 activity in the post-IO setting - Management indicated that GPC3 expression levels are not expected to be modulated by IO treatment, supporting their development plan [60][62]. Question: Expectations on durability for ZW191 and potential for partnerships - Management found early data from ZW191 encouraging and indicated ongoing discussions with potential partners [70][71]. Question: Correlation between H-score and PS2 plus scoring methodologies - Management confirmed that H-score is a validated method for evaluating expression levels and correlates well with PS2 plus scores [81][84].

3Q 2025 Results Conference Call and Webcast November 6, 2025 Nasdaq: ZYME | zymeworks.com Legal Disclaimer This presentation and the accompanying oral commentary include "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 presentation and the accompanying oral commentary include, but are no ...