Financial Performance - Total assets decreased from $463,091,000 as of December 31, 2024, to $397,269,000 as of September 30, 2025, representing a decline of approximately 14.2%[21] - Revenue from research and development collaborations increased to $27,614,000 for the three months ended September 30, 2025, compared to $16,000,000 for the same period in 2024, marking a growth of 72.6%[22] - Net loss for the three months ended September 30, 2025, was $19,602,000, a decrease from a net loss of $29,850,000 in the same period of 2024, reflecting an improvement of 34.5%[22] - Total current liabilities decreased from $88,294,000 as of December 31, 2024, to $42,043,000 as of September 30, 2025, a reduction of approximately 52.5%[21] - Cash and cash equivalents slightly decreased from $66,103,000 as of December 31, 2024, to $64,834,000 as of September 30, 2025[21] - Operating expenses for the three months ended September 30, 2025, totaled $49,724,000, a slight decrease from $50,205,000 in the same period of 2024[22] - The company reported interest income of $3,529,000 for the three months ended September 30, 2025, compared to $4,785,000 in the same period of 2024, a decline of 26.3%[22] - Stockholders' equity decreased from $338,768,000 as of December 31, 2024, to $320,064,000 as of September 30, 2025, a decline of approximately 5.5%[21] - The company reported a comprehensive loss of $19,312,000 for the three months ended September 30, 2025, compared to a comprehensive loss of $27,945,000 in the same period of 2024, indicating an improvement of 30.9%[22] - Net loss for the nine months ended September 30, 2025, was $39,921 thousand, compared to a net loss of $99,189 thousand for the same period in 2024, indicating a significant improvement[25] Cash Flow and Liquidity - Cash and cash equivalents at the end of the period were $64,834 thousand, down from $122,356 thousand at the end of September 2024, showing a decrease in liquidity[25] - The company reported a net cash used in operating activities of $22,746 thousand for the nine months ended September 30, 2025, compared to $68,548 thousand in 2024, indicating improved cash flow management[25] - The company reported a net change in cash and cash equivalents of $(1,269) thousand for the nine months ended September 30, 2025, compared to $(35,201) thousand in 2024, showing improved cash flow stability[25] - The company believes its principal sources of liquidity are sufficient to fund operations for at least the next 12 months[79] - The company anticipates that its existing cash and cash equivalents will fund its operating expenditures for at least the next twelve months[94] Stock and Equity - The weighted-average common stock outstanding for the three months ended September 30, 2025, was 75,767,778 shares, compared to 76,128,531 shares for the same period in 2024[22] - The Company repurchased 1,028,333 shares of common stock for a cost of $15,691 during the three months ended September 30, 2025, and 2,545,402 shares for $30,000 during the year ended December 31, 2024[46] - The average price paid per share for the repurchases was $15.26 for the three months ended September 30, 2025, and $11.79 for the year ended December 31, 2024[47] - As of September 30, 2025, there were 5,634,658 shares available for future award grants under the New Plan, up from 5,196,630 shares as of December 31, 2024[54] - The Company had 7,891,559 stock options outstanding as of September 30, 2025, with an average exercise price of $12.13[57] Research and Development - Research and development expenses for the three months ended September 30, 2025, were $35.6 million, a slight decrease of 2% from $36.4 million in the same period in 2024[138] - Research and development expenses increased by $8.2 million for the nine months ended September 30, 2025, totaling $105.8 million compared to $97.6 million in the same period in 2024, an 8% increase[139] - The company expects research and development expenses to increase in the future as it continues to advance and expand clinical development of its product candidates[126] - The company reported a significant decrease in expenses for zanidatamab and zanidatamab zovodotin due to reduced clinical support and program discontinuation, respectively[139] Revenue and Milestones - The Company recognized revenue of $27,614 for the three months ended September 30, 2025, compared to $16,000 for the same period in 2024, with total revenue for the nine months ended September 30, 2025, reaching $103,450[61] - The revenue for the three months ended September 30, 2025, included $25.0 million of non-refundable milestone revenue from J&J due to research milestones achieved in the Phase 3 clinical trial of pasritamig[135] - The company anticipates that collaboration revenue from strategic partnerships will be its primary source of revenue for the foreseeable future[123] - Cumulative milestone payments from Johnson & Johnson for pasritamig have reached $33.0 million, with potential future payments of up to $61.0 million in development milestones[113] Clinical Development and Approvals - The FDA granted accelerated approval for Ziihera® (zanidatamab-hrii) for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive second-line biliary tract cancer in 2024[91] - The company is currently recruiting patients for a global Phase 1 study of ZW191, targeting advanced solid tumors, with an expected enrollment of approximately 145 participants[97] - ZW251, a first-in-class GPC3-targeting antibody drug conjugate, has cleared the FDA's investigational new drug application and is currently in a global Phase 1 study with an expected enrollment of approximately 100 participants[99] - The company announced the decision to discontinue the clinical development program of ZW171 in September 2025 after completing the planned cohorts of the Phase 1 trial[211] Risks and Challenges - The life sciences industry is highly competitive, with many competitors having significantly greater financial and technical resources[216] - The company may face significant setbacks in clinical trials, as many companies have experienced failures in late-stage trials after positive early results[201] - Delays in clinical trials could significantly harm the commercial prospects for product candidates and increase costs, jeopardizing the ability to generate product revenue[188] - The company may face challenges in patient enrollment for clinical trials, particularly for rare diseases, which could hinder the ability to gain marketing approval[195] - The company may need to develop companion diagnostic tests for its product candidates, which could introduce uncertainties in the regulatory process[207] Future Outlook - The company’s long-term prospects depend on successfully executing its evolving business strategy and discovering, developing, and commercializing additional product candidates[191] - The company intends to anchor its future strategy around anticipated royalty and milestone revenues from Ziihera® and other potential future indications[194] - The company anticipates requiring substantial additional funding for its product development programs[172]

Financial Performance - Total revenue for Q3 2025 was $27.6 million, up from $16.0 million in Q3 2024, primarily due to a $25.0 million milestone from Johnson & Johnson and $1.0 million in royalty revenues[13] - Net loss for Q3 2025 was $19.6 million, an improvement from a net loss of $29.9 million in Q3 2024, attributed to increased revenue[13] - Revenue from research and development collaborations for Q3 2025 was $27,614,000, a 72.9% increase from $16,000,000 in Q3 2024[19] - Basic net loss per common share for Q3 2025 was $(0.26), an improvement from $(0.39) in Q3 2024[19] - Loss from operations for the nine months ended September 30, 2025, was $48,397,000, significantly improved from $114,893,000 for the same period in 2024[19] Expenses - Research and Development (R&D) expenses were $35.6 million in Q3 2025, slightly down from $36.4 million in Q3 2024, reflecting a decrease in expenses for several product candidates[13] - Total operating expenses for Q3 2025 were $49,724,000, slightly down from $50,205,000 in Q3 2024[19] Cash and Assets - Cash resources as of September 30, 2025, were $299.4 million, projected to fund operations into the second half of 2027[14] - Cash, cash equivalents, and short-term marketable securities increased to $251,933,000 as of September 30, 2025, up from $225,776,000 at the end of 2024[20] - Total assets decreased to $397,269,000 as of September 30, 2025, down from $463,091,000 at the end of 2024[20] - Stockholders' equity as of September 30, 2025, was $320,064,000, a decrease from $338,768,000 at the end of 2024[20] - Total liabilities decreased to $77,205,000 as of September 30, 2025, down from $124,323,000 at the end of 2024[20] Clinical Development - Initial Phase 1 clinical data for ZW191 showed an overall objective response rate of 53% and 64% for gynecological cancers[10] - The first patient was dosed in the Phase 1 trial of ZW251 for hepatocellular carcinoma, indicating progress in clinical development[7] - Zymeworks achieved a $25.0 million development milestone from Johnson & Johnson in Q3 2025 related to the clinical progress of pasritamig[11] Shareholder Actions - Share repurchases totaled $22.7 million as of November 4, 2025, under a $30.0 million program, enhancing shareholder value[13] - The company appointed Dr. Adam Schayowitz as Acting Chief Development Officer to support its strategic vision and advance its product portfolio[11] Accounts Receivable - Accounts receivable decreased to $29,352,000 as of September 30, 2025, from $55,815,000 at the end of 2024[20]

Core Insights - Zymeworks Inc. reported financial results for Q3 and nine months ended September 30, 2025, highlighting progress in clinical trials and financial performance [1][13]. Clinical Highlights - Initial Phase 1 clinical data for ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α, showed promising results, with objective response rates of 53% overall and 64% for gynecological cancers [3][8]. - The Phase 1 trial for ZW251, targeting GPC3 for hepatocellular carcinoma, has commenced with the first patient dosed [5][7]. - Dose optimization for ZW191 is set to begin in Q4 2025, focusing on safety and efficacy at doses of 6.4 mg/kg and 9.6 mg/kg [4]. Business Updates - The company achieved a $25 million development milestone from Johnson & Johnson in Q3 2025, reflecting ongoing clinical progress [9]. - Zymeworks earned $1 million in royalties from Ziihera® net product sales during Q3 2025 [7][9]. - As of September 30, 2025, Zymeworks had cash resources of $299.4 million, down from $324.2 million at the end of 2024, providing a cash runway into the second half of 2027 [14]. Financial Performance - Total revenue for Q3 2025 was $27.6 million, up from $16 million in Q3 2024, primarily due to higher milestone revenue [13]. - Research and development expenses were $35.6 million in Q3 2025, slightly down from $36.4 million in Q3 2024 [13]. - The net loss for Q3 2025 was $19.6 million, an improvement from a net loss of $29.9 million in Q3 2024 [13][19]. Leadership and Strategic Initiatives - Zymeworks appointed Dr. Adam Schayowitz as Acting Chief Development Officer to enhance R&D and business development efforts [11]. - The company completed $22.7 million in share repurchases as part of its strategic program, aimed at enhancing shareholder value [12][13].

Core Viewpoint - Zymeworks Inc. has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive earnings outlook that could lead to increased buying pressure and stock price appreciation [1][3]. Earnings Estimates and Stock Performance - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with stock price movements, particularly influenced by institutional investors [4][6]. - For the fiscal year ending December 2025, Zymeworks is expected to earn -$0.82 per share, unchanged from the previous year, but the Zacks Consensus Estimate has increased by 49.8% over the past three months [8]. Zacks Rating System - The Zacks Rank stock-rating system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7]. - The upgrade of Zymeworks to Zacks Rank 1 places it in the top 5% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Core Insights - The conference call discusses preliminary results from the Phase I trial of ZW191, presented at the AACR-NCI-EORTC Conference in Boston [1][3] - The presentation includes a review of the design rationale and scientific principles behind ZW191's development [2] - Initial Phase I clinical data highlights will be summarized by Dr. Patricia LoRusso from Yale Cancer Center [3] Company Development - Zymeworks is focusing on the development path forward for ZW191 following the initial trial results [3] - The call will conclude with a Q&A session involving Dr. LoRusso and the Senior Vice President of Clinical Development [3]

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]

Core Viewpoint - Zymeworks Inc. is set to report its third quarter 2025 financial results on November 6, 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, which has received accelerated approval from the U.S. FDA and conditional approvals in China and Europe for treating specific types of cancer [3]. - Zymeworks is advancing a robust pipeline of product candidates, including ZW191, which is currently in a Phase 1 study, and ZW251, expected to enter clinical trials in 2025 [3]. - The company has established strategic partnerships with global biopharmaceutical companies to leverage its therapeutic platforms [3].

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]