Company Performance - Zymeworks Inc. reported a quarterly loss of $0.30 per share, better than the Zacks Consensus Estimate of a loss of $0.45, and an improvement from a loss of $0.42 per share a year ago, resulting in an earnings surprise of 33.33% [1] - The company posted revenues of $27.11 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 57.36%, compared to revenues of $10.03 million in the same quarter last year [2] - Over the last four quarters, Zymeworks has surpassed consensus EPS estimates four times, but has only topped consensus revenue estimates once [2] Stock Outlook - Zymeworks shares have declined approximately 22.5% since the beginning of the year, while the S&P 500 has decreased by 4.3% [3] - The company's earnings outlook will be crucial for future stock performance, with current consensus EPS estimates at -$0.51 for the coming quarter and -$1.75 for the current fiscal year [4][7] Industry Context - The Medical - Biomedical and Genetics industry, to which Zymeworks belongs, is currently ranked in the top 33% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8] - Empirical research suggests a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can impact Zymeworks' stock performance [5]

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]

Making a Meaningful Difference Accelerating the next generation of therapeutics to improve the standard of care for the most challenging diseases in cancer, autoimmune and inflammatory disease May 2025 Nasdaq: ZYME | zymeworks.com The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no obligation to update, republish, or revise any forward-looking statements to reflect new info ...

Financial Performance - Total revenue for the three months ended March 31, 2025, was $27,110,000, a significant increase from $10,030,000 in the same period of 2024, representing a 170% growth[21] - The net loss for the three months ended March 31, 2025, was $22,636,000, an improvement from a net loss of $31,653,000 in Q1 2024, indicating a reduction of 28%[21] - The company reported a comprehensive loss of $22,090,000 for Q1 2025, compared to a comprehensive loss of $32,774,000 in Q1 2024, reflecting a 33% improvement[21] - Basic net loss per share improved to $(0.30) in Q1 2025 from $(0.42) in Q1 2024[35] - The net loss for Q1 2025 was $22,636,000, a 28.5% improvement from a net loss of $31,653,000 in Q1 2024[23] Research and Development - Research and development expenses for Q1 2025 were $35,738,000, compared to $32,042,000 in Q1 2024, reflecting an increase of 23%[21] - The company continues to focus on research and development of next-generation multifunctional biotherapeutics[25] - The company anticipates continued losses as it increases research and development expenditures for ongoing product candidate development[91] - Research and development expenses increased by 12% to $35.7 million for the three months ended March 31, 2025, compared to $32.0 million in the same period in 2024[132] - Research and development expenses for zanidatamab decreased by 59% to $1.4 million in Q1 2025 compared to $3.4 million in Q1 2024[132] Cash and Liquidity - Cash and cash equivalents increased to $76,204,000 as of March 31, 2025, compared to $66,103,000 at December 31, 2024, showing a growth of 15%[20] - The company has a cash resource of $321.6 million as of March 31, 2025, which is expected to fund operations for at least the next twelve months[90] - The company’s liquidity sources include cash, cash equivalents, and investments, which are deemed sufficient to fund operations for at least the next 12 months[75] - Cash used in operating activities decreased significantly to $3,407,000 in Q1 2025 from $37,675,000 in Q1 2024[23] - As of March 31, 2025, the company had $321.6 million in cash, cash equivalents, and marketable securities, including $76.2 million in cash and cash equivalents and $245.4 million in marketable securities[139] Assets and Liabilities - Total assets decreased to $425,522,000 as of March 31, 2025, down from $463,091,000 at the end of 2024, a decline of 8%[20] - Total current liabilities decreased to $65,103,000 as of March 31, 2025, down from $88,294,000 at December 31, 2024, a reduction of 26%[20] - The total stockholders' equity as of March 31, 2025, was $324,967,000, a decrease from $338,768,000 at the end of 2024, representing a decline of 4%[20] - The total liabilities decreased from $59,838 million as of December 31, 2024, to $38,223 million as of March 31, 2025[40] Strategic Partnerships and Revenue - The company recognized $27,110 in revenue from strategic partnerships in the three months ended March 31, 2025, compared to $10,030 in the same period of 2024, representing a 170% increase[59] - The company received $471.0 million in non-refundable upfront and milestone payments through collaboration agreements with Jazz and BeiGene, with potential future payments of up to $1.53 billion[113] - The company recognized $14.0 million in milestone revenue from GSK in January 2025, with potential future milestone payments totaling up to $203.5 million in R&D and $867.0 million in commercial payments[109] - The company received $3.1 million in milestone revenue from Daiichi Sankyo following the first patient dosed in a clinical trial, with potential future milestone payments totaling up to $60.3 million in development and $170.0 million in commercial payments[110] Clinical Development and Regulatory Approvals - The FDA granted accelerated approval for Ziihera® (zanidatamab-hrii) for the treatment of adults with previously-treated, unresectable or metastatic HER2-positive biliary tract cancer in 2024[86] - The company is currently focused on the development of two clinical-stage product candidates, ZW171 and ZW191, and is recruiting patients for ongoing global Phase 1 studies in multiple regions[173] - The confirmatory trial for Ziihera® related to its accelerated approval must demonstrate clinical benefit; failure could result in removal from the market, impacting milestone payments and royalties[172] - The FDA granted Fast Track and Breakthrough Therapy designations for zanidatamab, but these designations do not guarantee faster development or approval processes[190][191] Risks and Challenges - The company has incurred significant losses since inception and anticipates continued losses for the foreseeable future, requiring substantial additional funding that may not be available on acceptable terms[163] - Clinical trials are expensive and time-consuming, with high attrition rates; the company may face significant delays or inability to develop product candidates due to various factors[165][176] - Regulatory approval for product candidates is uncertain and may be impacted by changes in regulatory policies or disagreements with regulatory authorities regarding trial designs and data[169][177] - The company faces significant competition, and if competitors develop more effective or less expensive products, it could negatively impact commercial opportunities[162] - The company may encounter challenges in enrolling patients for clinical trials, particularly for rare diseases, which could hinder marketing approval[182]

Revenue and Financial Performance - Revenue for Q1 2025 was $27.1 million, a significant increase from $10.0 million in Q1 2024, including $14.0 million from GSK and $3.1 million from Daiichi Sankyo[15] - Net loss for Q1 2025 decreased to $22.6 million from $31.7 million in Q1 2024, attributed to increased revenue[20] - Revenue from research and development collaborations increased to $27,110,000 in Q1 2025, up from $10,030,000 in Q1 2024, representing a 170% increase[26] - Net loss for Q1 2025 was $22,636,000, an improvement from a net loss of $31,653,000 in Q1 2024, indicating a reduction of approximately 29%[26] - Total operating expenses for Q1 2025 were $52,723,000, compared to $47,832,000 in Q1 2024, reflecting an increase of 10%[26] Cash and Assets - Cash resources as of March 31, 2025, totaled $321.6 million, providing a projected cash runway into the second half of 2027[21] - Cash, cash equivalents, and short-term marketable securities increased to $265,287,000 as of March 31, 2025, compared to $225,776,000 at the end of 2024, showing a growth of 17%[27] - Total assets decreased to $425,522,000 as of March 31, 2025, down from $463,091,000 at the end of 2024, a decline of 8%[27] - Total liabilities decreased to $100,555,000 as of March 31, 2025, compared to $124,323,000 at the end of 2024, representing a reduction of 19%[27] - Stockholders' equity as of March 31, 2025, was $324,967,000, down from $338,768,000 at the end of 2024, a decrease of 4%[27] - The company anticipates sufficient cash resources to fund operations into the second half of 2027, assuming receipt of certain anticipated regulatory milestones[26] Research and Development - Research and development expenses rose to $35.7 million in Q1 2025, compared to $32.0 million in Q1 2024, primarily due to increased expenses for ZW251 and ZW209[16] - The investigational new drug application for ZW251 is expected to be submitted by mid-2025, indicating ongoing product development[3] - The company is actively developing its early-stage pipeline, with ongoing clinical trials and expected data presentations in the near future[26] Partnerships and Collaborations - The company recognized $14.0 million in milestone revenue from GSK in April 2025, with potential future milestone payments totaling up to $203.5 million[12] - Zanidatamab's partner Jazz reported net product sales of $2.0 million in Q1 2025, with Zymeworks receiving $0.2 million in royalties[11] - Zymeworks is focused on executing new collaborations and partnerships to enhance its product pipeline and market presence[26] Administrative and Personnel Changes - General and administrative expenses increased to $17.0 million in Q1 2025 from $15.8 million in Q1 2024, mainly due to higher stock-based compensation[17] - The company appointed Dr. Sabeen Mekan as Senior Vice President, Clinical Development, to enhance its clinical-stage oncology portfolio[4] Presentations and Conferences - Six posters were presented at the AACR annual meeting, showcasing advancements in the company's preclinical and clinical-stage candidates[5]

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 Insights - The article discusses potential investment opportunities in ZYME, indicating a possible long position in the stock within the next 72 hours [1]. Group 1 - The analyst has no current stock or derivative positions in the companies mentioned but may initiate a beneficial long position in ZYME [1]. - The article expresses the author's personal opinions and is not influenced by any compensation from the companies discussed [1]. - There is no business relationship between the author and the companies mentioned in the article [1].

Core Insights - Zymeworks Inc. has received FDA approval for Ziihera (zanidatamab-hrii) targeting HER2-positive biliary tract cancer, marking a significant milestone in its biotechnology journey [1] Company Overview - Zymeworks Inc. has been active in the biotechnology sector for over a decade, facing both successes and challenges in drug development [1] - The company focuses on high-growth opportunities within sectors that are expected to experience exponential expansion [1] Investment Perspective - The analysis emphasizes the importance of innovation and disruptive technologies in generating substantial returns, aligning with the company's strategic direction [1]

Core Insights - Zymeworks Inc. presented six posters at the AACR Annual Meeting, showcasing advancements in their antibody-drug conjugate and T cell engager platforms, particularly highlighting the promising preclinical data for ZW209 in small cell lung cancer [1][2]. T Cell Engagers (TCE) - ZW209, a DLL3-targeted trispecific T cell engager, shows safety and potent preclinical efficacy in small cell lung cancer models, with an IND submission expected in the first half of 2026 [4][8]. - ZW171, a bispecific antibody targeting mesothelin, demonstrates anti-tumor activity across various cancers, including ovarian and pancreatic cancers, and is currently in a global Phase 1 clinical study [3][5]. Antibody-Drug Conjugates (ADCs) - ZW327, a novel Ly6E-targeting ADC, exhibits significant in vitro cytotoxicity against multiple tumor types, including breast and lung cancers, and shows robust anti-tumor activity in xenograft models [6][9]. - A biparatopic ADC targeting protein tyrosine kinase 7 (PTK7) has been developed, demonstrating improved binding and internalization compared to previous ADCs, with promising results in breast and lung cancer models [7][10]. Preclinical Development and Technologies - Zymeworks has developed high-throughput functional screening methods in 3D tumor models to enhance the evaluation of ADCs during preclinical development [11]. - In vitro assays have been created to predict ADC hematological toxicity, which could improve the selection of optimal linkers and payloads in ADC development [12][16]. Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing multifunctional biotherapeutics for challenging diseases, including cancer and autoimmune conditions, leveraging its proprietary technologies [14][17].

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].