Novel trispecific T cell engager, ZW209, demonstrates potent preclinical efficacy against DLL3-expressing tumors and an encouraging safety profile New antibody-drug conjugate (ADC) candidate, ZW327, exhibits anti-tumor activity and a favorable pharmacokinetics profile in Ly6E-bearing cancers VANCOUVER, British Columbia, March 25, 2025 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve th ...

On Wednesday, Zymeworks Inc. ZYME released fourth-quarter financial results. The company reported an earnings loss of 31 cents per share, missing the consensus loss of 3 cents.Sales came at $31.03 million, missing the consensus of $45.2 million.In its fourth-quarter earnings results, Zymeworks said it is increasing its development efforts on plans for ZW251.“Based on our encouraging preclinical results and the unique potential opportunity to help hepatocellular carcinoma patients, we have decided to reprior ...

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 ...

Year End and 4Q 2024 Results Conference Call and Webcast March 5, 2025 Nasdaq: ZYME | zymeworks.com Forward-Looking Statements 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 ...

Core Points - Zymeworks Inc. reported a quarterly loss of $0.31 per share, slightly better than the Zacks Consensus Estimate of a loss of $0.32, but worse than the loss of $0.20 per share from the previous year, indicating a 55% increase in loss year-over-year [1] - The company posted revenues of $31.03 million for the quarter ended December 2024, missing the Zacks Consensus Estimate by 15.54%, and showing a significant increase from $16.93 million in the same quarter last year [2] - Zymeworks shares have declined approximately 12.9% since the beginning of the year, contrasting with the S&P 500's decline of 1.8% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.43 on revenues of $16.67 million, and for the current fiscal year, it is -$1.64 on revenues of $91.31 million [7] - The estimate revisions trend for Zymeworks is mixed, resulting in a Zacks Rank 3 (Hold), suggesting that the shares are expected to perform in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Zymeworks belongs, is currently in the top 30% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% of industries [8] - Empirical research indicates a strong correlation between near-term stock movements and trends in earnings estimate revisions, which can be tracked by investors [5]

Revenue Recognition and Financial Performance - The company recognized revenue of $19,228 thousand from Jazz Pharmaceuticals for drug supply related to ongoing studies for the year ended December 31, 2024[551]. - Total revenue for 2024 was $76,304,000, a slight increase from $76,012,000 in 2023[556]. - The company recognized milestone revenue of $25,000 from Jazz Pharmaceuticals for the year ended December 31, 2024[674]. - Revenue from strategic partnerships for the year ended December 31, 2024, totaled $76,304, an increase from $76,012 in 2023[674]. - The Company recognizes revenue when customers obtain control of promised goods or services, reflecting the expected consideration[570]. - The Company recognizes royalty income starting from the year ended December 31, 2024, based on net product sales reported by its commercial partner[578]. Expenses and Losses - Research and development expenses decreased to $134,621,000 in 2024 from $143,619,000 in 2023, reflecting a reduction of approximately 5.5%[556]. - General and administrative expenses also decreased to $61,506,000 in 2024 from $70,446,000 in 2023, a decline of about 12.5%[556]. - The company reported a net loss of $122,695,000 for 2024, compared to a net loss of $118,674,000 in 2023, indicating a worsening of approximately 3%[556]. - The company recorded stock-based compensation expenses of $17.8 million in 2024, compared to $8.1 million in 2023[558]. - The company recognized an impairment on in-process research and development (IPR&D) of $17,287,000 in 2024, which was not present in 2023[556]. Assets and Liabilities - The total assets decreased to $463,091,000 in 2024 from $580,880,000 in 2023, a reduction of about 20.3%[555]. - Cash and cash equivalents significantly decreased to $66,103,000 in 2024 from $157,557,000 in 2023, a decline of approximately 58%[555]. - Accounts receivable increased to $55,815,000 in 2024 from $19,477,000 in 2023, representing a growth of about 186%[555]. - Total liabilities increased to $124,323,000 in 2024 from $116,074,000 in 2023, an increase of approximately 7.3%[555]. - As of December 31, 2024, the company's total marketable securities amounted to $258,101, down from $298,700 in 2023[632]. Strategic Focus and Risks - The company is focused on expanding its therapeutic platforms and antibody engineering expertise to enhance product candidate commercialization[15]. - The company faces uncertainties regarding the ability to manage growth effectively and comply with regulatory standards, which could impact future performance[14]. - The company is reliant on third-party manufacturers for product candidate supplies, which poses risks related to production and operational aspects[19]. - The company is exposed to risks associated with global economic conditions, including geopolitical events such as the Russian invasion of Ukraine[17]. - The company must navigate potential disruptions in regulatory approvals and clinical trial progress, which could delay product revenue[15]. Partnerships and Collaborations - The company aims to achieve milestones and receive associated milestone payments and royalties from collaboration agreements, including the Amended Jazz Collaboration Agreement[15]. - The company emphasizes the importance of maintaining strategic partnerships to realize anticipated benefits and market opportunities[19]. - The Company received a total of $375 million in revenue from the Jazz Collaboration Agreement, including a $50 million upfront payment and a $325 million payment following the BTC Data Transfer[678]. - The Company is eligible to receive up to $1.1 billion in milestone and other payments from GSK, including $110 million for each product developed[705]. - The Company has received an upfront technology access fee payment of $6.0 million from GSK and recognized $2.5 million of milestone revenue in July 2024[708]. Stock and Equity - The weighted-average common stock outstanding increased to 75,846,681 shares in 2024 from 68,863,010 shares in 2023, an increase of about 10.4%[556]. - The company issued 3.35 million shares through At-The-Market sales, generating $26.2 million in 2024[558]. - The stock repurchase program authorized on August 1, 2024, allows for the repurchase of up to $60,000 million of common stock, with 2,545,402 shares repurchased at an average price of $11.79 per share for a total cost of $30,000 million[647][649]. - As of December 31, 2024, the company had 7,331,084 outstanding stock options as of December 31, 2024, with an average exercise price of $12.01[665]. - The company recorded stock-based compensation expense of $16,716 in additional paid-in capital for the year ended December 31, 2024, compared to $8,196 in 2023[668].

FDA Approvals and Clinical Trials - Zymeworks achieved FDA approval for zanidatamab, marking a significant milestone in 2024[3] - Phase 3 results for Ziihera® (zanidatamab-hrii) in HER2-positive gastroesophageal adenocarcinoma are expected in 2Q-2025, with potential sBLA submission later in 2025[5][12] - Zymeworks initiated first-in-human studies for ZW171 and ZW191, targeting solid tumors[6] Research and Development Pipeline - IND applications for ZW220 and ZW251 are anticipated in 2025, with additional IND applications for ZW209 and ZW1528 expected in 2026[5] - The company plans to nominate ZW209 as the fifth product in its '5 by 5' R&D program, with an IND application planned for 1H-2026[8] - The company aims to complete all five IND applications under the '5 by 5' R&D program by the end of 1H-2026[8] - Zymeworks is expanding its R&D pipeline into autoimmune and inflammatory diseases and hematological cancers[5] Financial Performance - The company reported cash, cash equivalents, and marketable securities of approximately $324 million as of December 31, 2024, providing a cash runway into 2H-2027[5][9] - The company successfully completed $30 million in share repurchases under its Share Repurchase Program announced in August 2024[8] Upcoming Events - Zymeworks will present at the J.P. Morgan Annual Healthcare Conference on January 16, 2024[10]

Core Insights - Zymeworks Inc. reported significant advancements in its product pipeline, including the initiation of first-in-human studies for ZW191 and ZW171, aimed at treating solid tumors, and plans to accelerate the IND submission for ZW251 to mid-2025 [2][6][8] - The company achieved a major milestone with the accelerated approval and launch of Ziihera (zanidatamab-hrii) for HER2-positive biliary tract cancer, with initial sales reported at $1.1 million in 2024 [2][10][9] - Financial results for 2024 showed revenue of $76.3 million, a slight increase from $76.0 million in 2023, driven by milestone payments and development support [13] Recent Developments - ZW191 and ZW171 are currently in first-in-human Phase 1 trials, targeting advanced FR⍺-expressing solid tumors and utilizing a bispecific T cell engager mechanism, respectively [3][4] - The company hosted an R&D day in December 2024 to highlight ongoing clinical progress in oncology and expansion into autoimmune and inflammatory diseases [5] - Zymeworks plans to initiate a Phase 1 trial for ZW251, targeting GPC3 for hepatocellular carcinoma, with IND submission expected in mid-2025 [7][8] Financial Performance - Total revenue for 2024 was $76.3 million, including $25 million from milestone revenue related to Ziihera's FDA approval and $37.5 million from development support [13] - Research and development expenses decreased to $134.6 million in 2024 from $143.6 million in 2023, primarily due to reduced expenses for zanidatamab [14] - The net loss for 2024 was $122.7 million, compared to a loss of $118.7 million in 2023, attributed to an impairment charge and increased tax expenses [19] Cash Position - As of December 31, 2024, Zymeworks had cash resources of $324.2 million, which is expected to fund operations into the second half of 2027 [20] - The cash resources included $66.1 million in cash and cash equivalents and $258.1 million in marketable securities [20] Strategic Partnerships - Zymeworks has entered into collaboration agreements with Jazz Pharmaceuticals and BeiGene, which include potential milestone payments totaling up to $1.1 billion and tiered royalties from net sales [12][9] - The company is also exploring strategic partnerships to leverage its proprietary technology platforms and enhance its product pipeline [8][21]

Core Insights - Zymeworks Inc. has achieved a $14 million cash research milestone from GSK related to a clinical milestone [1] - The collaboration with GSK includes potential milestone payments of up to $1.1 billion and tiered royalties on worldwide sales [3] Collaboration with GSK - Zymeworks entered into a technology transfer and license agreement with GSK in April 2016 to develop bispecific antibodies using the Azymetric™ platform [2] - The agreement was expanded in May 2019 to include access to Zymeworks' heavy-light chain pairing technology [2] Azymetric™ Platform - The Azymetric™ platform allows for the engineering of heterodimeric antibodies that can bind to multiple targets, providing unique mechanisms of action [4] - This technology enables the development of bispecific and trispecific antibodies, potentially overcoming therapeutic barriers [4] Clinical Validation - The Azymetric platform's clinical validation is highlighted by the accelerated approval of Ziihera® (zanidatamab-hrii) for advanced HER2-positive biliary tract cancer by the FDA in 2024 [5] Company Overview - Zymeworks is focused on developing multifunctional biotherapeutics for difficult-to-treat conditions, including cancer and autoimmune diseases [6] - The company has a robust pipeline, with ongoing clinical trials for multiple product candidates and plans for new investigational drug applications in 2025 [6]

Core Insights - Zymeworks Inc. is set to report its fourth quarter and full year 2024 financial results on March 5, 2025, followed by a conference call and webcast for discussion [1][2] Company Overview - Zymeworks is a clinical-stage biotechnology company focused on developing multifunctional biotherapeutics for challenging diseases such as cancer, inflammation, and autoimmune diseases [2] - The company utilizes its proprietary Azymetric™ technology to engineer and develop zanidatamab, a HER2-targeted bispecific antibody [2] - Zymeworks has exclusive agreements with BeiGene and Jazz Pharmaceuticals for the development and commercialization of zanidatamab in different regions [2] Product Development - 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. [2] - Zanidatamab is currently under regulatory review in the EU and China and is being evaluated in global clinical trials for various HER2-expressing cancers [2] - Zymeworks is advancing a pipeline of wholly-owned product candidates, with Phase 1 studies for ZW171 and ZW191 actively recruiting, and investigational new drug applications for ZW220 and ZW251 planned for 2025 [2] Strategic Partnerships - The company has leveraged its therapeutic platforms through strategic partnerships with global biopharmaceutical companies, enhancing its product development capabilities [2]