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]

Core Viewpoint - 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 to discuss the results and provide a corporate update [1] 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 [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 territories [2] Product Development and Regulatory Approvals - The U.S. FDA has 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, making it 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 for second-line biliary tract cancer and is being evaluated in multiple global clinical trials for various HER2-expressing cancers [2] - Zymeworks is advancing a robust 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]

Core Insights - Zymeworks Inc. is focused on advancing its pipeline of multifunctional biotherapeutics aimed at treating difficult diseases, including cancer and autoimmune conditions, with strategic priorities set for 2025 and 2026 [1][2] Key 2024 Accomplishments - The company achieved its first FDA approval for zanidatamab and made significant clinical progress with antibody-based therapeutics in solid tumors [2] - Zymeworks has a strong financial position with approximately $324 million in cash and marketable securities as of December 31, 2024, which supports operations into the second half of 2027 [4][9] - The company initiated first-in-human studies for ZW171 and ZW191, and plans to submit IND applications for ZW220 and ZW251 in 2025 [5][11] 2025 and 2026 Priorities - Zymeworks aims to continue the clinical development of its solid tumor pipeline and expand its R&D efforts into autoimmune and inflammatory diseases [7][11] - The company expects to present at the J.P. Morgan Annual Healthcare Conference on January 16, 2024, to discuss its strategic priorities [10] Regulatory and Clinical Milestones - Top-line results for the Phase 3 HERIZON-GEA-01 trial for Ziihera® (zanidatamab-hrii) are anticipated in Q2 2025, with potential regulatory submissions in the EU and China for zanidatamab in second-line biliary tract cancer expected as early as Q2 2025 [4][12] - The company is advancing its proprietary platforms to enhance product innovation and diversify its pipeline [11][12]

Core Viewpoint - Zymeworks Inc. (ZYME) shares have increased by 10.1% in the past four weeks, closing at $14.46, with a potential upside of 41.4% based on Wall Street analysts' mean price target of $20.44 [1] Price Targets - The mean estimate consists of eight short-term price targets with a standard deviation of $6.40, indicating variability among analysts; the lowest estimate is $12 (17% decline), while the highest is $30 (107.5% increase) [2][7] - A low standard deviation suggests a high degree of agreement among analysts regarding the stock's price movement direction, which can serve as a starting point for further research [7] Earnings Estimates - Analysts are optimistic about ZYME's earnings prospects, as indicated by a positive trend in earnings estimate revisions, which historically correlates with stock price movements [4][9] - Over the last 30 days, the Zacks Consensus Estimate for the current year has risen by 2.5%, with one estimate increasing and no negative revisions [10] Zacks Rank - ZYME holds a Zacks Rank 2 (Buy), placing it in the top 20% of over 4,000 ranked stocks based on earnings estimate factors, suggesting a strong potential upside in the near term [11] Conclusion on Price Targets - While consensus price targets may not reliably indicate the extent of ZYME's potential gains, they can provide a useful guide for the direction of price movement [12]

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VANCOUVER, British Columbia, Nov. 05, 2024 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the first patient has been dosed in the company’s first-in-human Phase 1 trial (NCT06555744) to evaluate the safety and tolerability of the investigational therapy ZW191 in the treatment of advanced folate receptor-⍺ (FR⍺ ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

| --- | --- | --- | --- | |----------------------------------------------|-------|-------|-------| | | | | | | | | | | | Q3 2024 Results | | | | | | | | | | Conference Call and Webcast October 31, 2024 | | | | | 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, an ...