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⍺ ...

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| --- | --- | --- | --- | |----------------------------------------------|-------|-------|-------| | | | | | | | | | | | 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 ...

Financial Data and Key Metrics - Net loss for the nine months ended September 30, 2024 was $99.2 million, compared to $104.2 million for the same period in 2023, primarily due to lower R&D and G&A expenses, and a decrease in income tax expense [17] - Revenue for the nine months ended September 30, 2024 was $45.3 million, down from $59.1 million in 2023, driven by a decrease in development support and drug supply revenue from Jazz [18] - Operating expenses decreased by 8% YoY to $160.2 million, primarily due to reduced R&D and G&A expenses [20] - Cash resources as of September 30, 2024 were $374.9 million, down from $456.3 million at the end of 2023 [24] Business Line Data and Key Metrics - ZW171 and ZW191 received FDA clearance for IND applications in August 2024, with ZW171 initiating Phase 1 trials [9] - ZW220 and ZW251 showed promising preclinical data at the ENA conference, with IND filings anticipated in 2025 [10] - Jazz Pharmaceuticals provided updates on Zani, showing a 59% 30-month overall survival rate in metastatic DEA patients in a Phase 2 study [12] - GSK contributed $2.5 million in milestone revenue, validating the company's internal platforms [13] Market Data and Key Metrics - The company has a global footprint with clinical trials for ZW171 and ZW191 active in North America, Europe, and the Asia-Pacific region [54] - ZW220 demonstrated robust activity in ovarian, endometrial, and non-small cell lung cancer models, with a single dose of 6 mg/kg showing significant antitumor efficacy [28] - ZW251 showed dose-responsive antitumor effects in hepatocellular carcinoma models, with a single 8 mg/kg dose active in 5 out of 6 cell line-derived models [38] Company Strategy and Industry Competition - The company is focused on advancing its R&D pipeline, with three 519 payload ADCs expected to enter early clinical development by the end of 2025 [42] - Zymeworks is exploring combination regimens for its ADCs to improve efficacy and tolerability, aiming to reach first-line patients [44] - The company is expanding into hematological cancers and autoimmune inflammatory diseases, leveraging its core strengths in solid tumors [62] Management Commentary on Operating Environment and Future Outlook - Management highlighted the transformative potential of the company's novel ADC designs, emphasizing the importance of target biology and tolerability [43] - The company expects to extend its cash runway into the second half of 2027, supported by anticipated regulatory milestone payments [26] - Management expressed confidence in the potential of Zani to make a significant impact in oncology, with upcoming clinical data readouts expected in 2025 [71] Other Important Information - The company completed the first $30 million of its $60 million share repurchase program, purchasing approximately 2.5 million shares at an average price of $11.79 per share [16] - A non-cash impairment charge of $17.3 million was recorded due to the discontinuation of the zanidatamab zovodotin clinical development program [22] - The company is eligible for commercial milestone payments and tiered royalties on Zani sales, with royalties ranging from 10% to 20% on Jazz's net sales and 10% to 19.5% on BeiGene's sales [27] Q&A Session Summary Question: Dose optimization for ZW171 and ZW191 Phase 1 trials - The company plans to explore multiple doses in the expansion phase to ensure a clear understanding of tolerability and efficacy [78] - Management emphasized the importance of collecting diverse patient data to optimize dosing strategies [80] Question: Combination strategies for ADCs - The company is considering combination strategies for all three ADC programs, with specific combinations tailored to the disease indication [83] - Potential combinations include VEGF inhibitors, PARP inhibitors, and PD1 inhibitors, depending on the target population [84] Question: Competitive landscape for Zani - Management expressed confidence in Zani's clinical data and its potential to outperform competitors, particularly in HER2-positive indications [89] - The company highlighted Zani's unique mechanism of action and tolerability profile as key differentiators [90] Question: Data sharing philosophy for ZW171 and ZW191 - The company plans to share clinical data only after collecting a robust dataset, likely at peer-reviewed scientific or medical meetings [95] - Early data from Phase 1 trials is not expected to be shared at the upcoming R&D Day [108] Question: Share repurchase program - The company completed the first $30 million of its $60 million share repurchase program and is evaluating market conditions before initiating the second tranche [98] - Management believes the share price remains undervalued and sees the repurchase program as a way to improve shareholder returns [100] Question: Future partnerships and collaborations - The company is open to partnerships to accelerate its R&D pipeline, particularly for its 5 by 5 portfolio and beyond [119] - Management is considering retaining more commercial rights in future collaborations compared to the Zani licensing deal [120] Question: Target selection for ADCs - The company prioritizes targets with strong antigen expression but also considers the potential for bystander activity in tumors with variable antigen expression [125] - The design of ADCs balances target recognition, internalization, and payload release to optimize efficacy and tolerability [126] Question: Expansion into autoimmune diseases - The company plans to discuss specific autoimmune programs at the R&D Day, leveraging its bispecific technology [129] - Target selection for Trispecific T-cell engagers focuses on tumor-biased expression to minimize off-target effects [130]

Zymeworks Inc. (ZYME) came out with a quarterly loss of $0.39 per share versus the Zacks Consensus Estimate of a loss of $0.40. This compares to loss of $0.41 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 2.50%. A quarter ago, it was expected that this company would post a loss of $0.27 per share when it actually produced a loss of $0.26, delivering a surprise of 3.70%.Over the last four quarters, the company has surpassed c ...

Financial Performance - The company reported a significant increase in revenue, with a year-over-year growth of 25% for the third quarter, totaling $150 million[16]. - The company anticipates a revenue growth of 30% for the next quarter, projecting total revenue of $195 million[16]. - Total revenue for the three months ended September 30, 2024, decreased by $0.5 million compared to the same period in 2023, with $12.1 million from Jazz, $2.5 million from GSK, and $1.4 million from BeiGene[134]. - Total revenue decreased by $13.8 million for the nine months ended September 30, 2024, compared to the same period in 2023[135]. - Revenue from research collaborations decreased by 23% to $45.3 million for the nine months ended September 30, 2024, from $59.1 million in the same period in 2023[136]. - The company reported a basic net loss per share of $1.30 for the nine months ended September 30, 2024, compared to $1.53 for the same period in 2023, reflecting a decrease of approximately 15.0%[40]. User Engagement - User data showed a 15% increase in active users, reaching 1.2 million by the end of the quarter[16]. Market Expansion - The company is expanding its market presence in Europe, targeting a 10% market share by the end of the fiscal year[16]. Research and Development - Research and development expenses increased by 20%, amounting to $30 million, reflecting the company's commitment to innovation[16]. - The company incurred research and development expenses of $6,477,000 for the nine months ended September 30, 2024, compared to $677,000 for the same period in 2023[65]. - Research and development expenses decreased by $20.5 million for the nine months ended September 30, 2024, primarily due to a decrease in expenses for zanidatamab[139]. - The company expects research and development expenditures to increase over time, subject to periodic fluctuations, in line with the advancement of clinical development[138]. Strategic Initiatives - New product launches are expected to contribute an additional $20 million in revenue over the next two quarters[16]. - The company successfully completed a strategic acquisition, enhancing its product portfolio and expected to generate $10 million in synergies[16]. - The company has secured a new partnership with a leading biotech firm, which is projected to accelerate product development timelines[16]. Financial Position - Total current assets decreased from $412,926 thousand as of December 31, 2023, to $343,769 thousand as of September 30, 2024, a decline of approximately 16.7%[17]. - Total liabilities increased from $116,074 thousand as of December 31, 2023, to $120,174 thousand as of September 30, 2024, an increase of approximately 3.6%[17]. - Cash and cash equivalents decreased from $157,557 thousand as of December 31, 2023, to $122,356 thousand as of September 30, 2024, a decline of about 22.3%[17]. - The total stockholders' equity decreased from $464,806 thousand as of December 31, 2023, to $366,978 thousand as of September 30, 2024, a decline of approximately 21%[17]. - The company reported a net loss of $37,686,000 for the quarter ending June 30, 2024, contributing to an accumulated deficit of $746,776,000[22]. - As of September 30, 2024, the company reported a net loss of $99.2 million for the nine months ended, with an accumulated deficit of $797.8 million[113]. Operational Efficiency - The company is focused on improving operational efficiency, aiming to reduce costs by 15% over the next year[16]. - The company reported a comprehensive loss of $27,945 thousand for the three months ended September 30, 2024, compared to a comprehensive loss of $29,172 thousand for the same period in 2023, a decrease of approximately 4.2%[19]. Stock and Equity - The weighted-average common stock outstanding for the three months ended September 30, 2024, was 76,128,531 shares, an increase from 70,575,773 shares for the same period in 2023[19]. - The issuance of common stock on the exercise of options resulted in an increase of 495,640 shares, raising $5,208,000 during the quarter ending June 30, 2024[22]. - The company completed a private placement on December 28, 2023, raising gross proceeds of $50,000 million from the sale of 5,086,521 pre-funded warrants[50]. - The company reported stock options outstanding of 7,016,762 as of September 30, 2024, with an aggregate intrinsic value of $19,081,000[62]. Risks and Challenges - The company highlighted potential risks including regulatory challenges and market competition, which could impact future performance[16]. - The company reported an impairment charge of $17,287 million for in-process research and development assets due to the discontinuation of the zanidatamab zovodotin clinical development program[45]. Future Outlook - The company expects to conduct a live R&D day on December 12, 2024, featuring updates on solid tumor targeting antibody-drug conjugates[119]. - The company remains eligible to receive up to $1.55 billion in potential milestone payments related to zanidatamab, pending regulatory approval[121].

Zymeworks Provides Corporate Update and Reports Third Quarter 2024 Financial Results • First patient dosed in Phase 1 clinical trial evaluating ZW171 in advanced mesothelin (MSLN)-expressing cancers • Preclinical data presented on ZW220 and ZW251 at EORTC-NCI-AACR conference • Our partner Jazz Pharmaceuticals presented new and updated clinical data at ESMO 2024 on zanidatamab highlighting its potential for the treatment of multiple HER2-positive (HER+) indications • Zymeworks to host in-person and virtual R ...

Presentations highlight key preclinical data that support investigational new drug application (IND) submissions for ZW220 in 1H and ZW251 in 2H in 2025 VANCOUVER, British Columbia, Oct. 25, 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 new preclinical data for Zymeworks’ antibody-drug conjugate (ADC) candida ...

Global Phase 1 clinical trial will evaluate the safety and tolerability of ZW171 in treatment of ovarian cancer, non-small cell lung cancer (NSCLC), and other mesothelin (MSLN) expressing cancers VANCOUVER, British Columbia, Oct. 21, 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 bee ...

VANCOUVER, British Columbia, Oct. 10, 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 management will report its third quarter 2024 financial results after market close on October 31, 2024. Following the announcement, management will host a conference call and webcast to discuss financial results and provi ...