Ziihera®
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Zymeworks(ZYME) - 2025 Q3 - Earnings Call Presentation
2025-11-06 21:30
Financial Performance - Revenue for 3Q 2025 was $253 million, including $253 million from milestones and research period extension fees from J&J and Merck, and $1 million in royalty revenues from Jazz and BeOne[17,18] - Cash, cash equivalents, and marketable securities totaled $3242 million as of 3Q 2025[17] - Completed share repurchases of $227 million of the remaining $30 million share repurchase program for 1439068 shares at an average price of $1580 per share[15] - R&D expenses were slightly decreased due to program mix and timing, partially offset by higher stock-based compensation expense[18] Pipeline Progress - Preliminary Phase 1 data on ZW191 provides early validation of ADC platform[15] - First patient dosed in Phase 1 clinical trial of ZW251, a DAR4 ADC targeting GPC3[15] - Partner Jazz presented a trial-in-progress poster on the DiscovHER PAN-206 phase 2 study of zanidatamab in HER2-overexpressing solid tumors, as well as a two-year follow-up in first-line mCRC at EMSO[15] - J&J Innovative Medicine initiated Phase 3 study for pasritamig (JNJ-78278343) triggering $25 million development milestone[15] ZW191 Clinical Data - ZW191 demonstrated a favorable clinical safety profile, with an any TRAE rate of 80% (33 out of 41 participants) and a Grade ≥3 TRAE rate of 17% (7 out of 41 participants)[20] - Preliminary efficacy data for response-evaluable participants with gynecological cancer showed a PR rate of 50% (12 out of 24 participants)[25] - Randomized dose optimization to begin in 4Q-2025 in platinum resistant ovarian cancer at 96 and 64 mg/kg doses (~30 pts/cohort)[27] Strategic Outlook - Diverse potential revenue streams from existing partnerships, with potential future milestone payments of up to $136 billion for zanidatamab-hrii and up to $434 million for JNJ-78278343[39] - Near-term revenue catalysts include continued royalties from Jazz and BeOne Medicines for Ziihera® expected in 2025[40]
Zymeworks Provides Corporate Update and Reports Third Quarter 2025 Financial Results
Globenewswire· 2025-11-06 21:05
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].