Financial Data and Key Metrics Changes - R&D expenses for Q1 2025 were $118.6 million, up from $100.1 million in Q1 2024, primarily due to a $30 million payment to Alnylam and expenses related to the ECLIPSE program initiation [36] - SG&A expenses for Q1 2025 were CAD 23.9 million, down from CAD 36.3 million in Q1 2024, largely due to cost savings from headcount reductions [37] - Net loss for Q1 2025 was $121 million compared to a net loss of $65.3 million in Q1 2024, driven by a significant drop in revenue from $52 million to approximately $3 million [38] Business Line Data and Key Metrics Changes - The hepatitis delta program has initiated the ECLIPSE Phase III program, with the first patient enrolled, marking a significant milestone [22] - The oncology portfolio continues to progress, with promising data from the Pro X10 dual masked T cell engager programs, particularly in HER2 positive colorectal cancer [15][28] Market Data and Key Metrics Changes - The estimated addressable market for hepatitis delta includes approximately 61,000 RNA positive patients in the U.S. and 113,000 in EU member countries plus the UK, highlighting the potential for significant commercial opportunity [10] - The company emphasizes that hepatitis delta has characteristics of a rare disease market with severe outcomes, supporting a value-based pricing model [11] Company Strategy and Development Direction - The strategic focus remains on advancing both infectious disease and oncology programs, with a commitment to developing a new standard of care for hepatitis delta virus infection [8] - The company is exploring collaborations to maximize value from the Pro X10 platform and has advanced a broadly neutralizing antibody in its HIV cure program [19] Management's Comments on Operating Environment and Future Outlook - Management acknowledges the challenging market environment for the biotechnology sector but emphasizes a disciplined approach to capital allocation and operational excellence [20] - The company maintains a strong cash position of approximately $1 billion, providing a runway extending into mid-2027 to advance key programs [39] Other Important Information - The agreement with Alnylam regarding the profit-sharing arrangement has been clarified, with the company recognizing CAD 30 million as R&D expense in Q1 2025 [39] - The company is preparing for the upcoming EASL Congress to present data from its hepatitis B program and the Solstice trial [26] Q&A Session Summary Question: Alnylam decision and future oncology updates - Alnylam opted out of the profit-sharing arrangement based on their strategic portfolio prioritization, prior to the latest HCV functional cure data being available [47] - Future oncology data updates will include mature data at higher dose levels and comparative data between dosing regimens, expected to be shared at medical congresses or focused investor events [46] Question: ECLIPSE study enrollment and timelines - The ECLIPSE one study aims to complete enrollment by the end of 2025, with ECLIPSE two having a 24-week endpoint [55] Question: Competitive positioning of T cell engagers - The company believes its dual mask technology offers a favorable safety profile and differentiates it from competitors, with a focus on convenience and quality of life for patients [60][62] Question: Functional cure rates and HBV program development - The company anticipates presenting data showing a 20% functional cure rate in the doublet and a 30% in the triplet at the upcoming EASL [77] - Further development of the HBV program is contingent on securing a global development and commercialization partner [78] Question: Changes in U.S. guidelines for HBV diagnosis - No changes have been made to U.S. guidelines for delta diagnosis, but there is hope for increased awareness and reflex testing in the future [101]

Positive IND-enabling data on MP0712 targeting DLL3, the most advanced Radio-DARPin program in co-development with Orano Med, entering clinical development in 2025 First preclinical data of novel targeted Radio-DARPin against mesothelin (MSLN), in co-development with Orano Med Additional preclinical proof-of-concept data on logic-gated CD3 Switch-DARPin T cell engager with CD2 co-stimulation ZURICH-SCHLIEREN, Switzerland and CONCORD, Mass., April 25, 2025 (GLOBE NEWSWIRE) -- Ad hoc announcement pursuant to ...

MacroGenics, Inc. (NASDAQ:MGNX) Q4 2024 Earnings Conference Call March 20, 2025 4:30 PM ET Company Participants James Karrels - SVP, CFO and Secretary Scott Koenig - President and CEO Stephen Eck - SVP, Clinical Development & Chief Medical Officer Conference Call Participants Peter Lawson - Barclays Jonathan Chang - Leerink Partners Nicholas Lorusso - TD Cowen Jonathan Miller - Evercore ISI Stephen Willey - Stifel Silvan Tuerkcan - Citizens JMP Securities Mayank Mamtani - B. Riley Securities Operator Good a ...

Financial Data and Key Metrics Changes - As of December 31, 2024, the company ended the year with $100.6 million in cash, cash equivalents, and investments, a decrease from $174.5 million at the end of 2023 [29] - Total revenue for 2024 was $138.1 million, compared to $101.2 million for the corresponding period in 2023, attributed to collaborations with BMS, Moderna, Astellas, and Regeneron [32] - Total operating expenses for 2024 were $113.1 million, an increase from $107.7 million in 2023, primarily due to a $5 million milestone payment for CX-2051 [33] Business Line Data and Key Metrics Changes - The lead program, CX-2051, is a first-in-class ADC targeting EPCAM, with a focus on colorectal cancer, which has a significant unmet need [7][13] - CX-801, a masked version of interferon alpha, is also progressing well in early clinical trials, with plans to initiate combination therapy with KEYTRUDA in 2025 [24] Market Data and Key Metrics Changes - The global unmet need in colorectal cancer is significant, with over 1.9 million new cases annually and limited new treatments emerging in the last two decades [13] - The company is focusing on late-line CRC patients who have generally received at least three prior systemic therapies, indicating a high unmet need in this patient population [15][70] Company Strategy and Development Direction - The company is prioritizing its lead programs, CX-2051 and CX-801, to extend its cash runway to Q2 2026 and support key clinical milestones [8][29] - The strategy includes a focus on antibody masking technology and collaborations with major pharmaceutical companies to enhance its pipeline [7][25] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the initial clinical data for CX-2051 and CX-801 expected in 2025, which could drive significant near-term value creation [8][28] - The company remains committed to disciplined capital allocation and resource management to progress its promising pipeline [34] Other Important Information - The company achieved a $5 million milestone in its collaboration with Astellas, indicating ongoing progress in its partnerships [31][25] - The company is not pre-selecting patients based on EPCAM expression or other disease characteristics in its Phase 1 study for CX-2051, aiming to characterize the drug across the full CRC population [15][56] Q&A Session Summary Question: Update on CX-2051 patient enrollment and data expectations - Management anticipates a meaningful update including initial safety profile characterization and potential antitumor activity data [41][42] Question: Timing for CX-801 and KEYTRUDA combination therapy - The initiation of the KEYTRUDA combination is expected in the second half of the year, likely before data presentation [45] Question: Therapeutically active doses in CX-2051 trial - A significant number of patients will be treated with doses predicted to be within the therapeutic active range by the time data is shared [51] Question: Expectations regarding KRAS status and liver metastases - There is no obvious biology suggesting a connection between KRAS status and EPCAM expression; the study aims to enroll a broad patient population [55] Question: Expression levels of EPCAM in CRC - EPCAM is highly expressed in colorectal cancer, and the clinical results are expected to validate this [61] Question: Focus on CRC for EPCAM targeting - The focus on CRC is due to its high and consistent EPCAM expression, significant unmet need, and the drug's design being optimized for this indication [70]

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 ...