Mersana Therapeutics(MRSN) - 2022 Q4 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended 2022 with approximately $281 million in cash, cash equivalents, and marketable securities, up from $178 million at the end of 2021 [33] - Research and development expenses for Q4 2022 were $45.7 million compared to $37.4 million for the same period in 2021, primarily due to higher manufacturing and clinical costs [34] - The net loss for Q4 2022 was $44.9 million, compared to a net loss of $49 million for the same period in 2021 [55] Business Line Data and Key Metrics Changes - The company advanced enrollment in the UP-NEXT Phase 3 clinical trial of UpRi as a monotherapy maintenance treatment in recurrent platinum-sensitive ovarian cancer [21] - The UPLIFT trial has enrolled approximately 270 patients, with a primary endpoint of objective response rate (ORR) [25] - In the dose expansion trial, UpRi generated an ORR of 34% in NaPi2b positive patients with a duration of response of approximately five months [27] Market Data and Key Metrics Changes - The company entered into three new collaborations in 2022, including agreements with Janssen, GSK, and Merck KGaA, indicating a high level of interest in antibody-drug conjugates (ADCs) [23] - Collaboration revenue for Q4 2022 was $14.7 million, compared to an immaterial amount for the same period in 2021, primarily due to the Janssen and GSK agreements [54] Company Strategy and Development Direction - The company aims to solidify its role as a leader in the ADC space and is focused on advancing its clinical pipeline and business development [20] - Plans for 2023 include significant advancements in UP-NEXT enrollment and reporting interim data from UPGRADE-A [37] - The company is evaluating new collaboration opportunities to expand the reach of its platforms and generate non-dilutive capital [37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made in 2022 and highlighted the potential for multiple significant milestones in 2023 [20][56] - The company is preparing for the top-line data readout from UPLIFT in mid-2023, with plans to file a Biologics License Application (BLA) if results are positive [56] Other Important Information - The company received a $30 million upfront payment from Merck and is eligible for up to $800 million in development, regulatory, and commercial milestones [14] - General and administrative expenses for Q4 2022 were $14.8 million, up from $10.7 million in the same period in 2021, primarily due to increased consulting and professional fees [16] Q&A Session Summary Question: What are the expectations for duration of response for UPLIFT? - Management believes that a duration of response of five months is clinically meaningful based on discussions with clinical investigators [44] Question: How does the company view the bar to beat the maintenance for UP-NEXT? - The best comparison is with niraparib in the NOVA study, which demonstrated a PFS of approximately 4.5 months in the placebo arm [77] Question: Will the FDA consider UP-NEXT data when reviewing UPLIFT? - Management speculated that the FDA may look at UP-NEXT data, but emphasized that UP-NEXT is in a different line population compared to UPLIFT [69] Question: What data will be available when UPLIFT results are disclosed? - The company expects to disclose overall response rate, safety, and duration of response metrics after major medical conferences in June [70][71] Question: What other companies are pursuing the B7-H4 target? - At least two other companies are working on the B7-H4 target, including Seattle Genetics and AstraZeneca, with the company differentiating itself through its Dolasynthen platform [73]