Mersana Therapeutics(MRSN) - 2022 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended the quarter with $290 million in cash, cash equivalents, and marketable securities, with an additional $35 million available through a line of credit [19] - Collaboration revenue for Q3 2022 was $5.6 million, a significant increase from an immaterial amount in the same period of 2021, attributed to agreements with Janssen and GSK [21] - Research and Development expenses for Q3 2022 were $50.6 million, up from $35.3 million in Q3 2021, driven by costs related to UpRi antibody manufacturing and increased clinical costs [22] - General and Administrative expenses for Q3 2022 were $14.6 million, compared to $10.1 million in Q3 2021, primarily due to increased consulting fees and headcount [23] - The net loss for Q3 2022 was $59.8 million, or $0.61 per share, compared to a net loss of $45.5 million, or $0.63 per share in Q3 2021 [23][24] Business Line Data and Key Metrics Changes - The UPLIFT trial in platinum-resistant ovarian cancer was fully enrolled within one year, with approximately 270 patients enrolled, exceeding initial targets [7][13] - The UP-NEXT trial is currently enrolling patients with NaPi2b-positive tumors, aiming for approximately 350 patients worldwide [14] - The company has initiated a Phase 1 trial for XMT-1660, targeting B7-H4 in various cancers, and expects to begin patient dosing for XMT-2056 later this quarter [10][18] Market Data and Key Metrics Changes - The company noted a significant unmet need in the platinum-sensitive recurrent space, with ongoing excitement from investigators regarding additional treatment options [42] - The prevalence of NaPi2b high patients is substantial, with data indicating 59% to 64% of patients in relevant studies [48] Company Strategy and Development Direction - The company aims to leverage its differentiated platforms for expanding its pipeline through collaborations, as demonstrated by recent agreements with Janssen and GSK [10][20] - The focus remains on advancing clinical trials and generating data, with expectations for a transformative 2023 highlighted by potential BLA submissions [11][25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress made across key areas, including the completion of enrollment in UPLIFT and the initiation of new clinical trials [11][25] - The company anticipates a robust top-line data readout in mid-2023, with potential BLA submission by the end of next year [8][11] Other Important Information - The company received Fast Track designation from the FDA for XMT-1660 for treating advanced or metastatic triple-negative breast cancer [10] - The management emphasized the importance of collaborations as a core part of the company's strategy moving forward [11][20] Q&A Session Summary Question: Clarification on UPLIFT study enrollment - Management confirmed that the minimum target number of NaPi2b-positive patients has been exceeded, with ongoing evaluations for full patient numbers [28] Question: Safety data in UPGRADE study - Management indicated that safety data from the 12 enrolled patients is encouraging, but more robust data will be shared later [30] Question: Success criteria for UPLIFT trial - The success bar is based on overall response rate (ORR) compared to single-agent chemotherapy, with a maximum response rate of 12% [32] Question: Dose levels in UPGRADE study - Multiple dose levels have been evaluated, with plans to initiate expansion cohorts in Q1 of the following year [33] Question: Biomarker strategy for 1660 study - The strategy includes evaluating B7-H4 expression while enrolling patients across various cancer types [34] Question: Rationale for UP-NEXT dosing - A lower dose of 30 mg/m² was selected to optimize disease control in the maintenance setting [37] Question: Interest in NaPi2b high patients - NaPi2b is highly expressed in ovarian cancer, and the company aims to optimize the treatment profile based on this expression [41] Question: Enrollment trends in UP-NEXT - There is excitement among investigators for the UP-NEXT trial, driven by the unmet need in the platinum-sensitive recurrent space [42] Question: FDA perspective on UPLIFT trial endpoints - Sufficient benefit must be demonstrated in both NaPi2b high and low populations to support a broad indication [46] Question: Commercial targeting based on NaPi2b status - The prevalence of NaPi2b high patients is significant, indicating potential benefits for a large portion of the platinum-resistant ovarian cancer population [48]