Financial Data and Key Metrics Changes - The company ended Q1 2021 with $228 million in cash and cash equivalents, with a net cash used in operating activities of $27 million [51] - Research and development expenses for Q1 2021 were approximately $27.4 million, up from $12.2 million in the same period in 2020, primarily due to increased manufacturing and clinical expenses [52] - General and administrative expenses for Q1 2021 were approximately $7.2 million, compared to $4.9 million in the same period in 2020, driven by increased headcount and consulting fees [53] - The net loss for Q1 2021 was $34.7 million or $0.50 per share, compared to a net loss of $16.9 million or $0.35 per share for the same period in 2020 [55] Business Line Data and Key Metrics Changes - The UpRi Phase 1 study in ovarian cancer showed a response rate of approximately 30%, significantly above the current standard of care [13] - The UPLIFT study has initiated patient dosing, focusing on a broader patient population and allowing for flexible inclusion criteria [15][16] - The UpRi lung adenocarcinoma expansion cohort continues to enroll patients, with a goal of approximately 40 to 45 patients this year [24] Market Data and Key Metrics Changes - The prevalence of NaPi2b high in the lung adenocarcinoma outpatient group is lower than in ovarian cancer, with about one-third of patients having high NaPi2b expression [65] - The company plans to disclose data from the UpRi lung adenocarcinoma cohort in the second half of the year [65] Company Strategy and Development Direction - The company aims to establish UpRi as a foundational medicine in ovarian cancer and expand its innovative ADC pipeline [57] - The UPGRADE study is designed to evaluate UpRi in combination with other therapies, with plans to initiate patient dosing in Q3 2021 [30][23] - The company is advancing two early-stage candidates, XMT-1660 and XMT-2056, through IND-enabling studies, with clinical studies expected to start in early 2022 [26][38] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about robust enrollment in the UPLIFT study, leveraging the momentum from the expansion cohort [62] - The company acknowledges the potential impact of COVID-19 on clinical trials but remains confident in its enrollment strategies [62][64] - Management highlighted the significant unmet medical need in ovarian cancer and the commitment to improving patient outcomes [58] Other Important Information - The company has developed a robust diagnostic assay for NaPi2b expression, which will be validated in the UPLIFT study [100] - The relationship with Leica for the diagnostic development is not exclusive, allowing for potential future partnerships [105] Q&A Session Summary Question: Impact of COVID-19 on UpRi clinical trials - Management reported robust enrollment in the expansion cohort and is optimistic about UPLIFT due to broad inclusion criteria and partnerships with cooperative groups [62][64] Question: Investor expectations for UpRi and XMT-1592 readouts - The company is on track to enroll 40 to 45 lung adenocarcinoma patients and disclose data in the second half of the year [65] Question: Relation between NaPi2b expression and duration of response - Management noted consistency in NaPi2b expression levels and potential for enrichment of objective response rates based on expression levels [72] Question: Bevacizumab's role in UPGRADE study - Management clarified that the study is initially combining UpRi with carboplatin, with potential for future combinations including bevacizumab [77] Question: Enrollment dynamics for lung cancer cohort - Management acknowledged previous delays due to COVID-19 but is now on track to recruit the targeted number of patients [86] Question: Dose escalation strategy for XMT-1592 - Management stated that comprehensive data will be disclosed in the second half of the year, maintaining a disciplined approach to data sharing [88] Question: Validation of the diagnostic assay - Management outlined plans to validate the diagnostic assay using the UPLIFT cohort, with potential for a complementary or companion diagnostic [102]
Mersana Therapeutics(MRSN) - 2021 Q1 - Earnings Call Transcript