Mersana Therapeutics(MRSN) - 2023 Q1 - Earnings Call Transcript

Financial Data and Key Metrics Changes - The company ended Q1 2023 with approximately $274 million in cash, cash equivalents, and marketable securities, and has a line of credit available [5] - General and administrative expenses for Q1 2023 were $18.3 million, up from $12.8 million in Q1 2022, primarily due to increases in medical affairs and pre-commercial activities [6] - Net loss for Q1 2023 was $56.2 million compared to a net loss of $47.3 million for the same period in 2022 [6] - Research and development expenses for Q1 2023 were $47.3 million, compared to $35.8 million in Q1 2022, driven by higher manufacturing and clinical costs related to UpRi [81] Business Line Data and Key Metrics Changes - The UPLIFT trial is a single-arm registration trial in platinum-resistant ovarian cancer, with rapid enrollment of approximately 270 patients [57] - The UPGRADE-A trial is a Phase 1 combination trial of UpRi with carboplatin, which has completed dose escalation and is moving into dose expansion [62] Market Data and Key Metrics Changes - The company is focusing on the unmet medical need in platinum-resistant ovarian cancer, with a significant patient population that is heavily pretreated [57][60] - The UPLIFT trial aims to exclude the 12% objective response rate for single-agent chemotherapy from the 95% confidence interval, indicating a high bar for efficacy [61] Company Strategy and Development Direction - The company is positioning UpRi as a foundational medicine for ovarian cancer, with plans for potential commercialization following topline data readout and a BLA submission [58][71] - The strategy includes establishing partnerships for UpRi in Europe and other regions globally, recognizing the concentrated nature of the European market [24][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the robust activity seen in the expansion cohort of UpRi and the significant unmet medical need for new agents in ovarian cancer [87] - The company anticipates sharing topline data from the UPLIFT trial mid-year, with a potential BLA submission planned for around the end of the year [82] Other Important Information - The company is working to ensure that diagnostic tests are available on day one of product launch, emphasizing the importance of NaPi2b as a biomarker [121] - The FDA placed a clinical hold on the Phase 1 trial of XMT-2056 due to a serious adverse event, which the company is addressing [103] Q&A Session Summary Question: How does the recent MIRASOL results impact your thinking on the UpRi opportunity and strategy? - Management indicated that they expect to complete dose escalation by the end of the year and are excited about the program, viewing it as a great target for an ADC [11] Question: Will you report data in the overall patient population for the UPLIFT readout? - Management confirmed that they expect to share data not only in the NaPi2b positive population but also in the overall population as a key secondary endpoint [91] Question: What are your expectations for the UPGRADE-A data? - The primary focus will be on safety, with efficacy data presented as available, recognizing that safety is the primary concern in a Phase 1 study [113]