Financial Data and Key Metrics Changes - The company ended Q3 2019 with $112 million in cash, cash equivalents, and marketable securities, having used net cash of $16.3 million in operations during the quarter [29] - Net loss for Q3 2019 was $16.8 million or $0.35 per share, compared to a net loss of $17.1 million or $0.74 per share for the same period in 2018 [31] - Collaboration revenue for Q3 2019 was approximately $0.8 million, down from $2.2 million in Q3 2018, primarily due to a decrease in services performed in support of partners' programs [30] Business Line Data and Key Metrics Changes - Research and development expenses for Q3 2019 were approximately $13.7 million, down from $15.2 million in Q3 2018, driven by a decrease in manufacturing costs for XMT-1536 and XMT-1522 [30] - General and administrative expenses remained flat at $4.4 million compared to the same period in 2018 [31] Market Data and Key Metrics Changes - The company noted substantial interest in pursuing accelerated registration strategies for XMT-1536 based on discussions with investigators and emerging profiles [28] - Data presented at ESMO indicated a potential paradigm shift in the standard of care for first-line ovarian cancer, increasing the need for new mechanisms of action in later lines and platinum-resistant patients [26] Company Strategy and Development Direction - Mersana is focused on achieving proof-of-concept in multiple data readouts in 2020, with plans to report data from the full dose escalation portion of the XMT-1536 study and early data from ovarian and lung cohorts [33] - The company aims to file an IND and enter the clinic with its next ADC candidate in the first half of 2020, while also strengthening its discovery pipeline [34] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the continued safety and efficacy profile of XMT-1536, indicating that 2020 will be a data-rich year with multiple potential inflection points [10][33] - The company is well-capitalized to execute its plans through mid-2021, with a cash balance of $112 million [35] Other Important Information - The company is leveraging its Dolaflexin, Dolasynthen, and Immunosynthen platforms to build a robust discovery pipeline for mid- to long-term growth [12] - The ongoing expansion study for XMT-1536 is evaluating patients with platinum-resistant ovarian cancer and NSCLC adenocarcinoma, with strong investigator interest and rapid site initiation [16] Q&A Session Summary Question: What is the experience at the 30 and 36 mg/m² cohorts? - The experience has been positive, with patients staying on study for extended periods and efficacy observed in doses between 20 and up [43] Question: Are there any durable responses beyond 4 months? - Management pointed to the ASCO poster as the last data disclosure, with plans to disclose full dose escalation and expansion datasets in 2020 [45] Question: What are the thoughts on the diagnostic and utilization in the ongoing expansion cohort? - A robust diagnostic has been developed and validated, being used in expansion cohorts to collect data on tissue expression levels [46] Question: Is the pharmacokinetic profile dose proportional? - Yes, the pharmacokinetic profile is dose proportional, with no accumulation observed over the current dosing schedule [48] Question: What is the pace of enrollment in the expansion study? - Enrollment is going very well, with the number of sites initiated ahead of schedule due to investigator enthusiasm [57]
Mersana Therapeutics(MRSN) - 2019 Q3 - Earnings Call Transcript