Anticipation Builds For Rain Oncology's Phase 3 MANTRA Trial Results, Analyst Sees Promise

  • In early March, in its Q4 earnings releaseRain Oncology Inc RAIN announced that the topline data from its Phase 3 (MANTRA) trial of milademetan (MDM2 inhibitor) vs. Yondelis (trabectedin) in liposarcoma would be delayed by a quarter, with a primary endpoint (progression-free survival, or PFS) readout now slated to occur imminently this quarter. 
  • Earlier data readout was expected in Q1 of 2023.
  • HC Wainwright says this is favorable, as the delay in reaching the required number (105) of PFS events could indicate that the active arm performed well. The analyst reiterates the Buy rating with a price target of $19.
  • The analyst estimates about three months of PFS for the control arm. 
  • The MANTRA trial finished enrolling 175 patients in July 2022, and in its Q1 earnings release, it announced that the required number of PFS events has been reached. PFS data release in 2Q23 suggests at least eight months between the last patient enrolled and the readout. 
  • The analyst notes that milademetan previously achieved a 7.4- month PFS duration in a Phase 1 trial in liposarcoma patients, more than double the PFS rate for standard-of-care therapies, providing another reason to expect positive results. 
  • Assuming positive data from the MANTRA trial, the competition might need to improve upon the benchmark set by Rain Oncology, writes the analyst.
  • Rain had $109.8 million in cash, cash equivalents, and short-term investments in Q1. But the company did not provide guidance on the cash runway. It is assessing its cash runway and might provide some update after the MANTRA topline results.
  • Price Action: RAIN shares are down 5.28% at $8.79 on the last check Friday.
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