Rain Enhancement Technologies Holdco, Inc.

Greetings and welcome to the RAINN Oncology, Inc. First Quarter 2023 Earnings Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star then zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry. Thank you. Dan, you might begin.

Thank you, operator, and good afternoon, everyone. With me today on the phone are Avinash Vellanki, Chief Executive Officer of RAIN Oncology, Dr. Robert Doble, Chief Scientific Officer, Dr. Richard Bryce, Chief Medical Officer, and Nelson Caviton, SVP of Finance. During today's call, Avinash will provide an update on the broader strategic vision for the Milidemetan franchise. Bob will review the biology and rationale of P53 reactivation and discuss possibilities for future clinical development of Milidemetan based on non-clinical research. Richard will provide an update on RAIN's clinical strategy, and Nelson will review the financials. Before we begin, I would like to remind you that statements made during this conference call that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon RAIN's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements, as a result of various risks and uncertainties as described in RAIN's most recent quarterly reports on Form 10-Q filed with the Securities and Exchange Commission and other SEC filings. All forward-looking statements made during this conference call are based on management's assumptions in estimates as of today, May 11, 2023. RAIN undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after today, except as required by law. With that, I'd like to turn the call over to Avinash Malaki, CEO of Rain Oncology. Avinash?

Thank you, Dan, and thanks to everyone for joining us for our first quarter 2023 earnings highlights and corporate update. As Rain continues to drive forward with our late-stage clinical program, Milidemetan, or Mila, our oral small molecule inhibitor of the MDM2-P53 complex, We know this is a very important quarter for the company. I'm happy to report that we have achieved the required number of events to trigger the analysis of the primary endpoint in the Global Phase 3 Registrational Study for Melodematan, or the Mantra Study. And therefore, we continue to expect the release of top-line data this quarter. We are very proud of the team at RAINN who showed a small company could take a Phase 1 program jump into a robust global registrational phase three trial and aggressively enroll ahead of schedule. In building a capital-efficient business, these capabilities are prerequisites. We hope we get the results we're looking for to enable a potential solution for cancer patients with an unmet medical need. For me, this embodies the vision we had of being a biotech that exudes urgency and the financial prudence to innovate in this very challenging business of bringing forth new drugs to market. We hope the MONTRA study provides a new solution for patients with dedifferentiated liposarcoma, or DDLPS. But further, we hope milodimutantin demonstrates how P53 reactivation could be impactful in treating a broad range of cancer patients. If the MONTRA top-line data are favorable, we believe it will signify that reactivation of P53 matters in cancer. This will be an important validation as we begin to think about our initiatives beyond DDLPS. We've already begun this work with ongoing and imminent planned studies to evaluate Milla across several tumor types in the Mantra 2 and upcoming Mantra 4 trials. Mechanistically, p53 is supposed to protect us from developing cancer. Today, there are no approved therapies in the treatment of cancers that are aimed at restoring or reactivating this innate anti-cancer agent. There are a multitude of potential indications to be considered with an effective strategy to restore p53, especially if the tolerability profile of Mila enables a wide-ranging set of combination partners. Bob and Richard will review some of our recent progress and plan next steps with the Melodemitan franchise. Our cash position at the end of the first quarter provides ample runway to complete all current ongoing and planned clinical trials in Melodematam. This includes the completion of the ongoing Phase II Montra II basket trial, which continues to enroll across tumor types, and the planned Phase I-II Montra IV basket trial, which is on track to start by mid-year, all on top of the pivotal Montra study. With that, I'd like to turn it over to our President and Chief Scientific Officer, Dr. Bob Doble. Bob?