Rain Enhancement Technologies Holdco, Inc.

Your conference call shall begin momentarily. Again, thank you for saying goodbye. Your conference call shall begin momentarily. Thank you. Thank you. Thank you for standing by, and welcome to the Reign Therapeutics Third Quarter 2021 Financial Results Conference Call. At this time, all participants are on a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question at that time, please press star then 1 on your touchstone telephone. As a reminder, today's conference call is being recorded. I will now turn the conference over to your host, Mr. Bob Yedit, for you may begin.

Thank you, Operator, and good afternoon, everyone. With me today on the phone are Avinash Valanki, Chief Executive Officer, Robert Doble, Chief Scientific Officer, Richard Bryce, Chief Medical Officer, and Nelson Kabat-Toon, Senior Vice President of Finance. During today's call, Avinash will provide an overall business update. Richard will provide an update on Rand's clinical program. Bob will provide an update on research efforts. And Nelson will review the financials. Before we begin, I'd like to remind you that statements 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 on RAINN's current expectations and involve assumptions that may never materialize or prove to be correct. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties as described in RAINN's quarterly report on Form 10-Q for the quarter ended March 31, 2021. and subsequent filings with the Securities and Exchange Commission. All forward-looking statements made during this conference call are based on management's assumptions and estimates as of today, November 10th. RAINN undertakes an obligation to update such statements to reflect events that may occur or circumstances that exist after today, except as required by law. With that, it's my pleasure to turn the call over to nomination Filanki, CEO of RAINN. Avinish?

Thank you, Bob, and thanks to everyone for joining us for our third quarter earnings call. As a matter of principle for these earnings calls, we're going to make it standard practice to be very brief, and we'll leave it to the Q&A to address the details that are of the most interest. In this most recent quarter and since the end of the third quarter, RAINN continues to advance the Mila Demetan and RAD 52 programs forward. As a reminder, we'll continue to refer to milodimetan as MILA wherever appropriate. First and foremost, our phase three trial, the Mantra study for MILA in patients with liposarcoma is proceeding according to plan with sites being activated on a regular basis around the world. As a potential registration enabling study, there is no interim read with final data anticipated in 2023. Richard will provide some more color here. Second, we also expect to dose our first patient in the Phase 2 tumor-agnostic Mantra 2 study shortly, and we'll announce that when it happens. This trial will evaluate Mila in a tumor-agnostic signal-finding basket study across 65 patients in the U.S. with solid tumors that exhibit a certain threshold of MDM2 gene amplification. We expect to provide an interim update for Mantra 2 in the second half of next year. Third, we announced that we will reprioritize our clinical strategy for our third planned study towards Merkel cell carcinoma, replacing our prior planned study of intimal sarcoma. This new trial will be called Mantra 3. The decision to prioritize Merkel cell was made for three key reasons. One, new non-clinical data presented by the Dana-Farber Cancer Institute demonstrating compelling efficacy for meledematans. which already adds to the biologic rationale that many Merkel cell tumors are MDM2 dependent. Two, we note there's already been presented signs of activity with MDM2 inhibition in Merkel cell from other MDM2 inhibitor programs. And three, the larger addressable market size of Merkel cell as compared to intimal sarcoma, hence representing the most appropriate use of our financial resources. Based on the larger population of Merkel cell, faster projected patient accrual rates and an expected shorter trial duration, the new planned Merkel cell study has no significant impact on RAIN's cash runway. We expect Mantra 3 to enroll 34 patients in the U.S. in the second line or later settings amongst patients relapsed to checkpoint inhibitors, which is the standard of care in the front line. And we expect to start the study in the middle of 2022. Finally, we held an R&D day yesterday where we hosted several prominent key opinion leaders across various treatment specialties where we think MDM2 inhibition could be applied. Speakers included Dr. Wafiq El-Diri from Brown University, who many of you may know for his discovery of P21, Drs. Murnal Gounder and David Hong from Memorial Sloan Kettering and MD Anderson Cancer Centers, respectively, who will be participating in RAINN's first two clinical studies for MELF, and Drs. Glenn Hanna and James Sid Caprio from Dana-Farber for their expertise in Merkel cell carcinoma. We also included talks from Drs. Francois Clement Bedard and Silvia Stacchiati, who shed light on some additional clinical opportunities for MILA. Our strategy continues to be to focus our early effort on the most sensitive MDM2-dependent tumor types first, and will be followed by combination strategies to further enhance patient outcomes and other P53 wild-type cancers. We're very excited about the potential for a range of opportunities for Mila to have a meaningful impact on patient care. Last, the early preclinical workaround programs targeting RAD52 continues to move forward, and we expect to provide updates at future scientific symposia as appropriate. With that, I'd like to turn it over to our chief medical officer, Dr. Richard Bryce.