Rain Enhancement Technologies Holdco, Inc.

Good day, and welcome to the RAIN Therapeutics Second Quarter 2022 Earnings Conference Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Bob Yeti. Please go ahead.

Thank you, Operator, and good afternoon, everyone. With me today on the call are Avinash Balanki, Chief Executive Officer of RAIN Therapeutics, Nelson Kabat-Juan, SVP of Finance. During today's call, Avanesh will provide an overall business update, including RAINN's clinical programs and research efforts, and Nelson will review the financials. Before we begin, I'd 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 RAINN's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results may differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, as described in RAINN's annual report on Form 10-K for the year ended December 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, August 4th, 2022. RAINN 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 said, it's my pleasure to turn the call over to Avinash Belanki. CEO of Varian Therapeutics. Abhinish.

Thank you, Bob. And thanks to everyone for joining us for our second quarter earnings call. We are pleased to share updates today on our two ongoing clinical trials, the Mantra Phase 3 Registrational Trial in patients with liposarcoma and the Mantra 2 Tumor Agnostic Basket Trial in advanced solid tumor patients exhibiting MDM2 gene amplification. We're going to have a different format on this call with prepared remarks from myself and Nelson Kabatouan, Reign Senior Vice President of Finance, and then move more quickly to Q&A, where we'll be joined by our President and Chief Scientific Officer, Dr. Bob Doble, and our Chief Medical Officer, Dr. Richard Bryce. First and foremost, we announced earlier this morning that we had completed enrollment in the Phase III MONTRA trial in patients with well-differentiated, de-differentiated liposarcoma. As of the end of July, we completed enrollment with 175 patients, exceeding our 160 patient target, and five months ahead of our prior year-end guidance. We saw a clear acceleration of enrollment since our update call at the end of the first quarter of this year, at which point we announced we were approximately half enrolled. We believe this speaks to the tremendous unmet need in patients with de-differentiated liposarcoma, for which milidimetan offers a targeted therapeutic strategy relative to standard cytotoxic options. We enrolled across 70 international sites in the U.S., Europe, and Asia. As a reminder, this pivotal trial compares milidimetan monotherapy to the approved agent yondelus or trebectodine. Melodematin was dosed at 260 milligrams daily for three days, followed by 11 days off therapy. We refer to this as the three out of 14 day schedule. We anticipate top line data from this trial in the first half of 2023. We also anticipate that if the mantra data are supportive, we would submit an NDA for melodematin and liposarcoma in the U.S. with similar submissions in Europe and possibly other regions as well. Second, our Phase II tumor-agnostic MONTRA-2 trial is progressing as planned, with 11 sites activated in the U.S. to date and additional just-in-time sites opening as necessary from referrals from the TEMPEST and CARIS genomic testing services. To recap, this trial is evaluating milidimetan in multiple solid tumor types in patients with P53 wild-type tumors that exhibit high MDM2 gene amplification at a copy number of 12 or greater. We anticipate enrolling approximately 65 patients across a range of solid tumors and using the same dosing regimen as in the registration mantra trial and continue to anticipate interim data of the first 10 valuable patients in the fourth quarter of this year. We continue to anticipate commencing two additional trials before year end. both the MONTRA-3 trial in Merkel cell carcinoma and the MONTRA-4 trial evaluating the combination of milidimetan with a checkpoint inhibitor, which is a tezolizumab, in patients with p53 wild-type advanced solid tumors that exhibit loss of the gene CDKN2A. Also, at the recent annual ASCO meeting, we presented preclinical data detailing the rationale for the MONTRA-4 trial. New preclinical data across multiple in vivo tumor models with CDK N2A loss and wild type P53 supported potential synergy of milodimetan and an immune checkpoint inhibitor in this genetic subset. We remain very excited about the potential for the MONTRA4 trial and its strategy. With that, I'd like to turn it over to Nelson to review our financial results. Nelson?