Rain Enhancement Technologies Holdco, Inc.

Today's conference is scheduled to begin shortly. Please continue to stand by and thank you for your patience. Thank you. Thank you. Thank you. Good day. And thank you for standing by. Welcome to the Business Highlights 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 during the session, you'll need to press star 1 on your telephone. Please be advised this call is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your host today, Christy Grabowski. Please go ahead.

Thank you, Operator, and good afternoon, everyone. With me today on the phone are Avinish Vallanki, Chief Executive Officer, Robert Doble, Chief Scientific Officer, Richard Bryce, Chief Medical Officer, and Nelson Kebatawan, Senior Vice President, Finance. During today's call, Avinish will provide an overall business update. Richard will provide an update on RAINN's clinical programs. 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 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. Factual 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 annual report on Form 10-K for the year ended December 31st, 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, March 3rd, 2022. 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 Valanki, CEO of RAIN Therapeutics. Avinash?

Thank you, Christy, and thanks to everyone for joining us for our fourth quarter earnings call. In this most recent quarter and since the end of 4Q, RAIN continues to advance the Melodematan program with two clinical trials currently active and enrolling. and two additional clinical trials planned. As a reminder, we may refer to milidimetan as Mila on occasion. 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. At the end of 2021, we exceeded the number of site activations that we had articulated as a goal and continue to be on pace for all sites to be up and running by the end of the first quarter of this year. 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, in November of 2021, we announced that the first patient had been dosed in the phase two tumor agnostic Mantra 2 study. This trial will evaluate MILA in a signal finding basket trial across approximately 65 patients in the U.S. with solid tumors that exhibit strong MDM2 gene amplification. We anticipate to reveal early data from this trial in the second half of this year. Third, we announced the Mantra 3 study in the fourth quarter and articulated that it will be focused on patients with Merkel cell carcinoma that test positive for the Merkel cell polyoma virus. The majority or up to 80% of Merkel cell carcinomas are induced by a virus. This virus induces MDM2 protein overexpression and is P53 wild type. We'll enroll second line patients relapsing to checkpoint inhibitors where there is an immense unmet need. We now anticipate this trial to start in the second half of this year, gated upon progress of our first two trials so that we may better control the timing of expenses as we strive to maintain our fiscal prudence. Finally, for our fourth trial for meledimetan, which we are calling the Mantra 4 study, Ray intends to combine meledimetan with Roche's PD-L1 monoclonal antibody atezolizumab in our first combination trial. This initial combination trial has a goal of confirming an appropriate combinatorial dose for the two agents and evaluate the safety, tolerability, and efficacy of this combination in a cancer population that could exceed 35,000 patients per year in the U.S. The MONTRA-4 study will represent another tumor-agnostic basket trial, this time in patients with P53 wild-type cancers that have lost function of the gene CDKN2A. The Mantra 4 study is anticipated to commence in the second half of this year. We also held an R&D day in November of 2021, which featured several key opinion leaders in oncology, along with members of RAIN's management team, who discussed the company's R&D program, as well as select clinical and preclinical data. We encourage interested parties to review the materials on our website. While we continue to focus on the most sensitive MgA2-dependent cancers, and have outlined four distinct strategies for milodimetan, it's perhaps key to emphasize that our cash balance is sufficient to complete all of these trials and should help inform the best manner to deploy future investment into the milodimetan franchise. We're very excited about the potential for a range of opportunities for Mila having a meaningful impact on patient care. Regarding our research program for inhibitors of RAD52, the preclinical work continues to move forward and we're very excited to note substantial improvements in both potency and selectivity of rain-generated compounds versus the initial set of compounds we acquired from our licensing efforts. However, in order to prioritize our resources on the Melodematan clinical trials to ensure ample cash cushion for the key data inflection points, And in light of what the BATCA capital markets have been doing, we will moderate the pace of expansion for the RAD52 effort. We plan to update investors on next steps for this program as details become available. With that, I'd like to turn it over to our Chief Medical Officer, Dr. Richard Rice.