Rain Enhancement Technologies Holdco, Inc.

Greetings and welcome to the RAIN Therapeutics Third Quarter Earnings Conference 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 zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry with LifeSci Advisors. Please go ahead.

Thank you, Operator. and good afternoon. With me today on the phone are Avinish Valanki, Chief Executive Officer of RAIN Therapeutics, Robert Doble, Chief Scientific Officer, Richard Bryce, Chief Medical Officer, and Nelson Cabotuan, SVP of Finance. During today's call, Avinish will provide an overall business update. Bob will review the interim Mantra 2 data. Richard will provide an update on RAIN's clinical programs. 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 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, November 10th, 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, Dan, and thanks to everyone for joining us for our third quarter earnings update. The team at RAIN continues to drive forward our lead late-stage clinical program, meledimetan, our oral small molecule inhibitor of the P53 MDM2 complex. Again, you may hear us refer to meledimetan as MILA to be brief. We were excited to release the early data for MILA from our second study called the Mantra 2 study last week, and we look forward to sharing a few additional insights from that trial on today's call. We will also share updates on our other ongoing and planned MILA trials, including some notable changes to our guidance initially discussed as part of our revised corporate presentation and 8K filing last week. We also remind you that we announced a $50 million registered offering last week, concurrent with the release of the early Mantra 2 data. With this additional capital, RAIN's cash position is even stronger, now providing a cash runway well into 2025. We're excited to welcome several new large healthcare-focused funds to RAIN as part of that financing. Let me start with our revised corporate guidance before turning to Mantra 2. First and foremost, we're getting closer to the release of results from our pivotal mantra trial, the registrational phase three study of Mila in patients with specific subtypes of liposarcoma. We completed enrollment with 175 patients in July of this year, and we can now refine our guidance for top line data to the first quarter of 2023 or next quarter from the prior guidance of the first half of 2023. Second, we previously stated our interest to pursue Merkel cell carcinoma as an indication with meledimetan, and we're aiming to start a new study there called the Mantra 3 study. However, while we continue to remain convinced of the opportunity for MDM2 inhibition in Merkel cell, we now intend to prioritize other larger market opportunities in our ongoing efforts to be very prudent with cash and personnel management, and therefore we do not intend to pursue the Mantra 3 study. Our priority is to ensure operational execution and the highest ROI indications for the milodimetan franchise. In light of those priorities, the Mantra 4 trial is certainly a priority for RAIN, and we expect to start that trial next quarter. The size of the Mantra 4 target patient population is materially large, and we're very excited about the science there. Therefore, you'll notice that after RAIN's initial indication for mila and liposarcoma tumors, which exhibit genetic uniformity and driven by where the initial data existed at the time of licensing the program, both of our other near-term priority indications represent large market tumor agnostic basket trials, the MDM2 amplified Mantra 2 study and the CDKN2A loss Mantra 4 study. This is very much consistent with our focus on a precision strategy at RAINN. Finally, I want to come back to the preliminary insights from the MONTRA2 phase two tumor agnostic trial released last week. Bob will comment in more detail shortly, but let me first provide our high level views. We noted clear monotherapy activity with two early unconfirmed partial responses and two other patients with early tumor regressions nearing the PR threshold in a study that was the first to evaluate MDM2 amplification as a patient selection strategy. There have already been several observations from this study, including, first, safety has thus far been consistent with the prior phase one study. And recall, a major reason for our licensing of this program was because we felt MeLa possessed an optimized dosing schedule that may meaningfully improve its therapeutic index to enable its use as a single agent and in future combinations with various other agents. This is how we intend to grow the value of this franchise. There were no surprise findings to us from the early Mantra 2 safety set. Second, we are starting to receive some early insight on tumor kinetics with the MDM2 protein-protein interaction inhibitors that was more unclear before. We anticipated responses might be more gradual with the PPI versus what we've historically seen for the TKI class. Time will tell if we can identify a pattern between early responders versus patients that may take a longer time to achieve a response. And lastly, MDM2 inhibition with milodimetan appeared to show initial activity both in patients with other genetic co-alterations and in patients with a significant number of prior therapies. These were all very encouraging early observations from Mantra 2. At RAINN, we remain very excited about the continued progress of our milodimetan program and are looking forward to the Phase III pivotal data for myelin liposarcoma next quarter. With that, I'd like to turn it over to our President and Chief Scientific Officer, Dr. Bob Doble. Bob?