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8/10/2023
Good afternoon, ladies and gentlemen, and welcome to the Reign Oncology, Inc. Second Quarter 2023 Earnings Conference Call. At this time, all lines are in listen-only mode, and following the presentation, we will conduct a question-and-answer session. If at any time during the call you require immediate assistance, please press star zero for the operator. This call is being recorded on Thursday, August 10, 2023. I would now like to turn the conference call over to Mr. Dan Barry of LifeSci Advisors, please go ahead.
Thank you, Operator, and good afternoon, everyone. With me today on the phone is Avinash Valenki, Chief Executive Officer of Raid Oncology, and Nelson Cabochon, Acting SVP of Finance. Following the call, Dr. Robert Doble, Chief Scientific Officer and Chief Medical Officer, will be joining Avinash and Nelson for a short Q&A. Earlier today, RAINN issued a news release announcing the company's results for the second quarter of 2023. Copies of this news release and SEC filings can be found in the Investors section of our website. Full details on updates from the quarter can be found in our news release and 10-Q issued today. 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 RAINN's current expectations and involve assumptions that may never materialize or may prove to be incorrect. Action 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 most recent quarterly reports on Form 10-Q and annual report on Form 10-K 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, August 10, 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 Valunkey, CEO of RAIN Oncology. Avinash?
Thank you, Dan, and thanks to everyone for joining us for our second quarter 2023 earnings call. The second quarter was an important time at Wayne Oncology as we provided the top-line data readout on our Phase III global registrational trial for milodontan, our oral small molecule inhibitor of the MDM2-P53 complex in dedifferentiated liposarcoma, or DD-LPS. We reported that the phase three trial for milodimetan did not meet its primary endpoint. We also announced that we would suspend the enrollment of our second clinical study, the Mantra 2 study. We have begun the process of closing down Mantra 2. Despite what we feel is very clear activity from the Mantra 2 study, we do not feel its monotherapy activity rises to a level sufficient for registrational purposes. The closure of this study will ensure we remain judicious with our use of capital. We hope to present final data from the Mantra Phase 3 study and updated data from the Mantra 2 Phase 2 study of milodimetan in MDM2-amplified solid tumor patients in the fourth quarter of this year. We note the Mantra 2 presentation will reflect a significant number of additional patients beyond what was presented last year. We continue to believe that reactivating p53 is an important therapeutic strategy to add to the armamentarium of the anti-cancer therapies. At RAINN, we're proud that we were able to move as quickly as we did to test the hypothesis in a robust trial, as we did for a global phase three study, despite the results not being what we had hoped. Given these top line data for milodermatin, we determined that RAINN would be best positioned to achieve its business objectives by taking action to streamline operations, reprioritize its activities, and implement certain cost saving measures, including a reduction in force. We will implement those actions very quickly, resulting in substantial moderation of cash burn that will be apparent in the third quarter and beyond. Looking forward, we believe there are exciting opportunities ahead. It is no surprise that the challenging climate in biotech over the last few years has resulted in a number of interesting programs, companies, and technologies being underfinanced and often without strong cross-departmental leadership. Our corporate development team has been rapidly reviewing an extraordinary number of actionable opportunities to license or acquire clinical stage programs and technologies that may allow RAIN to continue to try to make a difference for cancer patients. Although we won't comment on programs under diligence, there are a number of opportunities that could be a great fit for RAINN with fascinating technology and novel therapeutic strategies for patients. We will update investors when appropriate on how we intend to push forward to add value for our shareholders. Let me now hand it over to Nelson Tabatouan to discuss our financials. Nelson?
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