Lumos Pharma, Inc.

Good afternoon and welcome to Lumos Pharma's second quarter 2024 financial results and clinical programs update call. Currently, all participants are in a listen-only mode. Later, we will conduct a question and answer session, and instructions will follow at that time. As a reminder, this conference call is being recorded. I want to now turn the call over to Lisa Miller, Vice President of Investor Relations.

Thank you, Operator. Before we proceed with the call, I would like to remind everyone that certain statements made during this call are forward-looking statements under U.S. federal securities laws. These statements are subject to risks and uncertainties that could cause actual results to differ materially from historical experience or present expectations. Additional information concerning factors that could cause actual results to differ is contained in our periodic reports filed with SEC. The forward-looking statements made during this call can speak only as of the date hereof, and the company undertakes no obligation to update or revise the forward-looking statements. Information presented on this call is contained in the press release we issued this afternoon and in our Form 10Q and 8K, which may be accessed from the Investors Page of the Loomis Farmer website. Speaking on today's call will be Rick Hawkins, CEO and Chairman, John McHugh, President and Chief Scientific Officer, and Lori Lawley, Chief Financial Officer. Dr. Duke Patuptiwanand, our Chief Medical Officer, will also join the call for the question and answer section. It is now my pleasure to turn the call over to Rick for our opening remarks.

Thank you, Lisa, and good afternoon, everyone. I'm pleased to be speaking with you today to provide an update on our progress advancing Loom 201 as the first oral therapeutic for moderate pediatric growth hormone deficiency, or PGHD. During the second quarter and recent weeks, we've made significant progress in advancing our plans for a phase three pivotal trial of LIMB201 and PGHD. Following a very positive and productive end of phase two meeting with the FDA, we've nearly finalized our proposal for a phase three double-blinded placebo-controlled clinical trial with a two-to-one randomization in approximately 150 patients. The FDA's input has been instrumental in shaping our proposed trial design, acknowledging link 201's unique mechanism as a growth hormone secretagogue and recognizing that a placebo-controlled clinical trial is an appropriate approach for phase three. We expect to finalize the design details in the fourth quarter. Prior to our meeting with the FDA, we had not developed plans for manufacturing a placebo to match our patented form of LUM201. Now, with the decision to move forward with a placebo control phase three trial, additional time is required to complete the manufacturing process and create the placebo-matched materials necessary for use in the study. Consequently, extending our intended timeline to initiate phase three into the second quarter of 2025. And this extension also allows all of us to continue managing our cash resources and extend our cash runway. Additionally, in today's press release, we announced that we have engaged Piper Sandler to explore all strategic opportunities to maximize shareholder value and advance the Loom 201 platform. Our regular, ongoing business development activities have generated significant interest in the global potential for Loom 201 in multiple markets. Given this positive feedback, we felt it was the right time to formally engage Piper Sandler to ensure we're thoroughly exploring every potential transaction and opportunity that serves our shareholders' best interest. We're confident And Loom Tool wants potential as the first oral therapeutic in the expanding $5 billion global growth hormone market. We're going to continue to focus our efforts on optimizing value for all of our stakeholders. In a moment, Don and Laura are going to provide more details on this and other measures we're implementing to ensure we're well prepared to successfully initiate this trial next year. In the second quarter, we're pleased to see new analyses of data from our Orgo 212 trial presented at Endo 2024. The data emphasize the significance of the pulsatility pattern and growth hormone secretion for the growth response from LUM201. They further illustrate LUM201's unique ability to restore natural pulsatile growth hormone secretion, achieving similar to injectable recombinant growth hormone with significantly less exposure to circulating growth hormone. These findings strongly support our planned placebo control phase three trial of LUM201 in moderate PGHD. Top line results from the oral growth trial were presented at three major endocrinology conferences in May this year. At the Pediatric Endocrine Society meeting in Chicago, Dr. Andrew Dauber highlighted data showing that LUM201 at a dose of 1.6 mg per kg a day, achieved annually high velocity comparable to daily injectable growth hormone and PGHD with a promising safety profile. Meanwhile, at the Growth Hormone Research Society and the European Congress of Endocrinology, Dr. Peter Clayton presented detailed analysis of LUM201's effectiveness in restoring growth hormone secretion and increasing annualized height velocity in moderate PGSD patients. The evolving data from our oral growth trials continue to attract significant interest from the global endocrinology community. And we're encouraged by the growing enthusiasm from experts eager to participate in our phase three trial as we finalize our plans. Now I'm going to turn it over to John McHugh for more details on our engagement with the FDA and our phase three planning. John?