Lumos Pharma, Inc.

Good afternoon, and welcome to Lomas Parma 2023 fourth quarter and year-end conference call. Currently, all participants are on a listen-only mode. Later, we will conduct a question-and-answer session, and instructions will follow that time. As a reminder, this conference call is being recorded. I will now turn the call over to Lisa Miller, Vice President of Investor Relations. Please go ahead.

Thank you, Operator. Before we proceed with this call, I'd 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 the SEC. The forward-looking statements made during this call 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 10-K, which may be accessed from the investors' page of the company's website. Speaking on today's call will be Rick Hawkins, CEO and Chairman, John McHugh, our President and Chief Scientific Officer, Dr. Duke Patukchwanan, Chief Medical Officer, and Lori Lawley, our Chief Financial Officer. Following our prepared remarks, the management team will be available for a question and answer session. I will now turn the call over to Rick.

Thank you, Lisa, and good afternoon, everyone. After the market closed today, we issued a press release announcing our results for 2023. I'm pleased to report that 2023 was a successful year for Lumos, led by our announcement of positive top-line results from our Oral Growth 210 and Oral Growth 212 trials of LUM201 in pediatric growth hormone deficiency. On today's call, we'll briefly summarize our trial results and other progress made in 2020 to recap highlights for recent weeks and layout plans for 2024. Then we'll be happy to answer your questions. Before I begin, I'd like to take a moment to congratulate Dr. Peset Duke Pichakchewana on his recent promotion to the role of Chief Medical Officer for Lumos. Dr. Duke's exceptional credentials are widely acknowledged, given his renowned expertise in growth disorders and his current leadership at the Human Growth Foundation, among various other distinguished roles in his esteemed career. Since joining us in 2022, Dr. Duke played a pivotal role in steering our oral growth trials to fruition, providing invaluable guidance, leveraging his influential network for enrollment, and significantly contributing to analysis of trial data. As our new CMO, Dr. Duke will continue to advocate for exploration of LUM201 within the PGSD clinical community, a mission that has already garnered remarkable interest from pediatric endocrinologists globally, thanks to his advocacy efforts. Furthermore, Dr. Duke will be an integral part of shaping the trial design for a Pivotal Loom 201 trial in PGHD, details of which we're going to delve into later during this call. Dr. Duke will be joining the call today for our Q&A session. So please join me in congratulating him on his well-deserved promotion. Let's now revisit the key highlights of the results we disclosed last November. As many of you are aware, Loom 201 has successfully met all primary and secondary endpoints in both Wargrove trials, demonstrating clear proof of concept for its efficacy as an oral alternative to daily and weekly injectables for patients with PGHD. Results from Wargrove 210 demonstrated that the 1.6 mg per kg dose of Loom 201 achieved annualized high velocities, or AHVs, of 8.2 centimeters a year at six months, and 8 centimeters a year at 12 months, aligning consistently with historical growth rates for the moderate PGSD population. The difference in AHV at 6 and 12 months between the optimal 1.6 mg per kg LUM201 dose and the recombinant growth hormone comparator arm fell within the non-inferiority margin of less than 2 centimeters a year, and that's a criterion recently used for FDA approvals. Although oral growth 210 was not specifically designed to establish non-inferiority, we are pleased to note that the growth outcomes observed in this study are in line with the non-inferiority thresholds seen in recent successful FDA applications. These findings enable us to design a successful phase 3 trial to show non-inferiority against the daily injectable growth hormone comparator arms. Now, the preliminary 24 months of the 201 data we presented in November were gathered from a subset of the ORAGO 210 patient or participants who met the protocol requirements for an extension beyond 12 months combined with ORAGO 212 subjects. These data revealed a sustained effect showing a minimal decrease of approximately 6% in annualized high velocity from year one to year two. as opposed to the significant decline of approximately 20% reported for daily recombinant growth hormone in moderate PGHD patients. Now, OrgGrowth210 successfully achieved its pre-specified primary endpoint, validating our predictive enrichment marker or PEM test, while also meeting the secondary endpoint by demonstrating 100% reproducibility of PEM-positive classifications. Additional data from the oral growth 212 trial demonstrated that only 20% growth hormone concentration was needed to achieve comparable annualized height velocity. That suggests that LUM201 is more efficient than exogenous growth hormone to promote growth. These data confirm the importance of LUM201's unique mechanism of action to restore the natural physiology of pulsatile growth hormone secretion. Our data from both trials provided a clear safety profile for investigation on LUM201. Now, following the release of top-line results in November, ongoing data collection and analysis have continued. We anticipate presenting comprehensive 12-month annualized high-velocity data from the oral growth 210 trial in the second quarter of this year, most likely at a major medical conference. This data set will include 12-month AHV data on all enrolled patients from the Oral Growth 210 trial. Additional 24-month data beyond the data set we announced in November will also be available. We expect to present these data in additional analysis at several meetings throughout 2024 to capitalize on the growing interest and excitement in the pediatric endocrine community about LUM201 as potentially the first oral therapeutic in this population. And following the announcement of our top line results, we've been diligently conducting additional analyses in preparation for end of phase two meeting with the FDA, and that's scheduled for the second quarter. Our data package for this meeting is comprehensive, featuring a larger data set compared to other growth hormone counterparts at this developmental stage. These data show LUM201 induces annualized height velocities consistent with historical levels for moderate PGHD on recombinant growth hormone. Data also demonstrate that oral LUM201 produces a robust and enduring response at the 1.6 mg per kg dose, making use of our predictive enrichment marker or PEM strategy for selecting suitable moderate PGHD patients, thereby further de-risking our Phase III program As a result, we approached this end-of-Phase II meeting with a high level of confidence. Now, long before we announced top-line results from our Argrove trials, we've been actively involved in advanced planning for a pivotal Phase III trial. Following our Phase II meeting with the FDA, we will finalize the ultimate design of the trial, which we anticipate initiating in the fourth quarter of 2024. We believe that this trial's results will support a new drug application for Loom 201 and the PGSD indication. With that, I'm going to turn it over to Lori Lawley, our CFO, for a brief overview of our financial results.