Lumos Pharma, Inc.

Good afternoon and welcome to Lumos Pharma's fourth quarter 2021 results conference 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 will now turn the call over to Lisa Miller, Senior Director of Investor Relations. Ma'am, please go ahead.

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 filing 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 8-K, which may be accessed from the investors' page of the company's website. Joining today's call will be Rick Hawkins, CEO and Chairman, John McHugh, President and Chief Scientific Officer, Dr. David B. Karp, our Chief Medical Officer, and Lori Lawley, Chief Financial Officer. Following prepared remarks, we will open the call to questions. I will now turn the call over to Rick.

Thank you, Lisa, and good afternoon, everyone, and thank you for joining us on today's call. After the market closed today, we issued a press release announcing our new plan for an interim analysis of two of our ongoing oral growth trials and our financial results for the full year 2021. On today's call, I will provide a clinical update before turning it over to Lori, who will review our financial results. Then John and David will join us for a Q&A session. I'll begin with the exciting news we announced today for our Oral Growth 210 and 212 trials. We're very pleased to report that screening and enrollment trends in both trials are sufficient for us to announce interim analyses of clinical and safety data, the results of which we expect to report by year-end 2022. This early look at the data will evaluate the safety and annualized height velocity on three dose levels of LUM201 against a standard dose of recombinant human growth hormone in 40 patients at six months on therapy. We look forward to providing this preliminary assessment of LUM201's potential to treat idiopathic PGHD patients who would otherwise face years of burdensome injections as their only course of treatment. Now, as a reminder, our Oral Growth 210 trial is our global clinical study evaluating oral LUM201 in approximately 80 patients diagnosed with idiopathic PGHD. The primary clinical outcome is annualized height velocity in patients selected by our predictive enrichment marker, or PEM, strategy. The key clinical endpoint is the comparison of the annualized height velocity of LUM201 at three dose levels, 0.8, 1.6, and 3.2 milligrams per kilogram per versus a control arm of patients treated with injectable recombinant growth hormone at a daily dose of 0.24 milligrams per kilogram per week. Dose levels of LUM201 were selected to span the entire dose response curve elucidated in a prior PK PD study. The goals of our Oral Growth 210 trial are to identify the optimal dose of LUM201 to be used in a Phase III registration trial, as well as validate the PEM strategy. The Oral Growth 210 trial is nearing the 50% enrollment milestone, and essentially all of our trial sites, excluding Ukraine and Russia, are open for enrollment. Given the recent events in Ukraine and Russia, we have suspended all clinical activity at trial locations in Russia and are unable to enroll patients in Ukraine due to the ongoing conflict. We are, therefore, now targeting approximately 40 sites for our Oral Growth 210 trial. The enrollment and screening at these approximately 40 sites have maintained an encouraging trajectory, and, therefore, we continue to anticipate primary outcome data on 80 patients from oil growth 210 in the second half of 2023. The ongoing conflict may, however, adversely impact our business in the future, and it remains too early to evaluate all the potential effects of this crisis. Before moving on, I'd like to express our concerns and our support for our research colleagues and the people of Ukraine, as well as our sincere hope for their safety and rapid restoration of peace. So enrollment continues to meet our expectations in our Oral Growth 212 trial, our single-site, open-label trial evaluating the pharmacokinetic and pharmacodynamic effects of LUM201 in up to 24 PGAC patients at two dose levels, 1.6 and 3.2 milligrams per kilogram per day. We're pleased to report that the minimum subject enrollment we set for the interim analyses will soon be met with 10 subjects, and we anticipate announcing the results of this interim analyses, evaluating safety and high-velocity data by the end of 2022. You'll recall that the objective of our 212 trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone unique to LUM201 and the potential for this mechanism of action to increase growth hormone secretion across the entire dose-response curve in the majority of PGHD patients. The primary endpoint is six months of PKPD and high-velocity data, with a total of 12 months of high-velocity data to be captured in this trial. Turning now to our ORGO213 trial, or the exploratory SWITCH study. We have initiated an open-label, multi-center, Phase II study evaluating the growth effects and safety of LUM201 following 12 months of daily recombinant growth hormone in up to 20 PGHD patients who have completed the Oral Growth 210 trial. Subjects will be administered LUM201 at a dose level of 3.2 milligrams per kilogram per day for up to 12 months. Primary outcome for the 213 trial is annualized height velocity, and secondary outcomes include safety and other PD measures. In addition to advancing our clinical trials for LUM201 and PGHD, we continue to explore expansion opportunities for LUM201 and two other therapeutic areas where injectable recombinant human growth hormone is the standard of care. We believe that LUM201 is a pipeline and a product and through its unique mechanism of action, may have the potential to treat many of the indications comprising the $3.4 billion growth hormone market. I'll pass over to Lori for a review of our four-year 2021 financial results. Lori?