Lumos Pharma, Inc.

Today's conference is scheduled to begin shortly. Please continue to standby. Thank you for your patience. Thank you. Thank you. Good afternoon and welcome to Lumos Farmer's first quarter 2022 results and clinical update 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 would now like to turn the call over to Lisa Miller, Senior Director of Investor Relations. 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 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. Speaking on today's call will be Rick Hawkins, CEO and Chairman, John McHugh, our President and Chief Scientific Officer, Dr. David B. Karpf, our Chief Medical Officer, and Lori Lawley, our Chief Financial Officer. I will now turn the call over to Rick.

Thank you, Lisa. Good afternoon, everyone, and thank you for joining us on today's call. Now, after the market closed today, we issued a press release announcing our financial results for the 2022 first quarter of and detailing our progress advancing our clinical programs for the treatment of patients with idiopathic or moderate pediatric growth hormone deficiency, or PGHD, using our daily oral therapeutic LUM201. On today's call, I'll provide a brief update on our LUM201 clinical trials and other developments before turning it over to John, who will discuss our new collaboration with Massachusetts General Hospital for an investigator-initiated Phase II pilot trial. Then David will discuss an update to our clinical team. And finally, Lori will review our financial results. First, I want to say that during these turbulent times, both in our industry and in the markets in general, Loomis Pharma is fortunate to be in good position to advance our trials through key data milestones. Our company is on solid financial footing and continues to have sufficient cash on hand to get us through not only the interim readout by the end of this year, but also the primary outcome readout of our Oral Growth 210 trial expected the second half of 2023 and our Oral Growth 212 trial as well. Now, I'm pleased to report that 2022 has begun on a positive note. Encouraging enrollment trends we highlighted on our last call for Oral Growth 210 and Oral Growth 212 trials have continued. and the ORGO 210 trial has now exceeded the 50% randomization milestone. Enrollment trends in both trials are sufficient for us to reiterate our commitment to conducting an interim analysis of clinical efficacy and safety data and the results of which we will announce by the end of this year. Our interim analysis will provide an early look at the safety and annualized high-velocity data at three dose levels of LUM201 against a standard dose of recombinant human growth hormone in 40 subjects after at least six months on therapy. As a reminder, our Orgo 210 trial is our global clinical study evaluating oral LUM201 in approximately 80 subjects diagnosed with idiopathic or moderate PGHD. The primary clinical outcome is annualized high velocity in these subjects selected by our predictive enrichment marker or PEM strategy. Secondary outcome measures include comparison of annualized high velocity of LUM201 at three dose levels. That's at 0.8, 1.6, and 3.2 mg per kg versus a control arm of patients treated with recombinant growth hormone at a daily dose of 0.24 mg per kg a week. Dose levels of LUM201 were selected to span the entire dose response curve elucidated in a prior PK-PD study. The goals of Oral Growth 210 are to identify the optimal dose of LUM201 to be used in a Phase III registration trial, as well as validate the PEM strategy. You'll also remember that on our last call, we announced the initiation of our Oral Growth 213 trial, or the SWITCH study. This is an open-label, multi-center, Phase II study evaluating the growth effects and safety of LUM201 following 12 months of daily injectable growth hormone in up to 20 PGHD patients who have completed the Oral Growth 210 trial. Subjects will be administered Lume 201 at a dose of 3.2 mg per kg a day for up to 12 months. Primary outcome for the Oral Growth 213 trial is annualized high velocity, and secondary outcomes include safety and PKPD measures. Now, the Origo 212 trial is our single-site, open-label trial evaluating the pharmacokinetic and pharmacodynamic effects of LUM201, and up to 24 PGA-SKI subjects at two dose levels, 1.6 and 3.2 makes per kg a day. 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 additional 12-month data to be collected. We continue to anticipate primary outcome data from the Oral Growth 210 and 212 trials in the second half of 2023. Now, we're also pleased to announce that the U.S. Food and Drug Administration is now permitting treatment with lume 201 beyond 12 months following a review of preliminary unblinded safety and efficacy data from our oral growth trials. As you'll recall, in July 2021, we announced that the FDA had restricted treatment with lume 201 to no more than 12 months. And based on the agency's review of preliminary safety and efficacy data, from both oral growth trials we have in progress. The FDA has lifted its partial hold and will now permit treatment with LUM201 beyond 12 months. And as a result, we are extending the oral growth 210 trial to up to 24 months on treatment to allow subjects to continue LUM201 therapy uninterrupted. Additionally, we plan to extend the oral growth 212 trial. These extensions will not change the anticipated timing of primary outcome data readouts occur after six months on treatment. Again, the primary data readout for our Orgo 210 trial is anticipated for the second half of 2023. In addition to the progress we've been making in our prospective trials, we're pleased to see the publication of a retrospective analysis by Drs. George Bright and Michael Thorner in the journal Hormone Research and Pediatrics. This peer-reviewed manuscript titled, Loom 201, ELISA's Greater Growth Hormone Response than Standard Growth Hormone Secretagogues in Pediatric Growth Hormone Deficiency, presents an analysis of data from a prior clinical study comparing the peak growth hormone response of Loom 201 to that of standard diagnostic growth hormone secretagogues in children previously diagnosed with growth hormone deficiency who are naive to treatment. The analysis demonstrates that in children with growth hormone deficiency, the growth hormone response to a single oral dose of 0.8 mg per kg of LUM201, and that is the lowest dose administered in our oral growth trials, greatly exceeds that observed with standard growth hormone stimulation agents. Results of this study were originally presented at the 2021 Endo Annual Meeting and further support prior data suggesting that LUM201's therapeutic potential when administered to pediatric subjects with idiopathic growth hormone deficiency. Now I'll turn the call over to John McHugh, President and CSO, to discuss our new collaboration with Massachusetts General Hospital. John?