Lumos Pharma, Inc.

Good afternoon and welcome to Lumos Pharma's third quarter 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.

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 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 8K, 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, and Lori Lawley, Chief Financial Officer. Following their prepared remarks, Rick and Laurie will be joined by John McHugh, our President and Chief Scientific Officer, as well as Dr. David B. Karpf, our Chief Medical Officer for the question and answer session. 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. After the market closed today, we issued a press release announcing our financial results for the 2021 third quarter and detailing our progress advancing Loom 201 for the treatment of pediatric growth hormone deficiency, or PGHD. On today's call, I'll provide the overview of our Loom 201 program and broader development strategy and give an update on our clinical trials, and Lori Lawley will review our financial results. Then we'll be happy to take your questions. So I'm pleased to report that since we last spoke with you, we've made steady progress on our Loom 201 program. The majority of sites for our Oral Growth 210 trial are now open for enrollment, and importantly, most of those that we opened recently or will open soon are historically high enrollment sites. With screening and enrollment for Oral Growth 210 progressing, we continue to expect the primary outcome data readout for this trial in the second half of 2023. Enrollment has picked up in our Oral Grow 212 trial. You'll recall that Oral Grow 212 is a single-site, open-label trial designed to provide pharmacodynamic data on LUM201. Primary endpoint is six-month data with additional 12-month data to be captured. Since the trial is open-label, an interim analysis may be conducted at the company's discretion. As a reminder, our Orgo 210 trial is a global clinical study evaluating oral LUM201 in approximately 80 patients diagnosed with PGHD. The primary clinical outcome is annualized height velocity in patients selected by our predictive enrichment marker, or PEM, strategy. Secondary outcome measures include comparison of annualized height velocity of LUM201 in three dose levels, 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 per week. Dose levels of LUM201 were selected to span the entire dose response curve elucidated in a prior PKPD 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 and validate the PEM strategy. During the last quarter, we made significant progress toward our goal of opening approximately 50 sites. Currently, we have over 40 sites open and screening patients. Additional high-volume sites expected to open shortly include those in Russia, Ukraine, New Zealand, and Israel. And based on the progress made in recent weeks, we feel confident that enrollment supports our six-month data readout for the Oral Growth 210 trial the second half of 2023, with additional 12-month data to be collected. Turning now to our Oral Growth 212 study. This is 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 mg per kg per day. This trial continues to enroll patients at an encouraging pace. The objective of the oral growth 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 PGSD patients. The primary endpoint is six months of PK, PD, and high-velocity data with additional 12-month data to be captured. And given the open-label design of this trial, we have the ability to perform an interim analysis at our discretion. Now, in addition to advancing our clinical trials for LUM201 and PGHD, during the quarter, we continued to explore expansion opportunities for LUM201 and to other therapeutic areas where injectable recombinant human growth hormone is a standard of care. As we've said previously, we believe that LUM201 is a pipeline and a product, and through its unique mechanism of action, may have the potential to be efficacious in indications such as Turner syndrome, Prader-Willi syndrome, idiopathic short stature, and children born small for gestational age. We are actively reviewing potential clinical development plans for LUM201 in several of these indications and are in advanced discussions with key opinion leaders and our clinical and scientific advisory board about the best next step for expanding our Loom 201 pipeline. So we look forward to providing a more detailed update on these plans soon. We also continue to be judicious in our pursuit of rare disease assets beyond Loom 201 with careful attention to shareholder value creation. That said, our priority remains Loom 201 and its development. So before I turn the call over to Lori, I just want to remind everyone of some context surrounding our LUM201 program and some of the reasons why we have confidence in our current clinical trials and the potential of LUM201 generally. Now, you may recall, unlike standard of care PGST therapies or the weekly injectables coming to market, LUM201 is an oral growth hormone secretagogue that acts within the body's natural endocrine pathway. And LUM201 acts selectively on receptors in the pituitary and hypothalamus to stimulate the body's ability to release growth hormone at the same intervals and subject to the same intricate feedback loops that occur naturally. This mechanism enables the naturally occurring IGF-1 feedback loop to be preserved to help regulate the balance of growth hormone and IGF-1 levels in the body. So less severe PGHD patients are those with an intact pituitary growth hormone axis, but who are secreting insufficient growth hormone to attain normal height, are those who should respond best to LUM201. Evidence suggests that this group represents approximately 60% of the total PGHD population, and our trials are designed using specific predictive enrichment markers, or PEMs, to identify this addressable population. And with that, I'll pass it over to Lori for a review of our third quarter financial results. Lori?