Lumos Pharma, Inc.

Good afternoon and welcome to Lumos Pharma's Q2 2023 Financial 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 10-Q, 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, our CFO. John McHugh, our President and Chief Scientific Officer, as well as Dr. Patuk Chawanna, our Senior Vice President of Global Clinical Development and Medical Affairs, will join for the question and answer section. 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 second quarter 2023 financial results and providing an update on our clinical programs. As is our practice, We'll keep our prepared remarks on today's call brief so we can maximize the time available for Q&A. I'll touch on the highlights from the quarter in recent weeks before turning it over to Lori for review of our financial results. Then John McHugh and Dr. Patek Tawana, or Dr. Duke as we call him, will join us to answer your questions. Dr. Duke joined us about a year and a half ago from Ascendus, where he worked on their long-acting injectable growth hormone therapy or therapeutic through approval. He is also president of the Human Growth Foundation, and with his contacts and understanding of the potential of an oral therapeutic in this space, Duke has been instrumental in advancing the enrollment in our Oral Growth 210 trial and in the preparation for our Phase III trial in Pediatric Growth Hormone Deficiency, or PGHD. So let's begin. As reported this afternoon, during our second quarter of 2023, we made continued progress in advancing our oral therapeutic candidate, LUM201, in moderate idiopathic PGHD. We can confirm our expectation to report primary outcome data on up to 82 subjects in the dose range finding oral growth 210 trial, and up to 22 subjects in a mechanistic PK-PD oral growth 212 trial in the fourth quarter of 2023. And at this point, I'd like to remind everyone about our expectations for the primary readout. The primary endpoint for these trials is annualized height, velocity, or AHV at six months on treatment. And based on historical data, the predicted growth rate for LUM201 is between 8.3 centimeters in 8.6 centimeters per year for this moderate idiopathic PGSD population, according to observed growth in several large historical databases. The other objectives of the ERGRO 210 trial are to confirm the utility of the predictive enrichment marker, or PEM strategy, and to determine the optimal dose for a Phase III trial. We also expect our primary outcome readout to include AHP data at 12 months on treatment for up to 12 subjects per oral growth 210 cohort and up to seven subjects for oral growth 212 cohort for a total of up to 62 subjects from both trials. Additional AHP data at 18 and 24 months on treatment are also expected for a small number of subjects. In addition, The Phase II trial should demonstrate a safety profile comparable to the daily growth hormone control arm. And also, as is the case for all Phase II trials, the oral growth 210 trial is not powered to show non-inferiority of annualized high velocity between LUM201 and the control arm, but should inform the design of and dose selection for a successful registration Phase III trial. And as a reminder, the non-inferiority margin between the treatment arm and the controlled growth hormone arm for a pivotal phase 3 trial in this indication has historically been from 1.8 to 2 centimeters a year at 12 months on treatment. This has held true for recent approvals of long-acting growth hormone products as well. For the next steps in the program, we're obviously engaging in meticulous planning for a phase 3 trial. And after a thorough review of the data package, the first step will be to request an end of phase two meeting with the FDA to review the phase two results and agree upon the ultimate design of the phase three trial. And based on regulatory precedence, we expect that this registrational trial will include approximately 180 to 200 PEM positive subjects, randomized two to one versus growth hormone with a likely dose of 1.6 mg per kg of LUM201 to daily growth hormone, stratified by age and other factors to ensure balanced cohorts. Our proposed primary endpoint will be AHP at 12 months on therapy, and the trial will utilize the new LUM201 formulation for which we filed a novel formulation patent application last November enabled by unique properties of our compound, which could extend our IP protection to 2042. This formulation of LUM201 consists of many tablets in capsules, which we believe will provide an easier oral dosage form for the wide age range of our target population. We expect to hear from the US Patent Office later this year. Currently, Loom 201 has patent protection through 2036, plus applicable extensions for the detection and treatment of growth hormone deficiency, as well as orphan drug designation, which offers extended protection for up to 7 1⁄2 and 12 years from the date of drug approval in the U.S. and Europe, respectively. During the quarter, we were pleased to see further data and analysis from these two trials presented at the 2023 ENDO meeting. Data from these two abstracts were presented, including new data from the ORBO 212 trial that showed an increase in ITF1 levels on LUM201 at six months that remained within normal range. an increase in IGF-1 SDS greater than zero, and a durable growth response up to 12 months of LUM201 administration. There's clear evidence of potential drug effect for LUM201. It was also observed in consistent improvement in AHV over baseline. Also, new analysis of combined ORAGRO-210 and ORAGRO-212 trial data at the 1.6 and the 3.2 mixed per day dose levels in 15 subjects from the Orgo 212, 20 subjects from the Orgo 210. These combined results continue to demonstrate that there's a durable response to LUM201 from 6 to 12 months, and that the 1.6 and 3.2 mgs per gigaday doses are comparable in the growth each stimulated. And as many of you know, these data were highlighted in a key opinion leader webinar we hosted on June the 21st, where doctors Fernando Casorla and Michael Tansey shared their insights on the data and their continued convictions in the potential of LUM201 to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last four years. If you've not seen the webinar, we encourage you to review the replay, which is still available on our website. Additional analysis of data from the Orgo 212 trial was accepted as a late-breaking abstract for oral presentation at the upcoming annual meeting of the European Society of Pediatric Endocrinology, or ESPI, which was held in The Hague in the Netherlands, September 21 to 23. This abstract by Fernando Casorla will include a deconvolution analysis of growth hormone secretion with LUM201 administration in the moderate PGHD population. And turning to other developments, we continue to support our clinical collaboration with Dr. Laura Dichtel in Massachusetts General Hospital to explore the potential of orally administered LUM201 in non-alcoholic fatty liver disease, or NAFLD. Positive results from this investigator's prior trial evaluating injectable growth hormone in NAFLD were recently published in the Journal of Clinical Endocrinology and Metabolism. It was these compelling data that encouraged Dr. Dickel and Mass General to initiate the collaboration with Lumos Pharma to assess oral LUM201 in the same indications. In the prior study, investigators hypothesized that growth hormone might reduce hepatic steatosis or fat buildup in the liver in obese patients with NAFLD. Subjects were randomly assigned to a treatment group, 27 growth hormone and 26 of placebo group with 41 completers overall, 20 on growth hormone, 21 on placebo at six months. Reduction in absolute percent of enterohepatic lipid content by proton magnetic resonance spectroscopy was significantly greater in the growth hormone versus the placebo cohorts. Investigators concluded that growth hormone reduces liver fat without commensurate weight loss. These data are supportive of evaluation of oral LUM201 in the NAPLD indication. LUM201 pilot trial in NAPLD continues to enroll. As a reminder, the company's primary near-term focus remains on advancing LUM201 in PGHD. Now, as previously mentioned, we believe that LUM201 has the potential to address about 10 other indications currently treated by injectable growth hormone. We've done a lot of work internally to assess the potential of LUM201 and other indications in different geographic regions worldwide. And as we've said before, we narrowed our focus to idiopathic short stature, or ISS, and Prader-Willi syndrome, where we see a sizable opportunity both in the U.S. and internationally. And while we assess these opportunities, we remain committed to the prudent use of our cash and ensuring our capital allocation is focused on advancing our core program. So with that, I'm going to turn it over to Lori for a review of our financial results. Lori?