Lumos Pharma, Inc.

Good afternoon, ladies and gentlemen, and welcome to the LUMOS Farmers' Year-End 2020 Earnings Conference Call. At this time, 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, Director of Investor Relations, Ms. Miller, please go ahead.

Thank you. 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 earnings release we issued this afternoon and in our Form 8K, which may be accessed from the investor's page of the company's website. Joining me on today's call are Rick Hawkins, CEO, President and Chairman, John McHugh, Chief Operating Officer and Chief Scientific Officer, Gene Kennedy, our outgoing chief medical officer, and Carl Langren, chief financial officer. Rick Hawkins will provide a corporate update. John McHugh will review the company's lead therapeutic candidate. Gene Kennedy will discuss our clinical trials, and Carl Langren will wrap up the call with a review of the full year 2020 financials and an update of cash guidance. I will now turn the call over to Rick.

Thank you, Lisa, and good afternoon, and thank you for joining us on today's call. And after the market closed, we issued a press release highlighting our recent clinical and corporate activity, and providing an update on our year-end 2020 financials. Last year marked a period of significant achievement for Lumos Pharma, with the completion of our merger transaction, the monetization of our priority review voucher, and the initiation in the fourth quarter of our Phase IIb or Road 210 trial evaluating our novel therapeutic candidate, Loom 201, for pediatric growth hormone deficiency. Those events put Loomless Pharma on a solid foundation to pursue the development of orally administered Loom 201 with the potential to disrupt the PGHD therapeutic industry where the standard of care consists of daily injections of growth hormone. That momentum continues in 2021 as we move our clinical strategy forward. Our Phase IIb Oral Growth 210 trial continues to advance with data readout anticipated mid-2022. In addition, we expect to initiate our Oral Growth 212 trial shortly. This trial is a small, single-site trial to illustrate the pharmacokinetic and pharmacodynamic effects of LUM201 and PGSD and replicate the pulsatility data that currently exists for LUM201 in adults. Also, today, we introduced our Oral Growth 211 trial, a long-term extension study for eligible PGSD patients who have completed our other LUM201 trials. This extension trial will assess the long-term safety and efficacy of LUM201 in children with growth hormone deficiency. We believe LUM201 is essentially a pipeline and a product with the potential to target up to 11 other indications for which growth hormone has been approved. We're focusing first on PGHD, and once we gather data from our current program, We plan to evaluate LUM201 in a subset of these other indications I just alluded to. Jean Kennedy will review our current clinical efforts in more detail later. We're also pleased by the recent publications of peer-reviewed LUM201 data analyses in the Journal of Endocrine Society. These data from earlier studies of LUM201 in recombinant human growth hormone, or RHGH, demonstrates specific baseline IGF-1 levels and peak growth hormone levels from growth hormone stimulation tests may serve as predictive enrichment markers, or PEMs, useful in identifying the more moderate PGHD patients most likely to respond to LUM201. reviewed data support the approach we are using in our clinical trials. We are also honored to be presenting additional LUM201 data at the Endocrine Society Annual Meeting, also known as ENDO, in late March. As our recently published abstract illustrates, the data being presented at ENDO show a distinction between LUM201 and standard growth hormone secretagogues used to diagnose growth hormone deficiency. These data show that at the lowest dose we are using in our Phase IIb trial, LUM201 elicits statistically higher blood hormone response than standard diagnostic agents. We believe these data further support the potential for LUM201 to be efficacious in the subset of PGAC patients identified by our predictive enrichment markers. John McHugh, our COO and Chief Scientific Officer, will provide more details a bit later on in the call. As you may recall, a priority review voucher was issued upon FDA approval of the Ebola vaccine in which Lumos Pharma had 60% ownership, resulting in a $60 million gross to Lumos Pharma. We received the first payment of $34 million in September and the second and final tranche of $26 million in January of 2021. We continue to look for business development opportunities to expand our pipeline to the acquisition or licensure of another novel therapeutic candidate for rare diseases. These non-diluted funds further strengthen our balance sheet and will be available to support our business development strategy. Carl Langren, our CFO, will discuss our financials in more detail and provide updated guidance regarding our estimated cash use for 2021. So we are excited about the year ahead with the advancement of our oral growth trials in PGHD and the potential expansion of our rare disease pipeline. We believe that LUM201, an orally administered growth hormone secretagogue, offers the potential to disrupt the PGHD market where the current and potential therapies consist only of injectable treatments. Expanding our pipeline would offer an opportunity to reach additional individuals suffering from rare diseases. And we are fortunate to have a solid balance sheet and an experienced management team to execute on this mission. And with that, I will turn the call over to John to review our Oral Growth Pharma and Supretagogue LUM201 and recently published data. John? Thank you, Rick.