Lumos Pharma, Inc.

Good afternoon, ladies and gentlemen, and welcome to Lumos Pharma's first quarter 2021 financial results 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, Senior Director of Investor Relations.

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 these forward-looking statements. Information presented on this call is contained in the earnings release we issued this afternoon and in our Form 8K, which may be accessed from the Investor Relations 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, Carl Langren, Chief Financial Officer, and Lori Lawley, Senior Vice President, Finance and Corporate Controller. Rick Hawkins will provide a corporate update. John McKee will review the company's lead therapeutic candidate and our clinical trials. And Lori Lawley will wrap up the call with a review of the first quarter 2021 financial results and an update of cash guidance. Following our prepared remarks, we will open the call to questions. 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. After the market closed today, we issued a press release detailing our first quarter 2021 financial results and highlighting our recent clinical and corporate activity. I'm pleased to report that the quarter was a productive one, during which we saw a presentation and publication of new data and analyses supporting the differentiated mechanism of action of our novel oral therapeutic candidate, LUM201, for the treatment of pediatric growth hormone deficiency in patients identified by our predictive enrichment markers. We also continue to advance our clinical programs for LUM201, adding clinical sites for our Phase IIb Oral Growth 210 trial and moving towards initiation of our Oral Growth 212 trial during the second quarter. Finally, we completed the monetization of our priority review voucher, receiving in January the final $26 million tranche of the $60 million due to the company from this sale. With these resources in hand, we believe we are well positioned to advance our Loom 201 programs and explore business development options to enhance our pipeline and deliver value to our investors. And before turning the call over to John McHugh for a deeper dive on progress in our clinical programs, I just want to highlight a few recent events. Last week, we held a key opinion leader, a forum featuring presentations by Drs. Bradley Miller of the University of Minnesota and Fernando Casorla of the University of Chile. This was a well-attended and informative event where Dr. Miller and Dr. Casorla provided an overview of the current treatment landscape in PGAC and outlined the unmet medical needs in this space. As part of his presentation, Dr. Casorla also presented newly released PKPD data from a subgroup of the MERC 020 trial evaluating LUM201 in naive-to-treatment PGAC patients. These data were additive to the peer-reviewed data recently published in the Journal of Endocrine Society, demonstrating once again the potential of our predictive enrichment markers, or PEMs, of baseline IGF-1 levels and peak-stimulated growth hormone levels after a single dose of LUM201 to identify patients likely to respond to LUM201 therapy. Additional data were presented last month at the Endocrine Society 2021 annual meeting known as ENDO, further demonstrating LUM201's unique potential to elicit therapeutic-level response in PGHD patients and in differentiating this molecule from standard growth hormones, Cretagox. These results add to the previously mentioned data, further supporting the approach we are using in our clinical trials. John McHugh, our COO and Chief Scientific Officer, will have more to say about these data in a moment. So as I mentioned, our Phase IIb Oral Growth 210 trial in PGSD continues to enroll patients. Additional clinical sites have opened for enrollment with over 50% of our target number of sites now activated. Our Oral Growth 212 trial, a PK-PD study in PGSD, is expected to be initiated this quarter and with data from that trial anticipated to confirm prior data demonstrating the unique pulsatile MOA of LUM201. We believe LUM201 has the potential to disrupt the injectable therapeutic market for PGHD. We also believe that LUM201 is essentially a pipeline and a product with the potential to target up to 10 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. We're also pursuing business development opportunities to add other rare disease assets to expand our portfolio. We are excited about the programs we're making toward our clinical programs, and with our solid balance sheet strengthened by the receipt of the final tranche of the $26 million from our PRV sale, we are in a good position to advance our corporate strategy. So with that, I'm going to turn the call over to John to review our Orgo Hormone Secretagogue Loom 201 and recently published data.