Lumos Pharma, Inc.

and welcome to Lumos Pharma's Interim Data Update Conference Call. Currently, all participants are in listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at the time. As a reminder, this conference call is being recorded. I will now turn the call over to Lisa Muller, Senior Director of Investor Relations. Please go ahead, ma'am.

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 morning 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, John McHugh, our President and Chief Science Officer, and Lori Lawley, our CFO. David B. Karp, our Chief Medical Officer, will join for the question and answer session. I will now turn the call over to Rick.

Thank you, Lisa, and good morning, everyone. Thank you for joining the Illumifarma team for our announcement of encouraging interim results from our Oral Growth 210 and Oral Growth 212 trials. Earlier this morning, we issued a press release announcing interim data. On this call, we'll go through the results in additional detail and discuss how they inform the next development steps for LUM201 for the treatment of PGHD. In a moment, I'll turn the call over to John McHugh to walk through the data. For those of you who are new to our story, I'll begin with a brief overview of LUMOS and the indications we focused on. We're targeting the growth hormone market with our novel oral therapeutic called LUM201, and our initial indication is in pediatric growth hormone deficiency, or PGHD. Injectable growth hormone has dominated this market for almost 40 years, but the LUM201 is the first once-a-day oral therapeutic targeting this indication. LUM201 is differentiated in a number of ways. with a mechanism of action that works within a natural endocrine pathway. The global market opportunity for growth hormone disorder is quite large, at approximately $3.4 billion, $1.1 billion for PGSD alone, with additional upside in China of about $1.5 billion. The interim results we are reporting today are from two Phase II trials, World Growth 210, a study in moderate naivety treatment, PGSD, It's ongoing worldwide at about 45 sites, and the Oral Growth 212, a single-site PK-PD trial. Moderate or idiopathic PGHD makes up approximately two-thirds of the total treated PGHD patient population. As of the end of October 1, I'm pleased to report that we're approximately 80% enrolled in both trials and continue to be encouraged by the pace of enrollment. We have $74 million as a cash balance at the end of the third quarter of 2022, and this is enough cash to get us through a full readout of these two studies in the second half of 2023 with a cash runway into Q2 2024. Now to discuss the interim data. We are very pleased to announce this morning encouraging interim results from these two trials. Growth on Loom 201 met expectations. It demonstrated a durable response and showed a favorable safety and tolerability profile. As previously guided, we expected annualized growth velocity target of 8.3 centimeters a year based on several large historical databases of moderate, not naive to treatment, PTSD subjects treated with growth hormones. In fact, the 1.6 mg per kg per day LUM201 dose at six months on therapy achieved a mean annualized height velocity of 8.6 centimeters a year, meeting these expectations. Now, recall, this is for the enriched population we identified through our predictive enrichment marker, or PEM, this PEM strategy for selecting those moderate PGHD patients with the potential to respond to LUM201. Importantly, a durable response to LUM201 was observed at 9 and 12 months. We're also very pleased to say that the interim look, we have not observed any treatment-related SAEs, dropouts due to AEs, and no meaningful safety signal across the entire dose range evaluated. In addition to that, we believe these data support the selection of 1.6 mg per kg a day for a pivotal Phase III trial. Identifying this dose will now help with advanced planning of that pivotal trial. And finally, I'll mention again that our molecule's unique mechanism of action and oral administration, we believe these data support the potential for LUM201 to disrupt the injectable growth hormone therapeutic market worldwide. Now I'll turn the call over to our President and Chief Scientific Officer, John McHugh, to walk through the data in greater detail. John?