Lumos Pharma, Inc.

Good afternoon, and welcome to Lumos Pharma's Q1 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 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 afternoon and in our Form 10-Q, which may be accessed from the investor's 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 Science Officer, and David B. Karp, our Chief Medical Officer, will join for the question and answer section. I will now turn the call over to Rick.

Thank you, Lisa, and good afternoon, everyone. And after the market closed today, we issued a press release announcing our first quarter 2023 financial results and provided 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 some of the highlights from the quarter in recent weeks before turning it over to Lori for a review of our financial results. And John McHugh and David Karp will join us to answer your questions. So let's begin. As we reported this afternoon, during our first quarter of 2023, we made significant progress in advancing our oral therapeutic candidate, LUM201, in idiopathic pediatric growth hormone deficiency led by the completion of patient enrollment in both our Phase II Oral Growth 210 and Oral Growth 212 trials. And we can confirm our expectation to report primary outcome battle on up to 82 subjects in the dose range finding Oral Growth 210 trial and up to 22 subjects in the PKPD Oral Growth 212 trial in the fourth quarter of 2023. Importantly, as predicted, Baseline characteristics for OBRA 210 subjects converged across the 1.6 mg per kg LUM201 and the growth hormone cohorts between the interim data we announced in November and full enrollment. You may recall that the control arm for the interim analysis included outliers with greater growth than prior data precedence. With the convergence of age and other key predictive baseline characteristics across these two cohorts at full enrollment, we now have better balance in baseline characteristics and therefore believe we should see more similar growth rates between these two arms at final analysis. During the quarter, we were pleased to see an updated interim data from our trials presented at the 2023 International Meeting of Pediatric Endocrinology, or MPEG, That was held in Buenos Aires, Argentina in March. The presented data demonstrate that LUMSU01 possesses both a natural endogenous mechanism of action with potency to stimulate meaningful growth in a moderate idiopathic PGSD patient population, as well as a favorable safety profile. This included an oral presentation of oral growth 212 data by Dr. Fernando Casorla that further supported the pulsatile mechanism of action of LUM201 and highlighted growth stimulated with LUM201 in PEM-positive idiopathic PGHD subjects and a poster presentation by Dr. Allison Lumsford demonstrating that the 1.6 mgs per kg LUM201 dose produced 8.6 centimeters a year, annualized height velocity, again, in line with historical growth from modern idiopathic PGSD patients treated with injectable standard of care growth hormone. Again, data demonstrated that LUM201 possesses a favorable safety and tolerability profile. The presented data further reinforced our prediction from the interim analysis we announced last November that the 1.6 make per kg LUM201 dose is on track to meet growth expectations based on historical database averages. Importantly, we believe the MPA medical meeting was critical for raising awareness and understanding of LUM201 among key opinion leaders and global pediatric endocrine community. Among the pediatric endocrinologists in attendance at MPA, the interest in LUM201 and its potential as an oral therapeutic to treat PGHD was significant. There are those present who are familiar with Merck's original evaluation of LUM2-01 in an all comers PGHD trial and the lack of success there. Yet the trial, yet that trial I should say enrolled both severe PGHD patients unable to secrete growth hormone as well as more moderate or idiopathic PGHD subjects. Once this audience was shown Lumos Pharma's data demonstrating that moderate idiopathic PTSD patients selected by our PEM strategy grew in line with historical averages, there was an acknowledgement that LUM201 had the potential to become the first oral therapeutic to address this patient population treated solely by injectable therapies for the last 40 years. And we are pleased that interim data from our both oral growth trials were also accepted for presentation at the upcoming Pediatric Endocrine Society meeting later this week, including an oral presentation on oral growth 210 trial interim data given by Dr. Andrew Dauber, Chief of Endocrinology at Children's National Hospital, and a poster presentation on oral growth 212 trial interim data by Dr. Casorla and presented by our own Dr. David Karpf. We believe that presentations at MPEG and PES and other medical meetings will continue to increase awareness of Blum201 among the pediatric endocrinologist community and garner even greater excitement for the potential for our oral therapeutic candidate in pediatric growth hormone deficiency. And turning to other developments now, we continue to support our clinical collaboration with Dr. Laurel Dichtel and Massachusetts General Hospital to explore the potential of LUM201 in non-alcoholic fatty liver disease or NAFLD. This investigator-initiated pilot study was supported by data presented by Dr. Dichtel at the Endo22 conference. And at that medical meeting, Dr. Dichtel reviewed positive data evaluating injectable growth hormone in NAFLD, which supported the assessment of oral LUM201 in the same indications. As NAFLD is a chronic condition prevalent in approximately 25% of adults worldwide, a daily oral therapeutic such as LUM201 could provide a welcome alternative to a lifetime of daily injections of growth hormone in this indication. Enrollment in this pilot study of LUM201 in NAFLD is continuing. And as we mentioned on our last earnings call, LUMOS Pharma filed a novel formulation patent for LUM201 last year, which could extend IP protection to 2042. Now, currently, LUM201 has patent protection through 2036 for the detection and treatment of growth hormone deficiency, as well as orphan drug designation, which offers extended protection of up to seven and a half and 12 years from the date of drug approval in the U.S. and Europe, respectively. We expect to hear from the U.S. Patent Office later this year. As previously mentioned, we believe that LUM201 has the potential to address up to 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 and geographic regions. As we mentioned on our last earnings call, we have 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. 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. With that, I'm going to turn it over to Lori for a review of our financial results.