Lumos Pharma, Inc.

Good afternoon and welcome to Lumos Pharma's second quarter 2022 results and clinical update 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 8-K, 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 Scientific Officer, Dr. David B. Karp, our chief medical officer, and Lori Lawley, our chief financial officer. I will now turn the call over to Rick.

Thank you, Lisa, and good afternoon, everyone, and thank you for joining us on today's call. So after the market closed today, we issued a press release announcing our financial results for the 2022 second quarter and detailing our progress advancing our clinical program evaluating room 201 for the treatment of idiopathic or moderate pediatric growth hormone deficiency, or PGHD. On today's call, I'll provide a brief update on LUM201 clinical trials and other developments before turning it over to Lori Lawley for a review of our financial results. Then John and David will join us for our Q&A session. I'm pleased to report that the enrollment trends we highlighted on our last call for our Oral Growth 210 and 212 trials have continued and are able to confirm our intention to announce interim data from both trials in the fourth quarter of this year. Additionally, we expect the primary outcome data readouts for both trials in the second half of 2023, which we expect to include data in 80 subjects from the Oral Growth 210 trial and up to 24 subjects anticipated from our Oral Growth 212 trial. Our interim analysis from the Oral Growth 210 trial will provide an early look at the safety and annualized height velocity or AHV data at three dose levels of LUM201 compared to a standard dose of recombinant human growth hormone in 40 patients at six months on therapy. And as we approach interim data readout, I want to take a moment to explain what we'll be looking for in the data. As most of you know, OroGrow 210 is a global, multi-site, blinded, active control clinical study evaluating oral LUM201 in approximately 80 subjects diagnosed with idiopathic or moderate PGHD. The primary clinical outcome is annualized high velocity at six months on LUM201 for subjects selected by our Predictive Enrichment Marker, or PEM, strategy. compared to the control arm of subjects treated with recombinant growth hormone. So the data signal we will be looking for will be the annualized height velocity in these PEM-positive subjects versus the recombinant growth hormone control arm, not historic comparisons to the height velocity in other trials that typically enroll more severely growth hormone deficient subjects. It's also worth noting that oral growth 210 like all other six-month Phase II trials in the growth hormone space, is not powered to show non-inferiority. The Oral Growth 210 trial is different from all prior PGHD registration studies. This study is enriched to include only PEM-positive idiopathic or moderate PGHD subjects. Our trial does not include individuals with more severe organic PGHD. Now, this is important because it is well known that more severe PGHD subjects respond better to recombinant growth hormone than do moderate PGHD subjects. Therefore, the annualized high-velocity values we would expect in the more moderate idiopathic patient population enrolled in our trial will be lower in all treatment groups compared to, for example, prior long-acting growth hormone studies. You will recall that the overall goals for the Oral Growth 210 trial are one, to identify the optimal dose of BOOM-201 from three dose levels, that is 0.8, 1.6, and 3.2 mgs per kg a day, to be used in a Phase III registration trial, and two, for the annualized height velocity to be numerically comparable to the recombinant growth hormone control arm in this trial, three, to validate our PEM enrichment strategy, And finally, four, to confirm safety and tolerability of LUM201. And as we begin to plan for our single phase three trial required for approval, we expect that its design will mirror prior pivotal trials for growth hormone deficiency therapeutics conducted by our peers. We therefore anticipate enrolling approximately 150 to 200 subjects in our pivotal trial, randomized two to one, LUM201, to a control arm of daily injectable recombinant growth hormone. The subjects will remain on therapy for 12 months at which point height velocity and safety data from both cohorts will be obtained. Again, the LUM201 dose administered in our phase three trial will be determined from our phase two oral growth 210 trial results. These details are obviously subject to the approval of the FDA and other health authorities and we'll engage the agency in discussions about the trial design at the appropriate time. As I mentioned earlier, our upcoming interim data readout will also include data from our Oral Growth 212 trial, our single-site, open-label trial evaluating the pharmacokinetic and pharmacodynamic effects of LUM201 in up to 24 PGHD subjects at the two higher dose levels of 1.6 and 3.2 mg per kg a day. The objective of the 212 trial is to confirm prior clinical data demonstrating the amplified pulsatile release of endogenous growth hormone unique to LUM201 and the potential for this mechanism of action to increase growth hormone secretion across the entire dose response curve in the majority of PGHD patients. The primary endpoint for this trial is six months of PKPD data with additional height velocity data also being assessed at six months and from the extension of this trial to follow subjects to near adult height. We also expect to announce the interim data from the Oral Growth 212 trial in the fourth quarter of this year. For the interim data readout, comparability of baseline characteristics of subjects in each study will determine whether it is appropriate to pool annualized height velocity data from the oral growth 210 and 212 data sets for combined analysis. The primary outcome data readout for oral growth 312 is anticipated around the same time as the primary data readout for the oral growth 210 trial in the second half of 2023 and we expect this oral growth 212 data set to include data in up to 24 subjects. Last quarter we announced the initiation of our Oral Growth 213 trial, or the SWITCH study. This is an open-label, multi-center, phase two study evaluating the growth effects and safety of LUM201 following 12 months of daily recombinant growth hormone in up to 20 PGHD subjects who have completed the Oral Growth 210 trial. Subjects will then be administered LUM201 at a dose level of 3.2 mg per kg a day for up to 12 months. Primary outcome for the 213 trial is annualized height velocity. Secondary outcomes include safety and PK PD measures. This trial continues to enroll subjects from the Oral Growth 210 trial. Now, before turning to other updates, I want to touch on two operational matters related to our clinical trials. We announced last quarter that we had suspended enrollment at our Oral Growth 210 clinical sites in Russia and Ukraine due to ongoing conflict. Fighting in the region has continued, so we have decided to formally close these sites. And as a reminder, no subjects were enrolled at these sites prior to their suspension, so we do not expect these closures to impact our target data timelines. We're adding a few sites in the United States, which should allow us to maintain our original enrollment timelines. And additionally, as many of you probably know, COVID cases continue to have risen again, both in the U.S. and internationally, and the disease continues to be unpredictable. Fortunately, the world continues to adjust to the presence of COVID, and we therefore do not believe that the ongoing pandemic will alter our current clinical development plan. We will, of course, continue to monitor the situation closely. As our clinical trials advance toward data readouts, we're noticing significant interest in the potential of Loom 201 building within the wider PGHD research community. Attendees at both the Endo Conference in June and the Magic Foundation meeting in July advise us that they are following our progress closely and are looking forward to our interim data readout. Last quarter, we announced that renowned pediatric endocrinologist Dr. Pasit Patukchwanat, or Dr. Duke as we call him, joined our medical affairs leadership team. Dr. Duke recently attended the Human Growth Foundation Gala and has been holding investigator meetings in both the U.S. and internationally, and he is observed as growing interest as well. We believe that this reflects the desire among healthcare professionals for an alternative to daily or weekly injections of growth hormone to treat PGHD patients. Feedback, I can tell you, of this nature goes beyond mere buzz. Based on discussions we're having within the broader PGHD community, we believe that the availability of an oral option to treat PGHD has the potential to expand the overall market. Considering the hesitance of some parents have been when faced with the treatment of burden of daily or weekly injections involved with current standard of care, it's not surprising that an oral option may be more attractive. This is especially true in the more moderate cases that LUM201 is intended to treat for the exact patient population we are rolling in our current trials. We look forward to working with both the healthcare professionals and the PGHD patient community to raise awareness about LUM201 programs and the potential of this drug to be a real game changer in this space. Now turning to the collaboration, we announced last quarter with Dr. Laura Dichtel and Massachusetts General to explore the potential of LUM201 in patients with non-alcoholic fatty liver disease or NAFLD. This investigator-sponsored pilot trial is a single-site, six-month, open-label study of daily oral LUM201 in adults with NAFLD. The trial has been rapidly prescreening patients and should begin enrollment in the near future. Again, this pilot study will evaluate the dose of 25 mgs a day of LUM201 in 10 subjects with non-alcoholic fatty liver disease, or NAFLD, and relative IGF-1 deficiency. Prior studies evaluating growth hormone in this indication have been promising, supporting the potential for oral LUM201 to address this condition. And while we remain focused on our core LUM201 program and PGHD, we are pleased to support Mass General's exploration of LUM201's potential in this indication. The condition estimated to be prevalent in approximately 25% of adults worldwide and which can often advance to the more serious liver diseases and result in need for a liver transplant. As we have mentioned, we continue to explore expansion opportunities for LUM201 and other conditions where injectable recombinant human growth hormone is a standard of care. We believe that LUM201 is a pipeline and a product, and through its unique mechanism of action, may have the potential to be efficacious in indications such as Turner syndrome, Prader-Willi syndrome, idiopathic short stature, and children born small for gestational age. We're actively reviewing potential clinical development plans for LUM201 and several of these indications and believe that interim data from our ORAGO trials should clarify the direction we take. We continue to be judicious in our pursuit of rare disease assets beyond LUM201 with careful attention to shareholder value creation. That said, our priority remains Loom 201 and its development. And with that, I'm going to pass it over to Lori for a review of our second quarter financial results. Lori?