Lyra Therapeutics, Inc.

Welcome to the Lira Therapeutics fourth quarter and year-end 2020 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following management's prepared remarks, we will hold a Q&A session. To ask a question at that time, please press star followed by one on your touchtone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, March 9th, 2021. I would now like to turn the conference call over to Lawrence Watts, Managing Director at Gilmartin Group. Please go ahead.

Thank you, Cherry. Joining us on the call today from Lyra Therapeutics are President and Chief Executive Officer Maria Palazzo, Chief Financial Officer Don Elsie, Chief Medical Officer, Rob Kern, and Senior Vice President of Commercial Strategy and Market Development, Lauren Noyes. Earlier today, Lira released financial results for the fourth quarter ended December 31, 2020. If you have not received this news release or you would like to be added to the company's distribution list to receive future releases, please go to the investor relations sector's website, which can be found at www.liratherapeutics.com. Conference call management will make forward-looking statements, including statements related to Lira's financial results and guidance for 2021 and the clinical development of the company's product candidates, business strategy, and planned operations. These forward-looking statements are based on the company's current expectations and inherently involve significant risks and uncertainties. Lira's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. Factors that could cause results to be different from these statements include factors the company describes in the section titled Risk Factors in the company's annual report on Form 10-K, filed today, March 9, 2021. LERA cautions you not to place undue reliance on forward-looking statements and undertakes no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in its expectations. With that, I will now turn the call over to Maria Palacios, CEO, Therapeutics. Maria?

Thank you, Lawrence, and welcome, everyone, to Lira Therapeutics' fourth quarter and full year 2020 financial results conference call. 2020 was an exciting and successful year at Lira, culminating in the release of our Lantern Phase II trial results in December and the completion of enrollment in our 24-patient pharmacokinetic clinical studies. both despite the ongoing global COVID-19 pandemic. We believe this bodes well for future enrollment in our Pivotal Phase III programs. Before I turn to the Lantern results, let me remind you of some recent key appointments that Lyra has made. Recently, we were joined by Dr. Robert Kern, who has been appointed as our Chief Medical Officer. Rob is a renowned otolaryngologist and a world-leading expert in chronic rhinosinusitis. He is a chair of otolaryngology at Northwestern University and the immediate past president of the American Rhinologic Society. As a practicing otolaryngologist, he knows firsthand the enormous need for new treatment options for patients with chronic rhinosinusitis, or CRS. and we are delighted he will be overseeing the next phase of clinical development for LYR 210 and LYR 220. In the fourth quarter, we also expanded our board of directors through the appointment of Dr. Nancy Snyderman. We were pleased to have Nancy join our team and look forward to leaning on her extensive ENT experience as a board-certified otolaryngologist and head and neck surgeon. As you know, Lyric's first area of focus as a company is in the treatment of chronic rhinosinusitis, for which there are an estimated 8 million patients treated each year in the United States, with roughly half of them failing current medical therapy. The market for these failed patients is estimated to be 6 billion annually, just in the United States. the problem and opportunity is even greater when the ex-US markets are considered. Lyra has designed LYR210 and LYR220 to be disease-modifying and best-in-class for CRS patients who are currently underserved by medical management. Having now demonstrated effectiveness in our Phase II for our underlying X3O platform, Lyra intends to use LYR210 and 220. as a foundation on which we build a leading ear, nose, and throat company. Turning now to our Lantern study results. Let me just say that we were very pleased with the data and the patient experience that resulted from this trial. Our Lantern Phase II trial showed that CRS patients treated with 7,500 micrograms achieved a statistically significant improvement in their symptoms at several time points compared to the control, including 24 weeks, the intended treatment duration for our product candidate. As such, Lira believes that the results of this randomized, controlled, blinded clinical trial support a clear path to regulatory submission for LYR 210 and also provide sufficient insight and data to enable us to move the program forward to a pivotal trial, subject to an end-of-phase II meeting with the FDA. This meeting is planned to take place before the end of the first half of this year. Following agreement on the design of the single phase III pivotal trial that we believe will be sufficient to complete our registration package under a 505 new drug application, We anticipate initiating the pivotal study for LYR210 at the end of 2021. As a reminder, the lantern trial was completed with 67 patients. This was reduced from the planned enrollment due to the COVID-19 pandemic. The 67 patients were split into three treatment arms of 7,500 micrograms, 2,500 micrograms of momentazone furate and a control, and were evaluated for improvement in the four cardinal symptoms of chronic rhinosinusitis at four weeks and up to 24 weeks in addition to other secondary endpoints. We were excited to see a statistically significant treatment effect at 24 weeks for the 7,500 microgram dose in both the four cardinal symptoms and SNOT-22 scores. This gives us confidence that LYR210 could be an effective therapy for up to six months. Additionally, we saw improvement relative to control at earlier time points in both the four cardinal symptoms and the SNOT22 symptom scores. Another key takeaway from the LANTURN trial was demonstrating the safety of the 7,500 microgram dose of mometasone furate, three times the dose we used in our phase one trial. At this dose, 70% of patients achieved the minimal clinically important difference at four weeks, as measured by the SNOT22 score, and 100% by week 24. On the back of this data, we plan to move forward with a 7,500 microgram dose for our Phase III program. Based on the observed rapid and durable symptom relief over 24 weeks, we believe LYR 210, if approved, would deliver a major step forward in care for CRS patients who are facing surgery as their next treatment option. We intend to present the full data set from the Lantern Study at COSM, the Combined Otolaryngology Spring Meetings, which is being held from April 7th to April 11th. We believe the results of the trial support a clear pathway to pursue a larger pivotal Phase III trial for LYR210 and a proposed 24-week primary endpoint based on the cardinal symptoms of CRS, the FDA's preferred measure of efficacy. Importantly, the Lantern results also support Lyra's proprietary Xtrio platform, which is designed to deliver a drug directly, continuously, and consistently to to diseased tissue over a sustained period of time via a single administration. Because of this, the Lantern study gives us confidence to advance LYR220, our second program that will utilize the Xtrio platform for chronic rhinosinusitis patients who have previously undergone surgery and require ongoing medical management. Approximately 40% of patients who see an ENT have had a prior nasal surgery or even multiple surgeries. LYR220 utilizes a larger matrix than LYR210 and is designed to adapt to the anatomy of these patients. Given the positive results from our lantern study, we now plan to initiate a Phase II study for LYR220 using the 7,500 microgram dose. in the second half of 2021. Furthermore, LERA continues to see versatility in the Xtrio platform, which we believe has potential applications and many additional indications beyond CRS, where long-term delivery to treat chronic diseases would improve local drug bioavailability and enhance efficacy and safety. The Lantern study showed that Xtrio can successfully deliver continuous therapy for up to six months. We believe Xtrio to be tunable with regard to the drug being delivered and the period of delivery, which provides us with multiple expansion opportunities, either as additional internal development programs or as partnerships. Before I turn the call over to Don to discuss the financials, let me allow Dr. Kearns our newly appointed chief medical officer, to share his own perspective on the lantern study.