Lyra Therapeutics, Inc.

At this time, all participants are in a listen-only mode. After the speaker's prepared remarks, there will be a question-and-answer session, and if you have a question at that time, please press the star, then the number one key on your touch-tone telephone. Now, I'll turn the call over to Ms. Stephanie Marks with Argo Partners.

Thank you, Operator, and welcome, everyone, to today's call. With me today are Dr. Maria Palacios, Lira's President and Chief Executive Officer, Don Elsie, Chief Financial Officer, Dr. Robert Kern, Chief Medical Officer, and Corinne Noyes, SVP of Commercial Strategy and Market Development. This afternoon, Lira issued a press release announcing its second quarter 2021 financial results and business updates. A copy of the announcement can be found in the investor relations tab of the company's website, liratherapeutics.com. During the conference call, management will make forward-looking statements, including statements related to 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 current report on Form 10-Q filed today, August 9, 2021. LIRA 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. And with that, I'll turn the call over to Maria.

Thank you, Stephanie, and thank you all for joining us this afternoon. I hope everyone is doing well. Second quarter has been an exciting one for LERA. We released the full data set from our positive lantern phase two study. We had a very successful end of phase two meeting with the FDA for our lead program. We entered into a licensing agreement in Greater China and other Asian markets with LamBio. And we reported positive top line results from the PK study, which support a 505b2 new drug application for LYR210. Our fundamentals are strong and we are in a position to successfully execute against our upcoming milestones. The foundation of our company is our proprietary XTRIO technology platform which is grounded in drug formulation chemistry and polymer science. Our product candidates are pharmacologic interventions which target highly potent therapeutics directly to the site of disease for months to manage chronic illnesses. Our ability to deliver the right drug to the right place for the right amount of time translates into a number of potential benefits for patients, including increased efficacy, improved compliance, and avoidance of systemic side effects. Deep drug formulation expertise has been a core capability of LERA's, developed over many years. This expertise provides us with a distinct advantage over others in the field. Lyra is now at a major inflection point. We have strong validation of our technology in our first two indication, in our first indication, chronic rhinosinusitis, or CRS. The randomized controlled lantern phase two study clearly demonstrated with high statistical significance that LYR210 works as designed, providing six months of symptom relief for patients suffering with CRS from just a single treatment. We are deep in preparations to advance clinical programs for both of our de-risked pipeline candidates, LYR210 into Phase III and LYR220 into Phase II, both around the end of this year. Lyra is now in a strong position to bring these new therapies to the CRS patients who need them. Chronic rhinosinusitis has been described as an unrecognized epidemic, In the U.S., about 14 million people have CRS. Eight million of those patients are treated each year, but at least half of them fail current medical treatment. Of those four million patients who fail medical management each year, only about 400,000 go on to have invasive surgery, and the rest remain undertreated. This is an enormously underserved market and we know patients do not want to sign up for surgery. Similar dynamics apply globally with millions of CRS patients underserved in Asia and Europe. We believe our current candidates for the treatment of CRS will completely transform the current treatment landscape by uniquely addressing the unmet need in the broad CRS market. LYR 210 and 220 are designed to provide a therapeutic option for the full spectrum of CRS patients treated by ENTs, including both those seeking to avoid surgery and those returning after surgery. The ENT physician community is particularly eager to have a safe and effective treatment for the millions of CRS patients who are undertreated. Liris product candidates are the only ones designed to address this vastly under-penetrated patient population. As you can see, we are positioning ourselves to be a dominant player for this tremendous opportunity. There have been no products in this space that have had this type of broad potential. We remain confident that the purposeful design of our pharmacologic interventions, the strong data that we've generated to date in the clinic, and the relationships we are building with the ENT community give us a chance to truly create best-in-class products that will benefit millions of CRS patients. Dr. Robert Kern, our Chief Medical Officer and Chair of Northwestern's ENT Department, will share his insight into the current treatment landscape and unmet need in CRS and review our recent regulatory developments. Rob?