Lyra Therapeutics, Inc.

Welcome to the Lyra Therapeutics first quarter 2021 financial results and corporate update conference call. At this time, all participants are in a listen-only mode. Following the 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 touch-tone phone. If anyone has difficulty hearing the conference, please press star zero for operator assistance. As a reminder, this call is being recorded today, May 11, 2021. I would now like to turn the conference call over to Stephen Jasper from Gil Martin Group. Please go ahead.

Thank you, Operator. Joining us on the call today from Lyra Therapeutics are President and Chief Executive Officer Maria Palacios, Chief Financial Officer Don Elsie, Chief Medical Officer Rob Kern, and Senior Vice President of Commercial Strategy and Market Development, Corinne Noyes. Earlier today, Lira released financial results for the first quarter ended March 31, 2021. If you have not received this news release or would simply like to be added to the company's distribution list to receive future releases, please go to the Investor Relations section of Lira's website, which can be found at www.liratherapeutics.com. During this conference call, management will make forward-looking statements, including statements related to Lira's 2021 financial results and guidance 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 current report on Form 10-Q filed on or about May 11, 2021. We would caution you not to place undue reliance on forward-looking statements and undertake no duty or obligation to update any forward-looking statements as a result of new information, future events, or changes in expectations. With that, I will now turn the call over to Maria Palacios, CEO of Lyra Therapeutics. Maria?

Thank you, Stephen, and welcome, everyone, to Lyra Therapeutics' first quarter 2021 financial results conference call. As a reminder, Lyra Therapeutics' goal is to transform the ENT treatment paradigm by providing effective solutions for physicians and new treatment options for their patients. Lyra's first area of focus is the treatment of chronic rhinosinusitis, for which there are an estimated 8 million patients treated each year in the U.S., with roughly half of them failing medical therapy. Lyra has designed LYR 210 and 220 to be disease-modifying and best-in-class for CRS patients who are underserved by current medical management. Having now demonstrated effectiveness in our Phase II for our underlying exterio platform, Lyra intends to use LYR 210 and 220 as a foundation on which we build a leading ear, nose, and throat company. We made further progress towards this goal in the first quarter with the presentation of the full data from our Lantern Phase II study of LYR210 at the combined otolaryngology spring meetings in April. And with the appointment of Dr. Robert Kern as our chief medical officer, you will remember that we introduced Rob on our fourth quarter call. Looking ahead to the remainder of the second quarter, We look forward to sharing with you the feedback from our end of phase two meeting with the FDA for LYR210, as well as sharing with you the top line results from our pharmacokinetic clinical study. Later in the year, we plan to initiate a phase two clinical trial for our second development candidate, LYR220, an enlarged matrix using the same 7,500 microgram dose as LYR210. for patients who have previously undergone sinus surgery, followed by the initiation of a phase three clinical trial for LYR210 around year end. Before I hand the call over to Rob to cover our clinical pipeline, let me remind you of the highlights from our COSM presentation. The new data we presented included 100% of both non-polyp and polyp patients in the study achieved the minimal clinically important difference of 8.9 points of symptom improvement in SNOT22 score at week 24. This made LYR210 the first intranasal implant that has been found to be effective in non-polyp CRS patients, which represent 90% of the presurgical CRS patient population. LYR210 also achieved improvement in an objective imaging endpoint measuring sinus opacification at week 24 from baseline in a dose-dependent manner with a 7,500 microgram dose achieving significant improvement compared to control between the two time points. Furthermore, LYR210 at the 7,500 microgram dose reduced the need for rescue treatments Only one patient in the 7,500-microgram group required a rescue medication, compared to seven patients in the control group over the 24-week treatment period. Now, to give you further insight into our clinical development progress in LYR 210 and 220, I will hand the call over to Rob Kern. Rob?