Lyra Therapeutics, Inc.

business strategy, and planned operations. These forward-looking statements are based on the company's current expectations and inherently involve risks and uncertainties. LERA'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 that the company describes in the section titled Risk Factors and the company's current report on Form 10-Q, filed today on November 9, 2021. VERA 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. This third quarter of 2021 was another quarter of significant progress at Lyra. On the clinical front, we continue to generate data that strengthens the profile of our lead candidate, LYR210, for the treatment of chronic rhinosinusitis. We announced new positive data from the Phase II lantern post-treatment evaluation, which showed continued safety in all patients, and a durable response six months post-removal of LYR210 in roughly half the patients that we've treated. This durable response in some of the patients, even six months after removal, was impressive and an important differentiator relative to other treatments in the field. We also reported the full results from the 56-day pharmacokinetic clinical study, which demonstrated that mometasone furorate blood levels were low and constant over time, providing further evidence that LYR210 delivers a steady daily dose of mometasone. We believe that it is these drug release kinetics of LYR210 that underpin the rapid and prolonged symptom relief that we've observed in our clinical studies. This third study further strengthens our data and efficacy database. Dr. Kern will review these data in more detail shortly. Both clinical studies were presented at the 67th Annual Meeting of the American Rhinologic Society last month. At ARS, we presented the data in two oral presentations and also received additional recognition by the Society for our clinical research. The PK study was selected as a top clinical abstract at the meeting and the Lantern Phase II manuscript won the ARS 2021 Clinical Science Maurice Cottle Award. This recognition speaks to the quality of the science at Lira. Our clinical programs are advancing into late stage development with the start of the Phase III clinical program for LYR210 and the Phase II clinical trial for LYR220 in the coming months. On the corporate front, Jason Cavalier was appointed as our new chief financial officer in September. He brings over two decades of experience as an investment banker and has an extensive track record in advising companies on financing and strategic alternatives. Most recently, he was managing director of head of life sciences, mergers, and acquisitions at Cantor Fitzgerald, where he led numerous transactions across medical technology, diagnostics, and biopharma sectors. He also held other investment banking positions at RBC Capital Markets, Barclays Capital, Bear Stearns, and Lehman Brothers. Jason leads our financial and capital market strategy and will support our investor, public relations, and business development activities. He takes the reins from Don Elsie, who guided the company through our IPO. As you know, Don's retiring. He'll remain an advisor through year end. On behalf of the entire Lyra team, I'd like to thank Don for his tremendous dedication, commitment, and contributions to the company. Now, I'd like to take a few minutes to remind you why we have initially focused our development on a treatment for patients with chronic rhinosinusitis. CRS is a debilitating disease that has been largely ignored. The disease is highly prevalent in the world with about 14 million people just in the United States. Patients are currently treated with off-label medications that have not been approved to treat CRS. Consequently, about half of these patients fail medical treatment and continue to suffer with their disease. In the United States alone, there are 4 million patients that fail medical management each year. Their next option is invasive surgery. Currently, marketed products have only been developed to treat polyps, which only represent 10% of the CRS patients. LERA's mission is to provide the very first treatment for these millions of CRS patients who have been underserved by current treatment options. by developing an effective drug that directly targets inflammation at the epicenter of the disease. Our proprietary Xtrio platform technology enables delivery of a targeted and consistent therapeutic dosing directly to the disease submucosa for six months with one application. No one else has been able to achieve this to date. Lyra is developing two product candidates to fully address patients with CRS. LYR 210 and 220. Both are small shape memory implants that are placed deep in the nasal passage using a small diameter applicator in an ENT's office during a routine endoscopy. LYR 210 is designed to be used early in the treatment paradigm in surgically naive patients after topical steroid sprays have failed. We estimate this population to represent about 2.4 million patients in the United States each year. The post-surgical market opportunity is also significant at about 1.6 million patients each year. To address this market, we're developing LYR220, which is designed for the post-surgical anatomy in patients who continue to require therapy despite having had prior endoscopic sinus surgery. Our growing body of scientific evidence continues to support the safety and efficacy of LYR210 and highlights the benefits of our proprietary Xtrio platform technology. We have strong validation of our technology in CRS, our first targeted indication, and we intend to leverage the platform in new indications over the next year. In addition to our own research, we have also been hearing from key opinion leaders about their enthusiasm for the potential of LYR210 to be a new treatment alternative for their CRS patients. Over the past few months, we hosted two events with leading ENTs who all shared their experiences in treating CRS patients, the shortcomings of current therapies and the need for new effective treatments. We urge you to listen to the webcasts, which are found in the IR section of our corporate website. I'm sure that you will find their perspectives informative. With the upcoming initiations of our two clinical programs, our Phase III Enlightened program for LYR210 and the Phase II Beacon program for LYR220, we're one step closer to potentially changing the treatment paradigm for the millions of underserved CRS patients. I'll now turn the call over to Dr. Robert Kern, who will review the new data as well as the clinical trial designs for LYR210 and 220, which are both anticipated to initiate around year end. Rob?

Thank you, Maria. As Maria mentioned, new positive data on LYR210 was the subject of two presentations at the 67th annual ARS meeting at the American Rhinologic Society. Before I review these data, I wanted to remark on the award that the Lantern manuscript received at that meeting. In my 30 years as a rhinologist and a member of that society, I have not seen that award given to industry-sponsored research. So it was quite an accomplishment for Lyra and a validation of our rigorous clinical program. The Lantern post-treatment evaluation assessed the safety and efficacy over six months following matrix removal. During the post-treatment period, there was no increased incidence of treatment-related adverse events. Also, approximately half of these CRS patients experienced a durable response six months after the removal of LYR210, while roughly 90% of the patients in the control arm showed worsening CRS symptoms from weeks 24 to 48. The durable symptom relief observed in some patients after removal of LYR210 offers potential long-term benefit, and is a meaningful differentiator relative to other treatments. We also reported results from the 56-day pharmacokinetic study, which showed that LYR210 delivered a constant daily dose of mometasone furate over the study period without a drug burst. The PK study enrolled 24 patients across four U.S. sites to receive LYR210 2,500 and 7,500 picogram doses. or 7,500 picogrand doses. The study showed LYR2 tend to be safe and effective in patients with less severe disease, as patients in the PK study had baseline SNOT22 scores of around 38 compared to 68 in the Lantern Phase II trial. Impressively, 63% of patients achieved a score below 20, the common standard threshold for surgery, and 38% of patients achieved a normal score meaning below nine by day 56. These results further demonstrate our belief that LYR210 has the potential to provide an effective treatment for mild all the way to severe CRS disease. We've now shown in three separate trials both safety and efficacy for our lead product LYR210. We believe these impressive results validate the six month treatment duration provided with a single administration and the potential for a more durable effect post-removal. As a practicing physician and otolaryngologist, I believe that LYR210 offers a significant advantage over existing therapies and has the potential to establish a new standard of care for chronic rhinosinusitis. Looking ahead, the Global Phase III Enlightened Program for LYR210 is expected to initiate around year end. We anticipate enrollment in each trial of about 180 adult patients with CRS, who have failed medical management and are surgically naive. The two studies will be randomized two to one to LYR210 versus control. The primary endpoint will be the three cardinal symptom scores at 24 weeks with secondary endpoints to include SNOT22, rescue treatments, sinus CT scans, quality of life, and pharmacoeconomic evaluations. The design is largely similar to the Phase II lantern study, which was highly statistically significant in the three cardinal symptoms at 24 weeks. Enlightened 1 will include a six-month extension study where placebo patients will cross over to LYR210 treatment, and 50% of the treated patients will receive a repeat dose. It is important to note that the extension study will not delay top-line readout of the primary endpoint at 24 weeks. We believe that Enlighten is a robust clinical development program, the first of its kind in this field. Later this month, we will also start the Phase II Beacon Study for LYR220. We plan to enroll approximately 65 post-surgical patients across sites in the United States and Australia, randomized one-to-one-to-one to receive one of two different matrix designs, each at a dose of 7,500 picograms core control. Primary endpoint will be safety and feasibility over 24 weeks, with secondary endpoints including PK, SNOT-22, three cardinal symptoms, rescue treatments, sinus CT, nasal biomarkers, and quality of life. Let me now turn the call over to Jason, who will review the quarter's financials. Jason?