OptiNose, Inc.

third quarter 2022 performance and our plans for the remainder of the year i'm joined today by our ceo peter miller our president chief operating officer dr rami mamoud and our chief commercial officer vic clovelli the slides that will be presented on this call can be viewed on our website optinos.com in the investor section before we start i would like to remind you that our discussions during this conference call will include forward-looking statements all statements that are not historical facts are hereby identified as forward-looking statements Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those indicated by such statements. Additional information regarding these factors and forward-looking statements is discussed under the Cautionary Note on Forward-looking Statements section of the earnings release that we issued today, as well as under the Risk Factors section and elsewhere of Opti-Nose's most recent Form 10-K and Form 10-Q that are filed with the SEC and available at their website, sec.gov, and on our website at optinose.com. Your caution not to place undue reliance on forward-looking statements. The forward-looking statements during this conference call speak only as of the original date of this call or any earlier date indicated in such statement, and we undertake no obligation to update or revise any of these statements. We will now make prepared remarks, and then we will move to a question and answer session. With that, I will now turn the call over to Peter Miller. Peter.

Thanks, Jonathan, and good morning. We appreciate you joining us today. Starting on slide four, We'll go into more detail in a moment, but I'd like to highlight five key takeaways from today's presentation. First, consistent with the expectations set on our last call, we met with the FDA in September to discuss our supplemental NDA submission for ExHance as a treatment for chronic sinusitis. Rami will cover this further during his prepared remarks in a moment. In summary, we believe it was a positive meeting. Our second key takeaway for today is that following the discussion with FDA, we now expect to submit our supplemental NDA in early 2023. Third, we remain enthusiastic about the potential addition of an indication to treat chronic sinusitis. CF is diagnosed approximately 10 times more frequently than nasal polyps, and in the current healthcare environment where off-label use is increasingly constrained by payers, we believe the new indication will allow us to access significantly larger physician and patient audiences to drive growth. Fourth, We plan to materially reduce our use of cash in 2023 while continuing to position Xhance for successful launch for the first ever CS Indication, a launch that we believe can ultimately enable tremendous future success for our company. Fifth, I'd like to note that Xhance reached a milestone in the third quarter when the one millionth prescription was filled. We'd like to thank my colleagues at Opti-Nose for the efforts that made it possible to achieve this kind of scale as an approved treatment for nasal polyps. And importantly, given a significantly larger population diagnosed with chronic sinusitis, it makes us excited for what may come next. I'll now turn the call over to Rami to discuss the results of the reopened program and next steps. Thank you, Peter.

Turning to slide six. On our last earnings call, we shared with you our development roadmap for the remainder of 2022. which included a pre-NDA meeting with FDA that was planned for the end of September. That meeting was conducted as planned, and the feedback we received will help guide us as we prepare our submission. Based on our current expectations for the scope of content to include in the submission, we now anticipate submission of the SNDA in early 2023. Previously, we expected that to occur by the end of 2022. The additional time has enabled us to incorporate the feedback we received in September into the preparation of the submission. We continue to anticipate that the standard FDA review period for this type of application would be 10 months, and therefore, we continue to expect the FDA action date to fall in the fourth quarter of 2023. Overall, we were pleased with the outcome of the pre-NDA meeting and look forward to the possibility of Xhance being the first drug approved to treat the common disease of chronic sinusitis. The meeting reinforced our belief that our clinical safety and efficacy database is sufficient to support the filing of this supplemental NDA for this novel indication. Turning to the trials for a moment, I'd like to remind you that we have previously reported that both reopened trials were positive, showing statistically significant improvement on both co-primary endpoints for patients treated with ex-hands compared to those receiving the placebo comparator. We continue to believe that outcome measures of clinical importance are of particular interest to all stakeholders, including prescribers and patients. Therefore, we are pleased to report that REOPEN is the first Phase III program that we're aware of ever to show that a nasal therapy can significantly reduce the number of acute exacerbations of chronic rhinosinusitis. For context, exacerbations are a major source of disability for CRS patients. Data suggests that there are approximately 10 million physician office visits for CRS annually, and that approximately 70% of patients who visit a doctor for CRS receive an antibiotic, making this a top driver of all adult ambulatory care antibiotic use in the United States. As you're aware, acute exacerbations not only mediate loss of quality of life for CRS patients, but frequent antibiotic use can pose risks to both individuals, such as changes to the nasal or gut microbiome, and to society, such as the emergence of antibiotic-resistant organisms. It's comparatively easy to convey to all stakeholders the clinical importance of the finding that in pooled data from the REOPEN trials, treatment with ex-hands produced up to 66% reduction in acute exacerbations of CRS. Turning to slide seven. The successful REOPEN program is creating multiple opportunities for presentation of new and compelling data on ex-hands at scientific meetings. In September, the results from the first of our two phase three trials, REOPEN-1, were presented at the American Rhinologic Society annual meeting during the top-rated abstracts in clinical rhinology section. In October, we presented a late-breaking abstract podium presentation at ID Week 2022. ID Week is a major conference for specialists in infectious disease. The significant reduction in acute exacerbations and associated antibiotic use in chronic rhinosinusitis is important information for a range of stakeholders beyond our current targets of ENT and allergy specialty physicians, and this was an opportunity to begin to engage with that larger audience. Finally, we look forward to presenting the results from the second of our two Phase III trials, ReOPEN II, on November 12th at the American College of Asthma, Allergy, and Immunology annual scientific meeting. In addition, we look forward, of course, to publishing the results of ReOPEN I and ReOPEN II in the peer-reviewed scientific literature. We're working actively with our distinguished scientific steering committee and look forward to sharing an update when a primary report of findings manuscript is published. I'll now turn the call over to Peter to discuss our third quarter commercial performance.