Oyster Point Pharma, Inc.

In addition, this conference call discusses products that are under clinical investigation, which have not yet been approved for marketing by the U.S. Food and Drug Administration. They are currently limited by federal law to investigational use, and no representation is made as to their safety or effectiveness for the purpose for which they are being investigated. These statements are based upon information available to the company today, and Oyster Point assumes no obligation to update these statements as circumstances change. Future events and actual results could differ materially from those projected in the company's forward-looking statements. Additional information concerning factors that could cause results to differ materially from our forward-looking statements are described in greater detail under the caption, Risk Factors, in the company's filings with the SEC, including our quarterly report on Form 10-Q for the quarter ended September 30, 2020, that was filed with the SEC on November 5, 2020. I will now turn the call over to Dr. Jeffrey Nau, President and Chief Executive Officer of Oyster Point Pharma.

Thank you, Dan. Good evening, everyone, and thank you for joining us on our call today to discuss our third quarter 2020 financial results and recent business highlights. I would like to continue to provide an update regarding the ongoing SARS-CoV-2 virus pandemic. Oyster Point Pharma continues to monitor the impact of the SARS-CoV-2 virus pandemic and has taken proactive steps to ensure the safety of its employees, maintain business continuity of our operations, and to advance our R&D pipeline. To date, Oyster Point Pharma has continued to maintain a remote working environment for its employees. In addition, the company remains in close contact with its R&D contractors, and to date, the company's contractors have not reported significant disruption to their operations as a result of the SARS-CoV-2 virus pandemic. In May, Oyster Point announced positive top line results from onset two phase three trial of OCO-1 in subjects with dry eye disease. The Oyster Point team has continued to finalize our NDA package and is targeting submission to the Food and Drug Administration in Q4 2020. If approved by the FDA, OCO-1 nasal spray would be on track for a Q4 2021 launch. As we have compiled our NDA, we've been able to take a deeper dive into the data as you will see in the November corporate deck that we made public on our website. We have provided top line data from our integrated Phase 2b onset 1 and Phase 3 onset 2 analyses. From these analyses on slide 21 of our November corporate deck, you will see that both the 0.6 mg per mL and 1.2 mg per mL dose groups show statistically significant improvements in the categorical and mean changes in SHRMR scores. Importantly, we see this effect in both the study eye and fellow eye, illustrating the bilateral treatment benefit seen with our nasal spray approach. When looking at the symptom improvement data from our integrated efficacy analysis, we see a statistically significant improvement in both dose groups versus vehicle. Although we see a larger symptom benefit versus vehicle with the 1.2 milligram per mil dose group in the clinic environment, with that benefit in the higher dose group, even more pronounced in the low humidity, high airflow, controlled adverse environment, illustrative of an environment that many patients will experience. In addition to these analyses of the integrated data, when we include the use of concomitant artificial tears as a covariate in our statistical models, the difference between treatment and placebo is even more pronounced in both groups. We believe this highlights the benefit we might expect eye care providers to see with the real-world use of OCO1 nasal spray. Based on integrated analysis and the totality of data from our development program, we believe that the data supports our decision to seek FDA approval of the 1.2 milligram per mil dose of OCO1 for the treatment of the signs and symptoms of dry eye disease. In addition to our development of OCO1 for dry eye disease, we intend to file an IND this quarter to evaluate the potential of OCO1 for the treatment of stage 1 and stage 2 neurotrophic keratitis. We believe that OCO-1's unique mechanism of action of stimulating natural tear film via the trigeminal parasympathetic pathway may be beneficial for patients with corneal epithelial hyperplasia and or punctate keratopathy, as well as those with persistent epithelial defects. If the IND is accepted by the FDA, our clinical development team will begin enrolling the Phase II Olympia clinical trial in the first half of 2021. In summary, we remain committed to bringing innovative and transformative ocular surface disease treatments to patients and building Oyster Point Pharma into a best-in-class ophthalmology company. I will now turn the call over to John Smizerenko, Oyster Point's Chief Commercial Officer and to discuss our ongoing preparations for the potential commercial launch of OCO-1 in Q4 of 2021.

Thank you, Jeff. The dry eye disease segment is a large market with over 16 million adults diagnosed in the United States alone. Only a small proportion of these patients, approximately 2 million, are currently being treated with a therapeutic and over 7 million people diagnosed with dry eye disease have tried and abandoned the currently available options. We believe that OCO-1 has a compelling therapeutic profile that, if approved, may address some of the unmet needs of this large addressable dry eye market. As we continue to build out our commercial organization with an experienced team, in the second half of 2021, we are planning on fielding a sales force of between 150 to 200 reps, which would target close to 90% of the current prescriber base of therapeutic dry eye products. We also believe that patient access to OC01 will be critical. Our access strategy includes competitive contracting for broad payer coverage, comprehensive pharmacy distribution, along with patient support programs to enable broad patient access to OC01. I will now turn the call back over to Dan Lochner, Oyster Point's Chief Financial Officer, to discuss our third quarter financial results.