Oyster Point Pharma, Inc.

Good evening and welcome to Oyster Point Farmer's first quarter 2021 earnings conference call. My name is Sarah and I will be your operator today. After the company's formal remarks, there will be a question and answer session. At this time, I would like to turn the call over to Mr. Daniel Lochner, Oyster Point Farmer's Chief Financial Officer. Please go ahead.

Good evening, everyone, and welcome to the Oyster Point Pharma First Quarter Earnings Conference Call for the three months ending March 31, 2021. This year, we issued a press release containing our first quarter financial results and recent business highlights. In addition, our earnings press release and our Form 10-Q that was filed with the SEC after the close of market today are available on our website under the Investor and News section at www.oysterpointrx.com. Joining us on our call today are Dr. Jeffrey Now, President and Chief Executive Officer of Oyster Point Pharma, and John Snizerenko, Chief Commercial Officer. Following Dr. Now, Mr. Snizerenko, and my prepared remarks, we will open up the line for questions. During the call, we will make forward-looking statements regarding future events in the future of Oyster Point Pharma. Forward-looking statements include statements regarding oyster points possible or assumed future results of operations, expenses and financial position, business strategies and plans, research, development, and commercial plans or expectations, trends, market sizing, competitive position, our belief regarding our clinical trial outcomes, including secondary endpoint analysis regarding product approvals or FDA decision-making, our efforts to manage the impact of COVID-19 and the industry environment and potential growth opportunities, among other things. These statements are based upon the information available to the company today, and Worcester Point assumes no obligation to update these statements as circumstances change. Future events and actual results could differ materially from what is projected in the company's forward-looking statements. Additional information concerning factors that could cause the results to differ materially from our forward-looking statements are described in greater detail on the caption risk factors in the company's filings at the SEC, including our quarterly report on Form 10-Q for the quarter ended March 31st, 2021, filed with the SEC on May 6th, 2021, and our annual report on Form 10-K for the year ended December 31st, 2021, which was filed with the SEC on February 18th, 2021. 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 to investigational use, and no representation is made as to their safety or effectiveness for the purposes for which they are being investigated. I will now turn the call over to Dr. Jeffrey Now, President and Chief Executive Officer of Oyster Point Pharma.

Thank you, Dan. Good evening, everyone, and thank you for joining us on our call to discuss our first quarter 2021 financial results and recent business highlights. As you may know, on March 2nd, 2021, we announced that the FDA had accepted for filing the NDA for OCO-1 varenicline nasal spray for the treatment of signs and symptoms of dry eye disease, and the PDUFA target action date for OCO-1 nasal spray is set for October 17th, 2021. In addition to our development of OCO-1 nasal spray for dry eye disease, we filed an IND in November to evaluate the potential of OCO-1 for the treatment of stage 1 and stage 2 neurotrophic keratopathy. We believe that OCO-1's unique mechanism of action of stimulating natural tear film by the trigeminal parasympathetic pathway, as seen in preclinical and clinical studies, may be beneficial for patients with corneal epithelial hyperplasia and or punctate keratopathy and as well as those with persistent epithelial defects. We plan to begin enrollment in the Phase II Olympia clinical trial this quarter. As we prepare for a potential launch, there are a number of major ophthalmology meetings important for Oyster Point to attend either virtually or live during the summer of 2021, depending on the environment in light of the current pandemic. The 2021 Association for Research and Vision in Ophthalmology was held on May 1st through the 7th, OysterPoint's phase three onset two data was presented by Dr. Michael Raisman in the dry eye clinical treatment section on May 1st. The American Society of Cataract and Refractive Surgeons, ASCRS, is scheduled for July 23rd through the 27th in Las Vegas. Dr. Ed Holland will have a podium presentation with a date and time to be determined. And finally, Dr. Cynthia Matosian will be presenting data during a session at the Women in Ophthalmology 2021 Summer Symposium, August 26th through the 29th. We expect 2021 to be a pivotal year for the company as we evolve from a clinical development company to a commercial organization that remains committed to the research and development of therapies to treat diseases of the ocular surface while launching OCO and nasal spray. If approved by the FDA, our vision and focus on bringing innovative and transformative ocular disease treatments to patients and building Oyster Point Pharma into a best-in-class ophthalmology company remains steadfast. I would like to now turn the call over to John Snizerenko, Oyster Point's Chief Commercial Officer, to discuss our ongoing preparations for the potential commercial launch of OCO-1 nasal spray in dry eye disease in Q4 of 2021. Thank you, Jeff.