SCYNEXIS, Inc.

ladies and gentlemen good morning and welcome to the synexis inc second quarter 2022 earnings conference call at this time all participants are in a listen-only mode a question and answer session will follow the formal presentation if anyone should require operator assistance during the conference please press star 0 on your telephone keypad as a reminder this conference is being recorded I will now turn the conference over to Ms. Debbie Acheson, Communications and Investor Relations. Please go ahead.

Thank you. Hello everyone, and welcome to today's conference call to discuss our second quarter 2022 financial results and corporate update. Before we start, let me remind you that today's call will include forward-looking statements based on current expectations, including statements concerning our financial outlook for the future. leadership expectations for our future financial and operational performance, as well as our business strategy. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Please refer to our filings with the Securities and Exchange Commission, including our most recent annual report on Form 10-K and quarterly report on Form 10-Q, included in each case under the caption, Risk Factors. and another document subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today, August 15, 2022. Cenexus undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made. The information on today's call is not intended for promotional purposes and not sufficient for prescribing decisions. Joining us on today's call are Cenexus President and CEO, Dr. Marco Taglietti, Chief Commercial Officer Christine Coyne, Chief Medical Officer Dr. David Angulo, and Interim Chief Financial Officer Larry Hoffman. Following our prepared remarks, we'll open the call to your questions. Now, I'll turn the call over to Dr. Marco Taglietti, President and CEO.

Thank you, Debbie. Good morning, everyone. Buongiorno a tutti. Thank you for joining us today for our second quarter of 2022 earnings investor calls. Things are moving forward nicely here at Senexis. We are now one of the leading standalone anti-infective companies, a sector market by unpredictability and utmost urgency. We built a solid track record in drug development by achieving not only the approval of the first new class of antifungals in over 20 years, but by continuing to progress toward expanding the labeling and the use of iBrexaphone GERP. We launched iBrexaphone GERP with brand name Brexaphone last summer, and we have seen a steady adoption of Brexaphone despite the headwinds of the macro environment. Finally, we are well capitalized to execute on our goal of building a broad, long-lasting antifungal franchise, and we have a number of upcoming projects catalysts in 2022 and beyond. We continue to move Synaxis onward. Let me briefly summarize a few key accomplishments of the second quarter. FDA has assigned a November 30th, 2022 PDUFA date for our supplemental new drug application to expand the labeling of Brexfam to include the recurrent VVC indication. If approved for this second indication, Brexafem will be the only, only antifungal approved for both treatment of DBC and prevention of recurrent DBC. This is a critical piece of our commercial strategy to build additional confidence with both payers and prescribers and drive increased prescription growth. We have also started the Phase 3B vanquished study of oralibrexafum gerb in DBC patients who don't respond to fluconazole treatment. The goal of this trial is to further demonstrate Ibrexa-Punger's efficacy in treating the most challenging BVC patients. With regard to hospital indications, enrollment has started for the MARIO study in invasive candidiasis, with top-line results expected in 2024 and the potential approval by end of 2024. Dr. David Angulo, Our chief medical officer will provide you more details on these programs and the positive results to date. Our first commercial product, Brexafen, a Brexafen tablet, which Synexis launched in September 2021, achieved over 5,100 prescriptions and reached net revenues of $1.3 million in the second quarter of 2022, nearly double of what we did in the first quarter. We are excited by this progress as we work toward achieving our mission to meet the significant unmet needs in women's health today and beyond. Our Chief Commercial Officer, Christine Coyne, will provide more details on our commercial plans going forward. On the corporate side, we closed the second quarter of 2022 with more than $118 million in cash, having raised successfully $45 million in April despite the challenging times in the market, and we continue to have a solid cash runway into the first quarter of 2024. This cash is expected to support our refreshed commercial launch in recurrent VDC in early 2023. We also have the resources to complete our hospital programs to enable additional regulatory filings in 2024. Larry Hoffman, our interim chief financial officer, will provide more details on our expenses and cash balance. And then we will open the floor for a Q&A session. Now, I would like to turn the call over to our chief commercial officer, Christine Coyne. Christine?