SCYNEXIS, Inc.

Greetings and welcome to Synexis Inc. first quarter 2022 earnings conference call. At this time, all participants are in listen-only mode. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. Now I'd like to turn the conference over to your host, Debbie Hutchinson from Investor Relations. Please go ahead, ma'am.

Thank you. Thank you. Hello, everyone, and welcome to today's conference call to discuss our first 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, including, in each case, under the caption, Risk Factors, and in other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements speak only as of today May 12, 2022. Cinexus 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 today on our call is Cinexus 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 will turn the call over to Dr. Marco Teglietti, President and CEO.

Thank you, Debbie. Good morning, everyone. Buongiorno a tutti. Thank you for joining us today for our first quarter of 2022 earnings in Best of Corn. We are excited. to share with you updates on the progress of the launch of Brexafen and to outline our vision for the future of the iBrexafen Jerk franchise. 2022 is a pivotal year for Synaxis, and we are making great strides. Let me briefly summarize a few key recent accomplishments and near-term goals. On the R&D side, we continue our successful efforts to expand the labeling of iBrexafen Jerk. We expect to file the supplemental NDA for the recurrent BBC indication this quarter with an approval by the end of this year. We reported positive results from the new interim analysis of the Fourier and CARES trials, highlighting oral ibrexafone jerks' potency against severe fungal infections, with more than 83% of combined patients demonstrating a clinical response to oral ibrexafone jerks. Finally, the MARIO study is being initiated, and we expect the first patients to be enrolled soon. The MARIO study is expected to report results in 2024 with a potential approval for hospital indications by end of 2024. Dr. David Angulo, our chief medical officer, will provide you more details on this program and the positive results to date. Our first commercial product, Brexafem, a Brexafunger tablet, launched in September 2021, achieved nearly 4,000 prescriptions and reached the net revenues of $700,000 in the first quarter of 2022. We saw a promising growth trend in the first quarter of 2022 as we continue to boost our efforts to accelerate sales this year and beyond to reach our goals. Our Chief Commercial Officer, Christine Cohen, will discuss the set of coordinated and integrated actions that we are taking to grow prescriptions from field sales force to launching a direct to patient campaign. On the corporate side, we closed the first quarter 2022 with more than $95 million in cash. We've been extremely fortunate and very thankful to our investors for being able recently to strengthen our available cash with $45 million public offering. which will enable us to advance our goal of building a broad antifungal franchise for Ibrexa fungér across multiple indications. I say fortunate because strengthening our cash situation will allow us to navigate successfully through the current, let's call it, environmental challenges of today's world. A war in Ukraine, I mean a war in the heart of Europe, The pandemic that we hope, but we don't know yet if it's over. Inflation, higher interest rates, and whatnot. Having secured the cash to fund our corporate activities into the first quarter of 2024 puts us in a strong position. In fact, based on our cash, we currently have the resources to support our commercial efforts in VVC, including preparing for the launch in 2023 of Recurrent VVC, and we have the resources to complete our hospital programs to enable additional regulatory filings in 2024. And by the way, we also continue to look for business development deals like the one we did with Hanso for Greater China, and for other non-dilutive ways to strengthen our cash balance. I would like to underscore that our vision to make Ibraxia Fungi Earth a successful, sustainable, and profitable antifungal franchise is becoming a reality. With BrexFM now approved and launched for the treatment of BVC, we plan to expand its labeling by end of this year, as I mentioned, to include the prevention of recurrent BVC. We are diligently and successfully following our plan to attain each key milestone along our path to build a broad, long-lasting antifungal franchise. All these indications, when taken together, We'll create a franchise with the potential to generate $700 to $800 million a year in net sales in the U.S. alone. Larry, our interim CFO, 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?