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SCYNEXIS, Inc.
11/9/2022
And welcome to the CINEXUS 3rd Quarter 2022 Honors Conference Call. All participants will be in a listen-only mode. Should you need assistance, please signal a conference specialist by pressing the Start key followed by 0. After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press Start then 1 on your telephone keypad. To withdraw your question, This press is starting to. Please note this event is being recorded. I would now like to turn the conference over to Debbie Exson, Executive Director, Communication and Investor Relations. Please go ahead.
Hello, everyone, and welcome to today's conference call to discuss our third quarter 2022 financial results and corporate updates. 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, November 9th, 2022. Cinesys 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 Synexis President and CEO, Dr. Marco Taglietti, Chief Medical Officer, Dr. David Angulo, and Chief Financial Officer, Ivor McLeod. Following our prepared remarks, we'll open the call to your questions. Now, I will 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 third quarter 2022 earnings investor call. I want to begin by drawing your attention to a recent report issued by the World Health Organization or WHO. This was the first ever list of priority deadly fungal pathogens that are becoming a growing global public health menace. The list includes well-known vicious pathogens, such as Candida aureus and other Candida species, albicans, glabrata, parapsilosis, tropicalis, and moths, like Aspergillus fumigatus, histoplasma, mucorales, all pathogens against which Ibrexa punjab shows great activity, even in strains highly resistant to other antifungals. And the data from our Phase III studies, Fourier and CARES, provides evidence clinical hard evidence of the activity of a Brexafen gerb against severe, difficult-to-treat fungal infection, even when they are refractory to currently available treatments. Moreover, this WHO's call for action is further validating our corporate strategy to refocus on life-threatening invasive fungal infections while monetizing Brexafen in vulvovaginal candidiasis. So we at Synexis are proud to be on the front lines with a brush-up on germs to fight this never-ending warfare against antimicrobial resistant pathogens. We are prepared and we are ready. David will provide more details on our continuing efforts to stay in front of these deadly fungal pathogens. As we have recently announced, Synexis is transforming the company by refocusing our resources to the clinical development of the oral and intravenous liposomal formulation of Ibrexa fungér for severe hospital-based indications where higher long-term returns are expected. This is the right strategy at this time because of the growing threat of serious and potentially deadly fungal infections that I just mentioned, where we believe Ibrexa fungér can play a significant role saving lives while achieving its full market potential. At the same time, we are actively pursuing suitable commercialization partners for Brexfam in the U.S. for vulva vagina candidiasis, and for iBrexfam in Europe outside of the U.S. And we are making good progress on this front. Stay tuned. While we are in the process of out-licensing Brexfam in the U.S. for BBC, We will continue to keep this important product on the market in the U.S. and to make it available for the many patients who can benefit from its proven efficacy. We will minimize the resources allocated to the active promotion of Brexfem in order to redirect our cash to the development of the more urgent hospital indications. Our supplemental NDA filing for recurrent VBC is on track with the due for decision date of November 30th, 2022. If approved for this second indication, BrexFM will be the first and only therapy approved in the U.S. for both the treatment of VBC and the prevention of recurrent VBC. We believe that this anticipated second indication is extremely attractive to a commercialization partner and will help expand patients' access to our innovative treatment. On the corporate side, we closed the third quarter of 2022 with more than $96 million in cash, and with our new restructuring plan, we have extended our cash runway into the second quarter of 2024. This cash is expected to support our hospital programs to enable additional regulatory filings in 2024. Ivor McLeod, our new CFO, will provide more details on our expenses and cash balance. And then we will open the floor for the Q&A session. Now let me turn to BrexFM performance in vaginal infections for this quarter. We continue to increase the number of BrexFM prescribers. In Q3, almost 2,500 HCPs prescribed BrexFM. representing an increase of 11% quarter-over-quarter, and even an higher increase, over 30%, of repeat prescribers, showing that when HCPs use Brexafen for their patients, they are willing to prescribe it again. Brexafen prescriptions continued to grow in the third quarter. We generated almost 5,800 prescriptions in the third quarter of 2022. representing 30% growth over the second quarter of 2022, continuing a trend of growth. However, we do expect some disruption to this trend in the fourth quarter as a result of our decision to end the in-person promotion with Amplitude. After signing our contract with a major national pharmacy benefit manager, PBM, in October, we successfully garnered Breast FM coverage of 130 million commercially insured lives, representing 70% of the commercial universe. I will now turn the call over to Dr. David Angulo, our Chief Medical Officer and future Chief Executive Officer. David? Thank you, Marco.
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