Brickell Biotech, Inc.

Greetings, and welcome to Brickell Biotech Incorporated's Q2 2021 Financial Results 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 zero on your telephone keypad. As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Garth Russell of LifeSci Advisors.

Thank you, Operator, and good afternoon, everyone. Joining me on today's call are BRICL's Chief Executive Officer, Rob Brown, Chief Financial Officer, Burt Marcio, Chief R&D Officer, Deepak Chadha, and Chief Operating Officer, Andy Scholar. Before we begin, I would like to remind everyone that this conference call and webcast will contain forward-looking statements about the company. These statements are subject to risks and uncertainties that could cause actual results to differ materially. Please note that these forward-looking statements reflect our opinions only as of the date of this call. We will not undertake obligation to revise or publicly release the results of any revisions to these forward-looking statements in light of new information or future events. Factors that could cause actual results or outcomes to differ materially from those expressed or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and other periodic reports on Forms 10-Q and 8-K filed with the SEC. I would now like to turn the call over to the company's Chief Executive Officer, Rob Brown. Rob, the floor is yours.

Thanks, Garth. Good afternoon, everyone, and thank you for joining our call today. So far, 2021 has been a tremendously productive year for the entire BRICL team. As we've executed against our strategy to advance soft trunnion bromide through our pivotal Phase III program as a potential best-in-class treatment option for primary axillary hyperhidrosis, also known as excessive underarm sweating. First off, we recently announced that we completed enrollment in both of our phase three pivotal clinical studies, cardigan one and cardigan two, respectively, and that the last hyperhidrosis patients completed all scheduled visits in the cardigan one study. We expect the last hyperhidrosis patient in the cardigan two study to complete their final visit this month. Accordingly, We remain on track to receive and concurrently announce top-line results for both cardigan studies in the fourth quarter of this year. Secondly, as many of you are aware, we recently completed a financing of approximately $8.1 million. With this infusion of capital, we now expect to have sufficient cash to fund our operations beyond the potential NDA submission for soft-pronion and grub-mide gel 15% to the U.S. FDA. which is anticipated to occur in mid-2022, pending the Phase III results. Turning now to updates from Japan, Kakan is still in the very early stages of its commercial launch of E-Clock, or soft chromine bromide gel 5%, for the once-daily treatment of primary axillary hyperhidrosis in Japan. The E-Clock launch is an important milestone for both companies, as Japan is the first country to approve soft chromine bromide For any indication, an e-clock is the first topical prescription product for the treatment of primary axillary hyperhidrosis in the country. In addition to the benefit of Kakan building a regulatory and commercial track record for soft tronium bromide, Brickell currently receives royalties based on a percentage of net sales of e-clock in Japan and is also entitled to receive sales-based milestone payments. We are encouraged by Kakan's early sales progress as well as their continued investment in the commercial ramp-up of e-clock, disease state awareness, and life cycle management activities. Along those lines, this brings me to the most recent news of Kaken. In June, Kaken initiated a Phase I clinical study exploring the pharmacokinetics, safety, and efficacy of soft-pronion bromide gel in patients with primary palmoplantar hyperhidrosis or excessive sweating of the palms and soles. This is an extremely embarrassing and anxiety-provoking dermatological disorder that commonly interferes with the social and professional aspects of daily life, and there are currently no approved topical prescription treatment options for this disease in Japan or the United States. We look forward to seeing the results of this Phase I study, which will help us and Kakan determine next development steps, if any, in this new potential indication. Now let's turn the call over to Deepak to provide a clinical update. Deepak?