Brickell Biotech, Inc.

Greetings, and welcome to Brickell Biotech, Inc. First Quarter 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 a conference, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Garth Russell, with LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good afternoon, everyone. Joining me on today's call are BRICLS Chief Executive Officer Rob Brown, Chief Financial Officer Bert Martial, Chief R&D Officer Deepak Chadha, and Co-Founder and Chief Operating Officer Andy Squalor. Before we begin, I would like to remind everyone that this conference call and webcast will contain certain forward-looking statements about the company. These statements are subject to risks and uncertainties that could cause actual results to differ. Please note that these forward-looking statements reflect our opinions only as of the date of this call. We will not undertake any obligation to revise or publicly release these results, 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 that differ materially from those expressed or implied by such forward-looking statements are discussed in greater detail in our most recent filing on Form 10-K. and other periodic reports on Form 10Q and 8K as 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 thanks for joining us on our call. The beginning of 2021 has been a very exciting time here at Brickell. We continue to steadily advance our lead program, soft pronium bromide, through Phase III pivotal clinical trials, evaluating its safety and efficacy as a potential best-in-class treatment option for primary axillary hyperhidrosis, also known as excessive underarm sweating. This year, we've achieved some key milestones for soft craniobromine. First, we announced that patient enrollment was completed in the CARDIGAN1 study, and the CARDIGAN2 study surpassed 70% enrollment. As a reminder, both Phase III pivotal clinical studies are evaluating soft-pronium bromide gel 15% against placebo in approximately 350 patients each with primary axillary hyperhidrosis. Both cardigan studies remain on track, and we expect to announce top-line results from the Phase III program in the fourth quarter of 2021. Second, we are pleased to have the results of our Phase III open-label long-term safety study of soft-pronium bromide gel highlighted during a late-breaking oral presentation by Dr. Stacey Smith at the American Academy of Dermatology's 2021 virtual meeting experience in April. These results are important as they further support the safety, tolerability, and efficacy data we previously observed in our Phase IIb study. Considering primary axillary hyperhidrosis is a chronic condition, we expect this long-term data along with the two Phase III Pivotable Clinical Studies to form the basis for our prospective NDA filing. Third, in March, we hosted our first-ever Hyperhidrosis KOL event for investors, analysts, and other interested stakeholders. The event was led by two highly distinguished hyperhidrosis thought leaders in Drs. Adam Friedman and Joel Cohen. Through this event, we were able to share what many hyperhidrosis patients deal with in managing their daily lives, what the current treatment options are, and why we believe that hyperhidrosis remains an undertreated medical condition, adversely affecting their quality of life. If you are unable to attend the event, I encourage you to watch a replay, which can be found in events and presentations, on the investor sections of our company's website. Now turning to our Japanese development partner, Kaken Pharmaceuticals. As we previously announced, Kakan is still in the early stages of its commercial launch of soft-pronine bromide gel 5% in Japan under the brand name eClock for the once-daily treatment of primary axillary hyperhidrosis. The eClock launch is an important milestone for both companies, with Japan being the first country to approve soft-pronine bromide for any invocation and eClock being the first topical prescription product for the treatment of primary axillary hyperhidrosis in the country. As a reminder, BRICL is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of ECLOC in Japan. Finally, as a result of certain warrant exercises and proceeds raised through our ATM offering program, we've strengthened our balance sheet with $34.8 million of cash as of March 31st, 2021. This added financial stability provides us with sufficient cash runway to fund our operations in the next year and allows us to continue executing on key activities that will enable us to submit a new drug application with the FDA for soft bromine bromide gel in 2022, pending a successful outcome in phase three pivotal programs. Let's now turn the call over to Deepak to provide a clinical update. Deepak?