Brickell Biotech, Inc.

Greetings, and welcome to Brickle Biotech, Inc., fourth quarter and full year 2020 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, Dan Ferry, with Lifesize Advisors. Thank you. You may begin.

Thank you, and good afternoon, everyone. Joining me on today's call are Brickell's Chief Executive Officer, Rob Brown, Chief Financial Officer, Bert Marcio, Chief R&D Officer, Deepak Chadha, and Chief, excuse me, Co-Founder 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. 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 in or implied by such forward-looking statements are discussed in greater detail in our most recent filings on Form 10-K and our 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.

Thank you, Dan, and thanks to everyone for joining us on this call this afternoon. First, I will provide a business update and then ask Deepak to provide an update on our ongoing Phase III clinical program. Burt will then review the financial results we reported earlier today before we open up the call for questions. With that as an outline for the call, let's get started. We entered 2021 with a positive momentum surrounding our lead program, soft-burning bromide, which we are developing for as a potential best-in-class treatment option for the primary axillary hyperhidrosis, or more commonly known as excessive underarm sweating. Several recent achievements have put this program on a clear path, and we anticipate that various near-term milestones within the year will position the company for potential long-term success. We initiated both the pivotal Phase III clinical trials, Cardigan 1 and 2, in which we are evaluating the efficacy and safety of topically applied soft-running bromide gel, 15%, in approximately 350 patients per study. I am pleased to announce today that the Cardigan 1 study has already exceeded 50% enrollment, and we remain on track to announce top-line results for both pivotal studies in the fourth quarter of 2021. Secondly, the fourth quarter of last year, we raised approximately $13.7 million. In addition, already this year, we received approximately $10.5 million in aggregate net proceeds through the warrant exercises and the sale of shares under our existing ATM equity offering program. This capital further strengthens our balance sheets and provides us with cash runway for at least the next 12 months and allows the company to continue executing on key activities that will enable us to submit a new drug application pending the successful outcome of the pivotal phase three program. Now turning to our Japanese development partner, Kakan Pharmaceutical. Kakaen has proven to be a valuable partner. As we've previously announced, Kakaen recently launched commercial sales of soft peronium gel 5% in Japan under the brand name E-Clock for the once daily treatment of primary axillary hyperhidrosis. This is a significant milestone for both companies as Japan is the first country to approve soft peronium bromide for any indication, and soft peronium bromide is the first topical prescription product for the treatment of primary axillary hyperhidrosis in the country. As a reminder, Brickell is entitled to receive sales-based milestone payments, as well as tiered royalties based on a percentage of net sales of eClock in Japan. Along those lines, we are pleased to announce that we have already started to recognize the first of these royalties since the launch of eClock in the fourth quarter of last year. And we continue to believe that these future royalties and potential milestones have the opportunity to provide significant value to Brickell over the years to come. Lastly, I'd like to briefly touch on our collaboration agreement with Angie's, which provides us with certain rights to develop their proprietary investigational adjuvant plasmid DNA vaccine intended to prevent COVID-19. Angie's completed a Phase 1-2 study with its investigational COVID-19 vaccine candidate and recently initiated a Phase 2-3 study in Japan. As Angie's study progresses and the market evolves, we will continue to evaluate this opportunity. It is worth noting that if the development process continues for this vaccine candidate, a larger Phase 3 registration study will be required for any approval. Let's now turn the call over to Deepak for a discussion of our Phase 3 Cardigan 1 and Cardigan 2 studies. Deepak?