Brickell Biotech, Inc.

Musik Musik Musik Musik Musik Greetings and welcome to the Brickell Biotech Inc. 3rd Quarter 2020 Financial Results Call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star 0 on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Dan Ferry of LifeSciAdvisors. Thank you, you may begin.

Thank you, and good afternoon everyone. Joining me on today's call are BRICL's Chief Executive Officer, Rob Brown, Chief Financial Officer, Mike Carruthers, Chief R&D Officer, Deepak Chadha, and 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 our call this afternoon. I will provide a business update, and then ask Deepak to provide an update on our Phase 3 clinical program, and then Mike will review the financial results we reported earlier today. We continue to build positive momentum on our lead program, developing soft pronium bromide as a potential best-in-class treatment option for primary axillary hyperhidrosis, or more commonly described as excessive underarm sweating. Several recent achievements have put us on a clear path forward for this program with a set of near-term milestones on the horizon. Let me take a minute just to touch on some of our recently achieved milestones before I turn it over to Deepak to offer more detail on our Phase 3 program. First, we initiated the Phase 3 Cardigan 1 clinical study to evaluate the safety and efficacy of topically applied soft pronium bromide gel, 15%, for the treatment of primary axillary hyperhidrosis. Enrollment is going as planned. Additionally, we remain on track to initiate the second phase 3 study, Cardigan 2, before the end of the year. We anticipate announcing top-line results from these studies in the fourth quarter of 2021. We completed an equity financing round with net proceeds of approximately $13.7 million. This additional capital strengthens our balance sheet and is expected to fully fund our operations beyond top-line results of the U.S. Pivotal Phase III program. As previously mentioned during our last call, in July we completed our 12-month Phase III open-label long-term safety study, evaluating soft peronium bromide gel 5% and 15%, which confirmed both concentrations were safe and generally well tolerated. This data is consistent with our earlier Phase II clinical trial results. We expect to release additional details at an upcoming scientific forum. Now, turning to our Japanese development partner, Kakan Pharmaceutical. This past September, they received regulatory approval in Japan to manufacture and market soft protein bromide gel 5% under the brand name E-Clock, for the treatment of primary axillary hyperhidrosis. Kakan is now fully focused on launching eClock in Japan later this year. Important to note, Japan is the first country to approve soft pronium bromide for any indication. Furthermore, soft pronium bromide is a first-in-class therapy in Japan, and is also the first topical RX product for the treatment of primary axillary hyperhidrosis to be approved and marketed there. 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 soft pruning bromide gel in Japan. This could represent significant value to Brickell over the years to come. Importantly, together with Kakan, we were granted by the Japanese Patent Office a composition of matter patent, with claims directed to the novel polymorphic or crystal forms of soft protein bromide that is expected to provide additional protection for these newly developed and distinct forms in Japan through 2040. We are actively prosecuting patents related to this subject matter on a global basis. Lastly, we entered into a collaboration agreement with Anges, which provides us with certain rights to develop their proprietary patents investigational adjuvant plasma DNA vaccine intended to prevent COVID-19. Our rights include the U.S., South America, and certain other emerging markets. Angie's is conducting Phase I and Phase II clinical studies with its vaccine candidate in Japan, with data readouts expected through the first quarter of 2021. The results from these studies will guide our decision around any potential development efforts of this novel vaccine candidate. Now let's turn it over to Deepak to discuss our Phase 3, Cardigan 1, and Cardigan 2 studies. Deepak?