Brickell Biotech, Inc.

Greetings and welcome to BRCO Biotech's fourth quarter and full year 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 call over to Garth Russell of LifeSci Advisors. Thank you. You may begin.

Thank you, operator. And good morning, everyone. Joining me on today's call are BRICL's Chief Executive Officer, Rob Brown, Chief Operating Officer, Andy Scholar, Chief Financial Officer, Bert Marcio, Chief Medical Officer, Dr. Monica Lucchi, and Chief R&D Officer, Deepak Chadha. 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 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. Rob, the floor is yours.

Thanks, Garth. Good morning to everyone, and thank you for joining our call today. The past year was an exciting period in our company's history as the entire Brickell team executed against our growth strategy and successfully delivered on several key milestones that we believe will strengthen our ability to create long-term value for shareholders. This is highlighted by our recent partnering activity through which we've now established our presence in the field of immunology and inflammation by expanding our pipeline with multiple proprietary new chemical entities that modulate promising and novel targets. These include our phase one ready oral DERK1A inhibitor BBI-02, preclinical stage sting inhibitor portfolio, including our lead sting inhibitor candidate BBI-10, and our next-generation kinase inhibitor platform, all of which we acquired over the past seven months. We believe that our team's clinical and regulatory experience and track record of operational execution is what sets Brickle apart as a trusted partner to lead the development of these assets. A perfect example of this is soft-growing bromide, our most advanced program, which the Berkel team developed from an early preclinical stage to its current NDA-ready stage. As you may recall, during the fourth quarter of last year, we announced positive data from our two U.S. Phase III pivotal clinical studies of soft-growing bromide gel 15%, or SB gel for short, for the treatment of primary axillary hyperhidrosis. also known as excessive underarm sweating. In both studies, all primary and secondary efficacy endpoints achieved statistical significance, and SBGEL was generally well tolerated over six weeks of treatment. We believe the results of these studies further support the potential for SBGEL to become a best-in-class treatment option. Earlier this quarter, we held a pre-NDA meeting with the US FDA for SBGEL. Based on the outcome of this meeting, we remain on track for NDA submission in mid-2022 as we continue to evaluate and parallel all available options to maximize commercial product success. Now I'd like to pass it over to Deepak for an update on our pipeline. Deepak?