Brickell Biotech, Inc.

Greetings. Welcome to the Brickell Biotech Inc. Q3 2021 Financial Results Conference 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. Please note this conference is being recorded. I will now turn the conference over to your host, Garth Russell with LifeSci Advisors. 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, Burt Marcio, Chief Medical Officer, Monica Lucchi, Chief R&D Officer, Deepak Chadha, and Chief Operating Officer, Andy Squalor. Before we begin, I would like to remind everyone that this conference call and webcast contain certain forward-looking statements about the company. These statements are subject to certain 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 that 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 Form 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. The past couple months has been an exciting period in our company's history as we successfully delivered on several key milestones that we believe position us to execute against our future growth strategies and create long-term value for shareholders. Just last month, we announced positive data from our two Phase III pivotal clinical studies of soft-cronin bromide gel, 15%, 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 SB gel was generally well-tolerated over six weeks of treatment. to briefly summarize the key takeaways from the phase three cardigan studies top line results, starting with the co-primary efficacy endpoints. SVGEL resulted in a statistically significant greater proportion of subjects achieving at least a two-point improvement on the HDSM-AX7 patient-reported outcome scale from baseline to end of treatment as compared to vehicle, And SBGEL resulted in statistically significant greater reduction in sweat production from baseline to end of treatment when compared to vehicle. The results of all three secondary efficacy endpoints were statistically significant, favoring SBGEL over vehicle. SBGEL was generally well tolerated. The majority of treatment emergent adverse events in the SBGEL group were mild or moderate in severity and transient in nature. no treatment-related serious adverse events were reported. We appreciate the commitment from everybody that contributed to these two phase three pivotal studies, including the patients, study investigators, our CROs, partners, and the BRICL team. Looking forward, these results will form the basis for a new drug application, or NDA, to the US FDA, which we expect to submit in mid-2022. In addition, the results of these studies further support the potential for SBGEL to be a best-in-class treatment option. We will evaluate all options as we plan for the potential commercialization of SBGEL and will base any strategic decision on what we've determined to most likely to maximize the value of the asset for our shareholders while positioning the company for growth. Turning to our new pipeline programs, the DERK1A inhibitor platform. In September, we announced the acquisition of a phase one ready DERK1A inhibitor and cutting edge platform of small molecule precision MCEs with broad potential to treat autoimmune and inflammatory disorders. There are several key reasons we are excited about this platform technology. First, this is a novel mechanism. that comes with the potential to target both the adaptive and innate immune responses in patients whose immune system is imbalanced due to an underlying disease. Targeting DERK1A aims to restore this immune balance. Notably, achieving immune homostasis is an emerging field in the industry with real potential to completely change the way we think about treating autoimmune and inflammatory diseases. We believe there exists a significant market opportunity here for the DERK1A program under development, which is covered by strong IP position, including composition of matter patents in the U.S., Japan, China, and other countries through at least 2038. The initial lead program we will be advancing with this platform is DBI-02, which is a phase one ready, highly selective, orally bioavailable DERK1A inhibitor. BBI-02 has a scientifically robust data package that includes a thorough characterization of the molecule and its proposed mechanism of action, as well as a non-clinical data package that we believe supports the initiation of a first in human study. In addition, we have preclinical efficacy data in over 10 different animal models of various autoimmune diseases, which confirm that BBI-02 It has best-in-class potential to target autoimmune disorders. With respect to the next steps, we plan to initiate a Phase I study for BBI-02 in Canada in the first half of 2022, with top-line results anticipated by the end of 2022. This study picks up on the planning Voronoi, the company we acquired the asset from, had started, so we believe it is the most efficient path forward to initiate this first in-human study. Our second program from this platform, BBI-03, is a topically applied DERK1A inhibitor that is currently in the preclinical stages of development. Like BBI-02, BBI-03 has been tested in several preclinical efficacy models and has displayed promising preclinical efficacy in various debilitating diseases such as psoriasis and atopic dermatitis. Our team expects to conduct formulation development activities for the BBI-03 program next year. Lastly, the platform we acquired provides us with the possibility to expand efforts from immunology to neuroinflammation. To this end, we aim to select and initiate development of a lead next generation candidate from the platform in 2022. I want to take this opportunity to remind everyone that we recently hosted a webinar featuring a presentation by Key Opinion Leader Dr. Bernard Kaur of the Benaroya Research Institute. During this event, Dr. Kaur discussed the latest findings on the novel DERK1A target, its role in autoimmune and inflammatory diseases, and the broad therapeutic potential of restoring immune homostasis by inhibiting DERK1A. A replay of this event is available on the Investors section of our website. We believe this webinar offers a wealth of information about our novel therapeutic platform, and I invite everyone to listen to the event. Before I hand the call over to Bert for a financial update, I'd like to highlight two other recent events for the company. First, we expanded our leadership team with the appointment of Dr. Monica Lucchi as BRICL's chief medical officer. Dr. Lucchi brings over 20 years of immunotherapeutic and drug development experience to BRICL and will lead our clinical development and medical affairs functions. Second, we strengthened our balance sheet with the recent completion of an equity offering resulting in net proceeds of approximately $8.9 million, which Bert will discuss in more detail in a moment. With that, I'd like to turn the call over to Bert to provide a financial overview. Bert?