On May 13, 2020 Brickell Biotech, Inc. ("Brickell") (Nasdaq: BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, reported financial results for the first quarter ended March 31, 2020 and provided a corporate update (Press release, Vical, MAY 13, 2020, View Source [SID1234557902]).
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"Brickell has continued to make progress during the first quarter of 2020, and we remain committed to advancing sofpironium bromide into Phase 3 clinical studies in the U.S.," commented Robert Brown, Chief Executive Officer of Brickell. "As we continue to prepare for the initiation of our pivotal studies, we are encouraged by the top-line results of our recently completed Phase 3 long-term safety study. Furthermore, the Japanese Phase 3 pivotal study data that we expect to be presented by our Asian development partner, Kaken Pharmaceutical Co. Ltd. ("Kaken"), next month further strengthens our enthusiasm of sofpironium bromide’s potential to be a best-in-class therapy for hyperhidrosis."
Business and Recent Developments
Today, Brickell announced that, based on a preliminary review of the top-line results from the 12-month Phase 3 open-label long-term safety study, in 300 subjects >9 years old with primary axillary hyperhidrosis, sofpironium bromide gel, 5% and 15% was safe and generally well tolerated, which was consistent with the earlier Phase 2 clinical trial results. No treatment-related serious adverse events were observed.
On March 4, 2020, Brickell announced that positive results from Kaken’s Phase 3 pivotal study of topically applied sofpironium bromide gel, 5% in Japanese subjects with primary axillary hyperhidrosis were selected for oral presentation at the Late-Breaking Research Program of the American Academy of Dermatology ("AAD") Annual Meeting. Due to concerns related to COVID-19, the AAD canceled the conference and it is now rescheduled to be a virtual forum on June 12, 2020. The presentation will include details of the efficacy and safety results from Kaken’s Phase 3 pivotal study of sofpironium bromide gel.
On February 20, 2020, Brickell announced that positive results from its Phase 2b study with sofpironium bromide in patients with primary axillary hyperhidrosis were published in the peer-reviewed Journal of the American Academy of Dermatology ("JAAD"). In this Phase 2b dose-finding study, sofpironium bromide elicited clinically meaningful and statistically significant sustained reductions in sweating severity and was well tolerated. The paper, entitled "Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial," is available online (View Source) and will be published in volume 82, Issue 6 (2020) pp.1320-1327 in the June 2020 print edition of JAAD.
On February 18, 2020, Brickell announced that Brickell, Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor entered into a binding settlement agreement and an amended license agreement, concluding all litigation related thereto and allowing Brickell to continue development of sofpironium bromide for the treatment of hyperhidrosis.
On February 18, 2020, Brickell announced entry into a purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), a long-only Chicago-based institutional investor, whereby LPC purchased $2.0 million in Brickell common stock and warrants. Additionally, Brickell and LPC entered into a separate purchase agreement whereby Brickell, for up to a 36-month period, will have the right, in its sole discretion subject to satisfaction of certain conditions, to sell up to an additional $28 million of its common stock to LPC. This agreement is intended to augment the various potential sources of capital the Company may have access to as Brickell develops sofpironium bromide for the treatment of axillary hyperhidrosis.
On January 19, 2020, Brickell presented the results from pharmacokinetics and long-term safety extension trials with sofpironium bromide gel, 15% in pediatric patients (ages 9 to <17) with primary axillary hyperhidrosis at the Dermatology, Aesthetic & Surgical Conference. Sofpironium bromide was safe and well-tolerated over 24 weeks of treatment in this clinical trial.
On January 10, 2020, Brickell announced that Kaken submitted a new drug application for approval with the Pharmaceuticals and Medical Devices Agency in Japan for the manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis.
Financial Results
Cash, cash equivalents, and marketable securities were $7.1 million as of March 31, 2020 compared to $11.7 million as of December 31, 2019. In addition, Brickell has prepaid $4.6 million to third-party clinical research organizations in anticipation of commencing Phase 3 pivotal clinical trials of sofpironium bromide in the U.S.
Revenue was $1.0 million for the first quarter of 2020 compared to $3.5 million for the first quarter of 2019. The decrease in revenue recognized was attributable to the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary studies that were ongoing in 2019 but were concluded or winding down by the first quarter of 2020. Conducting these studies is the basis for revenue recognition for a $15.6 million R&D payment that was received from Kaken in the second quarter of 2018.
Research and development expenses were $2.7 million for the first quarter of 2020 compared to $6.0 million for the first quarter of 2019. This decrease was primarily due to a decrease in clinical study and other related regulatory and administrative costs of the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary studies that were ongoing in 2019, but were concluded or winding down by the first quarter of 2020.
General and administrative expenses were $2.5 million for the first quarter of 2020 compared to $2.1 million for the first quarter of 2019. This increase was primarily due to $0.3 million in higher fees for directors’ and officers’ liability insurance as a public company.
Brickell’s net loss was $4.1 million for the first quarter of 2020 compared to $4.6 million for the first quarter of 2019.
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-855-327-6837 for domestic participants and 1-631-891-4304 for international participants, with Conference ID #10009475. A live webcast of the conference call can be accessed through the "Investors" tab on the Brickell Biotech website at View Source A replay will be available on this website shortly after conclusion of the event for 90 days.
About Sofpironium Bromide
Sofpironium bromide is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. Sofpironium bromide is not approved for use in any country at this time.
About Hyperhidrosis
Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, and more than 16 million people, or 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States or 10 million individuals and an estimated 45% of patients with hyperhidrosis in Japan or 7.2 million individuals1,2. Additional information can be found on the International Hyperhidrosis Society website: View Source