ORGANIZATION AND NATURE OF OPERATIONS

9 Months Ended

Sep. 30, 2021

Organization, Consolidation and Presentation of Financial Statements [Abstract]

ORGANIZATION AND NATURE OF OPERATIONS

ORGANIZATION AND NATURE OF OPERATIONS

Brickell Biotech, Inc. (the “Company” or “Brickell”) is a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of dermatologic, autoimmune, and other debilitating diseases. The Company’s pipeline combines a potential best-in-class, late-stage program for the treatment of hyperhidrosis with a novel, cutting-edge platform and development-stage candidates with broad potential in autoimmune and neuroinflammatory disorders. The Company’s strategy includes in-licensing, acquiring, developing, and commercializing innovative pharmaceutical products that it believes can meaningfully benefit patients who are suffering from chronic, debilitating diseases that are underserved by available therapies.

The Company’s most advanced product candidate, sofpironium bromide, is a new chemical entity that belongs to a class of medications called anticholinergics. The Company has developed sofpironium bromide, 15% as a potential best-in-class, self-administered, once daily, topical therapy for the treatment of primary axillary hyperhidrosis, also known as excessive underarm sweating. In October 2021, the Company reported positive topline results of its United States (“U.S.”) Phase 3 pivotal clinical program for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis, which achieved statistical significance on all primary and secondary efficacy endpoints and was generally well-tolerated. Sofpironium bromide gel, 5% is approved in Japan for the same indication under the brand name ECCLOCK®. The Company’s operations to date have been limited to business planning, raising capital, developing its pipeline assets (in particular sofpironium bromide), identifying and in-licensing product candidates, conducting clinical trials, and other research and development.

Liquidity and Capital Resources

The Company has incurred significant operating losses and has an accumulated deficit as a result of ongoing efforts to in-license and develop product candidates, including conducting preclinical and clinical trials and providing general and administrative support for these operations. For the nine months ended September 30, 2021, the Company had a net loss of $33.4 million and net cash used in operating activities of $31.4 million. As of September 30, 2021, the Company had cash and cash equivalents of $21.4 million and an accumulated deficit of $139.3 million.

The Company believes that its cash and cash equivalents as of September 30, 2021, combined with the net proceeds of $8.9 million received from the subsequent sale of the Company’s common stock in a public offering (see Note 8. “Subsequent Events”), are sufficient to fund its operations for at least the next 12 months from the issuance of these condensed consolidated financial statements. The Company expects to continue to incur additional substantial losses in the foreseeable future as a result of the Company’s research and development activities. Additional funding will be required in the future to continue with the Company’s planned development and other activities.