Brickell Biotech Inc. (NASDAQ: BBI) has announced its financial results for the third quarter ending September 30, 2021, and offered a corporate update.
Brickell reported sofpironium bromide gel study data
The company disclosed encouraging topline findings from Phase 3 pivotal clinical trials of sofpironium bromide gel, with a 15 percent success rate in primary axillary hyperhidrosis patients. Plans are underway to file an NDA to the FDA in mid-next year. Currently, DYRK1A inhibitors are still being developed, with a Phase 1 study for BBI-02 set to begin in 2022.
CEO Robert Brown stated, “This has been an exciting period for Brickell, as we announced positive data from our Phase 3 pivotal clinical studies of sofpironium bromide gel, 15% and expanded our pipeline with the acquisition of a Phase 1-ready DYRK1A inhibitor and cutting-edge platform with broad potential in autoimmune and inflammatory disorders. We look to build on this momentum by focusing on several near-term clinical, regulatory, and operational milestones that we believe can drive our growth.”
Brown added, “We were pleased to announce last month that the Phase 3 Cardigan I and Cardigan II studies of sofpironium bromide gel, 15% in patients with primary axillary hyperhidrosis, or excessive underarm sweating, achieved statistical significance on all primary and secondary efficacy endpoints. Based on the positive results from these studies, we expect to submit an NDA for sofpironium bromide gel, 15% to the FDA in mid-2022. As we plan the commercial strategy for sofpironium bromide gel, 15%, if approved, we are evaluating all available options to maximize commercial product success and long-term value for the company.”
Brickell had $21.4 million at the end of the quarter
As of September 30, 2021, the Company has $21.4 million in cash and cash equivalents, compared to $30.1 million as of December 31, 2020.
For the third quarter of 2021, revenue was $0.1 million, which was made up of royalty revenue from Kaken’s sales of ECCLOCK® in Japan. A year ago, revenue was also $0.1 million, mostly due to collaboration revenue recognized for research and development funds provided by Kaken to Brickell in 2018.
