BBI - BBI STOCK NEWS

Brickell Biotech, Inc. (Nasdaq: BBI) announced its participation in the Piper Sandler 32nd Annual Healthcare Conference from December 1-3, 2020. CEO Robert Brown will present a corporate overview and conduct one-on-one meetings. A pre-recorded presentation will be available on the event's website and archived on Brickell's investor page for 90 days. The company is focused on innovative therapeutics for skin diseases, including its investigational drug, sofpironium bromide, for treating primary axillary hyperhidrosis, currently in a Phase 3 clinical program and approved in Japan.

Brickell Biotech, Inc. (Nasdaq: BBI) reported financial results for Q3 2020, revealing a net loss of $4.3 million, down from $4.8 million in Q3 2019. Cash and equivalents increased to $20.2 million, aided by a $13.7 million equity financing. The company initiated the Cardigan I Phase 3 trial for sofpironium bromide gel to treat hyperhidrosis and plans to start Cardigan II by year-end. Kaken, its partner in Japan, received regulatory approval for ECCLOCK® (sofpironium bromide gel, 5%) and expects to launch it commercially in late 2020.

Brickell Biotech, Inc. (Nasdaq: BBI) will report its financial results for Q3 2020 on November 12, 2020, after market close. A conference call hosted by management will occur at 4:30 PM ET on the same day to discuss these results and other corporate highlights. Brickell focuses on developing innovative therapeutics for skin diseases, with a pipeline targeting conditions like hyperhidrosis. The management team has substantial experience in product development from leading pharmaceutical and biotech firms.

Brickell Biotech, Inc. (Nasdaq: BBI) has announced an underwritten public offering of 20,833,322 shares of common stock and investor warrants for approximately $15 million. Each share is priced at $0.72, bundled with an investor warrant, exercisable at the same price over five years. The offering is set to close around October 27, 2020, dependent on customary conditions. Funds raised will support research, development, and working capital. Oppenheimer & Co. is the sole book-running manager for this offering.

Brickell Biotech (BBI) has launched its first pivotal U.S. Phase 3 clinical study, named Cardigan I, for sofpironium bromide gel, 15%, targeting primary axillary hyperhidrosis. This milestone follows the prior approval of a lower concentration gel in Japan. The study will enroll up to 350 participants, assessing safety and efficacy over six weeks. Positive past results from earlier trials indicate potential for significant improvements in hyperhidrosis symptoms. Brickell aims to submit a New Drug Application based on the outcomes of this and a subsequent trial, Cardigan II.

Brickell Biotech announced that its Japanese partner, Kaken Pharmaceutical, received approval for sofpironium bromide gel (5%) to treat primary axillary hyperhidrosis, making it the first topical prescription approved in Japan for this condition. A commercial launch is expected later this year. The approval is based on a successful Phase 3 study involving 281 patients. Brickell is also preparing to initiate its pivotal Phase 3 program in the U.S. for sofpironium bromide gel (15%) in Q4 2020. Under a sublicense agreement, Brickell will receive milestone payments and royalties from sales in Japan.

On September 8, 2020, Brickell Biotech (Nasdaq: BBI) announced a collaboration with AnGes, aiming to develop AnGes' investigational DNA vaccine for COVID-19 in the U.S. and select emerging markets. AnGes is currently conducting Phase 1/2 studies in Japan, with results expected by Q1 2021. Brickell will provide expertise while AnGes leads development in Japan. This partnership expands the vaccine's potential market reach and supports Brickell's goal to address the pandemic, alongside its Phase 3 clinical program for another product.

Brickell Biotech, Inc. (Nasdaq: BBI) has secured a composition of matter patent in Japan for novel crystalline forms of sofpironium bromide, expected to protect the compound until 2040. Partner Kaken Pharmaceutical is progressing towards a regulatory decision for a 5% sofpironium bromide gel later this year. Sofpironium bromide, an anticholinergic agent, targets primary axillary hyperhidrosis, a condition affecting millions in both the U.S. and Japan. This patent enhances Brickell's intellectual property, bolstering their position in the competitive dermatology market.

Brickell Biotech reported significant progress in developing sofpironium bromide for primary axillary hyperhidrosis. Key highlights include positive Phase 3 results in Japan and plans to initiate U.S. pivotal studies in Q4 2020. Financial results for Q2 2020 showed cash and equivalents at $21.6 million, down from $2.6 million in revenue a year prior. Research expenses fell to $2.7 million, but the net loss increased to $5.1 million. The company also confirmed Kaken is expected to receive regulatory approval in Japan by Q4 2020.