On May 12, 2022 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory, and other debilitating diseases, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Vical, MAY 12, 2022, View Source [SID1234614343]).
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"Last week, we announced the sale of our rights to sofpironium bromide to Botanix Pharmaceuticals, which we believe will provide an optimal pathway for sofpironium bromide gel, 15% to become a potential best-in-class treatment for millions of patients suffering from primary axillary hyperhidrosis," commented Robert Brown, Chief Executive Officer of Brickell. "Through this transaction, we have immediately started to unlock the value of sofpironium bromide while eliminating the significant investment required by Brickell through the NDA review process and commercialization. Importantly, this sale aligns with our new business strategy to develop innovative therapeutics in the immunology and inflammatory fields. The proceeds and potential future economics from this transaction allow us to directly invest additional resources to advance our pipeline of novel, potential first-in-class therapies."
Mr. Brown continued, "As we look ahead, there are several exciting company milestones planned for 2022 and beyond, which we believe will help us address the needs of several high-impact patient populations afflicted by autoimmune and inflammatory diseases, while creating shareholder value. Our plans include conducting a first-in-human Phase 1 clinical study starting in the second quarter of 2022 for our lead DYRK1A inhibitor, BBI-02, and progressing the development of our lead STING inhibitor, BBI-10, and other next-generation kinase inhibitors through early preclinical stage studies this year."
Research and Development Highlights
BBI-02: a potential first-in-class DYRK1A inhibitor for the treatment of autoimmune and inflammatory diseases
On track to initiate the Phase 1 clinical trial of BBI-02 (BBI-02-101) in Canada in the second quarter of 2022, which is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of BBI-02 capsules in both healthy subjects and patients with atopic dermatitis (AD).
Successfully submitted the Clinical Trial Application for BBI-02 to Health Canada and subsequently received a No Objection Letter in the first quarter of 2022, allowing the BBI-02-101 study to proceed as planned.
Part 1A of the study will be a single ascending dose (SAD) assessment of BBI-02 capsules or placebo in healthy subjects. Part 1B of the study will be a multiple ascending dose (MAD) assessment of BBI-02 capsules or placebo administered once daily for 14 days in healthy subjects. Part 2 of the study will compare BBI-02 to placebo in patients with moderate-to-severe AD over 28 days of dosing, and will include a preliminary assessment of efficacy.
Topline results from the SAD and MAD parts of the Phase 1 trial are expected to be announced by early 2023.
BBI-10: a covalent STING inhibitor for the potential treatment of autoimmune, inflammatory, and rare genetic diseases
In February 2022, Brickell acquired exclusive global rights to develop and commercialize a portfolio of novel, potent, and orally available Stimulator of Interferon Genes (STING) inhibitors from Carna Biosciences, Inc., an established Japanese drug discovery company.
Preclinical development activities for BBI-10 are underway, and the Company expects to conduct experimental characterization of the STING inhibitor library throughout 2022.
Next-Generation Kinase Inhibitors: a cutting-edge platform with the potential to produce treatments for autoimmune, inflammatory, and other debilitating diseases
Currently engaged in research to identify both brain penetrant and non-brain penetrant kinase inhibitors from the Company’s library of novel compounds, including next-generation DYRK1A inhibitors and other new chemical entities that specifically inhibit LRRK2, TTK, and CLK kinases, as potential treatments for autoimmune, inflammatory, and other debilitating diseases.
Recent Events
On May 3, 2022, Brickell signed and closed a definitive asset purchase agreement with Botanix SB Inc., a subsidiary of Botanix Pharmaceuticals Limited ("Botanix"). Under the terms of the agreement, Botanix acquired all of Brickell’s rights and assets primarily related to sofpironium bromide. In exchange, Brickell received $3 million at closing and is eligible to receive up to $6 million in potential near-term regulatory milestone payments over the next 18 months from Botanix. Brickell also is eligible to receive additional success-based regulatory and sales milestone payments of up to $168 million and tiered earnout payments ranging from high-single digits to mid-teen digits on net sales of sofpironium bromide gel. Certain of these amounts are subject to payments by Brickell to its former licensor. Brickell additionally will receive certain payments from sales by its former sublicensee, Kaken Pharmaceutical Co. ("Kaken"). Botanix will be responsible for all further research, development, and commercialization of sofpironium bromide globally. In connection with the sale of sofpironium bromide, Brickell and Botanix entered into a transition services agreement whereby Brickell will provide consulting services to Botanix as an independent contractor through submission and potential approval of the U.S. NDA for sofpironium bromide gel, 15%.
On May 3, 2022, Brickell adjourned its 2022 annual meeting of stockholders to May 17, 2022 at 10 a.m. MDT. At the time the annual meeting was adjourned, proxies had been submitted by stockholders constituting a quorum, but there were not sufficient votes to approve two of the proposals, one related to an increase in the number of authorized shares of common stock and the other to approve a reverse stock split, each of which requires approval by the holders of a majority of the outstanding shares of common stock of Brickell. Brickell continues to solicit votes from its stockholders with respect to all of the proposals for the annual meeting.
First Quarter 2022 Financial Results
The Company reported cash and cash equivalents of $17.3 million as of March 31, 2022, compared to $26.9 million as of December 31, 2021. The Company expects its cash and cash equivalents as of March 31, 2022, combined with $3.0 million in upfront fees it received from Botanix on May 3, 2022, and other expected near-term milestone payments under the agreement with Botanix, will support its operations for at least the next 12 months.
Revenue was $92.0 thousand for the first quarter of 2022, compared to $17.0 thousand for the first quarter of 2021. Revenue in both periods resulted from royalty revenue related to sales of ECCLOCK (sofpironium bromide gel, 5%) in Japan by Kaken.
Research and development expenses were $6.0 million for the first quarter of 2022, compared to $6.1 million for the first quarter of 2021. During the first quarter of 2022, Brickell incurred $3.3 million in lower clinical costs related to its U.S. Phase 3 pivotal clinical program for sofpironium bromide gel, 15%, which was completed in the fourth quarter of 2021. This decrease was almost fully offset by increases of $2.0 million in upfront costs related to Brickell’s acquisition of the STING inhibitor platform, $0.7 million in development costs related to its DYRK1A inhibitor program, and $0.4 million related to personnel and other expenses.
General and administrative expenses were $3.5 million for the first quarter of 2022, compared to $3.0 million for the first quarter of 2021. The increase was primarily due to higher compensation-related expenses, professional fees, insurance, and other miscellaneous expenses.
Brickell’s net loss was $9.4 million for the first quarter of 2022 compared to $9.0 million for the first quarter of 2021.
Conference Call and Webcast Information
Brickell’s management will host a conference call today at 4:30 p.m. EDT to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-877-705-6003 for domestic participants and 1-201-493-6725 for international participants, with Conference ID #: 13728736. A live webcast of the conference call can be accessed at (click here) or through the Investors section of the Brickell website at View Source A replay will be available on this website shortly after conclusion of the event for approximately 90 days.