BRICKELL BIOTECH, INC. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS (form 10-Q) | MarketScreener

2022-08-13 03:08:24 By : Mr. Mike Ma

Table of Contents The following image summarizes our current pipeline and corresponding development programs:

BBI-02: A Potential First-in-Class Oral DYRK1A Inhibitor for the Treatment of Autoimmune and Inflammatory Diseases

BBI-10: A Covalent STING Inhibitor for the Potential Treatment of Autoimmune, Inflammatory, and Rare Genetic Diseases

Next-Generation Kinase Inhibitors: A Cutting-Edge Platform with Potential to Produce Treatments for Autoimmune, Inflammatory, and Other Debilitating Diseases

Compounds from the next-generation kinase inhibitor platform are covered by U.S. and foreign composition of matter patent applications, as well as other applications, that are currently pending in global prosecution based on our exclusive license from Voronoi related to DYRK1A, LRRK2, TTK, and CLK kinases.

Strategic, Licensing, and Other Arrangements

Exclusive License and Development Agreement with Carna

License and Development Agreement with Voronoi

Asset Purchase Agreement with Botanix

Transition Services Agreement with Botanix

This section sets forth our recent and ongoing financing arrangements, all of which involve our common stock.

Public Offerings of Common Stock and Warrants

In October 2021, we completed the sale of 30,263,400 shares of our common stock (the "October 2021 Offering"). The October 2021 Offering resulted in net proceeds of approximately $10.3 million, after deducting the underwriting discount and offering expenses payable by us.

At Market Issuance Sales Agreements

•execute a Phase 1 clinical trial, along with other nonclinical development activities, for BBI-02;

•conduct preclinical development activities for BBI-10 and experimental characterization of the STING inhibitor library;

•engage in research to identify both brain penetrant and non-brain penetrant kinase inhibitors from the next-generation kinase inhibitor platform;

•advance research and development-related activities to develop and expand our product pipeline;

•maintain, expand, and protect our intellectual property portfolio for all our assets;

•hire additional staff, including clinical, regulatory, quality, program and alliance management, scientific, and management personnel; and

•add operational and finance personnel to support product and business development efforts.

Below is a summary of our research and development expenses related to our programs by categories of costs for the periods presented.

General and administrative expenses consist primarily of personnel costs, including wages, benefits, and share-based compensation, related to our executive, sales, marketing, finance, and human resources personnel, as well as professional fees, including legal, accounting, and sublicensing fees.

We believe that the impact of recently issued guidance, whether adopted or to be adopted in the future, is not expected to have a material impact on our condensed consolidated financial statements upon adoption.

Comparison of the Three Months Ended June 30, 2022 and 2021

Research and development expenses (1,865) (8,838) General and administrative expenses (3,908) (2,891)

Comparison of the Six Months Ended June 30, 2022 and 2021

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