BBI Brickell Biotech, Inc.

0.89
0  -0%
Previous Close 0.89
Open 0.9
52 Week Low 0.7101
52 Week High 6.51
Market Cap $24,339,879
Shares 27,271,573
Float 25,320,564
Enterprise Value $17,386,786
Volume 433,761
Av. Daily Volume 2,192,354
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Drug Pipeline

Drug Stage Notes
Sofpironium Bromide
Axillary hyperhidrosis
Phase 3
Phase 3
Phase 3 Japanese trial met all primary and secondary efficacy endpoints - June 15, 2020.

Latest News

  1. BOULDER, Colo., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that it will report its financial results for the second quarter ended June 30, 2020, after the market close on Wednesday, August 12, 2020. Brickell's management will host a conference call and webcast at 4:30pm ET to discuss the financial results and recent corporate highlights.

    To access the call, please dial 877-705-6003 in the U.S. or 201-493-6725 outside the U.S. and provide the conference ID number: 13706625. To access the live webcast, please go to the investors…

    BOULDER, Colo., Aug. 03, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that it will report its financial results for the second quarter ended June 30, 2020, after the market close on Wednesday, August 12, 2020. Brickell's management will host a conference call and webcast at 4:30pm ET to discuss the financial results and recent corporate highlights.

    To access the call, please dial 877-705-6003 in the U.S. or 201-493-6725 outside the U.S. and provide the conference ID number: 13706625. To access the live webcast, please go to the investors section of Brickell's website at https://ir.brickellbio.com/events-presentations. Following the live webcast, an archived version of the call will be available on the website.

    About Brickell Bio

    Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell's pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell's executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell's strategy is to leverage this experience to in-license, acquire, develop, and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit http://www.brickellbio.com.

    Brickell Investor Contact:

     

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  2. BOULDER, Colo., June 17, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced the pricing of an underwritten public offering of 17,500,000 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 17,500,000 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one investor warrant to purchase one share of common stock at…

    BOULDER, Colo., June 17, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced the pricing of an underwritten public offering of 17,500,000 shares of common stock or common stock equivalents (which includes pre-funded warrants to purchase shares of common stock in lieu of shares of common stock) and investor warrants to purchase up to an aggregate of 17,500,000 shares of common stock. Each share of common stock (or pre-funded warrant in lieu thereof) is being sold together with one investor warrant to purchase one share of common stock at a combined offering price of $1.15, for total gross proceeds of approximately $20.1 million, before underwriting discounts and commissions and offering expenses payable by Brickell.  The offering is expected to close on or about June 22, 2020, subject to the satisfaction or waiver of customary closing conditions.     

    Brickell anticipates using the net proceeds from the offering for research and development, including clinical trials, working capital and general corporate purposes.

    Oppenheimer & Co. Inc. is acting as the sole book-running manager in connection with the offering and Lake Street Capital Markets, LLC is acting as lead manager.

    The securities will be offered pursuant to a registration statement on Form S-1 (File No. 333-238298), which was declared effective by the Securities and Exchange Commission (the "SEC") on June 17, 2020, and an additional registration statement filed with the SEC on June 17, 2020 pursuant to Rule 462(b) under the Securities Act of 1933, as amended. The offering is being made solely by means of a prospectus. A preliminary prospectus relating to and describing the terms of the offering has been filed with the SEC and is available on the SEC's website at www.sec.gov.  Copies of the preliminary prospectus and, when available, copies of the final prospectus relating to this offering can be obtained at the SEC's website at www.sec.gov or from Oppenheimer & Co. Inc., Attention: Syndicate Prospectus Department, 85 Broad St., 26th Floor, New York, NY 10004, by telephone at (212) 667-8055 or by email at .

    This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor will there be any sales of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

    About Brickell

    Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell's pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell's executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell's strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit http://www.brickellbio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements made in this press release relating to our expectations regarding the completion, timing and size of the offering and the anticipated use of net proceeds are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, market conditions and the satisfaction of customary closing conditions related to the offering, ability to obtain adequate financing to advance product development, potential delays for any reason in product development, regulatory changes, unanticipated demands on cash resources, any disruption to our business caused by the current COVID-19 pandemic, and risks associated with developing, and obtaining regulatory approval for and commercializing novel therapeutics.

    Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell's filings with the SEC, which are available at http://www.sec.gov (or at http://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

    Brickell Investor Contact:

    Patti Bank

    Managing Director, Westwicke

     

    Source: Brickell Biotech, Inc.

    Released June 17, 2020

     

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  3. Data based on registration study in Japan of sofpironium bromide gel, 5% in patients with primary axillary hyperhidrosis

    All primary and secondary endpoints were met and achieved statistical significance

    BOULDER, Colo., June 15, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced the release of positive Phase 3 pivotal study results from its development partner, Kaken Pharmaceutical Co. Ltd., in Japan. All primary and secondary efficacy endpoints of the study were met. The results were presented as part of the Late-Breaking Research Program…

    Data based on registration study in Japan of sofpironium bromide gel, 5% in patients with primary axillary hyperhidrosis

    All primary and secondary endpoints were met and achieved statistical significance

    BOULDER, Colo., June 15, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced the release of positive Phase 3 pivotal study results from its development partner, Kaken Pharmaceutical Co. Ltd., in Japan. All primary and secondary efficacy endpoints of the study were met. The results were presented as part of the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Virtual Meeting Experience. The presentation is titled "A Phase 3, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 5% in Japanese Patients with Primary Axillary Hyperhidrosis."  Earlier this year, Kaken announced submission of a new drug application for approval in Japan of manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis based on these data.

    "We are encouraged by these positive results and are pleased by the filing of the Japanese New Drug Application based on this Phase 3 study by Kaken," said Deepak Chadha, Brickell's Chief Research & Development Officer. "We believe there is growing interest from the global medical community for novel therapeutic options for the treatment of primary axillary hyperhidrosis and think these data provide additional clinical support for sofpironium bromide to be a potential best-in-class treatment."

    The Phase 3 pivotal study evaluated a total of 281 Japanese subjects randomized 1:1 to apply sofpironium bromide gel, 5% ("SB") or vehicle gel (placebo) to the axillae for 42 days. All subjects had Hyperhidrosis Disease Severity Scale (HDSS) scores ≥ 3 and ≥ 50 mg/5 min gravimetric sweat production (GSP) in each axilla at baseline.

    All primary and secondary efficacy endpoints demonstrated statistically significant differences between sofpironium bromide and vehicle, with safety and tolerability, as follows:

    Primary Endpoint:

    • Proportion of subjects whose HDSS was improved to a score of 1 or 2 at the end of treatment (EOT) and > 50% reduction in GSP at EOT was 53.9% (SB) versus 36.4% (vehicle); p-value = 0.003

    Key Secondary Endpoints:

    • Proportion of subjects whose HDSS was improved to a score of 1 or 2 at the EOT was 60.3% (SB) versus 47.9% (vehicle); p=0.036

       
    • Change in the total GSP mean value for both axillae from baseline to EOT was -157.6 mg (SB) versus        -127.6 mg (vehicle); p=0.0151

       
    • Change in the HDSM-Ax score from baseline to EOT was -1.41 (SB) versus -0.93 (vehicle); p=0.001

       
    • Proportion of subjects with ≥50% reduction in the rate of GSP from baseline to EOT was 77.3% (SB) versus 66.4% (vehicle); p=0.042

    Safety and Tolerability:

    • Common adverse events (incidence ≥5%) in SB group were nasopharyngitis (14.2%), dermatitis at the application site (8.5%), and erythema at the application site (5.7%). The severity of adverse events was predominantly mild.
    • 2.8% of SB-treated subjects experienced any anticholinergic-class side effects; dry mouth (1.4%), constipation (0.7%) and mydriasis (0.7%).



    • No serious adverse events related to SB were reported in the study

    In addition to Japan, Kaken has rights to develop and commercialize sofpironium bromide in Korea, China and certain other Asian countries.  Under the sublicense agreement with Kaken there are royalties and sales-based milestone payments due to Brickell.

    About Sofpironium Bromide

    Sofpironium bromide is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. Sofpironium bromide is not approved for use in any country at this time.

    About Hyperhidrosis

    Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States and more than 16 million people, or 12.76% of the population in Japan, are believed to suffer from hyperhidrosis2,3. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States or 10 million individuals and an estimated 45% of patients with hyperhidrosis in Japan or 7.2 million individuals2,3. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/.

    About Brickell

    Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell's pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell's executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell's strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit http://www.brickellbio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of future clinical trials and prospects for commercializing any of Brickell's product candidates, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development, potential delays for any reason in product development, regulatory changes, unanticipated demands on cash resources, any disruption to our business caused by the current COVID-19 pandemic, and risks associated with developing, and obtaining regulatory approval for and commercializing novel therapeutics.

    Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell's filings with the United States Securities and Exchange Commission (SEC), which are available at http://www.sec.gov (or at http://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

    Brickell Investor Contact:

    Patti Bank

    Managing Director, Westwicke

    1 Change in the total GSP mean value for both axillae from baseline to EOT is one of the co-primary efficacy endpoints required by FDA for Brickell's prospective U.S. Phase 3 pivotal trials.

    2 Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.

    3 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.

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  4. BOULDER, Colo., May 13, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced financial results for the first quarter ended March 31, 2020 and provided a corporate update.

    "Brickell has continued to make progress during the first quarter of 2020, and we remain committed to advancing sofpironium bromide into Phase 3 clinical studies in the U.S.," commented Robert Brown, Chief Executive Officer of Brickell. "As we continue to prepare for the initiation of our pivotal studies, we are encouraged by the top-line results of our recently completed…

    BOULDER, Colo., May 13, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced financial results for the first quarter ended March 31, 2020 and provided a corporate update.

    "Brickell has continued to make progress during the first quarter of 2020, and we remain committed to advancing sofpironium bromide into Phase 3 clinical studies in the U.S.," commented Robert Brown, Chief Executive Officer of Brickell. "As we continue to prepare for the initiation of our pivotal studies, we are encouraged by the top-line results of our recently completed Phase 3 long-term safety study.  Furthermore, the Japanese Phase 3 pivotal study data that we expect to be presented by our Asian development partner, Kaken Pharmaceutical Co. Ltd. ("Kaken"), next month further strengthens our enthusiasm of sofpironium bromide's potential to be a best-in-class therapy for hyperhidrosis."

    Business and Recent Developments

    • Today, Brickell announced that, based on a preliminary review of the top-line results from the 12-month Phase 3 open-label long-term safety study, in 300 subjects >9 years old with primary axillary hyperhidrosis, sofpironium bromide gel, 5% and 15% was safe and generally well tolerated, which was consistent with the earlier Phase 2 clinical trial results.  No treatment-related serious adverse events were observed.   

    • On March 4, 2020, Brickell announced that positive results from Kaken's Phase 3 pivotal study of topically applied sofpironium bromide gel, 5% in Japanese subjects with primary axillary hyperhidrosis were selected for oral presentation at the Late-Breaking Research Program of the American Academy of Dermatology ("AAD") Annual Meeting.  Due to concerns related to COVID-19, the AAD canceled the conference and it is now rescheduled to be a virtual forum on June 12, 2020.  The presentation will include details of the efficacy and safety results from Kaken's Phase 3 pivotal study of sofpironium bromide gel.

    • On February 20, 2020, Brickell announced that positive results from its Phase 2b study with sofpironium bromide in patients with primary axillary hyperhidrosis were published in the peer-reviewed Journal of the American Academy of Dermatology ("JAAD"). In this Phase 2b dose-finding study, sofpironium bromide elicited clinically meaningful and statistically significant sustained reductions in sweating severity and was well tolerated. The paper, entitled "Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase II, Randomized, Controlled, Double-Blinded Trial," is available online (https://doi.org/10.1016/j.jaad.2020.02.016) and will be published in volume 82, Issue 6 (2020) pp.1320-1327 in the June 2020 print edition of JAAD.

    • On February 18, 2020, Brickell announced that Brickell, Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor entered into a binding settlement agreement and an amended license agreement, concluding all litigation related thereto and allowing Brickell to continue development of sofpironium bromide for the treatment of hyperhidrosis.

    • On February 18, 2020, Brickell announced entry into a purchase agreement with Lincoln Park Capital Fund, LLC ("LPC"), a long-only Chicago-based institutional investor, whereby LPC purchased $2.0 million in Brickell common stock and warrants. Additionally, Brickell and LPC entered into a separate purchase agreement whereby Brickell, for up to a 36-month period, will have the right, in its sole discretion subject to satisfaction of certain conditions, to sell up to an additional $28 million of its common stock to LPC.  This agreement is intended to augment the various potential sources of capital the Company may have access to as Brickell develops sofpironium bromide for the treatment of axillary hyperhidrosis.

    • On January 19, 2020, Brickell presented the results from pharmacokinetics and long-term safety extension trials with sofpironium bromide gel, 15% in pediatric patients (ages 9 to <17) with primary axillary hyperhidrosis at the Dermatology, Aesthetic & Surgical Conference.  Sofpironium bromide was safe and well-tolerated over 24 weeks of treatment in this clinical trial.

    • On January 10, 2020, Brickell announced that Kaken submitted a new drug application for approval with the Pharmaceuticals and Medical Devices Agency in Japan for the manufacturing and marketing of sofpironium bromide gel for primary axillary hyperhidrosis.

    Financial Results

    Cash, cash equivalents, and marketable securities were $7.1 million as of March 31, 2020 compared to $11.7 million as of December 31, 2019. In addition, Brickell has prepaid $4.6 million to third-party clinical research organizations in anticipation of commencing Phase 3 pivotal clinical trials of sofpironium bromide in the U.S.

    Revenue was $1.0 million for the first quarter of 2020 compared to $3.5 million for the first quarter of 2019. The decrease in revenue recognized was attributable to the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary studies that were ongoing in 2019 but were concluded or winding down by the first quarter of 2020.  Conducting these studies is the basis for revenue recognition for a $15.6 million R&D payment that was received from Kaken in the second quarter of 2018.

    Research and development expenses were $2.7 million for the first quarter of 2020 compared to $6.0 million for the first quarter of 2019. This decrease was primarily due to a decrease in clinical study and other related regulatory and administrative costs of the Phase 3 long-term safety study of sofpironium bromide gel and other ancillary studies that were ongoing in 2019, but were concluded or winding down by the first quarter of 2020.

    General and administrative expenses were $2.5 million for the first quarter of 2020 compared to $2.1 million for the first quarter of 2019. This increase was primarily due to $0.3 million in higher fees for directors' and officers' liability insurance as a public company.

    Brickell's net loss was $4.1 million for the first quarter of 2020 compared to $4.6 million for the first quarter of 2019.

    Conference Call and Webcast Information

    Brickell's management will host a conference call today at 4:30 p.m. ET to discuss the financial results and recent corporate developments. The dial-in number for the conference call is 1-855-327-6837 for domestic participants and 1-631-891-4304 for international participants, with Conference ID #10009475.  A live webcast of the conference call can be accessed through the "Investors" tab on the Brickell Biotech website at http://www.brickellbio.com. A replay will be available on this website shortly after conclusion of the event for 90 days.

    About Sofpironium Bromide

    Sofpironium bromide is a proprietary new molecular entity that belongs to a class of medications called anticholinergics. Anticholinergics block the action of acetylcholine, a chemical that transmits signals within the nervous system that are responsible for a range of bodily functions, including activation of the sweat glands. Sofpironium bromide was retrometabolically designed. Retrometabolic drugs are designed to exert their action topically and are potentially rapidly metabolized into a less active metabolite once absorbed into the blood. This proposed mechanism of action may allow for highly effective doses to be used while limiting systemic side effects. Sofpironium bromide was discovered at Bodor Laboratories, Inc. by Dr. Nicholas Bodor D.Sc., d.h.c. (multi), HoF, Graduate Research Professor Emeritus, University of Florida. Sofpironium bromide is not approved for use in any country at this time.

    About Hyperhidrosis

    Hyperhidrosis is a life-altering medical condition where a person sweats more than the body requires to regulate its temperature. More than 15 million people, or 4.8% of the population of the United States, and more than 16 million people, or 12.76% of the population in Japan, are believed to suffer from hyperhidrosis1,2. Primary axillary (underarm) hyperhidrosis is the targeted first indication for sofpironium bromide and is the most common site of occurrence of hyperhidrosis, affecting an estimated 65% of patients with hyperhidrosis in the United States or 10 million individuals and an estimated 45% of patients with hyperhidrosis in Japan or 7.2 million individuals1,2. Additional information can be found on the International Hyperhidrosis Society website: https://www.sweathelp.org/.

    About Brickell

    Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell's pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell's executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell's strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit http://www.brickellbio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of future clinical trials and prospects for commercializing any of Brickell's product candidates, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development, potential delays for any reason in product development, regulatory changes, unanticipated demands on cash resources, any disruption to our business caused by the current COVID-19 pandemic, and risks associated with developing, and obtaining regulatory approval for and commercializing novel therapeutics.

    Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell's filings with the United States Securities and Exchange Commission (SEC), which are available at http://www.sec.gov (or at http://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

    1Doolittle et al. Hyperhidrosis: an update on prevalence and severity in the United States. Arch Dermatol Res 2016; 308: 743-749.
    2 Fujimoto et al. Epidemiological study and considerations of focal hyperhidrosis in Japan. J Dermatol 2013; 40: 886-90.

     
     
    Brickell Biotech, Inc.
    Condensed Consolidated Statements of Operations
    (in thousands, except share and per share data)
     
      Three Months Ended
    March 31,
      2020   2019
           
    Collaboration revenue $ 1,046     $ 3,492  
           
    Operating expenses:      
    Research and development 2,664     6,019  
    General and administrative 2,481     2,066  
    Total operating expenses 5,145     8,085  
    Loss from operations (4,099 )   (4,593 )
    Investment and other income (loss), net (4 )   6  
    Interest expense     (224 )
    Change in fair value of warrant liability     231  
    Net loss (4,103 )   (4,580 )
    Reduction of redeemable convertible preferred stock to redemption value     10,519  
    Net income (loss) attributable to common stockholders $ (4,103 )   $ 5,939  
    Net income (loss) per common share attributable to common stockholders, basic $ (0.45 )   $ 10.08  
    Net loss per common share attributable to common stockholders, diluted $ (0.45 )   $ (2.48 )
    Weighted-average shares used to compute net income (loss) per share attributable to common stockholders, basic 9,106,209     589,001  
    Weighted-average shares used to compute net loss per share attributable to common stockholders, diluted 9,106,209     1,845,467  
               
               


    Brickell Biotech, Inc.
    Selected Financial Information
    Condensed Consolidated Balance Sheet Data
    (amounts in thousands)
           
      March 31,
    2020
      December 31,
    2019
    Cash and cash equivalents $ 7,127   $ 7,232
    Marketable securities, available-for-sale   4,497
    Prepaid expenses and other current assets 5,765   6,240
    Total assets 13,038   18,144
    Total liabilities 7,144   10,570
    Total stockholders' equity 5,894   7,574
           

    Brickell Investor Contact:

    Patti Bank
    Managing Director, Westwicke

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  5. BOULDER, Colo., May 04, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that it will report its first quarter 2020 financial results after the close of the U.S. financial markets on Wednesday, May 13, 2020. Brickell's management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights.

    The dial-in number for the conference call is 1-855-327-6837 for domestic participants and 1-631-891-4304 for international participants, with Conference ID #10009475.  A live webcast of the conference…

    BOULDER, Colo., May 04, 2020 (GLOBE NEWSWIRE) -- Brickell Biotech, Inc. ("Brickell") (NASDAQ:BBI), a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, today announced that it will report its first quarter 2020 financial results after the close of the U.S. financial markets on Wednesday, May 13, 2020. Brickell's management will host a conference call at 4:30 p.m. ET to discuss the financial results and recent corporate highlights.

    The dial-in number for the conference call is 1-855-327-6837 for domestic participants and 1-631-891-4304 for international participants, with Conference ID #10009475.  A live webcast of the conference call can be accessed through the "Investors" tab on the Brickell Biotech website at http://www.brickellbio.com/.  A replay will be available on this website shortly after conclusion of the event for 90 days.

    About Brickell

    Brickell Biotech, Inc. is a clinical-stage pharmaceutical company focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases. Brickell's pipeline consists of potential novel therapeutics for hyperhidrosis and other prevalent dermatological conditions. Brickell's executive management team and board of directors bring extensive experience in product development and global commercialization, having served in leadership roles at large global pharmaceutical companies and biotechs that have developed and/or launched successful products, including several that were first-in-class and/or achieved iconic status, such as Cialis®, Taltz®, Gemzar®, Prozac®, Cymbalta® and Juvederm®. Brickell's strategy is to leverage this experience to in-license, acquire, develop and commercialize innovative products that Brickell believes can be successful in the currently underserved dermatology global marketplace. For more information, visit http://www.brickellbio.com.

    Cautionary Note Regarding Forward-Looking Statements

    Any statements made in this press release relating to future financial, business and/or research and clinical performance, conditions, plans, prospects, trends, or strategies and other such matters, including without limitation, the anticipated timing, scope, design and/or results of future clinical trials and prospects for commercializing any of Brickell's product candidates, including in Japan, the United States or any other country, are forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Brickell, may identify forward-looking statements. Brickell cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time, often quickly and in unanticipated ways. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including without limitation, ability to obtain adequate financing to advance product development, potential delays for any reason in product development, regulatory changes, unanticipated demands on cash resources, any disruption to our business caused by the current COVID-19 pandemic, and risks associated with developing, and obtaining regulatory approval for and commercializing novel therapeutics.

    Further information on the factors and risks that could cause actual results to differ from any forward-looking statements are contained in Brickell's filings with the United States Securities and Exchange Commission (SEC), which are available at http://www.sec.gov (or at http://www.brickellbio.com). The forward-looking statements represent the estimates of Brickell as of the date hereof only, and Brickell specifically disclaims any duty or obligation to update forward-looking statements.

    Brickell Investor Contact:
    Patti Bank
    Managing Director, Westwicke
     

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