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Tag: Brickell Biotech

  • Did Anything Boost Brickell (BBI) Stock In Extended Trading?

    Brickell Biotech Inc. (BBI) charted higher today, an 8.13% increase to trade at $0.685 in afterhours trading. Brickell stock fell -3.28% on Tuesday to close at $0.63. BBI stock traded for 1.37 million shares on the day, compared to 1.26 million on average for the last three months. BBI’s stock fluctuated between $0.6101 and $0.655 during the trading session. The earnings per share ratio of BBI was -1.03. On a year-to-date basis, BBI stock has gained 2.18% and lost -18.83% over the past five sessions and on a monthly basis has gained -32.53%. The 50-day moving average of BBI stock is $0.8299, which is below the 200-day moving average of $0.9239. In addition, BBI stock has a current RSI of 27.91. A bought deal offering of common stock resulted in a rise in BBI stock.

    How did BBI complete the deal?

    Brickell is focused on developing innovative and differentiated prescription therapeutics for the treatment of debilitating skin diseases, particularly hyperhidrosis. BBI’s lead asset is sofpironium bromide for the treatment of this condition. BBI executives and board members have extensive product development and global commercialization experience. Several of the BBI team’s products have achieved first-in-class status and/or first-to-market status, including Cialis, Taltz, Gemzar, Prozac, Cymbalta and Juvederm, among others. By leveraging this experience, BBI aims to in-license, acquire, develop and market innovative and differentiating pharmaceutical products that could transform lives by solving currently unmet patient needs in the marketplace.

    It was announced last week that Brickell had closed its publicly announced offering of 12,983,871 shares of the company’s common stock.

    • The underwriter exercised its option to purchase 1,693,548 shares of BBI common stock in full as part of the offer.
    • In addition to underwriting discounts and commissions, the underwriter exercised the option for $0.62 per share to the public.
    • For the BBI offering, HC Wainwright & Co. served as the bookrunner.
    • According to the Securities and Exchange Commission (“SEC”), BBI offered the shares of common stock pursuant to a “shelf” registration statement on Form S-3 issued on March 17, 2021.
    • By virtue of the effective registration statement, shares of common stock of BBI were only offered through a prospectus, including a prospectus supplement.

    How BBI plans to utilize the proceeds?

    Before deducting underwriting discounts and commissions as well as BBI’s offering expenses, the gross proceeds of the offering were approximately $8.05 million. In addition to the net proceeds of the offering, Brickell (BBI) plans to use the working capital and general corporate purpose proceeds for research and development.

  • Here is why Brickell Biotech Inc. (BBI) stock faced the headwinds on the first day of the week?

    Here is why Brickell Biotech Inc. (BBI) stock faced the headwinds on the first day of the week?

    Brickell Biotech Inc. (BBI) shares fell 13.14% in after-hours on Monday, July 19, 2021, and closed Monday’s trading at $0.64. Earlier in the morning session, BBI’s stock lost 1.77% to close Monday’s session at $0.74. BBI shares have fallen 18.49% over the last 12 months, and they have moved down 10.16% in the past week. Over the past three months, the stock has lost 12.31%, while over the past six months, it has shed 33.03%. Further, the company has a current market of $51.08 million and its outstanding shares stood at 67.18 million.

    Let’s see is there any recent news or development behind its negative start on Monday?

    Increasing Bought Deal Offering of Common Stock

    On July 19, 2021, Brickell Biotech, Inc announced that the underwriter has agreed to increase the size of the previously announced public offering and purchase on a firm commitment basis 11,290,323 shares of common stock of the Company at a price to the public of $0.62 per share, less underwriting discounts and commissions, due to demand. The offer will close on July 22, 2021.

    Participation in the recent investor conference

    Brickell Biotech recently participated in one-on-one investor meetings at the William Blair Biotech Focus Conference 2021, which was held virtually on July 14 – 15, 2021.

    Update about patient enrollment in Phase 3 pivotal Cardigan I &II study

    On June 29, 2021, Brickell Biotech, Inc announced that the final patient has completed the Phase 3 pivotal Cardigan I study and that all planned patients have been enrolled in the Phase 3 pivotal Cardigan II study. Both studies are evaluating sofpironium bromide gel, 15% in patients with primary axillary (underarm) hyperhidrosis.

    Brickell’s U.S. Phase 3 clinical program for sofpironium bromide gel, 15% is comprised of two pivotal clinical studies, Cardigan I and Cardigan II. Each study has enrolled approximately 350 subjects nine years of age and older with primary axillary hyperhidrosis.

    Initiation of Phase 1 clinical study of sofpironium bromide gel in Japan

    On June 24, 2021, the development partner of Brickell Biotech, Kaken Pharmaceutical Co., Ltd initiated a Phase 1 clinical study to assess the pharmacokinetics (PK) of sofpironium bromide gel in patients with primary palmoplantar hyperhidrosis (PPH) in Japan.

    Publication of Phase 3 Results for ECCLOCKin the Journal of Dermatology

    On June 01, 2021, Brickell Biotech, Inc announced that the results from the Phase 3 long-term safety and efficacy study conducted in Japan by its development partner, Kaken Pharmaceutical Co., Ltd were published in the peer-reviewed Journal of Dermatology1.

    Conclusion

    The BBI stock faced negativity on Monday after it announced to increase in the size of the previously announced public offering. BBI stock can further slide down in the coming days.

  • Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) Stock Rallies Ahead of Sofpironium Bromide Clinical Trial Milestones

    Brickell Biotech, Inc. (BBI) stock prices were down by a marginal 0.52% as of the market closing on June 29th, 2021, bringing the price per share down to USD$0.93 at the end of the trading day. Subsequent pre-market fluctuations saw the stock rally by 5.91%, bringing it up to USD$0.98.

    Sofpironium Bromide Gel, 15%, Study

    The company’s U.S Phase 3 clinical program is comprised of two pivotal studies designed to evaluate sofpironium bromide gel, 15%. Cardigan I and Cardigan II each have approximately 350 subjects enrolled, each of which is above the age of 8 and has primary axillary hyperhidrosis. The efficacy and safety of topically applied sofpironium bromide gel will be evaluated in the multicenter, randomized, double-blinded, vehicle-controlled studies, with safety and tolerability assessments being performed throughout the studies.

    Details of the Study

    The regimen consists of subjects applying the treatment or a placebo to their underarms once daily before sleeping at night for a period of six consecutive weeks, with a 2-week post-treatment follow up. The co-primary efficacy endpoints of both studies include the demographic of patients that exhibited at least a 2-point improvement on the Hyperhidrosis Disease Severity Measure-Axillary (HDSM-Ax) scale, which is a proprietary and validated patient-reported outcome measure. The studies will also evaluate changes in gravimetric sweat production (GSP) from baseline to the end of treatment.

    Scope of Clinical Study

    Topline results from each of the Cardigan clinical studies is expected for the fourth quarter of 2021. The success of these results will form the basis of a potential NDA in the U.S for sofpironium bromide gel, 15% for the treatment of primary axillary hyperhidrosis.

    Phase 1 PPH Clinical Study

    June 24th, 2021 had seen the company announce that its development partner, Kaken Pharmaceutical, had initiated a Phase 1 clinical study to assess the pharmacokinetics of sofpironium bromide gel. The Study would assess the efficacy and safety of the treatment in patients with primary palmoplantar hyperhidrosis in Japan. PPH is a medical disorder that is very common, resulting in excessive sweating from the palms and soles. Primary palmar hidrosis is estimated to affect 5.33% of the Japanese population, while primary plantar hyperhidrosis is thought to affect 2.79% of the population. With no existing approved topical prescription treatments available for PPH in Japan, the study’s scope is potentially massive.

    Future Outlook for BBI

    Armed with a solid liquidity position, BBI is poised to capitalize on the strides made in its clinical studies, with the company pushing for the commercialization and proliferation of sofpirinium bromide gel, 15%. Current and potential investors are hopeful that management will continue to leverage the resources at their disposal to facilitate significant and sustained increases in shareholder value.

  • Brickell Biotech, Inc. (BBI) stock falls in Pre-Market: Why is it so?

    Brickell Biotech, Inc. (BBI) stock falls in Pre-Market: Why is it so?

    Brickell Biotech, Inc. (BBI) announced its fourth-quarter and full-year financial results of 2020 after which the BBI stock happened to be red, and its price saw a downtrend of 2.75% in today’s pre-market to drop at $1.06 a share at the time of this writing. BBI was gaining in the previous trading session and closed with a 0.93% gain. Let’s discuss the earnings report in detail.

    Fourth Quarter Results:

    • BBI stock recorded revenue of $27 thousand in the fourth quarter of 2020 which is significantly less than the $0.7 million in the same quarter of the prior year. The reduction in the revenue was mainly due to the winding down of the safety study of sofpironium bromide gel as well as various clinical activities in the first quarter of 2020.
    • Reduction of clinical activities resulted in less research and development costs of $4.6 million in the fourth quarter of 2020 as compared to $6.6 million in the same tenure of the previous year.
    • General and administrative expenses were reduced to $2.9 million of BBI stock as compared to$4.9 million in the same period of the previous year. This reduction is due to the reduction in cost related to the merger with Vical Incorporated, reduced impairment expenses, and other reduced miscellaneous expenses.

    Full Year Financial Results:

    • BBI stock generated $1.8 million revenue in 2020, a huge decrease as compared to the $7.9 million revenue of 2020. This decrease owes to the reduced clinical activities in 2020.
    • Research and development expenses reduced to $11.2 million in 2020 as compared to $20.2 million in 2019.
    • General and administrative expenses of BBI stock reduced to $11.6 million in 2020 while these were $12.2 in the prior-year period.
    • As of December 31, 2020, BBI recorded a net loss of $20.9 million as compared to a net loss of $23.9 million as of December 31, 2019.
    • BBI stock had cash and cash equivalents and market securities of $30.1 million at the end of 2020 while these were $11.7 million at the end of 2019.

    Recent Developments of BBI stock:

    Brickell Biotech completed an equity financing in 2020 that resulted in $13.7 million net proceeds.Moreover, Brickell Biotech initiated the enrollment of U.S. Phase 3 Cardigan I and Cardigan II studies related to sofpironium bromide gel and exceeded 50% enrollment in the former. Launching of ECCLOCK in Japan, publishing of phase 3 study results by Kaken, and completion of  Phase 1/2 study of investigational COVID-19 vaccine candidate and initiation of Phase 2/3 study in Japan are some other major business developments of BBI stock.

    Conclusion:

    Investors are responding to the earnings report released by BBI stock today. Results are not much satisfactory by BBI stock in 2020 as compared to 2019 as revenue as well as operating expenses decreased significantly which points to the decline in growth over the year.