(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425) | |
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) | |
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) | |
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||
Date: March 18, 2020 | Brickell Biotech, Inc. | ||
By: | /s/ Robert B. Brown | ||
Name: | Robert B. Brown | ||
Title: | Chief Executive Officer |
• | On March 4, 2020, Brickell announced that positive results from its Asian development partner, Kaken Pharmaceutical Co. Ltd.’s (“Kaken”) Phase 3 pivotal study in Japan were selected for oral presentation at the Late-Breaking Research Program during the American Academy of Dermatology (AAD) Annual Meeting on March 21, 2020, in Denver, CO. Due to concerns related to the novel coronavirus, the AAD canceled the conference and it is expected that there will be a forum to release the data in the near future. The presentation is expected to include the first public disclosure of efficacy and safety results from Kaken’s Phase 3 pivotal study of sofpironium bromide gel. Additionally, on January 10, 2020, Brickell announced that Kaken submitted a new drug application for approval in Japan of manufacturing and marketing for sofpironium bromide gel for primary axillary hyperhidrosis based on the positive results from this study. |
• | 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). The paper, entitled “Efficacy and Safety of Topical Sofpironium Bromide Gel for the Treatment of Axillary Hyperhidrosis: A Phase 2, Randomized, Controlled, Double-Blinded Trial,” is now available online at (https://doi.org/10.1016/j.jaad.2020.02.016) and is expected to be published in a future print edition of JAAD. |
• | On February 18, 2020, Brickell announced that Brickell, Bodor Laboratories, Inc. and Dr. Nicholas S. Bodor (collectively “Bodor”) entered into a settlement agreement and an amended license agreement. This resolved the litigation dispute disclosed on October 23, 2019 related to the sofpironium bromide license agreement and allows Brickell to continue its efforts to develop 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. |
• | In January 2020, the last patient completed the Phase 3 long-term safety study for sofpironium bromide. Brickell remains on track to report top-line results in the second quarter of 2020. To date, there have been 19 clinical studies conducted by Brickell and Kaken of sofpironium bromide gel that encompass over 1,300 subjects. |
• | 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. Pharmacokinetic analysis of sofpironium bromide did not show any evidence of drug or major metabolite accumulation. Pharmacokinetic findings were consistent with previous investigational evaluations in adults in which systemic sofpironium and its major metabolite concentrations were also variable, sporadic, and minimal. Sofpironium bromide was safe and well-tolerated in over 24 weeks of treatment in this clinical trial. The majority of pediatric subjects had no treatment-emergent adverse events, and there were no severe or serious adverse events. Additionally, while not designed as an efficacy study, clinically meaningful improvement, i.e., change of -1.00 point on a 5-point patient-reported outcome measures; Hyperhidrosis Disease |
Three Months Ended December 31, | Year Ended December 31, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
(unaudited) | |||||||||||||||
Collaboration revenue | $ | 669 | $ | 2,473 | $ | 7,917 | $ | 10,888 | |||||||
Operating expenses: | |||||||||||||||
Research and development | 6,629 | 4,389 | 20,214 | 12,960 | |||||||||||
General and administrative | 4,881 | 1,685 | 12,171 | 6,379 | |||||||||||
Total operating expenses | 11,510 | 6,074 | 32,385 | 19,339 | |||||||||||
Loss from operations | (10,841 | ) | (3,601 | ) | (24,468 | ) | (8,451 | ) | |||||||
Investment and other income, net | 93 | 16 | 157 | 61 | |||||||||||
Gain on extinguishment | — | — | 2,318 | — | |||||||||||
Interest expense | (114 | ) | (321 | ) | (2,096 | ) | (1,090 | ) | |||||||
Change in fair value of derivative liability | — | — | (11 | ) | — | ||||||||||
Change in fair value of warrant liability | — | 236 | 223 | 244 | |||||||||||
Net loss | (10,862 | ) | (3,670 | ) | (23,877 | ) | (9,236 | ) | |||||||
Reduction (accretion) of redeemable convertible preferred stock to redemption value | — | (865 | ) | 10,274 | (5,936 | ) | |||||||||
Net loss attributable to common stockholders | $ | (10,862 | ) | $ | (4,535 | ) | $ | (13,603 | ) | $ | (15,172 | ) | |||
Net loss per share attributable to common stockholders, basic and diluted | $ | (1.38 | ) | $ | (7.72 | ) | $ | (4.50 | ) | $ | (25.85 | ) | |||
Weighted-average shares used to compute net loss per share attributable to common stockholders, basic and diluted | 7,890,823 | 587,763 | 3,023,023 | 586,969 |
December 31, | |||||||
2019 | 2018 | ||||||
Cash and cash equivalents | $ | 7,232 | $ | 8,067 | |||
Marketable securities, available-for-sale | 4,497 | — | |||||
Prepaid expenses and other current assets | 6,240 | 204 | |||||
Total assets | 18,144 | 8,749 | |||||
Note payable | — | 4,639 | |||||
Total liabilities | 10,570 | 22,077 | |||||
Total stockholders’ equity (deficit) | 7,574 | (71,618 | ) |
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Cover Page |
Mar. 18, 2020 |
---|---|
Cover page. | |
Document Type | 8-K |
Document Period End Date | Mar. 18, 2020 |
Entity Registrant Name | BRICKELL BIOTECH, INC. |
Entity Incorporation, State or Country Code | DE |
Entity File Number | 000-21088 |
Entity Tax Identification Number | 93-0948554 |
Entity Address, Address Line One | 5777 Central Avenue |
Entity Address, Address Line Two | Suite 102 |
Entity Address, City or Town | Boulder |
Entity Address, State or Province | CO |
Entity Address, Postal Zip Code | 80301 |
City Area Code | 720 |
Local Phone Number | 505-4755 |
Written Communications | false |
Soliciting Material | false |
Pre-commencement Tender Offer | false |
Pre-commencement Issuer Tender Offer | false |
Title of 12(b) Security | Common stock, par value $0.01 per share |
Trading Symbol | BBI |
Security Exchange Name | NASDAQ |
Entity Emerging Growth Company | false |
Entity Central Index Key | 0000819050 |
Amendment Flag | false |