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 fourth quarter and full year ended December 31, 2019 and
provided a corporate update.
“Becoming a public company through the listing
on the Nasdaq was a significant milestone for the Company this past
year,” commented Robert Brown, Chief Executive Officer of Brickell.
“We remain enthusiastic about the potential for sofpironium bromide
as a drug candidate to potentially improve the quality of life of
the 10 million U.S. patients that suffer from primary axillary
hyperhidrosis.”
Business and Recent
Developments
- 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 Severity Measure-Axillary
(HDSM-Ax), were reported as early as Day 8 and improved through
week 24 in this pediatric patient population. The median change in
the HDSM-Ax from baseline to week 24 of was -2.10 (mean: -1.91;
standard deviation: 1.038).
Financial Results
Fourth Quarter 2019 Financial Results
Cash, cash equivalents, and marketable
securities were $11.7 million as of December 31, 2019 compared
to $8.1 million as of December 31, 2018. In addition, Brickell
has prepaid third-party clinical research organizations $4.9
million in anticipation of commencing the pivotal Phase 3 clinical
trials of sofpironium bromide.
Revenue was $0.7 million for the fourth quarter
of 2019 compared to $2.5 million for the fourth quarter of 2018.
The decrease is primarily due to the completion of certain research
and development activities by the first half of 2019 for which
funding was provided under the license agreement with Kaken.
Research and development expenses were $6.6
million for the fourth quarter of 2019 compared to $4.4 million for
the fourth quarter of 2018. This increase is primarily due to the
additional clinical study activities and drug supply costs
associated with sofpironium bromide.
General and administrative expenses were $4.9
million for the fourth quarter of 2019 compared to $1.7 million for
the fourth quarter of 2018. This increase includes $1.0 million in
legal settlement accrual, $0.7 million in added fees for
accounting, auditing, and legal services, including
litigation-related costs, $0.7 million in impairment expense, $0.5
million in insurance and rent expense, and $0.3 million in stock
compensation expense and increased headcount.
Brickell’s net loss was $10.9 million for the
fourth quarter of 2019 compared to $3.7 million for the fourth
quarter of 2018.
Full Year 2019 Financial Results
Revenue was $7.9 million for the year ended
December 31, 2019 compared to $10.9 million for the year ended
December 31, 2018. The decrease is primarily due to the
recognition in 2018 of a $5.0 million payment from Kaken.
Research and development expenses were $20.2
million for the year ended December 31, 2019 compared to $13.0
million for the year ended December 31, 2018. This increase is
primarily due to the additional clinical study activities,
including the Phase 3 long-term safety study, and drug supply costs
associated with sofpironium bromide.
General and administrative expenses were $12.2
million for the year ended December 31, 2019 compared to $6.4
million for the year ended December 31, 2018. This increase
includes $4.1 million in added fees for accounting, auditing, and
legal services, including Merger-related costs, $1.0 million in
stock compensation expense and increased headcount, $1.0 million in
legal settlement accrual, and $0.7 million in impairment expense,
partially offset by a decrease of $1.0 million in sub-licensing
fees.
Brickell’s net loss was $23.9 million for the
year ended December 31, 2019 compared to $9.2 million for the
year ended December 31, 2018.
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 1-877-705-6003 for domestic participants and
1-201-493-6725 for international participants, with Conference ID
#13700118. 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.
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 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.____________________
1 |
Doolittle 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 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 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Brickell Biotech,
Inc.Selected Financial
InformationCondensed Consolidated Balance Sheet
Data(amounts in thousands)
|
|
|
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 |
) |
|
|
|
|
|
Brickell Investor Contact:
Patti BankManaging Director,
WestwickeIR@brickellbio.com
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