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
InformationCondensed 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 BankManaging Director, WestwickeIR@brickellbio.com
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