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 third quarter ended September 30, 2019 and provided a
corporate update.
“Becoming a publicly listed company earlier this year was a
transformative milestone for Brickell and we remain confident about
the potential of our lead asset, sofpironium bromide, for primary
axillary hyperhidrosis,” commented Robert Brown, Chief Executive
Officer of Brickell. “Ten million people in the United States
suffer from this disease which can have a negative impact on a
patient’s social life, well-being, emotional and mental
health.”
Business and Recent Developments
- In September 2019, Brickell announced completion of its merger
with Vical Incorporated (“Vical”), following approval by Vical’s
shareholders, and commenced trading on The Nasdaq Capital Market
under the ticker symbol “BBI”. Vical contributed approximately $35
million to the combined company in addition to an R&D financing
arrangement entered into with NovaQuest Capital Management that
provides up to $25 million in funding.
- The long-term safety study for sofpironium bromide is fully
enrolled with 300 subjects and is on track to be completed in the
first quarter of 2020. Earlier this year, Brickell’s development
partner, Kaken Pharmaceutical Co. Ltd. (“Kaken”), achieved positive
pivotal Phase 3 results in its clinical study conducted in Japan.
To date there have been 19 clinical studies conducted by Brickell
and Kaken of sofpironium bromide gel that encompass over 1,200
subjects.
- On October 23, 2019, Bodor Laboratories, Inc. and Nicholas S.
Bodor (collectively, “Bodor”) filed a complaint against Brickell
disputing certain aspects of the license agreement between the
parties with respect to sofpironium bromide (“Complaint”). As
a result, NovaQuest notified the Company that additional
development funding for sofpironium bromide was suspended
temporarily. Subsequently, Brickell filed a motion to dismiss the
Complaint, initiated arbitration proceedings against Bodor and
asserted claims against Bodor for tortious interference and
material breach of the license agreement by Bodor.
- The sofpironium bromide pivotal Phase 3 studies in axillary
hyperhidrosis are ready to commence in the United States, pending
developments in the ongoing dispute resolution process with
Bodor.
Financial Results
Cash, cash equivalents, and short-term investments were $25.7
million as of September 30, 2019 compared to $8.1 million as
of September 30, 2018.
Revenue was $1.2 million for the third quarter of 2019 compared
to $3.0 million for the third quarter of 2018. The decrease is due
primarily to the completion of certain research and development
activities during the three months ended September 30, 2019
for which funding is provided under a license and collaboration
agreement with Kaken.
Research and development expenses were $3.3 million for the
third quarter of 2019 compared to $4.1 million for the third
quarter of 2018. The decrease in research and development expenses
is primarily due to a decrease in clinical studies costs associated
with sofpironium bromide following the completion of certain
clinical trials.
General and administrative expenses were $3.9 million for the
third quarter of 2019 compared to $1.2 million for the third
quarter of 2018. The increase in general and administrative
expenses is primarily due to an increase in professional fees for
legal, accounting, and auditing services, including merger-related
costs.
The Company’s net loss was $4.8 million for the third quarter of
2019, and $13.0 million for the nine months ended
September 30, 2019, compared to $2.5 million for the third
quarter of 2018, and $5.6 million for the nine months ended
September 30, 2018.
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 once absorbed into the
blood. This proposed mechanism of action may allow for highly
effective doses to be used while limiting systemic side
effects.
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, are believed to suffer from hyperhidrosis.
Axillary (underarm) hyperhidrosis is the targeted first indication
for sofpironium bromide and is the most common occurrence of
hyperhidrosis, affecting an estimated 65% of patients in the United
States or 10 million individuals. Doolittle et al. Arch Dermatol
Res (2016).
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, cutaneous T-cell lymphoma,
psoriasis, 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
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
are forward-looking statements within the meaning of the 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, whether Brickell prevails in arbitration and/or
litigation relating to its license agreement with Bodor, whether
NovaQuest will resume development payments under the funding
agreement or take any other actions related to the funding
agreement, the costs associated with, and the management time
associated with arbitration and/or litigation, potential delays in
product development, regulatory or law changes, unanticipated
demands on cash resources, 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 Brickell’s filings with the United States Securities and
Exchange Commission (SEC), which are available at www.sec.gov (or
at 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
BankManaging Director, WestwickeIR@brickellbio.com
Brickell Biotech,
Inc.Condensed Consolidated Statements of
Operations(in thousands, except share and per
share data)(unaudited)
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
Collaboration revenue |
$ |
1,183 |
|
|
$ |
3,042 |
|
|
$ |
7,248 |
|
|
$ |
8,415 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
3,337 |
|
|
4,135 |
|
|
13,585 |
|
|
8,571 |
|
General and administrative |
3,901 |
|
|
1,206 |
|
|
7,290 |
|
|
4,694 |
|
Total operating expenses |
7,238 |
|
|
5,341 |
|
|
20,875 |
|
|
13,265 |
|
Loss from operations |
(6,055 |
) |
|
(2,299 |
) |
|
(13,627 |
) |
|
(4,850 |
) |
Investment and other income, net |
54 |
|
|
23 |
|
|
64 |
|
|
45 |
|
Gain on extinguishment |
2,318 |
|
|
— |
|
|
2,318 |
|
|
— |
|
Interest expense |
(1,098 |
) |
|
(267 |
) |
|
(1,982 |
) |
|
(769 |
) |
Change in fair value of derivative liability |
— |
|
|
— |
|
|
(11 |
) |
|
— |
|
Change in fair value of warrant liability |
— |
|
|
2 |
|
|
223 |
|
|
8 |
|
Net loss |
(4,781 |
) |
|
(2,541 |
) |
|
(13,015 |
) |
|
(5,566 |
) |
Reduction (accretion) of
redeemable convertible preferred stock to redemption value |
(82 |
) |
|
(966 |
) |
|
10,274 |
|
|
(5,071 |
) |
Net loss attributable to
common stockholders |
$ |
(4,863 |
) |
|
$ |
(3,507 |
) |
|
$ |
(2,741 |
) |
|
$ |
(10,637 |
) |
Net loss per share attributable to common stockholders, basic and
diluted |
$ |
(1.65 |
) |
|
$ |
(5.98 |
) |
|
$ |
(1.98 |
) |
|
$ |
(18.13 |
) |
Weighted-average shares used to compute net loss per share
attributable to common stockholders, basic and diluted |
2,943,896 |
|
|
586,738 |
|
|
1,382,592 |
|
|
586,701 |
|
Brickell Biotech,
Inc.Selected Financial
InformationCondensed Consolidated Balance Sheet
Data(amounts in
thousands)(unaudited)
|
September 30, 2019 |
|
December 31, 2018 |
Cash and cash equivalents |
$ |
7,225 |
|
|
$ |
8,067 |
|
Marketable securities,
available-for-sale |
18,473 |
|
|
— |
|
Total assets |
31,369 |
|
|
8,749 |
|
Note payable |
— |
|
|
4,639 |
|
Total liabilities |
13,144 |
|
|
22,077 |
|
Total stockholders’ equity
(deficit) |
18,225 |
|
|
(71,618 |
) |
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