Brickell Biotech, Inc. and its subsidiary (collectively,
“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 Brickell, and Bodor Laboratories, Inc. and Dr. Nicholas
S. Bodor (collectively, “Bodor”), entered into a settlement
agreement and an amended license agreement. This resolves the
previously disclosed dispute related to the sofpironium bromide
license agreement and allows the Company to continue its efforts to
develop sofpironium bromide for the treatment of hyperhidrosis, a
life-altering medical condition with an estimated 15 million
sufferers in the United States.
Pursuant to the settlement, the parties agreed
to dismiss the related litigation and arbitration with
prejudice. As part of the settlement and amended license
agreement, Brickell agreed to make an upfront payment to Bodor of
$1.0 million in cash and pay future amounts, up to $1.0 million in
cash and $1.5 million in common stock, upon the achievement of
specified milestones (with shares to be valued at the closing price
on the day preceding each such issuance). Additionally,
Brickell agreed to pay Bodor a low single-digit royalty related to
a newly filed provisional patent application and modified the
percentage of certain sub-licensing income that Bodor may receive
in the future.
“Resolving the dispute with Bodor at this time
is, on balance, in the best interest of our stockholders as it
permits Brickell to continue to advance our lead product candidate
without the cloud of litigation,” said Robert Brown, Brickell’s
Chief Executive Officer. “We look forward to focusing on the
development of sofpironium bromide, including sharing top-line
results from our Phase 3 long-term safety study in the second
quarter of this year.”
Separately, Brickell entered 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 common stock and prefunded warrants in a private
placement, at a price of $1.285 per share reflecting a premium to
the closing price on February 14, 2020. As part of the
private placement, the Company also issued warrants to purchase an
equivalent number of shares at an exercise price of $1.16, and
these warrants may not be exercised for six months from the date of
issuance. The Company agreed to customary registration rights
in connection with the $2 million purchase by LPC.Additionally, the
Company and LPC entered into a separate purchase agreement whereby
Brickell, from time to time over a 36-month period, will have the
right, in its sole discretion, to sell up to an additional $28
million of its common stock to LPC. Under the terms and
conditions of this agreement, including the filing and
effectiveness of a registration statement, Brickell will control
the timing and amount of any future sale of shares and LPC is
obligated to purchase the shares at prices related to the current
market price of the stock at the time of each sale and in amounts
as described in the agreement. LPC has agreed not to cause or
engage in any manner whatsoever, in any direct or indirect short
selling or hedging of shares of the Company’s securities.
“Entering into these two purchase agreements
provides our Company with a new funding source,” said Robert
Brown. “We welcome Lincoln Park as an investor through their
$2 million investment and commitment to fund up to an additional
$28 million.”
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 considerably 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, Ph.D., D.Sc., d.h.c.
(multi), HoF.
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®. 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, obtaining future financing, 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 in 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
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