WOODCLIFF LAKE, N.J.,
April 6, 2020 /PRNewswire/
-- Timber Pharmaceuticals LLC ("Timber"), a privately held
biopharmaceutical company focused on the development and
commercialization of treatments for orphan dermatologic diseases,
today announced the company has been awarded the second tranche of
$500,000 of the $1.5 million grant from the U.S. Food & Drug
Administration (FDA) Office of Orphan Products Development (OOPD)
Orphan Products Clinical Trials Grants Program after reaching
certain clinical milestones in the development of TMB-001 (topical
isotretinoin).
"We are pleased to close on the second tranche of the grant that
was first awarded to us by the FDA in 2018 through a highly
competitive program that supports important clinical studies that
might lead to the regulatory approval of products for rare diseases
with high unmet need," said John
Koconis, chief executive officer of Timber. "We believe this
is a clear sign that we are making progress in the development of
TMB-001 and we look forward to advancing through the late stages of
clinical research."
Timber is developing TMB-001 for the treatment of congenital
ichthyosis (CI), a rare genetic keratinization disorder that leads
to dry, thickened, and scaling skin. In a Phase 2a study, treatment
with TMB-001 was shown to be well tolerated with minimal evidence
of systemic absorption of isotretinoin. There was a favorable
signal of efficacy in the study with patients showing a reduction
in scaling after eight weeks. The company is currently enrolling
patients in the Phase 2b CONTROL
Study focused on moderate to severe subtypes of CI that affect
about 80,000 people in the U.S.
The FDA's Orphan Products Clinical Trials Grants Program is
designed to support the clinical development of products for use in
rare diseases where no current therapy exists or where the proposed
product will be superior to the existing therapy. In 2018, Timber
was one of four biopharmaceutical companies to be awarded the grant
in addition to hospitals and academic institutions. The total grant
of $1.5 million is non-dilutive and
supports the Phase 2a and Phase 2b
studies evaluating TMB-001 in CI.
About Timber Pharmaceuticals LLC
Timber is a privately held pharmaceutical company focused on the
development and commercialization of treatments for orphan
dermatologic diseases. The company's investigational therapies have
proven mechanisms-of-action backed by decades of clinical
experience and well-established CMC (chemistry, manufacturing and
control) and safety profiles. Timber is initially focused on
developing non-systemic treatments for rare dermatologic diseases
including congenital ichthyosis (CI), tuberous sclerosis complex
(TSC), and localized scleroderma. For more information, visit
https://www.timberpharma.com/.
About BioPharmX® Corporation
BioPharmX Corporation (NYSE American: BPMX) is a specialty
pharmaceutical company focused on developing prescription
products utilizing its proprietary HyantX Topical Delivery System
for dermatology indications. To learn more about BioPharmX,
visit www.BioPharmX.com.
Information about the Proposed Merger and Where to Find
It
In connection with the proposed merger between BioPharmX
Corporation ("BioPharmX") and Timber, BioPharmX and Timber have
filed relevant materials with the Securities and Exchange
Commission (the "SEC"), including a registration statement on Form
S-4 that was filed on February 20,
2020, as amended by Amendment No. 1 thereto filed with the
SEC on March 30, 2020, and contained
a prospectus and a proxy statement of BioPharmX. INVESTORS AND
SECURITY HOLDERS OF BIOPHARMX AND TIMBER ARE URGED TO READ THESE
MATERIALS CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME
AVAILABLE BECAUSE THEY CONTAIN IMPORTANT INFORMATION ABOUT
BIOPHARMX, TIMBER AND THE PROPOSED MERGER AND RELATED MATTERS. The
proxy statement, prospectus and other relevant materials (when they
become available), and any other documents filed by BioPharmX with
the SEC, may be obtained free of charge at the SEC website at
www.sec.gov. In addition, investors and security holders may obtain
free copies of the documents filed with the SEC by BioPharmX by
directing a written request to BioPharmX Corporation, 900 E.
Hamilton Avenue, Suite 100, Campbell,
California 95008. Investors and security holders are urged
to read the proxy statement, prospectus and the other relevant
materials when they become available before making any voting or
investment decision with respect to the proposed merger.
This report shall not constitute an offer to sell or the
solicitation of an offer to sell or the solicitation of an offer to
buy any securities, nor shall there be any sale of securities in
any jurisdiction in which such offer, solicitation or sale would be
unlawful prior to registration or qualification under the
securities laws of any such jurisdiction. No offering of securities
in connection with the proposed merger shall be made except by
means of a prospectus meeting the requirements of Section 10 of the
Securities Act of 1933, as amended.
Participants in the Solicitation
BioPharmX and its directors and executive officers and Timber
and its managers and executive officers may be deemed to be
participants in the solicitation of proxies from the stockholders
of BioPharmX in connection with the proposed transaction under the
rules of the SEC. Information about the directors and executive
officers of BioPharmX and their ownership of shares of BioPharmX
common stock is set forth in its Annual Report on Form 10-K for the
year ended January 31, 2020, which
was filed with the SEC on March 23,
2020, and its subsequent documents filed with the SEC,
including the joint proxy statement/prospectus referred to above.
Additional information regarding the persons who may be deemed
participants in the proxy solicitations and a description of their
direct and indirect interests in the proposed merger, by security
holdings or otherwise, will also be included in the joint
prospectus/proxy statement and other relevant materials to be filed
with the SEC when they become available. These documents are
available free of charge at the SEC website (www.sec.gov) and from
BioPharmX at the address described above. The managers and officers
of Timber do not currently hold any direct or indirect interests,
by security holdings or otherwise, in BioPharmX except as pursuant
to the exercise of the bridge loan warrant described in BioPharmX's
SEC reports.
Forward-Looking Statements
This report, the documents incorporated herein by reference and
other written reports and oral statements made from time to time by
BioPharmX or Timber contain "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995.
Forward-looking statements are identified by terminology such as
"may," "should," "expects," "plans," "anticipates," "could,"
"intends," "target," "projects," "contemplates," "believes,"
"estimates," "predicts," "potential" or "continue" or the negative
of these terms or other words. These statements are only
predictions. BioPharmX and Timber have based these forward-looking
statements largely on their then-current expectations and
projections about future events, as well as the beliefs and
assumptions of management. Forward-looking statements are subject
to a number of risks and uncertainties, many of which involve
factors or circumstances that are beyond each of BioPharmX's and
Timber's control, and actual results could differ materially from
those stated or implied in forward-looking statements due to a
number of factors, including but not limited to: (i) risks as to
whether Timber's Phase 2b study will
be successful; (ii) risks associated with BioPharmX's ability to
obtain the stockholder approval required to consummate the proposed
merger transaction and the timing of the closing of the proposed
merger transaction, including the risks that a condition to closing
would not be satisfied within the expected timeframe or at all or
that the closing of the proposed merger transaction will not occur;
(iii) the outcome of any legal proceedings that may be instituted
against the parties and others related to the merger agreement;
(iv) the occurrence of any event, change or other circumstance or
condition that could give rise to the termination of the merger
agreement; (v) unanticipated difficulties or expenditures relating
to the proposed merger transaction, the response of business
partners and competitors to the announcement of the proposed merger
transaction, and/or potential difficulties in employee retention as
a result of the announcement and pendency of the proposed merger
transaction; (vi) if the merger is completed, whether the combined
business of Timber and BioPharmX will be successful; and (vii)
those risks detailed in BioPharmX's most recent Annual Report on
Form 10-K and subsequent reports filed with the SEC, as well as
other documents that may be filed by BioPharmX from time to time
with the SEC. Accordingly, you should not rely upon forward-looking
statements as predictions of future events. Neither BioPharmX nor
Timber can assure you that the events and circumstances reflected
in the forward-looking statements will be achieved or occur, and
actual results could differ materially from those projected in the
forward-looking statements. The forward-looking statements made in
this communication relate only to events as of the date on which
the statements are made. Except as required by applicable law or
regulation, BioPharmX and Timber undertake no obligation to update
any forward-looking statement to reflect events or circumstances
after the date on which the statement is made or to reflect the
occurrence of unanticipated events.
Media Contact:
Adam Daley
Berry & Company Public Relations
212-253-8881
adaley@berrypr.com
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SOURCE Timber Pharmaceuticals LLC