Phase 2b Clinical
Trials for Each of the Company’s Lead Assets in Orphan Dermatologic Diseases
are Progressing as Planned
WOODCLIFF LAKE, NJ – (NewMediaWire) – August 18, 2020 – Timber
Pharmaceuticals, Inc. (“Timber” or the “Company”) (NYSE American:
TMBR), a biopharmaceutical company focused on the development and
commercialization of treatments for orphan dermatologic diseases, today provided
a business update and announced financial results for the second quarter of
2020, ended June 30, 2020.
“Since Timber became a public company in mid-May, we have
continued to execute on our strategic plan to develop and commercialize
treatments for orphan and rare dermatologic diseases. Orphan and rare
dermatology remains a very attractive market for Timber, as we believe the
seven years of U.S. market exclusivity provided for the drugs in our strategic
pipeline will enable them to reach considerable value in the marketplace,” said
John Koconis, Chief Executive Officer of Timber.
“During the second quarter we announced that all 11 sites in
the CONTROL trial are open for TMB-001, and a significant portion have also
opened for TMB-002, enabling us to expand the enrollment of patients in each of
the Phase 2b clinical trials. We expect to complete the enrollment of patients
in both the TMB-001 and TMB-002 studies during the early months of 2021. We are
also working to advance the strategic options for the two assets we obtained in
the merger with BioPharmX. We believe these efforts are strengthened by the
notice we recently received from the European Patent Office (EPO) that it
intends to grant a patent for the Company’s topical composition of
pharmaceutical tetracycline (including minocycline) for dermatological use.
Patents covering the BPX-01 and BPX-04 assets have previously been granted in
the United States, South Africa and claims related to the patents have been
allowed in Australia.
“We encountered significant one-time charges and expenses in
connection with our merger and financing which are now behind us. We expect
that our cash balance of nearly $14 million will fund our trials and operations
through the completion of both the current TMB-001 and TMB-002 studies, which
are expected to conclude in Q3 2021. With the merger-related costs now behind
us, the Phase 2b clinical trials well underway, and supported by a strong
balance sheet, we believe that Timber is well positioned to achieve its goals,”
concluded Mr. Koconis.
For Timber’s complete financial results for the period ended
June 30, 2020, see the Company’s quarterly Form 10-Q filed with the Securities
and Exchange Commission on August 18, 2020.
About Timber Pharmaceuticals, Inc.
Timber Pharmaceuticals, Inc. is a biopharmaceutical 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. The Company is initially focused on developing non-systemic
treatments for rare dermatologic diseases including congenital ichthyosis (CI),
facial angiofibromas (FAs) in tuberous sclerosis complex (TSC), and localized
scleroderma. For more information, visit www.timberpharma.com.
This press release contains certain forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934 and Private Securities
Litigation Reform Act, as amended, including those relating to the Company’s
product development, clinical and regulatory timelines, market opportunity,
competitive position, possible or assumed future results of operations,
business strategies, potential growth opportunities and other statements that
are predictive in nature. These forward-looking statements are based on current
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forward-looking expressions, including, but not limited to, “expect,”
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“believe,” “estimate,” “potential,
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and similar expressions and the negatives of those terms. These statements
relate to future events or our financial performance and involve known and
unknown risks, uncertainties, and other factors which may cause actual results,
performance or achievements to be materially different from any future results,
performance or achievements expressed or implied by the forward-looking
statements. Such factors include those set forth in the Company’s Form 10-Q
filed on August [●], 2020 and its other filings with the Securities and
Exchange Commission. Prospective investors are cautioned not to place undue
reliance on such forward-looking statements, which speak only as of the date of
this press release. The Company undertakes no obligation to publicly update any
forward-looking statement, whether as a result of new information, future
events or otherwise.
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