Novan Focuses Strategic Direction and Announces Restructuring
31 Maggio 2023 - 10:05PM
Novan, Inc. (“the Company” or “Novan”) (Nasdaq: NOVN), today
announced that following an evaluation of its commercial and
developmental stage assets, it has decided to sharpen its focus and
resources on berdazimer gel, 10.3% (SB206) and announced that it
continues to explore strategic alternatives, with a focus on its
commercial product portfolio and a sale or out-license of one or
more of its commercial products.
Novan conducted a deliberate and thorough review
of its commercial and development portfolio of assets to determine
a path to optimally deploy capital and maximize shareholder value.
Following this review, the Company, has initiated a process to
explore a sale or out-license of its commercial assets, including
RHOFADE, MINOLIRA, and CLODERM. The Company will immediately reduce
certain of its operating expenses currently supporting its
commercial operations.
“We continue to face serious challenges
achieving profitability with our commercial assets in the current
economic environment, while also endeavoring to extend our cash
runway through the PDUFA goal date of January 5, 2024, for
berdazimer gel, 10.3%,” said Paula Brown Stafford, President and
CEO. “We have been evaluating our portfolio of assets for some time
to determine the optimal path for a product, if approved, to treat
molluscum contagiosum, an unmet medical need. After careful
consideration, we have made the strategic decision to implement a
reduction in force of our commercial team and continue to explore a
sale or out-license of our commercial assets. We will use our
resources, plus the proceeds from any dilutive or non-dilutive
financing or any strategic transaction, to work in earnest to
capture the potential value of berdazimer gel, 10.3% by supporting
the ongoing NDA review process.”
The restructuring of the Company’s commercial
business, impacting 39 employees, results in a reduction in force
of approximately 50% of employees of the Company, primarily among
its field sales representatives. The Company estimates that it will
incur approximately $0.9 million in charges related to the
reduction in force over a period of twelve months. The Company took
this step to concentrate its resources on pursuing the regulatory
approval for the Company’s berdazimer gel, 10.3% product
candidate.
The Company believes that its existing cash and
cash equivalents as of March 31, 2023, plus expected receipts
associated with product sales from its commercial product
portfolio, will provide it with liquidity to fund its planned
operating needs into late June of 2023, subject to the factors
described in the Company’s Form 10-Q for the quarter ended March
31, 2023. Any potential new business development transactions or
financing activities would target extending the Company’s runway
into the fourth quarter of 2023 and desirably beyond.
As the Company explores strategic alternatives
related to its commercial portfolio, it will continue to sell and
distribute its commercial products, and incur certain related
expenses associated with RHOFADE, WYNZORA, MINOLIRA and CLODERM in
the United States.
About Novan
Novan, Inc. is a medical dermatology company
focused on developing and commercializing innovative therapeutic
products for skin diseases. Our goal is to deliver safe and
efficacious therapies to patients, including developing product
candidates where there are unmet medical needs. The U.S. Food and
Drug Administration (“FDA”) accepted for filing Novan’s New Drug
Application (“NDA”) seeking approval for berdazimer gel, 10.3%
(SB206) for the treatment of molluscum contagiosum. The Company
also has a pipeline of potential product candidates using its
proprietary nitric oxide-based technology platform, NITRICIL™, to
generate new treatments for multiple indications.
Forward-Looking Statements
Any statements contained in this press release
that do not describe historical facts may constitute
forward-looking statements as that term is defined in the Private
Securities Litigation Reform Act of 1995. These statements may be
identified by words such as “believe,” “expect,” “target,”
“anticipate,” “may,” “plan,” “potential,” “will,” “look forward to”
and similar expressions, and are based on the Company’s current
beliefs and expectations. These forward-looking statements include,
but are not limited to, statements related to the Company’s
expectations with respect to the planned restructuring, including
the amount of termination costs, charges to be incurred, the
Company’s plans to continue to focus its resources on the
development of its SB206 product candidate, the Company’s ability
to complete a financing or strategic transaction and the Company’s
cash runway. Forward-looking statements are subject to a number of
risks and uncertainties that could cause actual results to differ
materially from the Company’s expectations, including, but not
limited to, risks related to the regulatory approval process, which
is lengthy, time-consuming and inherently unpredictable, including
the risk that the FDA will not agree with the Company’s approach in
its NDA submission for berdazimer gel, 10.3% (SB206) for molluscum
or any future NDA submission, that the Company’s product candidates
may not be approved or that additional studies may be required for
approval or other delays may occur, that the Company may not have
sufficient quantities of drug substance and/or drug product to
support regulatory submissions and that the Company may not obtain
funding sufficient to extend its cash runway beyond late second
quarter of 2023 or to complete the regulatory or development
process of any of its product candidates; the Company’s ability to
retain qualified personnel and recruit in the future; constraints
on the Company’s operations stemming from the restructuring,
including impacts on the Company’s ongoing sales from its
commercial product portfolio, higher than anticipated costs in
connection with the reduction in force and restructuring efforts;
risks and uncertainties related to the ability to raise additional
capital, such as the timing of cash needs; and other risks and
uncertainties described in the Company’s annual report filed with
the Securities and Exchange Commission on Form 10-K for the twelve
months ended December 31, 2022, and in the Company’s subsequent
filings with the Securities and Exchange Commission. Such
forward-looking statements speak only as of the date of this press
release, and the Company disclaims any intent or obligation to
update these forward-looking statements to reflect events or
circumstances after the date of such statements, except as may be
required by law.
INVESTOR AND MEDIA
CONTACT:Jenene Thomas JTC Team,
LLC833-475-8247NOVN@jtcir.com
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