PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company
developing and commercializing regenerative tissue products and
biomaterials, is pleased to provide this update. Our focus is on
building shareholder value by pursuing pre-market approval for
SkinTE® from the U.S. Food and Drug Administration (FDA) through
submission of an investigational new drug application (IND) and
eventual biologics license application (BLA), and protecting our
intellectual property.
Regulatory Update
Over the last several months, the Company has had meaningful
interactions with the FDA regarding the Company’s planned IND for
SkinTE. Through these interactions the Company gained valuable
insight regarding the critical information it expects to include in
the IND, and believes it remains on track to file the IND for
SkinTE in the second half of 2021.
Completion of Enrollment in Diabetic
Foot Ulcer Randomized Controlled Trial
On January 21, 2021 PolarityTE announced it has completed target
enrollment of 100 subjects in a randomized controlled trial (RCT)
evaluating SkinTE plus standard of care (SOC) versus SOC alone for
the treatment of diabetic foot ulcers (DFUs) and plans to report
topline data via press release and presentation at the Symposium on
Advanced Wound Care (SAWC) Spring 2021 to be held May 12-16, 2021,
barring any unforeseen scheduling or other disruptions due to
COVID-19. The Company believes this trial will provide supporting
data that can be incorporated into its IND application.
Capital Formation
As previously reported, PolarityTE finished the quarter ended
September 30, 2020 with cash, cash equivalents and short-term
investments of approximately $23.19 million. The Company then
raised $25.67 million (before fees and other costs) through two
registered direct offerings and the exercise of warrants in
December 2020 and January 2021. We believe the Company is now well
funded to execute on important milestones as it pursues the
preparation and filing of an IND and BLA.
Intellectual Property
On February 3, 2021, the Company reported that it has further
advanced its intellectual property portfolio with the recent notice
of allowance from the U.S. Patent and Trademark Office (USPTO) for
U.S. Application No. 16/165,169. This follows the allowance of U.S.
Patent Application No. 14/954,335, which is scheduled to issue on
February 23, 2021 as U.S. Patent No. 10,926,001. The allowed claims
in these patent applications relate to methods of making
compositions for regenerating functional skin tissue using the
Company’s minimally polarized functional unit (MPFU) technology, as
well as methods of treatment using the compositions. As a further
update, the Company was granted a standard patent in Hong Kong
(HK40009324) based on its UK Patent No. GB 2569056. The Company’s
total number of allowed and granted utility patents is currently
ten—eight internationally and two in the U.S.
Dismissal of Securities Class Action
and Derivative Suit
On November 24, 2020 the Company announced the dismissal with
prejudice of a consolidated class action lawsuit filed in the
United States District Court for the District of Utah under the
caption In re PolarityTE, Inc. Securities Litigation, Case No.
2:18-cv-00510. The Company is pleased to announce that the
plaintiffs will not be appealing the District Court’s order
dismissing that action with prejudice. In addition, a derivative
lawsuit brought in the United States District Court for the
District of Utah, Case No. 2:18-cv-00791-TC, was dismissed without
prejudice on January 29, 2021. Both of these lawsuits arose on the
heels of a “short-and-distort” report published by Citron Research
in June 2018, which the Company assailed as false and misleading at
that time.
David Seaburg, Chief Executive Officer, commented, “We are
pleased with what has been accomplished since July 2019 under new
leadership at PolarityTE. We have seen strong execution on a number
of fronts, including good progress on the transition in the
regulatory pathway for SkinTE, solid growth in our patent portfolio
in the US and abroad, the dismissal of securities-related
litigation stemming from false and misleading short-and-distort
reports, and the right-sizing of the Company coupled with important
capital formation work to shore up our balance sheet.” Mr. Seaburg
continued, “All of this positions PolarityTE for sustained
execution to deliver long-term value for all of our shareholders.
We are proud of our team, and are grateful for the extraordinary
efforts they have made to achieve what we have in 2020, and we are
excited to continue to execute on our strategy in 2021. We plan to
announce our results for the fourth quarter and fiscal year 2020 in
late March, and we look forward to providing additional information
regarding our progress to our shareholders and stakeholders at that
time.”
Peter Cohen, Chairman of the Board, commented, “Management has
made significant progress in the past year. Although their work is
far from done, we believe that the fundamentals of the Company are
very strong, especially now that they are bolstered by a robust
cash position to facilitate further execution as we continue to
pursue opportunities to drive shareholder value.”
About PolarityTE®
PolarityTE is focused on transforming the lives of patients by
discovering, designing, and developing a range of regenerative
tissue products and biomaterials for the fields of medicine,
biomedical engineering and material sciences. Rather than
manufacturing with synthetic and foreign materials within
artificially engineered environments, PolarityTE manufactures
products from the patient's own tissue and uses the patient's own
body to support the regenerative process. From a small piece of
healthy autologous tissue, the company creates an easily
deployable, dynamic, and self-propagating product designed to
regenerate the target tissues. PolarityTE's innovative methods are
intended to promote and accelerate growth of the patient's tissues
to undergo a form of effective regenerative healing. Learn more at
www.PolarityTE.com – Welcome to the Shift®.
About SkinTE®
SkinTE is a human cellular and tissue-based product derived from
a patient’s own skin (autologous) intended for the repair,
reconstruction, replacement, or supplementation of skin tissue.
Aseptic surgical procedures and handling during skin harvest, wound
preparation, and SkinTE deployment are mandatory.
SkinTE is currently marketed as a human cell, tissue, and
cellular and tissue-based product regulated solely under Section
361 of the Public Health Service Act (PHS Act) and 21 CFR Part 1271
(i.e., as a 361 HCT/P). PolarityTE plans to file an investigational
new drug application (IND) with FDA followed by a biologics license
application (BLA) to have SkinTE regulated as a biologic under the
federal Food Drug & Cosmetic Act and Section 351 of the PHS Act
(i.e., as a 351 HCT/P), and will propose to FDA a plan for
transitioning SkinTE from a 361 HCT/P to a 351 HCT/P.
Forward Looking Statements
Certain statements contained in this release are
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995. They are generally
identified by words such as "believes," "may," "expects,"
"anticipates," "intend," "plan," "will," "would," "should" and
similar expressions. Readers should not place undue reliance on
such forward-looking statements, which are based upon the Company's
beliefs and assumptions as of the date of this release. The
Company's actual results could differ materially due to the impact
of the COVID-19 pandemic and FDA regulatory matters, which cannot
be predicted, and the risk factors and other items described in
more detail in the "Risk Factors" section of the Company's Annual
Reports and other filings with the SEC (copies of which may be
obtained at www.sec.gov). Subsequent events and developments may
cause these forward-looking statements to change. The Company
specifically disclaims any obligation or intention to update or
revise these forward-looking statements as a result of changed
events or circumstances that occur after the date of this release,
except as required by applicable law. Our actual results could
differ materially due to risk factors and other items described in
more detail in the "Risk Factors" section of the Company's Annual
Reports and other filings with the SEC (copies of which may be
obtained at www.sec.gov).
POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES
SELF and WELCOME TO THE SHIFT are trademarks or registered
trademarks of PolarityTE, Inc.
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version on businesswire.com: https://www.businesswire.com/news/home/20210210005186/en/
Investors: Rich Haerle VP, Investor Relations PolarityTE,
Inc. ir@PolarityTE.com (385) 315-0697
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