8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 21, 2021

POLARITYTE, INC.

(Exact name of registrant as specified in its charter)

Delaware	001-32404	06-1529524
(State or other jurisdiction of incorporation)	(Commission File Number)	(IRS Employer Identification No.)

1960 S. 4250 West, Salt Lake City, UT 84104

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (800) 560-3983

(Former name or former address, if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol	Name of each exchange on which registered
Common Stock, Par Value $0.001	PTE	Nasdaq Capital Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure

On January 21, 2021, PolarityTE, Inc. (the “Company”) issued a press release titled “PolarityTE Announces Completion of Target Enrollment in Diabetic Foot Ulcer Trial.” A copy of the press release is furnished herewith as Exhibit 99.1.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press release dated January 21, 2021, titled “PolarityTE Announces Completion of Target Enrollment in Diabetic Foot Ulcer Trial.”
104	Cover Page Interactive Data File, formatted in Inline XBRL

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

	POLARITYTE, INC.
Dated: January 21, 2021	/s/ Jacob Patterson
	Jacob Patterson
	Interim Chief Financial Officer

EX-99.1

Exhibit 99.1

PolarityTE Announces Completion of Target Enrollment in Diabetic Foot Ulcer Trial

Company Expects to Release Topline Data at the Symposium on Advanced Wound Care—Spring 2021

SALT LAKE CITY, January 21, 2021 – PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, announced today 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). PolarityTE 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. Details for the SAWC 2021 Virtual Conference can be found at https://www.sawcspring.com/.

The primary endpoint of this Diabetic Foot Ulcer Trial (NCT03881254) is a comparison of the percent of index ulcers closed at 12 weeks, and additional details regarding the trial can be found at https://clinicaltrials.gov/ct2/show/study/NCT03881254.

David Seaburg, Chief Executive Officer, commented, “The completion of target enrollment for this DFU RCT is an important milestone for PTE and a step toward building what we believe will be additional scientific evidence to support the potential benefits SkinTE may offer patients suffering from debilitating diabetic foot ulcers.”

Nik Sopko, MD, PhD, Chief Scientific Officer, commented, “Enrollment completion of this trial in the midst of a global pandemic highlights the tremendous efforts by trial investigators and a dedicated PolarityTE team. We are incredibly grateful to all of the patients who participated in this study and look forward to presenting the results.”

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.

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.

CONTACTS

Investors:

Rich Haerle

VP, Investor Relations

PolarityTE, Inc.

ir@PolarityTE.com

(385) 315-0697

XML

Cover	Jan. 21, 2021
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Jan. 21, 2021
Entity File Number	001-32404
Entity Registrant Name	POLARITYTE, INC.
Entity Central Index Key	0001076682
Entity Tax Identification Number	06-1529524
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	1960 S. 4250 West
Entity Address, City or Town	Salt Lake City
Entity Address, State or Province	UT
Entity Address, Postal Zip Code	84104
City Area Code	(800)
Local Phone Number	560-3983
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, Par Value $0.001
Trading Symbol	PTE
Security Exchange Name	NASDAQ
Entity Emerging Growth Company	false