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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): February 17, 2022

 

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 8.01 Other Information

 

On February 17, 2022, PolarityTE, Inc., issued a press release titled “PolarityTE Announces Allowance of Fourth U.S. Patent.” A copy of the press release is included with this filing as Exhibit 99.1.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit No.   Description
     
99.1   Press release dated February 17, 2022, titled “PolarityTE Announces Allowance of Fourth U.S. Patent.”
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: February 17, 2022 /s/ Jacob Patterson
  Jacob Patterson
  Chief Financial Officer

 

 

 

 

Exhibit 99.1

 

 

PolarityTE Announces Allowance of Fourth U.S. Patent

 

SALT LAKE CITY, February 17, 2022—PolarityTE, Inc. (Nasdaq: PTE), a biotechnology company developing regenerative tissue products and biomaterials, today announced the U.S. Patent and Trademark Office (USPTO) recently issued a Notice of Allowance for U.S. Application No. 17/326,734 filed on May 21, 2021. This is the Company’s fourth patent allowance in the United States. The newly allowed claims are for compositions that relate to the Company’s minimally polarized functional unit (MPFU) technology in combination with a cryoprotectant.

 

Mary Bram, Vice President of Intellectual Property, commented: “This allowance is a significant step forward in building out the Company’s patent portfolio in the United States. The Company will continue to pursue patent protection surrounding its MPFU technology in the United States in line with patenting practices in the biologics space.” The Company continues to pursue additional patent applications in the United States and abroad related to its regenerative technologies, including SkinTE®.

 

Richard Hague, Chief Executive Officer and President of PolarityTE, commented: “PolarityTE understands the importance of intellectual property and building a patent portfolio that protects our regenerative tissue technology embodied in SkinTE®. Protecting this technology goes hand in hand with our effort to advance regulatory approval of SkinTE® through the first of two Phase 3 clinical studies we are preparing to start, as we seek to drive shareholder value through our differentiated technology and intellectual property.”

 

About PolarityTE®

 

PolarityTE, Inc., headquartered in Salt Lake City, Utah, is a biotechnology company developing regenerative tissue products. PolarityTE’s first regenerative tissue product is SkinTE®. PolarityTE has an open investigational new drug application (IND) for SkinTE® with the U.S. Food and Drug Administration (FDA) and is now pursuing the first of two pivotal studies on SkinTE® needed to support a biologics license application (BLA) for a chronic cutaneous ulcer indication. SkinTE® is available for investigational use only. Learn more at www.PolarityTE.com.

 

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, future clinical studies, 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.

 

POLARITYTE, the POLARITYTE logo, SKINTE, WHERE SELF REGENERATES SELF and WELCOME TO THE SHIFT are registered trademarks of PolarityTE, Inc.

 

CONTACTS

 

Investors:

 

PolarityTE Investor Relations

ir@PolarityTE.com

(385) 831-5284

 

Media:

 

David Schull or Ignacio Guerrero-Ros

David.schull@russopartnersllc.com

Ignacio.guerrero-ros@russopartnersllc.com