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): July 29, 2020

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
Preferred Stock Purchase Rights		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 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

Election of Dr. Shen as Director

On July 29, 2020, the Board of Directors of PolarityTE, Inc. (the “Company”), elected Jessica Shen, MD, MS, to serve as a member of the Board of Directors beginning July 29, 2020, for the term expiring at the Company’s 2022 annual meeting of stockholders and until her successor is duly elected and qualified, or until her earlier death, resignation or removal. Dr. Shen’s appointment was recommended to the Board by its Nominating and Governance Committee. No determination was made with respect to Dr. Shen’s service on committees of the Board.

In accordance with the Company’s compensation program for non-employee directors, Dr. Shen is entitled to receive a $45,000 annual retainer paid quarterly for service as a Board member, which is prorated for the period of actual service during the calendar year. Dr. Shen will be entitled to additional compensation if she serves on one of the standing committees of the Board. Under the Company’s compensation plan for non-employee directors, new directors are entitled to receive on-boarding equity awards with a value of $160,000. Effective July 29, 2020, Dr. Chen was granted under the Company’s 2017 Equity Incentive Plan equity awards that vest over three years beginning July 29, 2021, subject to continued service to the Company, consisting of an option to purchase 102,662 shares of the Company’s common stock at an exercise price of $1.57 per share exercisable over a term of 10 years and 37,838 restricted stock units.

The Company also entered into the Company’s standard form of indemnification agreement with Dr. Chen. Under the indemnification agreement, the Company agrees, among other things, to indemnify directors and certain officers under the circumstances and to the extent provided for therein, to the maximum extent permitted by Delaware law, including indemnification of expenses such as attorneys’ fees, judgments, penalties, fines and settlement amounts incurred by the director or officer in any claim arising out of the person’s service to the Company or its subsidiaries. The form of indemnification agreement was previously filed as Exhibit 10.1 to the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on March 25, 2020 and is incorporated herein by reference.

There are no arrangements or understandings between Dr. Chen and any other persons pursuant to which she was elected as a director of the Company. There are no family relationships between Dr. Chen and any director, executive officer, or any person nominated or chosen by the Company to become a director or executive officer. There are no related person transactions (within the meaning of Item 404(a) of Regulation S-K promulgated by the Securities and Exchange Commission) between Dr. Chen and the Company.

A copy of the Company’s press release announcing the election of Dr. Shen is attached hereto as Exhibit 99.1.

Resignation of Dr. Jon Mogford

On August 21, 2019, the Company reached a settlement with Dr. Denver Lough resolving Dr. Lough’s status with the Company, which was reported in the Company’s current report on Form 8-K filed with the Securities and Exchange Commission on August 26, 2019. The terms of the settlement include, among other items, the requirement that Dr. Jon Mogford will agree to resign as a director on or before July 31, 2020. Pursuant to that term of the settlement Dr. Mogford resigned as a director of the Company on July 29, 2020.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.	Description
99.1	Press release issued July 29, 2020, titled “PolarityTE Announces the Addition of Clinical Development and Regulatory Affairs Executive Jessica Chen, MD, MS, to Board of Directors.”

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: July 30, 2020	/s/ Jacob Patterson
	Jacob Patterson
	Interim Chief Financial Officer

EX-99.1

Exhibit 99.1

 

PolarityTE Announces the Addition of Clinical Development and Regulatory Affairs Executive Jessica Shen, MD, MS to Board of Directors

SALT LAKE CITY, July 30, 2020 – PolarityTE, Inc. (Nasdaq: PTE) today announced the appointment of Jessica Shen, MD, MS to the Company’s Board of Directors. Dr. Shen brings extensive clinical development, medical, health economics, regulatory, and quality control experience to PolarityTE’s Board of Directors. Dr. Shen spent more than 15 years at Johnson & Johnson, where she was most recently Vice President of Clinical Development and Regulatory Affairs of the Global Surgery Group. Dr. Shen joined Royal Philips over five years ago and currently serves as Senior Vice President, Head of Global Regulatory, Medical, Clinical & Health Economic Outcomes Research (HEOR) Affairs and Global Government Regulations & Standards. In her current role, Dr. Shen provides strategic direction and oversight for all clinical and regulatory functions, globally supporting three business sectors in 140 countries and 500 employees.

“Dr. Shen brings to our Board an extraordinary background in clinical product development, health economics, and regulatory affairs both in the United States and worldwide,” said David Seaburg, Chief Executive Officer of PolarityTE. Mr. Seaburg continued, “As we transition towards a biologics license application (BLA) for SkinTE, Dr. Shen’s broad and deep experience will be invaluable, especially her history of successfully bringing to market wound management products through the BLA pathway while at Johnson & Johnson.”

“I am honored to join PolarityTE’s Board of Directors,” said Dr. Shen. “I look forward to drawing from my prior clinical development and regulatory experiences and providing guidance as PolarityTE strives to develop and commercialize innovative regenerative products while successfully navigating the regulatory landscape. The Company and its leadership’s devotion to a patient-centric mission is inspiring, and I look forward to working closely with my fellow directors and management during this important time in PolarityTE’s evolution.”

In addition to Dr. Shen’s over 20 years of clinical and regulatory experience in roles at Johnson & Johnson, Royal Philips and Abbot Laboratories, she has participated in professional development programs at MIT Sloan Business School, as well as Harvard Business School. She has been credited with a multitude of publications, has helped secure Department of Defense research grants, and has received numerous awards and accolades, including the Johnson Medal (the highest Johnson & Johnson Research & Development award), and was the recipient of the Johnson & Johnson Global Standards of Leadership Award on five separate occasions. Dr. Shen obtained her medical degree from Nanjing Medical College in Nanjing, China and a Master of Science from the University of Kentucky, Lexington.

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®.

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