Form 8-K - Current report

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): August 26, 2024

HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

Delaware

001-35853

45-5210462

(State or other jurisdiction

of incorporation)

(Commission
File Number)

(IRS Employer
Identification No.)

84 October Hill Road, Suite 11, Holliston, MA		01746
(Address of principal executive offices)		(Zip Code)

Registrant’s telephone number, including area code: (774) 233-7300

(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: None

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
N/A		N/A		N/A

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.

On August 26, 2024, Mao Zhang, the Founder and Chief Executive Officer of Stellars Capital, joined the Board of Directors (the “Board”) of the Company as a Class I director. The appointment to the Board was effective immediately. As a Class I director, the initial term of Mr. Zhang as director will run until the Company’s 2026 annual meeting of stockholders and until his successor is duly elected and qualified, or until his resignation or removal.

In connection with his appointment, the Company will grant Mr. Zhang, on the fifth business day following his appointment, stock options with a value of $25,000 at the grant date that will vest in full in equal quarterly increments over a period of one year from the grant date. In addition, for his service, Mr. Zhang will receive compensation commensurate with that received by the Company’s other non-employee directors, which as may be modified by the Board from to time, currently includes annual compensation of cash fees of $20,000 to be paid in quarterly increments, and an annual grant of stock options, granted on the fifth business day following the Corporation’s annual stockholders meeting, with a value of $25,000 at the grant date to vest in full in equal quarterly increments over a period of one year from the grant date. In addition, all non-employee directors shall be reimbursed for their expenses incurred in connection with attending Board and committee meetings.

Mr. Zhang does not have any family relationship with any director or executive officer of the Company or any person nominated or chosen by the Company to become a director or officer.

On August 27, 2024, the Company issued a press release regarding the appointment of Mr. Zhang and related matters. The full text of the press release is attached as Exhibit 99.1 hereto and incorporated by reference herein.

Item 9.01

Financial Statements and Exhibits.

(d) Exhibits.

Exhibit Number		Title
99.1		Press Release issued by Harvard Apparatus Regenerative Technology, Inc. on August 27, 2024
104		Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

SIGNATURE

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

		HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
		(Registrant)

August 27, 2024		*/s/ Joseph Damasio*
(Date)		Joseph Damasio
		Chief Financial Officer

Exhibit 99.1

Harvard Apparatus Regenerative Technology Appoints Mao Zhang to Board of Directors

Holliston, MA – August 27, 2024 – Harvard Apparatus Regenerative Technology, Inc. (OTCQB: HRGN) (“Harvard Apparatus Regenerative Technology” or the “Company”), a clinical-stage biotechnology company developing the technology to regenerate organs inside the body to treat severe diseases, today announced the appointment of Mao Zhang as an independent director to its Board of Directors, adding strength in the areas of business innovation, strategy and finance.

Mr. Mao Zhang is the Founder and Chief Executive Officer of StellarS Capital, a multi-billion-dollar alternative asset management firm established in 2016. He has over 15 years of experience in financial markets including hedge fund and private equity. He began his career with Magnetar Capital in 2007, leading its Asian business. He holds a Bachelor of Science degree from the University of Pennsylvania.

“We are pleased to welcome Mao Zhang to the Harvard Apparatus Regenerative Technology Board,” said Jerry He, chairman of Harvard Apparatus Regenerative Technology, “Mao’s deep business and investment experience will be instrumental in helping the company to pursue the mission to serve the unmet patient needs. His appointment will be invaluable to Harvard Apparatus Regenerative Technology at a time of significant opportunity and growth.”

Mr. Zhang commented, “I am very pleased to be joining the Board of Directors for Harvard Apparatus Regenerative Technology at this exciting stage of its clinical development. Harvard Apparatus Regenerative Technology is developing promising novel cell therapies with the potential to change and extend the lives of patients with regenerated organs. I look forward to helping Harvard Apparatus Regenerative Technology reach its financial and strategic objectives.”

About Harvard Apparatus Regenerative Technology, Inc.

We are a clinical-stage biotechnology company developing regenerative-medicine treatments for disorders of the gastro-intestinal system and other organs resulting from cancer, trauma or birth defects. Our technology is based on our proprietary cell-therapy platform that uses a patient’s own stem cells to regenerate and restore function to damaged organs. We believe that our technology represents a next-generation solution for restoring organ function because it allows the patient to regenerate their own organ, thus eliminating the need for human donor or animal transplants, the sacrifice of another of the patient’s own organs or permanent artificial implants.

We conducted the world’s first successful regeneration of the esophagus in a patient with esophageal cancer in August 2017. This surgery was performed by Dr. Dennis Wigle, Chair of Thoracic Surgery at the Mayo Clinic. The results were published in the Journal of Thoracic Oncology Clinical and Research Reports in August 2021. The procedure demonstrated that our technology was able to successfully regenerate esophageal tissue, including the mucosal lining, to restore the integrity, continuity and functionality of the esophageal tube.

HRGN has 15 issued U.S. patents, 2 issued in China, 1 issued in Japan, 2 issued in Europe, 2 U.S. orphan-drug designations which can provide seven years of market exclusivity in the US market after market approval from the FDA and 1 EMA orphan drug designation, which can provide ten years of market exclusivity in the European market after market approval from the EMA.

For more information, please visit www.hregen.com and connect with the Company on LinkedIn.

Forward-Looking Statements

Some of the statements in this press release are “forward-looking” and are made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. These “forward-looking” statements in this press release include, but are not limited to, statements relating to the capabilities and performance of our products and product candidates; development expectations and regulatory approval of any of the Company’s products, by the U.S. Food and Drug Administration, the European Medicines Agency or otherwise, which expectations or approvals may not be achieved or obtained on a timely basis or at all; and success with respect to any collaborations, clinical trials and other development and commercialization efforts of the Company’s products, which such success may not be achieved or obtained on a timely basis or at all. These statements involve risks and uncertainties that may cause results to differ materially from the statements set forth in this press release, including, among other things, the Company’s inability to obtain needed funds in the immediate future; the Company’s ability to obtain and maintain regulatory approval for its products; plus other factors described under the heading “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2023 or described in the Company’s other public filings. The Company’s results may also be affected by factors of which the Company is not currently aware. The forward-looking statements in this press release speak only as of the date of this press release. The Company expressly disclaims any obligation or undertaking to release publicly any updates or revisions to such statements to reflect any change in its expectations with regard thereto or any changes in the events, conditions or circumstances on which any such statement is based.

Investor Relations Contact

Joseph Damasio

Chief Financial Officer

774-233-7330

jdamasio@hregen.com

Cover	Aug. 26, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Aug. 26, 2024
Entity File Number	001-35853
Entity Registrant Name	HARVARD APPARATUS REGENERATIVE TECHNOLOGY, INC.
Entity Central Index Key	0001563665
Entity Tax Identification Number	45-5210462
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	84 October Hill Road
Entity Address, Address Line Two	Suite 11
Entity Address, City or Town	Holliston
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01746
City Area Code	(774)
Local Phone Number	233-7300
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Entity Emerging Growth Company	false