8-K 1 form8-k.htm

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): April 23, 2021

PROTAGENIC THERAPEUTICS, INC.

(Exact name of Company as specified in its charter)

Delaware		000-51353		06-1390025
(State or other jurisdiction of incorporation)		(Commission File Number)		(I.R.S. Employer Identification No.)

149 Fifth Avenue, Suite 500, New York, NY		10010
(Address of principal executive offices)		(Zip Code)

212-994-8200

(Company’s telephone number, including area code)

(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 Company 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(s)	Name of each exchange on which registered
Protagenic Therapeutics, Inc. Common Stock	PTIX	Nasdaq
Protagenic Therapeutics, Inc. Common Stock Warrants	PTIXW	Nasdaq

Item 7.01. Regulation FD.

The company’s press release announcing a change in the timeline of initiation of the clinical trial of its lead drug candidate, PT00114, is furnished hereto as Exhibit 99.1.

The information in this Form 8-K (including the Exhibit) shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific referenced in such a filing.

Item 8.01. Other Events.

Upon review of the company’s investigational new drug (IND) application filed on June 29, 2021, the U.S. Food and Drug Administration has requested that the company provide clinical sites with ready-to-inject clinical vials rather than providing site pharmacies with the drug substance to be formulated locally. The company is immediately implementing this required change. As a result of this development, the company expects to refile its IND and commence patient enrollment in the fourth quarter of 2021.

Item 9.01. Financial Statements and Exhibits.

Exhibit No.		Description

99.1		Press release announcing a change in the timeline of initiation of the clinical trial of its lead drug candidate, PT00114, entitled “ Protagenic Therapeutics Updates Timeline for Commencement of Patient Enrollment for PT00114 Clinical Trial”

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.

	PROTAGENIC THERAPEUTICS, INC.

Date: July 23, 2021	By:	/s/ Alexander K. Arrow
	Name:	Alexander K. Arrow
	Title:	Chief Financial Officer

Protagenic Therapeutics Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits