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): May 22, 2024

PROTAGENIC THERAPEUTICS, INC.

(Exact name of Company as specified in its charter)

Delaware

001-12555

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 Disclosure.

On May 22, 2024, Protagenic Therapeutics, Inc. (“the Company”) issued a press release announcing the complete safety data set from the single dose portion of its Phase 1 trial involving PT00114, its synthetic stress-regulating peptide. A copy of the press release is furnished with this report as Exhibit 99.1.

In accordance with General Instruction B.2 of Form 8-K, the information in this Item 7.01 and Exhibit 99.1 of this Current Report on Form 8-K are being furnished and shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section. Furthermore, such information, including Exhibit 99.1 attached hereto, shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, except as expressly stated by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

Exhibit No.		Description

99.1		Press release

104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

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: May 22, 2024	By:	/s/ Alexander K. Arrow
	Name:	Alexander K. Arrow
	Title:	Chief Financial Officer

Exhibit 99.1

Protagenic Therapeutics’ Stress-Regulating Peptide Demonstrates Exceptional Safety in Single Dose Portion of Phase I Trial, Paving the Way for Next Steps Toward Potential Breakthrough Treatments in Stress Related Neuropsychiatric Disorders

No Clinically-Relevant Adverse Events Reported in Single Dose Portion, Multiple Dose Portion to Commence

Investor Call Scheduled for today, Wednesday, May 22, at 10:00 am ET to Discuss Potential Impact on PTSD, Depression, Anxiety, Addiction, and Obesity

NEW YORK, May 22, 2024 — Protagenic Therapeutics, Inc. (Nasdaq: PTIX), a leader in biopharmaceutical innovation, today announced the complete safety data set from the single dose portion of its Phase 1 trial involving PT00114, its synthesized version of a natural stress-regulating brain peptide. The trial, which included 30 subjects across five cohorts receiving doses up to 1,000 micrograms, reported zero clinically-relevant adverse events.

PT00114 targets stress reduction, which is increasingly recognized as the root cause of major psychiatric disorders, including PTSD, depression, anxiety, and addiction. Emerging evidence also suggests that stress may be a significant contributor to obesity. By addressing the stress-chemical cascade, PT00114 has the potential to offer a novel approach to treating these conditions.

“The exceptional safety results from the single dose portion of the Phase I trial are highly encouraging,” commented Dr. Robert B. Stein, Chief Medical Officer. “We are eager to begin the multiple ascending dose portion later this year, since PT00114 shows promise to revolutionize treatment for a wide range of stress-related disorders.”

The company will hold an interactive investor call today, Wednesday, May 22nd, at 10:00 am ET to discuss the safety data set and the implications for PT00114’s potential to address the unmet needs in mental health and obesity treatment. To participate, please use the link: https://www.webcaster4.com/Webcast/Page/3027/50682.

or the dial-in by phone number

Toll Free: 888-506-0062

International: 973-528-0011

Participant Access Code: 740983

and join at least five minutes before the scheduled start time.

For more details, visit www.protagenic.com.

About PT00114: PT00114 is a candidate to become a therapeutic for severe neuropsychiatric conditions, mimicking the naturally occurring brain peptide TCAP to counteract stress-induced hormonal effects.

Forward-Looking Statements: Statements in this release about future expectations are “forward-looking” and subject to risks and uncertainties. Investors are cautioned against placing undue reliance on such statements.

Company Contact: Alexander K. Arrow, MD, CFA, Chief Financial Officer, Protagenic Therapeutics, Inc. 149 Fifth Ave, Suite 500, New York, NY 10010. Tel: 213-260-4342 Email: alex.arrow@protagenic.com

Investor Relations Contact: Kirin M. Smith, President, PCG Advisory, Inc. 950 Third Avenue, Suite #2700, New York, NY 10022. Tel: 646-823-8656 Email: ksmith@pcgadvisory.com

Cover	May 22, 2024
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 22, 2024
Entity File Number	001-12555
Entity Registrant Name	Protagenic Therapeutics, Inc.new
Entity Central Index Key	0001022899
Entity Tax Identification Number	06-1390025
Entity Incorporation, State or Country Code	DE
Entity Address, Address Line One	149 Fifth Avenue
Entity Address, Address Line Two	Suite 500
Entity Address, City or Town	New York
Entity Address, State or Province	NY
Entity Address, Postal Zip Code	10010
City Area Code	212
Local Phone Number	994-8200
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Protagenic Therapeutics, Inc. Common Stock
Title of 12(b) Security	Protagenic Therapeutics, Inc. Common Stock
Trading Symbol	PTIX
Security Exchange Name	NASDAQ
Protagenic Therapeutics, Inc. Common Stock Warrants
Title of 12(b) Security	Protagenic Therapeutics, Inc. Common Stock Warrants
Trading Symbol	PTIXW
Security Exchange Name	NASDAQ