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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): 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
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