Form 8-K

8-K — Protagenic Therapeutics, Inc.\new

Accession: 0001493152-26-039410

Filed: 2026-08-20

Period: 2026-08-20

CIK: 0001022899

SIC: 2834 (PHARMACEUTICAL PREPARATIONS)

Item: Regulation FD Disclosure

Item: Other Events

Item: Financial Statements and Exhibits

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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):

August

20, 2026

PROTAGENIC THERAPEUTICS, INC.

Protagenic

Therapeutics, Inc.\new

(Exact

name of Company as specified in its charter)

Delaware

001-12555

06-1390025

(State

or other jurisdiction

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

Ticker

symbol(s)

Name

of each exchange on which registered

Common Stock, par value $0.0001

PTIX

OTCQB

Common Stock Purchase Warrant

PTIXW

OTCQB

Indicate

by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2

of the Securities Exchange Act of 1934.

Emerging

growth company ☐

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

7.01 Regulation FD Disclosure.

August 20, 2026, Protagenic Therapeutics, Inc. (the “Company”) issued a press release announcing that it has received written

responses from the U.S. Food and Drug Administration (the “FDA”) to the Company’s Type B pre-Investigational New Drug

(“pre-IND”) meeting request for PT00114, the Company’s lead investigational neuropeptide product candidate, for the

treatment of generalized anxiety disorder (“GAD”).

The

foregoing disclosure is qualified in its entirety by the full text of the press release.

copy of the press release is attached as Exhibit 99.1 and is hereby incorporated by reference into this Item 7.01. The information contained

in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1 furnished herewith, is being furnished and shall not be

deemed “filed” for any purpose, including for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended

(the “Exchange Act”), or otherwise subject to the liabilities of that Section and shall not be deemed incorporated by reference

into any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of any general incorporation language in

such filing, except to the extent expressly stated in such filing.

Item

8.01 Other Events.

August 20, 2026, the Company announced that it has received written responses from the FDA to the Company’s Type B pre-IND meeting

request for PT00114, the Company’s lead investigational neuropeptide product candidate targeting the teneurin C-terminal associated

peptide (“TCAP”) pathway, for the treatment of GAD.

Based

on the FDA’s feedback, the Company currently intends to submit the IND before the end of 2026 and is targeting first patient dosing

in the first half of 2027, in each case subject to FDA review and clearance and to the Company’s completion of IND-enabling CMC,

manufacturing and nonclinical activities. PT00114 is an investigational product candidate that has not been approved for any use by the

FDA or any other regulatory authority, and its safety and efficacy have not been established.

Forward-Looking

Statements

This

Current Report on Form 8-K contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of

1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Exchange Act. Forward-looking statements may be identified

by words such as “anticipate,” “believe,” “could,” “estimate,” “expect,”

“intend,” “may,” “plan,” “potential,” “target,” “will,” “would”

and similar expressions, and include, among others, statements regarding the implications of the FDA’s pre-IND written responses;

the Company’s plans to submit a new IND; the anticipated timing of the IND submission, FDA review and first patient dosing; the

design, initiation and conduct of the planned Phase 1 program; the sufficiency of the Company’s CMC, nonclinical and potency and

comparability packages; the relevance of prior ex-U.S. clinical experience; and PT00114’s mechanism of action and therapeutic potential

in GAD.

These

statements are not guarantees of future performance and are based on management’s current expectations and assumptions, which are

subject to substantial known and unknown risks and uncertainties that could cause actual results to differ materially, including, among

others: the risk that the FDA’s pre-IND advice is non-binding and that the FDA may raise additional questions, request additional

data, impose a clinical hold, or otherwise delay or prevent the planned program; the Company’s ability to complete IND-enabling

CMC, manufacturing and nonclinical activities on the anticipated timeline or at all; the risk that results from prior ex-U.S. studies

in healthy volunteers, and from preclinical animal models, are not predictive of results in U.S. clinical trials or in patients with

GAD; risks relating to clinical trial design, site activation, patient enrollment, retention and data integrity; the Company’s

need for substantial additional capital, its history of losses, and the substantial doubt about its ability to continue as a going concern

described in its filings; risks relating to reliance on third-party manufacturers, contract research organizations and collaborators;

risks relating to intellectual property protection and competition; risks associated with the Company’s status as an OTCQB-quoted

company, including limited trading liquidity, price volatility and dilution from future financings; and the other risks and uncertainties

described under “Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2025

and in the Company’s subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the Securities and Exchange

Commission, which are available at www.sec.gov.

Because

the Company’s common stock may be considered “penny stock,” the statutory safe harbor for forward-looking statements

under the Private Securities Litigation Reform Act of 1995 may not be available to the Company, and the Company therefore also relies

on the protections afforded by the “bespeaks caution” doctrine. Forward-looking statements speak only as of the date of this

Current Report on Form 8-K, and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a

result of new information, future events or otherwise, except as required by law.

Item

9.01. Financial Statements and Exhibits.

(d)

Exhibits.

Exhibit

No.

Description

99.1

Press Release of Protagenic Therapeutics, Inc., dated August 20, 2026

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:

August 20, 2026

By:

/s/

Bill Nichols

Name:

Bill

Nichols

Title:

Chief

Executive Officer

EX-99.1

Filename: ex99-1.htm · Sequence: 2

Exhibit 99.1

FOR

IMMEDIATE RELEASE

Protagenic

Therapeutics Receives FDA Pre-IND Feedback Supporting New IND for PT00114 in Generalized Anxiety Disorder

FDA

raises no objection to the Company’s planned Phase 1 program design, dose-escalation approach, or CMC and nonclinical packages;

IND submission remains on track for the fourth quarter of 2026

NEW

YORK, NY –August 20, 2026— (ACCESS Newswire) - Protagenic Therapeutics, Inc. (OTCQB: PTIX), a clinical-stage biopharmaceutical

company developing novel peptide-based treatments for stress-related neuropsychiatric disorders, today announced that it has received

written responses from the U.S. Food and Drug Administration (FDA) to its Type B pre-Investigational New Drug (pre-IND) meeting request

for PT00114, the Company’s leading investigational neuropeptide product candidate, for the treatment of generalized anxiety disorder

(GAD).

its written responses, FDA identified no clinical hold issues and raised no objection to the overall design of the Company’s planned

three-part Phase 1 program, including its dose-escalation approach and safety review governance, and did not identify deficiencies that

it indicated would preclude submission of an IND. FDA also indicated that the Company’s proposed potency and comparability strategy,

together with its chemistry, manufacturing, and controls (CMC) and nonclinical packages, appear reasonable to support an IND submission.

The

new IND builds directly on PT00114’s completed Phase 1 single ascending dose and multiple ascending dose studies, which were conducted

outside the United States. In those studies, PT00114 was reported to be well tolerated across all dose levels studied, with no serious

adverse events reported. These studies were conducted in a limited number of healthy volunteers outside the United States and were not

conducted under an IND. FDA’s guidance allows the Company to carry this clinical experience forward into a US clinical development

program in GAD, incorporating refined CMC specifications and expanded dose cohorts into the upcoming submission.

Based

on this feedback, Protagenic plans to submit the IND before the end of 2026 and is targeting first patient dosing in the first half of

2027, pending FDA review and clearance.

According

to the National Institute of Mental Health, generalized anxiety disorder affects approximately 6.8 million adults in the United States

in a given year. No new medicine has been approved by FDA specifically for GAD in nearly two decades, and many patients do not achieve

an adequate response to first-line treatment.

“FDA’s

feedback gives us a clear path to submitting a new IND for PT00114 in generalized anxiety disorder, and it reflects the clinical and

manufacturing groundwork our team has completed to date,” said Bill Nichols Jr., President of Protagenic Therapeutics. “In

preclinical studies, PT00114 has been observed to act directly on the brain’s stress response system rather than simply blunting

symptoms, and we believe that mechanism, if confirmed in clinical trials, could represent a meaningfully different approach for a patient

population this large and this underserved. Submitting this IND is our next milestone, and we look forward to continuing to work with

FDA.”

About

PT00114 PT00114 is Protagenic’s lead clinical asset, a first-in-class investigational neuropeptide targeting the teneurin C-terminal

associated peptide (TCAP) pathway for the treatment of stress-related neuropsychiatric disorders. PT00114 has completed single ascending

dose and multiple ascending dose Phase 1 studies in healthy volunteers outside the United States, in which it was reported to be well

tolerated with no serious adverse events reported. Preclinical studies of PT00114 have shown activity in validated animal models of anxiety,

depression, substance use, and post-traumatic stress. PT00114 is an investigational

product candidate that has not been approved for any use by FDA or any other regulatory authority, and its safety and efficacy have not

been established.

About

Generalized Anxiety Disorder Generalized anxiety disorder is a common and often chronic psychiatric condition characterized by persistent,

excessive worry that interferes with daily functioning. Current standard-of-care treatments, including SSRIs, SNRIs, and benzodiazepines,

are associated with delayed onset of action, incomplete response, and tolerability or dependence concerns, underscoring the need for

treatments with novel mechanisms of action.

About

Protagenic Therapeutics, Inc. Protagenic Therapeutics, Inc. (OTCQB: PTIX) is a clinical-stage biopharmaceutical company dedicated

to developing novel peptide-based treatments for stress-related neuropsychiatric disorders. The Company is headquartered in New York,

NY.

Forward-Looking

Statements

This

press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section

27A of the Securities Act of 1933, as amended, and Section 21E of the Securities

Exchange

Act of 1934, as amended. Forward-looking statements may be identified by words such as

“anticipate,”

“believe,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,”

“potential,” “target,” “will,” “would,” and similar expressions, and include, among others,

statements regarding the implications of FDA’s pre-IND written responses; the Company’s plans to submit a new IND; the anticipated

timing of the IND submission, FDA review, and first patient dosing; the design, initiation and conduct of the planned Phase 1 program;

the sufficiency of the Company’s CMC, nonclinical and potency and comparability packages; the relevance of prior ex-U.S. clinical

experience; and PT00114’s mechanism of action and therapeutic potential in GAD.

These

statements are not guarantees of future performance and are based on management’s current expectations and assumptions, which are

subject to substantial known and unknown risks and uncertainties that could cause actual results to differ materially, including, among

others: the risk that FDA’s pre-IND advice is non-binding and that FDA may raise additional questions, request additional data,

impose a clinical hold, or otherwise delay or prevent the planned program; the Company’s ability to complete IND-enabling CMC,

manufacturing and nonclinical activities on the anticipated timeline or at all; the risk that results from prior ex-U.S. studies in healthy

volunteers, and from preclinical animal models, are not predictive of results in U.S. clinical trials or in patients with GAD; risks

relating to clinical trial design, site activation, patient enrollment, retention and data integrity; the Company’s need for substantial

additional capital, its history of losses, and the substantial doubt about its ability to continue as a going concern described in its

filings; risks relating to reliance on third-party manufacturers, contract research organizations and collaborators; risks relating to

intellectual property protection and competition; risks associated with the Company’s status as an OTCQB-quoted company, including

limited trading liquidity, price volatility and dilution from future financings; and the other risks and uncertainties described under

“Risk Factors” in the Company’s Annual Report on Form 10-K for the fiscal year ended [ ] and in the Company’s

subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K filed with the Securities and Exchange Commission, which are

available at www.sec.gov.

Because

the Company’s common stock may be considered “penny stock,” the statutory safe harbor for forward-looking statements

under the Private Securities Litigation Reform Act of 1995 may not be available to the Company, and the Company therefore also relies

on the protections afforded by the “bespeaks caution” doctrine. Forward-looking statements speak only as of the date of this

press release, and the Company undertakes no obligation to update or revise any forward-looking statement, whether as a result of new

information, future events or otherwise, except as required by law.

Investor

& Media Contact: Protagenic Therapeutics,Inc. | info@protagenic.com | www.protagenic.com

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