Protagenic gains FDA support for GAD trial plan
Protagenic Therapeutics, Inc. (PTIX) reported U.S. FDA feedback on its Type B pre-IND meeting request for PT00114, its lead investigational neuropeptide for generalized anxiety disorder (GAD).
Rhea-AI Filing Summary
Protagenic Therapeutics, Inc. (PTIX) reported U.S. FDA feedback on its Type B pre-IND meeting request for PT00114, its lead investigational neuropeptide for generalized anxiety disorder (GAD). FDA identified no clinical hold issues, raised no objection to the planned three-part Phase 1 design and dose-escalation approach, and viewed the proposed CMC, nonclinical, and potency/comparability packages as reasonable to support an IND submission.
PT00114 has completed single and multiple ascending dose Phase 1 studies in healthy volunteers outside the U.S., where it was reported to be well tolerated with no serious adverse events. Based on FDA feedback, Protagenic currently plans to submit an IND before the end of 2026 and is targeting first patient dosing in the first half of 2027, subject to FDA review and completion of remaining CMC, manufacturing and nonclinical work. The company notes prior filings describing substantial doubt about its ability to continue as a going concern and highlights significant capital needs and OTCQB-related risks.
Positive
- FDA pre-IND feedback supports IND filing for PT00114 in GAD, with no clinical hold issues and no objection to the planned three-part Phase 1 design, dose-escalation approach, or supporting CMC and nonclinical packages.
- Prior Phase 1 SAD/MAD studies of PT00114 completed ex-U.S. reportedly showed the drug was well tolerated across all dose levels with no serious adverse events, providing a clinical foundation for the planned U.S. program.
- Clear development timeline articulated, with an IND submission planned before the end of 2026 and first patient dosing targeted in the first half of 2027, contingent on FDA review and completion of enabling work.
Negative
- Company cites substantial doubt about its ability to continue as a going concern in prior filings, alongside a need for substantial additional capital to execute its development plans.
- Status as an OTCQB-quoted “penny stock” is highlighted as a risk, including limited trading liquidity, price volatility, and potential dilution from future financings.
- Clinical and regulatory risks remain significant, including the possibility FDA may request additional data, impose a clinical hold, or otherwise delay or prevent the planned program despite the supportive pre-IND feedback.
Filing Explained
FDA feedback supports preparing an IND, but PT00114 remains unapproved and pre-IND, with submission and clearance still ahead.
The
Form 8-K reports specified material events; here, Item 7.01 furnishes the press release and Item 8.01 reports the event. The Item 7.01 material is expressly not deemed filed under Exchange Act Section 18.
As of
That balance was below the quarter’s operating cash outflow, giving the filing’s stated need for substantial additional capital a disclosed liquidity context.
8-K Event Classification
Key Figures
Key Terms
Type B pre-Investigational New Drug (pre-IND) meeting regulatory
chemistry, manufacturing, and controls (CMC) technical
generalized anxiety disorder (GAD) medical
teneurin C-terminal associated peptide (TCAP) pathway medical
penny stock financial
FAQ
What did FDA tell Protagenic Therapeutics (PTIX) about PT00114 in generalized anxiety disorder?
What is Protagenic Therapeutics’ planned timeline for the PT00114 IND and first dosing?
What prior clinical data exist for PT00114 mentioned by PTIX?
How large is the generalized anxiety disorder market relevant to PTIX’s PT00114?
What key risks does Protagenic Therapeutics (PTIX) highlight around PT00114 and its business?
What is PT00114’s mechanism of action according to Protagenic Therapeutics (PTIX)?
AI-generated analysis. How Rhea-AI works. Not financial advice.
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
CURRENT REPORT
PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
| Date of Report (Date of Earliest Event Reported): |
PROTAGENIC THERAPEUTICS, INC. |
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Item 7.01 Regulation FD Disclosure.
On 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.
A 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.
On 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 | |
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).
In 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.
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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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