aibioProtagenic reports FDA pre-IND feedback on PT00114 for generalized anxiety disorder
Tickers PTIX
The FDA raised no objection to the planned Phase 1 design and identified no clinical hold issues. Protagenic plans to submit the IND before the end of 2026.
Key facts
- Company
- Protagenic Therapeutics, Inc. (OTC: PTIX)
- News type
- Company Updates
- Primary source
- Protagenic Therapeutics Form 8-K
Protagenic Therapeutics, Inc. (OTCQB: PTIX) said on August 20, 2026 that the U.S. Food and Drug Administration has sent written responses to its Type B pre-Investigational New Drug (pre-IND) meeting request for PT00114, the company's lead investigational neuropeptide for generalized anxiety disorder (GAD).
What the FDA said
According to the release, the 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. The agency also did not identify deficiencies that it indicated would preclude submission of an IND. FDA indicated that the company's 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 on the completed Phase 1 single ascending dose and multiple ascending dose studies of PT00114. Those studies were conducted outside the United States in a limited number of healthy volunteers and were not run under an IND. The release says PT00114 was reported to be well tolerated across all dose levels studied, with no serious adverse events reported.
The timeline and the company's view
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. Bill Nichols Jr., President of Protagenic, said: "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."
The release cites National Institute of Mental Health data that GAD affects approximately 6.8 million US adults in a given year and says no new medicine has been approved by FDA specifically for GAD in nearly two decades.
The compound and the company
Protagenic's annual report filed August 14, 2026 describes PT00114 as a synthetic form of Teneurin Carboxy-terminal Associated Peptide-1, known as TCAP-1, an endogenous brain signaling peptide that the company says can dampen overactive stress responses. The company holds exclusive, worldwide rights to PT00114 under a license agreement with the University of Toronto. The report says the company completed the multiple-dose portion of its Phase I trial in healthy volunteers and expects to begin a Phase 2 study in late 2026.
The same report describes a reverse merger with Phytanix Bio during the year ended March 31, 2026, and the unwind of that merger.
Financial position
The XBRL data show research and development expense of $901,896 for the fiscal year ended March 31, 2026, compared with $376,740 a year earlier. Revenue was $0 in both years. The data list net income (loss) of $1.4 million for fiscal 2026 and negative $3.6 million for fiscal 2025, and cash from operations of negative $2.8 million for fiscal 2026 and negative $1.8 million for fiscal 2025.
Year-end cash and cash equivalents were $1.5 million at March 31, 2026, according to a 10-Q filed August 19, 2026, compared with $14,531 a year earlier. The company reported cash and cash equivalents of $565,985 at June 30, 2026. The release's cautionary language cites the need for substantial additional capital, a history of losses, and the substantial doubt about the company's ability to continue as a going concern.
What the FDA feedback does not mean
The feedback is a set of written responses to a meeting request. It is not an IND clearance, and the company still has to file and win FDA clearance before dosing a patient. The only human data are from a limited number of healthy volunteers outside the United States, with no efficacy results, and the release gives no safety numbers beyond saying no serious adverse events were reported. The company now targets first patient dosing in the first half of 2027, while the annual report expected a Phase 2 start in late 2026. With $565,985 of cash at June 30, 2026, against cash used in operations of $2.8 million in fiscal 2026, the going concern doubt matters. The data also show net income of $1.4 million for fiscal 2026 with no revenue, which the summary does not explain.