PTIX News & Events

Protagenic Therapeutics announced the closing of a settlement and separation related to its prior Phytanix Bio acquisition. The transaction simplifies Protagenic's capital structure, materially reducing liabilities and sharpens the Company's operating focus on PT00114. At the common-share level, the separation impact is measurable for shareholders. Protagenic reported 1,934,878 common shares outstanding as of November 26, 2025. Under the separation agreement, all 117,690 common shares issued in connection with the May 2025 transaction were returned to the Company and cancelled. As of March 5, 2026, Protagenic reported 1,810,208 common shares outstanding. The returned merger shares represented approximately 6% of the November 2025 common share base, increasing the ownership percentage represented by each remaining common share. The separation also removes more than $6.3 million of liabilities from Protagenic's balance sheet, reducing total liabilities from approximately $6.8 million to approximately $0.5 million, while eliminating more than $1mm in annualized costs associated with the Phytanix organization and their operations. Protagenic expects the remaining approximately $0.5 million of liabilities to consist principally of ordinary-course trade payables associated with ongoing operations. Key Implications for PTIX Shareholders: Greater per-share ownership. The 117,690 merger shares returned and cancelled represented approximately 6% of the 1,934,878 common shares outstanding reported as of November 26, 2025. As of March 5, 2026, the Company reported 1,810,208 common shares outstanding. Materially cleaner balance sheet. More than $6.3 million of liabilities were removed, reducing total liabilities to approximately $0.5 million, principally ordinary-course payables. Leaner cost structure. More than $1 million of annualized personnel and related operating expense tied to the Phytanix organization has been eliminated. Capital concentrated on PT00114. Management can now prioritize a first-in-class clinical program with positive multiple-dose Phase 1 safety data and Phase 2 enrollment planned for 2026. Reduced transaction overhang. Merger-related litigation has been resolved, governance has been simplified and each company can advance independently. PT00114, a first-in-class investigational compound targeting the TCAP pathway, is now the Company's primary clinical priority. In December 2025, Protagenic reported positive topline results from the program's Phase 1 multiple-dose study: PT00114 was well tolerated across all dose ranges studied, no serious adverse events were observed and all planned cohorts completed dosing. The Company remains on track to begin Phase 2 enrollment in 2026.

Protagenic Therapeutics reported topline safety results from its Phase 1 Multiple Dose study of PT00114. PT00114 is a synthetic analogue of a naturally occurring brain peptide thought to be involved in restoring homeostasis following prolonged exposure to stress. Its mechanism of action-rooted in rebalancing dysfunctional stress-response circuits-represents a departure from conventional neurotransmitter-focused approaches and may offer a new pathway for patients whose conditions remain insufficiently treated with existing therapies. The study was conducted in healthy volunteers and was designed to evaluate the safety, tolerability, and pharmacokinetic profile of PT00114 across multiple dose levels. All planned cohorts have completed dosing. Preliminary analyses show: PT00114 was well tolerated across all dose ranges studied. Reported adverse events were consistent with expectations for a peptide-based injectable therapy, including expected injection-site reactions. No serious adverse events were observed, and all participants completed the assigned dosing schedules. Protagenic Therapeutics is finalizing its detailed analysis of the full Phase 1 dataset, including pharmacokinetic modeling to support dose selection. A comprehensive report will be released once analyses are complete. The company expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in a targeted patient population affected by chronic stress-related psychiatric disorders. Additional details on study design and endpoints will be communicated in the coming months.

Protagenic Therapeutics announced the completion of enrollment and dosing in its Multiple Ascending Dose Phase 1 study evaluating its lead compound, known as PT00114. The study, conducted in healthy volunteers, was designed to assess the safety and tolerability profile of PT00114 following multiple doses over time. With all healthy volunteers now dosed, the company has achieved a milestone in the clinical development of its proprietary peptide-based therapeutic. The company expects to finalize and release top-line results from the MAD study by November 30.