PTIX News & Events

Protagenic Therapeutics announced the publication of new preclinical data for its lead candidate, PT00114, in the peer-reviewed journal Behavioural Pharmacology. In a well-established rodent model of chronic unpredictable stress, PT00114 reduced both physiological and behavioral markers of chronic stress after stress had been established, while the prototypical non-peptide corticotropin-releasing factor receptor 1 antagonist CP-154,526 did not show activity on the same endpoints. As part of their pre-clinical investigation program, using a 14-day chronic unpredictable stress paradigm in male Sprague Dawley rats, the researchers evaluated PT00114 against saline as a control and CP-154,526 as a comparator. PT00114 reduced stress-induced plasma corticosterone by 56.4%, relative to stressed, saline-treated controls, after two 250 nmol/kg doses administered subcutaneously on days 12 and 13. PT00114 increased time spent in the center of an open field arena by 282% versus controls. There was no significant change in total distance traveled-indicating that the effect was not attributable to a general change in locomotion. CP-154,526 did not affect either corticosterone or time spent in the center of the open field whether it was administered on days 12 and 13 or daily throughout the entire stress paradigm These data provide further preclinical rationale for Protagenic Therapeutic's development strategy of evaluating PT00114 for the potential treatment of chronic, stress-related conditions. Protagenic has reported positive topline safety results from Phase 1 studies of PT00114 and plans to initiate subsequent clinical studies in 2027. Multiple, structurally distinct CRF1 receptor antagonists have shown robust activity in acute-stress rodent models over the past two decades but have repeatedly failed to separate from placebo in clinical trials for generalized anxiety disorder, major depressive disorder, and related conditions. The study authors note that this preclinical-to-clinical gap has been attributed, in part, to an over-reliance on acute-stress models that may not reflect the sustained, heterogeneous nature of human anxiety and depression. In this study, PT00114 retained activity while a CRF1 antagonist was ineffective in a chronic stress environment even with continuous dosing.

Protagenic Therapeutics announced two strategic engagements to support the advancement of its lead candidate, PT00114. The Company has engaged Floyd Regulatory Strategic Consulting, led by regulatory affairs veteran Dr. Eric Floyd, Ph.D., MBA, as Regulatory Affairs Advisor, and DanforthHealth to establish institutional-grade operational processes and infrastructure. "Together, these engagements reflect Protagenic's deliberate, lean operating model concentrating resources and expertise on PT00114's Phase 2 advancement while positioning the Company for long-term value creation for patients and shareholders," the company said.

Protagenic Therapeutics announced the appointment of Bill Nichols Jr. as President. At Protagenic, Nichols will drive integrated clinical development, corporate strategy, and enterprise planning as the Company prepares to initiate Phase 2 enrollment for PT00114 in 2026.

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.