Protagenic Therapeutics, Inc.

Protagenic Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing therapeutics for stress-related neuropsychiatric and mood disorders. The company's lead compound, PT00114, is a proprietary, patent-protected, first-in-class synthetic form of Teneurin Carboxy-terminal Associated Peptide-1 (TCAP-1). TCAP-1 is an endogenous brain signaling peptide that can dampen overactive stress responses. Preclinical animal models have shown PT00114 to be effective in depression, anxiety, substance abuse and addiction, and PTSD, operating through a novel mechanism of action. Protagenic Therapeutics, Inc. holds exclusive, worldwide rights to PT00114 through a license agreement with the University of Toronto, and an exclusive right to license additional intellectual property from Dr. David Lovejoy's laboratory at the University of Toronto. The company is also developing follow-on compounds within the TCAP family. Extensive peer-reviewed research highlights the central role of stress in the onset and progression of disorders like depression, anxiety, substance abuse and addiction, and PTSD. TCAP-1's mechanism of action suggests it counterbalances excess stress signaling at the cellular level within the brain's stress response cascade. In preclinical animal models of these disorders, TCAP-1 has been observed to alleviate harmful behavioral, biochemical, and physiological effects of stress while supporting brain health. The company completed preclinical work for a clinical trial in the first half of 2023 and began its first human trial for PT00114 on September 26, 2023. On May 22, 2024, complete results of the single-dose portion of the Phase I trial were announced. In December 2025, the multiple-dose portion of the Phase I study in healthy volunteers was completed. A Phase 2 study is expected to begin in late 2026 to evaluate PT00114 in a targeted patient population affected by chronic stress-related psychiatric disorders.