Protagenic Therapeutics, Inc.

Protagenic Therapeutic, Inc. is a biopharmaceutical company focused on discovering and developing treatments for stress-related neuropsychiatric and mood disorders. The company's primary product is PT00114, a proprietary, patent-protected, first-in-class lead compound. PT00114 is a synthetic version of Teneurin Carboxy-terminal Associated Peptide ("TCAP"), a natural brain signaling peptide that helps reduce overactive stress responses. Preclinical studies have shown PT00114 to be effective in animal models of depression, anxiety, substance abuse and addiction, and PTSD. PT00114 operates through a novel mechanism of action. Protagenic holds exclusive, worldwide rights to PT00114 through a license agreement with the University of Toronto and has an exclusive right to license additional intellectual property from Dr. David Lovejoy's lab at the University of Toronto. The company also researches and develops follow-on compounds within the TCAP family. TCAP's mechanism of action suggests it counteracts stress overdrive at the cellular level within the brain's stress response cascade, aiming to alleviate harmful behavioral, biochemical, and physiological effects while restoring brain health. This mechanism has been confirmed in preclinical animal models of the psychiatric disorders mentioned. Protagenic completed preclinical experiments required for clinical trials in the first half of 2023. The company began its first human trial for PT00114 on September 26, 2023, to assess safety and efficacy. Complete results of the single-dose portion of the Phase I trial were announced on May 22, 2024.