Protagenic Therapeutics, Inc.\new PTIX

Protagenic Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing therapeutics for stress-related neuropsychiatric and mood disorders. The company's primary activities center on its proprietary, patent-protected lead compound, PT00114, a synthetic form of Teneurin Carboxy-terminal Associated Peptide-1 (TCAP-1). TCAP-1 is an endogenous brain signaling peptide that dampens overactive stress responses. Protagenic Therapeutics, Inc. operates exclusively in the biopharmaceutical industry, targeting disorders such as depression, anxiety, substance abuse and addiction, and PTSD through its novel mechanism of action.

Protagenic Therapeutics, Inc. currently generates no revenue as it has not yet commercialized any products. The company's revenue model will be based on the future sale of its therapeutic candidates, primarily PT00114 and follow-on compounds from the TCAP family, once they receive regulatory approval and reach the market. Until then, the company relies on funding from licensing agreements, potential partnerships, and other financial resources to support its research and development efforts.

The company operates through the following segments:

• Protagenic Therapeutics: This segment focuses on the discovery and development of TCAP-based therapeutics for stress-related neuropsychiatric and mood disorders. The segment's lead product candidate is PT00114, which has demonstrated efficacy in preclinical animal models for depression, anxiety, substance abuse and addiction, and PTSD. The segment also includes follow-on compounds in the TCAP family currently in preclinical evaluation.
• Phytanix Bio Programs: This segment encompasses the drug candidate programs acquired through the prior business of Phytanix Bio, including PHYX-001, a Kv7.2/7.3 agonist for epilepsy and mood disorders. PHYX-002 is an internally developed cannabinoid-based therapeutic targeting epilepsy, schizophrenia, autism spectrum disorder, anxiety, depression, and cardiovascular disorders. PHYX-003 is an internally developed preclinical asset targeting obesity, designed to enhance weight-loss outcomes compared to current therapies. PHYX-004 is an internally developed cannabis-derived extract for bladder pain syndrome/interstitial cystitis. PHYX-005 is an internally developed stilbenoid-based asset for central nervous system and inflammatory indications.

Protagenic Therapeutics, Inc. positions itself as an innovator in the neuropsychiatry space with a first-in-class mechanism of action targeting stress signaling pathways. The company faces competition from established pharmaceutical companies offering treatments for depression, anxiety, addiction, and PTSD, including SSRIs, SNRIs, atypical antipsychotics, ketamine, and esketamine. However, Protagenic believes its lead compound PT00114 offers competitive advantages such as a rapid onset of action, long-lasting effects, rapid clearance, natural blood-brain barrier penetration, low toxicity profile, and non-addictive properties based on preclinical data.

Protagenic Therapeutics, Inc. intends to serve patients suffering from stress-related neuropsychiatric and mood disorders, including those with treatment-resistant depression, generalized anxiety disorder, substance use disorder, and post-traumatic stress disorder. The company's future customer base will consist of individuals diagnosed with these conditions who are seeking alternative or adjunctive therapies due to inadequate responses to current treatments.