Protagenic Therapeutics, Inc.\new

Protagenic Therapeutics, Inc.

Overview

Protagenic Therapeutics is a clinical-stage biopharmaceutical company developing therapeutics for stress-related neuropsychiatric and mood disorders. Its principal lead candidate is PT00114, a synthetic form of TCAP-1, a TCAP-family neuropeptide.

Lead program and mechanism

• PT00114 is a synthetic TCAP-1 designed to modulate stress signaling in the brain.
• The candidate targets Latrophilin-1 and Latrophilin-3 receptors in circuits involved in stress and mood regulation.
• The company positions PT00114 as having a potentially differentiated safety profile versus existing CNS therapies based on this mechanism.

Development status

• Phase I/II clinical program initiated in 2023.
• First human trial began September 26, 2023.
• May 22, 2024: complete results reported for the single-dose portion of the Phase I trial.
• December 2025: completed the multiple-dose portion of the Phase I study in healthy volunteers.
• Plans to begin a Phase II study in late 2026 in a targeted population with chronic stress-related psychiatric disorders.
• IND re-submission anticipated later in 2026 to advance the Phase IIa portion in the United States.

Pipeline and strategy

• Developing follow-on compounds within the TCAP family to expand the pipeline.
• Exploring efficacy in additional stress-related neuropsychiatric, neurodegenerative, and mood disorders.
• Considering strategic partnerships, including international opportunities, while strengthening intellectual property around TCAP-related technologies.

Corporate history and structure

• In the year ended March 31, 2026, Protagenic completed a reverse merger with Phytanix Bio and subsequently unwound that merger; Phytanix Bio financials are consolidated only through the unwind date.
• PTI Canada Inc. is a wholly-owned Canadian subsidiary established to support operations in Canada and access Canadian R&D programs.

Intellectual property

• Exclusive global rights to PT00114 under a Technology License Agreement with the University of Toronto, with ongoing rights to license additional TCAP-related IP from Dr. David Lovejoy’s laboratory.
• As of March 31, 2026, the portfolio includes multiple patent families with issued patents in the US, Canada, Great Britain, Europe, and Hong Kong, plus additional related families and pending applications.
• License economics include royalties of 2.5% of net sales of products based on the licensed technologies, 10% of applicable upfront sub-license fees for sub-licenses granted after Sept 9, 2006, and 2.5% of net sales by sub-licensees. The University of Toronto may convert an exclusive license to non-exclusive under certain reporting or regulatory conditions.

Commercialization and manufacturing

• The company does not maintain in-house sales, marketing, or distribution capabilities and expects to rely on third-party partners or to build a commercial organization if products are approved.
• Protagenic does not own manufacturing facilities and uses contract manufacturers.
• PT00114 for the Phase I program was produced in cGMP facilities. Initial formulation is subcutaneous, with sublingual or intranasal routes under consideration for later stages.

Market opportunity

• Targets include populations with depression (including treatment-resistant depression), anxiety disorders (e.g., generalized anxiety disorder), PTSD, and substance use disorders (including opioid use disorder and AUD).
• The company cites substantial unmet need and market opportunities across these indications for TCAP-family therapies.

Financial and operating highlights (as of March 31, 2026)

• Employees: two full-time and one part-time employees; additional consultants and temporary staff engaged as needed.
• Revenue: no product sales for the year ended March 31, 2026.
• Net income / loss: net income of $1,367,977 for the year ended March 31, 2026; net loss of $3,591,858 for the year ended March 31, 2025.
• Accumulated deficit: $4,029,629 as of March 31, 2026.
• Cash runway: existing resources are sufficient to fund operations until the end of the third quarter of 2026.
• The company anticipates ongoing financing needs to fund development, including potential collaborations or licensing arrangements.

Geographic footprint and property

• Principal offices: 149 Fifth Avenue, Suite 500, New York, NY 10010.
• Does not own real property; uses partner-provided office space for certain meetings.

Key takeaway

Protagenic is a clinical-stage biotech advancing PT00114 (synthetic TCAP-1) in human trials, supported by a University of Toronto license and an expanding IP portfolio. The company has a small internal team, no product revenue to date, a cash runway into mid-2026, and plans to raise additional capital to support Phase II development and strategic partnerships.