Protagenic Therapeutics, Inc.\new
PTIX evidence brief
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Prepared research question
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BioSniper AI · PTIX
Protagenic Therapeutics, Inc. is a developmental-stage biopharmaceutical company focused on advancing PT00114, an investigational neuropeptide product candidate targeting the teneurin C-terminal associated peptide (TCAP) pathway for generalized anxiety disorder (GAD) and treatment-resistant depression, with no approved products and limited cash runway.
Key risk: Cash runway insufficient
BioSniper Score
Based on 3 of 6 signals
Limited data coverage
Financial data as of Jun 30, 2026.
Protagenic Therapeutics, Inc. is a developmental-stage biopharmaceutical company focused on advancing PT00114, an investigational neuropeptide product candidate targeting the teneurin C-terminal associated peptide (TCAP) pathway for generalized anxiety disorder (GAD) and treatment-resistant depression, with no approved products and limited cash runway.
- Lead candidate PT00114 targets the teneurin C-terminal associated peptide (TCAP) pathway for GAD and depression; no FDA approval has been received [sec · filed 2026-08-20].
- Cash and equivalents were $0.6M as of 2026-06-30, with a working capital deficit of $362,743; cash expected to fund operations only until approximately end of Q3 2026 [sec_mda · as of 2026-08-19].
- Company has two full-time employees and is transitioning to a virtual operating model to minimize cash burn [sec_mda · as of 2026-08-14].
- A Type B pre-IND meeting for PT00114 has been held; the Company intends to submit an IND before end of 2026 and target first patient dosing in H1 2027, subject to FDA clearance [sec · filed 2026-08-20].
- Net loss was -$1.0M for the period ending 2026-06-30; accumulated deficit and negative shareholders' equity of -$5.0M reflect ongoing developmental-stage losses [sec].
What works
- PT00114 has shown encouraging but not conclusive evidence of anti-anxiety and anti-depression activity in preclinical studies, providing a potential therapeutic rationale [sec_mda · as of 2026-08-19].
- The Company has received FDA feedback via a Type B pre-IND meeting and is advancing toward IND submission, indicating regulatory engagement [sec · filed 2026-08-20].
- Management is implementing a virtual operating model and restructuring to focus resources on the clinical program, potentially extending the cash runway [sec_mda · as of 2026-08-14].
What to weigh
- Cash of $0.6M as of 2026-06-30 is only sufficient to fund operations until approximately the end of Q3 2026, with no committed sources of additional capital [sec_mda · as of 2026-08-19].
- The Company has a working capital deficit of $362,743 and negative shareholders' equity of -$5.0M, indicating financial distress [sec_mda · as of 2026-08-19].
- PT00114 is an investigational product candidate that has not been approved by the FDA; its safety and efficacy have not been established [sec · filed 2026-08-20].
- The Company has only two full-time employees and relies on external vendors, creating operational and execution risk [sec_mda · as of 2026-08-14].
From the filings
Quoted directly from source documents.
Cash runway limited to end of Q3 2026
“Based on our current operating plans, we believe that our cash resources will be sufficient to fund its operations until approximately the end of the third quarter of 2026.”
SEC MD&A · August 19, 2026
PT00114 is not yet approved
“PT00114 is an investigational product candidate that has not been approved for any use by the FDA or any other regulatory authority, and its safety and efficacy have not been established.”
SEC filings · August 20, 2026
Company has only two employees
“Human Resources (current state of employees) The Company has two: two full-time employees: Bill Nichols, Jr, the Presi”
SEC MD&A · August 14, 2026
Risks & what to watch (4)›
Key risks
- Cash runway insufficient — Cash of $0.6M as of 2026-06-30 expected to fund operations only until end of Q3 2026; no committed additional capital [sec_mda · as of 2026-08-19].
- No approved products — PT00114 is investigational and has not been approved by the FDA; safety and efficacy unproven [sec · filed 2026-08-20].
- Thin management team — Only two full-time employees; heavy reliance on external CROs and vendors [sec_mda · as of 2026-08-14].
- Regulatory uncertainty — FDA pre-IND advice is non-binding; FDA may impose clinical hold or request additional data [sec · filed 2026-08-20].
What to watch
- IND submission for PT00114 expected before end of 2026; FDA clearance required [sec · filed 2026-08-20].
- First patient dosing targeted for H1 2027, subject to FDA review and completion of CMC activities [sec · filed 2026-08-20].
- Ability to raise additional capital given cash runway ending Q3 2026 [sec_mda · as of 2026-08-19].
- Completion of Phase 2 clinical trial of PT00114 (peptide analogue) expected in approximately 9-12 months [sec_mda · as of 2026-08-14].
Sources: SEC filings · SEC MD&A · Generated August 29, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 3 of 6 signals · derived from public data
No clinical pipeline tracked — this score reflects financial & catalyst signals only.
1.9 months
D/E 0.62 · 0% dilution
No tracked pipeline phase
No tracked pipeline candidates
No upcoming catalysts tracked
5 buys · 0 sells (180d)
Runway
Financials
Governance
Frequently asked questions
What is the AI investment thesis for Protagenic Therapeutics, Inc.\new?
Protagenic Therapeutics, Inc. is a developmental-stage biopharmaceutical company focused on advancing PT00114, an investigational neuropeptide product candidate targeting the teneurin C-terminal associated peptide (TCAP) pathway for generalized anxiety disorder (GAD) and treatment-resistant depression, with no approved products and limited cash runway.
Who is the CEO of Protagenic Therapeutics, Inc.\new?
Timothy R. Wright is the chief executive officer of Protagenic Therapeutics, Inc.\new (PTIX).
Where is Protagenic Therapeutics, Inc.\new headquartered?
Protagenic Therapeutics, Inc.\new (PTIX) is headquartered in New York, NY, United States.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.