# Protagenic Therapeutics, Inc.\new > Clarifo company profile — qualitative business description generated from > the company's filings. Financial statements, charts and ratios are > available on Clarifo (https://www.clarifo.com/en/companies/Protagenic Therapeutics, Inc.\new). ## Overview Protagenic Therapeutics, Inc. is a U.S.-based development-stage biopharmaceutical company focused on neuropeptide-based therapies. Its lead program, PT00114, is a synthetic form of TCAP being developed for neuropsychiatric disorders such as depression, anxiety, PTSD, and substance use-related conditions. ## Products & services • PT00114 neuropeptide therapeutic candidate • TCAP-family follow-on compounds • Preclinical neuropsychiatric drug development • Phase I/IIa clinical development services - **Lead drug candidate** (70%) — PT00114, a synthetic TCAP-based compound being developed for neuropsychiatric indications. - **Pipeline follow-on compounds** (20%) — Additional TCAP-family compounds under research and development. - **Preclinical development** (10%) — Discovery, animal studies, and IND-enabling work for neuropeptide programs. - PT00114 neuropeptide therapeutic candidate - TCAP-family follow-on compounds - Preclinical neuropsychiatric drug development - Phase I/IIa clinical development services ## Customers Protagenic does not sell commercial products in the traditional sense; its primary counterparties are clinical trial participants, research vendors, and regulatory agencies supporting drug development. If successful, its eventual customers would be physicians, hospitals, and patients in neuropsychiatric treatment markets. - **Clinical trial participants** (primary) — Healthy volunteers and patients enrolled in Phase I/IIa studies to evaluate safety, biomarkers, and early efficacy. - **Research and development vendors** (primary) — Contract research organizations, peptide synthesizers, and other outsourced service providers used to advance the pipeline. - **Regulatory agencies** (primary) — FDA and other regulators that review preclinical, IND, and clinical data before commercialization can proceed. - **Future neuropsychiatric patients** (emerging) — Potential end users of PT00114 if the program reaches approval for depression, anxiety, PTSD, or addiction-related conditions. - Clinical trial subjects enrolled in PT00114 studies - Patients with depression, anxiety, PTSD, and related disorders - CROs and lab vendors supporting outsourced development - Regulators reviewing IND and clinical trial submissions - Future prescribers and healthcare systems if approved ## Geography Protagenic is headquartered in the United States and conducts its development activities through a U.S.-centric clinical and regulatory framework. The company also references regulatory questions in Germany, indicating some cross-border scientific or regulatory interaction, but no country-level revenue disclosure is available. - Headquartered in the United States - Clinical and regulatory work centered on U.S. FDA pathways - Regulatory questions also referenced in Germany - No disclosed country-level revenue mix - Geography matters mainly through trial oversight and approvals ## Strategy Protagenic's strategy is to advance PT00114 through clinical development and obtain regulatory approval for commercialization. It is also building a broader TCAP-family pipeline and protecting the intellectual property around its neuropeptide platform. - **Advance PT00114 through clinical development** (short-term) — Clinical data are the main value driver for a development-stage biotech company. - **Secure regulatory progress** (short-term) — Regulatory clearance is required before broader testing and eventual commercialization. - **Build a broader TCAP pipeline** (medium-term) — A second or third asset can reduce single-program dependence and extend platform value. - Advance PT00114 through clinical proof-of-concept - Complete regulatory requirements for IND and trial progression - Expand the TCAP-family pipeline beyond the lead asset - Protect worldwide intellectual property rights - Use biomarker data to support mechanism and efficacy ## Risks Protagenic faces the typical risks of an early-stage biotech company: clinical failure, regulatory delay, and dependence on external funding. Its lead asset is still in development, so setbacks in safety, efficacy, or trial execution could materially impair the business. - **Going concern and financing dependence** [critical] — The company has limited cash and expects to need additional capital to fund operations. - **Clinical development failure** [high] — PT00114 must demonstrate acceptable safety and efficacy in human trials. - **Regulatory delay or rejection** [high] — Approval pathways depend on FDA and other regulator feedback and compliance. - **Single-program concentration** [high] — The company's value is concentrated in one lead candidate and a small pipeline. - **Outsourced development execution risk** [medium] — CROs, synthesizers, and other vendors are essential to preclinical and clinical work. - Clinical trial failure could end or delay the lead program - Regulatory questions can slow IND or trial progression - Heavy dependence on external financing increases dilution risk - Outsourced R&D creates vendor and execution risk - Single-asset concentration makes the company highly exposed ## Accounting As a development-stage biotech, Protagenic's reported results are driven mainly by research and development spending, stock compensation, and professional fees rather than product revenue. Investors should watch cash burn, accrued vendor obligations, and any judgments around going-concern disclosure, because these can materially affect the presentation of liquidity and future funding needs. - **Research and development expense recognition** — Operating loss and cash burn - **Stock-based compensation** — Operating expenses and net loss - **Accrued liabilities and professional fees** — Working capital and liabilities - **Going-concern disclosure** — Financial statement presentation and investor risk assessment - R&D expense reflects outsourced trial and preclinical activity - Stock compensation affects operating loss and non-cash expense - Accrued expenses capture vendor, legal, and accounting costs - Going-concern assessment depends on cash runway estimates - No commercial revenue means results are highly expense-driven --- *Last updated: 2026-09-24T10:46:57.213863+00:00*