Protagenic Therapeutics, Inc.\new

Protagenic Therapeutics, Inc. is a biopharmaceutical company focused on discovering and developing therapeutics for stress-related neuropsychiatric and mood disorders. The company's proprietary, patent-protected, first-in-class lead compound, PT00114, is a synthetic form of Teneurin Carboxy-terminal Associated Peptide-1 (TCAP-1), an endogenous brain signaling peptide that can dampen overactive stress responses. In preclinical animal models, PT00114 has demonstrated efficacy in depression, anxiety, substance abuse and addiction, and PTSD, and it works through a novel mechanism of action. The company owns exclusive, worldwide rights to PT00114 through a license agreement with the University of Toronto and holds an exclusive right to license additional intellectual property generated by Dr. David Lovejoy's laboratory at the University of Toronto. The company is also developing follow-on compounds in the TCAP family. Stress-related mental, mood and behavioral disorders include treatment resistant depression (TRD), a subgroup of major depressive disorder (MDD); addiction or substance use disorder (SUD); anxiety, including generalized anxiety disorder (GAD); and post-traumatic stress disorder (PTSD). These disorders are a leading cause of disability worldwide and also a major contributor to suicide. The majority of these patients are inadequately served by current therapeutic options, which can have limited efficacy, significant side effects and high treatment burden.

The pharmaceutical and biotechnology industries are highly competitive and characterized by rapidly evolving technology and intense research and development efforts. The company expects to compete with companies, including major international pharmaceutical companies and other institutions that have substantially greater financial, research and development, marketing and sales capabilities and have substantially greater experience in undertaking preclinical and clinical testing of products, obtaining regulatory approvals and marketing and selling biopharmaceutical products. The company will face competition based on, among other things, product efficacy and safety, the timing and scope of regulatory approvals, product ease of use and price. Despite a large patient population and current treatments that leave much room for improvement, industry-wide developmental pipelines are sparse and few novel candidates are in development. The serendipitous discoveries of current drug classes, side effects, and lack of efficacy have led to shrinkage or extinction of many pharma or small biotech neuroscience research programs. The company's preclinical data and the corroborated mechanism of action of PT00114 indicates its advantages as compared to current approved therapies, including a rapid onset of action in animal anxiety and depression models, long-lasting and potent effects (single 1-10 nmole/kg dose lasts up to one week for glucose/insulin blood-based biomarkers), rapid clearance (half-life of 5-10min if given intravenously, 20-30 minutes if given subcutaneously), natural crossing of the blood brain barrier, and studies demonstrating the compound does not cause dependency following multiple administrations.

The company generates revenue through licensing agreements and has no product revenue. The company's core business model is centered on discovering and developing therapeutics for stress-related neuropsychiatric and mood disorders. The company currently has no approved products and has generated no product revenue. The company expects that product development, preclinical and clinical programs will increase losses significantly over the next five years. The company may seek to obtain revenue from collaboration or licensing agreements with third parties and currently has no such agreements which will provide material, ongoing future revenue. The company's primary customer segments are patients affected by stress-related neuropsychiatric and mood disorders, including those with treatment resistant depression, substance use disorder, generalized anxiety disorder, and post-traumatic stress disorder.

The company's proprietary, patent-protected, first-in-class lead compound is PT00114, a synthetic form of Teneurin Carboxy-terminal Associated Peptide-1 (TCAP-1). TCAP-1 is an endogenous brain signaling peptide that can dampen overactive stress responses. In preclinical animal models, PT00114 has demonstrated efficacy in depression, anxiety, substance abuse and addiction, and PTSD, and it works through a novel mechanism of action. The company completed the preclinical work required to begin a clinical trial in the first half of 2023. The company began its first human trial, designed to evaluate the safety and efficacy of PT00114, on September 26, 2023. On May 22, 2024, the company announced the complete results of the single-dose portion of its Phase I trial. In December 2025, the company announced that it had completed the multiple-dose portion of its Phase I study in healthy volunteers. The company expects to begin a Phase 2 study in late 2026 to evaluate PT00114 in a targeted population of patients affected by chronic stress-related psychiatric disorders. The company is also developing follow-on compounds in the TCAP family. The initial dosage form is intended as a subcutaneous injection but is also amenable to other routes of administration including sublingually or intra-nasally. The company also had prior Phytanix Bio business consisting of drug candidate programs including PHYX-001 (Kv7.2/7.3 Agonist for Epilepsy and Mood Disorders), PHYX-002 (Cannabinoid-Based Therapeutics), PHYX-003 (Anti-Obesity Candidate), PHYX-004 (Cannabis Extract for Bladder Pain Syndrome / Interstitial Cystitis), and PHYX-005 (Modified Stilbenoid Program for Central Nervous System and Inflammatory Indications).

During the year ended March 31, 2026, the company entered into a reverse merger with Phytanix Bio as well as an unwind of this merger. Due to this reverse merger, the company presents the historical financial information of Phytanix Bio and only includes the financial information for Protagenic for the period after the reverse merger. The financial numbers for Phytanix Bio are consolidated only through the date of the unwind. The company currently does not own any manufacturing facilities and relies on third party contract manufacturers for synthesis of PT00114. The company manufactured sufficient PT00114 synthesized under Good Manufacturing Practices (cGMP) conditions for its Phase I study that was completed in 2025. The company currently has two full-time and one part-time employees. The company's principal offices are located at 149 Fifth Avenue, Suite 500, New York, New York 10010, in a conference room of Agenus, Inc. at no cost. The company currently has no sales, marketing, or distribution capabilities.

The company has generated net losses since it began operations, including net income of $1,367,977 ¹ and net loss of $3,591,858 ² for the years ended March 31, 2026 and March 31, 2025, respectively. As of March 31, 2026, the company had an accumulated deficit of $4,029,629 ³. The company has no approved products and has generated no product revenue. The company expects that product development, preclinical and clinical programs will increase losses significantly over the next five years. Based on its cash resources as of March 31, 2026, the company has sufficient resources to fund its operations until the end of the third quarter of 2026. The company's consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business.

The company expects to begin a Phase 2 study in late 2026 to evaluate PT00114 in a targeted population of patients affected by chronic stress-related psychiatric disorders. The company currently anticipates re-submitting an investigational new drug (IND) application, later in 2026, in advance of initiating the Phase IIa portion of its present clinical study, to ascertain whether this portion of the study may be conducted in the United States. The company aims to complete certain key strategic and tactical milestones over the coming two years, including efficiently advancing its lead product candidate, PT00114, through clinical trials in treatment resistant depression, substance use disorder, generalized anxiety disorder, and/or post-traumatic stress disorder; developing additional product candidates from the TCAP family to build out a broad pipeline of assets with differentiated features; exploring efficacy in additional stress-related neuropsychiatric, neurodegenerative and mood disorders beyond initially targeted indications; facilitating long-term growth by leveraging a team of nimble R&D, operational, clinical and commercial experts; proactively assessing strategic partnership opportunities including in important international markets; and continuing with its strategy of strengthening its IP position in this important novel field of neuropsychiatry.

The company plans to start its clinical program with patients diagnosed with Generalized Anxiety Disorder (GAD). Following that trial, the company will explore other disorders including, but not limited to, depression, addiction, and Post-Traumatic Stress Disorder (PTSD). The company will be using this study for both safety and preliminary efficacy to prioritize indications for later phase development that would ultimately support a New Drug Application (NDA) and registration. The four indications were chosen for multiple reasons, including the mechanism of TCAP in reducing biological stress signals, preclinical evidence of efficacy in animal models of these disorders and the high unmet need in these patient populations, which creates significant market opportunity. The company is also developing follow-on compounds in the TCAP family. The company anticipates further intellectual property filings as its cannabinoid program (PHYX-002) advances, with the goal of developing a product with improved potency and lower dosing requirements compared to currently available cannabinoid medicines, including Epidiolex. The company's anti-obesity candidate (PHYX-003) is designed to potentially enhance weight-loss outcomes compared with current blockbuster therapies such as tirzepatide (Mounjaro/Zepbound) and semaglutide (Ozempic/Wegovy). Given the rapid growth and high level of unmet need in the global obesity market, PHYX-003 could represent a significant opportunity for the company.

The company expects that product development, preclinical and clinical programs will increase losses significantly over the next five years. The company anticipates that it will continue to generate operating losses and negative cash flow from operations and its current cash position is sufficient to fund its current business plan until the third quarter of 2026. The company's research and development expenses could exceed its current expectations for many reasons, including if some or all of its product candidates fail in clinical or preclinical studies and the company is forced to seek additional product candidates, if its product candidates require more extensive clinical or preclinical testing than currently expected, if the company advances more of its product candidates than expected into costly later stage clinical trials, or if the company advances more preclinical product candidates than expected into early stage clinical trials.

The company currently does not own any manufacturing facilities and relies on third party contract manufacturers for synthesis of PT00114. The company manufactured sufficient PT00114 synthesized under Good Manufacturing Practices (cGMP) conditions for its Phase I study that was completed in 2025. PT00114 is highly soluble and has shown excellent preliminary stability in several storage conditions, with the material being stable for at least 12 months. The initial dosage form developed will be a subcutaneous injection. Because PT00114 is also amenable to other routes of administration including sublingually or intra-nasally, the company will be doing preliminary process work to develop these formulations, and anticipates using one of these dosage forms in later stage clinical studies. The company currently has two full-time and one part-time employees and expects that as its business grows it may hire additional personnel to handle the increased demands on its operations, preclinical and clinical activities.

The company expects to seek additional funding through public or private financings, but may not be able to obtain financing on acceptable terms, or at all. The company may also seek additional funds through arrangements with collaborators or other third parties, which would generally require the company to relinquish rights to some of its technologies, product candidates or products. The company has no existing bank lines of credit and has not established any definitive sources for additional financing. The company's research and development expenses could exceed its current expectations, including due to higher than expected costs to manufacture its product candidates, higher than expected costs for preclinical testing, an increase in the number, size, duration, and/or complexity of its clinical trials, slower than expected progress in developing PT00114 or other product candidates, higher than expected costs associated with attempting to obtain regulatory approvals, higher than expected personnel, consulting or other costs, and higher than expected costs to protect its intellectual property portfolio.

The company's financing strategy will be adversely affected by any economic downturn, volatile business environment and continued unpredictable and unstable market conditions. If the equity and credit markets deteriorate, it may make a debt or equity financing more difficult to complete, costlier, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms will have a material adverse effect on the company's business strategy and financial performance, and could require the company to cease or delay its operations. The company's common stock has been delisted from Nasdaq and now trades only in the over-the-counter market, which has substantially reduced liquidity and may adversely affect its stock price. The company may be unable to relist on Nasdaq or any other national securities exchange, and any relisting would require the company to satisfy more stringent initial listing standards. The company's delisting impairs its access to the capital markets, including its loss of eligibility to use Form S-3, and may make raising capital more difficult, more expensive, and more dilutive.

The company's financial statements have been prepared on a going concern basis, and as of March 31, 2026, the company had an accumulated deficit of $4,029,629 ⁴ and sufficient cash resources to fund operations only until the end of the third quarter of 2026, creating substantial doubt about its ability to continue as a going concern. The company has a history of losses, including net income of $1,367,977 ⁵ and net loss of $3,591,858 ⁶ for the years ended March 31, 2026 and March 31, 2025, respectively, and has no approved products and no product revenue. The company's most advanced product candidates are at an early proof-of-concept stage, and it does not expect to receive revenue from any product candidate for the foreseeable future. The company's common stock has been delisted from Nasdaq and now trades only in the over-the-counter market, which has substantially reduced liquidity, impairs access to capital markets including loss of eligibility to use Form S-3, and may make raising capital more difficult, more expensive, and more dilutive. The company may not be able to maintain its exclusive worldwide license to use and develop PT00114, as the University of Toronto may convert the exclusive license into a non-exclusive arrangement if the company fails to provide semi-annual reports on progress or fails to continue to make reasonable commercial efforts towards obtaining regulatory approval for products based on the technologies.

Management's message emphasizes the company's transition into a clinical-stage company following the completion of the multiple-dose portion of its Phase I study in healthy volunteers in December 2025. The key strategic priorities emphasized for the period ahead include efficiently advancing the lead product candidate PT00114 through clinical trials in treatment resistant depression, substance use disorder, generalized anxiety disorder, and/or post-traumatic stress disorder; developing additional product candidates from the TCAP family to build out a broad pipeline of assets with differentiated features; exploring efficacy in additional stress-related neuropsychiatric, neurodegenerative and mood disorders beyond initially targeted indications; facilitating long-term growth by leveraging a team of nimble R&D, operational, clinical and commercial experts; proactively assessing strategic partnership opportunities including in important international markets; and continuing with the strategy of strengthening the company's IP position in this important novel field of neuropsychiatry. The company expects to begin a Phase 2 study in late 2026 to evaluate PT00114 in a targeted population of patients affected by chronic stress-related psychiatric disorders.