Results from Phase 1 Multiple-Dose Study of PT00114

Protagenic Therapeutics (NASDAQ:PTIX) reported positive topline safety results from its Phase 1 multiple-dose study of PT00114 in healthy volunteers on December 9, 2025.

Rhea-AI Summary

Protagenic Therapeutics (NASDAQ:PTIX) reported positive topline safety results from its Phase 1 multiple-dose study of PT00114 in healthy volunteers on December 9, 2025. All planned cohorts completed dosing and PT00114 was reported as well tolerated across all dose ranges. No serious adverse events were observed; reported adverse events were consistent with a peptide injectable, including expected injection-site reactions. Several participants reported an improved sense of well-being (anecdotal). The company is finalizing full Phase 1 analyses and expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in chronic stress-related psychiatric disorders.

Positive

• All planned cohorts completed dosing in Phase 1
• No serious adverse events observed in the study
• PT00114 well tolerated across all dose ranges
• Company expects to start Phase 2 in early 2026

Negative

• Reported adverse events included injection-site reactions

Argus Dec 9 session

-1.82% close to close Open Argus

Details

News Market Reaction – PTIX

In the Dec 9 session, PTIX declined 1.82%, reflecting a mild negative market reaction.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement reports that PT00114’s Phase 1 multiple-dose study in healthy volunteers met its c...

Analysis

This announcement reports that PT00114’s Phase 1 multiple-dose study in healthy volunteers met its core safety and tolerability objectives, supporting advancement into Phase 2 for stress-related psychiatric conditions. Context from recent news shows a consistent focus on PT00114’s development alongside intellectual property expansion and financing activities. Investors may track upcoming detailed Phase 1 analyses, planned Phase 2 trial design, and ongoing Nasdaq listing and financing disclosures as key future datapoints.

Key Figures

Nasdaq equity minimum: $2,500,000 ATM offering size: up to $1,750,000 Sales agent commission: 3.0% +5 more

Nasdaq equity minimum

$2,500,000

Required stockholders’ equity under Listing Rule 5550(b)(1)

ATM offering size

up to $1,750,000

At-the-market common stock offering under sales agreement

Sales agent commission

3.0%

Commission on gross proceeds in ATM program

Public float

$7,911,378

Non‑affiliate public float as of Aug 25, 2025

Non‑affiliate shares

1,927,898 shares

Shares used to calculate public float

Reference share price

$4.51

Share price used for public float calculation on Aug 25, 2025

Prior ATM sales

$850,715

Securities sold in prior 12 months under Instruction I.B.6

Estimated dilution

$3.915 per share

Illustrative dilution if 585,284 shares sold at $2.99

Historical Context

5 past events · Latest: Nov 13

5 events

1. Nov 13

   Phase 1 MAD completion

   24h Move

   +9.4%

   Completed enrollment and dosing in Phase 1 MAD study for PT00114.

2. Aug 22

   Nasdaq compliance update

   24h Move

   +6.4%

   Nasdaq non-compliance notice tied to delayed Form 10-Q filing.

3. Aug 21

   Phase 1 progress

   24h Move

   +86.8%

   Advanced PT00114 into multiple-dose Phase 1 trial with planned Phase 2.

4. Jul 30

   Patent grant

   24h Move

   +3.9%

   New Japanese patent granted for modified stilbenoid program candidates.

5. Jul 23

   Financing update

   24h Move

   +0.9%

   Reported $3.1M warrant proceeds to support peptide-based development.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

pharmacokinetic, adverse events, injection-site reactions, serious adverse events, +4 more

8 terms

pharmacokinetic medical

"designed to evaluate the safety, tolerability, and pharmacokinetic profile of PT00114"

Pharmacokinetic describes how a drug moves through and leaves the body — how it is absorbed, spread to tissues, broken down and excreted — like tracking a package from pickup to delivery and disposal. For investors, these properties determine effective dose, safety risks, how often a medicine must be taken, and how reliably it works, which in turn influence clinical trial success, regulatory approval chances, production complexity and a drug’s commercial value.

adverse events medical

"Reported adverse events were consistent with expectations for a peptide-based injectable therapy"

Adverse events are any harmful or unwanted medical occurrences experienced by people using a drug, device, or undergoing a treatment, whether or not the problem is caused by the product. Think of them as complaints or breakdowns noticed during a trial or after a product is on the market; regulators record and investigate them. Investors care because clusters or serious adverse events can delay approvals, trigger costly studies or recalls, change labeling, and quickly alter a company’s revenue and risk profile.

injection-site reactions medical

"including expected injection-site reactions."

Injection-site reactions are local skin or tissue responses where a medication or vaccine is given by shot, commonly causing redness, pain, swelling, warmth or itching at the spot—like a temporary sore after a bee sting. For investors, how often and how severe these reactions are matters because they can affect regulatory approval, product labeling, patient acceptance, sales, and potential costs from additional studies, warnings or liability if reactions are serious or persistent.

serious adverse events medical

"No serious adverse events were observed, and all participants completed"

Serious adverse events are significant problems or negative outcomes that occur during a medical treatment or clinical trial, such as severe side effects, hospitalizations, or life-threatening conditions. They matter to investors because such events can impact a company's reputation, lead to regulatory scrutiny, or delay the development of new products, ultimately affecting the company’s financial performance.

phase 1 multiple dose medical

"reported positive topline safety results from its Phase 1 Multiple Dose (MD) study"

A phase 1 multiple dose study is an early clinical trial where a new medicine is given to people repeatedly over days or weeks to check safety, side effects, and how the body handles the drug at different dose levels. For investors, these results help reveal whether the drug is tolerable, what dose might work in later trials, and how quickly development can progress—similar to taking a prototype car on many drives to see how it performs under real conditions.

phase 2 study medical

"expects to initiate a Phase 2 study in early 2026 to evaluate PT00114"

A phase 2 study is a mid-stage clinical trial that tests whether an experimental drug or treatment actually works for the intended condition and continues to check safety in a larger group of patients than early trials. Think of it as a focused pilot test before a full market launch; positive or negative results strongly affect a drug’s chances of approval, the remaining development time and costs, and therefore an investment’s risk and potential value.

homeostasis medical

"brain peptide thought to be involved in restoring homeostasis following prolonged exposure to stress"

Homeostasis is the body's process of keeping internal conditions—like temperature, fluid balance, blood sugar and acid levels—within narrow ranges despite external changes, similar to how a thermostat keeps a room at a steady temperature. For investors, therapies or devices that restore, support or disrupt homeostasis can change patient outcomes, safety and regulatory approval chances, so knowing whether a treatment affects these balances helps assess clinical success and market risk.

neurotransmitter medical

"departure from conventional neurotransmitter-focused approaches and may offer a new pathway"

A neurotransmitter is a chemical messenger that carries signals between nerve cells and other body cells, like text messages sent across tiny gaps in the brain and nervous system. Investors care because many treatments, diagnostics and medical devices aim to change or measure these messengers to relieve symptoms, slow disease or predict outcomes; successes or failures in that work can drive product sales, regulatory decisions and company valuations.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Findings support advancement into Phase 2 to explore a first-in-class pathway aimed at stress-related neuropsychiatric conditions

NEW YORK CITY, NEW YORK / ACCESS Newswire / December 9, 2025 / Protagenic Therapeutics Inc. (NASDAQ:PTIX), a biopharmaceutical company developing therapeutics that target the biology of chronic stress and its downstream psychiatric and neurologic effects, today reported positive topline safety results from its Phase 1 Multiple Dose (MD) study of PT00114.

PT00114 is a synthetic analogue of a naturally occurring brain peptide thought to be involved in restoring homeostasis following prolonged exposure to stress. Its mechanism of action-rooted in rebalancing dysfunctional stress-response circuits-represents a departure from conventional neurotransmitter-focused approaches and may offer a new pathway for patients whose conditions remain insufficiently treated with existing therapies.

Phase 1 MD Study Overview

The study was conducted in healthy volunteers and was designed to evaluate the safety, tolerability, and pharmacokinetic profile of PT00114 across multiple dose levels. All planned cohorts have completed dosing.

Preliminary analyses show:

• PT00114 was well tolerated across all dose ranges studied.

• Reported adverse events were consistent with expectations for a peptide-based injectable therapy, including expected injection-site reactions.

• No serious adverse events were observed, and all participants completed the assigned dosing schedules.

"These results provide a clear safety foundation for advancing PT00114," said Dr. Garo Armen, Executive Chairman of Protagenic Therapeutics. "The Phase 1 study achieved what it was designed to do-establish tolerability and characterize the compound's behavior in humans. In addition, several participants who received PT00114 reported an improved sense of well-being, a finding that, while anecdotal at this stage, aligns with the compound's intended biological activity."

Dr. Armen added, "There is significant unmet need in stress-related psychiatric conditions, where many patients cycle through multiple therapies without adequate relief. PT00114's upstream mechanism-modulating the stress axis rather than solely neurotransmitter release-offers a fundamentally different approach. The safety profile emerging from Phase 1 gives us confidence to proceed."

Next Steps

Protagenic Therapeutics is finalizing its detailed analysis of the full Phase 1 dataset, including pharmacokinetic modeling to support dose selection. A comprehensive report will be released once analyses are complete.

The company expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in a targeted patient population affected by chronic stress-related psychiatric disorders. Additional details on study design and endpoints will be communicated in the coming months.

About Protagenic Therapeutics, Inc.

Protagenic Therapeutics, Inc. (NASDAQ:PTIX) is a biopharmaceutical company focused on developing innovative peptide-based therapeutics targeting the biological pathways underlying stress-related neurological and mood disorders. The company's lead compound, PT00114, is a synthetic analog of a naturally occurring brain peptide that helps regulate the body's stress response and emotional equilibrium.

Forward-Looking Statements

Statements in this press release contain "forward-looking statements" within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as "projects," "may," "will," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans," "potential," "promise" or similar references to future periods. Examples of forward-looking statements in this current report include, without limitation, statements regarding the Company's expected filing of its Quarterly Report on Form 10-Q, the Company's planned appeal before the Panel, and the continued listing of the Company's securities pending the appeal. Forward-looking statements are statements that are not historical facts nor assurances of future performance. Instead, they are based on the Company's current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks and uncertainties, and actual results may differ materially from those set forth in the forward-looking statements. Important factors that could cause actual results to differ include, without limitation, that there can be no assurance that the Company will file the Form 10-Q, that there can be no assurance that the Company will otherwise meet Nasdaq compliance standards, that there can be no assurance that Nasdaq will grant the Company any relief from delisting as necessary or whether the Company can agree to or ultimately meet applicable Nasdaq requirements for any such relief, and the other important factors described under the caption "Risk Factors" in the Company's filings with the SEC. Any forward-looking statement made by the Company in this current report is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, the Company expressly disclaims any obligation to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Company Contact:

Alexander K. Arrow, MD, CFA
Chief Financial Officer
Protagenic Therapeutics, Inc.
149 Fifth Ave, Suite 500, New York, NY 10010
Tel: 213-260-4342
Email: alex.arrow@protagenic.com

SOURCE: Protagenic Therapeutics, Inc.

View the original press release on ACCESS Newswire

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Protagenic Therapeutics announce about PT00114 on December 9, 2025 (PTIX)?

Protagenic announced positive topline Phase 1 multiple-dose safety results for PT00114, with all cohorts dosed and no serious adverse events.

Were there any serious adverse events reported in the PT00114 Phase 1 MD study (PTIX)?

No serious adverse events were observed; reported events were consistent with a peptide injectable, including injection-site reactions.

When does Protagenic expect to begin the PT00114 Phase 2 trial (PTIX)?

The company expects to initiate a Phase 2 study in early 2026 to evaluate PT00114 in chronic stress-related psychiatric disorders.

What population was used in the PT00114 Phase 1 multiple-dose study (PTIX)?

The Phase 1 multiple-dose study was conducted in healthy volunteers to assess safety, tolerability, and pharmacokinetics.

Did any participants report clinical effects after PT00114 dosing in Phase 1 (PTIX)?

Several participants reported an improved sense of well-being, described as anecdotal findings at this stage.