Protagenic Therapeutics and Phytanix Announce Business Combination to form Neuroactive Biopharmaceutical Company with Six Drug Candidates in Development including Treatments for Obesity and Metabolic Disorders

Rhea-AI Summary

Protagenic Therapeutics (NASDAQ: PTIX) and Phytanix Bio have agreed to merge in an all-stock transaction to form Phytanix, Inc., creating a neuroactive biopharmaceutical company. The combined entity will feature six drug candidates targeting stress-related and CNS disorders, including treatments for obesity and metabolic disorders. The pipeline includes PT-00114 in Phase I/IIa and five preclinical assets including PHYX-001, cannabinoid-based compounds, and modified stilbenoid assets. The merger structure results in Phytanix Bio stockholders owning approximately 65% of the combined company, while pre-merger Protagenic shareholders will retain about 35%. The transaction includes the issuance of common stock, convertible preferred stock, and warrants, subject to Nasdaq stockholder approval requirements.

Positive

• Expanded pipeline with six drug candidates including one clinical-stage asset (PT-00114) and five preclinical assets
• Entry into lucrative obesity and metabolic disorders market, competing with successful GLP-1 agonists
• Integration of CNS expertise from team members with experience in successful drugs like Sativex® and Epidiolex®
• Enhanced patent portfolio with broader composition-of-matter coverage
• Multiple potential milestone opportunities expected over next 18 months

Negative

• Significant dilution for existing Protagenic shareholders (ownership reduced to 35%)
• Most pipeline assets are still in preclinical stage, indicating long development timeline
• Stock conversion and warrant exercises subject to stockholder approval, creating execution risk
• Complex merger structure with multiple classes of preferred stock and warrants

Insights

Pharmaceutical Industry Analyst

Protagenic-Phytanix merger creates diversified CNS pipeline with obesity treatment potential, transforming PTIX's clinical prospects despite early-stage assets.

This business combination transforms Protagenic from a single-asset company into a more diversified CNS-focused biopharmaceutical organization with six development candidates. The merger brings together Protagenic's stress-disorder focused PT-00114 (in Phase I/IIa) with Phytanix's five preclinical assets, creating a pipeline spanning both clinical and preclinical stages.

Particularly noteworthy is the inclusion of a proprietary molecule targeting obesity and metabolic dysfunction, entering the same therapeutic area as blockbuster GLP-1 agonists like Wegovy and Ozempic. This positions the combined company in one of pharma's hottest and most lucrative markets, though as a much smaller competitor with earlier-stage assets.

The deal structure gives Phytanix Bio stockholders approximately 65% ownership (fully diluted, pre-financing), reflecting the relative valuation placed on Phytanix's assets despite their preclinical status. This suggests Protagenic's board sees significant potential in Phytanix's portfolio, particularly its cannabinoid and stilbenoid platforms.

The integration of team members with experience from GW Pharma (developers of FDA-approved cannabinoid medications Epidiolex and Sativex) adds credibility to their cannabinoid development capability. This expertise could accelerate development timelines and increase regulatory success probability.

The combined pipeline offers potential milestone catalysts over the next 18 months, which could drive valuation inflection points. However, investors should recognize that with only one clinical-stage asset and five preclinical programs, the company faces substantial development risk and will likely require significant additional financing to advance its pipeline.

Biotech Investment Strategist

Protagenic's acquisition by Phytanix restructures ownership and diversifies pipeline but represents high-risk, early-stage bet on CNS/metabolic disorders.

This transaction effectively represents a reverse merger where Phytanix Bio takes control of Protagenic's Nasdaq listing while maintaining the clinical-stage asset PT-00114. The deal structure awards Phytanix stockholders 65% of the combined entity, leaving original Protagenic shareholders with 35% ownership on a fully diluted basis.

The complex share exchange involves multiple classes of preferred stock and warrants, requiring stockholder approval for the conversion of these securities into common shares - a standard approach to navigate Nasdaq rules limiting issuance without shareholder approval to 19.99% of outstanding shares.

While the combined entity gains pipeline diversity with six development candidates versus Protagenic's previous single asset, investors should recognize this remains a predominantly early-stage portfolio. Only PT-00114 has reached clinical testing (Phase I/IIa), while the other five assets remain in preclinical development.

The strategic rationale centers on expanding into high-value therapeutic areas, most notably obesity treatment, where GLP-1 agonists have demonstrated blockbuster commercial potential. However, entering this competitive space with preclinical assets puts them years behind established players like Novo Nordisk and Eli Lilly.

The addition of GW Pharma veterans brings valuable cannabinoid development expertise, particularly relevant for their cannabinoid assets. This experience with successfully developing and commercializing Epidiolex could prove valuable for navigating regulatory pathways.

Investors should closely monitor the company's post-merger cash position and burn rate, as significant additional funding will likely be needed to advance this expanded pipeline through clinical development milestones over the next 18-24 months.

NEW YORK, NY AND SANTA BARBARA, CA / ACCESS Newswire / May 19, 2025 / Protagenic Therapeutics, Inc. (Nasdaq:PTIX) (the "Company") and Phytanix Bio Inc. have entered into a definitive share exchange agreement pursuant to which the two entities will combine in an all-stock transaction (the "Combination"). The combined entity, to be called Phytanix, Inc., will bring together two pipelines focused on stress-related and CNS disorders, five preclinical assets and one clinical-stage asset.

Pipeline Assets

• PT-00114 (Phase I/IIa): peptide asset in BLA pathway; may qualify for regulatory data exclusivity

• PHYX-001: potassium channel modulator with mechanism similar to XEN1101 and BHV-7000

• Cannabinoid Assets: multiple cannabinoid-based compounds with composition-of-matter IP; potential in CNS, cardiometabolic, and other indications. Including a proprietary molecule with significant potential in the obesity, metabolic dysfunction sector, where the GLP-1 agonists have become blockbuster medications

• Modified Stilbenoid Assets: modified stilbenoid compounds with composition-of-matter IP and anticonvulsant activity in preclinical models

Key Benefits for Protagenic Shareholders

• Pipeline Expansion: adds new CNS programs to existing stress-disorder portfolio

• Pipeline Diversity: clinical- and preclinical-stage assets with potential significant milestones over the next 18 months

• CNS Expertise: integrates Phytanix Bio team members who worked on Sativex® and Epidiolex® at GW Pharma

• Patent Estate: broader composition-of-matter coverage across the pipeline

• Talent Pool: combined teams to advance development and regulatory activities

"This combination aligns two pipelines with complementary assets and expertise to address unmet needs in neuropsychiatry, CNS and other disorders," said Garo H. Armen, PhD, Executive Chairman.

"We look forward to uniting our teams and advancing these programs for patients and shareholders," said Barrett Evans, President and Chief Executive Officer.

Structure of Combination

Under the terms of the Exchange Agreement, the Company, in exchange for all of the outstanding shares of Phytanix Bio, issued on a pro rata basis to each of the common stockholders of Phytanix Bio, an aggregate of (A) 117,690 shares of the Company's common stock, par value $0.0001 per share ("Common Stock"), which shares represent a number equal to no more than 19.99% of the outstanding shares of Common Stock as of immediately before the closing on May 16, 2025, (B) 5,705 shares of the Company's Series C Convertible Preferred Stock, par value $0.000001 per share (the "Series C"), and (C) 950,000 shares of the Company's Series C-1 Convertible Preferred Stock, par value $0.000001 per share (the "Series C-1"). In addition, in exchange for all of the outstanding preferred stock of Phytanix Bio, the Company issued on a pro rata basis to each of PHX's preferred stockholders an aggregate of (i) 20,000 shares of Series D Preferred Stock, par value $0.000001 per share of the Company (the "Series D" together with the Series C and Series C-1, the "Preferred Stock"), and (ii) common stock purchase warrants to purchase up to 715,493 shares of common stock (the "Warrants"). The issuance of the shares of Common Stock, the Preferred Stock, and the Warrants occurred on May 16, 2025. Each share of Preferred Stock is convertible into one of common stock, subject to certain conditions described in the Exchange Agreement.

As calculated on a fully diluted basis, post-Combination pre-financing ownership will be approximately 35% for the pre-Combination stockholders of the Company and approximately 65% for Phytanix Bio stockholders.

The issuance of shares of common stock upon conversion of the Preferred Stock and exercise of the Warrants issued in the Combination shall be subject to stockholder approval in compliance with the rules of the Nasdaq Stock Market.

About Protagenic Therapeutics, Inc.

Protagenic Therapeutics (Nasdaq: PTIX) is pioneering peptides for stress-related disorders. For more information, visit www.protagenic.com.

About Phytanix Bio Inc.

Phytanix Bio is an innovative pharmaceutical company specializing in the development of medicines manufactured from cannabinoid and "cannabinoid-like" molecules. For more information, visit www.phytanix.com.

Forward-Looking Statements

Statements in this press release contain "forward-looking statements," within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as "anticipate," "believe," "contemplate," "could," "estimate," "expect," "intend," "seek," "may," "might," "plan," "potential," "predict," "project," "suggest," "target," "aim," "should," "will," "would," or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on the Company's current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including risks related to the completion, timing and results of current and future clinical studies relating to the Company's product candidates. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section titled "Risk Factors" in the Amended Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and the Company undertakes no duty to update such information except as required under applicable law.

Important Additional Information and Where to Find It

The Company, its directors and certain of its executive officers are deemed to be participants in the solicitation of proxies from the Company's stockholders in connection with the Company's expected special meeting seeking stockholder approval of conversion of the Preferred Stock and other matters related to the conversion of the Preferred Stock and the Combination. Information regarding the names of the Company's directors and executive officers and their respective interests in the Company by security holdings or otherwise can be found in Protagenic Therapeutics, Inc.'s proxy statement for its 2023 Annual Meeting of Stockholders, filed with the SEC on January 6, 2025. The Company intends to file a proxy statement and accompanying proxy card with the SEC in connection with the solicitation of proxies from Company stockholders in connection with the Company's expected special meeting seeking stockholder approval of conversion of the Preferred Stock and other matters related to the conversion of the Preferred Stock and the Combination. Additional information regarding the identity of participants, and their direct or indirect interests, by security holdings or otherwise, will be set forth in the Company's proxy statement for such special meeting, including the schedules and appendices thereto. INVESTORS AND STOCKHOLDERS ARE STRONGLY ENCOURAGED TO READ ANY SUCH PROXY STATEMENT AND THE ACCOMPANYING PROXY CARD AND ANY AMENDMENTS AND SUPPLEMENTS THERETO AS WELL AS ANY OTHER DOCUMENTS FILED BY THE COMPANY WITH THE SEC CAREFULLY AND IN THEIR ENTIRETY WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION. Stockholders will be able to obtain copies of the proxy statement, any amendments or supplements to the proxy statement, the accompanying proxy card, and other documents filed by the Company with the SEC for no charge at the SEC's website at www.sec.gov. Copies will also be available at no charge at the Investor Relations section of the Company's corporate website.

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

What is the ownership structure of the PTIX merger with Phytanix Bio?

Post-merger, Phytanix Bio stockholders will own approximately 65% of the combined company, while pre-merger Protagenic Therapeutics shareholders will retain about 35% ownership on a fully diluted basis.

How many drug candidates does the combined PTIX-Phytanix company have in development?

The combined company has six drug candidates in development: one clinical-stage asset (PT-00114 in Phase I/IIa) and five preclinical assets, including treatments for obesity and metabolic disorders.

What are the main assets in PTIX's merged pipeline?

The key assets include PT-00114 (Phase I/IIa peptide), PHYX-001 (potassium channel modulator), cannabinoid-based compounds for obesity and metabolic disorders, and modified stilbenoid compounds with anticonvulsant properties.

What therapeutic areas will the combined PTIX-Phytanix company focus on?

The combined company will focus on stress-related and CNS disorders, obesity, metabolic disorders, and other neuropsychiatric conditions.

What is the structure of the PTIX-Phytanix merger transaction?

The merger is an all-stock transaction involving the issuance of common stock, multiple series of convertible preferred stock (Series C, C-1, and D), and warrants, subject to Nasdaq stockholder approval requirements.