Tuesday, 19 May 2026 08:15 AM
Company Update
NEW YORK, NY / ACCESS Newswire / May 19, 2026 / Protagenic Therapeutics, Inc. (OTCQB:PTIX), a clinical-stage biopharmaceutical company developing novel peptide-based therapies for stress-related neuropsychiatric disorders, today announced two strategic engagements to support the advancement of its lead candidate, PT00114. The Company has engaged Floyd Regulatory Strategic Consulting, led by regulatory affairs veteran Dr. Eric Floyd, Ph.D., MBA, as Regulatory Affairs Advisor, and DanforthHealth, a premier life science operational consulting firm, to establish institutional-grade operational processes and infrastructure. Together, these engagements reflect Protagenic's deliberate, lean operating model concentrating resources and expertise on PT00114's Phase 2 advancement while positioning the Company for long-term value creation for patients and shareholders.
Dr. Floyd brings more than 25 years of senior regulatory leadership experience in the pharmaceutical and biopharmaceutical industries. As U.S. Head of Regulatory Affairs at Lundbeck, he led strategic regulatory activities supporting the U.S. approvals of Abilify Maintena® (aripiprazole extended-release injectable suspension), Trintellix® (vortioxetine), and Rexulti® (brexpiprazole) - three landmark CNS products spanning schizophrenia and major depressive disorder. Dr. Floyd has also held senior regulatory roles at Novartis, Cephalon, and Axovant Sciences, and most recently served as Global Head of Regulatory Affairs at Neurogene, Inc. He serves as adjunct faculty in Neuroscience at Harvard Medical School and Wake Forest University School of Medicine. As Regulatory Affairs Advisor, Dr. Floyd will lead Protagenic's regulatory strategy for PT00114, including IND maintenance, pre-Phase 2 FDA meeting preparation and Phase 2 submission planning.
"Eric's regulatory track record in CNS and his leadership on three of the most important CNS approvals of the past decade is exceptional," said Bill Nichols Jr., President of Protagenic Therapeutics. "And his deep knowledge of FDA's expectations in neuropsychiatric drug development is precisely what PT00114 requires as we advance toward Phase 2."
"PT00114's mechanism of action targeting the TCAP pathway, and the clean Phase 1 safety data the program has generated, create a strong foundation for a rigorous Phase 2 program," said Dr. Eric Floyd, Ph.D., MBA, Founder and Principal of Floyd Regulatory Strategic Consulting. "I have spent my career moving CNS therapies from concept to patients and I look forward to bringing that experience to bear for Protagenic at this pivotal moment."
Protagenic has also engaged the finance & human resources consulting arm of Danforth Health to establish streamlined operational processes and infrastructure aligned with the Company's current stage and strategic priorities. Danforth has served more than 1,800 life science companies across business operations, development, and commercialization, and brings a flexible, scalable team of cross-functional biotech professionals. Danforth's extensive strategic relationships across the life science ecosystem - spanning investors, clinical service providers, and investment banks - provide Protagenic with access to a network very well uniquely suited to accelerate its development trajectory.
"Danforth has built an unmatched capability serving exactly the kind of company Protagenic is today," said Mr. Nichols. "Their flexible, scalable model allows us to build institutional-grade operations - investor-ready financial processes, disciplined governance, and strategic access to the broader life science ecosystem - without the overhead of a large internal infrastructure. That is precisely the model Protagenic needs as we advance PT00114 toward Phase 2."
These engagements build on recent operational and clinical milestones at Protagenic, including the completion of the Phytanix separation in March 2026, which strengthened the Company's balance sheet by removing more than $6.3 million in liabilities and more than $1 million in annualized costs. Coupled with its completed PT00114 Phase 1 multiple-dose safety and tolerability study, these milestones position Protagenic to advance PT00114 into Phase 2 enrollment in 2026 with a focused team, clean capital structure and experienced advisory partners.
About PT00114 PT00114 is Protagenic's lead clinical asset - a first-in-class investigational neuropeptide targeting the TCAP pathway for the treatment of stress-related neuropsychiatric disorders, including anxiety, PTSD, and treatment-resistant depression. In December 2025, the program reported positive Phase 1 multiple-dose safety and tolerability data, with no serious
adverse events observed across dose levels. Protagenic plans to advance PT00114 into Phase 2 clinical studies in 2026.
About Protagenic Therapeutics, Inc. Protagenic Therapeutics, Inc. (OTCQB: PTIX) is a clinical-stage biopharmaceutical company dedicated to developing breakthrough peptide-based treatments for stress-related neuropsychiatric disorders. The Company is headquartered in New York, NY.
About Floyd Regulatory Strategic Consulting Floyd Regulatory Strategic Consulting is a specialized regulatory affairs advisory firm founded and led by Dr. Eric Floyd, Ph.D., MBA. With more than 25 years of experience in pharmaceutical and biopharmaceutical regulatory affairs, Dr. Floyd provides strategic regulatory guidance to clinical-stage companies across CNS, oncology, and rare disease therapeutic areas. The firm's expertise spans IND strategy, FDA engagement and meeting management, clinical protocol regulatory review, NDA/BLA planning, and submission management.
About Danforth Health Danforth Health is a unified platform purpose-built to empower life science innovation. By integrating the capabilities of best-in-class affiliates, Danforth Health provides tailored, cross-functional support across finance and human resources, investor and public relations, discovery and development, regulatory and clinical, commercial and marketing, market research and analytics, and market access and value. The model is built for flexibility, scalability, and impact - serving life science companies at any stage and helping them move faster, smarter, and more efficiently to achieve transformative outcomes for patients. Headquartered in Waltham, Massachusetts, Danforth Health has partnered with more than 1,800 life science companies around the world. Learn more at www.danforthhealth.com.
Trademark Notice Abilify Maintena® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Trintellix® is a registered trademark of H. Lundbeck A/S. Rexulti® is a registered trademark of Otsuka Pharmaceutical Co., Ltd. Danforth Advisors™ is a trademark of Danforth Advisors, LLC. All other trademarks are the property of their respective owners.
For more information, visit www.protagenic.com
Forward-Looking Statements This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including but not limited to statements regarding the anticipated role and contribution of Dr. Floyd, the planned timing of Phase 2 enrollment for PT00114, and the therapeutic potential of PT00114. These statements are based on current expectations and assumptions and involve known and unknown risks and uncertainties that could cause actual results to differ materially from those expressed or implied. Protagenic Therapeutics undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.
Investor & Media Contact: Protagenic Therapeutics, Inc. | [email protected]| www.protagenic.com
SOURCE: Protagenic Therapeutics, Inc.