About Us

TregTherapeutics Inc. is a company pursuing the treatment and possible cure of inflammatory disease, including autoimmune and neurodegenerative disorders.

CORPORATE INFORMATION

TregTherapeutics Inc. is a company pursuing the treatment and possible cure of inflammatory disease, including autoimmune and neurodegenerative disorders.

The T lymphocyte is a key component in the adaptive immune system, and a subset of T cells, the T regulatory cell (Treg), plays an instrumental role in the control and regulation of the immune response. Named in recognition of the vital functions this cell executes, TregTherapeutics Inc. is focused on developing a tolerogenic approach for the treatment and possible cure of a wide range of diseases. The corporation is a North Carolina-based company whose proprietary technology is based upon an exclusive license granted by East Carolina University. The technology is a transformative platform that harnesses the power of Tregs to dramatically alter patient outcomes in response to immune system pathogenesis.

The operational team consists of experienced professionals, who, through shared vision and development objectives, are preparing the way for human clinical trials. The current focus of attention is communication with regulatory authorities and compliance with remaining requirements for preclinical testing of the formulation. During the earlier phases of clinical trial, it is the intention to partner with a pharmaceutical company that possesses the resources to move the therapy through the latter stages of regulatory activity. There are several exit points that may accelerate development and expedite market entry. All options will be considered at the appropriate time.

BUSINESS STRATEGY

The mission of TregTherapeutics, Inc is to provide resources to expedite development, and ultimately, the availability of next-generation therapeutics for the treatment of autoimmune and neurodegenerative disease.

The technology has potential application in a range of disease states that share inflammation as a common denominator. The approach defined by our platform technology is applicable to dozens of autoimmune diseases, as well as, numerous neurodegenerative diseases, but the roots of the technology are deeply embedded in the treatment and potential cure of multiple sclerosis. The company’s strategic plan recognizes that financial, technical, and time resources need to be focused, and management has developed a tactical plan to bring the technology into the clinic smoothly and quickly. That particular pathway can be discussed upon inquiry.

TregTherapeutics’ technical objectives, then, are clear. Human proof of concept studies have been formulated for a representative autoimmune disease and for a selected neurodegenerative disease. Resources are being assembled to proceed with first-in-human studies of both.

Financial resources are critical to the success of the enterprise. Availability of funding has an impact on our ability to proceed with planned activities, and acquiring the resources to enable execution of the chosen pathway is our highest priority. We are currently pursuing equity funding and are interested in establishing relationships with individual investors, venture capital firms, or appropriate pharmaceutical / biotech companies. Interested investors are urged to contact us for further information.

MANAGEMENT TEAM

The TregTherapeutics management team has years of technical and managerial experience in leading/execution of preclinical plans and Phase I clinical trials.

Individual backgrounds of the team include leadership positions within the pharmaceutical, biotech, and medical device industries, encompassing start-up and mature enterprises, IPOs, mergers, and acquisitions; in addition, the team possesses work experience within the FDA and other government agencies. Collaborative expertise, attitude, and ability, along with the licensing partnership with ECU, provide the tools needed to take this outstanding technology through the pre-clinical pathway into human trials quickly and efficiently, and the team is focused on and dedicated to this mission.

Ray Holloway

CEO

Forty years’ experience in medical device and related industry. Founder: CryoLife [NYSE: CRY], Luminal Solutions, 3D Surgical Solutions. Served as hands-on CEO of start-up ventures, various funding and corporate management roles, and as C-level positions for domestic and international multimillion dollar enterprises, some of which are currently publicly traded companies.

Brent Holloway

Engineering, MBA, Director

General Electric, Renewables Industry Services; Lucideon, Director of Sales and Marketing; Markforged, Director of Application Engineering and Strategic Sales. These experiences represent the engineering and business development acumen with startup and established businesses.

Glen Smotherman

MBA, CFO-Secretary/Treasurer

CPA and Harvard MBA with an accomplished career as primary financial officer in early-stage entrepreneurial ventures. Extensive merger and acquisition experience in medical, energy, and communications industries including two Initial Public Offerings.

Angela M. Lynch

MSPH, PhD, VP, Preclinical Dev. & Scientific Strategy

Pharmacologist/Toxicologist – Founder/Principal of ToxPlus Consulting, LLC; Twenty-five years of extensive research and regulatory experience that includes pharmacology and toxicology study protocol development, study monitoring/management, GLP/non-GLP nonclinical pharmacology and toxicology data review. Extensive experience with regulatory submissions and FDA interaction. Active member of the American College of Toxicology, Society of Toxicology, and Regulatory Affairs Professional Society.

Anita O’Connor

PhD, VP Regulatory & Scientific Affairs

Biologic and biosimilar development expert; 16 years with FDA as preclinical reviewer at Center for Biologics, Center for Drugs, Office of Vaccines, and Office of Blood; extensive experience in developing cytokines, chemokines, peptides, vaccines, monoclonal antibodies, and therapeutic blood products for a wide range of indications; founder of Anita O’Connor Consulting LLC, supporting novel biologic and biosimilar development; international speaker and workshop lecturer on biosimilars; CRO experience as Senior Director for Biopharmaceutical at Celerion.

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