Regenerex Pharma, Inc. - Business Summary

Overview

Regenerex Pharma, Inc. (the "Company" or "Regenerex Pharma") focuses on the development and commercialization of advanced wound care healing products. The Company leverages three proprietary technologies to address different stages and types of wounds:

• Chronic Wound Closure Technology: Designed to close persistent, non-healing wounds.
• Acute Wound Acceleration Technology: Focused on speeding up healing of acute or surgical wounds.
• Contamination Control Technology: Addresses contamination issues across all wound types, including destruction of biofilms.

Product Portfolio

The Company’s product offerings include:

• Wound Closure System and Protocols: Broadly effective for diabetic ulcers, pressure ulcers, venous ulcers, burns, and surgical wounds, aiming to provide comprehensive wound healing solutions.
• Xcellderma™ OTC: A sterile, over-the-counter liquid bandage and skin protectant effective for treating cuts, abrasions, and skin irritations.
• Accelerex™ Sterile Wound Cream: The first medical device containing the proprietary QBx™ active ingredient, formulated to treat chronic and acute wounds including diabetic ulcers, burns, pressure ulcers (Stages I-IV), and venous stasis ulcers. It is derived from oak bark extract.

Core Technology

• QBx™ Active Ingredient: Down-regulates proteases and matrix metalloproteases (MMPs), which are elevated in approximately 80% of chronic wounds and impair healing. This targeted mechanism actively promotes wound healing, especially in wounds resistant to conventional therapies.

Market and Clinical Efficacy

• Success in Clinical Trials: Demonstrated closure rates up to 95% in non-responding chronic wounds within 90 days, even for wounds previously unresponsive to existing treatments.

Market Need

• Addressing a significant healthcare challenge where chronic wounds remain open for extended periods, resist traditional treatments, and impose high financial and quality-of-life burdens.
• Prevalence: Nearly 7 million Americans with chronic wounds; 1 in 4 families affected; 3% of people over 65 have open wounds.
• Regulatory Environment: Changes under the ACA favor cost-effective, high-performance wound care solutions, especially within managed care and pay-for-performance models.

Operations and Manufacturing

• Facilities: Currently leased; manufacturing is based on an asset-light model with equipment in Tennessee. The Company has FDA clearance for manufacturing of Xcellderma™ and is undergoing re-certification for drug and medical device production.
• Strategic Initiatives: Developing managed care agreements with Southeastern states to provide wound management under Medicaid and seeking international expansion through regional distribution agreements in Asia and the Middle East.

Revenue and Financials

• Revenue: As of March 31, 2025, the Company is not profitable and has limited revenue history.
• Employees: The specific number of employees is not provided.
• Customer Base: No specific details on the number of customers are provided.

Financial Risks

• The Company is a start-up with high uncertainty regarding profitability.
• It relies on raising additional capital, which is uncertain.
• Has limited funds, making operational expansion challenging.
• Significant ownership control is held by officers and directors, owning approximately 71.23% of the stock.
• The company is classified as a penny stock, facing restrictions on trading and marketability of its shares.

Intellectual Property

• Secured patents for the Wound Closure System and related technologies.
• Trademark protections secured domestically and internationally.
• Digital assets include strategic domain names to support branding.

Regulatory Compliance

• Overseen by FDA, FTC, and international regulatory authorities.
• Adheres to standards for product efficacy, safety, manufacturing, labeling, and marketing.

Management & Facilities

• Led by a team with a Chief Executive Officer, CFO, and other senior officers.
• Operates headquarters in Gordonsville, TN, with additional offices in Nevada.
• The manufacturing facilities are leased through 2028; the Company maintains an asset-light business model.

Summary

Regenerex Pharma develops innovative wound healing products utilizing proprietary technologies focused on protease regulation, targeting both chronic and acute wounds. Its core product, Accelerex™, features the QBx™ active ingredient. The Company is expanding domestically (Southeastern U.S. Medicaid programs) and internationally (Asia and Middle East). It is currently unprofitable, with limited revenue, and a significant ownership concentration among insiders. The Company faces typical start-up risks, including funding, competition, and regulatory compliance.