RGPX

b.

Available as an over-the-counter solution

2.

Accelerex™ Sterile Wound Cream

a.

First commercially available medical device containing QBx™

b.

Designed for treating chronic and acute wounds including:

o

Diabetic ulcers

o

Burns

o

Pressure ulcers (stages I-IV)

o

Venous stasis ulcers

•

Custom-formulated sterile wound ointment utilizing technology originally derived from oak bark extract

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Market Opportunity

Clinical Efficacy

QBx™ represents the most efficacious, clinically proven chronic wound care technology globally. The Company's Wound Closure System has demonstrated remarkable success in clinical trials, achieving closure rates of up to 95% of non-responding chronic wounds within 90 days. Notably, these tested wounds had previously failed to respond to conventional treatment protocols.

Market Need

Chronic wounds represent a significant healthcare challenge characterized by:

•

Failure to progress through normal healing sequences

•

Delayed healing lasting weeks, months, or years

•

Resistance to conventional dressings and therapies

•

Substantial financial and quality-of-life burden on patients

•

Frustration for caregivers and clinicians

These wounds typically become trapped in a catabolic, inflammatory phase hostile to growth factors and cellular repair mechanisms. Traditional treatments using gauze and modern dressings (hydrocolloids, collagens) fail to address the underlying cellular environment, creating a significant market opportunity.

Economic Impact

Chronic wounds impose substantial costs on the U.S. healthcare system:

•

Nearly seven million Americans currently live with chronic wounds

•

One in four families has a member with a chronic wound

•

3% of individuals over 65 have open wounds

•

Growing prevalence due to aging population and increasing rates of diabetes and obesity

Regulatory and Market Environment

The Affordable Care Act (ACA) has fundamentally changed wound care reimbursement structures, transitioning all market segments—hospitals, nursing homes, home health, and wound care clinics—to pay-for-performance models. This shift creates significant opportunities for cost-effective, high-performance solutions like the Company's Wound Closure System.

Home health providers now receive single diagnostic code payments, transferring financial risk from payees to payers. The Company is strategically targeting market segments operating under these "at-risk" payment models, with home health and nursing homes representing the fastest-growing segments due to demographic trends.

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Operations and Manufacturing

The Company has established manufacturing capabilities through:

•

Purchase of proprietary wound care formulations

•

Lease agreement dated June 10, 2023, with Woundcare Labs, LLC for plant and equipment in Tennessee

•

Current FDA clearance for Xcellderma™ manufacturing

•

Ongoing FDA re-certification process for drug and medical device manufacturing

Strategic Initiatives

Domestic Market Development

Management is actively developing managed care agreements with southeastern states to manage Medicaid wound care patients. These partnerships would provide the Company's Wound Closure System, products, and protocols, resulting in substantial cost savings for state Medicaid programs.

International Expansion

The Company is pursuing distribution opportunities in Asian and Middle Eastern markets through negotiations with regional distributors.

UAE Market Development Agreement:

•

Agreement dated June 11, 2023, with First Forte Consultancy (UAE)

•

Total value: $45,000

•

Services: Meeting facilitation and roadshows for potential distribution clients

•

Payment structure: $22,500 paid June 15, 2023; balance due upon completion

•

Expected completion: Fiscal year ending March 31, 2026

Competitive Advantage

Regenerex Pharma maintains significant competitive advantages through:

•

Proprietary QBx™ technology with proven clinical efficacy

•

Superior closure rates compared to existing solutions

•

Cost-effective treatment protocols

•

Comprehensive product portfolio addressing multiple wound types

•

Strategic positioning within evolving reimbursement landscape

•

Manufacturing capabilities and regulatory compliance

Executive Leadership

Regenerex Pharma Inc. maintains a comprehensive C-suite leadership structure comprising the Chief Executive Officer, Chief Financial Officer, Chief Development Officer, Chief Revenue Officer, Chief Clinical Director, Chief Research & Development Officer, Chief Creative Officer, and Vice President of International Operations.

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Corporate Facilities and Real Estate

The Company operates under a strategic leasing model for its facilities. The primary corporate headquarters is located at 114 Main Street, Gordonsville, TN 38653, This property is secured through a lease agreement, allowing for operational flexibility and capital preservation.

We have an identity office at 5348 Vegas Drive #177, Las Vegas, Nevada 89108.

Manufacturing Operations

Regenerex Pharma Inc. employs an asset-light manufacturing strategy, utilizing leased production equipment and facilities rather than capital-intensive ownership. Current lease arrangements for production infrastructure extend through June 30, 2028, providing operational stability while maintaining financial flexibility.

Market Strategy and Distribution

Healthcare Partnerships

Management is actively developing managed care agreements with southeastern state governments to provide comprehensive wound care management for Medicaid populations. The Company's integrated Wound Closure System encompasses proprietary products, clinical protocols, and software solutions designed to deliver significant cost savings for state Medicaid programs.

International Expansion

The Company is pursuing strategic partnerships with distributors across Asian and Middle Eastern markets to expand global market penetration and diversify revenue streams.

Revenue Diversification

Regenerex anticipates generating revenue from multiple healthcare sectors, including:

•

U.S. Government-funded home care service providers

•

State Medicaid Programs

•

International Healthcare Programs

•

Veterans Administration

•

Correctional facility healthcare systems

•

Home Health Care Providers

•

Medicare reimbursement programs

Competitive Positioning

Wound Closure System Technology

Regenerex's proprietary Wound Closure System creates an optimal healing environment for wound closure through advanced biotechnology. The Company's unique approach addresses chronic, non-healing wounds through protease down-regulation and comprehensive wound bed preparation.

QBx™ Platform

The QBx™ technology represents a breakthrough in wound care, uniquely positioned in the market for its ability to successfully treat chronic, non-healing wounds through protease down-regulation. Unlike conventional wound dressings such as hydrocolloids and collagens that merely absorb wound fluids, Regenerex's solutions actively modify the cellular environment rather than simply providing protective coverage.

Market Differentiation

The Company maintains a significant competitive advantage as no other currently available products successfully heal chronic, non-healing wounds through the Company's proprietary mechanisms of action.

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Intellectual Property Portfolio

Patent Protection

Regenerex has secured primary patent rights for its Wound Closure System and Wound Care Platform. The Company maintains two additional patents pending for antimicrobial properties and acceleration of acute and surgical wound healing.

Trademark Portfolio

The United States Patent and Trademark Office has approved multiple trademarks for the Company, with additional trademark protections secured in various international jurisdictions.

Digital Assets

The Company has secured strategic domain names including regenerexpharmainc.com and regenerexpharma.com to support its digital presence and brand protection strategy.

Regulatory Compliance Framework

Regenerex Pharma Inc. operates within a comprehensive regulatory environment overseen by multiple authorities including:

•

Food and Drug Administration (FDA)

•

Federal Trade Commission (FTC)

•

Various federal, state, and local regulatory bodies

•

International regulatory authorities in markets where products are distributed

Compliance Areas

Regulatory oversight encompasses multiple operational aspects including:

•

Product efficacy validation

•

Ingredient and product safety protocols

•

Manufacturing standards and quality control

•

Labeling and packaging requirements

•

Marketing and advertising compliance

•

Product shipment and disposal procedures

•

Comprehensive safety management systems

WHERE YOU CAN FIND MORE INFORMATION

You are advised to read this Form 10-K in conjunction with other reports
and documents that we file from time to time with the SEC. In particular,
please read our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K
that we file from time to time. You
may obtain copies of these reports directly from us or from the SEC at the
SEC’s Public Reference Room at 100 F. Street, N.E. Washington, D.C. 20549, and
you may obtain information about obtaining access to the Reference Room by
calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains information
for electronic filers at its website http://www.sec.gov.

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