Regen Biopharma, Inc. - Company Summary

Business Overview

• Incorporation Date: April 24, 2012 (Nevada)
• Main Focus: Development of regenerative medical applications, primarily in the field of immunotherapy and cellular therapies.
• Business Model: License, develop internally, acquire, and potentially sell or license therapies after successful clinical trials.

Key Therapies in Development

1. HemaXellarate

   • Cellular composition of autologous stromal vascular fraction (SVF) derived from adipose tissue.
   • Contains endothelial progenitor cells and mesenchymal stem cells.
   • Intended to regenerate bone marrow and treat severe aplastic anemia.
   • Status: Filed IND with FDA for Phase I; in ongoing safety and efficacy assessments.

2. dCellVax

   • Autologous dendritic cells treated with siRNA targeting indoleamine-2,3-dioxygenase (IDO).
   • Designed to enable immune attack on cancers, particularly breast cancer.
   • Status: Filed IND for Phase I/II clinical trial; recruiting 10 patients with metastatic breast cancer.

3. tCellVax

   • Immune cells treated with siRNA to inhibit NR2F6, re-infused to activate immune response against tumors.
   • Status: Filed IND for Phase I clinical trial; recruiting 25 patients with metastatic or surgically unresectable solid tumors.

4. DiffronC

   • Uses proprietary siRNA to inhibit NR2F6 in vivo.
   • Objective: Activate T cells to inhibit cancer growth.
   • Status: In pre-clinical testing.

5. DuraCar

   • Car-T cell therapy with shRNA targeting NR2F6.
   • Aims to improve efficacy and persistence of CAR-T cells, especially for solid tumors.
   • Status: In pre-clinical testing; involved in evaluating delivery and effectiveness.

6. Small Molecule Drugs

   • Patented series of small molecules to both activate and inhibit NR2F6.
   • Intended for immune activation (anti-tumor) or immune suppression (autoimmune disorders).
   • Status: In pre-clinical testing.

Licenses & Intellectual Property

• Licensing agreements with Zander Therapeutics Inc. (veterinary applications) and Oncology Pharma Inc. (cancer therapies).
• Rights granted for development, licensing, and commercialization, with revenue primarily from royalties and sublicense considerations.
• Owned patents related to gene silencing, immunotherapy, and cancer treatment methods focusing on NR2F6 and BORIS.

Financial & Operational Highlights

• Number of Employees: 1 full-time employee (as of April 30, 2025).
• Research & Development Expenses (FY ended September 30, 2024): $153,685.
• Current Revenue: None (no licensed therapies on the market as of April 30, 2025).
• Main Activities: Ongoing pre-clinical research, clinical trial applications, and license management.

Facilities

• Occupies 2,320 sq. ft. office space at 4700 Spring Street, La Mesa, California.
• Subleased office space arrangement with BST Partners.

Regulatory and Legal

• Products are regulated by the FDA as drugs or biologics; clinical trials involve IND applications.
• No material pending legal proceedings.

Note: The company has not achieved significant revenue or profits as of the given date. Their operations are heavily focused on research, pre-clinical development, and licensing of innovative immunotherapy and cellular therapy products.