Regen BioPharma

What Regen BioPharma does

Regen BioPharma, Inc. is a publicly traded (OTC Pink: RGBP/RGBPP) pre-clinical and early-clinical biotechnology company headquartered in La Mesa, California, founded in 2012 with 1-10 employees. The company develops immune checkpoint therapies for cancer and autoimmune diseases, anchored on NR2F6, an orphan nuclear receptor that suppresses T-cell function by inhibiting NFAT and downstream cytokines including IL-2, IL-17, and IL-18. The product pipeline spans six platform technologies: DuraCAR (CAR-T cells with shRNA-mediated NR2F6 silencing for durable solid and liquid tumor activity), dCellVax and tCellVax (dendritic cell and PBMC-derived immunotherapies using ex vivo siRNA silencing of NR2F6), KimerApt (bispecific aptamer platform for receptor inhibition and siRNA delivery), DiffronC (siRNA-based differentiation therapy, lead indication myelodysplastic syndrome), HemaXellerate (autologous fat-derived endothelial cell therapy for bone marrow repair in aplastic anemia), and small molecule NR2F6 agonists and antagonists. All programs are protected by nine granted US patents issued between 2012 and 2022.

Regulatory progress includes one FDA-cleared IND (HemaXellerate, IND #15376, cleared December 2015) and two submitted INDs (dCellVax #16200 for breast cancer; tCellVax #16928 for solid tumors). The company has no commercial revenue and explicitly indicates a future licensing and royalty model contingent on regulatory approval. In November 2021 the company signed a Letter of Intent to acquire Canary Oncoceutics, an in vitro diagnostics start-up developing functional cancer tests, signaling intent to add a diagnostics vertical. Operations are US-only, and go-to-market activity consists of investor-facing communications (Emerging Growth Conference presentations, press releases, and the company website) rather than commercial sales infrastructure.

Name

Regen BioPharma

Legal name

REGEN BIOPHARMA, INC.

Website

https://regenbiopharmainc.com

Company type

Public

Founded year

2012

Operating status

Operating

Headcount range

1–10 employees

Short description

Regen BioPharma is a pre-revenue, publicly traded (OTC Pink: RGBP/RGBPP) biotechnology company developing immune checkpoint therapies that target the NR2F6 nuclear receptor to treat cancer and autoimmune diseases across cell therapy, RNA, and small molecule modalities.

Ownership category

akta.pro rank

Product category

Biopharmaceuticals / Immuno-Oncology Cell Therapy

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714), Pharmaceutical and Medicine Manufacturing (3254)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Cell Therapy Developers (Autologous) (HLAAABAA)

akta.pro secondary industries

Dendritic Cell & Other APC-based Therapies (HLAAABAF), Stem Cell–Based Regenerative Therapies (HLAAAGAA), Cell Therapy Enabling Technologies (gene editing, cell engineering, delivery methods) (HLAAABAL), Regenerative Immunology & Inflammation Modulation (pro-regenerative biologics) (HLAAAGAL), Personalized Therapeutic Design (neoantigen vaccines, individualized cell/gene therapies) (HLAAANAK), Immunology & Autoimmune Specialty Pharmaceuticals (HLAIACAB)

Keywords

• Cell therapy development
• Immune checkpoint inhibitors
• CAR-T cell therapy
• Regenerative medicine
• RNA therapeutics

Headquarters

HQ city

La Mesa

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Supply Chain

Revenue model

1. Biopharmaceutical Development Revenue: Pre-revenue biotechnology company focused on developing regenerative medical therapies and related intellectual property. The company is in the development stage with significant operating losses as it advances through pre-clinical and Phase I/II clinical trials. Revenue is not expected until regulatory approval of therapeutic products.

Go-to-market motion1 record

Marketing channels4 records

Core offering

Regen BioPharma is a publicly traded pre-clinical/early-clinical biotechnology company developing autologous cell therapies, RNA and DNA-based immunotherapies, and small molecule drugs targeting the NR2F6 immune checkpoint for cancer and autoimmune diseases. Its pipeline includes CAR-T cell therapy (DuraCAR), dendritic/T cell immunotherapies (dCellVax, tCellVax), an aptamer platform (KimerApt), siRNA differentiation therapy (DiffronC), and a personalized cellular bone marrow repair product (HemaXellerate) currently in Phase I/II clinical trials.

Product overview

Regen BioPharma is a publicly traded biotechnology company (OTC PINK: RGBP/RGBPP) with a diverse pre-clinical pipeline spanning cell therapies, RNA vaccines, RNA and DNA therapeutics, and small molecule drugs. The company focuses on immune checkpoint medicines, particularly targeting NR2F6, a novel immune checkpoint that regulates T cell function. The product portfolio includes DuraCAR (gene-silenced CAR-T cells), dCellVax and tCellVax (dendritic and T cell immunotherapies via gene silencing), KimerApt (bispecific aptamer platform), DiffronC (siRNA differentiation therapy), HemaXellerate (bone marrow repair stem cell therapy), and small molecule modulators of NR2F6 for cancer and autoimmune disorders. All technologies are protected by multiple granted and pending patents.

Differentiator

Problem solved

Functional benefit

Brands

• DuraCAR: Gene-silenced CAR-T cells designed to inhibit NR2F6 expression for long-term, durable effectiveness against solid and liquid tumors.
• KimerApt
• dCellVax
• tCellVax
• DiffronC
• HemaXellerate

Products and services

• DuraCAR

Quantifiable outcome

• FDA IND clearance for HemaXellerate (IND #15376) to proceed to Phase I/II clinical trials for aplastic anemia
• +1 more outcomes

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature7 records

Partnerships

Twelve partnerships are on record, tiered minor and core.

• Canary Oncoceutics, Inc.minorStrategic or Co-development Partner · 17 November 2021Regen BioPharma signed a Letter of Intent to acquire Canary Oncoceutics, an in vitro diagnostics start-up company developing functional cancer tests for personalized medicine. The acquisition would expand Regen's diagnostic capabilities alongside its therapeutic pipeline.
• Dr. Ravinder ReddyminorOthersDr. Ravinder Reddy, Professor of Radiology at the University of Pennsylvania and Director of the Center for Advanced Metabolic Imaging in Precision Medicine, joined the Scientific Advisory Board in December 2022.
• Dr. Mohammad HarisminorOthersDr. Mohammad Haris, Associate Professor in the Center for Advanced Metabolic Imaging in Precision Medicine at the University of Pennsylvania, joined the Scientific Advisory Board in December 2022.
• Dr. Stefano BertuzziminorOthersExecutive Director of the American Society for Cell Biology. Named Executive of the Year by CEO Today Magazine.
• Dr. David A. SuhyminorOthersSenior VP at Benitec Biopharma. Developed first clinical shRNA drug for hepatitis C virus.
• Dr. Weiping MinminorOthersProfessor at University of Western Ontario. First to utilize RNAi for immune modulation including cancer and organ rejection.
• Dr. Amit PatelminorOthersDirector of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah.
• Dr. Santosh KesaricoreOthersDirector of the Neuro-Oncology Program, the Neurotoxicity Treatment Center, and Translational Neuro-Oncology Laboratory at UCSD. Currently addressing FDA questions for dCellVax and tCellVax clinical programs.
• Dr. Rohit DuggalminorOthers17 years of professional experience in drug discovery field. Worked at Pfizer as leader of the cancer stem cell group.
• Dr. William S. BlanerminorOthersProfessor of Nutritional Sciences at Columbia University studying metabolism and actions of retinoids.
• Dr. Jonathan BaellminorOthersProfessor of Medicinal Chemistry at Monash University (Australia) focused on discovery of new medicines.
• Dr. Hinrich GronemeyerminorOthersResearch Director at IGBMC in Strasbourg-Illkirch and Research Director (Class Exceptional) of the French National Institute.

Scale indicators2 records

Recent moves6 records

Expansion highlights5 records

Broad incumbents

• Bristol Myers Squibb: Major oncology incumbent with both leading checkpoint inhibitors (Opdivo/PD-1, Yervoy/CTLA-4) and an approved CAR-T franchise (Breyanzi, Abecma). Comparable to Regen as the dominant benchmark Regen's NR2F6 and CAR-T programs must outperform or differentiate against.
• Gilead Sciences (Kite): Owns Kite Pharma, a leader in autologous CAR-T cell therapy (Yescarta, Tecartus), directly comparable to Regen's DuraCAR gene-silenced CAR-T program in modality and target tumor types.
• Novartis: Pioneered commercial CAR-T with Kymriah and operates a broad immuno-oncology portfolio. Relevant as both a checkpoint competitor and the established benchmark for autologous cell therapy commercialization that Regen's pipeline would need to compete with.
• Alnylam Pharmaceuticals: Established leader in RNAi therapeutics (Onpattro, Givlaari, Oxlumo). Comparable to Regen's siRNA/shRNA programs (DiffronC, DuraCAR shRNA) as the dominant commercial benchmark in RNA-based therapeutics.

Direct peers

• Fate Therapeutics: Clinical-stage cell therapy company developing engineered NK and T-cell therapies from iPSC platforms. Comparable to Regen as a small-cap, multi-program cell therapy developer with multiple INDs and a similar technology-platform narrative.
• Nkarta: Focused on allogeneic and gene-edited NK cell therapies for cancer, including checkpoint-inhibitor-enhanced NK cells. Directly comparable to Regen's NK/cord blood killer cell patent (US 11,141,471) and cell therapy approach.
• Allogene Therapeutics: Allogeneic CAR-T developer with multiple clinical-stage programs in solid tumors and hematologic malignancies. Comparable to Regen as a clinical-stage CAR-T innovator, though at a more advanced and better-capitalized stage.
• CRISPR Therapeutics: Gene-edited cell therapy company (Casgevy, partnered with Vertex) using CRISPR to engineer immune cells. Comparable to Regen as a clinical-stage cell therapy innovator using gene-silencing/editing approaches overlapping with Regen's shRNA and siRNA platforms.
• Northwest Biotherapeutics: Developer of dendritic cell-based cancer vaccines (DCVax), historically one of the few pure-play dendritic cell therapy companies. Directly comparable to Regen's dCellVax/tCellVax dendritic cell programs in modality and patient population.

Emerging players

• Compugen: Clinical-stage immuno-oncology company discovering novel checkpoints and developing first-in-class therapeutics (e.g., PVRIG, TIGIT). Comparable to Regen as an emerging developer of novel immune checkpoint targets, though at a more clinically advanced stage.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks7 records

Key highlights6 records

Customer concentration

• Xx.com/regenbiopharm
• LinkedInlinkedin.com/company/regen-biopharma-inc

Revenue estimate

Valuation estimate

Number of profiles

Profiles1 record

Subsidiaries1 record

Funding overview

Funding rounds

Investors

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Regen BioPharma