Regen BioPharma: No Revenue, Focus on Early-Stage Biotech Pipeline

TL;DR

**RGBPP is a pure-play, pre-revenue biotech gamble with a pipeline of promising but unproven therapies; invest only if you have a high tolerance for risk and a long-term horizon.**

AI Summary

Regen BioPharma Inc. (RGBPP) reported no revenue for the fiscal year ending September 30, 2025, as it remains a development-stage biotechnology company focused on regenerative medical applications. The company is advancing several therapies, including HemaXellarate for aplastic anemia, dCellVax and tCellVax for cancer, and DuraCar, a CAR-T cell therapy. A significant business change includes the FDA's clearance in December 2015 for Regen to initiate a Phase I clinical trial for HemaXellarate, assessing safety and efficacy in drug-refractory aplastic anemia patients. Key risks include dependence on key personnel, competitive factors in the biotech industry, and the inherent uncertainties of research and development programs, as no clinical trials on product candidates have commenced beyond HemaXellarate's Phase I clearance. The strategic outlook involves licensing, internal development, or acquisition of applications up to Phase I/II clinical trials, with potential sales or further advancement to Phase III based on efficacy indications.

Why It Matters

Regen BioPharma's continued pre-revenue status and reliance on early-stage drug development highlight the high-risk, high-reward nature of the biotech sector for investors. The company's pipeline, particularly its NR2F6-targeting therapies and CAR-T cell enhancements, could offer significant advancements in cancer and regenerative medicine if successful, potentially disrupting existing treatment paradigms from larger players like Novartis or Gilead in the CAR-T space. However, the lack of advanced clinical trial data means employees and customers face considerable uncertainty regarding future product availability and market impact, making it a speculative investment until further clinical milestones are achieved.

Risk Assessment

Risk Level: high — The company is a pre-revenue entity with no products on the market, indicating a high risk profile. Its primary focus is on early-stage research and development, with most therapies still in preclinical testing or only cleared for Phase I clinical trials, such as HemaXellarate. The filing explicitly states, "No clinical trials on our product candidates have commenced so no conclusions of efficacy can be made," underscoring the significant scientific and regulatory hurdles ahead.

Analyst Insight

Investors should approach Regen BioPharma with extreme caution, recognizing it as a highly speculative investment. Monitor progress on the HemaXellarate Phase I trial and any updates on the NR2F6-targeting small molecules and DuraCar, as these represent the most tangible near-term catalysts, though still years from commercialization.

Financial Highlights

debt To Equity

N/A

revenue

$0

operating Margin

N/A

total Assets

N/A

total Debt

N/A

net Income

N/A

eps

N/A

gross Margin

N/A

cash Position

N/A

revenue Growth

N/A

Revenue Breakdown

Key Numbers

• $1,054,545 — Aggregate market value of non-affiliate common equity (as of the last business day of the most recently completed second fiscal quarter)
• 108,054,704 — Common shares outstanding (as of December 26, 2025)
• 10,123,771 — Series A Preferred Stock outstanding (as of December 26, 2025)
• $100,000 — Upfront license fee from Zander Therapeutics (due within 90 days of June 23, 2015)
• $100,000 — Annual license payment from Zander Therapeutics (commencing July 15, 2016)
• 4% — Royalty rate from Zander Therapeutics (on Net Sales of Licensed Products)
• $10,000 — Minimum annual royalties from Zander Therapeutics (commencing on the second anniversary of June 23, 2015)
• $55,000 — Nonrefundable fee from Oncology Pharma, Inc. (for pancreatic cancer license, due by April 20, 2021)
• 5% — Royalty rate from Oncology Pharma, Inc. (on Net Sales of Licensed Products for pancreatic and colon cancer)
• 50,000 — Common shares of Oncology Pharma, Inc. (nonrefundable fee to KCL for colon cancer license, due by April 20, 2021)

Key Players & Entities

• Regen BioPharma Inc. (company) — registrant and developer of therapies
• KCL Therapeutics, Inc. (company) — wholly owned subsidiary of Regen BioPharma
• Zander Therapeutics, Inc. (company) — licensee for non-human veterinary therapeutic use
• Oncology Pharma, Inc. (company) — licensee for human pancreatic and colon cancer treatments
• United States Food and Drug Administration (regulator) — granted clearance for HemaXellarate Phase I trial
• United States Patent and Trademark Office (regulator) — granted multiple patents to Regen BioPharma
• HemaXellarate (company) — cellular composition for aplastic anemia
• dCellVax (company) — dendritic cell therapy for cancer
• tCellVax (company) — immune cell therapy for tumors
• DuraCar (company) — CAR-T cell therapy

FAQ

Risk Factors

• Dependence on Key Personnel [high — operational]: The company's success is heavily reliant on the expertise and continued involvement of its key personnel. Any departure or inability of these individuals to perform their duties could significantly hinder research, development, and strategic execution.
• Competitive Biotech Landscape [high — market]: The biotechnology industry is highly competitive, with numerous companies vying for market share and scientific advancement. Regen BioPharma faces competition from established players and emerging companies, which could impact its ability to secure funding, partnerships, and market adoption for its therapies.
• Uncertainty of R&D Programs [high — financial]: As a development-stage company, Regen BioPharma's future revenue and profitability are contingent on the successful outcome of its research and development programs. The inherent uncertainties in clinical trials, regulatory approvals, and market acceptance pose significant financial risks.
• Clinical Trial Progression [medium — regulatory]: While HemaXellarate received FDA clearance for Phase I trials in December 2015, no other product candidates have commenced clinical trials beyond this stage. The company's strategy relies on advancing applications up to Phase I/II trials, and any delays or failures in these trials could severely impact its business model.

Industry Context

Regen BioPharma operates in the highly competitive and rapidly evolving biotechnology sector, focusing on regenerative medicine and oncology. The industry is characterized by significant R&D investment, long development cycles, and stringent regulatory oversight. Success hinges on innovation, clinical trial outcomes, and strategic partnerships to navigate the path from preclinical research to market approval.

Regulatory Implications

The company's progress is heavily tied to FDA approvals and clinical trial outcomes. The clearance for HemaXellarate's Phase I trial is a positive step, but future advancements for all candidates depend on successfully navigating the complex regulatory pathways for drug development and approval.

What Investors Should Do

1. Monitor clinical trial progress for HemaXellarate.
2. Evaluate the company's ability to secure additional funding.
3. Assess the competitive landscape for aplastic anemia and cancer therapies.
4. Review any updates on licensing or partnership agreements.

Key Dates

• 2015-12-10: FDA Cleared HemaXellarate Phase I Trial — This clearance allowed Regen BioPharma to initiate its first clinical trial for HemaXellarate, a crucial step in validating its regenerative medicine approach for aplastic anemia.
• 2015-06-23: Zander Therapeutics License Agreement — This agreement provided an upfront payment of $100,000 and established future royalty streams, indicating early-stage commercial interest in Regen's technology.
• 2021-04-20: Oncology Pharma, Inc. License Agreement — This agreement secured a $55,000 nonrefundable fee and a 5% royalty for licensed pancreatic and colon cancer applications, diversifying potential revenue sources.
• 2013-02-05: HemaXellarate IND Application Filed — The initial filing with the FDA for HemaXellarate marked the beginning of the regulatory process for its lead drug candidate.

Glossary

Investigational New Drug (IND) application

An application submitted to the FDA to seek permission to administer an experimental drug or biologic to humans. It includes data from preclinical studies, manufacturing information, and the proposed clinical trial protocol. (Regen BioPharma filed an IND for HemaXellarate, which is a prerequisite for initiating Phase I clinical trials.)

Autologous Stromal Vascular Fraction (SVF)

A collection of cells derived from adipose (fat) tissue, including endothelial progenitor cells and mesenchymal stem cells, that are obtained from the patient's own body. (HemaXellarate is composed of autologous SVF, intended to regenerate bone marrow function.)

siRNA

Small interfering RNA, a double-stranded RNA molecule used to modulate gene expression by targeting and degrading specific messenger RNA (mRNA) molecules, thereby inhibiting protein production. (Regen BioPharma utilizes siRNA in dCellVax and tCellVax to inhibit specific enzymes or proteins involved in cancer progression.)

CAR-T cells

Chimeric Antigen Receptor T cells, a type of immunotherapy where a patient's T cells are genetically engineered to recognize and attack cancer cells. (DuraCar is Regen BioPharma's CAR-T cell therapy candidate, enhanced with shRNA targeting NR2F6.)

NR2F6

A nuclear receptor identified as a potential immune cell inhibitor and cancer stem cell differentiator. (Regen BioPharma targets NR2F6 with siRNA and shRNA in several of its drug candidates (tCellVax, DiffronC, DuraCar) to enhance immune response against cancer.)

Phase I Clinical Trial

The first stage of human testing for a new drug or treatment, primarily focused on assessing safety, determining a safe dosage range, and identifying side effects. (Regen BioPharma's HemaXellarate has received FDA clearance to initiate a Phase I trial.)

Year-Over-Year Comparison

As Regen BioPharma is a development-stage company with no reported revenue for the fiscal year ending September 30, 2025, direct year-over-year financial comparisons are not applicable. The primary focus remains on the progression of its R&D pipeline. Key developments since the previous filing period would include the FDA's clearance in December 2015 for the HemaXellarate Phase I trial, representing a significant milestone in advancing its lead therapeutic candidate.

Key Financial Figures

• $100,000 — ent of one hundred thousand US dollars ($100,000) as a license initiation fee which must
• $10,000 — l royalties of ten thousand US dollars ($10,000) payable per year on each anniversary o
• $55,000 — (a) pay to Regen a nonrefundable fee of $55,000 no later than April 20,2021 (b) pay t

Filing Documents

• form10-k.htm (10-K) — 1486KB
• ex31-1.htm (EX-31.1) — 12KB
• ex31-2.htm (EX-31.2) — 11KB
• ex32-1.htm (EX-32.1) — 6KB
• ex32-2.htm (EX-32.2) — 6KB
• 0001493152-25-029526.txt ( ) — 7068KB
• rgbp-20250930.xsd (EX-101.SCH) — 53KB
• rgbp-20250930_cal.xml (EX-101.CAL) — 73KB
• rgbp-20250930_def.xml (EX-101.DEF) — 253KB
• rgbp-20250930_lab.xml (EX-101.LAB) — 384KB
• rgbp-20250930_pre.xml (EX-101.PRE) — 371KB
• form10-k_htm.xml (XML) — 1036KB

From the Filing

UNITED SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K ANNUAL REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934: For the fiscal year ending September 30 , 2025 TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934: For the transition period from __________ to __________. Commission file number: 333-191725 REGEN BIOPHARMA, INC. (Name of small business issuer in its charter) Nevada 45-5192997 (State or other jurisdiction of incorporation or organization) (I.R.S. Employer Identification No.) 8697 La Mesa Blvd Suite C #107 La Mesa CA 91942 (Address of Principal executive offices) Issuer's telephone number: (619) 722 5505 Securities registered under Section 12(b) of the "Exchange Act": None Securities registered pursuant to Section 12(g) of the Act: None Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes No Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes No Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes No Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T ( 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or smaller reporting company. Large accelerated filer Accelerated reporting Company Emerging growth company If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. Indicate by check mark whether the registrant has filed a report on and attestation to its management's assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting firm that prepared or issued its audit report. Yes No If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant's executive officers during the relevant recovery period pursuant to 240.10D-1(b). Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes No the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant's most recently completed second fiscal quarter: $ $ 1,054,545 As of December 26, 2025 Regen Biopharma, Inc. had 108,054,704 common shares outstanding. As of December 26, 2025 Regen Biopharma, Inc. had 10,123,771 shares of Series A Preferred Stock outstanding. As of December 26, 2025 Regen Biopharma, Inc. had 34 shares of Series AA Preferred Stock outstanding. As of December 26, 2025 Regen Biopharma, Inc. had 29,338 shares of Series M Preferred Stock outstanding. As of December 26, 2025 Regen Biopharma, Inc. had 15,007 shares of Series NC Preferred Stock outstanding. PART I In this annual report, the terms "Regen Biopharma, Inc..", "Regent", "Company", "we", or "our", unless the context otherwise requires, mean Regen Biopharma, Inc., a Nevada corporation and its wholly owned subsidiary KCL, Therapeutics, Inc., a Nevada corporation. CAUTIONARY This annual report on Form 10-K and other reports that we file with the SEC contain statements that are considered forward-looking statements. Forward-looking statements give the Company's current expectations, plans, objectives, assumptions or forecasts of future events. All statements other than statements of current or historical fact contained in this annual report, including statements regarding the Company's future financial position, business strategy, budgets, projected costs and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "anticipate," "estimate," "plans," "potential," "proje

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