Regen Biopharma Inc (RGBAD)

[cash4]

Based on 437,868,406 shares issued and outstanding as of December 6, 2021

https://www.otcmarkets.com/filing/html?id=15437000&guid=rtfwknIyAUljOth

Title of Class Name and Address of Beneficial Owner Amount and Nature of Beneficial Ownership
Percentage

As of December 6, 2021 Regen Biopharma, Inc. had 4,564,002,832 common shares outstanding.

As of December 6, 2021 Regen Biopharma, Inc. had 437,868,406 shares of Series A Preferred Stock outstanding.

As of December 6, 2021 Regen Biopharma, Inc. had 50,000 shares of Series AA Preferred Stock outstanding.

As of December 6, 2021 Regen Biopharma, Inc. had 44,000,000 shares of Series M Preferred Stock outstanding.

As of December 6, 2021 Regen Biopharma, Inc. had 10,000 shares of Series NC Preferred Stock outstanding.

Series A Preferred David R. Koos 169,413,976 38 %
c/o Regen Biopharma, Inc.
4700 Spring Street St 304
La Mesa CA 91942*
Series A Preferred Bostonia Partners Inc 25,518,400 -0.058278697
1204 Tangerine El Cajone CA 92021

Series A Preferred Zander Therapeutics, Inc. 168,267,314 -38 %
4700 Spring Street St 304
La Mesa CA 91942
Seies A Preferred All Officers and Directors as a Group 169413976 -38%

Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.

Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.

If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.

As of September 30, 2021 we had Cash of $727,162 and as of September 30, 2020 we had cash of $0.

The increase in Cash is primarily attributable to:

(a) Net increase of $1,363, 00 of Notes Payable
(b) proceeds from sales of investment securities totaling $495,000
(c) $55,000 of revenue received in cash pursuant to a license granted by the Company to Oncology Pharma, Inc
Offset by the costs of operating the business of the Company as well as non recurring cash payment of $800,000 paid in connection with a legal settlement.

As of September 30, 2021 we had Accounts Receivable, Related Party of $213,192 and as of September 30, 2020 we had Accounts Receivable, Related Party of $ 103,192.

The increase in Accounts Receivable, Related Party of approximately 106.6% is attributable to the accrual of $110,000 of minimum royalties and anniversary fees pursuant to a license granted to Zander by Regen Biopharma, Inc.

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As of September 30, 2021 we had Prepaid Expenses of $48,144 and as of September 30, 2020 we had prepaid expenses of $28.

The increase in Prepaid Expenses is primarily attributable to an agreement entered into by and between the Company and a third party for the provision of Research and Development services. The term of the agreement is from July 1, 2021 to July 1, 2023. The total consideration due of $55,000 was paid to the contractor as of July 1, 2021 and is being expensed over the term of the agreement.

As of September 30, 2020 we had Notes Receivable, Related Party of $0 and as of September 30, 2021 we had Notes Receivable, Related Party of $ 5,396.

The increase in Notes Receivable is attributable to $5,396 loaned by the Company during the quarter ended June30, 2021 to Zander Therapeutics, Inc. an entity under common control.

As of September 30, 2020 we had Investment Securities ( Not Related Party) of 0 and as of September 30,2021 we had Investment Securities ( Not Related Party) of $198,006.

During the quarter ended June 30, 2021 the Company was paid 50,000 common shares of Oncology Pharma, Inc. pursuant to an agreement entered into by and between KCL Therapeutics, Inc. ( a wholly owned subsidiary of the Company) and Oncology Pharma, Inc. whereby Oncology Pharma, Inc. was granted a license for the development and commercialization of certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from April 7, 2021.

During the quarter ended June 30, 2021 13,700 of the aforementioned common shares were sold to an unrelated party for $300,000 cash.

During the quarter ended September 30, 2021 18,000 of the aforementioned common shares were sold to an unrelated party for $195,000 cash.

As of September 30, 2021 18,300 common shares of Oncology Pharma, Inc. constitute the sole investment securities other than shares of Zander Therapeutics, Inc. held by the Company.

On September 30, 2021 the Company revalued 18,300 common shares of Oncology Pharma, Inc. at the closing price of the common shares on the OTC Pink market.

As of September 30, 2020 we had Accounts Payable of $110,486 and as of September 30,2021 we had Accounts Payable of $91,498. The decrease in Accounts Payable of approximately 17% is primarily attributable to payment of $16,745 of payable due to the Company’s Transfer Agent offset by expenses incurred as a result of services provided by the Company’s Resident Agent as well as payment of expenses related to services provided by a patent attorney.

As of September 30, 2021 we had Notes Payable of $1,429,179 and as of September 30, 2020 we had Notes Payable of $62,127. The increase in Notes Payable of approximately 2200.42% is attributable to the issuance of a Note in the principal amount of $1,500,000 on September 17, 2021 of which $75,000 was retained by the Holder through an Original Issue Discount (“OID”) for due diligence and origination related to this transaction. The OID is being amortized by the Company over the term of the Note

As of September 30, 2020 we had Accrued Interest Payable of $830,061 and as of September 30, 2021 we had Accrued Interest Payable of $954,861.



The increase in Accrued Interest Payable of approximately 15 is attributable to additional interest accrued but unpaid during the year ended September 30,2021 on Notes and Convertible Notes issued by the Company offset primarily by conversion of interest accrued but unpaid due to holders of Convertible Notes Payable into equity securities of the Company during the same period.



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As of September 30, 2020 we had Accrued Payroll of $1,189,319 and as of September 30, 2021 we had Accrued Payroll of $1,266,679. The increase of approximately 6.5% is attributable to $77,360 of salary accrued but unpaid to the Company’s former Chief Financial Officer.



As of September 30, 2020 we had Accrued Rent of $23,548 which was paid by the Company during the year ended September 30, 2021.



As of September 30, 2020 we had a Derivative Liability of $2,634,215 and as of September 30, 2021 we had a Derivative Liability of $6,892,477.

The increase in Derivative Liability of approximately 162% is attributable to the recognition by the Company of embedded derivatives on Convertible Notes Payable with an aggregate face value of $1,795,973 outstanding as of September 30, 2021. Recognition of embedded derivatives on Convertible Notes Payable with an aggregate face value of $2,089,377 outstanding as of September 30, 2020 were recognized by the Company during the fiscal year ended 2020.

As of September 30, 2021 we had Convertible Notes Payable, Net of Unamortized Discount, of $2,152,811 and as of September 30, 2020 we had Convertible Notes Payable, Net of Unamortized Discount, of $2,541,766.



The decrease in Convertible Notes Payable, Net of Unamortized Discount, of approximately 15 % is primarily attributable to conversions of principal indebtedness into the equity securities of the Company offset by amortization of $47,063 of Discounts on Convertible Notes.



As of September 30, 2021 we had Unearned Income of $1,843,806 and as of September 30, 2020 we had Unearned Income of $0.

Unearned Income as of September 30,2021 represents that portion of $1,905,000 of license fees paid during the quarter ended June 30, 2021 to be recognized as revenue over the 15 year term of the licenses granted in accordance with ASC 606.

Material Changes in Results of Operations

Revenues from continuing operations were $110,000 for the twelve months ended September 30, 2020 and $171,194 for the same period ended 2021. $110,000 of revenue recognized during the years ended September 30, 2021 and September 30, 2020 consisted of $100,000 related to an anniversary expense receivable pursuant to a license granted by the Company to Zander Therapeutics, Inc. and $10,000 of minimum royalties recognized during the twelve months ended September 30 2021 and 2020 respectively pursuant to the same license. $61,194 of revenue recognized during the year ended September 30, 2021 were recognized pursuant to licenses granted to Oncology Pharma,Inc.

With regards to the aforementioned license granted to Zander On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.

The Company recognized an Operating Loss of $200,771 during the year ended September 30, 2021 whereas the Company recognized an Operating Loss of $209,317 for the same period ended September 30, 2020. The Company recognized a Net Loss of $6,765,233 for the twelve months ended September 30, 2021 whereas the Company recognized Net Income of $3,623,736 for the same period ended 2020. Contributing factors to the difference between the periods were:

(a) The recognition of a Derivative Loss of $4,264,975 during the twelve months ended September 30, 2021
(b) The recognition of Derivative Income of $4,566,669 during the twelve months ended September 30, 2020
(c) recognition of an $800,000 expense related to a legal settlement during the year ended September 30,2021
(d) Recognition of $524,960 of realized losses on sales of Investment Securities during the year ended September 30,2021
(e) Recognition of $632,094 of unrealized losses on sales of Investment Securities during the year ended September 30, 2021.


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As of September 30, 2021 we had $727,162 in cash on hand and current liabilities of $14,697,976 such liabilities consisting of Accounts Payable, Notes Payable, Convertible Notes Payable , Derivative Liability Recognized, Unearned Income and Accrued Expenses. We feel we will not be able to satisfy our cash requirements over the next twelve months and shall be required to seek additional financing.




The following is a list of intellectual property (“IP”) controlled by either Regen Biopharma, Inc. ( the “Company”) or KCL Therapeutics (“KCL”). KCL is a wholly owned subsidiary of the Company.

IP which has been granted patent protection by the United States Patent and Trademark Office (“USPTO”)

GENE SILENCING OF THE BROTHER OF THE REGULATOR OF IMPRINTED SITES (BORIS)

Provides methods and compositions useful for inhibiting expression of the gene encoding the transcription factor, Brother of the Regulatory of Imprinted Sites (BORIS) by RNA interference. Methods of the present invention can be used to silence BORIS in cancer cells, which results in apoptosis and may be useful as for treating cancer in mammals. The methods of the invention directed to cancer therapy can be used alone or in combination with standard cancer treatments such as surgery, radiation, chemotherapy, and immunotherapy.

Patent No: 8263571

METHODS AND MEANS OF GENERATING IL-17 ASSOCIATED ANTITUMOR EFFECTOR CELLS BY INHIBITION OF NR2F6 INHIBITION

Means, methods, and compositions of matter useful for generation of cancer inhibitory effector cells producing interleukin-17 (IL-17). In one embodiment a cellular population is obtained, said cellular population is exposed to agents capable of inhibiting NR2F6, whereby said inhibition of NR2F6 results in upregulation of IL-17 production, said upregulation of IL-17 production associated with acquisition of anti-tumor activity.

Patent No : 11,053,503

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METHODS OF SCREENING COMPOUNDS THAT CAN MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND

Compositions of matter, protocols and methods of screening test compounds to identifying agonists and antagonists of the orphan nuclear receptor NR2F6 by measuring the ability of a test compound to occupy the active site of NR2F6, in the presence of a reference compound.

Patent No: 10,088,485

MODULATION OF NR2F6 AND METHODS AND USES THEREOF

The application provides methods of modulating NR2F6 in a cell or animal in need thereof by administering an effective amount of a NR2F6 modulator

Patent No: 9091696

“UNIVERSAL DONOR CHECKPOINT INHIBITOR SILENCED/GENE EDITED CORD BLOOD KILLER CELLS”

The invention encompasses compositions of matters, cells, and treatment protocols useful for induction of anticancer responses in a patient suffering from cancer. In one embodiment the invention provides the use of NR2F6 silencing or gene editing in cord blood cells possessing anti-tumor activity in order to induce potentiated killer cells suitable for therapeutic use. In one embodiment said allogeneic cord blood killer cells are administered to initiate a cascade of antitumor immune responses, with initially responses mediated by allogeneic killer cells, and followed by endogenous immune responses.

Patent No: 11,141,471 B2

ANTIGEN SPECIFIC MRNA CELLULAR CANCER VACCINES

Antigen specific cancer vaccines in which immunogenic epitopes are produced intracellularly by administration of modified mRNA encoding said immunogenic epitopes. In one embodiment of the invention, said modified mRNA encodes peptides derived from the protein survivin. By directly inducing gene expression of the antigens to which an immune response is desired, immunogenic peptides are generated intracellularly, thus allowing for a wider repertoire of epitopes to be presented to the adaptive immune system, which augments likelihood of successful induction of immunity.

Patent No.11,090,332

METHOD OF CANCER TREATMENT USING SIRNA SILENCING

Comprises administering to a subject one or more siRNA constructs capable of inhibiting the expression of an immunosuppressive molecule. The invention also provides siRNA constructs and compositions.

Patent No: 8389708

Active Patent Applications:

ENHANCED DENDRITIC CELL IMMUNE ACTIVATION BY COMBINED INHIBITION OF NR2F6 WITH CANNIBIDIOL;

Application Number 17035955

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REDUCTION OF POST-SURGERY CANCER METASTASIS BY COMBINATION OF CANNABIDIOL AND NR2F6 INHIBITION.

Application Number 17037284

SUPPRESSION OF PATHOLOGICAL ANGIOGENESIS BY INHIBITION OF NR2F6

Application Number 17087386

STIMULATION OF T REGULATORY CELLS BY CANNABIDIOL AS A MEANS OF TREATING ARTHRITIS AND AUTOIMMUNITY

Application Number 17010720

SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS

Application Number 15820324

SMALL MOLECULE MODULATORS OF NR2F6 ACTIVITY.

Application Number 15652967

NR2F6 Inhibited Chimeric Antigen Receptor Cells

Application Number 15351414



Need for any government approval of principal products or services, effect of existing or probable governmental regulations on the business.

The US Food and Drug Administration (“FDA”) and foreign regulatory authorities will regulate our proposed products as drugs or biologics, , depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of the product on the human body. In the United States, products that are intended to be introduced into the body will generally be regulated as drugs, while tissues and cells intended for transplant into the human body will be generally be regulated as biologics.

Our domestic human drug and biological products will be subject to rigorous FDA review and approval procedures. After testing in animals, an Investigational New Drug Application (“IND”) must be filed with the FDA to obtain authorization for human testing. Extensive clinical testing, which is generally done in three phases, must then be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans.

Phase I

Phase 1 trials are designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses usually are a fraction of the dose that causes harm in animal testing and involve a small group of healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have end-stage disease and lack other treatment options.

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Phase II

Phase II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II trials are performed on larger groups.

Phase III

Phase III trials are aimed at being the definitive assessment of how effective the product is in comparison with current best standard treatment and to provide an adequate basis for physician labeling. Phase III trials may also be conducted for the purposes of (i) "label expansion" (to show the product works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing or (ii) to obtain additional safety data, or to support marketing claims for the product.

On occasion Phase IV (Post Approval) trials may be required by the FDA. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.

All phases, must be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans. Each clinical study is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. The time and expense required to perform this clinical testing can far exceed the time and expense of the research and development initially required to create the product. No action can be taken to market any therapeutic product in the United States until an appropriate New Drug Application (“NDA”) or Biologic License Application (“BLA”) or has been approved by the FDA. FDA regulations also restrict the export of therapeutic products for clinical use prior to NDA or BLA approval.

Even after initial FDA approval has been obtained, further studies may be required to provide additional data on safety or to gain approval for the use of a product as a treatment for clinical indications other than those initially targeted. In addition, use of these products during testing and after marketing could reveal side effects that could delay, impede, or prevent FDA marketing approval, resulting in FDA-ordered product recall, or in FDA-imposed limitations on permissible

The FDA regulates the manufacturing process of pharmaceutical products, and human tissue and cell products, requiring that they be produced in compliance with Current Good Manufacturing Practices (“cGMP”) . The FDA also regulates the content of advertisements used to market pharmaceutical products. Generally, claims made in advertisements concerning the safety and efficacy of a product, or any advantages of a product over another product, must be supported by clinical data filed as part of an NDA or an amendment to an NDA, and statements regarding the use of a product must be consistent with the FDA approved labeling and dosage information for that product.

Sales of drugs and biologics outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval

Amount spent during the fiscal year ended September 30, 2021 on research and development activities

During the fiscal year ended September 30, 2021 we expended $36,704 on research and development activities.

Costs and effects of compliance with environmental laws (federal, state and local)

Regen has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.