Regen BioPharma Inc - Annual Report: 2021 (Form 10-K)

United States 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, 2021

☐  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 

Issuer’s telephone number: (619) 722 5505 

Securities registered under Section 12(b) of the “Exchange Act”: None

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 ☒  

No

No

Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or smaller reporting company.

☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).

Yes ☐  No ☒  

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post such files).

Yes ☐ No ☒  

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which 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:  $ 7,330,721

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.

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 STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

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,” “projects,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend,” and similar expressions. These statements are based on the Company’s current plans and are subject to risks and uncertainties, and as such the Company’s actual future activities and results of operations may be materially different from those set forth in the forward looking statements. Any or all of the forward-looking statements in this annual report may turn out to be inaccurate and as such, you should not place undue reliance on these forward-looking statements. The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. The forward-looking statements can be affected by inaccurate assumptions or by known or unknown risks, uncertainties and assumptions due to a number of factors, including:

These forward-looking statements speak only as of the date on which they are made, and except to the extent required by federal securities laws, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date on which the statement is made or to reflect the occurrence of unanticipated events. In addition, we cannot assess the impact of each factor on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. All subsequent written and oral forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by the cautionary statements contained in this annual report.

PART I

Item 1. Business

We were incorporated April 24, 2012 under the laws of the State of Nevada. We intend to engage primarily in the development of regenerative medical applications which we intend to license, develop internally or acquire outright from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.

As of July 29, 2021 we have not licensed any existing therapies which may be marketed. On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (“ License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.

Pursuant to the Agreement, Zander shall pay to Regen one-time, non-refundable, upfront payment of one hundred thousand US dollars ($100,000) as a license initiation fee which must be paid within 90 days of June 23, 2015 and an annual non-refundable payment of one hundred thousand US dollars ($100,000) on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.

he abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander or in common stock of Entest BioMedical Inc. valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly within the 14 trading days prior to issuance.

Pursuant to the Agreement, Zander shall pay to Regen royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.

Pursuant to the Agreement, Zander will pay Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees ( excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment pursuant to the terms and conditions of the Agreement).

Zander is obligated pay to Regen minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).

The Agreement may be terminated by Regen:

If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.

The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to Regen with regard to that License IP.

The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to Regen with regard to that License IP is terminated.

The Agreement may be terminated by either party in the event of a material breach by the other party.

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.

On April 7, 2021 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby Regen granted to Licensee an exclusive right and license for the development and commercialization of certain intellectual property ( “License IP”) for the treatment in humans of pancreatic cancer for a term of fifteen years from April 7, 2021.

The License IP consists of antigen specific cancer vaccines in which modified mRNA is administered to produce epitopes able to produce an immune response which augments likelihood of successful induction of immunity. An epitope is the part of an antigen that is recognized by the immune system.

As consideration to Regen for the rights and license granted pursuant to the Agreement Licensee shall:

Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.

In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.

The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement , which is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this Item 1.01 by reference.

On April 7, 2021 KCL Therapeutics, Inc. (“KCL”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby KCL granted to Licensee an exclusive right and 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.

As consideration to KCL for the rights and license granted pursuant to the Agreement Licensee shall:

Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.

In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.

Zander and Regen are under common control. David Koos serves as sole officer and director of both Regen BioPharma, Inc. and Zander Therapeutics Inc.

Both Zander and Oncology Pharma, Inc. will be required to obtain approval from the United States Food and Drug Administration (“FDA”) in order to market any Licensed Product which may be developed within the United States and no assurance may be given that such approval would be granted.

Distribution methods of the products or services:

It is anticipated that Regen and /or KCL will enter into licensing and/or sublicensing agreements with outside entities in order that Regen and/or KCL may obtain royalty income on the products and services which it may develop and commercialize.

Competitive business conditions and Regen's competitive position in the industry and methods of competition

We are recently formed and have yet to achieve revenues or profits. The pharmaceutical and biologics industries in which we intend to compete are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do.

Sources and availability of raw materials and the names of principal suppliers

The supplies and materials required to conduct our operations are available through a wide variety of sources and may be obtained through a wide variety of sources.

Patents, trademarks, licenses, franchises, concessions, royalty agreements or labor contracts, including duration

Patents:

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

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

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.

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.

Number of total employees and number of full-time employees

As of July 29, 2021 Regen has 1 employee of which one is full time.

Item 2. Properties

On October 1, 2014 the Company entered into an agreement to sublease approximately 2,320 square feet of office space from Entest Biomedical, Inc. Entest Biomedical Inc. is under common control with the Company as the Chairman and CEO of the Company also serves as the Chairman and CEO of Entest Biomedical, Inc. the sublease was on a month to month basis and rent payable to Entest Biomedical Inc by the Company was equal to the rent payable to the lessor by Entest Biomedical Inc and is to be paid in at such time specified in accordance with the original lease agreement between Entest Biomedical Inc and the lessor. On January 20, 2015 the sublease was amended retroactive to January 1, 2015 as follows:

The rent payable to Entest BioMedical, Inc. by the subtenant is equal to Five Thousand Dollars per month ($5,000) and is to be paid in at such time specified in accordance with the original lease agreement between the Entest BioMedical, Inc. (“Entest”) and the lessor. All charges for utilities connected with premises which are to be paid under the master lease shall be paid by Regen Biopharma, Inc. for the term of this sublease to the extent that such charges exceed the difference between the rent payable to the lessor by Entest under the master lease and the rent payable to Entest by Regen Biopharma, Inc.

On November 16, 2018 Regen Biopharma Inc. and Entest Biomedical, Inc. agreed to terminate Regen’s sublease of office space with Entest Biomedical, Inc. effective the rental period commencing November, 2018.

On November 16, 2018 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning November 1, 2018.

BST is controlled by David Koos, Regen Biopharma, Inc.’s Chairman and Chief Executive Officer.

On January 20, 2020 the “Company and BST agreed that the month to month sublease by and between the Company and BST whereby the Company subleased office space from BST at 4700 Spring Street, St 304, La Mesa, California 91942 shall terminate as of 1pm Pacific Standard Time on January 22, 2020.

The Company currently continues to occupy 2,320 square feet of office space at 4700 Spring Street, Suite 304, La Mesa, California 91942 leased to BST free of charge although the Company may make rental payments on BST’s behalf. During the year ended September 30, 2021 the Company paid $25,000 of rental expenses to the landlord of BST Partners as consideration to BST Partners for use of office space.

The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.

Item 3. Legal Proceedings

On December 13, 2019 a complaint was filed in the Superior Court of California, County of San Diego  against  Regen Biopharma, Inc. (“Company”) ,  the Company’s Chairman, Zander Therapeutics Inc (“Zander”), and Does 1-50 by ChemDiv, Inc. (“Plaintiff”) alleging  Breach of Contract, Unfair Business Practices under the California Business and Professions Code, and  Bad Faith Denial of a Contract ( alleged solely against the Company  and DOE defendants) stemming from contract research work performed by the Plaintiff for the Company and contract research performed by the Plaintiff for Zander. The Plaintiff is also seeking a declaration from the court that the Plaintiff retains full and complete ownership, title, use, and all rights without any limits to the work, tangible property, intellectual property, and any other product or by-product of the work performed by Plaintiff for the Company and Zander. The action arises from approximately $1.2 million dollars of unpaid invoices (“Unpaid Invoices”) due and payable to the Plaintiff. The Company asserts that no portion of the Unpaid Invoices is due and payable by the Company.

On September 15, 2021 a Settlement and Release Agreement (the "Agreement") was entered into by and between CHEMDIV, INC. ("Chemdiv"), REGEN BIOPHARMA, INC. ("Regen"), ZANDER THERAPEUTICS, INC., and DAVID KOOS ("Koos").

Pursuant to the Agreement:

(a) Regen shall make payment to Chemdiv in the lump sum, gross amount of $800,000 no later than September 30,2021.

(b) Upon payment of $800,000 by Regen to Chemdiv, Chemdiv shall provide Regen with all results, compounds identified, and data generated by Chemdiv relative to its NR2F6 research conducted on behalf of or at the direction of Regen and/or Zander, together with specification of the means of conducting such research, including but not limited to protocols used in conducting such research.

(c) Upon Chemdiv’s receipt of the Eight Hundred Thousand Dollar payment from Regen by no later than September 30, 2021 Chemdiv shall cause the litigation to be dismissed with prejudice by filing the necessary requests for dismissal and taking all other steps reasonably necessary to accomplish such dismissal within ten business days of the receipt of the $800,000.

(d) In the event that payment is not made by September 30, 2021, then the Agreement is void and shall have no effect.

On September 21, 2021 the Company paid $800,000 to ChemDiv, Inc. pursuant to that Settlement and Release Agreement (“Settlement And Release Agreement”) entered into by and between CHEMDIV, INC. ("ChemDiv"), REGEN BIOPHARMA, INC. ("Regen"), ZANDER THERAPEUTICS, INC., and DAVID KOOS ("Koos") on September 15, 2021.

The Company and Zander are under common control. David Koos serves as Chief Executive Officer and Chairman of the Board of Zander and the Company.

Item 4. Submission of Matters to a Vote of Security Holders

No matter was submitted during the fourth quarter of the fiscal year covered by this report to a vote of security holders, through the solicitation of proxies or otherwise.

PART II

Item 5. Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities

The Company’s common stock is a "penny stock," as defined in Rule 3a51-1 under the Exchange Act. The penny stock rules require a broker-dealer, prior to a transaction in a penny stock not otherwise exempt from the rules, to deliver a standardized risk disclosure document that provides information about penny stocks and the nature and level of risks in the penny stock market. The broker-dealer also must provide the customer with current bid and offer quotations for the penny stock, the compensation of the broker-dealer and its sales person in the transaction, and monthly account statements showing the market value of each penny stock held in the customer's account. In addition, the penny stock rules require that the broker-dealer, not otherwise exempt from such rules, must make a special written determination that the penny stock is suitable for the purchaser and receive the purchaser's written agreement to the transaction. These disclosure rules have the effect of reducing the level of trading activity in the secondary market for a stock that becomes subject to the penny stock rules. So long as the common stock of the Company is subject to the penny stock rules, it may be more difficult to sell common stock of the Company.

The stockholders’ equity section of the Company contains the following classes of capital stock :

As of December 6, 2021 Common stock, $ 0.0001 par value; 4, 800,000,000 shares authorized: 4,564,002,832  shares issued and outstanding.

With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).

On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.

Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 50,000 shares issued and outstanding as of December 6,2021, 300,000,000 is designated Series A Preferred Stock of which 437,868,406 shares are outstanding as of December 6,2021 , 300,000,000 is designated Series M Preferred Stock of which 44,000,000 shares are outstanding as of December 6,2021 and 20,000 is designated  Series NC Preferred Stock of which 10,000 shares are outstanding as of December 6,2021

The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.

Series AA Preferred Stock

On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”).

The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times ten thousand (10,000). Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.

Series A Preferred Stock

On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).

The Board of Directors of the Company have authorized 300,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one . Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.

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. 

On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION ("Certificate of Designations") with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as "Series M Preferred Stock" (hereinafter referred to as "Series M Preferred Stock").

The Board of Directors of Regen have authorized 300,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single class on all matters submitted to the stockholders.

The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore

On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.

On March 26, 2021 Regen Biopharma, Inc. ( “Regen”) filed a CERTIFICATE OF DESIGNATION ("Certificate of Designations") with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as "Series NC Preferred Stock").

The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times 500,000. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.

The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore.

On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen. 

Our common stock is traded on the OTC Bulletin Board under the symbol "RGBP”. Below is the range of high and low bid information for our common equity for each quarter within the last two fiscal years. These quotations reflect inter-dealer prices, without retail mark-up, mark-down or commission and may not represent actual transactions.

As of December 6, 2021 there were approximately 454 holders of our Common Stock.

As of December 6, 2021 there were approximately 205 holders of our Series A Preferred Stock.

As of December 6, 2021 there was 1 holder of our Series AA Preferred Stock.

As of December 6, 2021 there were approximately 7 holders of our Series M Preferred Stock

As of December 6, 2021 there was one holder of our Series NC Preferred Stock.

Dividends

No cash dividends were paid during the fiscal year ending September 30, 2021. We do not expect to declare cash dividends in the immediate future. 

Recent Sales of Unregistered Securities

Issuance of Common Shares:

On October 28, 2020 the Company issued 80,065,846 common shares in satisfaction of $3,752 of convertible indebtedness and $1,452 of accrued interest on convertible indebtedness.

On November 6, 2020 the Company issued 83,934,153 common shares in satisfaction of $3,900 of convertible indebtedness and $1,555 of accrued interest on convertible indebtedness.

On December 11, 2020 the Company issued 87,020,000 common shares in satisfaction of $7,300 of convertible indebtedness and $3,142 of accrued interest on convertible indebtedness.

On December 16, 2020 the Company issued 6,437,153 common shares in satisfaction of $429 of convertible indebtedness and $236 of accrued interest on convertible indebtedness.

On December 16, 2020 the Company issued 88,158,923 common shares in satisfaction of $4,030 of convertible indebtedness and $1,700 of accrued interest on convertible indebtedness.

On December 17, 2020 the Company issued 83,216,917 common shares in satisfaction of $8,200 of convertible indebtedness and $1,786 of accrued interest on convertible indebtedness.

On December 23, 2020 the Company issued 108,444,444 common shares in satisfaction of $16,000 of convertible indebtedness and $3,250 of accrued interest on convertible indebtedness.

On December 31, 2020 the Company issued 117,837,384 common shares in satisfaction of $5,330 of convertible indebtedness and $2,329 of accrued interest on convertible indebtedness.

On January 28, 2021 the Company issued 85,900,000 common shares in satisfaction of $5,154 of convertible indebtedness.

On February 23, 2021 the Company issued 88,000,000 common shares in satisfaction of $4,400 of accrued interest on convertible indebtedness.

On February 24, 2021 the Company issued 82,759,286 common shares in satisfaction of $30,000 of convertible indebtedness and $4,758 of accrued interest on convertible indebtedness.

On March 2, 2021 the Company issued 119,269,538 common shares in satisfaction of $5,260 of convertible indebtedness and $2,492 of accrued interest on convertible indebtedness.

On March 18, 2021 the Company issued 70,000,000 common shares in satisfaction of $3,415 of convertible indebtedness and $84 of accrued interest on convertible indebtedness.

On March 31, 2021 the Company issued 40,000,000 common shares in satisfaction of $1926 of convertible indebtedness and $74 of accrued interest on convertible indebtedness.

Issuance of Common Shares

On April 12, 2021 the Company issued 85,000,000 common shares in satisfaction of $3111 of convertible indebtedness and $49 of accrued interest on convertible indebtedness.

On April 13, 2021 the Company issued 83,636,833 common shares in satisfaction of $3,510 of convertible indebtedness and $1508 of accrued interest on convertible indebtedness.

On April 13, 2021 the Company issued 10,000 Series NC Preferred shares to its Chief Executive Officer as consideration for services.

On April 13, 2021 the Company issued 32,968,042 common shares in satisfaction of $19,000 of convertible indebtedness and $4736 of accrued interest on convertible indebtedness.

On April 15, 2021 the Company issued 146,452,000 common shares in satisfaction of $6,340 of convertible indebtedness and $3,179 of accrued interest on convertible indebtedness.

On April 15, 2021 the Company issued 49482000 common shares in satisfaction of $2288 of convertible indebtedness and $680 of accrued interest on convertible indebtedness.

On April 16, 2021 the Company issued 70,755,885 common shares in satisfaction of $47,000 of convertible indebtedness and $8,189 of accrued interest on convertible indebtedness.

On April 16, 2021 the Company issued 90,311,411 common shares in satisfaction of $4,238 of convertible indebtedness and $17 of accrued interest on convertible indebtedness.

On April 21, 2021 the Company issued 163,814,000 common shares in satisfaction of $7655 of convertible indebtedness and $2,264 of accrued interest on convertible indebtedness.

On April 28, 2021 the Company issued 28,784,167 common shares in satisfaction of $22,000 of convertible indebtedness and $3,905 of accrued interest on convertible indebtedness.

On May 3, 2021 the Company issued 33,012,555 common shares in satisfaction of $1,416 of convertible indebtedness and $729 of accrued interest on convertible indebtedness.

On May 5, 2021 the Company issued 27,753,016 common shares in satisfaction of $1,187 of convertible indebtedness and $616 of accrued interest on convertible indebtedness.

On May 18, 2021 the Company issued 33,772, 000 common shares in satisfaction of $2,026 of convertible indebtedness.

On July 16, 2021 the Company issued 198,439,000 common shares in satisfaction of $500 of convertible indebtedness and $19,344 of accrued interest on convertible indebtedness .

On July 22, 2021 the Company issued 200,000,000 common shares in satisfaction of $10,000 of convertible indebtedness and $10,000 of accrued interest on convertible indebtedness .

On August 2, 2021 the Company issued 100,000,000 common shares in satisfaction of $10,000 of convertible indebtedness .

On September 10 , 2021 the Company issued 1,919,726 common shares in satisfaction of $35,000 of convertible indebtedness and $12,993 of accrued interest on convertible indebtedness .

On September 30, 2021 the Company issued 70,000,000 common shares in satisfaction of $4,200 of convertible indebtedness.

On October 1, 2021 the Company issued 101,718,058 common shares in satisfaction of $425,000 of convertible indebtedness and $154,991 of accrued interest on convertible indebtedness.

On October 29, 2021 the Company issued 25748147common shares in satisfaction of $140,000 of convertible indebtedness and $54,000 of accrued interest on convertible indebtedness.

On November 4 , 2021 the Company issued 8626613 common shares in satisfaction of $50,000 of convertible indebtedness and $69,012 of accrued interest on convertible indebtedness.

On November 24 , 2021 the Company issued 77355500 common shares in satisfaction of $92,247 of convertible indebtedness and $36,967 of accrued interest on convertible indebtedness.

Issuance of Series A Preferred Shares

On December 17, 2020 the Company issued 32,379,169 shares of Series A Preferred stock in satisfaction of $13,000 of convertible indebtedness and $8,046 of accrued interest on convertible indebtedness.

On September 30, 2021 the Company issued 17,850,919 shares of Series A Preferred stock in satisfaction of $140,000 of convertible indebtedness and $68,535 of accrued interest on convertible indebtedness.

On October 1, 2021 the Company issued 5,869,589 shares of Series A Preferred stock in satisfaction of $50,000 of convertible indebtedness and $23,369 of accrued interest on convertible indebtedness.

On December 10 2021 the Company issued 1,425,000 shares of Series A Preferred stock in satisfaction of $25,000 of convertible indebtedness and $10,625 of accrued interest on convertible indebtedness.

All the abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.

With the exception of securities eligible for public resale pursuant to Rule 144 promulgated under the Securities Act of 1933, as amended ( the “Act”) or 4(a)(1) of the Act , a legend was placed on the certificate that evidences the securities stating that the securities have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the securities.

Item 6. Selected Financial Data

As we are a “smaller reporting company” as defined by Rule 229.10(f)(1), we are not required to provide the information required by this Item.

Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations

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:

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.

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.

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:

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.

As of September 30, 2021 the Company was not party to any binding agreements which would commit Regen to any material capital expenditures.

 Item 7A. Quantitative and Qualitative Disclosures About Market Risk

As we are a smaller reporting company, as defined by Rule 229.10(f)(1), we are not required to provide the information required by this Item.

Item 8. Financial Statements

Report of Independent Registered Public Accounting Firm

To the shareholders and the board of directors of Regen Biopharma, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheets of Regen Biopharma, Inc. as of September 30, 2021 and 2020, the related statements of operations, stockholders' equity (deficit), and cash flows for the years then ended, and the related notes (collectively referred to as the "financial statements"). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of September 30, 2021 and 2020, and the results of its operations and its cash flows for the years then ended, in conformity with accounting principles generally accepted in the United States.

Substantial Doubt about the Company’s Ability to Continue as a Going Concern

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has suffered recurring losses from operations and has a significant accumulated deficit. In addition, the Company continues to experience negative cash flows from operations. These factors raise substantial doubt about the Company's ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.

/S/ BF Borgers CPA PC

BF Borgers CPA PC

We have served as the Company's auditor since 2021

Lakewood, CO

December 22, 2021

REGEN BIOPHARMA , INC.

Condensed Consolidated Statement of Shareholder's Deficit

Years  Ended September 30, 2020 and 2021