Regen BioPharma Inc - Annual Report: 2018 (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, 2018

☐  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

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  ☐

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:  $ 4,099,947

As of December18, 2018 Regen Biopharma, Inc. had 235,860,063 common shares outstanding.

As of December 18, 2018 Regen Biopharma, Inc. had 140,434,496 shares of Series A Preferred Stock outstanding.

As of December 18 2018 Regen Biopharma, Inc. had 50,000 shares of Series AA Preferred Stock outstanding.

As of December 18, 2018 Regen Biopharma, Inc. had 38,000,000 shares of Series M 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 December 18, 2018 , 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 a subsidiary of Entest Biomedical, Inc.

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 on July 15th, 2016 and each subsequent anniversary of the effective date of the Agreement.

The 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 Propertis”) 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.

Zander and Regen are under common control. David Koos serves as Chairman & CEO of both Regen BioPharma, Inc. and Zander Therapeutics Inc. Harry Lander serves as President and Chief Scientific Officer of both Regen BioPharma, Inc. and Zander Therapeutics, Inc. Todd S. Caven serves as CFO of both Regen BioPharma, Inc. and Zander Therapeutics Inc. Koos, Lander and Caven also serve as Directors of Zander Therapeutics, Inc. Zander Therapeutics, Inc. is the sole licensee of Regen's NR2F6 intellectual property for veterinary applications.

Zander 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.

Regen has been assigned intellectual property with regard to the gene NR2F6 . It is believed by the Company that NR2F6 activation leads to the shutting down of the immune system’s natural ability to generate cytokines that lead to inflammation. The Company believes that identification of a small molecule which could inhibit this receptor would potentially provide an avenue for immunotherapy of cancer and that identification of a small molecule which could activate this receptor could potentially provide a therapy for autoimmune disease.

The Company is actively identifying small molecules via a high throughput screening program that inhibit NR2F6 leading to immune cell activation for oncology applications. On December 15, 2015 Regen entered into an agreement (“Agreement”) with the National Center for Advancing Translational Sciences (“NCATS”), which is a component of the National Institutes of Health (“NIH”), an agency of the U.S. Department of Health and Human Services whereby Regen and NCATS shall collaborate to screen for small molecule compounds that activate or inhibit the orphan nuclear receptor, NR2F6.

Initial high throughput screening assays were performed in July to September of 2016 by the contract research organization Proteros, GMBH for Regen Biopharma, Inc. This assay is based on Regen Biopharma Inc.’s screening assay whereby the full-length or ligand-binding domain of NR2F6 Reporter gene assays are used to screen for compounds that modulate gene expression via binding to nuclear hormone receptors. Transfer of this assay to ChemDiv, Inc., another contract research organization, by Regen Biopharma, Inc. was effected in January, 2017.

In molecular biology, a reporter gene is a gene that researchers attach to a regulatory sequence of another gene of interest in bacteria, cell culture, animals or plants. Certain genes are chosen as reporters because the characteristics they confer on organisms expressing them are easily identified and measured, or because they are selectable markers. Reporter genes are often used as an indication of whether a certain gene has been taken up by or expressed in the cell or organism population.

High Throughput Screens (HTS) are recent scientific methods in which hundreds of thousands of experimental samples are subjected to simultaneous testing under given conditions. Through this process one can rapidly identify active compounds, antibodies, or genes that modulate a particular biomolecular pathway. The results of these experiments provide starting points for drug design and for understanding the interaction or role of a particular biochemical process in biology.

HTS performed on behalf of Regen Biopharma, Inc. have been ongoing as of September 9, 2016. Through HTS four newly discovered small molecule compounds which (a) can bind to the relevant structure in a cellular system and (b) show evidence of the ability to modulate activity of NR2F6 have been discovered. In addition, research conducted by ChemDiv on Regen’s behalf has identified a compound that activate NR2F6 which may be effective in treating autoimmune diseases with virtually no toxicity.

Regen will be required to obtain approval from the FDA in order to market any of Regen’s products or therapies. No approval has been granted by the FDA for the marketing and sale of any of the Company’s products and therapies and no assurance may be given that any of the Company’s products or therapies will be granted such approval. The Company’s current plans include the development of regenerative medical applications 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. We can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.

Distribution methods of the products or services:

It is anticipated that Regen will enter into licensing and/or sublicensing agreements with outside entities in order that Regen 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.

We intend to be competitive by utilizing the services and advice of individuals that we believe have expertise in their field in order that we can concentrate our resources on projects in which products and services in which we have the greatest potential to secure a competitive advantage may be developed and commercialized .

To that effect, we have established a Scientific Advisory Board of (the Advisory Board) comprised of individuals who we believe have a high level of expertise in their professional fields and who have agreed to provide counsel and assistance to us in (a) determining the viability of proposed projects (b) obtaining financing for projects and (c) obtaining the resources required to initiate and complete a project in the most cost effective and rapid manner.

Members of the Advisory Board include as follows:

Dr. Weiping Min, M.D., PhD

Dr. Min is currently a Professor, Department of Surgery at the University of Western Ontario. Dr. Min obtained his MD from Jiangxi Medical University, China, in 1983 and his Ph.D.in Immunology from Kyushu University, Japan. Dr. Min has completed postdoctoral training at the Department of Medical Microbiology and Immunology, University of Alberta and the Department of Immunology, University of Toronto.

Dr. Min has served on the Advisory Board since May 20, 2012. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, Bio Matrix Scientific Group, Inc. (“BMSN”) has agreed to issue to Dr. Min 200,000 of the common shares of BMSN.

David James Graham White, M.D., Ph.D.

Dr. White currently serves as Novartis/Stiller Professor of Xenotransplantation at the University of Western Ontario ( to which he was appointed in 2000) and is a member of British Transplantation Society, the British Society of Immunologists, the Transplantation Society, the European Society of Organ Transplantation, the Royal College of Pathologists and the Athenaeum. Dr. White obtained a B.Sc. degree from the University of Surrey and M.D. and Ph.D. degrees from Cambridge University.

Dr. White has served on the Advisory Board since May 20, 2012. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, BMSN has agreed to issue to Dr. White 200,000 of the common shares of BMSN.

David A. Suhy, PhD

Dr. Suhy currently serves as Vice President of Research and Development at Tacere Therapeutics, a position he has held since October 2012. From April 2008 to October 2012 Dr. Suhy served as Director of Research and Development at Tacere Therapeutics. Dr. Suhy was one of the inventors of Tacere Therapeutics’ TT-033 and has directed development of the TT-03x series of compounds which target the Hepatitis C virus (HCV) through to Investigational New Drug enabling studies.

 Dr. Suhy obtained a Bachelor’s Degree in biochemistry from the University of Pittsburgh in 1990 and a PhD in Biochemistry, Molecular Biology and Cell Biology from Northwestern University in 1996. Dr. Suhy conducted his post-doctoral work at Stanford University (Post Doctoral Fellow, Microbiology & Immunology) between 1996 and 1999.

Dr. Suhy has served on the Advisory Board since September 11, 2013. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, BMSN has agreed to issue to Dr. White 500,000 of the common shares of BMSN.

Dr. Amit Patel, MD MS

Dr. Patel currently serves as an associate professor in the Division of Cardiothoracic Surgery at the University of Utah School of Medicine and Director of Clinical Regenerative Medicine and Tissue Engineering at the University of Utah and and been involved in over 17 FDA trials in the area of cellular therapy.

Dr. Patel has served on the Advisory Board since October 12, 2014. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Patel 136,000 common shares of Regen.

Dr. Hinrich Gronemeyer

Dr. Hinrich Gronemeyer is a research director at the Institute of Genetics, Cellular & Molecular Biology (IGBMC) in Strasbourg-Illkirch. Dr. Gronemeyer is a Research Director (Class 'Exceptional') of the French National Institute of Health and Medical Research (INSERM) and was Privatdozent at the University Karlsruhe. Hinrich Gronemeyer had extensive collaborations with the pharmaceutical industry (Bristol Myers Squibb, Roussel-Uclaf, Schering AG, etc.) and has been involved in evaluations and brainstormings of several major companies. His 189 publications received an average citation of 83.34 and an h-factor of 59.

Lorraine J. Gudas, PhD

Dr. Gudas is Chairman and Revlon Pharmaceutical Professor of Pharmacology and Toxicology of the Department of Pharmacology at Weill Cornell Medical College and is recognized as one of the world experts on nuclear receptors.

Dr. Gudas is a member of the American Society for Pharmacology and Experimental Therapeutics and a Fellow of the American Association for the Advancement of Science. She has served a term as an elected member of the Board of Directors of the American Association of Cancer Research and as chair of the Board of Scientific Counselors of the National Institute of Diabetes and Digestive and Kidney Disorders as well as the Board of Scientific Counselors of the National Heart, Lung and Blood Institute. She has served as a member of the external advisory boards of three Cancer Centers: The Vermont Cancer Center, The Lineberger Cancer Center of U.N.C. Chapel Hill, and the University of Maryland Greenebaum Cancer Center. In 1999 she received the 2nd Annual "Women in Cancer Research" award from the American Association of Cancer Research. She is on the Editorial Boards of a number of journals, including Molecular Cancer Therapeutics, Molecular and Cellular Biology, Molecular Cancer Research and the Journal of Biological Chemistry. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Gudas 100,000 shares of Regen’s Series A Preferred Stock.

Rohit Duggal, PhD,

Dr. Dugal has 17 years of professional experience in the drug discovery field having worked at Pfizer as a leader of the cancer stem cell group. Dr. Duggal has experience in translating small molecules into clinical candidates, including development of Filibuvir, for which he was granted thePfizer Achievement Award. At Genelux Corp he established cancer stem cell program which aimed at utilization of viruses to selectively target cancer initiating cells. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Dugal 100,000 shares of Regen’s Series A Preferred Stock.

Dr. Jonathan Baell, PhD

Dr. Baell is a professor or Medicinal Chemist at Monash University (Australia). Dr. Baell is a Larkins Fellow, Co-Director of the Australian Translational Medicinal Chemistry Facility and an NHMRC Senior Research Fellow, at Monash Institute of Pharmaceutical Sciences (MIPS). 

Dr. Baell has served on the Advisory Board since August 5, 2015. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Baell 100,000 shares of Regen’s Series A Preferred Stock.

William S. Blaner, PhD

Dr. Blaner is Professor of Nutritional Sciences at Columbia University where he studies the metabolism and actions of retinoids. 

Dr. Santosh Kesari, MD PhD

Dr. Kesari is Director of the Neuro-Oncology Program, the Neurotoxicity Treatment Center, and the Translational Neuro-Oncology Laboratories at Moores Cancer Center and serves as Professor of Neurosciences at the UCSD School of Medicine.As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued 100,000 shares of the Company’s Series A Preferred Stock to Dr. Kesari.

Louise Purton, PhD:

Dr. Purdon is Associate Professor at the St. Vincent's Institute of Medical Research at the University of Melbourne, Co-Head of the Stem Cell Regulation Unit and Associate Director at the Institute.

Ralph Nachman, M.D.

Dr. Nachman, a hematologist, is a member of the Institute of Medicine and is a University Professor and former Chairman of Medicine at NY Presbyterian/Weill Cornell Medical Center. 

Dr. Nachman has served on the Advisory Board since November 13, 2015. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Nachman 100,000 shares of Regen’s Series A Preferred Stock.

Helen Sabzevari, Ph.D.

Dr. Sabzevari previously served as senior vice president and head of immuno-oncology, global research and early development at EMD Serono,Inc. Dr, Sabzevari is the co-founder of Compass Therapeutics, which is an antibody discovery and development company.

Stefano Bertuzzi, PhD, MPH 

Dr. Bertuzzi, is currently the Executive Director of the American Society for Cell Biology and has been named Executive Director and CEO of the American Society for Microbiology, effective January 4, 2016. Before leading the American Society for Cell Biology, Dr. Bertuzzi was a senior scientific executive at the National Institutes of Health where he served as Director of the Office of Science Policy, Planning, and Communications, and as a science policy advisor to the NIH Director.

Dr.Bertuzzi has served on the Advisory Board since October 14, 2015. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Bertuzzi 100,000 shares of Regen’s Series A Preferred Stock.

We have also established a Business Advisory Board. Members of the Business Advisory Board (“BAB”) include:

Jean Pierre Millon

On October 16, 2017 Mr. Millon agreed to serve as Chairman of the BAB pursuant to an agreement by and between Millon and the Company (“Millon BAB Agreement”).

Mr. Millon currently serves on the Board of Directors of CVS Health. Mr. Millon previously served as President and Chief Executive Officer of PCS Health Systems , Inc. from June 1996 until his retirement in September 2000. Mr. Millon also previously served in an executive capacity at Eli Lilly and Company.

The term of the Millon BAB Agreement shall be from October 9, 2017 to October 9, 2020.

The Millon BAB Agreement requires Millon to

Identify and introduce to the Company persons not previously known to the Company to serve as members of the Company’s Business Advisory Board (“Advisory Candidates”).

Identify and introduce to the Company potential purchasers of the Company’s securities, such purchasers not previously known to the Company (“Buyers”)

As consideration for agreeing to serve, Millon is to receive a total of 6,000,000 of the Company’s Series M Preferred shares (“Millon BAB Shares”).

4,000,000 of the BAB Shares were issued to Millon on November 1, 2017. An additional 1,000,000 of the BAB Shares are to be issued on the second anniversary of the Millon BAB Agreement and an additional 1,000,000 of the Millon BAB Shares are to be issued on the third anniversary of the Millon BAB Agreement.

Millon may convert his Millon BAB Shares into an equivalent number of the common shares of the Company upon the sooner of:

a) the execution of a licensing agreement for the Company’s NR2F6 intellectual property, or,

b) upon the third anniversary of the Millon BAB Agreement..

In the event that a candidate identified and introduced by Millon to the Company serves as a member of the BAB, Millon shall receive, ten business days subsequent to the completion of 12 months service by the candidate as a member of the BAB a referral fee equal to 5% (paid to Millon in Series M Preferred shares of the Company) of the shares of the Series M Preferred shares of the Company issued to the referred candidate.

In the event of a purchase of securities by one or more Buyers, such Buyers not previously known to the Company and identified and introduced by Millon to the Company, Millon shall receive a referral fee equal to 5% (paid to Millon in Series M Preferred shares of the Company) of the shares of common stock of the Company purchased by the Buyer.

Robert D. Hopkins

On October 2, 2017Robert D Hopkins agreed to serve as a member of the Company’s BAB pursuant to an agreement by and between the Company and Hopkins (“Hopkins BAB Agreement”).

The term of the Hopkins BAB Agreement shall be from October 2, 2017 to October 2, 2020.

The Hopkins BAB Agreement requires Hopkins to

Identify and introduce to the Company persons not previously known to the Company to serve as members of the Company’s Business Advisory Board (“Advisory Candidates”).

Identify and introduce to the Company potential purchasers of the Company’s securities, such purchasers not previously known to the Company (“Buyers”)

As consideration for agreeing to serve, Hopkins received 1,000,000 of the Company’s Series M Preferred shares. An additional 1,000,000 Series M Preferred Shares are to be issued on the first, second and third anniversary of the Fortisano BAB Agreement

Hopkins may convert these shares into an equivalent number of the Company’s common shares upon the sooner of

a) the execution of a licensing agreement for the Company’s NR2F6 intellectual property, or,

b) upon the third anniversary of the Hopkins BAB Agreement..

In the event that a candidate identified and introduced by Hopkins to the Company serves as a member of the BAB, Hopkins shall receive, ten business days subsequent to the completion of 12 months service by the candidate as a member of the BAB a referral fee equal to 5% (paid to Hopkins in Series A Preferred shares of the Company) of the shares of the common shares of the Company issued to the referred candidate.

In the event of a purchase of securities by one or more Buyers, such Buyers not previously known to the Company and identified and introduced by Hopkins to the Company, Hopkins shall receive a referral fee equal to 5% (paid to Hopkins in Series A Preferred shares of the Company) of the shares of common stock of the Company purchased by the Buyer.

Roger Fortisano

On October 2, 2017 Mr. Roger Fortisano agreed serve as a member of the Company’s BAB pursuant to an agreement by and between the Company and Fortisano (“Fortisano BAB Agreement”).

Mr. Fortisano currently serves as Vice-President for Leadership and Strategic Development at UW Health, the academic medical center and health system for the University of Wisconsin.

The term of the Fortisano BAB Agreement shall be from October 2, 2017 to October 2, 2020.

The Fortisano BAB Agreement requires Fortisano to

Identify and introduce to the Company persons not previously known to the Company to serve as members of the Company’s Business Advisory Board (“Advisory Candidates”).

Identify and introduce to the Company potential purchasers of the Company’s securities, such purchasers not previously known to the Company (“Buyers”)

As consideration for agreeing to serve, Fortisano is to receive a total of 4,000,000 of the Company’s Series M Preferred shares (“Fortisano BAB Shares”).

1,000,000 of the Fortisano BAB Shares were issued to Fortisano on October 11, 2017. An additional 1,000,000 of the BAB Shares are to be issued on the first, second and third anniversary of the Fortisano BAB Agreement.

Fortisano may convert his Fortisano BAB Shares into an equivalent number of the common shares of the Company upon the sooner of:

In the event that a candidate identified and introduced by Fortisano to the Company serves as a member of the BAB, Fortisano shall receive, ten business days subsequent to the completion of 12 months service by the candidate as a member of the BAB a referral fee equal to 5% (paid to Fortisano in Series A Preferred shares of the Company) of the shares of the common shares of the Company issued to the referred candidate.

In the event of a purchase of securities by one or more Buyers, such Buyers not previously known to the Company and identified and introduced by Fortisano to the Company, Fortisano shall receive a referral fee equal to 5% (paid to Fortisano in Series A Preferred shares of the Company) of the shares of common stock of the Company purchased by the Buyer.

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 Company has been assigned the following patents.

US Patent #8389708

METHOD OF CANCER TREATMENT USING SIRNA SILENCING

The present invention is a method for the treatment of cancer involving tumor derived immunosuppression in a subject. The method 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.

US Patent #9091696

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.

US Patent #8263571

Gene silencing of the brother of the regulator of imprinted sites (BORIS)

US Patent #10,088,485

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

This invention discloses 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.

Royalty Agreements

On November 20, 2014 the Company and Dr. Christine Ichim entered into a Consulting Agreement (“Christine Ichim Consulting Agreement”). Pursuant to the Christine Ichim Consulting Agreement, Dr. Ichim shall invent for the Company the following:

and shall assign to the Company 100% of her right, title, and interest in the above named inventions and any and patent applications filed for the above named inventions (as well as such rights in any divisions, continuations in whole or part or substitute applications).

Consideration to be paid by the company to Dr. Ichim pursuant to the Christine Ichim Consulting Agreement shall consist of the following:

Other than obligations to make royalty payments pursuant to the Christine Ichim Consulting Agreement the Company is party to no agreements which would require the Company to pay a royalty or license fee.

Other than pursuant to that agreement by and between the Company and Zander Therapeutics, Inc. the Company is party to no binding agreement which would require payments of any royalties or license fees to the Company.

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 last fiscal year on research and development activities

During the fiscal year ended September 30, 2018 we expended $374,436 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 December 18, 2018 Regen has 4 employees 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.

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

There are no material pending legal proceedings to which the Company is a party or of which any of the Company’s property is the subject. 

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 18, 2018:

Common stock, $ 0.0001 par value; 800,000,000 shares authorized: 235,860,063 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 18, 2018, 300,000,000 is designated Series A Preferred Stock of which 140,434,496 shares are outstanding as of December 18, 2018 and 300,000,000 is designated Series M Preferred Stock of which 38,000,000 shares are outstanding as of December 18, 2018. 

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.

Our common stock is traded on the OTC Bulletin Board as well as the OTCQB Tier of OTC Markets 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.

Holders

As of December 18, 2018 there were approximately 467 holders of our Common Stock.

As of December 18, 2018 there were approximately 217 holders of our Series A Preferred Stock.

As of December 18, 2018 there were 2 holders of our Series AA Preferred Stock.

As of December 18, 2018 there were approximately 7 holders of our Series M Preferred Stock

Dividends

No cash dividends were paid during the fiscal year ending September 30, 2017. We do not expect to declare cash dividends in the immediate future. 

Recent Sales of Unregistered Securities

Issuance of Common Shares

On October 9, 2017 the Company issued 2,500,000 of its Common Shares (“Shares”) as consideration for services rendered.

On December 6, 2017 the Company issued 3,976,852 of its Common Shares in conversion of $78,000 of convertible notes payable and payment of $7,900 of interest .

On January 10, 2018 the Company issued 332,955 Common Shares (“Shares”) in satisfaction of $10,000 of convertible indebtedness and $409 of accrued interest due on convertible indebtedness.

On February 5, 2018 the Company issued 2,500,000 of its Common Shares (“Shares”) for cash consideration of $25,000.

On February 6, 2018 the Company issued 522,255 Common Shares (“Shares”) in satisfaction of $13,000 of convertible indebtedness and $612 of accrued interest due on convertible indebtedness.

On March 6, 2018 the Company issued 796,254 Common Shares (“Shares”) in satisfaction of $18,000 of convertible indebtedness and $942 of accrued interest due on convertible indebtedness.

On March 15, 2015 the Company issued 250,000 Common Shares as consideration for non employee services rendered.

On March 27, 2018 the Company issued 744,948 Common Shares (“Shares”) in satisfaction of $12,000 of convertible indebtedness and $687 of accrued interest due on convertible indebtedness.

On April 20, 2018 the Company issued 785,237 Common Shares (“Shares”) in satisfaction of $12,000 of convertible indebtedness and $760 of accrued interest due on convertible indebtedness.

On April 30, 2018 the Company issued 363,597 of its Common Shares (“Shares”) in satisfaction of $5,000 of convertible indebtedness and $199 of accrued interest due on convertible indebtedness.

On May 7, 2018 the Company issued 403,583 of its Common Shares (“Shares”) in satisfaction of $5,000 of convertible indebtedness and $246 of accrued interest due on convertible indebtedness.

On June 1, 2018 the Company issued 405,858 of its Common Shares (“Shares”) in satisfaction of $5,000 of convertible indebtedness and $276 of accrued interest due on convertible indebtedness.

On June 11, 2018 the Company issued 728,390 of its Common Shares (“Shares”) in satisfaction of $10,000 of convertible indebtedness and $747 of accrued interest due on convertible indebtedness.

On May 18, 2018 the Company issued 4712320 of its Common Shares (“Shares”) in satisfaction of $50,000 of convertible indebtedness and $8904 of accrued interest due on convertible indebtedness.

On July 11, 2018 the Company issued 451,629 of its Common Shares (“Shares”) in satisfaction of $5,000 of convertible indebtedness and $313 of accrued interest due on convertible indebtedness.

On July 26, 2018 the Company issued 3630753 of its Common Shares (“Shares”) in satisfaction of $35,000 of convertible indebtedness and $2523 of accrued interest due on convertible indebtedness.

On August 20, 2018 the Company issued 7,500,000 of its Common Shares (“Shares”) in satisfaction of $56,250 of convertible indebtedness.

On August 24, 2018 the Company issued 659760 of its Common Shares (“Shares”) in satisfaction of $5,000 of convertible indebtedness and $360 of accrued interest due on convertible indebtedness.

On September 13, 2018 the Company issued 4273504 of its Common Shares (“Shares”) in satisfaction of $30,000 of convertible indebtedness.

On September 26, 2018 the Company issued 7720407 of its Common Shares (“Shares”) in satisfaction of $50,000 of convertible indebtedness and $4,197of accrued interest due on convertible indebtedness.

On September 28, 2018 the Company issued 1329500 of its Common Shares (“Shares”) in satisfaction of $8,000 of convertible indebtedness and $641 of accrued interest due on convertible indebtedness.

On October 1, 2018 the Company issued 5,128,205 Common Shares (“Shares”) in satisfaction of $30,000 of convertible indebtedness.

On October 18, 2018 the Company issued 8,961,988 Common Shares (“Shares”) in satisfaction of $30,650 of convertible indebtedness.

On October 23, 2018 the Company issued 2,019,140 Common Shares (“Shares”) in satisfaction of $7,000 of convertible indebtedness and $612 of accrued interest due on convertible indebtedness.

On October 29, 2018 the Company issued 3,015,618 Common Shares (“Shares”) in satisfaction of $11,000 of convertible indebtedness and $368 of accrued interest due on convertible indebtedness.

On November 15, 2018 the Company issued 7,100,591 Common Shares (“Shares”) in satisfaction of $30,000 of convertible indebtedness.

On November 28, 2018 the Company issued 9,198,923  Common Shares (“Shares”) in satisfaction of $20,000 of convertible indebtedness and $1,525 of accrued interest due on convertible indebtedness.

On November 28, 2018 the Company issued 10,120,491 Common Shares (“Shares”) in satisfaction of $20,392 of convertible indebtedness.

On November 28, 2018 the Company issued 10,000,000 Common Shares (“Shares”) in satisfaction of $2,896 of convertible indebtedness, $500 in fees and $5,903 of accrued interest due on convertible indebtedness.

The Abovementioned Shares 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 shares were sold directly through our management. No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares. 

Issuance of Series A Preferred Shares

On April 10 2018 the Company issued 40,080 Series A Preferred Shares (“Shares”) in satisfaction of $1,000 of convertible indebtedness and $42 of accrued interest due on convertible indebtedness.

On May 18, 2018 the Company issued 108,004 Series A Preferred Shares (“Shares”) in satisfaction of $2,000 of convertible indebtedness and $106 of accrued interest due on convertible indebtedness.

On June 1, 2018 the Company issued 146,407 Series A Preferred Shares (“Shares”) in satisfaction of $2,000 of convertible indebtedness and $112 of accrued interest due on convertible indebtedness.

On June 13, 2018 the Company issued 181,018 Series A Preferred Shares (“Shares”) in satisfaction of $2,000 of convertible indebtedness and $117 of accrued interest due on convertible indebtedness

On February 5, 2018 the Company issued 2,500,000 of its Series A Preferred Shares (“Shares”) for cash consideration of $25,000.

On July 17, 2018 the Company issued 492290 of its Series A Preferred Shares (“Shares”) in satisfaction of $3,000 of convertible indebtedness and $199 of accrued interest due on convertible indebtedness.

The Abovementioned Shares 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 shares were sold directly through our management. No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares. 

Issuance of Series M Preferred Shares

On October 11, 2017 the Company issued 2,000,000 shares of its Series M Preferred Stock (“Shares”) as consideration for nonemployee services.

On November 1, 2017 the Company issued 4,000,000 shares of its Series M Preferred Stock (“Shares”) as consideration for nonemployee services.

The Abovementioned Shares 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 shares were sold directly through our management. No commission or other consideration was paid in connection with the sale of the shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares. 

Cancellation of Common Shares

On August 20, 2018 the Company cancelled 3976852 originally issued for convertible indebtedness in accordance with the terms and conditions of the instrument.

Convertible Notes

On October 3, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for consideration consisting of $50,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is October 3, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”) 

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On October 4, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $40,000 for consideration consisting of $40,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is October 4, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On October 16, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $100,000 for consideration consisting of $100,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is October 9, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On November 1, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $25,000 for consideration consisting of $25,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is November 1, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On November 1, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $25,000 for consideration consisting of $25,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is November 1, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On October 9, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $100,000 for consideration consisting of $100,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is October 9, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On December 15, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $35,000 for consideration consisting of $35,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is December 15, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On December 20, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $100,000 for consideration consisting of $100,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is December 20, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On December 20, 2017 the Company issued a Convertible Note (“Note”) in the face amount of $115,000 for consideration consisting of $100,000 cash and payment on behalf of the Company of 13,250 of expenses incurred in connection with the issuance of the Note. The Note also carries an Original Issue Discount of $1,750.The Note pays simple interest in the amount of 8% per annum. The maturity of the Note is December 6, 2018. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to 65% of the lowest Trading Price of the Common Stock of the Company as reported on the National Quotations Bureau OTC Markets exchange upon which the Company's shares are traded or any exchange upon which the Common Stock of the Company may be traded in the future , for the fourteen prior trading days including the day upon which a Notice of Conversion is received by the Company or its transfer agent. In no event shall the Holder be allowed to effect a conversion if such conversion, along with all other shares of Company Common Stock beneficially owned by the Holder and its affiliates would exceed 9.9% of the outstanding shares of the Common Stock of the Company.

On December 6, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for consideration consisting of $50,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is December 6, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On January 24, 2018 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $25,000 for consideration consisting of $25,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is December 6, 2020. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On February 28, 2018 (“Issue date”) the Company issued a two Convertible Notes (“Notes”) in the aggregate face amount of $100,000 for consideration consisting of $100,000 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Notes is February 28, 2021. The Notes may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.025 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of these Notes, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On February 26, 2018 the Company issued a Convertible Note (“Note”)in the principal amount of $115,000 for net consideration of $100,000. The Company recognized an Original Issue Discount of $15,000 in connection with the Note. The Note bears simple interest of 12%.The Note matures on February 26, 2019.

The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to a 35% discount to the lowest trading price during the previous 14 trading days up to the conversion notice.

On May 18, 2018 the Company issued a Convertible Note (“Note”)in the principal amount of $114,000 for net consideration of $100,000. The Company recognized an Original Issue Discount of $14,000 in connection with the Note. The Note bears simple interest of 10%.The Note matures on February 18, 2019.

The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to equal the lesser of (i) the lowest Trading Price during the previous twenty-five (25) Trading Day period ending on the latest complete Trading Day prior to the date of the Note and (ii) the Variable Conversion Price. “Variable Conversion Price” shall mean 50% multiplied by the Market Price (representing a discount rate of 50%). “Market Price” means the lowest Trading Price for the Common Stock during the twenty-five (25) Trading Day period ending on the latest complete Trading Day prior to the Conversion Date.

On July 11, 2018 the Company issued a Convertible Note (“Note”) in the face amount of $11,500 to an entity controlled by the Company’s Chief Financial Officer for consideration consisting of $11,500 cash. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is May 4, 2021. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to the lower of (a) a 75% discount to the closing price of the common stock of the Company on the trading day immediately prior to the date a conversion notice is given by the Lender to Regen or (b) $0.01 per common share as of the date which is the earlier of:

(i)       One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.

(ii)       One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).

(iv) One day subsequent to a “Transaction Event”)

Transaction Event” shall mean either of:

(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party

(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property

(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.

On August 14, 2018 the Company issued a Convertible Note (“Note”) in the face amount of $75,000 for consideration consisting of $71,250 cash and payment on behalf of the Company of 3,750 of expenses incurred in connection with the issuance of the Note. The Note pays simple interest in the amount of 10% per annum. The maturity of the Note is August 13, 2019. The Note may be converted into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to 60% of the lowest Trading Price of the Common Stock of the Company as reported on the National Quotations Bureau OTC Markets exchange upon which the Company's shares are traded or any exchange upon which the Common Stock of the Company may be traded in the future , for the twenty prior trading days including the day upon which a Notice of Conversion is received by the Company or its transfer agent. In no event shall the Holder be allowed to effect a conversion if such conversion, along with all other shares of Company Common Stock beneficially owned by the Holder and its affiliates would exceed 4.99% ( which may be increased to 9.99% upon 60 days written notice by the Holder) of the outstanding shares of the Common Stock of the Company.

On September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $350,000 (“Note”) to Zander Therapeutics, Inc. (“Zander”). Consideration for the Note consisted of $350,000. A one time interest charge of 10% of the principal amount shall be applied to the principal amount of the Note. The Note is due and payable 24 months from the effective date.

Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion.

Zander and Regen are under common control. David Koos serves as Chairman & CEO of both Regen BioPharma, Inc. and Zander Therapeutics Inc. Harry Lander serves as President and Chief Scientific Officer of both Regen BioPharma, Inc. and Zander Therapeutics, Inc. Todd S. Caven serves as CFO of both Regen BioPharma, Inc. and Zander Therapeutics Inc. Koos, Lander and Caven also serve as Directors of Zander Therapeutics, Inc. Zander Therapeutics, Inc. is the sole licensee of Regen's NR2F6 intellectual property for veterinary applications.

All the abovementioned Notes contained a provision that until such time as the shares of stock issuable upon conversion of the Note have been registered under the Act or otherwise may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, each certificate for shares of stock issuable upon conversion of the Note that has not been so included in an effective registration statement or that has not been sold pursuant to an effective registration statement or an exemption that permits removal of the legend, shall bear a restrictive legend. The Notes 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 Notes were sold directly through our management. No commission or other consideration was paid in connection with the sale of the Notes. There was no advertisement or general solicitation made in connection with this Offer and Sale of Notes.

Use of Proceeds

With regard to all securities sold for cash consideration described above, Cash proceeds received from sale will be utilized by Regen for general corporate purposes.

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, 2018, we had Cash in the amount of $ 8,019 and as of September 30, 2017 we had Cash in the amount of $269,973.

The decrease in cash of approximately 97% is primarily attributable to the satisfaction of $111,128 of Notes Payable, the satisfaction of $198,500 of salaries accrued but unpaid owed to officers of the Company, a bonus compensation payment made to the Company’s President of $45,000, and the cost of operating the Company’s business offset by:

Sale by the Company of $1,382, 750 of Convertible Securities

Sale by the Company of $50,000 of Equity Securities

The satisfaction of a $40,000 Note receivable issued to the Company as consideration for a $40,000 Convertible Note issued by the Company.

As of September 30, 2018 we had Notes Receivable of 0 and as of September 30, 2017 we had Notes Receivable of $165,000.

The decrease in Notes Receivable is attributable to:

The cancellation of $125,000 in Notes Receivable issued to the Company as consideration for a Convertible Notes issued by the Company.

The satisfaction of a $40,000 Note receivable issued to the Company as consideration for a $40,000 Convertible Note issued by the Company.

As of September 30, 2018 we had Prepaid Expenses of $8,259 and as of September 30, 2017 we had Prepaid Expenses of $34,427.

The decrease in Prepaid Expenses of approximately 76% is attributable to recognition by the Company of $32,835  of Research and Development expenses which had been paid for in a prior period offset by prepayment by the Company of $6667 of consulting expenses.

As of September 30, 2017 we had Accrued Interest Receivable of $4,436 and as of September 30, 2018 we had Accrued Interest Receivable of $7,672.

The increase in Accrued Interest Receivable of approximately 72.95% is attributable to interest accrued but unpaid during the year ended September 30, 2018 resulting from amounts due to the Company by Entest Group, Inc. as well as interest accrued but unpaid due to the Company from LG Capital Funding LLC. During the year ended September 30, 2018 David R. Koos served as Chairman of the Board and Chief Executive Officer of both the Company and Entest Group, Inc.

As of September 30, 2018 we had Prepaid Rent of $14,270 and as of September 30, 2017 we had Prepaid Rent of $0.

The increase in Prepaid Rent is attributable to the payment by the Company of rental expenses not due until the quarter ended December 31, 2018.

As of September 30, 2018 we had Available for Sale Securities of $166,247 and as of September 30, 2017 we had Available for sale Securities of $465,852.

The decrease in Available for Sale Securities of approximately 64.3% is primarily attributable to:

As of September 30, 2018 we had a Bank Overdraft of $203 and as of September 30, 2017 we had a Bank Overdraft of $0.

The increase in Bank Overdraft is attributable to withdrawal of money that is greater than the available balance in a bank account maintained by the Company during the quarter ended June 30, 2018.

As of September 30, 2017 we had Accounts Payable of $495,749 and as of September 30, 2018 we had Accounts Payable of $80,567.

The decrease in Accounts Payable of 83.74% is attributable primarily to payments made on obligations of the Company to Contract Research Organizations incurred in the course of business.

As of September 30, 2017 we had Notes Payable of $111,355 and as of September 30, 2018 we had Notes Payable of $227.

The decrease in Notes Payable of approximately 97%  is attributable to:

As of September 30, 2018 we had Accrued Payroll Tax of $4,241 and as of September 30, 2017 we had Accrued Payroll Tax of $857.

The increase of 394% is primarily attributable to employer taxes owed by the Company as a result of a $45,000 compensation payment made to the Company’s President, Harry Lander, during the quarter ended March 31, 2018.

As of September 30, 2017 we had accrued rent of $5,000 and as of September 30, 2018 we had Accrued Rent of $0.

The decrease in accrued rent is attributable to a decrease in Rental Expenses accrued but unpaid due to Entest Biomedical, Inc.

As of September 30, 2018, we had Accrued Payroll of $655,663 and as of September 30, 2017 we had Accrued Payroll of $590,996.

The increase in Accrued Payroll of 10.9% is attributable to:

$45,000 in salary expense due to the Company’s Chief Executive Officer incurred but unpaid during the three months ended December 31, 2017.

$40,500 in salary expense due to the Company’s Chief Financial Officer incurred but unpaid during the three months ended December 31, 2017.

$35,000 in salary expense due to the Company’s Chief Executive Officer incurred but unpaid during the three months ended March 31, 2018.

$40,500 in salary expense due to the Company’s Chief Financial Officer incurred but unpaid during the three months ended March 31, 2018.

$45,000 in salary expense due to the Company’s Chief Executive Officer incurred but unpaid during the three months ended June 30 2018.

$40,500 in salary expense due to the Company’s Chief Financial Officer incurred but unpaid during the three months ended June 30, 2018.

$16,667 in salary expense due to the Company’s President incurred but unpaid during the three months ended June 30, 2018.

Offset by:

The satisfaction of $198,500 of salaries accrued but unpaid owed in aggregate to the Chief Executive Officer and Chief Financial Officer of the Company

As of September 30, 2017 we had Accrued Interest Payable of $122,807 and as of September 30, 2018 we had Accrued Interest Payable of $292,094.

The increase in Accrued Interest Payable of approximately 138 % is primarily attributable to interest expense on Notes Payable and Convertible Notes Payable incurred during the twelve months ended September 30, 2018 but not yet paid offset by

The cancellation during the period of an $85,000 convertible note issued by the Company in accordance with that instrument’s terms and conditions resulting in the derecognition of $2384 of accrued interest during the quarter ended March 31, 2018.

As of September 30, 2017 we had Other Accrued Expenses of $33,034 and as of September 30, 2018 we had Other Accrued Expenses of $41,243.

The increase in Other Accrued Expenses of approximately 24.8% is attributable to additional reimbursements due by the Company to the Company’s Chief Financial Officer for business expenses incurred by the Company’s Chief Financial Officer in the performance of his duties.

As of September 30, 2018 we had Convertible Notes Payable of $3,058,150 and as of September 30, 2017 we had Convertible Notes Payable of $2,084,000.

The increase in Convertible Notes Payable of approximately 47% is primarily attributable to:

Offset by:

The September 30, 2018 balance of convertible notes payable was also impacted by the rescission by a noteholder of 3976852 shares issued to the Holder for conversion of interest and principal in accordance with the terms and conditions of the Note.

As of September 30 2018 we had Unearned Income of $68,000 and as of September 30, 2017 we had Unearned Income of $0.

The increase in Unearned Income is attributable to prepayment by Zander Therapeutics, Inc. of Minimum Annual Royalties which will become due and payable to the Company by Zander Therapeutics, Inc. pursuant to the terms and conditions of an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years and an annual Anniversary Fee payable pursuant to the Terms and conditions of the Agreement. David Koos serves as Chairman and Chief Executive Officer of the Company and Zander. Harry Lander serves as President and Chief Scientific Officer of the Company and Zander. Todd Caven serves as Chief Financial Officer of the Company and Zander.

As of September 30, 2017 we had a Derivative Liability of $4,234,475 and as of September 30, 2018 we had a Derivative Liability of $ 6,736,607.

The increase in Derivative Liability of 59 % is primarily attributable to the recognition by the Company of embedded derivatives on Convertible Notes Payable with an aggregate face value of $2,218,150.

Material Changes in Results of Operations

Revenues from continuing operations were $110,000 for the fiscal year ended September 30, 2017 and $100,000 for the fiscal year ended September 30, 2018. Net losses were$5,839,03 8 for the fiscal year ended September 30, 2017 and $4,715,200 for the same year ended 2018. 

The decrease in Net Losses of approximately 19% is primarily attributable to lowered operating costs and derivative expense realized during the twelve months ended September 30, 2018 as compared to the same period ended 2017 partially offset by higher Interest Expense, Interest Expense attributable to Amortization of Beneficial Conversion Features and Loss on Early Extinguishment of Convertible Debt recognized during the year ended September 30, 2018 when compared to the same period ended 2017.

As of September 30 2018 we had $8,019 in cash on hand and current liabilities of $8,673,511 such liabilities consisting of Accounts Payable, Notes Payable, Unearned Income, Convertible Notes Payable ( Net of Unamortized Discount), Derivative Liability Recognized, bank overdraft 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 Company has historically funded operation through the issuance of securities for cash and intends to continue to meet cash needs through selling its securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise.

We cannot assure that we will be successful in obtaining additional financing necessary to implement our business plan. We have not received any commitment or expression of interest from any financing source that has given us any assurance that we will obtain additional financing in the future. For these and other reasons, we are not able to assure that we will obtain any additional financing or, if we are successful, that we can obtain any such financing on terms that may be reasonable in light of our current circumstances.

As of December 18,2018 we are 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.

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of

Regen BioPharma, Inc.

Opinion on the Financial Statements

We have audited the accompanying balance sheets of Regen BioPharma, Inc. (the “Company”) as of September 30, 2018 and September 30, 2017 and the related statements of operations, comprehensive income, stockholders’ equity, and cash flows for each of the years in the two-year period ended September 30, 2018, 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, 2018 and September 30, 2017, and the results of its operations and its cash flows for each of the years in the two-year period ended September 30, 2018 in conformity with accounting principles generally accepted in the United States of America.

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 audits. 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 audits 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 audits 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 audits 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 audits provide a reasonable basis for our opinion.

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 minimal revenues, has negative working capital at September 30, 2018, has incurred recurring losses and recurring negative cash flow from operating activities, and has an accumulated deficit which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning 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.

/s/ AMC Auditing

AMC Auditing
We have served as the Company’s auditor since 2013

Las Vegas, Nevada

December 20, 2018 

Item 8. Financial Statements and Supplementary Data