10-K 1 rgbp010516form10k.htm 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, 2015

 

☐  TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934:

 

For the transition period from __________ to __________. 

 

Commission file number: 333-191725

  

REGEN BIOPHARMA, INC.
(Name of small business issuer in its charter)
     
Nevada   45-5192997
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)
     
4700 Spring Street, Suite 304, La Mesa, California, 91942
(Address of Principal executive offices)
 
Issuer’s telephone number: (619) 702-1404

 

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.

 

 

Large accelerated filer  ☐ Accelerated filer  ☐
Non accelerated filer  ☐ 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:  $11,204,585

 

As of December 29, 2015 Regen Biopharma, Inc. had 124,287,272 common shares outstanding.

 

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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.

 

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:

 

  dependence on key personnel;
  competitive factors;
  degree of success of research and development programs
  the operation of our business; and
  general economic conditions

 

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 are a controlled subsidiary of Bio-Matrix Scientific Group, Inc, a Delaware corporation. We intend to engage primarily in the development of regenerative medical applications which we intend to license 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 29, 2015 , 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 wholly owned 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 the first anniversary of the effective date of the Agreement and each subsequent anniversary.

 

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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.

 

David R. Koos serves as sole officer and director of both Zander and Entest Biomedical, Inc. and also serves as Chairman and Chief Executive Officer of Regen.

 

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.

 

We have acquired certain intellectual property from Dr. Wei Ping Min on May 1, 2013and licensed certain intellectual property from Benitec Australia Limited on August 5, 2013. These collective intellectual properties comprise the therapeutic concept behind dCellVax , a cancer therapy in early stage development by the Company.

 

On May 1, 2013 Dr. Wei Ping Min (“Min”) entered into an agreement (“Agreement”) whereby Min assigned to Regen all right, title and interest in US Patent # 8,389,708 as well as all Patent applications from the same family corresponding to numbers PCT/CA2006/000984, CA2612200 and EP1898936.(“Min IP”) US Patent # 8,389,708 was granted to Min with regard to his invention of a method directed to the silencing of immunosuppressive cancer causing genes using short interfering RNA (siRNA) leading to an increase in the immune response, a decrease in tumor-induced immunosuppression and a decrease in in vivo tumor progression. siRNA are shorter pieces of double stranded RNA that allow the interference of a particular gene, without causing cell death.

 

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 As consideration for the Min IP, Regen is required to:

 

(a)negotiate in good faith with Min with regards to a proposed consulting agreement by and between Min whereby Min shall perform certain mutually agreed upon tasks for the benefit of Regen for consideration to Min consisting of $100,000 of the common shares of Bio-Matrix Scientific Group, Inc. valued as of the date of issuance and to be paid over a twelve month period in twelve equal installments (“Consulting Shares”) and registered under the Securities Act of 1933 on Form S-8.
  
(b)Cause to be issued to Min 100,000 of Bio-Matrix Scientific Group, Inc.’s preferred shares (“Assignor Preferred Shares”) exchangeable into common shares of Bio-Matrix Scientific Group, Inc. (“Exchange Common Shares”) under the following terms and conditions:

 

(1) upon any date subsequent to the date of the completion of a satisfactory review by the United States Food and Drug Administration (“FDA”) of an Investigational New Drug Application (“IND”) for the Min IP submitted by Regen which shall result in the ability of Regen to lawfully begin clinical testing of the Min IP on human subjects within the United States Min shall be permitted, at his option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of $333,000 such shares being valued at a price per share equal to the closing price as of the day written notice is given to Regen of Min’s intent to exchange.

 

(2) upon any date subsequent to the date that manufacturing procedures for the manufacture of the Min IP have been developed by Regen which comply to the Current Good Manufacturing Practices (“cGMP “) requirements of the Food Drug and Cosmetics Act of 1938 and the rules and regulations promulgated thereunder as they may apply to the manufacture of the Min IP Min shall be permitted, at his option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of $333,000 such shares being valued at a price per share equal to the closing price as of the day written notice is given to Regen of Min’s intent to exchange.

 

(3) upon any date subsequent to the date that, in connection with a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, both of (1) a clinical trial protocol has been completed and (2) a Principal Investigator has been appointed, Min shall be permitted, at Min’s option, to exchange 33,333 of the Assignor Preferred Shares into that number of Exchange Common Shares having a value of $333,000 such shares being valued at a price per share equal to the closing price as of the day written notice is given by Min to Regen of Min’s intent to exchange.

 

(4) Min shall receive, upon successful completion of a lawfully administered Phase I clinical trial of the Min IP being conducted by Regen within the United States on human subjects, the results of which (1) shall indicate that the Min IP can be safely tolerated by human subjects (2) shall not indicate that use of the Min IP in human subjects result in side effects of such severity that commencement of a Phase II clinical trial could not occur, and (3) establishes the optimal dosage and/or method of administration( as applicable )of the Min IP , Min shall receive that number of the common shares of BIO-MATRIX SCIENTIFIC GROUP, INC. which, at a price per share equal to the closing price of the shares as of the day of issuance, shall equal $1,000,000.

 

All common shares of Bio-Matrix Scientific Group, Inc issuable pursuant to the Agreement are subject to the condition that a sufficient number of common shares shall be authorized for issuance by BMSN in order that the required number common shares may be issued. Pursuant to the Agreement, Min shall be entitled to additional consideration for productivity and deliverables over and above listed items (“”Bonus””). The eligibility of Min to receive a Bonus as well as the nature and amount of any Bonus shall be at the sole discretion and determination of the Chief Executive Officer of the Company. On August 9, 2013 Bio-Matrix Scientific Group, Inc issued to Min 100,000 of its Preferred Shares pursuant to the Agreement.

 

On August 5, 2013 Regen was granted by Benitec Australia Limited (“Benitec”) an exclusive worldwide right and license to certain patents, patent applications, know-how and other intellectual property relating to RNA interference, a biological mechanism by which double-stranded RNA modifies gene expression (“RNAi”) possessed by Benitec.

 

Pursuant to the agreement between the parties for the grant of the license (“Agreement”) , Regen is obligated to make the following payments to Benitec as consideration for the grant of the license:

 

(1) a one-time, non-refundable, upfront payment of twenty five thousand US dollars ($25,000) as a license initiation fee on the execution date of the Agreement. On August 30, 2013 BMSN issued 8,512,088 of its common shares to Benitec in satisfaction of this obligation on behalf of the Company. Fair value of these common shares as of the date of issuance was determined to be $25,536.

 

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(2) a one-time non-refundable payment of twenty five thousand US dollars ($25,000) on the first anniversary of the execution date of the Agreement.

 

(3) The following milestone payments per each Licensed Product that meets such milestone:

 

Milestone

Amount

 

Start Phase I/II clinical trial – dosing first patient

$100,000 US Dollars

Start Phase III clinical trial

$500,000 US Dollars 

Regulatory Approval for a Licensed Product by first regulatory agency

$1,000,000 US Dollars 

Regulatory Approval for a Licensed Product by second regulatory agency

$2,000,000.00 US Dollars

 

As defined by the Agreement, “Licensed Product” shall mean any product sold by or on behalf of Regen, its Affiliates or its sublicensees pursuant to the license granted by the Agreement.

 

As further consideration to Benitec, Regen is required to pay:

 

(i)Royalties equal to the greater of (a) a minimum annual payment of $25,000 per year or (b) four percent (4%) of the Net Sales as defined in the Agreement of any Licensed Products sold pursuant to the license sold within a given year.
(ii)fifty percent (50%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Regen from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Benitec receives payment.

  

The term of this Agreement commenced on the date of execution (“Effective Date “) continues in full force and effect on a Licensed Product-by-Licensed Product and country-by-country basis until the expiration or termination of the Benitec’s Patent Rights covering such Licensed Product.

  

On August 1, 2015 the Agreement was amended as follows:

Any License Fees or Milestone Payments ( as those terms are defined in the Agreement”) to be paid subsequent to April 6, 2015 may be paid in the common stock of Regen .

On November 20, 2014 Dr. Christine Ichim assigned to the Company all right, title, and interest in and to the invention described in US Patent Application Serial No. 13/652,395 relating to methods and compositions for modulating NR2F6 for therapeutic applications. In particular, methods and compositions comprising modulators of NR2F6 for modulating stem cell growth, proliferation and differentiation and for treating associated conditions and diseases. As Consideration by the Company to Dr. Ichim for the rights the Company is required to issue to Dr. Ichim 100,000 of the Company’s common shares.

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:

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a)Cord Blood Small Molecule (“CBSM invention”)
b)Cancer Small Molecule Ligand Binding (“CSMLB Invention”)
c)Cancer Small Molecule Alpha helix Inhibitor (“CSMAI Invention”)
d)Cancer Small Molecule using 170 Compound List (“CSM170 Invention”)

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:

i)As consideration for the invention, patent prosecution and assignment of all right, title and interest to CBSM invention Dr. Ichim shall be issued One Hundred Thousand Common Shares of the Company and Three Thousand Dollars, such shares to be issued and dollars to be paid upon the filing with the United States patent and Trademark Office of a provisional applications for patent for the CBSM Invention

 

ii)As consideration for the invention, patent prosecution and assignment of all right, title and interest to CSMLB invention Dr. Ichim shall be issued One Hundred Thousand Common Shares of the Company and Three Thousand Dollars, such shares to be issued and dollars to be paid upon the filing with the United States patent and Trademark Office of a provisional applications for patent for the CSMLB Invention

 

iii)As consideration for the invention, patent prosecution and assignment of all right, title and interest to CSMAI invention Dr. Ichim shall be issued One Hundred Thousand Common Shares of the Company and Three Thousand Dollars, such shares to be issued and dollars to be paid upon the filing with the United States patent and Trademark Office of a provisional applications for patent for the CSMAI Invention

 

iv)As consideration for the invention, patent prosecution and assignment of all right, title and interest to CSM170 invention Dr. Ichim shall be issued One Hundred Thousand Common Shares of the Company and Three Thousand Dollars, such shares to be issued and dollars to be paid upon the filing with the United States patent and Trademark Office of a provisional applications for patent for the CSM170 Invention   v) Dr. Ichim shall be entitled to royalties during the term of any patent granted for the CBSM invention, CSMLB invention ,CSMAI invention and CSM170 invention of 5% of Net Sales made by the Company of the CBSM invention, CSMLB invention ,CSMAI invention and CSM170 invention. Net Sales" means the monetary consideration actually received by Company for the transfer of the invention less any of the following items

(a)outbound shipping, storage, packing and insurance expenses;

(b)distributor discounts;

(c)allowance for doubtful accounts or uncollectible accounts receivable;
(d)amounts repaid or credited as a result of rejections, defects, or returns
(e)sales and other excise taxes (excluding VAT), tariffs, export license fees and duties paid to a governmental entity
(f)sales commissions.
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On December 16, 2014 Dr. Christine Ichim assigned to the “Company all right, title, and interest in and to the invention described in US Patent Application Serial No. 14/571,262 “METHODS AND COMPOSITIONS FOR THE TREATMENT OF CANCER BY INHIBITION OF NR2F6”

On December 17, 2014 Dr. Christine Ichim assigned to the “Company all right, title, and interest in and to the invention described in US Patent Application Serial No. 14/572,574 “TREATMENT OF MYELODYSPLASTIC SYNDROME BY INHIBITION OF NR2F6”

On December 31, 2014 United States Patent Application No. 14588374 pertaining to the use of molecular interventions to treat myelodysplastic syndrome (MDS) was filed by Dr. Christine Ichim.

United States Patent Application No. 14588374 is a continuation-in-part to pending Non-Provisional U.S. Application Serial Number 13/652,395. All right, title and interest in and to the invention covered by Non-Provisional U.S. Application Serial Number 13/652,395 was assigned to Regen BioPharma, Inc. (“Regen”) by Dr. Ichim on November 20, 2014. In addition all right, title and interest in and to the invention covered by United States Patent Application No. 14588374 is assigned to Regen by Dr. Ichim pursuant to the November 20, 2014 assignment as Application No. 14588374 is a continuation-in-part to pending Non-Provisional U.S. Application Serial Number 13/652,395.

On December 31, 2014 United States Patent Application No. 14588373 pertaining to the suppression of the nuclear receptor NR2F2 using compositions that induce RNA interference for use as cancer stem cell inhibitors as well as cancer stem cell pathway inhibitors was filed by Dr. Christine Ichim.

United States Patent Application No. 14588373 is a continuation-in-part to pending Non-Provisional U.S. Application Serial Number 13/652,395. All right, title and interest in and to the invention covered by Non-Provisional U.S. Application Serial Number 13/652,395 was assigned to Regen BioPharma, Inc. by Dr. Ichim on November 20, 2014. In addition all right, title and interest in and to the invention covered by United States Patent Application No. 14588373 is assigned to Regen by Dr. Ichim pursuant to the November 20, 2014 assignment as Application No. 14588373 is a continuation-in-part to pending Non-Provisional U.S. Application Serial Number 13/652,395.

On March 3, 2015 Regen entered into an agreement (“Agreement”) with Dr. Thomas Ichim whereby Dr. Thomas Ichim would sell, assign, transfer and set over to Regen all rights, title and interest in and to the invention as described and claimed in the United States Patent Number: 8,263,571, dated September 11, 2011, titled “Gene Silencing of the Brother of the Regulator of Imprinted Sites” for consideration consisting of $9,000 and 1,000,000 shares of Regen’s Series A Preferred stock.

On June 8, 2015 Regen Biopharma, Inc. (the “Company”) entered into an agreement with Dr. Santosh Kesari (“Agreement”).

Pursuant to the terms and conditions of the Agreement

(a)Dr. Kesari shall conduct , for the benefit of the Company, certain experiments intended to demonstrate in vitro efficacy of human indolamine 2,3 deoxygenase small interfering RNA in the human Dendritic Cell in vitro model. These experiments are intended to provide a response to requests for information by the United States Food and Drug Administration (“FDA”) with regard to Investigational New Drug Application (“IND”) #16200 submitted by the Company to the FDA for the Company’s planned Phase I/II clinical trial assessing safety with signals of efficacy of the Company’s dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer.

 

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(b)Dr. Kesari shall assist the Company in the preparation of an IND to be submitted to the FDA with regard to the marketing of the Company’s proprietary product “DCellVax” as a treatment for gliomas such a assistance to be provided for a period of no less than twelve months from the execution date of the Agreement.

Consideration to Dr. Kesari shall consist of the following:

(a)Dr. Kesari shall receive that number of common shares of the Company, valued as of the closing price on the OTCBB as of the date of execution of this Agreement, which shall equal $66,000 USD (“Signing Shares”). One half of the Signing Shares to be issued shall be registered under the Securities Act of 1933 on Form S-8.

(b)Upon completion of the studies required to be performed by Dr. Kesari pursuant to the Agreement and successful demonstration of silencing of indolamine 2,3 deoxygenase in human dendritic cells Dr. Kesari shall be entitled to receive that number of common shares of the company, valued as of the closing price on the OTCBB as of the date that successful demonstration of silencing is presented to the Company by the Dr. Kesari (“Milestone Date”) , which shall equal $66,000 USD (“Milestone Shares”). ”). One half of the Signing Shares to be issued shall be registered under the Securities Act of 1933 on Form S-8.

 

(c)Upon the date of submission to the FDA of a response, prepared by the Dr. Kesari, providing evidence of vitro and/or in vivo confirmation of efficacy of the human siRNA sequences proposed for the clinical trial with regard to IND# 16200 for a proposed Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer ( “Response Date”) Dr. Kesari shall be entitled to receive that number of common shares of the company, valued as of the closing price on the OTCBB as of the Response Date which shall equal $66,000 USD (“Response Date Shares”). One half of the Response Date Shares to be issued shall be registered under the Securities Act of 1933 on Form S-8.

 

On December 15, 2015 Regen Biopharma, Inc. (“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 , pursuant to the following terms and conditions:

 

Regen and NCATS shall collaborate to screen for small molecule compounds that activate or inhibit the orphan nuclear receptor, NR2F6 (“Research Project”).

 

NR2F6 orphan nuclear receptor cell lines will be provided by Regen.

 

NPC and LOPAC compound libraries will be used to screen this receptor at NCATS.

 

Inventions made in the course of the Research Project will be owned by the Party employing the inventor or inventors. Inventions that are invented jointly by employees of both Parties will be owned jointly.

 

The Parties, moreover, agree to enter into an inter-institutional agreement with respect to joint inventions, which shall authorize Regen to have primary control and responsibility for any patenting and commercialization activities and shall be negotiated in good faith based on the respective parties’ contributions to each Joint Invention.

 

The term of this Agreement is for 3 years from December 16, 2015. This Agreement may be extended as mutually agreed by the Parties. This Agreement may be terminated upon thirty days written notice by the terminating Party to the other Party.

 

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Principal Products and Services

 

HemaXellarate I

 

The Company has begun development of HemaXellerate I, a cellular therapy designed to heal damaged bone marrow. HemaXellerate I is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based on previous animal studies. The initial application of HemaXellerate I will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia (underdevelopment or incomplete development of a tissue) and pancytopenia (reduction in the number of blood cells and platelets).

 

Adipose tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including mesenchymal stem cells and endothelial cells. Mesenchymal stem cells are connective tissue cells that can differentiate into a variety of cell types and endothelial cells are the cells that line the interior surface of blood vessels and lymphatic vessels and which play a vital role in angiogenesis ( the physiological process through which new blood vessels form from pre-existing vessels).

 

The isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood and the bone marrow.

 

On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing HemaXellerate I I in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.

 

Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees.

 

The Company believes that this application of HemaXellerate I qualifies for Orphan designation under the Orphan Drug Act due to the fact that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for Orphan designation for HemaXellerate.

 

On December 10, 2015 Regen was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate I and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.

 

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HemaXellerate II

 

Also in early stage development by the Company is a version of HemaXellerate called HemaXellerate II.

 

HemaXellerate II is intended to be a universal donor endothelial cell based therapeutic and is intended to be manufactured by obtaining cells from a part of the placenta called the “vascular lobules”. The cells are processed and utilized for the purpose of stimulating bone marrow hematopoetic stem cell repair and proliferation. The mechanism of action for HemaXellerate II is similar to HemaXellerate I whereby the harvested and processed cells would produce growth factors which would mediate the therapeutic effects of the product. The Company has not begun preclinical development of HemaXellerate II as of December 29, 2015.

 

 

The therapeutic concept behind the HemaXellerate products derives from intellectual property licensed to the Company by Oregon Health & Science University (US patent No. 6,821,513 “Method for enhancing hematopoiesis” issued Nov. 23, 2004) pursuant to an agreement entered into by the parties on June 5, 2013. This agreement was terminated by mutual consent on August 8, 2013 due to the fact that US patent No. 6,821,513 had expired due to nonpayment of the required maintenance fees by Oregon Health & Science University. The Company has been informed by its counsel and believes that the expiration of US patent No. 6,821,513 signifies that no party can be sued for future infringement based on the patent. Thus the Company is free to practice the claimed methods recited in the expired patent in the future without being liable for patent infringement based on the patent.

 

 dCell Vax 

dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body , treated with plasmid DNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.

 

The dendritic cells that are treated with the IDO-blocking plasmid become resistant to the influence of tumor cells which produce factors which cause the dendritic cell to express the IDO. Expression of IDO on the dendritic cell halts the dendritic cell from activating T cells and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in the human immune system’s attempt to eradicate tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer. The proposed trial will recruit 10 patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to l last one year, with tumor assessment before therapy and at 6 and 12 months.

 

The concepts utilized in formulating dCellVax are derived

 

(a)from patented intellectual property acquitted by the Company from Dr. Wei Ping Min which is method directed to the silencing of immunosuppressive cancer causing genes using short interfering RNA (siRNA) and which has been granted patent protection under US Patent # 8,389,708
(b)from patented intellectual property licensed to the Company by Benitec.

 

NR2F6

 

Regen has been assigned intellectual property with regard to the gene NR2F6 . It is believed by the Company that NR2F6 expression leads to the shutting down of the immune system’s natural ability to kill cancerous cells. The Company believes that identification of a small molecule which could inhibit this receptor would potentially provide an avenue for immunotherapy of cancer.

 

 10 
 

 

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.

 

Regen will be required to obtain approval from the FDA in order to market any of Regten’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.

 

 11 
 

 

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. Boris Minev, MD

 

Dr. Minev is Director of Immunotherapy and Translational Oncology at Genelux Corporation studying the phenotype and characterization of metastasized cancer stem cells in circulation. Dr. Minev previously worked as the Principal Investigator at the Laboratory of Tumor Immunology and Immunotherapy at the Moores UCSD Cancer Center

 

Dr. Minev has served on the Advisory Board since March 17,2015. As consideration for agreeing to serve as a member of the Scientific Advisory Board of Regen, the Company has issued to Dr. Minev 100,000 shares of Regen’s Series A Preferred Stock.

 

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. 

 

 12 
 

 

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

Dr. 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.

 13 
 

 

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.

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

 14 
 

Patents:

 

The following is a list of patents to which a license has been granted to the Company pursuant to the Benitec Agreement:

  

Title Inventors Country Number
GENETIC CONSTRUCTS FOR DELAYING OR REPRESSING THE EXPRESSION OF A TARGET GENE (‘099”) Graham, Rice, Waterhouse US 6,573,099

SYNTHETIC GENES AND GENETIC CONSTRUCTS COMPRISING THE SAME

 (Graham Family)

 

Waterhouse, Graham, Wang,

Rice

US 8,067,383 (was 10/346,853)
    US 11/218,999
    US 7754697
    US 8048670 (was 10/759,841)
    US 8053419 (was 10/821,726)
    US 90/007,247

CONTROL OF GENE EXPRESSION WO99/49029

 

 

Graham, Rice, Waterhouse, Wang AU 743316
    AU 2005211538
    AU 2005209648
    AU 2008249157
    BR PI9908967.0
    BR PI9917642.4
    CA 2323726
    CN 200510083325.1
    CN 200910206175
    CZ 295108
    EP 1555317 (formerly patent application no. 04015041.9)
    EP 1624060 (formerly patent application no.05013010.3
    EP 07008204.5
    EP 10183258.2
    UK GB 2353282
    HK 1035742
    HG PO5000631
    HG PO101225
    IN 3901/DELNP/2005
    IN 2000/00169/DE
    JP 2000-537990
    JP 2005-223953
    JP 2007-302237
    JP 2009-161847
    KR

10-2010-7006892

Divisional of 7010419/00

    MX PA/a/2000/008631
    MX PA/a/2005/006838

    NZ 506648
    NZ 547283
    PL P-377017
    SG 75542
    SG 200205122.5
    SG 141233
    SL 287538
    ZA 2000/4507
    SG 141233

 

 15 
 

 

Patent Name Inventors Country Application/ Grant No
METHODS AND MEANS FOR OBTAINING MODIFIED PHENOTYPES Waterhouse, Wang, Graham AU 29514/99 (760041)
    AU 2007201023
    CA 2325344
    CN ZL99805925.0 (CN1202246-C)
    EP 99910592.7 (EP1068311)
    JP 2000-543598
    NZ 507093
    US 09/287632
    US 11/364183
    US 11/841737 US20080104732.

 

Title Inventors Country Number
GENETIC SILENCING Graham, Rice, Murphy, Reed JP 2001-569332
BR PI0109269-3
UK GB2377221
SG 91678
ZA 2002/07428

DOUBLE-STRANDED NUCLEIC ACID

 

(LONG HAIR PIN)

Graham, Rice, Roelvink, Suhy, Kolkykhalov, Harrison, Reed. AU 2004243347
NZ 543815
EP 04735856.9
CA 2527907
JP 2006-508084
ZA 2005/09813
SG 200507474-5
IL 172191
US 12/914893 Continuation of 10/861191

RNAi EXPRESSION CONSTRUCTS (single promoter) 

 

Roelvink, Suhy, Kolykhalov, Couto US 7,803,611
US 11/883645
CN 200680010811.3
HK 08112495.7
EP 09015950.0
CA 2596711
AU 2006210443
IL 185315
NZ 560936

 

 16 
 

The Company has also 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)

Trademarks:

Regen has been granted a Notice of Allowance from the United States Patent and Trademark Office on the following marks based on intent to use:

DCELLVAX for pharmaceutical products for the prevention and treatment of cancer;


HEMAXELLERATE for biological tissue, namely, blood, stem cells, umbilical cords and placentas for scientific and medical research use.

Royalty Agreements:

Other than obligations to make royalty payments pursuant to the Benitec Agreement and 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.

 17 
 

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 uses.

 

 18 
 

 

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.

 

Regen has filed an Investigational New Drug (IND) application with the FDA to initiate clinical trials assessing the company’s HemaXellerate I drug currently in development in patients with drug-refractory aplastic anemia. Regen has also filed an IND to initiate a Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene silenced dendritic cell immunotherapy for treating breast cancer. The clinical trials for which the INDs were submitted may not commence until approval to commence such trials has been granted to Regen by the FDA. On December 10, 2015 the Company was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate I in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.

Amount spent during the last fiscal year on research and development activities

 

During the fiscal year ended September 30, 2015 we expended $282,295 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 29, 2014, Regen has 4 employees of which 4 are 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.

 19 
 

 

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

  

Item 3. Legal Proceedings

 

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 Company’s authorized capital stock consists of the following:

 

Common stock, $ 0.0001 par value; 500,000,000 shares authorized: 124,287,272 shares issued and outstanding as of December 29, 2015.

 

With respect to each matter submitted to a vote of stockholders of the Company, 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 Company, 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 Company.

 

Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 30,000 shares issued and outstanding as of December 29, 2015 and 300,000,000 is designated Series A Preferred Stock of which 80,248,364 shares are outstanding as of December 29 , 2015. 

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.

 

 20 
 

 

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 90,000,000 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.

Our common stock is traded on the OTC Bulletin Board as well as the OTC Pink Tier of OTC Markets under the symbol "RGBP”. Prior to September 3, 2014 our common stock was not eligible for trading or quotation on any market or stock exchange. 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.

 

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September 3, 2013 to September 30, 2014  HIGH  LOW
Fourth Quarter  $1.00   $0.01 
           
           
October 1, 2014 to September 30, 2015   HIGH   LOW
First Quarter  $.2798   $.10003 
Second Quarter  $.448   $.081 
Third Quarter  $.37   $.1011 
Fourth Quarter  $.26   $.1002 

 

Holders

 

 

As of September 30, 2015 there were approximately 460 holders of our Common Stock.

 

Dividends

 

No cash dividends were paid during the fiscal year ending September 30, 2015. We do not expect to declare cash dividends in the immediate future.

 

On March 11, 2015 stock dividend of 10,395,217 Series A Preferred shares was paid to the Company’s common shareholders of record as of March 10, 2015. Common shareholders received one share of Series A Preferred Stock for every 10 shares of Regen Biopharma, Inc. common Stock owned as of the Record Date.

 

Recent Sales of Unregistered Securities

 

Common Shares

 

On October 30, 2014 the Company issued 136,000 common shares (“Shares”) to a member of the Company’s Scientific Advisory Board as consideration for services

  

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. 

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On February 13, 2015 the Company issued 9,000,000 of its Common Shares (“Shares”) to David R. Koos, the Company’s Chairman and Chief Executive Officer, as a Restricted stock Award.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On February 13, 2015 the Company issued 7,500,000 of its Common Shares (“Shares”) to Todd Caven, the Company’s Chief Financial Officer, as a Restricted stock Award.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On February 13, 2015 the Company issued 6,000,000 of its Common Shares (“Shares”) to Thomas Ichim, the Company’s Chief Scientific Officer and a member of the Board of Directors, as a Restricted stock Award.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. 

 

On March 6 , 2015 19,932,520 Common Shares (“Shares”) were issued in satisfaction of $557,686 of convertible indebtedness and $890 of accrued interest on Convertible Notes.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 6, 2015 the Company issued 500,000 of its Common Shares (“Shares”) with a fair value of $140,000 as consideration for consulting services rendered.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 6, 2015 the Company issued 227,632 of its Common Shares (“Shares”) with a fair value of $ 63,737 to the Company’s Chief Financial Officer as consideration for consulting services rendered prior to his employment with the Company.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

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Between March 9, 2015 and March 26, 2015 11,606,742 Common Shares (“Shares”) were issued in satisfaction of $325,000 of convertible indebtedness.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On April 14, 2015 the Company issued 1,428, 571 of its common shares (“Shares”) in satisfaction of $40,000 of convertible indebtedness.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On May 12, 2015 the Company issued 500,000 of its common shares (“Shares”) in satisfaction of $15,000 of indebtedness.

 

The 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.

 

On May 18, 2015 the Company issued 500,000 of its common shares (“Shares”) in satisfaction of $15,000 of indebtedness.

 

The 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.

 

On May 19, 2015 the Company issued 1,785,714 of its common shares (“Shares”) in satisfaction of $50,000 of convertible indebtedness.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On July 1, 2015 the company issued 206,121 common shares ( “Shares”) to a consultant for services.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On August 17, 2015 the Company issued 149,954 common shares (“Shares”) to Benitec Australia Limited pursuant to the Company’s License Agreement with Benitec Australia Limited.

 

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The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On September 18, 2015 the Company issued 666,666 common shares (“Shares”) to an individual investor for consideration of $33,333,

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. Cash proceeds received from the investor will be utilized by Regen for general corporate purposes

 

On October 28, 2015 Regen issued 3,333,334 of its common shares (“Shares”) for cash consideration of $166,666.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate

On November 20, 2015 Regen issued 2,200,000 of its common shares (“Shares”) for cash consideration of $55,000.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate purposes

On December 29, 2015 Regen issued 4,000,000 of its common shares ( Shares”) for cash consideration of $100,000

 25 
 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate purposes

Series A Preferred Stock 

On March 17, 2015 the Company issued 26,181,719 shares of its Series A Preferred Stock (“Shares”) in accordance with the terms and conditions of convertible notes issued.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 17, 2015 the Company issued 2,500,000 shares of its Series A Preferred Stock (“Shares”) to David R. Koos, the Company’s Chairman and Chief Executive Officer, as a Restricted Stock Award

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 17, 2015 the Company issued 2,500,000 shares of its Series A Preferred Stock (“Shares”) to Todd Caven, the Company’s Chief Financial Officer, as a Restricted Stock Award

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 17, 2015 the Company issued 2,500,000 shares of its Series A Preferred Stock (“Shares”) to Thomas Ichim, the Company’s Chief Scientific Officer, as a Restricted Stock Award

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

 26 
 

On March 17, 2015 the Company issued 1,000,000 shares of its Series A Preferred Stock (“Shares”) to Thomas Ichim, the Company’s Chief Scientific Officer, as partial consideration for the sale to the company by Ichim of all right, title, and interest in and to the certain invention (hereinafter “Invention”) entitled “Gene Silencing of the Brother of the Regulator of Imprinted Sites” for which a U.S. Patent Number, 8,263,571, issued by the United States Patent and Trademark Office on September 11, 2011.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 17, 2015 the Company issued 2,500,000 shares of its Series A Preferred Stock (“Shares”) to an employee as a Restricted Stock Award.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On March 17, 2015 the Company issued 4,200,000 shares of its Series A Preferred Stock (“Shares”) to consultants for services.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On April 14, 2015 the Company issued 1,428,571 shares of its Series A Preferred Stock (“Shares”) in accordance with the terms and conditions of a convertible note.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

On May 19, 2015 the Company issued 200,000 of its shares of Series A Preferred Stock (“Shares”) as consideration for services rendered by nonemployees.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

 27 
 

 

On May 19, 2015 the Company issued 1,785,714 of its shares of Series A Preferred Stock (“Shares”) in accordance with the terms and conditions of a $50,000 face value convertible note issued by the Company.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

On August 19, 2015 Regen issued 100,000 of its shares of Series A Preferred Stock (“Shares”) as consideration for nonemployee services.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

On September 18, 2015 Regen issued 333,333 of its shares of Series A Preferred Stock (“Shares”) for cash consideration of $16,667.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate purposes.

On October 28, 2015 Regen issued 1,666,667 of its shares of Series A Preferred Stock (“Shares”) for cash consideration of $83,333.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate purposes.

On October 28, 2015 Regen issued 11,000,000 of its shares of Series A Preferred Stock (“Shares”) to Dr. Harry Lander, Regen’s President, pursuant to the terms and conditions of that employment agreement entered into by and between Dr. Lander and Regen dated October 9, 2015.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

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On November 20, 2015 Regen issued 400,000 of its shares of Series A Preferred Stock (“Shares”) as consideration for nonemployee services.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

On November 20, 2015 Regen issued 2,200,000 of its shares of Series A Preferred Stock (“Shares”) for cash consideration of $55,000.

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate purposes.

On December 29, 2015 Regen issued 4,000,000 of its Series A Preferred Stock ( Shares”) for cash consideration of $100,000

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares. The proceeds were utilized for general corporate purposes

Series AA Preferred Stock

On February 13, 2015 the Company issued 10,000 shares of its Series AA Preferred Stock (“Shares”) to Bio Matrix Scientific Group, Inc. (“BMSN”) in satisfaction of $2,000 of indebtedness owed by the company to BMSN.

 

On March 23, 2015 the Company issued 20,000 shares of its Series AA Preferred Stock (“Shares”) to Bio Matrix Scientific Group, Inc. (“BMSN”) in satisfaction of $4,000 of indebtedness owed by the company to BMSN.

 

The 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. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

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CONVERTIBLE NOTES:

 

During the quarter ended March 31, 2015 the Company issued Convertible Notes ( “Notes”) with an aggregate face value of $882,686 . Consideration for these Notes consisted of:

 

(a) $775,000 cash and

(b) Satisfaction of $107,686 of existing indebtedness:

 

Each Note becomes due and payable at the demand of the Lender at any time after one year subsequent to the issuance date and bears simple interest at 10% per annum payable quarterly at the demand of the Lender.

 

All or part of the principal and accrued but unpaid interest is convertible at any time at the demand of the Lender into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to a 65% discount to the lowest Trading Price (as defined below) for the Common Shares during the thirty (30) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the conversion date. “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by Regen and the Lender. “Trading Day” shall mean any day on which the Common Shares are tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Shares are then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by Regen relating to the Lender’s securities. Principal and interest may be prepaid in part or in full by Regen on not less than three Trading Days prior written notice to the Lender.

 

Upon expiration of the six month holding specified in Rule 144(d) promulgated under the Securities Act of 1933, Regen , at the request of the Lender, shale remove sale restrictions on one sixth (1/6) of the shares that resulted from conversions made through the issuance of this Note , each month, for a period of six months, with all restrictions being removed by the Company by the expiration of the six month subsequent to expiration of the aforementioned Rule 144 holding period.

 

If the Lender converts principal into Common Stock of Regen on or prior to 180 days from the issuance of the Note the Lender shall receive one share of Preferred Series “A” Stock of the Company for each share of Common Stock received through conversion.

 

All Notes were fully converted during the quarter ended March 31, 2015. 31,539,262 common shares of Regen were issued to the Convertible Noteholders in satisfaction of the convertible indebtedness. 31,538,862 of the Company’s Series A Preferred shares were issued to Noteholders pursuant to the terms and conditions of the Notes

 

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. A legend was placed on the Notes stating that the Notes have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Notes.

 30 
 

 

Cash proceeds received from all the aforementioned Notes will be utilized by Regen for general corporate purposes. 

 

On April 6, 2015 Regen issued a $40,000 face value Convertible Promissory Note ( “Note”) to joint individual investors (“Lender”) for consideration of $40,000. The Note becomes due and payable at the demand of the Lender at any time after March 6, 2016 and bears simple interest at 10% per annum payable quarterly at the demand of the Lender.

 

All or part of the principal and accrued but unpaid interest is convertible at any time at the demand of the Lender into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent the lower of (1) a 65% discount to the lowest Trading Price (as defined below) for the Common Shares during the thirty (30) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the conversion date. “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by Regen and the Lender. “Trading Day” shall mean any day on which the Common Shares are tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Shares are then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by Regen relating to the Lender’s securities.

 

Or

 

(2) $0.03 per share

 

Principal and interest may be prepaid in part or in full by Regen on not less than three Trading Days prior written notice to the Lender.

 

Upon expiration of the six month holding specified in Rule 144(d) promulgated under the Securities Act of 1933, Regen , at the request of the Lender, shale remove sale restrictions on one sixth (1/6) of the shares that resulted from conversions made through the issuance of this Note , each month, for a period of six months, with all restrictions being removed by the Company by the expiration of the six month subsequent to expiration of the aforementioned Rule 144 holding period.

 

If the Lender converts principal into Common Stock of Regen on or prior to 180 days from the issuance of the Note the Lender shall receive one share of Preferred Series “A” Stock of the Company for each share of Common Stock received through conversion.

 

The Note was 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 Note was sold directly through our management. No commission or other consideration was paid in connection with the sale of the Note. There was no advertisement or general solicitation made in connection with this Offer and Sale of the Note. A legend was placed on the Note stating that the Note has not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Note. Cash proceeds received from the Note will be utilized by Regen for general corporate purposes. On April 14, 2015 1,428,571 Common Shares of Regen were issued in satisfaction of the abovementioned convertible note. On April 14, 2015 the Company issued 1,428,571 shares of its Series A Preferred Stock in accordance with the terms and conditions of abovementioned convertible note.

 

 31 
 

On May 18, 2015 Regen issued a $50,000 face value Convertible Promissory Note ( “Note”) to an individual investor (“Lender”) for consideration of $50,000. The Note becomes due and payable at the demand of the Lender at any time after May 7, 2016 and bears simple interest at 10% per annum payable quarterly at the demand of the Lender.

 

All or part of the principal and accrued but unpaid interest is convertible at any time at the demand of the Lender into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent the lower of (1) a 65% discount to the lowest Trading Price (as defined below) for the Common Shares during the thirty (30) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the conversion date. “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by Regen and the Lender. “Trading Day” shall mean any day on which the Common Shares are tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Shares are then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by Regen relating to the Lender’s securities.

 

Or

 

(2) $0.03 per share

 

Principal and interest may be prepaid in part or in full by Regen on not less than three Trading Days prior written notice to the Lender.

 

Upon expiration of the six month holding specified in Rule 144(d) promulgated under the Securities Act of 1933, Regen , at the request of the Lender, shale remove sale restrictions on one sixth (1/6) of the shares that resulted from conversions made through the issuance of this Note , each month, for a period of six months, with all restrictions being removed by the Company by the expiration of the six month subsequent to expiration of the aforementioned Rule 144 holding period.

 

If the Lender converts principal into Common Stock of Regen on or prior to 180 days from the issuance of the Note the Lender shall receive one share of Preferred Series “A” Stock of the Company for each share of Common Stock received through conversion.

 

The Note was 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 Note was sold directly through our management. No commission or other consideration was paid in connection with the sale of the Note. There was no advertisement or general solicitation made in connection with this Offer and Sale of the Note. A legend was placed on the Note stating that the Note has not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Note. Cash proceeds received from the Note will be utilized by Regen for general corporate purposes. On May 19, 2015 1,785,714 Common Shares of Regen were issued in satisfaction of the abovementioned convertible note. On May 19, 2015 the Company issued 1,785,714 shares of its Series A Preferred Stock in accordance with the terms and conditions of abovementioned convertible note.

 

 32 
 

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, 2014, we had Cash in the amount of $0 and as of September 30, 2015 we had Cash in the amount of $38,620.

 

The increase in Cash is attributable to:

 

Net Cash Borrowings of $138,583 during the twelve months ended September 30, 2015.

 

$775,000 paid to the Company as a result of issuance of convertible notes during the six months ended March 31, 2015

 

$90,000 paid to the Company as a result of issuance of convertible notes during the three months ended June 30, 2015

Offset by expenses incurred by the Company in the operation of its business and payment of its obligations, rental payments paid to Entest Biomedical, Inc. by the Company and $1,629 loaned to Entest Biomedical, Inc. by the Company during the twelve months ended September 30, 2015.

 

As of September 30, 2014, we had Prepaid Expenses in the amount of $0 and as of September 30, 2015 we had Prepaid Expenses in the amount of $10,000.

 

The increase in Prepaid Expenses is attributable to $10,000 of salary prepaid to Thomas Ichim, the Company’s then Chief Scientific Officer.

 

 As of September 30, 2014 we had Notes Receivable of $10,422 and as of September 30, 2015 we had notes Receivable of $12,051.

 

The increase in Notes Receivable of 16% is attributable to $1,629 loaned to Entest Biomedical, Inc during the year ended September 30, 2015

As of September 30, 2014 we had Accrued Interest Receivable of $233 and as of September 30, 2015 we had Accrued Interest Receivable of $1,381.

 

The increase in Accrued Interest Receivable of 492% is attributable to interest accrued but not yet paid on funds loaned to Entest Biomedical, Inc. by the Company.

 

As of September 30, 2014 we had Available for Sale Securities of $0 and as of September 30, 2015 we had Available for Sale Securities of $158,400.

 

The increase in Available for Sale Securities is attributable to 8,000,000 of the common shares of Entest Biomedical, Inc. issued on behalf of Zander Therapeutics, Inc. (“Zander”) in satisfaction of one hundred thousand US dollars ($100,000) to be paid to the Company by Zander as a license initiation fee pursuant to an agreement by and between Zander and the Company.

 

As of September 30, 2014 we had Bank Overdraft of $6,137 and as of September 30, 2015 we had Bank Overdraft of $0.

 

The decrease in Bank Overdraft is attributable to loans made to the Company during the quarter ended December 31, 2014.

 

 33 
 

As of September 30, 2014 we had Accounts Payable of $3,305 and as of September 30, 2015 we had Accounts Payable of $25,854.

The increase in Accounts Payable of approximately 683% is attributable to increases in outstanding obligations of the Company incurred in the course of business.

As of September 30, 2014 we had Notes Payable of $120,169 and as of September 30, 2015 we had Notes Payable of $222,751

The increase in Notes Payable of approximately 85% is attributable to:

(a)$25,650 loaned to Regen by Regen’s Chief Executive Officer during the twelve months ended September 30, 2015
(b)$283,000 loaned to Regen by third party lenders during the twelve months ended September 30, 2015
(c)$8,500 loaned to the Company by Bio Matrix Scientific Group, Inc.( a company under common control with the Company) during the twelve months ended September 30, 2015

 Offset by:

(d)$72,799 in principal repayments of amounts owed to Bio Matrix Scientific Group, Inc.( a company under common control with the Company) during the twelve months ended September 30, 2015
(a)$6,000 of principal indebtedness to Bio Matrix Scientific Group, Inc.( a company under common control with the Company) satisfied through the issuance of equity securities of the Company
(b)$55,768 of principal indebtedness owed to the Company’s Chief Executive Officer reclassified as Convertible Notes Payable.
(c)$50,000 of third party principal indebtedness reclassified as Convertible Notes Payable.
(d)$30,000 of third party principal indebtedness satisfied through the issuance of equity securities of the Company

 As of September 30, 2014 we had Accrued Payroll Taxes of $8,463 and as of September 30, 2015 we had Accrued Payroll Taxes of $1,940.

The decrease in Accrued Payroll Taxes of approximately 77% is attributable to payment by the Company of employer tax obligations incurred but unpaid.

 As of September 30, 2014 we had Accrued Interest of $2,212 and as of September 20, 2015 we had Accrued Interest of $21,093. 

 

The increase in Accrued Interest of approximately 853% is attributable to interest accrued but unpaid on Notes Payable.

 

As of September 30, 2105 we had Accrued Rent of $10,000 and as of September 30, 2014 we had Accrued Rent of $0.

 

The increase in Accrued Rent is attributable to rental expense incurred but not paid for the months of August 2015 and September 2015.

 

As of September 30, 2015 we had Accrued Payroll of $36,001 and as of September 30, 2014 we had Accrued Payroll of $0.

 

 34 
 

 

The increase in Accrued Payroll is attributable to:

 

$15,000 of Salary Accrued but unpaid owed to Regen’s Chief Executive Officer

$20,050 of Salary Accrued but unpaid owed to Regen’s Chief Financial Officer

$751 of Salary Accrued but unpaid owed to a non-executive employee.

 

Material Changes in Results of Operations

 

Revenues from continuing operations were $192,000 for the fiscal year ended September 30, 2015 and $0 for the fiscal year ended September 30, 2014. Net losses were$11,195,147 for the fiscal year ended September 30, 2015 and $756,353 for the same year ended 2014.

 

The increase in Net Losses of 1,380 % is primarily attributable to $9,191,857 of expenses recognized during the twelve months ended September 30, 2015 resulting from the issuance for less than fair value of common shares in satisfactions of indebtedness, the recognition of $58,000 of Rental Expenses, and increases in Research and Development Related expenses, General and Administrative Expenses, and Interest Expense offset by the recognition of Revenue in the amount of $192,000 and Interest Income in the amount of $1,148.

 

As of September 30, 2015 we had $38,620 cash on hand and current liabilities of $317,639 such liabilities consisting of Accounts Payable, Notes Payable, 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 plans to meet cash needs through applying for governmental and non-governmental grants as well as 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. There is no guarantee that the Company will be able to raise any capital through any type of offerings. Management can give no assurance that any governmental or non-governmental grant will be obtained by the Company despite the Company’s best efforts. As of February 19, 2014 The Company has identified the National Heart Lung and Blood Institute Clinical Trial Pilot Studies (R34) grant which provides up to $450,000 in funding over a period of three years as well as the Omnibus Solicitation of the NIH for Small Business Technology Transfer Grant Applications administered by the Small Business Innovation Research (SBIR) program of the National Institute of Health as grants for which the Company intends to apply.

 

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 the amount of additional financing in the future that we currently anticipate. 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. During the nine months ended June 30, 2015 the Company raised $865,000 through the issuance of convertible debt. All principal convertible debt issued by the Company has been converted into equity as of June 30, 2015. During the three months ended September 30, 2015 the Company raised $50,000 through the issuance of equity securities.

 

As of December 29, 2015 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.

 

 35 
 

Item 8. Financial Statements and Supplementary Data

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

To the Board of Directors and Stockholders of

Regen BioPharma, Inc.

 

 

We have audited the accompanying balance sheets of Regen BioPharma, Inc. as of September 30, 2014 and 2015, and the related statements of operations, comprehensive income, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period ended September 30, 2015. Regen BioPharma, Inc.’s management is responsible for these financial statements. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, 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. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Regen BioPharma, Inc. as of September 30, 2014 and 2015, and the results of its operations and cash flows for each of the years in the two-year period ended September 30, 2015 in conformity with accounting principles generally accepted in the United States of America.

 

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 negative working capital at September 30, 2015, 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/ Seale and Beers, CPAs

 

Seale and Beers, CPAs

Las Vegas, Nevada

January 4, 2016

 

 36 
 

 

REGEN BIOPHARMA , INC.     
BALANCE SHEET     
       
   As of  As of
   September 30, 2015  September 30, 2014
       
ASSETS      
CURRENT ASSETS          
Cash  $38,620   $0 
Note Recievable   12,051    10,422 
Prepaid Expenses   10,000    0 
Accrued Interest Receivable   1,381    233 
     Total Current Assets   62,052    10,655 
           
OTHER ASSETS          
Available for Sale Securities   158,400    0 
Total Other Assets   158,400    0 
           
TOTAL ASSETS  $220,452   $10,655 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities:          
Bank Overdraft   0    6,137 
Accounts payable   25,854    3,305 
Notes Payable   222,751    120,169 
Accrued payroll taxes   1,940    8,463 
Accrued Interest   21,093    2,212 
Accrued Rent   10,000    0 
Accrued Payroll   36,001    0 
Total Current Liabilities   317,639    140,286 
Total Liabilities  $317,639   $140,286 
           
STOCKHOLDERS' EQUITY (DEFICIT)          
Common Stock ($.0001 par value) 500,000,000 shares authorized; 114,753,938 issued and outstanding as of September 30, 2015 and 51,907,917 shares issued and outstanding September  30, 2014   11,474    5,191 
Preferred Stock, 0.0001 par value, 100,000,000 authorized and 5,000,000 authorized as of September 30, 2015 and September 30, 2014 respectively          
Series A Preferred 90,000,000 Authorized and 0 authorized, 60,981,697 and 0 outstanding as of  September  30, 2105 and September 30, 2014 respectively   6,098    0 
Series AA Preferred ($0.0001 par value) 600,000 authorized and 30, 000  and 0 outstanding as of September  30, 2015 and September 30, 2014 respectively   3    0 
Additional Paid in capital   11,663,905    485,097 
Contributed Capital   728,658    658,658 
Retained Earnings (Deficit) accumulated during the development stage   (12,473,725)   (1,278,577)
Accumulated Other Comprehensive Income   (33,600)   0 
Total Stockholders' Equity (Deficit)  $(97,187)  $(129,631)
           
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT)  $220,452   $10,655 
           
The Accompanying Notes are an Integral Part of These Financial Statements

 37 
 

REGEN BIOPHARMA , INC.     
STATEMENT OF OPERATIONS     
       
    Year Ended     Year Ended  
    September 30, 2015    September 30, 2014 
           
           
           
REVENUES  $192,000   $0 
           
COST AND EXPENSES          
Research and Development   282,295    23,867 
General and Administrative   1,314,208    523,906 
Consulting and Professional Fees   516,701    158,581 
Rent   58,071    0 
Total Costs and Expenses  $2,171,276   $706,354 
           
OPERATING LOSS   (1,979,276)   (706,354)
           
OTHER INCOME & (EXPENSES)          
Interest Income   1,148    233 
Refunds of amounts previously paid   0    490 
Interest Expense   (21,688)   (2,212)
Capital contribution to parent        (48,510)
Loss on issuance of common shares for less than fair value   (9,191,857)   0 
Preferred shares issued pursuant contractual obligations   (3,475)   0 
           
TOTAL OTHER INCOME (EXPENSE)  $(9,215,872)  $(49,999)
           
NET INCOME (LOSS)   (11,195,147)   (756,353)
BASIC AND FULLY DILUTED EARNINGS (LOSS) PER SHARE   (0.1270)   (0.0146)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING   88,185,098    51,731,057 
           
The Accompanying Notes are an Integral Part of These Financial Statements

 38 
 

REGEN BIOPHARMA , INC.     
STATEMENT OF COMPREHENSIVE INCOME     
       
    Year Ended     Year Ended  
    September 30, 2015    September 30, 2014 
           
           
           
Net Income (Loss)   (11,195,147)   (756,353)
Add:          
Unrealized Gains on Securities   0    0 
Less:        
Unrealized Losses on Securities   (33,600)   0 
Total Other Comprehensive Income (Loss)   (33,600)   0 
Comprehensive Income   (11,228,747)   (756,353)
           
The Accompanying Notes are an Integral Part of These Financial Statements

 39 
 

 

REGEN BIOPHARMA , INC.                                 
Statement of shareholder's equity                                
For the years ended  September 30, 2015 and 2014                           
                                  
                                
    Series A Preferred    Series AA Preferred    Common                       
    Shares    Amount    Shares    Amount    Shares    Amount    Additional Paid-In Capital    Retained Earnings    Contributed Capital    Accumulated Other Comprehensive Income (Loss)    Total 
                                                       
Balance September 30, 2013                       51,610,000    5,161    185,127    (522,224)   447,858         115,922 
Common Stock issued for Cash at $1.00 per share issued October 14, 2013                       100000    10    99990                   100000 
Common Stock issued for Cash at $1.00 per share issued November 15, 2013                       100000    10    99990                   100000 
Common Stock issued for Cash at $1.00 per share issued December 12, 2013                       100000    10    99990                   100000 
Contributed Capital October 1, 2013 to December 31 2013                                           45000         45000 
Net Loss October 1, 2013 to December 31, 2103                                      (209,529)             (209,529)
Balance December 31, 2013                       51,910,000    5,191    485,097    (731,753)   492,858         251,393 
Contributed Capital January 1, 2014 to March 31 2014                                           50000         50000 
Net Loss January 1, 2014 to March 31 2014                                      (186,201)             (186,201)
                                                        
Balance March 31, 2014                       51,910,000    5,191    485,097    (917,954)   542,858         115,192 
Common Stock cancelled June 26, 2014                       (2,083)                              
Contributed Capital April 1, 2014 to June 30, 2014                                           45000         45000 
Net Loss April 1, 2014 to June 30, 2014                                      (166,021)             (166,021)
Balance June 30 , 2014                       51,907,917    5,191    485,097    (1,083,975)   587,858         (5,829)
Contributed Capital July 1, 2014 to September 30, 2014                                           70,800         70,800 
Net Loss July 1, 2014 to September 30, 2014                                      (194,602)             (194,602)
Balance September 30, 2014                       51,907,917    5,191    485,097    (1,278,577)   658,658         (129,631)
Common Stock issued to Consultant 10/30/2014                       136,000    14    22,426                   22,440 
Contributed Capital October 1, 2014 to December 31, 2014                                           65,000         65,000 
Net Loss October 1, 2014 to December 31, 2014                                      (219,191)             (219,191)
Balance  December 31, 2014   0    0    0    0    52,043,917    5,205    507,523    (1,497,768)   723,658         (261,382)
Restricted Stock award issued to Employee 2/13/2015                       9,000,000    900    (900)                  0 
Restricted Stock award issued to Employee 2/13/2015                       7,500,000    750    (750)                  0 
Restricted Stock award issued to Employee 2/13/2015                       6,000,000    600    (600)                  0 
Restricted Stock award issued to Employee 2/13/2015                       2,500,000    250    (250)                  0 
Preferred Stock issued for Debt             10,000    1              1,999                   2,000 
Common Shares issued for services 3/6/2015                       500,000    50    139,950                   140,000 
Common Shares issued for services 3/6/2015                       227,632    23    63,716                   63,739 
Common Shares issued for debt  March 6, 2015                       19,932,520    1,993    556,582                   558,575 
Common Shares issued for debt  March 9, 2015                       6,249,599    625    174,375                   175,000 
Preferred Stock issued as dividend 3/11/2015   10,395,217    1,040                        (1,040)                  0 
Common Shares issued for debt March 17,2015                       1,785,714    179    49,821                   50,000 
Common Shares issued for debt March 26,2015                       3,571,429    357    99,643                   100,000 
Restricted Stock award issued to Employees 3/17/2015   10,000,000    1,000                        (1,000)                  0 
Preferred Shares issued for Purchase of Patent   1,000,000    100                                            100 
Preferred Shares issued pursuant to contractual obligations 3/17/2015   31,538,862    3,154                                            3,154 
Preferred Shares issued for Debt             20,000    2              3,998                   4,000 
Preferred Shares issued to Consultants for Services 3/26/2015   4,200,000    420                                            420 
Loss on Issuance of Securities  for Less than fair value recognized during quarter                                 8,179,432                   8,179,432 
Restricted Stock Award compensation expense recognized during Quarter ended march 31, 2015                                 132,603                   132,603 
Contributed Capital January 1, 2015 to March 31, 2015                                           20,000         20,000 
Net Loss for the quarter ended March 31, 2015                                      (8,812,902)             (8,812,902)
Balance  March  31, 2015   57,134,079    5,714    30,000    3    109,310,811    10,932    9,905,102    (10,310,670)   743,658         354,739 
common Shares issued for debt 4/14/2015                       1,428,571    143    39,857                   40,000 
Preferred Shares issued pursuant to contractual obligations 4/14/2015   1,428,571    143                                            143 
Common Shares issued for Debt 5/12/2014                       500,000    50    14,950                   15,000 
Common Shares issued for Debt 5/18/2014                       500,000    50    14,951                   15,000 
Preferred Shares issued to Consultants for Services 5/19/2015   200,000    20                                            20 
Common Shares issued for Debt 5/19/2015                       1,785,714    178    49,822                   50,000 
Preferred Shares issued pursuant to contractual Obligations 5/19/2015   1,785,714    178                                            178 
Loss on Issuance of Securities  for Less than fair value recognized during quarter                                 937,425                   937,425 
Restricted Stock Award compensation expense recognized during Quarter ended June 30, 2015                                 247,588                   247,588 
Contributed Capital April 1, 2015 to June 30, 2015                                           (15,000)        (15,000)
Net Loss for the quarter ended June 30, 2015                                      (1,562,371)             (1,562,371)
Balance June 30, 2015   60,548,364    6,055    30,000    3    113,525,096    11,353    11,209,694    (11,873,041)   728,658         82,722 
Common Shares issued for services to Consultant 7/01/2015                       412,242    41    61,795                   61,836 
Common Shares issued for services to Consultant 8/17/2015                       149,934    14    19,927                   19,941 
Preferred Shares issued for services to Consultant 8/19/2015   100,000    10                                            10 
Common Shares issued for Cash at $0.05 per share issued 9/18/2015                       666,666    66    33,267                   33,333 
Preferred Shares issued for Cash at $0.05 per share issued 9/18/2015   333,333    33                        16,634                   16,667 
Loss on Issuance of Securities  for Less than fair value recognized during quarter                                 75,000                   75,000 
Restricted Stock Award compensation expense recognized during Quarter ended September 30, 2015                                 247,588                   247,588 
Unrealized Loss on Securities Available for Sale recognized during Quarter ended September 30, 2015                                                (33,600)   (33,600)
Net Loss for the quarter ended September 30, 2015                                      (600,684)             (600,684)
Balance September 30, 2015   60,981,697    6,098    30,000    3    114,753,938    11,474    11,663,905    (12,473,725)   728,658    (33,600)   (97,187)
                                                        
The Accompanying Notes are an integral part of these Financial Statements

 40 
 

       
REGEN BIOPHARMA , INC.     
STATEMENT OF CASH FLOWS     
      
   Year Ended  Year Ended
   30-Sep-15  30-Sep-14
       
       
       
CASH FLOWS FROM OPERATING ACTIVITIES          
           
Net Income (loss)   (11,195,147)   (756,353)
Adjustments to reconcile net Income to net cash          
Securities Received as Payment for Services   (192,000)   0 
Preferred Stock issued for Expenses   100    0 
Predrred Stock issued for interest   891    0 
Common Stock issued for expenses          
Preferred Stock issued pursuant to contractual obligations   3,475    0 
Common Stock issued to Consultants   307,955    0 
Preferred Stock issued to Consultants   450    0 
Changes in operating assets and liabilities:          
Increase (Decrease) in Accounts Payable   22,549    3,305 
(Increase) Decrease in Notes Receivable   (1,629)   (10,422)
(Increase) Decrease in Interest  Receivable   (1,148)   (233)
Increase ( Decrease) in Bank Overdraft   (6,137)   6,137 
Increase (Decrease) in accrued Expenses   58,359    10,675 
(Increase) Decrease in Prepaid Expenses   (10,000)   0 
Net Cash Provided by (Used in) Operating Activities   (11,012,283)   (746,891)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Common Stock issued for Cash   33,333    300,000 
Preferred Stock issued for Cash   16,667    0 
Increase in Contributed Capital   70,000    210,800 
Increase (Decrease)  in Notes Payable   138,582    120,169 
Increase in Convertible Notes payable   972,686    0 
Increase in issuance of stock below fair value   9,191,857    0 
Increase in Additional Paid in Capital   627,778    0 
Net Cash Provided by (Used in) Financing Activies   11,050,903    630,969 
           
           
Net Increase (Decrease) in Cash  $38,620    (115,922)
           
Cash at Beginning of Period   0    115,922 
           
Cash at End of Period  $38,620    0 
           
           
Supplemental Disclosure of Noncash investing and financing activities:          
Common Shares Issued for Debt  $1,002,686    0 
Preferred Shares issued for Debt  $6,000    0 
Cash Paid for Interest   0    0 
Cash Paid for Income Tax   0    0 
           
The Accompanying Notes are an Integral Part of These Financial Statements

 41 
 

 

REGEN BIOPHARMA, INC.

Notes to Financial Statements

As of September  30, 2015    

 

NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES  

 

The Company was organized April 24, 2012 under the laws of the State of Nevada. The Company is a majority owned subsidiary of Bio-Matrix Scientific Group, Inc, a Delaware corporation.  

 

The Company intends to engage primarily in the development of regenerative medical applications which we intend to license 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  

 

A. BASIS OF ACCOUNTING  

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.  

 

B. USE OF ESTIMATES  

 

The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.  

 

C. CASH EQUIVALENTS  

 

The Company considers all highly liquid investments with a maturity of three months or less when purchased to be cash equivalents.    

 

D. PROPERTY AND EQUIPMENT  

 

Property and equipment are recorded at cost. Maintenance and repairs are expensed in the year in which they are incurred. Expenditures that enhance the value of property and equipment are capitalized.  

 

E. FAIR VALUE OF FINANCIAL INSTRUMENTS  

 

Fair value is the price that would be received for an asset or the exit price that would be paid to transfer a liability in the principal or most advantageous market in an orderly transaction between market participants on the measurement date.  A fair value hierarchy requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required by the standard that the Company uses to measure fair value:  

 

Level 1:  Quoted prices in active markets for identical assets or liabilities.

 

Level 2:  Observable inputs other than Level 1 prices such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities.

 

Level 3:  Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities.

 

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F. INCOME TAXES  

 

The Company accounts for income taxes using the liability method prescribed by ASC 740, “Income Taxes.” Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and tax bases of assets and liabilities using enacted tax rates that will be in effect in the year in which the differences are expected to reverse. The Company records a valuation allowance to offset deferred tax assets if based on the weight of available evidence, it is more-likely-than-not that some portion, or all, of the deferred tax assets will not be realized. The effect on deferred taxes of a change in tax rates is recognized as income or loss in the period that includes the enactment date.  

 

The Company applied the provisions of ASC 740-10-50, “Accounting For Uncertainty In Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of September 30, 2015 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.  

 

The Company generated a deferred tax credit through net operating loss carry forward.  However, a valuation allowance of 100% has been established.  

 

Interest and penalties on tax deficiencies recognized in accordance with ACS accounting standards are classified as income taxes in accordance with ASC Topic 740-10-50-19.  

 

G.  BASIC EARNINGS (LOSS) PER SHARE  

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception.  

 

Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding.  

 

H. ADVERTISING  

 

Costs associated with advertising are charged to expense as incurred. Advertising expenses were $0 for the year ended September 30, 2015 and $0 for the year ended September  30, 2014.

 

 43 
 

 

NOTE 2.  RECENT ACCOUNTING PRONOUNCEMENTS  

 

In June 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-10, which eliminated certain financial reporting requirements of companies previously identified as "Development Stage Entities" (Topic 915). The amendments in this ASU simplify accounting guidance by removing all incremental financial reporting requirements for development stage entities. The amendments also reduce data maintenance and, for those entities subject to audit, audit costs by eliminating the requirement for development stage entities to present inception-to-date information in the statements of income, cash flows, and shareholder equity. Early application of each of the amendments is permitted for any annual reporting period or interim period for which the entity's financial statements have not yet been issued (public business entities) or made available for issuance (other entities). Upon adoption, entities will no longer present or disclose any information required by Topic 915. The Company has adopted this standard.  

 

The following accounting standards updates were recently issued and have not yet been adopted by us. These standards are currently under review to determine their impact on our consolidated financial position, results of operations, or cash flows.  

 

In May 2014, FASB issued Accounting Standards Update (ASU) No. 2014-09, Revenue from Contracts with Customers. The revenue recognition standard affects all entities that have contracts with customers, except for certain items. The new revenue recognition standard eliminates the transaction-and industry-specific revenue recognition guidance under current GAAP and replaces it with a principle-based approach for determining revenue recognition. Public entities are required to adopt the revenue recognition standard for reporting periods beginning after December 15, 2016, and interim and annual reporting periods thereafter. Early adoption is not permitted for public entities. The Company has reviewed the applicable ASU and has not, at the current time, quantified the effects of this pronouncement, however it believes that there will be no material effect on the consolidated financial statements.

 

In June 2014, FASB issued Accounting Standards Update (ASU) No. 2014-12 Compensation — Stock Compensation (Topic 718), Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could Be Achieved after the Requisite Service Period. A performance target in a share-based payment that affects vesting and that could be achieved after the requisite service period should be accounted for as a performance condition under Accounting Standards Codification (ASC) 718, Compensation — Stock Compensation. As a result, the target is not reflected in the estimation of the award's grant date fair value. Compensation cost would be recognized over the required service period, if it is probable that the performance condition will be achieved. The guidance is effective for annual periods beginning after 15 December 2015 and interim periods within those annual periods. Early adoption is permitted. The Company has reviewed the applicable ASU and has not, at the current time, quantified the effects of this pronouncement, however it believes that there will be no material effect on the consolidated financial statements.

 

In August2014, FASB issued Accounting Standards Update (ASU) No. 2014-15 Preparation of Financial Statements – Going Concern (Subtopic 205-40), Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. Under generally accepted accounting principles (GAAP), continuation of a reporting entity as a going concern is presumed as the basis for preparing financial statements unless and until the entity's liquidation becomes imminent. Preparation of financial statements under this presumption is commonly referred to as the going concern basis of accounting. If and when an entity's liquidation becomes imminent, financial statements should be prepared under the liquidation basis of accounting in accordance with Subtopic 205-30, Presentation of Financial Statements—Liquidation Basis of Accounting. Even when an entity's liquidation is not imminent, there may be conditions or events that raise substantial doubt about the entity's ability to continue as a going concern. In those situations, financial statements should continue to be prepared under the going concern basis of accounting, but the amendments in this Update should be followed to determine whether to disclose information about the relevant conditions and events. The amendments in this Update are effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Early application is permitted. The Company will evaluate the going concern considerations in this ASU, however, at the current period, management does not believe that it has met the conditions which would subject these financial statements for additional disclosure.  

 

On January 31, 2013, the FASB issued Accounting Standards Update [ASU] 2013-01, entitled Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities. The guidance in ASU 2013-01 amends the requirements in the FASB Accounting Standards Codification [FASB ASC] Topic 210, entitled Balance Sheet. The ASU 2013-01 amendments to FASB ASC 210 clarify that ordinary trade receivables and receivables in general are not within the scope of ASU 2011-11, entitled Disclosure about Offsetting Assets and Liabilities, where that ASU amended the guidance in FASB ASC 210. As those disclosures now are modified with the ASU 2013-01 amendments, the FASB ASC 210 balance sheet offsetting disclosures now clearly are applicable only where reporting entities are involved with bifurcated embedded derivatives, repurchase agreements, reverse repurchase agreements, and securities borrowing and lending transactions that either are offset using the FASB ASC 210 or 815 requirements, or that are subject to enforceable master netting arrangements or similar agreements. ASU 2013-01 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The adoption of this ASU is not expected to have a material impact on our financial statements.

 

 44 
 

 

On February 28, 2013, the FASB issued Accounting Standards Update [ASU] 2013-04, entitled Obligations Resulting from Joint and Several Liability Arrangements for Which the Total Amount of the Obligation Is Fixed at the Reporting Date. The ASU 2013-04 amendments add to the guidance in FASB Accounting Standards Codification [FASB ASC] Topic 405, entitled Liabilities and require reporting entities to measure obligations resulting from certain joint and several liability arrangements where the total amount of the obligation is fixed as of the reporting date, as the sum of the following:  

 

The amount the reporting entity agreed to pay on the basis of its arrangement among co-obligors.  

 

Any additional amounts the reporting entity expects to pay on behalf of its co-obligors.  

 

While early adoption of the amended guidance is permitted, for public companies, the guidance is required to be implemented in fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments need to be implemented retrospectively to all prior periods presented for obligations resulting from joint and several liability arrangements that exist at the beginning of the year of adoption. The adoption of ASU 2013-04 is not expected to have a material effect on the Company’s operating results or financial position.  

 

On April 22, 2013, the FASB issued Accounting Standards Update [ASU] 2013-07, entitled Liquidation Basis of Accounting. With ASU 2013-07, the FASB amends the guidance in the FASB Accounting Standards Codification [FASB ASC] Topic 205, entitled Presentation of Financial Statements. The amendments serve to clarify when and how reporting entities should apply the liquidation basis of accounting. The guidance is applicable to all reporting entities, whether they are public or private companies or not-for-profit entities. The guidance also provides principles for the recognition of assets and liabilities and disclosures, as well as related financial statement presentation requirements. The requirements in ASU 2013-07 are effective for annual reporting periods beginning after December 15, 2013, and interim reporting periods within those annual periods. Reporting entities are required to apply the requirements in ASU 2013-07 prospectively from the day that liquidation becomes imminent. Early adoption is permitted. The adoption of ASU 2013-07 is not expected to have a material effect on the Company’s operating results or financial position.

 

A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies.  Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.  

 

NOTE 3. GOING CONCERN  

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company generated net losses of $ 12,473,725  during the period from April 24, 2012 (inception) through September 30, 2015. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.  

 

Management plans to raise additional funds by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. During the quarter ended March 31, 2015 the Company raised $775,000 through the issuance of convertible debt ,  during the quarter ended June 30, 2015 the Company raised $90,000 through the issuance of convertible debt ( Note 4) and during the quarter ended September 30, 2015 the Company raised $50,000 through the issuance of 333,333 units of securities of the Company (“Units”) with each Unit consisting of 2 common shares and one share of the Company’s Series A Preferred Stock .  

 

 45 
 

 

NOTE 4. NOTES PAYABLE AND CONVERTIBLE NOTES PAYABLE

 

   September  30, 2015  September 30,
2014
Bio Matrix Scientific Group, Inc. (Note 7)   19,701    90,000 
David Koos ( Notes7)   50    30,168 
Bio Technology Partners Business Trust   84,000    0 
Bostonia Partners   119,000    0 
           
Notes payable  $222,751   $120,168 

 

$19,701 lent to the Company by Bio Matrix Scientific Group, Inc. is due and payable at the demand of the holder and bear simple interest at a rate of 10% per annum. This amount was loaned pursuant to a Line of Credit Promissory Note issued by Regen in the maximum amount of $700,000 or so much thereof as may be disbursed to, or for the benefit of the Borrower by Lender in Lender's sole and absolute discretion      

 

$50 lent to the Company by David Koos. is due and payable at the demand of the holder and bear simple interest at a rate of 15% per annum. This amount was loaned pursuant to a Line of Credit Promissory Note issued by Regen in the maximum amount of $700,000 or so much thereof as may be disbursed to, or for the benefit of the Borrower by Lender in Lender's sole and absolute discretion      

 

$84,000 lent to the Company by Bio Technology Partners Business Trust. is due and payable at the demand of the holder and bear simple interest at a rate of 10% per annum. This amount was loaned pursuant to a Line of Credit Promissory Note issued by Regen in the maximum amount of $500,000 or so much thereof as may be disbursed to, or for the benefit of the Borrower by Lender in Lender's sole and absolute discretion    

 

$60,000  lent to the Company by Bostonia Partners is due and  payable September 16, 2016 and bear simple interest at a rate of 10% per annum  

 

$59,000  lent to the Company by Bostonia Partners is due and  payable September 22, 2016 and bear simple interest at a rate of 10% per annum.  

 

The weighted average interest rate on all borrowings by Regen due in one year or less is 10% as of September 30, 2015.

 

The weighted average interest rate on all borrowings by Regen due in one year or less is 11.25% as of September 30, 2014.    

 

 46 
 

CONVERTIBLE NOTES PAYABLE  

 

During the quarter ended March 31, 2015 the Company issued Convertible Notes ( “Notes”) with an aggregate face value of $882,686 . Consideration for these Notes consisted of:  

 

(a) $775,000 cash and

(b) Satisfaction of $107,686 of existing indebtedness:  

 

Each Note becomes due and payable at the demand of the Lender at any time after one year subsequent to the issuance date and bears simple interest at 10% per annum payable quarterly at the demand of the Lender.  

 

All or part of the principal and accrued but unpaid interest is convertible at any time at the demand of the Lender into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent to a 65% discount to the lowest Trading Price (as defined below) for the Common Shares during the thirty (30) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the conversion date. “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by Regen and the Lender. “Trading Day” shall mean any day on which the Common Shares are tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Shares are then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by Regen relating to the Lender’s securities. Principal and interest may be prepaid in part or in full by Regen on not less than three Trading Days prior written notice to the Lender.  

 

Upon expiration of the six month holding specified in Rule 144(d) promulgated under the Securities Act of 1933, Regen , at the request of the Lender, shale remove sale restrictions on one sixth (1/6) of the shares that resulted from conversions made through the issuance of this Note , each month, for a period of six months, with all restrictions being removed by the Company by the expiration of the six month subsequent to expiration of the aforementioned Rule 144 holding period.  

 

If the Lender converts principal into Common Stock of Regen on or prior to 180 days from the issuance of the Note the Lender shall receive one share of Preferred Series “A” Stock of the Company for each share of Common Stock received through conversion.  

 

All Notes were fully converted during the quarter ended March 31, 2015. 31,539,262 common shares of Regen were issued to the Convertible Noteholders in satisfaction of the convertible indebtedness. 31,538,862 of the Company’s Series A Preferred shares were issued to Noteholders pursuant to the terms and conditions of the Notes.  

 

The Company analyzed the conversion feature of the Notes for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.  

 

 47 
 

 

The Company values the embedded derivative using the Black-Scholes pricing model and an aggregate derivative liability of $2,368,685 was recognized by the Company. This liability was eliminated prior to the end of the Company’s second quarter as a result of the full conversion of all Notes prior to the end of the Company’s second quarter.  

 

During the quarter ended June 30, 2015 the Company issued Convertible Notes ( “Notes”) with an aggregate face value of $90,000 . Consideration for these Notes consisted of $90,000.

 

All or part of the principal and accrued but unpaid interest is convertible at any time at the demand of the Lender into the Common Shares of Regen at a price per share ( “Conversion Price”) equivalent the lower of (1) a 65% discount to the lowest Trading Price (as defined below) for the Common Shares during the thirty (30) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the conversion date. “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by Regen and the Lender. “Trading Day” shall mean any day on which the Common Shares are tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Shares are then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by Regen relating to the Lender’s securities.      

 

Or      

 

(2) $0.03 per share      

 

Principal and interest may be prepaid in part or in full by Regen on not less than three Trading Days prior written notice to the Lender.      

 

Upon expiration of the six month holding specified in Rule 144(d) promulgated under the Securities Act of 1933, Regen , at the request of the Lender, shale remove sale restrictions on one sixth (1/6) of the shares that resulted from conversions made through the issuance of this Note , each month, for a period of six months, with all restrictions being removed by the Company by the expiration of the six month subsequent to expiration of the aforementioned Rule 144 holding period.      

 

If the Lender converts principal into Common Stock of Regen on or prior to 180 days from the issuance of the Note the Lender shall receive one share of Preferred Series “A” Stock of the Company for each share of Common Stock received through conversion.