10-K/A 1 rgbp093016form10ka.htm FORM 10-K/A

 

United States Securities and Exchange Commission

Washington, D.C.  20549

 

Form 10-K/A

Amendment No. 1

 

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

 

For the fiscal year ending September 30, 2016

 

☐  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:  $ 9,613,294

 

As of December 13, 2016 Regen Biopharma, Inc. had 145,212,605 common shares outstanding.

As of December 13, 2016 Regen Biopharma, Inc. had 140,766,697 shares of Series A Preferred Stock outstanding.

As of December 13, 2016 Regen Biopharma, Inc. had 30,000 shares of Series AA Preferred Stock 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.

 

EXPLANATORY NOTE:

THIS AMENDMENT NO.1 TO REGEN BIOPHARMA, INC’S (THE “COMPANY”) FORM 10-K FOR THE PERIOD ENDED SEPTEMBER 30, 2016 (“(“ORIGINAL FILING”) IS BEING FILED SOLELY TO AMEND THE FOLLOWING PORTIONS OF THE ORIGINAL FILING.  

 ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA

ITEM 9A. CONTROLS AND PROCEDURES

 

THE COMPANY HAS NOT MODIFIED OR UPDATED DISCLOSURES PRESENTED IN THE ORIGINAL FILING, EXCEPT AS INDICATED ABOVE. ACCORDINGLY, THIS AMENDMENT DOES NOT REFLECT EVENTS OCCURRING AFTER THE DATE OF THE ORIGINAL FILING AND DOES NOT MODIFY OR UPDATE THOSE DISCLOSURES AFFECTED BY SUBSEQUENT EVENTS, EXCEPT AS SPECIFICALLY REFERENCED HEREIN. INFORMATION NOT AFFECTED BY THE ABOVE AMENDMENTS IS UNCHANGED AND REFLECTS THE DISCLOSURES MADE AT THE TIME OF THE ORIGINAL FILING.

 

 

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 13, 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.

 

 

 

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

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

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

 

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

 

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

 

The Agreement may be terminated by Regen:

 

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

 

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

 

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

 

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

 

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.

 

 

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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.

 

(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.

 

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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:

 

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
(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.

 

 

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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.

On February 16, 2016 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Eli Lilly and Company (“Lily”) . Pursuant to the Agreement, Regen shall become a participant in Lily’s Open Innovation Drug Discovery Program. Pursuant to the Agreement, Regen may submit Structural Information for one or more compounds or mixtures of compounds for Informatics Screening to generate the Informatics Profile. Lilly will provide Regen with the Informatics Profile.

“Informatics Screening” is defined in the Agreement to mean the diversity evaluation, in silico calculations and evaluation of physical properties and molecular descriptors based upon the Structural Information supplied by Regen to Lilly

 

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“Informatics Profile” is defined in the Agreement to mean results from the Informatics Screening diversity evaluation and the results from the in silico calculations and evaluations of physical properties and molecular descriptors.

The Agreement also grants to Lily an option to negotiate an agreement with Regen including but not restricted to a compound purchase agreement, a license agreement, or a research collaboration agreement for further research and development of “Material” (collectively the “Research Opportunities”). The option shall expire sixty (60) days (the “Option Period”) after Lilly has received the “Chemical Structure” for the subject Material from Regen pursuant to a Structure Reveal Letter. The option may be exercised by Lilly in writing at any time prior to its expiration. The option period may be extended by mutual written agreement of the parties.

“Material” is defined in the Agreement as a physical sample of the compound or mixture of compounds corresponding to the information, in whatever form, identifying a compound or mixture of compounds submitted by Regen to the OIDD Program for Informatics Screening Structural Information for which Lilly has requested for evaluation in the Open Innovation Drug Discovery Program (“OIDD”) Program.

“Chemical Structure” is defined in the Agreement the chemical name and/or structure of the Material.

“Structure Reveal Letter” is defined in the Agreement as written notification by Lilly to Regen requesting the Chemical Structure and related information of a Material.

The term of the Agreement shall commence on February 16, 2016 and shall continue until:

1. the termination of the Open Innovation Drug Discovery Program by Lilly upon thirty (30) days written notice to Regen;

2. termination by Lilly upon thirty (30) days written notice to Regen;

3. replacement with a revised Program Agreement signed by the parties; or

4. the termination of Regen’s participation in the Open Innovation Drug Discovery Program and the Agreement by thirty (30) days written notice to Lilly.

 

On November 9, 2016 the Company formed Checkpoint Therapeutics, Inc., a Nevada corporation and wholly owned subsidiary of the Company.

 

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).

 

 

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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.

 

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.

 

 

 

10 
 

 

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.

 

Tcellvax

Tcellvax is intended to be an autologous cellular product comprised of NR2F6 gene-silenced peripheral blood mononuclear cells. It has been demonstrated that mice genetically deficient for NR2F6 are capable of immunologically rejecting tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a clinical trial .The proposed clinical trial would be a single center, open label, non-randomized Phase I/II trial to test the safety and efficacy of autologous peripheral blood mononuclear cells that have been gene-silenced for NR2F6 using short interfering RNA (siRNA)

Small Molecules

The Company is also actively identifying small molecules via a high throughput screening program that inhibit NR2F6 leading to immune cell activation for oncology applications.

 

 

On December 15, 2015 Regen entered into an agreement (“Agreement”) with the National Center for Advancing Translational Sciences (“NCATS”), which is a component of the National Institutes of Health (“NIH”), an agency of the U.S. Department of Health and Human Services whereby Regen and NCATS shall collaborate to screen for small molecule compounds that activate or inhibit the orphan nuclear receptor, NR2F6.

 

Regen will be required to obtain approval from the FDA in order to market any of Regen’s products or therapies. No approval has been granted by the FDA for the marketing and sale of any of the Company’s products and therapies and no assurance may be given that any of the Company’s products or therapies will be granted such approval. The Company’s current plans include the development of regenerative medical applications up to the point of successful completion of Phase I and/ or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. We can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.

 

11 
 

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.

 

12 
 

 

 

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. 

 

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.

 

 

 

13 
 

 

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

 

Rohit Duggal, PhD,

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

 

Dr. Jonathan Baell, PhD

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

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

William S. Blaner, PhD

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

Dr. Santosh Kesari, MD PhD

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

Louise Purton, PhD:

 

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

Ralph Nachman, M.D.

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

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

 

 

 

14 
 

 

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

 

 

15 
 

 

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

 

 

16 
 

 

 

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

 

 

17 
 

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.

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.

 

 

 

18 
 

 

Phase I

 

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

 

Phase II

 

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

 

Phase III

 

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

 

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

 

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

 

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

 

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

 

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

 

 

19 
 

 

 

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, 2016 we expended $ 671,095 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 13, 2016, 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.

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. 

 

 

20 
 

 

 

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: 145,212,605 shares issued and outstanding as of December 13, 2016.

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

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

Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 30,000 shares issued and outstanding as of December 13, 2016 and 300,000,000 is designated Series A Preferred Stock of which 140,766,697 shares are outstanding as of December 5, 2016.

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

Series AA Preferred Stock

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

 

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

Series A Preferred Stock

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

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

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

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

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

Our common stock is traded on the OTC Bulletin Board as well as the OTCQB 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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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  

 

October 1, 2015 to September 30, 2016   HIGH   LOW
First Quarter   $ .219     $ .125  
Second Quarter   $ .21     $ .1001  
Third Quarter   $ .1497     $ .0655  
Fourth Quarter   $ .17     $ .0741  

 

Holders

  

As of September 30, 2016 there were approximately 464 holders of our Common Stock.

As of September 30, 2016 there were approximately 214 holders of our Series A Preferred Stock.

As of September 30, 2016 there was 1 holder of our Series AA Preferred Stock.

 

Dividends

 

No cash dividends were paid during the fiscal year ending September 30, 2016. We do not expect to declare cash dividends in the immediate future.

 

Recent Sales of Unregistered Securities

Common Shares

On October 28, 2015 the Company issued 3,333,334 of its Common Shares (“Shares”) for cash consideration of $166,667.

 

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. 

 

On November 20, 2015 the Company 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. 

 

 

 

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On December 29, 2015 the Company issued 4,000,000 of its Common Shares (“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. 

 

On January 28, 2016 the Company issued 2,000,000 of its Common Shares (“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. 

 

On January 29, 2016 the Company issued 30,000 of its Common Shares (“Shares”) for cash consideration of $750.

 

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 2, 2016 the Company issued 270,000 of its Common Shares (“Shares”)for cash consideration of $6,750.

 

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 22, 2016 the Company issued 666,666 of its Common Shares (“Shares”) for cash 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. 

 

On February 22, 2016 the Company issued 1,000,000 of its Common Shares (“Shares”) for cash consideration of $12,500.

 

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 May 9, 2016 the Company issued 700,000 of its Common Shares (“Shares”) in satisfaction of $14,000 of principal 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 23, 2016 the Company issued 1,000,000 of its Common Shares (“Shares”)for cash consideration of $12,500.

 

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 June 6, 2016 the Company issued 3,500,000 of its Common Shares (“Shares”) for cash consideration of $118,750.

 

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 June 15, 2016 the Company issued 1,095,000 of its Common Shares (“Shares”) for cash consideration of $13,687.

 

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, 2016 the Company issued 3,966,667 of its Common Shares (“Shares”) in satisfaction of $109,000 of principal 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 September 8, 2016 the Company issued 197,000 of its Common Shares (“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. 

 

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On September 13, 2016 the Company issued 500,000 of its Common Shares (“Shares”) for cash consideration of $6,250.

 

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 14, 2016 the Company issued 500,000 of its Common Shares (“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 8, 2016 the Company issued 2,000,000 shares of its common stock (“Shares”)for cash consideration of $50,000.

 

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. 

 

On November 8, 2016 the Company issued 1,000,000 shares of its common stock (“Shares”) for cash consideration of $12,500.

 

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 8, 2016 the Company issued 2,000,000 shares of its common stock (“Shares”) for cash consideration of $50,000.

 

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. 

 

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On November 8, 2016 the Company issued 500,000 shares of its common stock (“Shares”)for cash consideration of $12,500

 

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 December 19, 2016 the Company issued 1,000,000 shares of its common 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

 

On December 19, 2016 the Company issued 3,000,000 shares of its common stock (“Shares”)for cash consideration of $37,500

 

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 December 19, 2016 the Company issued 500,000 shares of its common stock (“Shares”)for cash consideration of $12,500

 

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 December 19, 2016 the Company issued 1,500,000 shares of its common stock (“Shares”)for cash consideration of $37,500

 

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 December 19, 2016 the Company issued 1,700,000 shares of its common stock (“Shares”) for cash consideration of $42,500

 

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.

 

Series A Preferred Stock

 

On October 28, 2015 the Company issued 1,666,667 shares of its 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. 

 

On October 28, 2015 the Company issued 11,000,000 shares of its Series A Preferred stock (“Shares”)to Dr. Harry Lander, the Company’s President and Chief Scientific Officer, 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. 

 

 

On November 20, 2015 the Company issued 2,200,000 shares of its 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. 

 

 

 

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On November 20, 2015 the Company issued 400,000 shares of its 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 December 29, 2015 the Company issued 4,000,000 shares 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. 

 

 

On January 28, 2016 the Company issued 1,000,000 shares of its Series A Preferred stock(“Shares”) for cash consideration of $50,000.

 

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. 

 

 

On January 29, 2016 the Company issued 300,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $7,500.

 

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 22, 2016 the Company issued 333,333 shares of its Series A Preferred stock (“Shares”)for cash consideration of $16,666.

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. 

 

 

On March 22, 2016 the Company issued 3,000,000 shares of its Series A Preferred stock (“Shares”)for cash consideration of $37,500.

 

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 April 7, 2016 the Company issued 1,000,000 shares of its Series A Preferred stock (“Shares”) in satisfaction of $10,000 of principal 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 April 7, 2016 Regen Biopharma, Inc. (“Regen”) issued 10,000,000 shares of Regen’s Series A Preferred Stock (“Shares”) to David Koos, Regen’s Chief Executive Officer, as consideration for efforts expended by Koos with regards to addressing all clinical hold issues identified by the United States Food and Drug Administration (FDA) related to Regen’s Investigational New Drug Application for HemaXellerate..

 

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 7, 2016 Regen Biopharma, Inc. (“Regen”) issued 10,000,000 shares of Regen’s Series A Preferred Stock (“Shares”) to Harry Lander , Regen’s President and Chief Scientific Officer, as consideration for efforts expended by Lander with regards to addressing all clinical hold issues identified by the United States Food and Drug Administration (FDA) related to Regen’s Investigational New Drug Application for HemaXellerate.

 

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 7, 2016 Regen Biopharma, Inc. (“Regen”) issued 10,000,000 shares of Regen’s Series A Preferred Stock (“Shares”) to Todd Caven , Regen’s Chief Financial Officer, as consideration for efforts expended by Caven with regards to addressing all clinical hold issues identified by the United States Food and Drug Administration (FDA) related to Regen’s Investigational New Drug Application for HemaXellerate 

 

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 23, 2016 the Company issued 3,000,000 shares of its Series A Preferred stock (“Shares”)for cash consideration of $37,500.

 

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 June 6, 2016 the Company issued 5,500,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $106,250.

 

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 June 15, 2016 the Company issued 3,285,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $41,062.

 

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 27, 2016 the Company issued 100,000 shares of its 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 August 16, 2016 the Company issued 2,000,000 shares of its Series A Preferred stock (“Shares”)for cash consideration of $25,000.

 

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. 

 

On August 22, 2016 the Company issued 4,000,000 shares of its Series A Preferred stock (“Shares”)for cash consideration of $50,000.

 

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. 

 

 

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On September 13, 2016 the Company issued 1,500,000 shares of its Series A Preferred stock (“Shares”)for cash consideration of $18,750.

 

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 8, 2016 the Company issued 2,000,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $50,000.

 

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. 

 

 

On November 8, 2016 the Company issued 1,000,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $12,500.

 

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 December 19, 2016 the Company issued 3,000,000 shares of its Series A Preferred stock (“Shares”) for cash 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. 

 

On December 19, 2016 the Company issued 3,000,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $37,500.

 

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 December 19, 2016 the Company issued 500,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $12,500.

 

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 December 19, 2016 the Company issued 1,500,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $37500.

 

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 December 19, 2016 the Company issued 1,700,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $42,500.

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 8, 2016 the Company issued 2,000,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $50,000.

 

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. 

 

On November 8, 2016 the Company issued 500,000 shares of its Series A Preferred stock (“Shares”) for cash consideration of $12,500.

 

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 Debt

 

On March 8, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $100,000 for consideration consisting of $100,000 cash. The Note pays simple interest in the amount of 8% per annum . The maturity of the Note is three years from the issue date.

 

The Note was issued pursuant to Section 4(2) of the Securities Act of 1933, as amended. 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.

 

The Note contained a provision that until such time as the shares of stock issuable upon conversion of the Note have been registered under the Act or otherwise may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, each certificate for shares of stock issuable upon conversion of the Note  that has not been so included in an effective registration statement or that has not been sold pursuant to an effective registration statement or an exemption that permits removal of the legend, shall bear a restrictive legend.

 

 

On April 6, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for consideration consisting of $50,000 cash. The Note pays simple interest in the amount of 8% per annum . The maturity of the Note is three years from the issue date.

 

The Note was issued pursuant to Section 4(2) of the Securities Act of 1933, as amended. 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.

 

The Note contained a provision that until such time as the shares of stock issuable upon conversion of the Note have been registered under the Act or otherwise may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, each certificate for shares of stock issuable upon conversion of the Note  that has not been so included in an effective registration statement or that has not been sold pursuant to an effective registration statement or an exemption that permits removal of the legend, shall bear a restrictive legend. 

 

On August 26, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for consideration consisting of $50,000 cash. The Note pays simple interest in the amount of 10% per annum . The maturity of the Note is one year from the issue date.

 

The Note was issued pursuant to Section 4(2) of the Securities Act of 1933, as amended. 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.

 

The Note contained a provision that until such time as the shares of stock issuable upon conversion of the Note have been registered under the Act or otherwise may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, each certificate for shares of stock issuable upon conversion of the Note  that has not been so included in an effective registration statement or that has not been sold pursuant to an effective registration statement or an exemption that permits removal of the legend, shall bear a restrictive legend.

 

 

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On September 8, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for consideration consisting of $50,000 cash. The Note pays simple interest in the amount of 10% per annum . The maturity of the Note is one year from the issue date.

 

The Note was issued pursuant to Section 4(2) of the Securities Act of 1933, as amended. 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.

 

The Note contained a provision that until such time as the shares of stock issuable upon conversion of the Note have been registered under the Act or otherwise may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, each certificate for shares of stock issuable upon conversion of the Note  that has not been so included in an effective registration statement or that has not been sold pursuant to an effective registration statement or an exemption that permits removal of the legend, shall bear a restrictive legend.

 

 

On September 20, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $50,000 for consideration consisting of $50,000 cash. The Note pays simple interest in the amount of 10% per annum . The maturity of the Note is one year from the issue date.

 

The Note was issued pursuant to Section 4(2) of the Securities Act of 1933, as amended. 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.

 

The Note contained a provision that until such time as the shares of stock issuable upon conversion of the Note have been registered under the Act or otherwise may be sold pursuant to Rule 144 without any restriction as to the number of securities as of a particular date that can then be immediately sold, each certificate for shares of stock issuable upon conversion of the Note  that has not been so included in an effective registration statement or that has not been sold pursuant to an effective registration statement or an exemption that permits removal of the legend, shall bear a restrictive legend.

 

Use of Proceeds

 

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

 

Item 6. Selected Financial Data

 

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

 

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

  

As of September 30, 2016, we had Cash in the amount of $ 24,822 and as of September 30, 2015 we had Cash in the amount of $38,620.

 

The decrease in Cash of approximately 35.7% is attributable to funds expended in the operation of the Company’s business offset by:

 

  (a) Net Cash Borrowings from unaffiliated lenders of $53,696
  (b) Common Stock of the Issuer sold for cash consideration of $626,188
  (c) Series A Preferred Stock of the Issuer sold for cash consideration of $628,563
  (d) $50,000 deposited with the Company by an unaffiliated investor pursuant to an agreement (“Agreement”) whereby the investor agreed to buy and the Company agreed to sell 1,000,000 Units for consideration of $50,000. Each Unit issuable pursuant to the Agreement shall consist of one share of the Company’s common stock and three shares of the Company’s Series A Preferred Stock. During the quarter ended September 30, 2016 the outside investor paid consideration to the Company of $50,000 for One Million Units. As of September 30, 2016 the securities issuable pursuant to the Agreement have not been issued.

 

 

 

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As of September 30, 2016 we had Prepaid Expenses of $ 69,905 and as of September 30, 2015 we had Prepaid Expenses of $10,000.

 

The increase in Prepaid Expenses of approximately 599% is primarily attributable to:

 

  (a) Recognition of the fair market value of stock that was issued to a consultant to the Company as prepayment for services to be rendered, such fair market value being $68,905,
  (b) $1,000 in salary having been prepaid to an employee during the quarter ended December 31, 2015.

 

Offset by:

 

$10,000 of salary prepaid to the Company’s former Chief Scientific Officer having been reclassified during the quarter ended December 31, 2015 as amounts Due from Former Employee as a result of the resignation of the Company’s former Chief Scientific Officer during the quarter ended December 31, 2015

 

As of September 30, 2016 we had Accounts Receivable of $ 83,000 and as of September 30, 2015 we had Accounts Receivable of $0.

 

The increase in Accounts Receivable is attributable to the recognition by Regen of $100,000 in revenue during the quarter ended September 30,2016 such revenue consisting of a $100,000 fee (“Fee”) due and payable to the Company by Zander Therapeutics, Inc. pursuant to the terms and conditions of an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years offset by a partial payment of $17,000 paid to the Company by Zander during the quarter ended September 30,2016. Zander is a wholly owned subsidiary of Entest Biomedical, Inc. The Company, Zander and Entest Biomedical, Inc. are under common control.

 

 

As of September 30, 2016 we had Accrued Interest Receivable of $2,578 and as of September 30, 2015 we had Accrued Interest Receivable of $1,381.

 

The increase in Accrued Interest Receivable of 86.6 is attributable to interest accrued but not yet paid on funds loaned to Entest Biomedical, Inc. by the Company.

  

As of September 30 2016 we had Amounts Due from Former Employee of $15,000 and as of September 30, 2015 we had Amounts Due from Former Employee of $0.

 

The increase in Amounts Due from Former Employee is attributable to:

 

$10,000 of salary prepaid to the Company’s former Chief Scientific Officer having been reclassified during the quarter ended December 31, 2015 as amounts Due from Former Employee as a result of the resignation of the Company’s former Chief Scientific Officer during the quarter ended December 31, 2015.

 

$5,000 overpayment of salary due to the Company’s former Chief Scientific Officer during the quarter ended December 31, 2015.

 

As of September 30, 2016 we had Available for Sale Securities of $112,000 and as of September 30, 2015 we had Available for Sale Securities of $158,400

 

The decrease in Available for Sale Securities of 29.2 % is attributable to unrealized losses recognized on 8,000,000 common shares of Entest Biomedical, Inc. owned by the Company.

 

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As of September 30, 2016 we had Accounts Payable of $240,759 and as of September 30, 2015 we had Accounts payable of $25,854.

The increase in Accounts Payable of approximately 831% is attributable to increases in outstanding obligations of the Company incurred in the course of business.

As of September 30,2016 we had Notes Payable of $143,447 and as of September 30, 2015 we had Notes Payable of $222,751.

The decrease in Notes Payable of approximately 35% is attributable to:

 

  (a) The repayment of $141,401 of principal indebtedness during the twelve months ended September 30, 2016

 

  (b) The satisfaction of $133,000 of principal indebtedness through the issuance of Regen’s equity securities during the twelve months ended September 30, 2016

offset By borrowings of $195,097 during the twelve months ended September 30, 2016.

As of September 30, 2016 we had Accrued Payroll Taxes of $33,040 and as of September 30, 2015 we had Accrued Payroll Taxes of $1,940.

The increase in Accrued Payroll Taxes of approximately 1603% is attributable to payment by the Company of employer tax obligations incurred but unpaid.

 

As of September 30, 2016, we had Accrued Payroll of $263,996 and as of September 30, 2015 we had Accrued Payroll of $36,001

The increase in Accrued Payroll of approximately 633% is attributable to :

 

  (a) $105,000 in salary expense due to the Company’s Chief Executive Officer incurred but unpaid during the twelve months ended September 30, 2016
  (b) $94,500 in salary expense due to the Company’s Chief Financial Officer incurred but unpaid during the twelve months ended September 30, 2016
  (c) $28,495 in salary expense due to the Company’s President incurred but unpaid during the twelve months ended September 30, 2016.

As of September 30, 2016 we had Accrued Interest of $43,918 and as of September 30, 2015 we had Accrued Interest of $21,093.

The increase in Accrued Interest of approximately 108.2% is attributable to interest expense on Notes Payable and Convertible Notes Payable incurred during the twelve months ended September 30, 2016 but not yet paid.

 

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As of September 30,2016 we had Convertible Notes Payable of $300,000 and as of September 30, 2015 we had Convertible Notes Payable of $0.

The increase in Convertible Notes Payable is attributable to

(a) the issuance by the Company of a convertible note in the face amount of $100,000 during the quarter ended March 31, 2016.

(b) the issuance by the Company of a convertible note in the face amount of $50,000 during the quarter ended June 30, 2016.

(c) the issuance by the Company of convertible notes in the face amount of $150,000 during the quarter ended September 30, 2016.

As of September 30, 2016 we had Amounts due to Shareholder of $50,000 and as of September 30, 2015 we had Amounts Due to Shareholder of $0.

Amount due to Shareholder of $50,000 as of September 30, 2016 is attributable to the following:

On July 13, 2016 the Company entered into an agreement (“Agreement”) with an outside investor whereby the investor agreed to buy and the Company agreed to sell 1,000,000 Units for consideration of $50,000. Each Unit issuable pursuant to the Agreement shall consist of one share of the Company’s common stock and three shares of the Company’s Series A Preferred Stock. During the quarter ended September 30, 2016 the outside investor paid consideration to the Company of $50,000 for One Million Units. As of September 30, 2016 the securities issuable pursuant to the Agreement have not been issued.

 

As of September 30, 2016 we had Accrued Rent of $15,000 and as of September 30, 2015 we had Accrued Rent of $10,000.

 

The increase in Accrued Rent of 50% is attributable to Rental Expenses accrued but unpaid for the months of July 2016, August 2016, and September 2016.

Material Changes in Results of Operations

Revenues from continuing operations were $192,000 for the fiscal year ended September 30, 2015 and $100,000 for the fiscal year ended September 30, 2016. Net losses were$2,210,715 for the fiscal year ended September 30, 2015 and $3,413,519 for the same year ended 2016.

 

The increase in Net Losses of 54.4 % is primarily attributable to

 increases in Research and Development Related expenses, General and Administrative Expenses, Consulting and Professional Fees , Interest Expense and expenses related to amortization of Beneficial Conversion Features recognized as a result of the issuance of Convertible Debt during the twelve months ended September 30, 2016.

 

As of September 30, 2016 we had $24,822 cash on hand and current liabilities of $799,201 such liabilities consisting of Accounts Payable, Notes Payable, Amounts Due to Shareholder 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.

 

 

 

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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 twelve months ended September 30, 2016 the Company raised $300,000 through the issuance of convertible debt and $1,254,751 through the issuance of equity securities.

 

As of December 13, 2016 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.

 

 

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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, 2016 and the related statements of operations, comprehensive income, stockholders’ equity (deficit), and cash flows for the period ended September 30, 2016. 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, 2016 and the results of its operations and its cash flows for the year then ended in conformity with accounting principles generally accepted in the United States of America.

As discussed in Note 14 of the accompanying financial statements, the 2016 financial statements have been restated to correct an error.

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, 2016, has incurred recurring losses and recurring negative cash flow from operating activities, and has an accumulated deficit which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

/s/ AMC Auditing

 

AMC Auditing

Las Vegas, Nevada

December 15, 2016, except for Note 14, as to which the date is March 23, 2017

 

40 
 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of

Regen BioPharma, Inc.

 

We have audited the accompanying balance sheet of Regen BioPharma, Inc. as of September 30, 2015 and the related statements of operations, comprehensive income, stockholders’ equity (deficit), and cash flows for the year 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, 2015, and the results of its operations and cash flows for the year ended September 30, 2015 in conformity with accounting principles generally accepted in the United States of America.

As discussed in Note 11 of the accompanying financial statements, the 2015 financial statements have been restated to correct an error.

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, except for Note 12, as to which the date is March 23, 2017

 

 

 41 

 

 

REGEN BIOPHARMA, INC.      
BALANCE SHEET      
(as restated)      
   As of  As of
   September 30, 2016  September 30, 2015
ASSETS      
CURRENT ASSETS          
Cash   24,822    38,620 
Accounts Receivable   83,000      
Note Receivable   12,051    12,051 
Prepaid Expenses   69,905    10,000 
Accrued Interest Receivable   2,578    1,381 
Due from Former Employees   15,000      
     Total Current Assets   207,356    62,052 
           
OTHER ASSETS          
Available for Sale Securities   112,000    158,400 
Total Other Assets   112,000    158,400 
           
TOTAL ASSETS   319,356    220,452 
           
LIABILITIES AND STOCKHOLDERS' EQUITY          
Current Liabilities:          
Bank Overdraft   0    0 
Accounts payable   240,759    25,854 
Notes Payable   143,447    222,751 
Accrued payroll taxes   33,040    1,940 
Accrued Interest   43,918    21,093 
Accrued Rent   15,000    10,000 
Accrued Payroll   263,996    36,001 
Due to Shareholder   50,000      
Convertible Notes Payable   9,041      
Total Current Liabilities   799,201    317,639 
Long Term Liabilities:          
Convertible Notes Payable   107,057      
Total Long Term Liabilities   107,057      
Total Liabilities   906,258    317,639 
           
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 139,712,605 shares issued and outstanding September 30, 2016   13,970    11,474 
Preferred Stock, 0.0001 par value, 800,000,000 authorized and 100,000,000 authorized as of September 30,  2016 and September 30, 2015 respectively          
Series A Preferred 90,000,000 Authorized and 300,000,000 authorized, 60,981,697 and 135,266,697 outstanding as of  September  30, 2105 and September 30, 2016 respectively   13,527    6,098 
Series AA Preferred $0.0001 par value 600,000 authorized and 30, 000   outstanding as of September  30, 2015 and September 30, 2016   3    3 
Additional Paid in capital   5,639,753    2,679,473 
Contributed Capital   728,658    728,658 
Retained Earnings (Deficit) accumulated during the development stage   (6,902,812)   (3,489,293)
Accumulated Other Comprehensive Income   (80,000)   (33,600)
Total Stockholders' Equity (Deficit)   (586,902)   (97,187)
           
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT)   319,356    220,452 
           
The Accompanying Notes are an Integral Part of These Financial Statements

 

 42 

 

 

REGEN BIOPHARMA , INC.      
STATEMENT OF OPERATIONS      
(As Restated)      
       
       
    Year Ended    Year Ended 
    

September 30,

2016

    

September 30,

2015

 
REVENUES   100,000    192,000 
           
COST AND EXPENSES          
Research and Development   671,095    282,295 
General and Administrative   1,664,250    1,314,208 
Consulting and Professional Fees   661,617    516,701 
Rent   60,000    58,071 
Total Costs and Expenses   3,056,962    2,171,275 
           
OPERATING LOSS   (2,956,962)   (1,979,275)
           
OTHER INCOME & (EXPENSES)          
Interest Income   1,197    1,148 
Refunds of amounts previously paid          
Interest Expense   (27,824)   (21,688)
Interest Expense attributable to Amortization of Discount   (18,597)     
Loss on issuance of common shares for less than fair value   (411,333)   (207,425)
Preferred shares issued pursuant to contractual obligations        (3,475)
TOTAL OTHER INCOME (EXPENSE)   (456,558)   (231,440)
           
NET INCOME (LOSS)   (3,413,519)   (2,210,715)
BASIC AND FULLY DILUTED          
EARNINGS (LOSS) PER SHARE   (0.0267)   (0.0251)
WEIGHTED AVERAGE NUMBER OF COMMON          
SHARES OUTSTANDING   127,840,131    88,185,098 
           
The Accompanying Notes are an Integral Part of These Financial Statements

 

 43 

 

 

 

REGEN BIOPHARMA, INC.
STATEMENT OF COMPREHENSIVE INCOME
(As Restated)
   Year   Ended September   30
   2016  2015
Net Income (Loss)  $(3,413,519)  $(2,210,715)
Add:          
     Unrealized Gains on Securities          
Less:          
     Unrealized Losses on Securities   (46,400)   (33,600)
     Total Other Comprehensive Income (Loss)   (46,400)   (33,600)
Comprehensive Income  $(3,459,919)   (2,244,315)

 

The Accompanying Notes are an Integral Part of These Financial Statements

 

 44 

 

 

 

REGEN BIOPHARMA , INC.
Statement of shareholder's equity
For the years ended  September 30, 2015 and 2016
                                  
                                  
   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, 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                                 0                   0 
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                                      (633,470)             (633,470)
Balance  March  31, 2015   57,134,079    5,714    30,000    3    109,310,811    10,932    1,725,671    (2,131,238)   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                                 207,425                   207,425 
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                                      (832,371)             (832,371)
Balance June 30, 2015   60,548,364    6,055    30,000    3    113,525,096    11,353    2,300,263    (2,963,609)   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                                 0                   0 
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                                      (525,684)             (525,684)
Balance September 30, 2015   60,981,697    6,098    30,000    3    114,753,938    11,474    2,679,474    (3,489,293)   728,658    (33,600)   (97,187)
Common Stock issued for cash at $0.05 per share issued 10/28/2015                       3,333,334    333    166,334                   166,667 
Preferred Stock issued for cash at $0.05 per share issued 10/28/2015   1,666,667    167                        83,166                   83,333 
Preferred Stock issued for services as Restricted Stock Award  issued on 10/28/2015   11,000,000    1,100                        (1,100)                  0 
Common Stock issued for cash at $0.025 per share issued 11/20/2015                       2,200,000    220    54,780                   55,000 
Preferred  Stock issued for cash at $0.025 per share issued 11/20/2015   2,200,000    220                        54,780                   55,000 
Common Stock issued for cash at $0.025 per share issued 12/29/2015                       4,000,000    400    99,600                   100,000 
Preferred Stock issued for cash at $0.025 per share issued 12/29/2015   4,000,000    400                        99,600                   100,000 
Preferred Stock issued for services issued  11/30/2015   400,000    40                                            40 
Loss on Issuance of Securities  for Less than fair value recognized during quarter                                 0                   0 
Restricted Stock Award compensation expense recognized during Quarter ended December 31, 2015                                 247,724                   247,724 
Unrealized Loss on Securities Available for Sale recognized during Quarter ended December 31, 2015                                                (38,400)   (38,400)
Net Loss for the quarter ended December 31, 2015                                      (694,153)             (694,153)
Balance December 31, 2015   80,248,364    8,025    30,000    3    124,287,272    12,427    3,484,356    (4,183,446)   728,658    (72,000)   (21,976)
Common Stock issued for cash at $0.05 per share issued 1/28/2016                       2000000    200    99800                   100000 
Preferred Stock issued for cash at $0.05 per share issued 1/28/2016   1,000,000    100                        49,900                   50,000 
Common Stock issued for cash at $0.025 per share issued 1/29/2016                       30,000    3    747                   750 
Preferred Stock issued for cash at $0.025 per share issued 1/29/2016   300,000    30                        7,470                   7,500 
Common Stock issued for cash at $0.025 per share issued 2/2/2016                       270,000    27    6,723                   6,750 
Common Stock issued for cash at $0.05 per share issued 2/22/2016                       666,666    67    33,267                   33,333 
Common Stock issued for cash at $0.0125 per share issued 2/22/2016                       1,000,000    100    12,400                   12,500 
Preferred Stock issued for cash at $0.05 per share issued 2/22/2016   333,333    33                        16,633                   16,667 
Preferred Stock issued for cash at $0.0125 per share issued 3/22/2016   3,000,000    300                        37,200                   37,500 
Restricted Stock Award compensation expense recognized during Quarter ended March 31, 2016                                 247,739                   247,739 
Loss on Issuance of Securities  for Less than fair value recognized during quarter                                 0                   0 
Beneficial Conversion Feature Recognized during the Quarter Ended March 31, 2016                                 42,600                   42,600 
Unrealized Loss on Securities Available for Sale recognized during Quarter ended March 31, 2016                                                (63,200)   (63,200)
Net Loss for the quarter ended March 31, 2016                                      (726,064)             (726,064)
Balance March 31, 2016   84,881,697    8,488    30,000    3    128,253,938    12,824    4,038,835    (4,909,510)   728,658    (135,200)   (255,902)
Preferred Stock issued for debt issued April 7, 2016   1,000,000    100                        9,900                   10,000 
Preferred Stock issued for Officer Compensation April 7 2016   30,000,000    3,000                                            3,000 
                                                        
Common Stock issued for debt issued May 9 , 2016                       700,000    70    13,930                   14,000 
Common Stock issued for cash at $0.0125 per share issued 5/23/2016                       1,000,000    100    12,400                   12,500 
Preferred Stock issued for cash at $0.0125 per share issued 5/23/2016   3,000,000    300