UP 72% IN LAST HOUR ON REGEN SHARES DIVIDEND NEWS!
Post# of 5066
Posted On: 01/14/2014 4:00:01 PM
UP 72% IN LAST HOUR ON REGEN SHARES DIVIDEND NEWS!
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
_____________________
AMENDMENT NO. 2 TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
______________________
REGEN BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
Nevada 7389 45-5192997
(State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification Number)
incorporation or organization) Classification Code Number)
_______________________
4700 Spring Street, Suite 304, La Mesa, California, 91942
(619) 702-1404
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
________________________
Attn: David R. Koos
Chief Executive Officer
Bio Matrix Scientific Group, Inc.
4700 Spring Street, Suite 304
La Mesa CA 91942
Tel: 619-702-1404
(Name, address, including zip code, and telephone number, including area code, of agent for service)
_________________________
Copies to:
Attn: David R. Koos
Chief Executive Officer
Regen Biopharma, Inc.
4700 Spring Street, Suite 304
La Mesa CA 91942
Tel: 619-702-1404
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities To Be Registered
Amount To Be
Registered
Proposed Maximum
Offering Price
Per Share(1)
Proposed Maximum
Aggregate
Offering Price(1)
Aggregate
Amount of
Registration Fee
(1)
Common Stock, par value $0.0001 per share 20,000,000 $ 0.0001 $ 2,000 $ 0.27
We are registering 20,000,000 shares of our common stock that will be distributed by Bio Matrix Scientific Group, Inc. as a dividend in kind on a pro rata basis to:
(a) Holders of the outstanding common shares of Bio Matrix Scientific Group Inc, a Delaware corporation, as of the record date
(b) Holders of any outstanding series of the preferred shares of Bio Matrix Scientific Group Inc, a Delaware corporation, as of the record date
(1) Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rules 457(f) under the Act.
If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. o
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
Indicated by check mark whether the Registrant is large accelerated filer, an accelerated filer, a non-accelerated filer or a small reporting company as defined in Rule 12b-2 of the Securities Exchange Act of 1934. (Check one unless a smaller reporting company.)
Large Accelerated Filer o Accelerated Filer o
Non-accelerated Filer o Smaller Reporting Company x
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file an amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission (“SEC”) is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
PROSPECTUS
DATED ____, 2014
REGEN BIOPHARMA, INC.
20,000,000 Shares of Common Stock
You may only rely on the information contained in this prospectus or that we have referred you to. We have not authorized anyone to provide you with different information. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than the common stock offered by this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any common stock in any circumstances in which such offer or solicitation is unlawful. Neither the delivery of this prospectus nor any sale made in connection with this prospectus shall, under any circumstances, create any implication that there has been no change in our affairs since the date of this prospectus is correct as of any time after its date.
We are furnishing this prospectus to the common and preferred shareholders of Bio-Matrix Scientific Group, Inc. a Delaware corporation. This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by Bio Matrix Scientific Group, Inc (“BMSN”) to:
(a) Holders of record of the outstanding common shares of BMSN as of the record date
(b) Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.
Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen BioPharma, Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”)
We are considered an “Emerging Growth Company” under Section 101(a) of the Jumpstart Our Business Startups Act as we are an issuer that had total annual gross revenues of less than $1 billion during our most recently completed fiscal year.
This investment involves a high degree of risk. You should purchase shares only if you can afford a complete loss. See “Risk Factors” beginning on page 8 .
Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
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The date of this prospectus is____, 2014.
PROSPECTUS SUMMARY 3
ABOUT THIS OFFERING 6
SUMMARY FINANCIAL AND OPERATING INFORMATION 7
EXEMPTIONS UNDER JUMPSTART OUR BUSINESS STARTUPS ACT 8
RISK FACTORS 8
USE OF PROCEEDS 15
DETERMINATION OF OFFERING PRICE 15
DILUTION 15
DISTRIBUTING SECURITY HOLDER 15
PLAN OF DISTRIBUTION 16
DESCRIPTION OF SECURITIES TO BE REGISTERED 16
INTERESTS OF NAMED EXPERTS AND COUNSEL 17
BUSINESS 17
PROPERTIES 31
LEGAL PROCEEDINGS 31
MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS 32
FINANCIAL STATEMENTS 33
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 43
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 44
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS 45
TRANSACTIONS WITH RELATED PERSONS 47
CORPORATE GOVERNANCE 48
SUMMARY COMPENSATION TABLES 49
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 56
AVAILABLE INFORMATION 57
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES. 57
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PROSPECTUS SUMMARY
This summary highlights certain information contained elsewhere in this prospectus. Because it is a summary, it may not contain all of the information that is important to you. Before investing in our common stock, you should read this entire prospectus carefully, especially the sections entitled “Risk Factors” beginning on page 8 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 43 , as well our financial statements and related notes included elsewhere in this prospectus. In this prospectus, the terms “Regen Biopharma, Inc” “Regen ” “Company,” “we,” “us” and “our” refer to Regen Biopharma , Inc.. In this prospectus, the terms “Bio Matrix Scientific Group” “Bio Matrix ” and “BMSN” refer to Bio Matrix Scientific Group , Inc..
About Us
We were incorporated April 24, 2012 under the laws of the State of Nevada. We are a majority owned 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 January 6, 2014, we have not licensed any existing therapies however 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.
The Company has begun development of HemaXellerate I, a cellular therapy designed to heal damaged bone marrow. HemaXellarate I utilizes a collection of cells harvested from the patient’s own adipose (fat) tissue to repair damaged bone marrow and stimulate production of blood cells . The initial application of HemaXellerate I will be the treatment of severe aplastic anemia, a rare and serious condition in which the bone marrow fails to make enough blood cells: red blood cells, white blood cells, and platelets.
In this application, adipose (fat) tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF). SVF preparations contain significant numbers of cellular populations with therapeutic activity that would be relevant to aplastic anemia; namely:
a) Mesenchymal stem cells (MSC), which suppress pathological immune responses and accelerate hematopoiesis (the formation and development of blood cells);
b) Endothelial cells, which assist in repairing damaged bone marrow and stimulate hematopoiesis; and
c) T regulatory cells, which possess anti-inflammatory properties.
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.
In practice, the physician is shipped a kit, which is used to collect adipose tissue. The tissue is sent to a processing facility, and a standardized cellular product is delivered in a ready-to-use manner for administration into the patient intravenously.
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On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate a clinical trial. In this study we will seek to determine the safety and potential efficacy of intravenously administered autologous (derived or transferred from the same individual's body) SVF cells in 10 patients with severe aplastic anemia that is resistant to immune suppressive therapy.
Also in early stage development by the Company are HemaXellerate II and dCellVax.
Unlike HemaXellarate which utilizes the patient’s own fat tissue to harvest the cells needed to repair damaged bone marrow and stimulate production of blood cells HemaXellarate II utilizes third party placental tissue to harvest these cells.
dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body , treated with plasmid DNA (small DNA molecule that is physically separate from, and can replicate independently of, chromosomal DNA) within a cell that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient. A plasmid is a small DNA molecule that is physically separate from, and can replicate independently of, chromosomal DNA within a cell.
Dendritic cells assist a part of the immune system known as the adaptive immune system by identify cancer cells as foreign and presenting this information to other immune cells called T lymphocytes (‘T cells”) enabling the T-cells learn to recognize the tumor as a foreign invader and respond more strongly to destroy it. IDO is an enzyme that is believed to suppress the body’s immune response to the cancer cells by suppressing T Cells as well as halting the dendritic cell from activating T cells. The dendritic cells that are treated with the IDO-blocking plasmid become resistant to the influence of cancer cells which cause the dendritic cell to express IDO . T cells are a type of lymphocyte (itself a type of white blood cell) that play a vital role in the body’s immune response.
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.
Regen has filed applications for patent protection with respect to internally developed intellectual property covering the HemaXellarate products in development (61/648898 - Acceleration of Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells and 61/670791 - Treatment of Hematopoietic Disorders, covering placenta and fat tissue as sources of endothelial cells for therapy).
The therapeutic concept behind dCellVax is derived primarily from
(a) intellectual property acquired from Dr. Wei Ping Min on May 1, 2013
(b) Intellectual property licensed to the Company by Benitec Australia Limited on August 5, 2013
We generated net losses of $522,224 during the period from April 24, 2012(inception) through September 30, 2013. This condition raises substantial doubt about our ability to continue as a going concern. Our continuation as a going concern is dependent on our ability to meet our obligations, to obtain additional financing as may be required and ultimately to attain profitability. Our auditor's report dated December 16, 2013 expressed substantial doubt about our ability to continue as a going concern.
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At September 30, 2013
Selected Balance Sheet Information:
Cash $ 115,922
Current assets 115,922
Total assets $ 115,922
Current liabilities $ 0
Total liabilities 0
Total stockholders' equity (deficit) $ 115,922
As of September 30, 2013 we had $ 115,922 cash on hand and current liabilities of $0.
We feel we will not be able to satisfy its cash requirements over the next twelve months and shall be required to seek additional financing.
We currently plan to raise additional funds primarily by offering securities for cash and applying for grants.
From the period beginning July 1, 2013 and ending September 30 , 2013 the Company’s activities have been primarily focused upon
(a) the development of protocols for pre-clinical research required to be undertaken with regard to the HemaXellerate I product in development in response to the US Food and Drug Administration’s comments on the Company’s submitted IND
(b) the development of preclinical research to be undertaken with regard to the development of dCellVax
The following actions are required to be undertaken by the Company in order to address comments made by the US Food and Drug Administration with regards to the IND filed by the Company for HemaXellerate I
a) Demonstration of safety in an immune deficient model by intravenous administration bracketing the per kilogram dose proposed in the clinical study;
b) Augmentation of existing efficacy data by including details of blood cell responses after treatment.
Pursuant to a Service Agreement entered into by and between the Company and Dr. Wei-Ping Min, on Sept 24, 2013 the Company began experiments required to be undertaken in order to address the FDA’s comment concerning efficacy. Studies required to be undertaken in order to address the FDA’s comments concerning safety commenced in December 2013. It is estimated by the Company that completion of efficacy studies will require 3 months, and the safety studies will be completed in 2 months. It is estimated by the Company that appropriate review of the data by the FDA will take 30 days. Based on these assumptions, d uring the three months ending March 31, 2014 the Company anticipates completion of all actions required to be undertaken with regards to addressing comments made by the US Food and Drug Administration with regards to the IND filed by the Company for HemaXellerate I. The Company also anticipates commencement of the Phase I clinical trial for HemaXellerate I anticipated to begin July 2014. The Company intends, upon satisfaction of all comments, to seek Orphan Drug Designation under the Orphan Drug Act of 1983 from the US Food and Drug Administration for HemaXellerate I. During the three months ended March 31, 2014 the Company also anticipates completion of preclinical testing with regards to dCellVax as well as submission of an IND to the FDA with regards to dCellVax.
The Company has historically met its cash needs primarily through capital contributions made by BMSN and anticipates continuing to do so for the period beginning January 8, 2014 and ending March 31, 2014. The Company also 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.
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The Company anticipates hiring a Chief Financial Officer and a Project Coordinator as well as retaining the services of Contract Research Organizations (CROs) during the period beginning January 8, 2014 and ending September 30 , 2014. The utilization of CROs is intended to provide significant savings with regard to equipment expenditures and long term fixed research / development overhead. As such, the Company does not currently anticipate material acquisition of plant and equipment to be undertaken over the period beginning January 8, 2014 and ending September 30 , 2014
The foregoing statements that are not historical facts, including statements about Regen’s plans, beliefs or expectations, are forward-looking statements. These statements are based on plans, estimates and projections at the time Regen made the original statement, and you should not place undue reliance on them as these plans, estimates and projections may be subject to change. Forward-looking statements involve inherent risks and uncertainties and Regan cautions you that a number of important factors could cause actual results to differ materially from those contained in any such forward-looking statement.
ABOUT THIS OFFERING
Shares Issued BMSN will issue to all BMSN common and preferred shareholders of record on the Record Date a pro rata distribution of 20,000,000 common shares of Regen Biopharma, Inc. owned by BMSN.
Distribution Date
____ days after the Record Date.
Certain U.S. Federal Income Tax Consequences of the Spin-Off The spin-off is taxable to the recipient, as with any dividend.
Secondary Market There is currently no existing public market for the common shares of the Company
Dividend Policy The Company does not anticipate payment of dividends to shareholders in the foreseeable future.
Appraisal Rights Holders of BMSN common and preferred shares have no dissenters’ rights of appraisal in connection with this distribution of the Company’s common shares.
Relationship between BMSN and the Company subsequent to the Distribution. BMSN will own approximately 5 7 % of the outstanding shares of the Company following the distribution. The sole officer and director of BMSN, David Koos will also be Chairman, CEO, President and the sole executive officer of the Company following the distribution.
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SUMMARY FINANCIAL AND OPERATING INFORMATION
The following selected financial information is derived from our Financial Statements appearing elsewhere in this Prospectus and should be read in conjunction with our Financial Statements, including the notes thereto, appearing elsewhere in this Prospectus.
As of As of
September 30, 2013 September 30, 2012
Selected Balance Sheet Information:
Cash $ 115,922 $ 923
Current assets $ 115,922 $ 923
Total Assets $ 115,922 $ 923
Current liabilities $ 0 $ 0
Total liabilities $ 0 $ 0
Total stockholders' equity (deficit) $ 115,922 $ 923
For the twelve months ended
September 30, 2013
For the period from inception (April 24, 2012) to
September 30, 201 2
Selected Statement of Operations Information:
Revenues $ 0 0
Gross profit 0 0
Total operating expenses ( 319,836 ) ( 167,190 )
Operating income (loss) ( 319,836 ) ( 167,190 )
Net income (loss) to common shareholders $ ( 355,034 ) $ ( 167,190 )
Basis and diluted earnings (loss) per common share $ (0.0 187 ) $ ( 16.7 2)
Weighted average common shares outstanding basic and diluted 18,950,000 10,000
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EXEMPTIONS UNDER JUMPSTART OUR BUSINESS STARTUPS ACT
As a company with less than $1.0 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act.
An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company:
• We are permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations;
• We are exempt from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;
• We are permitted to provide less extensive disclosure about our executive compensation arrangements; and
• We are not required to give our stockholders non-binding advisory votes on executive compensation or golden parachute arrangements.
We may take advantage of these provisions for up to five years subsequent to the effective date of this registration statement or such earlier time that we are no longer an emerging growth company. We will cease to be an emerging growth company upon the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed $1 billion, (ii) December 31 of the fiscal year that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter and we have been publicly reporting for at least 12 months or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three-year period.
We hereby elect to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1).
RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully consider the risks described below as well as other information provided to you in this prospectus, including information in the section of this document entitled “Information Regarding Forward Looking Statements.” If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our common stock could decline, and you may lose all or part of your investment. The following discussion and analysis should be read in conjunction with the other financial information and consolidated financial statements and related notes appearing in this prospectus.
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Risks Related to our Business:
WE HAVE A LIMITED OPERATING HISTORY UPON WHICH AN EVALUATION OF OUR PROSPECTS CAN BE MADE.
The Company was incorporated April 24, 2012 and has only been pursuing its current business plan since April 24, 2012. The Company has never generated positive cash flow from operations. Due to the early stage of our development, limited financial and other historical data is available for investors to evaluate whether we will be able to fulfill our business strategy and plans. Further, financial and other limitations may force us to modify, alter, or significantly delay the implementation of such plans. We may incur substantial losses in the future, making it extremely difficult to implement our business plans and strategies and sustain our then current level of operations. Furthermore, no assurances can be given that our strategy will result in an improvement in operating results or that our operations will become profitable.
THERE IS SUBSTANTIAL DOUBT ABOUT THE COMPANY’S ABILITY TO CONTINUE AS A GOING CONCERN.
Our auditor’s report dated December 16 , 2013 expresses an opinion that substantial doubt exists as to whether we can continue as an ongoing concern. Because obtaining investment capital in not certain, we may not have the funds necessary to continue our operations. Our ability to meet our operating needs depends in large part on our ability to secure third party financing. We cannot provide any assurances that we will be able to obtain financing.
THERE IS SUBSTANTIAL DOUBT ABOUT THE COMPANY’S PARENT’S ABILITY TO CONTINUE AS A GOING CONCERN.
Our parent company, BMSN, has no revenues and generated net losses of $ 16,439, 725 (excluding $663,649 of Equity in Net Losses of Entest Biomedical, Inc. recognized) during the period from August 2, 2005 (inception) through September 30, 2013. This condition raises substantial doubt about BMSN’s ability to continue as a going concern.
THE COMPANY DOES NOT CURRENTLY OWN OR OPERATE ANY LABORATORY OR MANUFACTURING FACILITIES, THE COMPANY CAN PROVIDE NO ASSURANCE THAT THE USAGE OF SUCH FACILITIES CAN BE OBTAINED ON TERMS FAVORABLE TO THE COMPANY
The Company does not currently own or operate any laboratory or manufacturing facilities. As a result, we may outsource certain functions, tests and services to Contract Research Organizations (“CROs”), medical institutions and collaborators as well as outsourcing manufacturing to collaborators and/or contract manufacturers. We may also engage a CRO to run all aspects of a clinical trial on our behalf. There is no assurance that such individuals or organizations will be able to provide the functions, tests, or services as agreed upon or in a quality fashion or on terms favorable to the Company. Any failure to do so could cause us to suffer significant delays in the development of our products.
WE ARE IN THE EARLY STAGES OF DEVELOPING HEMAXELLERATE, THE EFFECTIVENESS OF WHICH IS UNPROVEN. OTHER PRODUCTS IN VARIOUS EARLY STAGES OF DEVELOPMENT ARE ALSO UNPROVEN.
The Company is currently in the early stage of developing HemaXellerate, a cellular drug designed to heal damaged bone marrows. HemaXellerate is unproven and no assurance can be given that HemaXellerate will prove effective for its intended purpose.
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WE ARE RELIANT ON BENITEC AUSTRALIA LIMITED AND THE COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION (“CSIRO”) OF AUSTRALIA WITH REGARD TO THE PROSECUTION OF RIGHTS TO PATENTS, PATENT APPLICATIONS, KNOW-HOW AND OTHER INTELLECTUAL PROPERTY RELATING TO RNA INTERFERENCE TO WHICH WE HAVE BEEN GRANTED AN EXCLUSIVE WORLDWIDE RIGHT AND LICENSE TO DEVELOP AND COMMERCIALIZ (“BENITEC LICENSE”).
Pursuant to the agreement between the Company and Benitec Australia Limited for the grant of the Benitec License; Benitec Australia Limited (or CSIRO to the extent applicable and permissible under an exclusive license by and between Benitec Australia Limited and CSIRO), shall have the right and the obligation to prosecute all Patents included within the Benitec License at its cost and expense. Regen BioPharma may not commence suit under any patents licensed or any patents which issue on the applications licensed without seeking and obtaining the prior written consent of Benitec Australia Limited or CSIRO, as the case may be. CSIRO has sole responsibility and control of legal action of any of that patents licensed to the Company under the Benitec License which have been licensed to Benitec Australia Limited by CSIRO. If Benitec Australia Limited or CSIRO fail to adequately maintain, prosecute or protect these intellectual property rights our business and prospects could suffer substantial harm.
WE WILL NEED TO RAISE ADDITIONAL CAPITAL TO CARRY OUT OUR BUSINESS PLAN.
To date, the Company’s operations have not generated cash flow sufficient to fund our capital requirements and there can be no assurance given that the Company’s operations will do so in the future. To date, the Company has generated no cash flow from operations and there can be no assurance given that the Company’s operations will do so in the future. As of January 8, 2014 the Company has cash of $267,000 which will allow us to satisfy our cash requirements over the next seven months exclusive of any additional financing . There is no guarantee that we will be able to access additional capital at rates and on terms which are attractive to us, if at all. Without the additional funding needed to fund our growth we may not be able to grow as planned.
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WE RELY ON HIGHLY SKILLED PERSONNEL AND, IF WE ARE UNABLE TO RETAIN OR MOTIVATE KEY PERSONNEL, HIRE QUALIFIED PERSONNEL, WE MAY NOT BE ABLE TO GROW EFFECTIVELY.
Our performance largely depends on the talents and efforts of highly skilled individuals. Among employees of the Company these individuals include Thomas E. Ichim, PhD, a director and Chief Scientific Officer and Director of Research . Our future success depends on our continuing ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of our organization, particularly sales and marketing. Competition in our industry for qualified employees is intense. In addition, our compensation arrangements may not always be successful in attracting new employees and retaining and motivating our existing employees. Our continued ability to compete effectively depends on our ability to attract new employees and to retain and motivate our existing employees.
DEPENDENCE ON DAVID R. KOOS, WITHOUT WHOSE SERVICES COMPANY BUSINESS OPERATIONS COULD CEASE.
At this time, the sole officer and director of the Company is David R. Koos, who is wholly responsible for the development and execution of our business. Mr. Koos is not party to an employment agreement with us. If Mr. Koos should choose to leave us for any reason before we have hired additional personnel our operations may fail. Even if we are able to find additional personnel, it is uncertain whether we could find qualified management who could develop our business along the lines described herein or would be willing to work for compensation the Company could afford. Without such management, the Company could be forced to cease operations and investors in our common stock or other securities could lose their entire investment. David Koos is not party to an employment agreement with the Company.
THE COMPANY DOES NOT MAINTAIN CERTAIN INSURANCE, INCLUDING ERRORS AND OMISSIONS INSURANCE.
The Company has limited capital and, therefore, does not currently have a policy of insurance against liabilities arising out of the negligence of its officers and directors and/or deficiencies in any of its business operations. Even assuming that the Company obtained insurance, there is no assurance that such insurance coverage would be adequate to satisfy any potential claims made against the Company, its officers and directors, or its business operations or products. Any such liability which might arise could be substantial and may exceed the assets of the Company.
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IN THE FUTURE WE MAY BE SUBJECT TO INTELLECTUAL PROPERTY RIGHTS CLAIMS, WHICH ARE COSTLY TO DEFEND, COULD REQUIRE US TO PAY DAMAGES AND COULD LIMIT OUR ABILITY TO SELL SOME OF OUR PRODUCTS.
Although we have not been subject to any intellectual property litigation or infringement claims, we may be in the future, which could cause us to incur significant expenses to defend such claims, divert management’s attention or prevent us from manufacturing, selling or using some aspect of our products. If we chose or are forced to settle such claims, we may be required to pay for a license to certain rights, paying royalties on both a retrospective and prospective basis, and/or cease our manufacturing and sale of certain products that are alleged to be infringing. Future infringement claims against us by third parties may adversely impact our business, financial condition and results of operations.
WE ARE SUBJECT TO NUMEROUS LAWS AND REGULATIONS, FAILURE TO COMPLY WITH THOSE LAWS AND REGULATIONS MAY ADVERSELY IMPACT OUR BUSINESS.
Products we are currently developing and which may be developed by us would be highly regulated. We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the Food and Drug Administration (FDA) in the United States and regulatory authorities in other countries, with regulations differing from country to country. We are not permitted to market our product candidates in the United States until we receive approval of a New Drug Application (NDA) or a Biologic License Application (BLA), as applicable, from the FDA.
In the United States, NDAs and BLAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication. NDAs and BLAs must also include significant information regarding the chemistry, manufacturing and controls for the product. Obtaining approval of a NDA or BLA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval. Regulators of other jurisdictions, such as the European Medicines Agency (EMA) , a European Union agency for the evaluation of medicinal products, have their own procedures for approval of product candidates. Even in the event that a product is approved, the FDA or the EMA, as the case may be, may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country.
NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF HEMAXELLERATE
On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the Company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia. A condition is classified as drug-refractory if the patient is unresponsive to drug therapy. Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market HemaXellerate. No approval has been granted by the FDA for the marketing and sale of HemaXellerate.
NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF HEMAXELLERATE II
Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to marketHemaXellerate II. No approval has been granted by the FDA for the marketing and sale of HemaXellerate II.
NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF DCELL VAX
Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market dCellVax. No approval has been granted by the FDA for the marketing and sale of dCellVax.
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NO ASSURANCE THAT ANY PRODUCT IN DEVELOPMENT OR WHICH MAY BE PUT INTO DEVELOPMENT WILL SUCCESFULLY COMPLETE ANY CLINICAL TRIALS.
Clinical trials involving new drugs and biologics are commonly classified into three phases. Each phase of the drug approval process is treated as a separate clinical trial and the drug-development process usually advances through all four phases over many years. Each phase exposes greater number of subjects to the drug and each phase builds on existing safety and efficacy information. Phase 1 trials are designed to assess the safety and tolerability of a drug or biologic. 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 III trials are aimed at being the definitive assessment of how effective the drug or biologic is, in comparison with current treatment and to provide an adequate basis for physician labeling. If the drug or biologic successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.
The Company’s plan is 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.
We have yet to complete a successful clinical trial of any product under development and no assurance can be made that any product under development will successfully complete a clinical trial.
THE COMPANY CAN PROVIDE NO ASSURANCE THAT IT WILL BE ABLE TO SELL OR LICENSE ANY PRODUCT UNDER DEVELOPMENT OR WHICH WE MAY DEVELOPIN THE FUTURE.
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.
WE HAVE NOT OBTAINED PATENT PROTECTION FOR OUR INTELLECTUAL PROPERTY.
With the exception of all proprietary rights to US Patent # 8,389,708 (Method of Cancer Treatment using siRNA Silencing ) assigned to the Company on May 1, 2013, the Company has not obtained patent protection on any of its intellectual property. Although the Company plans on attempting to obtain patents on its products and services, there can be no assurance that the Company can obtain effective protection against unauthorized duplication or the introduction of substantially similar products. The concept behind HemaXellerate I and HemaXellarate II, two therapies under development by the Company, derives from intellectual property not protected by patent and considered to be in the public domain.
LIABILITY OF DIRECTORS FOR BREACH OF DUTY OF CARE IS LIMITED. OUR BYLAWS INDEMNIFY MEMBERS OF OUR BOARD OF DIRECTORS, OUR OFFICERS, EMPLOYEES, AND AGENTS AND PERSONS WHO FORMERLY HELD SUCH POSITIONS, AND THE LEGAL REPRESENTATIVES OF ANY OF THEM, TO THE FULLEST EXTENT LEGALLY PERMISSIBLE UNDER THE GENERAL CORPORATION LAW OF THE STATE OF NEVADA AGAINST ANY OR ALL EXPENSE, LIABILITY AND LOSS REASONABLY INCURRED IN DEFENDING A CIVIL OR CRIMINAL ACTION, SUIT OR PROCEEDING TO WHICH ANY SUCH PERSON SHALL HAVE BECOME SUBJECT BY REASON OF HIS HAVING HELD SUCH A POSITION OR HAVING ALLEGEDLY TAKEN OR OMITTED TO TAKE ANY ACTION IN CONNECTION WITH SUCH POSITION.
According to Nevada law (NRS 78.138(7)), all Nevada corporations limit the liability of directors and officers, including acts not in good faith. Our stockholders’ ability to recover damages for fiduciary breaches may be reduced by this statute. In addition our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.
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Risks Related to an Investment in Our Common Stock
WE DO NOT PLANT TO PAY CASH DIVIDENDS IN THE FORESEEABLE FUTURE.
We currently intend to retain all future earnings for use in the operation and expansion of our business. We do not intend to pay any cash dividends in the foreseeable future. Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them. There is no assurance that stockholders will be able to sell shares when desired.
NO PUBLIC MARKET CURRENTLY EXISTS FOR SHARES OF OUR COMMON STOCK, NOR MAY A PUBLIC MARKET EVER EXIST AND OUR SHARES ARE ILLIQUID.
There is currently no public market for our securities and you may not be able to liquidate your investment since there is no assurance that a public market will develop for our common stock or that our common stock will ever be approved for trading on a recognized exchange. Our shares are not and have not been listed or quoted on any exchange or quotation system.
“PENNY STOCK” RULES MAY MAKE BUYING OR SELLING OUR COMMON STOCK DIFFICULT.
Trading in our securities, should a public market develop, will most likely be subject to the “penny stock” rules. The SEC has adopted regulations that generally define a penny stock to be any equity security that has a market price of less than $5.00 per share, subject to certain exceptions. These rules require that any broker-dealer who recommends our securities to persons other than prior customers and accredited investors, must, prior to the sale, make a special written suitability determination for the purchaser and receive the purchaser’s written agreement to execute the transaction. Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the risks associated with trading in the penny stock market. In addition, broker-dealers must disclose commissions payable to both the broker-dealer and the registered representative and current quotations for the securities they offer. The additional burdens imposed upon broker- dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. Broker-dealers who sell penny stocks to certain types of investors are required to comply with the Commission’s regulations concerning the transfer of penny stocks. These regulations require broker- dealers to:
? Make a suitability determination prior to selling a penny stock to the purchaser;
? Receive the purchaser’s written consent to the transaction; and
? Provide certain written disclosures to the purchaser.
These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.
CONCENTRATED CONTROL RISKS; SHAREHOLDERS COULD BE UNABLE TO CONTROL OR INFLUENCE KEY CORPORATE ACTIONS OR EFFECT CHANGES IN THE COMPANY’S BOARD OF DIRECTORS OR MANAGEMENT
Our sole officer and Chairman of our Board of Directors, David R. Koos, has voting power over 50,010,000,shares of our common stock, representing approximately 97% of the voting control of the Company as of September 22, 2013 . Mr. Koos is also, as of September 22, 2013 the sole executive officer of the Company. Subsequent to the distribution, Mr. Koos is anticipated to have voting power over 30,010,000,shares of our common stock, representing approximately 58% of the voting control. Mr. Koos therefore has the power to make many major decisions regarding our affairs, including decisions regarding whether or not to issue stock and for what consideration. In addition, due to Mr. Koos voting power, investors in this offering will have limited control over matters requiring approval by our security holders, including the election of directors, whether or not to sell all or substantially all of our assets and for what consideration and whether or not to authorize more stock for issuance or otherwise amend our charter or bylaws.
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BECAUSE WE HAVE ELECTED TO DEFER COMPLIANCE WITH NEW OR REVISED ACCOUNTING STANDARDS PURSUANT TO SECTION 102(b)(1) OF THE JOBS ACT OUR FINANCIAL STATEMENT DISCLOSURE MAY NOT BE COMPARABLE TO SIMILAR COMPANIES.
We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of our election, our financial statements may not be comparable to companies that comply with public company effective dates. .
FUTURE ISSUANCE OF SECURITIES MAY HAVE A DILUTING FACTOR ON EXISTING AND FUTURE SHAREHOLDERS.
The Company plans to meet cash needs through applying for governmental and nongovernmental grants as well as selling its securities for cash. The issuance of any additional shares of common stock or convertible securities in a subsequent offering could be substantially dilutive to stockholders of our common stock. Dilution is the difference between what you pay for your stock and the net tangible book value per share immediately after the additional shares are sold by us. Holders of our shares of common stock have no preemptive rights as a matter of law that entitle them to purchase their pro-rata share of any offering or shares of any class or series. The market price of our common stock could decline as a result of additional sales of shares of our common stock or the perception that such sales could occur.
FORWARD LOOKING STATEMENTS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION CONTAINED IN THIS PROSPECTUS
This prospectus contains forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve risks and uncertainties. Forward-looking statements include statements regarding, among other things, (a) our projected sales, profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in our industries, (d) our future financing plans and (e) our anticipated needs for working capital. They are generally identifiable by use of the words “may,” “will,” “should,” “anticipate,” “estimate,” “plans,” “potential,” “projects,” “continuing,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend” or the negative of these words or other variations on these words or comparable terminology. These statements may be found under “Management's Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” as well as in this prospectus generally. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements in this report may turn out to be inaccurate. They can be affected by inaccurate assumptions we might make or by known or unknown risks or uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this prospectus generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. You should not place undue reliance on these forward-looking statements.
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The 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 publicly update any forward-looking statements, whether as the result of new information, future events, or otherwise.
USE OF PROCEEDS
We will not receive any proceeds from the distribution of our common stock
DETERMINATION OF OFFERING PRICE
No consideration will be paid for the shares of common stock distributed in the spin-off.. The proposed offering price of the common shares to which this registration statement pertains is $0.0001 and has been estimated solely for the purpose of computing the amount of the registration fee in accordance with Rule 457(f) of the Securities Act of 1933, on the basis of the book value of such securities computed as of the latest practicable date prior to the date of filing the registration statement
DILUTION
We have determined that there is no substantial disparity between the public offering price and the effective cash cost to officers, directors, promoters and affiliated persons of common equity in the Company acquired by them in transactions during the past five years, or which they have the right to acquire.
DISTRIBUTING SECURITY HOLDER
We are furnishing this prospectus to the common and preferred shareholders of Bio Matrix Scientific Group, Inc. a Delaware corporation. This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by Bio Matrix Scientific Group, Inc (“BMSN”) to:
:
(a) Holders of record of the outstanding common shares of BMSN as of the record date
(b) Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.
Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen BioPharma, Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”)
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Name
Shares
Beneficially
Owned
Prior to
The Distribution
Shares to be
Distributed
Amount
Beneficially
Owned Before
Distribution
Percent
Beneficially
Owned After
Distribution
Bio Matrix Scientific Group, Inc. 50,010,000 20,000,000 9 6 % 58%
David R. Koos is the sole executive officer and director of BMSN and the sole executive officer of the Company.
PLAN OF DISTRIBUTION
The distribution will be effected through a pro rata property dividend to common and preferred shareholders of BMSN. The number of shares each BMSN common or preferred shareholder will be entitled to receive in the distribution will depend on how many common and preferred shares are issued and outstanding as of the Record Date which has yet to be determined. Assuming BMSN issues no additional common or preferred shares after January 8 , 201 4 , which cannot be assured, each BMSN common and preferred shareholder of record as of the Record Date will receive one common share of Regen for each 140 common and/or preferred shares of BMSN held of record as of that date. No fractional shares will be distributed. The Distribution Date will be ---- days after the Record Date.
BMSN will pay all expenses incident to the registration and distribution of the shares of our common stock to which this prospectus pertains other than:
DESCRIPTION OF SECURITIES TO BE REGISTERED
The stockholders' equity section of the Company contains the following classes of capital stock as January 8 , 201 4 :
Common stock, $ 0.0001 par value; 500,000,000 shares authorized: 50, 9 10,000 shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.
Preferred Stock, ,$0.0001 par value, 5,000,000 shares authorized: 0 shares issued and outstanding
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.
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This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by BMSN to:
(a) Holders of record of the outstanding common shares of BMSN as of the record date
(b) Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.
Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen BioPharma, Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”).
All shares being registered under this prospectus are common shares. The transfer agent for our common shares is:
Securities Transfer Corporation
2591 Dallas Parkway Suite 102
Frisco, Texas 75034
Phone - 469-633-0101
FAX 469-633-0088
INTERESTS OF NAMED EXPERTS AND COUNSEL
No expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or offering of the common stock was employed on a contingency basis, or had, or is to receive, in connection with the offering, a substantial interest, direct or indirect, in the registrant or any of its parents or subsidiaries. Nor was any such person connected with the registrant or any of its parents or subsidiaries as a promoter, managing or principal underwriter, voting trustee, director, officer, or employee.
The audited financial statements of the Company included in this prospectus and in the registration statement have been audited by Seale and Beers, CPAs.
Joseph L.. Pittera, our independent legal counsel, has provided an opinion on the validity of our common stock.
BUSINESS
We were incorporated April 24, 2012 under the laws of the State of Nevada. We are a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.
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Signature Title Date
January 10, 2014
/s/ David R. Koos Principal Executive Officer
David R. Koos
/s/ David R. Koos Principal Accounting Officer January 10, 2014
David R. Koos
/s/ David R. Koos Director January 10, 2014
David R. Koos
/s/ David R. Koos Principal Financial Officer January 10, 2014
David R. Koos
/s/ Thomas Ichim Director January 10, 2014
Thomas Ichim
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington D.C. 20549
_____________________
AMENDMENT NO. 2 TO
FORM S-1
REGISTRATION STATEMENT
UNDER
THE SECURITIES ACT OF 1933
______________________
REGEN BIOPHARMA, INC.
(Exact name of registrant as specified in its charter)
Nevada 7389 45-5192997
(State or other jurisdiction of (Primary Standard Industrial (I.R.S. Employer Identification Number)
incorporation or organization) Classification Code Number)
_______________________
4700 Spring Street, Suite 304, La Mesa, California, 91942
(619) 702-1404
(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)
________________________
Attn: David R. Koos
Chief Executive Officer
Bio Matrix Scientific Group, Inc.
4700 Spring Street, Suite 304
La Mesa CA 91942
Tel: 619-702-1404
(Name, address, including zip code, and telephone number, including area code, of agent for service)
_________________________
Copies to:
Attn: David R. Koos
Chief Executive Officer
Regen Biopharma, Inc.
4700 Spring Street, Suite 304
La Mesa CA 91942
Tel: 619-702-1404
CALCULATION OF REGISTRATION FEE
Title of Each Class of Securities To Be Registered
Amount To Be
Registered
Proposed Maximum
Offering Price
Per Share(1)
Proposed Maximum
Aggregate
Offering Price(1)
Aggregate
Amount of
Registration Fee
(1)
Common Stock, par value $0.0001 per share 20,000,000 $ 0.0001 $ 2,000 $ 0.27
We are registering 20,000,000 shares of our common stock that will be distributed by Bio Matrix Scientific Group, Inc. as a dividend in kind on a pro rata basis to:
(a) Holders of the outstanding common shares of Bio Matrix Scientific Group Inc, a Delaware corporation, as of the record date
(b) Holders of any outstanding series of the preferred shares of Bio Matrix Scientific Group Inc, a Delaware corporation, as of the record date
(1) Estimated solely for the purpose of calculating the amount of the registration fee pursuant to Rules 457(f) under the Act.
If any of the securities being registered on this form are to be offered on a delayed or continuous basis pursuant to Rule 415 under the Securities Act of 1933, check the following box. o
If this form is filed to register additional securities for an offering pursuant to Rule 462(b) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(c) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
If this form is a post-effective amendment filed pursuant to Rule 462(d) under the Securities Act, check the following box and list the Securities Act registration statement number of the earlier effective registration statement for the same offering. o
Indicated by check mark whether the Registrant is large accelerated filer, an accelerated filer, a non-accelerated filer or a small reporting company as defined in Rule 12b-2 of the Securities Exchange Act of 1934. (Check one unless a smaller reporting company.)
Large Accelerated Filer o Accelerated Filer o
Non-accelerated Filer o Smaller Reporting Company x
The Registrant hereby amends this Registration Statement on such date or dates as may be necessary to delay its effective date until the Registrant shall file an amendment which specifically states that this Registration Statement shall thereafter become effective in accordance with Section 8(a) of the Securities Act of 1933 or until the Registration Statement shall become effective on such date as the Securities and Exchange Commission, acting pursuant to said Section 8(a), may determine.
The information in this preliminary prospectus is not complete and may be changed. These securities may not be sold until the registration statement filed with the U.S. Securities and Exchange Commission (“SEC”) is effective. This preliminary prospectus is not an offer to sell these securities and it is not soliciting an offer to buy these securities in any jurisdiction where the offer or sale is not permitted.
PROSPECTUS
DATED ____, 2014
REGEN BIOPHARMA, INC.
20,000,000 Shares of Common Stock
You may only rely on the information contained in this prospectus or that we have referred you to. We have not authorized anyone to provide you with different information. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any securities other than the common stock offered by this prospectus. This prospectus does not constitute an offer to sell or a solicitation of an offer to buy any common stock in any circumstances in which such offer or solicitation is unlawful. Neither the delivery of this prospectus nor any sale made in connection with this prospectus shall, under any circumstances, create any implication that there has been no change in our affairs since the date of this prospectus is correct as of any time after its date.
We are furnishing this prospectus to the common and preferred shareholders of Bio-Matrix Scientific Group, Inc. a Delaware corporation. This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by Bio Matrix Scientific Group, Inc (“BMSN”) to:
(a) Holders of record of the outstanding common shares of BMSN as of the record date
(b) Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.
Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen BioPharma, Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”)
We are considered an “Emerging Growth Company” under Section 101(a) of the Jumpstart Our Business Startups Act as we are an issuer that had total annual gross revenues of less than $1 billion during our most recently completed fiscal year.
This investment involves a high degree of risk. You should purchase shares only if you can afford a complete loss. See “Risk Factors” beginning on page 8 .
Neither the SEC nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
1
The date of this prospectus is____, 2014.
PROSPECTUS SUMMARY 3
ABOUT THIS OFFERING 6
SUMMARY FINANCIAL AND OPERATING INFORMATION 7
EXEMPTIONS UNDER JUMPSTART OUR BUSINESS STARTUPS ACT 8
RISK FACTORS 8
USE OF PROCEEDS 15
DETERMINATION OF OFFERING PRICE 15
DILUTION 15
DISTRIBUTING SECURITY HOLDER 15
PLAN OF DISTRIBUTION 16
DESCRIPTION OF SECURITIES TO BE REGISTERED 16
INTERESTS OF NAMED EXPERTS AND COUNSEL 17
BUSINESS 17
PROPERTIES 31
LEGAL PROCEEDINGS 31
MARKET PRICE OF AND DIVIDENDS ON THE REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS 32
FINANCIAL STATEMENTS 33
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS 43
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE 44
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS 45
TRANSACTIONS WITH RELATED PERSONS 47
CORPORATE GOVERNANCE 48
SUMMARY COMPENSATION TABLES 49
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT 56
AVAILABLE INFORMATION 57
DISCLOSURE OF COMMISSION POSITION ON INDEMNIFICATION FOR SECURITIES ACT LIABILITIES. 57
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PROSPECTUS SUMMARY
This summary highlights certain information contained elsewhere in this prospectus. Because it is a summary, it may not contain all of the information that is important to you. Before investing in our common stock, you should read this entire prospectus carefully, especially the sections entitled “Risk Factors” beginning on page 8 and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” beginning on page 43 , as well our financial statements and related notes included elsewhere in this prospectus. In this prospectus, the terms “Regen Biopharma, Inc” “Regen ” “Company,” “we,” “us” and “our” refer to Regen Biopharma , Inc.. In this prospectus, the terms “Bio Matrix Scientific Group” “Bio Matrix ” and “BMSN” refer to Bio Matrix Scientific Group , Inc..
About Us
We were incorporated April 24, 2012 under the laws of the State of Nevada. We are a majority owned 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 January 6, 2014, we have not licensed any existing therapies however 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.
The Company has begun development of HemaXellerate I, a cellular therapy designed to heal damaged bone marrow. HemaXellarate I utilizes a collection of cells harvested from the patient’s own adipose (fat) tissue to repair damaged bone marrow and stimulate production of blood cells . The initial application of HemaXellerate I will be the treatment of severe aplastic anemia, a rare and serious condition in which the bone marrow fails to make enough blood cells: red blood cells, white blood cells, and platelets.
In this application, adipose (fat) tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF). SVF preparations contain significant numbers of cellular populations with therapeutic activity that would be relevant to aplastic anemia; namely:
a) Mesenchymal stem cells (MSC), which suppress pathological immune responses and accelerate hematopoiesis (the formation and development of blood cells);
b) Endothelial cells, which assist in repairing damaged bone marrow and stimulate hematopoiesis; and
c) T regulatory cells, which possess anti-inflammatory properties.
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.
In practice, the physician is shipped a kit, which is used to collect adipose tissue. The tissue is sent to a processing facility, and a standardized cellular product is delivered in a ready-to-use manner for administration into the patient intravenously.
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On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate a clinical trial. In this study we will seek to determine the safety and potential efficacy of intravenously administered autologous (derived or transferred from the same individual's body) SVF cells in 10 patients with severe aplastic anemia that is resistant to immune suppressive therapy.
Also in early stage development by the Company are HemaXellerate II and dCellVax.
Unlike HemaXellarate which utilizes the patient’s own fat tissue to harvest the cells needed to repair damaged bone marrow and stimulate production of blood cells HemaXellarate II utilizes third party placental tissue to harvest these cells.
dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body , treated with plasmid DNA (small DNA molecule that is physically separate from, and can replicate independently of, chromosomal DNA) within a cell that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient. A plasmid is a small DNA molecule that is physically separate from, and can replicate independently of, chromosomal DNA within a cell.
Dendritic cells assist a part of the immune system known as the adaptive immune system by identify cancer cells as foreign and presenting this information to other immune cells called T lymphocytes (‘T cells”) enabling the T-cells learn to recognize the tumor as a foreign invader and respond more strongly to destroy it. IDO is an enzyme that is believed to suppress the body’s immune response to the cancer cells by suppressing T Cells as well as halting the dendritic cell from activating T cells. The dendritic cells that are treated with the IDO-blocking plasmid become resistant to the influence of cancer cells which cause the dendritic cell to express IDO . T cells are a type of lymphocyte (itself a type of white blood cell) that play a vital role in the body’s immune response.
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.
Regen has filed applications for patent protection with respect to internally developed intellectual property covering the HemaXellarate products in development (61/648898 - Acceleration of Hematopoietic Reconstitution by Placental Endothelial and Endothelial Progenitor Cells and 61/670791 - Treatment of Hematopoietic Disorders, covering placenta and fat tissue as sources of endothelial cells for therapy).
The therapeutic concept behind dCellVax is derived primarily from
(a) intellectual property acquired from Dr. Wei Ping Min on May 1, 2013
(b) Intellectual property licensed to the Company by Benitec Australia Limited on August 5, 2013
We generated net losses of $522,224 during the period from April 24, 2012(inception) through September 30, 2013. This condition raises substantial doubt about our ability to continue as a going concern. Our continuation as a going concern is dependent on our ability to meet our obligations, to obtain additional financing as may be required and ultimately to attain profitability. Our auditor's report dated December 16, 2013 expressed substantial doubt about our ability to continue as a going concern.
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At September 30, 2013
Selected Balance Sheet Information:
Cash $ 115,922
Current assets 115,922
Total assets $ 115,922
Current liabilities $ 0
Total liabilities 0
Total stockholders' equity (deficit) $ 115,922
As of September 30, 2013 we had $ 115,922 cash on hand and current liabilities of $0.
We feel we will not be able to satisfy its cash requirements over the next twelve months and shall be required to seek additional financing.
We currently plan to raise additional funds primarily by offering securities for cash and applying for grants.
From the period beginning July 1, 2013 and ending September 30 , 2013 the Company’s activities have been primarily focused upon
(a) the development of protocols for pre-clinical research required to be undertaken with regard to the HemaXellerate I product in development in response to the US Food and Drug Administration’s comments on the Company’s submitted IND
(b) the development of preclinical research to be undertaken with regard to the development of dCellVax
The following actions are required to be undertaken by the Company in order to address comments made by the US Food and Drug Administration with regards to the IND filed by the Company for HemaXellerate I
a) Demonstration of safety in an immune deficient model by intravenous administration bracketing the per kilogram dose proposed in the clinical study;
b) Augmentation of existing efficacy data by including details of blood cell responses after treatment.
Pursuant to a Service Agreement entered into by and between the Company and Dr. Wei-Ping Min, on Sept 24, 2013 the Company began experiments required to be undertaken in order to address the FDA’s comment concerning efficacy. Studies required to be undertaken in order to address the FDA’s comments concerning safety commenced in December 2013. It is estimated by the Company that completion of efficacy studies will require 3 months, and the safety studies will be completed in 2 months. It is estimated by the Company that appropriate review of the data by the FDA will take 30 days. Based on these assumptions, d uring the three months ending March 31, 2014 the Company anticipates completion of all actions required to be undertaken with regards to addressing comments made by the US Food and Drug Administration with regards to the IND filed by the Company for HemaXellerate I. The Company also anticipates commencement of the Phase I clinical trial for HemaXellerate I anticipated to begin July 2014. The Company intends, upon satisfaction of all comments, to seek Orphan Drug Designation under the Orphan Drug Act of 1983 from the US Food and Drug Administration for HemaXellerate I. During the three months ended March 31, 2014 the Company also anticipates completion of preclinical testing with regards to dCellVax as well as submission of an IND to the FDA with regards to dCellVax.
The Company has historically met its cash needs primarily through capital contributions made by BMSN and anticipates continuing to do so for the period beginning January 8, 2014 and ending March 31, 2014. The Company also 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.
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The Company anticipates hiring a Chief Financial Officer and a Project Coordinator as well as retaining the services of Contract Research Organizations (CROs) during the period beginning January 8, 2014 and ending September 30 , 2014. The utilization of CROs is intended to provide significant savings with regard to equipment expenditures and long term fixed research / development overhead. As such, the Company does not currently anticipate material acquisition of plant and equipment to be undertaken over the period beginning January 8, 2014 and ending September 30 , 2014
The foregoing statements that are not historical facts, including statements about Regen’s plans, beliefs or expectations, are forward-looking statements. These statements are based on plans, estimates and projections at the time Regen made the original statement, and you should not place undue reliance on them as these plans, estimates and projections may be subject to change. Forward-looking statements involve inherent risks and uncertainties and Regan cautions you that a number of important factors could cause actual results to differ materially from those contained in any such forward-looking statement.
ABOUT THIS OFFERING
Shares Issued BMSN will issue to all BMSN common and preferred shareholders of record on the Record Date a pro rata distribution of 20,000,000 common shares of Regen Biopharma, Inc. owned by BMSN.
Distribution Date
____ days after the Record Date.
Certain U.S. Federal Income Tax Consequences of the Spin-Off The spin-off is taxable to the recipient, as with any dividend.
Secondary Market There is currently no existing public market for the common shares of the Company
Dividend Policy The Company does not anticipate payment of dividends to shareholders in the foreseeable future.
Appraisal Rights Holders of BMSN common and preferred shares have no dissenters’ rights of appraisal in connection with this distribution of the Company’s common shares.
Relationship between BMSN and the Company subsequent to the Distribution. BMSN will own approximately 5 7 % of the outstanding shares of the Company following the distribution. The sole officer and director of BMSN, David Koos will also be Chairman, CEO, President and the sole executive officer of the Company following the distribution.
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SUMMARY FINANCIAL AND OPERATING INFORMATION
The following selected financial information is derived from our Financial Statements appearing elsewhere in this Prospectus and should be read in conjunction with our Financial Statements, including the notes thereto, appearing elsewhere in this Prospectus.
As of As of
September 30, 2013 September 30, 2012
Selected Balance Sheet Information:
Cash $ 115,922 $ 923
Current assets $ 115,922 $ 923
Total Assets $ 115,922 $ 923
Current liabilities $ 0 $ 0
Total liabilities $ 0 $ 0
Total stockholders' equity (deficit) $ 115,922 $ 923
For the twelve months ended
September 30, 2013
For the period from inception (April 24, 2012) to
September 30, 201 2
Selected Statement of Operations Information:
Revenues $ 0 0
Gross profit 0 0
Total operating expenses ( 319,836 ) ( 167,190 )
Operating income (loss) ( 319,836 ) ( 167,190 )
Net income (loss) to common shareholders $ ( 355,034 ) $ ( 167,190 )
Basis and diluted earnings (loss) per common share $ (0.0 187 ) $ ( 16.7 2)
Weighted average common shares outstanding basic and diluted 18,950,000 10,000
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EXEMPTIONS UNDER JUMPSTART OUR BUSINESS STARTUPS ACT
As a company with less than $1.0 billion in revenue during our last fiscal year, we qualify as an “emerging growth company” as defined in the Jumpstart our Business Startups Act of 2012, or the JOBS Act.
An emerging growth company may take advantage of specified reduced reporting requirements and is relieved of certain other significant requirements that are otherwise generally applicable to public companies. As an emerging growth company:
• We are permitted to present only two years of audited financial statements and only two years of related Management’s Discussion and Analysis of Financial Condition and Results of Operations;
• We are exempt from the requirement to obtain an attestation and report from our auditors on the assessment of our internal control over financial reporting pursuant to the Sarbanes-Oxley Act of 2002;
• We are permitted to provide less extensive disclosure about our executive compensation arrangements; and
• We are not required to give our stockholders non-binding advisory votes on executive compensation or golden parachute arrangements.
We may take advantage of these provisions for up to five years subsequent to the effective date of this registration statement or such earlier time that we are no longer an emerging growth company. We will cease to be an emerging growth company upon the earliest of (i) the last day of the first fiscal year in which our annual gross revenues exceed $1 billion, (ii) December 31 of the fiscal year that we become a “large accelerated filer” as defined in Rule 12b-2 under the Securities Exchange Act of 1934, or the Exchange Act, which would occur if the market value of our common stock held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter and we have been publicly reporting for at least 12 months or (iii) the date on which we have issued more than $1 billion in non-convertible debt during the preceding three-year period.
We hereby elect to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1).
RISK FACTORS
An investment in our common stock involves a high degree of risk. You should carefully consider the risks described below as well as other information provided to you in this prospectus, including information in the section of this document entitled “Information Regarding Forward Looking Statements.” If any of the following risks actually occur, our business, financial condition or results of operations could be materially adversely affected, the value of our common stock could decline, and you may lose all or part of your investment. The following discussion and analysis should be read in conjunction with the other financial information and consolidated financial statements and related notes appearing in this prospectus.
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Risks Related to our Business:
WE HAVE A LIMITED OPERATING HISTORY UPON WHICH AN EVALUATION OF OUR PROSPECTS CAN BE MADE.
The Company was incorporated April 24, 2012 and has only been pursuing its current business plan since April 24, 2012. The Company has never generated positive cash flow from operations. Due to the early stage of our development, limited financial and other historical data is available for investors to evaluate whether we will be able to fulfill our business strategy and plans. Further, financial and other limitations may force us to modify, alter, or significantly delay the implementation of such plans. We may incur substantial losses in the future, making it extremely difficult to implement our business plans and strategies and sustain our then current level of operations. Furthermore, no assurances can be given that our strategy will result in an improvement in operating results or that our operations will become profitable.
THERE IS SUBSTANTIAL DOUBT ABOUT THE COMPANY’S ABILITY TO CONTINUE AS A GOING CONCERN.
Our auditor’s report dated December 16 , 2013 expresses an opinion that substantial doubt exists as to whether we can continue as an ongoing concern. Because obtaining investment capital in not certain, we may not have the funds necessary to continue our operations. Our ability to meet our operating needs depends in large part on our ability to secure third party financing. We cannot provide any assurances that we will be able to obtain financing.
THERE IS SUBSTANTIAL DOUBT ABOUT THE COMPANY’S PARENT’S ABILITY TO CONTINUE AS A GOING CONCERN.
Our parent company, BMSN, has no revenues and generated net losses of $ 16,439, 725 (excluding $663,649 of Equity in Net Losses of Entest Biomedical, Inc. recognized) during the period from August 2, 2005 (inception) through September 30, 2013. This condition raises substantial doubt about BMSN’s ability to continue as a going concern.
THE COMPANY DOES NOT CURRENTLY OWN OR OPERATE ANY LABORATORY OR MANUFACTURING FACILITIES, THE COMPANY CAN PROVIDE NO ASSURANCE THAT THE USAGE OF SUCH FACILITIES CAN BE OBTAINED ON TERMS FAVORABLE TO THE COMPANY
The Company does not currently own or operate any laboratory or manufacturing facilities. As a result, we may outsource certain functions, tests and services to Contract Research Organizations (“CROs”), medical institutions and collaborators as well as outsourcing manufacturing to collaborators and/or contract manufacturers. We may also engage a CRO to run all aspects of a clinical trial on our behalf. There is no assurance that such individuals or organizations will be able to provide the functions, tests, or services as agreed upon or in a quality fashion or on terms favorable to the Company. Any failure to do so could cause us to suffer significant delays in the development of our products.
WE ARE IN THE EARLY STAGES OF DEVELOPING HEMAXELLERATE, THE EFFECTIVENESS OF WHICH IS UNPROVEN. OTHER PRODUCTS IN VARIOUS EARLY STAGES OF DEVELOPMENT ARE ALSO UNPROVEN.
The Company is currently in the early stage of developing HemaXellerate, a cellular drug designed to heal damaged bone marrows. HemaXellerate is unproven and no assurance can be given that HemaXellerate will prove effective for its intended purpose.
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WE ARE RELIANT ON BENITEC AUSTRALIA LIMITED AND THE COMMONWEALTH SCIENTIFIC AND INDUSTRIAL RESEARCH ORGANISATION (“CSIRO”) OF AUSTRALIA WITH REGARD TO THE PROSECUTION OF RIGHTS TO PATENTS, PATENT APPLICATIONS, KNOW-HOW AND OTHER INTELLECTUAL PROPERTY RELATING TO RNA INTERFERENCE TO WHICH WE HAVE BEEN GRANTED AN EXCLUSIVE WORLDWIDE RIGHT AND LICENSE TO DEVELOP AND COMMERCIALIZ (“BENITEC LICENSE”).
Pursuant to the agreement between the Company and Benitec Australia Limited for the grant of the Benitec License; Benitec Australia Limited (or CSIRO to the extent applicable and permissible under an exclusive license by and between Benitec Australia Limited and CSIRO), shall have the right and the obligation to prosecute all Patents included within the Benitec License at its cost and expense. Regen BioPharma may not commence suit under any patents licensed or any patents which issue on the applications licensed without seeking and obtaining the prior written consent of Benitec Australia Limited or CSIRO, as the case may be. CSIRO has sole responsibility and control of legal action of any of that patents licensed to the Company under the Benitec License which have been licensed to Benitec Australia Limited by CSIRO. If Benitec Australia Limited or CSIRO fail to adequately maintain, prosecute or protect these intellectual property rights our business and prospects could suffer substantial harm.
WE WILL NEED TO RAISE ADDITIONAL CAPITAL TO CARRY OUT OUR BUSINESS PLAN.
To date, the Company’s operations have not generated cash flow sufficient to fund our capital requirements and there can be no assurance given that the Company’s operations will do so in the future. To date, the Company has generated no cash flow from operations and there can be no assurance given that the Company’s operations will do so in the future. As of January 8, 2014 the Company has cash of $267,000 which will allow us to satisfy our cash requirements over the next seven months exclusive of any additional financing . There is no guarantee that we will be able to access additional capital at rates and on terms which are attractive to us, if at all. Without the additional funding needed to fund our growth we may not be able to grow as planned.
.
WE RELY ON HIGHLY SKILLED PERSONNEL AND, IF WE ARE UNABLE TO RETAIN OR MOTIVATE KEY PERSONNEL, HIRE QUALIFIED PERSONNEL, WE MAY NOT BE ABLE TO GROW EFFECTIVELY.
Our performance largely depends on the talents and efforts of highly skilled individuals. Among employees of the Company these individuals include Thomas E. Ichim, PhD, a director and Chief Scientific Officer and Director of Research . Our future success depends on our continuing ability to identify, hire, develop, motivate and retain highly skilled personnel for all areas of our organization, particularly sales and marketing. Competition in our industry for qualified employees is intense. In addition, our compensation arrangements may not always be successful in attracting new employees and retaining and motivating our existing employees. Our continued ability to compete effectively depends on our ability to attract new employees and to retain and motivate our existing employees.
DEPENDENCE ON DAVID R. KOOS, WITHOUT WHOSE SERVICES COMPANY BUSINESS OPERATIONS COULD CEASE.
At this time, the sole officer and director of the Company is David R. Koos, who is wholly responsible for the development and execution of our business. Mr. Koos is not party to an employment agreement with us. If Mr. Koos should choose to leave us for any reason before we have hired additional personnel our operations may fail. Even if we are able to find additional personnel, it is uncertain whether we could find qualified management who could develop our business along the lines described herein or would be willing to work for compensation the Company could afford. Without such management, the Company could be forced to cease operations and investors in our common stock or other securities could lose their entire investment. David Koos is not party to an employment agreement with the Company.
THE COMPANY DOES NOT MAINTAIN CERTAIN INSURANCE, INCLUDING ERRORS AND OMISSIONS INSURANCE.
The Company has limited capital and, therefore, does not currently have a policy of insurance against liabilities arising out of the negligence of its officers and directors and/or deficiencies in any of its business operations. Even assuming that the Company obtained insurance, there is no assurance that such insurance coverage would be adequate to satisfy any potential claims made against the Company, its officers and directors, or its business operations or products. Any such liability which might arise could be substantial and may exceed the assets of the Company.
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IN THE FUTURE WE MAY BE SUBJECT TO INTELLECTUAL PROPERTY RIGHTS CLAIMS, WHICH ARE COSTLY TO DEFEND, COULD REQUIRE US TO PAY DAMAGES AND COULD LIMIT OUR ABILITY TO SELL SOME OF OUR PRODUCTS.
Although we have not been subject to any intellectual property litigation or infringement claims, we may be in the future, which could cause us to incur significant expenses to defend such claims, divert management’s attention or prevent us from manufacturing, selling or using some aspect of our products. If we chose or are forced to settle such claims, we may be required to pay for a license to certain rights, paying royalties on both a retrospective and prospective basis, and/or cease our manufacturing and sale of certain products that are alleged to be infringing. Future infringement claims against us by third parties may adversely impact our business, financial condition and results of operations.
WE ARE SUBJECT TO NUMEROUS LAWS AND REGULATIONS, FAILURE TO COMPLY WITH THOSE LAWS AND REGULATIONS MAY ADVERSELY IMPACT OUR BUSINESS.
Products we are currently developing and which may be developed by us would be highly regulated. We currently have no products approved for sale and we cannot guarantee that we will ever have marketable products. The development of a product candidate and issues relating to its approval and marketing are subject to extensive regulation by the Food and Drug Administration (FDA) in the United States and regulatory authorities in other countries, with regulations differing from country to country. We are not permitted to market our product candidates in the United States until we receive approval of a New Drug Application (NDA) or a Biologic License Application (BLA), as applicable, from the FDA.
In the United States, NDAs and BLAs must include extensive preclinical and clinical data and supporting information to establish the product candidate’s safety and effectiveness for each desired indication. NDAs and BLAs must also include significant information regarding the chemistry, manufacturing and controls for the product. Obtaining approval of a NDA or BLA is a lengthy, expensive and uncertain process, and we may not be successful in obtaining approval. Regulators of other jurisdictions, such as the European Medicines Agency (EMA) , a European Union agency for the evaluation of medicinal products, have their own procedures for approval of product candidates. Even in the event that a product is approved, the FDA or the EMA, as the case may be, may limit the indications for which the product may be marketed, require extensive warnings on the product labeling or require expensive and time-consuming clinical trials or reporting as conditions of approval. Regulatory authorities in countries outside of the United States and Europe also have requirements for approval of drug candidates with which we must comply prior to marketing in those countries. Obtaining regulatory approval for marketing of a product candidate in one country does not ensure that we will be able to obtain regulatory approval in any other country.
NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF HEMAXELLERATE
On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration to initiate clinical trials assessing the Company’s HemaXellerate drug currently in development in patients with drug-refractory aplastic anemia. A condition is classified as drug-refractory if the patient is unresponsive to drug therapy. Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market HemaXellerate. No approval has been granted by the FDA for the marketing and sale of HemaXellerate.
NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF HEMAXELLERATE II
Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to marketHemaXellerate II. No approval has been granted by the FDA for the marketing and sale of HemaXellerate II.
NO APPROVAL HAS BEEN GRANTED BY THE FDA FOR THE MARKETING AND SALE OF DCELL VAX
Regen will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market dCellVax. No approval has been granted by the FDA for the marketing and sale of dCellVax.
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NO ASSURANCE THAT ANY PRODUCT IN DEVELOPMENT OR WHICH MAY BE PUT INTO DEVELOPMENT WILL SUCCESFULLY COMPLETE ANY CLINICAL TRIALS.
Clinical trials involving new drugs and biologics are commonly classified into three phases. Each phase of the drug approval process is treated as a separate clinical trial and the drug-development process usually advances through all four phases over many years. Each phase exposes greater number of subjects to the drug and each phase builds on existing safety and efficacy information. Phase 1 trials are designed to assess the safety and tolerability of a drug or biologic. 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 III trials are aimed at being the definitive assessment of how effective the drug or biologic is, in comparison with current treatment and to provide an adequate basis for physician labeling. If the drug or biologic successfully passes through Phases I, II, and III, it will usually be approved by the national regulatory authority for use in the general population.
The Company’s plan is 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.
We have yet to complete a successful clinical trial of any product under development and no assurance can be made that any product under development will successfully complete a clinical trial.
THE COMPANY CAN PROVIDE NO ASSURANCE THAT IT WILL BE ABLE TO SELL OR LICENSE ANY PRODUCT UNDER DEVELOPMENT OR WHICH WE MAY DEVELOPIN THE FUTURE.
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.
WE HAVE NOT OBTAINED PATENT PROTECTION FOR OUR INTELLECTUAL PROPERTY.
With the exception of all proprietary rights to US Patent # 8,389,708 (Method of Cancer Treatment using siRNA Silencing ) assigned to the Company on May 1, 2013, the Company has not obtained patent protection on any of its intellectual property. Although the Company plans on attempting to obtain patents on its products and services, there can be no assurance that the Company can obtain effective protection against unauthorized duplication or the introduction of substantially similar products. The concept behind HemaXellerate I and HemaXellarate II, two therapies under development by the Company, derives from intellectual property not protected by patent and considered to be in the public domain.
LIABILITY OF DIRECTORS FOR BREACH OF DUTY OF CARE IS LIMITED. OUR BYLAWS INDEMNIFY MEMBERS OF OUR BOARD OF DIRECTORS, OUR OFFICERS, EMPLOYEES, AND AGENTS AND PERSONS WHO FORMERLY HELD SUCH POSITIONS, AND THE LEGAL REPRESENTATIVES OF ANY OF THEM, TO THE FULLEST EXTENT LEGALLY PERMISSIBLE UNDER THE GENERAL CORPORATION LAW OF THE STATE OF NEVADA AGAINST ANY OR ALL EXPENSE, LIABILITY AND LOSS REASONABLY INCURRED IN DEFENDING A CIVIL OR CRIMINAL ACTION, SUIT OR PROCEEDING TO WHICH ANY SUCH PERSON SHALL HAVE BECOME SUBJECT BY REASON OF HIS HAVING HELD SUCH A POSITION OR HAVING ALLEGEDLY TAKEN OR OMITTED TO TAKE ANY ACTION IN CONNECTION WITH SUCH POSITION.
According to Nevada law (NRS 78.138(7)), all Nevada corporations limit the liability of directors and officers, including acts not in good faith. Our stockholders’ ability to recover damages for fiduciary breaches may be reduced by this statute. In addition our Bylaws indemnify members of the board of directors, our officers, employees, and agents and persons who formerly held such positions, and the legal representatives of any of them, to the fullest extent legally permissible under the general corporation law of the state of Nevada against any or all expense, liability and loss reasonably incurred in defending a civil or criminal action, suit or proceeding to which any such person shall have become subject by reason of his having held such a position or having allegedly taken or omitted to take any action in connection with such position.
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Risks Related to an Investment in Our Common Stock
WE DO NOT PLANT TO PAY CASH DIVIDENDS IN THE FORESEEABLE FUTURE.
We currently intend to retain all future earnings for use in the operation and expansion of our business. We do not intend to pay any cash dividends in the foreseeable future. Unless we pay dividends, our stockholders will not be able to receive a return on their shares unless they sell them. There is no assurance that stockholders will be able to sell shares when desired.
NO PUBLIC MARKET CURRENTLY EXISTS FOR SHARES OF OUR COMMON STOCK, NOR MAY A PUBLIC MARKET EVER EXIST AND OUR SHARES ARE ILLIQUID.
There is currently no public market for our securities and you may not be able to liquidate your investment since there is no assurance that a public market will develop for our common stock or that our common stock will ever be approved for trading on a recognized exchange. Our shares are not and have not been listed or quoted on any exchange or quotation system.
“PENNY STOCK” RULES MAY MAKE BUYING OR SELLING OUR COMMON STOCK DIFFICULT.
Trading in our securities, should a public market develop, will most likely be subject to the “penny stock” rules. The SEC has adopted regulations that generally define a penny stock to be any equity security that has a market price of less than $5.00 per share, subject to certain exceptions. These rules require that any broker-dealer who recommends our securities to persons other than prior customers and accredited investors, must, prior to the sale, make a special written suitability determination for the purchaser and receive the purchaser’s written agreement to execute the transaction. Unless an exception is available, the regulations require the delivery, prior to any transaction involving a penny stock, of a disclosure schedule explaining the penny stock market and the risks associated with trading in the penny stock market. In addition, broker-dealers must disclose commissions payable to both the broker-dealer and the registered representative and current quotations for the securities they offer. The additional burdens imposed upon broker- dealers by such requirements may discourage broker-dealers from effecting transactions in our securities, which could severely limit the market price and liquidity of our securities. Broker-dealers who sell penny stocks to certain types of investors are required to comply with the Commission’s regulations concerning the transfer of penny stocks. These regulations require broker- dealers to:
? Make a suitability determination prior to selling a penny stock to the purchaser;
? Receive the purchaser’s written consent to the transaction; and
? Provide certain written disclosures to the purchaser.
These requirements may restrict the ability of broker-dealers to sell our common stock and may affect your ability to resell our common stock.
CONCENTRATED CONTROL RISKS; SHAREHOLDERS COULD BE UNABLE TO CONTROL OR INFLUENCE KEY CORPORATE ACTIONS OR EFFECT CHANGES IN THE COMPANY’S BOARD OF DIRECTORS OR MANAGEMENT
Our sole officer and Chairman of our Board of Directors, David R. Koos, has voting power over 50,010,000,shares of our common stock, representing approximately 97% of the voting control of the Company as of September 22, 2013 . Mr. Koos is also, as of September 22, 2013 the sole executive officer of the Company. Subsequent to the distribution, Mr. Koos is anticipated to have voting power over 30,010,000,shares of our common stock, representing approximately 58% of the voting control. Mr. Koos therefore has the power to make many major decisions regarding our affairs, including decisions regarding whether or not to issue stock and for what consideration. In addition, due to Mr. Koos voting power, investors in this offering will have limited control over matters requiring approval by our security holders, including the election of directors, whether or not to sell all or substantially all of our assets and for what consideration and whether or not to authorize more stock for issuance or otherwise amend our charter or bylaws.
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BECAUSE WE HAVE ELECTED TO DEFER COMPLIANCE WITH NEW OR REVISED ACCOUNTING STANDARDS PURSUANT TO SECTION 102(b)(1) OF THE JOBS ACT OUR FINANCIAL STATEMENT DISCLOSURE MAY NOT BE COMPARABLE TO SIMILAR COMPANIES.
We have elected to use the extended transition period for complying with new or revised accounting standards under Section 102(b)(1) of the JOBS Act. This allows us to delay the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards apply to private companies. As a result of our election, our financial statements may not be comparable to companies that comply with public company effective dates. .
FUTURE ISSUANCE OF SECURITIES MAY HAVE A DILUTING FACTOR ON EXISTING AND FUTURE SHAREHOLDERS.
The Company plans to meet cash needs through applying for governmental and nongovernmental grants as well as selling its securities for cash. The issuance of any additional shares of common stock or convertible securities in a subsequent offering could be substantially dilutive to stockholders of our common stock. Dilution is the difference between what you pay for your stock and the net tangible book value per share immediately after the additional shares are sold by us. Holders of our shares of common stock have no preemptive rights as a matter of law that entitle them to purchase their pro-rata share of any offering or shares of any class or series. The market price of our common stock could decline as a result of additional sales of shares of our common stock or the perception that such sales could occur.
FORWARD LOOKING STATEMENTS
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION CONTAINED IN THIS PROSPECTUS
This prospectus contains forward-looking statements. Forward-looking statements give our current expectations or forecasts of future events. You can identify these statements by the fact that they do not relate strictly to historical or current facts. Forward-looking statements involve risks and uncertainties. Forward-looking statements include statements regarding, among other things, (a) our projected sales, profitability, and cash flows, (b) our growth strategies, (c) anticipated trends in our industries, (d) our future financing plans and (e) our anticipated needs for working capital. They are generally identifiable by use of the words “may,” “will,” “should,” “anticipate,” “estimate,” “plans,” “potential,” “projects,” “continuing,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend” or the negative of these words or other variations on these words or comparable terminology. These statements may be found under “Management's Discussion and Analysis of Financial Condition and Results of Operations” and “Business,” as well as in this prospectus generally. In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, and financial results.
Any or all of our forward-looking statements in this report may turn out to be inaccurate. They can be affected by inaccurate assumptions we might make or by known or unknown risks or uncertainties. Consequently, no forward-looking statement can be guaranteed. Actual future results may vary materially as a result of various factors, including, without limitation, the risks outlined under “Risk Factors” and matters described in this prospectus generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur. You should not place undue reliance on these forward-looking statements.
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The 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 publicly update any forward-looking statements, whether as the result of new information, future events, or otherwise.
USE OF PROCEEDS
We will not receive any proceeds from the distribution of our common stock
DETERMINATION OF OFFERING PRICE
No consideration will be paid for the shares of common stock distributed in the spin-off.. The proposed offering price of the common shares to which this registration statement pertains is $0.0001 and has been estimated solely for the purpose of computing the amount of the registration fee in accordance with Rule 457(f) of the Securities Act of 1933, on the basis of the book value of such securities computed as of the latest practicable date prior to the date of filing the registration statement
DILUTION
We have determined that there is no substantial disparity between the public offering price and the effective cash cost to officers, directors, promoters and affiliated persons of common equity in the Company acquired by them in transactions during the past five years, or which they have the right to acquire.
DISTRIBUTING SECURITY HOLDER
We are furnishing this prospectus to the common and preferred shareholders of Bio Matrix Scientific Group, Inc. a Delaware corporation. This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by Bio Matrix Scientific Group, Inc (“BMSN”) to:
:
(a) Holders of record of the outstanding common shares of BMSN as of the record date
(b) Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.
Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen BioPharma, Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”)
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Name
Shares
Beneficially
Owned
Prior to
The Distribution
Shares to be
Distributed
Amount
Beneficially
Owned Before
Distribution
Percent
Beneficially
Owned After
Distribution
Bio Matrix Scientific Group, Inc. 50,010,000 20,000,000 9 6 % 58%
David R. Koos is the sole executive officer and director of BMSN and the sole executive officer of the Company.
PLAN OF DISTRIBUTION
The distribution will be effected through a pro rata property dividend to common and preferred shareholders of BMSN. The number of shares each BMSN common or preferred shareholder will be entitled to receive in the distribution will depend on how many common and preferred shares are issued and outstanding as of the Record Date which has yet to be determined. Assuming BMSN issues no additional common or preferred shares after January 8 , 201 4 , which cannot be assured, each BMSN common and preferred shareholder of record as of the Record Date will receive one common share of Regen for each 140 common and/or preferred shares of BMSN held of record as of that date. No fractional shares will be distributed. The Distribution Date will be ---- days after the Record Date.
BMSN will pay all expenses incident to the registration and distribution of the shares of our common stock to which this prospectus pertains other than:
DESCRIPTION OF SECURITIES TO BE REGISTERED
The stockholders' equity section of the Company contains the following classes of capital stock as January 8 , 201 4 :
Common stock, $ 0.0001 par value; 500,000,000 shares authorized: 50, 9 10,000 shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company's stockholders, a ratable share in the assets of the Corporation.
Preferred Stock, ,$0.0001 par value, 5,000,000 shares authorized: 0 shares issued and outstanding
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.
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This prospectus relates to the distribution on a pro rata basis as a dividend in kind of 20,000,000 of our common shares, par value $0.0001, currently owned by BMSN to:
(a) Holders of record of the outstanding common shares of BMSN as of the record date
(b) Holders of record of the shares of any outstanding series of the preferred shares of BMSN as of the record date.
Shareholders of BMSN will receive a proportionate allocation of the shares to be distributed in relation to the total number of common and or/preferred shares to which they are shareholders of record as of the record date. The record date is anticipated to be the date that the registration statement on Form S-1 of which this prospectus forms a part is declared effective by the United States Securities and Exchange Commission (“Record Date”). The distribution of the 20,000,000 common shares of Regen BioPharma, Inc. to the common and preferred shareholders of BMSN will occur ___ days after the Record Date (“Distribution Date”).
All shares being registered under this prospectus are common shares. The transfer agent for our common shares is:
Securities Transfer Corporation
2591 Dallas Parkway Suite 102
Frisco, Texas 75034
Phone - 469-633-0101
FAX 469-633-0088
INTERESTS OF NAMED EXPERTS AND COUNSEL
No expert or counsel named in this prospectus as having prepared or certified any part of this prospectus or having given an opinion upon the validity of the securities being registered or upon other legal matters in connection with the registration or offering of the common stock was employed on a contingency basis, or had, or is to receive, in connection with the offering, a substantial interest, direct or indirect, in the registrant or any of its parents or subsidiaries. Nor was any such person connected with the registrant or any of its parents or subsidiaries as a promoter, managing or principal underwriter, voting trustee, director, officer, or employee.
The audited financial statements of the Company included in this prospectus and in the registration statement have been audited by Seale and Beers, CPAs.
Joseph L.. Pittera, our independent legal counsel, has provided an opinion on the validity of our common stock.
BUSINESS
We were incorporated April 24, 2012 under the laws of the State of Nevada. We are a wholly owned subsidiary of Bio Matrix Scientific Group, Inc, a Delaware corporation.
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Signature Title Date
January 10, 2014
/s/ David R. Koos Principal Executive Officer
David R. Koos
/s/ David R. Koos Principal Accounting Officer January 10, 2014
David R. Koos
/s/ David R. Koos Director January 10, 2014
David R. Koos
/s/ David R. Koos Principal Financial Officer January 10, 2014
David R. Koos
/s/ Thomas Ichim Director January 10, 2014
Thomas Ichim
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