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EX-32.2 - EXHIBIT 32.2 - ENTEST GROUP, INC.ex32_2.htm
EX-32.1 - EXHIBIT 332.1 - ENTEST GROUP, INC.ex32_1.htm
EX-31.2 - EXHIBIT 31.2 - ENTEST GROUP, INC.ex31_2.htm
EX-31.1 - EXHIBIT 31.1 - ENTEST GROUP, INC.ex31_1.htm
EX-23.1 - EXHIBIT 23.1 - ENTEST GROUP, INC.ex23_1.htm
EX-10.45 - EXHIBIT 10.45 - ENTEST GROUP, INC.ex10_45.htm

 

United States Securities and Exchange Commission

Washington, D.C.  20549

 

Form 10-K

 

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

For the fiscal year ending August 31, 2016

 

 

 ☐ TRANSITION REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934:   For the transition period from ___________ to ___________.

 

Commission file number: 333-154989

 

ENTEST BIOMEDICAL, INC.

(Name of small business issuer in its charter)

 

Nevada   26-3431263
(State or other jurisdiction of incorporation or organization)   (I.R.S. Employer Identification No.)

 

 

4700 Spring Street, Suite 304, La Mesa, California, 91942

(Address of Principal executive offices)

 

Issuer’s telephone number: ( 619) 702-1404 

_______________

 

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

 

Securities registered under Section 12(g) of the Exchange Act: None

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.    

Yes ☒ No ☐

 

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

 

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

 

 

Large accelerated filer ☐ Accelerated filer ☐
Non accelerated filer ☐ Smaller reporting Company ☒

 

 

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

Yes ☐ No ☒ 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files).   

Yes  ☐ No ☒

 

State the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity was last sold, as of the last business day of the registrant’s most recently completed second fiscal quarter: $ 119,780

 

As of August 31, 2016 Entest BioMedical, Inc. had 40,170,472 common shares outstanding, 28, 009 Series B Preferred shares outstanding , 667 Series AA preferred shares outstanding and 533 Series AAA preferred shares outstanding .

 

i 
 

 

 

 

In this annual report, the terms “Entest BioMedical, Inc.. ”, “Entest”,  “Company”, “we”, or “our”, unless the context otherwise requires, mean Entest BioMedical, Inc., a Nevada corporation, and its subsidiaries.

 

CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS

 

This annual report on Form 10-K and other reports that we file with the SEC contain statements that are considered forward-looking statements.  Forward-looking statements give the Company’s current expectations, plans, objectives, assumptions or forecasts of future events. All statements other than statements of current or historical fact contained in this annual report, including statements regarding the Company’s future financial position, business strategy, budgets, projected costs and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plans,” “potential,” “projects,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend,” and similar expressions. These statements are based on the Company’s current plans and are subject to risks and uncertainties, and as such the Company’s actual future activities and results of operations may be materially different from those set forth in the forward looking statements. Any or all of the forward-looking statements in this annual report may turn out to be inaccurate and as such, you should not place undue reliance on these forward-looking statements.  The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. The forward-looking statements can be affected by inaccurate assumptions or by known or unknown risks, uncertainties and assumptions due to a number of factors, including:

 

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

 

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

 

 

ii 
 

 

 

PART I

 

Item 1. Business

 

We were incorporated in the State of Nevada on September 24, 2008 as JB Clothing Corporation.  Until July 10, 2009, our principal business objective was the offering of active/leisure fashion design clothing.

 

On July 10, 2009 we abandoned our efforts in the field of active/leisure fashion design clothing when we acquired 100% of the share capital of Entest BioMedical, Inc., a California corporation, (“Entest CA”) from Bio-Matrix Scientific Group, Inc. (“BMSN”) for consideration consisting of 10,000,000 shares of the common stock of the Company and the cancellation of 10,000,000 shares of the Company owned and held by Mr. Rick Plote.

 

As a result of this transaction, the former stockholder of Entest CA held approximately 70% of the voting capital stock of the Company immediately after the transaction.  For financial accounting purposes, this acquisition was a reverse acquisition of the Company by Entest CA under the purchase method of accounting, and was treated as a recapitalization with Entest CA as the acquirer. As of November 1, 2011 the former stockholder of Entest CA held approximately 48% of the outstanding common shares of the Company.

 

Upon acquisition of Entest CA, we abandoned our efforts in the field of active/leisure fashion design clothing.  Our business is currently the business of Entest CA, and we currently intend to develop and commercialize therapies, medical devices and medical testing procedures. On July 12, 2009 we adopted the name of Entest CA when we changed our name to Entest BioMedical, Inc.

 

On June 18, 2015 Entest established Zander Therapeutics, Inc., a wholly owned subsidiary.

 

On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an Regen Agreement (“Regen Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (“ License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is a wholly owned subsidiary of Entest Biomedical, Inc.

 

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

 

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

 

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

 

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

 

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

 

The Regen Agreement may be terminated by Regen:

 

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

 

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

 

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

 

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

 

1
 

 

On September 28, 2015 Zander caused to be issued to Regen 8,000,000 of the common shares of Entest Biomedical, Inc in satisfaction of one hundred thousand US dollars ($100,000) to be paid to Regen by Zander as a license initiation fee.

 

On September 8, 2016 Zander paid $17,000 to Regen as a partial payment of the July 15th, 2016 liability

 

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

 

The Company’s current strategy is to develop and commercialize therapies, medical devices and medical testing procedures for the veterinary market.  It is believed by the Company that any required regulatory approvals can be obtained much more rapidly with regard to products and services developed for the veterinary market and that the achievement of successful clinical trials and commercialization of such products and services may allow the company to enter into collaborations with larger pharmaceutical companies for the purpose of developing and commercializing these products and services for human usage.

 

The process by which a new drug is approved for use in humans within the United States generally begins prior to submission of the IND (Investigational New Drug Application) with the FDA.

 

Prior to submission of the IND, the sponsor of the drug compound under development must test the drugs on laboratory animals (preclinical testing) in order that toxicity may be determined and efficacy may be demonstrated. The results of such preclinical testing is crucial in determining whether or not the sponsor may proceed onto clinical trials on human beings and preclinical testing is required to be performed on multiple species.

 

Drug studies in humans can begin only after an IND is reviewed by the FDA and a local institutional review board (IRB). The board is a panel of scientists and non-scientists in hospitals and research institutions that oversees clinical research.

 

IRBs approve the clinical trial protocols, which describe the type of people who may participate in the clinical trial, the schedule of tests and procedures, the medications and dosages to be studied, the length of the study, the study's objectives, and other details. IRBs make sure the study is acceptable, that participants have given consent and are fully informed of their risks, and that researchers take appropriate steps to protect patients from harm.

 

After trial protocols have been approved the sponsor moves on to Phase I clinical trials (to determine safety and toxicity in a small number of volunteers) and, if Phase 1 studies don't reveal unacceptable toxicity, Phase II and Phase III clinical trials to determine effectiveness.

The process by which a new drug is approved for veterinary  use within the United States generally begins with the sponsor researching  and developing  the new compound and conducting  initial (“pilot”) studies on it for a specific use in a specific animal species (called the “target animal” species) If the results of the pilot studies are promising  and there is a potential market for the drug, the drug sponsor contacts The US Food and Drug Administration’s Center for Veterinary Medicine (CVM) to officially begin the drug approval process by opening an Investigational New Animal Drug (“INAD”) file.  Information is submitted regarding Chemistry, Manufacturing, and Controls; Effectiveness; Target Animal Safety; Human Food Safety(if applicable); Environmental Impact (if applicable) and Labeling in support of the NADA (New Animal Drug Application) which is submitted by the sponsor for approval by the FDA.

 

With the exception of a biologic product which can be classified as a medical device,  Biologics developed for human use generally are undergo the same path to FDA approval as  for drugs. Biologics classified as medical devices may, in most instance, be subject to premarket approval by the FDA. Medical devices intended for veterinary use are not subject to premarket approval by the FDA.

 

Veterinary Biologics are regulated by the U.S. Department of Agriculture (USDA)  which is authorized, under the 1913 Virus-Serum-Toxin Act as amended by the 1985 Food Security Act, to ensure that all veterinary biologics produced in, or imported into, the United States are not worthless, contaminated, dangerous, or harmful. The Veterinary Biologics Program of the USDA's Animal and Plant Health Inspection Service (APHIS) oversees the veterinary biologics industry in the United States.

 

Domestic manufacturers of veterinary biologics, for domestic use or for export, are required to possess a valid U.S. Veterinary Biologics Establishment License and an individual U.S. Veterinary Biologics Product License for each product produced for sale.  Prior to being granted a U.S. Veterinary Biologic Establishment License, the applicant must submit detailed information regarding the facilities and the qualifications of key personnel and must submit to an inspection of the facilities by the Center for Veterinary Biologics, a division of the USDA . To qualify for an establishment license, an applicant also must qualify for at least one product license.

 

Prior to being granted a U.S. Veterinary Biologics Product License, the applicant must submit detailed information including test reports and research data sufficient to establish purity, safety, potency and efficacy of the product, an Outline of Production, and information regarding labeling and  facilities that are to be used in preparation.

 

It is the Company’s opinion that factors such as the lack of need for multispecies pre clinical testing, smaller subject size in efficacy testing (subjects generally  in the hundreds for veterinary equivalent of Phase III clinical trials as opposed to generally  in the thousands for Phase III clinical trials for drug compounds for use in humans), lack of the requirement for premarket approval  for medical devices intended for veterinary use should generally lead to a shorter timeframe for approval by the appropriate regulators of drugs, biologics, and medical devices intended for veterinary use as opposed to drugs, biologics, and medical devices intended for human use.

 

2
 

 

The Company is currently focusing its efforts and allocating its resources towards:

 

(a)The development and commercialization of ImenVax™, a therapeutic cancer vaccine for use in canines
(b)The the development and commercialization of certain intellectual property for non-human veterinary therapeutic use licensed to Zander pursuant to the Regen Agreement.

The Company has not undertaken any discussions with any pharmaceutical companies regarding the commercialization of any products under development. None of the Company’s products have been approved by any regulatory body for marketing within the United States or anywhere else. No assurance can be given that all or any of the Company’s currently planned products will ever be commercialized.

 

 

 

 

 

 

 

 

 

 

 

Principal Products and Services

 

The Company is currently focusing its research and development efforts toward the successful development and commercialization of the ImenVax family of canine cancer vaccines as well as the development and commercialization of certain intellectual property for non-human veterinary therapeutic use licensed to Zander pursuant to the Regen Agreement

 

ImenVax™ I

 

ImenVax™ I, currently under development by the Company, is a therapeutic for canine cancer which involves isolating tumor cells from the patient and then placing the cells into a cell implant device that is inserted subcutaneously into the patient.  The resulting expression of tumor antigens from the device is intended to generate an anti-tumor immune response. The implant chamber device provokes immune responses to the tumor cells isolated from the patient’s own tumor through a process known as indirect presentation. Tumor cells implanted in the device are exposed to conditions that are distinct from the tumor’s environment from which they were isolated. This altered environment allows for anti-tumor responses that are not ordinarily observed in the natural tumor progression.

 

The cells are :

 

1) Isolated from the tumor and freed from the natural tumor microenvironment

2) Subjected to an initial ischemic condition of hypoxia that induces increased antigen expression

3) Allowed to repopulate within the device in a context that facilitates extended release of tumor antigens.

 

The device utilized is comprised of a 0.4 micron inner membrane to retain the implanted cells and an

outer 5 micron membrane that allows blood vessels to form on the surface to enhance biocompatibility. The outer membrane is held in place by a polyester mesh. The membranes are sonically sealed using a polyester mesh insert.

 

The device contains a surface architecture that promotes vascularization in-vivo. There is an initial ischemic phase that may additionally influence the tumor cell growth characteristics and genetic regulation of the tumor cells.

 

It is hypothesized that shortly after implantation, the expression of immunosuppressive molecules is down regulated while the release of antigens is maintained, thus allowing immune responses to occur that would normally be suppressed.

 

The Antigens that are released from the implanted device are taken up by antigen presenting cells (APC).

It is believed that the APCs will be trained to recognize the cancer cells and alert the body’s immune response, activating antibodies and T cells to destroy the tumor cells.

 

The Company is currently conducting a ten dog safety study to Evaluate ImenVax™ I for the Treatment of Canine Oral Melanoma and determine adverse effects, if any. As of May 17, 2012 three dogs suffering from oral melanoma have been administered the therapy with no dog suffering any material adverse reaction.

 

Inclusion in the Safety Study is limited to ten dogs with histologically confirmed canine oral melanoma with a Studied Karnofsky performance status of one or less. The subject are required to be over  eight kg with measurable tumor lesions by caliper or imaging, either primary or metastatic,  that may or may not have had prior non-immunological-based therapy. No concurrent NSAID therapy is allowed and previous use of immune-based therapies is not permitted. Subjects are required to have a two month life expectancy, and, not have any disease or condition (other than the cancer)  that would preclude living for 3 to 6 months.

 

Toxicity is evaluated prior to, and after, treatment and monthly for a period of 3 months. To date, 3 dogs have been enrolled in the safety study with none exhibiting any adverse effects. The Company estimates that an additional $100,000 will be required to be expended to complete the safety study.

 

ImenVax ™  II

 

Also in early stage development by the Company is a version of ImenVax ™  called ImenVax ™  II which utilizes cell lines for sustained release of immunologically relevant cytokines for maximum anti-tumor immune responses. It is believed by the Company that this controlled release of cytokines will act as an adjuvant to be combined with patient’s tumor cells (antigens) within an implantable membrane encapsulation device.

 

ImenVax ™  II is designed to function in a manner similar to ImenVax™ I. However, In order to further potentiate the tumor antigen specific immune responses, the Company intends to include adjuvant cytokine(s) along with tumor cells into the implantation device.   The adjuvants can be added through cytokine expressing cell line. The implantation device to be utilized for administering ImenVax ™  II is expected to be substantially similar to that utilized in administering ImenVax™ I.

 

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ImenVax ™  III

 

ImenVax III is intended to function by harnessing the ability of placental extracts to combat canine cancers. ImenVax™III is intended to treat existing tumors through stimulation of immune responses to:

 

a) kill tumor cells directly;

b) indirectly kill tumor cells by cutting off the tumor blood supply; and

c) block the ability of the tumor to suppress the immune system.

 

Xenogeneic (from different species) antigen induced immunity has been shown to break self tolerance and capable of engendering immune responses against the endogenous counterpart self - antigen. The use of xenogeneic placental derived agents such as VEGF (vascular endothelial growth factor) has demonstrated regression of soft tissue sarcomas in dogs (Kamstock D, Elmslie R, Thamm D, Dow S. 2007. Evaluation of a xenogeneic VEGF vaccine in dogs with soft tissue sarcoma. 56(8): 1299 - 309).  

 

ImenVax ™  III is intended to be an off the shelf formulation, manufactured under GMP, which shall harness the power of trophoblasts (cells forming the outer layer of a blastocyst, which provide nutrients to the embryo and develop into a large part of the placenta) derived  from human placental tissue to combat canine cancers . No tissue processing is required for the administration of the ImenVax ™  III therapy as opposed to I and II as no cellular material from the patient is utilized.

 

ENT-576 ™

 

ENT-576 ™  is a proprietary therapy being developed by the Company for the treatment of Chronic Obstructive Pulmonary Disease (COPD) such therapy comprising of:

 

a) extracting a therapeutic number of cells from a tissue containing in part a stem cell population;

b) processing said population of cells derived from said tissue so as to concentrate said stem cell population;

c) systemic re-administration of said cell population into the same patient; and

d) exposing the patient lung to a sufficient intensity and frequency of laser irradiation necessary to augment therapeutic activity of said cells in said patient suffering from COPD. The Company has also considered utilizing an FDA approved biochemical drug to produce the desired augmentation of therapeutic activity.

 

A therapeutic intervention in COPD would require addressing the issues of inflammation and regeneration. Although approaches such as administration of bone marrow stem cells or fat derived cellular components have both regenerative and anti-inflammatory activity in animal models, the Company feels that the need to enhance their potency for clinical applications can be addressed through the usage of low level lasers which studies have demonstrated may induce growth factor production, inhibit  inflammation and  stimulate angiogenesis.

 

There can be no assurance that approvals required will be obtained for any of the Company’s current therapies under development, or that if such approvals are obtained that the Company will be able to effectively market its therapies. There can be no assurance given that actual costs and timeframes related to commercialization for any proposed product will not deviate materially from the Company’s estimation. Currently, none of the Company’s products under development may be administered or marketed in the United States or outside of the United states except pursuant to an exemption from relevant regulation. The Company does not anticipate conducting further research and development related to ENT-576™ until completion of the Safety Study due to limited resources available to the Company.

 

On October 19, 2011 the Company entered into an agreement with RenovoCyte  LLC and Medistem Inc. (“Agreement”)  whereby the Company shall provide research services to RenovoCyte  LLC in connection with a ten dog pilot study to determine the safety and effectiveness of the utilization of stem cell therapy for the treatment of arthritis in animals (“Pilot Study”). The term of the Agreement is from October 19, 2011 until the earlier of the completion of the Pilot Study or October 19, 2015 unless terminated by RenovoCyte LLC due to an event of force majeure exceeding a period of 4 months. As consideration for providing services pursuant to the Agreement, the Company shall enjoy joint publishing rights with regards to the results of the Pilot Study.  Canine mesenchymal multipotent stem cell injections to be utilized during the course of the Pilot Study shall be provided to the Company by RenovoCyte LLC at no cost to the Company.

 

As of November 15, 2016 there have been 8 canine patients treated through the Pilot Study.

 

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Intellectual Property Licensed to Zander Therapeutics by Regen Biopharma, Inc.

 

On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (“ License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is a wholly owned subsidiary of Entest Biomedical, Inc.

 

The License IP consists of the following inventions for which patent applications with the United states Patent and Trademark Office have been filed:

 

Title   Country   Application #   Application
Type
  Application Filing Date
Antigen Specific mRNA Cellular Cancer Vaccines   United States   62165116   Provisional   05/21/2015
ACCELERATION OF HEMATOPOIETIC RECONSTITUTION BY...   United States   13/897,735   Utility   05/20/2013
CELLS, COMPOSITIONS, AND TREATMENT METHODS FOR STIMULATION OF HEMATOPOIESIS    United States   13/957,427    Utility   08/01/2013
CANCER THERAPY BY EX VIVO ACTIVATED AUTOLOGOUS IMMUNE CELLS   United States   13/957,431   Utility   08/02/2013
Stimulation of Immunity to Tumor Specific and Endothelial Specific Proteins by In Vivo DC Attractio    United States   62/050,418    Provisional   09/15/2014
Methods and Compositions for treatment of cancer by inhibition of NR2F6    United States   14/571,262    Utility   12/15/2014
Treatment of Myelodysplastic Syndrome by Inhibition of NR2F6   United States   14/572,574   Utility   12/16/2014
Treatment of Myelodysplastic Syndrome by Inhibition of NR2F2    United States   14/588,374    Utility   12/31/2014
Methods and Compositions for treatment of cancer by inhibition of NR2F2    United States   14/588,373    Utility   12/31/2014
Modulation of Hematopoietic Stem Cell Differentiation   United States   14/595,078       01/12/2015
                         

On October 17, 2016 David Koos, the Chairman and Chief Executive Officer of the Company and Harry Lander the President of Regen assigned to Zander the entire right, title, and interest in and to inventions described in U.S. Provisional Patent Application No. 62/406,374 Small Molecule Modulators of NR2F6 Activity For Animals, filed with the United States Patent and Trademark Office on October 10, 2016 and derived from the License IP.

 

On October 1, 2016 Thomas Ichim. A consultant to the Company, and David R . Koos , the sole officer of the Company, assigned to Zander the entire right, title, and interest in and to inventions described in United States Patent Application No. 15225484 “CANINE AUTOLOGOUS IMMUNOTHERAPY USING DENDRITIC CELL INDUCED CANCER KILLING IMMUNOCYTES”. The inventions described therein relates to the generation of potent cytotoxic cells through the utilization of antigen presenting cells as stimulators.

 

Distribution methods of the products or services:

 

The Company intends to distribute its products and services through several channels including:

 

(a)utilization of an internal sales force to market directly to veterinary professionals
(c)utilization of contract sales organizations

 

5
 

 

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

 

 

We have yet to achieve revenues or profits. The animal health pharmaceutical and biologics industries in which we intend to compete are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do. We intend to compete by licensing existing intellectual property which we deem promising and developing those properties to commercialization.

 

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

 

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

 

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

 

Entest has not been granted any patents. Other than pursuant to that agreement entered into by and between Zander and Regen previously disclosed in this document, Entest is not currently party to any royalty agreements.  Entest is not party to any binding labor contracts.

 

Need for any government approval of principal products or services, effect of existing or probable governmental regulations on the business

 

ImenVax™ I and ImenVax™ II are Veterinary Biologics. The U.S. Department of Agriculture (USDA) is authorized under the 1913 Virus-Serum-Toxin Act to ensure that all veterinary biologics produced in, or imported into, the United States are not worthless, contaminated, dangerous, or harmful. The Veterinary Biologics Program of the USDA's Animal and Plant Health Inspection Service (“APHIS”) oversees the veterinary biologics industry in the United States.

 

Domestic manufacturers of veterinary biologics, for domestic use or for export, are required to possess a valid U.S. Veterinary Biologics Establishment License and an individual U.S. Veterinary Biologics Product License for each product produced for sale.

 

Prior to being granted a U.S. Veterinary Biologics Product License, the applicant must submit detailed information including test reports and research data sufficient to establish purity, safety, potency and efficacy of the product, an Outline of Production, and information regarding labeling and  facilities that are to be used in preparation.

 

Prior to being granted a U.S. Veterinary Biologic Establishment License, the applicant must submit detailed information regarding the facilities and the qualifications of key personnel and must submit to an inspection of the facilities by the Center for Veterinary Biologics, a division of the USDA. To qualify for an establishment license, an applicant also must qualify for at least one product license.

 

ENT-576™ can be considered a “combination product” whose primary mode of action is through animal stem cells (a veterinary biologic) It is intended that the Company will obtain a U.S. Veterinary Biologics Establishment License and a U.S. Veterinary Biologics Product License from the U.S. Department of Agriculture.

 

ImenVax™ III can be considered a combination product whose primary mode of action is generated through trophoblasts derived from human placental tissue. Entest will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market ImenVax™ III. Entest will apply for an Investigational New Animal Drug exemption (INAD) in order that the product may be shipped for testing and trials and will submit a New Animal Drug Application for ImenVax™ III.

 

Products and Therapies that may be developed pursuant to the License IP may be Veterinary Biologics or may be Veterinary Drugs. The Company will be required to obtain approval from the US Food and Drug Administration (FDA) in order to market any Veterinary Drugs. An Investigational New Animal Drug exemption (INAD) must be applied for in order that any veterinary drug under development may be shipped for testing and trials and a New Animal Drug Application must be filed with and approved by the FDA before any veterinary drug may be marketed.

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

 

During the fiscal year ended August 31, 2016 we expended $192,500 on research and development activities.

 

Costs and effects of compliance with environmental laws (federal, state and local);

 

Entest has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.

 

Number of total employees and number of full-time employees

 

As of November 15, 2016, Entest has 1 employee of which 1 is full time.

 

6
 

 

Item 2. Properties

 

On November 1, 2011, the Company entered into an agreement to lease approximately 2,320 square feet of office space beginning December 1, 2011 for a period of five years.

 

Rent to be charged to the Company pursuant to the lease is as follows:

 

$2,996 per month for the period beginning December 1, 2011 and ending November 30, 2012

$3,116 per month for the period beginning December 1, 2012 and ending November 30, 2013

$3,241 per month for the period beginning December 1, 2013 and ending November 30, 2014

$3,371 per month for the period beginning December 1, 2014 and ending November 30, 2015

$3,506 per month for the period beginning December 1, 2015 and ending November 30, 2016

This property is utilized as office space. The Company believes that the foregoing property is adequate to meet its current needs. While it is anticipated that the Company will require access to laboratory facilities in the future, the Company believes that access to such facilities are available from a variety of sources.

 

Item 3. Legal Proceedings

 

None

 

 

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

 

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

 

PART II

 

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

 

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

 

The Company’s authorized capital stock consists of 500,000,000 shares of common stock with a par value $0.0001, and 5,000,000 shares of preferred stock with a par value $0.0001 per share (of which 100,000 are designated as Series AA Preferred Stock, 4,400,000 are designated as Series B Preferred Stock and 300,000 are designated as Series AAA Preferred Stock) and 200,000 shares authorized of Non Voting Convertible Preferred Stock, par value $1.00 . On July 27, 2015 the company effected a 1 for 150 reverse stock split of all issued series of stock with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock. One share of Common Stock was issued after the exchange for one hundred and fifty shares of Common Stock issued. One share of each series of preferred Stock (with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock) was issued after the exchange for one hundred and fifty shares of each series of Preferred Stock issued.  As of November 15, 2016 Entest BioMedical, Inc. had 40,170,472 common shares outstanding, 28, 009 Series B Preferred shares outstanding , 667 Series AA preferred shares outstanding and 533 Series AAA preferred shares outstanding.

 

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

 

7
 

 

September 1, 2014 to August 31, 2015*  High  Low
First Quarter  $0.075   $0.015 
Second Quarter   0.045    0.015 
Third Quarter   0.06    0.015 
Fourth Quarter  $0.08   $0.01 

 

September 1, 2015 to August 31, 2016*  High  Low
First Quarter  $0.043   $0.01 
Second Quarter   0.0249    0.0061 
Third Quarter   0.0145    0.0063 
Fourth Quarter  $0.0192   $0.0047 

* Adjusted retroactively for 1-150 reverse split July 27, 2015

 

Holders

 

 

As of August 31, 2016 there were approximately 341 holders of our Common Stock.

 

Dividends

 

No cash dividends were paid during the fiscal year ending August 31, 2016. We do not expect to declare cash dividends in the immediate future.

 

Recent Sales of Unregistered Securities

 

On September 28, 2015 the Company issued 8,000,000 shares of the Company’s Common Stock (“Shares”) to Regen Biopharma, Inc. in satisfaction of that license initiation fee due and payable to Regen Biopharma, Inc. pursuant to the terms and conditions of that agreement whereby Regen Biopharma, Inc. granted to Zander Therapeutics Inc. an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen Biopharma, Inc. for non-human veterinary therapeutic use for a term of fifteen years.

 

The Shares were issued pursuant to Section 4(a) (2) of the Securities Act of 1933, as amended. No underwriters were retained to serve as placement agents for the sale. The Shares were sold directly through our management. No commission or other consideration was paid in connection with the sale of the Shares. There was no advertisement or general solicitation made in connection with this Offer and Sale of Shares. A legend was placed on the certificate that evidences the Shares stating that the Shares have not been registered under the Act and setting forth or referring to the restrictions on transferability and sale of the Shares.

 

Item 6. Selected Financial Data

 

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

 

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

 

As of August 31, 2015, we had Cash in the amount of $2159 and as of August 31, 2016 we had Cash in the amount of $859.

 

The decrease in Cash of approximately 60% is primarily attributable to $42,062 of net cash borrowings by the Company offset by expenses incurred by the Company in the operation of its business and payment of its obligations:

 

As of August 31, 2015 we had Accrued Rent Receivable of $10,000 and as of August 31, 2016 we had Accrued Rent Receivable of $15,000.

 

The increase in Accrued Rent Receivable of 50% is attributable to rental income earned by but unpaid to the company by Regen biopharma, Inc. for the months of June 2016, July 2016 and August 2016

As of August 31, 2015 we had Accounts Payable of $106,425 and as of August 31, 2016 we had Accounts Payable of $112,162.

The increase in Accounts Payable of approximately 5% is attributable to payments of outstanding obligations of the Company incurred in the course of business.

8
 

 

As of August 31, 2015 we had Notes Payable of $413,539 and as of August 31, 2016 we had Notes Payable of $455,601

The increase in Notes Payable of approximately 10% is primarily attributable to :

 

(a)$100 borrowed from the Company’s Chief Executive Officer during the year ended August 31, 2016
(b)$79,600 borrowed from a third party lender during the year ended August 31, 2016

 

Offset by:

 

(a)$29,488 of principal indebtedness repaid to the Company’s Chief Executive Officer during the year ended August 31, 2016
(b)$8,150of principal indebtedness repaid to third party lenders during the year ended August 31, 2016

As of August 31, 2015 we had Accrued Expenses of $279,574 and as of August 31, 2016 we had Accrued Expenses of $426,965

The increase in Accrued Expenses of approximately 52% is primarily attributable to:

 

(a)$100,000 of expenses incurred as a result of that agreement entered into by and between Regen Biopharma, Inc. ( “Regen”) and Zander Therapeutics, Inc. ( “Zander”) whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen for non-human veterinary therapeutic use for a term of fifteen years.
(b)$27,391of accruals of interest payable during the twelve months ended August 31, 2016.
(c)accrual of salary due and payable to David Koos of $120,000 during the twelve months ended August 31, 2016

Offset by:

 

the issuance by the Company of 8,000,000 common shares in satisfaction of $100,000 of expenses incurred pursuant to that agreement by and between Zander Therapeutics, Inc. and Regen Biopharma, Inc. ( a company under common control with Zander Therapeutics, Inc and the Company) entered into on June 23, 2015.

 

Material Changes in Results of Operations

 

Revenues from continuing operations were $0 for the fiscal year ended August 31, 2015 and $0 for the fiscal year ended August 31, 2016 . Net losses from continuing operations were$485,274 for the fiscal year ended August 31, 2015 and $506,690 for the fiscal year ended August 31, 2016.

 

The increase in Net Losses from continuing operations of approximately 4% is primarily attributable to higher research and development related expenses and higher consulting expenses offset by lower general and administrative expenses , lower interest expenses, higher rental income during the year ended August 31, 2016 when compared to the year ended August 31, 2015 as well as the recognition of $65,880 of expenses attributable to the issuances of equity securities below fair value during the year ended August 31, 2015 .

 

As of August 31, 2016 we had $859 cash on hand and current liabilities of $1,002,728 such liabilities consisting of Accounts Payable, Notes Payable, Amounts due to Others and Accrued Expenses.

 

We feel we will not be able to satisfy our cash requirements over the next twelve months and shall be required to seek additional financing.

 

We currently plan to raise additional funds primarily by offering securities for cash.

 

There is no guarantee that we will be able to raise any capital through any type of offerings. We cannot assure that we will be successful in obtaining additional financing necessary to implement our business plan. We have not received any commitment or expression of interest from any financing source that has given us any assurance that we will obtain the amount of additional financing in the future that we currently anticipate. For these and other reasons, we are not able to assure that we will obtain any additional financing or, if we are successful, that we can obtain any such financing on terms that may be reasonable in light of our current circumstances.

 

As of November 15, 2016 we are not party to any binding agreements which would commit Entest to any material capital expenditures.

 

Item 7A. Quantitative and Qualitative Disclosures About Market Risk

 

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

 

 

9
 

Item 8. Financial Statements and Supplementary Data

 

 

 

 

 

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

 

To the Board of Directors and Stockholders of

Entest BioMedical, Inc.

 

 

We have audited the accompanying balance sheets of Entest BioMedical, Inc. as of August 31, 2016 and the related statements of operations, stockholders’ equity (deficit), and cash flows for the year ended August 31, 2016. Entest BioMedical, Inc.’s management is responsible for these financial statements. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Entest BioMedical, Inc. as of August 31, 2016, and the results of its operations and its cash flows for the year then ended in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 4 to the financial statements, the Company has no revenues, has negative working capital at August 31, 2016, has incurred recurring losses and recurring negative cash flow from operating activities, and has an accumulated deficit which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 4. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

 

/s/ AMC Auditing

 

AMC Auditing

Las Vegas, Nevada

November 22, 2016

10
 

SEALE AND BEERS, CPAs

PCAOB REGISTERED AUDITORS

www.sealebeers.com

 

REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

 

To the Board of Directors and Stockholders of

Entest Biomedical Inc.

 

We have audited the accompanying consolidated balance sheets of Entest Biomedical, Inc. as of August 31, 2014 and 2015, and the related statements of operations, stockholders’ equity (deficit), and cash flows for each of the years in the two-year period ended August 31, 2015. Entest Biomedical, Inc’s management is responsible for these financial statements. Our responsibility is to express an opinion on these financial statements based on our audits.

 

We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. The company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audit included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.

 

In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Entest Biomedical, Inc. as of August 31, 2014 and 2015, and the related statements of operations, stockholders’ equity (deficit), and the results of its operations and cash flows for each of the years in the two-year period ended August 31, 2015. in conformity with accounting principles generally accepted in the United States of America.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 4 to the financial statements, the Company has no revenues, has negative working capital at August 31, 2015, has incurred recurring losses and recurring negative cash flow from operating activities, and has an accumulated deficit which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 4. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Seale & Beers, CPAs

 

Seale and Beers, CPAs

Las Vegas, Nevada

November 23, 2015

11
 

 

ENTEST BIOMEDICAL, INC.          
Consolidated Balance Sheet          
    As of    As of 
    August 31, 2016    August 31, 2015 
ASSETS          
Current Assets          
Cash   859    2,159 
Current Portion of Prepaid Expenses   8,000    8,000 
Accrued Rent Recievable   15,000    10,000 
Total Current Assets   23,859    20,159 
           
TOTAL ASSETS   23,859    20,159 
           
LIABILITES AND STOCKHOLDERS' EQUITY          
Current Liabilities          
Accounts Payable   112,162    106,425 
Notes Payable   455,601    413,539 
Due to Other   8,000    8,000 
Accrued Expenses   426,965    279,574 
Total Current Liabilities   1,002,728    807,538 
           
TOTAL LIABILITIES   1,002,728    807,538 
           
STOCKHOLDERS' EQUITY          
Common Stock,  authorized 500,000,000  shares as of August 31, 2015 and August 31, 2016; issued and outstanding 32,170,472 (par value $0.0001) shares and 40,170,472(par value $0.0001) as of August 31, 2015 and August 31, 2016 respectively   4,011    3,211 
Preferred Stock ,par value  $0.0001 5,000,000 shares authorized,          
Series AA Preferred Stock, 100,000 shares authorized, 667 shares, par value $0.0001, issued and outstanding at August 31, 2015 and  as of August 31, 2016   0    0 
Series B Preferred 4,400,000 shares authorized, 28,009 ( par value $0.0001) issued and outstanding as of August 31, 2015 as of August 31, 2016   3    3 
Series AAA Preferred, 300,000 shares authorized, $0.0001 par value 533 shares outstanding as of August 31, 2015 and as of August 31, 2016   0    0 
NonVoting Convertible Preferred ($1 par value) 200,000 shares authorized, 0 and 0 issued and outstanding as of August  31,  2015 and August  31, 2016 respectively   0    0 
Additional Paid in Capital   6,148,054    5,833,654 
Contributed Capital   274,162    274,162 
Accumulated Deficit   (7,405,099)   (6,898,409)
Total Stockholders' Equity   (978,869)   (787,379)
           
TOTAL LIABILITIES & STOCKHOLDERS' EQUITY   23,859    20,159 
           
The accompanying Notes are an integral part of these Financial Statements
           
All stock amounts have been retroactively adjusted to reflect a 1 for 150 reverse stock split of all issued series of stock with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock effective as of . July 27, 2015.

12
 

ENTEST BIOMEDICAL INC.      
Consolidated Statement of Operations      
   Year Ended  Year Ended
  

August 31,

2016

  August 31, 2015
TOTAL REVENUE   0    0 
           
COSTS AND EXPENSES          
Research and Development   192,500    104,000 
Rent Costs   41,667    40,062 
General and Administrative   230,495    233,621 
Consultant's Expenses   74,125    63,438 
Total Costs and Expenses   538,787    441,121 
           
OPERATING LOSS   (538,787)   (441,121)
           
OTHER INCOME AND EXPENSE          
Rental income   60,000    51,871 
Loss on issuance of stock below fair value   0    (65,880)
Interest Expense   (27,903)   (28,225)
Impairment of Property and equipment   0    (1,919)
TOTAL OTHER INCOME AND EXPENSE   32,097    (44,153)
           
LOSS BEFORE INCOME TAXES   (506,690)   (485,274)
Income Taxes   0    0 
           
NET LOSS          
           
NET LOSS from continuing operations   (506,690)   (485,274)
           
NET LOSS available to common shareholders   (506,690)   (485,274)
           
BASIC AND DILUTED EARNINGS (LOSS) PER SHARE FROM CONTINUING OPERATIONS   (0.013)   (0.028)
           
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING   39,578,691    17,443,795 
           
The accompanying Notes are an integral part of these Financial Statements
           
All stock amounts have been retroactively adjusted to reflect a 1 for 150 reverse stock split of all issued series of stock with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock effective as of . July 27, 2015.

13
 

Entest BioMedical, Inc.
Consolidated Statement of Stockholders' Equity
For the Years Ended  August 31, 2016 and August 31, 2015
     Common      Series AA Preferred      Series AAA Preferred       Series B Preferred     Non Voting Convertible Preferred                      
     Shares      Amount      Shares      Amount      Shares      Amount      Shares      Amount      Shares      Amount      Additional Paid-In Capital       Contributed Capital     Accumulated Deficit during the Development Stage    Total 
Balance August 31, 2014   14,703,805    1,464    667    0    533    0    28,009    3    0    0    5,458,321    274,162    (6,413,135)   (679,185)
Common Shares issued for Debt 10/22/2014   1,333,333    133                                            39,867              40,000 
Common Shares issued for Debt 5/19/2015   1,333,333    133                                            19,866              20,000 
Common Shares issued for accrued salaries 7/31/2015   14800000    1480                                            192,400              193,880 
Restricted Stock Expense Recognized                                                     123,200              123,200 
Net Loss Year Ended August 31, 2015                                                               (485,274)   (485,274)
Balance August 31, 2015   32,170,472    3,211    667    0    533    0    28,009    3    0    0    5,833,654    274,162    (6,898,409)   (787,379)
Common Shares issued for expenses September 28, 2015   8000000    800                                            191200              192,000 
Restricted Stock Expense Recognized                                                     123200              123,200 
Net Loss Year Ended August 31 2016                                                               (506,690)   (506,690)
Balance August 31, 2016   40,170,472    4,011    667    0    533    0    28,009    3    0    0    6,148,054    274,162    (7,405,099)   (978,869)
                                                                       
The accompanying Notes are an integral part of these Financial Statements
 
All stock amounts have been retroactively adjusted to reflect a 1 for 150 reverse stock split of all issued series of stock with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock effective as of July 27, 2015.

14
 

ENTEST BIOMEDICAL, INC.          
Consolidated Statement of Cash Flows          
           
    Year Ended    Year Ended 
    August 31, 2016    August 31, 2015 
OPERATING ACTIVITIES          
Net (loss)   (506,690)   (485,274)
Adjustments to reconcile net loss to net cash used by operating activities:          
Increase (Decrease) in Additional paid in Capital   123,200    123,200 
Increase (Decrease) in loss on issuance of stock for less than fair value   —      65,880 
Increase ( Decrease) in Common Stock issued for expenses   192,000      
Increase in common stock issued for accrued compensation   —      148,000 
Changes in Operating Assets and Liabilities          
Increase (Decrease) in Accounts Payable   5,737    (9,424)
(Increase)Decrease in Accrued Rental Income Recievable   (5,000)   (10,000)
Increase (Decrease) in Accrued Expenses   147,391    97,025 
(Increase) Decrease in Prepaid Expenses   —        
Loss due to Impairment of Property and Equipment        1,919 
Net Cash Provided Used in Operating Activities   (43,362)   (68,674)
           
 FINANCING ACTIVITIES          
Increase (Decrease) in Notes Payable   42,062    70,099 
Net Cash Provided by Financing Activities   42,062    70,099 
Net ( Decrease)Increase in Cash   (1,300)   1,425 
           
    Cash at Beginning of Period   2,159    734 
    Cash at End of Period   859    2,159 
           
Supplemental Disclosure of Noncash investing and financing activities:          
Stock issued in payment of Debt          
Cash Paid During the Year for:          
Interest   512    700 
Income Taxes        —   
           
The accompanying Notes are an integral part of these Financial Statements

15
 

Entest BioMedical, Inc.

Notes to Consolidated Financial Statements

As of August 31, 2016

 

 

NOTE 1.  ORGANIZATION AND DESCRIPTION OF BUSINESS

 

Entest Biomedical, Inc ( The “Company”) was incorporated in the State of Nevada on September 24, 2008 as JB Clothing Corporation.  Until July 10, 2009, the Company’s principal business objective was the offering of active/leisure fashion design clothing.

 

On July 10, 2009 the Company abandoned its efforts in the field of active/leisure fashion design clothing when it acquired 100% of the share capital of Entest BioMedical, Inc., a California corporation, (“Entest CA”).

 

On June 18, 2015 the Company formed Zander Therapeutics, Inc. (“Zander”) , a Nevada corporation and a wholly owned subsidiary of the Company.

 

The Company’s current business consists of the development and commercialization of immunotherapeutic therapies for the veterinary market as well as the acquisition and operation of veterinary hospitals.

 

NOTE 2.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

A. BASIS OF ACCOUNTING

 

The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted an August 31 fiscal year-end.   The Company recognizes revenue from services and product sales when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable, and collectability is reasonably assured.

 

B. PRINCIPLES OF CONSOLIDATION

 

The consolidated financial statements include the accounts of Entest CA and Zander;. the Company’s wholly owned subsidiaries. Significant inter-company transactions have been eliminated.

 

C. USE OF ESTIMATES

 

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

 

D. CASH EQUIVALENTS

 

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

 

E. PROPERTY AND EQUIPMENT

 

As of August 31, 2016 Property and Equipment consists of $0 of Computer equipment. An impairment charge of $1,919 has been recognized by the Company on one personal computer during the quarter ended August 31, 2015 as the Company has determined that the equipment has no value due to obsolescence.

 

F. FAIR VALUE OF FINANCIAL INSTRUMENTS

 

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

 

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

 

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

 

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

 

16
 

 

The Company’s financial instruments as of August 31, 2016 consisted of $ 455,601 of Notes Payable and $8,000 due to TheraCyte, Inc.. The fair value of all of the Company’s financial instruments as of August 31, 2016 were valued according to the Level 3 input. The carrying amount of the financial instruments is equal to the fair value as determined by the Company.

 

The Company has determined that there are no Level 1 or Level 2 inputs for determining the fair value of the Company’s financial instruments. Fair value was determined by the Company utilizing its own assumptions and estimation. There were no transfers between levels for the period presented.

 

G. INCOME TAXES

 

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

 

The Company applied the provisions of ASC 740-10-50, “Accounting for Uncertainty in Income Taxes”, which provides clarification related to the process associated with accounting for uncertain tax positions recognized in our financial statements. Audit periods remain open for review until the statute of limitations has passed. The completion of review or the expiration of the statute of limitations for a given audit period could result in an adjustment to the Company’s liability for income taxes. Any such adjustment could be material to the Company’s results of operations for any given quarterly or annual period based, in part, upon the results of operations for the given period. As of August 31, 2016 the Company had no uncertain tax positions, and will continue to evaluate for uncertain positions in the future.

 

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

 

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

 

H.  BASIC EARNINGS (LOSS) PER SHARE

 

The Financial Accounting Standards Board (FASB) issued Accounting Standards Codification (ASC) 260, "Earnings Per Share", which specifies the computation, presentation and disclosure requirements for earnings (loss) per share for entities with publicly held common stock. ASC 260 requires the presentation of basic earnings (loss) per share and diluted earnings (loss) per share. The Company has adopted the provisions of ASC 260 effective from inception. Basic net loss per share amounts is computed by dividing the net income by the weighted average number of common shares outstanding. All convertible debt has an anti-dilutive effect on the EPS, therefore Diluted earnings per share are the same as basic earnings per share.

 

NOTE 3.  RECENT ACCOUNTING PRONOUNCEMENTS

 

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

 

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

 

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

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

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

 

NOTE 4.  GOING CONCERN

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company generated net losses of $7,405,099 during the period from August 22, 2008 (inception) through August 31, 2016. This condition raises substantial doubt about the Company's ability to continue as a going concern. The Company's continuation as a going concern is dependent on its ability to meet its obligations, to obtain additional financing as may be required and ultimately to attain profitability. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

 

Management plans to raise additional funds primarily by offering securities for cash. Management has yet to decide what type of offering the Company will use or how much capital the Company will raise. There is no guarantee that the Company will be able to raise any capital through any type of offerings.

 

NOTE 5.  NOTES PAYABLE  

 

As of August 31, 2016

 

Notes Payable:

David Koos ( See Note 6)  $100 
Bio Technology Partners Business Trust  $159,000 
The Sherman Family Trust (10% Interest)  $38,500 
The Sherman Family Trust (0% Interest)  $160,500 
Regen BioPharma Inc. ( See Note 6)  $12,051 
Bostonia Partners  $74,600 
Dunhill Ross Partners, Inc.  $10,850 
Total  $455,601 

 

Bio Technology Partners Business Trust has provided a line of credit to the Company in the amount of $200,000 or so much thereof as may be disbursed to, or for the benefit of the Company by Lender in Lender's sole and absolute discretion.   The unpaid principal of this line of credit bears simple interest at the rate of ten percent per annum. Interest is calculated based on the principal balance as may be adjusted from time to time to reflect additional advances or payments made hereunder. Principal balance and accrued interest shall become due and payable in whole or in part at the demand of the Lender. The Sherman Family Trust (10% Interest) has provided a line of credit to the Company in the amount of $700,000 or so much thereof as may be disbursed to, or for the benefit of the Company by Lender in Lender's sole and absolute discretion. The unpaid principal of this line of credit bears simple interest at the rate of ten percent per annum. Interest is calculated based on the principal balance as may be adjusted from time to time to reflect additional advances or payments made hereunder. Principal balance and accrued interest shall become due and payable in whole or in part at the demand of the Lender. $160,500 due to The Sherman Family Trust (0% Interest) is due and payable in whole or in part at the option of the Holder and bears no interest. Amounts due to Regen Biopharma Inc. are due and payable at the demand of the holder and bear simple interest at a rate of 10% per annum. Amounts due to Dunhill Ross Partners, Inc. are due and payable at the demand of the holder and bear simple interest at a rate of 10% per annum.

 

$37,000 lent to the Company by Bostonia Partners is due and payable September 3, 2016 and bears simple interest at a rate of 10% per annum

 

$15,000 lent to the Company by Bostonia Partners is due and payable December 8, 2016 and bears simple interest at a rate of 10% per annum

 

$10,000 lent to the Company by Bostonia Partners is due and payable February 24 2017 and bears simple interest at a rate of 10% per annum

 

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$10,000 lent to the Company by Bostonia Partners is due and payable as follows and bears simple interest at a rate of 10% per annum:

 

$5,000 principal due and payable 4/10/2016 or earlier

 

$5,000 principal due and payable 3/23/2017

 

$2,000 lent to the Company by Bostonia Partners is due and payable April 15 2017 and bears simple interest at a rate of 10% per annum.

 

$3,600 lent to the Company by Bostonia Partners is due and payable May 13 2017 and bears simple interest at a rate of 10% per annum.

 

$2,000 lent to the Company by Bostonia Partners is due and payable July 8, 2017 and bears simple interest at a rate of 10% per annum.

 

As of August 31, 2016 the Company remains indebted to David R. Koos , the Company’s sole officer and director, in the principal amount of $100 due and payable in whole or in part at the demand of David Koos and bearing simple interest at a rate of 15% per annum.

 

NOTE 6.  RELATED PARTY TRANSACTIONS

 

As of August 31, 2016 the Company remains indebted to David R. Koos , the Company’s sole officer and director, in the principal amount of $100 due and payable in whole or in part at the demand of David Koos and bearing simple interest at a rate of 15% per annum.

 

As of August 31, 2016 the Company remains indebted to Regen Biopharma, Inc. in the principal amount of $12,051  due and payable in whole or in part at the demand of Regen Biopharma, Inc and bearing simple interest at a rate of 10% per annum. David Koos, the Company’s Chairman and CEO, is also the Chairman and CEO of Regen of Regen Biopharma, Inc.

 

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

 

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

 

On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (“ License IP”) for non-human veterinary therapeutic use for a term of fifteen years.

 

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

 

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

 

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

 

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

 

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

 

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The Agreement may be terminated by Regen:

 

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

 

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

 

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

 

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

 

On September 28, 2015 the Company issued 8,000,000 of its common shares to Regen in satisfaction of the license initiation fee.

 

NOTE 7.  INCOME TAXES

 

As of August 31, 2016     
Deferred tax assets:     
Net operating tax carry forwards  $2,522,374 
Other   -0- 
      
Gross deferred tax assets   2,522,374 
Valuation allowance   (2,522,374)
Net deferred tax assets  $-0- 

 

As of  August 31, 2016  the Company has a Deferred Tax Asset of $ 2,522,374 completely attributable to net operating loss carry forwards of approximately $7,418,746 (which expire 20 years from the date the loss was incurred) consisting of:

 

(a)$13,647 of Net Operating Loss carry forwards acquired in the reverse acquisition of Entest BioMedical, Inc., a California corporation, and
(b)$7,405,099 of Net Operating Loss carry forwards attributable to Entest BioMedical, Inc.

 

Realization of deferred tax assets is dependent upon sufficient future taxable income during the period that deductible temporary differences and carry forwards are expected to be available to reduce taxable income. A valuation allowance is recorded when it is “more likely-than-not” that a deferred tax asset will not be realized. In addition, the reverse acquisition in which Entest BioMedical, Inc. was involved in 2009 has resulted in a change of control.  Internal Revenue Code Sec 382 limits the amount of income that may be offset by net operating loss (NOL) carryovers after an ownership change. As a result, the Company has recorded a valuation allowance reducing all deferred tax assets to $ -0-.

 

Income tax is calculated at the 34% Federal Corporate Rate.

 

NOTE 8.  ACQUISITION OF ENTEST CA

 

On July 10, 2009 the Company acquired 100% of Entest CA, a California corporation and wholly owned subsidiary of the Company, from BMSN for consideration consisting of (a) the issuance to BMSN of 10,000,000 newly issued common shares of Entest and (b) the return by Mr. Rick Plote of 10,000,000 shares of Entest’s common stock previously issued to him by Entest for cancellation.

 

NOTE 9.  ACQUISITION OF THE ASSETS OF PET POINTERS, INC.

 

On January 4, 2011 Entest CA acquired from Pet Pointers, Inc., a California corporation doing business as McDonald Animal Hospital (“Seller”), and Dr. Gregory McDonald DVM (“McDonald”) all the goodwill from McDonald and assets of Seller except cash and accounts receivables used in connection with the operation of a veterinary medical clinic located at 225 S. Milpas Street, Santa Barbara, CA 93103 (the "Business").

 

Consideration for the acquisition consisted of:

 

I. $70,000 in cash

II. $210,000 of the Company’s common shares valued at the closing price per share as of January 4, 2011

III. Payment of no more than $78,000 to a creditor of the Seller to be paid in monthly installments of $1,500 per month

IV. Payment of no more than $25,000 to additional creditors of the Seller to be paid in monthly installments of $825 per month

V. Payment of $50,000 to McDonald on the first business day of the fourth month following the closing of the acquisition (“Closing”).

 

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NOTE 10. DISPOSITION OF THE ASSETS OF PET POINTERS, INC.

 

On November 28, 2012 the “Company executed an agreement (“Agreement”) with Gregory McDonald ("McDonald"), Pet Pointers, Inc. ("Pet Pointer") whereby Mc Donald and Pet Pointer would acquire from the Company all assets (with the exception of cash and accounts receivable) utilized by the Company in the operation of the McDonald Animal Hospital, a full service veterinary clinic owned and operated by the Company and located in Santa Barbara, California (“McDonald Asset Sale”).

On October 10, 2012 a Complaint (“Complaint”) was filed in the Superior Court of the State of California against the Company and David Koos by McDonald, a former employee of the Company, alleging breach of contract and breach of the covenant of good faith and dealing in connection with the assumption of lease obligations by the Company in connection with the acquisition of the assets of Pet Pointers, Inc breach of contract and breach of the covenant of good faith and dealing in connection with an employment agreement enters into with McDonald inc connection with the Acquisition, breach of contract in connection with the Acquisition purchase agreement, breach of the covenant of good faith and dealing in connection with the Acquisition purchase agreement, implied indemnity in connection to amounts owed by McDonald to Anthony and Judi Marinelli, the Internal Revenue Service, and the California Franchise Tax Board, intentional misrepresentation, negligent misrepresentation , failure to pay wages and violations of Sections 2802, 203, and 2806 of the California Labor Code. The Complaint sought judgment for nominal damages, actual damages, compensatory damages, lost wages, compensation, expenses wage benefits and penalties pursuant to California Labor Code Sections 203 et al, 2802 and 2806, indemnification, accrued interest, punitive damages, costs of suit and attorney’s fees.

As consideration to the Company for the assets acquired, McDonald and Pet Pointers provided to the Company a General release whereby McDonald and Pet Pointer waive, release and discharge the Company and their respective assignees, officers, directors, shareholders, boards, owners, employees, attorneys, agents, trustors, trustees, beneficiaries, heirs, successors, and representatives from all known and unknown claims, demands, causes of action, attorney's fees, costs, or expenses including: 

 

(1) All claims relating to the Complaint.

(2) Those owed by McDonald to Anthony and Judi Marinelli which the Company became obligated to pay on McDonald’s behalf pursuant to the asset purchase agreement entered into between the Company and Gregory McDonald and Pet Pointers, Inc on January 4, 2011.

(3) Those amounts owed by McDonald to the Internal Revenue Service which the Company became obligated to pay on McDonald’s behalf pursuant to the asset purchase agreement entered into between the Company and Gregory McDonald and Pet Pointers, Inc on January 4, 2011.

(4) Those amounts owed by McDonald to the California Franchise Tax Board which the Company became obligated to pay on McDonald’s behalf pursuant to the asset purchase agreement entered into between the Company and Gregory McDonald and Pet Pointers, Inc on January 4, 2011.

Assets disposed of pursuant to the Agreement include approximately $4,840 of Property Plant and Equipment net of accumulated depreciation as well as all inventory held at the McDonald Animal Hospital.

 

Assets disposed of pursuant to the Agreement also include 

 

(i) Essentially all intellectual property, including computer software, utilized in connection with the operation of the McDonald Animal Hospital

(ii) All telephone numbers, fax numbers, service marks, trademarks, trade names, fictitious business names, websites, business email addresses, vendor lists, promotional materials, vendor records and any and all business records including, but not limited to, such items stored in computer memories, microfiche, paper record or by any other means relevant to the operation of the McDonald Animal Hospital.

(iii) All customer lists, customer contacts, and any and all customer records that are related to the McDonald Animal Hospital.

As a result of the agreement, the Company recorded a non-cash pre-tax charge for the impairment of goodwill recorded in connection with the acquisition of the McDonald Animal Hospital of approximately $405,000 for the quarter ended November 30, 2012.

 

Pursuant to the Agreement, the Company is obligated to make payment of $13,000 within five days of the Closing of the Agreement as such term is defined in the Agreement.

 

Pursuant to the Agreement, the Company agrees to waive, release and discharge McDonald and Pet Pointer from all known and unknown claims, demands, causes of action, attorney's fees, costs, or expenses.

 

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NOTE 11. COMMITMENTS AND CONTINGENCIES

 

On November 1, 2011, the Company entered into an agreement to lease approximately 2,320 square feet of office space beginning December 1, 2011 for a period of five years.

 

Rent to be charged to the Company pursuant to the lease is as follows:

 

$2,996 per month for the period beginning December 1, 2011 and ending November 30, 2012

$3,116 per month for the period beginning December 1, 2012 and ending November 30, 2013

$3,241 per month for the period beginning December 1, 2013 and ending November 30, 2014

$3,371 per month for the period beginning December 1, 2014 and ending November 30, 2015

$3,506 per month for the period beginning December 1, 2015 and ending November 30, 2016

 

This property is utilized as office space. The Company believes that the foregoing property is adequate to meet its current needs. While it is anticipated that the Company will require access to laboratory facilities in the future, the Company believes that access to such facilities are available from a variety of sources. 

 

NOTE 12. STOCKHOLDERS EQUITY

 

The stockholders' equity section of the Company contains the following classes of capital stock as of August 31 , 2016:

 

Common Stock:

 

$0.0001 par value, 500,000,000 shares authorized and 40,170,472 shares issued and outstanding as of August 31, 2016.

 

Preferred Stock:

 

$0.0001 par value 5,000,000 shares authorized of which:

 

(a)100,000 are authorized as Series AA Preferred Stock of which 667 shares are issued and outstanding  as of  August 31, 2016  and
(b)4,400,000 are authorized as Series B Preferred Stock of which 28,009 shares are issued and outstanding as of August 31, 2016 and
(c)300,000  are authorized as Series AAA Preferred Stock of which 533 shares are issued and outstanding  as of  August 31, 2016.

 

Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series B Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.10 per share of Series B Preferred Stock (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series B Preferred Stock held by them.

 

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

 

Non Voting Convertible Preferred Stock having a $1.00 par value:

 

200,000 shares authorized of which 0 shares are issued and outstanding as of  August 31, 2016 .

 

Non Voting Convertible Preferred Stock shall convert at the option of the holder into shares of the corporation’s common stock at a conversion price equal to seventy percent (70%) of the lowest Closing Price for the five (5) trading days immediately preceding written receipt by the corporation of the holder’s intent to convert.

 

“CLOSING PRICE" shall mean the closing bid price for the corporation’s common stock on the Principal Market on a Trading Day as reported by Bloomberg Finance L.P.

 

“PRINCIPAL MARKET" shall mean the principal trading exchange or market for the corporation’s common stock.

 

“TRADING DAY” shall mean a day on which the Principal Market shall be open for business.

 

On July 2, 2015 the Company filed a Certificate of Change with the Nevada Secretary of State authorizing changes to the Company’s Articles of Incorporation.

 

The changes are as follows:

 

(i) Authorized common shares have been reduced from 6,000,000,000 to 500,000,000 authorized shares.

(ii) A 1 for 150 reverse stock split of all issued series of stock with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock. One share of Common Stock will be issued after the exchange for one hundred and fifty shares of Common Stock issued. One share of each series of preferred Stock (with the exception of the Corporation’s authorized Non Voting Convertible Preferred Stock) will be issued after the exchange for one hundred and fifty shares of each series of Preferred Stock issued

 

The changes became effective July 27, 2015.

 

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NOTE 13. STOCK TRANSACTIONS

 

During the year ended August 31, 2016:

 

On September 28, 2015 the Company issued 8,000,000 shares of the Company’s Common Stock in satisfaction of a license initiation fee due pursuant to that agreement by and between Zander and Regen Biopharma, Inc. ( Note 6).

 

NOTE 14. CHANGES AFFECTING COMPARIBILITY

Within the Company’s Consolidated Statement of Cash Flows for the Years Ended August 31, 2015 and August 31, 2016 the line item entitled “Increase (Decrease) in Additional paid in Capital” which represents Restricted Stock Award compensation expense recognized for the periods on Restricted Stock Awards issued to employees and consultants on April 5 2012 is presented as an adjustment to reconcile net loss to net cash used in operating activities. The Company’s previously released Consolidated Statement of Cash Flows for the Year Ended August 31, 2015 presented the same line item as a financing activity. Management has determined that such presentation does not best reflect the nature of the expense incurred and has adjusted the prior period accordingly.

 

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Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure

 
During the Registrant's most two most recent fiscal years there were no disagreements with Seale and Beers, Certified Public Accountants LLC (“S&B”) , the Company’s independent registered public accounting firm until September 21, 2016, whether or not resolved, on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which, if not resolved to S&B’s satisfaction, would have caused it to make reference to the subject matter of the disagreement in connection with its report on the Registrant's financial statements.

 

During the Registrant's most two most recent fiscal years there were no disagreements with AMC Auditing (“AMC”) , the Company’s independent registered public accounting firm from September 21, 2016 to the present, whether or not resolved, on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which, if not resolved to AMC’s satisfaction, would have caused it to make reference to the subject matter of the disagreement in connection with its report on the Registrant's financial statements.

 

Item 9A. Controls and Procedures

 

a) Evaluation of disclosure controls and procedures.

 

The principal executive officer and principal financial officer have evaluated the Company’s disclosure controls and procedures as of August 31, 2016. Based on this evaluation, they have concluded that the disclosure controls and procedures were effective to ensure that the information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported, within the time periods specified in the Commission’s rules and forms and to ensure that information required to be disclosed by the Company in the reports that it files or submits under the Securities Exchange Act of 1934 is accumulated and communicated to the Company’s management, including its principal executive and principal financial officers, or persons performing similar functions, as appropriate to allow timely decisions regarding required disclosure. David Koos is the Company’s CEO and acting CFO. He functions as the Company’s principal executive officer and principal financial officer.

 

b) Management’s annual report on internal control over financial reporting.

 

Management of the Company is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) promulgated under the Securities and Exchange Act of 1934. Rule 13a-15(f) defines internal control over financial reporting as follows:

 

“The term internal control over financial reporting is defined as a process designed by, or under the supervision of, the issuer's principal executive and principal financial officers, or persons performing similar functions, and effected by the issuer's board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:

 

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the issuer;

 

Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the issuer are being made only in accordance with authorizations of management and directors of the issuer; and

 

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the issuer's assets that could have a material effect on the financial statements.”

 

The Company’s internal control over financial reporting is a process designed under the supervision of the Company’s management to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company’s financial statements for external purposes in accordance with U.S. generally accepted accounting principles.

 

In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only a reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met.

 

The Company’s management assessed the effectiveness of its internal control over financial reporting as of August 31, 2010 based on the framework in “Internal Control over Financial Reporting – Guidance for Smaller Public Companies (2006) issued by the Committee of Sponsoring Organizations of the Treadway Commission.” Based on its assessment, management believes that, as of August 31, 2010, the Company’s internal control over financial reporting is effective.

 

Management's report was not subject to attestation by the Company's registered public accounting firm pursuant to temporary rules of the Securities and Exchange Commission that permit the company to provide only management's report in this annual report. This exemption for smaller reporting companies provided under the temporary rules referenced above has been made permanent under Section 989G of the Dodd-Frank Wall Street Reform and Consumer Protection Act.

 

(c) There have been no changes during the quarter ended August 31, 2016 in the Company’s internal controls over financial reporting that have materially affected, or are reasonably likely to materially affect, internal control over financial reporting.

 

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Item 10. Directors, Executive Officers and Corporate Governance

 

On June 19, 2009 the Board of Directors of  the Company elected David R. Koos, 52,  a director of the Company and appointed Dr. Koos President, Chief Executive Officer, Secretary, Chief Financial Officer, Principal Accounting Officer of the Company. Dr. Koos resigned as Chief Financial Officer on March 31, 2010 and assumed the position of Acting Chief Financial Officer and Principal Accounting Officer on August 8, 2011 upon the resignation of Tammy L. Reynolds who served as Chief Financial Officer from the period from March 31, 2010 to August 8, 2011.

 

Dr. Koos has served as Chairman, CEO, President, Secretary, and Acting CFO of the BMSN since June 19, 2006, and as Chairman CEO, President, Secretary, and Acting CFO of Entest CA since August 22, 2008

education:

 

DBA - Finance (December 2003)

Atlantic International University

 

Ph.D. - Sociology (September 2003)

Atlantic International University

 

MA - Sociology (June 1983)

University of California - Riverside, California

 

Five Year Employment History:

 

Position: Company Name: Employment Dates:
Chairman, President, CEO and Acting CFO

Bio-Matrix Scientific Group, Inc.*

 

June 14, 2006 (Chairman) to Present

June 19, 2006 (President, CEO and Acting CFO)

June 19, 2006 (Secretary) to Present

Chairman and CEO Regen Biopharma, Inc.* April 24, 2012 to Present

Acting CFO

President

Regen Biopharma, Inc.

Regen Biopharma, Inc

April 24, 2012 to February 11, 2015

May 29, 2013 to October 9, 2013

Chairman, CEO, Secretary & Acting CFO  Frezer Inc. May 2, 2005 to February 2007
Chairman, CEO & Acting CFO

 BMXP Holdings, Inc.

 

December 6, 2004 to June 2008
Managing Director & President Cell Source Research Inc. December 5, 2001 to Present
Managing Director & President Venture Bridge Inc. November 21, 2001 to Present
Chairman of the Board of Directors, CFO & Secretary

Cell Bio-Systems Inc.

(New York)

July 17, 2003 to December 1, 2003
Registered Representative Amerivet Securities Inc.** March 31, 2004 to February 2008

 

* As of November 15, 2016 Bio-Matrix Scientific Group Inc. owned 66,667 common shares of the Company

As of November 15, 2016 Regen Biopharma owns 8,000,000 common shares of the Company

 

** Amerivet Securities Inc. has not been active during the period as the Chief Executive Officer was on deployment in Iraq through the U.S. Army Reserves.

 

Code of Ethics

 

On November 11, 2009 we adopted a Code of Ethics pursuant to Section 406 of the Sarbanes-Oxley Act of 2002

 

25
 

 

Director Independence

 

Audit Committee and Audit Committee Financial Expert

 

The sole member of the Company’s board of Directors may not be considered independent as he is also its sole officer. The Company is not a "listed company" under Securities and Exchange Commission (“SEC”) rules and is therefore not required to have an audit committee comprised of independent directors. The Company does not currently have an audit committee, however, for certain purposes of the rules and regulations of the SEC and in accordance with the Sarbanes-Oxley Act of 2002, the Company’s  Board of Directors is deemed to be its  audit committee and as such functions as an audit committee and performs some of the same functions as an audit committee including: (1) selection and oversight of our independent accountant; (2) establishing procedures for the receipt, retention and treatment of complaints regarding accounting, internal controls and auditing matters; and (3) engaging outside advisors. The Board of Directors has determined that its member is  able to read and understand fundamental financial statements and has substantial business experience that results in that member's financial sophistication. Accordingly, the Board of Directors believes that its member has  the sufficient knowledge and experience necessary to fulfill the duties and obligations that an audit committee would have.

 

Nominating and Compensation Committees

The Company does not have standing nominating or compensation committees, or committees performing similar functions. The board of directors believes that it is not necessary to have a compensation committee at this time because the functions of such committee are adequately performed by the board of directors. The board of directors also is of the view that it is appropriate for the Company not to have a standing nominating committee because the board of directors has performed and will perform adequately the functions of a nominating committee. The Company is not a "listed company" under SEC rules and is therefore not required to have a compensation committee or a nominating committee.

 

Shareholder Communications

 

There has not been any defined policy or procedure requirements for stockholders to submit recommendations or nomination for directors. There are no specific, minimum qualifications that the board of directors believes must be met by a candidate recommended by the board of directors. Currently, the entire board of directors decides on nominees, on the recommendation of any member of the board of directors followed by the board’s review of the candidates’ resumes and interview of candidates. Based on the information gathered, the board of directors then makes a decision on whether to recommend the candidates as nominees for director. The Company does not pay any fee to any third party or parties to identify or evaluate or assist in identifying or evaluating potential nominee.

 

Because management and the Board of Directors  of the Company are the same people, the Board of Directors has determined not to adopt a formal methodology for communications from shareholders on the belief that any communication would be brought to the Board of Directors’ attention by virtue of the co-extensive capacities of the Board of Directors.

 

Executive Compensation

 

SUMMARY COMPENSATION TABLE

 

Name and Principal Position  Year 

Salary

($)

 

Bonus

($)

 

Stock Awards

($)

 

Restricted Stock Awards

($)

 

Option Awards

($)

 

Non Equity Incentive Plan Compensation

($)

 

Nonqualified Deferred Compensation Earnings

($)

 

All Other Compensation

($)

 

Total

($)

David Koos

Chairman, President and CEO

    From September 1, 2014 to August 31, 2015   $120,000*   0   $193,880****   0    0    0    0    0   $313,880 
     From September 1, 2015 to  August 31, 2016   $120,000**   0    0    0    0    0    0    0   $120,000 

   * Includes $120,000 in salary earned by David Koos which was accrued but unpaid for the fiscal year ended August 31, 2015 

** Includes 120,000  in salary earned by David Koos which was accrued but unpaid for the fiscal year ended August 31, 2016

**** On July 31, 2105 the Company issued to David Koos 14,800,000 Common Shares with a fair value of $193,880 in satisfaction of $14,800 of salary accrued but unpaid

 

26
 

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters

 

The following table sets forth information known to the Company with respect to the beneficial ownership of each class of the Company’s capital stock as of November 15, 2016 for (1) each person known by the Company to beneficially own more than 5% of each class of the Company’s voting securities, (2) each executive officer, (3) each of the Company’s directors and (4) all of the Company’s executive officers and directors as a group. As of November 18, 2015 the Company had 40,170,472  common shares outstanding, 28,009 Series B Preferred Shares outstanding , 667 Series AA Preferred Shares outstanding, and 533 Series AAA Preferred Shares outstanding

 

Based on 40,170,472 shares issued and outstanding as of  November 15, 2016   

 

Title of Class 

Name and Address of

Beneficial Owner

  Amount and Nature
 of Beneficial Owner
  Percent of Class
 Common   David R. Koos*
C/o Entest Bio Medical Inc., Inc
4700 SPRING STREET, SUITE 203, LA MESA, CALIFORNIA, 91942
   23,300,001    58%
                
 Common   All Officers and Directors As a Group   23,300,001    3.1%

 

*Includes 66,667 common shares owned by Bio-Matrix Scientific Group, Inc. (David Koos is CEO, President and Chairman of Bio-Matrix Scientific Group, Inc.). Includes 8,000,000 common shares owned by Regen Biopharma, Inc. (David Koos is CEO and Chairman of Regen Biopharma, Inc.)

 

Based on 28,009 shares issued and outstanding as of  November 15, 2016   

  

Title of Class  Name and Address of Beneficial Owner  Amount and Nature of Beneficial Owner  Percent of Class
Series B Preferred  David R. Koos*
C/o Entest Bio Medical Inc., Inc
4700 SPRING STREET, SUITE 203, LA MESA, CALIFORNIA, 91942
   15,001    53.6%
              
Series B Preferred  Sleezer family Trust
c/o Charles Sleezer
12550 Carson Street
Hawaiian Gardens, CA
   4,584    16.4%
              
Series B Preferred  Ronald J. Titterington and Kathy Snell
3880 W 11th Street
Eugene Oregon
   2,084    7.4%
              
Series B Preferred  All Officers and Directors as a Group*   15,001    53.6%

 

*Includes 8,334 Series B Preferred  shares owned by Bio-Matrix Scientific Group, Inc. (David Koos is CEO, President and Chairman of Bio-Matrix Scientific Group, Inc.).

 

27
 

Based on 667 shares issued and outstanding as of  November 15, 2016   

 

          
Title of Class  Name and Address of Beneficial Owner  Amount and Nature
 of Beneficial Owner
  Percent of Class
Series AA Preferred Shares  David R. Koos
C/o Entest Bio Medical Inc., Inc
4700 SPRING STREET, SUITE 203, LA MESA, CALIFORNIA, 91942
   667    100%
              
Series AA Preferred Shares  All Officers and Directors
As a Group
   667    100%

 

Based on 533 shares issued and outstanding as of  November 15, 2016   

 

          
Title of Class  Name and Address of Beneficial Owner  Amount and Nature
 of Beneficial Owner
  Percent of Class
Series AAA Preferred Shares  David R. Koos
C/o Entest Bio Medical Inc., Inc
4700 SPRING STREET, SUITE 203, LA MESA, CALIFORNIA, 91942
   533    100%
              
Series AAA Preferred Shares  All Officers and Directors
As a Group
   533    100%

 

 

Item 13. Certain Relationships and Related Transactions, and Director Independence

 

During the year ended August 31, 2016 , David Koos loaned the Company $100 . These loans are due and payable at the demand of David Koos and bear simple interest at a rate of 15% per annum. During the years ended August 31, 2016 the Company repaid Davis Koos $29,488 of principal indebtedness owed to Koos by the Company.

 

As of August 31, 2016 the Company remains indebted to David R. Koos in the principal amount of $100  due and payable at the demand of David  Koos and bearing simple interest at a rate of 15% per annum.

 

As of August 31, 2016 the Company is indebted to Regen Biopharma Inc., a company under common control with Entest, in the amount of $12,051. This amount is due and payable in whole or in part at the demand of Regen Biopharma, Inc and bears simple interest at a rate of 10% per annum.

 

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

 

The rent payable to Entest BioMedical, Inc. by the subtenant is equal to Five Thousand Dollars per month ($5,000) and is to be paid in at such time specified in accordance with the original lease agreement between the Entest BioMedical, Inc. (“Entest”) and the lessor. All charges for utilities connected with premises which are to be paid under the master lease shall be paid by Regen Biopharma, Inc. for the term of this sublease to the extent that such charges exceed the difference between the rent payable to the lessor by Entest under the master lease and the rent payable to Entest by Regen Biopharma, Inc. As of August 31, 2016, Regen Biopharma Inc owes the Company the amount of $15,000 of accrued rent.

 

On June 23, 2015 Regen Biopharma, Inc. ( “Regen”) entered into an agreement (“Agreement”) with Zander whereby Regen granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by Regen (“ License IP”) for non-human veterinary therapeutic use for a term of fifteen years.

 

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

 

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

 

28
 

 

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

 

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

 

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

 

The Agreement may be terminated by Regen:

 

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

 

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

 

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

 

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

 

 On September 28, 2015 the Company issued 8,000,000 shares of the Company’s Common Stock to Regen Biopharma, Inc. in satisfaction of that license initiation fee due and payable to Regen Biopharma, Inc. pursuant to the terms and conditions of the Agreement.

 

On September 8, 2016 the Company paid $17,000 as partial payment of a $100,000 obligation incurred pursuant to the Agreement. 

Director Independence

 

Audit Committee and Audit Committee Financial Expert

 

The Company’s  sole director may not be considered independent as  he is also an  officer. The Company is not a "listed company" under Securities and Exchange Commission (“SEC”) rules and is therefore not required to have an audit committee comprised of independent directors. The Company does not currently have an audit committee, however, for certain purposes of the rules and regulations of the SEC and in accordance with the Sarbanes-Oxley Act of 2002, the Company’s  Board of Directors is deemed to be its  audit committee and as such functions as an audit committee and performs some of the same functions as an audit committee including: (1) selection and oversight of our independent accountant; (2) establishing procedures for the receipt, retention and treatment of complaints regarding accounting, internal controls and auditing matters; and (3) engaging outside advisors. The Board of Directors has determined that its sole member is able to read and understand fundamental financial statements and has substantial business experience that results in the member's financial sophistication. Accordingly, the Board of Directors believes that its member has the sufficient knowledge and experience necessary to fulfill the duties and obligations that an audit committee would have.

 

Nominating and Compensation Committees

 

The Company does not have standing nominating or compensation committees, or committees performing similar functions. The Board of Directors believes that it is not necessary to have a compensation committee at this time because the functions of such committee are adequately performed by the board of directors. The Board of Directors also is of the view that it is appropriate for the Company not to have a standing nominating committee because the Board of Directors has performed and will perform adequately the functions of a nominating committee. The Company is not a "listed company" under SEC rules and is therefore not required to have a compensation committee or a nominating committee.

 

Shareholder Communications

 

There has not been any defined policy or procedure requirements for stockholders to submit recommendations or nomination for directors. There are no specific, minimum qualifications that the board of directors believes must be met by a candidate recommended by the board of directors. Currently, the entire board of directors decides on nominees, on the recommendation of any member of the board of directors followed by the board’s review of the candidates’ resumes and interview of candidates. Based on the information gathered, the board of directors then makes a decision on whether to recommend the candidates as nominees for director. The Company does not pay any fee to any third party or parties to identify or evaluate or assist in identifying or evaluating potential nominee.

 

The Board of Directors has determined not to adopt a formal methodology for communications from shareholders on the belief that any communication would be brought to the board of directors’ attention by virtue of communication with management

 

29
 

 

Item 14. Principal Accounting Fees and Services

 

The following table sets forth the aggregate fees billed to us by Seale and Beers , CPAs during the period beginning September 1, 2015 and ending August 31, 2016:

 

Audit Fees  $15,000 
Audit Related Fees   13,523 
Tax Fees   0 
All Other Fees   0 
   $28,523 

 

Audit Fees: Aggregate fees billed for professional services rendered for the audit of the Company's annual financial statements.

 

Audit Related Fees:   Aggregate fees billed for professional services rendered for assurance and related services that were reasonably related to the performance of the audit or review of our financial statements and are not reported under “Audit Fees” above. During the year ended August 31, 2016 these fees were primarily derived from review of financial statements in the Company's Form 10Q Reports.

 

 All services listed were pre-approved by the Board of Directors, functioning as the Audit Committee in accordance with Section 2(a) 3 of the Sarbanes-Oxley Act of 2002.

 

The Board has considered whether the services described above are compatible with maintaining the independent accountant's independence and has determined that such services have not adversely affected the independence of Seale and Beers , CPAs.

 

30
 

 

Item 15. Exhibit Index

 

EXHIBIT INDEX

 

Exhibit No. Description
3(i)(a) Articles of Incorporation
3(ii)(b) Bylaws
10.1 ( c) Agreement by and Between David Koos and the Company
10.2 (Incorporated by Reference to  Exhibit 10.2 of the Company’s Form S-1 filed June 12, 2012) Terms of Employment Agreement by and between the Company and Tammy Reynolds
10.3 (d) August 2010 Agreement by and between the Company and TheraCyte, Inc.
10.3 (e) Asset Purchase Agreement by and between the Company, Dr. Gregory McDonald and Pet Pointers
10.4 (f) Exhibit A to Asset Purchase Agreement by and between the Company, Dr. Gregory McDonald and Pet Pointers
10.5 (g) Exhibit B to Asset Purchase Agreement by and between the Company, Dr. Gregory McDonald and Pet Pointers
10.6 (h) CRO Agreement by and between the Company and RenovoCyte LLC
3(i)(2)(i) Certificate of Designations Series AA Preferred Stock
10.7(j) 8% ASHER NOTE $42,500
10.8(k) 8% ASHER NOTE $37,500
10.9(l) 8% ASHER NOTE $35,000
10.10(m) 8% ASHER NOTE $32,500
3(i)(3) (n) Amendment to Certificate of Incorporation dated June 4, 2009
3(ii)(2) (o) Bylaws of Entest Biomedical, inc., a California corporation and wholly owned subsidiary of the Registrant
3(i)(4) (p) Certificate of Incorporation of Entest Biomedical, inc., a California corporation and wholly owned subsidiary of the Registrant
10.11(q) 8% ASHER NOTE $37,500
3(i)(5) ( r) Certificate of Designations Series B  Preferred Stock
3(i) (6)(s) Amendment to Certificate of Incorporation
10.12 (t) Equity purchase Agreement, Southridge Feb 27, 2012
10.13(u) Registration Rights Agreement, Southridge
10.14(Incorporated by Reference to   Exhibit 10.14 of the Company’s Form S-1 filed June 12, 2012) Line of Credit Promissory Note December 1, 2010 Bio Technology Partners Business Trust
10.15(Incorporated by Reference to Exhibit 10.15 of the Company’s Form S-1 filed June 12, 2012) Line of Credit Promissory Note December 1, 2010  Venture Bridge Advisors, Inc.
10.16(Incorporated by Reference to Exhibit 10.16 of the Company’s Form S-1 filed June 12, 2012) Line of Credit Promissory Note December 1, 2010  Bombardier Pacific ventures
10.17(Incorporated by Reference to Exhibit 10.17 of the Company’s Form S-1 filed June 12, 2012) Line of Credit Promissory Note December 1, 2010  David Koos
3(i)(7) (v) Amendment to Certificate of Incorporation
10.18(Incorporated by Reference to  Exhibit 10.18 of the Company’s Form S-1 filed June 12, 2012) Agreement amending terms of outstanding Debt by the Company
10.19(Incorporated by Reference to Exhibit 10.19 of the Company’s Form S-1 filed June 12, 2012) Agreement amending terms of outstanding Debt by the Company
10.20(Incorporated by Reference to Exhibit 10.20 of the Company’s Form S-1 filed June 12, 2012) Agreement amending terms of outstanding Debt by the Company
10.21(w) Form of Bonus Share Agreement
5.1 Opinion Regarding Legality
14 (y) Code of Ethics
10.24 (aaaa) Assignment dated June 15, 2009 by and between Entest Biomedical, Inc. and  Bio-Matrix Scientific Group, Inc.
10.22 (z) Lease
3(i)(8) (aa) Text of Amendment to Certificate of Incorporation
10.23(aaa) 8% ASHER NOTE $42,500
10.24 (aaaa) Assignment dated June 15, 2009 by and between Entest Biomedical, Inc. and  Bio-Matrix Scientific Group, Inc.
10.25(Incorporated by Reference to Exhibit 10.25 of the Company’s Form S-1 filed June 12, 2012) Advisory Board Letter Agreement
10.26 (aaaaa) Equity Purchase Agreement Southridge June 1 2012
   
10.27(Incorporated by Reference to Exhibit 10.27 of the Company’s Form S-1 filed June 12, 2012) Amendment to Registration Rights Agreement
10.28(Incorporated by Reference to Exhibit 10.28 of the Company’s Form S-1 filed June 12, 2012) Termination Letter February 27 Equity Purchase Agreement
10.29(zzzzzzzz1) AGREEMENT AMENDING TERMS OF OUTSTANDING DEBT BY THE COMPANY
10.30(zzzzzzzz2) AGREEMENT AMENDING TERMS OF OUTSTANDING DEBT BY THE COMPANY
10.31(zzzzzzzz3) AGREEMENT AMENDING TERMS OF OUTSTANDING DEBT BY THE COMPANY
10.32(zzzzzzzz4) AGREEMENT AMENDING TERMS OF OUTSTANDING DEBT BY THE COMPANY
10.33(zzzzzzzz5) AGREEMENT AMENDING TERMS OF OUTSTANDING DEBT BY THE COMPANY
10.34(zzzzzzzz6) AGREEMENT AMENDING TERMS OF OUTSTANDING DEBT BY THE COMPANY
10.35 ( incorporated by Reference to Exhibit 10.35 of the company’s amended Form S-1 Filed Auguust 17, 2012) ASHER NOTE $63,000
10.36( incorporated by Reference to Exhibit 10.36 of the company’s amended Form S-1 Filed August 17, 2012) TERMS OF COMPENSATION DAVID KOOS
10.37 (zzzzzzzz7) ASHER NOTE $63,000
10.38 (incorporated by reference to Exhibit 10.1 of the Company’s 8-K filed December 12, 2012) 3.i (8) (Incorporated by Reference to Exhibit 3(i) of the Company’s 8-K filed October 19, 2012) Settlement Agreement with G. McDonald
10.39 (incorporated by reference to Exhibit 10.39 of the Company’s 10-K for the year ended August 31, 2012) Line of Credit Promissory Note Sherman family Trust
Exhibit 10.40 SETTLEMENT AGREEMENT AND MUTUAL GENERAL RELEASE (incorporated by reference to exhibit 10.1 of the Company’s 8-K filed March 12, 2013)
3(1)(8)(zzzzzzzz8) Text of Amendment to Certificate of Incorporation
3(i)(9) (zzzzzzzz9) Certificate of Designations
3(i) (10) (zzzzzzzz10) Text of Amendment to Certificate of Incorporation
10.41((zzzzzzzz11) Employment Offer
10.42 (ab1) Sublease Agreement
10.43 (ab2) Amendment to Sublease Agreement
10.44 (ab3) AGREEMENT BY AND BETWEEN REGEN BIOPHARMA, INC. AND ZANDER THERAPEUTICS, INC.
3(i) (A) (ab4) CERTIFICATE OF CHANGE
10.45 Amendment to Regen Zander Agreement
23.1 Consent of Seale and Beers
10.45 (ab5) AGREEMENT BY AND BETWEEN REGEN BIOPHARMA, INC. AND ZANDER THERAPEUTICS, INC. dated September 28, 2015
31.1 CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO SECTION 302 OF THE SARBANESE-OXLEY ACT OF 2002
31.2 CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO SECTION 302 OF THE SARBANESE-OXLEY ACT OF 2002
32.1 CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
32.2 CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO 18 U.S.C. SECTION 1350 AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

(a) Incorporated by Reference to Exhibit 3(1) of the Company's Form S-1 Filed  November 4, 2008
(b) Incorporated by Reference to Exhibit 3(2) of the Company's Form S-1 Filed  November 4, 2008
(c) Incorporated by Reference to Exhibit 10(1) of the Company's Form10-K  Filed  November 17, 2009
(d) Incorporated by Reference to Exhibit 10(1) of the Company's Form10-K  Filed  November 16, 2010
(e) Incorporated by Reference to Exhibit 10(1) of the Company's Form 8-K Filed December 17, 2010
(f) Incorporated by Reference to Exhibit 10(2) of the Company's Form 8-K Filed December 17, 2010
(g) Incorporated by Reference to Exhibit 10(3) of the Company's Form 8-K Filed December 17, 2010
(h) Incorporated by Reference to Exhibit 10(3) of the Company's Form 8-K Filed October 24, 2011
(i) Incorporated by Reference to Exhibit 3(i) of the Company's Form 8-K Filed June 10, 2011
(j) Incorporated by Reference to Exhibit 10(9) of the Company's Form 10-K  filed November 3 2011
(k) Incorporated by Reference to Exhibit 10(10) of the Company's Form 10-K  filed November 3 2011
(l) Incorporated by Reference to Exhibit 10(11) of the Company's Form 10-K  filed November 3 2011
(m) Incorporated by Reference to Exhibit 10(12) of the Company's Form 10-K  filed November 3 2011
(n) Incorporated by Reference to Exhibit 3(i) (2)of the Company's Form 8-K Filed June 10, 2011
(o) Incorporated by Reference to Exhibit 3(ii) of the Company's Form 8-K Filed June 10, 2011
(p) Incorporated by Reference to Exhibit 3(i) of the Company's Form 8-K Filed June 10, 2011
(q) Incorporated by Reference to Exhibit 10.1 of the Company's Form 10-Q Filed January 11, 2012
( r) Incorporated by Reference to Exhibit 3(i) of the Company's Form 8-K Filed February 9, 2012
(s) Incorporated by Reference to Exhibit (3)(i) of the Company's Form 10-Q Filed February 9, 2012
(t) Incorporated by Reference to Exhibit 10.1 of the Company's Form 10-Q Filed February 9, 2012
(u) Incorporated by Reference to Exhibit 10.2 of the Company's Form 10-Q Filed February 9, 2012
(v) Incorporated by Reference to Exhibit 3(i) of the Company's Form 8-K Filed March 22, 2012
(w) Incorporated by Reference to Exhibit 10.1 of the Company's Form 8-K Filed April 5, 2012
(x) Filed as Exhibit 5.1
(y) Incorporated by Reference to Exhibit 14 of the Company's Form10-K  Filed  November 17, 2009
(z) Incorporated by Reference to Exhibit 10.1 of the Company's Form 10-Q Filed March 28, 2012
(aa) Incorporated by Reference to Exhibit 3(i) of the Company's Form 8-K Filed April 25, 2012
(aaa) Incorporated by Reference to Exhibit 10 of the Company's Form 8-K Filed April 25, 2012
(aaaa) Incorporated by Reference to Exhibit 10.2 of the Company's Form 8-K Filed July 10, 2009
(aaaaa) Incorporated by Reference to Exhibit 10.1 of the Company's Form 8-K Filed June 4, 2012
(zzzzzzzz1) Incorporated by Reference to Exhibit 10.1 of the Company's Form 10-Q Filed July 23, 2012
(zzzzzzzz2) Incorporated by Reference to Exhibit 10.2 of the Company's Form 10-Q Filed July 23, 2012
(zzzzzzzz3) Incorporated by Reference to Exhibit 10.3 of the Company's Form 10-Q Filed July 23, 2012
(zzzzzzzz4) Incorporated by Reference to Exhibit 10.4 of the Company's Form 10-Q Filed July 23, 2012
(zzzzzzzz5) Incorporated by Reference to Exhibit 10.5 of the Company's Form 10-Q Filed July 23, 2012
(zzzzzzzz6) Incorporated by Reference to Exhibit 10.6 of the Company's Form 10-Q Filed July 23, 2012
(zzzzzzzz7) Incorporated by Reference to Exhibit 10.37 of the Company's Form 10-K for the year ended August 31, 2012)
(zzzzzzzz8) Incorporated by Reference to Exhibit 3(i) of the company’s Form 8-K dated January 24, 2014
(zzzzzzzz9) Incorporated by Reference to Exhibit 3(i) of the company’s Form 8-K dated May 22, 2014
(zzzzzzzz10) Incorporated by Reference to Exhibit 3(i) of the company’s Form 8-K dated July 14, 2014
(zzzzzzzz11) Incorporated by Reference to Exhibit 10.1 of the company’s Form 8-K dated November 7, 2014
(ab1) Incorporated by Reference to Exhibit 10.1 of the company’s Form 10-Q filed January 13, 2015
(ab2) Incorporated by Reference to Exhibit 10.1 of the company’s Form 10-Q filed April 10, 2015
(ab3) Incorporated by Reference to Exhibit 10.1 of the company’s Form 8-K dated June 25, 2015
(ab4) Incorporated by Reference to Exhibit 3(i) of the company’s Form 8-K dated July 3, 2015
(ab5) Incorporated by Reference to Exhibit 10.1 of the company’s Form 8-K dated October 2, 2015

 

31
 

 

SIGNATURES

 

 

Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

 

      Entest BioMedical, Inc.
       
    By: /s/David R. Koos  
      Name: David R. Koos
     

Title: President, Chairman, Chief

Executive Officer

      Date: November 22, 2016.

 

 

Pursuant to the requirements of the Securities Exchange Act of 1934, this Report has been signed below by the following persons on behalf of the Registrant and in the capacities indicated on November 25, 2014.

 

    By: /s/ David R. Koos 
      Name: David R. Koos
      Title: President, Chairman of the Board of Directors, Chief Executive Officer, Acting Chief Financial Officer
      Date: November 22, 2016.

 

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