Regen BioPharma Inc 10-K for FY2023
Regen BioPharma Inc (RGBP)
About this 10-K
Regen BioPharma Inc filed this 10-K on November 20, 2023, covering the fiscal year ended September 30, 2023 (FY2023).
Headline figures
Fiscal year ended September 30, 2023, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $126.56K
- up 0.8% from $125.52K a year earlier
- Net income
- $1.16M
- down 52.7% from net income of $2.44M a year earlier
- Diluted EPS
- $0.29
- down 59.2% from $0.71 a year earlier
United States
Securities and Exchange Commission
Washington, D.C. 20549
Form
For
the fiscal year ending
For the transition period from __________ to __________.
Commission
file number:
| (Name of small business issuer in its charter) | |
| (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) |
| (Address of Principal executive offices) | |
Issuer’s
telephone number: (
Securities registered under Section 12(b) of the “Exchange Act”: None
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days.
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 ☐ |
| Smaller reporting Company | |
| Emerging growth company |
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act).
Yes
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
☐
State
the aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which
the common equity was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s
most recently completed second fiscal quarter: $
As of November 6, 2023 Regen Biopharma, Inc. had common shares outstanding.
As of November 6, 2023 Regen Biopharma, Inc. had 409,551 shares of Series A Preferred Stock outstanding.
As of November 6, 2023 Regen Biopharma, Inc. had 34 shares of Series AA Preferred Stock outstanding.
As of November 6, 2023 Regen Biopharma, Inc. had 29,338 shares of Series M Preferred Stock outstanding.
As of November 6, 2023 Regen Biopharma, Inc. had 15,007 shares of Series NC Preferred Stock outstanding.
| 1 |
In this annual report, the terms “Regen Biopharma, Inc.. ”, “Regent”, “Company”, “we”,
or “our”, unless the context otherwise requires, mean Regen Biopharma, Inc., a Nevada corporation and its wholly owned subsidiary
KCL, Therapeutics, Inc., a Nevada corporation.
CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This annual report on Form 10-K and other reports that we file with the SEC contain statements that are considered forward-looking statements. Forward-looking statements give the Company’s current expectations, plans, objectives, assumptions or forecasts of future events. All statements other than statements of current or historical fact contained in this annual report, including statements regarding the Company’s future financial position, business strategy, budgets, projected costs and plans and objectives of management for future operations, are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “anticipate,” “estimate,” “plans,” “potential,” “projects,” “ongoing,” “expects,” “management believes,” “we believe,” “we intend,” and similar expressions. These statements are based on the Company’s current plans and are subject to risks and uncertainties, and as such the Company’s actual future activities and results of operations may be materially different from those set forth in the forward looking statements. Any or all of the forward-looking statements in this annual report may turn out to be inaccurate and as such, you should not place undue reliance on these forward-looking statements. The Company has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that it believes may affect its financial condition, results of operations, business strategy and financial needs. The forward-looking statements can be affected by inaccurate assumptions or by known or unknown risks, uncertainties and assumptions due to a number of factors, including:
| • | 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.
| 2 |
PART I
Item 1. Business
We were incorporated April 24, 2012 under the laws of the State of Nevada. We intend to engage primarily in the development of regenerative medical applications which we intend to license, develop internally or acquire outright from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The primary factor to be considered by us in arriving at a decision to advance an application further to Phase III clinical trials would be a greater than anticipated indication of efficacy seen in Phase I trials.
As of September 15, 2023 we have not licensed any existing therapies which may be marketed.
Patents and Patent Applications:
The following is a list of intellectual property (“IP”) controlled by either Regen Biopharma, Inc. (the “Company”) or KCL Therapeutics (“KCL”). KCL is a wholly owned subsidiary of the Company.
IP which has been granted patent protection by the United States Patent and Trademark Office (“USPTO”)
GENE SILENCING OF THE BROTHER OF THE REGULATOR OF IMPRINTED SITES (BORIS)
Provides methods and compositions useful for inhibiting expression of the gene encoding the transcription factor, Brother of the Regulatory of Imprinted Sites (BORIS) by RNA interference. Methods of the present invention can be used to silence BORIS in cancer cells, which results in apoptosis and may be useful as for treating cancer in mammals. The methods of the invention directed to cancer therapy can be used alone or in combination with standard cancer treatments such as surgery, radiation, chemotherapy, and immunotherapy.
Patent No: 8263571
METHODS AND MEANS OF GENERATING IL-17 ASSOCIATED ANTITUMOR EFFECTOR CELLS BY INHIBITION OF NR2F6 INHIBITION
Means, methods, and compositions of matter useful for generation of cancer inhibitory effector cells producing interleukin-17 (IL-17). In one embodiment a cellular population is obtained, said cellular population is exposed to agents capable of inhibiting NR2F6, whereby said inhibition of NR2F6 results in upregulation of IL-17 production, said upregulation of IL-17 production associated with acquisition of anti-tumor activity.
Patent No : 11,053,503
METHODS OF SCREENING COMPOUNDS THAT CAN MODULATE NR2F6 BY DISPLACEMENT OF A REFERENCE LIGAND
Compositions of matter, protocols and methods of screening test compounds to identifying agonists and antagonists of the orphan nuclear receptor NR2F6 by measuring the ability of a test compound to occupy the active site of NR2F6, in the presence of a reference compound.
Patent No: 10,088,485
| 3 |
MODULATION OF NR2F6 AND METHODS AND USES THEREOF
The application provides methods of modulating NR2F6 in a cell or animal in need thereof by administering an effective amount of a NR2F6 modulator
Patent No: 9091696
“UNIVERSAL DONOR CHECKPOINT INHIBITOR SILENCED/GENE EDITED CORD BLOOD KILLER CELLS”
The invention encompasses compositions of matters, cells, and treatment protocols useful for induction of anticancer responses in a patient suffering from cancer. In one embodiment the invention provides the use of NR2F6 silencing or gene editing in cord blood cells possessing anti-tumor activity in order to induce potentiated killer cells suitable for therapeutic use. In one embodiment said allogeneic cord blood killer cells are administered to initiate a cascade of antitumor immune responses, with initially responses mediated by allogeneic killer cells, and followed by endogenous immune responses.
Patent No: 11,141,471 B2
ANTIGEN SPECIFIC MRNA CELLULAR CANCER VACCINES
Antigen specific cancer vaccines in which immunogenic epitopes are produced intracellularly by administration of modified mRNA encoding said immunogenic epitopes. In one embodiment of the invention, said modified mRNA encodes peptides derived from the protein survivin. By directly inducing gene expression of the antigens to which an immune response is desired, immunogenic peptides are generated intracellularly, thus allowing for a wider repertoire of epitopes to be presented to the adaptive immune system, which augments likelihood of successful induction of immunity.
Patent No. 11,090,332
METHOD OF CANCER TREATMENT USING SIRNA SILENCING
Comprises administering to a subject one or more siRNA constructs capable of inhibiting the expression of an immunosuppressive molecule. The invention also provides siRNA constructs and compositions.
Patent No: 8389708
SMALL MOLECULE AGONISTS AND ANTAGONISTS OF NR2F6 ACTIVITY IN HUMANS.
Patent No. 11,324,719
The invention relates to compounds useful to alteration of NR2F6 activity.
Patent No. 11,712,474
Means of stimulating systemic immunity and reduction of post-surgery tumor metastasis through the concurrent intralymphatic inhibition of NR2F6 and treatment with cannabidiol. Through the combination of immunogenic cell death and immune stimulation, the invention provides a means of enhancing the abscopal effect and in some embodiments to cause immunological mediated destruction primary and secondary neoplasia.
Patent No. 11,241,427
Compounds useful for alteration of NR2F6 activity.
| 4 |
Patent no. 11,655,474
Means, methods and compositions of matter useful for suppressing pathological production of new blood vessels in conditions such as cancer and wet macular degeneration. In one embodiment the invention provides silencing of NR2F6 using nucleic acid based approaches such as RNA interference, antisense oligonucleotides, or DICER. In another embodiment, the invention teaches the administration of small molecule NR2F6 inhibitors as means of selectively inhibiting pathological but not healthy angiogenesis.
Active Patent Applications:
| Title | Application Number | |||
| Enhancement Of Chimeric Antigen Receptor T Cell Efficacy By Dedifferentiation | 18447150 | |||
| Enhanced
Dendritic Cell Immune Activation By Combined Inhibition Of NR2F6 With Cannibidiol | 62882931 | |||
| Immune Modulation By TLR Activation For Treatment Of Filovirus Infections Including Ebola | 14954902 | |||
| Nr2f6 Silenced Autologous Immunotherapeutics | 15299400 | |||
| Treatment Of Liver Cancer Through Embolization Depot Delivery Of BORIS Gene Silencing Agents | 15250877 | |||
| Acceleration Of Hematopoietic Reconstitution By Placental, Endothelial And Endothelial Progenitor Cells | 13 /897,735 | |||
| Cells, Compositions, And Treatment Methods For Stimulation Of Hematopoiesis | 13 /957,427 | |||
| Cancer Therapy By Ex Vivo Activated Autologous Immune Cells | 13 /957,431 | |||
| Nr2f6 Inhibited Chimeric Antigen Receptor Cells | 62254330 | |||
| Personalized T Cell Immunotherapy Utilizing Nr2f6 Gene Silencing | 15402151 | |||
| Reduction
Of Post-Surgery Cancer Metastasis By Combination Of Cannabidiol And NR2F6 Inhibition | 62885740 | |||
| Stimulation Of Immunity To Tumor Specific And Endothelial Specific Proteins By In Vivo DC Attractio | 62 /050,418 | |||
| Augmentation Of Survivin Modified Mrna Vaccine Efficacy Using Dendritic Cells | 18 /358,432 | |||
| Enhancement Of T Cell Homing To Tumors Through Augmentation Of Chemokine Responsiveness And Activation Dependent Chemokine Secretion | 63 /410,205 | |||
| Combination Therapy Of Solid Tumors Using Chimeric Antigen Receptor Cells Representing Adaptive And Innate Immunity | 18 /455,544 | |||
| Dual Checkpoint Inhibitor Aptamer Based Therapeutics | 63 /406,160 | |||
| Modulation Of Tumor Microenvironment To Augment Efficacy Of Immunotherapy | 63 /384,754 | |||
| Generation Of Tolerance Promoting CAR-T Cells By Enhancement Of NR2F6 | 63 /520,062 | |||
| Stimulation Of T Regulatory Cells By Cannabidiol As A Means Of Treating Arthritis And Autoimmunity | 17 /010,720 | |||
| Activation Of Survivin-Specific Immune Responses Using Dendritic Cell Derived Exosomes Alone And/Or From Sirna / Gene Edited Dendritic Cells | 63 /439,526 | |||
License Agreements:
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 under common control with the Company.
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.
| 5 |
The abovementioned payments may be made, at Zander’s discretion, in cash or newly issued common stock of Zander or in common stock of Entest BioMedical Inc. valued as of the lowest closing price on the principal exchange upon which said common stock trades publicly within the 14 trading days prior to issuance.
Pursuant to the Agreement, Zander shall pay to Regen royalties equal to four percent (4%) of the Net Sales , as such term is defined in the Agreement, of any Licensed Products, as such term is defined in the Agreement, in a Quarter.
Pursuant to the Agreement, Zander will pay Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Zander from sublicensees (excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment pursuant to the terms and conditions of the Agreement).
Zander is obligated pay to Regen minimum annual royalties of ten thousand US dollars ($10,000) payable per year on each anniversary of the Effective Date of this Agreement, commencing on the second anniversary of June 23, 2015. This minimum annual royalty is only payable to the extent that royalty payments made during the preceding 12-month period do not exceed ten thousand US dollars ($10,000).
The Agreement may be terminated by Regen:
If Zander has not sold any Licensed Product by ten years of the effective date of the Agreement or Zander has not sold any Licensed Product for any twelve (12) month period after Zander’s first commercial sale of a Licensed Product.
The Agreement may be terminated by Zander with regard to any of the License IP if by five years from the date of execution of the Agreement a patent has not been granted by the United States patent and Trademark Office to Regen with regard to that License IP.
The Agreement may be terminated by Zander with regard to any of the License IP if a patent that has been granted by the United States patent and Trademark Office to Regen with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On April 7, 2021 Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) with Oncology Pharma,
Inc. (“Licensee”) whereby Regen granted to Licensee an exclusive right and license for the development and commercialization
of certain intellectual property (“License IP”) for the treatment in humans of pancreatic cancer for a term of fifteen years
from April 7, 2021.
The License IP consists of antigen specific cancer vaccines in which modified mRNA is administered to produce epitopes able to produce an immune response which augments likelihood of successful induction of immunity. An epitope is the part of an antigen that is recognized by the immune system.
| 6 |
As consideration to Regen for the rights and license granted pursuant to the Agreement Licensee shall:
(a) pay to Regen a nonrefundable fee of $55,000 no later than April 20,2021
(b) pay to Regen royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in a quarter.
(c) pay to Regen ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which Regen receives payment.
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.
In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
The foregoing description of the Agreement is not complete and is qualified in its entirety by reference to the text of the Agreement , which is attached to this Current Report on Form 8-K as Exhibit 10.1 and incorporated in this Item 1.01 by reference.
On April 7, 2021 KCL Therapeutics, Inc. (“KCL”) entered into an agreement (“Agreement”) with Oncology Pharma, Inc. (“Licensee”) whereby KCL granted to Licensee an exclusive right and license for the development and commercialization of certain intellectual property (“License IP”) for the treatment in humans of colon cancer for a term of fifteen years from April 7, 2021.
As consideration to KCL for the rights and license granted pursuant to the Agreement Licensee shall:
(a) pay to KCL a nonrefundable fee of Fifty Thousand common shares of Oncology Pharma, Inc. no later than April 20,2021
(b) pay to KCL royalties equal to five percent (5%) of the Net Sales as Net Sales are defined in the Agreement of any Licensed Products in a quarter.
(c) pay to KCL ten percent (10%) of all consideration (in the case of in-kind consideration, at fair market value as monetary consideration) received by Licensee from sublicensees, excluding royalties from sublicensees based on Net Sales of any Licensed Products for which KCL receives payment.
Licensed Product is defined in the Agreement as (a) any method, procedure, service or process that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions; and (b) any apparatus, material, equipment, machine or other product that incorporates, uses, used, is covered by, infringes or would infringe any of the License IP in the U.S. or foreign jurisdictions but for the rights granted pursuant to the Agreement.
In the event that development of the License IP by the Licensee is not commenced as of the date that is nine months from the effective date of the Agreement the rights and license granted pursuant to the Agreement shall become nonexclusive.
Zander and Regen are under common control. David Koos serves as sole officer and director of both Regen BioPharma, Inc. and Zander Therapeutics Inc.
Both Zander and Oncology Pharma, Inc. will be required to obtain approval from the United States Food and Drug Administration (“FDA”) in order to market any Licensed Product which may be developed within the United States and no assurance may be given that such approval would be granted.
| 7 |
Principal Products and Services
The Company has begun development of HemaXellerate, a cellular therapy designed to heal damaged bone marrow. HemaXellerate is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based in previous animal studies. The initial application of HemaXellerate will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia (underdevelopment or incomplete development of a tissue) and pancytopenia (reduction in the number of blood cells and platelets).
Adipose tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including mesenchymal stem cells and endothelial cells. Mesenchymal stem cells are connective tissue cells that can differentiate into a variety of cell types and endothelial cells are the cells that line the interior surface of blood vessels and lymphatic vessels and which play a vital role in angiogenesis (the physiological process through which new blood vessels form from pre-existing vessels).
The isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood and the bone marrow.
On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees.
The Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act due to the fact
that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for
Orphan designation for HemaXellerate.
On December 10, 2015 Regen was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body, treated with siRNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.
| 8 |
The dendritic cells that are treated with the IDO-blocking RNA become resistant to the influence of tumor cells which produce factors which cause the dendritic cell to express the IDO. Expression of IDO in the dendritic cell halts the dendritic cell from activating T cells and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in the human immune system’s attempt to eradicate tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene-silenced dendritic cell immunotherapy for treating breast cancer. The proposed trial will recruit 10 patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to last one year, with tumor assessment before therapy and at 6 and 12 months.
On May 12, 2021 the “Company executed a consulting agreement with Biotech Research Group Corporation, an FDA Specialist Group and Global Regulatory and Scientific Experts, for the purpose of review and guidance with regard to the planned reinstatement of the Company’s inactive Investigational New Drug applications (INDs) #15376 (HemaXellerate) and #16200 (dCellVax) filed with the United States Food and Drug Administration (“FDA”). The securing of the services to be provided to the Company pursuant to this consulting agreement marks the first step taken by the Company with regard to activating the Company’s currently inactive applications to initiate clinical trials.
tCellVax is intended to be a therapy where immune cells are removed from the cancer patient, treated with siRNA which inhibits NR2F6 and the cells re-infused to the patient. NR2F6 normally acts as a brake on the ability of various immune cells from being activated. The immune cells that are treated with the NR2F6-blocking siRNA become highly activated and can efficiently kill tumors.. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing safety and feasibility of the dCellVax gene-silenced immune cell immunotherapy for treating patients with solid tumors that are metastatic or not able to be removed surgically. The proposed trial will recruit 25 patients with metastatic cancer and will involve 3 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to last one year, with tumor assessment before therapy and at 6 and 12 months.
DiffronC: NR2F6 is a transcription factor that is present in many cells in the body, including immune cells but also highly expressed in certain solid tumors. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. The Company has developed a proprietary drug that is based on shRNA technology, which prevents NR2F6 from being expressed. By inhibiting the expression of NR2F6, immune cells that are treated with the NR2F6-blocking shRNA become highly activated and can efficiently kill tumors and tumors that have NR2F6 suppressed begin to differentiate.. We are currently in pre-clinical testing of this drug to optimize its delivery in vivo.
DuraCar: DuraCar is a new cellular therapy being developed by the Company. It is comprised of CAR-T cells which contain an shRNA targeting the gene NR2F6. CAR-T cells are T cells (the lymphoid cells of the body that kill tumors) isolated from a cancer patient that have been modified by expressing a chimeric antigen receptor (CAR) which is specific for the patient’s tumor. These CAR-T cells are then re-infused back into the patient. The CAR-T cells then home in directly on the tumor because they have been given the tumor-specific address via the CAR. While CAR-T cells are very effective in treating leukemias, they are not effective at treating most solid tumors. The reason for this is believed to be that the CAR-T cells are “turned-off” by the physical environment surround solid tumors. By inhibiting NR2F6, we expect our DuraCar cells to have greater efficacy and persistence than conventional CAR-T cells and create a new, optimal way to manufacture CAR-T cells. We are currently in pre-clinical testing of this drug.
Experiments performed on behalf of the Company by two unrelated contract research organizations (CROs) found that T cells which express the chimeric antigen receptor (CAR) construct targeting CD19 and expressing siRNA for NR2F6 had high expression levels of NR2F6 mRNA. NR2F6 is considered an immune checkpoint and thus increasing its activity is likely to lead to immune suppression which may be utilized in the development of therapies for the treatment of autoimmune disorders.
| 9 |
Small molecule: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. By inhibiting the function of NR2F6 using small molecules, immune cells that are treated with the NR2F6-blocking agents, similar to using the shRNA approach, should become highly activated and efficiently kill tumors. In addition, tumors that have NR2F6 blocked by using these small molecules should begin to differentiate. Conversely, activating NR2F6 is expected to suppress the immune system. This ability to suppress the immune system can be very useful for treating autoimmune disorders. We are currently in pre-clinical testing of these drugs.
None of the abovementioned statements regarding any of our products in development are intended to be a prediction or conclusion of efficacy. No clinical trials on our product candidates have commenced so no conclusions of efficacy can be made.
Research Conducted
The Company has begun development of HemaXellerate, a cellular therapy designed to heal damaged bone marrow. HemaXellerate is a patient-specific composition of cells that have been demonstrated to repair damaged bone marrow and stimulate production of blood cells based in previous animal studies. The initial application of HemaXellerate will be the treatment of severe aplastic anemia which is characterized by immune-mediated bone marrow hypoplasia (underdevelopment or incomplete development of a tissue) and pancytopenia (reduction in the number of blood cells and platelets).
Adipose tissue is collected from the patient and processed in order to separate, extract and isolate Stromal Vascular Fraction (SVF), a mix of various cell types including mesenchymal stem cells and endothelial cells. Mesenchymal stem cells are connective tissue cells that can differentiate into a variety of cell types and endothelial cells are the cells that line the interior surface of blood vessels and lymphatic vessels and which play a vital role in angiogenesis (the physiological process through which new blood vessels form from pre-existing vessels).
The isolated SVF is then intravenously administered to the patient. The Company believes that the isolated SVF will generate growth factors with the ability to repair damaged hematopoietic stem cells. Hematopoietic stem cells are immature cells that can develop into all types of blood cells, including white blood cells, red blood cells, and platelets. Hematopoietic stem cells are found in the peripheral blood and the bone marrow.
On February 5, 2013 Regen filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous SVF cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
Under the Orphan Drug Act, the FDA may designate a product as an orphan drug if it is a previously unapproved drug or biologic intended to treat a rare disease or condition, which is generally defined as a patient population of fewer than 200,000 individuals annually in the United States. Generally, if a product with an orphan drug designation subsequently receives the first marketing approval for the indication for which it has such designation, the product is entitled to a seven year period of marketing exclusivity, which precludes the FDA from approving another marketing application for the same drug for that time period. The sponsor of the product would also be entitled to a United States federal tax credit equal to 50% of clinical investigation expenses as well as exemptions from certain fees.
The Company believes that this application of HemaXellerate qualifies for Orphan designation under the Orphan Drug Act due to the fact that aplastic anemia is a rare disease with prevalence in the United States of less than 200,000 and intends to apply to the FDA for Orphan designation for HemaXellerate.
On December 10, 2015 Regen was informed by the United States Food and Drug Administration that Regen has satisfactorily addressed all clinical hold issues related to Regen’s Investigational New Drug Application for HemaXellerate and may initiate a Phase I clinical trial assessing HemaXellerate in patients with drug-refractory aplastic anemia. The Phase I clinical trial is intended to determine safety and potential efficacy of intravenously administered autologous stromal vascular fraction (SVF) cells in patients with severe, immune suppressive refractory aplastic anemia with the primary endpoints of safety and feasibility and secondary endpoints of efficacy as determined by patients having complete response, partial response or relapse.
| 10 |
The costs to perform this Phase I clinical trial is estimated to be approximately $5,000,000 and it is estimated to take 1 year to complete.
The company is developing another cell therapy product termed dCellVax. dCellVax is intended to be a therapy whereby dendritic cells of the cancer patient are harvested from the body, treated with siRNA that has the ability to block the dendritic cell from expressing indoleamine 2,3-dioxygenase (“IDO”) and subsequently reimplanted in the cancer patient.
The dendritic cells that are treated with the IDO-blocking RNA become resistant to the influence of tumor cells which produce factors which cause the dendritic cell to express the IDO. Expression of IDO in the dendritic cell halts the dendritic cell from activating T cells and causes the dendritic cell to suppress T cells. T lymphocytes (‘T cells”) are a lymphocyte that play a central role in the human immune system’s attempt to eradicate tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I/II clinical trial assessing safety with signals of efficacy of the dCellVax gene-silenced dendritic cell immunotherapy for treating breast cancer. The proposed trial will recruit 10 patients with metastatic breast cancer and will involve 4 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to cost $5,000,000 and last one year, with tumor assessment before therapy and at 6 and 12 months.
On May 12, 2021 the “Company executed a consulting agreement with Biotech Research Group Corporation, an FDA Specialist Group and Global Regulatory and Scientific Experts, for the purpose of review and guidance with regard to the planned reinstatement of the Company’s inactive Investigational New Drug applications (INDs) #15376 (HemaXellerate) and #16200 (dCellVax) filed with the United States Food and Drug Administration (“FDA”). The securing of the services to be provided to the Company pursuant to this consulting agreement marks the first step taken by the Company with regard to activating the Company’s currently inactive applications to initiate clinical trials.
Another cell therapy that focuses on a different mechanism of action than dCellVax is tCellVax. tCellVax is intended to be a therapy in which immune cells are removed from the cancer patient, treated with siRNA which inhibits NR2F6 and the cells re-infused to the patient. NR2F6 normally acts as a brake on the ability of various immune cells from being activated. The immune cells that are treated with the NR2F6-blocking siRNA become highly activated and can efficiently kill tumors. The Company has filed an Investigational New Drug (IND) application with the United States Food and Drug Administration (“FDA”) to initiate a Phase I clinical trial assessing safety and feasibility of the dCellVax gene-silenced immune cell immunotherapy for treating patients with solid tumors that are metastatic or not able to be removed surgically. The proposed trial will recruit 25 patients with metastatic cancer and will involve 3 monthly injections of the dCellVax gene-silenced dendritic cell therapy. The trial is anticipated to cost $5,000,000 and last one year, with tumor assessment before therapy and at 6 and 12 months.
DiffronC: NR2F6 is a transcription factor that is present in many cells in the body, including immune cells but also highly expressed in certain solid tumors. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. The Company has developed a proprietary drug that is based on shRNA technology, which prevents NR2F6 from being expressed. By inhibiting the expression of NR2F6, immune cells that are treated with the NR2F6-blocking shRNA become highly activated and can efficiently kill tumors and tumors that have NR2F6 suppressed begin to differentiate.. We are currently in pre-clinical testing of this drug to optimize its delivery in vivo. The two main risks associated with this drug development plan is that the NR2F6 siRNA is not effective at inhibiting NR2F6 expression or that this inhibition will not result in immune cells with enhanced tumoricidal activity.
| 11 |
DuraCar: DuraCar is a new cellular therapy being developed by the Company. It is comprised of CAR-T cells which contain an shRNA targeting
the gene NR2F6. CAR-T cells are T cells (the lymphoid cells of the body that kill tumors) isolated from a cancer patient that have been
modified by expressing a chimeric antigen receptor (CAR) which is specific for the patient’s tumor. These CAR-T cells are then
re-infused back into the patient. The CAR-T cells then home in directly on the tumor because they have been given the tumor-specific
address via the CAR. While CAR-T cells are very effective in treating leukemias, they are not effective at treating most solid tumors.
The reason for this is believed to be that the CAR-T cells are “turned-off” by the physical environment surround solid tumors.
By inhibiting NR2F6, we expect our DuraCar cells to have greater efficacy and persistence than conventional CAR-T cells and create a
new, optimal way to manufacture CAR-T cells. We have engaged two contract research organizations to advance our pre-clinical testing
of this drug. Pre-clinical testing includes design and construction of the relevant plasmids, efficient transfection of T cells, assessment
of the expression levels of the siRNA directed at NR2F6 and measurement of its effectiveness at inhibition of NR2F6 expression. Then,
these cells will be analyzed for enhanced tumor-killing activity. The two main risks associated with this drug development plan is that
the NR2F6 siRNA is not effective at inhibiting NR2F6 expression or that this inhibition will not result in a T cell with enhanced tumoricidal
activity. Successful completion of these pre-clinical experiments will significantly de-risk the project.
Experiments performed on behalf of the Company by two unrelated contract research organizations (CROs) found that T cells which express the chimeric antigen receptor (CAR) construct targeting CD19 and expressing siRNA for NR2F6 had high expression levels of NR2F6 mRNA. NR2F6 is considered an immune checkpoint and thus increasing its activity is likely to lead to immune suppression which may be utilized in the development of therapies for the treatment of autoimmune disorders
Small Molecule Drugs: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. NR2F6 normally acts as a brake on the ability of various immune cells from being activated and also allows tumor cells to keep growing. By inhibiting the function of NR2F6 using small molecules, immune cells that are treated with the NR2F6-blocking agents, similar to using the shRNA approach, should become highly activated and efficiently kill tumors. In addition, tumors that have NR2F6 blocked by using these small molecules should begin to differentiate. Conversely, activating NR2F6 is expected to suppress the immune system. This ability to suppress the immune system can be very useful for treating autoimmune disorders. We are currently in pre-clinical testing of these drugs.
Distribution methods of the products or services:
It is anticipated that Regen and /or KCL will enter into licensing and/or sublicensing agreements with outside entities in order that Regen and/or KCL may obtain royalty income on the products and services which it may develop and commercialize.
Competitive business conditions and Regen’s competitive position in the industry and methods of competition
We have yet to achieve significant revenues or profits. The pharmaceutical and biologics industries in which we intend to compete are highly competitive and characterized by rapid technological advancement. Many of our competitors have greater resources than we do.
We intend to be competitive by utilizing the services and advice of individuals that we believe have expertise in their field in order that we can concentrate our resources on projects in which products and services in which we have the greatest potential to secure a competitive advantage may be developed and commercialized. The Company’s intent is to enter into nonemployee consulting agreements with individuals who we believe have a high level of expertise in their professional fields and who have agreed to provide counsel and assistance to us in (a) determining the viability of proposed projects (b) obtaining financing for projects and (c) obtaining the resources required to initiate and complete a project in the most cost effective and rapid manner.
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.
Need for any government approval of principal products or services, effect of existing or probable governmental regulations on the business.
| 12 |
The US Food and Drug Administration (“FDA”) and foreign regulatory authorities will regulate our proposed products as drugs or biologics, , depending upon such factors as the use to which the product will be put, the chemical composition, and the interaction of the product on the human body. In the United States, products that are intended to be introduced into the body will generally be regulated as drugs, while tissues and cells intended for transplant into the human body will be generally be regulated as biologics.
Our domestic human drug and biological products will be subject to rigorous FDA review and approval procedures. After testing in animals, an Investigational New Drug Application (“IND”) must be filed with the FDA to obtain authorization for human testing. Extensive clinical testing, which is generally done in three phases, must then be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans.
Phase I
Phase 1 trials are designed to assess the safety (pharmacovigilance), tolerability, pharmacokinetics, and pharmacodynamics of a drug. These trials are often conducted in an inpatient clinic, where the subject can be observed by full-time staff. The subject who receives the drug is usually observed until several half-lives of the drug have passed. Phase I trials normally include dose-ranging, also called dose escalation, studies so that the appropriate dose for therapeutic use can be found. The tested range of doses usually are a fraction of the dose that causes harm in animal testing and involve a small group of healthy volunteers. However, there are some circumstances when real patients are used, such as patients who have end-stage disease and lack other treatment options.
Phase II
Phase II trials are designed to assess how well the drug or biologic works, as well as to continue Phase I safety assessments in a larger group of volunteers and patients. Phase II trials are performed on larger groups.
Phase III
Phase III trials are aimed at being the definitive assessment of how effective the product is in comparison with current best standard treatment and to provide an adequate basis for physician labeling. Phase III trials may also be conducted for the purposes of (i) “label expansion” (to show the product works for additional types of patients/diseases beyond the original use for which the drug was approved for marketing or (ii) to obtain additional safety data, or to support marketing claims for the product.
On occasion Phase IV (Post Approval) trials may be required by the FDA. Phase IV trials involve the safety surveillance (pharmacovigilance) and ongoing technical support of a drug after it receives permission to be sold.The safety surveillance is designed to detect any rare or long-term adverse effects over a much larger patient population and longer time period than was possible during the Phase I-III clinical trials.
All phases, must be undertaken at a hospital or medical center to demonstrate optimal use, safety, and efficacy of each product in humans. Each clinical study is conducted under the auspices of an independent Institutional Review Board (“IRB”). The IRB will consider, among other things, ethical factors, the safety of human subjects, and the possible liability of the institution. The time and expense required to perform this clinical testing can far exceed the time and expense of the research and development initially required to create the product. No action can be taken to market any therapeutic product in the United States until an appropriate New Drug Application (“NDA”) or Biologic License Application (“BLA”) or has been approved by the FDA. FDA regulations also restrict the export of therapeutic products for clinical use prior to NDA or BLA approval.
Even after initial FDA approval has been obtained, further studies may be required to provide additional data on safety or to gain approval for the use of a product as a treatment for clinical indications other than those initially targeted. In addition, use of these products during testing and after marketing could reveal side effects that could delay, impede, or prevent FDA marketing approval, resulting in FDA-ordered product recall, or in FDA-imposed limitations on permissible.
| 13 |
The FDA regulates the manufacturing process of pharmaceutical products, and human tissue and cell products, requiring that they be produced in compliance with Current Good Manufacturing Practices (“cGMP”). The FDA also regulates the content of advertisements used to market pharmaceutical products. Generally, claims made in advertisements concerning the safety and efficacy of a product, or any advantages of a product over another product, must be supported by clinical data filed as part of an NDA or an amendment to an NDA, and statements regarding the use of a product must be consistent with the FDA approved labeling and dosage information for that product.
Sales of drugs and biologics outside the United States are subject to foreign regulatory requirements that vary widely from country to country. Even if FDA approval has been obtained, approval of a product by comparable regulatory authorities of foreign countries must be obtained prior to the commencement of marketing the product in those countries. The time required to obtain such approval may be longer or shorter than that required for FDA approval
Amount spent during the fiscal year ended September 30, 2022 on research and development activities
During the fiscal year ended September 30, 2022 we expended $175,388 on research and development activities.
Costs and effects of compliance with environmental laws (federal, state and local)
Regen has not incurred any unusual or significant costs to remain in compliance with any environmental laws and does not expect to incur any unusual or significant costs to remain in compliance with any environmental laws in the foreseeable future.
Number of total employees and number of full-time employees
As of November 7, 2023 the Company has 1 full time employee.
Item 2. Properties
The Company currently occupies 2,320 square feet of office space at 4700 Spring Street, Suite 304, La Mesa, California 91942. The property is utilized as office space. We believe that the foregoing properties are adequate to meet our current needs for office space.
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet the aforementioned office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022. BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
Item 3. Legal Proceedings
There are no material pending legal proceedings to which the Company is a party or of which any of the Company’s property is the subject.
Item 4. Submission of Matters to a Vote of Security Holders
No matter was submitted during the fourth quarter of the fiscal year covered by this report to a vote of security holders, through the solicitation of proxies or otherwise.
| 14 |
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 par value of our common stock is $0.0001. There are 5,800,000,000 shares authorized and 3,558,861 shares issued and outstanding as of November 6, 2023
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
Our common shareholders are entitled to dividends if and when declared by the Board of Directors and in accordance with the Company’s Bylaws as well as the laws of the State of Nevada.
The Company also has the following classes and series of stock authorized and outstanding.
Preferred Stock, $0.0001 par value, 800,000,000 shares authorized of which 600,000 is designated as Series AA Preferred Stock: 34 shares issued and outstanding as of November 6 , 2023 , 739,000 is designated Series A Preferred Stock of which 409,551 shares are outstanding as of November 6 , 2023 , 60,000,000 is designated Series M Preferred Stock of which 29,338 shares are outstanding as of November 6, 2023 and 20,000 is designated Series NC Preferred Stock of which 15,007 shares are outstanding as of November 6, 2023
The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.
| 15 |
Series AA Preferred Stock
On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”).
The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times seven (7). Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Series A Preferred Stock
On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).
The Board of Directors of the Company have authorized 540,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
| 16 |
On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series M Preferred Stock” (hereinafter referred to as “Series M Preferred Stock”).
The Board of Directors of Regen have authorized 60,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
On March 26, 2021 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as “Series NC Preferred Stock”).
The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times 500,000. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
Our common stock is traded on the OTC Pink Market operated by OTC Markets Group under the symbol “RGBP” and our Series A Preferred stock is traded on the OTC Pink Market under the symbol “RGBPP”. No public market currently exists for any other equity securities of the Company.
We had approximately 454 holders of record of our common stock as of November 6, 2023.
| 17 |
We have never paid any cash dividends on our common stock. We currently anticipate that we will retain all future earnings for use in our business. Consequently, we do not anticipate paying any cash dividends in the foreseeable future. The payment of dividends in the future will depend upon our results of operations, as well as our short term and long-term cash availability, working capital, working capital needs, and other factors as determined by our Board of Directors. Currently, except as may be provided by applicable laws, there are no contractual or other restrictions on our ability to pay dividends if we were to decide to declare and pay them.
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.
All stock prices have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023.
| October 1, 2021 to September 30, 2022 | HIGH | LOW | ||||||
| First Quarter | $ | 53.23 | $ | 12.23 | ||||
| Second Quarter | $ | 24.18 | $ | 8.21 | ||||
| Third Quarter | $ | 16.72 | $ | 5.13 | ||||
| Fourth Quarter | $ | 19.70 | $ | 5.52 | ||||
| October 1, 2022 to December 31, 2022 | HIGH | LOW | ||||||
| First Quarter | $ | 10.89 | $ | 5.89 | ||||
| January 1, 2023 to March 31, 2023 | HIGH | LOW | ||||||
| Second Quarter | $ | 7.16 | $ | 1.25 | ||||
| April 1, 2023 to June 30, 2023 | HIGH | LOW | ||||||
| Third Quarter | $ | 2.28 | $ | 1.50 | ||||
| July 1, 2023 to September 30, 2023 | HIGH | LOW | ||||||
| Fourth Quarter | $ | 2.00 | $ | 1.46 | ||||
As of November 6, 2023 there were approximately 454 holders of our Common Stock.
As of November 6, 2023 there were approximately 211 holders of our Series A Preferred Stock.
As of November 6, 2023 there was 1 holder of our Series AA Preferred Stock.
As of November 6, 2023 there were approximately 7 holders of our Series M Preferred Stock
As of November 6, 2023 there was one holder of our Series NC Preferred Stock.
| 18 |
Dividends
No cash dividends were paid during the fiscal year ending September 30, 2023. We do not expect to declare cash dividends in the immediate future.
Recent Sales of Unregistered Securities
Retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
Quarter Ended September 30, 2023
On September 12, 2023 the Company issued 125,000 common shares to Coventry Enterprises LLC pursuant to the terms and conditions of the Investment Agreement by and between the Company and Coventry Enterprises LLC. These common shares were registered for resale pursuant to the Securities of 1933 on Form S-1 on September 29, 2023.
On September 12, 2023 the Company entered into a common stock purchase agreement (the “Investment Agreement”) with Coventry providing for an equity financing facility (the “Equity Line”). The Investment Agreement provides that upon the terms and subject to the conditions in the Investment Agreement, Coventry is committed to purchase up to Ten Million Dollars ($10,000,000) of shares of common stock, $0.0001 par value per share (the “Common Stock”), over the 36-month term of the Investment Agreement (the “Total Commitment”).
Under the terms of the Investment Agreement, Coventry will not be obligated to purchase shares of Common Stock unless and until certain conditions are met, including but not limited to a Registration Statement on Form S-1 (the “Registration Statement”) becoming effective which registers Coventry’s resale of any Common Stock purchased by Coventry under the Equity Line.
From time to time over the 36-month term of the Commitment Period (as such term is defined in the Investment Agreement) the Company, in its sole discretion, may provide Coventry with a draw down notice (each, a “Draw Down Notice”), to purchase a specified number of shares of Common Stock (each, a “Draw Down Amount Requested”), subject to the limitations discussed below. The actual amount of proceeds the Company will receive pursuant to each Draw Down Notice (each, a “Draw Down Amount”) is to be determined by multiplying the Draw Down Amount Requested by the applicable purchase price. The purchase price of each share of Common Stock equals 80% of the lowest trading price of the Common Stock during the ten business days prior to the Draw Down Notice date (the “Pricing Period”).
The maximum number of shares of Common Stock requested to be purchased pursuant to any single Draw Down Notice cannot exceed the lesser of (i) 200% of the Average Daily Traded Value (as such term is defined in the Investment Agreement) during the ten business days immediately preceding the Drawdown Notice Date or (ii) $250,000. The Company is prohibited from delivering a Draw Down Notice if the sale of shares of Common Stock pursuant to the Draw Down Notice would cause the Company to issue and sell to Coventry or Coventry to acquire or purchase an aggregate number of shares of Common Stock that would result in Coventry beneficially owning more than 4.99% of the issued and outstanding shares of Common Stock of the Company.
Average Daily Traded Value is defined in the Investment Agreement as a per share price that shall be equal to the lowest trading price of the Company’s common stock on OTC Pink during the during the ten business days immediately preceding the respective Drawdown Notice Delivery Date multiplied by the Average Daily Trading Volume.
Average Daily Trading Volume. is defined in the Investment Agreement as the average trading volume of the Company’s common stock for the ten business days immediately preceding the respective Drawdown Notice Date.
Drawdown Notice Date is defined in the Investment Agreement as the business day a Drawdown Notice is received by Coventry.
| 19 |
Pursuant to the Investment Agreement the Company issued to Coventry as a commitment fee 125,000 shares of its common stock (“Commitment Shares”) in reliance upon the exemptions from the registration requirements of the Securities Act of 1933, as amended, afforded the Company under Section 4(a)(2) promulgated thereunder.
Coventry
has agreed that:
(a) for so long as the market price of the Company’s common stock is above $1.25 per share and
(b) the Company is in full compliance with all agreements entered into with Coventry and
(c) and
the Company has not issued any common shares at a per share price below $1.50,
Coventry will agree to a leak out provision and will not sell more than 10,000 shares of the Commitment shares without permission from
the Issuer.
Quarter ended December 31, 2022
On October 25, 2022 the Company issued 6,667 Series A preferred shares as consideration for nonemployee services
On November 11, 2022 the Company issued 105126 Series A preferred shares in satisfaction of $761,500 of convertible indebtedness and $380,262 of accrued interest on convertible indebtedness.
On November 11, 2022 the Company issued 11,279 common shares in satisfaction of $25,639 of accrued interest on convertible indebtedness.
On December 5, 2022 the Company issued 1,112 Series A preferred shares as consideration for nonemployee services.
Item 6. Selected Financial Data
As we are a “smaller reporting company” as defined by Rule 229.10(f)(1), we are not required to provide the information required by this Item.
Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations
As of September 30, 2023 we had Cash of $ 121,037 and as of September 30, 2022 we had cash of $51,204. The increase in cash of approximately 137% is primarily attributable to:
| (a) | $243,750 in net cash proceeds received by the Company through the issuances of Notes Payable |
| (b) | $329,400 in combined minimum royalty and anniversary fees paid to the Company by Zander Therapeutics, Inc. pursuant to a license agreement offset by cash expended in the operation of the Company’s business. |
As of September 30, 2023 we had Accounts Receivable, Related Party of $0 and as of September 30, 2022 we had Accounts Receivable, Related Party of $ 295,466. The decrease in Accounts Receivable, Related Party is attributable to the payment to the Company by Zander Therapeutics, Inc. of all licensing fees due and payable.
As of September 30, 2023 we had Prepaid Expenses of $0 and as of September 30, 2022 we had prepaid expenses of $20,945. The decrease in Prepaid Expenses is attributable to the recognition of expenses incurred over the nine months ended June 30, 2023 resulting from an agreement to provide Research and Development services which was prepaid during the quarter ended September 30, 2021. The term of the agreement is from July 1, 2021 to July 1, 2023. The total consideration due of $55,000 was paid to the contractor as of July 1, 2021 and was being expensed over the term of the agreement.
| 20 |
As of September 30, 2022 we had Current Notes Payable of $710 and as of September 30, 2023 we had Current Notes Payable of $95,710 attributable to Promissory Notes issued by the Company during the quarter ended March 31, 2023 in the principal amount of $100,000 offset by .repayment of $5,000 of principal indebtedness by the Company during the quarter ended September , 2023
As of September 30, 2023 we had Long Term Notes Payable of $149,614 and as of September 30, 2022 we had Long Term Notes Payable of $0.
Long Term Notes Payable as of September 30, 2023 consisted of a 10% unsecured promissory Note (the “Note”) from the Company in the principal amount of $175,000 less the unamortized portion of an Original Issue Discount of $26,250.
As of September 30, 2022 we had Accrued Interest Payable of $689,785 and as of September 30, 2023 we had Accrued Interest Payable of $342,588. The decrease in Accrued Interest Payable of approximately 50.4% is attributable to the issuance of equity securities of the Company during the quarter ended December 31, 2022 in satisfaction of $405,631 of interest accrued but unpaid on Convertible Notes issued by the Company offset by additional interest accrued but unpaid during the year ended September 30, 2023 on Notes Payable and Convertible Notes Payable.
As of September 30, 2023 we had total Convertible Notes Payable of $509,880 and as of September 30, 2022 we had total Convertible Notes Payable of $1,272,340. The decrease in total Convertible Notes Payable of approximately 60 % is attributable to the conversion of $761,500 of convertible indebtedness into shares of the Company’s Series A Preferred Stock as well as the derecognition of $1,000 of convertible indebtedness.
As of September 30, 2023 we had Unearned Income of $1,591,731 and as of September 30, 2022 we had Unearned Income of $1,798,290. Unearned Income represents that portion of $1,905,000 of license fees paid during the quarter ended June 30, 2021 to be recognized as revenue over the 15 year term of the licenses granted in accordance with ASC 606. The decrease of 7.3% is attributable to the recognition by the Company of $126,560 of licensing revenue over the year ended September 30, 2023.
As of September 30, 2023 we had Unearned Income ( Related Party) of $15,126 and as of September 30, 2022 we had Unearned Income( Related Party) of $0. Unearned Income (Related Party) as of September 30, 2023 consisted solely of licensing fees paid to the Company by Zander Therapeutics, Inc. but not yet earned. Zander Therapeutics, Inc. and the Company are under common control.
As of September 30, 2022 we had a Derivative Liability of $3,551,793 and as of September 30, 2023 we had a Derivative Liability of $1,400,000. The decrease in Derivative Liability of approximately 61% is attributable to the recognition by the Company of embedded derivatives on Convertible Notes Payable with an aggregate face value of $350,000 outstanding as of September 30, 2023.
Revenues from continuing operations were $236,560 for the twelve months ended September 30, 2023 and $235,517 for the same period ended 2022. $110,000 of revenue from related parties recognized during the twelve months ended September 30, 2023 and September 30, 2022 consisted of anniversary expense receivable pursuant to a license granted by the Company to Zander Therapeutics, Inc. and minimum royalties recognized during the twelve months ended September 30, 2023 and 2022 respectively pursuant to the same license. $126,560 of revenue recognized during the twelve months ended September 30, 2023 were recognized pursuant to licenses granted to Oncology Pharma,Inc. and $125,517 of revenue was recognized during the twelve months ended September 30, 2022 pursuant to those same licenses.
The Company recognized an Operating Loss of $689,650 during the twelve months ended September 30, 2023 whereas the Company recognized an Operating Loss of 339,605 for the same period ended 2022. The large disparity in Operating Losses is primarily attributable to $606,237 in Consulting and Professional fees expensed during the period ended 2023 although all operating expenses (with the exception of total Research and Development expenses) were greater during the twelve months ended 2023 as compared to the same period ended 2022. The Company recognized Net Income of $1,156,507 for the twelve months ended September 30, 2023 as opposed to Net Income of $2,443,531 the difference primarily attributable to the recognition by the Company of Derivative Income of $3,340,683 during the twelve months ended September 30, 2022.
| 21 |
As of September 30, 2023 we had $121,307 in cash on hand and current liabilities of $5,308,003 such liabilities materially consisting of Accounts Payable, Notes Payable, Convertible Notes Payable, Derivative Liability Recognized, Unearned Income 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.
On September 12, 2023 the Company entered into a common stock purchase agreement (the “Equity Line Agreement”) with Coventry Enterprises LLC ( “Coventry”) providing for an equity financing facility (the “Equity Line”). The Equity Line Agreement provides that upon the terms and subject to the conditions in the Equity Line Agreement, Coventry is committed to purchase up to Ten Million Dollars ($10,000,000) of shares of common stock, $0.0001 par value per share (the “Common Stock”), over the 36-month term of the Equity Line Agreement (the “Total Commitment”).
Under the terms of the Equity Line Agreement, Coventry will not be obligated to purchase shares of Common Stock unless and until certain conditions are met, including but not limited to a Registration Statement on Form S-1 (the “Registration Statement”) becoming effective which registers Coventry’s resale of any Common Stock purchased by Coventry under the Equity Line.
From time to time over the 36-month term of the Commitment Period ( as such term is defined in the Equity Line Agreement) the Company, in its sole discretion, may provide Coventry with a draw down notice (each, a “Draw Down Notice”), to purchase a specified number of shares of Common Stock (each, a “Draw Down Amount Requested”), subject to the limitations discussed below. The actual amount of proceeds the Company will receive pursuant to each Draw Down Notice (each, a “Draw Down Amount”) is to be determined by multiplying the Draw Down Amount Requested by the applicable purchase price. The purchase price of each share of Common Stock equals 80% of the lowest trading price of the Common Stock during the ten business days prior to the Draw Down Notice date (the “Pricing Period”).
The maximum number of shares of Common Stock requested to be purchased pursuant to any single Draw Down Notice cannot exceed the lesser of (i) 200% of the Average Daily Traded Value ( as such term is defined in the Equity Line Agreement) during the ten business days immediately preceding the Drawdown Notice Date or (ii) $250,000. The Company is prohibited from delivering a Draw Down Notice if the sale of shares of Common Stock pursuant to the Draw Down Notice would cause the Company to issue and sell to Coventry or Coventry to acquire or purchase an aggregate number of shares of Common Stock that would result in Coventry beneficially owning more than 4.99% of the issued and outstanding shares of Common Stock of the Company.
As of September 30, 2023 the Company was not party to any binding agreements which would commit Regen to any material capital expenditures.
Item 7A. Quantitative and Qualitative Disclosures About Market Risk
As we are a smaller reporting company, as defined by Rule 229.10(f)(1), we are not required to provide the information required by this Item.
| 22 |
Item 8. Financial Statements
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Regen Biopharma, Inc.:
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Regen Biopharma, Inc. (the "Company") as of September 30, 2023 and 2022 and the related consolidated statements of operations, shareholders' equity, and cash flows for the two years in the period ended September 30, 2023, and the related notes and schedules (collectively referred to as the financial statements). In our opinion, the financial statements present fairly, in all material respects, the financial position of the Company as of September 30, 2023 and 2022, and the results of its operations and its cash flows for the two years in the period ended September 30, 2023 and 2022, in conformity with accounting principles generally accepted in the United States of America.
Going Concern Matter
The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 3 to the financial statements, the Company has suffered recurring losses from operations that raises substantial doubt about its ability to continue as a going concern. Management's plans in regard to these matters are also described in Note 3. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on the Company's financial statements based on our audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audit in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audit, we are required to obtain an understanding of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audit included performing procedures to assess the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements. Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the financial statements. We believe that our audit provide a reasonable basis for our opinion.
Critical Audit Matter
Critical audit matters are matters arising from the current-period audit of the financial statements that were communicated or required to be communicated to the audit committee and that (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our especially challenging, subjective, or complex judgments.
We determined that there are no critical audit matters.
/S BF Borgers CPA PC
We have served as the Company's auditor since 2019
November 20, 2023
| 23 |
REGEN BIOPHARMA , INC.
CONSOLIDATED BALANCE SHEETS
| As of | As of | |||||||
| September 30, 2023 | September 30, 2022 | |||||||
| ASSETS | ||||||||
| CURRENT ASSETS | ||||||||
| Cash | $ | $ | ||||||
| Accounts Receivable, Related Party | ||||||||
| Note Receivable, Related Party | ||||||||
| Prepaid Expenses | ||||||||
| Prepaid Rent | ||||||||
| Total Current Assets | ||||||||
| OTHER ASSETS | ||||||||
| Investment Securities, Related Party | ||||||||
| Total Other Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS' EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | ||||||||
| Notes Payable | ||||||||
| Accrued payroll taxes | ||||||||
| Accrued Interest | ||||||||
| Accrued Payroll | ||||||||
| Other Accrued Expenses | ||||||||
| Bank Overdraft | ||||||||
| Due to Investor | ||||||||
| Unearned Income | ||||||||
| Unearned Income ( Related Party) | ||||||||
| Derivative Liability | ||||||||
| Convertible Notes Payable Less unamortized discount | ||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | ||||||||
| Total Current Liabilities | ||||||||
| Long Term Liabilities: | ||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | — | |||||||
| Notes Payable | ||||||||
| Total Long Term Liabilities | ||||||||
| Total Liabilities | ||||||||
| STOCKHOLDERS' EQUITY (DEFICIT) | ||||||||
| Common Stock ($ par value) 500,000,000 shares authorized; authorized and issued and outstanding as of September 30,2022 and shares issued and outstanding as of September 30, 2023. | ||||||||
| Preferred Stock, par value, authorized as of September 30,2022 and September 30, 2023 respectively | ||||||||
| Series A Preferred; authorized as of September 30, 2023 and authorized as of September 30, 2022; and outstanding as of September 30,2022 and September 30, 2023 respectively | ||||||||
| Series AA Preferred; $ par value authorized and and outstanding as of September 30, 2022 and September 30,2023 respectively | ||||||||
| Series M Preferred; $ par value authorized and outstanding as of September 30, 2023 and authorized and outstanding as of September 30, 2022 | ||||||||
| Series NC Preferred; $ par value authorized and outstanding as of September 30, 2023 and outstanding as of September 30,2022 | ||||||||
| Additional Paid in capital | ||||||||
| Contributed Capital | ||||||||
| Retained Earnings (Deficit) | ( | ) | ( | ) | ||||
| Total Stockholders' Equity (Deficit) | ( | ) | ( | ) | ||||
| TOTAL LIABILITIES & STOCKHOLDERS' EQUITY (DEFICIT) | $ | $ | ||||||
| The Accompanying Notes are an Integral Part of These Financial Statements | ||||||||
| All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023 | ||||||||
| 24 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Year Ended September 30, 2023 | Year Ended September 30, 2022 | |||||||
| REVENUES | ||||||||
| Revenues | $ | $ | ||||||
| Revenues, Related Party | ||||||||
| TOTAL REVENUES | ||||||||
| COST AND EXPENSES | ||||||||
| Research and Development | ||||||||
| Research and Development, Related Party | ||||||||
| General and Administrative | ||||||||
| Consulting and Professional Fees | ||||||||
| Rent | ||||||||
| Total Costs and Expenses | ||||||||
| OPERATING INCOME (LOSS) | $ | ( | ) | $ | ( | ) | ||
| OTHER INCOME & (EXPENSES) | ||||||||
| Interest Income | ||||||||
| Interest Expense | ( | ) | ( | ) | ||||
| Interest Expense attributable to Amortization of Discount | ( | ) | ( | ) | ||||
| Penalties | ( | ) | ||||||
| Unrealized Gain ( Loss) on sale of Investment Securities | ||||||||
| Gain(Loss) on sale of Investment Securities | ( | ) | ||||||
| Gain (Loss) on derecognition of Accounts Payable | ||||||||
| Derivative Income (Expense) | ||||||||
| Financing Fees | ( | ) | ( | ) | ||||
| Gain (Loss) on Extinguishment Convertible Debt | ( | ) | ||||||
| TOTAL OTHER INCOME (EXPENSE) | ||||||||
| NET INCOME (LOSS) | $ | $ | ||||||
| NET INCOME (LOSS) attributable to common shareholders | $ | |||||||
| BASIC AND FULLY DILUTED EARNINGS (LOSS) PER SHARE | $ | $ | ||||||
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||||||||
| The Accompanying Notes are an Integral Part of These Financial Statements | ||||||||
| All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023 | ||||||||
| 25 |
CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY (DEFICIT)
Years Ended September 30, 2022 and September 30, 2023
| Series A Preferred | Series AA Preferred | Series NC Preferred | Common | Series M Preferred | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Additional Paid-in Capital | Retained Earnings | Contributed Capital | Total | |||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2021 | Balance September 30, 2021 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/1/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/1/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/29/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/29/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 10/29/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 10/29/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/4/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/4/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/24/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 11/24/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 11/24/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 12/10/2021 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 12/10/2021 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended December 31,2021 | Net Loss for the Quarter Ended December 31,2021 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance December 31, 2021 | Balance December 31, 2021 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 3/28/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 3/28/2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended March 31, 2022 | Net Loss for the Quarter Ended March 31, 2022 | ( | ) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance March 31, 2022 | Balance March 31, 2022 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/5/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 4/5/2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 4/8/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 4/8/2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 5/16/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 6/8/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income for the Quarter Ended June 30, 2022 | Net Income for the Quarter Ended June 30, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance June 30, 2022 | Balance June 30, 2022 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 7/15/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Interest | 7/15/2022 | Shares issued for Interest | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Debt | 7/20/2022 | Shares issued for Debt | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Shares issued for Expenses | 8/4/2022 | Shares issued for Expenses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Loss for the Quarter Ended September 30, 2022 | Net Loss for the Quarter Ended September 30, 2022 | ( | ) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30,2022 | Balance September 30,2022 | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | ||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Nonemployee Services | 10/25/2022 | Preferred Shares Issued for Nonemployee Services | $ | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Debt | 11/11/2022 | Preferred Shares Issued for Debt | $ | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Interest | 11/11/2022 | Preferred Shares Issued for Interest | $ | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares Issued For Interest | 11/11/2022 | Common Shares Issued For Interest | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Nonemployee Services | 12/5/2022 | Preferred Shares Issued for Nonemployee Services | $ | $ | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income for the Quarter ended December 31, 2022 | Net Income for the Quarter ended December 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance December 31,2022 | Balance December 31,2022 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares issued pursuant to round up provision March 6,2023 reverse stock split | 3/13/2023 | Common Shares issued pursuant to round up provision March 6,2023 reverse stock split | $ | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares issued pursuant to round up provision March 6,2023 reverse stock split | 3/13/2023 | Preferred Shares issued pursuant to round up provision March 6,2023 reverse stock split | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares issued for accrued salaries | 3/17/2023 | Preferred Shares issued for accrued salaries | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income (Loss) for the Quarter Ended March 31, 2023 | Net Income (Loss) for the Quarter Ended March 31, 2023 | ( | ) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance March 31, 2023 | Balance March 31, 2023 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||||
| Net Income (Loss) for the Quarter Ended June 30, 2023 | Net Income (Loss) for the Quarter Ended June 30, 2023 | ( | ) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance June 30, 2023 | Balance June 30, 2023 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||||
| Common shares issued for financing expenses | 9/12/2023 | Common shares issued for financing expenses | $ | |||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income (Loss) for the Quarter Ended September 30, 2023 | Net Income (Loss) for the Quarter Ended September 30, 2023 | ( | ) | ( | ||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2023 | Balance September 30, 2023 | $ | $ | $ | $ | $ | $ | ( | ) | $ | $( | |||||||||||||||||||||||||||||||||||||||||||||||
| The Accompanying Notes are an Integral Part of These Financial Statements | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 26 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| Year Ended | Year Ended | |||||||
| September 30, 2023 | September 30, 2022 | |||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net Income (loss) | $ | $ | ||||||
| Adjustments to reconcile net Income to net cash | ||||||||
| Common Stock issued for Expenses | ||||||||
| Preferred Stock issued as compensation | ||||||||
| Increase (Decrease) in Interest expense attributable to amortization of Discount | ||||||||
| Increase (Decrease) in Accounts Payable | ( | ) | ||||||
| (Increase) Decrease in Accounts Receivable | ( | ) | ||||||
| Increase (Decrease) in accrued Expenses | ||||||||
| (Increase) Decrease in Prepaid Expenses | ||||||||
| Increase(Decrease) in Contributed Capital | ||||||||
| Increase ( Decrease) in Derivative Expense | ( | ) | ( | ) | ||||
| Increase ( Decrease) in Unearned Income | ( | ) | ( | ) | ||||
| Increase ( Decrease) in Penalties | ||||||||
| (Increase( Decrease in Notes Receivable | ||||||||
| (Increase( Decrease in Accrued Interest Receivable | ||||||||
| Securities accepted as compensation | ||||||||
| (Gain) Loss on forgiveness of Debt | ( | ) | ||||||
| Increase (Decrease) in Loss on Sale of Investment Securities | ||||||||
| Unrealized Loss(Gain) on Investment Securities | ( | ) | ||||||
| Net Cash Provided by (Used in) Operating Activities | $ | ( | ) | $ | ( | ) | ||
| Cash Flows from Investment Activities | ||||||||
| Increase(Decrease) in Sale of Investment Securities | ||||||||
| Net Cash Provided By Investment Activities | $ | |||||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Increase (Decrease) in Convertible Notes Payable | ( | ) | ||||||
| Increase (Decrease) in Notes Payable | ||||||||
| Net Cash Provided by (Used in) Financing Activities | $ | $ | ( | ) | ||||
| Net Increase (Decrease) in Cash | $ | $ | ( | ) | ||||
| Cash at Beginning of Period | $ | $ | ||||||
| Cash at End of Period | $ | $ | ||||||
| Supplemental Disclosure of Noncash investing and financing activities: | ||||||||
| Common shares Issued for Debt | $ | |||||||
| Preferred Shares Issued for Debt | $ | $ | ||||||
| Cash Paid for Interest | $ | |||||||
| Common shares Issued for Interest | $ | $ | ||||||
| Preferred Shares issued for Interest | $ | $ | ||||||
| The Accompanying Notes are an Integral Part of These Financial Statements | ||||||||
| All stock amounts have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023 | ||||||||
| 27 |
REGEN BIOPHARMA, INC.
Notes to Consolidated Financial Statements
As of September 30, 2023
These Notes have been retroactively adjusted to reflect a 1 for 1500 reverse stock split of all issued series of stock effective as of March 6, 2023
NOTE 1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
The Company was organized April 24, 2012 under the laws of the State of Nevada
The Company intends to engage primarily in the development of regenerative medical applications which we intend to license from other entities up to the point of successful completion of Phase I and or Phase II clinical trials after which we would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials.
The Company is currently engaged in actively identifying small molecules that inhibit or express NR2F6 leading to immune cell activation for oncology applications and immune cell suppression for autoimmune disease.
The Company is in the early stages of development of its proposed products and therapies. The Company will be required to obtain approval from the FDA in order to market any of The Company’s products or therapies. No approval has been granted by the FDA for the marketing and sale of any of the Company’s products and therapies and no assurance may be given that any of the Company’s products or therapies will be granted such approval. The Company’s current plans include the development of regenerative medical applications up to the point of successful completion of Phase I and/ or Phase II clinical trials after which the Company would either attempt to sell or license those developed applications or, alternatively, advance the application further to Phase III clinical trials. The Company can provide no assurance that the Company will be able to sell or license any product or that, if such product is sold or licensed, such sale or license will be on terms favorable to the Company.
A. BASIS OF ACCOUNTING
The financial statements have been prepared using the basis of accounting generally accepted in the United States of America. Under this basis of accounting, revenues are recorded as earned and expenses are recorded at the time liabilities are incurred. The Company has adopted a September 30 year-end.
B. PRINCIPLES OF CONSOLIDATION
The consolidated financial statements include the accounts of KCL Therapeutics, Inc., a Nevada corporation and wholly owned subsidiary of Regen. Significant inter-company transactions have been eliminated.
The Company analyzes the conversion feature of Convertible Notes for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change. The Company values the embedded derivative using the Black-Scholes pricing model.
The Black Scholes pricing model used to determine the Derivative Liability on convertible notes issued by the Company in which an embedded derivative is recognized as of September 30, 2023 utilized the following inputs:
| Schedule of Derivative liability | ||||
| Risk Free Interest Rate | % | |||
| Expected Term | () – () Yrs | |||
| Expected Volatility | % | |||
| Expected Dividends | ||||
| 28 |
H. 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 June 30, 2023 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
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.
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.
J. ADVERTISING
Costs
associated with advertising are charged to expense as incurred. Advertising expenses were $
K. NOTES RECEIVABLE
Notes receivable are stated at cost, less impairment, if any.
| 29 |
L. REVENUE RECOGNITION
Sales of products and related costs of products sold are recognized when: (i) persuasive evidence of an arrangement exists; (ii) delivery has occurred; (iii) the price is fixed or determinable; and (iv) collectability is reasonably assured. These terms are typically met upon the prepayment or invoicing and shipment of products.
The Company determines the amount and timing of royalty revenue based on its contractual agreements with intellectual property licensees. The Company recognizes royalty revenue when earned under the terms of the agreements and when the Company considers realization of payment to be probable. Where royalties are based on a percentage of licensee sales of royalty-bearing products, the Company recognizes royalty revenue by applying this percentage to the Company’s estimate of applicable licensee sales. The Company bases this estimate on an analysis of each licensee’s sales results. Where warranted, revenue from licensees for contractual obligations such as License Initiation Fees are recognized upon satisfaction of all conditions required to be satisfied in order for that revenue to have been earned by the Company.
M. INTEREST RECEIVABLE
Interest receivable is stated at cost, less impairment, if any.
NOTE 2. RECENT ACCOUNTING PRONOUNCEMENTS
In June 2014, the Financial Accounting Standards Board issued Accounting Standards Update No. 2014-10, which eliminated certain financial reporting requirements of companies previously identified as “Development Stage Entities” (Topic 915). The amendments in this ASU simplify accounting guidance by removing all incremental financial reporting requirements for development stage entities. The amendments also reduce data maintenance and, for those entities subject to audit, audit costs by eliminating the requirement for development stage entities to present inception-to-date information in the statements of income, cash flows, and shareholder equity. Early application of each of the amendments is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued (public business entities) or made available for issuance (other entities). Upon adoption, entities will no longer present or disclose any information required by Topic 915. The Company has adopted this standard.
As of the fiscal year ending September 30, 2019 the Company has adopted Accounting Standards Update 2014-09, Revenue from Contracts with Customers (Topic 606). The guidance in this Update supersedes the revenue recognition requirements in Topic 605, Revenue Recognition, and most industry-specific guidance throughout the Industry Topics of the Codification.
The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve that core principle, an entity should apply the following steps: Step 1: Identify the contract(s) with a customer. Step 2: Identify the performance obligations in the contract. Step 3: Determine the transaction price. Step 4: Allocate the transaction price to the performance obligations in the contract. Step 5: Recognize revenue when (or as) the entity satisfies a performance obligation.
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.
| 30 |
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.
On January 31, 2013, the FASB issued Accounting Standards Update [ASU] 2013-01, entitled Clarifying the Scope of Disclosures about Offsetting Assets and Liabilities. The guidance in ASU 2013-01 amends the requirements in the FASB Accounting Standards Codification [FASB ASC] Topic 210, entitled Balance Sheet. The ASU 2013-01 amendments to FASB ASC 210 clarify that ordinary trade receivables and receivables in general are not within the scope of ASU 2011-11, entitled Disclosure about Offsetting Assets and Liabilities, where that ASU amended the guidance in FASB ASC 210. As those disclosures now are modified with the ASU 2013-01 amendments, the FASB ASC 210 balance sheet offsetting disclosures now clearly are applicable only where reporting entities are involved with bifurcated embedded derivatives, repurchase agreements, reverse repurchase agreements, and securities borrowing and lending transactions that either are offset using the FASB ASC 210 or 815 requirements, or that are subject to enforceable master netting arrangements or similar agreements. ASU 2013-01 is effective for annual reporting periods beginning on or after January 1, 2013, and interim periods within those annual periods. The adoption of this ASU is not expected to have a material impact on our financial statements.
On February 28, 2013, the FASB issued Accounting Standards Update [ASU] 2013-04, entitled Obligations Resulting from Joint and Several Liability Arrangements for Which the Total Amount of the Obligation Is Fixed at the Reporting Date. The ASU 2013-04 amendments add to the guidance in FASB Accounting Standards Codification [FASB ASC] Topic 405, entitled Liabilities and require reporting entities to measure obligations resulting from certain joint and several liability arrangements where the total amount of the obligation is fixed as of the reporting date, as the sum of the following:
The amount the reporting entity agreed to pay on the basis of its arrangement among co-obligors.
Any additional amounts the reporting entity expects to pay on behalf of its co-obligors.
While early adoption of the amended guidance is permitted, for public companies, the guidance is required to be implemented in fiscal years, and interim periods within those years, beginning after December 15, 2013. The amendments need to be implemented retrospectively to all prior periods presented for obligations resulting from joint and several liability arrangements that exist at the beginning of the year of adoption. The adoption of ASU 2013-04 is not expected to have a material effect on the Company’s operating results or financial position.
On April 22, 2013, the FASB issued Accounting Standards Update [ASU] 2013-07, entitled Liquidation Basis of Accounting. With ASU 2013-07, the FASB amends the guidance in the FASB Accounting Standards Codification [FASB ASC] Topic 205, entitled Presentation of Financial Statements. The amendments serve to clarify when and how reporting entities should apply the liquidation basis of accounting. The guidance is applicable to all reporting entities, whether they are public or private companies or not-for-profit entities. The guidance also provides principles for the recognition of assets and liabilities and disclosures, as well as related financial statement presentation requirements. The requirements in ASU 2013-07 are effective for annual reporting periods beginning after December 15, 2013, and interim reporting periods within those annual periods. Reporting entities are required to apply the requirements in ASU 2013-07 prospectively from the day that liquidation becomes imminent. Early adoption is permitted. The adoption of ASU 2013-07 is not expected to have a material effect on the Company’s operating results or financial position.
| 31 |
In January 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (ASU) 2016-01, which amends the guidance in U.S. GAAP on the classification and measurement of financial instruments. Changes to the current guidance primarily affect the accounting for equity investments, financial liabilities under the fair value option, and the presentation and disclosure requirements for financial instruments. In addition, the ASU clarifies guidance related to the valuation allowance assessment when recognizing deferred tax assets resulting from unrealized losses on available-for-sale debt securities. The new standard is effective for fiscal years and interim periods beginning after December 15, 2017, and upon adoption, an entity should apply the amendments by means of a cumulative-effect adjustment to the balance sheet at the beginning of the first reporting period in which the guidance is effective. Early adoption is not permitted except for the provision to record fair value changes for financial liabilities under the fair value option resulting from instrument-specific credit risk in other comprehensive income. The Company adopted ASU 2016-01 as of the fiscal year ending September 30, 2019.
In August 2020, FASB issued ASU 2020-06, Accounting for Convertible Instruments and Contracts in an Entity; Own Equity (“ASU 2020-06"), as part of its overall simplification initiative to reduce costs and complexity of applying accounting standards while maintaining or improving the usefulness of the information provided to users of financial statements. Among other changes, the new guidance removes from GAAP separation models for convertible debt that require the convertible debt to be separated into a debt and equity component, unless the conversion feature is required to be bifurcated and accounted for as a derivative or the debt is issued at a substantial premium. As a result, after adopting the guidance, entities will no longer separately present such embedded conversion features in equity, and will instead account for the convertible debt wholly as debt. The new guidance also requires use of the “if-converted” method when calculating the dilutive impact of convertible debt on earnings per share, which is consistent with the Company’s current accounting treatment under the current guidance. The guidance is effective for financial statements issued for fiscal years beginning after December 15, 2021, and interim periods within those fiscal years, with early adoption permitted, but only at the beginning of the fiscal year. The Company has adopted ASU 2020-06 as of the Fiscal Year ending September 30, 2022.
A variety of proposed or otherwise potential accounting standards are currently under study by standard setting organizations and various regulatory agencies. Due to the tentative and preliminary nature of those proposed standards, the Company’s management has not determined whether implementation of such standards would be material to its financial statements.
NOTE 3. GOING CONCERN
The
accompanying financial statements have been prepared assuming that the Company will continue as a going concern. The Company generated
net losses of $
On
September 12, 2023 the Company entered into a common stock purchase agreement (the “Equity Line Agreement”) with Coventry
Enterprises LLC ( “Coventry”) providing for an equity financing facility (the “Equity Line”). The Equity Line
Agreement provides that upon the terms and subject to the conditions in the Equity Line Agreement, Coventry is committed to purchase
up to Ten Million Dollars ($
Under the terms of the Equity Line Agreement, Coventry will not be obligated to purchase shares of Common Stock unless and until certain conditions are met, including but not limited to a Registration Statement on Form S-1 (the “Registration Statement”) becoming effective which registers Coventry’s resale of any Common Stock purchased by Coventry under the Equity Line.
| 32 |
From
time to time over the 36-month term of the Commitment Period ( as such term is defined in the Equity Line Agreement) the Company, in
its sole discretion, may provide Coventry with a draw down notice (each, a “Draw Down Notice”), to purchase a specified number
of shares of Common Stock (each, a “Draw Down Amount Requested”), subject to the limitations discussed below. The actual
amount of proceeds the Company will receive pursuant to each Draw Down Notice (each, a “Draw Down Amount”) is to be determined
by multiplying the Draw Down Amount Requested by the applicable purchase price. The purchase price of each share of Common Stock equals
The
maximum number of shares of Common Stock requested to be purchased pursuant to any single Draw Down Notice cannot exceed the lesser of
(i)
The Company issued Coventry shares of its Common Stock in connection with the Equity Line Agreement.
Coventry has agreed that:
| (a) | for so long as the market price of the Company’s common stock is above $ per share and |
| (b) | the Company is in full compliance with all agreements entered into with Coventry and |
| (c) | and the Company has not issued any common shares at a per share price below $, Coventry will agree to a leak out provision and will not sell more than shares of the Commitment shares without permission from the Issuer. |
In connection with the Equity Line Agreement the Company also entered into a Registration Rights Agreement, dated September 12, 2023 with Coventry (the “Registration Rights Agreement”), pursuant to which the Company agreed to register for resale under the Securities Act of 1933 shares issuable in accordance with the Equity Line Agreement as well as the aforementioned common shares issued in connection with the Equity Line Agreement in a Registration Statement to be filed with the Securities and Exchange Commission. Up to Shares of Common Stock were registered for resale under the Securities Act of 1933 pursuant to the Registration Rights Agreement.
NOTE 4. NOTES PAYABLE
(a) RELATED PARTY
| Schedule of notes payable related party | ||||
| As of September 30, 2023 | ||||
| David Koos | $ | |||
| Total: | $ | |||
$
| 33 |
(b) NON RELATED PARTY As of September 30, 2023
| Schedule of notes payable non related party | ||||
| Bostonia Partners, Inc. | $ | |||
| Coventry Enterprises LLC | $ | |||
| Total: | $ |
$
$
Effective
September 12, 2023 Coventry Enterprises purchased a 10% unsecured promissory Note (the “Note”) from the Company in the principal
amount of $
The
Note carries “Guaranteed Interest” on the principal amount at the rate of
Upon an Event of Default (as such term is defined in the Note) the Note shall become convertible, in whole or in part, into shares of Common Stock at the option of the Holder at price per share equivalent to 90% of the lowest per-share trading price for the 20 Trading Days preceding a Conversion Date.
Upon the event that while this Note has been outstanding for four months, the Company consummates another financing transaction or if the Company has an effective Regulation A Offering Statement then the Investor may choose to convert any amount up to the entire balance of the note including guaranteed interest into shares at the same offering price as the aforementioned financing transaction or the Regulation A Offering..
NOTE 5. CONVERTIBLE NOTES PAYABLE
On
March 8, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock, as such Common Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Common Stock shall hereafter be changed or reclassified pursuant to the following terms and conditions:
(a) For the period beginning on the Issue Date and ending 365 days subsequent to the Issue Date (“Year 1") a 50% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(b) For the period beginning one day subsequent to the final day of Year One and ending 365 days subsequent to Year One (“Year 2") a 35% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
(c)
For the period beginning one day subsequent to the final day of Year 2 and ending 365 days subsequent to Year 2 (“Year 3")
a 25% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below)
period ending on the latest complete Trading Day prior to the Conversion Date or $
| 34 |
(d) “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by the Company and the Lender. “Trading Day” shall mean any day on which the Common Stock is tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Stock is then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by the Company relating to the Lender’s securities.
The Company shall have the right, exercisable on not less than five (5) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
Upon closing of a Transaction Event the Lender shall receive 0.10% (one tenth of one percent)of the consideration actually received by the Company from an unaffiliated third party as a result of the closing of a Transaction Event.
“Transaction Event” shall mean either of:
(a) The sale by the Company of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
As
of September 30, 2023 $
On
April 6, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into fully paid and non- assessable shares of Common Stock, as such Common Stock exists on the Issue Date, or any shares of capital stock or other securities of the Company into which such Common Stock shall hereafter be changed or reclassified pursuant to the following terms and conditions:
(a) For the period beginning on the Issue Date and ending 365 days subsequent to the Issue Date (“Year 1") a 50% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or$150 per share (whichever is greater).
(b)
For the period beginning one day subsequent to the final day of Year One and ending 365 days subsequent to Year One (“Year 2")
a 35% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below)
period ending on the latest complete Trading Day prior to the Conversion Date or $
(c) For the period beginning one day subsequent to the final day of Year 2 and ending 365 days subsequent to Year 2 (“Year 3") a 25% discount to the lowest Trading Price (as defined below) for the Common Stock during the ten (10) Trading Day (as defined below) period ending on the latest complete Trading Day prior to the Conversion Date or $150 per share (whichever is greater).
| 35 |
(d) “Trading Price” means the closing bid price on the Over-the-Counter Bulletin Board, or applicable trading market (the “OTCQB”) as reported by a reliable reporting service (“Reporting Service”) designated by the Lender (i.e. Bloomberg) or, if the OTCQB is not the principal trading market for such security, the closing bid price of such security on the principal securities exchange or trading market where such security is listed or traded or, if no closing bid price of such security is available in any of the foregoing manners, the average of the closing bid prices of any market makers for such security that are listed in the “pink sheets” by the National Quotation Bureau, Inc. If the Trading Price cannot be calculated for such security on such date in the manner provided above, the Trading Price shall be the fair market value as mutually determined by the Company and the Lender. “Trading Day” shall mean any day on which the Common Stock is tradable for any period on the OTCQB, or on the principal securities exchange or other securities market on which the Common Stock is then being traded. “Trading Volume” shall mean the number of shares traded on such Trading Day as reported by such Reporting Service. The Conversion Price shall be equitably adjusted for stock splits, stock dividends, rights offerings, combinations, recapitalization, reclassifications, extraordinary distributions and similar events by the Company relating to the Lender’s securities.
The Company shall have the right, exercisable on not less than five (5) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
Upon closing of a Transaction Event the Lender shall receive 0.10% (one tenth of one percent) of the consideration actually received by the Company from an unaffiliated third party as a result of the closing of a Transaction Event.
“Transaction Event” shall mean either of:
(a) The sale by the Company of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
As
of September 30, 2023 $
On
October 31, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
The
Lender shall have the right from time to time to convert all or a part of the outstanding and unpaid principal amount of this Note into
fully paid and non- assessable shares of Common Stock and/or Series A Preferred Stock, as such Stock exists on the Issue Date, or any
shares of capital stock or other securities of the Company into which such Stock shall hereafter be changed or reclassified at a conversion
price of $
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
As
of September 30, 2023 $
| 36 |
On May 5, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iii) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In
the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount
of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received
had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of
$
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company(“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2023 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
| 37 |
On
December 20, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the
outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.5 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2023 $
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
| 38 |
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
October 3, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”) in the face amount of $
(i) One day subsequent to the execution of an agreement to a transaction whose completion would result in a “Change of Control” of the Company or KCL Therapeutics. For purposes of this Note, a Change of Control shall be defined as any transaction or series of transactions, whether by merger, sale of substantially all of the assets, or sale or transfer of more than fifty percent (50%) of the outstanding stock of the relevant entity in which the members of the Board of Directors immediately preceding the closing of the Change of Control transaction no longer constitute a majority of the Board of Directors of the surviving entity following the closing of such transaction.
(ii) One day subsequent to the commencement, in compliance with applicable law, of a broad solicitation by a third party to purchase a majority percentage of the Company’s outstanding equity securities for a limited period of time contingent on shareholders of the Company tendering a fixed number of their equity securities (“Tender Offer”).
(iv) One day subsequent to a “Transaction Event”)
Transaction Event” shall mean either of:
(a) The sale by the Company or by KCL Therapeutics , Inc. of the Company’s proprietary NR2F6 intellectual property to an unaffiliated third party
(b) The granting of a license by the Company or by KCL Therapeutics , Inc to an unaffiliated third party granting that unaffiliated third party the right to develop and/or commercialize the Company’s proprietary NR2F6 intellectual property
(v) That date which is twenty four (24) months subsequent to the date of execution of this Note.
The Company shall have the right, exercisable on not less than ten (10) Trading Days prior written notice to the Lender, to prepay the outstanding Note in part or in full, including outstanding principal and accrued interest.
In the event that that the Company exercises its right to prepay the note, or if the Lender chooses not to convert the remaining amount of the note into Common Shares of the company, the Lender shall receive warrants equal to 10% of the Common shares it would have received had the Lender converted the remaining amount of the Note into Common shares of the Company. The warrants shall have a strike price of $37.5 per share.
The warrants shall be exercisable:
In the event that the Company exercises its right to Prepay the Note on or prior to the close of business on the three (3) month anniversary of the date that the Note shall have been prepaid by the Company (“Prepayment Date”)
In the event , part of the outstanding and unpaid principal amount of this Note and any Accrued Interest remains outstanding on the Maturity Date of the Note, or prior to the close of business on the three (3) month anniversary of the Maturity Date of the Note
As
of September 30, 2023, $
| 39 |
The Company analyzed the conversion feature of the Note for derivative accounting consideration under ASC 815-15 “Derivatives and Hedging” and determined that the embedded conversion feature should be classified as a liability due to their being no explicit limit to the number of shares to be delivered upon settlement of the above conversion features. ASC 815-15 requires that the conversion features are bifurcated and separately accounted for as an embedded derivative contained in the Company’s convertible debt. The embedded derivative is carried on the balance sheet at fair value. Any unrealized change in fair value, as determined at each measurement period, is recorded as a component of the income statement and the associated carrying amount on the balance sheet is adjusted by the change.
The
Company values the embedded derivative using the Black-Scholes pricing model and a derivative liability of $
On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As
of September 30, 2023,
Zander and Regen are under common control. Zander Therapeutics, Inc. is the sole licensee of Regen’s NR2F6 intellectual property for veterinary applications.
NOTE 6. RELATED PARTY TRANSACTIONS
On June 23, 2015 the Company entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. (“Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to The Company 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.
Pursuant to the Agreement, Zander shall pay to The Company 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 The Company 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 The Company receives payment pursuant to the terms and conditions of the Agreement).
| 40 |
Zander is obligated pay to The Company 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 The Company:
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 The Company 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 The Company with regard to that License IP is terminated.
The Agreement may be terminated by either party in the event of a material breach by the other party.
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On December 16, 2019 Zander Therapeutics, Inc. (“Zander”), KCL Therapeutics, Inc. (“KCL”) and Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) whereby:
1) Zander shall return for cancellation 194,285,714 shares of the Series A Preferred stock of Regen (“Conversion Shares”) acquired by Zander through conversion of $340,000 of principal indebtedness of a $350,000 convertible note payable issued by Regen to Zander. Subsequent to this event the principal amount due to Zander by Regen pursuant to the Convertible Note shall be $350,000 which shall be applied pursuant to the Agreement.
2) A $35,000 one time charge due to Zander by Regen (“One Time Charge”) shall be applied pursuant to the Agreement.
3) $75,900 of principal indebtedness due to Regen by Zander and $4,328 of accrued but unpaid interest due by Regen to Zander shall be applied pursuant to the Agreement.
No actions were taken by any of the parties to enforce the terms of the Agreement.
On April 15, 2021 the Agreement was amended as follows so that the material terms and conditions shall be:
a) Zander shall not return the Conversion shares for cancellation and the principal indebtedness of the aforementioned convertible note shall not reflect such return
b) As of December 16, 2019 all principal and accrued interest payable by Regen to Zander on that date resulting from Promissory Notes issued by Regen to Zander shall be credited towards amounts due by Zander pursuant to that agreement, as amended, entered into by and between Zander and Regen on June 23, 2015 (“License Agreement”) 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 and that License Assignment And Consent agreement entered into by and between Regen, KCL and Zander on December 17, 2018 whereby Regen transferred and assigned to KCL all rights, duties, and obligations of Regen under the License Agreement and KCL agreed to assume such duties and obligations thereunder and be bound to the terms of the License Agreement with respect thereto.
| 41 |
Zander and Regen are under common control.
On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As
of June 30, 2023, $
On October 8,2021 the Company entered into an agreement with Dr. Brian Koos, MD PhD whereby Dr. Brian Koos would provide services to the Company consisting of :
a) Reviewing existing publications on research being conducted on Checkpoint NR2F6.
b) Identifying the most promising applications for the Company’s technology
c) Drafting a “white paper” on results for 1(b)
d) Making introductions to known experts in appropriate fields identified in 1(b).
Dr. Brian Koos is to be paid compensated $117,000 as total consideration for performing the abovementioned tasks. During the quarter ended December 31, 2021 Dr. Brian Koos was paid the amount of $80,275 and during the quarter ended June 30, 2022 Dr. Brian Koos was paid $36,975. Dr. Brian Koos is the brother of David Koos the Chairman and Chief Executive Officer of the Company.
As
of June 30, 2023 the Company is indebted to David R. Koos the Company’s sole officer and director in the amount of $
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022.
BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
| 42 |
NOTE 7. UNEARNED INCOME, RELATED PARTY
Unearned Income , Related Party as of September 30, 2023 consists solely of amounts paid but not yet earned by the Company resulting from the Company’s license agreement with KCL Therapeutics (See Note 6)
NOTE 8. STOCKHOLDERS’ EQUITY
The stockholders’ equity section of the Company contains the following classes of capital stock as of September 30, 2023:
Common stock, $ 0 par value; shares authorized: shares issued and outstanding.
With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Common Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Common Stock owned by such holder times one (1).
On any voluntary or involuntary liquidation, dissolution or winding up of the Corporation, the holders of the Common Stock shall receive, out of assets legally available for distribution to the Company’s stockholders, a ratable share in the assets of the Corporation.
Preferred Stock, $ par value, shares authorized of which is designated as Series AA Preferred Stock: shares issued and outstanding as of September 30, 2023, is designated Series A Preferred Stock of which shares are outstanding as of September 30, 2023, is designated Series M Preferred Stock of which shares are outstanding as of September 30, 2023, and is designated Series NC stock of which shares are outstanding as of September 30, 2023..
The abovementioned shares authorized pursuant to the Company’s certificate of incorporation may be issued from time to time without prior approval of the shareholders. The Board of Directors of the Company shall have the full authority permitted by law to establish one or more series and the number of shares constituting each such series and to fix by resolution full or limited, multiple or fractional, or no voting rights, and such designations, preferences, qualifications, restrictions, options, conversion rights and other special or relative rights of any series of the Stock that may be desired.
Series AA Preferred Stock
On September 15, 2014 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series AA Preferred Stock” (hereinafter referred to as “Series AA Preferred Stock”).
The Board of Directors of the Company have authorized 600,000 shares of the Series AA Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series AA Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series AA Preferred Stock owned by such holder times seven (7). Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series AA Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Series A Preferred Stock
On January 15, 2015 the Company filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series A Preferred Stock” (hereinafter referred to as “Series A Preferred Stock”).
| 43 |
The Board of Directors of the Company have authorized 739,000,000 shares of the Series A Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of the Corporation, each holder of Series A Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series A Preferred Stock owned by such holder times one. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by the Corporation, and Series A Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
Holders of the Series A Preferred Stock will be entitled to receive, when, as and if declared by the board of directors of the Company (the “Board”) out of funds legally available therefore, non-cumulative cash dividends of $0.01 per quarter. In the event any dividends are declared or paid or any other distribution is made on or with respect to the Common Stock , the holders of Series A Preferred Stock as of the record date established by the Board for such dividend or distribution on the Common Stock shall be entitled to receive, as additional dividends (the “Additional Dividends”) an amount (whether in the form of cash, securities or other property) equal to the amount (and in the form) of the dividends or distribution that such holder would have received had each share of the Series A Preferred Stock been one share of the Common Stock, such Additional Dividends to be payable on the same payment date as the payment date for the Common Stock.
Upon any liquidation, dissolution, or winding up of the Company, whether voluntary or involuntary (collectively, a “Liquidation”), before any distribution or payment shall be made to any of the holders of Common Stock or any other series of preferred stock, the holders of Series A Preferred Stock shall be entitled to receive out of the assets of the Company, whether such assets are capital, surplus or earnings, an amount equal to $0.01 per share of Series A Preferred (the “Liquidation Amount”) plus all declared and unpaid dividends thereon, for each share of Series A Preferred held by them.
If, upon any Liquidation, the assets of the Company shall be insufficient to pay the Liquidation Amount, together with declared and unpaid dividends thereon, in full to all holders of Series A Preferred, then the entire net assets of the Company shall be distributed among the holders of the Series A Preferred, ratably in proportion to the full amounts to which they would otherwise be respectively entitled and such distributions may be made in cash or in property taken at its fair value (as determined in good faith by the Board), or both, at the election of the Board.
On January 10, 2017 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as “Series M Preferred Stock” (hereinafter referred to as “Series M Preferred Stock”).
The Board of Directors of Regen have authorized 60,000,000 shares of the Series M Preferred Stock, par value $0.0001. With respect to
each matter submitted to a vote of stockholders of Regen, each holder of Series M Preferred Stock shall be entitled to cast that number
of votes which is equivalent to the number of shares of Series M Preferred Stock owned by such holder times one. Except as otherwise
required by law holders of Common Stock, other series of Preferred issued by Regen, and Series M Preferred Stock shall vote as a single
class on all matters submitted to the stockholders.
The holders of Series M Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series M Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
| 44 |
On March 26, 2021 Regen Biopharma, Inc. (“Regen”) filed a CERTIFICATE OF DESIGNATION (“Certificate of Designations”) with the Nevada Secretary of State setting forth the preferences rights and limitations of a newly authorized series of preferred stock designated and known as Nonconvertible Series NC Preferred Stock (hereinafter referred to as “Series NC Preferred Stock”).
The Board of Directors of Regen have authorized 20,000 shares of the Series NC Preferred Stock, par value $0.0001. With respect to each matter submitted to a vote of stockholders of Regen, each holder of Series NC Preferred Stock shall be entitled to cast that number of votes which is equivalent to the number of shares of Series NC Preferred Stock owned by such holder times 334. Except as otherwise required by law holders of Common Stock, other series of Preferred issued by Regen, and Series NC Preferred Stock shall vote as a single class on all matters submitted to the stockholders.
The holders of Series NC Preferred Stock shall be entitled receive dividends, when, as and if declared by the Board of Directors in accordance with Nevada Law, in its discretion, from funds legally available therefore
On any voluntary or involuntary liquidation, dissolution or winding up of Regen, the holders of the Series NC Preferred Stock shall receive, out of assets legally available for distribution to Regen’s stockholders, a ratable share in the assets of Regen.
NOTE 9. INVESTMENT SECURITIES, RELATED PARTY
On June 11, 2018 Regen Biopharma, Inc. was paid a property dividend consisting of of the common shares of Zander Therapeutics, Inc.
On November 29, 2018 the Company accepted shares of the Series M Preferred stock of Zander Therapeutics, Inc. in satisfaction of prepaid rent and accrued interest owed to the Company collectively amounting to $.
On June 30, 2023 the Company revalued of the common shares of Zander Therapeutics, Inc. and shares of the Series M Preferred stock of Zander Therapeutics, Inc. based on the following inputs:
| Schedule of investment securities related party | ||||
| Fair Value of Intellectual Property | $ | |||
| Prepaid Expenses | ||||
| Due from Employee | ||||
| Note Receivable | ||||
| Accrued Interest Receivable | ||||
| Investment Securities | ||||
| Convertible Note Receivable | ||||
| Accounts Payable | ||||
| Notes Payable | ||||
| Accrued Expenses Related Parties | ||||
| Notes Payable Related Party | ||||
| Accrued Expenses | ||||
| Enterprise Value | ||||
| Less: Total Debt | ( | ) | ||
| Portion of Enterprise Value Attributable to Shareholders | ||||
| Fair Value Per Share | $ | |||
The abovementioned constitute the Company’s sole related party investment securities as of September 30, 2023.
| 45 |
As of September 30, 2023:
| Schedule of comprehensive Income | ||||||||||||||
| 470,588 Common Shares of Zander Therapeutics, Inc. | ||||||||||||||
| Basis | Fair Value | Total Unrealized Gains |
Net Unrealized Gain or (Loss) realized during the quarter ended September 30, 2023 | |||||||||||
| $ | $ | $ | $ | |||||||||||
| 725,000 Series M Preferred of Zander Therapeutics, Inc. | ||||||||||||||
| Basis | Fair Value | Total Unrealized Gain | Net Unrealized Gain or (Loss) realized during the quarter ended September 30, 2023 | |||||||||||
| $ | $ | $ | $ | |||||||||||
NOTE 10. INCOME TAXES
As of September 30, 2023
| Schedule of deferred tax assets | ||||
| Deferred tax assets: | ||||
| Net operating tax carry forwards | $ | |||
| Other | ( | ) | ||
| Gross deferred tax assets | ||||
| Valuation allowance | ( | ) | ||
| Net deferred tax assets | $ | ( | ) | |
As
of September 30 2023 the Company has a Deferred Tax Asset of $
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. The achievement of required future taxable income is uncertain.
A corporation is considered to undergo “an ownership change” if, as a result of changes in the stock ownership by “5-percent shareholders” or as a result of certain reorganizations, the percentage of the corporation’s stock owned by those 5-percent shareholders increases by more than 50 percentage points over the lowest percentage of stock owned by those shareholders at any time during the prior three-year testing period. Five-percent shareholders are persons who hold 5% or more of the stock of a corporation at any time during the testing period as well as certain groups of shareholders (based typically on whether they acquired their shares in a single offering or exchange transaction) who are not individually 5-percent shareholders.
As the Company will require cash infusions in order to implement its business plan, and as it is probable, although not guaranteed, that such funding needs may be met through the sale of equity securities to “5-percent shareholders”, the Company recognized a valuation allowance equal to the deferred Tax Asset and the Company recorded a valuation allowance reducing all deferred tax assets to 0.
| 46 |
NOTE 11. STOCK TRANSACTIONS
Quarter ended December 31, 2022
On October 25, 2022 the Company issued Series A preferred shares as consideration for nonemployee services
On November 11, 2022 the Company issued Series A preferred shares in satisfaction of $ of convertible indebtedness and $ of accrued interest on convertible indebtedness.
On
November 11, 2022 the Company issued common shares in satisfaction of $
On December 5, 2022 the Company issued Series A preferred shares as consideration for nonemployee services.
Quarter Ended March 31, 2023
On
March 13, 2023 the Company issued Common shares and Series A Preferred Shares pursuant to roundup requirements related to
the Company’s
On March 17, 2023 the Company issued Series NC preferred shares (“Shares”) to David Koos, the Company’s Chief Executive Officer, in consideration of $ of salaries accrued but unpaid owed to David Koos by Regen.
Quarter ended September 30, 2023
On September 12, 2023 the Company issued shares of Common Stock ( “Shares”) to Coventry Enterprises, LLC (“Coventry”) in connection with that common stock purchase agreement (the “Equity Line Agreement”) with Coventry providing for an equity financing facility (the “Equity Line”).( See Note 3).
NOTE 12. SUBSEQUENT EVENTS
On
October 13 2023 the Company issued common shares for cash consideration of $
On
October 27 2023 the Company issued common shares for cash consideration of $
| 47 |
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 September 30, 2023. 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 functions as the Company’s principal executive officer and principal financial officer respectively.
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 September 30, 2022 is based on the framework in 2013 Committee of Sponsoring Organizations of the Treadway Commission, or COSO. Based on its assessment, management believes that, as of September 30, 2023 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 September 30, 2023 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.
| 48 |
Item 10. Directors, Executive Officers and Corporate Governance
Management and Directors:
David R. Koos
David R. Koos has served as Chairman of the Board of Directors, Chief Executive Officer, Secretary, and Treasurer since April 24, 2012 until his resignation in January 22, 2020.
David R. Koos has served as Acting Chief Financial Officer of the Company for the period beginning April 24, 2012 and ending February 11, 2015.
On March 23, 2021 David R. Koos was appointed Chairman and Sole Director of Regen Biopharma, Inc. On March 23, 2021 David R. Koos was appointed Chief Executive Officer, President, Secretary and Treasurer of Regen Biopharma, Inc.
On March 23, 2021 David R. Koos was appointed Chairman and Sole Director of KCL Therapeutics, Inc. On March 23, 2021 David R. Koos was appointed Chief Executive Officer, President, Secretary and Treasurer of KCL Therapeutics, Inc.
KCL Therapeutics, Inc. is a wholly owned subsidiary of Regen Biopharma, Inc.
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:
David R. Koos, 62 has served as Chairman of the Board of Directors, Chief Executive Officer, President, Secretary and Treasurer of SYBLEU INC., a biotechnology company, from June 12, 2020 to December 13, 2022. David R. Koos served as Chief Financial Officer of SYBLEU INC. from June 12, 2020 to July 21, 2020. On March 23, 2021 David R. Koos assumed the position of sole officer and director of Zander Therapeutics, Inc., a biotechnology company.
| 49 |
| Position: | Company Name: | Employment Dates: | ||
| Chairman, President, Chief Executive Officer, Secretary, Acting Chief Financial Officer, Principal Accounting Officer | Entest Group, Inc. | June 19, 2009 to November 28, 2018 | ||
| Chairman, President, Chief Executive Officer, Secretary, Chief Financial Officer, Principal Accounting Officer | Entest BioMedical, Inc.(a California corporation) | August 22,2008 to the Present | ||
| Chairman and CEO | Regen BioPharma, Inc. | April 24, 2012 to January 22,2020 | ||
| Acting CFO | Regen BioPharma, Inc. | April 24, 2012 to February 11, 2015 | ||
| President | Regen BioPharma, Inc. | May 29, 2013 to October 9, 2013 | ||
| Chairman, CEO | Zander Therapeutics, Inc. | February 2017 to January 22,2020 | ||
| Sole Officer and Director | Cell Source Research, Inc. | March 24, 2003 to the Present | ||
| Chairman, President, CEO and Acting CFO | Bio-Matrix Scientific Group, Inc. | June 14, 2006 (Chairman) to July 31;2019 June 19, 2006 (President, CEO and Acting CFO); June 19, 2006 (Secretary) to July 31, 2019 | ||
| Chairman & CEO | BST Partners Inc. (A California Corporation) | November 30, 2018 to the Present | ||
| Chairman & CEO | BST Partners Inc. (A Wyoming Corporation) | March 17, to 2017 to the Present |
Code of Ethics
On September 25, 2013 we adopted a Code of Ethics pursuant to Section 406 of the Sarbanes-Oxley Act of 2002.
Director Independence
Audit Committee and Audit Committee Financial Expert
The members of the Company’s board of Directors may not be considered independent. 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.
| 50 |
Because the Chief Executive Officer of the Company is also the Chairman of the Board of Directors of the Company, 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 Chairman of the Board of Directors.
Executive Compensation
| Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Non
Equity Incentive Plan Compensation ($) | Nonqualified
Total Deferred Compensation Earnings ($) | ||||||||||||||||||
| David
Koos Chairman, and CEO | From October 1, 2022 to September 30, 2023 | $ | 10,050 | * | 0 | 0 | 0 | 0 | ||||||||||||||||
| Name and Principal Position | Year | Salary ($) | Bonus ($) | Option Awards ($) | Non
Equity Incentive Plan Compensation ($) | Nonqualified
Total Deferred Compensation Earnings ($) | ||||||||||||||||||
| David
Koos Chairman, and CEO | From October 1, 2021 to September 30, 2022 | $ | 0 | 0 | 0 | 0 | 0 | |||||||||||||||||
There is a balance of $457,111 of salary accrued but unpaid due to David Koos.
*On March 17, 2023 David Koos was issued 15,000 Series NC Preferred shares in satisfaction of $10,050 of salaries accrued yet unpaid.
Employment Agreements
Currently neither the Company nor the Company’s wholly owned subsidiary is party to any employment agreement.
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 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.
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 6, 2023 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.
| 51 |
Based on 3,558,861 shares issued and outstanding as of November 6, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | ||||||||
| Common | David R. Koos | 504 | * | 0.01 | % | ||||||
| c/o Regen Biopharma, Inc. | |||||||||||
| 4700 Spring Street St 304 | |||||||||||
| La Mesa CA 91942* | |||||||||||
| Common | All Officers and Directors as a Group | 504 | * | 0.01 | % | ||||||
*includes 4 shares held by BMXP Holdings Shareholder’s Business Trust and 2 shares held by the AFN Trust
Based on 409,551 shares issued and outstanding as of November 6, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series A Preferred | David R. Koos | 30.10 | % | |||||||
| c/o Regen Biopharma, Inc. | 122,221 | |||||||||
| 4700 Spring Street St 304 | ||||||||||
| Series A Preferred | Zander Therapeutics, Inc. | 105,204 | 25.90 | % | ||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942 | ||||||||||
| Series A Preferred | RGBP HOLDINGS LLC | 40,949 | 10.87 | % | ||||||
| 9962 S CLYDE PLACE HIGHLANDS RANCH, CO 80129 | ||||||||||
| Series A Preferred | All Officers and Directors as a Group | 122,221 | 30.10 | % | ||||||
* Includes 1 share held by BMXP Holdings Shareholder’s Business Trust, 17,013 shares held by BST Partners, 105, 204 shares held by Zander Therapeutics, Inc. and 1 share held by the AFN Trust.
| 52 |
Based on 29,338 shares outstanding as of November 6, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series M Preferred | David R. Koos | 7,667 | 26.14 | % | ||||||
| c/o Regen Biopharma, Inc | ||||||||||
| 4700 Spring Street, Suite 304, | ||||||||||
| La Mesa, California 91942 | ||||||||||
| Series M Preferred | Todd S. Caven | 6,667 | 22.73 | % | ||||||
| 8578 TERRACEVIEW LANE NORTH | ||||||||||
| MAPLE GROVE, MN 55311 | ||||||||||
| Series M Preferred | Roger Formisano | 2,001 | 6.82 | % | ||||||
| 4124 N. 64th Street | ||||||||||
| Scottsdale, AZ 85251 | ||||||||||
| Series M Preferred | Robert D. Hopkins | 2,001 | 6.82 | % | ||||||
| 11642 N. 40th Place | ||||||||||
| Phoenix, AZ 85028 | ||||||||||
| Series M Preferred | Harry Lander | 6,667 | 22.73 | % | ||||||
| 50 SUTTON PLACE SOUTH | ||||||||||
| APT. 6A | ||||||||||
| NEW YORK, NY 10022 | ||||||||||
| Series M Preferred | Jean-Pierre Millon | 4,001 | 13.64 | % | ||||||
| 3908 E. San Miguel Ave | ||||||||||
| Paradise Valley, AZ 85253 | ||||||||||
| Series M Preferred | All Officers and Directors as a Group | 7,667 | 26.14 | % | ||||||
based on 334 shares outstanding as of November 6, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series AA Preferred | David R. Koos | |||||||||
| c/o Regen Biopharma, Inc. | 334 | 100 | % | |||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942 | ||||||||||
| Series AA Preferred | All Officers and Directors as a Group | 334 | 100 | % | ||||||
based on 15,007 shares outstanding as of November 6, 2023
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series NC Preferred | David R. Koos | |||||||||
| c/o Regen Biopharma, Inc. | 15,007 | 100 | % | |||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942 | ||||||||||
| Series NC Preferred | All Officers and Directors as a Group | 15,007 | 100 | % | ||||||
| 53 |
Item 13. Certain Relationships and Related Transactions, and Director Independence
On June 23, 2015 the Company entered into an agreement (“Agreement”) with Zander Therapeutics, Inc. (“Zander”) whereby The Company granted to Zander an exclusive worldwide right and license for the development and commercialization of certain intellectual property controlled by The Company (” License IP”) for non-human veterinary therapeutic use for a term of fifteen years. Zander is under common control with the Company.
Pursuant to the Agreement, Zander shall pay to The Company 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.
Pursuant to the Agreement, Zander shall pay to The Company 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 The Company 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 The Company receives payment pursuant to the terms and conditions of the Agreement).
Zander is obligated pay to The Company 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 The Company:
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 The Company 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 The Company 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.
| 54 |
On December 17, 2018 Regen Biopharma, Inc.(“Licensor”) , KCL Therapeutics, Inc. (“Assignee”) and Zander Therapeutics, Inc. (“Licensee”) entered into a LICENSE ASSIGNMENT AND CONSENT AGREEMENT whereby, with regards to certain intellectual property which was assigned by Regen Biopharma, Inc.(“Assigned Properties”) to its wholly owned subsidiary KCL Therapeutics, Inc., Licensor hereby transfers and assigns to Assignee all rights, duties, and obligations of Licensor under the Agreement with respect to the Assigned Properties , and Assignee agrees to assume such duties and obligations thereunder and be bound to the terms of the Agreement with respect thereto.
On December 16, 2019 Zander Therapeutics, Inc. (“Zander”), KCL Therapeutics, Inc. (“KCL”) and Regen Biopharma, Inc. (“Regen”) entered into an agreement (“Agreement”) whereby:
1) Zander shall return for cancellation 194,285,714 shares of the Series A Preferred stock of Regen (“Conversion Shares”) acquired by Zander through conversion of $340,000 of principal indebtedness of a $350,000 convertible note payable issued by Regen to Zander. Subsequent to this event the principal amount due to Zander by Regen pursuant to the Convertible Note shall be $350,000 which shall be applied pursuant to the Agreement.
2) A $35,000 one time charge due to Zander by Regen (“One Time Charge”) shall be applied pursuant to the Agreement.
3) $75,900 of principal indebtedness due to Regen by Zander and $4,328 of accrued but unpaid interest due by Regen to Zander shall be applied pursuant to the Agreement.
No actions were taken by any of the parties to enforce the terms of the Agreement.
On April 15, 2021 the Agreement was amended as follows so that the material terms and conditions shall be:
a) Zander shall not return the Conversion shares for cancellation and the principal indebtedness of the aforementioned convertible note shall not reflect such return
b) As of December 16, 2019 all principal and accrued interest payable by Regen to Zander on that date resulting from Promissory Notes issued by Regen to Zander shall be credited towards amounts due by Zander pursuant to that agreement, as amended, entered into by and between Zander and Regen on June 23, 2015 (“License Agreement”) 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 and that License Assignment And Consent agreement entered into by and between Regen, KCL and Zander on December 17, 2018 whereby Regen transferred and assigned to KCL all rights, duties, and obligations of Regen under the License Agreement and KCL agreed to assume such duties and obligations thereunder and be bound to the terms of the License Agreement with respect thereto.
Zander and Regen are under common control.
| 55 |
On September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $350,000 (“Note”) to Zander Therapeutics, Inc. (“Zander”). Consideration for the Note consisted of $350,000. A onetime interest charge of 10% of the principal amount shall be applied to the principal amount of the Note. The Note is due and payable 24 months from the effective date.
Zander has the right, at any time after the September 30, 2018, at its election, to convert all or part of the outstanding and unpaid Principal Sum and accrued interest (and any other fees) into shares of fully paid and non-assessable shares of Series A Preferred stock of Regen as per this conversion formula: Number of shares receivable upon conversion equals the dollar conversion amount divided by the Conversion Price. The Conversion Price is the greater of $0.0001 or 60% of the lowest trade price in the 25 trading days previous to the conversion. Zander, at any time prior to selling all of the shares from a conversion, may, for any reason, rescind any portion, in whole or in part, of that particular conversion attributable to the unsold shares and have the rescinded conversion amount returned to the Principal Sum with the rescinded conversion shares returned to Regen.
As of September 30, 2023, $10,000 of the principal amount of the Note remains outstanding.
On October 8,2021 the Company entered into an agreement with Dr. Brian Koos, MD PhD whereby Dr. Brian Koos would provide services to the Company consisting of :
| a) | Reviewing existing publications on research being conducted on Checkpoint NR2F6. |
| b) | Identifying the most promising applications for the Company’s technology |
| c) | Drafting a “white paper” on results for 1(b) |
| d) | Making introductions to known experts in appropriate fields identified in 1(b). |
Dr. Brian Koos is to be paid compensated $117,000 as total consideration for performing the abovementioned tasks. During the quarter ended December 31, 2021. Dr. Brian Koos was paid the amount of $80,275 and during the quarter ended March 31, 2022 Dr. Brian Koos was paid $36,975. Dr. Brian Koos is the brother of David Koos the Chairman and Chief Executive Officer of the Company.
As of September 30, 2023 the Company is indebted to David R. Koos the Company’s sole officer and director in the amount of $710. $710 lent to the Company by Koos is due and payable at the demand of the holder and bear simple interest at a rate of 15% per annum.
During the quarter ended December 31, 2021 the Company paid $5,000 of rental expenses to the landlord of BST Partners as consideration to BST Partners for use of office space. BST Partners is controlled by David R. Koos the Chairman and Chief Executive Officer of the Company.
On January 13, 2022 Regen Biopharma, Inc. entered into a sublease agreement with BST Partners (“BST”) whereby Regen Biopharma, Inc. would sublet office space located at 4700 Spring Street, Suite 304, La Mesa, California 91942 from BST on a month to month basis for $5,000 per month beginning January 14, 2022.
BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
| 56 |
Director Independence
Audit Committee and Audit Committee Financial Expert
The Company’s Board of Directors may not be considered independent as the sole director 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 members are 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 members have 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.
| 57 |
The following table sets forth the aggregate fees billed to us by BF Borgers CPA PC for the period beginning October 1, 2021 and ending September 30, 2022:
| Audit Fees | $ | 21,600 | ||
| Audit Related Fees | 16,300 | |||
| Tax Fees | 0 | |||
| All Other Fees | 0 | |||
| $ | 37,900 |
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 September 30, 2021 these fees were primarily derived from review of financial statements in the Company's Form 10-Q Reports.
The following table sets forth the aggregate fees billed to us by BF Borgers CPA PC for the period beginning October 1, 2021 and ending September 30, 2023:
| Audit Fees | $ | 22,000 | ||
| Audit Related Fees | 16,500 | |||
| Tax Fees | 0 | |||
| All Other Fees | 0 | |||
| $ | 38,500 |
| 58 |
Item 15. Exhibit Index
| 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 |
| 59 |
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.
| Regen Biopharma, Inc. | ||
| By: | /s/ David R. Koos | |
| Name: | David R. Koos | |
| Title: | Chairman, Chief Executive Officer | |
| Date: | November 20, 2023 |
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.
| Regen Biopharma, Inc. | ||
| By: | /s/ David R. Koos | |
| Name: | David R. Koos | |
| Title: | Acting Chief Financial Officer, Director | |
| Date: | November 20, 2023 |
| 60 |
CERTIFICATION OF CHIEF EXECUTIVE OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David R. Koos, certify that:
1. I have reviewed this annual report on Form 10-K for the year ended September 30, 2023 of Regen Biopharma, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant’s, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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:
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Dated: November 20, 2023 | By: | /s/ David R. Koos | |
| David R. Koos | |||
| Chief Executive Officer |
CERTIFICATION OF CHIEF FINANCIAL OFFICER PURSUANT TO
SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002
I, David R. Koos certify that:
1. I have reviewed this annual report on Form 10-K for the year ended September 30, 2023 of Regen Biopharma, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal controls over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant’s, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, 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:
(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of registrant’s board of directors (or persons performing the equivalent function):
(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
(b) Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
| Dated: November 20, 2023 | By: | /s/ David R. Koos | |
| David R. Koos | |||
| Chief Financial Officer |
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
In connection with the Annual Report of Regen Biopharma, Inc. on Form 10-K for the year ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David R. Koos, Chief Executive Officer certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge and belief:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Dated: November 20, 2023 | By: | /s/ David R. Koos | |
| David R. Koos | |||
| Chief Executive Officer |
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
In connection with the Annual Report of Regen Biopharma, Inc. on Form 10-K for the year ended September 30, 2023 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David R. Koos, Chief Financial Officer certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that, to the best of my knowledge and belief:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934 and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Dated: November 20, 2023 | By: | /s/ David R. Koos | |
| David R. Koos | |||
| Chief Financial Officer |