Regen BioPharma Inc 10-K for FY2024
Regen BioPharma Inc (RGBP)
About this 10-K
Regen BioPharma Inc filed this 10-K on May 13, 2025, covering the fiscal year ended September 30, 2024 (FY2024).
Headline figures
Fiscal year ended September 30, 2024, as reported in this filing, compared with the same period a year earlier where the filing states it.
- Revenue
- $236.56K
- unchanged from $236.56K a year earlier
- Net loss
- $668.26K
- compared with net income of $1.16M a year earlier
- Diluted EPS
- -$0.16
- compared with $0.29 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
Securities registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes ☐
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2)
has been subject to such filing requirements for the past 90 days. Yes ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files). Yes ☐
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 |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness of
its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public
accounting firm that prepared or issued its audit report. Yes ☐
No
If
securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant
included in the filing reflect the correction of an error to previously issued financial statements.
Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐
No
State the aggregate market
value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at which the common equity
was last sold, or the average bid and asked price of such common equity, as of the last business day of the registrant’s most recently
completed second fiscal quarter: $ $
As of April 30, 2025 Regen Biopharma, Inc. had common shares outstanding.
As of April 30, 2025 Regen Biopharma, Inc. had 10,123,771 shares of Series A Preferred Stock outstanding.
As of April 30, 2025 Regen Biopharma, Inc. had 34 shares of Series AA Preferred Stock outstanding.
As of April 30, 2025 Regen Biopharma, Inc. had 29,338 shares of Series M Preferred Stock outstanding.
As of April 30, 2025 Regen Biopharma, Inc. had 15,007 shares of Series NC Preferred Stock outstanding.
PART I
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.
| 1 |
ITEM 1. BUSINESS
Overview
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.
The Company has the following therapies in development:
| ● | HemaXellarate : HemaXellarate is a cellular composition of autologous stromal vascular fraction derived from adipose tissue. HemaXellarate contains endothelial progenitor cells as well as mesenchymal stem cells. It is believed by the Company that once re-infused into the patient, the patient’s bone marrow will regenerate and begin to function normally. | |
| ● | dCellVax: dCellVax is comprised of autologous dendritic cells which have been treated with an siRNA inhibitor of indoleamine-2,3-dioxygenase (IDO), an immunosuppressive enzyme. The Company believes that by inhibiting this enzyme in these dendritic cells, the patient’s cells can now attack cancers, particularly breast cancer. | |
| ● | tCellVax: Immune cells are removed from the patient, treated with siRNA to inhibit NR2F6 and the cells re-infused to the patient. The Company believes that once the inhibitor protein is blocked, the immune system will be very activated and kill tumors. siRNA is a double-stranded RNA molecule that is non-coding and is a powerful tool in drug targeting and therapeutics development as it is used to modulate gene expression through transcriptional or translational repression. The NR2F6 nuclear receptor has been identified as a potentially very important immune cell inhibitor (an immune checkpoint) and cancer stem cell differentiator. | |
| ● | DiffronC: This drug is intended to use our proprietary siRNA in vivo to inhibit cancer growth and activate T cells. The siRNA targets NR2F6. T cells are part of the immune system and develop from stem cells in the bone marrow. | |
| ● | DuraCar: DuraCar is comprised of CAR-T cells which have been treated with an shRNA targeting the gene NR2F6. 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. Chimeric antigen receptor T cells ( CAR-T cells) are T cells that have been genetically engineered to produce an artificial T cell receptor for use in immunotherapy. Chimeric antigen receptors are receptor proteins that have been engineered to give T cells the new ability to target a specific antigen. | |
| ● | Small molecule: We have identified and patented a series of small molecules which can both activate and inhibit NR2F6. 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.
As of April 30, 2025, we have not licensed any existing therapies which may be marketed.
The Company has entered into license agreements with Zander Therapeutics, Inc. ( an entity under common control) and Oncology Pharma Inc. ( an unrelated entity).
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.
| 2 |
Patents:
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 | ||
| ● | 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 |
| 3 |
| ● | 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. | |
| 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. |
| 4 |
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.
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.
| 5 |
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.
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 non-refundable 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. |
| 6 |
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.
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.
| 7 |
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 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.
| 8 |
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.
| 9 |
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.
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.
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.
| 10 |
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.
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.
| 11 |
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
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
| 12 |
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.
Amount spent during the fiscal year ended September 30, 2024 on research and development activities:
| ● | During the fiscal year ended September 30, 2024 we incurred $153,685 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 April 30, 2025, the Company has 1 full time employee. |
ITEM 1B. UNRESOLVED STAFF COMMENTS
Not applicable.
ITEM 1C. CYBERSECURITY
The Company’s Chief Executive Officer assesses risks from cybersecurity threats on an ongoing basis. As the Company grows it plans to develop a more robust and detailed strategy for cybersecurity. The Company has not encountered cybersecurity challenges that have materially impaired operations or financial condition.
Governance; Board Oversight
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.
On April 26, 2024 the Company and BST Partners ( Sublessor) agreed to amend that sublease agreement (“Sublease Agreement”) entered into between the parties as follows:
| ● | The Company agreed that in addition to the base rent of $5,000 per month to be paid by the Company to Sublessor the Company shall also reimburse Sublessor for any and all shared expenses as such term is defined within the Sublease Agreement. |
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. MINE SAFETY DISCLOSURES
Not applicable.
| 13 |
PART II
ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Market information
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.
Holders of Record
As of May 7, 2025, we had 482 holders of record of our Common Stock. As of May 7, 2025 there were approximately 479 holders of our Series A Preferred Stock. As of May 7, 2025 there was 1 holder of our Series AA Preferred Stock.As of May 7, 2025 there were approximately 7 holders of our Series M Preferred Stock. As of May 7, 2025 there was one holder of our Series NC Preferred Stock.
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.
| October 1, 2023 to September 30, 2024 | High | Low | ||||||
| First Quarter | $ | 1.6279 | $ | 0.4337 | ||||
| Second Quarter | 0.9302 | 0.4983 | ||||||
| Third Quarter | 0.9966 | 0.3330 | ||||||
| Fourth Quarter | 0.6645 | 0.1152 | ||||||
| October 1, 2022 to September 30, 2023 | High | Low | ||||||
| First Quarter | $ | 10.89 | $ | 5.89 | ||||
| Second Quarter | 7.16 | 1.25 | ||||||
| Third Quarter | 2.28 | 1.50 | ||||||
| Fourth Quarter | 2.00 | 1.46 | ||||||
We have never paid a cash dividend on our common stock. We do not anticipate paying any cash dividends on our common stock in the foreseeable future, and we plan to retain our earnings to finance our operations and future growth.
| 14 |
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
October 1, 2024 to April 30, 2025
On November 4, 2024 the Company issued 500,000 common shares in settlement of $20,000 of outstanding principal indebtedness. .
The abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.
On November 13, 2024 the Company issued 370,084 common shares as consideration for nonemployee services.
The abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.
Quarter Ended September 30, 2024
Effective September 4, 2024 the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Coventry Enterprises, LLC (“Coventry”), pursuant to which Coventry Enterprises purchased a 10% unsecured promissory Note (the “Note”) from the Company in the principal amount of $250,000 of which $25,000 was retained by Coventry through an Original Issue Discount.
The Note carries “Guaranteed Interest” on the principal amount at the rate of 10% per annum for the ten month term of the Note for an aggregate Guaranteed Interest $25,000. The Principal Amount and the Guaranteed Interest shall be due and payable in ten equal monthly payments $27,500 commencing on November 4, 2024, and continuing on the fourth day of each month thereafter (each, a “Monthly Payment Date”) until paid in full not later than September 4, 2025.
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.
$152,000 of the proceeds received has been utilized to repay an aggregate of $152,000 of outstanding principal indedebteness and interest due to Coventry by the Company resulting from a $175,000 Note issued to Coventry on September 12, 2023.
| 15 |
In Connection with the Purchase Agreement the Company issued to Coventry 500,000 common shares (“Commitment Shares”) on September 4 .2024. If The Company has satisfied all the terms of the Note without default the Coventry shall, within 10 calendar days thereafter, return to the Company’s treasury for cancellation 350,000 of the Commitment Shares.
The abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.
On September 26, 2024 the Company issued 249,915 shares as consideration for nonemployee services.
The abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.
Quarter Ended June 30, 2024
On April 2, 2024 the Company issued 20,068 of its Series A Preferred Shares to an independent consultant as consideration for services.
The abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities.
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.
| 16 |
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.
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.
All the abovementioned securities were issued pursuant to Section 4(a) (2) of the securities Act of 1933, as amended (the “Act”). No underwriters were retained to serve as placement agents for the sale. The securities were sold directly through our management. No commission or other consideration was paid in connection with the sale of the securities. There was no advertisement or general solicitation made in connection with this Offer and Sale of securities..
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.
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.
| 17 |
ITEM 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
The following Management’s Discussion and Analysis of Financial Condition and Results of Operations is intended to provide information necessary to understand our audited consolidated financial statements for the fiscal years ended September 30, 2024 and 2023 and highlight certain other information which, in the opinion of management, will enhance a reader’s understanding of our financial condition, changes in financial condition and results of operations. In particular, the discussion is intended to provide an analysis of significant trends and material changes in our financial position and the operating results of our business during the year ended September 30, 2024, as compared to the fiscal year ended September 30, 2023. This discussion should be read in conjunction with our consolidated financial statements for the fiscal years ended September 30, 2024 and 2023 and related notes included elsewhere in this 10-K. These historical financial statements may not be indicative of our future performance. This Management’s Discussion and Analysis of Financial Condition and Results of Operations contains numerous forward-looking statements, all of which are based on our current expectations and could be affected by the uncertainties and risks.
Throughout this report, the terms “our,” “we,” “us,” and the “Company” refer to Regen Biopharma, Inc. and its subsidiaries.
Forward Looking Statements
All statements other than statements of historical facts contained in this report, including statements regarding future operations, are forward-looking statements. In some cases, forward-looking statements may be identified by words such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “could,” “would,” “expect,” “objective,” “plan,” “potential,” “seek,” “grow,” “target,” “if,” and similar expressions intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations, objectives, and financial needs.
Overview
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 May 7, 2024 we have not licensed any existing therapies which may be marketed.
Results of Operations
Years Ended September 30, 2024 and 2023
Revenues
Revenues from continuing operations were $236,560 for the twelve months ended September 30, 2024 and $236,560 for the same period ended 2023. $110,000 of revenue from related parties recognized during the twelve months ended September 30, 2024 and September 30, 2023 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, 2024 and 2023 respectively pursuant to the same license. $126,560 of revenue recognized during the twelve months ended September 30, 2024 were recognized pursuant to licenses granted to Oncology Pharma,Inc. and $126,560 of revenue was recognized during the twelve months ended September 30, 2023 pursuant to those same licenses..
| 18 |
Operating Expenses
Operating Expense were $417,221 for the twelve months ended September 30, 2024 and $ 923,509 for the same period ended 2023. The primarily operating expense for 2024 consist of $ 363,961 to Consulting & Professional expenses and $ 153,695 to research and development expenses. In the same period in previous year Consulting and Professional fees expensed were $606,237 and research and development expenses amounted to $212,297.
Other Income
For the year ended 2024, the Company reported a net other expense of $(251,034), a substantial decline from the net other income of $1,843,456 in 2023. The decrease was primarily driven by the recognition of a Derivative Gain of $2.151, 755 in 2023 as opposed to a Derivative Loss of $(4,091) in recognized in 2024. Additionally, the Company recorded higher amortization of discount of $(28,998) related to debt instruments, compared to $(864) in the prior year. Interest expense also rose to $(72,445) due to increased borrowings, while financing fees decreased to $(145,500) as opposed to $(250,000) in 2023. Financing fees in both instances were attributable to Common Shares issued in conjunction with Promissory Notes.
The reduction in financing fees partially offset the rise in interest expenses and derivative losses, but the net impact was a significant decline in other income, highlighting the volatility associated with fair value remeasurements and debt-related costs.
Net Loss
The Company recognized an Operating Loss of $ 417,221 during the twelve months ended September 30, 2024 whereas the Company recognized an Operating Loss of $ 686,950 for the same period ended 2023. The reduction in operating loss is for the reduction of Consulting and Professional Fees services for the period.
Net Loss is $ 668,255 for the twelve months ended September 30, 2024 as opposed to Net Income of 1,156,507 the difference primarily attributable to the recognition by the Company of Derivative Income of $ 2,151,755 during the twelve months ended September 30, 2023.
Working Capital
As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Current assets | $ | 143,351 | $ | 131,037 | ||||
| Current liabilities | 5,378,456 | 5,308,003 | ||||||
| Working capital | $ | (5,235,105 | ) | $ | (5,176,966 | ) | ||
Working capital deficit increased by $ 58,139 from September 30, 2023 to September 30, 2024, primarily due to increase in notes payable offset by increase in accounts receivable.
| 19 |
Liquidity and Capital Resources
| Year Ended | ||||||||
| September 30, | ||||||||
| 2024 | 2023 | |||||||
| Net cash used in operating activities | $ | (751,536 | ) | $ | (173,917 | ) | ||
| Net cash provided by financing activities | 631,215 | 243,750 | ||||||
| Net increase (decrease) in cash and cash equivalents | $ | (120,321 | ) | $ | 69,833 | |||
| Cash, beginning of year | 121,037 | 51,204 | ||||||
| Cash, end of year | $ | 716 | $ | 121,037 | ||||
Operating Activities
Net cash used in operating activities for the year ended September 30, 2024 was $751,536, compared to $173,917, for the year ended September 30, 2023, an increase of $577,619. The increase in cash used in operating activities is primarily attributable to increases in accounts receivables and prepaids. Net cash used in operating activity also includes impact of Unrealized Loss on Investment Securities of $ 204,847 and adjustment of Unearned Income.
Financing Activities
Net cash generated by financing activities for the year ended September 30, 2024 was $631,215 which consisted of proceeds from notes payables and common stock issued for cash.
Liquidity & Capital Resources Outlook
As of September 30, 2024, the Company had cash of $ 716 and net working capital of ($5,235,105)
The Company has incurred and expects to continue to incur significant professional costs to remain as a publicly traded company and it has incurred and expects to continue incur significant research & development cost for products development.
The accompanying financial statements have been prepared as if the Company will continue as a going concern. The Company has incurred significant operating losses and negative cash flows from operations since inception. As of September 30, 2024, the Company had cash of approximately $716 and an accumulated deficit of approximately $20.6 million. The Company has incurred recurring losses, experienced recurring negative operating cash flows, and requires significant cash resources to execute its business plans. The Company is dependent on obtaining additional working capital funding from the sale of equity and/or debt securities in order to continue to execute its development plans and continue operations. Without additional funding, there is substantial doubt about the Company’s ability to continue as a going concern for the twelve months from the date of these financial statements.
Contractual Obligations
As of September 30, 2024 the Company was not party to any binding agreements which would commit Regen to any material capital expenditures.
Off-Balance Sheet Arrangements
We did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K promulgated under the Exchange Act.
| 20 |
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.
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
The information called for by Item 8 is included following the “Index to Financial Statements” on page F-1 contained in this Annual Report on Form 10-K.
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
None.
ITEM 9A. CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
Our management has evaluated the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), as of September 30, 2024. Based on such evaluation, our Chief Executive Officer and Chief Financial Officer have concluded that as of September 30, 2024, our disclosure controls and procedures were ineffective to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act (a) is recorded, processed, summarized and reported within the time periods specified by Securities and Exchange Commission (“SEC”) rules and forms and (b) is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding any required disclosure.
Management has identified control deficiencies regarding inadequate accounting resources, the lack of segregation of duties and the need for a stronger internal control environment. Management of the Company believes that these material weaknesses are due to the small size of the Company’s staff. The small size of the Company’s accounting outsourced staff may prevent adequate controls in the future due to the cost/benefit of such remediation.
To mitigate the current limited resources and limited employees, we rely heavily on direct management oversight of transactions, along with the use of external legal and accounting professionals. As we grow, we expect to increase our number of employees, which will enable us to implement adequate segregation of duties within the internal control framework. In light of this material weakness, we performed additional analyses and procedures in order to conclude that our financial statements for the year ended September 30, 2024 included in this Annual Report on Form 10-K were fairly stated in accordance with GAAP. Accordingly, management believes that despite our material weaknesses, our financial statements for the year ended September 30, 2024 are fairly stated, in all material respects, in accordance with GAAP.
| 21 |
Management’s Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Securities Exchange Act of 1934 Rule 13a-15(f). Our internal control over financial reporting is designed 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. Our internal control over financial reporting 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 our assets; | |
| ● | provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made only in accordance with authorizations of our management and directors; and | |
| ● | provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements. |
Because of the inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management assessed the effectiveness of our internal control over financial reporting as of September 30, 2024. In making this assessment, our management used the criteria set forth by the Committee of Sponsoring Organizations of the 2013 Treadway Commission (“COSO”) in Internal Control-Integrated Framework. Based upon this assessment, our Chief Executive Officer and Chief Financial Officer concluded that as of September 30, 2024 our internal controls over financial reporting were ineffective.
Changes in Internal Control Over Financial Reporting
There were no changes in our internal controls over financial reporting that occurred during our most recent fiscal quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Limitations on Effectiveness of Controls and Procedures
In designing and evaluating the disclosure controls and procedures and internal control over financial reporting, management recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving the desired control objectives. In addition, the design of disclosure controls and procedures and internal control over financial reporting must reflect the fact that there are resource constraints and that management is required to apply judgment in evaluating the benefits of possible controls and procedures relative to their costs.
ITEM 9B. OTHER INFORMATION
ITEM 9C. DISCLOSURE REGARDING FOREIGN JURISDICTIONS THAT PREVENT INSPECTIONS
Not applicable.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
Executive Officers, Non-Executive Employees and Directors
The following table sets forth the name, age as of May 7, 2025, and current position of the individuals who serve as directors and executive officers of the Company. The following also includes certain information regarding the individual experience, qualifications, attributes and skills of our directors and executive officers as well as brief statements of those aspects of our directors’ backgrounds that led us to conclude that they are qualified to serve as directors.
As of May 7,2025 David R. Koos serves as the Company’s sole officer and director. During the fiscal years ended 2023 and 2024 David R. Koos served as the Company’s sole officer and director
| 22 |
Management and Directors:
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.
| 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 |
| 23 |
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.
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.
| 24 |
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, 2023 to September 30, 2024 | $ | 0 | 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, 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.
*On March 17, 2023 David Koos was issued 15,000 Series NC Preferred shares in satisfaction of $10,050 of salaries accrued yet unpaid.
| 25 |
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 April 30, 2025 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.
Based on 21,554,705 shares issued and outstanding
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Common | David R. Koos | 436,799 | * | 2 | % | |||||
| c/o Regen Biopharma, Inc. | ||||||||||
| 4700 Spring Street St 304 | ||||||||||
| La Mesa CA 91942* | ||||||||||
| Common | All Officers and Directors as a Group | 436,799 | * | 2 | % | |||||
*includes 19 shares held by BMXP Holdings Shareholder’s Business Trust and 11 shares held by the AFN Trust and 366,651 shares held by Zander Therapeutics, Inc.
Based on 10,123,771 shares issued and outstanding
| Title of Class | Name and Address of Beneficial Owner | Amount and Nature of Beneficial Ownership | Percentage | |||||||
| Series A Preferred | David R. Koos | 4.08 | % | |||||||
| c/o Regen Biopharma, Inc. | 413,288 | |||||||||
| 4700 Spring Street St 304 | ||||||||||
| Series A Preferred | All Officers and Directors as a Group | 413,288 | 4.08 | % | ||||||
* Includes 11 share held by BMXP Holdings Shareholder’s Business Trust, , 366,651 shares held by Zander Therapeutics, Inc. and 7 share held by the AFN Trust.
| 26 |
Based on 29,338 shares outstanding
| 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
| 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
| 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 | % | ||||||
| 27 |
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.
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.
| 28 |
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.
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. On April 26, 2024 the Company and BST agreed to amend that sublease agreement as follows:
The Company agreed that in addition to the base rent of $5,000 per month to be paid by the Company to BST the Company shall also reimburse BST for any and all shared expenses as such term is defined within the original lease agreement by and between BST and CIF LaMesa LLP beginning January 1, 2024..
BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
$1,708 lent to the Company by David Koos, the Company’s sole Board Member and Officer, is due and payable at the demand of the holder and bears simple interest at a rate of 15% per annum.
$15,000 lent to the Company by Zander Therapeutics, Inc. is due and payable on May 3. 2025 and bears simple interest at a rate of 10% per annum.
$25,000 lent to the Company by Zander Therapeutics, Inc. is due and payable on June 5. 2025 and bears simple interest at a rate of 10% per annum.
$10,000 lent to the Company by Zander Therapeutics, Inc. is due and payable on October 4, 2025 and bears simple interest at a rate of 10% per annum.
$4,700 lent to the Company by Zander Therapeutics, Inc. is due and payable on October 15 2025 and bears simple interest at a rate of 10% per annum.
$4,500 lent to the Company by Zander Therapeutics, Inc. is due and payable on October 23 2025 and bears simple interest at a rate of 10% per annum.
| 29 |
Zander Therapeutics, Inc. and the Company are under common control.
During the quarter ended December 31, 2024 BST Partners lent the Company the amounts indicated which are due and payable with accrued interest thereon on the dates indicated below:
| Due and Payable | Interest Rate | Principal Amount | ||||||
| 10/31/2025 | 10 | % | $ | 500 | ||||
| 10/31/2025 | 10 | % | $ | 1,400 | ||||
| 11/7/2025 | 10 | % | $ | 500 | ||||
| 11/14/2025 | 10 | % | $ | 500 | ||||
| 11/20/2025 | 10 | % | $ | 399 | ||||
| 11/21/2025 | 10 | % | $ | 500 | ||||
| 11/27/2025 | 10 | % | $ | 1,400 | ||||
| 12/4/2025 | 10 | % | $ | 10,000 | ||||
| 12/4/2025 | 10 | % | $ | 7,500 | ||||
| 12/12/2025 | 10 | % | $ | 1,400 | ||||
| 12/5/2025 | 10 | % | $ | 500 | ||||
| 12/19/2025 | 10 | % | $ | 500 | ||||
| 12/27/2025 | 10 | % | $ | 1,400 | ||||
| 12/31/2025 | 10 | % | $ | 1,500 | ||||
| 11/4/2025 | 10 | % | $ | 17,500 | ||||
| 12/19/2025 | 10 | % | $ | 500 | ||||
| 12/20/2025 | 10 | % | $ | 600 | ||||
. BST Partners and the Company are under common control.
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.
| 30 |
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.
Item 14. Principal Accountant Fees and Services
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, 2024 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, 2022 and ending September 30, 2023:
| Audit Fees | $ | 22,000 | ||
| Audit Related Fees | 16,500 | |||
| Tax Fees | 0 | |||
| All Other Fees | 0 | |||
| $ | 38,500 |
The following table sets forth the aggregate fees billed to us by BF Borgers CPA PC for the period beginning October 1, 2023 and ending September 30, 2024:
| Audit Fees | $ | 22,000 | ||
| Audit Related Fees | 11,000 | |||
| Tax Fees | 0 | |||
| All Other Fees | 0 | |||
| $ | 38,000 |
The following table sets forth the aggregate fees billed to us by Bush and Associates CPA LLC for the period beginning October 1, 2023 and ending September 30, 2024:
| Audit Fees | $ | 0 | ||
| Audit Related Fees | 6,000 | |||
| Tax Fees | 0 | |||
| All Other Fees | 0 | |||
| $ | 6,000 |
| 31 |
ITEM 15. EXHIBIT AND FINANCIAL STATEMENT SCHEDULES
| (a) | Financial Statements |
Our consolidated financial statements are set forth in Part II, Item 8 of this 10-K and are incorporated herein by reference.
| (b) | Financial Statement Schedules |
No financial statement schedules have been filed as part of this 10-K because they are not applicable or are not required or because the information is otherwise included herein.
| (c) | Exhibits required by Regulation S-K |
10.1 ** Coventry Note (INCORPORATED BY REFERENCE TO EXHIBITS 10.L AND 10.2 FORM 8-K FILED 9/4/2024)
* Filed herewith.
ITEM 16. FORM 10-K SUMMARY
Not applicable.
| 32 |
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: | May 13, 2025 |
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: | May 13, 2025 |
| 33 |
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
REGEN BIOPHARMA, INC.
CONSOLIDATED FINANCIAL STATEMENTS
TABLE OF CONTENTS
| F-1 |
Report of Independent Registered Public Accounting Firm
To the Board of Directors
and Stockholders of Regen Biopharma, Inc. and Subsidiary
Opinion on the Consolidated Financial Statements
Substantial Doubt about the Company’s Ability to Continue as a Going Concern
The accompanying consolidated financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 2 to the consolidated financial statements, the Company’s significant operating losses raise substantial doubt about its ability to continue as a going concern. The consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. 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 audits 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 consolidated 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 audits, 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 audits included performing procedures to assess the risks of material misstatement of the consolidated 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 consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated 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 consolidated financial statements and (2) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing separate opinions on the critical audit matter or on the accounts or disclosures to which it relates.
| ● | Going Concern – As discussed in Note 2 to the consolidated financial statements, the Company has a going concern due to negative working capital and losses from operations which raises substantial doubt about its ability to continue as a going concern. Auditing management’s evaluation of a going concern can be a significant judgment given the fact that the Company uses management estimates on future revenues and expenses, which are difficult to substantiate. To evaluate the appropriateness of the going concern, we examined and evaluated the financial information along with management’s plans to mitigate the going concern and management’s disclosure on going concern. | |
| ● | Valuation of Level 3 Investments Securities in Related Parties – As described in Note 6 to the consolidated financial statements, the Company holds investment securities, including Level 3 securities whose fair values are based on significant unobservable inputs. The fair value of these securities was $17,733 and $222,580 as of September 30, 2024 and 2023, respectively. Management uses valuation models and assumptions, including discount rates, projected cash flows, and market comparables, to estimate fair value. |
We identified the valuation of Level 3 investment securities as a critical audit matter due to the significant judgment required by management to estimate fair value and the high degree of estimation uncertainty. This required a high degree of auditor judgment and increased audit effort.
How the Matter Was Addressed in the Audit
Our audit procedures related to the valuation of Level 3 investment securities included, among others:
| ● | Testing management’s valuation process, including the review and approval of key assumptions and inputs. | |
| ● | Evaluating the appropriateness of the valuation methodologies used by management. | |
| ● | Assessing the reasonableness of key assumptions, such as discount rates and projected cash flows, by comparing them to observable market data and industry benchmarks. | |
| ● | Reviewing subsequent events and transactions for evidence of fair value. |
/s/
BCRG
Group (PCAOB ID
We have served as the Company’s auditor since 2024.
May 13, 2025
| F-2 |
REGEN BIOPHARMA , INC.
CONSOLIDATED BALANCE SHEETS
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| (As Restated) | ||||||||
| ASSETS: | ||||||||
| Current Assets | ||||||||
| Cash | $ | $ | ||||||
| Accounts receivable, related party | ||||||||
| Prepaid expenses | ||||||||
| Total Current Assets | ||||||||
| Other Assets | ||||||||
| Investment securities, related party | ||||||||
| Total Other Assets | ||||||||
| TOTAL ASSETS | $ | $ | ||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| Current Liabilities: | ||||||||
| Accounts payable | $ | $ | ||||||
| Accrued expenses | ||||||||
| Notes payable | ||||||||
| Unearned income | ||||||||
| Unearned income - related party | ||||||||
| Unearned Income | ||||||||
| Derivative liability | ||||||||
| Convertible notes payable, net of unamortized debt discount | ||||||||
| Convertible notes payable, related parties, net of unamortized debt discount | ||||||||
| Other current liabilities | ||||||||
| Total Current Liabilities | ||||||||
| Long Term Liabilities: | ||||||||
| Notes Payable | ||||||||
| Total Long Term Liabilities | ||||||||
| TOTAL LIABILITIES | ||||||||
| STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||
| Common Stock ($ par value) authorized and and shares issued and outstanding, respectively | ||||||||
| Preferred Stock, par value, authorized and shares issued and outstanding | ||||||||
| Series A Preferred; authorized and and shares issued and outstanding, resepctively | ||||||||
| Series AA Preferred; $ par value authorized and shares issued and outstanding | ||||||||
| Series M Preferred; $ par value authorized and shares issued and outstanding | ||||||||
| Series NC Preferred; $par value authorized and shares issued and outstanding | ||||||||
| Additional Paid in capital | ||||||||
| Other Comprehensive Income | ( | ) | ||||||
| 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
| F-3 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| 2024 | 2023 | |||||||
| Years Ended September 30 | ||||||||
| 2024 | 2023 | |||||||
| (As Restated) | ||||||||
| Net revenue: | ||||||||
| Revenues | $ | $ | ||||||
| Revenues, Related Party | ||||||||
| Net revenue | ||||||||
| Operating expenses: | ||||||||
| Research and Development | ||||||||
| General and Administrative | ||||||||
| Consulting and Professional Fees | ||||||||
| Rent | ||||||||
| Total operating expenses | ||||||||
| Loss from operations | ( | ) | ( | ) | ||||
| Other income (expense): | ||||||||
| Interest Expense | ( | ) | ( | ) | ||||
| Interest Expense attributable to Amortization of Discount | ( | ) | ( | ) | ||||
| Derivative Income (Expense) | ( | ) | ||||||
| Financing Fees | ( | ) | ( | ) | ||||
| Gain (Loss) on Extinguishment Convertible Debt | ||||||||
| Total other income (expense), net | ( | ) | ||||||
| Net loss before income taxes | ( | ) | ||||||
| Income tax provision | ||||||||
| Net loss | $ | ( | ) | $ | ||||
| Net income (loss) attributable to common shareholders | $ | ( | ) | $ | ||||
| Per common share basic and diluted: | ||||||||
| Net loss per common share attributable to Regen Biopharma shareholders, basic and diluted | $ | ) | $ | |||||
| Number of weighted average shares - basic and diluted | ||||||||
The Accompanying Notes are an Integral Part of These Financial Statements
All stock amounts
have been retroactively adjusted to reflect a
| F-4 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS )
| 2024 | 2023 | |||||||
| Year ended September 30 | ||||||||
| 2024 | 2023 | |||||||
| Net Income ( Loss) | $ | ( | ) | $ | ||||
| Other Comprehensive Loss: | ||||||||
| Unrealized Loss Investment Securities | ( | ) | ||||||
| Comprehensive Loss | $ | ( | ) | $ | ||||
The accompanying Notes are an integral part of these Financial Statements
| F-5 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENT OF SHAREHOLDERS’ DEFICIT
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Deficit | Total | ||||||||||||||||||||||||||||||||||||||||||||
| Series A Preferred | Series AA Preferred | Series NC Preferred | Common | Series M Preferred | Additional Paid-in | Accumulated Other Comprehensive | Accumulated | |||||||||||||||||||||||||||||||||||||||||||||||||
| Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Shares | Amount | Capital | Income | Deficit | Total | |||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2022 | $ | $ | $ | $ | $ | $ | $ | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Nonemployee Services | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Debt | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Interest | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares Issued For Interest | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Nonemployee Services | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| March 6,2023 reverse stock split | - | - | - | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares issued for accrued salaries | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common shares issued for financing expenses | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income ( Loss) for the year | - | - | - | - | - | |||||||||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2023 | ( | ) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares issued for Cash | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares issued for Financing Expenses | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Common Shares issued for services | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Issued for Services | - | - | - | - | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Preferred Shares Distributed as dividend | - | - | - | - | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||
| Unrealized Loss | ( |
) | ( | ) | ||||||||||||||||||||||||||||||||||||||||||||||||||||
| Net Income ( Loss) for the year | - | - | - | - | - | ( | ) | ( | ) | |||||||||||||||||||||||||||||||||||||||||||||||
| Balance September 30, 2024 (As Restated) | $ | $ | $ | $ | $ | $ | $ | ( |
) | $ | ( | ) | $ | ( | ) | |||||||||||||||||||||||||||||||||||||||||
The Accompanying Notes are an Integral Part of These Financial Statements
All
stock amounts have been retroactively adjusted to reflect a
| F-6 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
| 2024 | 2023 | |||||||
| Years Ended September 30, | ||||||||
| 2024 | 2023 | |||||||
| (As Restated) | ||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES | ||||||||
| Net Income (loss) | $ | ( | ) | $ | ||||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Common Stock issued for Expenses | ||||||||
| Preferred Stock issued as compensation | ||||||||
| Common Stock issued for Compensation | ||||||||
| Interest expense attributable to amortization of Discount | ( | ) | ||||||
| Derivative Expense | ( | ) | ||||||
| (Gain) Loss on forgiveness of Debt | ( | ) | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Accounts Payable | ( | ) | ||||||
| Accounts Receivable | ( | ) | ||||||
| Accrued Expenses | ||||||||
| Prepaid Expenses | ( | ) | ||||||
| Unearned Income | ( | ) | ( | ) | ||||
| Net Cash Provided by (Used in) Operating Activities | ( | ) | ( | ) | ||||
| CASH FLOWS FROM FINANCING ACTIVITIES | ||||||||
| Repayments on convertible notes payable | ( | ) | ||||||
| Borrowings from notes payable | ||||||||
| Proceeds from issuances of common stock | ||||||||
| 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: | ||||||||
| Preferred Shares issued for Debt | $ | $ | ||||||
| Common shares Issued for Interest | $ | $ | ||||||
| Preferred Shares issued for Interest | $ | $ | ||||||
| Preferred Shares Distributed as dividend | $ | $ | ||||||
The Accompanying Notes are an Integral Part of These Financial Statements
All
stock amounts have been retroactively adjusted to reflect a
| F-7 |
REGEN BIOPHARMA , INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Regen Biopharma, Inc. (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.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Going Concern
The
accompanying consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates,
among other things, the realization of assets and satisfaction of liabilities in the normal course of business. The Company had an accumulated
deficit of $
Basis of Presentation and Consolidation
The consolidated 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.
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.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires the Company to make estimates and assumptions that affect the amounts reported in our consolidated financial statements and the accompanying notes. Such estimates include accounts receivables, accrued liabilities, income taxes, long-lived assets, and deferred tax valuation allowances. These estimates generally involve complex issues and require management to make judgments, involve analysis of historical and future trends that can require extended periods of time to resolve, and are subject to change from period to period. In all cases, actual results could differ materially from estimates.
| F-8 |
Reverse Stock Split
On March 6, 2023, the Company filed a Certificate of Amendment (the “Certificate of Amendment”) to the Company’s Certificate of Incorporation to effect a reverse stock split of its issued Common Stock in the ratio of 1-for-1,500 (the “Reverse Stock Split”).
As a result of the Reverse Stock Split, the total number of shares of common stock held by each shareholder was converted automatically into the number of whole shares of common stock equal to (i) the number of shares of common stock held by such shareholder immediately prior to the Reverse Split, divided by (ii) 1,500, and then rounded up to the nearest whole number. No fractional shares were issued, and no cash or other consideration was paid to any shareholder. Instead, the Company issued one whole share of the post-Reverse Stock Split common stock to any shareholder who otherwise would have received a fractional share as a result of the Reverse Stock Split.
Except for the Company’s historical financial statements and unless otherwise stated, all option, share, and per share information gives effect to the Reverse Stock Split.
Segment Reporting
FASB ASC Topic 280, Segment Reporting, requires public companies to report financial and descriptive information about their reportable operating segments. The Company’s management identifies operating segments based on how the Company’s management internally evaluate separate financial information, business activities and management responsibility. At the current time, the Company has only one reportable segment, primarily in the development of regenerative medical applications.
The Company generates revenues from one geographic area, consisting of North America.
Advertising
Costs
associated with advertising are charged to expenses as incurred. Advertising expenses were $
Research and Development Cost
Research
and development (R&D) costs are expensed as incurred. R&D costs are related to the Company’s internally funded development
of the Company’s product developments and patents. The Company R&D costs were $
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.
| F-9 |
Income Taxes
The Company uses the asset and liability method of accounting for income taxes in accordance with ASU 740, “Income Taxes”. Under this method, income tax expense is recognized as the amount of: (i) taxes payable or refundable for the current year and (ii) future tax consequences attributable to differences between the consolidated financial statements carrying amounts of existing assets and liabilities and their respective tax bases. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in the results of operations in the period that includes the enactment date. A valuation allowance is provided to reduce the deferred tax assets reported 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 Company is subject to Income tax filings requirements in U.S. federal and various state jurisdictions. The Company’s tax returns for all years are subject to U.S. federal, state, and local income tax examinations by tax authorities.
The Company reports income tax related interest and penalties within the income tax line item on the consolidated statements of operations. The Company likewise reports the reversal of income tax-related interest and penalties within such line item to the extent the Company resolves the liabilities for uncertain tax positions in a manner favorable to the accruals.
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.
Fair Value Measurements
The estimated fair values of financial instruments reported in the consolidated financial statements have been determined using available market information and valuation methodologies, as applicable. The fair value of cash due to its short maturity is classified as a Level 1 instrument within the fair value hierarchy.
Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Entities are required to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value based upon the following fair value hierarchy:
| Level 1 — | Quoted prices in active markets for identical assets or liabilities; | |
| Level 2 — | Observable inputs other than Level 1 prices, such as quoted prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the assets or liabilities; and | |
| Level 3 — | Unobservable inputs that are supported by little or no market activity and that are significant to the fair value of the assets or liabilities. |
As of September 30, 2024, the following table represents the Company’s fair value hierarchy for items that are required to be measured at fair value on a recurring basis:
SCHEDULE OF FAIR VALUE HIERARCHY MEASURED AT RECURRING BASIS
| Level 1 | Level 2 | Level 3 | ||||||||||
| Investment Securities (Related Party) | $ | |||||||||||
As of September 30, 2023, the following table represents the Company’s fair value hierarchy for items that are required to be measured at fair value on a recurring basis:
| Level 1 | Level 2 | Level 3 | ||||||||||
| Investment Securities (Related Party) | $ | |||||||||||
| F-10 |
Non-recurring Fair Value Measurements
Certain assets and liabilities are measured at fair value on a nonrecurring basis. In other words, the instruments are not measured at fair value on an ongoing basis but are subject to fair value adjustments only in certain circumstances (for example, when there is evidence of impairment). No such losses were recorded during the year ended September 30, 2024 and 2023.
The Company accounts for share-based compensation in accordance with the fair value recognition provisions of FASB ASC Topic 718, Share-based Payment, which requires all share-based payments to employees, including grants of employee stock options, to be recognized in the consolidated financial statements based on their fair values. The fair value of stock options is calculated by using the Black-Scholes option pricing formula that requires estimates for expected volatility, expected dividends, the risk-free interest rate and the term of the option. If any of the assumptions used in the Black-Scholes model change significantly, share-based compensation expense may differ materially in the future from that recorded in the current period.
Recent Accounting Pronouncements
In June 2016, the FASB issued ASU 2016-13, Financial Instruments – Credit Losses, which requires entities to estimate all expected credit losses for financial assets measured at amortized cost basis, including trade receivables, held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. The Company adopted this guidance on January 1, 2023. The adoption of this accounting standard did not have an impact on the Company’s consolidated financial statements as the Company is in a pre-revenue state and does not generate revenue and has no receivables from third party.
In November 2023, the FASB issued ASU 2023-07, Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures, which requires incremental disclosure of segment information on an interim and annual basis. This ASU is effective for public entities for fiscal years beginning after December 15, 2023, and interim periods within fiscal years beginning after December 15, 2024. Retrospective application to all prior periods presented in the financial statements is required for public entities. The Company adopted ASU 2023-07 as of January 1, 2024, which resulted in additional disclosures of significant segment expenses and other segment items as well as incremental qualitative disclosures.
Other recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the AICPA and the SEC did not or are not believed by management to have a material impact on the Company’s present or future consolidated financial statements.
4. ACCOUNTS RECEIVABLES
Accounts receivable were comprised of the following:
SCHEDULE OF ACCOUNTS RECEIVABLE
| September 30, 2024 | September 30, 2023 | |||||||
| Customer- Related Party | ||||||||
| Total | ||||||||
During
the year ended September 30, 2024 and 2023, there was
5. PREPAID EXPENSES
Prepaid Expenses were comprised of the following:
SCHEDULE OF PREPAID EXPENSES
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Prepaid Expenses | $ | $ | ||||||
| Prepaid Rent | ||||||||
| Total | $ | $ | ||||||
Prepaid expenses consist of payments of certain expenses by cash or issuance of shares for which services are pending to be received.
| F-11 |
6. INVESTMENTS
The Company classifies its investment securities as available-for-sale. Available-for-sale securities are recorded at fair value, with unrealized gains and losses reported as a component of other comprehensive income (loss), net of related tax effects, until realized. Realized gains and losses are recognized in earnings when the securities are sold, using the specific identification method. Declines in fair value judged to be other-than-temporary are recognized in earnings.
The Company evaluates its investment portfolio for credit losses on a quarterly basis. If a decline in fair value below amortized cost is determined to be credit-related and the Company does not intend to sell the security, nor is it more likely than not that the Company will be required to sell the security before recovery of its amortized cost basis, the expected credit loss is recognized in earnings and the non-credit portion is recorded in other comprehensive income.
As of September 30, 2024 and 2023, the Company determined that no allowance for credit losses was required for its available-for-sale securities. Fair value measurements are categorized based on the inputs used to determine fair value. The fair values of the Company’s AFS securities are primarily based on Level 3 inputs.
The Company also holds investments in certain privately held equity securities that do not have a readily determinable fair value and are not accounted for under the equity method. These securities are measured at cost, less impairment (if any), and adjusted for observable price changes in orderly transactions for identical or similar investments.
As
of September 30 , 2024 and 2023, the carrying amount of such investments was $
The fair value of Level 3 investments is based on valuation models that include unobservable inputs such as projected cash flows, market comparables, and management assumptions. These valuations require significant judgment and estimation by management.
The above mentioned constitute the Company’s sole related party investment securities as of September 30, 2024. No public market exists for any of the securities of Zander Therapeutics, Inc. The Company owns of the total shares of Zander Therapeutics, Inc.
Investments consisted of the following:
SCHEDULE OF INVESTMENT
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Common Shares of Zander Therapeutics, Inc. | $ | $ | ||||||
| Series M Preferred of Zander Therapeutics, Inc. | ||||||||
| Investments, net | $ | $ | ||||||
On June 11, 2018, Regen Biopharma, Inc. was paid a property dividend consisting of of the common shares of Zander Therapeutics, Inc.
| Basis | Fair Value | Total Unrealized Gains/(Loss) | ||||||||
| $ | $ | $ | ( | ) | ||||||
Series M Preferred 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 $
| Basis | Fair Value | Total Unrealized Gains/(Loss) | ||||||||
| $ | $ | $ | ( | ) | ||||||
On September 30, 2024, 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:
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| 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 Shares | $ | $ | ||||||
| F-12 |
As of September 30, 2024:
| Basis | Fair Value | Total Unrealized Gains | Net Unrealized Gain or (Loss) realized during the quarter ended September 30, 2024 | |||||||||||
| $ | $ | $ | $ | ( | ) | |||||||||
Series M Preferred of Zander Therapeutics, Inc.
| Basis | Fair Value | Total Unrealized Loss | Net Unrealized Gain or (Loss) realized during the quarter ended September 30, 2024 | |||||||||||
| $ | $ | $ | ( | ) | $ | ( | ) | |||||||
7. ACCRUED EXPENSES
Accrued Expenses were comprised of the following:
SCHEDULE OF ACCRUED EXPENSES
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Accrued payroll taxes | $ | $ | ||||||
| Accrued Interest | ||||||||
| Accrued Payroll | ||||||||
| Other Accrued Expenses | ||||||||
| Total | $ | $ | ||||||
8. UNEARNED INCOME
Unearned income is attributable to payments made to the Company and its wholly owned subsidiary pursuant to two license agreements for which income is recognized over the terms of the agreement.
| F-13 |
9. NOTES PAYABLE
Notes Payable comprise of below:
(a) RELATED PARTY
Notes payable to related parties consisted of the following:
SCHEDULE OF NOTES PAYABLE TO RELATED PARTIES
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| David Koos | $ | $ | ||||||
| Zander Therapeutics, Inc. | ||||||||
| Total notes payable to related parties | $ | $ | ||||||
$
$
$
Zander Therapeutics, Inc. and the Company are under common control.
(b) NON RELATED PARTY
Notes payable consisted of the following:
SCHEDULE OF NOTES PAYABLE TO NON RELATED PARTY
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Bostonia Partners, Inc. | $ | $ | ||||||
| Coventry Enterprises LLC (Long Term) | ||||||||
| Coventry Enterprises LLC (Short Term) | ||||||||
| Less: Amortizatio of Notes | ( | ) | ||||||
| Total notes payable to un-related parties | $ | $ | ||||||
| Total Notes Payable Short Term | ||||||||
| Total Notes Payable Long Term | ||||||||
$
Effective
September 4, 2024 the Company entered into a securities purchase agreement (the “Purchase Agreement”) with Coventry Enterprises,
LLC (“Coventry”), pursuant to which Coventry Enterprises purchased a 10% unsecured promissory Note (the “Note”)
from the Company in the principal amount of $
$
In Connection with the Purchase Agreement the Company issued to Coventry common shares (“Commitment Shares”). If The Company has satisfied all the terms of the Note without default the Coventry shall, within 10 calendar days thereafter, return to the Company’s treasury for cancellation of the Commitment Shares.
| F-14 |
10. CONVERTIBLE NOTES PAYABLE
Convertible notes comprise of below:
SCHEDULE OF CONVERTIBLE NOTES
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Lender 1 | ||||||||
| Lender 2 | ||||||||
| Lender 3 | ||||||||
| Lender 4 | ||||||||
| Lender 5 | ||||||||
| Lender 6 | ||||||||
| Total | $ | $ | ||||||
| i. | On
May 5, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”)
in the face amount of $ |
| ii. | On
March 8, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”)
in the face amount of $ |
| iii. | On
April 6, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”)
in the face amount of $ |
| iv. | On
December 20, 2017 (“Issue date”) the Company issued a Convertible Note (“Note”)
in the face amount of $ |
| v. | On
October 31, 2016 (“Issue date”) the Company issued a Convertible Note (“Note”)
in the face amount of $ |
| F-15 |
11. DERIVATIVE LIABILITY
Derivative Liability consisted of the following:
SCHEDULE OF DERIVATIVE LIABILITY
| 2024 | 2023 | |||||||
| As of September 30, | ||||||||
| 2024 | 2023 | |||||||
| Lender 1 | $ | $ | ||||||
| Lender 4 | $ | $ | ||||||
| Lender 5 | $ | $ | ||||||
| Total convertible notes payable | $ | $ | ||||||
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 $
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, 2024 utilized the following inputs:
SCHEDULE OF DERIVATIVE LIABILITY ON CONVERTIBLE NOTES USING BLACK SCHOLES PRICING MODEL
| Schedule of Derivative liability | ||||
| Risk Free Interest Rate | % | |||
| Expected Term | ( | |||
| Expected Volatility | % | |||
| Expected Dividends |
12. STOCKHOLDER’S EQUITY
The stockholders’ equity section of the Company contains the following classes of capital stock as of September 30 30, 2024:
Common stock, $ 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, 2024, is designated Series A Preferred Stock of which shares are outstanding as of September 30, 2024, is designated Series M Preferred Stock of which shares are outstanding as of September 30, 2024, and is designated Series NC stock of which shares are outstanding as of September 30, 2024.
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.
| F-16 |
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 shares of the Series AA Preferred Stock, par value $. 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 shares of the Series A Preferred Stock, par value $. 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 shares of the Series M Preferred Stock, par value $. 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.
| F-17 |
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 shares of the Series NC Preferred Stock, par value $. 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.
On May 20, 2024 Regen Biopharma, Inc. amended its Certificate of Incorporation adding the following Article 8 which is and reads as follows:
Shares of one class or series of stock may be issued as a share dividend in respect of another class or series.
On May 21 , 2024 the Board of Directors of Regen Biopharma, Inc declared a dividend to all shareholders of record as of June 20,2024 (“Record Date”) to be paid to shareholders on or about July 1, 2024 such dividend to be payable in shares of the Regen’s authorized but unissued Series A Preferred Stock and to consist of two share of Series A Preferred Stock for every one share of Regen Biopharma, Inc. Common Stock owned as of the Record Date, every one share of Regen Biopharma, Inc. Series A Preferred Stock owned as of the Record Date, every one share of Series AA Preferred Stock owned as of the Record Date, every one share of Series M Preferred Stock owned as of the Record Date and every one share of Series NC Preferred Stock owned as of the Record Date.
On July 3, 2024 Series A Preferred Shares were issued as a dividend to the Shareholders of Record.
On September 18, 2024 the Board of Directors of Regen Biopharma, Inc.(“Regen”) declared a dividend to all shareholders of record as of October 17,2024 (“Record Date”) to be paid to shareholders on or about November 1, 2024 such dividend to be payable in shares of the Regen’s authorized but unissued Common Stock and to consist of one share of Common Stock for every one share of Regen Biopharma, Inc. Common Stock owned as of the Record Date, every one share of Regen Biopharma, Inc. Series A Preferred Stock owned as of the Record Date, every one share of Series AA Preferred Stock owned as of the Record Date, every one share of Series M Preferred Stock owned as of the Record Date and every one share of Series NC Preferred Stock owned as of the Record Date
13. STOCK TRANSACTIONS
| ● | 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 $ | |
| ● | On
November 10, 2023 the Company issued common shares for cash consideration of $ | |
| ● | On
November 27, 2023 the Company issued common shares for cash consideration of $ | |
| ● | On
December 11 2023 the Company issued common shares for cash consideration of $ | |
| ● | On
December 20, 2023 the Company issued common shares for cash consideration of $ | |
| ● | On
January 3, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
January 10, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
February 2, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
February 21, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
March 6, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
March 20, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
April 3, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On May 2, 2024 the Company issued Series A Preferred shares for nonemployee services . | |
| ● | On
May 29, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
June 7, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
June 20, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On July 3, 2024 Series A Preferred Shares were distributed as a dividend to shareholders. | |
| ● | On
July 12, 2024 the Company issued common shares for cash consideration of $ | |
| ● | On
September 4, 2024 , 2024 the Company issued common shares as a commitment fee in
connection with the issuance of a promissory note in the face amount of $ | |
| ● | On September 26,2024 the Company issued shares as consideration for nonemployee services. |
| F-18 |
14. INCOME TAXES
As of September 30, 2024
SCHEDULE OF DEFERRED TAX ASSETS
| Deferred tax assets: | ||||
| Net operating tax carry forwards | $ | |||
| Other | ||||
| Gross deferred tax assets | ||||
| Valuation allowance | ( | ) | ||
| Net deferred tax assets | $ |
NOTE 10. INCOME TAXES
As of September 30, 2023
| Deferred tax assets: | ||||
| Net operating tax carry forwards | $ | |||
| Other | ( | ) | ||
| Gross deferred tax assets | ||||
| Valuation allowance | ( | ) | ||
| Net deferred tax assets | $ | ( | ) | |
As
of September 30 2024 the Company has a Deferred Tax Asset of $
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 .
15. 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 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).
| F-19 |
Zander
is obligated pay to The Company minimum annual royalties of ten thousand US dollars ($
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 shares of the Series A Preferred stock of Regen (“Conversion Shares”) acquired
by Zander through conversion of $
2)
A $
3)
$
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.
On
September 30, 2018 Regen Biopharma, Inc. (“Regen”) issued a convertible promissory note in the principal amount of $
| F-20 |
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 $
As
of June 30, 2024, $
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 $
The
Company agreed that in addition to the base rent of $
BST Partners is controlled by David Koos who serves as the sole officer and director of Regen Biopharma, Inc.
$
$
$
Zander Therapeutics, Inc. and the Company are under common control.
RESTATEMENT OF PREVIOUSLY ISSUED FINANCIAL STATEMENTS
Subsequent to the original issuance of Regen’s annual unaudited financial statements for the year ended September 30, 2024 the Company determined that the following revisions are required
The value given to common shares issued as nonemployee compensation has been adjusted to $ per share
The market price utilized in calculating Derivative Liability as of September 30, 2024 has been corrected to $ per share.
$
| F-21 |
Cumulative Effect of Restatement of Previously Issued Financial Statements for the Year ended September 30, 2024:
REGEN BIOPHARMA , INC.
CONSOLIDATED BALANCE SHEETS
| Originally Presented | Restated | |||||||||||
| As of September 30, 2024 | Adjustments | As of September 30, 2024 | ||||||||||
| ASSETS | ||||||||||||
| Current Assets | ||||||||||||
| Cash | $ | $ | ||||||||||
| Accounts Receivable, Related Party | ||||||||||||
| Prepaid Assets | ( | ) | ||||||||||
| Total Current Assets | ( | ) | ||||||||||
| Other Assets | ||||||||||||
| Investment Securities, Related Party | ||||||||||||
| Total Other Assets | ||||||||||||
| TOTAL ASSETS | $ | ( | ) | $ | ||||||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||||||
| Current Liabilities: | ||||||||||||
| Accounts payable | ||||||||||||
| Accrued Expenses | ||||||||||||
| Notes Payable | ||||||||||||
| Unearned Income | ||||||||||||
| Unearned Income ( Related Party) | ||||||||||||
| Derivative Liability | ||||||||||||
| Convertible Notes Payable Less unamortized discount | ||||||||||||
| Convertible Notes Payable, Related Parties Less unamortized discount | ||||||||||||
| Other Current Liabilities | ||||||||||||
| Total Current Liabilities | ||||||||||||
| Long Term Liabilities: | ||||||||||||
| Notes Payable | ||||||||||||
| Total Long Term Liabilities | ||||||||||||
| TOTAL LIABILITIES | ||||||||||||
| STOCKHOLDERS’ EQUITY (DEFICIT) | ||||||||||||
| Common Stock ($ par value) 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 | ||||||||||||
| Preferred Stock, Value | ||||||||||||
| Additional Paid in capital | ( | ) | ||||||||||
| Contributed Capital | ||||||||||||
| Accumulated Other Comprehensive Income | ( | ) | ( | ) | ||||||||
| Retained Earnings (Deficit) | ( | ) | ( | ) | ( | ) | ||||||
| Total Stockholders’ Equity (Deficit) | ( | ) | ( | ) | ( | ) | ||||||
| TOTAL LIABILITIES & STOCKHOLDERS’ EQUITY (DEFICIT) | $ | ( | ) | $ | ||||||||
| F-22 |
REGEN BIOPHARMA , INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
| Originally Presented | Restated | |||||||||||
| As of September 30, 2024 | Adjustments | As of September 30, 2024 | ||||||||||
| REVENUES | ||||||||||||
| Revenues | $ | $ | ||||||||||
| Revenues, Related Party | ||||||||||||
| TOTAL REVENUES | ||||||||||||
| COST AND EXPENSES | ||||||||||||
| Research and Development | ||||||||||||
| General and Administrative | ||||||||||||
| Consulting and Professional Fees | ( | ) | ||||||||||
| Rent | ||||||||||||
| Total Costs and Expenses | ( | ) | ||||||||||
| OPERATING INCOME (LOSS) | $ | ( | ) | $ | ( | ) | ||||||
| OTHER INCOME & (EXPENSES) | ||||||||||||
| Interest Expense | ( | ) | ( | ) | ||||||||
| Interest Expense attributable to Amortization of Discount | ( | ) | ( | ) | ||||||||
| Unrealized Gain ( Loss) on sale of Investment Securities | ( | ) | ||||||||||
| Derivative Income (Expense) | ( | ) | ( | ) | ||||||||
| Financing Fees | ( | ) | ( | ) | ||||||||
| Gain (Loss) on Extinguishment Convertible Debt | ||||||||||||
| Adjustment | ||||||||||||
| TOTAL OTHER INCOME (EXPENSE) | ( | ) | ( | ) | ||||||||
| NET INCOME (LOSS) | $ | ( | ) | $ | ( | ) | ||||||
17. SUBSEQUENT EVENTS
On November 1, 2024 the Company paid a dividend to all shareholders of record as of the record date of October 17. 2024 a dividend consisting of one share of the Company’s common stock for every one share held as of October 17, 2024. common shares were paid to Shareholders of Record.
On
November 4, 2024 the Company issued shares of the Company’s common stock in satisfaction of $
On November 13, 2024 the Company issued shares of the Company’s common stock as consideration for nonemployee services.
| F-23 |
Exhibit 31.1
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, 2024 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: May 13, 2025 | By: | /s/ David R. Koos |
| David R. Koos | ||
| Chief Executive Officer |
Exhibit 31.2
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, 2024 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: May 13, 2025 | By: | /s/ David R. Koos |
| David R. Koos | ||
| Chief Financial Officer |
Exhibit 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
In connection with the Annual Report of Regen Biopharma, Inc. on Form 10-K for the year ended September 30, 2024 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: May 13, 2025 | By: | /s/ David R. Koos |
| David R. Koos | ||
| Chief Executive Officer |
Exhibit 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
In connection with the Annual Report of Regen Biopharma, Inc. on Form 10-K for the year ended September 30, 2024 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: May 13, 2025 | By: | /s/ David R. Koos |
| David R. Koos | ||
| Chief Financial Officer |