Item 1.
BUSINESS
Overview of the Company and its Prior Strategy
We were incorporated in Florida on February 1, 2002.
Prior Operations.
We were seeking the proper mix of product offerings, community identity and unique venue for cafes. We spent time developing the proper taste we want to offer to our customers in coffee selection, the right reasons that customers will choose us over many other choices as well as develop an adequate base of financial support to sustain operations through the period necessary until cash flow from operations can sustain us. We did not have any operating locations built, nor any agreements in place to open any locations. The primary reason we did not opened a location is the financial requirement necessary to operate at a level necessary to sustain operations through the first six months. We anticipated that amount to be $150,000 which we were unable to raise.
Our Prior Business.
We planned to develop cafes in South Carolina and then in other states in the South East, featuring gourmet coffee, pastries and related items. Our objective was to develop cafes that will provide a forum for rapid service and a strong community identity with the widespread popularity of coffee and related products. We intended to meet what we believe is an increasing demand for convenience and community at an affordable price.
Due to intense competition, we believed that it was no longer good enough just to open a cafe. We believed that cafe owners must look for ways to differentiate their cafe from others in order to achieve and maintain a competitive advantage.
We recognized this need for differentiation and strongly believed that two features would add to this competitive advantage. The first concept was to offer a convenient drive through that would allow the morning commuters rapid access to coffee without having to find parking and exit their automobile. Secondly, we intended to have an active program of artistic entertainment and dialog through literature readings and orchestrated debates.
The Stem Cell Business Opportunity
On July 16, 2008 the Company changed focus to a new stem cell therapy business opportunity as set forth in a Letter of Intent dated March 31, 2008 with TheraVitae, Inc. by completing several actions. These actions included the filing of Amended Articles of Incorporation which among other matters changed the name of the corporation to RegenoCELL Therapeutics, Inc. and increased its authorized capitalization to 600,000,000 shares, approved Amended Bylaws, issued restricted common shares, par value $.0001 per share, to Douglas T. Rice (250,000), Domenic Mazza (5,000,000) and James F. Mongiardo (15,000,000), ratified the March 31 Letter of Intent with TheraVitae, and approved the Employment Agreement with James F. Mongiardo as President and Chief Executive Officer.
The Letter of Intent with TheraVitae provides for a non-exclusive license in Mexico and later the Islands of the Caribbean to commercialize TheraVitae’s stem cell therapy for cardiovascular indications. The Company may establish clinics to treat congestive heart failure patients with VesCell, TheraVitae’s stem cell therapy. It also provides for an exclusive license in the United States, Canada and Mexico to obtain regulatory approvals and then market VesCell stem cell therapy for the treatment of peripheral artery disease.
Further in connection with this change in business focus, the Board of Directors accepted the resignations of Scott Massey and Phillips N. Dee as Directors and Officers of the Company and elected James F. Mongiardo to fill the vacancy on the Board. Mr. Mongiardo was also elected to serve as Chief Executive Officer, President, Treasurer and Secretary.
Stem Cell Therapy
The ability to treat disease has been enhanced in the past two decades through the development of products utilizing techniques commonly referred to as “biotechnology”. Our ability to treat has also been enhanced by a better understanding of the human genome. Added to this mix of advanced new treatments have been products which are tissue engineered, that is utilizing cells to create tissue which treats the disease or damaged tissue. Holding great promise for significant new advances in the treatment of disease and damaged tissue are stem cells.
Stem cells are cells which have the ability to produce other cells identical to themselves or to differentiate into specific cell lineages. With these properties, stem cells play important roles in normal development and in the regeneration and repair of damaged tissue through the ability to differentiate into the type of cell needed for growth or repair.
The main sources of stem cells include (1) embryonic and fetal tissues; (2) umbilical cord blood; and (3) adult stem cells. Embryonic stem cells are totipotent which means that they can differentiate into all cell types. Use of embryonic stem cells has been subject to ethical controversy. Because their proliferation is difficult to control, they have been linked to the formation of cancers. More importantly, they possess a genome which is different than the patient’s genome raising safety issues which will take extensive clinical testing to resolve.
Umbilical cord blood stem cells are also capable of significant differentiation. While not being subject to ethical controversy as embryonic stem cells, they still possess a genome which is different than the patient’s genome. Many different choices may get a similarity in genomes but it will never be an identical match to the one person whose umbilical cord blood is being used to create the stem cells.
Adult stem cells are different. They are autologous, meaning that they are derived from the patient for use in that patient. Typical sources of adult stem cells include bone marrow or blood. Any tissue of the patient may be used. Adult stem cells are capable of differentiating into a variety of cell types without a risk of immunological rejection. Without the safety concerns of immunological rejection associated with embryonic and umbilical cord blood stem cells, it is expected that the first stem cell products to market will be derived from adult stem cells.
Stem Cell Business
The mission of the Company is to bring stem cell therapy treatments to the market as quickly as possible. The Company’s therapy utilizes a process to identify and process adult stem cells found in a patient’s blood. These adult stem cells are grown into large numbers in vitro (outside the body) and then encouraged to differentiate into angiogenic precursor cells or blood vessel forming cells for the treatment of congestive heart failure. These adult stem cells can also be used for the treatment of other conditions such as peripheral artery disease.
Currently congestive heart failure patients cleared for treatment have less than one-half pint of blood drawn which is sent to the Company’s cell processing facility in Israel. After the adult stem cells in the patient’s blood have been extracted and grown into large numbers of angiogenic precursor cells, they are sent to the Dominican Republic, Greece or other locations for infusion into the patient in a minimally invasive procedure. The stem cell therapy is either delivered through a catheter or injected directly into the myocardium. All patients are private pay.
The results to date have been impressive. After an animal trial in nude rats demonstrated safety and efficacy after myocardial infarction, a clinical trial was conducted with 24 patients. Statistically significant improvements between baseline and the three month and six month follow-up were achieved for:
·
Improvement in the six minutes walking test.
·
Increase in metabolic equivalent units (METs) during the stress test.
·
Decrease in the perfusion defect at region of the target artery.
·
Decrease in the Canadian Cardiovascular Society (CCS) Grading Scale.
Subsequent to this clinical trial, compassionate use treatment of no option congestive heart failure patients began. In total over five hundred (500) patients have been treated with this stem cell therapy. The compassionate use results are very similar to the initial clinical trial reported. Many of these compassionate use patients are from the United States and are still living many months and years after they had been told they would not survive more than three to six months.
Business Opportunity
The Company has acquired certain assets and assumed certain liabilities of Thera Vitae, Ltd. through its wholly owned Israeli subsidiary, Regenocell Laboratories, Ltd. As a result on February 4, 2010 the Company’s primary asset is Regenocell Laboratories Ltd. which is manufacturing and selling stem cell therapy product used to treat congestive heart failure and peripheral artery disease. Purchases are being made to treat patients for these indications in several countries. It is anticipated that purchases will also be made to treat patients in additional countries.
The primary source of patients being treated for congestive heart failure is the United States.
The initial stem cell business focus is to treat patients outside the United States for congestive heart failure and all other cardiovascular indications. Patients may not be treated in the United States. However, patients from the United States may be identified, qualified, agree to the treatment, pay for it in advance and then have their blood drawn for processing. When the stem cell therapy is ready for administration, the patient will travel outside the United States to a country in which autologous therapy is permitted with minimal regulatory requirements. The treatment will be administered in a catherization laboratory at a Company approved hospital. Approximately five million patients have been diagnosed in the United States with congestive heart failure. Up to seven hundred thousand (700,000) new cases are diagnosed each year.
The Company intends to find patients in the United States through its contacts with physicians and other health care professionals, a website, recommendations from professionals seeking alternative healthcare options for patients, medical seminars, public relations, standard marketing and word of mouth from treated patients. Once a patient expresses interest and is qualified by a physician and approved by Regenocell Laboratories, Ltd., the patient will enter into a Cell Product Supply Agreement. That payment amount is anticipated to be about $55,000 which will be paid by the patient. in advance of the blood draw. The patient will travel to the Fort Lauderdale, Florida area where the patient will be examined by a physician prior to performing a blood draw which is then sent to our cell processing facility in Israel. The patient will subsequently travel to a country where the autologous therapy can be administered with minimal regulatory requirements in a Company approved hospital.
Alternatively, the Company will sell its stem cell therapy to distributors which in turn treat the patient in a Company approved hospital. The Company is working with three distributors with additional distributors expected during 2012.
There are over 1100 investigation stem cell clinical trials being conducted in the United States. It will take multiple years for any product to be approved, especially products derived from embryonic or umbilical cord blood stem cells. In the interim, patients may benefit from adult stem cell treatment today through identification and qualification in the United States and the administration of treatment outside the United States. The Company intends to be one of the first companies to benefit from the commercial possibilities associated with adult stem cell therapy through the treatment of patients from the United States in the Dominican Republic, Greece and other countries.
The second stem cell business focus is to obtain regulatory approval to treat peripheral artery disease (“PAD”) in the United States and Europe. Over ten million Americans suffer from poor circulation to their extremities with a similar number in Europe. PAD is especially prevalent among diabetics. After standard treatments fail, the only alternative is amputation of the toes, foot or leg, sometimes fingers, hand or arm. This adult stem cell therapy has been shown in pilot clinical trials to re-establish blood flow to the extremities resulting in saving the limbs from amputation. The process for treating PAD is very similar to the process for treating congestive heart failure. After the patient is qualified, less than a half-liter of blood is drawn and sent for processing. The adult stem cells are extracted, grown into large numbers and then encouraged to become angiogenic precursor cells. This adult stem cell therapy is then injected in multiple locations in the limb which is experiencing poor circulation.
The Company intends to obtain an Investigational New Drug exemption and its equivalent in Europe to initiate clinical trials designed to obtain regulatory approval to market the product from both the Food and Drug Administration and the EMEA. We believe that such an approval in the United States and Europe will have block buster potential, meaning that the market size is so large and flexibility of pricing so great given the alternative of amputation, that the approved PAD stem cell therapy product may potentially generate revenues in excess of one billion dollars per annum. Thus, this second business has substantial long term upside potential.
On January 7, 2010, the Company through its wholly owned Israeli subsidiary, Regenocell Laboratories, Ltd., acquired certain assets and assumed certain liabilities of TheraVitae, Ltd. The transaction closed on February 4, 2010. Pursuant to the terms of the agreement, certain assets were acquired and certain liabilities assumed. These assets include all the manufacturing and office equipment and the transfer of the lease. All the employees were terminated then offered and accepted employment with Regenocell Laboratories, Ltd. Concurrent with this Asset Purchase Agreement, a second Assignment of Rights Agreement was executed with Yieldex, Ltd. The second agreement provides for the acquisition of certain rights. This includes clinical data, the non-exclusive use of the CRM System which manages clinical data and input necessary to schedule a patient for stem cell production, and all rights in patent and patent applications, if any, in connection with activities of stem cell research, therapy development and clinical trials under the trade name ”TheraVitae” for the world except for Asia. Israel is excluded by definition from being part of Asia. The cash price is $5,000,000 (five million United States dollars), of which $75,000 was paid to TheraVitae Limited and $25,000 to Yieldex on January 7. The balance is due in monthly installments on or before January 4, 2015. Minimum installments are $5,000 per patient processed in Israel after the first eight patients during the preceding month. In addition 25% of any equity raised by the Company will be applied to the outstanding balance. In addition 40,000,000 (forty million) shares of the Company’s common stock, par value $.0001, was issued to Yieldex Ltd and its nominees. The 40,000,000 shares are restricted and subject to a two year Lock-Up period beginning January 4, 2010. These shares are also subject to a voting agreement.
As a result of the actions described above, on February 4, 2010 the Company’s primary business operation is the Regenocell Laboratories Ltd. manufacturing and selling of stem cell therapy products used to treat congestive heart failure and peripheral artery disease. Purchases are being made to treat patients for these indications in the Dominican Republic, Greece and other countries.
The processing of eight patients during a month for distributors at Regenocell Laboratories, Ltd. will result in revenues exceeding $130,000. The combination of the existing business being serviced by the manufacturing operations and the addition of patients to be treated in other locations is expected to keep patient flow for the manufacturing facility at or above the breakeven of eight patients in the second half of 2012. Capacity at the current configuration of the manufacturing facility is more than double the breakeven. There can be no assurance of any patient flow for any given month.
Patients have been treated in the Dominican Republic and Greece. The business of the Company’s subsidiary providing for cell processing services will be expanded through the anticipated expansion by the Company through treating its own patients and expansion into other countries in which there are minimal requirements for autologous therapy. In addition new distributors are expected to expand treatment sites into new countries. Such expansion will make it more convenient for patients to receive the Company’s adult stem cell therapy and increase the total number of patients being treated per month.
Manufacturing and Distribution
We will be purchasing the stem cell therapy from our wholly owned subsidiary, Regenocell Laboratories, Ltd. at the same price it is currently selling to other customers. These other customers are treating patients the Dominican Republic and Greece. It is anticipated that other customers will be added over time. There is sufficient capacity to fulfill expanded orders over present monthly order flow. Distribution will remain the same with blood being drawn from the patient by the customer, sent to Regenocell Laboratories, Ltd. in Israel for cell processing and the resulting cells being sent to the customer for administration to the patient in the country designated by the customer.
Competition
With over 1,100 stem cell clinical trials authorized by the United States Food and Drug Administration in the United States, there are many companies researching and developing progenitor cell treatments for cardiovascular disease and peripheral artery disease. Among these are a number of well-established companies with recognized names. In order to effectively compete, we will be required to make substantial investments in sales and marketing as well as research and development. Many products are sold by companies with greater resources than the Company and there is no assurance that we will be successful in gaining significant market share for the treatment of congestive heart failure outside the United States with stem cell therapy, obtaining approval to market stem cell therapy in the United States for the treatment of peripheral artery disease or even with such approval that such product will earn a return on investment.
While there are many approved treatment options for congestive heart failure and peripheral artery disease, the focus of the Company is on no option patients. Thus, the many approved treatment options are no longer effective and the patient is either at risk of dying within a short period of time (congestive heart failure) or having a limb amputated (peripheral artery disease). There are many investigations and research programs underway by companies with more resources to develop new treatment options which would be competitive to the Company’s stem cell therapy. In addition to the potential competition from these efforts, the Company does have one primary direct competitor for the treatment outside the United States of congestive heart failure patients. Regenocycte Therapeutic, LLC has established a clinic in the Dominican Republic for the administration of stem cell therapy which has been purchased from Regenocell Laboratories, Ltd.
Regardless of any perceived or actual benefits and advantages, our technologies and products may be rendered obsolete or noncompetitive as a result of products introduced by competitors. Most of our competitors have substantially greater financial and technical resources, production and marketing capabilities and related experience. The greater resources, capabilities and experience of our competitors may enable them to develop, manufacture and market their products more successfully and at a lower cost. In addition, many of our competitors have significantly greater experience in conducting preclinical testing and clinical trials and obtaining regulatory approvals. Accordingly, our competitors may succeed in obtaining Food and Drug Administration (“FDA”) and related approvals for products more rapidly than we will, which may give them an advantage in achieving market acceptance of their products.
Moreover, our technologies and products will likely be affected by technological change in the future. Management will have to continue to stay abreast of these changes as they affect product configuration, and will have to remain vigilant and nimble in order to prevent early investments from becoming obsolete and other competitive firms who enter later obtaining an advantage with newer technologies and processes. There can be no assurances that we will be able to successfully develop and market our products or respond effectively to technological changes or new product announcements by others. Further, our success depends on the popularity of our products and services and related technology in the commercial arena, which we cannot guarantee. We also cannot guarantee that our products and services will not become unmarketable or obsolete by a competitor’s more rapid introduction to the marketplace.
Intellectual Property Matters
Where appropriate, we will seek patent, trademark and other proprietary rights protection for the products and brands we develop or introduce. In other cases, we will seek to license the rights to use the patents, trademarks and other proprietary rights of others in support of our business strategy. However, there can be no assurance that patent, trademark and other proprietary rights will issue for any applications we file or that we will be able to license such products and rights on terms acceptable to the Company, or at all. To date, the Company has not filed any applications or registrations for any patent, trademark and other proprietary rights.
Regulatory Matters
The research and development, preclinical studies and clinical trials, and ultimately, the culturing, manufacturing, marketing and labeling of our product candidates are subject to extensive regulation by the FDA and other regulatory authorities in the United States and other countries. All approvals necessary to manufacture the stem cell therapy product in Israel for use outside of Israel has been obtained by Regenocell Laboratories, Ltd. While stem cell therapy may be regulated pursuant to different statutes, we believe that stem cell therapy is subject to regulation in the United States as a biological product. Whatever regulatory pathway is selected by the FDA, any pathway will involve similar requirements as those for biological products.
Biological products are subject to regulation under the Federal Food, Drug, and Cosmetic Act, or the FD&C Act, the Public Health Service Act, or the PHS Act and their respective regulations as well as other federal, state, and local statutes and regulations. The FD&C Act and the PHS Act and the regulations promulgated thereunder govern, among other things, the testing, cell culturing, manufacturing, safety, efficacy, labeling, storage, record keeping, approval, clearance, advertising and promotion of stem cell therapy. Preclinical studies, clinical trials and the regulatory approval process typically take years and require the expenditure of substantial resources. If regulatory approval or clearance of a product is granted, the approval or clearance may include significant limitations on the indicated uses for which the product may be marketed.
FDA Regulation - Approval of Biological Products
The steps ordinarily required before a biological product may be marketed in the United States include:
•
completion of preclinical studies according to good laboratory practice regulations;
•
the submission of an IND application to the FDA, which must become effective before human clinical trials may commence;
•
performance of adequate and well-controlled human clinical trials according to good clinical practices to establish the safety and efficacy of the proposed biological product for its intended use;
•
satisfactory completion of an FDA pre-approval inspection of the manufacturing facility or facilities at which the product is manufactured, processes, packaged or held to assess compliance cGMP; and
•
the submission to, and review and approval by, the FDA of a biologics license application, or BLA, that includes satisfactory results of preclinical testing and clinical trials.
Preclinical tests include laboratory evaluation of the product candidate, its formulation and stability, as well as animal studies to assess the potential safety and efficacy of the product candidate. The FDA requires that preclinical tests be conducted in compliance with good laboratory practice regulations. The results of preclinical testing are submitted as part of an IND application to the FDA together with manufacturing information for the clinical supply, analytical data, the protocol for the initial clinical trials and any available clinical data or literature. A 30-day waiting period after the filing of each IND application is required by the FDA prior to the commencement of clinical testing in humans. In addition, the FDA may, at any time during this 30-day waiting period or any time thereafter, impose a clinical hold on proposed or ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot commence or recommence without FDA authorization.
Clinical trials to support BLAs involve the administration of the investigational product to human subjects under the supervision of qualified investigators. Clinical trials are conducted under protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the efficacy criteria to be evaluated.
Clinical trials are typically conducted in three sequential phases, but the phases may overlap:
In Phase I clinical trials, the initial introduction of the biological product candidate into human subjects or patients, the product candidate is tested to assess safety, dosage tolerance, absorption, metabolism, distribution and excretion, including any side effects associated with increasing doses.
Phase II clinical trials usually involve studies in a limited patient population to identify possible adverse effects and safety risks, preliminarily assess the efficacy of the product candidate in specific, targeted indications; and assess dosage tolerance and optimal dosage.
If a product candidate is found to be potentially effective and to have an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken within an expanded patient population at multiple study sites to further demonstrate clinical efficacy and safety, further evaluate dosage and establish the risk-benefit ratio of the product and an adequate basis for product labeling.
Phase IV, or post-marketing, trials may be mandated by regulatory authorities or may be conducted voluntarily. Phase IV trials are typically initiated to monitor the safety and efficacy of a biological product in its approved population and indication but over a longer period of time, so that rare or long-term adverse effects can be detected over a much larger patient population and time than was possible during prior clinical trials. Alternatively, Phase IV trials may be used to test a new method of product administration, or to investigate a product’s use in other indications. Adverse effects detected by Phase IV trials may result in the withdrawal or restriction of a drug.
If the required Phase I, II and III clinical testing is completed successfully, the results of the required clinical trials, the results of product development, preclinical studies and clinical trials, descriptions of the manufacturing process and other relevant information concerning the safety and effectiveness of the biological product candidate are submitted to the FDA in the form of a BLA. In most cases, the BLA must be accompanied by a substantial user fee. The FDA may deny a BLA if all applicable regulatory criteria are not satisfied or may require additional data, including clinical, toxicology, safety or manufacturing data. It can take several years for the FDA to approve a BLA once it is submitted, and the actual time required for any product candidate may vary substantially, depending upon the nature, complexity and novelty of the product candidate.
Before approving an application, the FDA will inspect the facility or facilities where the product is manufactured. The FDA will not approve a BLA unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements.
If the FDA evaluations of the BLA and the manufacturing facilities are favorable, the FDA may issue either an approval letter or an approvable letter. The approvable letter usually contains a number of conditions that must be met to secure final FDA approval of the BLA. When, and if, those conditions have been met to the FDA’s satisfaction, the FDA will issue an approval letter. If the FDA’s evaluation of the BLA or manufacturing facility is not favorable, the FDA may refuse to approve the BLA or issue a non-approvable letter that often requires additional testing or information.
There can be no assurances that approval will be granted for stem cell therapy or any future product or product candidate, whether in the United States or elsewhere, on a timely basis or at all. Furthermore, if approval is granted, the product would be subject to continuing regulatory regulations and oversight. The approval process is expensive and can take a long time to complete, and the cost involved in satisfying applicable ongoing compliance requirements is high.
Research and Development
The Company did not invest in research and development for its previous business plan to develop cafes in South Carolina and then in other states in the South East featuring gourmet coffee, pastries and related items. In order to implement the new business strategy, the Company will have to invest in research and development with respect to its treatment of patients outside the United States for submitting an IND for stem cell therapy treatment for peripheral artery disease in the United States and Europe and conducting the clinical trials necessary to apply for approval to market for this indication. In addition Regenocell Laboratories, Ltd. will invest in research and development to create new stem cell therapy products.
Employees
The Company currently employs one individual, James F. Mongiardo. Regenocell Laboratories, Ltd. has eight (8) employees.
Item 1A.
Item 1A.
Risk Factors
Risks Concerning Our Business
The new stem cell business is subject to claims by TheraVitae, Inc. that it is covered by intellectual property owned by it.
As more fully described in Legal Proceedings, our new stem cell business is subject to claims by TheraVitae, Inc. that it is covered by intellectual property owned by it. While the Company disputes these claims, there is no assurance that litigation pending in Canada will be resolved in the Company’s favor.
There is no assurance that there will be sufficient monthly patient flow for Regenocell Laboratories, Ltd. to break even.
Patient flow is dependent upon marketing efforts of other companies and changing regulatory climates. There is no assurance that there will be sufficient monthly patient flow for Regenocell Laboratories, Ltd. to break even.
Any adverse development in our ability to treat patients outside the United States with stem cell technology could substantially depress our stock price and prevent us from raising the capital we will need to further develop our stem cell technology.
To an unusual extent, our ability to progress as a company is significantly dependent on our ability to treat patients outside the United States with stem cell technology. Any clinical, regulatory or other development that prevents or delays us from treating patients outside the United States, or any safety issue or adverse side effect to any patient that occurs during such treatment, or the failure to enroll patients as anticipated or to show the results expected by investors, would likely significantly impact our plan of operations and could prevent us from raising the substantial additional capital we will require to further develop stem cell technologies.
We have limited operating capital and will likely seek additional financing in the future.
The growth of our business will require significant additional investment. We do not presently have adequate cash from operations or financing activities to meet our short-term or long-term needs and are dependent on cash infusions in order to continue operations. We are dependent on cash flows from our operations and new Offerings to implement our business plan.
Due to our early stage of operations, regardless of the amount of funds raised in new offerings, there is a substantial risk that all investors may lose all of their investment.
Our financial situation is precarious and, based on currently estimated operating expenses, our existing capital resources may not be sufficient to fund our operations beyond the next 6 months.
We have incurred significant operating losses and negative cash flows from operations since inception. We have not achieved profitability and may not be able to realize sufficient revenues to achieve or sustain profitability in the future. We expect to incur additional and increasing operating losses. We have limited liquidity and capital resources and must obtain significant additional capital resources in order to sustain our product development efforts and for acquisition of technologies and intellectual property rights, preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals, acquisition of capital equipment, laboratory and office facilities, establishment of production capabilities, maintaining and enforcing our intellectual property portfolio, general and administrative expenses and other working capital requirements. We rely on cash reserves and proceeds from equity offerings to fund our operations. If we exhaust our cash reserves and are unable to realize adequate financing, we may be unable to meet operating obligations and be required to initiate bankruptcy proceedings. Our existing capital resources may not be sufficient to fund our operations beyond the next 6 months. We intend to pursue opportunities to obtain additional financing in the future through equity and debt financings, corporate alliances, grants and collaborative research arrangements. The source, timing and availability of any future financing will depend principally upon market conditions, interest rates and, more specifically, on our progress in our exploratory, preclinical and future clinical development programs. Funding may not be available when needed - at all or on terms acceptable to us. Lack of necessary funds may require us to delay, scale back or eliminate some or all of our research and product development programs and/or our capital expenditures or to license our potential products or technologies to third parties.
Our product development programs are based on novel technologies and are inherently risky.
We are subject to the risks of failure inherent in the development of products based on new technologies. The novel nature of our therapeutic products creates significant challenges in regards to product development and optimization, manufacturing, government regulation, third party reimbursement and market acceptance. For example, the FDA has relatively little experience with stem cell-based therapeutics, and the pathway to regulatory approval for our product candidates may accordingly be more complex and lengthy than the pathway for new conventional drugs. These challenges may prevent us from developing and commercializing products on a timely or profitable basis or at all.
Our technology is at an early stage of development, and we may fail to develop any commercially acceptable or profitable products.
Before we may commercially market any product in the United States, we must obtain regulatory approval from the FDA after conducting extensive preclinical studies and clinical trials that demonstrate that our product candidates are safe and effective for each disease for which we seek approval. We expect that none of our stem cell therapy product candidates will be commercially available for five years, if at all, in the United States.
In the United States we will have to obtain approval from the FDA to conduct clinical trials.
There is no assurance that the FDA will ever grant such approval. Even with approval by the FDA to conduct Phase I or Phase I/II clinical trials, there can be no assurance that the clinical investigators will be able to identify suitable candidates for the trials or of a successful outcome of the trials if candidates are enrolled. We may fail to obtain regulatory approvals or to commercialize any products. Any product using stem cell technology may fail to:
o
provide the intended therapeutic benefits; or
o
achieve therapeutic benefits equal to or better than the standard of treatment at the time of testing.
In addition, our products may cause undesirable side effects. Results of preclinical research may not be indicative of the results that will be obtained in later stages of preclinical or clinical research. If regulatory authorities do not approve our products or if we fail to maintain regulatory compliance, we would be unable to commercialize our products, and our business and results of operations would be harmed. Furthermore, because stem cells are a new form of therapy, the marketplace may not accept any products we may develop. If we do succeed in developing products, we will face many potential obstacles such as the need to obtain regulatory approvals and to develop or obtain manufacturing, marketing and distribution capabilities. In addition, we will face substantial additional risks such as product liability claims.
We may need but fail to obtain partners to support our stem cell development efforts and to commercialize our technology.
Equity and debt financings alone may not be sufficient to fund the cost of developing our stem cell technologies, and we may need to rely on our ability to reach partnering arrangements to provide financial support for our stem cell discovery and development efforts. In addition, in order to successfully develop and commercialize our technology, we may need to enter into a wide variety of arrangements with corporate sponsors, pharmaceutical companies, universities, research groups and others. While we expect to engage in discussions regarding such arrangements, we have not reached any agreement, and we may fail to obtain any such agreement on terms acceptable to us. Even if we enter into these arrangements, we may not be able to satisfy our obligations under them or renew or replace them after their original terms expire. Furthermore, these arrangements may require us to grant certain rights to third parties, including exclusive marketing rights to one or more products, may require us to issue securities to our collaborators or may contain other terms that are burdensome to us. If any of our collaborators terminates our relationship with us or fails to perform our obligations in a timely manner, the development or commercialization of our technology and potential products may be adversely affected.
We have a history of operating losses, and we may fail to obtain revenues or become profitable.
We expect to continue to incur substantial operating losses in the future in order to conduct our research and development activities, and, if those activities are successful, to fund clinical trials and other expenses. These expenses include the cost of acquiring technology, product testing, acquiring regulatory approvals, establishing production, marketing, sales and distribution programs and administrative expenses.
If we are unable to protect our patents and proprietary rights, our business, financial condition and results of operations will be harmed.
Patent protection for products such as those we propose to develop is highly uncertain and involves complex and continually evolving factual and legal questions. The governmental authorities that consider patent applications can deny or significantly reduce the patent coverage requested in an application before or after issuing the patent. Consequently, we do not know if any future patents will provide sufficient protection or significant commercial advantage or if others will circumvent these patents. We cannot be certain that we were the first to discover the inventions covered by each future patent applications or that we were the first to file patent applications for such inventions because patent applications are secret until they are published, and because publication of discoveries in the scientific or patent literature often lags behind actual discoveries. Patents may not issue from our future patent applications or, if issued, may not be of commercial benefit to us. In addition, our patents may not afford us adequate protection from competing products. Third parties may challenge our patents or governmental authorities may declare them invalid or reduce their scope. In the event that a third party has also filed a patent application relating to inventions claimed in our patent applications, we may have to participate in proceedings to determine priority of invention. Even if a patent issues, a court could decide that the patent was issued invalidly. Because patents issue for a limited term, our patents may expire before we utilize them profitably. Procedures of the European Patent Office, third parties may oppose our issued European patents during the relevant opposition period. These proceedings and oppositions could result in substantial uncertainties and cost for us, even if the eventual outcome is favorable to us, and the outcome might not be favorable to us.
If we learn of third parties who infringe our patent rights, we may need to initiate legal proceedings to enforce our patent rights. These proceedings may entail significant costs, and these third parties may have significantly greater financial resources than us. We may not prevail in these proceedings.
Proprietary trade secrets and unpatented know-how are also important to our research and development activities. We cannot be certain that others will not independently develop the same or similar technologies on their own or gain access to our trade secrets or disclose such technology or that we will be able to meaningfully protect our trade secrets and unpatented know-how. We require our employees, consultants, and significant scientific collaborators and sponsored researchers to execute confidentiality agreements upon the commencement of an employment or consulting relationship with us. These agreements may, however, fail to provide meaningful protection or adequate remedies for us in the event of unauthorized use, transfer or disclosure of such information or technology.
If others are first to discover and patent the stem cells we are seeking to discover, we could be blocked from further work on those stem cells.
Because the first person or entity to discover and obtain a valid patent to a particular stem cell may effectively block all others, it will be important for us or our collaborators to be the first to discover any stem cell and methods that we are seeking to discover. Failure to be the first could prevent us from commercializing all of our research and development affected by that patent.
If we are unable to obtain necessary licenses to third-party patents and other rights, we may not be able to commercially develop our expected products.
A number of pharmaceutical, biotechnology and other companies, universities and research institutions have filed patent applications or have received patents relating to cell therapy, stem cells and other technologies potentially relevant to or necessary for our expected products. We cannot predict which, if any, of the applications will issue as patents, and there may be existing patents of which we are currently unaware which the commercialization of our product candidates would infringe. If third party patents or patent applications contain valid claims that our technology infringes upon their technology, we may be prevented from commercializing that technology unless the third party is willing to grant a license to us. We may be unable to obtain licenses to the relevant patents at a reasonable cost, if at all, and may also be unable to develop or obtain alternative non-infringing technology. If we are unable to obtain such licenses or develop non-infringing technology at a reasonable cost, our business could be significantly harmed. Also, any infringement lawsuits commenced against us may result in significant costs, divert our management's attention and result in an award against us for substantial damages.
We are aware of intellectual property rights held by third parties that relate to products or technologies we are developing. For example, some aspects of our stem cell product candidates involve the use of growth factors, antibodies and other reagents that may, in certain cases, be the subject of third party rights. Before we commercialize any product using these growth factors, antibodies or reagents, we may need to obtain license rights from third parties or use alternative growth factors, antibodies and reagents that are not then the subject of third party patent rights. We currently believe that the commercialization of our products as currently planned will not infringe these third party rights, or, alternatively, that we will be able to obtain necessary licenses or otherwise use alternate non-infringing technology. However, third parties may nonetheless bring suit against us claiming infringement. If we are unable to prove that our technology does not infringe their patents, or if we are unable to obtain necessary licenses or otherwise use alternative non-infringing technology, we may not be able to commercialize any products. Also, if we use alternative non-infringing technology, we may need to demonstrate comparability in subsequent clinical trials.
We have obtained rights to technologies, processes and compounds that we believe may be important to the development of our products. These licensors, however, may cancel our licenses if we fail to use the relevant technology or otherwise breach these agreements. Loss of these licenses could expose us to the risk that our technology infringes the rights of third parties. We can give no assurance that any of these licenses will provide effective protection against our competitors.
We compete with companies that have significant advantages over us.
It is expected that our therapeutic products will have to compete with a variety of therapeutic products and procedures. Major pharmaceutical companies currently offer a number of pharmaceutical products to treat congestive heart failure and peripheral artery disease and other diseases for which our technologies may be applicable. Many pharmaceutical and biotechnology companies are investigating new drugs and therapeutic approaches for the same purposes, which may achieve new efficacy profiles, extend the therapeutic window for such products, alter the prognosis of these diseases, or prevent their onset. We believe that our products, when and if successfully developed, will compete with these products principally on the basis of improved and extended efficacy and safety and their overall economic benefit to the health care system. The market for therapeutic products is large, and competition is intense. We expect competition to increase. We believe that our most significant competitors will be fully integrated pharmaceutical companies and more established biotechnology companies. Smaller companies may also be significant competitors, particularly through collaborative arrangements with large pharmaceutical or biotechnology companies. Many of these competitors have significant products approved or in development that could be competitive with our products.
Competition for any stem cell products that we may develop may be in the form of existing and new drugs, other forms of cell transplantation, ablative and simulative procedures, and gene therapy. Some competitors are also trying to develop stem and progenitor cell-based technologies. These products may compete with our therapeutic products based on efficacy, safety, cost and intellectual property positions.
We may also face competition from companies that have filed patent applications relating to the use of genetically modified cells to treat disease, disorder or injury. In the event our therapies should require the use of such genetically modified cells, it may be required to seek licenses from these competitors in order to commercialize certain of our proposed products, and such licenses may not be granted or may be available only on unfavorable terms.
With over 1,100 stem cell clinical trials authorized by the United States Food and Drug Administration in the United States, there are many companies researching and developing progenitor cell treatments for cardiovascular disease and peripheral artery disease. Among these are a number of well-established companies with recognized names. In order to effectively compete, we will be required to make substantial investments in sales and marketing as well as research and development. Many products are sold by companies with greater resources than the Company and there is no assurance that we will be successful in gaining significant market share for the treatment of congestive heart failure outside the United States with stem cell therapy, obtaining approval to market stem cell therapy in the United States for the treatment of peripheral artery disease or even with such approval that such product will earn a return on investment.
While there are many approved treatment options for congestive heart failure and peripheral artery disease, the focus of the Company is on no option patients. Thus, the many approved treatment options are no longer effective and the patient is either at risk of dying within a short period of time (congestive heart failure) or having a limb amputated (peripheral artery disease). There are many investigations and research programs underway by companies with more resources to develop new treatment options which would be competitive to the Company’s stem cell therapy.
If we develop products that receive regulatory approval, we would then have to compete for market acceptance and market share. For certain of our products, an important success factor will be the timing of market introduction of competitive products. This is a function of the relative speed with which we and our competitors can develop products, complete the clinical testing and approval processes, and supply commercial quantities of a product to market. These competitive products may also impact the timing of clinical testing and approval processes by limiting the number of clinical investigators and patients available to test our products.
While we believe that the primary competitive factors will be product efficacy, safety, and the timing and scope of regulatory approvals, other factors include, in certain instances, obtaining marketing exclusivity under the Orphan Drug Act, availability of supply, marketing and sales capability, reimbursement coverage, price, and patent and technology position.
Development of our technology is subject to and restricted by extensive government regulation, which could impede our business.
Our research and development efforts, as well as any future clinical trials, and the manufacturing and marketing of any products we may develop, will be subject to and restricted by extensive regulation by governmental authorities in the United States and other countries. The process of obtaining FDA and other necessary regulatory approvals is lengthy, expensive and uncertain. We or our collaborators may fail to obtain the necessary approvals to commence or continue clinical testing or to manufacture or market our potential products in reasonable time frames, if at all. In addition, the United States Congress and other legislative bodies may enact regulatory reforms or restrictions on the development of new therapies that could adversely affect the regulatory environment in which we operate or the development of any products we may develop.
We base our research and development on the use of human stem cells obtained from the blood of the patient. The federal and state governments and other jurisdictions impose restrictions on the use of blood. These regulatory and other constraints could prevent us from obtaining cells and other components of our products in the quantity or quality needed for their development or commercialization. These restrictions change from time to time and may become more onerous. Certain components used to manufacture our stem cell product candidates may need to be manufactured in compliance with the FDA's Good Manufacturing Practices, or cGMP. Accordingly, we may need to enter into supply agreements with companies that manufacture these components to cGMP standards.
Government regulation and threatened regulation of embryonic tissue may lead top researchers to leave the field of stem cell research, or the country, in order to assure that their careers will not be impeded by restrictions on their work. Similarly, these factors may induce the best graduate students to choose other fields less vulnerable to changes in regulatory oversight, thus exacerbating the risk, discussed below, that we may not be able to attract and retain the scientific personnel we need in face of the competition among pharmaceutical, biotechnology and health care companies, universities and research institutions for what may become a shrinking class of qualified individuals. Moreover, it is possible that concerns regarding research using embryonic stem cells will negatively impact our stock price and our ability to attract collaborators and investors.
We may apply for status under the Orphan Drug Act for some of our therapies to gain a seven-year period of marketing exclusivity for those therapies. The United States Congress in the past has considered, and in the future again may consider, legislation that would restrict the extent and duration of the market exclusivity of an orphan drug. If enacted, such legislation could prevent us from obtaining some or all of the benefits of the existing statute even if we were to apply for and obtain orphan drug status with respect to a potential product.
We are dependent on the services of key personnel.
We are highly dependent on the principal members of our management and scientific staff and some of our outside consultants, including our chief executive officer, our chief medical officer and the chief technical officer of Regenocell Laboratories, Ltd. Although we have entered into employment agreements with some of these individuals, they may terminate their agreements at any time. In addition, our operations are dependent upon our ability to attract and retain additional qualified scientific and management personnel. We may not be able to attract and retain the personnel we need on acceptable terms given the competition for experienced personnel among pharmaceutical, biotechnology and health care companies, universities and research institutions.
Our activities involve hazardous materials and experimental animal testing; improper handling of these animals and materials by our employees or agents could expose us to significant legal and financial penalties.
Our research and development activities involve the controlled use of hazardous chemicals and potentially hazardous biological materials such as human tissue and animals. Their use subjects us to environmental and safety laws and regulations such as those governing laboratory procedures, exposure to blood-borne pathogens, use of animals and the handling of bio-hazardous materials. Compliance with current or future laws and regulations may be expensive and the cost of compliance could adversely affect us.
Although we believe that our safety procedures for using, handling, storing and disposing of hazardous and potentially hazardous materials comply with the standards prescribed by state and federal regulations, the risk of accidental contamination or injury from these materials cannot be eliminated. In the event of such an accident or of any violation of these or future laws and regulations, state or federal authorities could curtail our use of these materials; we could be liable for any civil damages that result, the cost of which could be substantial; and we could be subjected to substantial fines or penalties. In addition, any failure by us to control the use, disposal, removal or storage, or to adequately restrict the discharge, or to assist in the cleanup of hazardous chemicals or hazardous, infectious or toxic substances could subject us to significant liability. Any such liability could exceed our resources and could have a material adverse effect on our business, financial condition and results of operations. Moreover, an accident could damage our research and manufacturing facilities and operations and result in serious adverse effects on our business.
The manufacture, development and commercialization of stem cell products expose us to product liability claims, which could lead to substantial liability.
By developing and, ultimately, commercializing medical products, we are exposed to the risk of product liability claims. Product liability claims against us could entail substantial litigation costs and damage awards against us. We may not be able to obtain insurance on acceptable terms, if at all, and the policy limits on our insurance policies may be insufficient to cover our liability.
Since health care insurers and other organizations may not pay for our products or may impose limits on reimbursements, our ability to become profitable could be reduced.
In both domestic and foreign markets, sales of potential products are likely to depend in part upon the availability and amounts of reimbursement from third party health care payor organizations, including government agencies, private health care insurers and other health care payors, such as health maintenance organizations and self-insured employee plans. There is considerable pressure to reduce the cost of therapeutic products, and government and other third party payors are increasingly attempting to contain health care costs by limiting both coverage and the level of reimbursement for new therapeutic products and by refusing, in some cases, to provide any coverage for uses of approved products for disease indications for which the FDA has not granted marketing approval. Significant uncertainty exists as to the reimbursement status of newly approved health care products or novel therapies such as ours. Even if we obtain regulatory approval to market our products, we can give no assurance that reimbursement will be provided by such payors at all or without substantial delay or, if such reimbursement is provided, that the approved reimbursement amounts will be sufficient to enable us to sell products we develop on a profitable basis. Changes in reimbursement policies could also adversely affect the willingness of pharmaceutical companies to collaborate with us on the development of our stem cell technology. We also expect that there will continue to be a number of federal and state proposals to implement government control over health care costs. Efforts at health care reform are likely to continue in future legislative sessions. We do not know what legislative proposals federal or state governments will adopt or what actions federal, state or private payers for health care goods and services may take in response to health care reform proposals or legislation. We cannot predict the effect government control and other health care reforms may have on our business.
We have limited liquidity and capital resources and may not obtain the significant capital resources we will need to sustain our research and development efforts.
We have limited liquidity and capital resources and must obtain substantial additional capital to support our research and development programs, for acquisition of technology and intellectual property rights and, to the extent we decide to undertake these activities ourselves, for preclinical and clinical testing of our anticipated products, pursuit of regulatory approvals, establishment of production capabilities, maintaining and enforcing our intellectually property portfolio, establishment of marketing and sales capabilities and distribution channels, and general administrative expenses. If we do not obtain the necessary capital resources, we may have to delay, reduce or eliminate some or all of our research and development programs or license our technology or any potential products to third parties rather than commercialize them ourselves. We intend to pursue our needed capital resources through equity and debt financings, corporate alliances, grants and collaborative research arrangements. We may fail to obtain the necessary capital resources from any such sources when needed or on terms acceptable to us. Our ability to complete successfully any such arrangements will depend upon market conditions and, more specifically, on continued progress in our research and development efforts.
Ethical and other concerns surrounding the use of stem cell therapy may negatively affect regulatory approval or public perception of our product candidates, which could reduce demand for our products.
The use of stem cells for research and therapy has been the subject of debate regarding related ethical, legal and social issues. Although these concerns have mainly been directed to the use of embryonic stem cells, which we do not use, the distinction between embryonic and non-embryonic stem cells is frequently overlooked. Negative public attitudes toward stem cell therapy could result in greater governmental regulation of stem cell therapies, which could harm our business. For example, concerns regarding such possible regulation could impact our ability to attract collaborators and investors. Government regulation and threatened regulation of embryonic tissue could also harm our ability to attract and retain qualified scientific personnel by causing top researchers to leave the country or the field of stem cell research altogether; and by encouraging the best graduate students to choose other fields that are less vulnerable to changes in regulatory oversight.
Risks Related to the Securities Market
Our stock price is highly volatile, which may negatively affect our ability to obtain additional financing in the future.
The market price of our Shares is highly volatile due to the risks and uncertainties described in this risk factors section, as well as other factors, including:
·
our ability to develop and test our technology;
·
our ability to patent or obtain licenses to necessary technology;
·
our ability to find private pay patients for treatment outside the United States;
·
our ability to treat patients in the Dominican Republic and Greece;
·
conditions and publicity regarding the industry in which we operate, as well as the specific areas our product candidates seek to address;
·
competition in our industry;
·
price and volume fluctuations in the stock market at large that are unrelated to our operating performance; and
·
comments by securities analysts, or our failure to meet market expectations.
As a result of this volatility, an investment in our Shares is subject to substantial risk. Furthermore, the volatility of our stock price could negatively impact our ability to raise capital in the future.
We are contractually obligated to issue shares in the future, diluting the interest of current shareholders.
As of December 1, 2011, there were contractual obligations to issue stock options to purchase 860,000 shares of our common stock. Moreover, we expect to issue additional options to purchase shares of our common stock to compensate employees, consultants and directors, and may issue additional shares to raise capital, to acquire other companies or technologies, to pay for services or for other corporate purposes. Any such issuances will have the effect of diluting the interest of current shareholders.
Item 1B.
Item 1B.
Unresolved Staff Comments
There are no unresolved staff comments.
Item 2.
Item 2.
PROPERTIES
The Company does not own any real property or any interest in real property and does not invest in real property or have any policies with respect thereto as a part of its operations or otherwise.
The principal business address of the Company is 2 Briar Lane, Natick, Massachusetts 01760, which is space owned by the President and Chief Executive Officer of the Company. Rent has not been charged for the office space and it is not expected that rent will be charged in the near-term.
Regenocell Laboratories, Ltd. has assumed a lease with Africa-Israel for its manufacturing operations in Israel. That lease ended August 31. 2011. The Company is in negotiations with Africa-Israel to extend the lease although there can be no assurance that the lease will be extended. While these negotiations continue, lease payments converted to dollars are $10,400 plus VAT totaling $12,050 per month. There is $135,000 in a restricted account used by Bank Hapoalim to guarantee payment of the lease.
Item 3.
Item 3.
LEGAL PROCEEDINGS
On February 10, 2010, Kwalata Trading Limited, a wholly owned subsidiary of TheraVitae, Inc., a Canadian corporation, obtained an ex parte order from the District Court for the Central Region of Israel to seize the intellectual property allegedly owned by Kwalata which is in the possession of either Theravitae, Ltd. or Regenocell Laboratories Ltd., the wholly owned Israeli subsidiary corporation of the Company. The Court appointed trustee took files and computers including computers dedicated solely to equipment from Regenocell Laboratories facilities at 7, Pinchas St., Ness Ziona in what the Company considered to be an unlawful attempt to close the facilities.
Prior to a scheduled hearing, a settlement agreement was reached which then became the resolution of the case by the District Court for the Central Region of Israel. All equipment and files taken are to be returned subject to copying by the applicants at their expense. Excluded from copying are attorney-client privileged documents, business documents and private documents. Regenocell Laboratories and the Company agree not to disclose the alleged intellectual property to third parties except in the ordinary course of business, for government filings and when a non disclosure agreement is obtained. This order remains in effect until a subsequent order by the Court or the resolution of an arbitration begun in Canada by Kwalata against TheraVitae, Ltd.
On October 20, 2010, TheraVitae, Inc., the same Canadian corporation involved in the litigation in Israel, served the Company with a Statement of Claim filed with the Ontario, Canada Superior Court of Justice alleging breach of a Confidentiality and Non-Circumvention Agreement. On December 29, 2010, the company filed its Statement of Defence. On February 23, 2011, the Company moved for Summary Judgment. TheraVitae at the same time cross moved to dismiss the Company’s defenses. Neither motion has been scheduled for hearing. The Company believes that the Statement of Claim is totally without merit.
In July 2011 nine employees/former employees brought an action to recover certain benefits they claim are due but have not been paid. The claims made for the payment of certain benefits are now being investigated. To the extent that the claims are valid, it is the intention to resolve the matter amicably.
On November 3, 2011, Kwalata Trading Limited, a wholly owned subsidiary of TheraVitae, Inc., a Canadian corporation, attempted to obtain an ex parte order from the District Court for the Central Region of Israel to issue a preliminary injunction for alleged violations of a patent issued in Israel. The Court declined the ex parte application and set a hearing for November 10. At the conclusion of an abbreviated hearing, the District Court did not issue the requested preliminary injunction. In February 2012 the Court ruled against Kwalata Trading Limited and refused to grant the preliminary injunction requested. The Court did affirm the settlement agreement previously made in the first case in Israel in which Regenocell Laboratories, Ltd. agreed to limit the sale of its stem cell therapy for heart failure and peripheral artery disease and related indications.
Item 4.
Item 4.
SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On January 4, 2010 through written consent in lieu of a special meeting of the stockholders of RegenoCELL Therapeutics, Inc., stockholders representing at least of majority of the outstanding stock of the Company agreed to purchase certain assets which will give the Company control over the manufacture of the stem cell product which will be used to treat patients as well as supply that products for patients being treated by other corporations in the Dominican Republic, Greece and other locations, and the Company having arranged for the funding needed to execute the agreements which will give it control over the manufacture of the stem cell product thereupon approved, adopted, ratified and confirmed the following actions taken by the Board of Directors: (1) Effective January 4, 2010, or as soon as practicable thereafter, create a wholly-owned subsidiary incorporated under the laws of the state of Israel with the corporate name “Regenocell Laboratories, Ltd.” The sole shareholder of Regenocell Laboratories, Ltd. shall be the Corporation; and upon creation of Regenocell Laboratories, Ltd., authorize James F. Mongiardo to serve as its sole director; and upon the appointment of James F. Mongiardo as the sole director of Regenocell Laboratories, Ltd., authorize the opening of corporate accounts for Regenocell Laboratories, Ltd. with Bank Hapoalim or another local bank in Israel with employees of Regenocell Laboratories, Ltd. being authorized as signatories on said accounts; (2) approve an Asset Purchase Agreement between Regenocell Laboratories, Ltd. and TheraVitae Ltd., a company incorporated under the laws of the state of Israel; (3) approve an Assignment of Rights between Yieldex, Ltd., a company incorporated under the laws of Hong Kong; (4) pursuant to the terms of the Yieldex agreement, issue forty million (40,000,000) restricted common shares, par value $0.0001. Said shares shall be initially issued in the name of “Yieldex, Ltd.”, held in escrow by the Corporation and voted in accordance with recommendations by the Corporation’s Board until agreed upon Share Lock-Up and Corporate Governance documents are executed by each entity or person to receive these shares. When presented with such documents setting forth the entire re-allocation of these shares, the Corporation shall instruct the transfer agent to cancel the Yieldex, Ltd. stock certificate and re-issue the same number shares in accordance with the instructions and documentation received; (5) approve a Loan Agreement between Mr. Christian Frampton and the Corporation for one hundred sixty thousand United States dollars ($160,000); and (6) in return for the personal guarantee of the President of the Corporation James F. Mongiardo to guarantee the repayment of the capital but not the fee of the loan, grant James F. Mongiardo a first lien on all assets of the Corporation including its wholly owned subsidiaries until said capital has been repaid by the Corporation.
PART II.
Item 5.
Item 5.
MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
Our common stock is currently quoted on the OTC Bulletin Board under the symbol “RCLL.OB”. Trading began on May 23, 2011. The following table sets forth the high and low closing prices per share of common stock as reported on the OTC Bulletin Board. Prices per share f or common stock have been adjusted for the three to one stock split on March 31, 2008 and the ten to one stock split May 29, 2008.
Price Range of Common Stock
As of March 31, 2012, there were approximately 30 holders of record of the common stock. We have never paid any cash dividends on our common stock and we do not anticipate paying such cash dividends in the foreseeable future. We currently anticipate that we will retain all future earnings, if any, for use in the development of our business.
At inception, Mr. Scott Massey who is the founder of our Company purchased 2,000,000 shares of our common stock at par value for a total purchase price of $200.
During the year ended December 31, 2006, the Company repurchased 206,250 shares of its outstanding common stock from unaffiliated shareholders for a total amount of $8,750. The shares were retired.
On March 12, 2008, the Board of Directors voted unanimously for a 3 to 1 stock split to be effective for stockholders of record on March 31, 2008. This increased the number of outstanding shares of common stock from approximately 2,344,000 to 7,031,250 shares as of that date. Subsequently, on May 29, 2008 the Board of Directors voted unanimously for a 10 to 1 stock split to be effective for stockholders of record on June 13, 2008. This increased the number of outstanding shares of common stock from approximately 7,031,000 shares to 70,312,500 as of that date.
The above actions were filed with the State as amendments to the Company’s Articles of Incorporation on May 29, 2008.
On July 7, 2008, the Company Amended its Articles of Incorporation changing the name of the corporation to RegenoCELL Therapeutics, Inc. and increasing the authorized capitalization to 600,000,000 shares.
The Company also issued restricted common shares to the following:
On July 22, 2008, the Board authorized the issuance of 90,000,000 restricted common shares par value $0.0001 to TheraVitae, Inc. in accordance with the Letter of Intent. Said shares were held by the Company in escrow with full control of voting rights until release to TheraVitae upon completion and execution of the agreements incorporating the terms of the Letter of Intent.
On July 23, 2008, the Board authorized the cancellation from certain shareholders of 49,125,000 restricted common shares, par value $0.0001. Said shares were returned to the transfer agent for cancellation and were cancelled.
On December 31, 2009, the Board concluded that the agreements incorporating the terms of the Letter of Intent with TheraVitae, Inc. had not been completed and there appeared to be no possibility of their completion and authorized the cancellation of 90,000,000 restricted common shares par value $0.0001 being held by the Company in escrow for TheraVitae, Inc. Said shares were returned to the transfer agent for cancellation and were cancelled.
On January 4, 2010, pursuant to the terms of the Assignment of Rights Agreement between Yieldex, Ltd. and the Company, 40,000,000 shares of the Company’s common stock, par value $.0001, were issued subject to a two year Lock-Up period beginning January 4, 2010 and a voting rights agreement.
On July 6, 2010, the Company issued 200,000 shares of its common stock as payment for legal services rendered. These shares were value at $0.05 per share, resulting in an aggregate value of $10,000.
On August 5, 2010 the Company issued 59,091 shares of common stock for cash at $0.11 per share, for an aggregate share value of $6,500. Pursuant to this transaction the investor also received warrants to purchase 50,000 shares of common stock at $0.75 per share.
On July 25, 2011 the Company issued 125,000 shares of its common stock as payment for accounting services. These shares were valued at $0.18 per share, resulting in an aggregate value of $22,500.
On August 5, 2011, in exchange for the services provided, the Company issued 90,909 shares of the Company’s common stock with a fair value of $10,000. During the year ended December 31, 2011, $10,000 was recorded as consulting expense. The value of the shares issued was based on the trading price of the stock on the date of issuance.
As of December 31, 2011, there were 81,962,500 shares of the registrant's Common Stock outstanding and approximately 28 shareholders of record.
Issuer Purchases Of Equity Securities
During the year ended December 31, 2006, the Company repurchased 206,250 shares of its outstanding common stock from unaffiliated shareholders for a total amount of $8,750. The shares were retired.
On July 23, 2008, the Board authorized the cancellation from certain shareholders of 49,125,000 restricted common shares, par value $0.0001. Said shares were returned to the transfer agent for cancellation and were cancelled.
On December 31, 2009, the Board concluded that the agreements incorporating the terms of the Letter of Intent with TheraVitae, Inc. had not been completed and there appeared to be no possibility of their completion and authorized the cancellation of 90,000,000 restricted common shares par value $0.0001 being held by the Company in escrow for TheraVitae, Inc. Said shares were returned to the transfer agent for cancellation and were cancelled.
Equity Compensation Plan Information
The Company did not have an Equity Compensation Plan during the year ended December 31, 2010.
Item 6.
Item 6.
SELECTED FINANCIAL DATA
The following tables present selected consolidated historical financial data and should be read together with “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” the consolidated financial statements and notes thereto and other financial information included elsewhere in this Annual Report on Form 10-K. We derived the selected consolidated statement of operations data for the years ended December 31, 2007, 2008, 2009, 2009, 2010 and 2011 and consolidated balance sheet data as of December 31, 2007, 2008, 2009, 2010 and 2011 from our audited financial statements and notes thereto that are included elsewhere in this Annual Report on Form 10-K.
Item 7.
Item 7.
MANAGEMENT'S DISCUSSION AND ANALYSIS OR PLAN OF OPERATIONS
The following discussion and analysis by our management of our financial condition and results of operations should be read in conjunction with our consolidated financial statements and the accompanying notes included in this annual report.
Cautionary Statement Regarding Forward-Looking Statements
This report may contain forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act, and we intend that such forward-looking statements be subject to the safe harbors created thereby. These forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Any such forward-looking statements would be contained principally in “Management’s Discussion and Analysis or Plan of Operations” and “Risk Factors.” Forward-looking statements include information concerning our possible or assumed future results of operations, business strategies, financing plans, competitive position, industry environment, potential growth opportunities and the effects of regulation. Forward-looking statements include all statements that are not historical facts and can be identified by terms such as “anticipates,” “believes,” “could,” “estimates,” “expects,” “hopes,” “intends,” “may,” “plans,” “potential,” “predicts,” “projects,” “should,” “will,” “would” or similar expressions.
Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. We discuss many of these risks in greater detail in “Risk Factors.” Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, forward-looking statements represent our management’s beliefs and assumptions only as of the date of this report. You should read this report and the documents that we reference in this report and have filed as exhibits to the report completely and with the understanding that our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future.
Our Ability To Continue as a Going Concern
Our independent registered public accounting firm has issued its report dated May 15, 2012 in connection with the audit of our financial statements as of December 31, 2011 that included an explanatory paragraph describing the existence of conditions that raise substantial doubt about our ability to continue as a going concern. Our consolidated financial statements as of December 31, 2011 have been prepared under the assumption that we will continue as a going concern. If we are not able to continue as a going concern, it is likely that holders of our common stock will lose all of their investment. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
Discussion and Analysis
The new mission of the Company is to bring stem cell therapy treatments to the market as quickly as possible. The Company identified a company treating patients with adult stem cells for congestive heart failure and other indications. The company located in Bangkok, Thailand, has developed a process to identify and process adult stem cells found in a patient’s blood. These adult stem cells are grown into large numbers in vitro (outside the body) and then encouraged to differentiate into angiogenic precursor cells or blood vessel forming cells for the treatment of congestive heart failure. These adult stem cells can also be used for the treatment of other conditions such as peripheral artery disease. The manufacturing operations for this process are located in Israel.
Currently congestive heart failure patients cleared for treatment have one-half pint of blood drawn which is sent to the cell processing facility in Israel. After the adult stem cells in the patient’s blood have been extracted and grown into large numbers of angiogenic precursor cells, they are sent to the Dominican Republic and Greece for infusion into the patient in a minimally invasive procedure. The stem cell therapy is either delivered through a catheter or injected directly into the myocardium. All patients are private pay.
The results to date have been impressive. Over three hundred (500) congestive heart failure patients with no other options have shown similar results to a clinical trial of 24 patients. In that trial, statistically significant improvements between baseline and the three month and six month follow-up were achieved for:
·
Improvement in the six minutes walking test.
·
Increase in metabolic equivalent units (METs) during the stress test.
·
Decrease in the perfusion defect region of the target artery.
·
Decrease in the Canadian Cardiovascular Society (CCS) Grading Scale.
On January 7, 2010 the Company entered into two agreements, which closed on February 4, 2010.
The first agreement is between TheraVitae Limited, the Israeli corporation manufacturing the stem cell therapy product, and a newly formed Israeli corporation which is a wholly owned subsidiary of the Company, Regenocell Laboratories, Ltd. Pursuant to the terms of the agreement, certain assets were acquired and certain liabilities assumed. These assets include all the manufacturing and office equipment and the transfer of the lease. At signing the Company paid $75,000 toward the reduction of the assumed liabilities. All the employees were terminated then offered and accepted employment with Regenocell Laboratories, Ltd.
The second agreement is between Yieldex, Ltd. and the Registrant for the acquisition of certain rights. This includes clinical data, the non exclusive use of the CRM System which manages clinical data and input necessary to schedule a patient for stem cell production, and all rights in patent and patent applications, if any, in connection with activities of stem cell research, therapy development and clinical trials under the trade name ”TheraVitae” for the world except for Asia. Israel is excluded by definition from being part of Asia. The cash price is $5,000,000 (five million United States dollars), of which $75,000 was paid to TheraVitae Limited and $25,000 to Yieldex on January 7. The balance is due in monthly installments on or before January 4, 2015. Minimum installments are $5,000 per patient processed in Israel after the first eight patients during the preceding month. In addition 25% of any equity raised by the Company will be applied to the outstanding balance.
In addition 40,000,000 (forty million) shares of the Company’s common stock, par value $0.0001, was issued to Yieldex Ltd and its nominees. The 40,000,000 shares are restricted and subject to a two year Lock-Up period beginning January 4, 2010. These shares are also subject to a voting agreement. During the Lock-Up period and for any subsequent period until the shares are sold to the public in the open market, the Board of Directors will be expanded to five members and the shareholders whose shares are locked up will vote for a maximum of two directors. The Company’s shareholders who are not parties to the Lock-Up agreement will vote their shares for the same two directors until the aggregate number of Yieldex shares are 15,000,000 (fifteen million) or less. The Yieldex shareholders agree to vote the Yieldex shares for a maximum of three directors designated by James F. Mongiardo. While this voting rights agreement is in effect, unanimous approval of all the directors then in office or approval of holders of at least a majority of the shares will be required for: (i) any proposal to increase capital in a way that would result in dilution of existing shareholders’ percentages by ten percent (10%) or more; (ii) any proposal to merge, consolidate or amalgamate with any other corporate entity; (iii) any proposal to sell all or a material part of the assets; and, (iv) any proposal to amend the bylaws.
As a result of the actions described above, on February 4, 2010 the Company’s primary business is the Regenocell Laboratories Ltd. operation which is manufacturing and selling stem cell therapy product used to treat congestive heart failure and peripheral artery disease. Purchases are being made to treat patients for these indications in Bangkok, Thailand and the Dominican Republic. It is anticipated that purchases will also be made to treat patients in other countries.
For the year ended December 31, 2011, the Company had revenues of $865,020 compared to $910,048 for the same year ended 2010. Net loss from operations for the twelve months ended December 31, 2011 was $862,874 compared to $3,555,257 for the same twelve months in 2010. Revenues in 2011 and 2010 were similar with a small decrease in the number of cell processing patients in 2011. The decrease in net loss in 2011 was primarily a function of the Company recognizing a $2,740,614 impairment expense in 2010 relating to certain licensing rights acquired during the year.
Cash on hand was $11,054 as of December 31, 2011 which amount is inadequate to fund the company’s current projected capital requirements. In order to implement the new strategy of the Company, the Company will need to raise capital during the next twelve months. The Company has funded operations to date in part through the sale of equity securities and loans, although such efforts have been insufficient to effectively pursue its business strategy.
With respect to Regenocell Laboratories, Ltd., processing eight patients obtained through distributors during a month will likely result in revenues exceeding $130,000. The combination of the existing business being serviced by the manufacturing operations and the addition of patients to be obtained directly and treated in other locations is expected to keep patient flow for the manufacturing facility at or above the breakeven of eight patients during the second half of 2012. Capacity at the current configuration of the manufacturing facility is more than double the breakeven. There can be no assurance of any patient flow for any given month.
Our capital requirements will depend on numerous factors, including but not limited to the commitments and progress of our research and development efforts, the progress of clinical trials, the cost of sales and marketing for the congestive heart failure stem cell therapy business and other products, medical and business consultants and advisors, the time and cost involved in maintaining regulatory compliance, and competing technological and market developments. Future activities, including the establishment of stem cell therapy for the treatment of peripheral artery disease in the medical marketplace, will be subject to our ability to raise funds.
We intend to raise capital primarily through the public or private sale of securities (equity and/or debt), although there can be no assurance that we will be able to obtain capital or, if such capital is available, that the terms of any financing will be acceptable. If the Company succeeds in raising capital, such funds will be used to facilitate the manufacturing operations of Regenocell Laboratories Ltd., to find new customers for Regenocell Laboratories Ltd. With respect to peripheral artery disease, capital will be used for completing the research and development to submit an IND (and its equivalent in Europe) for authorization to begin clinical trials in the United States and Europe. This may include payment for additional animal trials. Payment for clinical trials includes retaining the services of a clinical research organization, payment to the clinical research site(s) for patients enrolled in the clinical trials, payment for the stem cell therapy used in these clinical trials, payment for costs associated with Institution Review Board Approval, and preparation of reports to the Food and Drug Administration (“FDA”) and European Medicines Agency (“EMEA”), requests to continue later phase clinical trials and submission of a BLA to the FDA and its equivalent to the EMEA requesting marketing approval for the treatment of peripheral artery disease.
The Company also does not expect to purchase any plant or significant equipment over the next 12 months. Regenocell Laboratories, Ltd. may purchase between $100,000 - $300,000 in new equipment for its manufacturing operations.
If we are unsuccessful at raising sufficient capital to fund our operations, for whatever reason, we may be forced to seek opportunities outside of our new corporate focus or to seek a buyer for our business or another entity with which we could partner. Ultimately, if all of these alternatives fail, we may be required to cease operations and seek protection from creditors under applicable bankruptcy laws.
Item 7A.
Item 7A.
QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Interest Rate Risk
Our primary market risk exposure with respect to interest rates is changes in short-term interest rates in the U.S. We do not use any interest rate risk management contracts to manage our fixed-to-floating ratio. The impact on our results of operations from a hypothetical 10% change in interest rates would not be significant.
The majority of our investments are expected to be in short-term debt securities. The primary objective of our investment activities is to preserve principal while at the same time maximizing the income we receive without significantly increasing risk. To reduce risk, we maintain our cash and cash equivalents in short-term interest-bearing instruments, including certificates of deposit and overnight funds. We do not have any derivative financial investments in our investment portfolio.
Item 8.
Item 8.
FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
RegenoCELL Therapeutics, Inc.
REGENOCELL THERAPEUTICS, INC.
SADLER, GIBB & ASSOCIATES, L.L.C.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
RegenoCELL Therapeutics, Inc.
We have audited the accompanying consolidated balance sheets of RegenoCELL Therapeutics, Inc. as of December 31, 2011 and 2010 and the related consolidated statements of operations, stockholders’ deficit and cash flows for the periods then ended. These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on these consolidated financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. Our audits included consideration of internal control over financial reporting as a basis for designing audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion. An audit also includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements, assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audits provide a reasonable basis for our opinion.
In our opinion the consolidated financial statements referred to above present fairly, in all material respects, the financial position of RegenoCELL Therapeutics, Inc. as of December 31, 2011 and 2010 and the results of their operations and their cash flows for the years then ended, in conformity with U.S. generally accepted accounting principles.
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 has not yet established an ongoing source of revenue sufficient to cover its operating costs which raises substantial doubt about its ability to continue as a going concern. Management’s plans concerning these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.
/s/ Sadler, Gibb & Associates, LLC
Sadler, Gibb & Associates, LLC
Salt Lake City, UT
May 24, 2012
The accompanying notes are an integral part of these consolidated financial statements
The accompanying notes are an integral part of these consolidated financial statements
The accompanying notes are an integral part of these consolidated financial statements
The accompanying notes are an integral part of these consolidated financial statements
The accompanying notes are an integral part of these consolidated financial statements
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 1 - NATURE OF OPERATIONS
RegenoCELL Therapeutics, Inc. (“the Company") was incorporated in the State of Florida on February 1, 2002 and was originally located in South Carolina. In July 2008 the Company relocated its headquarters to Massachusetts and amended its corporate mission so as to develop a stem-cell therapy business for the treatment of congestive heart failure and peripheral artery disease. On July 7, 2008, the Company amended its articles of incorporation changing the name of the corporation to RegenoCELL Therapeutics, Inc.
The mission of the Company is to bring stem cell therapy treatments to the market as quickly as possible. The Company’s therapy utilizes a process to identify and process adult stem cells found in a patient’s blood. These adult stem cells are grown into large numbers in vitro (outside the body) and then encouraged to differentiate into angiogenic precursor cells or blood vessel-forming cells for the treatment of congestive heart failure. These adult stem cells can also be used for the treatment of other conditions such as peripheral artery disease.
NOTE 2 - GOING CONCERN
The Company's financial statements are prepared using generally accepted accounting principles in the United States of America applicable to a going concern which contemplates the realization of assets and liquidation of liabilities in the normal course of business. The Company has not yet established an ongoing source of revenues sufficient to cover its operating costs and allow it to continue as a going concern. The ability of the Company to continue as a going concern is dependent on the Company obtaining adequate capital to fund operating losses until it becomes profitable. If the Company is unable to obtain adequate capital, it could be forced to cease operations.
In order to continue as a going concern, the Company will need, among other things, additional capital resources. Management's plan is to obtain such resources for the Company by obtaining capital from management and significant shareholders sufficient to meet its minimal operating expenses and seeking equity and/or debt financing. However management cannot provide any assurances that the Company will be successful in accomplishing any of its plans.
The ability of the Company to continue as a going concern is dependent upon its ability to successfully accomplish the plans described in the preceding paragraph and eventually secure other sources of financing and attain profitable operations. The accompanying financial statements do not include any adjustments that might be necessary if the Company is unable to continue as a going concern.
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Principles of Consolidation
The accompanying financial statements include the accounts of RegenoCELL Therapeutics, Inc. and its wholly-owned subsidiaries, Regenocell Laboratories, Ltd., and Regenocell, Ltd. All inter-company transactions have been eliminated in the consolidation.
Accounting Basis
The Company’s financial statements are prepared using accounting principles generally accepted in the United States of America. The Company has elected a December 31 year-end.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Cash and Cash Equivalents
For purposes of cash flows, the Company considers all highly liquid instruments purchased with a maturity of three months or less to be cash equivalents to the extent the funds are not being held for investment purposes. The Company at times may maintain a cash balance in excess of insured limits. The Company had $11,054 and $3,436 of cash and cash equivalents outstanding as of December 31, 2011 and 2010.
Accounts Receivable
The Company periodically reviews its trade receivables for potential collectability issues. The Company has implemented the policy to periodically create an allowance for bad debts for those trade receivables older than 120 days outstanding. For the years ended December 31, 2011 and 2010, the Company recognized no bad debt expense as all accounts were deemed to be fully collectible.
Property and Equipment
Property and equipment are stated at cost. Major additions and improvements are capitalized in the month following the month in which the assets or improvement are deemed to be placed in service. Maintenance and repairs are expensed as incurred. Upon disposition, the net book value is eliminated from the accounts, with the resultant gain or loss reflected in operations. Depreciation expense is computed on a straight-line basis over the estimated useful lives of the assets as follows:
Machinery and equipment:
5 years
Furniture and fixtures & leasehold improvements:
5-7 years
Computers and software:
2 years
Vehicles:
5 years
The Company periodically assesses the recoverability of property, plant and equipment and evaluates such assets for impairment whenever events or changes in circumstances indicate that the net carrying amount of an asset may not be recoverable. Asset impairment is determined to exist if estimated future cash flows, undiscounted and without interest charges, are less than the net carrying amount.
Intangible Assets
Intangible assets are stated at cost. Amortization expense is computed on a straight-line basis over the estimated useful lives of the intangible assets. Periodically, management reviews intangible assets for potential impairment issues. If management determines that the carrying value of an intangible asset is less than the undiscounted future cash flows expected to be derived from the intangible asset, the Company records an impairment expense for the calculated difference. During the year ended December 31, 2011 and 2010, respectively, the Company recorded impairment expense of $-0- and $2,740,614, relating to certain licensing rights acquired.
Financial Instruments
Pursuant to ASC 820, Fair Value Measurements and Disclosures, an entity is required to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 establishes a fair value hierarchy based on the level of independent, objective evidence surrounding the inputs used to measure fair value. A financial instrument’s categorization within the fair value hierarchy is based upon the lowest level of input that is significant to the fair value measurement. ASC 820 prioritizes the inputs into three levels that may be used to measure fair value:
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Financial Instruments (Continued)
Level 1
Level 1 applies to assets or liabilities for which there are quoted prices in active markets for identical assets or liabilities.
Level 2
Level 2 applies to assets or liabilities for which there are inputs other than quoted prices that are observable for the asset or liability such as quoted prices for similar assets or liabilities in active markets; quoted prices for identical assets or liabilities in markets with insufficient volume or infrequent transactions (less active markets); or model-derived valuations in which significant inputs are observable or can be derived principally from, or corroborated by, observable market data.
Level 3
Level 3 applies to assets or liabilities for which there are unobservable inputs to the valuation methodology that are significant to the measurement of the fair value of the assets or liabilities.
The Company’s financial instruments consist principally of cash, property and equipment, accounts receivable and payable, accrued liabilities, notes payable and amounts due to related parties. The recorded values of all of the Company’s financial instruments approximate their current fair values because of their nature and respective maturity dates or durations.
Revenue Recognition
The Company recognizes revenue primarily from stem cell processing. The Company recognizes revenue when the services are completed, delivery has occurred, and collection is reasonably assured and all obligations with respect to the transaction are satisfied.
Comprehensive Loss
Total comprehensive loss represents the net change in stockholders' equity during a period from sources other than transactions with stockholders and as such, includes net loss. For the Company, the components of other comprehensive loss are the changes in the cumulative foreign currency translation adjustments and are recorded as components of stockholders' deficit.
Stock-Based Compensation
In October 1995, the FASB issued SFAS No. 123, “Accounting for Stock-Based Compensation” (ASC 718). ASC 718 prescribes accounting and reporting standards for all stock-based compensation plans, including employee stock options, restricted stock, employee stock purchase plans and stock appreciation rights. ASC 718 requires compensation expense to be recorded using the new fair value method. The Company has opted for the disclosure provisions of ASC 718.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 3 - SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (CONTINUED)
Provision for Taxes
The Company applies ASC 740, which requires the asset and liability method of accounting for income taxes. This method requires that the current or deferred tax consequences of all events recognized in the financial statements be measured by applying the provisions of enacted tax laws to determine the amount of taxes payable or refundable currently or in future years. Deferred tax assets are reviewed for recoverability and the Company records a valuation allowance to reduce its deferred tax assets when it is more likely than not that all or some portion of the deferred tax assets will not be recovered. ASC 740 requires the reduction of deferred tax assets by a valuation allowance if, based on the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized.
Basic and Diluted Loss per Common Share
Basic loss per share is calculated by dividing the Company’s net loss applicable to common shareholders by the weighted average number of common shares during the period. Diluted earnings per share is calculated by dividing the Company’s net income available to common shareholders by the diluted weighted average number of shares outstanding during the year. The diluted weighted average number of shares outstanding is the basic weighted number of shares adjusted for any potentially dilutive debt or equity. There 8,431,085 and -0- such common stock equivalents as a result of convertible notes payable and warrants outstanding as of December 31, 2011 and 2010, respectively.
Foreign Currency Translation
Assets and liabilities of the Company's foreign operations are translated from its functional currency of the New Israeli Shekel into its reporting currency of the U.S. dollar at period-end exchange rates. Net exchange gains or losses resulting from such translation are excluded from net loss but are included in comprehensive loss and accumulated in a separate component of stockholders' equity. Income and expenses are translated at the average exchange rate for the period. Equity transactions are translated at historical rates.
Business Segments
The Company operates in one segment, and therefore segment information is not presented.
Concentration of Credit Risk
The Company's financial instruments that are exposed to concentration of credit risk are cash. Additionally, the Company maintains cash balances in bank deposit accounts which, at times, may exceed federally insured limits.
Major Customers
During the year ended December 31, 2011 the Company had two customers to whom sales exceeded 10 percent of the Company’s total sales for the period. Each customer is an unrelated third party. These two companies combined to constitute approximately 95 percent of the Company’s gross revenues for the years ended December 31, 2011 and December 31, 2010.
Reclassifications
Certain comparative figures have been reclassified to conform to the current year’s presentation.
Recent Accounting Pronouncements
The Company has evaluated recent accounting pronouncements and their adoption has not had or is not expected to have a material impact on the Company’s financial position, or statements.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 4 - PROPERTY AND EQUIPMENT
Property and equipment are stated at cost. Depreciation is computed over the estimated life of the assets. Depreciation expense for the years ended December 31, 2011 and 2010 amounted to $63,510 and $58,788, respectively. Gains from losses on sales and disposals are included in the statements of operations. Maintenance and repairs are charged to expense as incurred. As of December 31, 2011 and 2010 property and equipment consisted of the following:
NOTE 5 - ASSET ACQUISITION
In January, 2010 the Company created a wholly-owned foreign subsidiary in Israel for the purpose of developing and operating the laboratory facilities associated with its products. The name of the subsidiary is Regenocell Laboratories Ltd. On January 7, 2010, Regenocell Laboratories Ltd. consummated an Asset Purchase Agreement with TheraVitae Limited. Under the terms of the agreement the Company acquired certain assets of TheraVitae Limited at a book value of approximately $370,000, in exchange for assuming certain liabilities of approximately $334,000 and $100,000 in cash (all currency is in US dollars).
NOTE 6 - RELATED PARTY NOTES PAYABLE
During the year ended December 31, 2011, the Company borrowed $774,249 from a related party to fund continuing operations. Of this amount, $121,449 represented expenses paid on behalf of the Company by the related party. The Company made payments on the note totaling $571,734 during the period, leaving an outstanding balance of $581,090 at December 31, 2011. The note is uncollateralized, bears no interest and is due on demand.
On January 7, 2010 the Company consummated an agreement to purchase the intangible assets of Yieldex, Inc., a company incorporated in Hong Kong. Pursuant to the terms of the agreement, the Company purchased the rights to certain patents and patent applications in connection with its activities of stem cell research, therapy development, and clinical trials, under the trade name "TheraVitae." The agreement also assigned rights to testing procedures, testing results, and full copy data from clinical trials conducted by the seller over its operating and research history. This also includes all other related procedures, software files, etc.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 6 - RELATED PARTY NOTES PAYABLE (CONTINUED)
The assets were acquired in exchange for 40,000,000 shares of the Company’s common stock, $100,000 cash, and a non-interest bearing note, payable January 25, 2015, in the amount of $4,900,000. Per the terms of the agreement, repayment of the note will be made out of proceeds of revenues relating to the assigned intangible assets and out of capital raised by the Company. Pursuant to this transaction, Yieldex became a related-party entity (greater than 10 percent shareholder).
The Company’s related-party note payable with a face value of $4,900,000, which has been discounted to present value assuming a 12 percent interest rate. On the date of issuance, the amount of the discount was calculated to be $2,227,302, and is being amortized using the effective interest method over the term of the note and charged to interest expense on the income statement. As of December 31, 2011 the unamortized discount was $1,533,870.
NOTE 7 - NOTES PAYABLE
As of December 31, 2011, the Company holds $224,500 in notes payable to unrelated third party entities. One of these notes, with a principal balance of $102,000, is non-interest bearing and due on demand. The remaining notes, with an aggregate principal balance of $122,500, bear interest at a rate of five percent per annum, and are also due on demand. During the year ended December 31, 2011, the Company borrowed an additional $50,000 and made no principal payments on these notes. Total accrued interest payable on the notes at December 31, 2011 was $117,704.
NOTE 8 - CONVERTIBLE NOTES PAYABLE
On July 19, 2011, the Company executed a convertible promissory note in the amount of $65,000. The note bears interest at a rate of eight percent per annum and has a maturity date of April 23, 2012. Any amount of principal or interest not paid in full at maturity will bear an interest rate of 22 percent. The convertible promissory note may be converted in whole or in part, at the option of the holder, to shares of common stock at any time following 180 days after the issuance date of the note. The conversion price under the note is 60 percent multiplied by the market price (representing a 40 percent discount rate).
On August 10, 2011, the Company executed a convertible promissory note in the amount of $50,000. The note bears interest at a rate of eight percent per annum and has a maturity date of May 15, 2012. Any amount of principal or interest not paid in full at maturity will bear an interest rate of 22 percent. The convertible promissory note may be converted in whole or in part, at the option of the holder, to shares of common stock at any time following 180 days after the issuance date of the note. The conversion price under the note is 60 percent multiplied by the market price (representing a 40 percent discount rate).
NOTE 9 - DERIVATIVE LIABILITY
The Company follows ASC 815 which defines determining whether an instrument (or embedded feature) is solely indexed to an entity’s own stock. The Company borrowed $65,000 on July 19, 2011, and $50,000 on August 10, 2011. These notes are convertible at the holder’s option at 60 percent of the average of the lowest three closing prices during the 10 days prior to conversion. The number of shares issuable upon conversion of these notes is limited so that the holder’s total beneficial ownership of the Company’s common stock may not exceed 4.99 percent of the total issued and outstanding shares.
The exercise price of both conversion options are subject to “reset” provisions in the event the Company subsequently issues common stock, stock warrants, stock options or convertible debt with a stock price, exercise price or conversion price lower than effective conversion price of the conversion option. If these provisions are triggered, the exercise price of all their warrants will be reduced. As a result, the conversion options are not considered to be solely indexed to the Company’s own stock and are not afforded equity treatment.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 9 - DERIVATIVE LIABILITY (CONTINUED)
The total fair value of the conversion option of the July 19, 2011 note ($65,824), and the July 19, 2011 note ($48,896) has been recognized as a derivative liability on the dates of issuance with all future changes in the fair value of these conversion options being recognized in earnings in the Company’s statement of operations under the caption “Other income (expense) - Gain (loss) on derivative liability” until such time as the warrants are exercised or expire.
ASC 815 requires the Company to assess the fair market value of certain derivatives at each reporting period and recognize any change in the fair market value of the derivatives as gain (loss) on the income statements. The Company uses the Black-Scholes option pricing model to value the derivative liabilities and subsequent remeasurements. Included in the models are the following assumptions: a risk free rate of 0.02 percent, an exercise price of $0.01 per share, a dividend yield of -0- percent, and annual volatility ranging from 346.7 percent to 364.9 percent. For the years ended December 31, 2011 and 2010, the Company recognized a loss on derivative liability of $29,899 and $-0-, respectively.
NOTE 10 - STOCKHOLDERS’ EQUITY
Stock Issued for Cash
On August 5, 2010 the Company issued 50,000 shares of common stock for cash at $0.50 per share, for an aggregate share value of $25,000. Pursuant to this transaction the investor also received warrants to purchase an 50,000 shares of common stock at $0.75 per share.
Stock Issued for Services
On August 5, 2011, in exchange for the services provided, the Company issued 150,000 shares of the Company’s common stock with a fair value of $10,000. During the year ended December 31, 2011, $10,000 was recorded as consulting expense. The value of the shares issued was based on the trading price of the stock on the date of issuance.
Stock Issued for Settlement of Debt
On July 25, 2011 the Company issued 125,000 shares of common stock as extinguishment of $21,480 of debt. The shares were valued at $0.18 per share, resulting in a total share value of $22,625 and a loss on extinguishment of debt of $1,145. The value of the shares issued was based on the trading price of the stock on the date of issuance.
NOTE 11 - STOCK OPTIONS AND WARRANTS
The following tables summarize all stock options granted for the years ended December 31, 2011, and the related changes during these periods are presented below.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 11 - STOCK OPTIONS AND WARRANTS (continued)
The following table summarizes information regarding our outstanding and exercisable options at December 31, 2011 and 2010:
In determining the compensation cost of the stock options granted, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes option pricing model. The assumptions used in these calculations are summarized as follows:
NOTE 12 - COMMITMENTS AND CONTINGENCIES
Litigation
Kwalata Trading Limited - On February 10, 2010, Kwalata Trading Limited, a wholly owned subsidiary of TheraVitae, Inc., a Canadian corporation, obtained an ex parte order from the District Court for the Central Region of Israel to seize the intellectual property alleged owned by Kwalata which is in the possession of either Theravitae, Ltd. or Regenocell Laboratories Ltd., the wholly owned Israeli subsidiary corporation of the Company. The Court appointed trustee took files and computers including computers dedicated solely to equipment from Regenocell Laboratories facilities at 7, Pinchas St., Ness Ziona in what the Company considered to be an unlawful attempt to close the facilities.
Prior to a scheduled hearing, a settlement agreement was reached which then became the resolution of the case by the District Court for the Central Region of Israel. All equipment and files taken are to be returned subject to copying by the applicants at their expense. Excluded from copying are attorney-client privileged documents, business documents and private documents. Regenocell Laboratories and the Company agree not to disclose the alleged intellectual property to third parties except in the ordinary course of business, for government filings and when a non disclosure agreement is obtained. This order remains in effect until a subsequent order by the Court or the resolution of an arbitration begun in Canada by Kwalata against TheraVitae, Ltd.
As a consequence, the Company continues to operate in Israel, is able to process patients and is able to open new locations to treat patients. The Company also believes that the claims made by Kwalata Trading are without merit and no monies will be due after resolution of the arbitration.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 12 - COMMITMENTS AND CONTINGENCIES (continued)
TheraVitae, Inc. - On October 20, 2010, TheraVitae, Inc., the same Canadian corporation involved in the litigation in Israel, served the Company with a Statement of Claim filed with the Ontario, Canada Superior Court of Justice alleging breach of a Confidentiality and Non-Circumvention Agreement. On December 29, 2010, the company filed its Statement of Defence. On February 23, 2011, the Company moved for Summary Judgment. TheraVitae at the same time cross moved to dismiss the Company’s defenses. The hearing on the two motions is scheduled for October 1, 2011. The Company believes that the Statement of Claim is without merit and that no monies will be due after resolution of this action.
Office Lease
The Company leases office space in Kiryat Weizmann, Israel under an operating lease. The lease provides for a lease payment of $11,713 per month beginning August 30, 2006 expiring August 31, 2011. Currently the Company is renegotiating the lease and is on a month-to-month lease term.
NOTE 13 - INCOME TAXES
The Company accounts for income taxes in accordance with ASC 740, Income Taxes , which requires the recognition of deferred tax liabilities and assets at currently enacted tax rates for the expected future tax consequences of events that have been included in the financial statements or tax returns. A valuation allowance is recognized to reduce the net deferred tax asset to an amount that is more likely than not to be realized.
ASC 740 provides guidance on the accounting for uncertainty in income taxes recognized in a company’s financial statements. ASC 740 requires a company to determine whether it is more likely than not that a tax position will be sustained upon examination based upon the technical merits of the position. If the more likely-than-not threshold is met, a company must measure the tax position to determine the amount to recognize in the financial statements.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 13 - INCOME TAXES (CONTINUED)
Net deferred tax assets consist of the following components as of December 31, 2011 and 2010:
The income tax provision differs from the amount of income tax determined by applying the estimated U.S. federal and state income tax rates of 34 percent to pretax income from continuing operations for the year ended December 31, 2011 and 2010 due to the following:
At December 31, 2011, the Company had net operating loss carry forwards of approximately $2,068,280 through 2031. No tax benefit has been reported in the December 31, 2011 financial statements since the potential tax benefit is offset by a valuation allowance of the same amount.
Due to the change in ownership provisions of the Tax Reform Act of 1986, net operating loss carry forwards for Federal income tax reporting purposes are subject to annual limitations. Should a change in ownership occur, net operating loss carry forwards may be limited as to use in future years.
NOTE 14 - SUBSEQUENT EVENTS
On January 4, 2012, the Company executed a convertible promissory note in the amount of $42,500. The note bears interest at a rate of eight percent per annum and has a maturity date of October 6, 2012. Any amount of principal or interest not paid in full at maturity will bear an interest rate of 22 percent. The convertible promissory note may be converted in whole or in part, at the option of the holder, to shares of common stock at any time following 180 days after the issuance date of the note. The conversion price under the note is 60 percent multiplied by the market price (representing a 40 percent discount rate).
On February 10, 2012, the Company executed a convertible promissory note in the amount of $37,500. The note bears interest at a rate of eight percent per annum and has a maturity date of November 14, 2012. Any amount of principal or interest not paid in full at maturity will bear an interest rate of 22 percent. The convertible promissory note may be converted in whole or in part, at the option of the holder, to shares of common stock at any time following 180 days after the issuance date of the note. The conversion price under the note is 60 percent multiplied by the market price (representing a 40 percent discount rate).
Subsequent to the period end, the Company issued 500,000 shares of common stock at $0.03 per share for services rendered to the Company. The Company also issued 7,968,714 shares of common stock in conversion of $65,000 of convertible debt outstanding at December 31, 2011.
REGENOCELL THERAPEUTICS, INC.
Notes to Consolidated Financial Statements
December 31, 2011 and December 31, 2010
NOTE 15 - RESTATEMENT
During November 2012, the Company discovered material errors associated with the financial statements issued for the period January 1, 2010 to December 31, 2010.
The Company has determined that its previously filed Form 10-K included an amount related to payroll liabilities that was overstated. The previous balance was $391,124; the new restated amount is $131,982. As a result the Company restated the December 31, 2010 financial statements.
The Company adjusted previously issued financial statements to reflect the following in connection with the restatement:
Item 9.
Item 9.
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
By letter dated March 20, 2010, Lieberman, Sharma & Associates PA (“Lieberman”) resigned as the independent auditor for the Company effective January 1, 2010 because the firm has elected to no longer continue as a reporting firm under the guidelines of the Public Company Accounting Oversight Board (PCAOB).
Lieberman’s reports on the financial statements of the Company for the fiscal years ended December 31, 2008, December 31, 2007, December 31, 2006, December 31, 2005, December 31, 2004 and for the period from February 1, 2002 (inception) through December 31, 2008 contain no adverse opinion or disclaimer of opinion. Except for the going concern qualifications, there were no other qualifications.
The Company’s Board of Directors approved the change in independent auditors.
For the fiscal year ended December 31, 2008, December 31, 2007, December 31, 2006, December 31, 2005, December 31, 2004 and for the period from February 1, 2002 (inception) through December 31, 2008 and for the period January 1, 2009 through January 1, 2010 (the date the relationship ended with the former auditor), there has been no disagreement between the Company and Lieberman, on any matter of accounting principles or practices, financial statement disclosure, or auditing scope or procedure, which disagreement, if not resolved to the satisfaction of Lieberman would have caused it to make a reference to the subject matter of the disagreement in connection with its reports.
During the fiscal years ended December 31, 2008, December 31, 2007, December 31, 2006, December 31, 2005 and December 31, 2004, and for the period from February 1, 2002 (inception) through December 31, 2008 and for the period from January 1, 2009 through January 1, 2010 (the date the relationship ended with the former auditor), the Company has not been advised of any matter described in Regulation S-B, Item 304 (a) (1) B).
The Company engaged Sadler, Gibb and Associates, P.O. Box 411, Farmington, Utah 84025 (“Gibb”) as its new independent auditors as of February 23, 2010. Prior to such date the Company did not consult with Gibb regarding (i) the application of accounting principles, (ii) the type of audit opinion that might be rendered by Gibb, or (iii) any other matter that was subject of a disagreement between the Company and its former auditor as described in Item 304 (a) (1) (iv) of Regulation S-B.
ITEM 9A.
ITEM 9A.
CONTROLS AND PROCEDURES
Evaluation of Disclosure Controls and Procedures
In connection with the preparation of this annual report on Form 10-K, an evaluation was carried out by our management, with the participation of the Chief Executive Officer and Principal Accounting Officer, of 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 ("Exchange Act")) as of December 31, 2010. Disclosure controls and procedures are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC rules and forms and that such information is accumulated and communicated to management, including the Chief Executive Officer and the Principal Financial Officer, to allow timely decisions regarding required disclosures.
Based on that evaluation, our management concluded, as of the end of the period covered by this report, that our disclosure controls and procedures were effective in recording, processing, summarizing, and reporting information required to be disclosed, within the time periods specified in the SEC's rules and forms.
Management's Report on Internal Control Over Financial Reporting
Management of our company is responsible for establishing and maintaining adequate internal control over financial reporting. Our company's internal control over financial reporting is a process, under the supervision of the Chief Executive Officer and the Principal Accounting Officer, designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of the Company's financial statements for external purposes in accordance with United States generally accepted accounting principles. 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 the Company's assets;
• Provide reasonable assurance that transactions are recorded as necessary to permit preparation of the financial statements in accordance withgenerally accepted accounting principles, and that receipts and expenditures are being made only in accordance with authorizations of management and the Board of Directors; and
• Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the Company's assets that could have a material effect on the financial statements.
Because of its 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 conducted an assessment of the effectiveness of the Company's internal control over financial reporting as of December 31, 2011, based on criteria established in Internal Control - Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission ("COSO").
Based on this assessment, our management has concluded that, as of December 31, 2011, the Company's internal control over financial reporting is effective.
Changes in Internal Control over Financial Reporting
As of the end of the period covered by this report, there have been no changes in internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) during the quarter ended December 31, 2011, that materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
Item 9B.
Item 9B.
OTHER INFORMATION
None.
Part III
Item 10.
Item 10.
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
The following table sets forth certain information as of the date of this report with respect to the directors and executive officers of the Company. A summary of the background and experience of each of these individuals is set forth after the table. Each director holds such position until the next annual meeting of the Company's shareholders and until his respective successor has been elected and qualifies. Any of the Company's directors may be removed with or without cause at any time by the vote of the holders of not less than a majority of the Company's then outstanding Common Stock. Other than as otherwise provided in an employment agreement, officers are elected annually by the Board of Directors. Any of the Company's officers may be removed with or without cause at any time by the Company's Board of Directors.
Directors and Executive Officers
Our directors, executive officers and key employees are as follows:
From September 30, 2002 through July 2, 2008, Scott Massey, 39, was the sole officer and director of the Company. Mr. Massey served as the Company’s President, principal executive officer, principal financial officer and director.
Beginning July 16, 2008, James F. Mongiardo replaced Mr. Massey as director and was elected Chief Executive Officer, President, Treasurer and Secretary of the Company. Mr. Mongiardo will serve as a director of the Company until the next annual meeting of stockholders and until his successor is elected and qualified or until his earlier resignation or removal. Mr. Mongiardo will serve as Chief Executive Officer, President, Treasurer and Secretary of the Company until his successor is chosen and qualified or until his earlier resignation or removal.
Mr. Mongiardo served as interim and then Chief Operating Officer and director of Total ReCord, Inc. from November 2005 to December 2006. He served as sole director and President, Chief Executive Officer, Treasurer and Secretary of CardioBioMedical Corporation from its inception May 2003. In 2000, Mr. Mongiardo formed Homewood Capital Group, LLC, an investment advisory firm specializing in institutional private placements for emerging companies, at which he currently serves as Managing Director. From 1995 to 2000, Mr. Mongiardo served as Managing Director of LBC Capital, LLC, an investment banking firm. Mr. Mongiardo was Chief Executive Officer of Epigen, Inc., which subsequently changed its name to Egenix, Inc, from 1991 to 1993, and President in 1994. During 1989 and 1990, he served as Vice President of Corporate Development for Organogenesis, Inc. He served as Chief Executive Officer of Medivix, Inc., a public health care services company that provided mail order prescription services for employers and unions, from 1986 to 1988. From 1984 to 1986, Mr. Mongiardo served as President and Chief Operating Officer of Photec Diagnostics, a venture-capital financed diagnostic company that subsequently changed its name to Photest Diagnostics Inc. He served in various capacities from 1973 to 1984 at Schering-Plough Corporation. While head of U.S. marketing for the pharmaceutical division of Schering-Plough from 1980 to 1983, he introduced 12 new over-the-counter and prescription products. Mr. Mongiardo is a graduate of Johns Hopkins University (B.A.) and Harvard Law School (J.D.).
Neither Mr. Massey nor Mr. Mongiardo serve as a director of any other reporting company, and there are no family relationships among the directors or executive officers (or any nominees therefor) of the Company or its subsidiary or any legal proceedings involving such individuals except as noted below.
Joanna C. Coogan was elected Secretary on January 26, 2011. Ms. Coogan is a graduate of Johns Hopkins University (Bachelor of Arts.) and the Yale University (School of Music Masters of Music). She is an internationally acclaimed soprano and recognized for her effortless coloratura and spell-binding charisma on stage and is in high demand for both operatic and symphonic repertoire. Opera News gushes:”Petite, with a theater-filling smile, she radiated warmth through her unforced, pearly-fresh timbre.” Sharing the stage with such conductors as Neeme Jarvi, Charles Dutoit and John Fiore, the singer has appeared at New York City Opera, Portland Opera, Caramoor Festival, Central City Opera and with such orchestras as Philadelphia Orchestra, Pittsburgh Symphony, Detroit Symphony and the Minnesota Orchestra. She is the daughter of the President and Chairman, James F. Mongiardo.
Audit Committee
The Company currently does not have an audit committee; until expansion of the Board to five members as provided in the Yieldex agreement, the sole director will act as the audit committee of the Board of Directors.
Nominations
The Board of Directors nominates candidates to stand for election as directors; other candidates also may be nominated by any stockholder, provided that such other nomination(s) are submitted in writing to the Secretary of the Company no later than 90 days prior to the meeting of stockholders at which such directors are to be elected, together with the identity of the nominator and the number of shares of the Company’s stock owned, directly or indirectly, by the nominator. Directors are elected at the annual meeting of the stockholders, except for vacancies and newly created directorships resulting from any increase in the authorized number of directors elected by all of the stockholders having the right to vote as a single class (which positions may be filled by the affirmative vote of a majority of the directors then in office, although fewer than a quorum, or by a sole remaining director), and each director elected shall hold office until such director’s successor is elected and qualified or until the director’s earlier death, resignation or removal. ) Pursuant to the terms of the Assignment of Rights agreement between Yieldex, Ltd. and the Company, 40,000,000 (forty million) shares of the Company’s common stock, par value $0.0001, were issued subject to the following. The 40,000,000 shares are restricted and subject to a two year Lock-Up period beginning January 4, 2010. These shares are also subject to a voting agreement. During the Lock-Up period and for any subsequent period until the shares are sold to the public in the open market, the shareholders whose shares are locked up will vote for a maximum of two directors. The Company’s shareholders who are not parties to the Lock-Up agreement will vote their shares for the same two directors until the aggregate number of Yieldex shares are 15,000,000 (fifteen million) or less. The Yieldex shareholders agree to vote the Yieldex shares for a maximum of three directors designated by James F. Mongiardo. While this voting rights agreement is in effect, unanimous approval of all the directors then in office or approval of holders of at least a majority of the shares will be required for: (i) any proposal to increase capital in a way that would result in dilution of existing shareholders’ percentages by ten percent (10%) or more; (ii) any proposal to merge, consolidate or amalgamate with any other corporate entity; (iii) any proposal to sell all or a material part of the assets; and, (iv) any proposal to amend the bylaws.
Directors’ Remuneration
Our directors are presently not compensated for serving on the board of directors.
Code Of Ethics and Standards of Conduct
In 2011 we had limited operations and have not as of yet adopted a Code of Ethics and Standards of Conduct. We plan to consider adopting a Code of Ethics and Standards of Conduct applicable to our directors, officers and employees in 2011.
Section 16(a) Beneficial Ownership Reporting Compliance
The Company is aware of the following directors, officers or beneficial owners of more than ten percent of the Company's Common Stock that, during the fiscal year 2006 or for the fiscal year 2007 failed to file on a timely basis reports required by Section 16(a) of the Securities Exchange Act of 1934.
Scott Massey
Form 5
Phil Dee
Form 5
Item 11.
Item 11.
EXECUTIVE COMPENSATION.
Employment Agreements
On July 16, 2008 the Company entered into an employment agreement with Mr. Mongiardo, as Chief Executive Officer and President, for a term of five years at an annual salary of $250,000, payable at the annual rate of $150,000 upon the Company raising in aggregate in equity or gross revenues $500,000, and at the annual rate of $250,000 upon the Company raising in aggregate in equity or gross revenues $1,000,000 with additional annual increases of $50,000 every July 1 over the life of the agreement. The agreement also calls for the officer to receive fringe benefits and participate in all Company employment benefits as approved by the Board of Directors.
Summary Compensation Table
The table below sets forth the total compensation accrued by the Company for the years ended December 31, 2011, 2010, 2009, 2008, 2007, 2006, 2005, 2004 and 2003 for the Company’s present and former President.
Summary Compensation Table
*Pursuant to the terms of James F. Mongiardo’s Employment Agreement, a reduced salary was due after the Company had gross revenues in excess of $500,000 which was reached beginning July 1, 2010 and full salary when gross revenues exceeded $ 1,000,000 which was reached beginning February 1, 2011. The salary due pursuant to the Employment Agreement has been accrued but not paid.
Option and Long-Term Incentive Plans
Effective November 23, 2009, the Company created the 2009 Stock Option and Incentive Plan (the “Plan”) to provide stock options and other equity interests in the Corporation to employees, officers, directors, consultants and advisors of the Corporation and its Subsidiaries, all of whom are eligible to receive Awards under the Plan. The Plan has up to six million (6,000,000) shares of Corporation’s common stock, par value $.0001, available for Awards. Said awards will vest over four years, one quarter after one year and the balance at one forty-eighth (1/48) of the total Award over the next three years.
On November 23, 2009, the Company approved the issuance of an Award of five hundred thousand (500,000) shares to Americo Simonini, MD, to serve as Chief Medical Officer of the Corporation, at a price of fifty cents ($.50) per share.
On August 1, 2011 the Company approved the issuance of an Award of three hundred sixty thousand (360,000) shares to Cellcare, LLC, to provide managerial and operational services to the Company with one of the Consultant’s Managers/Members, Paul Schwartz, having the title of Chief Operating Officer, Caribbean Operations. serve as Chief Medical Officer at a price of fifty cents ($.50) per share.
Item 12.
Item 12.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER MATTERS.
Security Ownership of Certain Beneficial Owners and Management
The following table shows, as of March 31, 2011 the beneficial ownership of Common Stock of the Company by (i) any person or group who is known to the Company to be the beneficial owner of more than 5% of the Company’s Common Stock, (ii) the sole current director of the Company, (iii) the sole named executive officer of the Company, and (iv) all current directors and executive officers as a group.
(1) Unless otherwise indicated, each of the persons named in the table above has sole voting and investment power with respect to the shares set forth opposite such person’s name. With respect to each person or group, percentages are calculated based on the number of shares beneficially owned, including shares that may be acquired by such person or group within 60 days of March 31, 2011 upon the exercise of stock options, warrants or other purchase rights, but not the exercise of options, warrants or other rights held by any other person.
(2) As part of the transaction between Yieldex, Ltd. and the Company, 40,000,000 (forty million) shares of the Company’s common stock, par value $.0001, was issued to Yieldex Ltd and its nominees. The 40,000,000 shares are restricted and subject to a two year Lock-Up period beginning January 4, 2010. These shares are also subject to a voting agreement. During the Lock-Up period and for any subsequent period until the shares are sold to the public in the open market, the Board of Directors will be expanded to five members and the shareholders whose shares are locked up will vote for a maximum of two directors. The Company’s shareholders who are not parties to the Lock-Up agreement will vote their shares for the same two directors until the aggregate number of Yieldex shares are 15,000,000 (fifteen million) or less. The Yieldex shareholders agree to vote the Yieldex shares for a maximum of three directors designated by James F. Mongiardo. While this voting rights agreement is in effect, unanimous approval of all the directors then in office or approval of holders of at least a majority of the shares will be required for: (i) any proposal to increase capital in a way that would result in dilution of existing shareholders’ percentages by ten percent (10%) or more; (ii) any proposal to merge, consolidate or amalgamate with any other corporate entity; (iii) any proposal to sell all or a material part of the assets; and, (iv) any proposal to amend the bylaws.
(3) Ms. Coogan has no beneficial ownership in any shares.
Item 13.
Item 13.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Mr. Scott Massey is the founder of our company. At inception, Mr. Massey purchased 2,000,000 shares of our common stock at par value for a total purchase price of $200. On July 16, 2008, pursuant to an Employment Agreement, James F. Mongiardo, President and Chief Executive Officer, was issued 15,000,000 common shares.
Item 14.
Item 14.
Principal Accountant Fees and Services.
The Company paid audit fees to its independent certified public accountant, Sadler, Gibb & Associates in the amount of $15,000 for the year ended December 31, 2011, $15,000 for the year ended December 31, 2010 and $1,500 for the year ended December 31, 2009.
Item 15.
Item 15.
EXHIBITS.
SIGNATURES
Pursuant to the requirements of Section 13 or 15 (d) of the Securities Exchange Act of 1934, the registrant has caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
REGENOCELL THERAPEUTICS, INC.
Dated: May 24, 2012
By: /s/ James F. Mongiardo
James F. Mongiardo
President and Chief Executive Officer
In accordance with the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in the capacities indicated on May 24, 2012.
/s/ James F. Mongiardo
James F. Mongiardo
Principal Executive Officer,
President, Principal Financial
Officer, Principal Accounting
Officer and Director
/s/ Joanna C. Coogan
Secretary