UNITED
STATES


SECURITIES
AND EXCHANGE COMMISSION


WASHINGTON,
D.C. 20549





FORM
10-K





ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE


SECURITIES
EXCHANGE ACT OF 1934





For the
fiscal year ended December 31, 2008





Commission
File No.


000-50639





RegenoCELL Therapeutics,
Inc.


(Exact
name of registrant as specified in its Charter)





Florida
              22-3880440(State of Incorporation)
              (I.R.S. Employer Identification No.)





2 Briar
Lane, Natick, Massachusetts 01760


(Address
of Principal Executive Offices)





(508)
647-4065


(Registrant's
telephone number. including area code)





Securities
registered pursuant to Section 12(g) of the Act: None





Common
Stock, par value $0.0001 per share


(Title of
Class)





OTC
Bulletin Board (Subject To Approval of New Market Maker)


(Name of
Each Exchange on Which Registered)





Check
whether the issuer is not required to file reports pursuant to Section 13 or
15(d) of the Exchange Act.   ̈





Indicate
by check mark whether the issuer (1) has filed all reports required to be filed
by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days. Yes x No
 ̈





Indicate
by check mark if disclosure of delinquent filers pursuant to Item405 of
Regulation S-B is not contained herein, and will not be contained, to the best
of registrant's knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this
Form 10-K.  ̈









Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting
company.  See the definitions of “large accelerated filer”,
“accelerated filer”, and “smaller reporting company” in Rule 12b-2 of the
Exchange Act. Yes x No  ̈





Large Accelerated filer  ̈
            Accelerated filer  ̈Non-accelerated filer (Do not check
            Smaller reporting company xif a smaller reporting company)  ̈





Indicate
by checkmark whether the registrant is a shell company (as defined in Rule 12b-2
of the Exchange Act).  Yes x  No
 ̈





The
Company's revenues for the year ended December 31, 2008 were $0.





As of
March 23, 2009, the aggregate market value of the voting stock held by
non-affiliates of the registrant (based on a value of  $.02 per share)
on March 23, 2009 was $528,750.





As of
March 23, 2009, there were 131,437,500 shares of the registrant's Common Stock
outstanding.











REGENOCELL
THERAPEUTICS, INC.


INDEX TO ANNUAL REPORT ON FORM
10-K


Fiscal Year Ended December 31,
2008





PART
      IItem
      1.
              Business
              3Item
      1A.
              Risk
      Factors
              10Item
      1B.
              Unresolved
      Staff Comments
              17Item
      2.
              Properties
              17Item
      3.
              Legal
      Proceedings
              17Item
      4.
              Submission
      of Matters to a Vote of Security Holders
              1818PART
      IIItem
      5.
              Market
      for Registrant’s Common Equity, Related Stockholder Matters and Issuer
      Purchases of Equity Securities
              18Item
      6.
              Selected
      Financial Data
              19Item
      7.
              Management’s
      Discussion and Analysis or Plan of Operations
              21Item
      7A.
              Quantitative
      and Qualitative Disclosures about Market Risk
              24Item
      8.
              Financial
      Statements and Supplementary Data
              24Item
      9.
              Changes
      in and Disagreements with Accountants on Accounting and Financial
      Disclosure
              34Item
      9A.
              Controls
      and Procedures
              35Item
      9B.
              Other
      Information
              36PART
      IIIItem
      10.
              Directors,
      Executive Officers and Corporate Governance
              37Item
      11.
              Executive
      Compensation
              39Item
      12.
              Security
      Ownership of Certain Beneficial Owners and Management and Related
      Stockholder Matters
              40Item
      13.
              Certain
      Relationships and Related Transactions, and Director
      Independence
              41Item
      14.
              Principal
      Accounting Fees and Services
              41PART
      IVItem
      15.
              Exhibits
              41




2





PART
I.





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
anticipate 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.





3





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 new mission of the Company is to
bring stem cell therapy treatments to the market as quickly as
possible.  The Company has identified and entered into a Letter of
Intent (“LOI”) with a company currently treating patients with adult stem cells
for congestive heart failure and other indications.  TheraVitae,
located in Bangkok, Thailand, has developed a process for which patent
applications are pending 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 one-half pint of blood drawn which is sent
to TheraVitae’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 Bangkok, Thailand 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 three hundred (300) 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.





4





The Company’s operations include two
basic businesses. The first is an opportunity to generate revenue in the short
term for the treatment of congestive heart failure.  The second is an
opportunity to generate substantial revenues in the long term for the treatment
of peripheral artery disease.


The first stem cell business is a non
exclusive license to establish  clinics initially in Mexico and later
in the Caribbean (exclusive of the Dominican Republic) to treat patients with
adult stem cell therapy 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
clinic (treatment site such as a hospital with a catherization laboratory) in
Mexico or the Caribbean operated by a subsidiary of the Company to receive the
treatment.  The market size for congestive heart failure in the United
States is so large that multiple treatment clinics will be needed to handle
potential demand.  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.





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 establishment of clinics initially in Mexico and later in
the Caribbean where  patients from the United States may be
treated.  Thus, the Company will be among the first companies to be
able to earn revenues and profit from adult stem cell therapy.





The second business is an exclusive
license for the United States, Canada and Mexico for the treatment of peripheral
artery disease (“PAD”).  Over ten million Americans suffer from poor
circulation to their extremities.  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, 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 will be responsible for all
costs associated with obtaining all required regulatory approvals to market PAD
in the United States, Canada and Mexico.  It will obtain an
Investigational New Drug exemption to initiate clinical trials in the United
States designed to obtain regulatory approval to market the
product.  Such an  approval in the United States 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.





Manufacturing
and Distribution





We will be purchasing the stem cell
therapy from TheraVitae.  The price for cardiovascular indications for
our clinic to be established in Mexico is $ 20,000 per patient subject to
certain discounts.  We are entitled to the best pricing offered any
customer for cardiovascular indications in either Mexico or the Islands of the
Caribbean.  For the clinical trials which we intend to conduct in the
United States for the treatment of peripheral artery disease, TheraVitae will
supply the product at cost in accordance with the Food and Drug Administration
Clinical Trial regulations.





5





Delivery of the stem cell therapy for
cardiovascular indications is made in a catherization laboratory equipped to
conduct angiograms, angioplasty and minimally invasive cardiac
procedures.  Such laboratories are found in hospitals or can be free
standing.  It is the initial intention of the Company to find a
suitable catherization laboratory in Mexico which is located in an area with
additional medical facilities capable of handling emergency cardiac cases to
administer the stem cell therapy purchased from TheraVitae.  It is
anticipated that a contract can be negotiated with the catherization laboratory
for use of its facilities on reasonable terms. Eventually it may be economically
advantageous for the Company to construct such a facility.





Competition





With over 1100 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 entered into a similar non-exclusive relationship for cardiovascular
indications with TheraVitae and has established a clinic in the Dominican
Republic for the administration of stem cell therapy purchased from
TheraVitae.  The principal shareholder of Regenocycte Therapeutic,
LLC  is the United States Director of Cardiology for
TheraVitae, a physician with a cardiovascular clinic in Florida.





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.





6





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, such as is currently the case with the
TheraVitae stem cell therapy.  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.





With respect to the Letter of Intent,
TheraVitae is the owner of certain proprietary technology and rights for an
angiogenic cell precursor-based product (VesCellTM) covered by trade secret and
patent applications, actions or continuations; more specifically, November 24,
2004 United States Patent Application 11/271,043; June 1, 2005 United States
Number 60/576,266; 60/588,520; PCT/IL2005/000571; December 14, 2005 United
States Number 60/636,391; 60/668,739; PCT/IL2005/001345; December 14, 2005
United States Number 60/668,739; 60/636,391; PCT/IL2005/001348; May 31, 2006
United States Number 60/687,115; PCT/IL2006/000633; and March 8, 2006 United
States Number 60/780,781, Provisional Application. TheraVitae and/or its
affiliates presently treat patients in Bangkok, Thailand and other locations
with VesCellTM for cardiovascular and other indications such as peripheral artery
disease.  Pursuant to the grant of a non exclusive license for
congestive heart failure and exclusive license for peripheral artery disease,
the Letter of Intent provides that the Company will pay TheraVitae upon closing
its first and subsequent financings as a license fee of twenty-five percent
(25%) of the proceeds of each financing to a maximum of $1,000,000.





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. 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:




7




•
            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.





8





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
(Biologics License Application (“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 initially in a clinic in Mexico and later in the Caribbean and for
submitting an IND for stem cell therapy treatment for peripheral artery disease
in the United States and Canada and conducting the clinical trials necessary to
apply for approval to market for this indication.





Employees





The
Company currently employs one individual, James F. Mongiardo, its sole director
and officer.  We anticipate that we will hire additional employees
once we have raised adequate funding and as we commence operations. From
time-to-time, we anticipate that we will use the services of independent
contractors and consultants to support our business development. We believe our
future success depends in large part upon the continued service of our key
technical and senior management personnel and our ability to attract and retain
highly qualified technical and managerial personnel.





9





Item
1A.  Risk Factors




Risks
Related to our Business




The
new stem cell business is subject to completion of definitive
agreements.




Our new
stem cell business is subject to completion of definitive agreements with
TheraVitae, Inc.  There is no assurance that such agreements will be
completed or that they will be completed on substantially the same terms as set
forth in the Letter of Intent.




Any
adverse development in our ability to treat patients in Mexico 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 in Mexico with stem cell
technology.  Any clinical, regulatory or other development that
prevents or delays us from treating patients in Mexico, 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 depress our stock price and could prevent
us from raising the substantial additional capital we will require to further
develop stem cell technologies.




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.





10




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. We have not earned any revenues from sales of any
product. We expect that any revenues we may obtain in the foreseeable future
will be derived from the treatment of patients in Mexico with stem cell
technology. We have not yet treated any patients in Mexico.





11




If
we are unable to protect our patents and proprietary rights, our business,
financial condition and results of operations will be harmed.




We have
entered into a Letter of Intent to license or intend to license a number of
patents and pending patent applications related to various stem cells and
methods of deriving and using them. 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 whether any of our pending applications will result in the issuance
of patents, if any existing or 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 of our pending 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 pending or 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.





12




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.





13




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 onthe 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.





14




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 and
our chief medical officer. 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 are not
able to obtain product liability insurance for the treatment of patients in
Mexico and therefore are exposed to product liability claims which could lead to
substantial liability. We intend to obtain liability insurance that covers our
clinical trials in the United States, and we will need to increase our insurance
coverage if and when we begin commercializing products in the United States. 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.





15




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 will likely be highly volatile, which may negatively affect our
ability to obtain additional financing in the future.




The
market price of our stock is likely to be 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;




16





·
            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
Mexico;


·
            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 stock 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
March 31, 2009, there were contractual obligations to issue stock options to
purchase 500,000 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.




We
are not able to trade on the OTC Bulletin Board until a new market maker is
approved.




The
shares of the Company have not traded.  The market maker who obtained
approval to trade the Company’s shares on the OTC Bulletin Board has gone out of
business.  Until a new market maker is identified and approved for
trading the Company’s shares on this market, the Company’s shares may not be
traded on the OTC Bulletin Board.  While the Company believes that
this issue will be resolved in the next 30 to 90 days, there is no assurance
that this will occur.




Item 1B.
Unresolved Staff Comments





There are
no unresolved staff comments.





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 was 7 Richmond Lane, Blythewood, South
Carolina 29016, which was space owned by the former sole director and officer of
the Company.  The Company has moved its principal place of business to
2 Briar Lane, Natick, Massachusetts 01760, which is space owned by the new sole
director and officer of the Company.  In both cases rent has not been
charged for the office space, and it is not expected that rent will be charged
in the near-term.





Item
3.  LEGAL PROCEEDINGS





We
are not party to any legal proceedings as of the date of this Form
10-K.





17





Item
4.  SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS





On
July 2, 2008 through written consent in lieu of a special meeting of the
stockholders of Good Buddy’s Coffee Express, Inc., stockholders representing at
least of majority of the outstanding stock of the Company agreed to pursue a new
business opportunity as set forth in the March 31, 2008 Letter of Intent between
TheraVitae, Inc. and RegenoCELL Therapeutics, Inc. to commercialize stem cell
technology and approved, adopted, ratified and confirmed the following actions
taken by the Board of Directors: (1)  Amending the Articles of
Incorporation; (2) Amending the Bylaws; (3) Issuing restricted common shares par
value $0.0001 to Douglas T. Rice (250,000), Dominick Mazza (5,000,000) and James
F. Mongiardo (15,000,000); (4) ratifying the Letter of Intent between
TheraVitae, Inc. and RegenoCELL Therapeutics, Inc. dated March 31, 2008: (5)
approving the Employment Agreement with James F. Mongiardo as President and
Chief Executive Officer; and (6) upon concurrence of a majority of shareholders
to the previous resolutions and actions, acceptance of the resignation of Scott
Massey as President, Chief Executive Officer and director, the resignation of
Phillips N. Dee as director, and the election and appointment of James F.
Mongiardo as Chief Executive Officer, President, Treasurer and Secretary and
director.





PART
II.





Item
5.  MARKET FOR COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND SMALL
BUSINESS ISSUER PURCHASES OF EQUITY SECURITIES





There is
no established public market for our common stock.  Although we have
been approved for quotation  by the OTC Bulletin Board under the
symbol “RCLL.OB”, the market maker approved for trading the stock on the OTC
Bulletin Board  has gone out of business.  Until a new
market maker is approved, the stock may not be traded on the OTC Bulletin
Board.  Even if such approval is obtained, no quotation has been
previously posted and  no shares or  our common stock have
ever traded. There can be no assurance that any market for our stock will ever
develop or, if developed, will be sustained.





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:





Douglas T. Rice
            -
            250,000 common sharesDomenic Mazza
            -
            5,000,000 common sharesJames F. Mongiardo
            -
            15,000,000 common shares





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 are being 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.





18





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.





As of
March 23, 2009, there were 131,437,500 shares of the registrant's Common Stock
outstanding and approximately 18 shareholders of record.





We have
not issued any options or warrants to purchase common stock or any other class
of our securities.





Recent
Sales Of Unregistered Securities





On July
7, 2008,the
Company issued restricted common shares to the following:





Douglas T. Rice
            -
            250,000 common sharesDomenic Mazza
            -
            5,000,000 common sharesJames F. Mongiardo
            -
            15,000,000 common shares





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 are being 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.





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.





Equity
Compensation Plan Information





The
Company did not have an Equity Compensation Plan during the year ended December
31, 2008.





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, 2004, 2005, 2006, 2007 and
2008 and consolidated balance sheet data as of December 31, 2004, 2005,
2006, 2007 and 2008 from our audited financial statements and notes thereto that
are included elsewhere in this Annual Report on Form 10-K.





19





Statement
      of Operational Data:
                                        
                                        Year
      Ended December 31,(In
      thousands, except per share data)2004
                                        
                                        
                                        2005
                                        
                                        
                                        2006
                                        
                                        
                                        2007
                                        
                                        
                                        2008Revenue
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -Operating
      Expenses:Development
      Costs
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        (14
                                        )Marketing
      General and Administrative
                                        
                                        
                                        (8
                                        )
                                        
                                        
                                        (26
                                        )
                                        
                                        
                                        (21
                                        )
                                        
                                        
                                        (9
                                        )
                                        
                                        
                                        (27
                                        )Total
      Operating Expenses
                                        
                                        
                                        (8
                                        )
                                        
                                        
                                        (26
                                        )
                                        
                                        
                                        (21
                                        )
                                        
                                        
                                        (9
                                        )
                                        
                                        
                                        (41
                                        )Loss
      from Development Stage Operations
                                        
                                        
                                        (8
                                        )
                                        
                                        
                                        (26
                                        )
                                        
                                        
                                        (21
                                        )
                                        
                                        
                                        (9
                                        )
                                        
                                        
                                        (41
                                        )Depreciation
                                        
                                        
                                        -
                                        
                                        
                                        
                                        (1
                                        )
                                        
                                        
                                        (1
                                        )
                                        
                                        
                                        (1
                                        )Interest
      Exp
                                        
                                        
                                        (1
                                        )
                                        
                                        
                                        (2
                                        )
                                        
                                        
                                        (3
                                        )
                                        
                                        
                                        (3
                                        )
                                        
                                        
                                        (5
                                        )Loss
      on Abandonment
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        
                                        (2
                                        )Loss
      Before Income Taxes
                                        
                                        
                                        (9
                                        )
                                        
                                        
                                        (29
                                        )
                                        
                                        
                                        (25
                                        )
                                        
                                        
                                        (13
                                        )
                                        
                                        
                                        (48
                                        )Income
      Taxes
                                        
                                        
                                        -
                                        
                                        
                                        
                                        -
                                        
                                        
                                        
                                        -
                                        
                                        
                                        
                                        -
                                        
                                        
                                        
                                        -Net
      (Loss)
                                        
                                        $
                                        (9
                                        )
                                        
                                        $
                                        (29
                                        )
                                        
                                        $
                                        (25
                                        )
                                        
                                        $
                                        (13
                                        )
                                        
                                        $
                                        (48
                                        )Basic
      and Diluted Net Loss Per Share
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -
                                        
                                        
                                        $
                                        -Weighted
      Average Shares Outstanding - basic and diluted
                                        
                                        
                                        76,500,000
                                        
                                        
                                        
                                        71,859,375
                                        
                                        
                                        
                                        70,312,500
                                        
                                        
                                        
                                        70,312,500
                                        
                                        
                                        
                                        96,187,500





Balance
      Sheet
                    
                    Year
      Ended December 31,(In
      thousands, except per share data)2004
                    
                    
                    2005
                    
                    
                    2006
                    
                    
                    2007
                    
                    
                    2008Current
      Assets
                    
                    
                    10
                    
                    
                    
                    32
                    
                    
                    
                    3
                    
                    
                    
                    -
                    
                    
                    
                    -Working
      Capital Deficit
                    
                    
                    9
                    
                    
                    
                    27
                    
                    
                    
                    (5
                    )
                    
                    
                    (13
                    )
                    
                    
                    (6
                    )Net
      Capital Assets
                    
                    
                    1
                    
                    
                    
                    4
                    
                    
                    
                    3
                    
                    
                    
                    2
                    
                    
                    
                    -Net
      Intangible Development Costs
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    -
                    
                    
                    
                    -
                    
                    
                    
                    9Accounts
      Payable and Accrued Expenses
                    
                    
                    1
                    
                    
                    
                    3
                    
                    
                    
                    4
                    
                    
                    
                    5
                    
                    
                    
                    3Accrued
      Interest
                    
                    
                    -
                    
                    
                    
                    2
                    
                    
                    
                    4
                    
                    
                    
                    8
                    
                    
                    
                    3Long
      Term Debt
                    
                    
                    15
                    
                    
                    
                    65
                    
                    
                    
                    65
                    
                    
                    
                    68
                    
                    
                    
                    119Deficit
      Accumulated during Development Stage
                    
                    
                    (16
                    )
                    
                    
                    (45
                    )
                    
                    
                    (70
                    )
                    
                    
                    (86
                    )
                    
                    
                    (134
                    )Total
      Shareholder's Equity
                    
                    
                    (5
                    )
                    
                    
                    (34
                    )
                    
                    
                    (68
                    )
                    
                    
                    (77
                    )
                    
                    
                    (116
                    )








20





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
March 23, 2009 in connection with the audit of our financial statements as
of December 31, 2008 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, 2008 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 has identified and entered into a
Letter of Intent with a company currently treating patients with adult stem
cells for congestive heart failure and other indications.  TheraVitae,
located in Bangkok, Thailand, has developed a process for which patent
applications are pending 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.





21





Currently
congestive heart failure patients cleared for treatment have one-half pint of
blood drawn which is sent to TheraVitae’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 Bangkok,
Thailand 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 (300)
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.





The
Company has entered into a Letter of Intent which provides for two basic
businesses. The first is an opportunity to generate revenue in the short term
for the treatment of congestive heart failure.  The second is an
opportunity to generate substantial revenues in the long term for the treatment
of peripheral artery disease.





The first
stem cell business is a non exclusive license to establish  clinics
initially in Mexico and later in the Caribbean (exclusive of the Dominican
Republic) to treat patients with TheraVitae’s stem cell therapy for congestive
heart failure and all other cardiovascular indications. The non exclusive
license is for four years but automatically renewable if 500 patients are
treated in either year three or four.  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 the treatment in advance
and then have their blood drawn for processing by TheraVitae.





When the
stem cell therapy is ready for administration, the patient will travel outside
the United States to a clinic in Mexico or the Caribbean operated by a
subsidiary of the Company to be formed to receive the
treatment.  Because this is an autologous treatment, it is anticipated
that the regulatory requirements for administering this stem cell therapy in
Mexico and the Islands of the Caribbean will be less extensive than the United
States.  The market size for congestive heart failure in the United
States is so large that multiple treatment clinics will be needed to handle
potential demand.  Approximately five million patients have been
diagnosed in the United States with congestive heart failure.





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 establishment
of clinics initially in Mexico and later in the Caribbean where patients from
the United States may be treated.  Thus, the Company will be among the
first to be able to earn revenues from adult stem cell therapy.





The
second business is an exclusive license for the United States, Canada and Mexico
for the treatment of peripheral artery disease.  The exclusive license
is for four years automatically renewable for additional four year periods if
there is either (a) an active IND in the United States or (b) an approval to
market for peripheral artery disease in the United States.  Over ten
million Americans suffer from poor circulation to their extremities. Peripheral
artery disease 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.  TheraVitae’s 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.





22





The
process for treating peripheral artery disease is very similar to the process
for treating congestive heart failure.  After the patient is
qualified, a half liter of blood is drawn and sent to TheraVitae 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 will be responsible for all costs associated with obtaining all required
regulatory approvals for the treatment of peripheral artery disease in the
United States, Canada and Mexico.  It intends to submit to the Food
and Drug Administration an IND application for authorization to initiate
clinical trials in the United States and complete what is necessary to apply for
regulatory approval to market the product.  Such an approval in the
United States will have substantial potential since the market size is large and
flexibility of pricing is great given the alternative of
amputation.





The
Company has not generated any revenues from its operations. To effectuate the
new stem cell business plan during the next twelve months, the Company must
raise funding, locate a suitable source for congestive heart failure patients
and/or implement marketing programs to find these patients who may benefit from
stem cell therapy, establish a review procedure and staging center to draw blood
from qualified patients,  establish a site outside the United States
which can administer and obtain local regulatory approvals to administer the
stem cell therapy.  In addition the Company must begin assembling or
developing the required data, finalizing a clinical protocol and clinical case
report form, contracting with clinical sites able to conduct the requisite
clinical trials, obtaining Institutional Review Board approval for these
clinical trials, and contracting with a clinical research organization to
administer these clinical trials as part of or in conjunction with the
submission of an INDto the
Food and Drug Administration for authorization to begin clinical trials in the
United States for the treatment of peripheral artery disease.





The
Company anticipates earning revenues for the treatment of congestive heart
failure patients sometime in 2009.  The Company does not anticipate
that during the next twelve months the Company will earn sufficient revenues to
fully support all aspects of the new stem cell business plan and, therefore,
will continue to seek new funding through equity financings.





For the
twelve month period following the date of this Annual Report, the Company will
be required to obtain additional financing in order to continue to pursue the
business plan.  The Company believes that additional debt financing
will not be a suitable alternative for funding as the Company does not have
tangible assets to secure any debt financing.  The Company anticipates
that additional funding will be in the form of equity financing from the sale of
its common stock.  The Company cannot provide investors with any
assurance that the Company will be able to raise sufficient funding from the
sale of its common stock to fund the business plan going forward.





If the
Company is unsuccessful at raising sufficient capital to fund its operations,
for whatever reason, the Company may be forced to seek opportunities outside of
its new business focus or to seek a buyer for its business or another entity
with which the Company could partner.  Even if the Company is
successful in obtaining equity financing to fund its business plan, there is no
assurance that the Company will obtain the funding necessary to pursue its plan
over the long-term.





23





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.
            FINANCIAL
      STATEMENTS AND SUPPLEMENTARY DATA


RegenoCELL
Therapeutics, Inc.


(A
Development Stage Corporation)





INDEX TO
FINANCIAL STATEMENTS





Page No.Report of Independent Registered Public Accounting Firm
                                25Balance Sheets at December 31, 2008 (audited)and December 31, 2007 (audited)
                                26Statement of Operations for the YearsEnded December 31, 2008 and 2007and for the period from February 1, 2002 (inception) toDecember 31, 2008
                                27Statement of Stockholders’ Equity (Deficit) Forthe period from February 1, 2002 (inception) toDecember 31, 2008
                                28Statement of Cash Flow for the Years EndedDecember 31, 2008 and 2007 and for the periodfrom February 1, 2002 (inception) to December 31, 2008
                                29Notes to Interim Financial Statements
                                30





24





LIEBERMAN
& ASSOCIATES P.A.


CERTIFIED
PUBLIC ACCOUNTANT




800 E. Cypress Creek Rd. Suite 200 Ft. Lauderdale, FL 33334             Office (954) 491-0411        Fax (954) 491-0211Auditing
              Accounting
              TaxesCondominium
      Accounting
              Financial
      Management
              Consulting





To the
Board of Directors and Stockholders


RegenoCELL
Therapeutics, Inc.


2 Briar
Lane


Natick,
MA 01760





To the
Board of Directors





We have
audited the accompanying balance sheets of RegenoCELL Therapeutics, Inc. as of
December 31, 2008 and December 31, 2007 and the related income statements,
stockholders’ deficit and cash flows for the periods ended December 31, 2008 and
2007. These financial statements are the responsibility of the Company’s
management. Our responsibility is to express an opinion on these financial
statements based on our audit.





We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audit provides a
reasonable basis for our opinion.





In our
opinion, the financial statements referred to above present fairly, in all
material respects, the financial position of RegenoCELL Therapeutics, Inc. as of
December 31, 2008 and December 31, 2007 and the related income statements,
shareholders’ deficit, and cash flows for the period ended December 31, 2008 and
December 31, 2007, in conformity with U.S. generally accepted accounting
principles.





The
accompanying financial statements have been prepared assuming that the Company
will continue as a going concern. As discussed in Note 7 to the financial
statements, the Company has suffered recurring losses from development stage
operations and has a net capital deficiency that raises substantial doubt about
its ability to continue as a going concern. Management’s plans in regard to
these matters are also described in Note 7. The financial statements do not
include any adjustments that might result from the outcome of this
uncertainty.




We have
also audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), RegenoCELL Therapeutics,
Inc.’s  internal control over financial reporting as of December 31,
2008, based n the criteria established in Internal Control-Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission and our report dated March 13, 2009 expressed an unqualified
opinion.




//Lieberman
& Associates//





Lieberman
& Associates, P.A.


Ft.
Lauderdale, Florida


March 27,
2009





American Institute of Certified Public Accountants ▪ Public Company Accounting Oversite Board Florida Institute of


Certified Public Accountants ▪ Certified Fraud Examiners ▪ American Institute of Certified Bookkeepers





25




RegenoCell
Theraputics Inc.
 (A
Development Stage Corporation)
 Balance
Sheet
 As
of December 31,
 
 2008
                    
                    
                    2007AssetsCurrent
      AssetsCash
                    
                    $
                    -
                    
                    
                    $
                    (390
                    )Other
      Receivable
                    
                    
                    -
                    
                    
                    
                    250Total
      Current Assets
                    
                    
                    -
                    
                    
                    
                    (140
                    )Net
      Fixed Assets
                    
                    
                    -
                    
                    
                    
                    1,875Net
      Intangible Development Costs
                    
                    
                    9,000
                    
                    
                    
                    -Total
      Assets
                    
                    $
                    9,000
                    
                    
                    $
                    1,735Liabilities
      and Stockholders' EquityLiabilitiesCurrent
      LiabilitiesAccounts
      Payable
                    
                    $
                    -
                    
                    
                    $
                    2,200Accrued
      Interest
                    
                    
                    3,460
                    
                    
                    
                    7,640Accrued
      Expenses
                    
                    
                    3,000
                    
                    
                    
                    2,500Total
      Current Liabilities
                    
                    
                    6,460
                    
                    
                    
                    12,340Note
      Payable
                    
                    
                    118,653
                    
                    
                    
                    68,000Total
      Liabilities
                    
                    
                    125,112
                    
                    
                    
                    80,340Stockholders'
      EquityPreferred
      Stock $.0001 par value, 80,000,000 shares authorized, no shares issued and
      outstanding as of December 31, 2008 and December 31, 2007
      respectively
                    
                    
                    -
                    
                    
                    
                    -Common
      Stock, $.0001 par value, 520,000,000 shares authorized, 131,437,500 and
      70,312,500 shares issued and outstanding as of December 31, 2008 and
      December 31, 2007 respectively
                    
                    
                    13,144
                    
                    
                    
                    7,031Additional
      Paid in Capital
                    
                    
                    4,913
                    
                    
                    
                    -Accumulated
      Deficit during the development stage
                    
                    
                    (134,168
                    )
                    
                    
                    (85,636
                    )Total
      Stockholders' Equity
                    
                    
                    (116,112
                    )
                    
                    
                    (78,605
                    )Total
      Liabilities and Stockholders' Equity
                    
                    $
                    9,000
                    
                    
                    $
                    1,735
 
 The
accompanying notes are an integral part of these financial
statements
 
 26
  RegenoCell
Theraputics Inc.
 (A
Development Stage Corporation)
 Income
Statement
 For
the Year Ending December 31,
 
 February
      1,2002
      (Inception)ThroughDecember
      31,2008
                    
                    
                    2007
                    
                    
                    2008Revenues
                    
                    $
                    -
                    
                    
                    $
                    -
                    
                    
                    $
                    -Administrative
      Expenses
                    
                    
                    46,657
                    
                    
                    
                    12,592
                    
                    
                    
                    132,293Net
      (Loss) from development stage operations
                    
                    
                    (46,657
                    )
                    
                    
                    (12,592
                    )
                    
                    
                    (132,293
                    )Loss
      on abandonment of assets
                    
                    
                    (1,875
                    )
                    
                    
                    -
                    
                    
                    
                    (1,875
                    )Net
      (Loss)
                    
                    $
                    (48,532
                    )
                    
                    $
                    (12,592
                    )
                    
                    $
                    (134,168
                    )Basic
      net loss per common share
                    
                    $
                    (0.00
                    )
                    
                    $
                    (0.00
                    )
                    
                    $
                    (0.00
                    )Weighted
      Average of Common Shares Outstanding
                    
                    
                    96,187,500
                    
                    
                    
                    70,312,500
                    
                    
                    
                    96,187,500
 
 The
accompanying notes are an integral part of these financial
statements
  27
 RegenoCell
Theraputics Inc.
 (A
Development Stage Corporation)
 Statement
of Stockholders Equity
 As
of December 31, 2008
 Shares
                            
                            
                            Par Value
                              $.0001
                            
                            
                            Paid in
                              Capital
                            
                            
                            Retained
                              Earnings
                            
                            
                            TotalFebruary
      1, 2002 - Restricted commonshares
      issued to President of Company  for expenses
                            
                            
                            2,000,000
                            
                            
                            $
                            200
                            
                            
                            $
                            -
                            
                            
                            $
                            -
                            
                            
                            $
                            200December
      31, 2002 - Net (Loss)
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (200
                            )
                            
                            
                            (200
                            )December
      31, 2002 – Balance
                            
                            
                            2,000,000
                            
                            
                            
                            200
                            
                            
                            
                            -
                            
                            
                            
                            (200
                            )
                            
                            
                            -February
      15, 2003 - Sale of restricted shares to various
    stockholders
                            
                            
                            550,000
                            
                            
                            
                            55
                            
                            
                            
                            10,945
                            
                            
                            
                            -
                            
                            
                            
                            11,000December
      31, 2003 - Net (Loss)
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (6,669
                            )
                            
                            
                            (6,669
                            )December
      31, 2003 – Balance
                            
                            
                            2,550,000
                            
                            
                            
                            255
                            
                            
                            
                            10,945
                            
                            
                            
                            (6,869
                            )
                            
                            
                            4,331December
      31, 2004 - Net (Loss)
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (9,272
                            )
                            
                            
                            (9,272
                            )December
      31, 2004 – Balance
                            
                            
                            2,550,000
                            
                            
                            
                            255
                            
                            
                            
                            10,945
                            
                            
                            
                            (16,141
                            )
                            
                            
                            (4,941
                            )December
      31, 2005 - Net (Loss)
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (28,583
                            )
                            
                            
                            (28,583
                            )December
      31, 2005 - Balance
                            
                            
                            2,550,000
                            
                            
                            
                            255
                            
                            
                            
                            10,945
                            
                            
                            
                            (44,724
                            )
                            
                            
                            (33,524
                            )February
      2006 repurchase of stock
                            
                            
                            (106,250
                            )
                            
                            
                            (11
                            )
                            
                            
                            (6,739
                            )
                            
                            
                            -
                            
                            
                            
                            (6,750
                            )March
      2006 repurchase of stock
                            
                            
                            (100,000
                            )
                            
                            
                            (10
                            )
                            
                            
                            (1,990
                            )
                            
                            
                            -
                            
                            
                            
                            (2,000
                            )December
      31, 2006 - Net (Loss)
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (25,389
                            )
                            
                            
                            (25,389
                            )December
      31, 2006 - Balance
                            
                            
                            2,343,750
                            
                            
                            
                            234
                            
                            
                            
                            2,216
                            
                            
                            
                            (70,113
                            )
                            
                            
                            (67,663
                            )Prior
      Year adjustment for expense  reversal
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            1,650
                            
                            
                            
                            1,650December
      31, 2007 - Net (Loss)
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            -
                            
                            
                            
                            (12,592
                            )
                            
                            
                            (12,592
                            )December
      31, 2007 – Balance
                            
                            
                            2,343,750
                            
                            
                            
                            234
                            
                            
                            
                            2,216
                            
                            
                            
                            (81,055
                            )
                            
                            
                            (78,605
                            )March
      31, 2008 -additional shares  issued resulting from a 3 for 1 common
       stock split
                            
                            
                            7,031,250
                            
                            
                            
                            703
                            
                            
                            
                            (703
                            )
                            
                            
                            -
                            
                            
                            
                            -June
      13, 2008 -additional shares issued  resulting from a 10 for 1 common
      stock  split
                            
                            
                            70,312,500
                            
                            
                            
                            7,031
                            
                            
                            
                            (1,747
                            )
                            
                            
                            (4,581
                            )
                            
                            
                            -July
      7, 2008 - Restricted common stock  issued in lieu of employee
       compensation
                            
                            
                            15,000,000
                            
                            
                            
                            1,500
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            1,500July
      7, 2008 - Restricted common stock  issued for contracted
      services
                            
                            
                            5,250,000
                            
                            
                            
                            525
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            525July
      22, 2008 - Issuance of restricted  common stock to Thera Vitae, Inc.
      per  the terms of the letter of intent dated  July 22,
      2008
                            
                            
                            90,000,000
                            
                            
                            
                            9,000
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            9,000July
      23, 2008 - Cancellation of common  stock
                            
                            
                            (58,500,000
                            )
                            
                            
                            (5,850
                            )
                            
                            
                            5,850
                            
                            
                            
                            
                            
                            
                            
                            -December
      31, 2008 - Net (Loss)
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            
                            (48,532
                            )
                            
                            
                            (48,532
                            )December
      31, 2008 - Balance
                            
                            
                            131,437,500
                            
                            
                            $
                            13,143
                            
                            
                            $
                            5,616
                            
                            
                            $
                            (134,168
                            )
                            
                            $
                            (116,112
                            )
  The
accompanying notes are an integral part of these financial
statements
  28
  RegenoCell
Theraputics Inc.
 (A
Development Stage Corporation)
 Cash
Flow Statement
 For
the Year Ending December 31,
  2008
                                
                                
                                2007
                                
                                
                                February 1, 2002
                                  (date of
                                  inception)
                                  through
                                  December 31,
                                  2008Cash
      Flows From Operating Activities:Cash
      paid to suppliers
                                
                                $
                                (41,262
                                )
                                
                                $
                                (3,663
                                )
                                
                                $
                                (107,502
                                )Net
      cash provided by (used in) operating activities
                                
                                
                                (41,262
                                )
                                
                                
                                (3,663
                                )
                                
                                
                                (107,502
                                )Cash
      Flows From Investing Activities(Purchase)
      of equipment
                                
                                
                                -
                                
                                
                                
                                -
                                
                                
                                
                                (4,600
                                )Investment
      in production activites
                                
                                
                                (9,000
                                )
                                
                                
                                -
                                
                                
                                
                                (9,000
                                )Net
      cash used in investing activities
                                
                                
                                (9,000
                                )
                                
                                
                                -
                                
                                
                                
                                (13,600
                                )Cash
      Flows From Financing Activities:Proceeds
      from note payable
                                
                                
                                78,418
                                
                                
                                
                                3,000
                                
                                
                                
                                146,418Repayment
      of notes payable
                                
                                
                                (27,765
                                )
                                
                                
                                -
                                
                                
                                
                                (27,765
                                )Sale
      of common stock
                                
                                
                                -
                                
                                
                                
                                -
                                
                                
                                
                                11,200Repurchase
      of common stock
                                
                                
                                -
                                
                                
                                
                                -
                                
                                
                                
                                (8,750
                                )Net
      cash provided by (used in) financing activities
                                
                                
                                50,653
                                
                                
                                
                                3,000
                                
                                
                                
                                121,103Net
      Increase (Decrease) in Cash
                                
                                
                                390
                                
                                
                                
                                (663
                                )
                                
                                
                                1Cash
      Beginning of Period
                                
                                
                                (390
                                )
                                
                                
                                273
                                
                                
                                
                                -Cash
      End of Period
                                
                                $
                                1
                                
                                
                                $
                                (390
                                )
                                
                                $
                                1Reconciliation
      of Income in Net Assets to Net Cash Provided
      by Operating Activities:Net
      Loss from Development Stage Activities
                                
                                $
                                (48,532
                                )
                                
                                $
                                (12,592
                                )
                                
                                $
                                (129,587
                                )Non
      cash activities:Depreciation
                                
                                
                                -
                                
                                
                                
                                920
                                
                                
                                
                                2,725Prior
      Year Adjustment
                                
                                
                                -
                                
                                
                                
                                1,650
                                
                                
                                
                                -Abandonment
      of Assets
                                
                                
                                1,875
                                
                                
                                
                                -
                                
                                
                                
                                1,875Write
      off uncollected other receivable
                                
                                
                                250
                                
                                
                                
                                2,508Stock
      issued in lieu of compensation
                                
                                
                                11,025
                                
                                
                                
                                -
                                
                                
                                
                                11,025Reconciliation
      Adjustments(Decrease)
      in Accounts Payable
                                
                                
                                (2,200
                                )
                                
                                
                                2,200
                                
                                
                                
                                -(Decrease)
      in Accrued Expenses
                                
                                
                                (4,180
                                )
                                
                                
                                (1,649
                                )
                                
                                
                                (1,680
                                )(Decrease)
      in Accrued Interest
                                
                                
                                500
                                
                                
                                
                                3,300
                                
                                
                                
                                8,140Net
      cash provided by (used in) operating activites
                                
                                $
                                (41,262
                                )
                                
                                $
                                (3,663
                                )
                                
                                $
                                (107,502
                                )
  The
accompanying notes are an integral part of these financial
statements
  29
  Note 1 -
Summary of Significant Company & Organization Policies





Organization
and Business Operations





RegenoCELL
Therapeutics, Inc. (formerly Good Buddy's Coffee Express, Inc.) (the "Company")
was incorporated in the State of Florida on February 1, 2002. The Company’s main
office was located in South Carolina and planned to develop a national chain of
drive through, high quality coffee outlets. In July 2008 the main office was
relocated to Massachusetts and the corporate mission was amended to develop a
stem cell therapy business for the treatment of congestive heart failure and
peripheral artery disease in lieu of its original goals. On July 7, 2008, the
Company amended its Articles of Incorporation changing the name of the
corporation to RegenoCELL Therapeutics, Inc.  In
addition  the Company approved an employment agreement with James F.
Mongiardo as President and Chief Executive Officer. In addition, Scott Massey,
the former President, Chief Executive Officer and Director of the Company, and
Phillips N. Dee, the former Director of the Company resigned from their
positions as officers and directors of the Company and James F. Mongiardo was
elected as Chief Executive Officer, President, Treasurer, Secretary and sole
Director of the Company.





At the
current time the Company is still in the development stage and as such reports
its financial statements as a Development Stage Enterprise. All costs associated
with the development of the Company’s market are expenses as per SPO
98-5.





Note 2 -
Summary of Significant Accounting Policies





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.





Cash and
Cash Equivalents





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





Accrued
Expenses





At year
end management recognizes an appropriate expense for the audit of its financial
records.





Fair
Value of Financial Instruments





Financial
instruments, including cash, receivables, accounts payable, and notes payable
are carried at amounts which reasonably approximate their fair value due to the
short term nature of these amounts or due to variable rates of interest which
are consistent with market rates. At present, the Company does not have any
material accounts receivables or accounts payable.





30




Intangible
Assets





The
Company has acquired a non-exclusive license to market the TheraVitae, Inc.’s
stem cell technology in Mexico and the Caribbean. The cost of the license is
recorded as intangible assets and will be amortized at the time when the company
begins recognizing revenue over the life of the agreement.





Income
Taxes





The
Financial Accounting Standards Board (FASB) issued Statements of Financial
Accounting Standards (SFAS) No. 109 "Accounting for Income Taxes", which
requires companies to use the asset and liability method of accounting for
income taxes. Under the asset and liability method, deferred income taxes are
recognized for the tax consequence of temporary differences by applying enacted
statutory tax rates applicable to future year's differences between the
financial statements carrying amounts and the tax basis of existing assets and
liabilities. Pursuant to SFAS No. 109, the effect on deferred taxes of a change
in tax rates is recognized as income in the period that includes the enactment
date. Under the deferred method, deferred taxes recognized using the tax
applicable to the year of the calculation and were not adjusted for subsequent
changes in tax rates.





Earnings
(Loss) Per Share





The
Company presents "basic" earnings (loss) per share and, if applicable, "diluted"
earnings per share pursuant to the provisions of Statement of Financial
Accounting Standards No. 128, Earnings per Share (SFAS 128). Basic earnings
(loss) per share are calculated by dividing net income or loss by the weighted
average number of shares outstanding during each period. The calculation of
diluted earnings (loss) per share is the same as the basic earnings (loss) per
share.





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.





Note 3 -
Fixed Assets





Fixed
Assets are stated at cost less accumulated depreciation. Expenditures for
ordinary maintenance and repairs are charged to operations as incurred. Major
additions and improvements are capitalized using the straight-line method over
the estimated useful life of the asset.





31




2008
                                
                                
                                2007
                                
                                
                                EstimatedUseful LifeRestaurant
      Equipment
                                
                                $
                                -0-
                                
                                
                                $
                                1,300
                                
                                
                                5 yearsEquipment
                                
                                
                                -0-
                                
                                
                                
                                1,000
                                
                                
                                5 yearsComputers
                                
                                
                                -0-
                                
                                
                                
                                2,300
                                
                                
                                5 years-0-
                                
                                
                                
                                4,600Less:
      Accumulated Depreciation
                                
                                
                                -0-
                                
                                
                                
                                2,725Net
      Fixed Assets
                                
                                $
                                -0-
                                
                                
                                $
                                1,875





Note 4 -
Notes Payable





The
Company has issued various unsecured demand promissory notes to the majority
shareholder and other unrelated individuals as of December 31,
2008.  No demand has been placed or is anticipated to be placed and
therefore, they have been classified as long term debt. The detail of the long
term debt is as of December 31, is as follows:





Principal
                                                          
                                                          
                                                          Principal2008
                                                          
                                                          
                                                          2007November
      28, 2003 - Due June 1, 2009
                                                          
                                                          $
                                                          -
                                                          
                                                          
                                                          $
                                                          15,000
                                                          
                                                          5% per annumFebruary
      5, 2005 - Demand Note
                                                          
                                                          
                                                          47,824
                                                          
                                                          
                                                          
                                                          53,000
                                                          
                                                          5%
      per annumJune
      26, 2008 – Convertible Demand Note5%
      per annum, convertible to common stockat
      $1.00 per share
                                                          
                                                          
                                                          39,164
                                                          
                                                          
                                                          
                                                          -September
      30, 2008 – Demand Notes, 0% perAnnum.
                                                          
                                                          
                                                          12,408
                                                          
                                                          
                                                          
                                                          -October
      1, 2008 – Demand Notes, 5% perAnnum.
                                                          
                                                          
                                                          10,000
                                                          
                                                          
                                                          
                                                          -December
      31, 2008 – Demand Notes, 0% perAnnum.
                                                          
                                                          9,257
                                                          
                                                          
                                                          
                                                          -Total
      Debt
                                                          
                                                          
                                                          118,653
                                                          
                                                          
                                                          
                                                          68,000Less
      Current Portion
                                                          
                                                          
                                                          -
                                                          
                                                          
                                                          
                                                          -Long
      Term Debt
                                                          
                                                          $
                                                          118,653
                                                          
                                                          
                                                          $
                                                          68,000Interest
      expense for the year endingDecember
      31,
                                                          
                                                          $
                                                          5,473
                                                          
                                                          
                                                          $
                                                          3,300




32





Note 5 -
Income Taxes





The
reconciliation of the statutory Federal income tax rate to the effective tax
rate for the year ended December 31, are as follows:





2008
                                      
                                      
                                      2007Amount
                                      
                                      
                                      Rate
                                      
                                      
                                      Amount
                                      
                                      
                                      RateIncome
      Taxes at Statutory Rate
                                      
                                      $
                                      (
      20,189
                                      )
                                      
                                      
                                      -15.0
                                      %
                                      
                                      $
                                      (12,845
                                      )
                                      
                                      
                                      -15.0
                                      %Increase
      (Decrease) in taxes Valuation Allowance
                                      
                                      
                                      20,189
                                      
                                      
                                      
                                      15.0
                                      %
                                      
                                      $
                                      12,845
                                      
                                      
                                      
                                      15.0
                                      %$
                                      -
                                      
                                      
                                      
                                      0.0
                                      %
                                      
                                      $
                                      -
                                      
                                      
                                      
                                      0.0
                                      %




The major
components of deferred tax assets are as follows:





2008
                          
                          
                          2007Deferred
      tax assets:Net
      operating loss carryforward
                          
                          $
                          (134,591
                          )
                          
                          $
                          (85,636
                          )Valuation
      allowance
                          
                          
                          134,591
                          
                          
                          
                          85,636Net
      deferred tax assets
                          
                          $
                          -
                          
                          
                          $
                          -





Note 6 -
Stockholders Equity





On May
29, 2008 the Board of Directors unanimously voted to increase the authorized
shares of both the preferred stock and common stock from 5,000,000 to 10,000,000
shares and from 20,000,000 to 200,000,000 shares respectively.





On May
29, 2008, the Board of Directors unanimously voted for a 10 for 1 forward stock
split of the common shares effective for stockholders of record on June 13,
2008. The number of outstanding shares of common stock was adjusted from
approximately 7,031,250 to 70,312,500 shares, resulting from the
split.





On July
7, 2008, the Company Amended its Articles of Incorporation and increased the
number of authorized common stock to 520,000,000 shares at a par value of $.0001
per share. The Company also issued 250,000 restricted common shares to Douglas
T. Rice in lieu of payment for business consulting services, 5,000,000
restricted common shares to Domenic Mazza for marketing consultation services
and 15,000,000 restricted common shares to James F. Mongiardo CEO of the Company
as employee compensation.





33




On July
22, 2008, in accordance with a Letter of Intent between TheraVitae, Inc and the
Company to secure licensing rights from Thera Vitae, Inc., the Board of
Directors placed 90,000,000 restricted common shares at par value of $0.0001.in
escrow. These shares will be released  upon completion and execution
of the agreements incorporating the terms of the Letter of Intent. 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.





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.





Note 7 -
Going Concern





The
Company has no revenues to date. Since its inception the Company has been
dependent upon the receipt of capital investment to fund its continuing
activities. In addition to the normal risks associated with a new business
venture, there can be no assurance that the Company's business plan will be
successfully executed. As has been stated, an insignificant amount of funds have
been raised to date. In order to raise the necessary capital to commence its
planned principal operations and to implement its business plan, the Company's
management plans to complete a private placement of its common stock. The
Company's ability to execute its business model will depend on its ability to
obtain additional financing and achieve a profitable level of operations. There
can be no assurance that sufficient financing will be obtained. Nor can any
assurance be made that the Company will generate substantial revenues or that
the business operations will prove to be profitable.





Item
      9.
            CHANGES
      IN AND DISAGREEMENTS WITH ACCOUNTANTS ONACCOUNTING
      AND FINANCIAL DISCLOSURE.





The previous Independent Auditors
Robert C. Seiwell, Jr., CPA ("Seiwell") resigned as the independent auditor for
the Company on July 15, 2004 2004 because he ceased performing SEC audits.
Seiwell's reports on the financial statements of the Company for the fiscal year
ended December 31, 2003, for the period from February1, 2002 (inception) through
December 31, 2002 and for the period from February 1, 2002 (inception) through
December 31, 2003 contain no adverse opinion or disclaimer of opinion and were
not qualified or modified as to uncertainty, audit scope or accounting
principles except that there was an explanatory paragraph relating to our
ability to continue as a going concern.





For the fiscal year ended December
31, 2003, for the period from February 1, 2002 (inception) through December 31,
2002 and for the period from January 1, 2004 through July 15, 2004 (the date the
relationship ended with the former accountant), there has been no disagreement
between the Company and Seiwell, 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 Seiwell would have caused
it to make a reference to the subject matter of the disagreement in connection
with its reports.





34




During the fiscal year ended December
31 2003, for the period from February 1, 2002 (inception) through December 31,
2002 and for the period from January 1, 2004 through July 15, 2004 (the date the
relationship ended with the former accountant), the Company has not been advised
of any matters described in Regulation S-B, Item 304(a)(1)(B).





The Company engaged Siegelaub
Lieberman & Associates, P.A., 2801 North University Drive, Suite 301, Coral
Springs, Florida 33065 ("Siegelaub"), as its new independent accountants as of
July 29, 2004, Prior to such date the Company did not consult with Siegelaub
regarding (i) the application of accounting principles, (ii) the type of audit
opinion that might be rendered by Siegelaub, 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.
            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, 2008. 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:





35




•          Pertain
to the maintenance of records that in reasonable detail accurately and fairly
reflect the transactions and dispositions of the Company'sassets;





•          Provide
reasonable assurance that transactions are recorded as necessary to permit
preparation of the financial statements in accordance with generally 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, 2008, 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, 2008, the
Company's internal control over financial reporting is effective.





Our
independent registered public accounting firm, Lieberman & Associates,
performed an audit of internal control over financial reporting and in a report
dated March 13, 2009 concluded that in all material respects, effective internal
control over financial reporting based on the COSO criteria were maintained by
the Company as of December 31, 2008.  This report appears as part of
March 27, 2009 audit report to the Board of Directors of RegenoCELL
Therapeutics, Inc. and Stockholders.





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, 2008, that materially affected, or
are reasonably likely to materially affect, our internal control over financial
reporting.





Item
9B.  OTHER INFORMATION





None.





36





Part
III





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:





Name:
            Age
            Position
            Director
      sinceJames F. Mongiardo
            63
            President and Chairman
            2008





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.).





37




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.





Audit
Committee





The audit committee of our Board of
Directors previously consisted of one director, Phillips N. Dee.  Upon
his and Scott Massey’s resignation and the election of James F. Mongiardo to
fill these vacancies, the Company currently does not have an audit committee;
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 Letter of Intent with
TheraVitae, 90,000,000 restricted common shares which are being held in escrow
will be issued to TheraVitae upon closing. For a period of two years after these
shares are released from escrow, TheraVitae has agreed to vote these shares in
accordance with the recommendations of the Board of Directors.  At
closing the Board will be expanded to five members, two selected by TheraVitae,
two selected by James F. Mongiardo and one non-executive chairman selected by
the Board.





Directors'
Remuneration





Our
directors are presently not compensated for serving on the board of
directors.





Code
Of Ethics and Standards of Conduct





The
Company has adopted a code of business conduct and ethics applicable to the
Company's directors, officers (including the Company's principal executive
officer, principal financial officer and principal accounting officer), and
employees, known as the Code of Ethics and Standards of Conduct.  The
Code of Ethics and Standards of Conduct has been filed as an exhibit to the
Company's Form 10-KSB for the fiscal year ended December 31, 2005.A copy of the
Code of Ethics may be retrieved at www.sec.gov.





38




In the
event that we amend or waive any of the provisions of the Code of Ethics and
Standards of Conduct applicable to our principal executive officer, principal
financial officer, or principal accounting officer, we intend to disclose the
same by filing a Form 8-K with the Securities and Exchange
Commission.





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 5Phil Dee
            Form 5





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.  As of this date, the
Company has not raised the aggregate minimum equity capital or gross revenues
and no salary has been accrued or paid to Mr. Mongiardo.





Summary
Compensation Table





The table
below sets forth the total compensation accrued by the Company for the years
ended December 31, 2008, 2007, 2006, 2005, 2004, 2003 and from inception for the
Company’s former President and for the present President who was the sole
executive and financial officer of the Company as of December 31,
2008.





39




Summary
Compensation Table





Annual Compensation
                                                                  
                                                                  
                                                                  Long-Term CompensationAwards
                                                                  
                                                                  
                                                                  PayoutsName
      and
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  Shares Underlying
                                                                  
                                                                  
                                                                  All OtherPrincipal Position
                                                                  
                                                                  Year
                                                                  
                                                                  Salary
                                                                  
                                                                  
                                                                  Bonus
                                                                  
                                                                  
                                                                  Options Granted (#)
                                                                  
                                                                  
                                                                  CompensationJames F. Mongiardo(7/16/08-12/31/08)President, principal
                                                                  
                                                                  2008
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0executive officer,principal financial officerand directorScott Massey
                                                                  
                                                                  2008
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0Former President, principal
                                                                  
                                                                  2007
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0executive officer,
                                                                  
                                                                  2006
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0principal financial officer
                                                                  
                                                                  2005
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0and director
                                                                  
                                                                  2004
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  02003
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0Inception to 12/31/02
                                                                  
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0
                                                                  
                                                                  
                                                                  
                                                                  0





Stock
Option Grants in the past fiscal year





We have
not issued any grants of stock options in the past fiscal year.





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 23, 2009 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.





Name and Address of
                                  Beneficial Owner
                                
                                Amount and Nature of
                                  Beneficial Ownership(1)
                                
                                
                                Percent of classJames
      F. Mongiardo
                                  2
      Briar Lane
                                  Natick,
      MA 01760
                                
                                
                                15,000,000
                                
                                
                                
                                11.41
                                %All
      current directors and executive officers as a group  (1
      person)
                                
                                
                                15,000,000
                                
                                
                                
                                11.41
                                %





(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 December 31, 2008
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.





40




Pursuant
to a Board of Directors resolution, on August 8, 2008, 90,000,000 restricted
common shares were issued to TheraVitae, Inc..  These shares are being
held in escrow by the Company 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.   For a period of two years,
TheraVitae has agreed to vote these shares in accordance with the
recommendations of the Board of Directors.  At closing the Board will
be expanded to five, two selected by TheraVitae, two selected by James F.
Mongiardo and one non-executive chairman selected by the Board.





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.
            Principal
      Accountant Fees and Services.





The
Company paid audit fees to its independent certified public accountant,
Lieberman & Associates, P.A. in the amount
of  $3,000         for
the year ended December 31, 2008, $2,500 for the year ended December 31, 2007
and $2,500 for the year ended December 31, 2006.  The Company also
paid to the independent certified public accountants $2,750 for other services
related to the 2008 fiscal year.





Item
15.  EXHIBITS.




Exhibit
      Number
              Description




(31.1)
Certification of Chief Executive Officer and Chief Financial Officer pursuant to
Rule 13a-14 or 15d-14 of the Securities Exchange Act of 1934, as adopted
pursuant to section 302 of the Sarbanes-Oxley act of 2002.





(32.1)
Certification of Chief Executive Officer and Chief Financial Officer pursuant to
18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley
Act of 2002.





41




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:  March
      30, 2009
            By: /s/ James F. MongiardoJames
      F. MongiardoPresident
      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 March 30,
2009.





/s/ James F. MongiardoJames
      F. MongiardoPrincipal
      Executive Officer,President,
      Principal FinancialOfficer,
      Principal AccountingOfficer
      and Director




42