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, 2009





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  ̈  No x





The
Company's revenues for the year ended December 31, 2009 were $0.





As of
March 31, 2010, 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 31, 2010 was $928,750.





As of
March 31, 2010, there were 81,437,500 shares of the registrant's Common Stock
outstanding.





REGENOCELL
THERAPEUTICS, INC.


INDEX TO
ANNUAL REPORT ON FORM 10-K


Fiscal
Year Ended December 31, 2009




PART
      IItem 1.
                
                Business
                3Item 1A.
                
                Risk
      Factors
                14Item 1B.
                
                Unresolved
      Staff Comments
                24Item 2.
                
                Properties
                24Item 3.
                
                Legal
      Proceedings
                24Item 4.
                
                Submission
      of Matters to a Vote of Security Holders
                25PART
      IIItem 5.
                
                Market
      for Registrant’s Common Equity, Related Stockholder Matters and Issuer
      Purchases of Equity Securities
                25Item 6.
                
                Selected
      Financial Data
                28Item 7.
                
                Management’s
      Discussion and Analysis or Plan of Operations
                29Item 7A.
                
                Quantitative
      and Qualitative Disclosures about Market Risk
                33Item 8.
                
                Financial
      Statements and Supplementary Data
                33Item 9.
                
                Changes
      in and Disagreements with Accountants on Accounting and Financial
      Disclosure
                50Item
      9A.
                
                Controls
      and Procedures
                51Item
      9B.
                
                Other
      Information
                52PART
      IIIItem 10.
                
                Directors,
      Executive Officers and Corporate Governance
                52Item 11.
                
                Executive
      Compensation
                55Item 12.
                
                Security
      Ownership of Certain Beneficial Owners and Management and Related
      Stockholder Matters
                56Item 13.
                
                Certain
      Relationships and Related Transactions, and Director
      Independence
                57Item 14.
                
                Principal
      Accounting Fees and Services
                57PART
      IVItem 15.
                
                Exhibits
                57


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.


3


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 provided 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 provided 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.


4


Stem
Cell Therapy




The
ability to treat disease has been enhanced in the past two decades through the
development of products utilizing techniques commonly referred to as
“biotechnology”.  Our ability to treat has also been enhanced by a
better understanding of the human genome.  Added to this mix of
advanced new treatments have been products which are tissue engineered, that is
utilizing cells to create tissue which treats the disease or damaged
tissue.  Holding great promise for significant new advances in the
treatment of disease and damaged tissue are stem cells.





Stem cells are cells which have the
ability to produce other cells identical to themselves or to differentiate into
specific cell lineages.  With these properties, stem cells play
important roles in normal development and in the regeneration and repair of
damaged tissue through the ability to differentiate into the type of cell needed
for growth or repair.





The main sources of stem cells include
(1) embryonic and fetal tissues; (2) umbilical cord blood; and (3) adult stem
cells.  Embryonic stem cells are totipotent which means that they can
differentiate into all cell types.  Use of embryonic stem cells has
been subject to ethical controversy.  Because their proliferation is
difficult to control, they have been linked to the formation of
cancers.  More importantly, they possess a genome which is different
than the patient’s genome raising safety issues which will take extensive
clinical testing to resolve.





Umbilical cord blood stem cells are
also capable of significant differentiation.  While not being subject
to ethical controversy as embryonic stem cells, they still possess a genome
which is different than the patient’s genome.  Many different choices
may get a similarity in genomes but it will never be an identical match to the
one person whose umbilical cord blood is being used to create the stem
cells.





Adult stem cells are
different.  They are autologous, meaning that they are derived from
the patient for use in that patient.  Typical sources of adult stem
cells include bone marrow or blood.  Any tissue of the patient may be
used.  Adult stem cells are capable of differentiating into a variety
of cell types without a risk of immunological rejection.  Without the
safety concerns of immunological rejection associated with embryonic and
umbilical cord blood stem cells, it is expected that the first stem cell
products to market will be derived from adult stem cells.





Stem
Cell Business





After an extended period of due
diligence and meetings with the founder of TheraVitae, Inc., the letter of
intent which forms the initial basis of the stem cell business of the Company
was executed on March 31, 2008. That letter provides for two
businesses.  The first is immediately revenue generating, the
treatment of no option congestive heart failure patients from the United States
in Mexico.  The second is longer term, taking the same product through
the regulatory process in the United States for the treatment of peripheral
artery disease.  This second business is exclusive for North
America.





To
implement the stem cell business plan, the first step taken was to find a Chief
Medical Officer.  Through previous dealings with Americo Simonini, MD,
he was approached and was excited to serve as Chief Medical
Officer.  Americo Simonini, MD is a leading cardiac clinician at the
Cedars-Sinai Medical Center in Los Angeles.  As part of his diverse
interests in leading edge cardiac technologies, he also serves as Clinical
Assistant Professor of Medicine at the UCLA Medical School.


5


Dr.
Simonini is a graduate of New York University (BA) and SUNY-Stony Brook, NY
(MD).  His postdoctoral training was at multiple institutions
including the New York University-Bellevue Hospital Center, the Cardiovascular
Research Institute at UCSF and a Cardiology Fellowship at the University of
Michigan Medical Center.  He was recruited to serve as Director at the
Advanced Heart Failure Program at the Cedars-Sinai Medical Center, Los Angeles
where he continues to practice as a clinician.  His abstracts and
manuscripts have included an examination of the causes of heart failure as well
as the role of angiogenic molecules in coronary artery disease.





As Chief
Medical Officer for RegenoCELL Therapeutics, Dr. Simonini will provide oversight
to the company’s clinical programs.  Among his responsibilities are
the development of data which can be used to support the Company’s stem cell
treatment at scientific and medical meetings.  He is responsible for
overview of any clinical trial conducted. He must qualify any patient to be
treated and is responsible for the follow-up visits after
treatment.  Further, he is a source of patients from the United States
to be treated in Mexico.





The next major step in implementing the
stem cell business plan was to find a place suitable in Mexico to treat no
option congestive heart failure patients from the United States.  It
had to be conveniently located, be a place where Americans will be comfortable
and offer first class medical facilities and personnel to administer the
treatment.  The focus was on Monterrey, Mexico which had all the
requisite characteristics.  Two hospitals, both of which are
qualified, were considered and Christus Muguerza Hospital
selected.  Christus is 50% owned by a United States hospital
chain.  It is Joint Commission accredited meaning it meets all the
standards that hospitals meet in the United States.  It has
state-of-the-art catherization laboratories employing GE
equipment.  It also is a GE beta testing site for new software for
medical equipment.





More importantly, the cardiologist
administering the treatment in Mexico is Jose Luis Assad Morrell,
MD.  Dr. Assad trained at Johns Hopkins, Georgetown and the Mayo
Clinic. He is a Diplomate Mexican Board of Internal Medicine with Certified
Subspecialties of Cardiovascular Disease, a Fellow of the American College of
Cardiology and a Fellow of the Society of Cardiac Angiography and
Interventions.  Agreements were reached with both Christus Muguerza
and Dr. Assad for services which they are to provide.





As part of the discussions with
Christus Muguerza, it was learned that the Hospital had Class 10,000 clean room
space.  This is significant since the plan is open local manufacture
in Mexico.  Building a clean room takes 12-18
months.  Leasing space from Christus Muguerza would permit local
manufacture to ramp up in a shorter period of time.





In a subsequent meeting at Christus
Muguerza, the Hospital suggested that the Company consider Class 10,000 clean
room space at the University of Monterrey Medical School.  We visited
with the Director of the Medical School and inspected the clean room which was
then under construction.  The Medical School/University offers not
only Class 10,000 clean room space but also personnel with the requisite
technical training who could be employed to provide for local Mexican
manufacture.  Subsequent discussions with the founder of TheraVitae
led to a joint venture manufacturing proposal from the Company.


6


The key part of the business plan,
namely the treatment of no option congestive heart failure patients from the
United States in Mexico, required obtaining approval from COFEPRIS (Mexican FDA)
to conduct a clinical trial in Mexico for an unapproved product.  This
is analogous to the United States where the Food and Drug Administration
approves clinical trials for unapproved products.





A clinical trial requires a protocol
which includes the safety and efficacy data supporting the
product.  It also requires information about other similar products
and details about the manufacturing process.  We put together an
extensive Mexican information package.  The process in Mexico required
that our clinical trial first be approved by the Research and Bioethics
Committee of Christus Muguerza Hospital, similar to an Institutional Review
Board in the United States.  Since we are applying in Mexico, any
documents we created had to be translated into Spanish.





We obtained the Research and Bioethics
Committee approval to conduct the clinical trial in March.  Before we
submitted to COFEPRIS, a local Mexico City firm, Accelerated Clinical Research
(“ACR”) was retained to assist with the application and to follow it through
COFEPRIS.  A regulatory strategy was agreed upon and multiple
additional documents were created to satisfy what ACR said COFEPRIS would expect
to see.    The documents are so numerous that ACR sent two
discs for the Company’s files.





COFEPRIS does not mail any letters
about action it is taking. Rather all letters are hand delivered and if you miss
a deadline because you did not pick up your letter on time, you start all
over.  Through ACR, we had someone go to the offices of COFEPRIS in
Mexico City every day post our submission.  COFEPRIS responded in
early June requesting three changes to our program.  The most
significant was their request that instead of following patients for 6 months,
we follow them for 2 years with visits every three months which include
measuring the left ventricular ejection fraction at each visit.  We
agreed to the three changes but before we could resubmit had to obtain approval
for these changes from the Research and Bioethics Committee at Christus Muguerza
Hospital.  We did obtain that approval and resubmitted to COFEPRIS on
June 19 which was on time (within 10 business days of issuance of the
letter).  Subsequently COFEPRIS raised another issue concerning
language in the Informed Consent.  The Company then engaged local
counsel who negotiated with COFEPRIS revised language to the Informed
Consent.





At the request of COFEPRIS, the entire
application was resubmitted after obtaining approval again from the Research and
Bioethics Committee of Christus Muguerza Hospital for the revised language. The
re-submission was made on October 13, 2009.  COFEPRIS approved the
application on November 30, 2009.  The final step in this process is
to obtain an import license from another section of COFEPRIS.  It
takes an average of 15 (fifteen) business days to obtain a license from the date
the import license application is submitted.


7


Concurrent with the final steps in the
Mexican approval process, the Company was asked to become its staging center for
patients in North America.  We will screen and qualify them, draw
their blood and ship it to the cell processing facility in
Israel.  The patients will fly to Bangkok to receive the stem cell
treatment.  It should be noted that both the shipment of blood and the
shipment of stem cells from that blood must be done under a 48 window under
controlled temperature conditions.  The Staging Center Services
Agreement was executed on November 4, 2009.





The
Company also reached agreement with Titan Imaging located in West Hollywood,
California to serve as the staging center for patients.  It is
expected that patients will be screened, have their blood dawn and receive all
the tests in the subsequent follow-up visits at the LA Advanced Heart Therapy
Center located at Titan Imaging’s facilities which are required by the protocol
submitted to COFEPRIS.  Titan has not requested any up-front payments
but rather will be paid as each patient is processed.  The Diagnostic
Imaging Services Agreement between the Company and Cardio Diagnostic Imaging,
doing business as Titan Imaging, was executed on November 19, 2009.





Final training was conducted the first
week of February 2010 making the staging center at Titan Imaging operational in
Los Angles.  Referrals will be processed there and the Company will
receive payment for these services.  The first such patient was
processed on March 23-24, 2010. Once approval to treat in Mexico is obtained,
Company patients will be staged at the LA Advanced Heart Therapy Center located
at Titan Imaging and treated in Mexico.  Follow-up visits will be over
two years in Los Angeles.





Patient flow will be as
follows.  A no option congestive heart failure patient (3 to 6 months
to live) decides to have the Company’s stem cell treatment.  The
patient is screened by Dr. Simonini to determine if the patient qualifies for
treatment.  The patient decides to pursue this treatment and enters
into a cell therapy logistical services agreement.  The charge is
expected to be $64,500.  After payment, the patient goes to the LA
Advanced Heart Therapy Center located at Titan Imaging, is evaluated and
qualified for the treatment and has their blood drawn.  It is then
under controlled temperature conditions sent to Israel for processing within 48
hours.  In Israel, the patient’s stem cells are segregated and grown
over 5 days from tens of thousands into many millions.





The patient then flies to Monterrey,
Mexico.  They will be staying at the Safi Royal Luxury Hotel Valley
where we have negotiated a special rate.  They will be examined by Dr.
Assad before the Company’s stem cells are received.  Upon receipt, the
patient will be admitted to Christus Muguerza Hospital for treatment pursuant to
the approved protocol.  Dr. Assad will administer the Company’s stem
cells in one of Christus Muguerza’s catherization laboratories.  The
process is very similar to angioplasty except the stem cells are released as
opposed to a balloon/stent removing a blockage.  The patient then
recovers from this 45 minute procedure (insure that the artery through which the
catheter was placed has fully healed).  Dr. Assad then clears the
patient to fly back to the United States.





Patient follow-up is conducted at the
LA Advanced Heart Therapy Center located at Titan Imaging by Dr.
Simonini.  Visits are scheduled for one month, three months and every
three months thereafter until two years from receipt of
treatment.  Data gathered through these visits will be used by Drs.
Simonini and Assad to publish papers and present at scientific and medical
meetings.


8


On January 7, 2010 the Company entered
into two agreements.  Closing occurred on February 4,
2010.





The first
agreement is between TheraVitae Limited, the Israeli corporation manufacturing
the stem cell therapy product, and a newly formed Israeli corporation which is a
wholly owned subsidiary of the Company, Regenocell Laboratories,
Ltd.  Pursuant to the terms of the agreement, certain assets were
acquired and certain liabilities assumed.  These assets include all
the manufacturing and office equipment and the transfer of the
lease.  At signing the Company paid $75,000 toward the reduction of
the assumed liabilities.  All the employees were terminated then
offered and accepted employment with Regenocell Laboratories, Ltd.





The
second agreement is between Yieldex, Ltd. and the Registrant for the acquisition
of certain rights.  This includes clinical data, the non exclusive use
of the CRM System which manages clinical data and input necessary to schedule a
patient for stem cell production, and all rights in patent and patent
applications, if any, in connection with activities of stem cell research,
therapy development and clinical trials under the trade name ”TheraVitae” for
the world except for Asia.  Israel is excluded by definition from
being part of Asia.  The cash price is $5,000,000 (five million United
States dollars), of which $75,000 was paid to TheraVitae Limited and $25,000 to
Yieldex on January 7.  The balance is due in monthly installments on
or before January 4, 2015.  Minimum installments are $5,000 per
patient processed in Israel after the first eight patients during the preceding
month.  In addition 25% of any equity raised by the Company will be
applied to the outstanding balance.





In addition 40,000,000 (forty million)
shares of the Company’s common stock, par value $.0001, was issued to Yieldex
Ltd and its nominees.  The 40,000,000 shares are restricted and
subject to a two year Lock-Up period beginning January 4, 2010.  These
shares are also subject to a voting agreement.  During the Lock-Up
period and for any subsequent period until the shares are sold to the public in
the open market,  the Board of Directors will be expanded to five
members and the shareholders whose shares are locked up will vote for a maximum
of two directors.  The Company’s shareholders who are not parties to
the Lock-Up agreement will vote their shares for the same two directors until
the aggregate number of Yieldex shares are 15,000,000 (fifteen million) or less.
The Yieldex shareholders agree to vote the Yieldex shares for a maximum of three
directors designated by James F. Mongiardo.  While this voting rights
agreement is in effect, unanimous approval of all the directors then in office
or approval of holders of at least a majority of the shares will be required
for: (i) any proposal to increase capital in a way that would result in dilution
of existing shareholders’ percentages by ten percent (10%) or more; (ii) any
proposal to merge, consolidate or amalgamate with any other corporate entity;
(iii) any proposal to sell all or a material part of the assets; and, (iv) any
proposal to amend the bylaws.


9


As a
result of the actions described above, on February 4, 2010 the Company’s primary
asset is Regenocell Laboratories Ltd. which is manufacturing and selling stem
cell therapy product used to treat congestive heart failure and peripheral
artery disease.  Purchases are being made to treat patients for these
indications in Bangkok, Thailand and the Dominican Republic.  It is
anticipated that purchases will also be made to treat patients in Mexico and
other countries.





Manufacturing
and Distribution





We will be purchasing the stem cell
therapy from our wholly owned subsidiary, Regenocell Laboratories, Ltd. at the
same price it is currently selling to other customers.  These other
customers are treating patients in Bangkok and the Dominican
Republic.  It is anticipated that other customers will be added over
time.  There is sufficient capacity to fulfill expanded orders over
present monthly order flow.  Distribution will remain the same with
blood being drawn from the patient by the customer, sent to Regenocell
Laboratories, Ltd. in Israel for cell processing and the resulting cells being
sent to the customer for administration to the patient in the country designated
by the customer.





Competition





With over 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 establish a clinic in the Dominican Republic for the administration of stem
cell therapy which will be purchased from Regenocell Laboratories,
Ltd.


10


Regardless of any perceived or actual
benefits and advantages, our technologies and products may be rendered obsolete
or noncompetitive as a result of products introduced by
competitors.  Most of our competitors have substantially greater
financial and technical resources, production and marketing capabilities and
related experience.  The greater resources, capabilities and
experience of our competitors may enable them to develop, manufacture and market
their products more successfully and at a lower cost.  In addition,
many of our competitors have significantly greater experience in conducting
preclinical testing and clinical trials and obtaining regulatory
approvals.  Accordingly, our competitors may succeed in obtaining Food
and Drug Administration (“FDA”) and related approvals for products more rapidly
than we will, which may give them an advantage in achieving market acceptance of
their products.





Moreover,
our technologies and products will likely be affected by technological change in
the future.  Management will have to continue to stay abreast of these
changes as they affect product configuration, and will have to remain vigilant
and nimble in order to prevent early investments from becoming obsolete and
other competitive firms who enter later obtaining an advantage with newer
technologies and processes.  There can be no assurances that we will
be able to successfully develop and market our products or respond effectively
to technological changes or new product announcements by
others.  Further, our success depends on the popularity of our
products and services and related technology in the commercial arena, which we
cannot guarantee. We also cannot guarantee that our products and services will
not become unmarketable or obsolete by a competitor’s more rapid introduction to
the marketplace.





Intellectual
Property Matters





Where appropriate, we will seek patent,
trademark and other proprietary rights protection for the products and brands we
develop or introduce.  In other cases, we will seek to license the
rights to use the patents, trademarks and other proprietary rights of others in
support of our business strategy.  However, there can be no assurance
that patent, trademark and other proprietary rights will issue for any
applications we file or that we will be able to license such products and rights
on terms acceptable to the Company, or at all.  To date, the Company
has not filed any applications or registrations for any patent, trademark and
other proprietary rights.





Regulatory
Matters





The
research and development, preclinical studies and clinical trials, and
ultimately, the culturing, manufacturing, marketing and labeling of our product
candidates are subject to extensive regulation by the FDA and other regulatory
authorities in the United States and other countries. All approvals necessary to
manufacture the stem cell therapy product in Israel for use outside of Israel
has been obtained by Regenocell Laboratories, Ltd. While stem cell therapy may
be regulated pursuant to different statutes, we believe that stem cell therapy
is subject to regulation in the United States as a biological
product.  Whatever regulatory pathway is selected by the FDA, any
pathway will involve similar requirements as those for biological
products.





Biological
products are subject to regulation under the Federal Food, Drug, and Cosmetic
Act, or the FD&C Act, the Public Health Service Act, or the PHS Act and
their respective regulations as well as other federal, state, and local statutes
and regulations. The FD&C Act and the PHS Act and the regulations
promulgated thereunder govern, among other things, the testing, cell culturing,
manufacturing, safety, efficacy, labeling, storage, record keeping, approval,
clearance, advertising and promotion of stem cell therapy. Preclinical studies,
clinical trials and the regulatory approval process typically take years and
require the expenditure of substantial resources. If regulatory approval or
clearance of a product is granted, the approval or clearance may include
significant limitations on the indicated uses for which the product may be
marketed.


11




FDA Regulation — Approval of
Biological Products





The steps
ordinarily required before a biological product may be marketed in the United
States include:





•
            completion
      of preclinical studies according to good laboratory practice
      regulations;





•
            the
      submission of an IND application to the FDA, which must become effective
      before human clinical trials may
commence;





•
            performance
      of adequate and well-controlled human clinical trials according to good
      clinical practices to establish the safety and efficacy of the proposed
      biological product for its intended
use;





•
            satisfactory
      completion of an FDA pre-approval inspection of the manufacturing facility
      or facilities at which the product is manufactured, processes, packaged or
      held to assess compliance cGMP; and





•
            the
      submission to, and review and approval by, the FDA of a biologics license
      application, or BLA, that includes satisfactory results of preclinical
      testing and clinical trials.





Preclinical
tests include laboratory evaluation of the product candidate, its formulation
and stability, as well as animal studies to assess the potential safety and
efficacy of the product candidate. The FDA requires that preclinical tests be
conducted in compliance with good laboratory practice regulations. The results
of preclinical testing are submitted as part of an IND application to the FDA
together with manufacturing information for the clinical supply, analytical
data, the protocol for the initial clinical trials and any available clinical
data or literature. A 30-day waiting period after the filing of each IND
application is required by the FDA prior to the commencement of clinical testing
in humans. In addition, the FDA may, at any time during this 30-day waiting
period or any time thereafter, impose a clinical hold on proposed or ongoing
clinical trials. If the FDA imposes a clinical hold, clinical trials cannot
commence or recommence without FDA authorization.





Clinical
trials to support BLAs involve the administration of the investigational product
to human subjects under the supervision of qualified investigators. Clinical
trials are conducted under protocols detailing, among other things, the
objectives of the study, the parameters to be used in monitoring safety and the
efficacy criteria to be evaluated.





Clinical
trials are typically conducted in three sequential phases, but the phases may
overlap:


In Phase
I clinical trials, the initial introduction of the biological product candidate
into human subjects or patients, the product candidate is tested to assess
safety, dosage tolerance, absorption, metabolism, distribution and excretion,
including any side effects associated with increasing doses.


12





Phase II
clinical trials usually involve studies in a limited patient population to
identify possible adverse effects and safety risks, preliminarily assess the
efficacy of the product candidate in specific, targeted indications; and assess
dosage tolerance and optimal dosage.




If a
product candidate is found to be potentially effective and to have an acceptable
safety profile in Phase II evaluations, Phase III trials are undertaken within
an expanded patient population at multiple study sites to further demonstrate
clinical efficacy and safety, further evaluate dosage and establish the
risk-benefit ratio of the product and an adequate basis for product
labeling.




Phase IV,
or post-marketing, trials may be mandated by regulatory authorities or may be
conducted voluntarily. Phase IV trials are typically initiated to monitor the
safety and efficacy of a biological product in its approved population and
indication but over a longer period of time, so that rare or long-term adverse
effects can be detected over a much larger patient population and time than was
possible during prior clinical trials. Alternatively, Phase IV trials may be
used to test a new method of product administration, or to investigate a
product’s use in other indications. Adverse effects detected by Phase IV trials
may result in the withdrawal or restriction of a drug.





If the
required Phase I, II and III clinical testing is completed successfully, the
results of the required clinical trials, the results of product development,
preclinical studies and clinical trials, descriptions of the manufacturing
process and other relevant information concerning the safety and effectiveness
of the biological product candidate are submitted to the FDA in the form of a
BLA. In most cases, the BLA must be accompanied by a substantial user fee. The
FDA may deny a BLA if all applicable regulatory criteria are not satisfied or
may require additional data, including clinical, toxicology, safety or
manufacturing data. It can take several years for the FDA to approve a BLA once
it is submitted, and the actual time required for any product candidate may vary
substantially, depending upon the nature, complexity and novelty of the product
candidate.




Before
approving an application, the FDA will inspect the facility or facilities where
the product is manufactured. The FDA will not approve a BLA unless it determines
that the manufacturing processes and facilities are in compliance with cGMP
requirements.





If the
FDA evaluations of the BLA and the manufacturing facilities are favorable, the
FDA may issue either an approval letter or an approvable letter. The approvable
letter usually contains a number of conditions that must be met to secure final
FDA approval of the BLA. When, and if, those conditions have been met to the
FDA’s satisfaction, the FDA will issue an approval letter. If the FDA’s
evaluation of the BLA or manufacturing facility is not favorable, the FDA may
refuse to approve the BLA or issue a non-approvable letter that often requires
additional testing or information.





There can be no assurances that
approval will be granted for stem cell therapy or any future product or product
candidate, whether in the United States or elsewhere, on a timely basis or at
all.  Furthermore, if approval is granted, the product would be
subject to continuing regulatory regulations and oversight.  The
approval process is expensive and can take a long time to complete, and the cost
involved in satisfying applicable ongoing compliance requirements is
high.


13


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
Mexico and for submitting an IND for stem cell therapy treatment for peripheral
artery disease in the United States and Europe and conducting the clinical
trials necessary to apply for approval to market for this
indication.  In addition Regenocell Laboratories, Ltd. will invest in
research and development to create new stem cell therapy products.





Employees





The
Company currently employs one individual, James F.
Mongiardo.  Regenocell Laboratories, Ltd. has thirteen (13)
employees.





Item
1A.  Risk Factors





Risks
Related to our Business




The
new stem cell business is subject to claims by TheraVitae, Inc. that it is
covered by intellectual property owned by it.




As more
fully described in Item 3, Legal Proceedings, our new stem cell business is
subject to claims by TheraVitae, Inc. that it is covered by intellectual
property owned by it.  While the Company disputes these claims, there
is no assurance that litigation pending in Canada will be resolved in the
Company’s favor.




There
is no assurance that there will be sufficient monthly patient flow for
Regenocell Laboratories, Ltd. to break even.




Patient
flow is dependent upon marketing efforts of other companies and changing
regulatory climates.  There is no assurance that there will be
sufficient monthly patient flow for Regenocell Laboratories, Ltd. to break
even.




Any
adverse development in our ability to treat patients 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.




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.




14


Our
financial situation is precarious and, based on currently estimated operating
expenses, our existing capital resources may not be sufficient to fund our
operations beyond the next 6 months.




We have
incurred significant operating losses and negative cash flows from operations
since inception. We have not achieved profitability and may not be able to
realize sufficient revenues to achieve or sustain profitability in the future.
We expect to incur additional and increasing operating losses. We have limited
liquidity and capital resources and must obtain significant additional capital
resources in order to sustain our product development efforts and for
acquisition of technologies and intellectual property rights, preclinical and
clinical testing of our anticipated products, pursuit of regulatory approvals,
acquisition of capital equipment, laboratory and office facilities,
establishment of production capabilities, maintaining and enforcing our
intellectual property portfolio, general and administrative expenses and other
working capital requirements. We rely on cash reserves and proceeds from equity
offerings to fund our operations. If we exhaust our cash reserves and are unable
to realize adequate financing, we may be unable to meet operating obligations
and be required to initiate bankruptcy proceedings. Our existing capital
resources may not be sufficient to fund our operations beyond the next 6 months.
We intend to pursue opportunities to obtain additional financing in the future
through equity and debt financings, corporate alliances, grants and
collaborative research arrangements. The source, timing and availability of any
future financing will depend principally upon market conditions, interest rates
and, more specifically, on our progress in our exploratory, preclinical and
future clinical development programs. Funding may not be available when needed —
at all or on terms acceptable to us. Lack of necessary funds may require us to
delay, scale back or eliminate some or all of our research and product
development programs and/or our capital expenditures or to license our potential
products or technologies to third parties.




Our
product development programs are based on novel technologies and are inherently
risky.




We are
subject to the risks of failure inherent in the development of products based on
new technologies. The novel nature of our therapeutic products creates
significant challenges in regards to product development and optimization,
manufacturing, government regulation, third party reimbursement and market
acceptance. For example, the FDA has relatively little experience with stem
cell-based therapeutics, and the pathway to regulatory approval for our product
candidates may accordingly be more complex and lengthy than the pathway for new
conventional drugs. These challenges may prevent us from developing and
commercializing products on a timely or profitable basis or at all.




Our
technology is at an early stage of development, and we may fail to develop any
commercially acceptable or profitable products.




Before we
may commercially market any product in the United States, we must obtain
regulatory approval from the FDA after conducting extensive preclinical studies
and clinical trials that demonstrate that our product candidates are safe and
effective for each disease for which we seek approval. We expect that none of
our stem cell therapy product candidates will be commercially available for five
years, if at all, in the United States.




15


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.




16


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 through December 31, 2009.




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




Patent
protection for products such as those we propose to develop is highly uncertain
and involves complex and continually evolving factual and legal questions. The
governmental authorities that consider patent applications can deny or
significantly reduce the patent coverage requested in an application before or
after issuing the patent. Consequently, we do not know 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.




17


If
others are first to discover and patent the stem cells we are seeking to
discover, we could be blocked from further work on those stem
cells.




Because
the first person or entity to discover and obtain a valid patent to a particular
stem cell may effectively block all others, it will be important for us or our
collaborators to be the first to discover any stem cell and methods that we are
seeking to discover. Failure to be the first could prevent us from
commercializing all of our research and development affected by that
patent.




If
we are unable to obtain necessary licenses to third-party patents and other
rights, we may not be able to commercially develop our expected
products.




A number
of pharmaceutical, biotechnology and other companies, universities and research
institutions have filed patent applications or have received patents relating to
cell therapy, stem cells and other technologies potentially relevant to or
necessary for our expected products. We cannot predict which, if any, of the
applications will issue as patents, and there may be existing patents of which
we are currently unaware which the commercialization of our product candidates
would infringe. If third party patents or patent applications contain valid
claims that our technology infringes upon their technology, we may be prevented
from commercializing that technology unless the third party is willing to grant
a license to us. We may be unable to obtain licenses to the relevant patents at
a reasonable cost, if at all, and may also be unable to develop or obtain
alternative non-infringing technology. If we are unable to obtain such licenses
or develop non-infringing technology at a reasonable cost, our business could be
significantly harmed. Also, any infringement lawsuits commenced against us may
result in significant costs, divert our management's attention and result in an
award against us for substantial damages.




We are
aware of intellectual property rights held by third parties that relate to
products or technologies we are developing. For example, some aspects of our
stem cell product candidates involve the use of growth factors, antibodies and
other reagents that may, in certain cases, be the subject of third party rights.
Before we commercialize any product using these growth factors, antibodies or
reagents, we may need to obtain license rights from third parties or use
alternative growth factors, antibodies and reagents that are not then the
subject of third party patent rights. We currently believe that the
commercialization of our products as currently planned will not infringe these
third party rights, or, alternatively, that we will be able to obtain necessary
licenses or otherwise use alternate non-infringing technology. However, third
parties may nonetheless bring suit against us claiming infringement. If we are
unable to prove that our technology does not infringe their patents, or if we
are unable to obtain necessary licenses or otherwise use alternative
non-infringing technology, we may not be able to commercialize any products.
Also, if we use alternative non-infringing technology, we may need to
demonstrate comparability in subsequent clinical trials.




18


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.




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.




19


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.




We
are dependent on the services of key personnel.




We are
highly dependent on the principal members of our management and scientific staff
and some of our outside consultants, including our chief executive officer, our
chief medical officer and our chief technology 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.




20


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.




21


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.




22


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;


·
            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, 2010, 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 90 days, there is no assurance that this
will occur.




23


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 is 2 Briar Lane, Natick, Massachusetts 01760, which is space owned by
the President and Chief Executive Officer of the Company. Rent has not been
charged for the office space and it is not expected that rent will be charged in
the near-term.





Regenocell Laboratories, Ltd. has
assumed a lease with Africa-Israel for its manufacturing operations in
Israel.  Lease payments converted to dollars are $10,400 plus VAT
totaling $12,050 per month.  The lease runs through August 31, 2011
with a two year option to renew.  There is $135,000 in a restricted
account used by Bank Hapoalim to guarantee payment of the
lease.  These funds are to be transferred and accordingly the bank
guarantee transferred from TheraVitae Limited to Regenocell Laboratories,
Ltd.





Item
3.  LEGAL PROCEEDINGS





On February 10, 2010, Kwalata Trading
Limited, a wholly owned subsidiary of TheraVitae, Inc., a Canadian corporation,
obtained an ex parte order from the District Court for the Central Region of
Israel to seize the intellectual property alleged owned by Kwalata which is in
the possession of either Theravitae, Ltd. or Regenocell Laboratories Ltd., the
wholly owned Israeli subsidiary corporation of the Company. The Court appointed
trustee took files and computers including computers dedicated solely to
equipment from  Regenocell Laboratories facilities at 7, Pinchas St.,
Ness Ziona in what the Company considered to be an unlawful attempt to close the
facilities.





Prior to
a scheduled hearing, a settlement agreement was reached which then became the
resolution of the case by the District Court for the Central Region of
Israel.  All equipment and files taken are to be returned subject to
copying by the applicants at their expense.  Excluded from copying are
attorney-client privileged documents, business documents and private
documents.  Regenocell Laboratories and the Company agree not to
disclose the alleged intellectual property to third parties except in the
ordinary course of business, for government filings and when a non disclosure
agreement is obtained. This order remains in effect until a subsequent order by
the Court or the resolution of an arbitration begun in Canada by Kwalata against
TheraVitae, Ltd.




24


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





On January 4, 2010 through written
consent in lieu of a special meeting of the stockholders of RegenoCELL
Therapeutics, Inc., stockholders representing at least of majority of the
outstanding stock of the Company agreed to purchase certain assets which will
give the Company control over the manufacture of the stem cell product which
will be used to treat patients in Mexico as well as supply that products for
patients being treated by other corporations in Bangkok, the Dominican Republic
and other locations, and the Company having arranged for the funding needed to
execute the agreements which will give it control over the manufacture of the
stem cell product thereupon approved, adopted, ratified and confirmed the
following actions taken by the Board of Directors: (1)  Effective
January 4, 2010, or as soon as practicable thereafter, create a wholly owned
subsidiary incorporated under the laws of the state of Israel with the corporate
name “Regenocell Laboratories, Ltd.”  The sole shareholder of
Regenocell Laboratories, Ltd. shall be the Corporation; and upon creation of
Regenocell Laboratories, Ltd., authorize James F. Mongiardo to serve as its sole
director; and upon the appointment of James F. Mongiardo as the sole director of
Regenocell Laboratories, Ltd., authorize the opening of corporate accounts for
Regenocell Laboratories, Ltd. with Bank Hapoalim or another local bank in Israel
with employees of Regenocell Laboratories, Ltd. being authorized as signatories
on said accounts; (2) approve an Asset Purchase Agreement between Regenocell
Laboratories, Ltd. and TheraVitae Ltd., a company incorporated under the laws of
the state of Israel; (3) approve an Assignment of Rights between Yieldex, Ltd.,
a company incorporated under the laws of Hong Kong; (4) pursuant to the terms of
the Yieldex agreement, issue forty million (40,000,000) restricted common
shares, par value $.0001. Said shares shall be initially issued in the name of
“Yieldex, Ltd.”, held in escrow by the Corporation and voted in accordance with
recommendations by the Corporation’s Board until agreed upon Share Lock-Up and
Corporate Governance documents are executed by each entity or person to receive
these shares. When presented with such documents setting forth the entire
re-allocation of these shares, the Corporation shall instruct Florida Atlantic
Stock Transfer to cancel the Yieldex, Ltd. stock certificate and re-issue the
same number shares in accordance with the instructions and documentation
received; (5) approve a Loan Agreement between Mr. Christian Frampton and the
Corporation for one hundred sixty thousand United States dollars ($160,000); and
(6) in return for the personal guarantee of the President of the Corporation
James F. Mongiardo to guarantee the repayment of the capital but not the fee of
the loan, grant James F. Mongiardo a first lien on all assets of the Corporation
including its wholly owned subsidiaries until said capital has been repaid by
the Corporation.





PART
II.





Item
5.  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.




25


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 were held by the Company in escrow with full
control of voting rights until release to TheraVitae upon completion and
execution of the agreements incorporating the terms of the Letter of
Intent.





On July
23, 2008, the Board authorized the cancellation from certain shareholders of
49,125,000 restricted common shares, par value $0.0001.  Said shares
were returned to the transfer agent for cancellation and were
cancelled.





On
December 31, 2009, the Board concluded that the agreements incorporating the
terms of the Letter of Intent with TheraVitae, Inc. had not been completed and
there appeared to be no possibility of their completion and authorized the
cancellation of 90,000,000 restricted common shares par value $0.0001 being held
by the Company in escrow for TheraVitae, Inc. Said shares were returned to the
transfer agent for cancellation and were cancelled.


26


On
January 4, 2010, pursuant to the terms of the Assignment of Rights Agreement
between Yieldex, Ltd. and the Company, 40,000,000 shares of the Company’s common
stock, par value $.0001, were issued subject to a two year Lock-Up period
beginning January 4, 2010 and a voting rights agreement.





As of
March 31, 2010, there were 81,437,500 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 were held by the Company in escrow with full
control of voting rights until release to TheraVitae upon completion and
execution of the agreements incorporating the terms of the Letter of
Intent.





On
December 31, 2009, the Board concluded that the agreements incorporating the
terms of the Letter of Intent with TheraVitae, Inc. had not been completed and
there appeared to be no possibility of their completion and authorized the
cancellation of 90,000,000 restricted common shares par value $0.0001 being held
by the Company in escrow for TheraVitae, Inc. Said shares were returned to the
transfer agent for cancellation and were cancelled.





On
January 4, 2010, pursuant to the terms of the Assignment of Rights Agreement
between Yieldex, Ltd. and the Company, 40,000,000 shares of the Company’s common
stock, par value $.0001, were issued subject to a two year Lock-Up period
beginning January 4, 2010 and a voting rights agreement.





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.


27


Equity
Compensation Plan Information





The
Company did not have an Equity Compensation Plan during the year ended December
31, 2009.





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,
2008 and 2009 and consolidated balance sheet data as of December 31, 2004,
2005, 2006, 2007, 2008 and 2009 from our audited financial statements and notes
thereto that are included elsewhere in this Annual Report on Form
10-K.





Statement of Operational Data:
                                                                            
                                                                            Year Ended December 31,(In thousands, except per share data)2004
                                                                            
                                                                            
                                                                            2005
                                                                            
                                                                            
                                                                            2006
                                                                            
                                                                            
                                                                            2007
                                                                            
                                                                            
                                                                            2008
                                                                            
                                                                            
                                                                            2009Revenue
                                                                            
                                                                            $
                                                                            -
                                                                            
                                                                            
                                                                            $
                                                                            -
                                                                            
                                                                            
                                                                            $
                                                                            -
                                                                            
                                                                            
                                                                            $
                                                                            -
                                                                            
                                                                            
                                                                            $
                                                                            -
                                                                            
                                                                            
                                                                            $
                                                                            -Operating
      Expenses:Development
      Costs
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            (14
                                                                            )
                                                                            
                                                                            
                                                                            (47
                                                                            )Marketing
      General and Administrative
                                                                            
                                                                            
                                                                            (8
                                                                            )
                                                                            
                                                                            
                                                                            (26
                                                                            )
                                                                            
                                                                            
                                                                            (21
                                                                            )
                                                                            
                                                                            
                                                                            (9
                                                                            )
                                                                            
                                                                            
                                                                            (27
                                                                            )
                                                                            
                                                                            
                                                                            (176
                                                                            )Total
      Operating Expenses
                                                                            
                                                                            
                                                                            (8
                                                                            )
                                                                            
                                                                            
                                                                            (26
                                                                            )
                                                                            
                                                                            
                                                                            (21
                                                                            )
                                                                            
                                                                            
                                                                            (9
                                                                            )
                                                                            
                                                                            
                                                                            (41
                                                                            )
                                                                            
                                                                            
                                                                            (223
                                                                            )Loss
      from Development Stage Operations
                                                                            
                                                                            
                                                                            (8
                                                                            )
                                                                            
                                                                            
                                                                            (26
                                                                            )
                                                                            
                                                                            
                                                                            (21
                                                                            )
                                                                            
                                                                            
                                                                            (9
                                                                            )
                                                                            
                                                                            
                                                                            (41
                                                                            )
                                                                            
                                                                            
                                                                            (223
                                                                            )Depreciation
                                                                            
                                                                            
                                                                            -
                                                                            
                                                                            
                                                                            
                                                                            (1
                                                                            )
                                                                            
                                                                            
                                                                            (1
                                                                            )
                                                                            
                                                                            
                                                                            (1
                                                                            )Interest
      Exp
                                                                            
                                                                            
                                                                            (1
                                                                            )
                                                                            
                                                                            
                                                                            (2
                                                                            )
                                                                            
                                                                            
                                                                            (3
                                                                            )
                                                                            
                                                                            
                                                                            (3
                                                                            )
                                                                            
                                                                            
                                                                            (5
                                                                            )
                                                                            
                                                                            
                                                                            (5
                                                                            )Loss
      on Abandonment
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            
                                                                            (2
                                                                            )Loss
      Before Income Taxes
                                                                            
                                                                            
                                                                            (9
                                                                            )
                                                                            
                                                                            
                                                                            (29
                                                                            )
                                                                            
                                                                            
                                                                            (25
                                                                            )
                                                                            
                                                                            
                                                                            (13
                                                                            )
                                                                            
                                                                            
                                                                            (48
                                                                            )
                                                                            
                                                                            
                                                                            (228
                                                                            )Income
      Taxes
                                                                            
                                                                            
                                                                            -
                                                                            
                                                                            
                                                                            
                                                                            -
                                                                            
                                                                            
                                                                            
                                                                            -
                                                                            
                                                                            
                                                                            
                                                                            -
                                                                            
                                                                            
                                                                            
                                                                            -
                                                                            
                                                                            
                                                                            
                                                                            -Net
      (Loss)
                                                                            
                                                                            $
                                                                            (9
                                                                            )
                                                                            
                                                                            $
                                                                            (29
                                                                            )
                                                                            
                                                                            $
                                                                            (25
                                                                            )
                                                                            
                                                                            $
                                                                            (13
                                                                            )
                                                                            
                                                                            $
                                                                            (48
                                                                            )
                                                                            
                                                                            $
                                                                            (228
                                                                            )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
                                                                            
                                                                            
                                                                            
                                                                            131,190,925


28





Balance Sheet
                                                        
                                                        Year Ended December 31,(In thousands, except per share data)2004
                                                        
                                                        
                                                        2005
                                                        
                                                        
                                                        2006
                                                        
                                                        
                                                        2007
                                                        
                                                        
                                                        2008
                                                        
                                                        
                                                        2009Current
      Assets
                                                        
                                                        
                                                        10
                                                        
                                                        
                                                        
                                                        32
                                                        
                                                        
                                                        
                                                        3
                                                        
                                                        
                                                        
                                                        -
                                                        
                                                        
                                                        
                                                        -
                                                        
                                                        
                                                        
                                                        -Working
      Capital Deficit
                                                        
                                                        
                                                        9
                                                        
                                                        
                                                        
                                                        27
                                                        
                                                        
                                                        
                                                        (5
                                                        )
                                                        
                                                        
                                                        (13
                                                        )
                                                        
                                                        
                                                        (6
                                                        )
                                                        
                                                        
                                                        (357
                                                        )Net
      Capital Assets
                                                        
                                                        
                                                        1
                                                        
                                                        
                                                        
                                                        4
                                                        
                                                        
                                                        
                                                        3
                                                        
                                                        
                                                        
                                                        2
                                                        
                                                        
                                                        
                                                        -
                                                        
                                                        
                                                        
                                                        102Net
      Intangible Development Costs
                                                        
                                                        
                                                        
                                                        
                                                        
                                                        
                                                        
                                                        
                                                        
                                                        
                                                        -
                                                        
                                                        
                                                        
                                                        -
                                                        
                                                        
                                                        
                                                        9
                                                        
                                                        
                                                        
                                                        -Accounts
      Payable and Accrued Expenses
                                                        
                                                        
                                                        1
                                                        
                                                        
                                                        
                                                        3
                                                        
                                                        
                                                        
                                                        4
                                                        
                                                        
                                                        
                                                        5
                                                        
                                                        
                                                        
                                                        3
                                                        
                                                        
                                                        
                                                        176Accrued
      Interest
                                                        
                                                        
                                                        -
                                                        
                                                        
                                                        
                                                        2
                                                        
                                                        
                                                        
                                                        4
                                                        
                                                        
                                                        
                                                        8
                                                        
                                                        
                                                        
                                                        3
                                                        
                                                        
                                                        
                                                        111Long
      Term Debt
                                                        
                                                        
                                                        15
                                                        
                                                        
                                                        
                                                        65
                                                        
                                                        
                                                        
                                                        65
                                                        
                                                        
                                                        
                                                        68
                                                        
                                                        
                                                        
                                                        119
                                                        
                                                        
                                                        
                                                        -Deficit
      Accumulated during Development Stage
                                                        
                                                        
                                                        (16
                                                        )
                                                        
                                                        
                                                        (45
                                                        )
                                                        
                                                        
                                                        (70
                                                        )
                                                        
                                                        
                                                        (86
                                                        )
                                                        
                                                        
                                                        (134
                                                        )
                                                        
                                                        
                                                        (363
                                                        )Total
      Shareholder's Equity
                                                        
                                                        
                                                        (5
                                                        )
                                                        
                                                        
                                                        (34
                                                        )
                                                        
                                                        
                                                        (68
                                                        )
                                                        
                                                        
                                                        (77
                                                        )
                                                        
                                                        
                                                        (116
                                                        )
                                                        
                                                        
                                                        (354
                                                        )





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.


29


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 April
30, 2010 in connection with the audit of our financial statements as of
December 31, 2009 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, 2009 have been prepared under the assumption that we will
continue as a going concern. If we are not able to continue as a going concern,
it is likely that holders of our common stock will lose all of their investment.
Our financial statements do not include any adjustments that might result from
the outcome of this uncertainty.





Discussion
and Analysis





The new
mission of the Company is to bring stem cell therapy treatments to the market as
quickly as possible.  The Company identified a company treating
patients with adult stem cells for congestive heart failure and other
indications.  The company located in Bangkok, Thailand, has developed
a process to identify and process adult stem cells found in a patient’s
blood.  These adult stem cells are grown into large numbers in vitro
(outside the body) and then encouraged to differentiate into angiogenic
precursor cells or blood vessel forming cells for the treatment of congestive
heart failure.  These adult stem cells can also be used for the
treatment of other conditions such as peripheral artery disease.  The
manufacturing operations for this process are located in Israel.





Currently
congestive heart failure patients cleared for treatment have one-half pint of
blood drawn which is sent to the cell processing facility in Israel. After the
adult stem cells in the patient’s blood have been extracted and grown into large
numbers of angiogenic precursor cells, they are sent to Bangkok, Thailand and
the Dominican Republic 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.


30




The
results to date have been impressive.  Over three hundred (500)
congestive heart failure patients with no other options have shown similar
results to a clinical trial of 24 patients.  In that trial,
statistically significant improvements between baseline and the three month and
six month follow-up were achieved for:
 
 ·
              Improvement
      in the six minutes walking test.
 
 ·
              Increase
      in metabolic equivalent units (METs) during the stress
    test.
 
 ·
              Decrease
      in the perfusion defect region of the target
  artery.
 
 ·
              Decrease
      in the Canadian Cardiovascular Society (CCS) Grading
  Scale.
 
 On January 7, 2010 the Company entered
into two agreements.  Closing occurred on February 4,
2010.
 
 The first
agreement is between TheraVitae Limited, the Israeli corporation manufacturing
the stem cell therapy product, and a newly formed Israeli corporation which is a
wholly owned subsidiary of the Company, Regenocell Laboratories,
Ltd.  Pursuant to the terms of the agreement, certain assets were
acquired and certain liabilities assumed.  These assets include all
the manufacturing and office equipment and the transfer of the
lease.  At signing the Company paid $75,000 toward the reduction of
the assumed liabilities.  All the employees were terminated then
offered and accepted employment with Regenocell Laboratories, Ltd.
 
 The
second agreement is between Yieldex, Ltd. and the Registrant for the acquisition
of certain rights.  This includes clinical data, the non exclusive use
of the CRM System which manages clinical data and input necessary to schedule a
patient for stem cell production, and all rights in patent and patent
applications, if any, in connection with activities of stem cell research,
therapy development and clinical trials under the trade name ”TheraVitae” for
the world except for Asia.  Israel is excluded by definition from
being part of Asia.  The cash price is $5,000,000 (five million United
States dollars), of which $75,000 was paid to TheraVitae Limited and $25,000 to
Yieldex on January 7.  The balance is due in monthly installments on
or before January 4, 2015.  Minimum installments are $5,000 per
patient processed in Israel after the first eight patients during the preceding
month.  In addition 25% of any equity raised by the Company will be
applied to the outstanding balance.
 
 In addition 40,000,000 (forty million)
shares of the Company’s common stock, par value $.0001, was issued to Yieldex
Ltd and its nominees.  The 40,000,000 shares are restricted and
subject to a two year Lock-Up period beginning January 4, 2010.  These
shares are also subject to a voting agreement.  During the Lock-Up
period and for any subsequent period until the shares are sold to the public in
the open market,  the Board of Directors will be expanded to five
members and the shareholders whose shares are locked up will vote for a maximum
of two directors.  The Company’s shareholders who are not parties to
the Lock-Up agreement will vote their shares for the same two directors until
the aggregate number of Yieldex shares are 15,000,000 (fifteen million) or less.
The Yieldex shareholders agree to vote the Yieldex shares for a maximum of three
directors designated by James F. Mongiardo.  While this voting rights
agreement is in effect, unanimous approval of all the directors then in office
or approval of holders of at least a majority of the shares will be required
for: (i) any proposal to increase capital in a way that would result in dilution
of existing shareholders’ percentages by ten percent (10%) or more; (ii) any
proposal to merge, consolidate or amalgamate with any other corporate entity;
(iii) any proposal to sell all or a material part of the assets; and, (iv) any
proposal to amend the bylaws.
  31
 
 As a
result of the actions described above, on February 4, 2010 the Company’s primary
asset is Regenocell Laboratories Ltd. which is manufacturing and selling stem
cell therapy product used to treat congestive heart failure and peripheral
artery disease.  Purchases are being made to treat patients for these
indications in Bangkok, Thailand and the Dominican Republic.  It is
anticipated that purchases will also be made to treat patients in Mexico and
other countries.
 
 The Company has not generated any
revenues from operations or otherwise since its inception through the formation
of Regenocell Laboratories, Ltd..  The Company intended to generate
revenue through the development of cafes in South Carolina and then in other
states in the South East, featuring gourmet coffee, pastries and related items.
Through December 31, 2007, the Company had not been successful in raising
capital for the development, marketing or sale of either these cafes or any
products. The Company then adopted a new stem cell therapy business strategy on
July 16, 2008.
 
 In order to implement the new strategy
of the Company, the Company will need to raise capital during the next 12
months:  cash on hand was $102,079 as of December 31, 2009 which
amount is inadequate to fund the company’s current projected capital
requirements.  Net loss for the Company for the year ended December
31, 2009 was equal to $228,663, with total net loss from inception through
December 31, 2009 equal to $362,831.  The Company has funded
operations to date in part through the sale of equity securities and loans,
although such efforts have been insufficient to effectively pursue its business
strategy.
 
 With
respect to Regenocell Laboratories, Ltd., processing eight patients during a
month will result in revenues exceeding $130,000.  The combination of
the existing business being serviced by the manufacturing operations, namely
patients being treated in Bangkok and the Dominican Republic, and the addition
of patients to be treated by the Company in Mexico and other locations is
expected to keep patient flow for the manufacturing facility at or above the
breakeven of eight patients.  Capacity at the current configuration of
the manufacturing facility is more than double the breakeven.  There
can be no assurance of any patient flow for any given month.
 
 Our capital requirements will depend on
numerous factors, including but not limited to the commitments and progress of
our research and development efforts, the progress of clinical trials, the cost
of sales and marketing for the congestive heart failure stem cell therapy
business and other products, medical and business consultants and advisors, the
time and cost involved in maintaining regulatory compliance, and competing
technological and market developments.  Future activities, including
the establishment of stem cell therapy for the treatment of peripheral artery
disease in the medical marketplace, will be subject to our ability to raise
funds.
  32
 
 We intend
to raise capital primarily through the public or private sale of securities
(equity and/or debt), although there can be no assurance that we will be able to
obtain capital or, if such capital is available, that the terms of any financing
will be acceptable.  If the Company succeeds in raising capital, such
funds will be used to facilitate the manufacturing operations of Regenocell
Laboratories Ltd., to find new customers for Regenocell Laboratories Ltd. and to
find patients for treatment in Mexico. With respect to peripheral artery
disease, capital will be used for completing the research and development to
submit an IND (and its equivalent in Europe) for authorization to begin clinical
trials in the United States and Europe. This may include payment for additional
animal trials. Payment for clinical trials includes retaining the services of a
clinical research organization, payment to the clinical research site(s) for
patients enrolled in the clinical trials, payment for the stem cell therapy used
in these clinical trials, payment for costs associated with Institution Review
Board Approval, and preparation of reports to the FDA and EMEA, requests to
continue later phase clinical trials and submission of a BLA to the FDA and its
equivalent to the EMEA requesting marketing approval for the treatment of
peripheral artery disease.
 
 The
Company also does not expect to purchase any plant or significant equipment over
the next 12 months.  Regenocell Laboratories, Ltd. may purchase
between $100,000-$300,000 in new equipment for its manufacturing
operations.
 
 If we are unsuccessful at raising
sufficient capital to fund our operations, for whatever reason, we may be forced
to seek opportunities outside of our new corporate focus or to seek a buyer for
our business or another entity with which we could
partner.  Ultimately, if all of these alternatives fail, we may be
required to cease operations and seek protection from creditors under applicable
bankruptcy laws.
 
 Item
7A.  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
  33
  REGENOCELL THERAPEUTICS,
INC.
 AUDIT
REPORT OF INDEPENDENT ACCOUNTANTS
 AND
 FINANCIAL
STATEMENTS
 
 December
31, 2009 and 2008
  34
  REGENOCELL
THERAPEUTICS, INC.
 
 TABLE
OF CONTENTS
 
 PageAudit
      Report of Independent Accountants
                36Balance
      Sheets – December 31, 2009 and 2008
                37Statements
      of Operations for the Years Ended December 31, 2009 and
    2008
                38Statements
      of Stockholder’s Equity for the Years Ended December 31, 2009 and
      2008
                39Statements
      of Cash Flows for the Years Ended December 31, 2009 and
    2008
                40Notes
      to Financial Statements
                41
 
 
  35
 
 SADLER, GIBB& ASSOCIATES,
L.L.C.
 
 REPORT OF
INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
 
 To the Board of
Directors
 RegenoCELL Therapeutics, Inc.
 (A Development Stage
Company)
 
 We have auditedthe accompanying balance
sheetsofRegenoCELL Therapeutics, Inc.(A Development Stage Company) as ofDecember 31,
2009, andthe related statements of operations,
stockholders’ equity (deficit) and cash flows for theyear then ended. 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.The financial statements ofRegenoCELL
Therapeutics,
Inc.as of December 31, 2008, were audited by
other auditors whose report dated March 27, 2009, expressed an unqualified
opinion on those statements.
 
 We conduct our auditin accordance with standards of the
Public Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audits to obtain reasonable assurance about whether the financial
statements are free of material misstatement.The company is not required to have, nor
were we engaged to perform, an audit of its internal control over financial
reporting. Our audit included consideration of internal control over financial
reporting as a basis for designing audit procedures that are appropriate in the
circumstances, but not for the purpose of expressing an opinion on the
effectiveness of the company’s internal control over financial reporting.
Accordingly, we express no such opinion.An audit 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
auditprovidesa reasonable basis for our
opinion.
 
 In our opinion, theconsolidatedfinancial statementsreferred to above present fairly, in all
material respects, the
financial position ofRegenoCELL Therapeutics, Inc. (A Development Stage Company) as
of December 31, 2009, and the relatedconsolidatedstatements of operations, stockholders’
equity (deficit) and cash flows for theyear then ended, in conformity with
accountingprinciples
generally accepted in the United States of America.
 
 The accompanyingconsolidatedfinancial statements have been prepared
assuming that the Company will continue as a goingconcern. As discussed in Note
2to the financial
statements, the Companyhas
not yet established an ongoing source of revenue sufficient to cover its
operating costswhich
raises substantial doubt about itsability to continue as a going concern.
Management’s plans concerning these matters are also described in Note
2. Theconsolidatedfinancial statements do not include any
adjustments that might result from the outcome of this
uncertainty.
 
 SADLER, GIBB AND ASSOCIATES,
      LLC
 
 Salt Lake City, UT
 April 30, 2010
  36
 
 REGENOCELL
THERAPEUTICS, INC.
 (FKA
GOOD BUDDY’S COFFEE EXPRESS, INC.)
 (A
Development Stage Company)
 BALANCE
SHEETS
 
 December 31,
                            2009
                          
                          
                          December31,
                            2008AssetsCurrent
      AssetsCash
                          
                          $
                          102,079
                          
                          
                          $
                          -Total
      Current Assets
                          
                          
                          102,079
                          
                          
                          
                          -Net
      Fixed Assets
                          
                          
                          2,893
                          
                          
                          
                          -Net
      Intangible Development Costs
                          
                          
                          -
                          
                          
                          
                          9,000Total
      Assets
                          
                          $
                          104,972
                          
                          
                          $
                          9,000Liabilities and
      Stockholders'  EquityLiabilitiesCurrent
      LiabilitiesAccounts
      Payable
                          
                          $
                          64,982
                          
                          
                          $
                          -Accrued
      Interest
                          
                          
                          110,597
                          
                          
                          
                          3,457Accrued
      Expenses
                          
                          
                          750
                          
                          
                          
                          3,000Notes
      Payable - Related Party
                          
                          
                          81,018
                          
                          
                          
                          -Notes
      Payable - Current
                          
                          
                          201,400
                          
                          
                          
                          -Total
      Current Liabilities
                          
                          
                          458,747
                          
                          
                          
                          6,457Notes
      Payable - Long-term
                          
                          
                          -
                          
                          
                          
                          118,653Total
      Liabilities
                          
                          
                          458,747
                          
                          
                          
                          125,110Stockholders'  EquityPreferred
      Stock $.0001 par value, 80,000,000 shares authorized,  no shares
      issued and outstanding as of December 31, 2009 and 2008
      respectively
                          
                          
                          -
                          
                          
                          
                          -Common
      Stock, $.0001 par value, 520,000,000 shares authorized, 41,437,500 and
      131,437,500 shares issued and outstanding as of December 31, 2009 and 2008
      respectively
                          
                          
                          4,143
                          
                          
                          
                          13,144Additional
      Paid in Capital
                          
                          
                          4,913
                          
                          
                          
                          4,913Accumulated
      Deficit during the development stage
                          
                          
                          (362,831
                          )
                          
                          
                          (134,168
                          )Total
      Stockholders' Equity
                          
                          
                          (353,775
                          )
                          
                          
                          (116,111
                          )Total
      Liabilities and Stockholders' Equity
                          
                          $
                          104,972
                          
                          
                          $
                          9,000
 
 The
accompanying notes are an integral part of these financial
statements.
  37
 
 REGENOCELL
THERAPEUTICS, INC.
 (FKA
GOOD BUDDY’S COFFEE EXPRESS, INC.)
 (A
Development Stage Company)
 STATEMENTS
OF OPERATIONS
 
 From February 1,2002 (Inception)For the Years Ended
                            
                            
                            ThroughDecember 31,
                            
                            
                            December 31,2009
                            
                            
                            2008
                            
                            
                            2009Revenues
                            
                            $
                            -
                            
                            
                            $
                            -
                            
                            
                            $
                            -Administrative
      Expenses
                            
                            
                            176,612
                            
                            
                            
                            41,429
                            
                            
                            
                            303,677Development
      Costs
                            
                            
                            46,914
                            
                            
                            
                            -
                            
                            
                            
                            46,914Net
      (Loss) from development stage operations
                            
                            
                            (223,526
                            )
                            
                            
                            (41,429
                            )
                            
                            
                            (350,591
                            )Interest
      expense
                            
                            
                            (5,137
                            )
                            
                            
                            (5,228
                            )
                            
                            
                            (10,365
                            )Loss
      on abandonment of assets
                            
                            
                            -
                            
                            
                            
                            (1,875
                            )
                            
                            
                            (1,875
                            )Net
      (Loss)
                            
                            $
                            (228,663
                            )
                            
                            $
                            (48,532
                            )
                            
                            $
                            (362,831
                            )Basic
      net loss per common share
                            
                            $
                            (0.00
                            )
                            
                            $
                            (0.00
                            )Weighted
      Average of Common Shares Outstanding
                            
                            
                            131,190,925
                            
                            
                            
                            96,187,500
 
 The
accompanying notes are an integral part of these financial
statements.
  38
 
 REGENOCELL
THERAPEUTICS, INC.
 (FKA
GOOD BUDDY’S COFFEE EXPRESS, INC.)
 (A
Development Stage Company)
 STATEMENTS
OF STOCKHOLDERS’ EQUITY (DEFICIT)
 
 AdditionalCommon Stock
                    
                    
                    Paid-In
                    
                    
                    AccumulatedShares
                    
                    
                    Amount
                    
                    
                    Capital
                    
                    
                    Deficit
                    
                    
                    TotalDecember
      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
                    
                    
                    
                    (2,450
                    )
                    
                    
                    (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
                    
                    
                    
                    4,913
                    
                    
                    
                    (134,168
                    )
                    
                    
                    (116,111
                    )December
      30, 2009 - Cancellation of restrictd common stock issued to Thera Vitae,
      Inc., on  July 22, 2008
                    
                    
                    (90,000,000
                    )
                    
                    
                    (9,000
                    )
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    (9,000
                    )December
      31, 2009 - Net (Loss)
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    
                    (228,663
                    )
                    
                    
                    (228,663
                    )December
      31, 2009 - Balance
                    
                    
                    41,437,500
                    
                    
                    $
                    4,143
                    
                    
                    $
                    4,913
                    
                    
                    $
                    (362,831
                    )
                    
                    $
                    (353,774
                    )
 
 The
accompanying notes are an integral part of these financial
statements.
 
  39
 
 REGENOCELL
THERAPEUTICS, INC.
 (FKA
GOOD BUDDY’S COFFEE EXPRESS, INC.)
 (A
Development Stage Company)
 STATEMENTS
OF CASH FLOWS
 
 From February 1,2002 (Inception)For the Years Ended
                  
                  
                  ThroughDecember 31,
                  
                  
                  December 31,2009
                  
                  
                  2008
                  
                  
                  2009Operating
      Activities:Net
      Loss from Development Stage Activities
                  
                  
                  (228,663
                  )
                  
                  
                  (48,532
                  )
                  
                  
                  (362,831
                  )Non
      cash activities:Depreciation
                  
                  
                  207
                  
                  
                  
                  -
                  
                  
                  
                  2,932Accrual
      of Interest Expense
                  
                  
                  107,137
                  
                  
                  
                  -
                  
                  
                  
                  107,137Abandonment
      of Assets
                  
                  
                  -
                  
                  
                  
                  1,875
                  
                  
                  
                  1,875Write
      off uncollected other receivable
                  
                  
                  -
                  
                  
                  
                  250
                  
                  
                  
                  -Cancellation
      of licensing agreeement
                  
                  
                  (9,000
                  )
                  
                  
                  -
                  
                  
                  
                  (9,000
                  )Stock
      issued in lieu of compensation
                  
                  
                  -
                  
                  
                  
                  11,025
                  
                  
                  
                  11,025Reconciliation
      Adjustments
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  
                  -Accounts
      Payable
                  
                  
                  64,982
                  
                  
                  
                  (2,200
                  )
                  
                  
                  64,982Accrued
      Expenses
                  
                  
                  (2,250
                  )
                  
                  
                  (4,180
                  )
                  
                  
                  (3,949
                  )Accrued
      Interest
                  
                  
                  -
                  
                  
                  
                  500
                  
                  
                  
                  8,140Net
      cash (used in) operating activities
                  
                  
                  (67,587
                  )
                  
                  
                  (41,262
                  )
                  
                  
                  (179,689
                  )Investing
      Activities:Purchase
      of equipment
                  
                  
                  (3,099
                  )
                  
                  
                  -
                  
                  
                  
                  (3,099
                  )Investment
      in production activites
                  
                  
                  9,000
                  
                  
                  
                  (9,000
                  )
                  
                  
                  -Net
      cash provided by (used in) investing activities
                  
                  
                  5,901
                  
                  
                  
                  (9,000
                  )
                  
                  
                  (3,099
                  )Financing
      Activities:Proceeds
      from note payable - related party
                  
                  
                  81,018
                  
                  
                  
                  -
                  
                  
                  
                  81,018Proceeds
      from note payable
                  
                  
                  82,747
                  
                  
                  
                  78,418
                  
                  
                  
                  229,164Repayment
      of notes payable
                  
                  
                  -
                  
                  
                  
                  (27,765
                  )
                  
                  
                  (27,765
                  )Sale
      of common stock
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  11,200Repurchase
      of common stock
                  
                  
                  -
                  
                  
                  
                  -
                  
                  
                  
                  (8,750
                  )Net
      cash provided by financing activities
                  
                  
                  163,765
                  
                  
                  
                  50,653
                  
                  
                  
                  284,867Net
      Change in CashNet
      Increase (Decrease) in Cash
                  
                  
                  102,079
                  
                  
                  
                  391
                  
                  
                  
                  102,079Cash
      Beginning of Period
                  
                  
                  -
                  
                  
                  
                  (390
                  )
                  
                  
                  -Cash
      End of Period
                  
                  
                  102,079
                  
                  
                  
                  -
                  
                  
                  
                  102,079Supplemental
      Cash Flow Disclosure:Cash
      Paid For:Interest
                  
                  $
                  -
                  
                  
                  $
                  -
                  
                  
                  $
                  -Income
      taxes
                  
                  $
                  -
                  
                  
                  $
                  -
                  
                  
                  $
                  -
 
 The
accompanying notes are an integral part of these financial
statements.
  40
 
 NOTE
1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING 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.
 
 The
mission of the Company is to bring stem cell therapy treatments to the market as
quickly as possible.
The Company’s therapy will utilize a process to identify and process adult stem
cells found in a patient’s blood. These adult stem cells are grown into large
numbers in vitro (outside the body) and then encouraged to differentiate into
angiogenic precursor cells or blood vessel forming cells for the treatment of
congestive heart failure. These adult stem cells can also be used for the
treatment of other conditions such as peripheral artery disease.
 
 At the
current time the Company is still in the development stage and as such reports
its financial statements as a Development Stage Enterprise.
 
 Accounting
Method
 
 The
Company’s financial statements are prepared using the accrual method of
accounting.  The Company has elected a December 31
year-end.
 
 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
Equivalents
 
 For
purposes of cash flows, the Company considers all highly liquid instruments
purchased with a maturity of three months or less to be cash equivalents to the
extent the funds are not being held for investment purposes.  The
Company at times may maintain a cash balance in excess of insured
limits.
  41
 
 NOTE
1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(CONTINUED)
 
 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.
 
 Fixed
Assets
 
 Fixed
assets are stated at cost.  Major additions and improvements are
capitalized in the month following the month in which the assets or improvement
are deemed to be placed in service. Maintenance and repairs are expensed as
incurred. Upon disposition, the net book value is eliminated from the accounts,
with the resultant gain or loss reflected in operations. Depreciation expense is
computed on a straight-line basis over the estimate useful lives of the assets
as follows:
 
 Machinery
      and equipment:
              10-15
      yearsFurniture
      and fixtures & transportation equipment:
              3-7
      years
 
 The
Company periodically assesses the recoverability of property, plant and
equipment and evaluates such assets for impairment whenever events or changes in
circumstances indicate that the net carrying amount of an asset may not be
recoverable. Asset impairment is determined to exist if estimated future cash
flows, undiscounted and without interest charges, are less than the net carrying
amount.
 
 Intangible
Assets
 
 In 2008,
the Company had completed a Letter of Intent to acquire a non-exclusive license
to market TheraVitae Inc.’s stem cell technology in Mexico and the
Caribbean.  The cost of implementing this business was recorded as an
intangible asset and would have been amortized at the time when the company
began recognizing revenue over the life of the agreement.  However, in 2009
the parties to the Letter of Intent reached an impasse and the license was not
acquired.
 
 Provision
for Taxes
 
 The
Company applies ASC 740, which requires the asset and liability method of
accounting for income taxes.  This method requires that the current or
deferred tax consequences of all events recognized in the financial statements
be measured by applying the provisions of enacted tax laws to determine the
amount of taxes payable or refundable currently or in future years. Deferred tax
assets are reviewed for recoverability and the Company records a valuation
allowance to reduce its deferred tax assets when it is more likely than not that
all or some portion of the deferred tax assets will not be
recovered.
  42
 
 NOTE
1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(CONTINUED)
 
 Earnings
(Loss) Per Share
 
 The
Company presents "basic" earnings (loss) per share and, if applicable, "diluted"
earnings per share pursuant to the provisions of ASC 740. 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.
 
 Recent
Accounting Pronouncements
 
 In
January 2010, the FASB issued Accounting Standards Update 2010-02, Consolidation
(Topic 810): Accounting and Reporting for Decreases in Ownership of a
Subsidiary. This amendment to Topic 810 clarifies, but does not change, the
scope of current US GAAP. It clarifies the decrease in ownership provisions of
Subtopic 810-10 and removes the potential conflict between guidance in that
Subtopic and asset de-recognition and gain or loss recognition guidance that may
exist in other US GAAP. An entity will be required to follow the amended
guidance beginning in the period that it first adopts FAS 160 (now included in
Subtopic 810-10). For those entities that have already adopted FAS 160, the
amendments are effective at the beginning of the first interim or annual
reporting period ending on or after December 15, 2009. The amendments should be
applied retrospectively to the first period that an entity adopted FAS 160. The
Company does not expect the provisions of ASU 2010-02 to have a material effect
on the financial position, results of operations or cash flows of the
Company.
 
 In
January 2010, the FASB issued Accounting Standards Update 2010-01, Equity (Topic
505): Accounting for Distributions to Shareholders with Components of Stock and
Cash (A Consensus of the FASB Emerging Issues Task Force). This amendment to
Topic 505 clarifies the stock portion of a distribution to shareholders that
allows them to elect to receive cash or stock with a limit on the amount of cash
that will be distributed is not a stock dividend for purposes of applying Topics
505 and 260. Effective for interim and annual periods ending on or after
December 15, 2009, and would be applied on a retrospective basis. The Company
does not expect the provisions of ASU 2010-01 to have a material effect on the
financial position, results of operations or cash flows of the
Company.
  43
 
 NOTE
1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(CONTINUED)
 
 Recent
Accounting Pronouncements (Continued)
 
 In
December 2009, the FASB issued Accounting Standards Update 2009-17,
Consolidations (Topic 810): Improvements to Financial Reporting by Enterprises
Involved with Variable Interest Entities. This Accounting Standards Update
amends the FASB Accounting Standards Codification for Statement 167. The Company
does not expect the provisions of ASU 2009-17 to have a material effect on the
financial position, results of operations or cash flows of the
Company.
 
 In
December 2009, the FASB issued Accounting Standards Update 2009-16, Transfers
and Servicing (Topic 860): Accounting for Transfers of Financial Assets. This
Accounting Standards Update amends the FASB Accounting Standards Codification
for Statement 166. The Company does not expect the provisions of ASU 2009-16 to
have a material effect on the financial position, results of operations or cash
flows of the Company.
 
 In
October 2009, the FASB issued Accounting Standards Update 2009-15, Accounting
for Own-Share Lending Arrangements in Contemplation of Convertible Debt Issuance
or Other Financing. This Accounting Standards Update amends the FASB Accounting
Standard Codification for EITF 09-1. The Company does not expect the provisions
of ASU 2009-15 to have a material effect on the financial position, results of
operations or cash flows of the Company.
 
 In
October 2009, the FASB issued Accounting Standards Update 2009-14, Software
(Topic 985): Certain Revenue Arrangements That Include Software Elements. This
update changed the accounting model for revenue arrangements that include both
tangible products and software elements. Effective prospectively for revenue
arrangements entered into or materially modified in fiscal years beginning on or
after June 15, 2010. Early adoption is permitted. The Company does not expect
the provisions of ASU 2009-14 to have a material effect on the financial
position, results of operations or cash flows of the Company.
 
 In
October 2009, the FASB issued Accounting Standards Update 2009-13, Revenue
Recognition (Topic 605): Multiple-Deliverable Revenue Arrangements. This update
addressed the accounting for multiple-deliverable arrangements to enable vendors
to account for products or services (deliverables) separately rather than a
combined unit and will be separated in more circumstances that under existing US
GAAP. This amendment has eliminated that residual method of allocation.
Effective prospectively for revenue arrangements entered into or materially
modified in fiscal years beginning on or after June 15, 2010. Early adoption is
permitted. The Company does not expect the provisions of ASU 2009-13 to have a
material effect on the financial position, results of operations or cash flows
of the Company.
  44
 
 NOTE
1 - ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
(CONTINUED)
 
 Recent
Accounting Pronouncements (Continued)
 
 In
September 2009, the FASB issued Accounting Standards Update 2009-12, Fair Value
Measurements and Disclosures (Topic 820): Investments in Certain Entities That
Calculate Net Asset Value per Share (or Its Equivalent). This update provides
amendments to Topic 820 for the fair value measurement of investments in certain
entities that calculate net asset value per share (or its equivalent). It is
effective for interim and annual periods ending after December 15, 2009. Early
application is permitted in financial statements for earlier interim and annual
periods that have not been issued. The Company does not expect the provisions of
ASU 2009-12 to have a material effect on the financial position, results of
operations or cash flows of the Company.
 
 In July
2009, the FASB ratified the consensus reached by EITF (Emerging Issues Task
Force) issued EITF No. 09-1, (ASC Topic 470) "Accounting for Own-Share Lending
Arrangements in Contemplation of Convertible Debt Issuance" ("EITF 09-1"). The
provisions of EITF 09-1, clarifies the accounting treatment and disclosure of
share-lending arrangements that are classified as equity in the financial
statements of the share lender. An example of a share-lending arrangement is an
agreement between the Company (share lender) and an investment bank (share
borrower) which allows the investment bank to use the loaned shares to enter
into equity derivative contracts with investors. EITF 09-1 is effective for
fiscal years that beginning on or after December 15, 2009 and requires
retrospective application for all arrangements outstanding as of the beginning
of fiscal years beginning on or after December 15, 2009. Share-lending
arrangements that have been terminated as a result of counterparty default prior
to December 15, 2009, but for which the entity has not reached a final
settlement as of December 15, 2009 are within the scope. Effective for
share-lending arrangements entered into on or after the beginning of the first
reporting period that begins on or after June 15, 2009. The Company does not
expect the provisions of EITF 09-1 to have a material effect on the financial
position, results of operations or cash flows of the Company.
 
 NOTE
2 - GOING CONCERN ASSUMPTION
 
 The
Company’s financial statements are prepared using accounting principles
generally accepted in the United States of America applicable to a going concern
which contemplates the realization of assets and liquidation of liabilities in
the normal course of business.  However, the Company does not have
significant cash or other current assets, nor does it have an established source
of revenues sufficient to cover its operating costs and to allow it to continue
as a going concern which raises substantial doubt regarding its ability to
continue as a going concern.
 
 In order
to continue as a going concern, the Company will need, among other things,
additional capital resources. Management's plan is to obtain such resources for
the Company by obtaining capital from management and significant shareholders
sufficient to meet its minimal operating expenses and seeking equity and/or debt
financing. However management cannot provide any assurances that the Company
will be successful in accomplishing any of its plans.
  45
 
 NOTE
2 – GOING CONCERN ASSUMPTION (CONTINUED)
 
 The
ability of the Company to continue as a going concern is dependent upon its
ability to successfully accomplish the plan described in the preceding paragraph
and eventually attain profitable operations.  The accompanying
financial statements do not include any adjustments that may be necessary if the
Company is unable to continue as a going concern.
 
 NOTE
3 – PROPERTY AND EQUIPMENT
 
 Property
and equipment are stated at cost.  Depreciation is computed over the
estimated life of the assets. Depreciation expense for the years ended December
31, 2009 and 2008 amounted to $207 and
 $-0-,
respectively.  Gains from losses on sales and disposals are included
in the statements of operations.  Maintenance and repairs are charged to expense as
incurred.  As of December 31, 2009 and 2008 property and equipment
consisted of the following:
 
 December 31,
                      2009
                    
                    
                    December 31,
                      2008
                    
                    Estimated
                      Useful LifeEquipment
                    
                    $
                    3,100
                    
                    
                    $
                    -
                    
                    5
      years3,100
                    
                    
                    
                    -Accumulated  depreciation
                    
                    
                    (207
                    )
                    
                    
                    -Total
      property and equipment
                    
                    $
                    2,893
                    
                    
                    $
                    -
 
 NOTE
4 – RELATED PARTY TRANSACTIONS
 
 During
the year ended December 31, 2009, the Company has borrowed $81,018 from a
related party to fund continuing operations.  This note bears no
interest, is due on demand and is uncollateralized.
 
 NOTE
5 – NOTES PAYABLE
 
 The
Company has issued various unsecured demand promissory notes to a major
shareholder and other unrelated individuals as of December 31,
2009.  This major shareholder has personally guaranteed the principal
of one demand note and in return has been granted first lien on the assets of
the corporation.  Subsequent to year end, one of the notes payable
outstanding went into default which meant that the default terms of the note
went into effect.  Please see Note 8 for description of default terms
of this note.  The detail of the Company debt as of December 31, 2009,
is as follows:
  46
 
 NOTE
5 – NOTES PAYABLE (CONTINUED)
 Principle
                        2009
                      
                      
                      Principle
                        2008February
      5, 2005 - Demand Note, 5% per annum.
                      
                      $
                      47,822
                      
                      
                      $
                      47,822June
      26, 2008 – Convertible Demand Note 5% per annum, convertible to common
      stock at $1.00 per share
                      
                      
                      39,164
                      
                      
                      
                      39,164September
      30, 2008 – Demand Notes, 0% per annum.
                      
                      
                      12,408
                      
                      
                      
                      12,408October
      1, 2008 – Demand Notes, 5% per annum.
                      
                      
                      10,000
                      
                      
                      
                      10,000December
      31, 2008 – Demand notes, 0% per annum.
                      
                      
                      9,257
                      
                      
                      
                      9,257March
      31, 2009 – Demand notes, 0% per annum.
                      
                      
                      8,960
                      
                      
                      
                      -June
      30, 2009 - Demand notes, 0% per annum.
                      
                      
                      6,782
                      
                      
                      
                      -September
      1, 2008 – Demand Notes, 5% per annum.
                      
                      
                      2,500
                      
                      
                      
                      -September
      30, 2009-Demand Notes, 0% per annum.
                      
                      
                      17,196
                      
                      
                      
                      -December
      24, 2009- Loan Payable, Principal amount of $160,000, 0% per annum.,
      payable March 30, 2010
                      
                      
                      102,000
                      
                      
                      
                      -Total
      Debt
                      
                      
                      256,092
                      
                      
                      
                      118,653Less
      Current Portion
                      
                      
                      256,092
                      
                      
                      
                      118,653Long
      Term Debt
                      
                      $
                      -
                      
                      
                      $
                      -Interest
      expense for the year ending December 31, 2009 and 2008
                      
                      $
                      5,137
                      
                      
                      $
                      5,228
 
 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 in lieu of
payment for business consulting services, 5,000,000 restricted common shares for
marketing consultation services and 15,000,000 restricted common shares for
employee compensation.
  47
 
 NOTE
6 – STOCKHOLDERS’ EQUITY (CONTINUED)
 
 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.  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 December 30, 2009, the agreement was cancelled and the shares were returned
to the company.
 
 On July
23, 2008, the Board authorized the cancellation from certain shareholders of
58,500,000 restricted common shares, par value $0.0001.  Said shares
were returned to the transfer agent for cancellation.
 
 On
November 16, 2009 the Company issued a private placement memorandum expiring on
March 31, 2010 to raise $ 500,000. The terms of the offering consists of 1 share
of common stock and one five year warrant exercisable at $.75. Each unit costs
$.50, and there are 1,000,000 units available. The minimum subscription is
100,000 units.  As of December 31, 2009 no shares have been issued in
connection with the private placement memorandum.
 
 NOTE
7 – INCOME TAXES
 
 The
Company provides for income taxes under Statement of Financial Accounting
Standards No. 109, Accounting for Income Taxes. SFAS No. 109 requires the use of
an asset and liability approach in accounting for income taxes. Deferred tax
assets and liabilities are recorded based on the differences between the
financial statement and tax bases of assets and liabilities and the tax rates in
effect when these differences are expected to reverse. The Company’s predecessor
operated as entity exempt from Federal and State income taxes.
 
 SFAS No.
109 requires the reduction of deferred tax assets by a valuation allowance if,
based on the weight of available evidence, it is more likely than not that some
or all of the deferred tax assets will not be realized.
 
 The
provision for income taxes differs from the amounts which would be provided by
applying the statutory federal income tax rate of 39% to net the loss before
provision for income taxes for the following reasons:
 
 December 31,
                      2009
                    
                    
                    December 31,
                      2008Income
      tax expense at statutory rate
                    
                    $
                    (89,179
                    )
                    
                    $
                    (18,927
                    )Common
      stock issued for services
                    
                    
                    -
                    
                    
                    
                    4,300Valuation
      allowance
                    
                    
                    89,179
                    
                    
                    
                    14,627Income
      tax expense per books
                    
                    $
                    -
                    
                    
                    $
                    -
 
  48
  
 NOTE
7 – INCOME TAXES (CONTINUED)
 
 Net
deferred tax assets consist of the following components as of:
 
 December 31,
                      2009
                    
                    
                    December 31,
                      2008NOL
      carryover
                    
                    $
                    141,504
                    
                    
                    $
                    52,326Valuation
      allowance
                    
                    
                    (141,504
                    )
                    
                    
                    (52,326
                    )Net
      deferred tax asset
                    
                    $
                    -
                    
                    
                    $
                    -
 
 Due to
the change in ownership provisions of the Tax Reform Act of 1986, net operating
loss carry forwards of $141,504 for federal income tax reporting purposes are
subject to annual limitations. When a change in ownership occurs, net operating
loss carry forwards may be limited as to use in future years.
 
 NOTE
8 – SUBSEQUENT EVENTS
 
 In early
January 2010 the Company created a wholly owned foreign subsidiary in Israel for
the purpose of developing and operating the laboratory facilities associated
with its products. The name of the subsidiary is Regenocell Laboratories
Ltd.
 
 On
January 7th 2010,
the Companies foreign subsidiary Regenocell Laboratories Ltd. consummated an
asset purchase agreement with TheraVitae Limited. Under the terms of the
agreement the Company will acquire certain assets of TheraVitae Limited,
approximate net book value of $346,000, in exchange for assuming certain
liabilities of approximately $334,000 and $75,000 in cash (all currency is in US
dollars).
 
 In early
January 2010 the Company signed an Assignment of Rights agreement with Yieldex
LTD a Hong Kong corporation.  Under the agreement the Company
purchased the right to use outside of Asia the patents and patent applications
related to Yieldex LTD’s stem cell research, therapy development and clinical
trials. In addition the Company obtained the rights to all the clinical trial
results, endorsements, files and other pertinent information.  Under
the terms of the agreement the Company will pay Yieldex LTD $5,000,000 (US) in
cash over a period of 5 years. In addition the Company will also irrevocably
issue 40,000,000 shares of Common stock to Yieldex LTD.
 
 On
February 10, 2010, Kwalata Trading Ltd., a wholly owned subsidiary of
TheraVitae, Inc., a Canadian corporation, obtained an ex parte order to seize
alleged intellectual property owned by it in the possession of the Company’s
wholly owned Israeli corporation, Regenocell Laboratories, Ltd.  A
response was filed on February 24 and the Court scheduled a hearing for March
3.  A settlement was negotiated through suggestions from the Judge. 
All equipment and files taken are to be returned subject to copying by the
applicants at their expense.  Excluded from copying are attorney-client
privileged documents, business documents and private documents.  Regenocell
Laboratories and the Company agree not to disclose the alleged intellectual
property to third parties except in the ordinary course of business, for
government filings and when a non disclosure agreement is
obtained.
  49
 
 NOTE
8 – SUBSEQUENT EVENTS (CONTINUED)
 
 On March
30, 2010, a note payable representing 36 percent of total notes payable
outstanding went into default which meant that the default terms of the note
went into effect.  According to the terms of the agreement, in the
event of default, the borrower is to pay an interest rate of 18 percent per
annum on all outstanding amounts owing to the lender until all amounts including
interest are paid in full. The interest began to accrue from the date of breach
and will extend up to the date all amounts owing are repaid in full by the
Company to the lender.
 
 Item 9.
              CHANGES
      IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL
      DISCLOSURE
 By letter dated March 20, 2010,
Lieberman, Sharma & Associates PA (“Lieberman”) resigned as the independent
auditor for the Company effective January 1, 2010 because the firm has elected
to no longer continue as a reporting firm under the guidelines of the Public
Company Accounting Oversight Board (PCAOB).
 
 Lieberman’s reports on the financial
statements of the Company for the fiscal years ended December 31, 2008, December
31, 2007, December 31, 2006, December 31, 2005, December 31, 2004 and for the
period from February 1, 2002 (inception) through December 31, 2008 contain no
adverse opinion or disclaimer of opinion. Except for the going concern
qualifications, there were no other qualifications.
 
 The Company’s Board of Directors
approved the change in independent auditors.
 
 For the fiscal year ended December 31,
2008, December 31, 2007, December 31, 2006, December 31, 2005, December 31, 2004
and for the period from February 1, 2002 (inception) through December 31, 2008
and for the period January 1, 2009 through January 1, 2010 (the date the
relationship ended with the former auditor), there has been no disagreement
between the Company and Lieberman, on any matter of accounting principles or
practices, financial statement disclosure, or auditing scope or procedure, which
disagreement, if not resolved to the satisfaction of Lieberman would have caused
it to make a reference to the subject matter of the disagreement in connection
with its reports.
 
 During the fiscal years ended December
31, 2008, December 31, 2007, December 31, 2006, December 31, 2005 and December
31, 2004, and for the period from February 1, 2002 (inception) through December
31, 2008 and for the period from January 1, 2009 through January 1, 2010 (the
date the relationship ended with the former auditor), the Company has not been
advised of any matter described in Regulation S-B, Item 304 (a) (1)
B).
  50
 
 The Company engaged Sadler, Gibb and
Associates, P.O. Box 411, Farmington, Utah 84025 (“Gibb”) as its new independent
auditors as of February 23, 2010.  Prior to such date the Company did
not consult with Gibb regarding (i) the application of accounting principles,
(ii) the type of audit opinion that might be rendered by Gibb, or (iii) any
other matter that was subject of a disagreement between the Company and its
former auditor as described in Item 304 (a) (1) (iv) of Regulation
S-B.
 
 ITEM
9A.           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, 2009. Disclosure controls and procedures are designed to ensure
that information required to be disclosed in reports filed or submitted under
the Exchange Act is recorded, processed, summarized, and reported within the
time periods specified in the SEC rules and forms and that
such information is accumulated and communicated to management, including the
Chief Executive Officer and the Principal Financial Officer, to allow timely
decisions regarding required disclosures.
 
 Based on
that evaluation, our management concluded, as of the end of the period covered
by this report, that our disclosure controls and procedures were effective in
recording, processing, summarizing, and reporting information required to be
disclosed, within the time periods specified in the SEC's rules and
forms.
 
 Management's
Report on Internal Control Over Financial Reporting
 
 Management
of our company is responsible for establishing and maintaining adequate internal
control over financial reporting. Our company's internal control over financial
reporting is a process, under the supervision of the Chief Executive Officer and
the Principal Accounting Officer, designed to provide reasonable assurance
regarding the reliability of financial reporting and the preparation of the
Company's financial statements for external purposes in accordance with United
States generally accepted accounting principles. Internal control over financial
reporting includes those policies and procedures that:
 
 •          
  Pertain to the maintenance of records that in reasonable detail
accurately and fairly reflect the transactions and dispositions of the Company's
assets;
 
 •           
 Provide reasonable assurance that transactions are recorded as necessary
to permit preparation of the financial statements in accordance 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
  51
 
 •            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, 2009, 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, 2009, the
Company's internal control over financial reporting is effective.
 
 Changes
in Internal Control over Financial Reporting
 
 As of the
end of the period covered by this report, there have been no changes in internal
control over financial reporting (as defined in Rule 13a-15(f) of the Exchange
Act) during the quarter ended December 31, 2009, that materially affected, or
are reasonably likely to materially affect, our internal control over financial
reporting.
 
 Item
9B.  OTHER INFORMATION
 
 None.
 
 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.
  52
 
 Directors
and Executive Officers
 
 Our
directors, executive officers and key employees are as follows:
 
 Name:
              
              Age
              
              Position
              
              Director
      sinceJames
      F. Mongiardo
              
              64
              
              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.).
 
 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.
  53
 
 Audit
Committee
 
 The Company currently does not have an
audit committee; until expansion of the Board to five members as provided in the
Yieldex agreement, the sole director will act as the audit committee of the
Board of Directors.
 
 Nominations
  The Board
of Directors nominates candidates to stand for election as directors; other
candidates also may be nominated by any stockholder, provided that such
other nomination(s) are submitted in writing to the Secretary of the Company no
later than 90 days prior to the meeting of stockholders at which such directors
are to be elected, together with the identity of the nominator and the number of
shares of the Company’s stock owned, directly or indirectly, by the
nominator.  Directors are elected at the annual meeting of the
stockholders, except for vacancies and newly created directorships resulting
from any increase in the authorized number of directors elected by all of the
stockholders having the right to vote as a single class (which positions may be
filled by the affirmative vote of a majority of the directors then in office,
although fewer than a quorum, or by a sole remaining director), and each
director elected shall hold office until such director’s successor is elected
and qualified or until the director’s earlier death, resignation or
removal.  )Pursuant to the
terms of the Assignment of Rights agreement between Yieldex, Ltd. and the
Company,  40,000,000 (forty million) shares of the Company’s common
stock, par value $.0001, were issued subject to the following.  The
40,000,000 shares are restricted and subject to a two year Lock-Up period
beginning January 4, 2010.  These shares are also subject to a voting
agreement.  During the Lock-Up period and for any subsequent period
until the shares are sold to the public in the open market,  the
shareholders whose shares are locked up will vote for a maximum of two
directors.  The Company’s shareholders who are not parties to the
Lock-Up agreement will vote their shares for the same two directors until the
aggregate number of Yieldex shares are 15,000,000(fifteen million) or less. The
Yieldex shareholders agree to vote the Yieldex shares for a maximum of three
directors designated by James F. Mongiardo.  While this voting rights
agreement is in effect, unanimous approval of all the directors then in office
or approval of holders of at least a majority of the shares will be required
for: (i) any proposal to increase capital in a way that would result in dilution
of existing shareholders’ percentages by ten percent (10%) or more; (ii) any
proposal to merge, consolidate or amalgamate with any other corporate entity;
(iii) any proposal to sell all or a material part of the assets; and, (iv) any
proposal to amend the bylaws.
 
 Directors'
Remuneration
 
 Our
directors are presently not compensated for serving on the board of
directors.
 
 Code
Of Ethics and Standards of Conduct
 
 In 2009
we had limited operations and have not as of yet adopted a Code of Ethics and
Standards of Conduct.  We plan to consider adopting a Code of Ethics
and Standards of Conduct applicable to our directors, officers and employees in
2010.
 
 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.
  54
 
 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, 2009, 2008, 2007, 2006, 2005, 2004 and 2003 for the Company’s
present and former President.
 
 Summary
Compensation Table
 
 Long-Term CompensationAnnual Compensation
                                        
                                        
                                        PayoutsName
      and
                                        
                                        
                                        
                                        Awards
                                        
                                        
                                        Shares
      Underlying
                                        
                                        
                                        All
      OtherPrincipal Position
                                        
                                        Year
                                        
                                        Salary
                                        
                                        
                                        Bonus
                                        
                                        
                                        Options Granted (#)
                                        
                                        
                                        CompensationJames
      F. Mongiardo
                                        
                                        2009
                                        
                                        
                                        0
                                        
                                        
                                        
                                        0
                                        
                                        
                                        
                                        0
                                        
                                        
                                        
                                        02008
                                        
                                        
                                        0
                                        
                                        
                                        
                                        0
                                        
                                        
                                        
                                        0
                                        
                                        
                                        
                                        0Scott
      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
  55
 
 Option
and Long—Term Incentive Plans
  Effective November 23, 2009, the Companycreated the 2009 Stock Option and Incentive Plan (the “Plan”) to provide
stock options and other equity interests in the Corporation to employees,
officers, directors, consultants and advisors of the Corporation and its
Subsidiaries, all of whom are eligible to receive Awards under the
Plan.  The Plan has up to six million (6,000,000) shares of
Corporation’s common stock, par value $.0001, available for
Awards.  Said awards will vest over four years, one quarter after one
year and the balance at one forty-eighth (1/48) of the total Award over the next
three years.
 
 On November 23, 2009, the Company
approved the issuance of an Award of five hundred thousand (500,000) shares to
Americo Simonini, MD, to serve as Chief Medical Officer of the Corporation
effective the first trading day of the Corporation’s common stock or the date
that the fair market value for the common stock can be determined, whichever is
earlier.
  Item
12.         SECURITY OWNERSHIP OF
CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
AND RELATED STOCKHOLDER MATTERS.
  Security Ownership of
Certain Beneficial Owners and Management
  The
following table shows, as of March 31, 2010 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
                                      
                                      
                                      15,000,000
                                      
                                      
                                      
                                      18.12
                                      %2
      Briar LaneNatick,
      MA 01760Domenic
      Mazza
                                      
                                      
                                      5,000,000
                                      
                                      
                                      
                                      6.14
                                      %Apartment
      5033700
      Galt Ocean Drive N.E.Fort
      Lauderdale, FL 33306Yieldex,
      Ltd.(2)
                                      
                                      
                                      40,000,000
                                      
                                      
                                      
                                      49.12
                                      %BasementKwong
      Long Tai Building1016
      Tai Nam West StreetHong
      KongAll
      current directors and executive officers as a group  (1
      person)
                                      
                                      
                                      15,000,000
                                      
                                      
                                      
                                      18.12
                                      %
  56
 
 (1)  Unless otherwise
indicated, each of the persons named in the table above has sole voting and
investment power with respect to the shares set forth opposite such person’s
name.  With respect to each person or group, percentages are
calculated based on the number of shares beneficially owned, including shares
that may be acquired by such person or group within 60 days of March 31, 2010
upon the exercise of stock options, warrants or other purchase rights, but not
the exercise of options, warrants or other rights held by any other
person.
 
 (2)As part of the
transaction between Yieldex, Ltd. and the Company, 40,000,000 (forty million)
shares of the Company’s common stock, par value $.0001, was issued to Yieldex
Ltd and its nominees.  The 40,000,000 shares are restricted and
subject to a two year Lock-Up period beginning January 4, 2010.  These
shares are also subject to a voting agreement.  During the Lock-Up
period and for any subsequent period until the shares are sold to the public in
the open market,  the Board of Directors will be expanded to five
members and the shareholders whose shares are locked up will vote for a maximum
of two directors.  The Company’s shareholders who are not parties to
the Lock-Up agreement will vote their shares for the same two directors until
the aggregate number of Yieldex shares are 15,000,000 (fifteen million) or less.
The Yieldex shareholders agree to vote the Yieldex shares for a maximum of three
directors designated by James F. Mongiardo.  While this voting rights
agreement is in effect, unanimous approval of all the directors then in office
or approval of holders of at least a majority of the shares will be required
for: (i) any proposal to increase capital in a way that would result in dilution
of existing shareholders’ percentages by ten percent (10%) or more; (ii) any
proposal to merge, consolidate or amalgamate with any other corporate entity;
(iii) any proposal to sell all or a material part of the assets; and, (iv) any
proposal to amend the bylaws.
 
 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, Sadler,
Gibb & Associates in the amount of  $1,500 for the year ended
December 31, 2009.
 
 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.
  57
 
 (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.
 
 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:April 30,
      2010
              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 April 30,
2010.
 
 /s/ James F. MongiardoJames
      F. MongiardoPrincipal
      Executive Officer,President,
      Principal FinancialOfficer,
      Principal AccountingOfficer
      and Director
  58