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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): August 10, 2007
CT HOLDINGS ENTERPRISES, INC.
(Exact name of registrant as specified in its charter)
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Delaware
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0-18718
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75-2242792 |
(State or other jurisdiction of incorporation)
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(Commission File Number)
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(I.R.S. Employer Identification Number) |
2100 McKinney Avenue, Suite 1500, Dallas, Texas 75201
(Address of principal executive offices, including zip code)
(214) 750-2454
(Registrants telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the
filing obligation of the registrant under any of the following provisions (see General Instruction
A.2 below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.24d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.23e-4(c))
Forward-Looking Statements
This report contains forward-looking statements that involve risks and uncertainties. Our
actual results may differ materially from those discussed due to factors such as, among others, the
risk that the contemplated merger with Xcorporeal might not be fully consummated, limited operating
history of Xcorporeal, difficulty in developing, exploiting and protecting proprietary
technologies, intense competition and substantial regulation in the biotechnology industry.
Additional information concerning factors that could cause or contribute to such differences can be
found in the following discussion, including the Risk Factors set forth below.
Item 1.01 Entry into a Material Definitive Agreement
Merger Agreement
On August 10, 2007, we entered into a definitive Merger Agreement with Xcorporeal, Inc.
Pursuant to the merger agreement, we will effect a 1 for 8.27 reverse split of our outstanding
common stock, issue 14,200,050 post-split shares (approximately 97.6%
of our outstanding shares) in exchange for all of the outstanding common stock of
Xcorporeal, adopt an option plan substantially identical to the 2006 Incentive Compensation Plan of
Xcorporeal, replace our officers and directors with those of Xcorporeal, and change our name to
Xcorporeal, Inc. Copies of the incentive plan and charter
amendments are attached hereto as Exhibit 10.1 and
Exhibits 3.1, 3.2 and 3.3, respectively.
The parties each made customary representations and warranties in the merger agreement, which
is subject to customary closing conditions. The merger agreement contains termination rights for both parties, including a provision which
would allow the board of directors of each of the parties to terminate the merger agreement in
order to comply with its fiduciary duties and a provision that would allow Xcorporeal to terminate
the agreement and rescind the merger within 10 days after the closing in the event that our shares
do not continue to be quoted on the OTC Bulletin Board immediately following the merger. No
assurance can be given that the conditions to closing the transactions contemplated by the merger
agreement will be satisfied, or that the transactions contemplated by the merger agreement
ultimately will be fully consummated.
The transactions were approved by Xcorporeals board of directors and CT Holdings board of
directors and special committee, which was formed as a result of the ownership by Steven B.
Solomon, CT Holdings Chief Executive Officer, of 50,000 shares of Xcorporeal common stock
purchased in a December 2006 private placement. Although the transaction
also requires shareholder
approval, a majority-in-interest of the shareholders of both companies have already agreed to vote
in favor of the merger. The foregoing description is qualified in its entirety by reference to the
merger agreement, a copy of which is attached as Exhibit 2.1.
The merger is expected to close in the third quarter of 2007.
Item 3.02 Unregistered Sales of Equity Securities
Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of
Certain Officers; Compensatory Arrangements of Certain Officers
On August 7, 2007, we issued 500,000 shares of restricted common stock to Steven B. Solomon, our
Chief Executive Officer, in connection with his services to the company and further advances of
funds. We issued the restricted common stock in reliance upon the exemption from registration
provided by Section 4(2) of the Securities Act of 1933, as amended, pursuant to a transaction to
one accredited investor not involving any public offering.
Item 8.01 Other Events
Basis of Presentation
Set forth below is information regarding the business and management of Xcorporeal as set
forth in their public reports. When used below, the terms us, our, we and the Company
refer to the registrant, CT Holdings Enterprises, Inc., after consummation of the merger with
Xcorporeal. For ease of reference, such information is set forth as if the merger has already been
effected, even though this has not yet occurred and there can be no
assurance that the merger will be fully completed. As a result, all of the matters set forth below
should be considered forward-looking statements.
Description of Xcorporeal, Inc.
Plan of Operation
Overview
We are a medical device company actively researching and developing an extracorporeal platform
to perform functions of various human organs. Our prototype systems apply modern electronics and
engineering principals to reduce the size, cost and power requirements of conventional
extracorporeal therapies including ultrafiltration therapy for fluid overload resulting from
congestive heart failure and acute and chronic renal replacement therapies (kidney dialysis). Our
platform may also improve the quality of therapy delivered ultimately leading to better patient
outcomes and reduced healthcare costs.
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Since we began implementing our current business model on August 31, 2006, we have
accomplished the following milestones:
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Raised over $29 million in equity financing in the
fourth quarter of 2006 selling shares of Xcorporeal common stock at
$7.00 per share |
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Recruited experienced independent board members |
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Recruited top industry management team and scientific staff |
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Advanced the clinical studies for our technology |
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Paid in excess of $1 million in licensed product development expenses. |
We are a development stage company, have been unprofitable since our inception, and will incur
substantial additional operating losses for at least the next twelve months as we continue to
implement commercial operations and allocate significant and increasing resources to research,
development, clinical trials, and other activities. Accordingly, our activities to date are not as
broad in depth or scope as the activities we will undertake in the future, and our historical
operations and financial information are not indicative of our future operating results, financial
condition, or ability to operate profitably as a commercial enterprise.
License Agreement
On September 1, 2006, we entered into the License Agreement pursuant to which we obtained
exclusive rights to our technology relating to the treatment of kidney failure, congestive heart
failure and other medical devices, with no geographic restrictions, that will last for a period of
ninety-nine years or until the expiration of its proprietary rights in each item of intellectual
property, if earlier. As consideration for granting the license, we agreed to reimburse designated
costs and expenses of our licensor, and pay a minimum royalty of 7% of net sales, with an annual
minimum royalty of $250,000. As a result, we have become a developmental stage company focused on
researching, developing, and commercializing technology and products related to the treatment of
kidney failure and congestive heart failure.
Intellectual Property
We have exclusive license rights to two issued US patents, No. 20050101901 Wearable
continuous renal replacement therapy device, and No. 20040254514 Wearable ultrafiltration device
from the US Patent & Trademark Office. We also have exclusive rights to a pending application
specifically for the pump, the most critical part of all four devices, Dual-Ventricle Pump
Cartridge, and another proposed patent for Method For Installing and Servicing a Wearable
Continuous Renal Replacement Therapy Device which is aimed to prevent entry into the wearable
device market.
In addition, we are actively developing additional intellectual property that in part
supersedes the rights licensed under the License Agreement. We are filing patent applications to
protect and improve the inventions that are commercially important for the development of our
business and we plan to continually expand our patent portfolio.
We also have pending applications to register our trademarks Xcorporeal, Xcorporeal WUD
and Xcorporeal WAK.
Description of Business
For the coming year we plan to test and develop the technology for our extracorporeal platform
and other medical devices. In its simplest configuration, our product platform can be used as an
ultrafiltration machine which will remove a predetermined amount of water from a patients blood
stream. Removal of excess water by ultrafiltration has been shown to be an effective therapy for
management of fluid overload in patients with congestive heart failure under physician supervision.
We can also add additional components to our platform to
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configure a full dialysis machine, which can remove metabolic waste (urea, creatinine) and toxins
from the blood. Dialysis has been shown to be an effective therapy for treatment of kidney failure.
The resulting four products in the order in which we plan to market them are:
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Hospital ultrafiltration therapy for fluid overload resulting from congestive heart failure |
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Hospital acute renal replacement therapy |
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Home chronic renal replacement therapy |
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Wearable Artificial Kidney (WAK) for chronic treatment of End Stage Renal Disease (ESRD) |
We will also plan our Validation and Verification strategy including bench testing, clinical
testing, and regulatory strategy in the US and abroad.
Some of our products may qualify for the 510(k) regulatory process in the US based on the
existence of predicate devices. Other products, for example our Wearable Artificial Kidney and
Wearable Ultrafiltration Device are likely to require a full PMA treatment which will be longer and
more expensive.
Product Applications
Our platform technology enables us to build small, light-weight, portable medical devices that
filter and cleanse a patients blood. In addition, our devices will consume less water and
electricity than competitor devices currently in use.
The first application of the technology will be an ultrafiltration device that will be used to
remove excess salt and water from congestive heart failure patients hospitalized with fluid
overload. The Xcorporeal CHF device will provide patients with simple, convenient, efficient and
cost effective ultrafiltration therapy. An initial prototype of this device was successfully tested
during the third quarter of 2006. The second application of the platform technology will be
portable renal replacement devices that will remove unwanted chemicals, toxins and excess fluids
from the blood of patients with renal failure. The same attributes (portability, size, weight, and
fluid and electricity reduction) will make the renal replacement device an attractive alternative
to conventional Continuous Renal Replacement Therapy (CRRT) machines for hospitalized patients. The
technology will also be adapted to provide a truly portable device for home hemodialysis.
Finally, we are also developing a breakthrough product for the treatment of End Stage Renal Disease
(ESRD), the Wearable Artificial Kidney (WAK). This miniature, wearable device will enable
continuous (24 hrs/day and 7 days/week) renal replacement therapy that should reduce the morbidity
and mortality of ESRD patients as well as improve their quality of life. The feasibility of such a
device was demonstrated in a clinical study conducted in London during the first quarter of 2007.
Research and Development
R&D Team
We have recruited an experienced scientific team to execute our research and development plan.
The goals of our research and development efforts will include:
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Adapting the extracorporeal platform technology to develop four devices for
medical use. We believe our technology is a platform for a number of devices that can
be used to treat other diseases and will offer substantive value propositions for
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Developing software to allow physicians to customize the function of the device
to meet the specific dialysis needs of each patient. |
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Expanding our recruiting and retaining an experienced team of scientists and
engineers. |
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Improving the chemicals used in the dialysis process. The current chemicals
have been used for decades. We believe new chemicals that last longer and can be used
in smaller quantities would further reduce the cost and weight of our product. |
Clinical Studies
The feasibility of the Xcorporeal platform technology was demonstrated in a porcine model
during 2004 and 2005. The feasibility of a prototype UF device for treatment of fluid overload in
humans was demonstrated by the treatment of six volunteers in Vicenza, Italy in July and August
2006. We demonstrated the feasibility of the WAK prototype for dialysis treatment in humans by the
treatment of eight volunteers in London in March 2007. We are planning additional clinical trials
over the next few years, culminating in a pivotal study to support a regulatory submission.
We incurred approximately $1.5 million and $2.7 million in research and development expenses
for the three and six months ended June 30, 2007, respectively. This compares to $1.3 million
incurred during the year ended December 31, 2006. We expect our research and development expenses
to increase as a result of additional headcount in the areas of product development and quality
assurance and regulatory affairs, a higher level of third-party consulting activity and other
related expenses.
Third-party Arrangements
In July 2007, we entered into an agreement with Aubrey Group, Inc., an FDA-registered
third-party contract developer and manufacturer of medical devices for the design and development
of a Portable Artificial Kidney (PAK). The PAK will be designed for use as a Continuous Renal
Replacement Therapy (CRRT) in either a hospital (with medical supervision) or home setting. The
development is expected to be completed by the end of 2008 and projected labor and material costs
are estimated at approximately $5.1 million over the term. The agreement can be terminated at any
time with 30 business days notice.
We also contract with other third parties to assist in our research and development efforts
and to supplement our internal resources while we continue to grow our organization.
Government Regulation
US Regulation
We are subject to extensive government regulation relating to the development and marketing of
our products. Due to the relatively early nature of our development efforts, we have not yet
confirmed with the FDA its view of the regulatory status of any of our products or which center of
the FDA might have primary responsibility for review of the regulatory submissions we intend to
make. Depending on the claims made and the FDAs ruling regarding the regulatory status of each of
our products, they may be designated as a device, a biologic or as a combination product. However,
we anticipate that regardless of regulatory designation, we will need to conduct clinical studies
involving human subjects before being able to market our products in the US.
To support a regulatory submission, the FDA commonly requires clinical studies to show safety
and effectiveness. While we cannot currently state the nature of the studies the FDA may require
due to our early stage of product development, it is likely any product we attempt to develop will
require time-consuming clinical studies in order to secure approval.
Outside the US, our ability to market potential products is contingent upon receiving market
application authorizations from the appropriate regulatory authorities. These foreign regulatory
approval processes may involve differing requirements than those of the FDA, but also generally
include many, if not all, of the risks associated with the FDA approval process described above,
depending on the country involved.
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In the US, medical devices are classified into three different classes, Class I, II and III,
on the basis of controls deemed reasonably necessary to ensure the safety and effectiveness of the
device. Class I devices are subject to general controls, including labeling, pre-market
notification and adherence to the FDAs Good Manufacturing Practices (GMP), Class II devices are
subject to general and special controls, including performance standards, post-market surveillance,
patient registries and FDA guidelines, and Class III devices are those which must receive
pre-market approval by the FDA to ensure their safety and effectiveness, that is, life-sustaining,
life-supporting and implantable devices, or new devices, which have been found not to be
substantially equivalent to legally marketed devices. Because of their breakthrough nature, some of
our devices may be considered Class III.
Before new medical devices such as our products can be marketed, marketing clearance must be
obtained through a pre-market notification under Section 510(k) of the Federal Food, Drug and
Cosmetic (FDC) Act. Noncompliance with applicable requirements can result in fines, injunctions,
civil penalties, recall or seizure of products, total or partial suspension of production, refusal
to authorize the marketing of new products or to allow us to enter into supply contracts and
criminal prosecution. A 510(k) clearance will typically be granted by the FDA, if it can be
established that the device is substantially equivalent to a predicate device, which is a legally
marketed Class I or II device or a pre-amendment Class III device (that is, one that has been
marketed since a date prior to May 28, 1976), for which the FDA has not called for pre-market
approval (PMA). The FDA has been requiring an increasingly rigorous demonstration of substantial
equivalence, which may include a requirement to submit human clinical trial data. It generally
takes 4 to 12 months from the date of a 510(k) submission to obtain clearance, but it may take
longer.
If clearance or approval is obtained, any device manufactured or distributed by us will be
subject to pervasive and continuing regulation by the FDA. We will be subject to routine inspection
by the FDA and will have to comply with the host of regulatory requirements that usually apply to
medical devices marketed in the U.S. including labeling regulations, GMP requirements, Medical
Device Reporting (MDR) regulation which requires a manufacturer to report to the FDA certain types
of adverse events involving its products, and the FDAs prohibitions against promoting products for
unapproved or off-label uses.
European Community
International Organization for Standards (ISO) standards were developed by the European
Community (EC) as a tool for companies interested in increasing productivity, decreasing cost and
increasing quality. The EC uses ISO standards to provide a universal framework for quality
assurance and to ensure the good quality of products and services across borders. The ISO standards
(it is now ISO13485) have facilitated trade throughout the EC, and businesses and governments
throughout the world are recognizing the benefit of the globally accepted uniform standards. Any
manufacturer we utilize for purposes of producing our products (including us, if we manufacture any
of our own products) will be required to obtain ISO certification to facilitate the highest quality
products and the easiest market entry in cross-border marketing. This will enable us to market our
products in all of the member countries of the EC. We also will be required to comply with
additional individual national requirements that are outside the scope of those required by the
European Economic Area.
Any medical device that is legally marketed in the US may be exported anywhere in the world
without prior FDA notification or approval. The export provisions of the FDC Act apply only to
unapproved devices. While FDA does not place any restrictions on the export of these devices,
certain countries may require written certification that a firm or its devices are in compliance
with US law. In such instances FDA will accommodate US firms by providing a Certificate for Foreign
Government. In cases where there are devices which the manufacturer wishes to export during the
interim period while their 510(k) submission is under review, exporting may be allowed without
prior FDA clearance under certain limited conditions.
Competition
We compete directly and indirectly with other biotechnology and healthcare equipment
businesses, including those in the dialysis industry. The major competitors for the Xcorporeal
platform technology are those companies manufacturing and selling dialysis equipment and supplies.
Xcorporeal will compete with these companies in the critical care markets as well as the wearable
application markets. In many cases, these competitors
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are larger and more firmly established than we are. In addition, our competitors have greater
marketing and development budgets and greater capital resources than our company. The Wearable
Artificial Kidney will also compete with dialysis clinics in treating ESRD patients. We anticipate
that some of our primary competitors will be companies such as Baxter, Fresenius, Gambro, NxStage,
and Nephros.
Employees
We have ten full-time employees, comprised of our President and Chief Operating Officer, Chief
Medical and Scientific Officer, Vice President of Quality Assurance and Regulatory Affairs, and
seven other personnel in research and development and administration. We also have one full-time
contract employee, our Interim Chief Financial Officer. We believe that our employee relations are
good.
Business Development
Formation
We were incorporated in the State of Nevada as Pacific Spirit Inc. on May 4, 2001 to engage in
the acquisition, exploration and development of natural resource properties. On August 31, 2006, we
changed our name to Xcorporeal, Inc.
Contribution and License Agreement
On August 11, 2006, Consolidated National, LLC (CNL), whose sole managing member is our
current Chairman, entered into an Irrevocable Option Agreement with National Quality Care, Inc.
(NQCI) following extensive negotiations that commenced in late 2005. There was no pre-existing
relationship between NQCI and CNL or their principals.
On August 31, 2006, we entered into a Contribution Agreement with CNL, giving us the right to
enter into a Merger Agreement and a License Agreement with NQCI. We issued 9,600,000 shares of
common stock, a 96% voting interest in our company, to CNL in exchange for all of our right, title,
and interest to the name Xcorporeal and related trademark applications and domain names, and the
right to enter into a License Agreement with NQCI. Prior to the August 31, 2006 transaction, we
were a shell corporation.
On September 1, 2006, we entered into a License Agreement with NQCI, pursuant to which we
obtained the exclusive rights to the technology relating to our congestive heart failure treatment,
kidney failure treatment, and other medical devices. As a result, we have become a developmental
stage company focused on researching, developing, and commercializing technology and products
related to the treatment of kidney failure and congestive heart failure.
On December 1, 2006, we initiated an arbitration against NQCI for its breach of the License
Agreement, which remains pending. On December 29, 2006, NQCI served us with a written notice
purporting to terminate the License Agreement for unspecified alleged breaches. On January 2, 2006,
we advised NQCI that we did not consent to termination of the License Agreement, that we have not
breached the License Agreement, and that NQCI has no right to unilaterally terminate the License
Agreement in any event. Accordingly, the License Agreement cannot be terminated.
Delaware Reincorporation
We were incorporated in the State of Nevada as Pacific Spirit Inc. on May 4, 2001 to engage in
the acquisition, exploration and development of natural resource properties. On August 31, 2006, we
changed our name to Xcorporeal, Inc., and thereafter acquired the rights to our congestive heart
failure treatment products, Wearable Artificial Kidney, and other medical devices. As a result, we
have become a developmental stage company focused on researching, developing, and commercializing
technology and products related to the treatment of kidney failure and congestive heart failure.
On October 13, 2006, Xcorporeal, Inc., a Nevada corporation (Xcorporeal Nevada), consummated a
merger with and into its newly-formed, wholly-owned subsidiary, Xcorporeal Merger Corporation, a
Delaware corporation, for the purpose of changing the Companys domicile from Nevada to Delaware.
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Terminated Prior Merger Agreement
On September 1, 2006, we entered into a Merger Agreement with NQCI which contemplated that we
would acquire NQCI as a wholly owned subsidiary pursuant to a triangular merger, or we would issue
to NQCI shares of our common stock in consideration of the assignment of the technology relating to
our Wearable Artificial Kidney and other medical devices.
The merger was not consummated, and the Merger Agreement expired by its own terms on December
31, 2006. In addition, on December 29, 2006, NQCI served written notice that it was terminating the
Merger Agreement, and on January 2, 2006, we consented to the termination. Accordingly, the Merger
Agreement is now terminated. We will not be proceeding with any merger with NQCI. The termination
of the Merger Agreement had no effect on the License Agreement, the Contribution Agreement, or the
shares we issued to CNL.
Risk Factors
You should carefully consider and evaluate all of the information in this report, including
the risk factors listed below and the risk factors listed in the
annual reports and quarterly reports of CT Holdings Enterprises, Inc. If any of these risks occur, our business, results of operations and
financial condition could be harmed, the price of our common stock could decline, and future events
and circumstances could differ significantly from those anticipated in the forward-looking
statements contained in this report.
Risks Relating to the Proposed Merger
Xcorporeal and CTHE may not achieve the benefits they expect from the merger, which may have
a material adverse effect on the combined companys business, financial, and operating
results.
Xcorporeal and CTHE entered into the merger agreement with the expectation that the merger
will result in benefits to the combined company arising out of the combination of the wearable
kidney and related technology businesses of Xcorporeal and CTHE. These benefits may include
operational efficiencies resulting from synergies between the companies and greater sales levels
due to increases in product and services offerings and consolidation of sales and marketing
expertise, among others. To realize any benefits from the merger, the combined company will face
the following post-merger challenges:
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retaining and assimilating the management and employees of each company; |
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developing new products and services that utilize the assets and resources of both companies; |
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retaining existing customers, strategic partners and suppliers of each company; |
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realizing expected cost savings and synergies from the merger; and |
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developing and maintaining uniform standards, controls, procedures, policies and
information systems. |
If the combined company is not successful in addressing these and other challenges, then the
benefits of the merger will not be realized and, as a result, the combined companys operating
results and the market price of Xcorporeals common stock may be adversely affected. These
challenges, if not successfully met by the combined company, could result in possible unanticipated
liabilities, unanticipated costs, diversion of management attention and loss of personnel. Neither
Xcorporeal nor CTHE can assure you that the combined company will successfully integrate CTHEs
business or profitably manage the combined company. Further, neither Xcorporeal nor CTHE can assure
you that the growth rate of the combined company after the merger will equal the historical growth
rates experienced by Xcorporeal or CTHE.
The issuance of shares of CTHEs common stock to Xcorporeal stockholders in the merger will
substantially dilute the percentage ownership interests of current CTHE stockholders.
If the merger is completed, is anticipated that CTHE will issue to Xcorporeal stockholders
approximately 14.2 million shares of CTHE common stock, and approximately 4.2 million shares to be
subject to stock options and warrants to be issued to Xcorporeal and stock option and warrant
holders. Upon completion of the merger, the former Xcorporeal stockholders, together with the
holders of assumed Xcorporeal stock options, will be issued shares of our common stock and options
and warrants to acquire shares of our common stock representing in the aggregate 1.9% of CTHE
common stock on a fully-diluted basis immediately following the merger. The issuance of CTHE common
stock
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to Xcorporeal stockholders will cause a significant reduction in the relative percentage
interest of current CTHE stockholders in CTHEs earnings, if any, voting power and market
capitalization.
If we proceed with the merger, Xcorporeal stockholders will receive one share of CTHE common
stock for each share of Xcorporeal common stock regardless of changes in the market value of
CTHE common stock or Xcorporeal common stock.
Each share of Xcorporeal common stock will be exchanged for one share of CTHE common stock
upon completion of the merger. This exchange ratio is a fixed number and the merger agreement does
not contain any provision to adjust this ratio for changes in the market price of either Xcorporeal
common stock or CTHEs common stock. Neither party is permitted to terminate the merger agreement
solely because of changes in the market price of Xcorporeal or CTHE common stock. Consequently, the
specific dollar value of CTHEs common stock to be received by Xcorporeal stockholders will depend
on the market value of CTHE common stock at the time of completion of the merger and may decrease
from the date of this information statement. You are urged to obtain recent market quotations
for Xcorporeal common stock and CTHE common stock. Neither Xcorporeal nor CTHE can predict or give
any assurances as to the market price of CTHE common stock at any time before or after the merger.
The prices of Xcorporeal common stock and CTHE common stock may vary because of factors such as:
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changes in the business, operating results or prospects of Xcorporeal or CTHE; |
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actual or anticipated variations in quarterly results of operations of Xcorporeal or CTHE; |
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market assessments of the likelihood that the merger will be completed; |
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the timing of the completion of the merger; |
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sales of Xcorporeal common stock or CTHE common stock; |
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additions or departures of key personnel of Xcorporeal or CTHE; |
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announcements of significant acquisitions, strategic partnerships, joint ventures or
capital commitments by Xcorporeal; |
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conditions or trends in the medical technology industry; |
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announcements of technological innovations, new products or services by Xcorporeal,
CTHE or their competitors; |
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changes in market valuations of other medical technology companies; |
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the prospects of post-merger operations; |
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regulatory considerations; and |
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general market and economic conditions. |
If the merger is successfully completed, holders of Xcorporeal common stock will become
holders of CTHE common stock. Xcorporeals business differs from CTHEs business, and Xcorporeals
results of operations, as well as the price of Xcorporeal common stock, may be affected by factors
different than those affecting CTHEs results of operations and the price of CTHEs common stock.
If the costs associated with the merger exceed the benefits, the combined company may
experience adverse financial results, including increased losses.
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Xcorporeal and CTHE will incur significant transaction costs as a result of the merger,
including legal and accounting fees that may exceed their current estimates. In addition,
Xcorporeal and CTHE expect that the combined company will incur consolidation and integration
expenses, which they cannot accurately estimate at this time. Actual transaction costs may
substantially exceed the current estimates of Xcorporeal and CTHE and may affect the combined
companys financial condition and operating results negatively. If the benefits of the merger do
not exceed the costs associated with the merger, including any dilution to CTHEs stockholders
resulting from the issuance of shares in connection with the merger, the combined companys
financial results could be adversely affected, including increased losses.
No Independent Financial Advisor.
Neither Xcorporeal nor CTHE has engaged an independent financial advisor to consult on the
relative advantages and disadvantages of the transactions. Therefore, the stockholders of both
companies are dependent solely on the judgment of the board of directors of each company.
The market price of CTHEs common stock may decline as a result of the merger.
The market price of CTHEs common stock may decline as a result of the merger for a number of
reasons, including if:
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the integration of Xcorporeal and CTHE is not completed in a timely and efficient
manner; |
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the combined company does not achieve the perceived benefits of the merger as
rapidly or to the extent anticipated by financial or industry analysts; |
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the effect of the merger on the combined companys financial results is not
consistent with the expectations of financial or industry analysts; or |
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significant stockholders of Xcorporeal or CTHE decide to dispose of their stock
following completion of the merger. |
Sales of substantial amounts of CTHE common stock in the public market after the proposed
merger could materially adversely affect the market price of CTHE common stock.
Based on the number of shares of Xcorporeal common stock outstanding as of August 10, 2007,
and assuming no outstanding options or warrants to purchase Xcorporeal common stock are exercised
before the merger becomes effective, at the closing of the merger, CTHE will issue approximately
14.2 million shares of CTHE common stock to Xcorporeal stockholders in the merger. The sale of
substantial amounts of CTHE common stock may result in substantial fluctuations in the price of
CTHE common stock. In addition, sales of a substantial number of shares of CTHE common stock within
a short period of time could cause CTHE stock price to fall. The sale of these shares could also
impair the combined companys ability to raise capital through sales of additional common stock.
Failure to complete the merger could negatively impact the market price of Xcorporeal common
stock and CTHE common stock.
The obligations of CTHE and
Xcorporeal to complete the merger are subject to the satisfaction
or waiver of certain conditions set forth in the merger agreement. If these conditions are not satisfied or waived, the merger may not be completed. If the merger is
not completed for any reason, both CTHE and Xcorporeal may be subject to other material risks,
including:
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a negative effect on the stock trading price of CTHE common stock and Xcorporeal
common stock to the extent that the current market price reflects a market assumption
that the merger will be completed; |
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either party may be required to pay a termination fee; and |
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costs related to the merger, such as legal and accounting fees, must be paid even if
the merger is not completed. |
In addition, if the merger is consummated but CTHE common stock ceases to be traded on the
OTC Bulletin Board immediately after the effectiveness of the merger, Xcorporeal may
terminate the merger and rescind the merger agreement which could result in uncertainty in,
or have an adverse impact on, the trading market for CTHE common stock.
Xcorporeals officers and directors have interests different from yours that may influence
them to support or approve the merger.
The terms of the merger agreement and the agreements contemplated thereby affect the directors
and officers of Xcorporeal in ways that may create interests for them in the merger that are
different from, or in addition to, yours. These interests include:
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the existing rights to indemnification benefiting Xcorporeals directors and
officers found in Xcorporeals certificate of incorporation or bylaws, applicable law
or other sources will be duplicated in CTHEs certificate of incorporation and will
continue indefinitely. |
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Messrs. Terren S. Peizer, Executive Chairman of Xcorporeal, and Robert Weinstein,
Xcorporeals Chief Financial Officer, will enter into employment agreements with
Xcorporeal in connection with closing of the merger; and |
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Steven B. Solomon, an officer, director and majority shareholder of CTHE is the
record owner of 50,000 shares of Xcorporeal common stock which he purchased in
connection with a private placement consummated in the fourth quarter of 2006. |
Uncertainty regarding the merger and the effects of the merger could cause each companys
customers or strategic partners to delay or defer decisions.
Xcorporeals customers and strategic partners, in response to the announcement of the merger,
may delay or defer decisions, which could have a material adverse effect on the business of the
relevant company, regardless of whether the merger is ultimately completed.
Risks Related to Our Business
Our limited operating history may make it difficult to evaluate our business to date and our future
viability.
We are in the early stage of operations and development, and have only a limited operating history
on which to base an evaluation of our business and prospects, having just commenced operations in
August 2006 in accordance with our new business plan and entry into the medical devices industry.
In addition, our operations and developments are subject to all of the risks inherent in the growth
of an early stage company. We will be subject to the risks inherent in the ownership and operation
of a company with a limited operating history such as regulatory setbacks and delays, fluctuations
in expenses, competition, the general strength of regional and national economies, and governmental
regulation. Any failure to successfully address these risks and uncertainties would seriously harm
our business and prospects. We may not succeed given the technological, marketing, strategic and
competitive challenges we will face. The likelihood of our success must be considered in light of
the expenses, difficulties, complications, problems and delays frequently encountered in connection
with the growth of a new business, the continuing development of new technology, and the
competitive and regulatory environment in which we operate or may choose to operate in the future.
We have generated no revenues to date, and there can be no assurance that we will be able to
successfully develop our products and penetrate our target markets.
We expect to continue to incur operating losses, and if we are not able to raise necessary
additional funds we may have to reduce or stop operations.
We have not generated revenues or become profitable, may never do so, and may not generate
sufficient working capital to cover the cost of operations. No party has guaranteed to advance
additional funds to us to provide for any operating deficits. Until we begin generating revenue, we
may seek funding through the sale of equity, or securities convertible into equity, further
dilution to our then existing stockholders may result. If we raise additional capital through the
incurrence of debt, our business may be affected by the amount of leverage we incur, and our
borrowings may subject us to restrictive covenants. Additional funding may not be available to us
on acceptable terms, or at all. If we are unable to obtain adequate financing on a timely basis, we
may be required to delay, reduce or stop operations, any of which would have a material adverse
effect on our business.
Our success will depend on our ability to retain our managerial personnel and to attract additional
personnel.
Our success will depend largely on our ability to attract and retain managerial personnel.
Competition for desirable personnel is intense, and we cannot guarantee that we will be able to
attract and retain the necessary staff. The loss of members of managerial, sales or scientific
staff could have a material adverse effect on our future operations and
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on successful development of products for our target markets. The failure to maintain our
management, particularly our President and Chief Operating Officer and our Chief Medical and
Scientific Officer, and to attract additional key personnel could materially adversely affect our
business, financial condition and results of operations. Although we intend to provide incentive
compensation to attract and retain our key personnel, we cannot guarantee that these efforts will
be successful.
We will need to expand our finance, administrative, product development, sales and marketing, and
operations staff. There are no assurances that we will be able to make such hires. In addition, we
may be required to enter into relationships with various strategic partners and other third parties
necessary to our business. Planned personnel may not be adequate to support our future operations,
management may not be able to hire, train, retain, motivate and manage required personnel or
management may not be able to identify, manage and exploit existing and potential strategic
relationships and market opportunities. If we fail to manage our growth effectively, it could have
a material adverse effect on our business, results of operations and financial condition.
We need to develop our financial and reporting processes, procedures and controls to support our
anticipated growth.
We have not historically invested significantly in our financial and reporting systems. To comply
with our public reporting requirements, and manage the anticipated growth of our operations and
personnel, we will be required to improve existing or implement new operational and financial
systems, processes and procedures, and to expand, train and manage our employee base. Our current
and planned systems, procedures and controls may not be adequate to support our future operations.
The laws and regulations affecting public companies, including the provisions of the Sarbanes-Oxley
Act of 2002 and rules adopted or proposed by the Securities and Exchange Commission, will result in
increased costs to us as we evaluate the implications of any new rules and respond to their
requirements. New rules could make it more difficult or more costly for us to obtain certain types
of insurance, including director and officer liability insurance, and we may be forced to accept
reduced policy limits and coverage or incur substantially higher costs to obtain the same or
similar coverage. We cannot predict or estimate the amount of the additional costs we may incur or
the timing of such costs to comply with any new rules and regulations, or if compliance can be
achieved.
We cannot assure you that we will be able to complete development and obtain necessary approvals
for our proposed products even if we obtain sufficient funding.
Even if we obtain sufficient funding, no assurance can be given that we will be able to design or
have designed parts necessary for the manufacture of our products or complete the development of
our proposed products within our anticipated time frames, if at all. Such a situation could have a
material adverse effect upon our ability to remain in business.
The success of our business will depend on our ability to develop and protect our intellectual
property rights, which could be expensive.
Patent and other proprietary rights are essential to our business. Our success depends to a
significant degree on our ability to obtain and enforce patents and licenses to patent rights, both
in the U.S. and in other countries. We cannot be certain that the patents that we license from
others will be enforceable and afford protection against competitors. Our patent rights may not
provide us with proprietary protection or competitive advantages against competitors with similar
technologies. Even if such patents are valid, we cannot guarantee that competitors will not
independently develop alternative technologies that duplicate the functionality of our technology.
We also rely on trademarks, copyrights, trade secrets and know-how to develop, maintain and
strengthen our competitive positions. While we protect our proprietary rights to the extent
possible, we cannot guarantee that third parties will not know, discover or develop independently
equivalent proprietary information or techniques, that they will not gain access to our trade
secrets or disclose our trade secrets to the public. Therefore, we cannot guarantee that we can
maintain and protect unpatented proprietary information and trade secrets. Misappropriation of our
intellectual property would have an adverse effect on our competitive position and may cause us to
incur substantial litigation costs.
-11-
We may be subject to claims that we infringe the intellectual property rights of others, and
unfavorable outcomes could harm our business.
Our future operations may be subject to claims, and potential litigation, arising from our alleged
infringement of patents, trade secrets or copyrights owned by other third parties. We intend to
fully comply with the law in avoiding such infringements. However, within the medical devices
industry, established companies have actively pursued such infringements, and have initiated such
claims and litigation, which has made the entry of competitive products more difficult. We may
experience such claims or litigation initiated by existing, better-funded competitors.
Court-ordered injunctions may prevent us from bringing new products to market, and the outcome of
litigation and any resulting loss of revenues and expenses of litigation may substantially affect
our ability to meet our expenses and continue operations.
We compete against other dialysis equipment manufacturers with much greater financial resources and
better established products and customer relationships, which may make it difficult for us to
penetrate the market and achieve significant sales of our products.
Our proposed products will compete directly against equipment produced by Fresenius Medical Care
AG, Baxter Healthcare Corporation, Gambro AB, and others, each of which markets one or more
FDA-cleared medical devices for the treatment of acute or chronic kidney failure.
Each of these competitors offers products that have been in use for a longer time than our products
and are more widely recognized by physicians, patients and providers. Most of our competitors have
significantly more financial and human resources, more established sales, service and customer
support infrastructures and spend more on product development and marketing than we do. Many of our
competitors also have established relationships with the providers of dialysis therapy. Most of
these companies manufacture additional complementary products enabling them to offer a bundle of
products and have established sales forces and distribution channels that may afford them a
significant competitive advantage.
The market for our products is competitive, subject to change and affected by new product
introductions and other market activities of industry participants, including increased
consolidation of ownership of clinics by large dialysis chains. If we are successful, our
competitors are likely to develop products that offer features and functionality similar to our
proposed products. Improvements in existing competitive products or the introduction of new
competitive products may make it more difficult for us to compete for sales, particularly if those
competitive products demonstrate better safety, convenience or effectiveness or are offered at
lower prices. If we are unable to compete effectively against existing and future competitors and
existing and future alternative treatments and pharmacological and technological advances, it will
be difficult for us to penetrate the market and achieve significant sales of our products.
We have not commissioned or obtained marketing studies which support the likelihood of success of
our business plan.
No independent studies with regard to the feasibility of our proposed business plan have been
conducted by any independent third parties with respect to our present and future business
prospects and our capital requirements. In addition, there can be no assurances that our products
or our treatment modality for ESRD will find sufficient acceptance in the marketplace to enable us
to fulfill our long and short term goals, even if adequate financing is available and our products
are approved to come to market, of which there can be no assurance.
Material weaknesses in our internal control over financial reporting may make it difficult to
accurately evaluate our results of operations and financial condition
In our amended quarterly report for the quarterly period ending September 30, 2006 and this annual
report, we are reporting material weaknesses in the effectiveness of our internal controls over
financial reporting related to the application of generally accepted accounting principles arising
from (a) our accounting for the transaction by which we ceased to be a shell corporation, (b) the
assumptions used in estimating the fair value of warrants issued to consultants, (c) our accounting
for research, development and other expenses incurred pursuant to the License
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Agreement, and (d) the calculation of the weighted average number of share outstanding. Despite our
substantial efforts to ensure the integrity of our financial reporting process, we cannot guarantee
that we will not identify additional weaknesses as we continue to work with the new systems that we
have implemented. Any continuing material weaknesses in our internal control over financial
reporting could result in errors in our financial statements, which could erode market confidence
in our company, and make it more difficult to raise needed additional funds, and adversely affect
the market price of our common stock, if such a market ever develops.
An unfavorable result in the pending arbitration could have a material adverse effect on our
business.
We consider the protection of our proprietary technology for treatment of kidney failure and
congestive heart failure to be critical to our business prospects. We obtained the rights to some
of our most significant patented and patent-pending technologies through a License Agreement with
National Quality Care, Inc. (NQCI). On December 1, 2006 we initiated arbitration against NQCI for
failure to fully perform its obligations under our License Agreement. NQCI has filed counterclaims
seeking to invalidate the License Agreement and claiming monetary damages against us. If NQCI were
to prevail on some or all of its claims, we could be prevented from using some or all of the
patented technology we licensed from it. That could significantly impact our ability to use and
develop our technologies, which would have a material adverse effect on our business and results of
operations.
Risks Related to Our Industry
Our business will always be strictly regulated by the federal and other governments, and we cannot
assure you that we will remain in compliance with all applicable regulation.
Clinical testing, manufacture, promotion and sale of our proposed products are subject to extensive
regulation by numerous governmental authorities in the U.S., principally the FDA, and corresponding
foreign regulatory agencies. Changes in existing regulations or adoption of new regulations or
policies could prevent us from obtaining, or affect the timing of, future regulatory approvals or
clearances. We cannot assure you that we will be able to obtain necessary regulatory clearances or
approvals on a timely basis, or at all, or that we will not be required to incur significant costs
in obtaining or maintaining such foreign regulatory approvals. Delays in receipt of, or failure to
receive, such approvals or clearances, the loss of previously obtained approvals or clearances or
the failure to comply with existing or future regulatory requirements could have a material adverse
effect on our business, financial condition and results of operations.
Any enforcement action by regulatory authorities with respect to past or future regulatory
noncompliance could have a material adverse effect on our business, financial condition and results
of operations. Noncompliance with applicable requirements can result in fines, injunctions, civil
penalties, recall or seizure of products, total or partial suspension of production, refusal to
authorize the marketing of new products or to allow us to enter into supply contracts and criminal
prosecution.
Even if our proposed products are approved for market, we will be subject to continuing regulation.
We will continuously be subject to routine inspection by the FDA and will have to comply with the
host of regulatory requirements that usually apply to medical devices marketed in the U.S.
including labeling regulations, GMP requirements, MDR regulation (which requires a manufacturer to
report to the FDA certain types of adverse events involving its products), and the FDAs
prohibitions against promoting products for unapproved or off-label uses. Our failure to comply
with applicable regulatory requirements could result in enforcement action by the FDA, which could
have a material adverse effect on our business, financial condition and results of operations.
In addition, failure to comply with applicable international regulatory requirements can result in
fines, injunctions, civil penalties, recalls or seizures of products, total or partial suspensions
of production, refusals by foreign governments to permit product sales and criminal prosecution.
Furthermore, changes in existing regulations or adoption of new regulations or policies could
prevent us from obtaining, or affect the timing of, future regulatory approvals or clearances.
There can be no assurance that we will be able to obtain necessary regulatory clearances or
approvals on a timely basis, or at all, or that we will not be required to incur significant costs
in obtaining or maintaining such foreign regulatory approvals. Delays in receipt of, or failure to
receive, such approvals or clearances, the loss of previously obtained approvals or clearances or
the failure to comply with existing or future regulatory requirements could have a material adverse
effect on our business, financial condition and results of
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operations. Any enforcement action by regulatory authorities with respect to past or future
regulatory noncompliance could have a material adverse effect on our business, financial condition
and results of operations.
Our failure to respond to rapid changes in technology and its applications and intense competition
in the medical devices industry could make our treatment system obsolete.
The medical devices industry is subject to rapid and substantial technological development and
product innovations. To be successful, we must respond to new developments in technology, new
applications of existing technology and new treatment methods. Our response may be stymied if we
require, but cannot secure, rights to essential third-party intellectual property. We may compete
against companies offering alternative treatment systems to ours, some of which have greater
financial, marketing and technical resources to utilize in pursuing technological development and
new treatment methods. Our financial condition and operating results could be adversely affected if
our medical device products fail to compete favorably with these technological developments, or if
we fail to be responsive on a timely and effective basis to competitors new devices, applications,
treatments or price strategies.
Product liability claims could adversely affect our results of operations
The risk of product liability claims, product recalls and associated adverse publicity is inherent
in the testing, manufacturing, marketing and sale of medical products. In an effort to minimize our
liability we purchase product liability insurance coverage. In the future we may not be able to
secure product liability insurance coverage on acceptable terms or at reasonable costs when needed.
Any liability for mandatory damages could exceed the amount of our coverage. A successful product
liability claim against us could require us to pay a substantial monetary award. Moreover, a
product recall could generate substantial negative publicity about our products and business and
inhibit or prevent commercialization of other future product candidates.
Risks Related to Our Common Stock
If a market for our common stock does not develop, our stockholders may be unable to sell their
shares.
There is currently no market for our common stock and we can provide no assurance that a market
will develop. If no market is ever developed for our shares, it will be difficult for stockholders
to sell their stock. In such a case, stockholders may find that they are unable to achieve benefits
from their investment.
If a market for our common stock develops, our stock price may be volatile.
If a market for our common stock develops, the price at which our common stock will trade may be
highly volatile and may fluctuate as a result of a number of factors, including the number of
shares available for sale in the market, quarterly variations in our operating results, actual or
anticipated announcements of new data, studies, products or services by us or competitors,
regulatory investigations or determinations, acquisitions or strategic alliances by us or our
competitors, recruitment or departures of key personnel, the gain or loss of significant customers,
changes in the estimates of our operating performance, market conditions in our industry and the
economy as a whole.
Approximately 68% of our stock is controlled by a single stockholder who has the ability to
substantially influence the election of directors and the outcome of matters submitted to
stockholders.
As of December 31, 2006, Consolidated National, LLC (CNL), a limited liability company whose
managing member is our Chairman, directly owned 9,600,000 shares, which represent 68% of our
14,200,050 shares of outstanding common stock as of April 9, 2007. As a result, CNL presently and
is expected to continue to have the ability to determine the outcome of issues submitted to our
stockholders. The interests of this stockholder may not always coincide with our interests or the
interests of other stockholders, and it may act in a manner that advances its best interests and
not necessarily those of other stockholders. One consequence to this substantial stockholders
interest is that it may be difficult for investors to remove management of the company. It could
also deter unsolicited takeovers, including transactions in which stockholders might otherwise
receive a premium for their shares over then current market prices.
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Investors interests in our company will be diluted and investors may suffer dilution in their net
book value per share if we issue additional shares or raise funds through the sale of equity
securities.
In the event that we are required to issue any additional shares or enter into private placements
to raise financing through the sale of equity securities, investors interests in our company will
be diluted and investors may suffer dilution in their net book value per share depending on the
price at which such securities are sold. If we issue any such additional shares, such issuances
also will cause a reduction in the proportionate ownership and voting power of all other
stockholders. Further, any such issuance may result in a change in our control.
We have never paid cash dividends and do not intend to do so.
We have never declared or paid cash dividends on our common stock. We currently plan to retain any
earnings to finance the growth of our business rather than to pay cash dividends. Payments of any
cash dividends in the future will depend on our financial condition, results of operations and
capital requirements, as well as other factors deemed relevant by our board of directors.
Security Ownership of Certain Beneficial Owners
Following consummation of the merger, Xcorporeals stockholders will hold approximately 97.4%
of our common stock and exercise control over us. The following table sets forth the securities
ownership of Xcorporeals directors, named executive officers, and any person or group who is known
to us to be the beneficial owner of more than five percent of Xcorporeals common stock as of
August 10, 2007:
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Amount and |
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nature of |
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beneficial |
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Percent of |
Name and address of beneficial owner (1) |
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ownership |
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class |
Terren S. Peizer (2)
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9,600,000 |
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68 |
% |
Marc G. Cummins (3)
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428,572 |
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3 |
% |
Jay A. Wolf (4)
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357,143 |
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3 |
% |
Nicholas S. Lewin (5)
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35,714 |
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* |
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Daniel S. Goldberger
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Victor Gura
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Hervé de Kergrohen
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Kelly J. McCrann |
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Hans-Dietrich Polaschegg |
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Robert Weinstein
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All directors and executive officers as a group (8 persons)
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10,421,429 |
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73 |
% |
* Less than one percent.
(1) Unless otherwise indicated, the address of all of the above named persons is c/o Xcorporeal,
Inc., 11150 Santa Monica Blvd., Suite 340, Los Angeles, California 90025.
(2) Includes 9,600,000 shares held of record by Consolidated National, LLC, of which Mr. Peizer
is the sole managing member and beneficial owner.
(3) Includes 428,572 shares held of record by Prime Logic Capital, LLC, CPS Opportunities, and
GPC LXI, LLC. Mr. Cummins is a Managing Partner of Prime Capital, LLC. He disclaims beneficial
ownership of the reported securities except to the extent of his pecuniary interest therein.
(4) Includes 357,143 shares held of record by Trinad Capital Master Fund Ltd. (the Master
Fund), that may be deemed to be beneficially owned by Trinad Management, LLC, the investment
manager of the Master Fund and Trinad Capital LP; a controlling stockholder of the Master Fund;
Trinad Advisors GP, LLC, the general partner of Trinad Capital LP; and Jay Wolf a director of the
issuer and a managing director of Trinad Management, LLC and a
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managing director of Trinad Advisors GP, LLC. Mr. Wolf disclaims beneficial ownership of the
reported securities except to the extent of his pecuniary interest therein.
(5) Includes 27,514 shares held of record by Paizon Capital, which is beneficially owned and
controlled by Mr. Lewins immediate family members. Mr. Lewin disclaims beneficial ownership of
these shares.
Unless otherwise indicated, we believe that all persons named in the table have sole voting
and investment power with respect to all shares of our common stock beneficially owned by them. A
person is deemed to be the beneficial owner of securities which may be acquired by such person
within 60 days from the date on which beneficial ownership is to be determined, upon the exercise
of options, warrants or convertible securities. Each beneficial owners percentage ownership is
determined by assuming that options, warrants and convertible securities that are held by such
person (but not those held by any other person) and which are exercisable, convertible or
exchangeable within such 60 day period, have been so exercised, converted or exchanged.
Officers and Directors
Upon effectiveness of the merger, the officers and directors of CT Holdings Enterprises, Inc.
will resign and be replaced by the current officers and directors of Xcorporeal.
Officers
Terren S. Peizer (age 47) serves as Executive Chairman of the Board, and has served as Chairman of
the Board of Directors since August 2006. From April 1999 to October 2003, Mr. Peizer served as
Chief Executive Officer of Clearant, Inc., which he founded to develop and commercialize a
universal pathogen inactivation technology. He served as Chairman of its board of directors from
April 1999 to October 2004 and a Director until February 2005. From February 1997 to February
1999, Mr. Peizer served as President and Vice Chairman of Hollis-Eden Pharmaceuticals, Inc. In
addition, from June 1999 through May 2003 he was a Director, and from June 1999 through December
2000 he was Chairman of the Board of supercomputer designer and builder Cray Inc. and remains its
largest beneficial stockholder. Mr. Peizer has been the largest beneficial stockholder and held
various senior executive positions with several technology and biotech companies. In these
capacities, he has assisted the companies with assembling management teams, boards of directors and
scientific advisory boards, formulating business and financial strategies, investor and public
relations, and capital formation. Mr. Peizer has been a Director, Chairman of the Board and Chief
Executive Officer of Hythiam, Inc., a healthcare services management company focused on delivering
solutions to those suffering from alcoholism and other substance dependencies, since September
2003. Mr. Peizer has a background in venture capital, investing, mergers and acquisitions,
corporate finance and previously held senior executive positions with the investment banking firms
Goldman Sachs, First Boston and Drexel Burnham Lambert. He received his B.S.E. in Finance from the
Wharton School of Finance and Commerce.
Winson
W. Tang (age 50) serves as Chief Operating Officer since August 2007. Dr. Tang is an
executive with over 20 years of experience in academic medicine, biomedical research and the
biopharmaceutical industry. Dr. Tang has held drug development positions of increasing
responsibility at Amgen, Vertex, Tularik, and Isis Pharmaceuticals. During his biopharmaceutical
career, he has successfully filed for Investigation New Drug Applications and Clinical Trial
Applications, two Biologic License Applications, in-licenses a preclinical drug candidate that is
now marketed (Sensipar®) and commercialized two drugs (Infergen® and Aranesp®). Both Infergen® and
Aranesp® are important therapies for patients with end stage renal disease. He was most recently
the Director of Research for the Pacific Capital Group, a private equity group where he managed the
biotech investment portfolio. Dr. Tang is a Diplomate of American Board of Internal Medicine and a
fellow of the American College of Physicians. He has published more than 30 original research
articles and book chapters. Dr. Tang is a graduate of The Albert Einstein College of Medicine and
completed a Residency in Internal Medicine at the University of Southern California, a Clinical
Fellowship in Nephrology at the University of California San Diego and a Research Fellowship in
Immunology at The Scripps Research Institute.
Robert
Weinstein (age 47) has served as Chief Financial Officer since August 2007. Prior to
joining us, Mr. Weinstein served as Vice President, Director of Quality Control & Compliance of
Citi Private Equity Services (formerly BISYS Private Equity Services), New York, NY, a worldwide private equity fund administrator
and accounting service provider. In 2005, Mr.
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Weinstein was the Founder, Finance & Accounting Consultant for EB Associates, LLC, Irvington, NY,
an entrepreneurial service organization. From 2003 to 2004, Mr. Weinstein served as the Chief
Financial Officer for Able Laboratories, Inc., Cranbury, NJ. In 2002, he served as Acting Chief
Financial Officer for Eurotech, Lid., Fairfax, VA, a distressed, publicly traded early-stage
technology transfer and development company. Mr. Weinstein received as M.B.A, Finance &
International Business from the University of Chicago, Graduate School of Business and a B.S. in
Accounting from the State University of New York at Albany. Mr. Weinstein is a Certified Public
Accountant (inactive) in the State of New York.
Directors
Marc G.
Cummins has served as a Director since November 2006. He is a Managing Partner of
Prime Capital, LLC, a private investment firm focused on consumer companies. Prior to founding
Prime Capital, Mr. Cummins was managing partner of Catterton Partners, a private equity investor in
consumer products and service companies with over $1 billion of assets under management. He has
served as a director of Hythiam, Inc. since 2004. Prior to joining Catterton in 1998, Mr. Cummins
spent fourteen years at Donaldson, Lufkin & Jenrette Securities Corporation where he was Managing
Director of the Consumer Products and Specialty Distribution Group, and was also involved in
leveraged buyouts, private equity and high yield financings. Mr. Cummins received a B.A. in
Economics, magna cum laude, from Middlebury College, where he was honored as a Middlebury College
Scholar and is a member of Phi Beta Kappa. He also received an M.B.A. in Finance with honors from
The Wharton School at University of Pennsylvania.
Daniel
S. Goldberger served as our President and Chief Operating Officer from October
2006 to August 10, 2007. Mr. Goldberger has been the Chief Executive Officer of Glucon Inc., a
privately held glucose monitoring business since 2004. From 2001 to 2004, Mr. Goldberger served as
President and as a Director of the Medical Group of OSI Systems, Inc. (NASDAQ: OSIS), which
included the Spacelabs, Dolphin, Osteometer product lines with combined revenue approaching $250
million. Mr. Goldberger was also the co-founder of Optiscan Biomedical Corporation, where he served
as Director from 1994 to 2001 and also served as its Vice President from 1994 to 1998 and then as
its President from 1998 to 2001. Mr. Goldberger has over 25 years of management experience with
large and small medical device companies, including Nellcor and Square One Technology. He received
his B.S.M.E. from Massachusetts Institute of Technology and his M.S.M.E. from Stanford University.
Victor Gura, M.D. has served as our Chief Medical and Scientific Officer in December 2006. Dr. Gura
has been a member of our board of directors since October 13, 2006. He served as Chief Scientific
Officer of National Quality Care, Inc. from 2005 to November 2006. He was formerly its Chairman of
the Board, President and Chief Executive Officer. Dr. Gura is board certified in internal
medicine/nephrology. He has been a director and principal shareholder of Medipace Medical Group,
Inc. in Los Angeles, California, since 1980. Dr. Gura has been an attending physician at
Cedars-Sinai Medical Center since 1984 and the medical director of Los Angeles Community Dialysis
since 1985. He also serves as a Clinical Assistant Professor at UCLA School of Medicine. He was a
fellow at the nephrology departments at Tel Aviv University Medical School and USC Medical Center.
Dr. Gura received his M.D. from School of Medicine, Buenos Aires University.
Hervé
de Kergrohen, M.D. has served as a Director since November 2006. Since August 2002,
he has been a Partner with CDC Enterprises Innovation in Paris, a European venture capital firm,
and since January 2001 has been Chairman of BioData, an international healthcare conference in
Geneva. He sits on several boards with U.S. and European private health care companies, including
Kuros BioSurgery and Bioring SA in Switzerland since January 2003, Praxim SA, Biomethode, and
Hythiam, Inc. since September 2003, and Clearant, Inc. since December 2001. From February 1999 to
December 2001 he was Head Analyst for Darier Hentsch & Co., then the third largest Geneva private
bank and manager of its CHF 700 million health care fund. From February 1997 to February 1998 he
was the Head Strategist for the international health care sector with UBS AGin Zurich. Dr. de
Kergrohen started his involvement with financial institutions in 1995 with Bellevue Asset
Management in Zug, Switzerland, the fund manager of BB Biotech and BB Medtech, where he covered the
healthcare services sector. He was previously Marketing Director with large U.S. pharmaceutical
companies such as Sandoz USA and G.D. Searle, specialized in managed care. Dr. de Kergrohen
received his M.D. from Université Louis Pasteur, Strasbourg, and holds an M.B.A. from Insead,
Fontainebleau.
-17-
Nicholas
S. Lewin has served as a Director since February 2007. He has been a private
investor since 2000 operating in both the public and private markets. Mr. Lewin has invested across
many industries, and throughout the capital structure. He invests in special situations and in
companies with innovative technologies and strong intellectual property. Generally, these are
activist situations working with management. Representative industries include biotechnology,
healthcare, telecom and media. Mr. Lewin sits on the boards of directors of VirnetX and Duramedic.
He holds a BA from Johns Hopkins University.
Kelly
J. McCrann was appointed as a Director on August 10, 2007. Mr. McCrann is a senior
healthcare executive with extensive experience in board governance, strategic leadership, profit
and loss management and strategic transactions. He was most recently Senior Vice President of
DaVita Inc., where he was responsible for all home based renal replacement therapies for the United
States second largest kidney dialysis provider. Prior to that, Mr. McCrann was the Chief
Executive Officer and President of PacifiCare Dental and Vision, Inc. Mr. McCrann has held
positions of increasing responsibility at Professional Dental Associates, Inc., Coram Healthcare
Corporation, HMSS, Inc. and American Medical International. He is a graduate of the Harvard
Business School and began his career as a consultant for KPMG and McKinsey & Company.
Jay A.
Wolf has served as a Director since November 2006. He has over a decade of
investment and operations experience in a broad range of industries. His investment experience
includes: senior and subordinated debt, private equity (including leveraged transactions), mergers
& acquisitions and public equity investments. Since 2003, Mr. Wolf has served as a Managing
Director of Trinad Capital. From 1999 to 2003, he served as the Executive Vice President of
Corporate Development for Wolf Group Integrated Communications Ltd. where he was responsible for
the companys acquisition program. From 1996 to 1999, Mr. Wolf worked at Canadian Corporate
Funding, Ltd., a Toronto-based merchant bank in the senior debt department and subsequently for
Trillium Growth, the firms venture capital Fund. He sits on the boards of Shells Seafood
Restaurants, Prolink Holdings Corporation, Optio Software, Inc. and Starvox Communications, Inc.
Mr. Wolf received a Bachelor of Arts from Dalhousie University.
Description of Real Estate
We currently lease approximately 3,000 square feet of office space located at 11150 Santa
Monica Blvd., Suite 340, Los Angeles, California 90025, for monthly rent of approximately $11,000
under a lease expiring February 2, 2008. We also lease approximately 600 square feet of laboratory
space located at Cedars-Sinai Medical Center, 8700 Beverly Blvd. Los Angeles, CA 90048 for monthly
rent of approximately $4,200 under a month-to-month lease. All of the space is in good condition
and we expect it to remain suitable to meet our needs for the foreseeable future. At December 31,
2006, in addition to the laboratory space described above, we occupied medical office space
subleased from a related party at $1,400 per month for a 4-month period at the end of 2006.
Investment Policies
We invest our cash in short term high grade commercial paper, certificates of deposit, money
market accounts and marketable securities. We consider any liquid investment with an original
maturity of three months or less when purchased to be cash equivalents. We will classify
investments with maturity dates greater than three months when purchased as marketable securities,
which have readily determined fair values and are classified as available-for-sale securities. Our
investment policy requires that all investments be investment grade quality and no more than ten
percent of our portfolio may be invested in any one security or with one institution. At December
31, 2006, all of Xcorporeals cash was held in money market accounts.
Legal Proceedings
On December 1, 2006, Xcorporeal initiated arbitration against National Quality Care, Inc.
(NQCI) for its failure to fully perform its obligations under our License Agreement. On December
29, 2006, NQCI filed suit against us in Los Angeles County Superior Court entitled National Quality
Care, Inc. v. Victor Gura, M.D., et al., Case No. BC364140. We do not believe there is any
reasonable likelihood that NQCI can prevail on its claims. On January 5, 2007, we filed a petition
to compel arbitration, and NQCI subsequently stipulated to resolve all claims in the pending
arbitration. On March 20, 2007, the lawsuit was dismissed without prejudice.
-18-
Managements Discussion and Analysis
Results of Operations for the three and six months ended June 30, 2007
Xcorporeal has not generated any revenues since inception. We incurred net loss of $2.8
million and $7.7 million for the three and six months ended June 30, 2007, compared to a net loss
of $5,587 and $11,790 for the three and six months ended June 30, 2006, respectively. The net loss
for the three and six months ended June 30, 2007 was primarily due to (i) research, development and
other expenses related to advancing our kidney and congestive heart failure treatment technologies,
(ii) stock compensation expense related to options and warrants granted to directors, officer,
employees and consultants, and (iii) legal and audit fees. The net loss for the three and six
months ended June 30, 2006 was a result of general and administrative expenses incurred for the
non-operating public shell entity. At June 30, 2007, we had positive working capital of $22.0
million compared to positive working capital of $25.4 million for beginning of the year.
Liquidity and Capital Resources
We expect to incur operating losses and negative cash flows for the foreseeable future. During
the fourth quarter of 2006 we raised approximately $27.3 million (net of placement fees of $2.1
million) through a private placement. Our ability to execute on our current business plan is
dependent upon our ability to develop and market our products, and, ultimately, to generate
revenue.
At June 30, 2007 we had cash, cash equivalents and marketable securities of approximately
$23,106,516. We are currently expending cash at a rate of approximately $0.9 million per month. At
present rates, we will not have to raise additional funds in the next twelve months.
Off-Balance Sheet Arrangements
As of June 30, 2007, we had no off-balance sheet arrangements that have or are reasonably
likely to have a current or future effect on our financial condition, results of operations or cash
flows.
Critical Accounting Policies and Estimates
The discussion and analysis of our financial condition and results of operations is based upon
our financial statements, which have been prepared in accordance with accounting principles
generally accepted in the United States. Generally accepted accounting principles require
management to make estimates, judgments and assumptions that affect the reported amounts of assets,
liabilities, revenues and expenses, and the disclosure of contingent assets and liabilities. We
base our estimates on experience and on various other assumptions that we believe to be reasonable
under the circumstances, the results of which form the basis for making judgments about the
carrying values of assets and liabilities that may not be readily apparent from other sources. Our
actual results may differ from those estimates.
We consider our critical accounting policies to be those that involve significant
uncertainties, require judgments or estimates that are more difficult for management to determine
or that may produce materially different results when using different assumptions. We consider the
following accounting policies to be critical:
Marketable Securities
We classify investments with maturity dates greater than three months when purchased as
marketable securities. Investments, including auction rate securities and certificates of deposit
with maturity dates greater than three months when purchased and which have readily determined fair
values are classified as available-for-sale investments and reflected in current assets as
marketable securities at fair market value. Auction rate securities are recorded at cost, which
equals fair market value, as the rate on such securities generally resets every 7, 28 or 35 days.
Our investment policy requires that all investments be investment grade quality and no more than
ten percent of our portfolio may be invested in any one security or with one institution.
Identifiable Intangibles
-19-
Certain costs associated with obtaining and licensing patents and trademarks are capitalized
as incurred and are amortized on a straight-line basis over the shorter of their estimated useful
lives or their legal lives of 17 to 20 years. Amortization of such costs begins once the patent or
trademark has been issued. We evaluate the recoverability of our patent costs and trademarks
quarterly based on estimated undiscounted future cash flows.
Stock-Based Compensation
Statements of Financial Accounting Standards (SFAS) No. 123 (revised 2004), Share-Based
Payment, (SFAS 123(R)) and Securities and Exchange Commission issued Staff Accounting Bulletin
(SAB) No. 107 (SAB 107) require the measurement and recognition of compensation expense for all
share-based payment awards made to employees and directors based on estimated fair values. We have
applied the provisions of SAB 107 in its adoption of SFAS 123(R).
-20-
Item 9.01 Financial Statements and Exhibits
(a) Financial statements of business acquired
Following is information obtained from the publicly-filed the financial statements of
Xcorporeal, Inc., the business to be acquired upon consummation of the merger described in Item
1.01 above.
PART I FINANCIAL INFORMATION
ITEM 1. Financial Statements
XCORPOREAL, INC.
(a Development Stage Company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2007 |
|
|
2006 |
|
|
|
(Unaudited) |
|
|
|
|
|
ASSETS |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
346,887 |
|
|
$ |
27,440,987 |
|
Marketable securities, at fair value |
|
|
22,676,578 |
|
|
|
|
|
Restricted cash |
|
|
83,050 |
|
|
|
|
|
Prepaids |
|
|
158,802 |
|
|
|
70,850 |
|
Other current assets |
|
|
12,066 |
|
|
|
19,378 |
|
|
|
|
|
|
|
|
Total current assets |
|
|
23,277,383 |
|
|
|
27,531,215 |
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
56,094 |
|
|
|
3,328 |
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
951 |
|
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets |
|
|
23,334,428 |
|
|
|
27,535,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
455,036 |
|
|
|
143,606 |
|
Accrued placement agent fees |
|
|
|
|
|
|
1,348,470 |
|
Accrued professional fees |
|
|
427,259 |
|
|
|
312,208 |
|
Accrued royalties |
|
|
208,333 |
|
|
|
83,333 |
|
Accrued other liabilities |
|
|
111,630 |
|
|
|
121,189 |
|
Other current liabilities |
|
|
115,400 |
|
|
|
124,676 |
|
|
|
|
|
|
|
|
Total Current Liabilities |
|
|
1,317,658 |
|
|
|
2,133,482 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY |
|
|
|
|
|
|
|
|
Preferred Stock, $0.001 par value, 10,000,000
shares authorized, none outstanding |
|
|
|
|
|
|
|
|
Common Stock, $0.0001 par value, 40,000,000
shares authorized, 14,200,050 outstanding on June
30, 2007 and December 31, 2006 |
|
|
1,420 |
|
|
|
1,420 |
|
Additional paid-in capital |
|
|
34,202,998 |
|
|
|
29,924,410 |
|
Deficit accumulated during the development stage |
|
|
(12,187,648 |
) |
|
|
(4,523,769 |
) |
|
|
|
|
|
|
|
Total Stockholders Equity |
|
|
22,016,770 |
|
|
|
25,402,061 |
|
|
|
|
|
|
|
|
Total Liabilities & Stockholders Equity |
|
$ |
23,334,428 |
|
|
$ |
27,535,543 |
|
|
|
|
|
|
|
|
See accompanying notes to the interim financial statements
-21-
XCORPOREAL, INC.
(a Development Stage Company)
STATEMENTS OF OPERATIONS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 4, 2001 (Date |
|
|
|
Three Months Ended |
|
|
Six Months Ended |
|
|
of Inception) to |
|
|
|
June 30, |
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and administrative |
|
$ |
1,611,188 |
|
|
$ |
5,587 |
|
|
$ |
5,590,288 |
|
|
$ |
11,790 |
|
|
$ |
8,908,940 |
|
Research and development |
|
|
1,482,037 |
|
|
|
|
|
|
|
2,688,134 |
|
|
|
|
|
|
|
3,975,456 |
|
Depreciation and amortization |
|
|
3,862 |
|
|
|
|
|
|
|
5,383 |
|
|
|
|
|
|
|
5,478 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before Other Income and Income Tax |
|
|
(3,097,087 |
) |
|
|
(5,587 |
) |
|
|
(8,283,805 |
) |
|
|
(11,790 |
) |
|
|
(12,889,874 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Income |
|
|
308,060 |
|
|
|
|
|
|
|
619,926 |
|
|
|
|
|
|
|
702,226 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(2,789,027 |
) |
|
|
(5,587 |
) |
|
|
(7,663,879 |
) |
|
|
(11,790 |
) |
|
|
(12,187,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(2,789,027 |
) |
|
$ |
(5,587 |
) |
|
$ |
(7,663,879 |
) |
|
$ |
(11,790 |
) |
|
$ |
(12,187,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
$ |
(0.20 |
) |
|
$ |
(0.00 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.00 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding |
|
|
14,200,050 |
|
|
|
3,820,000 |
|
|
|
14,200,050 |
|
|
|
3,820,000 |
|
|
|
|
|
See accompanying notes to the interim financial statements
-22-
XCORPOREAL, INC.
(a Development Stage Company)
STATEMENTS OF CASH FLOWS
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 4, 2001 (Date |
|
|
|
Six Months Ended |
|
|
of Inception) to |
|
|
|
June 30, |
|
|
June 30, |
|
|
|
2007 |
|
|
2006 |
|
|
2007 |
|
Cash flows used in operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the Period |
|
$ |
(7,663,879 |
) |
|
$ |
(11,790 |
) |
|
$ |
(12,187,648 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash used in
operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Non-employee Stock Based Compensation |
|
|
2,795,124 |
|
|
|
|
|
|
|
4,957,735 |
|
Stock Based Compensation |
|
|
1,483,464 |
|
|
|
|
|
|
|
1,747,715 |
|
Depreciation and amortization |
|
|
5,383 |
|
|
|
|
|
|
|
5,478 |
|
Net Change in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid Expenses |
|
|
(87,952 |
) |
|
|
|
|
|
|
(158,802 |
) |
Other Current Assets |
|
|
7,312 |
|
|
|
|
|
|
|
(12,066 |
) |
Other Assets |
|
|
|
|
|
|
|
|
|
|
(1,000 |
) |
Accounts Payable and Accrued Liabilities |
|
|
(806,548 |
) |
|
|
5,459 |
|
|
|
1,202,257 |
|
Other Current Liabilities |
|
|
(9,276 |
) |
|
|
|
|
|
|
115,400 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Operating Activities |
|
|
(4,276,372 |
) |
|
|
(6,331 |
) |
|
|
(4,330,931 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Capital Expenditures |
|
|
(58,100 |
) |
|
|
|
|
|
|
(61,523 |
) |
Restricted Cash |
|
|
(83,050 |
) |
|
|
|
|
|
|
(83,050 |
) |
Purchase of marketable securities |
|
|
(25,000,000 |
) |
|
|
|
|
|
|
(25,000,000 |
) |
Sale of marketable securities |
|
|
2,323,422 |
|
|
|
|
|
|
|
2,323,422 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Investing Activities |
|
|
(22,817,728 |
) |
|
|
|
|
|
|
(22,821,151 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Capital Stock issued |
|
|
|
|
|
|
|
|
|
|
27,434,349 |
|
Advances from related party |
|
|
|
|
|
|
6,590 |
|
|
|
64,620 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities |
|
|
|
|
|
|
6,590 |
|
|
|
27,498,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) in cash during the period |
|
|
(27,094,100 |
) |
|
|
259 |
|
|
|
346,887 |
|
Cash, beginning of the period |
|
|
27,440,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of the period |
|
$ |
346,887 |
|
|
$ |
259 |
|
|
$ |
346,887 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information; cash paid for: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the interim financial statements
-23-
XCORPOREAL, INC.
(a Development Stage Company)
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
For the Period May 4, 2001 (Inception) to June 30, 2007
(Unaudited)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
During |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Stage |
|
|
Total |
|
Common stock issued for cash at $0.01 per share |
|
|
2,500,000 |
|
|
$ |
250 |
|
|
$ |
24,750 |
|
|
|
|
|
|
$ |
25,000 |
|
Net Loss for the year ended December 31, 2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(40,255 |
) |
|
|
(40,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2001 |
|
|
2,500,000 |
|
|
|
250 |
|
|
|
24,750 |
|
|
|
(40,255 |
) |
|
|
(15,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash at $0.05 per share |
|
|
1,320,000 |
|
|
|
132 |
|
|
|
65,868 |
|
|
|
|
|
|
|
66,000 |
|
Net Loss for the year ended December 31, 2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,249 |
) |
|
|
(31,249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2002 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(71,504 |
) |
|
|
19,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31, 2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,962 |
) |
|
|
(12,962 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2003 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(84,466 |
) |
|
|
6,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31, 2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23,338 |
) |
|
|
(23,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2004 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(107,804 |
) |
|
|
(16,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31, 2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,753 |
) |
|
|
(35,753 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2005 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(143,557 |
) |
|
|
(52,557 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for a licence rights |
|
|
9,600,000 |
|
|
|
960 |
|
|
|
40 |
|
|
|
|
|
|
|
1,000 |
|
Capital stock cancelled |
|
|
(3,420,000 |
) |
|
|
(342 |
) |
|
|
342 |
|
|
|
|
|
|
|
|
|
Warrants granted for consulting fees |
|
|
|
|
|
|
|
|
|
|
2,162,611 |
|
|
|
|
|
|
|
2,162,611 |
|
Forgiveness of related party debt |
|
|
|
|
|
|
|
|
|
|
64,620 |
|
|
|
|
|
|
|
64,620 |
|
Common stock issued for cash at $7.00, net of
placement fees of $2,058,024 |
|
|
4,200,050 |
|
|
|
420 |
|
|
|
27,341,928 |
|
|
|
|
|
|
|
27,342,348 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
264,251 |
|
|
|
|
|
|
|
264,251 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,380,212 |
) |
|
|
(4,380,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2006 |
|
|
14,200,050 |
|
|
|
1,420 |
|
|
|
29,924,410 |
|
|
|
(4,523,769 |
) |
|
|
25,402,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrants granted for consulting services |
|
|
|
|
|
|
|
|
|
|
2,795,124 |
|
|
|
|
|
|
|
2,795,124 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
1,483,464 |
|
|
|
|
|
|
|
1,483,464 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(7,663,879 |
) |
|
|
(7,663,879 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of June 30, 2007 |
|
|
14,200,050 |
|
|
$ |
1,420 |
|
|
$ |
34,202,998 |
|
|
$ |
(12,187,648 |
) |
|
$ |
22,016,770 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the interim financial statements
-24-
XCORPOREAL,
INC.
(formerly Pacific Spirit Inc.)
(a Development Stage Company)
BALANCE SHEETS
|
|
|
|
|
|
|
|
|
|
|
Years ended |
|
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Cash |
|
$ |
27,440,987 |
|
|
$ |
|
|
Prepaids |
|
|
70,850 |
|
|
|
|
|
Other current assets |
|
|
19,378 |
|
|
|
|
|
|
|
|
|
|
|
|
Total current assets |
|
|
27,531,215 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Property and equipment, net |
|
|
3,328 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other assets |
|
|
1,000 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total Assets |
|
|
27,535,543 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES |
|
|
|
|
|
|
|
|
Current |
|
|
|
|
|
|
|
|
Accounts payable |
|
|
143,606 |
|
|
|
|
|
Accrued placement agent fees |
|
|
1,348,470 |
|
|
|
|
|
Accrued professional fees |
|
|
312,208 |
|
|
|
|
|
Accrued other liabilities |
|
|
204,522 |
|
|
|
18,330 |
|
Due to related party |
|
|
|
|
|
|
34,227 |
|
Other current liabilities |
|
|
124,676 |
|
|
|
|
|
|
|
|
|
|
|
|
Total Current Liabilities |
|
|
2,133,482 |
|
|
|
52,557 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Commitments and contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS EQUITY (DEFICIENCY) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred Stock, $0.001 par value, 10,000,000
shares authorized, none outstanding |
|
|
|
|
|
|
|
|
Common Stock, $0.0001 par value, 40,000,000
shares authorized, 14,200,050 and 3,820,000
outstanding on December 31, 2006 and 2005,
respectively |
|
|
1,420 |
|
|
|
382 |
|
Additional
paid-in capital |
|
|
29,924,410 |
|
|
|
90,618 |
|
Deficit accumulated during the development stage |
|
|
(4,523,769 |
) |
|
|
(143,557 |
) |
|
|
|
|
|
|
|
Total Stockholders Equity/(Deficiency) |
|
|
25,402,061 |
|
|
|
(52,557 |
) |
|
|
|
|
|
|
|
Total Liabilities & Stockholders Equity |
|
$ |
27,535,543 |
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
-25-
XCORPOREAL, INC.
(formerly Pacific Spirit Inc.)
(a Development Stage Company)
STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 4, 2001 (Date |
|
|
|
Years ended |
|
|
of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
Operating Expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Selling, general and
administrative |
|
$ |
3,174,995 |
|
|
$ |
35,753 |
|
|
$ |
3,318,652 |
|
Research and development |
|
|
1,287,322 |
|
|
|
|
|
|
|
1,287,322 |
|
Depreciation |
|
|
95 |
|
|
|
|
|
|
|
95 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before Other Income and Income
Tax |
|
|
(4,462,412 |
) |
|
|
(35,753 |
) |
|
|
(4,606,069 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest Income |
|
|
82,200 |
|
|
|
|
|
|
|
82,300 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss before income taxes |
|
|
(4,380,212 |
) |
|
|
(35,753 |
) |
|
|
(4,523,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss |
|
$ |
(4,380,212 |
) |
|
$ |
(35,753 |
) |
|
$ |
(4,523,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted loss per share |
|
$ |
(0.67 |
) |
|
$ |
(0.01 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares
outstanding |
|
|
6,542,312 |
|
|
|
3,820,000 |
|
|
|
|
|
See accompanying notes to the financial statements
-26-
XCORPOREAL, INC.
(formerly Pacific Spirit Inc.)
(a Development Stage Company)
STATEMENTS OF STOCKHOLDERS EQUITY (DEFICIENCY)
For the Period May 4, 2001 (Inception) to December 31, 2006
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deficit |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Accumulated |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Additional |
|
|
During |
|
|
|
|
|
|
Common Stock |
|
|
Paid-in |
|
|
Development |
|
|
|
|
|
|
Shares |
|
|
Amount |
|
|
Capital |
|
|
Stage |
|
|
Total |
|
Common stock issued for cash at $0.01 per
share |
|
|
2,500,000 |
|
|
$ |
250 |
|
|
$ |
24,750 |
|
|
|
|
|
|
$ |
25,000 |
|
Net Loss for the year ended December 31,
2001 |
|
|
|
|
|
|
|
|
|
|
|
|
|
$ |
(40,255 |
) |
|
|
(40,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2001 |
|
|
2,500,000 |
|
|
|
250 |
|
|
|
24,750 |
|
|
|
(40,255 |
) |
|
|
(15,255 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash at $0.05 per
share |
|
|
1,320,000 |
|
|
|
132 |
|
|
|
65,868 |
|
|
|
|
|
|
|
66,000 |
|
Net Loss for the year ended December 31,
2002 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(31,249 |
) |
|
|
(31,249 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2002 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(71,504 |
) |
|
|
19,496 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31,
2003 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(12,962 |
) |
|
|
(12,962 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2003 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(84,466 |
) |
|
|
6,534 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31,
2004 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(23,338 |
) |
|
|
(23,338 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2004 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(107,804 |
) |
|
|
(16,804 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the year ended December 31,
2005 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(35,753 |
) |
|
|
(35,753 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2005 |
|
|
3,820,000 |
|
|
|
382 |
|
|
|
90,618 |
|
|
|
(143,557 |
) |
|
|
(52,557 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for licence rights |
|
|
9,600,000 |
|
|
|
960 |
|
|
|
40 |
|
|
|
|
|
|
|
1,000 |
|
Capital stock cancelled |
|
|
(3,420,000 |
) |
|
|
(342 |
) |
|
|
342 |
|
|
|
|
|
|
|
|
|
Warrants granted for consulting fees |
|
|
|
|
|
|
|
|
|
|
2,162,611 |
|
|
|
|
|
|
|
2,162,611 |
|
Forgiveness of debt |
|
|
|
|
|
|
|
|
|
|
64,620 |
|
|
|
|
|
|
|
64,620 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Common stock issued for cash at $7.00, net
of placement fees of $2,058,024 |
|
|
4,200,050 |
|
|
|
420 |
|
|
|
27,341,928 |
|
|
|
|
|
|
|
27,342,348 |
|
Stock-based compensation expense |
|
|
|
|
|
|
|
|
|
|
264,251 |
|
|
|
|
|
|
|
264,251 |
|
Net loss for the period |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
(4,380,212 |
) |
|
|
(4,380,212 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance as of December 31, 2006 |
|
|
14,200,050 |
|
|
$ |
1,420 |
|
|
$ |
29,924,410 |
|
|
$ |
(4,523,769 |
) |
|
$ |
25,402,061 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
-27-
XCORPOREAL, INC.
(formerly Pacific Spirit Inc.)
(a Development Stage Company)
STATEMENTS OF CASH FLOWS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
May 4, 2001 (Date |
|
|
|
Years ended |
|
|
of Inception) to |
|
|
|
December 31, |
|
|
December 31, |
|
|
|
2006 |
|
|
2005 |
|
|
2006 |
|
Cash flows used in operating activities |
|
|
|
|
|
|
|
|
|
|
|
|
Net Loss for the Period |
|
$ |
(4,380,212 |
) |
|
$ |
(35,753 |
) |
|
$ |
(4,523,769 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Adjustments to reconcile net loss to net cash provided by
(used in) operating activities: |
|
|
|
|
|
|
|
|
|
|
|
|
Non-employee Stock Based Compensation |
|
|
2,162,611 |
|
|
|
|
|
|
|
2,162,611 |
|
Stock Based Compensation |
|
|
264,251 |
|
|
|
|
|
|
|
264,251 |
|
Depreciation |
|
|
95 |
|
|
|
|
|
|
|
95 |
|
Net Change in assets and liabilities: |
|
|
|
|
|
|
|
|
|
|
|
|
Prepaid Expenses |
|
|
(70,850 |
) |
|
|
800 |
|
|
|
(70,850 |
) |
Other Current Assets |
|
|
(19,378 |
) |
|
|
|
|
|
|
(19,378 |
) |
Other Assets |
|
|
(1,000 |
) |
|
|
|
|
|
|
(1,000 |
) |
Accounts Payable and Accrued Liabilities |
|
|
1,990,475 |
|
|
|
5,826 |
|
|
|
2,008,805 |
|
Other Current Liabilities |
|
|
124,676 |
|
|
|
|
|
|
|
124,676 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by (Used in) Operating Activities |
|
|
70,668 |
|
|
|
(29,127 |
) |
|
|
(54,559 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Investing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Capital Expenditures |
|
|
(3,423 |
) |
|
|
|
|
|
|
(3,423 |
) |
|
|
|
|
|
|
|
|
|
|
Net Cash Used in Investing Activities |
|
|
(3,423 |
) |
|
|
|
|
|
|
(3,423 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash Flows from Financing Activities |
|
|
|
|
|
|
|
|
|
|
|
|
Capital Stock issued in Private Placement for $29,400,351 in
cash; fees of $2,057,002 |
|
|
27,343,349 |
|
|
|
|
|
|
|
27,434,349 |
|
Advances from related party |
|
|
30,393 |
|
|
|
28,551 |
|
|
|
64,620 |
|
|
|
|
|
|
|
|
|
|
|
Net Cash Provided by Financing Activities |
|
|
27,373,742 |
|
|
|
28,551 |
|
|
|
27,498,969 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increase/(decrease) in cash during the period |
|
|
27,440,987 |
|
|
|
(576 |
) |
|
|
27,440,987 |
|
Cash, beginning of the period |
|
|
|
|
|
|
576 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cash, end of the period |
|
$ |
27,440,987 |
|
|
$ |
|
|
|
$ |
27,440,987 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supplemental disclosure of cash flow information; cash paid for: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
Income taxes |
|
$ |
|
|
|
$ |
|
|
|
$ |
|
|
|
|
|
|
|
|
|
|
|
|
See accompanying notes to the financial statements
-28-
XCORPOREAL, INC.
(A DEVELOPMENT STAGE COMPANY)
NOTES TO FINANCIAL STATEMENTS
DECEMBER 31, 2006
1. NATURE OF OPERATIONS
We were incorporated in the State of Nevada as Pacific Spirit Inc. on May 4, 2001 to engage in
the acquisition, exploration and development of natural resource properties. On August 31, 2006,
we changed our name to Xcorporeal, Inc. and thereafter acquired the rights to our Wearable
Artificial Kidney, congestive heart failure treatment products, and other medical devices. As a
result, we transitioned to a development stage company focused on researching, developing and
commercializing technology and products related to the treatment of kidney failure and congestive
heart failure.
On October 13, 2006, Xcorporeal, Inc., a Nevada corporation (Xcorporeal Nevada), consummated a
merger with and into its newly-formed, wholly-owned subsidiary, Xcorporeal Merger Corporation, a
Delaware corporation (Xcorporeal Delaware) for the purpose of changing the Companys domicile from
Nevada to Delaware. Each outstanding share of Xcorporeal Nevada common stock, par value $0.001 per
share, was automatically converted into one share of Xcorporeal Delaware common stock, par value
$0.0001 per share. The change in par value has been applied retroactively. As a result of the
reincorporation, the total number of common stock authorized changed from 100,000,000 shares to
40,000,000 common shares; the total number of preferred stock authorized remained at 10,000,000
shares, resulting in a total number of capital stock authorized of 50,000,000 shares.
The financial statements as of December 31, 2005, have been prepared using generally accepted
accounting principles in the United States of America applicable for a going concern which assumes
that the Company will realize its assets and discharge its liabilities in the ordinary course of
business. Realization values may be substantially different from carrying values as shown and these
financial statements do not give affect to adjustments that would be necessary to the carrying
values and classifications of assets and liabilities should the Company be unable to continue as a
going concern. The Company has a working capital deficiency of $52,557 and as at December 31, 2005,
has not yet attained profitable operations and has accumulated a deficit of $143,557 since
inception. Its ability to continue as a going concern is dependent upon the ability of the Company
to generate profitable operations in the future and/or to obtain the necessary financing to meet
its obligations and repay its liabilities arising from normal business operations when they come
due. These financial statements do not include any adjustments to the amounts and classification of
assets and liabilities that may be necessary should the Company be unable to continue as a going
concern. The Company anticipates that additional funding will be in the form of equity financing
from the sale of common shares. The Company may also seek to obtain short-term loans from the
directors of the Company. There are no current arrangements in place for equity funding or
short-term loans.
2. DEVELOPMENT STAGE COMPANY
We were previously a pre-exploration stage company as defined in the Statement of Financial
Accounting Standards (SFAS) No. 7 and the Securities and Exchange Act Guide No. 7. Effective with
the execution of the license agreement on August 31, 2006, we are a development stage company,
devoting substantially all of our efforts to the research, development and commercialization of
kidney and congestive heart failure treatment technologies.
Risks and Uncertainties We operate in an industry that is subject to intense competition,
government regulation and rapid technological change. Our operations are subject to significant
risk and uncertainties including financial, operational, technological, regulatory and other risks
associated with a development stage company, including the potential risk of business failure.
3. SUMMARY OF ACCOUNTING POLICIES
Cash and Cash Equivalents Cash equivalents are comprised of certain highly liquid
investments with original maturities of less than three months.
Property and Equipment Property and equipment are stated at cost less accumulated
depreciation and amortization, which are calculated using the straight-line method over the shorter
of the estimated useful lives of the related assets (generally ranging from three to five years),
or the remaining lease term when applicable. Gains and losses on disposals are included in results
of operations at amounts equal to the difference between the book value of the disposed assets and
the proceeds received upon disposal. There were no gains or losses on disposals from inception
through the end of 2006. Expenditures for replacements and leasehold improvements are capitalized,
while expenditures for maintenance and repairs are expensed as incurred.
Identifiable Intangibles and Amortization Costs associated with obtaining and licensing
patents and trademarks are capitalized as incurred and are amortized on a straight-line basis over
the shorter of their estimated useful lives or their legal lives of 17 to 20 years. Amortization
of such costs begins once the patent or trademark has been issued. We evaluate the recoverability
of our patent costs and trademarks quarterly based on estimated undiscounted future cash flows.
-29-
Research and Development Research and development is expensed as incurred. Upfront and
milestone payments made to third parties in connection with research and development collaborations
prior to regulatory approval are expensed as incurred. Payments made to third parties subsequent to
regulatory approval are capitalized and amortized over the shorter of the remaining license or
product patent life. At December 31, 2006, the Company had no such capitalized research and
development costs.
Income Taxes Under SFAS 109, Accounting for Income Taxes, deferred tax assets and
liabilities are recognized for the future tax consequences attributable to differences between the
consolidated financial statements and their respective tax basis. Deferred income taxes reflect
the net tax effects of (a) temporary differences between the carrying amounts of assets and
liabilities for financial reporting purposes and the amounts reported for income tax purposes, and
(b) tax credit carry-forwards. We record a valuation allowance for deferred tax assets when, based
on managements best estimate of taxable income in the foreseeable future, it is more likely than
not that some portion of the deferred income tax assets may not be realized.
Earnings per Share Under SFAS 128, Earnings per Share, basic earnings per share is
computed by dividing net income available to common stockholders by the weighted average number of
common shares assumed to be outstanding during the period of computation. Diluted earnings per
share reflect the potential dilution that could occur if securities or other contracts to issue
common stock were exercised or converted into common stock. As the Company had net losses for all
periods presented, basic and diluted loss per share are the same, as any additional common stock
equivalents would be anti-dilutive.
Share-Based Compensation Effective January 1, 2006, we adopted FASB Statement No. 123R,
Share-Based Payment (FAS 123R) (see Note 14). FAS 123R requires all share-based payments to
employees to be expensed over the requisite service period based on the grant-date fair value of
the awards and requires that the unvested portion of all outstanding awards upon adoption be
recognized using the same fair value and attribution methodologies previously determined under FASB
Statement No. 123, Accounting for Stock-Based Compensation. We continue to use the Black-Scholes
valuation method and applied the requirements of FAS 123R using the modified prospective method.
Prior to January 1, 2006, there was no share-based compensation expense.
Use of Estimates The consolidated financial statements are prepared in conformity with
accounting principles generally accepted in the United States (GAAP) and, accordingly, include
certain amounts that are based on managements best estimates and judgments. Estimates are used in
determining such items as provisions for sales discounts and returns, depreciable and amortizable
lives, recoverability of inventories produced in preparation for product launches, amounts recorded
for contingencies, environmental liabilities and other reserves, pension and other postretirement
benefit plan assumptions, share-based compensation, acquisitions and taxes on income. Because of
the uncertainty inherent in such estimates, actual results may differ from these estimates.
Reclassifications Certain reclassifications have been made to prior year amounts to conform
with the current year presentation.
Recently Issued Accounting Standards
In February 2007, the Financial Accounting Standards Board (FASB) issued Statement of
Financial Accounting Standards No. (SFAS) 159, The Fair Value Option for Financial Assets and
Financial Liabilities Including an Amendment of FASB Statement No. 115, Accounting for Certain
Investments in Debt and Equity Securities. SFAS No. 159 permits an entity to choose to measure
many financial instruments and certain items at fair value. The objective of this standard is to
improve financial reporting by providing entities with the opportunity to mitigate volatility in
reporting earnings caused by measuring related assets and liabilities differently without having to
apply complex hedge accounting provisions. SFAS No. 159 permits all entities to choose to measure
eligible items at fair value at specified election dates. Entities will report unrealized gains
and losses on items for which the fair value option has been elected in earnings at each subsequent
reporting date. The fair value option: (a) may be applied instrument by instrument, with a few
exceptions, such as investments accounted for by the equity method; (b) is irrevocable (unless a
new election date occurs); and (c) is applied only to entire instruments and not to portions of
instruments. SFAS No. 159 is effective as of the beginning of an entitys first fiscal year that
begins after November 15, 2007, which for us would be our fiscal year beginning January 1, 2008.
Early adoption is permitted as of the beginning of the previous fiscal year provided that the
entity makes that choice in the first 120 days of that fiscal year and also elects to apply to
provision of FASB Statement No. 157, Fair Value Measurements. We are
(b) Pro forma financial information
(d) Exhibits
|
|
|
2.1
|
|
Merger Agreement with Xcorporeal, Inc. |
3.1
|
|
Certificate of Ownership Merging XC Acquisition Corporation into Xcorporeal, Inc. |
3.2
|
|
Certificate of Amendment of Certificate of Incorporation of Xcorporeal, Inc. |
3.3
|
|
Amended and Restated Certificate of Incorporation of CT Holdings Enterprises, Inc. |
10.1
|
|
2007 Incentive Compensation Plan |
-30-
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly
caused this report to be signed on its behalf by the undersigned duly authorized.
|
|
|
|
|
|
CT HOLDINGS ENTERPRISES, INC.
|
|
Date: August 10, 2007 |
By: |
/s/ Steven B. Solomon
|
|
|
|
Steven B. Solomon |
|
|
|
President and Chief Executive Officer |
|
|
-31-