Filed Pursuant to Rule 424(b)(3)
Registration No. 333-130816
PROSPECTUS
BIO-BRIDGE SCIENCE, INC.
3,618,064 shares of Common Stock
This prospectus covers the resale of an aggregate 3,618,064 shares of common
stock, par value $0.001, by selling stockholders named on page 15. Of these
shares, up to 2,000,000 are being offered hereby by Dutchess Private Equities
Fund, LP, a selling stockholder under this prospectus. Up to 1,618,064 shares of
our common stock are being offered by other selling stockholders.
These securities will be offered for sale by the selling stockholders identified
in this prospectus in accordance with the methods and terms described in the
section of this prospectus entitled "Plan of Distribution." The selling
stockholders will sell the shares at prices determined by the prevailing market
prices for the shares or in privately negotiated transactions.
We will not receive any of the proceeds from the sale of these shares. We will
pay all expenses, except for the brokerage expenses, fees, discounts and
commissions, which will all be paid by the selling stockholders, incurred in
connection with the offering described in this prospectus. Our common stock is
more fully described in the section of this prospectus entitled "Description of
Securities."
Our common stock is quoted on the Nasdaq OTC Bulletin Board under the symbol
"BGES.OB." On December 27, 2005, the last reported sale price for our common
stock as reported on the Nasdaq OTC Bulletin Board was $1.95 per share.
AN INVESTMENT IN OUR COMMON STOCK INVOLVES A HIGH DEGREE OF RISK. SEE "RISK
FACTORS" BEGINNING AT PAGE 6.
Dutchess Private Equities Fund, LP, a selling stockholder is an "underwriter"
within the meaning of the Securities Act of 1933, as amended, with respect to
the shares being offered hereby that it shall purchase from us under the
investment agreement. Selling stockholders may be deemed an "underwriter" within
the meaning of the Securities Act of 1933, as amended with respect to all other
shares being offered hereby.
NEITHER THE SECURITIES AND EXCHANGE COMMISSION NOR ANY STATE SECURITIES
COMMISSION HAS APPROVED OR DISAPPROVED THESE SECURITIES OR PASSED UPON THE
ADEQUACY OR ACCURACY OF THIS PROSPECTUS. ANY REPRESENTATION TO THE CONTRARY IS A
CRIMINAL OFFENSE.
The date of this prospectus is January 11, 2006
TABLE OF CONTENTS
Prospectus Summary........................................................... 3
Risk Factors................................................................. 6
Special Note Regarding Forward-Looking Statements............................ 14
Use of Proceeds.............................................................. 15
Selling Stockholders ........................................................ 15
Plan of Distribution......................................................... 18
Legal Proceedings............................................................ 19
Directors, Executive Officers, Promoters and Control Persons................. 19
Security Ownership of Certain Beneficial Owners and Management............... 21
Description of Securities ................................................... 21
Legal Matters................................................................ 22
Experts...................................................................... 22
Disclosure of Commission Position of Indemnification for Securities
Act Liabilities ............................................................. 22
Description of Business...................................................... 23
Management Discussion and Analysis........................................... 31
Description of Property...................................................... 35
Certain Relationships and Related Transactions............................... 35
Market For Common Equity and Related Stockholder Matters..................... 36
Executive Compensation....................................................... 38
Financial Statements ........................................................ 39
Where You Can Find More Information.......................................... 40
i
PROSPECTUS SUMMARY
This summary highlights information contained elsewhere in this prospectus. It
is not complete and does not contain all of the information that you should
consider before investing in our common stock. You should read the entire
prospectus carefully, including the section entitled "Risk Factors" and our
consolidated financial statements and the related notes. In this prospectus, we
refer to Bio-Bridge Science, Inc. and our wholly owned subsidiaries, including
Bio-Bridge Science (Beijing) Co. Ltd., a Wholly-Foreign Funded Enterprise of the
People's Republic of China ("Bio-Bridge (Beijing)") and Bio-Bridge Science
Corporation, a Cayman Islands corporation as "we," "us," "our," "Bio-Bridge" and
"the company."
OUR COMPANY
Bio-Bridge Science, Inc. is a development stage company whose subsidiaries are
focused on the commercial development of biological products for the prevention
and treatment of human infectious diseases. Our subsidiary located in Beijing,
China, Bio-Bridge Science (Beijing) Co. Ltd., has commenced pre-clinical testing
of our HIV-PV Vaccine I product on laboratory animals through an agreement with
Beijing Institute of Radiation Medicine, a leading research institute for
biological products in China. Most of the pre-clinical studies was completed in
October 2005. HIV-PV Vaccine I is a vaccine designed to prevent and treat
infection by the human immunodeficiency virus, or HIV. The original HIV-PV
Vaccine I technology was co-developed by our chief executive officer Dr. Liang
Qiao, an associate professor at Loyola University Chicago, and is owned by
Loyola University. In June 2002, Loyola University exclusively licensed this
technology to us with respect to China (including mainland China, Taiwan, Hong
Kong and Macau), Japan and the United States.
Our primary strategy is to develop, test and obtain regulatory approval for
HIV-PV Vaccine I in China first and then in the United States and Japan. Once
the pre-clinical testing is completed, we plan to apply to China's State Food
and Drug Administration for approval to conduct clinical trials of HIV-PV
Vaccine I. In May 2003, we acquired the right to use for fifty years
approximately 2.8 acres of land in the Tianzhu Export Processing Zone, Shunyi
District, Beijing, China, which we plan to develop into a laboratory and
biomanufacturing facility in compliance with Good Manufacturing Practices, or
GMP, regulations primarily for clinical trials of HIV-PV Vaccine I. We may also
provide outsource services to U.S. and Europe based pharmaceutical companies
once this research laboratory is completed. Under Chinese law, there is no
private ownership of land, and accordingly, we do not own this land. As of
September 30, 2005, we have received all necessary permits and approvals and
construction of the outside body of the facility has been completed. The cost of
building and outfitting this facility is approximately $3,000,000, of which
approximately $2,600,000 remains to be funded as of September 30, 2005. We
currently have no commitments to make payments for this construction project.
The construction and istallation of equipment related to the facility will be
substantially completed by April 2006.
We believe that the principal obstacles remaining before our HIV-PV Vaccine I
can be brought to market include the following:
o Our ability to raise additional capital needed to complete product development
and complete construction of a GMP facility in China, which we estimate will be
$10 million to bring the vaccine to market for therapeutic use and an additional
$6 million to bring the vaccine to market to prevent HIV infection;
o The possibility that pre-clinical animal studies or clinical studies on humans
fail to prove the safety and efficacy of the vaccine, or that any demonstrated
efficacy will be so limited as to significantly reduce or altogether eliminate
the acceptability of the vaccine in the marketplace;
o The possibility that the costs of development, which can far exceed the best
of estimates, may render commercialization of the vaccine marginally profitable
or altogether unprofitable; and
o The possibility that the amount of time required for SFDA approval of a drug
may extend for years beyond that which is originally estimated by the Green Mile
policy.
We expect our therapeutic HIV-PV Vaccine I will be available in 2008, and our
preventative HIV-PV Vaccine I will be available in approximately 2011 in China.
On November 21, 2005, we entered into an exclusive agency agreement with Xinhua
Surgical Instruments Co., Ltd., located in Shandong, China. Under this
agreement, we have been granted exclusive distribution rights for all Xinhua
surgical instruments in the United States, which are subject to FDA approval. On
December 6, 2005, we received confirmation from the FDA of our registration as a
medical device establishment which enables us to perform initial distributor and
repackager operations. This does not mean that we have received FDA approval of
any product or activity. We intend to market Xinhua surgical instruments that
meet the criteria for Class I medical devices and FDA rules, which do not
require pre-market notification to the FDA, mainly through existing distributors
in the U.S. Class I medical devices are typically simple in design, manufacture
and have a history of safe use. Examples of Class I medical devices include
tongue depressors, arm-slings and hand-held surgical instruments.
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Our business was founded in February 2002. Our wholly owned subsidiary
Bio-Bridge Science Corporation was incorporated in the Cayman Islands on
February 11, 2002, and its wholly owned subsidiary, Bio-Bridge Science (Beijing)
Co. Ltd., was established in the People's Republic of China on May 20, 2002. An
operating license was issued to Bio-Bridge Science (Beijing) on May 20, 2002 for
a term of 25 years which can be renewed for another 25 years for a nominal fee.
Bio-Bridge Science, Inc., the holding company of these subsidiaries, was
incorporated in Delaware on October 26, 2004. The address of our principal
executive offices in the U.S. is 1211 West 22nd Street, Suite 615, Oak Brook,
Illinois where our telephone number is 630-928-0869. Our China office is located
at Tianzhu Export Processing Zone, Shunyi District Beijing, China 101312. Our
website is www.bio-bridge-science.com. Information contained on our website does
not constitute part of this prospectus.
THE OFFERING
This prospectus relates to the sale of up to 3,618,064 shares of our common
stock by the selling stockholders identified in the section of this prospectus
entitled "Selling Stockholders." Of these shares, up to 2,000,000 are being
offered hereby by Dutchess Private Equities Fund, LP, a selling stockholder
under this prospectus. Up to 1,618,064 shares of our common stock are being
offered by other selling stockholders.
On November 29, 2005, we entered into an Investment Agreement with Dutchess
Private Equities Fund, LP, a Delaware limited partnership. Under the terms of
the agreement, Dutchess has agreed to purchase from us up to $10,000,000 of our
common stock over a 24-month period. After a registration statement covering the
resale of up to 2,000,000 shares of our common stock is declared effective, we
have the right to deliver a put notice and sell to Dutchess (i) $100,000 of our
common stock or (ii) 200% of the average daily volume of our common stock for
the 10 trading days prior to the put notice date, multiplied by the average of
three daily closing bid prices immediately preceding the put date. The purchase
price per share identified in each put notice will be equal to 95% of the lowest
closing best bid price of the Company's common stock during five trading days
after the applicable put notice date. Pursuant to the terms of the agreement, we
have the right to control the timing and amount of stock sold to Dutchess. We
are not entitled to submit a put notice until after the closing of the previous
put notice. Pursuant to the agreement, upon receipt of a put notice, Dutchess
will be required to purchase from us during the applicable pricing period a
number of shares having an aggregate purchase price equal to the lesser of (i)
the put amount identified in the put notice, and (ii) 20% of the aggregate
trading volume of our common stock during the pricing period multiplied by the
lowest closing bid price during the applicable pricing period. In addition, the
agreement requires us to pay a registered broker dealer 2.5% of the put amount
on each draw toward the placement agent fee up to a total cumulative amount of
$10,000. The agreement terminates upon the earlier to occur of the following
events: (i) when Dutchess has purchased an aggregate $10,000,000 in our common
stock, or an aggregate of 2,000,000 shares of our common stock; and (ii) on the
date which is 24 months after the effective date of the registration statement.
Dutchess Private Equities Fund, a selling stockholder under this prospectus, is
offering for sale up to 2,000,000 shares of our common stock that it may in the
future acquire from us pursuant to the investment agreement. Certain other
selling stockholders under this prospectus are offering up to 1,618,064 shares
of our common stock, which consist of:
o 8,116 shares of common stock issued on November 2, 2005 as finder's fees for
our previous private placement; and
o 1,609,948 shares of common stock, 1,494,948 of which were issued pursuant to
Regulation S and 115,000 shares of which were issued pursuant to Section 4(2) of
the Securities Act of 1933, as amended, in September 2005.
As of November 1, 2005, there were 32,471,537 shares of common stock
outstanding, which does not include:
o 1,192,663 shares of common stock to be issued upon exercise of options
outstanding outside of the 2004 Stock Incentive Plan;
o 1,965,000 shares of common stock to be issued upon exercise of options
outstanding under our 2004 Stock Incentive Plan;
o 35,000 shares of common stock reserved under our 2004 Stock
Incentive Plan; and
o 2,000,000 shares of common stock issuable pursuant to the investment agreement
with Dutchess Private Equities Fund.
o 8,116 shares issued on November 2, 2005.
The number of shares offered by this prospectus represents approximately 11% of
the total common stock outstanding as of November 1, 2005. The number of shares
ultimately offered for sale by Dutchess Private Equities Fund is dependent upon
the number of shares purchased by Dutchess Private Equities Fund under the
investment agreement.
Information regarding the selling stockholders, the common shares they are
offering to sell under this prospectus, and the times and manner in which they
may offer and sell those shares is provided in the sections of this prospectus
entitled "Selling Stockholders" and "Plan of Distribution." We will not receive
any of the proceeds from these sales. The registration of common shares pursuant
to this prospectus does not necessarily mean that any of those shares will
ultimately be offered or sold by the selling stockholders.
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SUMMARY FINANCIAL DATA
The following historical consolidated financial information is that of
Bio-Bridge Science, Inc., a development stage company, and should be read in
conjunction with the consolidated financial statements and the notes to those
statements and the section entitled "Management's Discussion and Analysis"
included elsewhere in this prospectus.
Nine Months
Ended September 30 Year Ended Year Ended
2005 2004 December 31, 2004 December 31, 2003
------------- ------------ ----------------- -----------------
(unaudited) (unaudited)
CONSOLIDATED STATEMENTS OF
OPERATIONS DATA:
Revenues, net $ -- $ -- $ -- $ --
General and administrative
expenses $ (706,671) $ (394,677) $ (833,642) $ (255,814)
Research and development
expenses $ (60,649) $ (42,300) $ (109,835) $ (30,739)
Comprehensive Loss $ (740,460) $ (436,903) $ (944,894) $ (255,664)
Basic and diluted loss per
share $ (0.02) $ (0.02) $ (.03) $ (.01)
Weighted-average common
shares outstanding 30,704,441 28,386,684 28,785,388 23,419,575
CONSOLIDATED BALANCE SHEET DATA: As of September 30, 2005
Cash and cash equivalents $ 1,054,130
Working capital $ 947,561
Total assets $ 2,077,472
Total shareholders' equity $ 1,922,507
Total liabilities and
shareholders' equity $ 2,077,472
We have incurred significant losses since inception, and we are not profitable.
As of September 30, 2005, we had an accumulated deficit of $2,076,883. We expect
to continue to incur substantial losses over at least the next year as we
complete our pre-clinical trials on laboratory animals, apply for regulatory
approvals of clinical trials, complete outfitting of our laboratory and
manufacturing facility and continue development of our technology. We do not
expect to generate significant revenue in the next twelve months. Based on our
current operating plan, we believe that we have sufficient cash and cash
equivalents to continue our operations through approximately July 2006. See
"Plan of Operation." Our independent auditors have added an explanatory
paragraph to their report of our consolidated financial statements for the year
ended December 31, 2004 stating that our net losses, lack of revenues and
dependence on our ability to raise additional capital to continue our existence,
raise substantial doubt about our ability to continue as a going concern. Our
future liquidity is dependent upon our ability to raise additional capital. If
we are not successful in raising sufficient additional capital, we may be forced
to reduce operating costs and postpone completion of our laboratory and
manufacturing facility. Development of our vaccine would likely be adversely
affected or suspended altogether from such cost reductions, and we may be forced
to cease our business.
5
RISK FACTORS
You should carefully consider the risks described below before making an
investment decision. Our business could be harmed by any of these risks. The
trading price of our common stock could decline due to any of these risks, and
you may lose all or part of your investment. In assessing these risks, you
should also refer to the other information contained in this prospectus,
including our financial statements and related notes.
RISKS RELATED TO OUR BUSINESS AND THIS OFFERING
WE HAVE A HISTORY OF LOSSES AND AN ACCUMULATED DEFICIT OF $2,076,883 AS OF
SEPTEMBER 30, 2005, AND WE MAY NEVER ACHIEVE PROFITABILITY.
We have yet to establish any history of profitable operations. We are a
development stage company and have not had any revenues since our inception in
February 2002. We have incurred net losses of $944,437 in 2004 and $255,020 in
2003. As of September 30, 2005, we had an accumulated deficit of $2,076,883.
These losses have resulted principally from research and development and general
and administrative expenses. To date, we have engaged primarily in research,
development and pre-clinical testing on laboratory animals. We anticipate that
we will continue to incur substantial operating losses based on projected
research and development and other operating costs for an indefinite period of
time due to the significant costs associated with the development of our
products. Our profitability will require the successful development and
commercialization of our HIV-PV Vaccine I. We may not be able to successfully
develop and commercialize our HIV-PV Vaccine I and generate enough revenue to
achieve profitability.
WE HAVE RECEIVED AN OPINION OF GOING CONCERN FROM OUR AUDITORS. IF WE DO NOT
RECEIVE ADDITIONAL FUNDING, WE WOULD HAVE TO CURTAIL OR CEASE OPERATIONS.
Our independent auditors noted in their report accompanying our financial
statements for each of the years ended December 31, 2004 and December 31, 2003
that we have incurred losses and generated no revenues since inception and that
additional capital will be necessary for the continuation of our existence. They
further stated that the uncertainty related to these conditions raised
substantial doubt about our ability to continue as a going concern. Our
resources as of the end of September 30, 2005 are sufficient to fund operations
through July 2006. We do not currently have sufficient capital resources to
fund the completion of our pre-clinical testing, construction of our laboratory
and manufacturing facility and application for clinical testing. Therefore, we
need additional funds to support the necessary development programs required to
develop, test and obtain regulatory approval of our HIV-PV Vaccine I and other
product candidates and to operate beyond August 2006. To date, we have funded
our operations through equity offerings whereby we raised an aggregate
$3,340,006. It is highly likely that we will continue to raise money through
public or private sales of our securities, debt financing or short-term bank
loans, or a combination of the foregoing.
The extent we rely on Dutchess Private Equities Fund as a source of funding will
depend on a number of factors including, the prevailing market price of our
common stock and the extent to which we are able to secure working capital from
other sources, such as through commercialization of our products. If obtaining
sufficient funding from Dutchess Private Equities Fund were to prove
prohibitively expensive and if we are unable to commercialize and sell our
products and our working capital needs, we will need to secure another source of
funding in order to satisfy our working capital needs. Even if we are able to
access the full $10 million under the investment agreement with Dutchess, we may
still need additional capital to fully implement our business, operating and
development plans. However, additional funding may not be available on favorable
terms to us, or at all. To the extent that money is raised through the sale of
our securities, the issuance of those securities could result in dilution to our
existing shareholders. If we raise money through debt financing or bank loans,
we may be required to secure the financing with all of our business assets,
which could be sold or retained by the creditor should we default in our payment
obligations. If we fail to raise sufficient funds, we would have to curtail or
cease operations.
AS A COMPANY IN THE EARLY STAGE OF DEVELOPMENT WITH AN UNPROVEN BUSINESS
STRATEGY, OUR LIMITED HISTORY OF OPERATIONS MAKES EVALUATION OF OUR BUSINESS AND
FUTURE PROSPECTS DIFFICULT.
We have had a limited operating history and are at an early stage of
development. Since our business was founded in February 2002, our activities
have primarily consisted of securing intellectual rights to our proprietary
technology and undertaking pre-clinical trials of HIV-PV Vaccine I. We have not
yet demonstrated any ability to commercialize HIV-PV Vaccine I. As a result of
these factors, it is difficult to evaluate our prospects, and our future success
is more uncertain than if we had a longer or more proven history of operations.
OUR INTELLECTUAL PROPERTY RIGHTS MAY NOT PROVIDE MEANINGFUL PROTECTION FOR OUR
PRODUCTS UNDER DEVELOPMENT, WHICH COULD ENABLE THIRD PARTIES TO USE OUR
TECHNOLOGY, OR VERY SIMILAR TECHNOLOGY, AND COULD PREVENT US FROM DEVELOPING OR
MARKETING OUR PRODUCT CANDIDATES.
We rely on patent and trade secret laws to limit the ability of others to
compete with us using the same or similar technology in the U.S. and other
countries. However, as described below, these laws afford only limited
protection and may not adequately protect our rights to the extent necessary to
sustain any competitive advantage we may have. The laws of some foreign
countries do not protect proprietary rights to the same extent as the laws of
the U.S., and many companies have encountered significant problems in protecting
their proprietary rights abroad. These problems can be caused by the absence of
adequate rules and methods for defending and enforcing intellectual property
rights.
6
We will be able to protect our technology from unauthorized use by third parties
only to the extent that they are covered by valid and enforceable patents or are
effectively maintained as trade secrets. The patent positions of companies
developing drugs for pharmaceutical, biotechnology and biomedical industries,
including our patent position, generally are uncertain and involve complex legal
and factual questions, particularly as to questions concerning the
enforceability of such patents against alleged infringement. The biotechnology
patent situation outside the U.S. is even more uncertain. Changes in either the
patent laws or in interpretations of patent laws in the U.S. and other countries
may therefore diminish the value of our intellectual property. Moreover, our
patent and patent applications may not be sufficiently broad to prevent others
from practicing our technologies or from developing competing products. We also
face the risk that others may independently develop similar or alternative
technologies or design around our patented technologies.
We control through a license with Loyola University of Chicago an issued patent
and pending patent applications. However, the patent on which we rely may be
challenged and invalidated, and the patent applications may not result in issued
patents. The patent that we have licensed from Loyola covering our technology
was issued by the U.S. Patent and Trademark Office on April 12, 2005 and has a
term of 20 years from the date of filing. This patent will not expire until
2022. We recently have filed a continuation application of this issued patent
with the Patent and Trademark Office to seek broader protection on our
technology than the protection provided by the original patent.
We have taken measures to protect our proprietary information. These measures,
however, may not provide adequate protection of our trade secrets or other
proprietary information. We seek to protect our proprietary information by
entering into confidentiality agreements with employees, collaborators and
consultants. Nonetheless, employees, collaborators or consultants may still
disclose our proprietary information, and we may not be able to protect our
trade secrets in a meaningful way. If we lose employees, we may not be able to
prevent the disclosure or use of our technical knowledge or other trade secrets
by those former employees despite the existence of nondisclosure and
confidentiality agreements and other contractual restrictions to protect our
proprietary technology. In addition, others may independently develop
substantially equivalent proprietary information or techniques or otherwise gain
access to our trade secrets.
OUR RIGHTS TO THE USE OF TECHNOLOGY LICENSED TO US BY A THIRD PARTY ARE NOT
WITHIN OUR CONTROL, AND WITHOUT THIS TECHNOLOGY, OUR PRODUCTS UNDER DEVELOPMENT
MAY NOT BE SUCCESSFUL AND OUR BUSINESS PROSPECTS COULD BE HARMED.
We rely on a license to use technologies that are material to our business. We
do not own the patents that underlie this license. Our rights to use these
technologies and employ the inventions claimed in the licensed patents are
subject to the continuation of and compliance with the terms of that license and
the continued validity of these patents. Our license from Loyola University
Chicago provides us with exclusive rights within the United States, Japan and
China, including the right to enforce the patents licensed to us from this
university, but the scope of our rights under this license may become subject to
dispute by our licensor or third parties. This license contains due diligence
obligations, as well as provisions that allow the licensor to terminate the
license upon specific conditions.
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IF WE ARE UNABLE TO COMMERCIALIZE OUR PRODUCT CANDIDATE, WE WILL NOT HAVE
REVENUES TO CONTINUE OPERATIONS.
HIV-PV Vaccine I is our sole product candidate. We do not know whether the
HIV-PV Vaccine I will be effective in preventing or treating HIV infection.
Although our research has indicated that the HIV-PV Vaccine I technology
contains a pseudovirus that induces both mucosal and systemic neutralizing
antibodies and cytotoxic T-cell responses that may be used to prevent and treat
HIV infection, other elements may be necessary to develop an effective vaccine.
Our success will depend primarily on the success of HIV-PV Vaccine I. In
particular, we must be able to:
o complete pre-clinical trials on laboratory animals and obtain regulatory
approvals to proceed with clinical trials of HIV-PV Vaccine I;
o establish the safety, purity, potency and efficacy of HIV-PV Vaccine I in
humans;
o obtain regulatory approvals for HIV-PV Vaccine I; and
o successfully commercialize HIV-PV Vaccine I.
If we are unable to commercialize HIV-PV Vaccine I, we do not have other
products from which to derive revenues.
WE MAY NOT BE ABLE TO OBTAIN REGULATORY APPROVAL TO MARKET OUR PRODUCT
CANDIDATES IN CHINA, THE UNITED STATES OR JAPAN ON A TIMELY BASIS, OR AT ALL, TO
COMMERCIALIZE OUR PRODUCT CANDIDATES.
Clinical testing is a long, expensive and uncertain process. If the Chinese
government approves our application for clinical testing, we cannot assure you
that the data collected from our clinical trials will be sufficient to support
approval of HIV-PV Vaccine I by the SFDA or regulatory authorities in Japan and
the United States, that the clinical trials will be completed on schedule or,
even if the clinical trials are successfully completed and on schedule, that the
SFDA or other regulatory authorities in the United States or Japan will
ultimately approve HIV-PV Vaccine I for commercial sale.
To gain SFDA regulatory approval for the sale of HIV PV Vaccine I in China, we
believe, based on SFDA's Green Mile policy, that we will need to complete the
following five steps:
o pre-clinical laboratory and animal testing;
o the submission to the SFDA of an application for approval of clinical study,
which must be effective before clinical trials may commence;
o adequate Phase I, II and III clinical studies to establish the safety, purity
and potency of the product candidate and demonstrate how it behaves in the human
body;
o obtain Drug Production Quality Control Procedure or GMP certification;
o the submission of an application to the SFDA for Drug Registration Document,
and obtain new drug approval certificate; and
o sales for pre-production drugs in the market and phase IV clinical study.
We estimate that the total drug approval process in China may take approximately
three years for therapeutic vaccine and five to seven years for preventative
vaccine. However, the SFDA has substantial discretion in the drug approval
process and may require us to conduct additional pre-clinical and clinical
testing or to perform post-marketing studies. The approval process may also be
delayed due to changes in government regulation, future legislation or
administrative action or changes in SFDA policy that occur prior to or during
our regulatory review. Delays or failure to obtain regulatory approvals may:
o delay or prevent commercialization of, and our ability to derive product
revenues from, our product candidates;
o impose significant costs on us to comply with such laws and regulations; and
o diminish any competitive advantage the we may otherwise have.
In the United States and Japan, we must receive approval from the appropriate
regulatory authorities before we can commercialize our product candidates. We
anticipate that the regulatory approval to market HIV-PV Vaccine I in the United
States and Japan will vary and may differ from that required by the SFDA. We may
incur significant costs to comply with government regulations in the future, and
such regulations may have a material adverse effect on us.
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DELAY IN COMMENCEMENT AND COMPLETION OF OUR CLINICAL TRIALS COULD JEOPARDIZE OUR
ABILITY TO OBTAIN REGULATORY APPROVAL TO MARKET OUR PRODUCT CANDIDATES IN CHINA,
THE UNITED STATES AND JAPAN ON A TIMELY BASIS.
Our clinical trials could be delayed for a variety of reasons, including:
o availability of funds;
o unforeseen safety issues;
o determination of dosing issues;
o lower-than-anticipated retention rate of volunteers in the trial;
o serious adverse events related to the vaccine;
o inability to monitor patients adequately during or after treatment; or
o different interpretations of our pre-clinical and clinical data, which can
lead initially to inconclusive results.
Our inability to commence or complete our clinical trials in a timely manner
could jeopardize our ability to obtain regulatory approval.
THE RESULTS OF OUR CLINICAL TRIALS MAY NOT SUPPORT OUR PRODUCT CANDIDATE CLAIMS.
Even if our clinical trials are commenced and completed as planned, their
results may not support our product candidate claims. Success in pre-clinical
testing and early phases of clinical trials does not ensure that later phases of
clinical trials will be successful, and the results of later phases of clinical
trials may not replicate the results of prior clinical trials and pre-clinical
testing. The clinical trial process may fail to demonstrate that our product
candidates are safe for humans and effective for indicated uses. This failure
would cause us to abandon a product candidate and may delay or prevent
development of other product candidates.
ALTHOUGH THE OUTSIDE BODY OF OUR LABORATORY AND MANUFACTURING FACILITY IN CHINA
IS COMPLETED, WE MAY NOT BE SUCCESSFUL AT MANUFACTURING OR SUPPLYING OUR PRODUCT
CANDIDATES IN NECESSARY QUANTITIES, OR AT ALL.
In May 2003, we purchased a right to use for fifty years land located in the
Shunyi District of Beijing, China for the purpose of building and operating a
laboratory and manufacturing facility in China. Under Chinese law, there is no
private ownership of land, and accordingly, we do not own this land. In April
2005, we completed the construction of the outside body of this laboratory and
manufacturing facility. However, if:
o we are unable to raise the anticipated, or necessary, funding; or
o approval of the facility in compliance with GMP requirements is not obtained
we will be unable to complete the manufacturing facility in Beijing, China. Even
if we successfully build this laboratory and manufacturing facility, the
facility may not pass domestic or foreign regulatory approvals or be able to
manufacture our product candidates in commercial quantities, or at all, or we
may not be able to manufacture our product candidates on a cost-effective basis.
WE DEPEND ON KEY MANAGEMENT EMPLOYEES FOR OUR FUTURE SUCCESS. IF WE LOSE OUR KEY
MANAGEMENT EMPLOYEES, OUR ABILITY TO OBTAIN FINANCING, DEVELOP OUR PRODUCT
CANDIDATES, CONDUCT CLINICAL TRIALS OR EXECUTE OUR BUSINESS STRATEGY COULD BE
SUBSTANTIALLY HARMED AND THE VALUE OF THE STOCK YOU OWN COULD BE ADVERSELY
AFFECTED.
Our future success is substantially dependent on the efforts of our senior
management and scientific staff, particularly our chief executive officer, Liang
Qiao, M.D. and his brother, Wenhui Qiao, who is our president. These individuals
have played a critical role in developing the vaccine and conducting
pre-clinical trials, raising financing and negotiating business development
opportunities. The loss of the services of these key members of our senior
management and scientific staff may prevent us from achieving our business
objectives, and the value of the stock you own could be adversely affected. We
do not maintain key person life insurance for any of our key personnel.
WE CURRENTLY HAVE NO MANUFACTURING FACILITY AND NO MANUFACTURING EXPERIENCE.
We currently have no manufacturing facilities and no manufacturing experience.
Pre-clinical study of the vaccine on laboratory animals is being conducted
through the collaboration between us and Loyola University of Chicago and
Beijing Institute of Radiation Medicine, respectively. We have completed the
outside body of the manufacturing facility in China to produce HIV-PV Vaccine I
for clinical trials and on a commercial scale, and are in the process of
outfitting this facility. However, we may not have adequate manufacturing
capacity to produce HIV-PV Vaccine I on a commercial scale. Our lack of
manufacturing experience could delay commercialization of our HIV-PV Vaccine I,
entail higher costs and result in our being unable to effectively sell our
product.
WE HAVE NO EXPERIENCE IN MARKETING, SELLING OR DISTRIBUTING PRODUCTS AND NO
INTERNAL CAPABILITY TO DO SO. OUR LACK OF SALES AND MARKETING PERSONNEL AND
DISTRIBUTION RELATIONSHIPS MAY IMPAIR OUR ABILITY TO GENERATE REVENUES.
9
We have no sales, marketing or distribution capability. We do not anticipate
having the resources in the foreseeable future to allocate to the sales and
marketing of our product candidates under development. Our future success
depends, in part, on our ability to enter into and maintain such collaborative
relationships, the collaborator's strategic interest in the products under
development and such collaborator's ability to successfully market and sell any
such products. We intend to pursue collaborative arrangements regarding the
sales, marketing and distribution of our products, however, we may not be able
to establish marketing or distribution arrangements with collaborators in a
timely manner or on favorable terms, or at all.
WE FACE COMPETITION FROM SEVERAL COMPANIES WITH GREATER FINANCIAL, PERSONNEL AND
RESEARCH AND DEVELOPMENT RESOURCES THAN OURS, WHICH MAY HAVE A MATERIAL ADVERSE
EFFECT ON OUR BUSINESS.
The goal of developing an HIV vaccine is an area of interest to competitors, and
several companies with substantially greater financial, personnel and research
and development resources than ours have announced that they are trying to
develop an HIV vaccine and are planning, conducting or have completed clinical
trials. Although our research has indicated that HIV-PV Vaccine I contains a
pseudovirus that induces both mucosal and systemic neutralizing antibodies and
cytotoxic T-cells that may be used to prevent and treat HIV infection, other
elements may be necessary to develop an effective vaccine, and several of our
competitors are working to develop vaccines that affect the immune system
differently. In addition, several of these companies are working to develop new
drug cocktails and other treatments that may mitigate the impact of the disease.
Even if we commence and complete our clinical trials, obtain SFDA and other
required regulatory approvals and commercialize HIV-PV Vaccine I, our
competitors may develop vaccines or treatments that are as or more effective, or
less complex or less expensive to produce, than HIV-PV Vaccine I.
ADVERSE PUBLICITY REGARDING THE SAFETY OR SIDE EFFECTS OF HIV-PV VACCINE I COULD
HARM OUR BUSINESS AND CAUSE OUR STOCK PRICE TO FALL.
There may be potential side effects or safety concerns in connection with
clinical trials of Vaccine I. If our studies or other researchers' studies were
to raise or substantiate concerns over the safety or side effects of Vaccine I
or vaccine development efforts generally, our reputation and public support for
our future clinical trials could be harmed, which would harm our business and
could cause our stock price to fall.
OUR USE OF HAZARDOUS MATERIALS, CHEMICALS AND VIRUSES REQUIRE US TO COMPLY WITH
REGULATORY REQUIREMENTS AND EXPOSES US TO POTENTIAL LIABILITIES.
Our research and development activities involve the controlled use of hazardous
materials, chemicals and viruses. We are subject to federal, state, local and
foreign laws governing the use, manufacture, storage, handling and disposal of
such materials. Although we believe that our safety procedures for the use,
manufacture, storage, handling, disposal of such materials comply with the
standards prescribed by the federal, state, local and foreign regulations, we
cannot eliminate the risk of accidental contamination or injury from these
materials. In the event of such an accident, we could be held liable for
significant damages or fines. These damages could exceed our resources and any
applicable insurance coverage. In addition, we may be required to incur
significant costs to comply with regulatory requirements in the future.
WE MAY BECOME SUBJECT TO PRODUCT LIABILITY CLAIMS AND INCUR SUBSTANTIAL
LIABILITIES, WHICH COULD REDUCE DEMAND FOR HIV-PV VACCINE I OR LIMIT
COMMERCIALIZATION OF HIV-PV VACCINE I.
We will face an inherent risk of exposure to product liability suits in
connection with HIV-PV Vaccine I, vaccines to be tested in human clinical trials
and products that may be sold commercially. We may become subject to a product
liability suit if HIV-PV Vaccine I causes injury, or if vaccinated individuals
subsequently become infected with HIV. We currently do not carry clinical trial
insurance or product liability insurance. Although we intend to obtain clinical
trial insurance prior to commencement of any clinical trials, we may not be able
to obtain insurance at a reasonable cost, if at all. Regardless of merit or
eventual outcome, product liability claims may result in decreased demand for a
vaccine, injury to our reputation, withdrawal of clinical trial volunteers and
loss of revenues.
POLITICAL OR SOCIAL FACTORS MAY DELAY OR REDUCE REVENUES BY DELAYING OR
IMPAIRING OUR ABILITY TO MARKET HIV-PV VACCINE I.
10
Products developed for use in addressing the HIV/AIDS epidemic have been, and
will continue to be, subject to competing and changing political and social
pressures. The political and social response to the HIV/AIDS epidemic has been
highly charged and unpredictable. Political or social pressures may delay or
cause resistance to bringing our product to market or limit pricing of our
product.
RISKS RELATED WITH OWNERSHIP OF OUR SECURITIES
THE SALE OF OUR COMMON STOCK TO DUTCHESS PRIVATE EQUITIES FUND MAY CAUSE
DILUTION AND THE SALE OF SHARES OF COMMON STOCK ACQUIRED BY DUTCHESS PRIVATE
EQUITIES FUND COULD CAUSE THE PRICE OF OUR COMMON STOCK TO DECLINE.
The purchase price for the common stock to be issued to Dutchess Private
Equities Fund pursuant to the investment agreement will fluctuate based on the
price of our common stock. All shares in this offering will be freely tradable
once sold pursuant to the terms outline in the section entitled "Plan of
Distribution" in this prospectus. Dutchess Private Equities may sell none, some
or all of the common shares purchased from us at any time. We expect that the
shares offered by this prospectus will be sold over a period of up to 24 months
from the date of this prospectus. Depending upon market liquidity at the time, a
sale of shares under this offering at any given time could cause the trading
price of our common stock to decline. The sale of a substantial number of shares
of our common stock under this offering, or anticipation of such sales, could
make it more difficult for us to sell equity securities in the future at a time
and at a price that we might otherwise wish to effect sales.
THE TRADING PRICE OF OUR COMMON STOCK MAY DECREASE DUE TO FACTORS BEYOND OUR
CONTROL. THIS MAY RESULT IN SUBSTANTIAL LOSSES TO INVESTORS IF THEY ARE UNABLE
TO SELL THEIR SHARES AT OR ABOVE THEIR PURCHASE PRICE.
The trading price of our common stock is subject to significant fluctuations due
to a number of factors, including:
o our status as a development stage company with a limited operating history and
no revenues to date, which may make risk-averse investors more inclined to sell
their shares on the market more quickly and at greater discounts than would be
the case with the shares of a seasoned issuer in the event of negative news or
lack of progress;
o announcements of new products by us or our competitors;
o the timing and development of our products;
o general and industry-specific economic conditions;
o actual or anticipated fluctuations in our operating results;
o our capital commitments; and
o the loss of any of our key management personnel.
In addition, the financial markets have experienced extreme price and volume
fluctuations. The market prices of the securities of biotechnology companies,
particularly companies like ours without consistent revenues and earnings, have
been highly volatile and may continue to be highly volatile in the future, some
of which may be unrelated to the operating performance of particular companies.
The sale or attempted sale of a large amount of common stock into the market may
also have a significant impact on the trading price of our common stock. Many of
these factors are beyond our control and may decrease the market price of our
common stock, regardless of our operating performance. In the past, securities
class action litigation has often been brought against companies that experience
volatility in the market price of their securities. Whether or not meritorious,
litigation brought against us could result in substantial costs, divert
management's attention and resources and harm our financial condition and
results of operations.
WE DO NOT ANTICIPATE PAYING ANY CASH DIVIDENDS IN THE FORESEEABLE FUTURE, WHICH
MAY REDUCE YOUR RETURN ON AN INVESTMENT IN OUR COMMON STOCK.
We plan to use all of our earnings, to the extent we have earnings, to fund our
operations. We do not plan to pay any cash dividends in the foreseeable future.
We cannot guarantee that we will, at any time, generate sufficient surplus cash
that would be available for distribution as a dividend to the holders of our
common stock. Therefore, any return on your investment would derive from an
increase in the price of our stock, which may or may not occur.
11
WE MAY RAISE ADDITIONAL CAPITAL THROUGH A SECURITIES OFFERING THAT COULD DILUTE
YOUR OWNERSHIP INTEREST AND VOTING RIGHTS.
Our certificate of incorporation currently authorizes our board of directors to
issue up to 100,000,000 shares of common stock and 5,000,000 shares of preferred
stock. As of November 1, 2005, after taking into consideration our outstanding
shares, our board of directors will be entitled to issue up to 67,528,463
additional common shares and 5,000,000 additional preferred shares. The power of
the board of directors to issue shares of common stock, preferred stock or
warrants or options to purchase shares of our stock is generally not subject to
shareholder approval.
We require substantial working capital to fund our business. If we raise
additional funds through the issuance of equity, equity-related or convertible
debt securities, these securities may have rights, preferences or privileges
senior to those of the holders of our common stock. The issuance of additional
common stock or securities convertible into common stock by our board of
directors will also have the effect of diluting the proportionate equity
interest and voting power of holders of our common stock.
OUR PRINCIPAL STOCKHOLDERS, EXECUTIVE OFFICERS AND DIRECTORS WILL CONTINUE TO
OWN A SIGNIFICANT PERCENTAGE OF OUR STOCK AFTER THE OFFERING, AND AS A RESULT,
THE TRADING PRICE FOR OUR SHARES MAY BE DEPRESSED AND THESE STOCKHOLDERS CAN
TAKE ACTIONS THAT MAY BE ADVERSE TO YOUR INTERESTS.
After the offering, our principal stockholders, executive officers and directors
will, in the aggregate, beneficially own approximately 71.0% of our common
stock. These stockholders, acting together, will have the ability to exert
substantial influence over all matters requiring approval by our stockholders,
including the election and removal of directors and any proposed merger,
consolidation or sale of all or substantially all of our assets. In addition,
they could dictate the management of our business and affairs. This
concentration of ownership could have the affect of delaying, deferring or
preventing a change in control, or impeding a merger or consolidation, takeover
or other business combination that could be favorable to you. This significant
concentration of share ownership may also adversely affect the trading price for
our common stock because investors may perceive disadvantages in owning stock in
companies with controlling stockholders.
OUR INCORPORATION DOCUMENTS AND DELAWARE LAW MAY INHIBIT A TAKEOVER THAT
STOCKHOLDERS CONSIDER FAVORABLE AND COULD ALSO LIMIT THE MARKET PRICE OF YOUR
STOCK, WHICH MAY INHIBIT AN ATTEMPT BY OUR STOCKHOLDERS TO CHANGE OUR DIRECTION
OR MANAGEMENT.
Our certificate of incorporation and bylaws contain provisions that could delay
or prevent a change in control of our company. Some of these provisions:
o authorize our board of directors to determine the rights, preferences,
privileges and restrictions granted to, or imposed upon, the preferred stock and
to fix the number of shares constituting any series and the designation of such
series without further action by our stockholders; and
12
o prohibit cumulative voting in the election of directors, which would otherwise
allow less than a majority of stockholders to elect director candidates.
In addition, we are governed by the provisions of Section 203 of Delaware
General Corporate Law. These provisions may prohibit large stockholders, in
particular those owning 15% or more of our outstanding voting stock, from
merging or combining with us, which may prevent or frustrate any attempt by our
stockholders to change our management or the direction in which we are heading.
These and other provisions in our amended and restated certificate of
incorporation and bylaws and under Delaware law could reduce the price that
investors might be willing to pay for shares of our common stock in the future
and result in the market price being lower than it would be without these
provisions.
WE ARE SUBJECT TO THE PENNY STOCK RULES. THESE RULES MAY ADVERSELY AFFECT
TRADING IN OUR COMMON STOCK.
Our common stock is a low-priced security under the penny
stock rules promulgated under the Securities Exchange Act of 1934. In accordance
with these rules, broker-dealers participating in transactions in low-priced
securities must first deliver a risk disclosure document which describes the
risks associated with such stocks, the broker-dealer's duties in selling the
stock, the customer's rights and remedies and certain market and other
information. Furthermore, the broker-dealer must make a suitability
determination approving the customer for low-priced stock transactions based on
the customer's financial situation, investment experience and objectives.
Broker-dealers must also disclose these restrictions in writing to the customer,
obtain specific written consent from the customer, and provide monthly account
statements to the customer. The effect of these restrictions may decrease the
willingness of broker-dealers to make a market in our common stock, decrease
liquidity of our common stock and increase transaction costs for sales and
purchases of our common stock as compared to other securities.
Stockholders should be aware that, according to Securities and Exchange
Commission Release No. 34-29093, dated April 17, 1991, the market for penny
stocks has suffered in recent years from patterns of fraud and abuse. Such
patterns include:
(i) control of the market for the security by one or a few broker-dealers that
are often related to the promoter or issuer;
(ii) manipulation of prices through prearranged matching of purchases and sales
and false and misleading press releases;
(iii) boiler room practices involving high-pressure sales tactics and
unrealistic price projections by inexperienced sales persons;
(iv) excessive and undisclosed bid-ask differential and markups by selling
broker-dealers; and
(v) the wholesale dumping of the same securities by promoters and broker-dealers
after prices have been manipulated to a desired level, along with the resulting
inevitable collapse of those prices and with consequent investor losses.
Our management is aware of the abuses that have occurred historically in the
penny stock market. Although we do not expect to be in a position to dictate the
behavior of the market or of broker-dealers who participate in the market,
management will strive within the confines of practical limitations to prevent
the described patterns from being established with respect to our securities.
RISKS RELATING TO OUR FOREIGN OPERATIONS
OUR OPERATIONS ARE LOCATED IN CHINA AND MAY BE ADVERSELY AFFECTED BY CHANGES IN
THE POLICIES OF THE CHINESE GOVERNMENT.
We have operations in China, where we are currently engaged in pre-clinical
testing of our HIV-PV Vaccine I product on laboratory animals. Our business
operations may be adversely affected by the political environment in the PRC.
The PRC has operated as a socialist state since 1949 and is controlled by the
Communist Party of China. In recent years, however, the government has
introduced reforms aimed at creating a "socialist market economy" and policies
have been implemented to allow business enterprises greater autonomy in their
operations. Changes in the political leadership of the PRC may have a
significant effect on laws and policies related to the current economic reforms
program, other policies affecting business and the general political, economic
and social environment in the PRC, including the introduction of measures to
control inflation, changes in the rate or method of taxation, the imposition of
additional restrictions on currency conversion and remittances abroad, and
foreign investment. These effects could substantially impair our business,
profits or prospects in China. Moreover, economic reforms and growth in the PRC
have been more successful in certain provinces than in others, and the
continuation or increases of such disparities could affect the political or
social stability of the PRC.
13
THE CHINESE GOVERNMENT EXERTS SUBSTANTIAL INFLUENCE OVER THE MANNER IN WHICH WE
MUST CONDUCT ITS BUSINESS ACTIVITIES.
The PRC only recently has permitted greater provincial and local economic
autonomy and private economic activities. The government of the PRC has
exercised and continues to exercise substantial control over virtually every
sector of the Chinese economy through regulation and state ownership.
Accordingly, government actions in the future, including any decision not to
continue to support recent economic reforms and to return to a more centrally
planned economy or regional or local variations in the implementation of
economic policies, could have a significant effect on economic conditions in the
PRC or particular regions thereof, and could require us to divest ourselves of
any interests we then hold in Chinese properties or joint ventures. Any such
developments could have a material adverse effect on our business, operations,
financial condition and prospects.
FUTURE INFLATION IN CHINA MAY INHIBIT ECONOMIC ACTIVITY IN CHINA AND ADVERSELY
AFFECT OUR OPERATIONS.
In recent years, the Chinese economy has experienced periods of rapid expansion
and high rates of inflation which have led to the adoption by the PRC
government, from time to time, of various corrective measures designed to
restrict the availability of credit or regulate growth and contain inflation.
While inflation has moderated since 1995, high inflation may in the future cause
the PRC government to impose controls on credit and/or prices, or to take other
action, which could inhibit economic activity in China, and thereby adversely
affecting our business operations and prospects in the PRC.
WE MAY BE UNABLE TO ENFORCE OUR RIGHTS DUE TO POLICIES REGARDING THE REGULATION
OF FOREIGN INVESTMENTS IN CHINA.
The PRC's legal system is a civil law system based on written statutes in which
decided legal cases have little value as precedents, unlike the common law
system prevalent in the United States. The PRC does not have a well-developed,
consolidated body of laws governing foreign investment enterprises. As a result,
the administration of laws and regulations by government agencies may be subject
to considerable discretion and variation, and may be subject to influence by
external forces unrelated to the legal merits of a particular matter. China's
regulations and policies with respect to foreign investments are evolving.
Definitive regulations and policies with respect to such matters as the
permissible percentage of foreign investment and permissible rates of equity
returns have not yet been published. Statements regarding these evolving
policies have been conflicting and any such policies, as administered, are
likely to be subject to broad interpretation and discretion and to be modified,
perhaps on a case-by-case basis. The uncertainties regarding such regulations
and policies present risks which may affect our ability to achieve our business
objectives. We may not be able to enforce any legal rights we may have under our
contracts or otherwise. Our failure to enforce our legal rights may have a
material adverse impact on our operations and financial position, as well as our
ability to compete with other companies in our industry.
IT MAY BE DIFFICULT FOR SHAREHOLDERS TO ENFORCE ANY JUDGMENT OBTAINED IN THE
UNITED STATES AGAINST US, WHICH MAY LIMIT THE REMEDIES OTHERWISE AVAILABLE TO
OUR SHAREHOLDERS.
Substantially all of our assets are located outside the United States. Our
current operations are conducted in China. Moreover, most of our directors and
officers are nationals or residents of countries other than the United States.
All or a substantial portion of the assets of these persons are located outside
the United States. As a result, it may be difficult for shareholders to effect
service of process within the United States upon these persons. In addition,
there is uncertainty as to whether the courts of China would recognize or
enforce judgments of United States courts obtained against us or such officers
and/or directors predicated upon the civil liability provisions of the
securities law of the United States or any state thereof, or be competent to
hear original actions brought in China against us or such persons predicated
upon the securities laws of the United States or any state thereof.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus, including sections entitled "Prospectus Summary," "Risk
Factors," "Management's Discussion and Analysis" and "Business," contains
forward-looking statements.
Forward-looking statements include, but are not limited to, statements about:
o our lack of capital and whether or not we will be able to raise capital when
we need it;
o our ability to complete development of our products under development;
o our ability to market and manufacture our future products; and
o our ability to protect our intellectual property and operate our business
without infringing upon the intellectual property rights of others.
14
These statements relate to future events or our future financial performance,
and involve known and unknown risks, uncertainties and other factors that may
cause our actual results, levels of activity, performance or achievements to be
materially different from any future results, levels of activity, performance or
achievements expressed or implied by these forward-looking statements. These
risks and other factors include those listed under "Risk Factors" and elsewhere
in this prospectus. In some cases, you can identify forward-looking statements
by terminology such as "may," "expects," "intends," "plans," "anticipates,"
"believes," "potential," "continue" or the negative of these terms or other
comparable terminology. Although we believe that the expectations reflected in
the forward-looking statements are reasonable, we cannot guarantee future
results, levels of activity, performance or achievements. We do not intend to
update any of the forward-looking statements after the date of this prospectus
or to conform these statements to actual results. Neither the Private Securities
Litigation Reform Act of 1995 nor Section 27A of the Securities Act of 1933
provides any protection for statements made in this prospectus.
USE OF PROCEEDS
We will not receive any proceeds from the sale of the shares by the selling
stockholders. All proceeds from the sale of the shares offered hereby will be
for the account of the selling stockholders, as described below in the sections
entitled "Selling Stockholders" and "Plan of Distribution."
We may receive up to $10.0 million in proceeds from the sale of our common stock
to Dutchess Private Equities Fund under the investment agreement. As of December
29, 2005 we have received no funds from Dutchess Private Equities Fund. Although
we may receive up to $10.0 million from the sale of our common stock under the
investment agreement, we are only registering 2,000,000 shares. Assuming we sell
2,000,000 shares to Dutchess Private Equities Fund pursuant to investment
agreement at a purchase price of $1.95 per share (the closing sale price of the
common stock on December 27, 2005), proceeds to us would only be $3,900,000.
Accordingly, we can only receive proceeds from the sale of up to 2,000,000
shares, which is dependent on the market price of our shares at the time of the
sales.
We intend to use any proceeds from Dutchess Private Equities Fund that we
receive under the investment agreement primarily for working capital and for
general corporate purposes, including capital investment in our laboratory and
biomanufacturing facility in Beijing, China. For illustrative purposes only, the
following table lists the amount of proceeds we would receive from Dutchess
Private Equities Fund from the sale of shares of our common stock offered by
this prospectus at varying purchase prices:
Assumed Purchase Price(1) Assumed Number of Shares to Percentage Outstanding After Proceeds from the Sale of
be Sold(2) Giving Effect to Issuance to Shares to Dutchess under the
Dutchess(3) Investment Agreement
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$1.00 2,000,000 5.8% $2,000,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$1.50 2,000,000 5.8% $3,000,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$1.95* 2,000,000 5.8% $3,900,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$2.25 2,000,000 5.8% $4,500,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$2.50 2,000,000 5.8% $5,000,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$3.00 2,000,000 5.8% $6,000,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$4.00 2,000,000 5.8% $8,000,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
$5.00 2,000,000 5.8% $10,000,000
- --------------------------------- ------------------------------- ------------------------------ -------------------------------
* Closing sale price of our common stock on December 27, 2005.
(1) Under the terms of the investment agreement, the purchase price is 95% of
the lowest closing best bid price of our common stock within five trading days
of the put notice.
(2) Under the terms of the investment agreement, the maximum amount of shares
shall not exceed 2,000,000 shares of our common stock. In order for us to
receive the maximum proceeds of $10 million under the investment agreement, the
selling price of our common stock to Dutchess would have to average at least
$5.00 per share.
(3) Based on 32,471,537 shares outstanding as of November 1, 2005. In addition,
includes the number of shares issuable at the corresponding assumed purchase
price set forth in the adjacent column.
The amounts actually spent by us for any specific purpose may vary significantly
and will depend on a number of factors, including the progress of our
commercialization and development efforts. Accordingly, management has broad
discretion to allocate any proceeds from the investment agreement.
With the exception of any brokerage fees and commission which are the obligation
of the selling stockholders, we are responsible for the fees, costs and expenses
of this offering which are estimated to be $100,000, inclusive of our legal and
accounting fees, printing costs and filing and other miscellaneous fees and
expenses.
SELLING STOCKHOLDERS
The following table sets forth the names of the selling stockholders who may
sell their shares under this prospectus from time to time. No selling
stockholder has, or within the past three years has had, any position, office or
other material relationship with us or any of our predecessors or affiliates. In
addition, the following table provides certain information with respect to the
selling stockholders' ownership of our securities as of the date of this
prospectus, the total number of securities they may sell under this prospectus
from time to time, and the number of securities they will own thereafter
assuming no other acquisitions or dispositions of our securities. The selling
stockholders can offer all, some or none of their securities, thus we have no
way of determining the number they will hold after this offering. Therefore, we
have prepared the table below on the assumption that the selling stockholders
will sell all shares covered by this prospectus.
Some of the selling stockholders may distribute their shares, from time to time,
to their limited and/or general partners or managers, who may sell shares
pursuant to this prospectus. Each selling stockholder may also transfer shares
owned by him or her by gift, and upon any such transfer the donee would have the
same right of sale as the selling stockholder.
We may amend or supplement this prospectus from time to time to update the
disclosure set forth herein. See our discussion entitled "Plan of Distribution"
for further information regarding the selling stockholders' method of
distribution of these shares.
15
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Name of Selling Stockholder Number of Number of Shares Number of Shares Percentage Owned
Shares Owned Being Offered Owned After Offering After Offering (1)
Before Offering
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Dutchess Private Equities Fund, LP(2) 2,000,000 2,000,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Misuzu Mitsuta 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Masasue Mitsuta 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Tomoko Toyota 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Rieko Kuboyama 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Junya Yoshino 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Fumito Yuasa 30,000 30,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Koji Sadamune 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yuko Goto 46,250 46,250 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Tatsuo Asamizu 50,000 50,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yuko Ogawa 20,046 20,046 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Masakatu Fujiwara 40,000 40,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Toshiyuki Matsushita 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Mitsuhiro Kikuchi 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Kyoichi Kinoshita 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yozo Kato 25,000 25,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Jun Mukaidono 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Michiaki Matsuura 11,000 11,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Teruyuki Koshimizu 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Toyoko Saimu 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Kenji Eikawa 140,000 140,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yasuo Fujiwara 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Kazuyuki Koda 40,000 40,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Kazutaka Morioka 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Masakazu Kimura 40,000 40,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Hiromi Oshita 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Atsuyuki Naito 40,000 40,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Eiji Ueda 100,000 100,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Toshiki Sato 100,000 100,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Shizuko Nitanda 30,000 30,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yutaka Asai 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Keiichi Narai 50,000 50,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Hiroshi Koshino 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yukio Hosoda 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Masako Kuroki 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yaeko Yamasaki 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Kayo Miyamura 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Shigeru Ota 20,000 20,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Junji Ishiwata 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yoshiharu Fujii 10,000 10,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Yukio Nakagawa 352,652 352,652 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Xin J. Zhou 15,000 15,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Xiaojiang Qi 100,000 100,000 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
Ma Suifang 8,116 8,116 0 *
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
TOTAL 3,618,064 3,618,064
- -------------------------------------- ---------------- --------------------- ----------------------- -----------------------
16
* Represents less than 1% of our common stock.
(1) Based on 32,471,537 shares issued and outstanding as of November 1, 2005.
Assumes that each selling stockholder sells all shares registered under this
prospectus. However, to our knowledge, there are no agreements, arrangements or
understandings with respect to the sale of any of our common stock, and each
selling stockholder may decide not to sell his or her shares that are registered
under this prospectus.
(2)Includes 2,000,000 shares of our common stock that Dutchess Private Equities
Fund, LP may acquire under the investment agreement. Douglas H. Leighton, the
managing member of Dutchess Private Equities Fund, LP, has voting and
disposition power over the shares being offered under this prospectus.
17
PLAN OF DISTRIBUTION
We are registering 3,618,064 shares of our common stock for resale by the
selling stockholders identified in the section above entitled "Selling
Stockholders." We will receive none of the proceeds from the sale of these
shares by the selling stockholders.
The selling stockholders may sell the shares offered by this prospectus in one
or more transactions at prevailing market prices or privately negotiated prices.
The selling stockholders may use any one or more of the following methods when
selling shares:
o ordinary brokerage transactions and transactions in which the broker-dealer
solicits purchasers;
o a block trade in which the broker-dealer so engaged will attempt to sell such
shares as agent, but may position and resell a portion of the block as principal
to facilitate the transaction;
o purchases by a broker-dealer as principal and resale by such broker-dealer for
its own account pursuant to this prospectus;
o an exchange distribution in accordance with the rules of the applicable
exchange;
o privately negotiated transactions;
o settlement of short sales;
o broker-dealers may agree with the selling stockholders to sell a specified
number of such shares at a stipulated price per share;
o a combination of any such methods of sale;
o through the writing or settlement of options or other hedging transactions,
whether through an options exchange or otherwise; or
o any other method permitted pursuant to applicable law.
The selling stockholders and their successors, including their transferees,
pledgees or donees or their successors-in-interest, may sell the common shares
directly to a purchaser or through underwriters, broker-dealers or agents, who
may receive compensation in the form of discounts, concessions or commissions
from the selling stockholder or the purchaser. Neither the selling stockholders
nor Bio-Bridge can presently estimate the amount of such compensation. We know
of no existing arrangements between the selling stockholders, broker-dealers,
underwriters or agents relating to the sale or distribution of the shares.
The selling stockholders may also enter into hedging transactions, and persons
with whom they effect such transactions, including broker-dealers, may engage in
short sales of our common shares. Our selling stockholders may also engage in
short sales and short sales against the box, and in options, swaps, derivatives
and other transactions in our securities, and may sell and deliver the shares
covered by this prospectus in connection with such transactions or in settlement
of securities loans. These transactions may be entered into with broker-dealers
or other financial institutions that may resell those shares pursuant to this
prospectus (as supplemented or amended to reflect such transaction).
18
Dutchess Private Equities Fund, LP is an underwriter within the meaning of
section 2(11) of the Securities Act of 1933, as amended, with respect to the
shares being offered hereby which it shall purchase from us under the investment
agreement. The selling stockholders and any broker-dealers or agents that are
involved in selling the shares may be deemed to be "underwriters" within the
meaning of section 2(11) of the Securities Act of 1933, as amended, in
connection with the sales and distributions contemplated under this prospectus,
and may have civil liability under Sections 11 and 12 of the Securities Act for
any omissions or misstatements in this prospectus and the registration statement
of which it is a part. Additionally, any profits which our selling stockholders
may receive might be deemed to be underwriting compensation under the Securities
Act. Because the selling stockholders may be deemed to be an underwriter under
Section 2(11) of the Securities Act, the selling stockholders will be subject to
the prospectus delivery requirements of the Securities Act.
The resale shares will be sold only through registered or licensed
broker-dealers if required under applicable state securities laws. In addition,
in certain states, the resale shares may not be sold unless they have been
registered or qualified for sale in the applicable state or an exemption from
the registration or qualification requirement is available and is complied with.
We will bear all expenses relating to the sale of our common shares under this
prospectus, except that the selling stockholders will pay any applicable
underwriting commissions and expenses, brokerage fees and transfer taxes, as
well as the fees and disbursements of counsel to and experts for the selling
stockholders.
Any common shares offered under this prospectus that qualify for sale pursuant
to Rule 144 of the Securities Act may also be sold under Rule 144 rather than
pursuant to this prospectus.
Under applicable rules and regulations under the Exchange Act of 1934, any
person engaged in the distribution of the resale shares may not simultaneously
engage in market making activities with respect to our common stock for a period
of two business days prior to the commencement of the distribution. In addition,
the selling stockholders will be subject to applicable provisions of the
Exchange Act and the rules and regulations thereunder, including Regulation M,
which may limit the timing of purchases and sales of shares of our common stock
by the selling stockholders or any other person. We will make copies of this
prospectus available to the selling stockholders and have informed them of the
need to deliver a copy of this prospectus to each purchaser at or prior to the
time of the sale.
LEGAL PROCEEDINGS
We are not currently subject to either threatened or pending litigation, actions
or administrative proceedings.
DIRECTORS, EXECUTIVE OFFICERS, PROMOTERS AND CONTROL PERSONS
The following table identifies our current executive officers and directors,
their respective offices and positions, and their respective dates of election
or appointment:
INITIAL ELECTION OR
NAME AGE POSITION HELD APPOINTMENT DATE
- ----------------------------------------------------------------------------------------------------------------------------------
Liang Qiao, M.D. 45 Chairman of the Board, Chief October 26, 2004
Executive Officer and Secretary
- ----------------------------------------------------------------------------------------------------------------------------------
Wenhui Qiao 36 President and Director October 26, 2004
- ----------------------------------------------------------------------------------------------------------------------------------
Chuen Huei (Kevin) Lee 34 Chief Financial Officer October 27, 2004
- ----------------------------------------------------------------------------------------------------------------------------------
Toshihiro Komoike 52 Director October 26, 2004
- ----------------------------------------------------------------------------------------------------------------------------------
Isao Arimoto 56 Vice President and Director October 26, 2004
- ----------------------------------------------------------------------------------------------------------------------------------
Shyh-Jing (Philip) Chiang 44 Director October 26, 2004
- ----------------------------------------------------------------------------------------------------------------------------------
Mr. Wenhui Qiao and Dr. Liang Qiao are brothers. There are no other family
relationships among the executive officers and directors.
Our executive officers are appointed by our board of directors and serve at the
board's discretion. There is no arrangement or understanding between any of our
directors or executive officers and any other person pursuant to which any
director or officer was or is to be selected as a director or officer, and there
is no arrangement, plan or understanding as to whether non-management
stockholders will exercise their voting rights to continue to elect the current
board of directors. There are also no arrangements, agreements or understandings
to our knowledge between non-management stockholders that may directly or
indirectly participate in or influence the management of our affairs. None of
our directors or executive officers has, during the past five years,
19
o had any bankruptcy petition filed by or against any business of which such
person was a general partner or executive officer, either at the time of the
bankruptcy or within two years prior to that time,
o been convicted in a criminal proceeding and none of our directors or executive
officers is subject to a pending criminal proceeding,
o been subject to any order, judgment, or decree, not subsequently reversed,
suspended or vacated, of any court of competent jurisdiction, permanently or
temporarily enjoining, barring, suspending or otherwise limiting his involvement
in any type of business, securities, futures, commodities or banking activities,
or
o been found by a court of competent jurisdiction (in a civil action), the
Securities and Exchange Commission or the Commodity Futures Trading Commission
to have violated a federal or state securities or commodities law, and the
judgment has not been reversed, suspended, or vacated.
BUSINESS EXPERIENCE
DR. LIANG QIAO is one of our co-founders and has served as our chairman of the
board of directors, chief executive officer and secretary since October 2004.
Since February 2002, Dr. Qiao has served as director of our wholly owned
subsidiary Bio-Bridge Science Corp. and has served as its chief executive
officer and chairman of the board since May 2004. Since July 2000, Dr. Qiao has
served as an Associate Professor at Loyola University Chicago, Strich School of
Medicine. From May 1994 to June 2000, Dr. Qiao was an Assistant Professor at
Loyola University Chicago, Strich School of Medicine. Dr. Qiao also worked as a
research scholar at the German Cancer Research Center in Heidelberg, Germany,
where he made his discovery of mucosal immune regulation mechanisms. Dr. Qiao
received a B.M. from Henan Medical University in China and an M.D. from Lausanne
University in Switzerland.
MR. WENHUI QIAO is one of our co-founders and has served as our president and
director since October 2004. Mr. Qiao has served as director of
Bio-BridgeScience Corp. since February 2002 and its president since May 2004.
From July 1999 to December 2001, Mr. Qiao served as chief executive officer of
Dongfang Huayin Anti- Radiation Company, which was located in Henan Province,
China. From 1994 to 1998, he served as the chief representative for Henan
Province in Japan. Mr. Qiao received a B.A. in Economics from Doshisha
University in Japan.
MR. CHUEN HUEI (KEVIN) LEE, CFA, FRM, has served as our chief financial officer
since October 2004. Mr. Lee also has served as chief financial officer of
Bio-Bridge Science Corp. since May 2004. From October 2001 to June 2004, he
served as Vice President of CMV in Beijing and Shanghai, China. From February
2000 to August 2001, Mr. Lee served as Manager of Grand Cathay Securities
Corporation in Taipei, Taiwan. From September 1998 to February 2000, he was the
Manager of American Express Bank's Taipei Branch. Mr. Lee received a B.A. from
Taiwan University and an M.B.A. from Columbia University. He is a chartered
financial analyst (CFA) charter holder and a financial risk manager (FRM).
MR. TOSHIHIRO KOMOIKE has served as our director since October 2004. Mr. Komoike
also has served as director of Bio-Bridge Science Corp. since May 2004. From
1998 to 2004, Mr. Komoike served as Senior Manager of Sumisho Textile Company in
Japan. He received a degree in Commerce from Kansai University in Japan.
MR. ISAO ARIMOTO is one of our co-founders and has served as our vice president
and director since October 2004. Mr. Arimoto also has served as vice president
of Bio-Bridge Science Corp. since May 2004 and its director since February 2002.
Since February 1975, Mr. Arimoto has served as chief executive officer of
Chugoko-Knit Company in Japan. He has 30 years of business experience as an
entrepreneur in Japan and China.
MR. SHYH-JING (PHILIP) CHIANG has served as our director since October 2004. Mr.
Chiang also has served as director of Bio-Bridge Science Corp. since February
2002. Since June 2004, Mr. Chiang has served as head of investment banking at
Nomura Securities in Taipei, Taiwan. From March 2004 to May 2004, he served as
chief representative of Rabobank's office in Taipei. From June 2001 to May 2004,
he was director of investment banking at ING Baring in Taipei. Mr. Chiang served
as executive vice president of Grand Cathay Securities from August 2000 to June
2001. From September 1996 to April 2000, he served as vice president of Credit
Agricole Indosuez. Mr. Chiang received a B.A. from Tunghai University in Taiwan
and an M.B.A. from the University of Missouri.
Our board of directors currently consists of five members. Our bylaws provide
that our directors will be elected at each annual meeting of the stockholders.
Their term of office will run until the next annual meeting of the stockholders
and until their successors have been elected.
To date, our board of directors has not separately designated a standing audit
committee. Since no such committee exists, our entire board of directors
constitutes the audit committee pursuant to Section 3(a)(58)(A) of the Exchange
Act of 1934.
20
No individual on our board of directors possesses all of the attributes of an
audit committee financial expert and no one on our board of directors is deemed
to be an audit committee financial expert. In forming our board of directors, we
sought out individuals who would be able to guide our operations based on their
business experience, both past and present, or their education. Mr. Lee, our
Chief Financial Officer, serves as our financial expert regarding generally
accepted accounting principals and general application of such principles in
connection with the accounting for estimates and accruals, including an
understanding of internal control procedures and policies over financial
reporting, and maintains sufficient experience analyzing or evaluating financial
statements in such depth and breadth as may be required of an audit committee
financial expert. However, Mr. Lee is not an elected director of the company. We
recognize that having a person who possesses all of the attributes of an audit
committee financial expert would be a valuable addition to our board of
directors, however, we are not, at this time, able to compensate such a person.
Therefore, we may find it difficult to attract such a candidate.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT
The following tables set forth certain information regarding beneficial
ownership of our securities as of December 15, 2005 by (i) each person who is
known by us to own beneficially more than five percent (5%) of the outstanding
shares of each class of our voting securities, (ii) each of our directors and
executive officers, and (iii) all of our directors and executive officers as a
group. We believe that each individual or entity named has sole investment and
voting power with respect to the securities indicated as beneficially owned by
them, subject to community property laws, where applicable, except where
otherwise noted. Unless otherwise stated, their address is c/o Bio-Bridge
Science, Inc., 1211 West 22nd Street, Suite 615, Oak Brook, IL 60523. As of
December 15, 2005, there were 32,471,537 shares of common stock issued and
outstanding.
COMMON STOCK
PERCENTAGE OF
NUMBER OF SHARES OF OUTSTANDING SHARES
NAME OF DIRECTOR, OFFICER AND COMMON STOCK OF COMMON
BENEFICIAL OWNER BENEFICIALLY OWNED STOCK
---------------- --------------------- --------
Named Executive Officers and Directors:
Liang Qiao, M.D.(1) 13,800,000 42.4%
Wenhui Qiao(2) 1,845,833 5.7%
Chuen Huei (Kevin) Lee(3) 170,833 *
Toshihiro Komoike(4) 1,262,500 3.9%
Isao Arimoto(5) 5,495,833 16.9%
Shyh-Jing (Philip) Chiang(6) 786,582 2.4%
Five Percent Stockholders of Common Stock:
None.
All Officers and Directors as a Group
(6 Persons)(1)(2)(3)(4)(5) 23,361,581 71.0%
* Less than one percent beneficially owned.
(1) Includes 13,750,000 shares and an option to purchase 600,000 shares of which
50,000 is exercisable within 60 days.
(2) Includes 825,000 shares, an option to purchase 150,000 shares, and an option
to purchase 250,000 shares of which 20,833 shares are exercisable within 60 days
owned by Wenhui Qiao individually. Also includes 850,000 shares held by Mingjin
Yu, Mr. Qiao's wife. Mr. Qiao disclaims beneficial ownership of the shares held
by his wife, except to the extent of his pecuniary interest therein.
(3) Includes an option to purchase 150,000 shares, and an option to purchase
250,000 shares of which 20,833 shares are exercisable within 60 days.
(4) Includes 750,000 shares and an option to purchase 150,000 shares of which
12,500 shares are exercisable within 60 days owned by Toshihiro Komoike
individually. Additionally includes 250,000 shares and 250,000 shares held by
Atsushi Komoike and Yumi Komoike, respectively, Mr. Komoike's children living at
home. Mr. Komoike disclaims beneficial ownership of the shares held by his
children, except to the extent of his pecuniary interest therein.
(5) Includes 2,125,000 shares and an option to purchase 250,000 shares of which
20,833 shares are exercisable within 60 days owned by Isao Arimoto himself
individually, 1,500,000 shares owned by Yukiko Arimoto, Mr. Arimoto's wife,
650,000 shares, 600,000 shares and 600,000 shares held by Kenshi Arimoto, Masayo
Arimoto and Noriyo Arimoto, respectively, Mr. Arimoto's children living at home.
Mr. Arimoto disclaims beneficial ownership of the shares held by his wife and
children, except to the extent of his pecuniary interest therein.
(6) Includes 786,111 shares and an option to purchase 5,000 shares of which 417
are exercisable within 60 days.
CHANGE OF CONTROL
To the knowledge of management, there are no present arrangements or pledges of
securities of our company that may result in a change in control of the company.
DESCRIPTION OF SECURITIES
GENERAL
We are authorized to issue 100,000,000 shares of common stock, par value $0.001
per share, and 5,000,000 shares of undesignated preferred stock, par value
$0.001 per share.
COMMON STOCK
The securities being offered by the selling stockholders are shares of our
Common stock.
21
As of December 15, 2005, there were issued and outstanding 32,471,537 shares of
common stock that were held of record by approximately 142 stockholders.
The holders of common stock are entitled to one vote per share on all matters to
be voted upon by the stockholders. Subject to preferences that may be applicable
to any outstanding preferred stock, the holders of common stock are entitled to
receive ratably any dividends that may be declared from time to time by the
board of directors out of funds legally available for that purpose. In the event
of our liquidation, dissolution or winding up, the holders of common stock are
entitled to share ratably in all assets remaining after payment of liabilities,
subject to prior distribution rights of preferred stock then outstanding. The
common stock has no preemptive or conversion rights or other subscription
rights. All outstanding shares of common stock are fully paid and nonassessable,
and the shares of common stock offered in this offering will be fully paid and
not liable for further call or assessment.
Please review our certificate of incorporation and bylaws, copies of which have
been filed with the SEC, as well as the applicable statutes of the State of
Delaware for a more complete description of the rights and liabilities of
holders of our shares.
The holders of common stock do not have cumulative voting rights, which means
that the holders of more than fifty percent of the shares of common stock voting
for election of directors may elect all the directors if they choose to do so.
In this event, the holders of the remaining shares aggregating less than fifty
percent will not be able to elect directors. Except as otherwise required by
Delaware law, all stockholder action is taken by the vote of a majority of the
issued and outstanding shares of common stock present at a meeting of
stockholders at which a quorum consisting of a majority of the issued and
outstanding shares of common stock is present in person or proxy.
PREFERRED STOCK
As of December 15, 2005, there were no issued and outstanding shares of
preferred stock. Pursuant to our certificate of incorporation, our board of
directors has the authority, without further action by the stockholders, to
issue up to 5,000,000 shares of undesignated preferred stock. Our board will
also have the authority, without the approval of the stockholders, to fix the
designations, powers, preferences, privileges and relative, participating,
optional or special rights and the qualifications, limitations or restrictions
of any preferred stock issued, including dividend rights, conversion rights,
voting rights, terms of redemption and liquidation preferences, any or all of
which may be greater than the rights of the common stock. Preferred stock could
thus be issued with terms that could delay or prevent a change in control of our
company or make removal of management more difficult. In addition, the issuance
of preferred stock may decrease the market price of the common stock and may
adversely affect the voting and other rights of the holders of common stock. We
have no plans at this time to issue any preferred stock.
LEGAL MATTERS
The validity of the common stock to be sold by the selling stockholders under
this prospectus will be passed upon for us by Richardson & Patel LLP. Richardson
& Patel LLP owns 100,000 shares of our common stock and an option to purchase
50,000 shares of our common stock.
EXPERTS
The financial statements for Bio-Bridge Science, Inc. as of December 31, 2004
and for the years ended December 31, 2004 and 2003 and for the period February
11, 2002 (inception) through December 31, 2004 included in this prospectus have
been audited by Weinberg & Company, P.A., the registered independent accounting
firm to the extent and for the periods set forth in their report appearing
elsewhere herein and are included in reliance upon such report given upon the
authority of that firm as experts in auditing and accounting.
DISCLOSURE OF COMMISSION POSITION OF INDEMNIFICATION FOR
SECURITIES ACT LIABILITIES
We have adopted provisions in our certificate of incorporation that limit the
liability of our directors for monetary damages for breach of their fiduciary
duty as directors, except for liability that cannot be eliminated under the
Delaware General Corporation Law. Delaware law provides that directors of a
company will not be personally liable for monetary damages for breach of their
fiduciary duty as directors, except for liabilities:
o for any breach of their duty of loyalty to us or our stockholders;
o for acts or omissions not in good faith or which involve intentional
misconduct or a knowing violation of law;
o for unlawful payment of dividend or unlawful stock repurchase or redemption,
as provided under Section 174 of the Delaware General Corporation Law; or
o for any transaction from which the director derived an improper personal
benefit.
22
In addition, our bylaws provide for the indemnification of officers, directors
and third parties acting on our behalf, to the fullest extent permitted by
Delaware General Corporation Law, if our board of directors authorizes the
proceeding for which such person is seeking indemnification (other than
proceedings that are brought to enforce the indemnification provisions pursuant
to the bylaws).
These indemnification provisions may be sufficiently broad to permit
indemnification of the registrant's executive officers and directors for
liabilities (including reimbursement of expenses incurred) arising under the
Securities Act of 1933.
Insofar as indemnification for liabilities arising under the Securities Act of
1933 may be permitted to our directors, officers and controlling persons
pursuant to the foregoing provisions, or otherwise, we have been advised that in
the opinion of the SEC such indemnification is against public policy as
expressed in the Securities Act of 1933 and is, therefore, unenforceable. No
pending material litigation or proceeding involving our directors, executive
officers, employees or other agents as to which indemnification is being sought
exists, and we are not aware of any pending or threatened material litigation
that may result in claims for indemnification by any of our directors or
executive officers.
DESCRIPTION OF BUSINESS
GENERAL
We are a development stage company whose subsidiaries are focused on the
commercial development of biological products for the prevention and treatment
of human infectious diseases. Through our wholly owned subsidiaries, we develop
and commercialize HIV-PV Vaccine I, a vaccine designed to prevent and treat
infection by the human immunodeficiency virus, or HIV. The original HIV-PV
Vaccine I technology was co-developed by Dr. Liang Qiao, our chief executive
officer and an associate professor at Loyola University Chicago, and is owned by
Loyola University. In June 2002, Loyola University exclusively licensed this
technology to our subsidiary Bio-Bridge Science Corporation with respect to
People's Republic of China, Japan and the United States. Pursuant to an
agreement with the Beijing Institute of Radiation Medicine, most of the
pre-clinical testing of HIV-PV Vaccine I on laboratory animals in mainland China
was completed in October 2005. Once the pre-clinical testing is completed, we
plan to apply to China's State Food and Drug Administration for approval to
conduct clinical trials of HIV-PV Vaccine I.
Our primary strategy is to develop, test and obtain regulatory approval for
HIV-PV Vaccine I in China first and then in the United States and Japan. In May
2003, we purchased the right to use for fifty years approximately 2.8 acres of
land in the Tianzhu Export Processing Zone, Shunyi District, Beijing, China to
develop a laboratory and biomanufacturing facility in compliance with Good
Manufacturing Practices, or GMP, regulations primarily for clinical trials of
HIV-PV Vaccine I. Under Chinese law, there is no private ownership of land, and
accordingly, we do not own this land. In July 2003, we engaged a contractor to
design the GMP facility. As of December 15, 2005, we have completed the
construction of the outside body of our laboratory and biomanufacturing
facility. The approximate cost of building and outfitting this facility is
$3,000,000. As of December 29, 2005, we have paid all amounts owed.
After completion of pre-clinical animal testing through collaboration with
Beijing Institute of Radiation Medicine, we intend to submit application for
approval of clinical study to Beijing branch of SFDA. If we receive approval, we
will conduct Phase I, II and III human clinical trials. If these clinical trials
show that our vaccine is safe and effective, we will apply for a new drug
approval certificate and approval for sale. We intend to conduct a phase IV
clinical study after our vaccine is made available to the market.To date, we
have not commenced clinical testing of this vaccine, nor has it been approved by
the China State Food and Drug Administration or any other regulatory agency.
Further, we have not received any revenues to date and, until we receive the
necessary approvals from the SFDA or a similar regulatory authority located in
Japan or the United States, we will not have any revenues.
On November 21, 2005, we entered into an exclusive distribution agreement with
Xinhua Surgical Instruments Co., Ltd., located in Shandong, China. Under this
agreement, we have been granted exclusive distribution rights for all Xinhua
surgical instruments in the United States, which are subject to FDA approval.
Our minimum turnover requirement begins in the second year in the amount of
$50,000 and increases to $60,000 during the third year and increases 10%
annually thereafter. We are responsible for advertising and marketing expenses
in connection with distribution of Xinhua surgical instruments in the United
States. Subject to minimum turnover requirements, our exclusivity rights in the
United States will be extended unless we fail to fulfill the minimum turnover
requirements. On December 6, 2005, we received confirmation from the FDA of our
registration as a medical device establishment, which enables us to perform
initial distributor and repackager operations. This confirmation is not FDA
approval of any product or any of our activities. It is neither a license, nor a
certification. We intend to begin marketing Xinhua surgical instruments that
meet the criteria for class I medical devices under FDA rules, which do not
require pre-market notification to FDA.
We have incurred significant losses since inception as a result of research and
development and general and administrative expenses in support of our
operations. We expect to continue to incur substantial losses over at least the
next year as we complete our pre-clinical trials, apply for regulatory approvals
of clinical trials, construct our laboratory and biomanufacturing facility and
continue development of our technology. We will need to raise additional capital
in the next 12 months to meet these operating expenses. See "Plan of Operation."
23
HISTORY, REORGANIZATIONS AND CORPORATE STRUCTURE OF THE COMPANY
We were incorporated in Delaware on October 26, 2004 for the purpose of creating
a holding company for Bio-Bridge Science Corp. On November 4, 2004, we initiated
exchange offers to the shareholders of Bio- Bridge Science Corp. By November 12,
2004, 100% of the shareholders of Bio-Bridge Science Corp. had tendered their
shares. Effective December 1, 2004, we issued 29,971,590 shares of our common
stock to the shareholders of Bio-Bridge Science Corp. pursuant to the Agreement
for the Exchange of Shares dated as of November 4, 2004 ("Exchange Agreement")
by and among us, Bio-Bridge Science Corp. and the shareholders of record of
Bio-Bridge Science Corp. As a result of this exchange reorganization, effective
the date of December 1, 2004, we became the sole shareholder of Bio-Bridge
Science Corp., and it became our wholly owned subsidiary. The Bio-Bridge Science
Corp. shareholders acquired control of our company pursuant to the Exchange
Agreement, resulting in Dr. Liang Qiao's ownership of 13,750,000 shares or
approximately 45% of our company. The directors and members of management of
Bio-Bridge Science Corp. are the same directors and management of Bio-Bridge
Science, Inc., the Delaware corporation. There was no change in corporate
structure before and after the incorporation of Bio-Bridge Science, Inc. The
acquisition will be accounted for as a reverse merger (recapitalization) with
Bio-Bridge Science Corp. deemed to be the accounting acquirer, and Bio-Bridge
Science Inc. deemed to be the legal acquirer. Accordingly, the historical
financial information presented herein is that of Bio-Bridge Science Corp. as
adjusted to give effect to any difference in the par value of the issuer's and
the accounting acquirer's stock with an offset to capital in excess of par
value. The historical basis of assets, liabilities and retained earnings of
Bio-Bridge Science Corp., the accounting acquirer will also be carried forward
after the acquisition. Also, Bio-Bridge Science Corp. basis of its assets and
liabilities will be carried over in the recapitalization.
Bio-Bridge Science Corp. was incorporated in the Cayman Islands on February 11,
2002 to complete development of, and commercialize, HIV-PV Vaccine I, a vaccine
designed to prevent and treat infection and disease caused by HIV, the virus
that causes AIDS. At the time of the share exchange Bio-Bridge Science Corp.'s
directors included Dr. Liang Qiao, Wenhui Qiao, Toshihiro Komoike, Isao Arimoto
and Shyh-Jing (Philip) Chiang. Its executive officers consisted of Dr. Liang
Qiao, chief executive officer and secretary, Wenhui Qiao, president, Chuen Huei
(Kevin) Lee, chief financial officer, and Isao Arimoto, vice president.
Bio-Bridge Science Corp. holds a 100% interest in Bio-Bridge Science (Beijing)
Corp. Ltd., a Wholly-Foreign Funded Enterprise of the People's Republic of
China, which was established on May 20, 2002. Bio-Bridge Science (Beijing) was
issued an operating license for 25 years on May 20, 2002. This license can be
renewed for an additional 25 years after it pays a nominal fee. This 25-year
limitation currently applies to all commercial enterprises in the People's
Republic of China. Bio-Bridge Science Corp., through its wholly owned subsidiary
in Beijing, China, is currently engaged in the development and commercialization
of HIV-PV Vaccine I, in China. Bio-Bridge Science (Beijing)'s executive officer
is Wenhui Qiao, general manager. Its directors include Wenhui Qiao, chairman,
Dr. Liang Qiao, vice chairman, Mingjin Yu, Isao Arimoto and Shyh- Jing (Philip)
Chiang.
On April 12, 2004, Bio-Bridge Science Corp. acquired 2,240,000, or 100% of the
outstanding shares, of Aegir Ventures, Inc., a public reporting company, for a
purchase price of $40,000. As a result of this acquisition, Aegir Ventures,
Inc., a Delaware corporation, became a wholly owned subsidiary of Bio-Bridge
Science Corp. In connection with this transaction, Mingjin Yu was appointed
president, secretary, treasurer and director of Aegir Ventures, Inc. On November
26, 2004, Bio-Bridge Science Corp. sold 2,240,000 shares, representing all
issued and outstanding capital stock of Aegir Ventures, to Nakagawa Corporation,
a Japan corporation, in exchange for $40,000 payable by promissory note over one
year. In connection with the closing of this transaction on November 26, 2004,
Mingjin Yu resigned from the positions of president, secretary, treasurer and
director of Aegir Ventures, and Nakagawa Koichi was appointed to these
positions.
OVERVIEW OF HIV AND AIDS IN CHINA, JAPAN AND THE UNITED STATES
HIV is the virus that causes Acquired Immunodeficiency Syndrome, or AIDS, a
lethal disease characterized by the gradual deterioration of the human immune
system. HIV is transmitted by three predominant means: sexual contact; exposure
to blood from an infected person, such as sharing needles in drug use; and
transmission from infected mothers to their newborns. Although the disease is
manifested in many ways, the problem common to all patients is the destruction
of essential immune cells known as T lymphocytes, or T cells. Destruction of
these T cells by HIV makes the body particularly vulnerable to infections and
cancers that typify AIDS and ultimately cause death. Blocking HIV infection
would prevent AIDS.
CHINA
It is officially estimated that China has 840,000 people infected with HIV, and
the number is growing according to a survey by the Ministry of Health of China
in 2003. According to the United Nations and other various estimates, the number
of HIV-infected population in China is around 800,000 to 1.5 million and the
number can reach 10-15 million by 2010 if no major precautionary measure is
taken. According to the Joint United Nations Program on HIV/AIDS, or UNAIDS, and
the World Health Organization, or WHO, and their report dated 2003, high rates
of HIV prevalence has been found among injecting drug users - 35-80% in Xinjiang
and 20% in Guangdong provinces of China - while a severe HIV epidemic has
affected communities in China where unsafe blood-collection practices occurred
in the 1990s. The HIV epidemic has spread to 31 provinces, autonomous regions
and municipalities, and the number of reported HIV/AIDS cases has increased
significantly in recent years.
24
The Chinese government has taken steps to curb the HIV/AIDS epidemic, including
prioritizing AIDS drug approval and establishing a policy, referred to as the
Green Mile policy in this prospectus, to expedite the drug approval process. In
2001, the PRC Ministry of Health, the lead government agency responsible for
addressing the HIV/AIDS issue, formed a Center for Disease Control and
Prevention, adopted a five-year action plan, and increased government spending
at the national and provincial levels. The funding for safety of national blood
banks has been increased through a RMB 1.5 billion (about $181 million)
government bond issue, and China's 2001 budget for HIV/AIDS prevention and
treatment increased to RMB 100 million per year (US$12 million). As a
comparison, from 1990 to 1995, annual spending by the central government on
HIV/AIDS was estimated to be around US$500,000 per year, reaching approximately
$1.8 million per year from 1996 to 2000. In 2003, the central government spent
$40 million on HIV/AIDS, and it was expected that the amount will be increased
to $56.8 million in 2004 according to Vice Minister of Ministry of Health, who
chaired a press conference on curing HIV/AIDS in China on June 29,2004. To date,
we have not received any funding commitments from the Chinese government, nor
have we applied for any government funding. However, we may apply for government
funding in the future.
International and domestic programs have been undertaken to help prevent the
spread of HIV in China and treat the patients infected by HIV. Grassroots
organizations have created peer-education groups, and even small groups of
independently organized college students are traveling to the countryside to
teach prevention and raise awareness of HIV. International non-governmental
organizations, foreign governments and the United Nations are all active in
China and have invested funds and expertise in addressing the HIV epidemic. The
Chinese government has expressed a willingness to work with the international
community to create policies and programs that will prevent HIV/AIDS from
spreading.
Chinese government policies currently emphasize treatment of HIV/AIDS by locally
producing more affordable antiretroviral treatments and negotiating reduced
prices for patented antiretrovirals produced by multinational pharmaceutical
companies to create "cocktail" treatments to suppress HIV. The prices of
imported and Chinese-produced medications are still well beyond the reach of the
vast majority of Chinese who have HIV. As a result, China is encouraging
HIV/AIDS research in order to develop effective HIV/AIDS vaccine and treatment
drugs. China's SFDA has given priority to domestically produced anti-AIDS drugs
during the examination and approval process, so as to expedite public access to
HIV drugs.
JAPAN
There are an estimated 20,000 people living with HIV/AIDS in Japan as of 2003.
Statistics reveal that the number of newly reported HIV infections and AIDS
diagnoses continues to climb steadily, making Japan an exception among
high-income countries. Experts point out that the epidemic may be spreading much
more quickly than available figures indicate, and that this increase may be
linked to changes in the sexual behavior of young people, greater migration
across national borders, and delays in the early identification of infection due
to inadequate availability of testing and counseling. Unless effective
preventive action is taken, the number of infected is likely to more than double
to 50,000 by the year 2010.
The Ministry of Health, Labor and Welfare is at the forefront of domestic
policies while the Ministry of Foreign Affairs formulates foreign policies on
HIV/AIDS, and no concerted national policy has yet been articulated to bridge
the various efforts in the fight against the domestic and global spread of the
epidemic. Much of Japan's present-day legal and regulatory framework, social
welfare coverage, promotion of basic and clinical research and provision of
medical care and treatment concerning HIV/AIDS in Japan has arisen out of the
1996 settlement agreed to by representatives of the HIV-infected hemophiliacs
and the Ministry of Health, Labour and Welfare. The epidemic was first
identified in Japan among hemophiliacs who had been infected through
contaminated blood products. When the contamination was linked to the failure of
pharmaceutical companies and government officials to exercise proper safeguards,
scandal erupted. This scandal peaked in the mid-1990's and became the climactic
point in the history of HIV/AIDS in Japan, but once the legal settlement was
reached, the issue of AIDS appeared to have been put to rest in the eyes of the
general public. Ever since, the level of interest in HIV/AIDS in Japanese
society has remained low. The implementation of effective measures to promote
prevention and awareness-raising regarding sexual transmission of the disease,
in comparison to the 1996 settlement, lags far behind. Nonetheless, there is a
growing demand for greater efforts to counter the rapid spread of the epidemic
among populations vulnerable to HIV infection.
Fighting infectious diseases has been given priority in Japan's Official
Development Assistance scheme, and the government has pledged a total of US$3
billion under the Okinawa Infectious Diseases Initiative for the five-year
period from 2000 to 2004. Although Japan can boast considerable expertise in
treating tuberculosis, polio, and parasitic diseases, the same cannot be said in
the case of HIV/ AIDS, an area where Japan's potential contribution is seen as
relatively limited. Consequently, the Japanese government has resorted to taking
a comprehensive approach to fight all infectious diseases rather than focusing
solely on HIV/AIDS. In this sense, the Okinawa Infectious Diseases Initiative
fails to give high priority to HIV/AIDS, including it as one of many targeted
infectious and parasitic diseases. Indeed, projects under this initiative that
are specifically related to HIV/AIDS have only accounted for 8 percent of total
expenditures.
There are approximately 100 community-based nongovernmental organizations
involved in HIV/AIDS issues on the domestic scene, which are mostly run on a
volunteer basis by medical experts or people living with HIV/AIDS. They have
been effective in conducting prevention programs and offering care and support
for population groups vulnerable to HIV infection and not adequately reached by
public agencies. Private financial resources for NGOs involved in HIV/AIDS
issues are severely limited. Grants from private foundations seldom go to
support nongovernmental organizations engaged in grassroots activities.
Meanwhile, although many foundations fund research and offer scholarships in the
fields of health, medicine and welfare, none give top priority to HIV/AIDS.
25
United States
The UNAIDS 2004 report on the global AIDS epidemic finds that infections are on
the rise in the U.S. An estimated 950,000 people are living with HIV in the
U.S., an increase from 900,000 in 2001. An estimated 40 000 people have been
infected with HIV each year in the U.S. in the last ten years, but the epidemic
is now disproportionately lodged among African Americans and is affecting much
greater numbers of women. In 2003, African Americans accounted for at least 25%
of all AIDS cases, compared with 20% in 2001. That proportion could be higher,
since the estimate was based on data collected in just 29 states. Although
African Americans represent just 12% of the country's population, over half of
new HIV diagnoses in recent years have been among them. Especially affected are
African American women, who account for up to 72% of new HIV diagnoses in all
U.S. women. According to the Centers for Disease Control and Prevention, AIDS
ranked among the top three causes of death for African American men aged 25-54
and for African American women aged 35-44 years in 2000. Although race and
ethnicity are not per se risk factors for HIV, poverty and other forms of
socioeconomic deprivation, however, are known to increase vulnerability to HIV
infection. It is estimated that one in four African Americans lives in poverty,
and some studies in the U.S. have discerned a close relationship between higher
AIDS incidence and lower income. It is possible that high incarceration rates,
particularly for African American men, could be an amplifying factor in the
epidemic through injecting drug use and unprotected sex in prison institutions.
For men overall, and African American men specifically, the vast majority of HIV
infections occur during injecting drug use and sex between men. High levels of
risk behaviour are still being found especially among younger men who have sex
with men. However, heterosexual intercourse accounts for most HIV diagnoses
among women, and there are strong indications that the main risk factor for many
women acquiring HIV is the often-undisclosed risk behaviour of their male
partners. Recent research in a low-income area of New York City, for example,
has shown that women were more than twice as likely to be infected by a husband
or steady boyfriend than by casual sex partners. Along with injecting drug use,
unsafe sex with other men on the part of male partners appears to be a
significant risk factor for some women. A seven-city study among men who have
sex with men has found that 9% of them also had sex with women, and a more
recent study among young African American men who have sex with men found that
20% of the men reported also having female sex partners.
The great majority of people living with HIV in high-income countries, including
the U.S., who need antiretroviral therapy have access to it, so they are staying
healthy and surviving longer than infected people elsewhere. After the
introduction of antiretroviral therapy in 1995 and 1996, AIDS-related deaths
fell steeply in the U.S until the late 1990s and then continued to decline more
gradually--from 19,005 reported AIDS deaths in 1998 to 16,371 deaths in 2002.
However, the rate of death due to AIDS among African Americans was over twice as
high as that among whites in 2002. African Americans now have the poorest
survival rates among people diagnosed with AIDS-probably reflecting late
diagnoses, often after the disease has become symptomatic, and inadequate access
to quality health care services.
Progress recently has been made in treating HIV infection. Current HIV therapies
slow multiplication of the virus and delay the onset of AIDS. They do not cure
HIV infection or AIDS. Considering costs, toxicities, difficulties in compliance
with complex drug regimens and the development of resistance to these drugs, we
believe such therapies will be available only to a small fraction of the
HIV-infected population. Accordingly, we believe they will probably have a
minimal impact on the worldwide epidemic.
GOVERNMENT REGULATION IN CHINA, JAPAN AND THE UNITED STATES
Our HIV-PV Vaccine I product candidate must receive regulatory approval before
it is marketed. The regulatory requirements involve stringent standards that may
vary among different countries. In general, before a drug can qualify for
marketing approval, a registration application must be submitted to a regulatory
authority for review and evaluation. The registration application principally
contains detailed information about the safety and efficacy of a new medication.
It also provides details about the manufacturing process, the proposed
production facility and information to be provided to health care providers or
patients. The registration process can last from several months to several years
and depends, among other things, on the laws and regulations of the country in
which the review takes place, the nature of the medication under review, the
quality of the submitted data, and the efficiency of the review procedure. The
process of developing a drug from discovery through testing, registration and
initial product launch typically takes 10 to 15 years and, according to recent
research by the Tufts Center for Drug Development, exceeds U.S. $800 million.
There are three phases to clinical testing of unapproved drug candidates in
humans:
o Phase I involves the first trial of a new drug candidate in humans. The focus
at this phase is an assessment of clinical safety, tolerability, and metabolic
and pharmacologic properties. Testing generally is performed in a small number
of human volunteers;
26
o Phase II trials are controlled clinical studies that test the safety and
efficacy of the drug candidate in several hundred patients with the targeted
disease. The goals of this phase include determining the appropriate doses for
further testing and identifying common side effects and risks that may be
associated with the drug;
o Phase III trials establish safety and effectiveness for regulatory approval
for indicated uses and to evaluate overall benefit-risk relationship. These
studies usually include from several hundred to several thousand people. The
results of these clinical trials are then submitted to appropriate regulatory
authorities with the objective of obtaining approval to sell the drug; and
o Phase IV trials may be conducted after approval and commercial launch to
further evaluate the safety and efficacy of the products or to investigate
potential new applications.
The State Drug Administration, or SFDA, in China regulates the drug approval
process. The process involves pre-clinical in vitro laboratory and in vitro
animal testing for toxicity and pharmacological effects, and submission to the
SFDA of an application for approval of clinical studies. The provincial branch
of the SFDA conducts an on-site review and sampling process and accepts the
application within a maximum of five days from the date of submission. The
Medicine Review Center of the SFDA then reviews the technology and may request
supplementary information from the applicant. The Medicine Review Center
completes its review within at least 100 days and the SFDA then approves the
clinical study or disapproves it. After the SFDA approves the application for
clinical trials, the applicant then presents the clinical study plan and
information concerning participating parties. The applicant may then proceed
with human clinical trial Phases I. II and III. Estimated completion times for
each phase includes six months for Phase I, nine to 12 months for Phase II and
12 to 18 months for Phase III (for therapeutic vaccines). The next step is to
apply to the SFDA for new drug certificates and approval for production and
sale. This step of the process takes approximately three months. The Green Mile
policy allows qualified applicants to enter the drug approval process
immediately without waiting in line for application. Thousands of new drugs
ordinarily wait for application each year. We estimate that the total drug
approval process in China may take at least three years for the therapeutic
HIV-PV Vaccine I and five to seven years for the preventative HIV-PV Vaccine I.
We plan to submit our application for approval of clinical study to the SFDA by
the end of 2005, if the pre-clinical animal testing is completed in October 2005
and our laboratory facility meets the GMP standards. However, any delay in
completion of pre-clinical testing or construction of our laboratory facility in
compliance with GMP standards would change the estimated date for submittal of
our application for approval of clinical study, and accordingly, increase the
amount of time estimated for SFDA approval. Moreover, positive results of
pre-clinical tests will not necessarily indicate positive results in clinical
trials. The SFDA has substantial discretion in the drug approval process and may
require us to conduct additional pre-clinical and clinical testing or to perform
post-marketing studies. We estimate the total cost to bring the therapeutic
HIV-PV Vaccine I to market in China is US$10 million, and we anticipate an
additional US$6 million will be needed to commercialize the preventative HIV-PV
Vaccine I in this market. We also anticipate that it will take longer,
approximately an additional 3 to 5 years, to conduct clinicial trials of the
preventative HIV-PV Vaccine I and test efficacy and safety of the drug in humans
for prevention of HIV infection.
The principal regulatory authority with respect to prescription drug approvals
in the U.S. is the Food and Drug Administration, or the FDA. The FDA administers
and executes requirements covering the research, development, testing, approval,
safety, effectiveness, manufacturing, labeling and marketing of prescription
drugs. Drug safety and efficacy are evaluated pursuant to FDA regulations
throughout the life of a product, and in particular at four distinct stages:
o preclinical safety assessment;
o pre-approval safety or efficacy assessment in humans, or Phase I, II and III
clinical trials;
o safety and efficacy assessment during FDA regulatory review, which is usually
completed in 10 to 12 months or six months for priority drugs; and
o post-marketing safety surveillance.
The results of the pre-clinical safety assessment together with manufacturing
information and analytical data are submitted to the FDA as part of the
Investigational New Drug Application, or IND, and are reviewed by the FDA before
the commencement of clinical trials. Unless the FDA objects to an IND by placing
the study on clinical hold, the IND will become effective 30 days following its
receipt by the FDA. If the FDA does place the study on clinical hold, the
sponsor must resolve all of the FDA's concerns before the study may proceed. The
IND application process may become extremely costly and substantially delay
development of products.
Clinical trials for drug candidates are typically conducted in three sequential
phases that may overlap. We estimate that Phase I clinical trial will take
approximately one year to complete. Phase II clinical trial is estimated to take
up to two years, and the Phase III clinical trial program is estimated to take
approximately three years. A New Drug Application, or NDA, is the formal step
asking the FDA for marketing approval of a new drug in the U.S., which includes
all animal and human testing and analyses of the data, as well as information
about how the drug behaves in the body and how it is manufactured. After the NDA
is received, the FDA has 60 days to decide whether to file it so that it can be
reviewed. The FDA can refuse to file an application, if it is incomplete. If the
FDA files the NDA, it then evaluates the safety, effectiveness and manufacturing
processes, which generally takes about 10 months, or six months for priority
drugs.
27
The FDA permits accelerated approval of biologics that are intended to reduce or
prevent serious or life-threatening conditions. Under these requirements, new
drugs may be approved for use in humans based on evidence of effectiveness
derived from appropriate animal studies and any additional supporting data.
Products evaluated for effectiveness under these requirements are evaluated for
safety under preexisting requirements for establishing the safety of new drug
and biological products, including Phase I and Phase II clinical trials. Most
drugs to treat HIV have been approved under accelerated approval provisions,
with the company required to continue its studies after the drug is on the
market. We intend to pursue FDA review of our HIV-PV Vaccine I candidate under
these requirements, which would shorten the approval process. However, under
accelerated approval rules, if studies do not confirm the initial results, the
FDA can withdraw the approval.
The FDA may also withdraw the product approval if compliance with pre- and
post-market regulatory standards is not maintained or if problems occur after
the product reaches the marketplace. In addition, the FDA may require
post-marketing studies to monitor the effect of approved products, and may limit
further marketing of the product based on the results of these post-market
studies. The FDA has broad post-market regulatory and enforcement powers,
including the ability to levy fines and civil and criminal penalties, suspend or
delay issuance of approvals, seize or recall products, and withdraw approvals.
Foreign regulatory bodies also enforce regulatory requirements.
We estimate that it will cost approximately $150 million to commercialize HIV-PV
Vaccine I in the U.S. However, we are focused on commercialization in China
first because the estimated cost of bringing the vaccine to market is lower in
China.
Japanese regulatory authorities recognize clinical data developed outside of
Japan, however, we will face two particular challenges that make the drug
approval process sometimes difficult for drugs developed outside of Japan.
First, the Japanese regulatory authorities request bridging studies to verify
that foreign clinical data are applicable to Japanese patients. Second, Japanese
regulatory authorities require the tests to determine appropriate dosages for
Japanese patients to be conducted on Japanese patient volunteers. Due to these
requirements, delays of two to three years in introducing a drug developed
outside of Japan to the Japanese market are possible. In recent years, efforts
have been made between the U.S. and Japan and countries in other regions to
achieve shorter development and registration times for medicinal products by
harmonizing the individual requirements of these three regions. The process is
called the International Conference on Harmonization. For the foreseeable
future, however, approval must be obtained separately in each market. The
Japanese regulatory process for approval of new drugs is similar to the FDA
approval process, and the estimated time needed to bring a new drug to market in
each step of the process is substantially the same. Japan has a fast track
program to accelerate approval of new drugs, but each case is considered
differently. Accordingly, we cannot estimate the time needed to commercialize
our product in Japan at this time. We anticipate that the cost to bring HIV-PV
Vaccine I to market in Japan will be US$150 million.
We anticipate that we will submit the application to SFDA for approval of
clinical trials by the end of 2005. We estimate that clinical trials for HIV-PV
Vaccine I to treat HIV-1-infected individuals may take at least two years and
that the entire approval process for the therapeutic HIV-PV Vaccine I will take
approximately three years from the date of this prospectus and five to seven
years for the preventative HIV-PV Vaccine I. However, the SFDA may require us to
conduct additional pre-clinical and clinical testing or to perform
post-marketing studies. Once the vaccine is approved for sale in China, we will
apply for regulatory approval of the vaccine in the U.S. and Japan.
VACCINES
Vaccines are preventative, and as a result, they are particularly suited to
address epidemics, including the HIV/AIDS epidemic.
Vaccines prevent infection by activating the immune system to neutralize
infectious viruses. The immune system's initial response to a virus includes the
production of antibodies, which are the only human immune response known to
prevent viral infection. The antibodies bind to a specific part of the virus and
prevent it from entering the cells. This specific structure, called an antigen,
is often a protein on the viral surface. If a virus cannot enter a cell, it is
unable to multiply and dies within a few hours in the host. This protection
against infection is called neutralization.
Several neutralizing antibodies isolated from HIV-infected individuals can
globally neutralize diverse strains of HIV. Administration of the neutralizing
antibodies in HIV patients resulted in reductions in amount of viruses present
in a given volume of blood. Thus, eliciting broadly neutralizing antibodies is a
major goal in HIV vaccine development. Neutralizing antibody-based HIV vaccine
can induce neutralizing antibodies, which block the viral entry into target
cells.
Different vaccine strategies are required to activate the immune system's
cytotoxic T-cells, which are white blood cells that search for and eliminate
virus-infected cells. Viruses replicate by subverting the metabolism of the
infected cell to make more virus. Once this process is completed, a new crop of
viruses leave the cell, often killing it in the process, and infect new cells.
Except while in transit between cells, viruses work inside the cells safe from
any antibodies. But early in the process, infected cells display fragments of
the viral proteins in their surface molecules. Cytotoxic T-cells recognize and
bind to the infected cell and often will be able to destroy it before it can
release a new crop of viruses. Most cytotoxic T-cells will die after they have
eliminated the infected cell, but some will become memory cells, or long-lived
cells ready to respond to a later exposure to the virus.
Virus specific cytotoxic T-cells have been detected in HIV-infected individuals.
These cytotoxic T-cells have been found to control viral replication, resulting
in slower progression of the AIDS disease. Cytotoxic T-cells-based HIV vaccine
can induce HIV specific cytotoxic T-cells that eliminate HIV infected cells and
control viral replication.
THE ROLE OF MUCOUS MEMBRANE DURING HIV INFECTION
HIV is transmitted sexually or directly into the bloodstream. The mucosal
surface is one of the most important portals for HIV transmission. The mucosal
surface is the membranous tissue that covers surfaces or lines a tube or cavity
of the body and serves to enclose and protect parts of the body from the
exterior environment. Mucosal surfaces include the mouth, intestinal and vaginal
cavity. The tissue in intestinal mucosa contains many immune cells that are
usually infected with HIV-1 in patients with AIDS. During the course of an AIDS
infection, the intestine is the earliest target for viral infection and loss of
immune cells. Thus, now it is clear that HIV infection is primarily a disease of
the mucosal immune system. Some candidate vaccines that induced relatively
strong systemic immune responses in connection with virus transmitted directly
into the bloodstream have failed to provide adequate protection in non-human
primate models. Therefore, there is reason to believe that mucosal immunity will
be essential for designing an effective AIDS vaccine. Accordingly, we believe
that it is important for the ideal HIV vaccines to induce not only systemic but
also mucosal HIV-specific immune response to prevent the entry of HIV into the
mucosa, to inhibit HIV replication, and to clear HIV during and after
transmission. We believe that stimulating mucosal immune responses, including
neutralizing antibodies and cytotoxic T cells, will be key in the development of
an effective AIDS vaccine.
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PRODUCTS UNDER DEVELOPMENT
HIV-PV VACCINE I FOR HIV/AIDS
Bio-Bridge HIV-PV Vaccine I is based on the unique papillomavirus pseudovirus
technology co-developed by Dr. Liang Qiao. The basic principle is to package
selected HIV genes, such as those encoding HIV-1 Gag, or the core protein of
HIV-1, by the non-infectious papillomavirus virus-like particles to form
papillomavirus pseudoviruses.
Papillomavirus are sexually transmitted viruses and their major structural
protein can spontaneously assemble into virus-like particles. These particles
can package unrelated genes encoding proteins of interest, including genes for
HIV proteins, to form papillomavirus pseudovirus. Papillomavirus pseudoviruses
are benign viruses, or vectors, that deliver the genes for HIV proteins to cells
in mucosal and systemic lymphoid tissues via oral route. The infected cells then
produce HIV proteins, or antigens, that can then attract the attention of
cytotoxic T-cells. Our tests show that oral immunization with papillomavirus
pseudoviruses encoding HIV-1 Gag induces mucosal and systemic HIV-1 Gag-specific
cytotoxic T-cell response.
Our papillomavirus pseudovirus technology is also designed to administer viral
peptides, or fragments of viral proteins, to induce an immune response. Three
regions of the major structural protein of bovine papillomavirus can be replaced
by unrelated viral peptides to generate chimeric virus-like particles, or
particles that consist of parts from two or more proteins of diverse origins. We
have introduced HIV gp41 fragments on papillomavirus chimeric virus-like
particles, which have induced mucosal and systemic HIV-specific neutralizing
antibody response in orally immunized mice. HIV gp41 is one of two proteins
located on the surface of HIV that facilitates the fusion of the viral membrane
with the cellular membrane. If gp41 can be inhibited, then viral membrane fusion
may be blocked and HIV may be prevented from entering and infecting cells. Thus,
we use gp41-papillomavirus chimeric virus-like particles presenting HIV-1 gp41
fragments to package selected genes encoding HIV-1 Gag to generate
HIV-papillomavirus pseudoviruses, which can be used as an oral vaccine to induce
both mucosal and systemic HIV-1- neutralizing antibodies and cytotoxic T-cells.
PRE-CLINICAL TESTING OF HIV-PV VACCINE I
Most of the pre-clinical animal testing of Bio-Bridge HIV-PV
Vaccine I, or Vaccine I, has been completed in China pursuant to agreements with
the Beijing Institute of Radiation Medicine. We entered into an agreement with
Beijing Institute of Radiation Medicine on May 6, 2004 to conduct the
pre-clinical studies of safety and immunogenicity assessment of HIV-PV Vaccine
I. These studies include acute toxicity test, chronic toxicity test,
immunogenicity and immunological test, safety pharmacology and reproductive
toxicity test. The information obtained from toxicity tests is generally useful
for determining doses for additional studies, including Phase I clinical trials,
providing preliminary identification of target organs of toxicity and,
occasionally, revealing delayed toxicity. The immunogenicity and immunological
tests are useful for detecting anti-drug antibodies in response to a drug
candidate that may compromise the safety of the drug candidate. The term of this
agreement is from May 6, 2004 to March 15, 2005, however the parties have agreed
to continue the testing pursuant to the agreement. The aggregate amount for the
testing is RMB 800,000 or US$96,734, under the terms of the agreement. As of
September 30, 2005, the amount paid under this agreement was 400,000 RMB, or
$48,367, and the remaining commitment was 400,000 RMB, or US$48,367.
Beijing Institute of Radiation Medicine will also conduct biodistribution and
integration studies for HIV-PV Vaccine I pursuant to an agreement that we
entered into on May 12, 2004. This agreement does not specify a termination
date. However, Beijing Institute of Radiation Medicine has agreed to accomplish
the tests within 10 months after beginning the program pursuant to the terms of
the agreement. Our aggregate fee for these tests pursuant to the agreement is
200,000 RMB, or $24,184. As of September 30, 2005, we have paid $19,347, or
160,000 RMB under this agreement, and the remaining commitment was 40,000 RMB,
or US$4,837. To date, the acute toxicity test and immunogenicity test have been
successfully completed. We entered into confidential agreements with Beijing
Institute of Radiation Medicine to protect our proprietary interests. We
anticipate that Beijing Institute of Radiation Medicine will submit a final
report on the preclinical studies by the end of 2005. We will then submit the
application for clinical studies to SFDA.
THE MARKET FOR HIV-PV VACCINE I
According to Datamonitor, the worldwide market for HIV/AIDS drugs is expected to
increase from nearly $8 billion in 2004 to $12 billion by 2012. Although
industrialized countries currently share a disproportion amount on spending
related to HIV/AIDS, major international organizations, including United
Nations, have and may continue to provide funds to developing countries in order
to effectively curb the spread of HIV/AIDS epidemic in these countries. The
Global Fund to Fight AIDS, Tuberculosis and Malaria was created in 2002 to
increase resources to fight three of the world's most devastating diseases, and
to direct those resources to areas of greatest need. Total spending by Global
Fund as of 2004 was $3 billion, over 50% of which was spent on fighting HIV/AIDS
in developing countries.
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The Chinese government has increased its resources to fighting HIV/AIDS
including treatment to people living with HIV and additional resources for HIV
prevention programs targeting vulnerable groups. In 2003, the central government
spent $40 million on HIV/AIDS, and it was expected the amount will be increased
to $56.8 million in 2004. The Global Fund has also committed $56 million to
China for HIV/AIDS related programs as of November 2004, but there is no
guarantee that China will receive these funds.
We anticipate that our initial market for HIV-PV Vaccine I will be primarily in
China. To our knowledge, currently there is no effective HIV/AIDS vaccine drug
commercially available either in China or other parts of the world. However, we
estimated the size of this market to be at least $300 million per annum, based
on the current HIV/AIDS population in China and average cost of HIV/AIDS
treatment available in China, which is currently growing at more than 20% per
year.
INTELLECTUAL PROPERTY
In April 2002, our wholly owned subsidiary, Bio-Bridge Science Corporation,
entered into an agreement with Loyola University Chicago for an exclusive
license of our core technology related to papillomavirus pseudovirions as a
genetic vector and vaccine. The license is royalty-bearing, covers the countries
of the U.S., Japan and PRC, and includes the right to grant sublicenses. This
exclusive license gives us rights to all uses in all fields under the
papillomavirus technology. The term of this license is perpetual or for the
maximum period of time permitted by law, unless terminated pursuant to the terms
of the license. We may terminate the license at will upon no earlier than 45
days and no later than 30 days notice to Loyola University. If, five years after
U.S., Japan and China governments have granted permit for its use as a drug, and
Bio-Bridge has made no effort in marketing the product, then Loyola University
of Chicago may terminate this agreement. Pursuant to the agreement, we will pay
to Loyola a royalty of 4% from the net profit for all uses of the licensed
technology, including uses under sublicenses, reimbursement of expenditures and
legal fees in the amount of $3,000 in granting the exclusive license for each
country, and $50,000 in the event we are granted a permit of production under
the licensed technology in these countries. To date, we have not generated any
revenues from the sale of any products under development, nor any revenues from
sublicenses, and accordingly, no royalty is due under the agreement. We have
reimbursed Loyola for expenditures and legal fees in an aggregate amount of
$9,000 in connection with granting the exclusive license in each of the three
countries. Since we have not been granted a permit of production in these
countries, no payment of $50,000 is due under the agreement.
Under the license agreement with Loyola we have the right to file patent
applications and the right to initiate and control any actions concerning any
claims of infringement. Dr. Liang Qiao has applied for patents related to the
papillomavirus technology in China, Japan and the U.S. The patent was granted in
China on July 16, 2003 under patent publication number CN 133338A for a term of
20 years. The U.S. Patent and Trademark Office issued the patent for papilloma
pseudo-virus and preparation on April 12, 2005 under patent number 6,878,541 B2.
U.S. patents generally have a term of 20 years from the date of filing. This
patent is due to expire in 2022. In the biotechnology industry, it often takes
several years from the date of filing of a patent application to the date of a
patent issuance, often resulting in a shortened period of patent protection,
which may adversely affect our ability to exclude competitors from our markets.
The patent application in Japan is pending. On February 17, 2005, we filed a
continuation application of the U.S. patent for broader protection of the
technology than the issued patent. Under the license agreement, Loyola owns the
patents related to the papillomavirus technology.
This license was followed by a second exclusive license agreement for the same
technology between our wholly owned subsidiary Bio-Bridge Science Corporation
and Bio-Bridge Science (Beijing), effective as of June, 2002. This sublicense
covers the territory of mainland China and expires in June 2012. Under the terms
of the sublicense, Bio-Bridge (Beijing) may use the technology at no charge and
has the right to file patent applications and enforce its right to the
technology.
RESEARCH AND DEVELOPMENT
As of September 30, 2005, we had a total of 6 employees dedicated to research
and development. Our research team includes biologists and doctors. We spent
approximately $109,835 during the fiscal year ended December 31, 2004 on the
research and development of HIV-PV Vaccine I. We also spent $394,559 on the
purchase of a land use right for fifty years of approximately 2.8 acres in
Tianzhu Export Processing Zone, Beijing, China during 2003 in order to build our
research laboratory. Under current Chinese law, the land use right may be
extended for an additional 50 years for a one-time fee of approximately $78,780.
Under Chinese law, there is no private ownership of land, and accordingly, we do
not own this land. Currently, we have engaged Beijing Institute of Radiation
Medicine to conduct the pre-clinical animal testing of the HIV-PV Vaccine I.
Beijing Institute of Radiation Medicine is a SFDA-approved national pre-clinical
new drug safety evaluation center that meets national laboratory standards. It
is a leading institution in biotech medicine in China. Its members include four
members of the Chinese Academy of Science or Chinese Academy of Engineering and
32 nationally well-known professionals.
LABORATORY/LAND USE
On May 28, 2003, we entered into a land use agreement with Beijing Airport
High-Tech Park Co. Ltd, or BTA, regarding the use of the 2.8 acres of land, on
which we are currently building our research laboratory to conduct the clinical
trial of HIV-PV Vaccine I. This agreement expires in 2053. Under current Chinese
law, the land use right may be extended for an additional 50 years for a
one-time fee of approximately $78,780. We have paid the entire land use price to
BTA pursuant to the agreement. As of April 2005, the construction of the outside
body of the facility was completed. When finished, we expect that the lab will
meet the GMP standard and will be eligible to conduct the clinical trial under
the current China SFDA rules. The facility is expected to have total utilized
areas of 53,753 square feet. Under Chinese law, there is no private ownership of
land, and accordingly, we do not own this land. Land use rights can be purchased
and sold under Chinese law.
30
COMPETITION
To our knowledge, currently there is no effective HIV vaccine commercially
available to patients in the world. We are currently focused on the commercial
development of an HIV vaccine. The pharmaceutical industry in which we
participate is highly competitive. We face intense competition from a number of
companies in the pharmaceutical industry, including Chiron Corp., Merck & Co.,
Inc., Aventis Pasteur and Targeted Genetics Corp. These companies are conducting
or have completed Phase I or Phase II clinical trials of HIV vaccines. In
addition, several of these companies and others are developing new drug
therapies and other treatments that may mitigate the impact of the disease. In
February 2004, Vaxgen announced that it failed the AIDS phase III clinical
trial. These companies are all substantially larger and more established than we
are and have significantly greater financial resources and experience in
developing and marketing drugs than we do. Thus, they may be in a better
position to compete in the pharmaceutical industry. Companies in this industry
compete based on technological leadership and superiority, speed to market,
improved patient outcomes, effective marketing and distribution and acceptance
by medical professionals, and therefore, continually seek to develop products
that provide benefits that are similar to the product being developed by us.
Although there are companies that are developing competing vaccines, we believe
that we can prevent others from developing a competing vaccine using the same or
similar technology.. We intend to explore potential collaborative relationships
with Chinese pharmaceutical companies and other companies with vaccine sales
experience to market our product candidate. By developing such strategic
relationships, we believe that we can enhance our competitive position in this
highly competitive marketplace.
ENVIRONMENTAL REGULATION
The construction of our laboratory facility in China is subject to extensive
inspection and evaluation by the respectively regulatory agencies in China,
including Beijing Tianzhu Export Processing Zone Management Commission and
Beijing Municipal Planning Commission. We also retained the Environmental Impact
Assessment Center at China Agriculture University to conduct the environmental
impact assessment of the project as required by Chinese law. The environmental
assessments were provided with regard to the construction of the laboratory
facility. These assessments found no potential environmental hazard resulting
from our research and development efforts. The assessment confirms our
compliance with the environmental regulations and was accepted by the EPA of
Beijing Government.
SCIENTIFIC ADVISORY BOARD
Our Scientific Advisory Board provides specific expertise in areas of research
and development relevant to our business and meets with our management personnel
from time to time to discuss our present and long-term research and development
activities. Scientific Advisory Board members include:
o Gregory T. Spear, PhD, Professor, Department of Immunology and Microbiology,
Rush University. Dr. Spear is an expert in the areas of HIV infection and its
interactions with the immune system.
o Katherine L. Knight, PhD, Professor and Chairperson, Department of
Microbiology and Immunology, Stritch School of Medicine, Loyola University
Chicago. Dr. Knight is an expert in immunology.
EMPLOYEES
We currently have 22 employees, including four on our clinical staff, six on our
research and development staff, seven on our management/administration staff,
one person for regulatory and quality services and four on our manufacturing and
general affairs staff.
MANAGEMENT DISCUSSION AND ANALYSIS
The following discussion of our financial condition and results of operations
should be read in conjunction with our consolidated financial statements and the
notes to those statements included elsewhere in this prospectus. In addition to
the historical consolidated financial information, the following discussion and
analysis contains forward-looking statements that involve risks and
uncertainties. Our actual results may differ materially from those anticipated
in these forward-looking statements as a result of certain factors, including
those set forth under "Risk Factors" and elsewhere in this prospectus.
OVERVIEW
Bio-Bridge Science, Inc. is a development stage company whose subsidiaries are
focused on the commercial development of HIV-PV Vaccine I technology. We are
currently conducting pre-clinical testing of HIV-PV Vaccine I on laboratory
animals in Beijing, China, most of which was completed in October 2005. Once the
pre-clinical testing is completed, we will apply to China's State Food and Drug
Administration for approval to conduct clinical trials of HIV-PV Vaccine I. As
of April 2005, we have completed the construction of the outside body of our
laboratory and biomanufacturing facility in Beijing, China.
Since inception, we have generated no revenues. We incurred net losses of
$944,437 in 2004 and $255,020 in 2003. As of September 30, 2005, we had an
accumulated deficit of $2,076,883. We will not receive any proceeds from the
resale of shares under this prospectus. Our continued existence is dependent
upon our ability to obtain additional financing. Our capital requirements for
the next 12 months, as they relate to further research and development relating
to our product candidate, HIV-PV Vaccine I, have been and will continue to be
significant. As of September 30, 2005, we have funded our operations through
equity offerings whereby we raised an aggregate $3,340,006 since inception. We
will need to obtain additional financing in addition to the funding already
raised through the sale of equity securities to fund our cash needs and continue
our operations beyond August 2006. As of December 31, 2004, our independent
auditors have added an explanatory paragraph to their report of our audited
financial statements for the year ended December 31, 2004 stating that our net
loss of $944,437, lack of revenues and dependence on our ability to raise
additional capital to continue our existence, raise substantial doubt about our
ability to continue as a going concern. Our consolidated financial statements
and their explanatory notes included as part of this prospectus do not include
any adjustments that might result from the outcome of this uncertainty. If we
fail to obtain additional financing, either through an offering of our
securities or by obtaining loans, we may be forced to reduce operating costs and
postpone completion of our laboratory and manufacturing facility. Development of
our vaccine would likely be adversely affected or suspended altogether from such
cost reductions, and we may be forced to cease our business.
31
PLAN OF OPERATION
Our primary corporate focus is on the commercial development of HIV-PV Vaccine I
through our subsidiaries. Our capital requirements, particularly as they relate
to product research and development, have been and will continue to be
significant. Our future cash requirements and the adequacy of available funds
will depend on many factors, including the pace at which we are able to obtain
regulatory approvals of HIV-PV Vaccine I, whether or not a market develops for
our products and, if a market develops, the pace at which it develops, and the
pace at which the technology involved in making our products changes.
To date, our wholly owned subsidiary, Bio-Bridge Science Corporation, has funded
its activities through private equity financings. During the next 12 months, we
need to raise capital through an offering of our securities or from loans to
continue research and development of HIV-PV Vaccine I in China as well as
complete the construction of our laboratory in China, which we estimate will
cost approximately $3 million, of which approximately $2,600,000 remains to be
funded as of September 30, 2005. From April 22, 2005 to September 30, 2005, we
issued 2,179,947 shares of common stock at a price per share of $0.50 to 52
investors pursuant to private placements and raised gross proceeds of
$1,089,974. We currently have no commitments to make payments for the
construction of the outside body of the facility. We estimate that our capital
requirements for the next 12 months will be as follows:
o approximately $2,600,000 for our laboratory/biomanufacturing facility inner
purified environment decoration project and electricity work project;
o approximately $800,000 to purchase advanced laboratory equipment for our
vaccine study;
o approximately $500,000 to finish Phase I clinical study an the preparatory
work; and
o approximately $800,000 for working capital and general corporate needs.
In addition, we estimate that the total cost to bring our product to market in
China will be $10 million for the therapeutic vaccine, and an additional $6
million to bring the preventative vaccine to market. We believe that the
therapeutic vaccine can be brought to market within three years and the
preventative vaccine can be brought to market within five to seven years, if we
are successful in raising the funds to complete development of the vaccine.
On November 21, 2005, we entered into an exclusive agency agreement with Xinhua
Surgical Instruments Co., Ltd., located in Shandong, China. Under this
agreement, we have been granted exclusive distribution rights for all Xinhua
surgical instruments in the United States, which are subject to FDA approval. On
December 6, 2005, we received confirmation from the FDA of our registration as a
medical device establishment which enables us to perform initial distributor and
repackager operations. This does not mean that we have received FDA approval of
any product or activity. We intend to market Xinhua surgical instruments that
meet the criteria for Class I medical devices and FDA rules, which do not
require pre-market notification to the FDA, mainly through existing distributors
in the U.S. Class I medical devices are typically simple in design, manufacture
and have a history of safe use. Examples of Class I medical devices include
tongue depressors, arm-slings and hand-held surgical instruments.
As of September 30, 2005, our cash and cash equivalents position was $1,054,130,
which we expect will fund our operations through August 2006. Although we
recently have raised gross proceeds of $1,089,974 pursuant to private equity
financings, we will need to raise additional funds through the public or private
sales of our securities, or loans, or a combination of the foregoing. We cannot
guarantee that financing will be available to us, on acceptable terms or at all.
We also may borrow from the local bank in China given that we own our land use
right that could be used as collateral for borrowing. We do not expect to
generate any significant revenues in the next 12 months. If we fail to obtain
other financing, either through an offering of our securities or by obtaining
additional loans, we may be unable to maintain our operations and may be forced
to cease our business.
RESULTS OF OPERATIONS
NINE MONTHS ENDED SEPTEMBER 30, 2005 COMPARED TO NINE MONTHS ENDED SEPTEMBER 30,
2004
During the nine months ended September 30, 2005 and 2004, we had no revenue. We
do not expect to have significant revenues relating to our product candidates in
development prior to 2007.
For the nine months ended September 30, 2005, research and development expense
was $60,649 as compared to $42,300 for the nine months ended September 30, 2004.
The increase of $18,349 is due primarily to an increase of research and
development staff and cost
For the nine months ended September 30, 2005, general and administrative expense
was $706,671 as compared to $394,677 for the nine months ended September 30,
2004. The increase of $311,994 is due primarily to increases in consulting fees
and salary expenses of approximately $195,600 and $75,300 respectively. In
addition we had increases in expenses related to rent, travel and all other
expenses of $30,500 $6,200 and $4,394, respectively.
For the nine months ended September 30, 2005, interest and other income (loss)
was $4,370 as compared to $78 for the nine months ended September 30, 2004. The
increase of $4,292 is due primarily to an increase in cash balances.
Net loss for the nine months ended September 30, 2005, was $762,950 as compared
to $436,899 for the nine months ended September 30, 2004. This increase in net
loss is attributable primarily to the above-mentioned salary, rent increase and
an increase of consulting related fees..
2004 VERSUS 2003
During each of the years ended December 31, 2004 and 2003, we had no revenue. We
do not expect to have revenues relating to our technologies in the near future.
For the year ended December 31, 2004, research and development expense was
$109,835 as compared to $30,739 for the year ended December 31, 2003. The
increase of $79,096 is due primarily to pre-clinical development of our HIV-PV
Vaccine I on laboratory animals, and the continuing hiring of the research and
development staff.
For the year ended December 31, 2004, general and administrative expense was
$833,642 as compared to $225,814 for the year ended December 31, 2003. The
increase of $607,828 was due primarily to professional fees and advisory fees of
approximately $177,000 and expense related to options that we granted to
financial advisors and our legal counsel of approximately $304,162. In addition,
we had increases in salaries expense of approximately $87,077. Also, the cost
associated with the stock issued for service from our financial advisor and
legal counsel was $50,000.
Comprehensive loss for the year ended December 31, 2004, was $944,894 as
compared to $255,664 for the year ended December 31, 2003. This increase in net
loss was attributable to increase in research and development cost and general
and administrative cost.
32
LIQUIDITY AND CAPITAL RESOURCES
Our principal sources of liquidity are cash and cash equivalent balances, which
were $498,576 at December 15, 2005, $495,805 at December 31, 2004 and
$220,291 at December 31, 2003. Since our inception, we have incurred significant
losses, and as of September 30, 2005 we had an accumulated deficit of
$2,076,883.
Net cash used in operating activities was $509,453 for the twelve months ended
December 31, 2004 as compared with $256,843 for the twelve months ended December
31, 2003 and $426,749 for the nine months ended September 30, 2005. For the year
ended December 31, 2004, general and administrative expense was $833,642 as
compared to $225,814 for the year ended December 31, 2003. The increase of
$607,828 was due primarily to professional fees and advisory fees of
approximately $177,000 and expense related to options that we granted to
financial advisors and our legal counsel of approximately $304,162. In addition,
we had increases in salaries expense of approximately $87,077. Also, the cost
associated with the stock issued for service from our financial advisor and
legal counsel was $50,000.
Cash flows used in investing activities was $465,010 for the twelve months ended
December 31, 2004 as compared to cash used in investing activities of $433,161
for the twelve months ended December 31, 2003 and $127,410 used in investing
activities for the first nine months ended September 30, 2005. This change was
from $362,472 for our advance payment to construction company, and $57,641 for
increase in construction in progress, and $40,000 for the purchase of Aegir
Ventures
Net cash provided by financing activities increased from $455,398 in 2003 to
$1,250,434 in 2004 due to proceeds from the issuance of common stock in 2004. In
the nine months ended September 30, 2005, there was $1,089,994 net cash provided
by financing activities.
To date, our operations have been funded through issuances of our common stock
whereby we raised an aggregate $3,340,006 from inception through September 30,
2005.
Based on our current operating plan we believe that we have sufficient cash and
cash equivalents to last approximately through July 2006. We will need to obtain
additional financing in addition to the funds already raised through the sale of
equity securities to fund our cash needs and continue our operations beyond July
2006. Additional financing, whether through public or private equity or debt
financing, arrangements with stockholders or other sources to fund operations,
may not be available, or if available, may be on terms unacceptable to us. Our
ability to maintain sufficient liquidity is dependent on our ability to raise
additional capital. If we issue additional equity securities to raise funds, the
ownership percentage of our existing stockholders would be reduced. New
investors may demand rights, preferences or privileges senior to those of
existing holders of our common stock. Debt incurred by us would be senior to
equity in the ability of debt holders to make claims on our assets. The terms of
any debt issued could impose restrictions on our operations. If adequate funds
are not available to satisfy either short or long-term capital requirements, our
operations and liquidity could be materially adversely affected and we could be
forced to cease operations.
We will pay all of the costs for registering the common shares offered for sale
under this prospectus, which we estimate to be $100,033, except for the
brokerage expenses, fees, discounts and commissions, which will all be paid by
the selling stockholders. The payment of our costs will not have a material
effect on our liquidity.
33
CRITICAL ACCOUNTING POLICIES AND ESTIMATES
Our discussion and analysis of our financial condition and results of operations
are based on our consolidated financial statements, which have been prepared in
accordance with accounting principles generally accepted in the U.S. The
preparation of these financial statements requires us to make estimates and
judgments that affect the reported amounts of assets, liabilities, revenues and
expenses for each period. The following represents a summary of our critical
accounting policies, defined as those policies that we believe are the most
important to the portrayal of our financial condition and results of operations
and that require management's most difficult, subjective or complex judgments,
often as a result of the need to make estimates about the effects of matters
that are inherently uncertain.
Stock compensation costs. We account for stock-based compensation issued to
employees using the intrinsic-value method prescribed in Accounting Principles
Board Opinion (APB) No. 25, "Accounting for Stock Issued to Employees."
We account for stock option and warrant grants issued to non-employees using the
guidance of SFAS No. 123, "Accounting for Stock-Based Compensation" and EITF No.
96-18: "Accounting for Equity Instruments that are Issued to Other Than
Employees for Acquiring, or in Conjunction with Selling, Goods or Services,"
whereby the fair value of such option and warrant grants is determined using the
Black-Scholes option pricing model at the date of grant.
In December 2004, the FASB issued SFAS No. 123(R), "Share-Based Payment". This
Statement revises FASB Statement No. 123, "Accounting for Stock-Based
Compensation" and supersedes APB Opinion No. 25, "Accounting for Stock Issued to
Employees". SFAS No. 123(R) focuses primarily on the accounting for transactions
in which an entity obtains employee services in share-based payment
transactions. SFAS No. 123(R) requires companies to recognize in the statement
of operations the cost of employee services received in exchange for awards of
equity instruments based on the grant-date fair value of those awards (with
limited exceptions). This Statement is effective as of the first reporting
period that begins after June 15, 2005 for large business issuers and December
15, 2005 for small business issuers. 123R offers us alternative methods of
adoption of this standard. At the present time, we have not yet determined which
alternative method we will use and the resulting impact on our financial
position or results of operations.
Impairment of long-lived assets. We account for long-lived assets in accordance
with Statement of Financial Accounting Standards No. 144, Accounting for the
Impairment or Disposal of Long-Lived Assets, or SFAS No. 144, which was adopted
on January 1, 2002. SFAS No. 144 supersedes Statement of Financial Accounting
Standards No. 121, Accounting for the Impairment of Long-Lived Assets and for
Long- Lived Assets To Be Disposed of, or SFAS No. 121. Our long-lived assets
consist of land use right, notes, fixed assets, construction in process, and
prepaid consulting fees. We regularly evaluate our long-lived assets, including
our intangible assets, for indicators of possible impairment whenever events or
changes in business circumstances indicate that the carrying amount of the
assets may not be fully recoverable. An impairment loss would be recognized when
estimated undiscounted future cash flows expected to result from the use of an
asset and its eventual disposition are less than its carrying amount.
Impairment, if any, is measured using discounted cash flows. In the years ending
December 31, 2004 and 2003, we performed an evaluation of our long-lived assets
and noted no impairment.
OFF-BALANCE SHEET ARRANGEMENTS
We do not have any off-balance sheet transactions.
34
RECENT ACCOUNTING PRONOUNCEMENTS
In March 2004, the U.S. Securities and Exchange Commission's Office of the Chief
Accountant and the Division of Corporate Finance released Staff Accounting
bulletin ("SAB") No. 105, "Loan Commitments Accounted for as Derivative
Instruments". This bulletin contains specific guidance on the inputs to a
valuation-recognition model to measure loan commitments accounted for at fair
value, and requires that fair- value measurement include only differences
between the guaranteed interest rate in the loan commitment and market interest
rate, excluding any expected future cash flows related to the customer
relationship or loan servicing. In addition, SAB105 requires the disclosure of
the accounting policy for loan commitments, including methods and assumptions
used to estimate the fair value of loan commitments, and any associated hedging
strategies. SAB105 is effective for derivative instruments, entered into
subsequent to March 31, 2004 and should also be applied to existing instruments
as appropriate.
In November 2004, the FASB issued Statement of Financial Accounting Standards
No. 151, "Inventory Costs". This Statement amends the guidance in ARB No. 43
Chapter 4 Inventory Pricing, to require items such as idle facility costs,
excessive spoilage, double freight and rehandling costs to be expensed in the
current period, regardless if they are abnormal amounts or not. This Statement
will become effective for us in the first quarter of 2006.
The implementation of the above provisions are not expected to have a
significant effect on our consolidated financial statements.
DESCRIPTION OF PROPERTY
Our corporate office is located in approximately 1,253 square feet of leased
office space in Oak Brook, Illinois. We lease this office space at a monthly
base rent of approximately $2,140 and thereafter, it is adjusted as follows:
$2,193 on September 1, 2005 and $2,245 on September 1, 2006 for the remainder of
the term. We have agreed under the terms of the lease to pay our proportionate
share, or 0.33%, of any additional expenses or taxes due to the landlord. This
lease will expire on August 31, 2007. We expect that this property will be
adequate for our needs for the lease term. We do not have any policies with
respect to investments in real estate or interests in real estate, real estate
mortgages or securities of or interests in persons primarily engaged in real
estate activities.
We have an office located in Beijing, China that is leased from one of our
directors, Wenhui Qiao, and his wife, Mingjin Yu. We entered into the lease for
this 1302.48 square feet of office space on July 1, 2004 and the lease is for a
term of one year. The rent is approximately $1,450 per month.
Financial Commitments:
Lease commitment
As of September 30, 2005, we had remaining outstanding commitments in respect to
our non-cancelable operating lease for our office in Oak Brook, IL, of which
$25,680 is due in 2005, and our office in Beijing, PRC, which is leased from
Wenhui Qiao, our director and president, of which $5,234 is due in 2005.
Rental expense for the year ended December 31, 2004 and 2003 was $29,417 and
$23,280, respectively.
Construction commitment
In May 2003, we acquired a land use right for approximately 2.8 acres of land in
the Tianzhu Export Processing Zone, Shunyi District, Beijing, China, which we
plan to develop into a laboratory and biomanufacturing facility in compliance
with Good Manufacturing Practices, or GMP, regulations primarily for clinical
trials of HIV-PV Vaccine I. As of April 21, 2005, we have received all necessary
permits and approvals and construction of the outside body of the facility has
been completed. We have entered into a construction contract relating to the
completion for this facility, and as of December 29, 2005 we have paid all
amounts owed. We estimate that the cost of the building and outfitting of this
facility is $3,000,000, and the construction and installation of equipment
related to the facility will be substantially completed by April 2006.
We have purchased the right to use for fifty years land located at Tianzhu
Export Processing Zone, Shunyi District, Beijing, China 10131, where we have
completed the outside body of our laboratory and manufacturing facility. This
purchase agreement was executed in May 2003 and expires in 2053. To date, we
have paid the total amount due for this land use right pursuant to the terms of
the agreement. Under Chinese law, there is no private ownership of land, and
accordingly, we do not own this land.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
Described below are certain transactions or series of transactions since
inception between us and our executive officers, directors and the beneficial
owners of 5% or more of our common stock, on an as converted basis, and certain
persons affiliated with or related to these persons, including family members,
in which they had or will have a direct or indirect material interest in an
amount that exceeds $60,000 other than compensation arrangements that are
otherwise required to be described under "Executive Compensation." In addition,
Dr. Liang Qiao, our chief executive officer and chairman of the board, as well
as his brother, Wenhui Qiao, our director and president, and Isao Arimoto, our
vice-president and director, are also considered our promoters. All transactions
with the promoters are set forth below.
SHARE EXCHANGE WITH BIO-BRIDGE SCIENCE CORP.
On December 1, 2004, we issued to various related parties shares of common stock
in connection with the share exchange with Bio-Bridge Science Corp., a Cayman
Islands corporation. See the section in this prospectus entitled "Description of
Business - History, Reorganization and Corporate Structure of the Company" for a
more detailed description regarding the share exchange.
35
NAME(1) NUMBER OF SHARES OF COMMON STOCK
- ------- --------------------------------
Dr. Liang Qiao 13,750,000
Wenhui Qiao 825,000
Isao Arimoto 2,125,000
Toshihiro Komoike 750,000
Shyh Jing (Philip) Chiang 786,111
(1) See "Security Ownership of Certain Beneficial Owners and Management" for
more detail on shares held by these persons.
ROYALTY AND LICENSE ARRANGEMENTS
Liang Qiao, M.D., our co-founder and chief executive officer, is one of the two
co-inventors of our core technology that was assigned to Loyola University
Chicago in April 2001. Under a license agreement with Loyola University Chicago,
our wholly owned subsidiary Bio-Bridge Science Corporation has obtained
exclusive rights to this technology for use in our future products within the
United States, Japan and PRC. This license continues perpetually or for the
maximum period of time permitted by law, unless terminated earlier by us at will
with prior notice or by Loyola University in the event we do not make any effort
to market the product after five years from the date on which the U.S., Japan or
China grant us a permit for production. See the section in this prospectus
entitled "Business--Intellectual Property." Pursuant to this agreement, Loyola
is entitled to receive a royalty of four percent from the net profit for all
uses of the licensed technology, including uses under sublicenses. To date, we
have not generated any revenues from the sale of any products under development,
nor any revenues from sublicenses.
Our director, Wenhui Qiao, is president of Bio-Bridge Science (Beijing). In
April 2002, Bio-Bridge Science Corporation, or Bio-Bridge Science Corp. signed a
sublicense agreement with Bio-Bridge Science (Beijing). Under the terms of the
agreement, Bio-Bridge Science Corp, granted an exclusive license to Bio-Bridge
Science Beijing within mainland China. The term of the license agreement is 10
years. There are no royalty fees nor one-time costs owed to us under this
agreement.
OFFICE LEASE IN BEIJING, CHINA
In July 2004, we entered into a lease agreement with one of our directors,
Wenhui Qiao, and his wife, Mingjin Yu, to lease office space for our office
located in Beijing, China. See the section in this prospectus entitled
"Description of Property."
OPTION GRANTS TO DIRECTORS AND EXECUTIVE OFFICERS
On October 14, 2005, our board of directors granted options pursuant to our 2004
Stock Incentive Plan to the following directors and executive officers:
Name of Optionee Number of Shares
Liang Qiao, MD 600,000
Wenhui Qiao 250,000
Chuen Huei Lee 250,000
Toshihiro Komoike 150,000
Isao Arimoto 250,000
Shyh Jing (Philip) Chiang 5,000
These options expire on October 13, 2015. One-twelfth of the shares underlying
each option shall vest each month commencing on January 1, 2006. The exercise
price per share is $0.50, except for Dr. Qiao's option which has an exercise
price per share of $0.55 pursuant to the terms of the 2004 Stock Incentive Plan.
On November 1, 2005, our board of directors granted an option to purchase
150,000 shares of our common stock to each Mr. Wenhui Qiao and Mr. Chuen Huei
(Kevin) Lee. These options are immediately exercisable at an exercise price per
share of $0.001.
MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS
Our common shares are traded on the Nasdaq OTC Bulletin Board under the symbol
"BGES.OB. We currently have 32,471,537 shares of common stock issued and
outstanding. We have approximately 142 stockholders of record of our common
stock.
Our board of directors has also issued options to consultants to purchase a
total of 1,392,663 shares of our common stock. The price for each share of
common stock purchased pursuant to the options is $.001. Please see the section
above entitled "Certain Relationships and Related Party Transactions" regarding
options issued to our directors and executive officers.
DIVIDENDS
We have never paid any dividends on the common stock or the preferred stock. We
anticipate that any future earnings will be retained for the development of our
business and do not anticipate paying any dividends on the common stock or the
preferred stock in the foreseeable future.
2004 STOCK INCENTIVE PLAN
Our board of directors and stockholders approved our 2004 stock incentive plan
in December 2004. The 2004 stock incentive plan provides for the grant of
incentive stock options to our employees, and for the grant of nonstatutory
stock options, restricted stock, stock appreciation rights and performance
shares to our employees, directors and consultants.
We have reserved a total of 2,000,000 shares of our common stock for issuance
pursuant to the 2004 stock incentive plan. Our 2004 stock incentive plan does
not provide for automatic annual increases in the number of shares available for
issuance under the plan. As of December 27, 2005, we had granted 1,965,000
options available under this plan.
Our board of directors, or a committee of our board, administers our 2004 stock
incentive plan. The board or its committee, who are referred to as the
administrator in this prospectus, has the power to determine the terms of the
awards, including the exercise price, the number of shares subject to each such
award, the exercisability of the awards and the form of consideration, if any,
payable upon exercise. The administrator also has the authority to institute an
exchange program whereby the exercise prices of outstanding awards may be
reduced or outstanding awards may be surrendered in exchange for awards with a
lower exercise price.
The administrator determines the exercise price of options granted under our
2004 stock incentive plan, but the exercise price must not be less than 85% of
the fair market value of our common stock on the date of grant. In the event the
participant owns 10% or more of the voting power of all classes of our stock,
the exercise price must not be less than 110% of the fair market value per share
of our common stock on the date of grant. With respect to all incentive stock
options, the exercise price must at least be equal to the fair market value of
our common stock on the date of grant. The term of an incentive stock option may
not exceed 10 years, except that with respect to any participant who owns 10% of
the voting power of all classes of our outstanding stock or the outstanding
stock of any parent or subsidiary of ours, the term must not exceed five years
and the exercise price must equal at least 110% of the fair market value on the
grant date. The administrator determines the term of all other options; however,
no option will have a term in excess of 10 years from the date of grant.
36
After termination of an employee, director or consultant, he or she may exercise
his or her option generally for a three-month period of time, or a twelve-month
period in the event of termination by death. However, an option generally may
not be exercised later than the expiration of its term.
Our 2004 stock incentive plan does not allow for the transfer of options and
only the recipient of an option may exercise an option during his or her
lifetime. However, the recipient of an option may designate one or more
beneficiaries of his or her outstanding options, which will automatically
transfer to such beneficiaries upon the participant's death. With respect to
nonstatutory stock options, a participant may assign his or her options to
immediate family members or trusts for estate planning purposes during his or
her lifetime.
Stock appreciation rights may be granted under our 2004 stock incentive plan.
Stock appreciation rights allow the recipient to receive the appreciation in the
fair market value of our common stock between the exercise date and the date of
grant. The administrator determines the terms of stock appreciation rights,
including when such rights become exercisable and whether to pay the increased
appreciation in cash or with shares of our common stock, or a combination
thereof.
Restricted stock may be granted under our 2004 stock incentive plan. Restricted
stock awards are shares of our common stock that vest in accordance with terms
and conditions established by the administrator. The administrator will
determine the number of shares of restricted stock granted to any employee. The
administrator determines the purchase price of the restricted stock, but the
purchase price must not be less than 85% of the fair market value of our common
stock on the date of issuance. In the event that the participant owns 10% or
more of the voting power of all classes of our stock, the purchase price must
not be less than 100% of the fair market value per share of our common stock on
the date of issuance. The administrator may impose whatever conditions to
vesting it determines to be appropriate. For example, the administrator may set
restrictions based on the achievement of specific performance goals. Shares of
restricted stock that do not vest are subject to our right of repurchase or
forfeiture.
Performance shares, or share rights awards, may be granted under our 2004 stock
incentive plan. These shares are awards that will result in a payment to a
participant only if performance goals established by the administrator are
achieved or the awards otherwise vest, unless the administrator waives these
goals. The administrator has authority to establish organizational or individual
performance goals in its discretion, which, depending on the extent to which
they are met, will determine the number and/or the value of performance units
and performance shares to be paid out to participants.
Our 2004 stock incentive plan provides that in the event of our change in
control, outstanding options will automatically accelerate and become
exercisable, unless the successor corporation or its parent assumes or
substitutes a cash incentive program for each outstanding option, or the
administrator placed restrictions on acceleration at the time of the grant. With
respect to restricted stock or share rights awards, our repurchase rights will
automatically terminate and all the shares will fully vest upon a change of
control, unless the repurchase rights are assigned to the successor corporation
or its parent or the administrator place restrictions on acceleration of vesting
at the time of the issuance.
Our 2004 stock incentive plan will automatically terminate on November 20, 2014,
unless it terminates sooner because all shares available under the plan have
been issued or all outstanding options terminate in connection with a change of
control. In addition, our board of directors has the authority to amend the 2004
stock incentive plan provided this action does not impair the rights of any
participant.
We had no compensation plans prior to the adoption of our 2004 stock incentive
plan.
37
EXECUTIVE COMPENSATION
SUMMARY OF COMPENSATION
The following executive compensation disclosure reflects all compensation
awarded to, earned by or paid to the executive officers below, for the fiscal
years ended December 31, 2004, 2003 and 2002. The following table summarizes all
compensation for fiscal years 2004, 2003 and 2002 received by our chief
executive officer and all officers who earned more than $100,000 in fiscal year
2004.
SUMMARY COMPENSATION TABLE
LONG TERM COMPENSATION
ANNUAL COMPENSATION AWARDS PAYOUTS
------------------- ------ -------
OTHER SECURITIES
ANNUAL RESTRICTED UNDERLYING LTIP
NAME AND PRINCIPAL BONUS COMPENSATION STOCK OPTIONS/ PAYOUT ALL OTHER
POSITION YEAR SALARY ($) ($) ($) AWARDS ($) SARS(1) ($) COMPENSATION ($)
- ------------------------ ------- ---------------- --------- --------------- ----------- ------------ --------- ---------------------
Dr. Liang Qiao, Chief 2004 -- -- -- -- -- -- --
Executive Officer, 2003 -- -- -- -- -- -- --
Chairman of the 2002 -- -- -- -- -- -- --
Board and
Secretary(1)
Chuen Huei (Kevin) 2004 $45,000 -- -- -- -- -- --
Lee, Chief Financial 2003 -- -- -- -- -- -- --
Officer (2) 2002 -- -- -- -- -- -- --
Wen Hui Qiao 2004 -- -- -- -- -- -- --
President (3) 2003 -- -- -- -- -- -- --
2002 -- -- -- -- -- -- --
(1) Dr. Qiao's employment with Bio-Bridge Science, Inc. commenced on October 26,
2004. At this time, he does not receive a salary.
(2) Mr. Kevin Lee's employment with Bio-Bridge Science Corporation commenced in
May 2004, and his salary of $45,000 (including $15,000 of which is deferred)
began on July 1, 2004. Mr. Lee's employment with Bio-Bridge Science, Inc.
commenced on October 26, 2004. He received no salary in 2003 and 2002.
(3) Mr. Qiao's employment with Bio-Bridge Science, Inc. commenced on October 26,
2004. At this time, he does not receive a salary.
We do not have a long term incentive plan or arrangement of compensation with
any individual in the group of officers and directors.
COMPENSATION OF DIRECTORS
Directors do not currently receive compensation for their services as directors,
but we plan to reimburse them for expenses incurred in attending board meetings.
EMPLOYMENT AGREEMENTS, TERMINATION OF EMPLOYMENT AND CHANGE-IN-CONTROL
ARRANGEMENTS
We are currently do not have any employment agreements with our executive
officers.
38
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004
AND DECEMBER 31, 2003
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONTENTS
--------
PAGE 1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
PAGE 2 CONSOLIDATED BALANCE SHEET AS OF DECEMBER 31, 2004
PAGE 3 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR
THE YEARS ENDED DECEMBER 31, 2004 AND 2003 AND FOR THE PERIOD FROM
FEBRUARY 11, 2002 (INCEPTION) THROUGH DECEMBER 31, 2004
PAGE 4 CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY FOR THE
PERIOD FROM FEBRUARY 11, 2002 (INCEPTION) THROUGH DECEMBER 31, 2004
PAGE 5 CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER
31, 2004 AND 2003 AND FOR THE PERIOD FROM FEBRUARY 11, 2002
(INCEPTION) THROUGH DECEMBER 31, 2004
PAGE 6-20 NOTES TO CONSOLIDATED FINANCIAL STATEMENTS FOR THE YEARS ENDED
DECEMBER 31, 2004 AND 2003
39
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors and Shareholders of Bio-Bridge Science Inc.
We have audited the accompanying consolidated balance sheet of Bio-Bridge
Science Inc. and Subsidiaries (a development stage company) as of December 31,
2004 and the related consolidated statements of operations and comprehensive
loss, changes in shareholders' equity and cash flows for the years ended
December 31, 2004 and 2003, and for the period from February 11, 2002
(Inception) through December 31, 2004. These financial statements are the
responsibility of the Company's management. Our responsibility is to express an
opinion on these financial statements based on our audits.
We conducted our audits in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audits to obtain reasonable assurance about whether the
consolidated financial statements are free of material misstatement. An audit
includes examining, on a test basis, evidence supporting the amounts and
disclosures in the financial statements. An audit also includes assessing the
accounting principles used and significant estimates made by management, as well
as evaluating the overall financial statement presentation. We believe that our
audits provide a reasonable basis for our opinion.
In our opinion, the financial statements referred to above present fairly, in
all material respects, the financial position of Bio-Bridge Science Inc. and
Subsidiaries (a development stage company) as of December 31, 2004 and the
results of their operations and their cash flows for the years ended December
31, 2004 and 2003 and for the period from February 11, 2002 (Inception) through
December 31, 2004, in conformity with accounting principles generally accepted
in the United States of America.
The accompanying consolidated financial statements have been prepared assuming
the Company will continue as a going concern. As discussed in Note 1 to the
consolidated financial statements, the Company has no established source of
revenue and has incurred accumulated losses and negative operating cash flows
since inception of $1,315,533 and $880,584, respectively, as of December 31,
2004. These factors raise substantial doubt about the Company's ability to
continue as a going concern. Management's plan in regards to these matters is
also described in Note 1. The consolidated financial statements do not include
any adjustment that might result from the outcome of this uncertainty.
WEINBERG & COMPANY, P.A.
Boca Raton, Florida
February 28, 2005
1
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEET
DECEMBER 31, 2004
ASSETS
CURRENT ASSETS
Cash and cash equivalents $ 495,805
Prepaid expenses and other current assets 19,538
Land use right, current portion 15,783
-----------
Total Current Assets 531,126
NOTE RECEIVABLE, NET OF DISCOUNT 37,893
ADVANCE TO CONSTRUCTION CONTRACTOR 362,472
PREPAID CONSULTING EXPENSE 390,890
FIXED ASSETS, NET 18,599
CONSTRUCTION IN PROGRESS 81,133
LAND USE RIGHT, NET OF CURRENT PORTION 355,111
-----------
TOTAL ASSETS $ 1,777,224
===========
LIABILITIES AND SHAREHOLDERS' EQUITY
CURRENT LIABILITIES
Accrued expenses and other payables $ 67,143
-----------
Total current liabilities 67,143
-----------
COMMITMENTS AND CONTINGENCIES --
SHAREHOLDERS' EQUITY
Preferred stock, $.001 par value,
5,000,000 shares authorized,
none issued or outstanding --
Common stock, $0.001 par value, 100,000,000 shares authorized,
30,271,590 shares issued and outstanding 30,272
Additional paid-in capital 2,995,342
Accumulated other comprehensive loss (1,600)
Deficit accumulated during the development stage (1,313,933)
-----------
Total Shareholders' Equity 1,710,081
-----------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 1,777,224
===========
See accompanying notes to the consolidated financial statements.
2
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF OPERATIONS
AND COMPREHENSIVE LOSS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003 AND FOR THE PERIOD
FROM FEBRUARY 11, 2002 (INCEPTION) THROUGH DECEMBER 31, 2004
For the Period
from February 11,
2002
For the Year For the Year (Inception)
Ended Ended through
December 31, December 31, December 31,
2004 2003 2004
------------ ------------ ------------
REVENUES $ -- $ -- $ --
Research and development cost (109,835) (30,739) (140,574)
General and administrative expenses (833,642) (225,814) (1,174,316)
------------ ------------ ------------
LOSS FROM OPERATIONS (943,477) (256,553) (1,314,890)
INTEREST INCOME 1,336 1,533 3,253
LOSS ON SALE OF INVESTMENT (2,296) -- (2,296)
------------ ------------ ------------
NET LOSS (944,437) (255,020) (1,313,933)
FOREIGN CURRENCY TRANSLATION LOSS (457) (644) (1,600)
------------ ------------ ------------
COMPREHENSIVE LOSS $ (944,894) $ (255,664) $ (1,315,533)
============ ============ ============
LOSS PER SHARE, BASIC AND DILUTED $ (0.03) $ (0.01)
============ ============
WEIGHTED AVERAGE SHARES OUTSTANDING, BASIC AND DILUTED 28,785,388 23,419,575
============ ============
See accompanying notes to the consolidated financial statements.
3
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CHANGES IN SHAREHOLDERS' EQUITY
FOR THE PERIOD FROM FEBRUARY 11, 2002 (INCEPTION) THROUGH
DECEMBER 31, 2004
Deficit
Accumulated Accumulated
Additional Other During the
Common Stock Paid-in Comprehensive Development
Shares Amount Capital Loss Stage Total
------ ------ ------- ---- ----- -----
Issuance of 13,750,000 shares at $0.00004 13,750,000 $ 13,750 $ (13,200) $ -- $ -- $ 550
Issuance of 7,461,090 shares at $0.0468 7,461,090 7,461 341,719 -- -- 349,180
Issuance of 1,875,000 shares at $0.12 1,875,000 1,875 223,125 -- -- 225,000
Foreign currency translation loss -- -- -- (499) -- (499)
Net loss -- -- -- -- (114,476) (114,476)
----------- ----------- ----------- ----------- ----------- -----------
BALANCE DECEMBER 31, 2002 23,086,090 23,086 551,644 (499) (114,476) 459,755
Issuance of 3,508,425 shares at $0.12 3,508,425 3,509 417,502 -- -- 421,011
Issuance of 201,200 shares at $0.32 201,200 201 64,186 -- -- 64,387
Foreign currency translation loss -- -- -- (644) -- (644)
Net loss -- -- -- -- (255,020) (255,020)
----------- ----------- ----------- ----------- ----------- -----------
BALANCE DECEMBER 31, 2003 26,795,715 26,796 1,033,332 (1,143) (369,496) 689,489
Issuance of 434,600 shares at $0.12 434,600 435 51,715 -- -- 52,150
Issuance of 1,125,275 shares at $0.32 1,125,275 1,125 358,961 -- -- 360,086
Issuance of 1,616,000 shares at $0.5 1,616,000 1,616 806,382 -- -- 807,998
Fair market value of Stock options granted
for services -- -- 695,052 -- -- 695,052
Fair value of shares issued for services 100,000 100 49,900 -- -- 50,000
Exercise of options 200,000 200 -- -- -- 200
Foreign currency translation loss -- -- -- (457) -- (457)
Net loss -- -- -- -- (944,437) (944,437)
----------- ----------- ----------- ----------- ----------- -----------
BALANCE DECEMBER 31, 2004 30,271,590 $ 30,272 $ 2,995,342 $ (1,600) $(1,313,933) 1,710,081
=========== =========== =========== =========== =========== ===========
See accompanying notes to the consolidated financial statements.
4
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003 AND FOR THE PERIOD
FROM FEBRUARY 11, 2002 (INCEPTION) THROUGH DECEMBER 31, 2004
For the
Period From
February 11,
2002
For the For the (Inception)
Year Ended Year Ended Through
December December December
31, 2004 31, 2003 31, 2004
------------ ----------- ------------
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (944,437) $ (255,020) $(1,313,933)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation 3,603 2,124 5,810
Amortization of land use right 15,774 7,891 23,665
Amortization of prepaid consulting expenses 279,208 -- 279,208
Stock issued for services 50,000 -- 50,000
Fair value of option issued for shares 24,954 -- 24,954
Loss on sale of investment 2,107 2,296 2,107
(Increase) decrease in prepaid expense and other assets (3,471) (15,138) (19,538)
Increase in accrued expenses and other payable 62,809 3,300 67,143
----------- ----------- -----------
Net Cash Used In Operating Activities (509,453) (256,843) (880,581)
----------- ----------- -----------
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of land use right -- (394,559) (394,559)
Increase in construction in progress (57,641) (23,492) (81,133)
Purchase of fixed assets (4,897) (15,110) (24,409)
Purchase of investment (40,000) (40,000) (40,000)
Advance payment to construction company (362,472) -- (362,472)
----------- ----------- -----------
Net Cash Used In Investing Activities (465,010) (433,161) (902,573)
----------- ----------- -----------
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock 1,220,434 455,398 2,280,562
Collection of subscription receivable 30,000 -- --
----------- ----------- -----------
Net Cash Provided By Financing Activities 1,250,434 455,398 2,280,562
----------- ----------- -----------
Effect of exchange rate changes on cash (457) (644) (1,600)
----------- ----------- -----------
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS 275,514 (235,250) 495,805
Cash and cash equivalents, beginning of period 220,291 455,541 --
----------- ----------- -----------
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 495,805 $ 220,291 $ 495,805
=========== =========== ===========
SUPPLEMENTAL CASH FLOW INFORMATION
Interest Paid $ -- $ -- $ --
=========== =========== ===========
Income taxes Paid $ -- $ -- $ --
=========== =========== ===========
SUPPLEMENTAL NONCASH FINANCING AND INVESTING ACTIVITIES
In 2004, the Company disposed of its investment in Aegir Ventures Inc. in
exchange for a $40,000 unsecured, non interest bearing promissory note that
matures in 2006. The company valued the note at its present value of $37,704 at
the date of disposition, resulting in a loss of $2,296.
5
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
1. ORGANIZATION AND PRINCIPAL ACTIVITIES
Bio-Bridge Science, Inc. (a development stage company) ("the Company") was
incorporated in the State of Delaware on October 26, 2004 to serve as a vehicle
to effect a merger, exchange of capital stock, asset acquisition or other
business combination with a domestic or foreign private business. The Company's
fiscal year end is December 31.
The Company is a development stage enterprise as defined by Statement of
Financial Accounting Standards (SFAS) No. 7, "Accounting and Reporting by
Development Stage Enterprises." All losses accumulated since the inception of
the Company will be considered as part of the Company's development stage
activities. The Company has not commenced revenue generating activities.
On December 1, 2004, the Company acquired all of the outstanding shares of
Bio-Bridge Science Corporation ("BBSC"), a Cayman Islands corporation, in
exchange for 29,971,590 shares of its common stock, and as a result, BBSC became
a wholly owned subsidiary of Bio-Bridge Science, Inc. BBSC was incorporated in
the Cayman Islands on February 11, 2002. At the time of the exchange, BBSC held
a 100% interest in Bio-Bridge Science (Beijing) Corp. ("BBS Beijing") a
wholly-foreign funded enterprise of the People's Republic of China ("PRC") which
was established on May 20, 2002. Bio-Bridge Science (Beijing) has been issued an
operating license for 25 years, which can be renewed for an additional 25-year
term for a nominal fee. BBS Beijing is currently engaged in the development and
commercialization of the HIV-PV vaccine, I in mainland China.
The acquisition was accounted for as a reverse merger (recapitalization) with
Bio-Bridge Science Corporation deemed to be the accounting acquirer, and
Bio-Bridge Science Inc. deemed to be the legal acquirer. Accordingly, the
historical financial information presented in the financial statements is that
of Bio-Bridge Science Corporation as adjusted to give effect to any difference
in the par value of the issuer's and the accounting acquirer's stock with an
offset to capital in excess of par value. The basis of the assets, liabilities
and retained earnings of BBSC, the accounting acquirer, have been carried over
in the recapitalization.
On April 12, 2004, the Company acquired Aegir Ventures Inc., a company
incorporated in Delaware. This Company had no operations during the period from
the acquisition to November 26, 2004, and was disposed of on November 26, 2004
(See Note 5).
The accompanying consolidated financial statements have been prepared on the
basis that the Company will continue as a going concern which assumes the
realization of assets and settlement of liabilities in the normal course of
business. Since its inception, the Company has been engaged in organizational
and pre-operating activities. Furthermore, the Company has generated no revenue
and has incurred accumulated losses and negative operating cash flows of
$1,315,533 and $880,584, respectively, since inception. The uncertainty related
to these conditions raises substantial doubt about the Company's ability to
continue as going concern. The accompanying consolidated financial statements do
not include any adjustments that might result from the outcome of this
uncertainty.
6
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
1. ORGANIZATION AND PRINCIPAL ACTIVITIES (CONTINUED)
During the next 12 months, the Company will need to raise capital through an
offering of its securities or from loans to continue research and development of
HIV-PV Vaccine I in China as well as complete the construction of its laboratory
in China and continue operations beyond November 2005. The Company will seek to
raise funds through the public or private sales of its securities, or loans, or
a combination of the foregoing. The Company cannot guarantee financing will be
available, on acceptable terms or at all. From April 22, 2005 to June 23, 2005,
the Company issued 570,000 shares of its common stock to ten investors pursuant
to Regulation S under the Securities Act of 1933, and raised gross proceeds of
$285,000. At this time, the Company is unable to determine when the HIV-PV
Vaccine I will become fully developed, manufactured and sold. The Company does
not expect to generate any significant revenues in the next 12 months. If the
Company fails to obtain other financing, either through an offering of its
securities or by obtaining additional loans, it may be unable to maintain its
operations. The Company's future liquidity is dependent upon its ability to
raise additional capital. If it is not successful in raising sufficient
additional capital, it may be forced to reduce operating costs and postpone
completion of its laboratory and manufacturing facility. Development of its
vaccine would likely be adversely affected or suspended altogether from such
cost reductions, and it may be forced to cease its business.
2. SUMMARY OF PRINCIPAL ACCOUNTING POLICIES
(a) Principles of Consolidation
The consolidated financial statements include the accounts of Bio-Bridge Science
Inc. and its wholly owned subsidiaries, Bio-Bridge Science Corp. and Bio-Bridge
Science (Beijing) Corp.
The Company's acquisition of Aegir Ventures Inc. was recorded at cost, and
accounted for as an investment as it did not operate and was disposed of on
November 26, 2004 (See Note 5).
Inter-company accounts and transactions have been eliminated in consolidation.
(b) Economic and Political Risks
The Company faces a number of risks and challenges since its operation is in PRC
and its primary market is in the PRC.
We have operations in China, where we are currently engaged in pre-clinical
testing of our HIV-PV Vaccine I product. Our business operations may be
adversely affected by the political environment in the PRC. The PRC has operated
as a socialist state since 1949 and is controlled by the Communist Party of
China. In recent years, however, the government has introduced reforms aimed at
creating a "socialist market economy" and policies have been implemented to
allow business enterprises greater autonomy in their operations. Changes in the
political leadership of the PRC may have a significant effect on laws and
policies related to the current economic reforms program, other policies
affecting business and the general political, economic and social environment in
the PRC, including the introduction of measures to control inflation, changes in
the rate or method of taxation, the imposition of additional restrictions on
currency conversion and remittances abroad, and foreign investment. These
effects could substantially impair our business, profits or prospects in China.
Moreover, economic reforms and growth in the PRC have been more successful in
certain provinces than in others, and the continuation or increases of such
disparities could affect the political or social stability of the PRC.
(c) Use of Estimates
The preparation of the consolidated financial statements in conformity with
generally accepted accounting principles in the United States of America
requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities and disclosure of contingent assets and
liabilities at the date of the consolidated financial statements and the
reported amounts of revenues and expenses during the reporting periods.
7
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
2. SUMMARY OF PRINCIPAL ACCOUNTING POLICIES (CONTINUED)
Management makes these estimates using the best information available at the
time the estimates are made; however actual results could differ materially from
those estimates.
(d) Fixed Assets
Fixed assets are stated at cost. Depreciation is provided over the estimated
useful lives of the related assets, using the straight-line method. Estimated
useful lives are as follows:
Motor vehicles 5 years Furniture and fixtures 5 years
The cost and related accumulated depreciation of assets sold or otherwise
retired are eliminated from the accounts and any gain or loss is included in the
statement of operations. The cost of maintenance and repairs is charged to
income as incurred, whereas significant renewals and betterments are
capitalized.
(e) Land Use Right
Land use right represents the 50 year right to use and lease land in the PRC.
The cost of such acquired right has been capitalized, and is being amortized
using the straight-line method over twenty five years, the operating tenure of
Bio-Bridge Science, Beijing. (See note 4).
(f) Construction in Progress
Construction in progress represents direct costs of constructing our facility in
the PRC. Capitalization of these costs will cease and the construction in
progress will be transferred to fixed assets when substantially all the
activities necessary to prepare the assets for their intended use are completed.
No depreciation will be provided until the facility is completed and ready for
its intended use. (See note 10)
(h) Cash and Cash Equivalents
For financial reporting purpose, the Company considers all highly liquid
investments purchased with original maturity of three months or less to be cash
equivalents. Cash of the Bio-Bridge Science (Beijing) Corporation, a subsidiary
of the Company, is held in accounts at financial institutions, which are located
in the PRC. The Company and subsidiaries have not experienced any losses in such
accounts and do not believe that cash is exposed to any significant credit risk.
All of BBS Beijing's cash on hand and certain bank deposits are denominated in
Renminbi ("RMB") and translated at the exchange rate at the end of the period
(See Note 2(k)).
8
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
2. SUMMARY OF PRINCIPAL ACCOUNTING POLICIES (CONTINUED)
(j) Fair Value of Financial Instruments
The Company's financial instruments include cash and cash equivalents, advance
to construction contractor, accrued expenses and other payable. Management has
estimated that the carrying amount approximates fair values due to their
short-term nature. The Company's investment in its Note Receivable has been
discounted to its present value based upon current market rates.
(k) Foreign Currency Translation
The accompanying consolidated financial statements are presented in United
States dollars. The functional currency of the Company is the Renminbi (RMB).
The consolidated financial statements are translated into United States dollars
from RMB at year-end exchange rates as to assets and liabilities and average
exchange rates as to revenues and expenses. Capital accounts are translated at
their historical exchange rates when the capital transactions occurred.
2004
Year end RMB : US$ exchange rate 8.2765 Average yearly RMB : US$ exchange rate
8.2766
The RMB is not freely convertible into foreign currency and all foreign exchange
transactions must take place through authorized institutions. No representation
is made that the RMB amounts could have been, or could be, converted into US$ at
the rates used in translation.
(l) Income Taxes
The Company accounts for income tax using the liability method that allows for
recognition of deferred tax benefits in future years. Under the liability
method, deferred taxes are provided for the net tax effects of temporary
differences between the carrying amounts of assets and liabilities for financial
reporting purposes and the amounts used for income tax purposes. A valuation
allowance is provided for deferred tax assets if it is more likely than not
these items will either expire before the Company is able to realize their
benefits, or that future utilization is uncertain.
(m) Comprehensive Income
Comprehensive income is defined to include all changes in equity except those
resulting from investments by owners and distributions to owners. Among other
disclosures, all items that are required to be recognized under current
accounting standards as components of comprehensive income should be reported in
a financial statement that is presented with the same prominence as other
financial statements. The Company's only current component of comprehensive
income is a foreign currency translation adjustment.
9
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
2. SUMMARY OF PRINCIPAL ACCOUNTING POLICIES (CONTINUED)
(n) Loss Per Share
Basic loss per share has been computed using the weighted average number of
common shares outstanding during the period. Diluted loss per share is computed
based on the weighted average number of common shares and all common equivalent
shares outstanding during the period in which they are dilutive. Common
equivalent shares consist of shares issuable upon the exercise of stock options
(using the treasury stock method) or warrants. As of December 31, 2004 common
stock equivalents consist of 1,192,675 options that each convert into one share
of the Company's common stock. For the years ended December 31, 2004 and 2003,
common equivalent shares have been excluded from the calculation of loss per
share as their effect is anti-dilutive.
(o) Stock-Based Compensation
The Company accounts for stock-based compensation issued to employees using the
intrinsic-value method prescribed in Accounting Principles Board Opinion (APB)
No. 25, "Accounting for Stock Issued to Employees."
The Company accounts for stock option and warrant grants issued to non-employees
using the guidance of SFAS No. 123, "Accounting for Stock-Based Compensation"
and EITF No. 96-18: "Accounting for Equity Instruments that are Issued to Other
Than Employees for Acquiring, or in Conjunction with Selling, Goods or
Services," whereby the fair value of such option and warrant grants is
determined using the Black-Scholes option pricing model at the date of grant.
(p) Recent Accounting Pronouncements
In March 2004, the U.S. Securities and Exchange Commission's Office of the Chief
Accountant and the Division of Corporate Finance released Staff Accounting
Bulletin No. 105 ("SAB 105"), "Loan Commitments Accounted for as Derivative
Instruments". This bulletin contains specific guidance on the inputs to a
valuation-recognition model to measure loan commitments accounted for at fair
value, and requires that fair-value measurement include only differences between
the guaranteed interest rate in the loan commitment and market interest rate,
excluding any expected future cash flows related to the customer relationship or
loan servicing. In addition, SAB105 requires the disclosure of the accounting
policy for loan commitments, including methods and assumptions used to estimate
the fair value of loan commitments, and any associated hedging strategies.
SAB105 is effective for derivative instruments, entered into subsequent to March
31, 2004 and should also be applied to existing instruments as appropriate.
In November 2004, the FASB issued Statement of Financial Accounting Standards
No. 151, "Inventory Costs". This Statement amends the guidance in ARB No. 43
Chapter 4 Inventory Pricing, to require items such as idle facility costs,
excessive spoilage, double freight and rehandling costs to be expensed in the
current period, regardless if they are abnormal amounts or not. This Statement
will become effective for us in the first quarter of 2006.
10
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
2. SUMMARY OF PRINCIPAL ACCOUNTING POLICIES (CONTINUED)
In December 2004, the FASB issued SFAS No. 153, "Exchanges of Nonmonetary
Assets, an amendment to APB Opinion No. 29" ("SFAS 153"). SFAS 153 amends
Accounting Principles Board Opinion No. 29, "Accounting for Nonmonetary
Transactions", to require that exchanges of nonmonetary assets be measured and
accounted for at fair value, rather than at carryover basis, of the assets
exchanged. Nonmonetary exchanges that lack commercial substance are exempt from
this requirement. SFAS 153 is effective for nonmonetary exchanges entered into
in fiscal periods beginning after June 15, 2005. The Company does not routinely
enter into nonmonetary exchanges. Accordingly, the Company does not expect the
adoption of SFAS 153 will have a significant effect on the Company's financial
statement presentation or disclosures.
In December 2004, the FASB issued a revised SFAS No. 123, "Accounting for
Stock-Based Compensation", which supersedes APB opinion No. 25, "Accounting for
Stock Issued to Employees", and its related implementation guidance. This
statement requires a public entity to recognize and measure the cost of employee
services it receives in exchange for an award of equity instruments based on the
grant-date fair value of the award (with limited exceptions). These costs will
be recognized over the period during which an employee is required to provide
service in exchange for the award - the requisite service period (usually the
vesting period). This statement also establishes the standards for the
accounting treatment of these share-based payment transactions in which an
entity exchanges its equity instruments for goods or services. It addresses
transactions in which an entity incurs liabilities in exchange for goods or
services that are based on the fair value of the entity's equity instruments or
that may be settled by the issuance of those equity instruments. This statement
shall be effective the first interim or annual reporting period that begins
after December 15, 2005.
The implementation of the above provisions except for 123(r) is not expected to
have a significant effect on the Company's consolidated financial statements.
3. FIXED ASSETS
Fixed assets consist of the following at December 31, 2004:
Motor vehicles $14,138
Furniture and fixtures 10,271
-------
24,409
Less accumulated depreciation 5,810
-------
Fixed assets, net $18,599
=======
Depreciation expense for the years ended December 31, 2004 and 2003 was $3,603
and $2,124, respectively.
11
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
4. LAND USE RIGHT
In July 2003, the Company obtained a 50 year land use right to build a research
factory in Beijing, PRC for an amount of $394,559. This type of arrangement is
common for the use of land in the PRC. This amount has been capitalized and is
being amortized over the land use term of twenty-five years, the operating life
of Bio-Bridge Science Beijing. The land use right is extendable beyond 50 years
for a fee of $78,780 for an additional 50 years.
Land use right as of December 2004, consisted of the following:
Cost $394,559
Less accumulated amortization 23,665
--------
Net land use rights 370,894
Less current portion 15,783
--------
Long-term portion $355,111
========
The expected amortization of the land use right over each of the next five years
and thereafter is summarized as follows:
Year ending December 31, AMOUNT
------
2005 $ 15,783
2006 15,783
2007 15,783
2008 15,783
2009 15,783
Thereafter 291,978
--------
$370,894
========
5. LOSS ON INVESTMENT
In contemplation of acquiring a vehicle for reorganization, the Company acquired
Aegir Ventures Inc. ("Aegir"). On April 12 2004, the Company acquired 100% of
the outstanding shares of Aegir, a public company incorporated in the State of
Delaware for consideration of $40,000. Aegir Ventures Inc. had no assets or
liabilities as of the acquisition date. The Company subsequently determined that
it was not a preferable vehicle for the reorganization and decided to sell it.
On November 26, 2004, the Company sold to Nakagawa Corporation ("Nakagawa"), a
Japan corporation, all of the issued and outstanding shares of Aegir for a
$40,000 unsecured, non interest bearing promissory note, payable on or before
November 26, 2006. The company valued the note at its present value of $37,704
at the date of the sale. The basis of the Company's investment in Aegir was
$40,000, resulting in a loss of $2,296 that has been reflected as a loss from
investment in the accompanying statement of operations for the year ended
December 31, 2004.
12
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
6. CAPTIAL STOCK
Common Stock
The Company is authorized to issue 100,000,000 shares of common stock, par value
$0.001 per share.
Preferred Stock
Pursuant to the Company's certificate of incorporation, its board of directors
has the authority, without further action by the stockholders, to issue up to
5,000,000 shares of undesignated preferred stock, par value $0.001 per share. As
of December 31, 2004, no shares of stock have been issued. The Company's board
will also have the authority, without the approval of the stockholders, to fix
the designations, powers, preferences, privileges and relative, participating,
optional or special rights and the qualifications, limitations or restrictions
of any preferred stock issued, including dividend rights, conversion rights,
voting rights, terms of redemption and liquidation preferences, any or all of
which may be greater than the rights of the common stock. Preferred stock could
thus be issued with terms that could delay or prevent a change in control of our
company or make removal of management more difficult. In addition, the issuance
of preferred stock may decrease the market price of the common stock and may
adversely affect the voting and other rights of the holders of common stock.
7. INCOME TAXES
(a) Corporation Income Tax ("CIT")
In accordance with the relevant tax laws and regulations of PRC, the applicable
corporation income tax rate for the subsidiary is 15%. The Company is entitled
to full exemption from CIT for the first two years and a 50% reduction in CIT
for the next three years, commencing from the first profitable year after
offsetting all tax losses carried forward from the previous five years. The
Company suffered continuing loss from its inception, and the cummualative
taxable net operating losses are $620,238 at December 31, 2004. A valuation
allowance has been provided for 100% of the future tax savings because its
realization is not predicable.
The foreign net losses carried forward will expire five years from when they
arose. The expiring amounts for the five years after 2004 are as follows:
EXPIRED YEAR AMOUNT
- ------------ --------
2005 $ --
2006 --
2007 --
2008 96,076
2009 139,074
2010 385,088
--------
Total $620,238
========
13
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
7. INCOME TAXES (CONTINUED)
Significant components of the Company's deferred income tax assets at December
31, 2004 and 2003 are as follows:
2004 2003
---- ----
Deferred income tax asset:
Amortization of land use right $ 2,367 $ --
Other 1,183 --
Net operating loss carried forward 93,036 35,273
Valuation allowance (96,586) (35,273)
-------- --------
Net deferred income tax asset $ -- $ --
======== ========
The Company's income tax expense differs from the "expected" tax benefit for the
years ended December 31, 2004 and 2003 (computed by applying the CIT rate of 15
percent to loss before income taxes) as follows:
2004 2003
---- ----
Computed "expected" benefit $ 141,665 $ 38,253
Timing difference 3,550 --
Valuation allowance difference (61,313) (35,273)
Permanent difference (83,902) (2,980)
--------- ---------
Income tax expense $ -- $ --
========= =========
At present, the Company is not a U.S. taxpayer.
(b) Value added tax ("VAT")
In accordance with the relevant tax laws in the PRC, VAT is levied at 17% on the
invoiced value of sales and is payable by the consumer. The Company is required
to remit the VAT collected to the tax authority, but may deduct therefore the
VAT it has paid on eligible purchases.
8. SHAREHOLDER'S EQUITY
The following represents transactions involving the purchases of the Company's
common stock for cash categorized by period (for the period from the date of
inception to December 31, 2004):
14
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
8. SHAREHOLDER'S EQUITY (CONTINUED)
2002:
ISSUANCE OF 13,750,000 SHARES AT $0.00004 FOR TOTAL CONSIDERATION OF $550
o At inception, 13,750,000 shares of common stock were issued for a total cash
payment of $550.
ISSUANCE OF 7,461,090 SHARES AT $0.0468 FOR TOTAL CONSIDERATION OF $349,180
o On July 15, 2002, 1,675,000 shares were issued to two individuals for a total
cash payment of $78,390.
o On July 19, 2002, 2,125,000 shares were issued for a cash payment of $99,450.
o On June 27, 2002, 786,090 shares were issued for a cash payment of $36,790.
o On November 8, 2002, 2,875,000 shares were issued to 9 individuals for a total
cash payment of $134,550.
ISSUANCE OF 1,875,000 SHARES AT $0.12 FOR TOTAL CONSIDERATION OF $225,000
o On September 6, 2002, 375,000 shares of common stock were issued for a cash
payment of $45,000.
o On November 8, 2002, 250,000 shares were issued for a cash payment of $30,000.
o On November 12, 2002, 1,250,000 shares were issued to five individuals for a
total cash payment of $150,000.
2003:
ISSUANCE OF 3,508,425 SHARES AT $0.12 FOR TOTAL CONSIDERATION OF $421,011
o On July 14, 2003, 250,000 shares were issued for a cash payment of $30,000.
o On July 28, 2003, 75,000 shares were issued for a cash payment of $9,000.
o On July 29, 2003, 291,750 shares were issued for a cash payment of $35,010.
o On August 7, 2003, 50,000 shares were issued to two individuals for a total
cash payment of $6,000.
o On September 2, 2003, 125,000 shares were issued for a cash payment of
$15,000.
o On September 3, 2003, 1,500,000 shares were issued for a cash payment of
$180,000.
o On September 12, 2003, 83,350 shares were issued for a cash payment of
$10,001.
o On November 5, 2003, 883,325 shares were issued to two individuals for a total
cash payment of $106,000.
o On December 31, 2003, 250,000 shares were issued for $30,000. This amount was
recorded as subscription receivable by the Company as of December 31, 2003 and
subsequently collected on January 5, 2004.
ISSUANCE OF 201,200 SHARES AT $0.32 FOR TOTAL CONSIDERATION OF $64,387
o On October 20, 2003, 93,750 shares were issued to two individuals for a total
cash payment of $30,000.
15
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
8. SHAREHOLDER'S EQUITY (CONTINUED)
o On November 5, 2003, 28,025 shares were issued for a cash payment of $8,977.
o On November 6, 2003, 25,000 shares were issued for a cash payment of $8,000.
o On November 12, 2003, 23,175 shares were issued to three individuals for a
total cash payment of $7,410.
o On December 18, 2003, 31,250 shares were issued for a cash payment of $10,000.
IN 2004:
ISSUANCE OF 434,600 SHARES AT $0.12 FOR TOTAL CONSIDERATION OF $52,150
o On March 25, 2004, 434,600 shares were issued to three individuals for a total
cash payment of $52,150.
ISSUANCE OF 1,125,275 SHARES AT $0.32 FOR TOTAL CONSIDERATION OF $360,086
o On January 26, 2004, 12,500 shares of common stock were issued for a cash
payment of $4,000.
o On January 30 2004, 14,750 shares were issued for a cash payment of $4,720.
o On February 18, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On March 5, 2004, 14,175 shares were issued for a cash payment of $4,540.
o On March 15, 2004, 23,375 shares were issued to three individuals for a total
cash payment of $7,480.
o On March 17, 2004, 15,625 shares were issued for a cash payment of $5,000.
o On March 26, 2004, 46,875 shares were issued to two individuals for a total
cash payment of $15,000.
o On March 31, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On April 2, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On April 6, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On April 28, 2004, 57,500 shares were issued for a cash payment of $18,400.
o On April 30, 2004, 251,725 shares were issued to ten individuals for a total
cash payment of $80,546.
o On May 11, 2004, 50,000 shares were issued to two individuals for a total cash
payment of $16,000.
o On May 15, 2004, 13,750 shares were issued for a cash payment of $4,400.
o On May 28, 2004, 500,000 shares were issued for a cash payment of $160,000.
ISSUANCE OF 1,616,000 SHARES AT $0.50 FOR TOTAL CONSIDERATION OF $807,998
o On May 31, 2004, 20,000 shares were issued for a cash payment of $10,000.
o On June 1, 2004, 240,000 shares were issued to three individuals for a total
cash payment of $120,000.
o On June 4, 2004, 85,000 shares were issued to four individuals for a total
cash payment of $42,498.
o On June 5, 2004, 81,000 shares were issued to three individuals for a total
cash payment of $40,500.
16
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
8. SHAREHOLDER'S EQUITY (CONTINUED)
o On June 7, 2004, 80,000 shares were issued to four individuals for a total
cash payment of $40,000.
o On June 8, 2004, 40,000 shares were issued to two individuals for a total cash
payment of $20,000.
o On June 9, 2004, 60,000 shares were issued to two individuals for a total cash
payment of $30,000.
o On June 11, 2004, 140,000 shares were issued to six individuals for a total
cash payment of $70,000.
o On June 12, 2004, 60,000 shares were issued to two individuals for a total
cash payment of $30,000.
o On June 13, 2004, 20,000 shares were issued for a cash payment of $10,000.
o On June 14, 2004, 260,000 shares were issued to nine individuals for a total
cash payment of $130,000.
o On June 15, 2004, 530,000 shares were issued to twelve individuals for a total
cash payment of $265,000.
Other Capital Stock Transactions
On December 1, 2004, the Company issued to Columbia China Capital Group, Inc. an
option to purchase 1,342,675 shares of common stock at $.001 per share to be
exercised within a three-year period in consideration for financial consulting
services to be provided over a two year period. The options granted were granted
outside the Company's stock option plan. On December 1, 2004, 200,000 of these
options were exercised. The options were valued at their fair value of $670,098
at the date of grant, which was determined by the Black-Scholes valuation method
using the following assumptions: no expected dividend yield; risk-free interest
rates of 3.4%; expected lives of 3 years; and estimated volatility of 85% based
on recent history of the stock price in the industry. The value of the options
issued was capitalized by the company as a prepaid consulting fee and is being
amortized over the two year term of the service agreement. During the year ended
December 31, 2004, $279,208 of this amount was amortized and included in the
accompanying statement of operations, and the remaining unamortized amount of
$390,890 was reflected as prepaid consulting costs in the accompanying balance
sheet as of December 31, 2004. The option values will be recalculated at the end
of each quarter until the services are complete. As such, the amounts required
to be expensed may vary from the original amount.
On December 1, 2004, the Company issued 100,000 shares of its common stock and
an option to purchase an additional 50,000 shares of its common stock at $.001
per share to Richardson & Patel, LLC in consideration for legal services. The
shares issued were valued at $50,000, their fair value at the date of issuance.
The options granted were valued at $24,954 at the date of grant, which was
determined by the Black-Scholes valuation method, using the following
assumptions: no expected dividend yield; risk-free interest rates of 3.4%;
expected lives of 3 years; and estimated volatility of 85 percent based on
recent history of the stock price in the industry.
On December 1, 2004, 200,000 shares of common stock were issued at $0.001 per
share for a cash payment of $200 from an exercise of stock options.
17
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
9. STOCK OPTION PLAN
On December 1, 2004, the Company approved and adopted the 2004 Stock Incentive
Plan The 2004 stock incentive plan provides for the grant of incentive stock
options to our employees, and for the grant of nonstatutory stock options,
restricted stock, stock appreciation rights and performance shares to our
employees, directors and consultants. The Company has reserved a total of
2,000,000 shares of its common stock for issuance pursuant to the 2004 stock
incentive plan. The 2004 stock incentive plan does not provide for automatic
annual increases in the number of shares available for issuance under the plan.
As of December 31, 2004, no options had been granted under this plan.
The administrator determines the exercise price of options granted under our
2004 stock incentive plan, but the exercise price must not be less than 85% of
the fair market value of our common stock on the date of grant. In the event the
participant owns 10% or more of the voting power of all classes of our stock,
the exercise price must not be less than 110% of the fair market value per share
of our common stock on the date of grant. With respect to all incentive stock
options, the exercise price must at least be equal to the fair market value of
our common stock on the date of grant. The term of an incentive stock option may
not exceed 10 years, except with respect to any participant who owns 10% of the
voting power of all classes of our outstanding stock or the outstanding stock of
any parent or subsidiary of ours, which the term must not exceed five years and
the exercise price must equal at least 110% of the fair market value on the
grant date. The administrator determines the term of all other options; however,
no option will have a term in excess of 10 years from the date of grant.
The following table summarizes the stock option activity under the plan and non
plan issuances:
Options Granted Weighted Average
Exercise Price
--------------- ----------------
Outstanding at December 31, 2003 and prior --
Granted 1,392,675 $ 0.001
Exercised 200,000 $ 0.001
Cancelled -- --
---------
Outstanding at December 31, 2004 1,192,675 $ 0.001
=========
Exercisable at December 31, 2004 1,192,675 $ 0.001
=========
Options granted in excess of shares available
at December 31, 2004 -- --
=========
18
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
9. STOCK OPTION PLAN (CONTINUED)
The following table summarizes information about stock options outstanding as of
December 31, 2004:
Options Outstanding Options Exercisable
- -----------------------------------------------------------------------------------------------------------------------------
Range of Exercise Number of Weighted Weighted Average Number of Weighted Average
Prices Shares Average Exercise Remaining Contractual Shares Exercise Price
Price Life (in years)
- -----------------------------------------------------------------------------------------------------------------------------
$0.001 1,192,675 $0.001 1.1 1,192,675 $0.001
--------- ---------
1,192,675 1,192,675
========= =========
10. COMMITMENTS AND CONTINGENCIES
Lease commitment
As of December 31, 2004, the Company had remaining outstanding commitments in
respect to its non-cancelable operating lease for its office in Oak Brook, IL,
of which $25,680 is due in 2005, and its office in Beijing, PRC (which is leased
from Wenhui Qiao, the Company's director and president), of which $5,234 is due
in 2005.
Rental expense for the year ended December 31, 2004 and 2003 was $29,417 and
$23,280, respectively.
Construction commitment
In May 2003, the Company acquired a land use right for approximately 2.8 acres
of land in the Tianzhu Export Processing Zone, Shunyi District, Beijing, China,
which the Company plans to develop into a laboratory and biomanufacturing
facility in compliance with Good Manufacturing Practices, or GMP, regulations
primarily for clinical trials of HIV-PV Vaccine I. As of December 31, 2004, the
Company has received all necessary permits and approvals and construction of the
facility had commenced. The outside main body of the GMP laboratory has been
completed as of December 31, 2004. The Company has entered into a construction
contract relating to the completion for this facility, and as of December 31,
2004 had made an advance payment of $362,472 to this contractor, and has a
further outstanding commitment under this contract of $362,472 as of December
31, 2004. The Company estimates that the cost of the building and outfitting of
this facility is $3,000,000, and the construction and installation of equipment
related to the facility will be substantially completed by September 2005.
Royalty and License Arrangements
Liang Qiao, M.D., the Company's co-founder and chief executive officer, is one
of the two co-inventors of the Company's core technology that was assigned to
Loyola University Chicago in April 2001. Under an agreement with Loyola
University Chicago, the Company
19
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
FOR THE YEARS ENDED DECEMBER 31, 2004 AND 2003
10. COMMITMENTS AND CONTINGENCIES (CONTINUED)
has obtained exclusive rights to this technology for use in its future products
within the United States, Japan and the People's Republic of China. The license
continues perpetually or for the maximum period of time permitted by law, unless
terminated earlier under the terms of the agreement. Pursuant to this agreement,
Loyola receives a royalty of 4% from the net profit for all uses of the licensed
technology, including uses under sublicenses. As of December 31, 2004, the
Company had not generated any revenues from the sale of any products under
development, nor any revenues from sublicenses.
20
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
FOR THE PERIODS ENDED SEPTEMBER 30, 2005 AND 2004
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONTENTS
PAGE 1 UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET AS OF SEPTEMBER 30,
2005
PAGE 2 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND
COMPREHENSIVE LOSS FOR THREE AND NINE MONTHS ENDED SEPTEMBER 30,
2005 AND 2004 AND FOR THE PERIOD FROM FEBRUARY 11, 2002 (INCEPTION)
THROUGH SEPTEMBER 30, 2005
PAGE 3 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN
SHAREHOLDERS' EQUITY FOR THE PERIOD FROM FEBRUARY 11, 2002
(INCEPTION) THROUGH SEPTEMBER 30, 2005
PAGE 4 UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS FOR
NINE MONTHS ENDED SEPTEMBER 30, 2005 AND 2004, AND FOR THE PERIOD
FROM FEBRUARY 11, 2002 (INECEPTION) THROUGH SEPTEMBER 30, 2005
PAGE 5-10 NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS AS
OF SEPTEMBER 30, 2004 AND 2005
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET
AS OF SEPTEMBER 30, 2005
ASSETS
September 30, December 31,
2005 2004
-------------- --------------
(UNAUDITED)
CURRENT ASSETS
Cash and cash equivalents $ 1,054,130 $ 495,805
Prepaid expenses and other current assets 32,613 19,538
Land use right, current portion 15,783 15,783
-------------- --------------
Total Current Assets 1,102,526 531,126
NOTE RECEIVABLE, NET OF DISCOUNT 38,742 37,893
ADVANCE TO A CONSTRUCTION CONTRACTOR -- 362,472
FIXED ASSETS, NET 29,846 18,599
CONSTRUCTIONS IN PROGRESS 554,897 81,133
LAND USE RIGHT, NET OF CURRENT PORTION 351,461 355,111
-------------- --------------
TOTAL ASSETS $ 2,077,472 $ 1,386,334
============== ==============
LIABILITIES AND SHAREHOLDERS' EQUITY
------------------------------------
CURRENT LIABILITIES
Accrued expenses and other payables $ 154,965 $ 67,143
-------------- --------------
Total current liabilities 154,965 67,143
-------------- --------------
COMMITMENTS AND CONTINGENCIES -- --
SHAREHOLDERS' EQUITY
Common stock, $0.001 par value, 100,000,000 shares
authorized,
32,471,537 and 30,271,590 shares issued and
outstanding, respectively 32,472 30,272
Additional paid-in capital 4,093,118 2,995,342
Prepaid consulting expense (147,090) (390,890)
Accumulated other comprehensive income (loss) 20,890 (1,600)
Deficit accumulated during the development stage (2,076,883) (1,313,933)
-------------- --------------
Total Shareholders' Equity 1,922,507 1,319,191
-------------- --------------
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 2,077,472 $ 1,386,334
============== ==============
See accompanying notes to the condensed consolidated financial statements.
1
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS AND COMPREHENSIVE LOSS
FOR THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2005 AND 2004, AND FOR THE PERIOD
FROM FEBRUARY 11, 2002 (INCEPTION) THROUGH SEPTEMBER 30, 2005
For the Period From
February 11, 2002
Three months ended Nine months ended (Inception) Through
September 30, September 30, September 30, 2005
---------------------------- ---------------------------- ------------------
2005 2004 2005 2004
------------ ------------ ------------ ------------
REVENUE $ -- -- $ -- -- $ --
Research and development costs (39,639) (34,300) (60,649) (42,300) (201,005)
General and Administrative Expenses (289,141) (161,343) (706,671) (394,677) (1,881,206)
------------ ------------ ------------ ------------ ------------------
LOSS FROM OPERATIONS (328,780) (195,643) (767,320) (436,977) (2,082,211)
OTHER INCOME 2,999 270 4,370 78 7,620
LOSS ON SALE OF INVESTMENT -- -- -- -- (2,292)
------------ ------------ ------------ ------------ ------------------
NET LOSS (325,781) (195,373) (762,950) (436,899) (2,076,883)
FOREIGN CURRENCY TRANSLATION GAIN (LOSS) 22,490 (23) 22,490 (4) 20,890
------------ ------------ ------------ ------------ ------------------
COMPREHENSIVE LOSS $ (303,291) (195,396) $ (740,460) (436,903) $ (2,055,993)
============ ============ ============ ============ ==================
LOSS PER SHARE, BASIC AND DILUTED $ (0.01) (0.01) $ (0.02) (0.02)
============ ============ ============ ============
WEIGHTED AVERAGE SHARES OUTSTANDING,
BASIC AND DILUTED 31,343,714 29,971,590 30,704,441 28,386,684
============ ============ ============ ============
See accompanying notes to the condensed consolidated financial statements.
2
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CHANGES
IN SHAREHOLDERS' EQUITY FOR THE PERIOD FROM FEBRUARY 11, 2002
(INCEPTION) THROUGH SEPTEMBER 30, 2005
Deficit
Accumulated Accumulated
Additional Prepaid Other During the
Common Stock Paid-in Consulting Comprehensive Development
Shares Amount Capital Expense Loss Stage Total
----------- ----------- ----------- ----------- ------------ ----------- -----------
Issuance of 13,750,000
shares at $0.00004 13,750,000 $ 13,750 $ (13,200) $ -- $ -- $ -- $ 550
Issuance of 7,461,090
shares at $0.0468 7,461,090 7,461 341,719 -- -- -- 349,180
Issuance of 1,875,000
shares at $0.12 1,875,000 1,875 223,125 -- -- -- 225,000
Foreign currency
translation loss -- -- -- -- (499) -- (499)
Net loss -- -- -- -- -- (114,476) (114,476)
----------- ----------- ----------- ----------- ------------ ----------- -----------
BALANCE DECEMBER 31, 2002 23,086,090 23,086 551,644 -- (499) (114,476) 459,755
- ------------------------
Issuance of 3,508,425
shares at $0.12 3,508,425 3,509 417,502 -- -- -- 421,011
Issuance of 201,200 shares
at $0.32 201,200 201 64,186 -- -- -- 64,387
Foreign currency
translation loss -- -- -- -- (644) -- (644)
Net loss -- -- -- -- -- (255,020) (255,020)
----------- ----------- ----------- ----------- ------------ ----------- -----------
BALANCE DECEMBER 31, 2003 26,795,715 26,796 1,033,332 -- (1,143) (369,496) 689,489
- -------------------------
Issuance of 434,600 shares
at $0.12 434,600 435 51,715 -- -- -- 52,150
Issuance of 1,125,275
shares at $0.32 1,125,275 1,125 358,961 -- -- -- 360,086
Issuance of 1,616,000
shares at $0.5 1,616,000 1,616 806,382 -- -- -- 807,998
Fair market value of Stock
options granted for services -- -- 695,052 -- -- -- 695,052
Fair value of shares
issued for services 100,000 100 49,900 -- -- -- 50,000
Exercise of options 200,000 200 -- -- -- -- 200
Deferred compensation -- -- -- (390,890) -- -- (390,890)
Foreign currency
translation loss -- -- -- -- (457) -- (457)
Net loss -- -- -- -- -- (944,437) (944,437)
----------- ----------- ----------- ----------- ------------ ----------- -----------
BALANCE DECEMBER 31, 2004 30,271,590 30,272 2,995,342 (390,890) (1,600) (1,313,933) 1,319,191
- -------------------------
Issuance of 2,179,947
shares at $0.5 (unaudited) 2,179,947 2,180 1,087,794 -- -- -- 1,089,974
Exercise of stock options 20,000 20 -- -- -- -- 20
Deferred compensation 9,982 (9,982) --
Amortization of deferred
compensation (unaudited) -- -- -- 253,782 -- -- 253,782
Foreign currency
translation gain (unaudited) -- -- -- -- 22,490 -- 22,490
Net loss (unaudited) -- -- -- -- -- (762,950) (762,950)
----------- ----------- ----------- ----------- ------------ ----------- -----------
BALANCE SEPTEMBER 30, 2005
- --------------------------
(unaudited) 32,471,537 $ 32,472 $ 4,093,118 $ (147,090) $ 20,890 $(2,076,883) $ 1,922,507
- ---------- =========== =========== =========== =========== ============ =========== ===========
See accompanying notes to the condensed consolidated financial statements.
3
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR NINE MONTHS ENDED SEPTEMBER 30, 2005 AND 2004, AND FOR THE PERIOD
FROM FEBRUARY 11, 2002 (INCEPTION) THROUGH SEPTEMBER 30, 2005
For the Period From
February 11, 2002
For Nine Months Ended (Inception) Through
September 30, September 30, 2005
-------------------------- ------------------
2005 2004
----------- -----------
CASH FLOWS FROM OPERATING ACTIVITIES
Net loss $ (762,950) $ (436,899) $ (2,076,883)
Adjustments to reconcile net loss to net cash used in
operating activities:
Depreciation 4,871 2,539 10,681
Amortization of land use right 3,650 (4) 27,316
Amortization of interest income (849) -- (849)
Amortization of prepaid consulting expenses 253,782 -- 557,944
Stock issued for services -- -- 50,550
Loss on sale of investment -- -- 2,296
Decrease (increase) in prepaid expenses and other assets (13,075) (87,091) (347,150)
Increase in accrued expenses and other payables 87,822 47,047 154,965
----------- ----------- ------------------
Net Cash Used In Operating Activities (426,749) (474,408) (1,621,130)
----------- ----------- ------------------
CASH FLOWS FROM INVESTING ACTIVITIES
Purchase of land use right -- (394,559)
Increase in constructions in progress (473,764) (45,088) (554,896)
Purchase of fixed assets (16,118) (3,994) (40,528)
Purchase of investment -- (40,000)
Decrease in Advance to a construction contractor 362,472 -- 344,348
----------- ----------- ------------------
Net Cash Used In Investing Activities (127,410) (49,082) (685,635)
----------- ----------- ------------------
CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from sale of common stock 1,089,994 1,220,234 3,340,006
----------- ----------- ------------------
Net Cash Provided By Financing Activities 1,089,994 1,220,234 3,340,006
----------- ----------- ------------------
EFFECT OF EXCHANGE RATE CHANGES ON CASH 22,490 4 20,889
----------- ----------- ------------------
NET INCREASE IN CASH AND CASH EQUIVALENTS
558,325 696,748 1,054,130
Cash and cash equivalents, beginning of period 495,805 220,291 --
----------- ----------- ------------------
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 1,054,130 $ 917,039 $ 1,054,130
- ---------------------------------------- =========== =========== ==================
SUPPLEMENTAL CASH FLOW INFORMATION
Interest Paid $ -- $ -- $ --
=========== =========== ==================
Income taxes Paid $ -- $ -- $ --
=========== =========== ==================
Non-Cash investing and financing transactions
Value of options issued
for deferred compensation $ 9,982 $ -- $ 9,982
=========== =========== ==================
See accompanying notes to the condensed consolidated financial statements.
4
BIO-BRIDGE SCIENCE INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS AS OF SEPTEMBER 30, 2005
NOTE 1 - BASIS OF PRESENTATION
The unaudited condensed consolidated financial statements of Bio Bridge Science
Inc. (the "Company") have been prepared in accordance with generally accepted
accounting principles for interim financial information and pursuant to the
requirements for reporting on Form 10-QSB and Item 310(b) of Regulation S-B.
Accordingly, they do not include all the information and footnotes required by
accounting principles generally accepted in United States of America for
complete financial statements. However, such information reflects all
adjustments (consisting solely of normal recurring adjustments), which are, in
the opinion of management, necessary for the fair presentation of the
consolidated financial position and the consolidated results of operations.
Results shown for interim periods are not necessarily indicative of the results
to be obtained for a full fiscal year. The condensed consolidated balance sheet
information as of December 31, 2004 was derived from the audited consolidated
financial statements included in the Company's Registration Statement Form SB -
2. These interim financial statements should be read in conjunction with that
report.
NOTE 2 - NATURE OF COMPANY
Bio-Bridge Science, Inc. (a development stage company) ("the Company") was
incorporated in the State of Delaware on October 26, 2004 to serve as a vehicle
to effect an exchange of capital stock with Bio-Bridge Science Corporation, a
Cayman Islands corporation, to redomicile from the Cayman Islands to Delaware.
The Company's fiscal year end is December 31.
The Company is a development stage enterprise as defined by Statement of
Financial Accounting Standards (SFAS) No. 7, "Accounting and Reporting by
Development Stage Enterprises." All losses accumulated since the inception of
the Company will be considered as part of the Company's development stage
activities. The Company has not commenced revenue generating activities.
On December 1, 2004, the Company acquired all of the outstanding shares of
Bio-Bridge Science Corporation ("BBSC"), a Cayman Islands corporation, in
exchange for 29,971,590 shares of its common stock, and as a result, BBSC became
a wholly owned subsidiary of Bio-Bridge Science, Inc. BBSC was incorporated in
the Cayman Islands on February 11, 2002. At the time of the exchange, BBSC held
a 100% interest in Bio-Bridge Science (Beijing) Corp. ("BBS Beijing") a
wholly-foreign funded enterprise of the People's Republic of China ("PRC") which
was established on May 20, 2002. Bio-Bridge Science (Beijing) has been issued an
operating license for 25 years, which can be renewed for an additional 25-year
term for a nominal fee. BBS Beijing is currently engaged in the development and
commercialization of the HIV-PV vaccine I in mainland China.
The acquisition was accounted for as a reverse merger (recapitalization) with
Bio-Bridge Science Corporation deemed to be the accounting acquirer, and
Bio-Bridge Science Inc. deemed to be the legal acquirer. Accordingly, the
historical financial information presented in the financial statements is that
of Bio-Bridge Science Corporation as adjusted to give effect to any difference
in the par value of the issuer's and the accounting acquirer's stock with an
offset to capital in excess of par value. The basis of the assets, liabilities
and retained earnings of BBSC, the accounting acquirer, have been carried over
in the recapitalization.
NOTE 3 - GOING CONCERN
The accompanying condensed consolidated financial statements have been prepared
on the basis that the Company will continue as a going concern which assumes the
realization of assets and settlement of liabilities in the normal course of
business. Since its inception, the Company has been engaged in organizational
and pre-operating activities. Furthermore, the Company has generated no revenue
and has incurred accumulated losses and negative operating cash flows of
$2,076,883 and $1,621,130, respectively, since inception. Continuation of the
Company's existence is dependent upon its ability to obtain additional capital
and sustain profitable operations.
5
The uncertainty related to these conditions raises substantial doubt about the
Company's ability to continue as going concern. The accompanying condensed
consolidated financial statements do not include any adjustments that might
result from the outcome of this uncertainty.
During the next 12 months, the Company intends to raise capital through an
offering of its securities or from loans to continue research and development of
HIV-PV Vaccine I in China as well as complete the construction of its laboratory
in China. The Company has no current arrangements for obtaining the additional
cash and working capital it may require, and will seek to raise it through the
public or private sales of its securities, or loans, or a combination of the
foregoing. The Company cannot guarantee financing will be available, on
acceptable terms or at all. At this time, the Company is unable to determine
when the HIV-PV Vaccine I will become fully developed manufactured and sold. The
Company does not expect to generate any significant revenues in the next 12
months. If the Company fails to obtain other financing, either through an
offering of our securities or by obtaining additional loans, we may be unable to
maintain our operations.
NOTE 4 - ECONOMIC AND POLITICAL RISKS
The Company faces a number of risks and challenges since its operation is in PRC
and its primary market is in the PRC. We have operations in China. Most of the
pre-clinical testing of our HIV-PV Vaccine I product on laboratory animals in
Beijing, China was completed in October 2005. Our business operations may be
adversely affected by the political environment in the PRC. The PRC has operated
as a socialist state since 1949 and is controlled by the Communist Party of
China. In recent years, however, the government has introduced reforms aimed at
creating a "socialist market economy" and policies have been implemented to
allow business enterprises greater autonomy in their operations. Changes in the
political leadership of the PRC may have a significant effect on laws and
policies related to the current economic reforms program, other policies
affecting business and the general political, economic and social environment in
the PRC, including the introduction of measures to control inflation, changes in
the rate or method of taxation, the imposition of additional restrictions on
currency conversion and remittances abroad, and foreign investment. These
effects could substantially impair our business, profits or prospects in China.
Moreover, economic reforms and growth in the PRC have been more successful in
certain provinces than in others, and the continuation or increases of such
disparities could affect the political or social stability of the PRC.
NOTE 5 - USE OF ESTIMATES
The preparation of the condensed consolidated financial statements in conformity
with generally accepted accounting principles requires management to make
estimates and assumptions that affect the reported amounts of assets and
liabilities and disclosure of contingent assets and liabilities at the date of
the condensed consolidated financial statements, and expenses during the
reporting periods. Actual results when ultimately realized could differ from
those estimates.
NOTE 6 - LOSS PER SHARE
Basic loss per share has been computed using the weighted average number of
common shares outstanding during the corresponding periods. Diluted loss per
share is computed based on the weighted average number of common shares and all
common equivalent shares outstanding during the periods in which they are
dilutive. Common equivalent shares consist of shares issuable upon the exercise
of stock options (using the treasury stock method) or warrants. As of September
30, 2005 common stock equivalents consist of 1,192,675 options that each convert
into one share of the Company's common stock. For the three months and nine
months ended September 30, 2005 and 2004, common equivalent shares have been
excluded from the calculation of loss per share as their effect is
anti-dilutive.
6
NOTE 7 - FAIR VALUE OF FINANCIAL INSTRUMENTS
The carrying value of financial instruments including cash and cash equivalents,
note receivable, prepaid expenses and other current assets, accrued expenses and
other payables, approximates their fair value at September 30, 2005 and December
31, 2004 due to the relatively short-term nature of these instruments.
NOTE 8 - FOREIGN CURRENCY CONVERSION
The Company's financial information is presented in US dollars. The functional
currency Renminbi (RMB) of the Company is translated into United States dollars
from RMB at quarter / year-end exchange rates as to assets and liabilities and
average exchange rates as to revenues and expenses. Capital accounts are
translated at their historical exchange rates when the capital transactions
occurred.
2005 2004
------ ------
Quarter / Year end RMB : US$ exchange rate 8.0920 8.2765
Average yearly RMB : US$ exchange rate 8.1843 8.2766
The RMB is not freely convertible into foreign currency and all foreign exchange
transactions must take place through authorized institutions. No representation
is made that the RMB amounts could have been, or could be, converted into US
dollars at the rates used in translation.
On July 22, 2005, Renminbi rose approximately 2 percent against the US dollar at
the exchange rate of 8.11 to 1.
NOTE 9 - SHAREHOLDER'S EQUITY
The following represents transactions involving the purchases of the Company's
common stock for cash categorized by period (for the period from the date of
inception to September 30, 2005):
2002:
ISSUANCE OF 13,750,000 SHARES AT $0.00004 FOR TOTAL CONSIDERATION OF $550
o At inception, 13,750,000 shares of common stock were issued for a total cash
payment of $550.
ISSUANCE OF 7,461,090 SHARES AT $0.0468 FOR TOTAL CONSIDERATION OF
$349,180
o On July 15, 2002, 1,675,000 shares were issued to two individuals for a total
cash payment of $78,390.
o On July 19, 2002, 2,125,000 shares were issued for a cash payment of $99,450.
o On June 27, 2002, 786,090 shares were issued for a cash payment of $36,790.
7
o On November 8, 2002, 2,875,000 shares were issued to 9 individuals for a total
cash payment of $134,550.
ISSUANCE OF 1,875,000 SHARES AT $0.12 FOR TOTAL CONSIDERATION OF $225,000
o On September 6, 2002, 375,000 shares of common stock were issued for a cash
payment of $45,000.
o On November 8, 2002, 250,000 shares were issued for a cash payment of $30,000.
o On November 12, 2002, 1,250,000 shares were issued to five individuals for a
total cash payment of $150,000. 2003:
ISSUANCE OF 3,508,425 SHARES AT $0.12 FOR TOTAL CONSIDERATION OF $421,011
o On July 14, 2003, 250,000 shares were issued for a cash payment of $30,000.
o On July 28, 2003, 75,000 shares were issued for a cash payment of $9,000.
o On July 29, 2003, 291,750 shares were issued for a cash payment of $35,010.
o On August 7, 2003, 50,000 shares were issued to two individuals for a total
cash payment of $6,000.
o On September 2, 2003, 125,000 shares were issued for a cash payment of
$15,000.
o On September 3, 2003, 1,500,000 shares were issued for a cash payment of
$180,000.
o On September 12, 2003, 83,350 shares were issued for a cash payment of
$10,001.
o On November 5, 2003, 883,325 shares were issued to two individuals for a total
cash payment of $106,000.
o On December 31, 2003, 250,000 shares were issued for $30,000. This amount was
recorded as subscription receivable by the Company as of December 31, 2003 and
subsequently collected on January 5, 2004.
ISSUANCE OF 201,200 SHARES AT $0.32 FOR TOTAL CONSIDERATION OF $64,387
o On October 20, 2003, 93,750 shares were issued to two individuals for a total
cash payment of $30,000.
o On November 5, 2003, 28,025 shares were issued for a cash payment of $8,977.
o On November 6, 2003, 25,000 shares were issued for a cash payment of $8,000.
o On November 12, 2003, 23,175 shares were issued to three individuals for a
total cash payment of $7,410.
o On December 18, 2003, 31,250 shares were issued for a cash payment of $10,000.
NOTE 9 - SHAREHOLDER'S EQUITY (CONTINUED)
2004:
ISSUANCE OF 434,600 SHARES AT $0.12 FOR TOTAL CONSIDERATION OF $52,150
o On March 25, 2004, 434,600 shares were issued to three individuals for a total
cash payment of $52,150.
ISSUANCE OF 1,125,275 SHARES AT $0.32 FOR TOTAL CONSIDERATION OF $360,086
o On January 26, 2004, 12,500 shares of common stock were issued for a cash
payment of $4,000.
o On January 30 2004, 14,750 shares were issued for a cash payment of $4,720.
o On February 18, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On March 5, 2004, 14,175 shares were issued for a cash payment of $4,540.
o On March 15, 2004, 23,375 shares were issued to three individuals for a total
cash payment of $7,480.
o On March 17, 2004, 15,625 shares were issued for a cash payment of $5,000.
o On March 26, 2004, 46,875 shares were issued to two individuals for a total
cash payment of $15,000.
o On March 31, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On April 2, 2004, 31,250 shares were issued for a cash payment of $10,000.
o On April 6, 2004, 31,250 shares were issued for a cash payment of $10,000.
8
o On April 28, 2004, 57,500 shares were issued for a cash payment of $18,400.
o On April 30, 2004, 251,725 shares were issued to ten individuals for a total
cash payment of $80,546.
o On May 11, 2004, 50,000 shares were issued to two individuals for a total cash
payment of $16,000.
o On May 15, 2004, 13,750 shares were issued for a cash payment of $4,400.
o On May 28, 2004, 500,000 shares were issued for a cash payment of $160,000.
ISSUANCE OF 1,616,000 SHARES AT $0.50 FOR TOTAL CONSIDERATION OF $807,998
o On May 31, 2004, 20,000 shares were issued for a cash payment of $10,000.
o On June 1, 2004, 240,000 shares were issued to three individuals for a total
cash payment of $120,000.
o On June 4, 2004, 85,000 shares were issued to four individuals for a total
cash payment of $42,498.
o On June 5, 2004, 81,000 shares were issued to three individuals for a total
cash payment of $40,500.
o On June 7, 2004, 80,000 shares were issued to four individuals for a total
cash payment of $40,000.
o On June 8, 2004, 40,000 shares were issued to two individuals for a total cash
payment of $20,000.
o On June 9, 2004, 60,000 shares were issued to two individuals for a total cash
payment of $30,000.
o On June 11, 2004, 140,000 shares were issued to six individuals for a total
cash payment of $70,000.
o On June 12, 2004, 60,000 shares were issued to two individuals for a total
cash payment of $30,000.
o On June 13, 2004, 20,000 shares were issued for a cash payment of $10,000.
o On June 14, 2004, 260,000 shares were issued to nine individuals for a total
cash payment of $130,000.
o On June 15, 2004, 530,000 shares were issued to twelve individuals for a total
cash payment of $265,000.
Other Capital Stock Transactions
On December 1, 2004, the Company issued 100,000 shares of its common stock and
an option to purchase an additional 50,000 shares of its common stock at $.001
per share to Richardson & Patel, LLC in consideration for legal services. The
shares issued were valued at $50,000, their fair value at the date of issuance.
The options granted were valued at $24,954 at the date of grant, which was
determined by the Black-Scholes valuation method, using the following
assumptions: no expected dividend yield; risk-free interest rates of 3.4%;
expected lives of 3 years; and estimated volatility of 85 percent based on
recent history of the stock price in the industry.
On December 1, 2004, 200,000 shares of common stock were issued at $0.001 per
share for a cash payment of $200 from an exercise of stock options.
2005:
ISSUANCE OF 2,179,947 SHARES AT $0.5 FOR TOTAL CONSIDERATION OF $1,089,974
o On April 22, 2005, 20,000 shares were issued to one individual for a total
cash payment of $10,000.
o On May 9, 2005, 100,000 shares were issued to one individual for a cash
payment of $50,000.
o On May 10, 2005, 100,000 shares were issued to one individual for a cash
payment of $50,000.
o On May 20, 2005, 100,000 shares were issued to one individual for a total cash
payment of $50,000.
o On June 6, 2005, 60,000 shares were issued to one individual for a total cash
payment of $30,000.
o On June 13, 2005, 50,000 shares were issued to two individuals for a total
cash payment of $25,000.
o On June 15, 2005, 40,000 shares were issued to one individual for a total cash
payment of $20,000.
o On June 20, 2005, 100,000 shares were issued to two companies for a total cash
payment of $50,000.
o On August 23, 2005, 30,000 shares were issued to two individuals for a total
cash payment of $15,000.
o On August 26, 2005, 60,000 shares were issued to three individuals for a total
cash payment of $30,000.
o On August 29, 2005, 130,000 shares were issued to five individuals for a total
cash payment of $65,000.
o On August 30, 2005, 116,250 shares were issued to three individuals for a
total cash payment of $58,125.
o On August 31, 2005, 766,046 shares were issued to twenty-five individuals for
a total cash payment of $383,023.
o On September 5, 2005, 40,000 shares were issued to one individual for a total
cash payment of $20,000.
o On September 12, 2005, 352,651 shares were issued to one individual for a
total cash payment of $176,326.
o On September 22, 2005, 100,000 shares were issued to one individual for a
total cash payment of $50,000.
o On September 23, 2005, 15,000 shares were issued to one individual for a total
cash payment of $7,500.
9
EXERCISE OF 20,000 STOCK OPTIONS AT $0.001 FOR TOTAL CONSIDERATION OF $20
o On July 1, 2005, 20,000 stock options were exercised by two individuals for a
total cash payment of $20.
Other Capital Stock Transactions
On December 1, 2004, the Company issued to Columbia China Capital Group, Inc. an
option to purchase 1,342,675 shares of common stock at $.001 per share to be
exercised within a three-year period in consideration for financial consulting
services to be provided over a two year period. The options granted were granted
outside the Company's stock option plan. On December 1, 2004, 200,000 of these
options were exercised. The options were valued at their fair value of $670,098
at the date of grant, which was determined by the Black-Scholes valuation method
using the following assumptions: no expected dividend yield; risk-free interest
rates of 3.4%; expected lives of 3 years; and estimated volatility of 85% based
on recent history of the stock price in the industry. The value of the options
issued was capitalized by the company as a prepaid consulting fee and is being
amortized over the two year term of the service agreement. During the year ended
September 30, 2005, $530,494 of this amount was amortized and included in the
accompanying statement of operations, and the remaining unamortized amount of
$139,604 was reflected as prepaid consulting costs in the accompanying balance
sheet as of September 30, 2005. The option values will be recalculated at the
end of each quarter until the services are complete. As such, the amounts
required to be expensed may vary from the original amount.
On December 1, 2004, the Company issued 100,000 shares of its common stock and
an option to purchase an additional 50,000 shares of its common stock at $.001
per share to Richardson & Patel, LLC in consideration for legal services. The
shares issued were valued at $50,000, their fair value at the date of issuance.
The options granted were valued at $24,954 at the date of grant, which was
determined by the Black-Scholes valuation method, using the following
assumptions: no expected dividend yield; risk-free interest rates of 3.4%;
expected lives of 3 years; and estimated volatility of 85 percent based on
recent history of the stock price in the industry.
On December 1, 2004, 200,000 shares of common stock were issued at $0.001 per
share for a cash payment of $200 from an exercise of stock options.
On July 1, 2005, the Company issued to two individual consultants an option to
purchase 20,000 shares of common stock at $.001 per share to be exercised within
a three-year period in consideration for scientific advisory service to be
provided over a one-year period, and all of these shares were exercised at the
same time when they were granted. The options granted were valued at $9,982 at
the date of grant, which was determined by the Black-Scholes valuation method,
using the following assumptions: no expected dividend yield; risk-free interest
rates of 3.4%; expected lives of 3 years; and estimated volatility of 85 percent
based on recent history of the stock price in the industry. The value of the
options issued was capitalized by the company as a prepaid consulting fee and is
being amortized over the one year term of the service agreement.
During the nine months ended September 30, 2005, $253,782 of this amount was
amortized and included in the accompanying statement of operations, and the
remaining unamortized amount of $147,090 was reflected as prepaid consulting
costs in the accompanying statement of changes in shareholders' equity as of
September 30, 2005. The option values are recalculated at the end of each
quarter until the services are complete. During the nine months ended September
30, 2005, there have been new issuances of 1,629,947 shares of common stock at
$0.5 per share. All the external conditions and assumptions used in the
Black-Scholes valuation method remain unchanged. Therefore the Company believes
there is no change in the valuation of the carrying stock options as of
September 30, 2005.
NOTE 10 - COMMITMENTS AND CONTINGENCIES
Construction commitment
In May 2003, the Company acquired a land use right for approximately 2.8 acres
of land in the Tianzhu Export Processing Zone, Shunyi District, Beijing, China,
which the Company plans to develop into a laboratory and biomanufacturing
facility in compliance with Good Manufacturing Practices, or GMP, regulations
primarily for clinical trials of HIV-PV Vaccine I. As of September 30, 2005, the
Company has received all necessary permits and approvals and construction of the
facility had commenced. The outside main body of the GMP laboratory has been
completed as of September 30, 2005. The Company has entered into a construction
contract relating to the completion for this facility. As of September 30, 2005
a payment of $362,472 has been made to this contractor, and has a further
outstanding commitment under this contract of $362,472, of which $61,789 has
been accrued and is included in accrued expenses as of September 30, 2005. The
Company estimates that the cost of the building and outfitting of this facility
is $3,000,000, and the construction and installation of equipment related to the
facility will be substantially completed by April 2006.
NOTE 11 - SUBSEQUENT EVENTS
On November 21, 2005, the Company entered into an exclusive distribution
agreement with Xinhua Surgical Instruments Co., Ltd., located in Shandong,
China. Under this agreement, the Company has been granted exclusive distribution
rights for all Xinhua surgical instruments in the United States, which are
subject to FDA approval. The Company's minimum turnover requirement begins in
the second year in the amount of $50,000 and increases to $60,000 during the
third year and increases 10% annually thereafter. The Company is responsible for
advertising and marketing expenses in connection with distribution of Xinhua
surgical instruments in the United States. Subject to minimum turnover
requirements, the Company's exclusivity rights in the United States will be
extended unless it fails to fulfill the minimum turnover requirements. On
December 6, 2005, the Company received confirmation from the FDA of its
registration as a medical device establishment, which enables it to perform
initial distributor and repackager operations.
The outside construction of the Company's laboratory and biomanufacturing
facility in Beijing, China has been completed and all amounts owed have been
paid.
In December 2005, the Company paid the contractor $61,939 in advance for the
purification project.
On October 14 2005, the Company granted options to purchase an aggregate of
1,945,000 shares of common stock under its 2004 stock incentive plan to
employees, directors and consultants. Of this amount, 115,000 shares were
granted to non-employees and 1,830,000 to employees. One-twelfth of the shares
of each option shall vest commencing on January 1, 2006 and thereafter on the
first business day of each quarter if optionee remains a continuous services
provider to the company. Expiration date will be 10 years after date of grant.
The vesting period is 3 years.
Management will record the compensation costs related to the issuance of options
using the Black-Scholes option pricing model in accordance with the fair value
method prescribed by Statement of Financial Accounting Standards No.123 (R) for
all options issued to employees and amortize over the vesting period. The fair
value of each option granted will be estimated on the date of the grant using
the Black-Scholes option pricing model with the following weighted average
assumptions: no expected dividend yield; risk -free interest rates of 3.4%;
expected lives of 5 years; and estimated volatility of 85% based on resent
history of the stock price in the industry.
In accordance with SFAS No.123(R) issued by the FASB, the Company will recognize
the cost of employee services received in exchange for awards of equity
instruments based on the grant-date fair value of those awards.
On November 2 2005, the Company issued 8,116 shares of common stock as
additional finder's fees.
On October 17, 2005, CCCG notified the Company that it exercised 300,000 options
on a cashless basis, and the Company issued 300,000 shares of restricted common
stock to CCCG. On November 1, 2005, CCCG also returned 350,000 option shares, or
part of an option previously issued to CCCG, to the Company.
On November 1, 2005, the Company issued an option to purchase 50,000 shares to a
consultant pursuant to an investment relations agreement. The Company issued an
option to purchase 150,000 shares to an executive officer. The Company also
issued an option to purchase 150,000 shares to the Company's chief financial
officer. All these options are exercisable at price per share of $0.001. The
expiration date for the options granted to the consultant is November 3, 2008,
and the expiration date for the options granted to the executive officers is
October 31, 2015.
Management will record compensation costs relating to the 350,000 options using
the Black-Scholes option pricing model in accordance with the fair value method
prescribed by Statement of Financial Accounting Standards No.123 (R) for all
options issued to employees and amortize over the vesting period. The fair value
of each option granted will be estimated on the date of the grant using the
Black-Scholes option pricing model with the following weighted average
assumptions: no expected dividend yield; risk -free interest rates of 3.4%;
expected lives of 5 years for options granted to Wenhui Qiao and Kevin Lee while
the expected lives for options granted to Adam Friedman Associates is 1.5 years;
and estimated volatility of 85% based on resent history of the stock price in
the industry.
On November 29, 2005, the Company entered into an Investment Agreement with
Dutchess Private Equities Fund, LP, a Delaware limited partnership. Under the
terms of the agreement, Dutchess has agreed to purchase from the Company up to
$10,000,000 of its common stock over a 24-month period. After a registration
statement covering the resale of up to 2,000,000 shares of the Company's common
stock is declared effective, the Company has the right to deliver a put notice
and sell to Dutchess (i) $100,000 of its common stock or (ii) 200% of the
average daily volume of its common stock for the 10 trading days prior to the
put notice date, multiplied by the average of three daily closing bid prices
immediately preceding the put date. The purchase price per share identified in
each put notice will be equal to 95% of the lowest closing best bid price of the
Company's common stock during five trading days after the applicable put notice
date. Pursuant to the terms of the agreement, the Company has the right to
control the timing and amount of stock sold to Dutchess. The Company is not
entitled to submit a put notice until after the closing of the previous put
notice. Pursuant to the agreement, upon receipt of a put notice, Dutchess will
be required to purchase from the Company during the applicable pricing period a
number of shares having an aggregate purchase price equal to the lesser of (i)
the put amount identified in the put notice, and (ii) 20% of the aggregate
trading volume of the Company's common stock during the pricing period
multiplied by the lowest closing bid price during the applicable pricing period.
In addition, the agreement requires the Company to pay a registered broker
dealer 2.5% of the put amount on each draw toward the placement agent fee up to
a total cumulative amount of $10,000. The agreement terminates upon the earlier
to occur of the following events: (i) when Dutchess has purchased an aggregate
$10,000,000 in our common stock, or an aggregate of 2,000,000 shares of the
Company's common stock; and (ii) on the date which is 24 months after the
effective date of the registration statement.
10
WHERE YOU CAN FIND MORE INFORMATION
We have filed with the SEC a registration statement on Form SB-2 under the
Securities Act with respect to the common stock being offered in this offering.
A copy of the registration statement, and the exhibits and schedules thereto,
may be read and copied at the SEC's Public Reference Room at 450 Fifth Street,
N.W., Washington D.C. 20549. Copies of these materials can be obtained at
prescribed rates from the Public Reference Section of the SEC at the principal
offices of the SEC, 450 Fifth Street, N.W., Washington D.C. 20549. You may
obtain information regarding the operation of the public reference room by
calling 1(800) SEC-0330. The SEC also maintains a website (http://www.sec.gov)
that contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC.
40
BIO-BRIDGE SCIENCE, INC.
3,618,064 SHARES
COMMON STOCK
PROSPECTUS
January 11, 2006
You should rely only on the information contained in this prospectus to make
your investment decision. We have not authorized anyone to provide you with
different information. This prospectus may be used only where it is legal to
sell these securities. You should not assume that the information in this
prospectus is accurate as of any date other than the date on the front page of
this prospectus.
All dealers that effect transactions in these securities, whether or not
participating in this offering, may be required to deliver a prospectus. This is
in addition to the dealers' obligation to deliver a prospectus when acting as
underwriters and with respect to their unsold allotments or subscriptions.