Filed Pursuant to Rule 424(b)(3)
Registration No. 333-102526
PROSPECTUS
13,075,267 SHARES
BIOPHAN TECHNOLOGIES, INC.
COMMON STOCK
There are hereby offered up to 13,075,267 shares of the common stock, of
Biophan Technologies, Inc. All of these shares are being offered by selling
stockholders. Biophan will not receive any of the proceeds from the sale of
shares by the selling stockholders.
This prospectus relates to the resale of the following shares:
o 3,325,757 shares that were issued to Spectrum Advisors Ltd. under a
common stock purchase agreement between us and Spectrum;
o 166,288 shares of our common stock underlying 166,288 warrants
issued to Carolina Financial Services, LLC for services rendered in
relation to the Spectrum common stock purchase agreement;
o 5,521,100 shares of common stock, and 2,760,550 shares of common
stock underlying warrants, issued to certain purchasers in a private
placement of our securities, pursuant to which the purchasers were
granted the right to have their common stock registered in a
subsequent registration statement;
o 121,572 common shares underlying warrants granted to principals of
CFS for financial advisory and investment banking services; and
o 1,180,000 shares issuable upon exercise of warrants issued to Biomed
Solutions, LLC.
Our common stock trades on the over-the-counter market under the symbol
"BIPH." The last reported sales price for our common stock on February 17, 2004
was $1.33 per share.
THE SECURITIES OFFERED HEREBY INVOLVE A HIGH DEGREE OF RISK.
INVESTING IN OUR COMMON STOCK INVOLVES RISKS WHICH ARE DESCRIBED UNDER
"RISK FACTORS" BEGINNING ON PAGE 5.
Neither the Securities and Exchange Commission nor any state securities
commission has approved or disapproved of these securities or determined if this
prospects is accurate or complete. It is illegal for anyone to tell you
otherwise.
The date of this prospectus is February 18, 2004.
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You should rely only on the information contained in this prospectus. We have
not, and the selling stockholders have not, authorized anyone to provide you
with different information. If anyone provides you with different information,
you should not rely on it. We are not, and the selling stockholders are not,
making an offer to sell these securities in any jurisdiction where the offer or
sale is not permitted. You should assume that the information contained in this
prospectus is accurate only as of the date on the front cover of this
prospectus. Our business, financial condition, results of operations and
prospects may have changed since that date.
TABLE OF CONTENTS
Risk Factors...................................................................5
Use of Proceeds...............................................................12
Nature of Trading Market......................................................12
Dividend Policy...............................................................12
Capitalization................................................................12
SBI Stock Purchase Agreement..................................................14
Prior Stock Purchase Agreements...............................................15
Conversion of Outstanding Debt................................................15
Plan of Operation.............................................................17
Business......................................................................20
Legal Proceedings.............................................................38
Management....................................................................39
Executive Compensation........................................................43
Security Ownership of Certain Beneficial Owners and Management................45
Certain Relationships and Related Transactions................................47
Description of Securities.....................................................49
Shares Eligible for Future Sale...............................................50
Selling Stockholders..........................................................51
Plan of Distribution..........................................................58
Legal Matters.................................................................59
Experts.......................................................................59
Where you Can Find Additional Information.....................................59
Financial Statements..........................................................60
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PROSPECTUS SUMMARY
This summary 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 more detailed information
regarding our company, the risks of purchasing our common stock discussed under
"risk factors," and our financial statements and the accompanying notes.
BIOPHAN TECHNOLOGIES, INC.
Biophan is an early-stage research and development company focusing on
technology that will enable certain medical procedures and biomedical devices,
including cardiac pacemakers, defibrillators, guidewires, stents, prosthetic
devices and others, to become safe and compatible with magnetic resonance
imaging (MRI) diagnostics. Our approach is based on multiple technologies, some
that are patented and others for which we or our licensors have U.S. and foreign
patents pending. Our research efforts are focused on demonstrating the
feasibility of our coating and filtering solutions. We intend to license medical
device manufacturers to use our technology in their existing and future products
and to supply them with coating equipment and critical components. We
incorporated on August 1, 1968 and began our current line of business on
December 1, 2000. From that date through our fiscal quarter ended November 30,
2003, we have had no material revenues from operations and have incurred
cumulative net losses of $10,056,465. Since December 1, 2000, we have relied
almost entirely on sales of our securities and loans to fund our operations.
STATUS OF SPECTRUM STOCK PURCHASE AGREEMENT
This prospectus originally related to the resale of up to 8,960,000 shares
of our common stock that may have been issued to Spectrum Advisors Ltd. under a
common stock purchase agreement between us and Spectrum and upon the exercise of
up to 448,000 warrants that may have been issued to Carolina Financial Services,
LLC for services rendered in relation to the Spectrum agreement. We have issued
a total of 3,325,757 shares of common stock to Spectrum and have issued warrants
to purchase 166,288 shares of common stock to Carolina Financial Services. We
and Spectrum agreed to terminate the stock purchase agreement on February 9,
2004. We will not issue any additional shares to Spectrum under the stock
purchase agreement and will not issue any additional warrants to Carolina
Financial Services with respect to the stock purchase agreement. We have been
advised by Spectrum that it has resold all of the shares it has purchased under
the stock purchase agreement.
THE OFFERING
Securities offered by
Selling Stockholders 13,075,267 shares of common stock,
representing:
o 3,325,757 shares issued to
Spectrum Advisors Ltd. under a
common stock purchase agreement
between us and Spectrum;
o 166,288 shares issuable upon
exercise of warrants issued in
relation to the Spectrum common
stock purchase agreement;
o 8,281,650 shares issued to
investors in a private placement
or upon exercise of warrants
issued in connection with that
private placement;
o 121,572 shares issuable upon
exercise of warrants issued to
our financial advisors; and
o 1,180,000 shares issuable upon
exercise of warrants issued to
Biomed Solutions, LLC.
Use of Proceeds We will not receive any proceeds
from the sale of shares by the
selling stockholders.
Risk Factors An investment in our common
stock involves a high degree of
risk and could result in a loss
of your entire investment.
OTC symbol BIPH
EXECUTIVE OFFICES
Our executive offices are located at 150 Lucius Gordon Drive, Suite 215,
West Henrietta, New York 14586. Our telephone number is (585) 214-2441 and our
website is: www.biophan.com. The information on our website is not part of this
prospectus.
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SUMMARY HISTORICAL FINANCIAL INFORMATION
The following table presents summarized financial information as of and
for the nine months ended November 30, 2003 and as of and for the fiscal years
ended February 28, 2003, 2002 and 2001. The information is extracted from the
consolidated financial statements presented elsewhere in this prospectus and in
previous filings and should be read in conjunction therewith.
FOR THE NINE
MONTHS ENDED FOR THE FISCAL YEAR ENDED FEBRUARY 28,
NOVEMBER 30, --------------------------------------------
2003 2003 2002 2001
---- ---- ---- ----
(Unaudited)
Operating Data:
Revenues...................... $ 75,000 -- -- --
Salaries and related.......... 376,874 $ 648,304 $ 461,629 $ 59,861
General & administrative expenses 423,173 582,174 475,520 16,059
Total expenses................ 1,847,627 3,438,252 3,705,917 729,130
Net (loss).................... (2,083,308) (3,438,252) (3,705,917) (729,130)
Net (loss) per share.......... (0.05) (0.11) (0.14) (0.08)
Weighted average shares
outstanding................. 40,359,446 31,731,051 27,000,962 9,166,887
AS OF AS OF FEBRUARY 28,
NOVEMBER 30, ----------------------------------------------
2003 2003 2002 2001
---- ---- ---- ----
(Unaudited)
Balance Sheet Data:
Current assets................ $ 205,280 $ 476,353 $ 672,823 $ 172,092
Total assets.................. 345,631 683,056 866,638 343,752
Current liabilities........... 867,092 796,187 645,389 280,992
Long-term liabilities......... 333,334 83,333 -- 438,000
Stockholders' equity (deficiency) (854,795) (196,464) 221,249 (375,240)
Working capital (deficiency).. (661,812) (319,834) 27,434 (108,900)
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RISK FACTORS
Please consider the following risk factors together with the other
information presented in this prospectus, including the financial statements and
the notes thereto, before investing in our common stock. The trading price of
our common stock could decline due to any of the following risks, and you might
lose all or part of your investment.
WE ARE A NEW BUSINESS WITH A LIMITED OPERATING HISTORY AND NO MATERIAL REVENUES
TO DATE AND ARE NOT LIKELY TO SUCCEED UNLESS WE CAN OVERCOME THE MANY OBSTACLES
WE FACE.
We are a development-stage company with limited prior business operations
and no material revenues. We are presently engaged in the early stage
development of certain medical procedures and biomedical devices. Because of our
limited operating history, you may not have adequate information on which you
can base an evaluation of our business and prospects. To date, our efforts have
been devoted primarily to the following:
o organizational activities;
o developing a business plan;
o obtaining funding;
o conducting research and working toward the ultimate successful
development of our products;
o marketing to major biomedical manufacturers;
o aggressively patenting our intellectual property; and
o licensing technology from third parties related to our business.
In order to establish ourselves in the medical device market, we are
dependent upon continued funding and the successful development and marketing of
our products. You should be aware of the increased risks, uncertainties,
difficulties and expenses we face as a research and development company and that
an investment in our common stock may be worthless if our business fails.
WE HAVE GENERATED NO MATERIAL REVENUES AND IF WE ARE UNABLE TO GENERATE
SUFFICIENT REVENUES IN THE FUTURE, WE MAY NOT BE ABLE TO CONTINUE OUR BUSINESS.
We are still in our formative and development stage. As an investor, you
should be aware of the difficulties, delays and expenses normally encountered by
an enterprise in its development stage, many of which are beyond our control,
including unanticipated research and developmental expenses, employment costs,
and administrative expenses. We cannot assure our investors that our proposed
business plans as described in this prospectus will materialize or prove
successful, or that we will ever be able to finalize development of our products
or operate profitably. If we cannot operate profitably, you could lose your
entire investment. As a result of the start-up nature of our business, initially
we expect to sustain substantial operating expenses without generating
significant revenues.
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WE HAVE A HISTORY OF LOSSES AND A LARGE ACCUMULATED DEFICIT AND WE EXPECT FUTURE
LOSSES THAT MAY CAUSE OUR STOCK PRICE TO DECLINE.
For the fiscal years ended February 28, 2003, 2002 and 2001, we incurred
net losses of $3,438,252, $3,705,917 and $729,130, respectively, and for the
nine months ended November 30, 2003 we incurred a net loss of $2,083,308. We
expect to continue to incur losses as we spend additional capital to develop and
market our technologies and establish our infrastructure and organization to
support anticipated operations. We cannot be certain whether we will ever earn a
significant amount of revenues or profit, or, if we do, that we will be able to
continue earning such revenues or profit. Also, the current economic weakness
may limit our ability to develop and ultimately market our technologies. Any of
these factors could cause our stock price to decline and result in you losing a
portion or all of your investment.
OUR INABILITY TO RETAIN AND ATTRACT KEY PERSONNEL COULD ADVERSELY AFFECT OUR
BUSINESS.
We believe that our future success will depend on the abilities and
continued service of certain of our senior management and executive officers,
particularly our president and CEO and those persons involved in the research
and development of our products. If we are unable to retain the services of
these persons, or if we are unable to attract additional qualified employees,
researchers and consultants, we may be unable to successfully finalize and
eventually market our medical devices and other products being developed, which
will have a material adverse effect on our business.
OUR RESEARCH AND DEVELOPMENT EFFORTS MAY NOT RESULT IN COMMERCIALLY VIABLE
PRODUCTS WHICH COULD RESULT IN A DECLINE OF OUR STOCK PRICE AND A LOSS OF YOUR
INVESTMENT.
Our technologies are in the development stage. Further research and
development efforts will be required to develop these technologies to the point
where they can be incorporated into commercially viable or salable products. We
have set forth in this prospectus our proposed research and development program
as it is currently conceived. We cannot assure you, however, that this program
will be accomplished in the order or in the time frame set forth. We reserve the
right to modify the research and development program. We may not succeed in
developing commercially viable products from our technologies. Also, our
research and development efforts are aimed at technology that will enable
certain medical procedures and biomedical devices to become safe and compatible
with MRI diagnostics. If MRI diagnostics are replaced by the healthcare
industry, our technology and products, if any, may become obsolete. If we are
not successful in developing commercially viable products or if such products
become obsolete, our ability to generate revenues from our technologies will be
severely limited. This would result in the loss of all or part of your
investment.
WE MAY NOT HAVE OPPORTUNITIES TO ENTER INTO ADDITIONAL STRATEGIC PARTNERSHIPS
FOR THE COMMERCIALIZATION OF OUR TECHNOLOGIES WHICH COULD HAVE A SEVERE NEGATIVE
IMPACT ON OUR ABILITY TO MARKET OUR PRODUCTS.
We intend to enter into strategic partnerships or other relationships with
established biomedical, pharmaceutical and bio-pharmaceutical companies to
obtain necessary regulatory approvals and to undertake the manufacturing and
marketing efforts required to commercialize our products. On September 25, 2003,
we entered into a development agreement with Boston Scientific Corp., a
biomedical device company. We are also developing relationships with other
potential partners; however, we have not yet entered into any definitive
agreements with them. If we are unable to enter into any new partnerships or if
our relationship with Boston Scientific is not successful, then we may be unable
to commence the commercialization of our products.
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WE MAY NOT BE ABLE TO DEVELOP A MARKET FOR OUR TECHNOLOGY WHICH WILL MOST LIKELY
CAUSE OUR STOCK PRICE TO DECLINE.
The demand and price for our technology and related products will be based
upon the existence of markets for the technology and products and the markets
for products of others, which may utilize our technology. The extent to which we
may gain a share of our intended markets will depend, in part, upon the cost
effectiveness and performance of our technology and products when compared to
alternative technologies, which may be conventional or heretofore unknown. If
the technology or products of other companies provide more cost-effective
alternatives or otherwise outperform our technology or products, the demand for
our technology or products maybe adversely affected. Our success will be
dependent upon market acceptance of our technology and related products. Failure
of our technology to achieve and maintain meaningful levels of market acceptance
would materially and adversely affect our business, financial condition, results
of operations and market penetration. This would likely cause our stock price to
decline.
IF WE ARE NOT ABLE TO COMPETE EFFECTIVELY IN THE COMPETITIVE MEDICAL DEVICE
INDUSTRY, OUR FUTURE GROWTH AND OPERATING RESULTS WILL SUFFER.
Our future success depends on our ability to compete effectively with
other manufacturers of medical devices, including major manufacturers of
pacemakers and other implantable devices that may have internal development
programs. We are an early-stage research and development company engaged
exclusively in developing our initial products. We have not yet completed our
first product and have generated no material revenue from operations. As a
result, we may have difficulty competing with larger, established medical device
companies. Most of our potential competitors will be established, well-known
companies that have:
o substantially greater financial, technical and marketing resources;
o larger customer bases;
o better name recognition;
o related product offerings; and
o larger marketing areas.
Companies such as Medtronic Incorporated, Guidant Corporation, St. Jude
Medical, Boston Scientific and Johnson & Johnson are major, international
providers of active medical devices currently contraindicated for MRI. Because
these companies may possibly develop MRI safe solutions for their own product
lines, they may ultimately be in competition with us. These companies represent
a wide array of medical devices and products, technologies and approaches. Most
of these companies have more resources than we do and, therefore, a greater
opportunity to develop comparable products and bring those products to market
more efficiently than we can. If we do not compete effectively with current and
future competitors, our future growth and operating results will be adversely
affected.
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WE MAY NOT BE ABLE TO OBTAIN NECESSARY GOVERNMENT APPROVAL TO MARKET OUR
TECHNOLOGY WHICH WILL MOST LIKELY CAUSE OUR STOCK PRICE TO DECLINE AND OUR
BUSINESS TO FAIL.
Our marketing partners must obtain the approval of the U.S. Food and Drug
Administration in order to market our MRI-safe technology. If these approvals
are not obtained, or are significantly delayed, our ability to generate revenues
may be adversely affected and our development and marketing efforts inhibited.
This would most likely cause our stock price to decline and result in the loss
of all or part of your investment.
WE MAY NOT BE ABLE TO PROTECT OUR PROPRIETARY RIGHTS AND WE MAY INFRINGE THE
PROPRIETARY RIGHTS OF OTHERS. OUR INABILITY TO PROTECT OUR RIGHTS COULD IMPAIR
OUR BUSINESS AND CAUSE US TO INCUR SUBSTANTIAL EXPENSE TO ENFORCE OUR RIGHTS.
Proprietary rights are critically important to us. Although we have
exclusive licenses to four issued U.S. patents for MRI safety-related
technology, and multiple patents pending, and we intend to aggressively pursue
additional patent protection for our technologies as we continue to develop
them, we cannot assure you that any additional patents will be issued. Although
we will seek to defend our patents and to protect our other proprietary rights,
our actions may be inadequate to protect our patents and other proprietary
rights from infringement by others, or to prevent others from claiming
infringement of their patents and other proprietary rights.
Policing unauthorized use of our technology is difficult, and some foreign laws
do not provide the same level of protection as U.S. laws. Litigation may be
necessary in the future to enforce our intellectual property rights, to protect
our trade secrets or patents that we may obtain, or to determine the validity
and scope of the proprietary rights of others. Such litigation could result in
substantial costs and diversion of resources and have a material adverse effect
on our future operating results.
WE MAY NOT BE ABLE TO FULLY UTILIZE OUR ARRANGEMENTS WITH SBI AND, IF SUCH
UTILIZATION IS NECESSARY, WE WILL BE REQUIRED TO , AMEND OUR ARTICLES OF
INCORPORATION AND REGISTER ADDITIONAL SHARES FOR RESALE BY SBI, OR IDENTIFY
ALTERNATIVE SOURCES OF CAPITAL
Our authorized capital currently consists of 80,000,000 shares of common
stock. As of February 10, 2004, we had 65,489,496 outstanding shares, and
outstanding options and warrants to purchase an additional 8,240,562 shares.
Also, we may grant options to purchase an additional 155,007 shares under our
stock option plan. As a result, we have only 6,114,935 shares of common stock
available to sell to SBI under our stock purchase agreement with SBI. Of these
shares, 6,000,000 have been registered for resale by SBI.
If our need for capital requires us to sell more than 6,000,000 shares to
SBI under the stock purchase agreement, we will need to amend our articles of
incorporation to increase the number of shares of our authorized common stock
and register additional shares for resale by SBI. In lieu of or in addition to
those actions, we may need to identify alternative sources of capital.
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WE MAY NEED TO RAISE ADDITIONAL CAPITAL. IF WE ARE UNABLE TO RAISE NECESSARY
ADDITIONAL CAPITAL, OUR BUSINESS MAY FAIL OR OUR OPERATING RESULTS AND OUR STOCK
PRICE MAY BE MATERIALLY ADVERSELY AFFECTED.
Because we are a development stage company and have no material revenues,
we need to secure adequate funding. The funds that we raise by selling stock to
SBI under the stock purchase agreement may not be sufficient to carry out all of
the plans described in this prospectus or to fund our operating losses until we
are able to generate enough revenues to sustain our business. If we are unable
to obtain adequate funding, we may not be able to successfully develop and
market our products and our business will most likely fail. We do not have
commitments for additional financing. To secure additional financing, we may
need to borrow money or sell more securities, which may reduce the value of the
securities to be sold by the selling stockholders in this offering. Under these
circumstances, we may be unable to secure additional financing on favorable
terms or at all.
Selling additional stock, either privately or publicly, would dilute the
equity interests of our stockholders. If we borrow more money, we will have to
pay interest and may also have to agree to restrictions that limit our operating
flexibility. If we are unable to obtain adequate financing, we may have to
curtail business operations which would have a material negative effect on
operating results and most likely result in a lower stock price.
BECAUSE TWO OF OUR DIRECTORS ARE EQUITY OWNERS AND MANAGERS OF BIOMED SOLUTIONS,
LLC, A SIGNIFICANT SHAREHOLDER OF BIOPHAN, THERE MAY BE CONFLICTS OF INTEREST.
Michael L. Weiner, our President, CEO and director, is the Manager and a
24.3% beneficial equity member of Biomed, a company engaged in the business of
identifying and acquiring technologies in the biomedical field for exploitation.
Mr. Weiner and Ross Kenzie, also a director of Biophan, make up the Biomed Board
of Members. Biomed and its members own a significant amount of our outstanding
common stock. We have issued to Biomed 1,180,000 warrants for the purchase of
our common stock. Mr. Weiner is also the Manager and 42.3% equity member of
Technology Innovations, LLC, which is a 57% equity member of Biomed. Further,
Mr. Weiner is on the board of Nanoset, LLC, an entity owned in part by Biomed
and with which we have entered into a technology license agreement.
Because of the nature of our business and the business of these other
entities, the relationships of Messrs. Weiner and Kenzie with these other
entities may give rise to conflicts of interest with respect to certain matters
affecting us. All potential conflicts may not be resolved in a manner that is
favorable to us. We believe it is impossible to predict the precise
circumstances under which future potential conflicts may arise and therefore
intend to address potential conflicts on a case-by-case basis. Under Nevada law,
directors have a fiduciary duty to act in good faith and with a view to the
interests of the corporation.
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THE SO-CALLED "PENNY STOCK RULE" COULD MAKE IT CUMBERSOME FOR BROKERS AND
DEALERS TO TRADE IN OUR COMMON STOCK, MAKING THE MARKET FOR OUR COMMON STOCK
LESS LIQUID WHICH COULD CAUSE THE PRICE OF OUR STOCK TO DECLINE.
Trading of our common stock on the OTC Bulletin Board may be subject to
certain provisions of the Securities Exchange Act of 1934, commonly referred to
as the "penny stock" rule. A penny stock is generally defined to be any equity
security that has a market price less than $5.00 per share, subject to certain
exceptions. If our stock is deemed to be a penny stock, trading in our stock
will be subject to additional sales practice requirements on broker-dealers.
These may require a broker-dealer to:
o make a special suitability determination for purchasers of our
shares;
o receive the purchaser's written consent to the transaction prior to
the purchase; and
o deliver to a prospective purchaser of our stock, prior to the first
transaction, a risk disclosure document relating to the penny stock
market.
Consequently, penny stock rules may restrict the ability of broker-dealers
to trade and/or maintain a market in our common stock. Also, prospective
investors may not want to get involved with the additional administrative
requirements, which may have a material adverse effect on the trading of our
shares.
THE SALE OF SHARES BY THE SELLING STOCKHOLDERS AS CONTEMPLATED BY THIS
PROSPECTUS MAY ENCOURAGE SHORT SELLING AND HAVE AN ADVERSE IMPACT ON THE MARKET
PRICE OF OUR COMMON STOCK, AND THE SALE TO SBI OF SHARES UNDER THE STOCK
PURCHASE AGREEMENT WILL RESULT IN DILUTION TO OUR EXISTING STOCKHOLDERS.
The resale by the selling stockholders of our common stock as contemplated
by this prospectus will increase the number of our publicly traded shares, which
could depress the market price of our common stock. Moreover, the mere prospect
of resales by the selling stockholders as contemplated by this prospectus could
depress the market price for our common stock. The issuance of shares to SBI
under the stock purchase agreement will dilute the equity interest of existing
stockholders and could have an adverse effect on the market price of our common
stock.
The perceived risk of dilution may cause our stockholders to sell their
shares, which would contribute to a decline in the price of our common stock.
Moreover, the perceived risk of dilution and the resulting downward pressure on
our stock price could encourage investors to engage in short sales of our common
stock. By increasing the number of shares offered for sale, material amounts of
short selling could further contribute to progressive price declines in our
common stock.
The trading price of our common stock during the several week period
leading up to February 5, 2004 was generally greater than the price per share
for the first 8,000,000 shares that would be sold under our stock purchase
agreement with SBI; however, our trading price during this period was less than
the weighted-average purchase price of all shares covered by the SBI stock
purchase agreement. The closing price of our common stock on February 9, 2004
was $1.43 per share and exceeded the purchase price for 8,000,000 of the
17,750,000 shares covered by the stock purchase agreement. If we sell shares to
SBI at prices less than the current trading price of our common stock at the
time of the sale, SBI may have an incentive to immediately resell such shares in
the market which may, in turn, cause the trading price of our common stock to
decline. Also, if we do not sell the shares covered by the later tranches under
the stock purchase agreement, it could adversely affect the trading price of our
common stock because the earlier tranches have a purchase price per share that
is lower than the trading price of our common stock at the time we entered into
the stock purchase agreement.
12
OUR COMMON STOCK HAS EXPERIENCED IN THE PAST, AND IS EXPECTED TO EXPERIENCE IN
THE FUTURE, SIGNIFICANT PRICE AND VOLUME VOLATILITY, WHICH SUBSTANTIALLY
INCREASES THE RISK THAT YOU MAY NOT BE ABLE TO SELL YOUR SHARES AT OR ABOVE THE
PRICE THAT YOU PAY FOR THE SHARES.
Because of the limited trading market for our common stock, and because of
the possible price volatility, you may not be able to sell your shares of common
stock when you desire to do so. During 2002 and 2003, and through the date of
this prospectus, our common stock was sold and purchased at prices that ranged
from a high of $6.45 to a low of $.10 per share. The inability to sell your
shares in a rapidly declining market may substantially increase your risk of
loss because of such illiquidity and because the price for our common stock may
suffer greater declines because of its price volatility.
The price of our common stock that will prevail in the market after this
offering may be higher or lower than the price you pay. Certain factors, some of
which are beyond our control, that may cause our share price to fluctuate
significantly include, but are not limited to, the following:
o variations in our quarterly operating results;
o our ability to complete the research and development of our
technologies;
o the development of a market in general for our products;
o changes in market valuations of similar companies;
o announcement by us or our competitors of significant contracts,
acquisitions, strategic partnerships, joint ventures or capital
commitments;
o loss of a major customer or failure to complete significant
transactions;
o additions or departures of key personnel; and
o fluctuations in stock market price and volume.
Additionally, in recent years the stock market in general, and the
Over-the-Counter Bulletin Board and technology stocks in particular, have
experienced extreme price and volume fluctuations. In some cases, these
fluctuations are unrelated or disproportionate to the operating performance of
the underlying company. These market and industry factors may materially and
adversely affect our stock price, regardless of our operating performance.
Over the past few months, there have been periods of significant increases
in trading volume of our common stock during which the price of our stock has
both increased and decreased. The historical trading of our common stock is not
necessarily an indicator of how it will trade in the future and our trading
price as of the date of this prospectus is not necessarily an indicator of what
the trading price of our common stock might be in the future.
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In the past, class action litigation has often been brought against
companies following periods of volatility in the market price of those
companies' common stock. If we become involved in this type of litigation in the
future, it could result in substantial costs and diversion of management
attention and resources, which could have a further negative effect on your
investment in our stock.
A FINDER THAT WE ENGAGED IN A PRIVATE PLACEMENT HAD PREVIOUSLY BEEN CONVICTED OF
SECURITIES LAW VIOLATIONS AND MAY HAVE BEEN REQUIRED TO BE REGISTERED AS A
BROKER- DEALER AS A RESULT OF ITS ACTIVITIES IN OUR PRIVATE PLACEMENT. WE MAY
SUFFER ADVERSE CONSEQUENCES AS A RESULT OF SUCH FINDER'S PARTICIPATION IN OUR
PRIVATE PLACEMENT.
Westbay Consulting, Inc., a Nevada corporation beneficially owned by Jason
Cope, acted as finder and consultant to Biophan in connection with a private
placement of our common stock that we conducted from September 2002 through
January 2003. On August 14, 2001, the SEC obtained a final judgment against
Jason Cope and three other defendants. Mr. Cope and the other defendants were
ordered by the U.S. District Court for the Southern District of New York to pay
a total of $19.4 million in disgorgement, interest and civil penalties. Mr. Cope
was also enjoined from committing any further violation of the antifraud
provisions of the federal securities laws These orders were based on allegations
that Mr. Cope unlawfully offered and sold securities without being registered as
a broker-dealer. Until after the completion of the private placement, we were
unaware that Mr. Cope had previously been convicted of violations of the
securities laws. If we had been aware of Mr. Cope's prior violations of the
securities laws, we would not have hired Westbay to assist in our private
placement.
The SEC has informed us that, in the opinion of the Division of Market
Regulation, Westbay acted as an unregistered broker-dealer in connection with
our private placement. The SEC further alleges that the shareholders that
acquired our shares in the private placement may have acquired their shares in
violation of federal securities laws. Although we believe that Westbay acted as
a finder and not a broker-dealer in connection with our private placement, there
can be no assurance that the SEC will not find otherwise. We also believe that
the private placement complied with the provisions of Regulation D and Rule 506
of the Securities Act of 1933, and was exempt from the registration provisions
of the Securities Act. However, there can be no assurance that the SEC will not
conclude that the private placement was defective or that the exemption from
registration was not available. Without further information from the SEC, we are
unable to predict the possible consequences to us should an adverse finding
against Westbay or us be made by the SEC.
SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
This prospectus contains forward-looking statements that involve risks and
uncertainties. These include statements about our expectations, plans,
objectives, assumptions or future events. In some cases, you can identify
forward-looking statements by terminology such as "anticipate," "estimate,"
"plans," "potential," "projects," "continuing," "ongoing," "expects,"
"management believes," "we believe," "we intend" and similar expressions. These
statements involve estimates, assumptions and uncertainties that could cause
actual results to differ materially from those expressed for the reasons
described in this prospectus. You should not place undue reliance on these
forward-looking statements.
14
You should be aware that our actual results could differ materially from
those contained in the forward-looking statements due to a number of factors
such as:
o continued development of our technology;
o dependence on key personnel;
o competitive factors;
o the operation of our business; and
o general economic conditions.
The forward-looking statements speak only as of the date on which they are
made, and, except to the extent required by federal securities laws, we
undertake no obligation to update any forward-looking statement to reflect
events or circumstances after the date on which the statement is made or to
reflect the occurrence of unanticipated events. In addition, we cannot assess
the impact of each factor on our business or the extent to which any factor, or
combination of factors, may cause actual results to differ materially from those
contained in any forward-looking statements.
15
USE OF PROCEEDS
We will not receive any of the proceeds from the sale of shares by any
selling shareholder. Further, no warrant holder is compelled to exercise their
warrants, so we may not receive any proceeds from warrant exercise.
NATURE OF TRADING MARKET
Our common stock is listed on the OTC Bulletin Board under the symbol
BIPH. The stock was not actively traded until October 2001, and the following
table sets forth, for the fiscal quarters indicated, the high and low bid
prices. These quotations reflect inter-dealer prices, without mark-up, mark-down
or commission, and may not represent actual transactions.
Quarter Ended High Low
November 30, 2001 $6.50 $5.50
February 28, 2002 $7.25 $2.37
May 31, 2002 $2.65 $ .75
August 31, 2002 $1.13 $ .30
November 30, 2002 $ .38 $ .18
February 28, 2003 $1.15 $ .29
May 31, 2003 $ .51 $ .27
August 31, 2003 $ .37 $ .12
November 30, 2003 $ .49 $ .10
Through February 17, 2004 $1.65 $ .32
We currently have outstanding 65,489,496 shares of our common stock. Our
shares of common stock are held by 364 stockholders of record.
DIVIDEND POLICY
We have never paid cash dividends and have no plans to do so in the
foreseeable future. Our future dividend policy will be determined by our Board
of Directors and will depend upon a number of factors, including our financial
condition and performance, our cash needs and expansion plans, income tax
consequences, and the restrictions that applicable laws and our credit
arrangements then impose.
CAPITALIZATION
The following table sets forth our capitalization (unaudited) as of
November 30, 2003 and as adjusted to reflect the following transactions which
occurred subsequent to November 30, 2003:
o the issuance of 11,000,000 shares by us to SBI pursuant to a stock
purchase agreement between us and SBI dated October 1, 2003; and
o the conversion of our obligations under the transfer agreement and
line of credit into shares of our common stock on February 10, 2004.
16
You should read this information in conjunction with our financial statements
and the accompanying notes, and the other financial information appearing
elsewhere in this prospectus.
AS OF
NOVEMBER 30,
2003 AS ADJUSTED
------------ ------------
Long-term debt ............................ $ 333,334 $ -0-
============ ============
Stockholders' equity (deficiency):
Common stock, $.005 par value
Authorized, 80,000,000 shares
Issued and outstanding, 46,004,071 and
64,949,000 shares as adjusted ..... $ 230,020 $ 324,745
Additional paid-in capital ............. 8,971,650 12,662,523
Accumulated deficit .................... (10,056,465) (10,314,229)
------------ ------------
$ (854,795) $ 2,673,039
============ ============
17
SBI STOCK PURCHASE AGREEMENT
On February 5, 2004, we entered into a stock purchase agreement with SBI
Brightline Consulting, LLC that obligates SBI to purchase, upon our election, up
to 17,750,000 shares of our common stock for an aggregate purchase price of
$25.0 million. If we sell all the shares to SBI, the shares will be sold at a
weighted average purchase price of $1.408 per share. At our election, we may
sell the shares to SBI in 14 tranches that must be sold in the following order:
NUMBER OF PURCHASE PRICE
SHARES PER SHARE
Tranche 1 2,000,000 $.60
Tranche 2 2,000,000 $.65
Tranche 3 2,000,000 $.70
Tranche 4 2,000,000 $.80
Tranche 5 1,000,000 $2.00
Tranche 6 1,000,000 $2.00
Tranche 7 1,000,000 $2.00
Tranche 8 1,000,000 $2.00
Tranche 9 1,000,000 $2.00
Tranche 10 1,000,000 $2.00
Tranche 11 1,000,000 $2.00
Tranche 12 1,000,000 $2.00
Tranche 13 1,000,000 $2.00
Tranche 14 750,000 $2.00
Except for the requirement to sell the tranches in order and the
requirement that the resale of the shares be registered as described below,
there is no limitation on when we may require SBI to purchase the shares
included in any tranche. In particular, there is no specified expiration date
for SBI's obligation to purchase the shares. The agreement permits us to
exercise our right to sell multiple tranches at the same time, and no particular
period of time must elapse between the sale of tranches. We are not obligated to
sell any shares to SBI unless and until we elect to do so. However, if we want
to sell any shares in a tranche we must exercise our right to sell all of the
shares in the tranche.
SBI is not obligated to purchase shares pursuant to the stock purchase
agreement unless the resale of the shares by SBI is registered under the
Securities Act of 1933, as amended. On February 10, 2004, we filed a
registration statement for the purpose of registering 6,000,000 shares. Such
registration statement is not yet effective. Even after such registration
statement becomes effective, SBI will not be obligated to purchase the remaining
shares covered by the stock purchase agreement unless and until we have
registered the resale of such shares by SBI. In addition, we do not currently
have sufficient authorized and unissued shares to issue such remaining shares to
SBI. We intend to seek approval at our next annual meeting of stockholders to
amend our articles of incorporation to increase our number of authorized shares.
If such amendment is approved, we will then decide whether or not to register
additional shares for resale by SBI so that we will have the right to sell such
additional shares to SBI under the stock purchase agreement.
18
SBI's obligation to purchase the shares is subject to customary conditions
for transactions of this kind. In particular, SBI's obligation is contingent on:
o the continued accuracy of our representations and warranties
contained in the stock purchase agreement; and
o our compliance with our agreements contained in the stock purchase
agreement.
If we have exercised our right to sell a particular tranche of shares and the
closing of the sale of such shares does not occur for any reason, we will have
the right to exercise our right with respect to those shares again; however,
SBI's obligation to purchase the shares remains contingent on our ability to
satisfy the closing conditions at the time we seek to sell the shares.
Our obligation to sell a tranche of shares to SBI once we have made an
election is contingent on SBI's satisfaction of corresponding closing conditions
which we may waive in our discretion.
PRIOR STOCK PURCHASE AGREEMENTS
Effective November 22, 2002, we entered into a restated common stock
purchase agreement with Spectrum Advisors, Ltd. that established what is
sometimes termed an equity line of credit or an equity draw down facility.
Pursuant to the Spectrum agreement, we had the option to require Spectrum to
purchase shares of our common stock at our sole discretion and from time to time
over a period of 24 months ending July 11, 2005 at 80% of the average daily
volume weighted average price of our common stock during the trading days
relating to a particular draw. Spectrum was committed to purchase shares for
consideration of up to $3 million under the agreement. Because of the stock
purchase agreement we entered into with SBI on February 5, 2004, we determined
that our arrangement with Spectrum was no longer necessary. We and Spectrum
mutually agreed to terminate the Spectrum agreement on February 9, 2004.
On October 1, 2003 we entered into a stock purchase agreement with SBI
pursuant to which SBI agreed to purchase up to 11,000,000 shares of our common
stock on terms comparable to those contained in our stock purchase agreement
with SBI described above. We registered the 11,000,000 shares covered by that
stock purchase agreement and have sold all of such shares to SBI pursuant to
such agreement for an aggregate purchase price of $2.9 million. SBI has advised
us that it has resold all of the shares purchased by it pursuant to such
agreement.
CONVERSION OF OUTSTANDING DEBT
In connection with our acquisition of MRI intellectual property rights
from Biomed Solutions, LLC on December 1, 2000, we owed Biomed $500,000 under
the terms of a transfer agreement between us and Biomed. Also, in June 2002 we
entered into a line of credit with Biomed that provided for borrowings of up to
$250,000. The line of credit was increased over time to provide for borrowings
of up to $350,000. As of February 10, 2004, we owed Biomed $200,300 under the
line of credit. The obligations under the transfer agreement and the line of
credit accrued interest at a rate of 8% per annum. Our obligations under the
transfer agreement were secured by a security interest in the intellectual
property rights we acquired from Biomed in connection with our reorganization in
December, 2000. If we defaulted in paying our obligations under the transfer
agreement, Biomed would have been entitled to reclaim those intellectual
property rights.
19
In consideration of the making of the line of credit, increases to the
line of credit and the extension of the payment obligations under the line of
credit and transfer agreement, the obligations under the transfer agreement and
the line of credit contain provisions making our obligations under them
convertible into shares of our common stock at a conversion price that is based
on a formula. Under the formula, the conversion price under the transfer
agreement and line of credit as of February 10, 2004 was $.10 per share. On
February 10, 2004, the following transactions occurred:
o We paid to Biomed all accrued and unpaid interest due under the
transfer agreement and the line of credit;
o Biomed assigned its rights with respect to $300,000 of the $500,000
due under the transfer agreement to SBI who converted those rights
into 3,000,000 shares of our common stock;
o Biomed assigned its rights with respect to $50,000 due under the
line of credit to an independent third party who converted those
rights into 500,000 shares of our common stock;
o Biomed exercised its right to convert the balance of our obligations
under the transfer agreement and the line of credit into 3,513,000
shares of our common stock;
o Biomed released all of the collateral securing our obligations under
the transfer agreement and line of credit and the line of credit was
terminated; and
o We agreed to register the resale by Biomed and SBI of the 6,513,000
shares of our common stock issued upon the conversion of our
obligations under the note and line of credit.
Of the $200,300 outstanding under the line of credit as of February 10,
2004, $75,950 was borrowed during the six month period prior to February 10,
2004. Because Biomed effectively acquired $75,950 of convertible debt during
this period, we are entitled under applicable provisions of the securities laws
to recover from Biomed its profit on $75,950 of the $300,000 of our obligations
that it transferred to SBI. This profit amounts to approximately $835,000.
Biomed has agreed to pay this profit to us pro rata as it receives payment from
SBI of the purchase price for the obligations Biomed sold to SBI.
20
PLAN OF OPERATION
We are currently in the development stage of operations and expect to be
in that mode for at least the next twelve months. Our primary mission is to
develop and commercially exploit technologies for enabling cardiac pacemakers
and other implantable medical devices and surgical devices to be safe and
compatible with MRI. We believe that we have successfully demonstrated an
effective solution for making pacemakers safe for use with MRI and providing a
meaningful margin of safety. Our solution addresses both the problems of device
heating and induced voltages in pacemakers, the two primary problems associated
with the use of MRI for patients with pacemakers. Today, approximately 3 million
pacemaker recipients are denied access to MRI when needed, due to safety
concerns and FDA contraindications. If manufacturers of pacemakers incorporated
our solution into their products, we believe they would be safe for use with
MRI. We are in ongoing discussions with the major pacemaker manufacturers, and
one or more of these companies is currently evaluating our technologies and
patents. We are also negotiating with a major research university to undertake a
study to demonstrate further the dangers posed to pacemaker patients by MRI
imaging and the effectiveness of our solution. We believe that pacemaker
manufacturers, once provided with further evidence of the dangers associated
with their products in the context of MRI and the effectiveness of our
technology, will wish to incorporate our technology into their products to avoid
potential liabilities from the sale of devices that could have been made safer.
On October 1, 2003, we entered into a stock purchase agreement with SBI
Brightline Consulting, LLC that obligated SBI to purchase, upon our election, up
to 11,000,000 shares of our common stock for an aggregate purchase price of $2.9
million. The agreement required that the shares be registered with the SEC and a
registration statement for that purpose became effective on November 17, 2003.
All 11,000,000 shares have now been purchased by SBI for gross proceeds of $2.9
million, providing us with a positive net worth and cash on hand in excess of
$2.0 million as of the date of this prospectus.
In addition to the stock purchase agreement with SBI, we had been a party
to a restated stock purchase agreement with Spectrum Advisors Ltd. that became
effective on November 22, 2002. Under the Spectrum agreement we sold Spectrum a
total of 3,325,757 shares for aggregate consideration of $491,190. We and
Spectrum mutually agreed to terminate the Spectrum agreement on February 9,
2004.
On February 5, 2004, we entered into a second stock purchase agreement
with SBI that obligates SBI to purchase, upon our election, up to 17,750,000
shares of our common stock for an aggregate purchase price of $25.0 million. SBI
is not obligated to purchase shares pursuant to this stock purchase agreement
unless the resale of the shares by SBI is registered under the Securities Act.
On February 10, 2004, we filed a registration statement for the purpose of
registering 6,000,000 shares. Such registration statement is not yet effective.
Even after such registration statement becomes effective, SBI will not be
obligated to purchase the remaining shares covered by the stock purchase
agreement unless and until we have registered the resale of such shares by SBI.
In addition, we do not currently have sufficient authorized and unissued shares
to issue such remaining shares to SBI. We intend to seek approval at our next
annual meeting of stockholders to amend our articles of incorporation to
increase our number of authorized shares. If such amendment is approved, we will
then decide whether or not to register additional shares for resale by SBI so
that we will have the right to sell such additional shares to SBI under the
stock purchase agreement. No shares have yet been sold to SBI under the second
stock purchase agreement.
21
During January and February 2004, obligations of $294,500 under our line
of credit and our obligation of $500,000 payable under the transfer agreement,
both owed to Biomed Solutions, LLC and its assignees, were converted according
to their terms into 7,945,000 shares of our common stock, thereby eliminating
these liabilities and increasing our stockholders' equity.
We estimate that the proceeds from the sale of our common stock pursuant
to the previous SBI stock purchase agreement and Spectrum agreement, coupled
with the additional equity financing when it becomes available under the new SBI
stock purchase agreement, will be more than sufficient to satisfy our projected
cash requirements over the next 12 months. Our estimate of these cash
requirements is as follows:
Research and product development $ 973,000
Operating expenses, including administrative salaries and benefits, office
expenses, rent expense, legal and accounting, publicity, investor
relations 1,137,000
----------
Total Cash Requirements $2,110,000
==========
In December 2003, we announced three major strategic initiatives for 2004:
(1) Acquisition of Intellectual Assets, (2) Market Expansion, and (3) Strategic
Partnerships.
(1) With four United States patents under license and more than 50
patents pending, we are aggressively pursuing internal research and
development projects, as well as sourcing leading-edge providers of
related technologies. Intellectual property, such as technology
solutions and patents, may be developed internally, through joint
ventures, or purchased. To ensure the continuing value of our
intellectual assets, we will aggressively defend our patents and
licensed technology, both domestically and abroad.
(2) We currently enjoy a leadership position in developing technologies
designed to make implanted medical devices, such as heart
pacemakers, safe for use with MRI and other diagnostic imaging
tools. We have also developed technologies that allow for the use of
interventional MRI, without the heating problems that can cause
tissue damage or imaging problems that obscure the outcome of the
procedures. Based on discussions underway with several biomedical
device manufacturers, both in the U.S. and overseas, we plan to
expand the use of the technologies we have developed to make a wider
range of devices compatible with MRI. These technologies reduce
radio frequency interference, heating, and induced voltages. In
2004, we will explore opportunities for these technologies in the
guidewire, stent, drug pump, biopsy needle and other prosthetic and
surgical tool markets, where the lack of MRI compatibility
negatively impacts investigational and diagnostic procedures.
Discussions with these device manufacturers indicate a need for, and
interest in, solutions to additional problems where we can develop
solutions based on our technology. Part of our strategic initiative
for 2004 will include expanding our technology offerings to the
companies with whom we are already in discussions or collaborating.
22
Our Photonic MRI Microcoil (PMM) is one example of our expanded
technology. Recent studies indicate up to 85% of heart attacks and
strokes may be caused by vulnerable plaque which may result in
thrombosis, and is not easily detected by other methods. Our
technologies are designed to pinpoint specific sites where therapies
can address the problem. By inserting the PMM directly into a blood
vessel, MRI can provide a detailed look at vulnerable plaque without
injury-causing heating or image degradation. There are other uses of
our photonic catheter for diagnostics and therapeutic applications.
We were recently notified that the United States Patent and
Trademark Offfice (US PTO) has allowed three of our pending patent
applications for issuance, and we have paid the fees to allow these
patents to file.
Another example of our expanding on the use of our nanomagnetic
particle coating technology is NanoView. The concept of our NanoView
technology is to utilize nanomagnetic particles, a specific type of
nanotechnology, as contrast agents to preferentially bind to tissues
of diagnostic interest with the goal of improving detail and
contrast in MRI diagnostic image processes. We expect NanoView to
improve performance in terms of signal intensity and the use of
multiple markers, which broadens the applications of MRI imaging.
(3) Leveraging strategic partnerships is vital to our mission. By
exploiting our established relationships, such as the recently
announced joint development agreement with Boston Scientific, a
major medical device manufacturer, we not only gain access to a
platform to validate our technology but also develop a relationship
with our potential sales channels. We have entered into Non-
Disclosure Agreements with a number of major manufacturers of
implanted biomedical and related devices. We are discussing with
these companies potential strategic partnership arrangements that
may include joint development projects, original equipment
manufacturing arrangements and licensing agreements.
We estimate that our ongoing research and development plan will require
approximately $973,000 of our funds over the next 12 months, dedicated to the
following activities:
MRI Shielding for Active Medical Devices $ 563,000
MRI Shielding for Passive Medical Devices 410,000
----------
Total $ 973,000
==========
These amounts may increase as customer contracts identify specific tasks
and testing that may be required.
The MRI Shielding project entails the development of technology that may
be applied to active medical devices and passive medical devices to allow
patients to undergo MRI diagnostics. Active medical devices include such items
as pacemakers and drug pumps, and passive medical devices include such items as
biopsy needles, stents and guidewires.
23
In November 2004, we recorded $75,000 as a development payment from one of
our biomedical device customers for prototype development of a prospective
product adaptation. Additional revenues are expected from this customer for
additional work, which may lead to a license for one or more of our technologies
in the context of one or more product lines.
Our current strategic plan does not indicate a need for material capital
expenditures in the conduct of research and development activities, nor does the
plan contemplate any significant change in the number of employees. We currently
employ eleven full-time individuals.
Our plans do not include funding for FDA approvals, as our strategy is to
supply solutions to the major biomedical device manufacturers, who will
incorporate our technology into their existing and future product lines. It will
be the responsibility of these manufacturers to apply for and receive FDA
approval of their products. Since our technologies are made of known
biocompatible, non-toxic materials, and since we do not change the method by
which the devices conduct diagnostic and/or therapeutic functionality, we
anticipate reasonable timeframes for our customers to obtain FDA approvals of
devices that add our capability for safety and/or image enhancements.
24
BUSINESS
COMPANY BUSINESS
Our core business is providing technology that will enable both
implantable medical devices such as pacemakers, and interventional devices such
as minimally-invasive surgical tools, to be used safely and effectively in
conjunction with Magnetic Resonance Imaging (MRI), thereby enabling surgical
procedures to be performed under real-time MRI guidance. We recently expanded
our focus in the MRI arena to improve the ability of the healthcare industry to
provide imaging under MRI by reducing the image artifacts caused by many devices
that are otherwise safe to use with MRI, such as stents, screws, nuts, bolts,
wires, spinal supports, and shunts. These devices are usually difficult if not
impossible to view under MRI. We have published research with scientists from
the University of Rochester demonstrating that our nanomagnetic particle coating
technology can alter the signal received by an MRI device and can help make
devices more visible. We have further expanded our technology offerings to
provide materials which we believe will enable improved contrast agents for use
in MRI diagnostics.
We intend to supply our technologies primarily to large, well established
biomedical and biotechnology companies but do not deliver end user products. FDA
testing and approval requirements will be undertaken by our customers in the
context of the approval of their products, although our product designs and
manufacturing processes are designed to facilitate and enhance FDA approval.
BACKGROUND TERMS, FACTS, AND ASSUMPTIONS:
MRI is widely considered to be the premiere non-invasive imaging method
due to the following capabilities:
o Superb soft tissue contrast.
o No ionizing (x-ray) radiation that can cause cancer.
o No toxic contrast agents such as those used in some x-ray procedures
to highlight specific tissues that can cause allergic or other
reactions.
o Images are not obstructed by bone.
o Multi-plane images (`slices' having different orientation in the
body) can be obtained without repositioning the patient.
o The ability to use MRI to guide surgical procedures.
Due to these and other advantages, we believe the use of MRI will continue
to increase and our technologies will be attractive to commercial partners. As
the technology continues to evolve, MRI systems using higher power levels will
provide better image quality.
Pacemakers
Exposing pacemaker patients to MRI creates risks and liabilities that can
include fatalities. We have developed a solution that can substantially reduce
these risks for patients with pacemakers, that can be affordably implemented by
pacemaker manufacturers. We are in discussions with several manufacturers, and
have received offers for exclusive licenses for which we have proposed
counteroffers which we believe are more in line with industry pricing, and
providing an equitable return for our shareholders who have funded our research,
given the improvements in product safety and marketing advantage that we are
offering.
25
We believe that our pacemaker solution can provide our prospective
licensees with the opportunity to increase their market share by offering safer
devices, as well as reduce potential liabilities from continuing to offer
products with known safety risks. Biophan's MRI-safe technology platforms could
make this possible in a way that requires minimal changes to existing product
designs, minimal incremental cost for materials, and requires very minor
modifications to existing product manufacturing processes.
FDA regulations and manufacturer labeling for pacemaker devices include
strict contraindications against use in an MRI environment (See Achenbach S, et
al Am Heart J 1997;134:467-473; ECRI, Health Devices Alert, May 27,1988, pp. 1;
Shellock FG, Reference Manual for Magnetic Resonance Safety: 2002 edition,
Amirsys, Inc., Salt Lake City, 2001; Zaremba L. FDA guidance for MR system
safety and patient exposures: current status and future considerations /
Magnetic resonance procedures: health effects and safety. CRC Press, Boca Raton
Fl, pp. 183-196, 2001). Contraindication means that a particular action or
procedure, in this case, use in an MRI environment, is inadvisable. This
pacemaker contraindication is based on evidence that induced electrical currents
in the pacemaker lead can falsely pace the heart rapidly, can damage the device
itself, and can create localized heating that causes tissue damage that may
degrade the effectiveness of the pacing system. Independent description of these
problems can be found in the following references:
1. Experimental studies showing that pacemaker electrodes could heat up to
100 C (increase of 63.1 C) within 90 seconds of MRI scanning: S. Achenbach, et.
al. "Effects of MRI on Cardiac Pacemakers and Electrodes, American Heart
Journal, 1997, 134, 467-473.
2. Professional opinion that "In practice, it is not possible to design a
device for use in an MR environment, incorporating long metallic parts such as
guidewires, mechanical cables, or electrical leads, and be completely sure of
safety." Conclusions from experimental studies showing 74 C (and higher)
temperature increases in guidewires after 30 seconds of MR scanning. M. Konings,
et. al. MEDICA MUNDI, 45/1, March 2001, page 35.
3. Experimental data indicating a maximum temperature of almost 90 C and
myocardial necrosis (that) could be demonstrated in histological studies. F.
Duru, et. al. Pacing in MRI environment: Clinical and technical considerations
on compatibility. Eur Heart J, 2001, 22: 113-124.
A conservative estimate of pacemaker population worldwide is 2.5 million
(See Barbaro, V.; Bartolini, P., and Bernarducci, R. Biomedical Engineering
Laboratory, Istituto Superiore di Sanita, Rome, Italy. ingbio:net.iss.it 2.5
million in 1997 and growing annually). Another reference ("Interference in
Implanted Cardiac Devices, Part II" by Sergio L. Pinski and Richard G. Trohman,
October 2002, PACE, Vol. 25, No. 10) cites a Japanese survey in which 17% of
Japanese pacemaker patients stated that they presented conditions for which MRI
would have been recommended if the device (pacemaker) had not been present.
Since the practice of medicine in Japan reflects standards of care in the US and
other countries where the use of pacemakers is widespread, it is reasonable to
use the 17% figure across the worldwide population of pacemaker patients
(2,500,000) to reach a number of 425,000 people who have at some time in the
past been denied access to MRI diagnosis as a result of their pacemaker implant.
Biophan has taken a conservative approach to these numbers and estimated that at
least 300,000 pacemaker patients have been denied an MRI. However, currently no
pacemaker patient can safely undergo an MRI and FDA regulations and manufacturer
labeling for pacemaker devices include strict contraindication against use in an
MRI environment.
26
Our solution is a combination of a patented radio frequency (RF) filter
which we license from Johns Hopkins University, exclusively for implantable
medical devices. We have demonstrated that this RF Filter, placed at the distal
end of the pacemaker lead near the electrode that paces the heart, eliminates
well over 90% of the heating that occurs in tissue near the pacemaker electrode.
Without the filter, this heating may cause tissue scarring where the pacemaker
electrode connects to the heart tissue, and that scarring can subsequently cause
the pacemaker to have difficulty sensing the heart signal, and when the heart
needs to be paced by the device, the scar tissue may impede the signal's ability
to pace the heart. The RF energy in the MRI machine is the direct cause of the
heating. The Johns Hopkins patented RF filter permits the high frequency energy
that causes tissue heating to be blocked, while allowing the lower frequencies
that monitor the heart and pace it to pass through. This type of filter is
called a low-pass filter.
A second problem in pacemakers exposed to MRI is caused by the gradiant
field, which sweeps across the body rapidly during the MRI procedure, and is the
cause of the loud sound that one hears during an MRI procedure. This gradiant
field produces an energy field which is important in producing the MRI image. As
it passes across a pacemaker lead this energy can cause a small voltage to be
induced in the pacing lead. This voltage can cause the heart to beat. The
gradiant field can cause heartbeats of 200 to 300 beats per minute, which
interferes with proper blood pumping, and can lead to potentially fatal
conditions, including fibrillation. Biophan has developed and filed patents for
a very low cost solution to this problem which we have demonstrated eliminates
the voltage levels that can pace the heart.
These solutions will be used on the lead that connects the implanted pulse
generator, or pacemaker, to the electrodes that are placed in the internal heart
wall. In order to eliminate risks associated with MRI for current pacemaker
patients, the existing lead would need to be removed and replaced with a new
lead. This removal procedure is typically not done due to associated risks to
the patient. As a result of this, our pacemaker technology is intended primarily
for future products, not previously implanted pacemakers. Approximately 600,000
people receive a pacemaker implant annually, and our technology could
potentially be applied to the majority of these devices if it were adopted by
all pacemaker and lead manufacturers worldwide. See
http://biomed.brown.edu/Courses/BI108/BI108_1999_Groups/Cardiapacing_Team/
economics.html.
Other Devices
Other medical devices also contraindicated for use with MRI could be made
safe with Biophan's technologies. (See "The Reference Manual for Magnetic
Resonance Safety, by Dr. Frank G. Shellock, 2002 edition, Amirsys Inc., ISBN
1-931-884-00-5). Technologies currently under development by us for MRI safety
and compatibility provide the following advantages to devices that use them:
27
o Reduction of heating to long metallic components resulting from
radio frequency energy and pulsed magnetic fields used in MRI;
o Reduction of electrical currents induced in metallic components
resulting from radio frequency energy used in MRI; and
o Reduction of MRI distortion resulting from metallic or other
conductive components in or near the body area being imaged.
Pacemakers are one example of implanted devices used to control organ
function. Other cardiac-related devices, such as implantable cardioverter
defibrillators, are used to not only pace, but also to help the heart recover
from episodes of dangerously high pulse rate (cardioversion) and from random
chaotic behavior (defibrillation). Other stimulation devices are used to help
organize the contraction of the four heart chambers to reverse the effects of
congestive heart failure (CHF). Neurostimulators are being used to stimulate
brain tissue and eliminate symptoms of Parkinson's disease. Electrical
stimulators are also being used for bladder dysfunction and the treatment of
obesity. All of these devices use electrical leads similar to those in
pacemakers. These devices are subject to the same heating and electrical
currents and can benefit from the technologies being developed by Biophan.
Guidewires
Guidewires are used for surgical placement of leads used with pacemakers
and other implantable devices, placement of catheters for short-term use, and
placement of more permanent devices such as stents within the circulatory
system. These guidewires typically use long metal wires for reasons of strength,
flexibility, and reliability. The use of guidewires benefits from direct,
real-time visualization. MRI is preferred in many cases due in part to the fact
that x-ray imaging exposes patients and physicians to radiation, and due to the
improved soft-tissue imaging available with MRI. However, guidewires and long
wire components in catheters are subject to the same problems associated with
pacemaker leads when used in MRI. Thus, our technologies being developed can
also provide benefits to these devices. MRI safe and image compatible guidewires
would allow certain procedures that today are conducted using X-Ray, fluoscopy
and/or CAT scan to be performed using MRI. With these imaging devices, the
patient and the physician are today exposed to dangerous ionizing radiation.
Because it does not use ionizing radiation and generally provides improved
visibility, MRI will be an attractive alternative once the MRI limitations we
are addressing are resolved.
We are presently in the process of establishing one or more partnerships
to complete the development process for our technologies. These partnerships may
be with one or more companies involved in the manufacture and sale of:
o components such as pacemaker leads;
o active devices such as pacemakers that make active use of wires to
conduct data and stimulating pulses;
28
o passive devices such as guidewires that only make use of the
physical properties of the wire elements in them; and
o MRI diagnostics systems.
All of these potential business relationships are being pursued with the
interest of funding the remaining development work, supporting necessary
clinical trials and approvals, and ultimately resulting in a license for
manufactured products with royalties coming to Biophan. Consistent with our
business strategy, on September 25, 2003, we entered into a development
agreement with Boston Scientific Corp., a medical device manufacturer, to
develop MRI capability for one of their products. The nature and terms of this
development agreement are confidential. Additionally, our negotiations with
other biomedical device manufacturers and our evaluation of their proposals is
continuing.
We recently completed financing that allows us the ability to continue
developing these solutions in parallel with our efforts to close additional
customers. Our R&D continues to produce know-how and new patent applications,
and helps us demonstrate capabilities that improve our ability to close
additional customers. We are currently in discussions with multiple divisions of
several medical device companies, as well as MRI manufacturers.
An MRI procedure may be crucial to diagnosing colon cancer, a brain tumor,
or a host of other serious, life threatening problems. The existence of a
medical device that is not MRI safe and compatible requires physicians and
patients to make a very difficult decision to either forego the MRI, or risk
serious injury and potential death from undergoing MRI with a pacemaker,
neurostimulator, or other implantable device installed. See the following
references for information relating to patient deaths:
1. FDA Medical Device Report (MDR) records of pacemaker patient deaths
during or shortly after an MR exam. FDA Medical Device Records (MDRs) # 351516,
748838, 175218, and 1259381.
2. Pacemaker patient who died 15 minutes after MRI scan of the brain.
"Fiber Optics May Allow Pacemaker Users To Undergo MRIs Without Health Threat."
The Wall Street Journal, Feb 22, 2002. D. Pennell, M.D. Imperial College,
London.
3. Pacemaker patient who suffered severe brain damage and death following
an MRI exam. Loss prevention case of the month. "Not my responsibility!" Journal
of the Tennessee Medical Association. 1988;81(8): 523, J. K. Avery, M.D. St.
Thomas Hospital, Nashville, TN.
TECHNOLOGY
A brief description of the terms used to describe our technologies may be
helpful and is presented below.
o The term "MRI safe" refers to a situation in which MRI testing will
cause no harm to the patient or to any implantable or interventional
device within them.
29
o The term "MRI compatible" refers to a situation in which image
interference is minor, and the resulting MRI image is useful in
diagnosing the patient's state of health.
o The term "active" refers to an implantable device or surgical
implement that uses optical, electrical, and/or other energy to
sense or transmit information, and/or modify or treat diseased
tissue. Examples include pacemakers and related devices, catheter
imaging devices, and drug pumps, all of which may be affected during
MRI.
o The term "passive" refers to an implantable device or surgical
implement that does not transmit information but serves to move,
secure or modify tissue or another device, and does so via its
mechanical action or presence only.
o Carbon composite materials consist of ultra-fine whiskers of carbon
dispersed in a plastic material. The resulting material has the
ability to absorb and/or reflect electromagnetic energy at
frequencies that relate to the size of the whiskers. This material
can be extruded and molded to make components.
o Nanomagnetic materials consist of ultra-fine particles of magnetic
material (such as iron) embedded in a ceramic material. These
particles are so small that they behave differently than they would
in a continuous layer or solid. The choice of magnetic and ceramic
materials, particle sizes, and layer thickness permit "tuning" the
nanomagnetic layer to reflect and/or absorb specific frequencies of
energy. They are also so thin that they can flex without breaking
and are extremely tough.
o Filtering technology that essentially blocks unwanted induced
currents at both ends of a catheter or other device.
o Photonic technology that uses miniature diode lasers and photocells
at each end of a catheter or pacemaker lead or surgical device to
transmit energy and information without any electrical conductors.
Diode lasers are semiconductor devices that can be as small as the
size of a grain of salt that convert an electrical pulse to light at
a single frequency or color. Photocells reverse this process and can
also be very small. By integrating these elements carefully at each
end of an optical fiber, we can send power and information without
the use of wires. This technology has been made very reliable and
cost effective by development in support of the telecommunications
industry. We have successfully paced an animal's heart with our
prototype of a photonic pacemaker lead, and demonstrated that it
does not heat up or alter voltages. Discussions with pacemaker
manufacturers regarding this technology caused us to shift focus to
our current solutions, described earlier. Our photonic technology
has potential in other devices, such as intraluminal catheters,
described in the following paragraph.
o A further application of photonics is in intraluminal imaging. This
is an extension of MRI imaging where the MRI receiver coil that is
traditionally outside the body, is reduced to a very small size
(microcoil) so that it can be placed inside (intra) a body cavity or
blood vessel (lumen). This can provide significant improvements in
resolution. We believe the performance and safety of these
microcoils can be greatly improved by using our photonic technology
to replace the wires currently being used by researchers to connect
them to the external MRI system.
30
RESEARCH AND PRODUCT DEVELOPMENT ACTIVITIES
We are developing technology that will enable patients with implanted
biomedical devices to safely undergo MRI. The research and development expenses
incurred by us were $113,144 for the fiscal year ended February 28, 2001;
$949,124 for the fiscal year ended February 28, 2002, $1,373,124 for the year
ended February 28, 2003, and $682,671 for the nine months ended November 30,
2003.
We are committed to the development of MRI-safe solutions for pacemakers
and other biomedical devices.
We have also demonstrated that fiber-optic systems can be used to replace
metal wire leads in devices, and that the fiber-optic systems resolve the
problems of heating and induced voltages. We have also created concepts and
filed patent applications dealing with the use of fiber-optic systems to provide
power and signal handling capability to MRI microcoils that can be used to image
within arteries and other body cavities. Initially, we also planned to develop a
photonic temporary pacemaker ourselves, through clinical trials, FDA approval
and into commercial use.
At this time we are not pursuing further development of the fiber-optic
systems until funded by one or more industry partners. We are maintaining the
intellectual property and we remain interested in licensing or development
opportunities. We are continuing to explore other potential uses of fiber-optic
leads as an alternative to metal wire leads in implantable applications and in
minimally invasive surgery. The U.S. Patent and Trademark Office (US PTO)
recently allowed three of our pending patents in fiber-optic technology, and
these patents will issue as a result. Wilson Greatbatch, the inventor of the
first successful pacemaker, is a co-inventor on several of these patents, and he
developed a fiber-optic pacemaker device which was successfully tested in
animals and was able to successfully pace the animal's heart.
Our current research efforts are focused on demonstrating the feasibility
of our coating and filtering solutions that we intend to license to medical
device manufacturers. Initial tests of these solutions have been promising
enabling us to have discussions with several companies regarding potential
development arrangements. Consistent with our business strategy, on September
25, 2003, we entered into a development agreement with Boston Scientific Corp.,
a medical device manufacturer, to develop MRI capability for one of their
products. Preliminary results from this activity, while confidential, are
encouraging and moving towards the contractual goals. The specific nature and
terms of this development agreement are confidential. Additionally, our
negotiations with other biomedical device manufacturers and our evaluation of
their proposals is continuing. These coating and filtering solutions are
significantly less expensive to implement than our fiber-optic solution. The
coating and filtering solutions do not use any additional battery power, whereas
the fiber-optic solution is more energy intensive.
31
The results of tests regarding pacemaker solutions are discussed below.
Until these tests were recently completed, it was not clear if these solutions
could solve the MRI safety issues of pacemakers and other devices. With the
initial results we have achieved, it appears that these solutions can
significantly reduce the heating and other problems that have caused the MRI
contraindications of many devices. Our discussions with major manufacturers of
pacemakers and other devices have indicated a strong preference for
coating/filtering solutions versus photonic solutions for several reasons
including battery life and ease of engineering redesign. To date, we have
received licensing interest in our technology, and several offers from one of
the pacemaker companies. We are in discussions with several guidewire and
neurological device companies.
Our original focus was solely on pacing technology. However, following the
testing of our coating and filtering technologies and the corresponding positive
feedback from medical device manufactures, both inside and outside the pacing
industry, we believe our potential market has been significantly increased. This
increase is a result of developing technology that could be utilized by medical
devices, including guidewire, catheter, prosthetic devices, stents, biopsy
needles, and neurological devices in addition to pacemakers. As the
coating/filtering technology does not require a complete product redesign, and
manufacturers have indicated a preference for this technology, we believe the
time to commercialize our technology has been reduced. Further, we anticipate
that additional manufacturers will partner with us in developing the technology,
thereby reducing our capital requirements.
The fiber-optic lead has been tested in an MRI machine and does not heat
up as do existing catheters that contain metal wires. We are exploring the use
of this technology with third parties, under license, for use in deep brain
stimulation applications, such as treating movement related disorders like
Parkinson's disease and epilepsy. We have also received OEM licensing interest
from several companies wishing to use the fiber-optic lead to power intraluminal
coils. We are anticipating one or more R&D contracts to help finance the
development of this product that is based upon Biophan's photonic technology
platform.
Nanomagnetic Particle Coatings
We have licensed, on an exclusive basis, issued patents for shielding and
electromagnetic interference (EMI) filtering technologies that include the use
of carbon composite and nanomagnetic particle technologies.
We have obtained a license from Johns Hopkins University for an issued
patent for an MRI-safe electrocardiogram and pacemaker lead. The license is
exclusive to us for implantable devices and also covers other market segments.
This technology provides a low-pass radio frequency (RF) filter at the electrode
tip in the heart that permits conduction of pacemaker signals but blocks
high-frequency MRI electromagnetic signals that cause problems in implanted
devices.
Two tests of our technologies were recently conducted in active MRI
imaging systems at imaging centers located in Western New York. The first test
showed a reduction of thermal heating caused by an MRI machine on a metal wire
similar to a pacing lead that is protected by one of our MRI technologies. The
control sample heated over 22 degrees Centigrade in less than one minute. With
the Biophan technology added, the heating was reduced to about 1 degree
Centigrade, below the level that can cause tissue damage and well within FDA
safety guidelines. The second test showed a reduction of 89% in the electrical
energy induced in a metal object by the MRI radio frequency field after our MRI
safety technology is added to the sample.
32
The two tests of Biophan's coating and filtering technology were conducted
on November 11, 2002 and February 13, 2003. These tests were performed in an
actual MRI chamber at the University Medical Imaging Center (UMI), located at
4901 Lac de Ville Boulevard, Rochester, New York. Both tests were run by Biophan
and UMI personnel.
We have also filed patents for reducing the energy output of an MRI
machine in order to minimize the energy that causes lead heating. The
combination of shielding, filtering, and MRI output reduction could possibly
result in solving the MRI heating problem in both active medical devices (e.g.,
pacemakers, defibrillators), and passive medical devices (e.g., catheters and
guidewires).
We conduct our R&D and prototype development through sub-contract
arrangements with third parties.
Biophan has entered into R&D agreements with Alfred University and
Nanoset, LLC, to develop nanomagnetic shield technology, and with the University
of Buffalo for carbon composite polymers (extremely fine carbon fibers in a
polymer, or plastic base material). These arrangements are discussed below in
more detail.
Biophan has entered into a development agreement with the UB Business
Alliance (at the University of Buffalo). The objective of the first phase of
this collaboration focused on developing the means to shield implanted medical
devices, such as a catheter, from the harmful effects of MRI. The second phase
of this collaboration is focusing on improving the shielding technology
developed in phase one by optimizing the formulation through the use of a
magnetic additive. The technology being developed by this collaboration consists
of small carbon materials manufactured in a flexible polymer support. Major
activities include development of optimally performing mixtures of carbon and
polymer materials and the application of these optimal formulations to medical
devices. Under the terms of the agreement for phase one of the collaboration, we
paid $23,375 toward the total project cost of $42,994. All aspects and
obligations of phase one have been completed and satisfied. Biophan will pay
$31,922 toward the total phase two project cost of $50,539 in four equal
installments of $7,980.50. The first three installments were paid August 15,
2003, October 24, 2003 and December 12, 2003, and a final payment is due within
30 days of the receipt of the final project report. Phase two of this
collaboration is expected to be completed in August of 2004.
Biophan has also entered into agreements with Alfred University. The
objective of this collaboration is to develop the means to shield implanted
medical devices, such as pacemaker leads, from the harmful effects of MRI and to
resolve image artifacts in medical devices such as guidewires, stents, pacing
leads and other medical devices. The technology being developed by this
collaboration consists of nano-magnetic materials and the processes used to
apply these materials as uniform, thin-film coatings. Major activities include
the development of optimal nano-magnetic coating formulations, delivery of
coated pacemaker leads, the delivery of coated guidewires and other devices
suitable for testing, processes for applying these formulations to medical
devices, and the testing of these devices in an MRI system. This collaboration
also provides Biophan with access to expensive, thin-film coating equipment
considered essential to the development of effective nano-magnetic MRI shielding
materials. Biophan has paid Alfred University $44,051 to date for these
services. We recently expanded our agreement with Nanoset, LLC and acquired
additional technology rights, which are described in the next section. The work
being done at Alfred has recently extended to demonstrating the use of
nanomagnetic materials in particulate form, as MRI contrast agents, potentially
improving the effectiveness of, and expanding the applications for, these
image-enhancing agents.
33
Biophan recently entered into an expanded Research and Development and
Licensing Agreeement with Nanoset, LLC, the holder of the nanomagnetic particle
coating technology, and other technologies. Under our expanded agreement with
Nanoset, LLC, Biophan has exclusive rights to nanomagnetic particle technology
for any medical application; plus use of any other technologies developed by
Nanoset, LLC for improving MRI safety and/or MRI image compatibility. Biophan
also has exclusive rights to technologies for implanted power systems for
medical devices, including a patent owned by Nanoset, LLC for an implantable
fuel cell device which derives energy from various forms of fat found in tissue
and/or blood. The output of this device design is electrical power for powering
implantable devices, including pacemakers. Under the revised agreement with
Nanoset, LLC Biophan provides minimum royalty payments in advance of actual
royalties, and a minimum R&D agreement, funding research by Dr. Xingwu Wang, a
professor at Alfred University. Under the revised agreement, Biophan will pay
Nanoset, LLC for research services performed at Alfred University, and Nanoset,
LLC will, in turn, pay Alfred. Michael Weiner, CEO of Biophan, serves as a
director on the board of Nanoset, LLC, and is a co-founder. Nanoset, LLC
originally was formed to pursue technologies outside of the medical field. Dr.
Wang subsequently identified an opportunity to use his nanomagnetic particle
coatings to assist Biophan in its mission, which led to the relationship between
Nanoset, LLC and Biophan.
While the objectives of these collaborations are similar (i.e., the
development and evaluation of MRI shielding materials), it should be understood
that each collaboration is developing a different technology. The success of
these collaborations would provide Biophan with multiple solutions to the MRI
safety problem. Biophan considers this to be very important, since the MRI
shielding requirements differ by product type, and having multiple solutions
enables us to apply our technologies to a broader range of products. It also
reduces the potential for third parties to "work around" our technology.
Specific product technology development activities along with timelines and
estimated costs can be found in the section "Products and Markets" below in this
document.
PATENTS AND INTELLECTUAL PROPERTY
We have been aggressive in filing patent applications on these
technologies, and plan to continue to be aggressive in pursuit of patent
coverage for our innovations. Due to the importance of our patent portfolio, it
may be helpful to provide more detail regarding the patent process:
o Once a patent application is filed, the United States Patent &
Trademark Office (USPTO) examines it over a period that may range
from a year to two or more. USPTO Office Action is a challenge to
the content or scope of the patent, and may require one or more
iterative responses to the Examiner's questions or challenges.
During this process, typically after 18 months from filing, the
USPTO will publish the application, making it available on the USPTO
database so that it is publicly available. Once negotiation over the
Office Action is complete, the USPTO may allow the patent,
essentially informing the inventor(s) that they may pay fees and the
patent will then issue, or become a formal patent.
34
o As previously discussed, we have exclusive licenses, for medical
device applications, to three issued patents; one each in the areas
of carbon composite shielding, nanomagnetic shielding, and RF (radio
frequency) filtering. RF filters are commonly used in communications
equipment to block unwanted signals.
o Biophan has filed 42 US patent applications covering various aspects
of photonic and other technologies providing improvements in MRI
safety and compatibility, as well as other aspects of implantable
device performance. Three of these patents have been allowed by the
U.S. Patent and Trademark Office, and are expected to issue within
approximately six months.
o The inventor of the nanomagnetic shield technology, Dr. Xingwu Wang,
at Alfred University, New York, has been granted a second issued
U.S. patent, and has applied for an additional twelve, one of which
has been allowed. (US patent applications covering further
improvements and extensions to that technology; these will also be
licensed exclusively to Biophan for medical markets.)
o Biophan has recently secured additional technology rights expanding
its exclusive license for use of nanomagnetic particle and other
technology. The technology rights are granted under an expanded
license agreement executed on January 15, 2004 with Nanoset, LLC
that increases Biophan's rights to technology that may be applied to
medical devices and other uses. The expanded rights include the
exclusive right to any technology that affects magnetic resonance
imaging (MRI) safety or image compatibility or involves an
implantable power system.
o Additional patent filings in nanomagnetic materials, and in MRI
microcoil designs, are in process.
The issued patents have remaining lifetimes, as follows:
o U.S. 6,506,972; Magnetically Shielded Conductor; 19 years
o U.S. 6,673,999; Magnetically Shielded Assembly; 19 years
o U.S. 5.827,997; Metal Filaments for Electromagnetic Interference
Shielding; 11 years
o U.S. 5,217,010; ECG Amplifier and Cardiac Pacemaker for Use During
Magnetic Resonance Imaging; six years
o New patent filings incorporate combinations of these inventions in
devices, to extend through the life of our patent coverage.
Lifetimes for any additional patent applications that are granted as
patents by the USPTO will be the greater of:
o 17 years from the date of issue; or
o 20 years from the date of filing.
35
The patent strategy being pursued by us is based on both broad coverage at
the system level and focused coverage at the component level. This strategy is
being applied to active medical devices such as cardiac assist devices
(pacemakers and defibrillators), intraluminal imaging coils, stents, patient
monitoring instrumentation, neurostimulators, drug pumps, endoscopes and to
passive medical devices such as biopsy needles, guidewires, and to other medical
devices that need to be made safe and effective in an MRI environment.
Michael L. Weiner, our President and CEO, has participated as inventor or
co-inventor in a number of the patent applications currently being pursued by
Biophan, each of which has been assigned to us. Throughout his employment, Mr.
Weiner has assigned and will continue to assign to us rights to patents that
deal with MRI safety, image compatibility and HIV antisense. Biophan does not
have proprietary rights in six unrelated patents, of which Mr. Weiner is the
inventor or co-inventor, in areas of technology outside of Biophan's business
interests. One of the six patents was the basis for an infringement suit against
LeapFrog Enterprises, which was recently settled. The terms of the settlement
agreement are confidential. This infringement suit was unrelated to the business
of Biophan as is the patent upon which it is based. Of the patents, for which
Mr. Weiner is an inventor of co-inventor, assigned to entities other than
Biophan, none will be directly or indirectly competitive with Biophan. All
material assignments of patent applications from Mr. Weiner to Biophan have been
filed as exhibits to the registration statement, of which this prospectus is a
part.
PRODUCTS AND MARKETS
We are addressing three basic areas of technology and product development
that apply across several market segments:
o MRI shielding for active medical devices;
o MRI shielding for passive medical devices, such as guidewires and
biopsy needles, enabling surgery be done under MRI guidance;
o Photonic and shielding solutions for MRI imaging; and
o MRI contrast agents.
We do not intend to produce by ourselves a product for sale, but rather to
make our technologies available to other companies or partners that would like
to include in their own product portfolio a new product(s) containing our
technology. We anticipate that any such product(s) would be developed through
collaboration with external companies or partners. Most likely, we would enter
into licensing and R&D agreements with these partners, which ultimately could be
potential sources of funding. Although we would consider lump-sum license
payments, if offered, we anticipate licensing income in advance of product sales
to tie up rights for each market segment, and then ongoing royalties once these
products are in the market. Potential revenue streams above any negotiated
minimum license payments would likely commence six to nine months following
approval by the FDA for product shipments.
Following are brief descriptions of the planned development activities,
each with a set of milestones with timeline and estimated Biophan cost net of
any revenues. In each case, we are assuming that a commercialization partner
will be identified and provide revenues, in the form of development payments, to
assist us in the further development of the particular technology. The milestone
projections comprehend receiving such development revenues, in each case, at the
milestone/activity stage denoted as "3. Complete a Detailed Product Design",
generally, during the first half of calendar year 2004.
36
MRI SHIELDING FOR ACTIVE MEDICAL DEVICES
We have licensed, developed, and patented technology in both carbon
composite shielding and nanomagnetic shielding. For certain devices, this
approach has the potential to provide a more cost-effective path to MRI safety
and compatibility than the photonic approach. Results of direct testing in an
MRI device to date have been quite promising, and further work is underway to
refine the designs of materials and coating methods. This MRI shielding
technology may be applied to active medical devices such as pacemakers and
related devices, drug pumps, and the like. We are currently having discussions,
under confidentiality agreements, with manufacturers of primary device
components such as pacemaker leads, as well as manufacturers of complete
systems, concerning their use of this technology. Ongoing research, test, and
evaluation activities in nanomagnetic shielding are being done internally, and
in conjunction with Dr. Wang (the inventor of the technology) at Alfred
University, and Dr. Chung at the University of Buffalo. The material terms of
these contracts are discussed under the heading "Research and Product
Development Activities."
MILESTONES / ACTIVITIES - MRI SHIELDING FOR ACTIVE DEVICES:
----------------------------------------------------------------- -------------------------------- ----------------------
MILESTONE/ACTIVITY TIME PERIOD REQUIRED FUNDING
(000s)
----------------------------------------------------------------- -------------------------------- ----------------------
1. Demonstrate Technical Feasibility
a. Demonstrate the ability to minimize or Completed
eliminate device heating and
electrical problems caused by MRI
b. Demonstrate the ability to meet December 03 - June 04 $80
secondary product performance
requirements (e.g. biocompatibility,
flexibility, etc)
c. Demonstrate that the technology can be December 03 - June 04 $60
manufactured at acceptable costs and
quality
d. Continue to file related patent Completed
applications
----------------------------------------------------------------- -------------------------------- ----------------------
2. Identify a commercialization partner(s) Ongoing $ 33
----------------------------------------------------------------- -------------------------------- ----------------------
37
----------------------------------------------------------------- -------------------------------- ----------------------
3. Complete a Detailed Product Design December 03 - June 04 $180
a. Further optimize the technology's performance
and manufacturability
b. Develop detailed Product Design and
Manufacturing Process Specifications
----------------------------------------------------------------- -------------------------------- ----------------------
4. Complete Design Verification May 04 - October 04 $210
a. Demonstrate that a product manufactured to the
Product Design Specifications will satisfy the
Product Performance Requirements
b. Develop documentation required to initiate
clinical testing
----------------------------------------------------------------- -------------------------------- ----------------------
Spending through October 2004 $563
----------------------------------------------------------------- -------------------------------- ----------------------
5. Complete Design Validation November 04 - June 05 $150
a. Demonstrate that a product manufactured to the
Product Design Specifications is clinically
effective and safe when used as intended
b. Develop documentation required for regulatory
body approval to distribute and sell the product
----------------------------------------------------------------- -------------------------------- ----------------------
Total Project Spending $ $713
========
----------------------------------------------------------------- -------------------------------- ----------------------
Biophan intends to identify a commercialization
partner(s) to help focus and financially support
activities (3), (4), and (5).
----------------------------------------------------------------- -------------------------------- ----------------------
38
MRI SHIELDING FOR PASSIVE MEDICAL DEVICES
The same MRI shielding technology may be applied to a wide variety of
passive devices that are used in implantable medical devices and in surgery,
such as biopsy needles, guidewires, endoscopes, etc. We believe that our MRI
shielding will eliminate the problems of patient risks and image degradation for
passive devices and surgical implements which incorporate the technology. We are
currently having discussions with a variety of manufacturers of passive devices,
and are involving them in test procedures we are conducting. Ongoing research,
testing, and evaluation of this technology is also being done with Dr. Wang (the
inventor of the technology) at Alfred University, and Dr. Chung at the
University of Buffalo.
MILESTONES / ACTIVITIES - MRI SHIELDING FOR PASSIVE DEVICES
The table below summarizes current R&D activities being funded by Biophan
and partners. The recently completed financing, and the financing which will be
enabled by this registration, provides adequate working capital to execute these
targeted spending allocations, and to increase them, as may be needed.
Additionally, the company is now posititioned to explore additional technology
acquisitions and to retain additional contract research.
---------------------------------------------------------------- -------------------------- -----------------------------
MILESTONE/ACTIVITY TIME PERIOD REQUIRED FUNDING
(000s)
---------------------------------------------------------------- -------------------------- -----------------------------
1. Demonstrate Technical Feasibility
a. Demonstrate the ability to minimize or
Completed eliminate device heating and
electrical problems caused by MRI
b. Demonstrate the ability to meet December 03 - June 04
secondary product performance $50
requirements (e.g. biocompatibility,
flexibility, etc) December 03 - June 04
c. Demonstrate that the technology can be
manufactured at acceptable costs and October 03 - February 04 $40
quality
d. Continue to file related patent
applications $40
---------------------------------------------------------------- -------------------------- -----------------------------
2. Identify a commercialization partner(s) Ongoing $ 30
---------------------------------------------------------------- -------------------------- -----------------------------
3. Complete a Detailed Product Design December 03 - May 04 $ 80
a. Further optimize the technology's
performance and manufacturability
b. Develop detailed Product Design and
Manufacturing Process Specifications
---------------------------------------------------------------- -------------------------- -----------------------------
4. Complete Design Verification April 04 - August 04 $150
a. Demonstrate that a product
manufactured to the Product Design
Specifications will satisfy the
Product Performance Requirements
b. Develop documentation required to
initiate clinical testing
---------------------------------------------------------------- -------------------------- -----------------------------
39
---------------------------------------------------------------- -------------------------- -----------------------------
5. Complete Design Validation September 04 - October 04 $20
a. Demonstrate that a product Spending through October
manufactured to the Product Design 04 $410
Specifications is clinically effective
and safe when used as intended November 04 -
b. Develop documentation required for April 05 $100
regulatory body approval to distribute
and sell the product
---------------------------------------------------------------- -------------------------- -----------------------------
Total Project Spending $510
========
---------------------------------------------------------------- -------------------------- -----------------------------
Once again, Biophan intends to identify a
commercialization partner(s) to help prioritize
and financially support activities (3), (4) and (5).
---------------------------------------------------------------- -------------------------- -----------------------------
MRI CONTRAST AGENTS
MRI provides excellent soft tissue contrast, and various image analysis
techniques provide the ability to differentiate between fat, muscle, brain, and
other fundamentally different tissue types. Beyond that, however, contrast
agents are used to enhance the contrast between different tissue types,
permitting image analysis software to highlight specific features (e.g. vascular
structures). Typical materials used for traditional MRI contrast agents are
either iron oxides or gadolinium-based compounds; while there are other
materials in commercial use, their performance and breadth of use are
substantially lower. Iron-based and gadolinium-based compounds have shortcomings
in terms of signal strength and toxicity, respectively. They also are typically
used in a serial and highly time-dependent fashion. This means that typically
one target tissue type is image-enhanced per diagnostic procedure, and the
buildup and clearance of contrast agents is highly time dependent, requiring
careful orchestration of the diagnostic imaging procedure.
As part of our work with nanomagnetic particles, we have licensed a
technology that is the subject of a recently filed patent application relating
to the use of these particles as contrast media for MRI. We believe that our
ability to manipulate the chemical makeup of these particles, and our ability to
use multiple imaging modes in detecting them, will permit us to develop MRI
contrast agents having substantial advantage over current materials, including
the ability to deliver a `cocktail' contrast agent that permits MRI to detect
multiple disease or tissue injury types during a single MRI imaging sequence.
Active R&D work is contemplated by the Company, but specific plans have
not yet been formalized; in the meantime the patent application will be
prosecuted aggressively with our support.
MARKETS
The global market for medical devices that could benefit from technology
that will enable those devices to operate safely and effectively in an MRI
environment was approximately $5 billion in the year 2002 and is growing
annually by 15%. (See Wedbush Morgan Securities' Equity Research Report 13 Mar.
2002 on NYSE-GB.)
40
We anticipate that we will license our technology to one or more
development partners who would be responsible to develop commercial products,
obtain necessary approvals, manufacture, market and distribute the products. We
expect our search for development partners will be global, although our current
efforts are focused on the U.S. operations of certain multi-national companies.
However, we can not presently identify or predict the precise target markets,
distribution methods or other marketing efforts of our potential development
partners.
The market for devices that have imaging compatibility problems are in
addition to the market opportunity for safer device. We estimate the market for
devices which had imaging limitations to be an additional $5 billion or greater.
These include implantable artificial hips, knees, bones, and other prosthetics;
stents, shunts, screws, wires, shanks, etc.
COMPETITION
There are a number of major companies engaged in the development of
medical devices, some of which may be investigating MRI safe options. However,
to the best of our knowledge, none of these companies, nor other companies that
serve as their suppliers, have successfully developed technology enabling
implantable medical devices to be operated in the presence of MRI equipment. We
believe that, in order to commercialize our technologies, we will have to enter
into a development or licensing agreement with one or more of the companies
engaged in the development of medical devices.
Currently, the major providers of active medical devices contraindicated
for MRI include the following companies:
Medtronic Incorporated is a leading manufacturer of cardiac rhythm
management, cardiovascular and other medical devices. The company has a
dominant position in cardiac pacemakers, is the leading manufacturer of
implantable cardiac defibrillators, and is a major player in most other
device markets in which it competes. In May, 2003 a patent application
filed by Medtronic was published on web site of the United States Patent
and Trademark Office. This patent teaches a proposed method of reducing
the induced voltage of a pacemaker lead. We do not know how effective the
Medtronic approach will prove to be. It appears to use more complex
electrical components than the Biophan solution. The entrance of Medtronic
into the market with an MRI safe pacemaker solution, if it should occur,
is viewed by us to be a very positive event that will propel the industry
forward, and may result in licenses for our technology to be sought by the
other pacemaker companies competing with Medtronic.
Guidant Corporation is also a leading manufacturer of cardiac rhythm
management devices such as cardiac pacemakers, implantable cardiac
defibrillators, interventional cardiology devices (including coronary
stents), and other cardiac and vascular surgery devices and instruments.
41
St. Jude Medical, Inc. is a global developer, manufacturer, and
distributor of medical device products for cardiac rhythm management,
cardiology and vascular access. Other products include mechanical and
tissue heart valves and vascular closure devices.
Boston Scientific Corporation is the world's largest medical device
company dedicated to less-invasive therapies. The Company's products and
technologies are designed to improve surgical procedures and improve
patient response, and involve a range of interventional tools and
procedures. Biophan has announced a joint development agreement with
Boston Scientific to explore the use of our technology to make one of
their products MRI safe and image compatible.
Johnson & Johnson is the world's largest healthcare company. In addition
to OTC and home healthcare products, they provide a wide variety of
pharmaceutical, diagnostic, and surgical products.
Biotronik is a leading European biomedical technology company; their 2500
people develop and market products focused on cardiac electrotherapy and
vascular intervention.
ELA Medical is an innovative leader in research, development,
manufacturing and marketing of cardiac rhythm management implantable and
diagnostic systems.
The COOK family of companies includes medical device manufacturing
companies that produce products for interventional radiology,
interventional cardiology, urology, neuroradiology, vascular medicine,
critical care, and many other disciplines.
Baxter International is a global health care company providing critical
therapies for people with life-threatening conditions, including cancer,
hemophilia, immune deficiencies, infectious diseases, kidney disease and
trauma. Baxter is a global leader in developing innovative medical
therapies that improve the quality of life for people around the world.
Arrow International is a leading supplier of disposable critical care
catheterization products used to access the central vascular system for
administration of fluids, drugs and blood products, and for patient
monitoring and diagnosis.
Philips, Siemens, General Electric and Toshiba, are major manufacturers of
MRI imaging devices, are believed to have research and development
initiatives underway, involving MRI safety and image compatibility.
C. R. Bard, Inc. is a leading multinational developer, manufacturer, and
marketer of innovative, life-enhancing medical technologies in the fields
of Vascular, Urology, Oncology, and Surgical Specialty products.
42
Each of these companies has the potential to be a direct competitor,
and/or a licensee. Each may have or develop future interest in adopting one or
more of our technologies into their products. Additionally, these companies may
wish to enter into licensing agreements with us in the event that one or more of
their prospective solutions under development would infringe our issued patents,
or those of our pending patents when they issue.
Various first and second tier suppliers to these companies may be directly
affected by technologies we are developing, and since to the best of our
knowledge, none of them has satisfactory solutions to MRI issues, they are
potential additional or alternative prospects for commercializing our technology
as well as potential competitors.
MANUFACTURING AND COMPONENT STRATEGY
We are developing technology for MRI safety and image compatibility which
will be licensed to leading biomedical device manufacturers. We may provide
critical components and coating devices sourced from third parties and resold to
our customers.
REGULATORY APPROVAL
We believe that our technology will be incorporated into various medical
devices by major manufacturers and that these manufacturers will be responsible
for obtaining Food and Drug Administration (FDA) and other regulatory approvals
required for clinical studies and marketing of their products. The time and cost
of these activities can be substantial, especially for Class III implantable
products, and could delay the introduction to the marketplace of products
utilizing our technology.
Currently, the FDA, specifically The Center for Drug Evaluation and
Research (CDER), is responsible for the approval to market products resulting
from the technology currently being developed by Biophan. Approval to market may
take the form of a New Drug Application (NDA). An NDA is sought by a company
prior to the commencement of clinical testing in humans. Before approving an
NDA, the FDA will seek substantial documentation demonstrating that the product
candidate technology is safe and effective. Once the NDA has been approved,
clinical trials are conducted in three sequential phases which may overlap.
Phase I clinical trials are performed in healthy human subjects to establish
initial data about the safety and efficacy of the product. In Phase II clinical
trials, in addition to accumulating safety and efficacy data, the product is
evaluated in a limited number of patients with the targeted disease condition.
Phase III clinical trials typically involve continued testing for safety and
efficacy, as well as other criteria, in expanded, large-scale, multi-center
studies of patients with the targeted disease condition.
We do not intend to produce by ourselves a product for sale, rather we
intend to make our technologies available to other companies or partners that
would like to include the technology in their own product. We believe that these
companies will be willing to share a portion of the costs required to obtain FDA
approval. In certain instances, the FDA may require a partner's participation if
approval is being sought for modification of a partner's existing product to
include our technology, a product that uses the partner's existing manufacturing
processes, or a situation where a partner requires that Biophan use the
partner's quality system.
43
We believe that the timeframe for FDA approval of our photonic technology
for intra-luminal MR imaging, enabling us to make, use, and sell the product,
will depend upon the following factors:
o the FDA's classification of the photonic intra-luminal MR imaging
catheter;
o the specific ways in which a partner plans to use the product, such
as the specific parts of the body they would like to image with the
product (e.g., cardiovascular system, brain, etc.); and
o the level of urgency placed on the activities required to obtain
product regulatory approval.
The FDA has already approved for sale intra-luminal imaging catheters that
utilize electrical leads to provide power to the microcoil and to carry received
signals back to the MRI system. Biophan is in discussions with one company that
has such a product, and we believe that our photonic technology will permit
improvements in performance due to its inherent immunity to electromagnetic
noise created by the MRI environment. We are under a non-disclosure agreement
with this other company, and it is our expectation that if we move forward to
develop a photonic intraluminal imaging catheter, they will be responsible for
regulatory approval and for marketing and sale of the product. There will be no
competition between Biophan and any other company based on an intraluminal
imaging catheter. We plan to provide technology that improves the market
position of another company already in the marketplace and not to develop a
Biophan stand-alone product. In the event that this program moves forward, our
plans provide for a contribution of $500,000 toward regulatory approval efforts
costing approximately $1,500,000. However, the partner company will be
responsible for oversight and conduct of clinical trials, and for applying to
the FDA for approval.
Because sufficient information exists from already-approved products to
assure the safety and efficacy of these devices in the applications we envision,
we anticipate, but cannot guarantee, that the FDA will require a Pre-Market
Notification or 510(k) approval. This would be in place of a Pre-Market
Approval, a more involved process usually reserved for devices that sustain
human life and for which there is insufficient information to assure patient
safety. A 510(k) approval will require that we demonstrate to the FDA data that
the product design and intended uses of the product are substantially equivalent
to a product(s) already approved by the FDA for commercial distribution in the
U.S.
In the event the FDA considers the Biophan product to be a Class II
Medical Device subject to 510(k) approval, we would work with a partner to
collect or develop the product performance data the FDA requires to prove that
the our product is substantially equivalent to intra-luminal catheters already
on the market. We anticipate that collecting or developing this data would be at
least a moderately high priority by a partner, and would take approximately
three to six months to complete. Biophan and its partner would include this data
in an application to the FDA for 510(k) approval, 90 days before selling the
device. The FDA can refuse to allow this approval to be granted by responding
with questions during the 90 day review period. Based upon this possibility, we
estimate that the approval process will require a total of 180 days.
Accordingly, the total time for product regulatory approval would be
approximately 12 months.
44
The FDA has also previously approved for sale the types of active devices
(pacemaker leads) and passive devices (guidewires and catheters) that we would
like to improve by the addition of our MRI (MRI) shielding technologies. We
believe that the technology would improve the performance of these existing
products during MRI examinations. The FDA considers these devices to be Class II
Medical Devices, and historically they have been subject to Pre-Market
Notification or 510(k) approval requirements.
We anticipate working with a partner to collect or develop the product
performance data required for FDA approval of our shielding technologies. This
data will include proof of the following:
o that the product modified to include Biophan's shielding technology
is still substantially equivalent to products already approved for
sale by the FDA; and
o that the addition of Biophan's shielding technology actually does
improve the performance of the existing product during MRI
examinations.
The addition of Biophan's shielding technology to an existing product
requires that we apply a proprietary coating to the product. Because the coating
process does not require any significant changes to the product design or to its
manufacturing process and therefore little risk to the safety of its operation,
we anticipate that a minimal amount of data will be required. We feel that it is
reasonable to expect that the FDA will consider the 510(k) approval process they
required to approve the original device as sufficient to approve the minor
modifications to a partner's device required to integrate Biophan's technology.
We anticipate that collecting or developing this data would be at least a
moderately high priority by a partner, and would take approximately three to six
months to complete. Biophan and its partner would include this data in an
application to the FDA for 510(k) approval, 90 days before selling the device,
as is required by the 510(k) approval process. The FDA can refuse to grant
510(k) approval by responding with questions during the stipulated 90 day review
period. Based upon this possibility, we conservatively estimate that the
approval process will require a total of 180 days. Accordingly, the total time
for product regulatory approval for planning purposes is 12 months for both
active and passive devices.
During the 510(k) approval process, it will be necessary to collect
biocompatibility and toxicity data, to establish that the modified product is
safe. The FDA provides specific guidelines for evaluating the biocompatibility
and toxicity risk associated with medical devices in their document entitled
"Guidance for the Submission of Research and Marketing Applications for
Permanent Pacemaker Leads and for Pacemaker Lead Adapter 510(k) Submissions,"
issued on 1 November 2000. This guidance document clearly states (Attachment C -
"Biocompatibility Flow Chart for the Selection of Toxicity Tests for 510(k)s")
that device materials that do not contain toxic substances (as is the case with
Biophan's shielding material) satisfy biocompatibility requirements. Biophan can
collect this toxicity data from available toxicology literature without the need
for human studies. We believe that the FDA will support this procedure and not
require human studies to demonstrate biocompatibility and the absence of any
toxicity risk. However, if this proves not to be the case, then we expect the
FDA would follow the guidelines it recommends for determining the
biocompatibility and toxicity of unknown substances. These are also outlined in
their guidance document entitled "Guidance for the Submission of Research and
Marketing Applications for Permanent Pacemaker Leads and for Pacemaker Lead
Adapter 510(k) Submissions," issued on 1 November 2000. These guidelines
stipulate the use of in vitro (out of the body) extraction methods. This testing
is relatively minor in nature, and has already been included in the proposed
regulatory approval timeline and budget requirements.
45
Demonstrating that Biophan's shielding technologies improve the products
performance during MRI examinations will require evaluating the performance of
the product in an MRI coil. Given the perceived low level of patient risk
associated with our shielding technologies, we anticipate that these data can be
obtained through testing that also does not involve human subjects and only a
limited number of animals.
We anticipate that the collection and development of these data will
require $450,000 for each of the limited number of active device applications
and passive device applications initially envisioned, and $1,500,000 for the
intra-luminal imaging catheter. We also anticipate that a partner or licensee
would fund at least 67% of these expenses. We anticipate our contribution to
come from the sale of stock to SBI, the Spectrum equity line of credit or, if
necessary, other equity investors. If we are unable to establish the
partnerships or licenses that would provide a portion of the funds necessary to
pursue regulatory approval then our submission of applications for regulatory
approval to the FDA would be delayed, in whole or part, and our development
efforts may also have to be delayed, in whole or part, until alternative funding
was obtained.
The approach to regulatory approval for nanomagnetic MRI contrast agents will
follow a similar path to that intended for the above product opportunities; it
is expected that the eventual manufacturing/marketing partner will both direct,
and bear the costs, of clinical studies and regulatory approval for contrast
agent products. Cost estimates and timelines for these activities have not as
yet been developed.
LICENSES
We have entered into licenses for issued, allowed and pending patents.
These licenses require annual minimum royalties up to $10,000 each, some of
which escalate in future years, and provide for ongoing royalties of 4-5% of
product sales. Each license is for the life of the patent(s) and each is
exclusive for the medical market or segments thereof, and permit sub-licensing:
o A license from Johns Hopkins University for an issued patent for an
MRI-safe electrocardiogram and pacemaker lead. This agreement
provides for an initial licensing fee of $10,000 and a running
royalty of 4% on product sales. This agreement remains in effect for
the life of the patents underlying the license. The license may be
terminated earlier, at Biophan's election, upon 60 days' written
notice to Johns Hopkins. Johns Hopkins may only terminate the
agreement early if there is a breach by Biophan which is not cured
within 30 days following written notice of such breach or default.
46
Alicense agreement for additional shielding technologies from
Nanoset, LLC. This license agreement provides for an initial
licensing fee of $10,000 and a running royalty of 5% of product
sales. The license agreement currently covers 15 patents and/or
patent applications. This agreement remains in effect for the life
of the patents underlying the license. The license may be terminated
earlier, at Biophan's election, upon 60 days' written notice to
Nanoset. Nanoset may only terminate the agreement early if there is
a breach by Biophan which is not cured within 60 days following
notice of such breach or default. This license agreement was
recently expanded to include any inventions relating to MRI safety
and MRI image compatibility, including electrical circuits and
filtering combined with nanotechnology coatings.
o A license from Deborah D. L. Chung for an issued patent entitled
Metal Filament for Electromagnetic Shielding. This agreement
provides for an initial licensing fee of $10,000 and a running
royalty of 5% of product sales. This agreement remains in effect for
the life of the patents underlying the license. The license may be
terminated earlier, at Biophan's election, upon 60 days' written
notice to Chung. Chung may only terminate the agreement early if
there is a breach by Biophan which is not cured within 60 days
following notice of such breach or default.
COMPANY HISTORY
We incorporated in the State of Idaho on August 1, 1968 under the name
Idaho Copper and Gold, Inc. On February 9, 1999, we amended our Articles of
Incorporation to change our name from Idaho Copper and Gold, Inc. to Idaho
Technical, Inc. On January 12, 2000 we formed a corporation in Nevada with the
intent to move our domicile to Nevada. On January 24, 2000, we implemented the
change of domicile to Nevada by filing Articles of Merger between the Idaho and
Nevada Corporations. On December 1, 2000, we amended our Articles of
Incorporation to change our name from Idaho Technical, Inc. to GreatBio
Technologies, Inc. and on July 19, 2001, we amended our Articles of
Incorporation to change our name from GreatBio Technologies, Inc. to Biophan
Technologies, Inc.
On December 1, 2000, we acquired LTR Antisense Technology, Inc., a New
York corporation, from Biomed Solutions, LLC (formerly Biophan, LLC), a New York
limited liability company, in a share for share exchange. As a result of the
exchange, LTR became a wholly owned subsidiary. The exchange was consummated
pursuant to and in accordance with an Exchange Agreement, dated December 1, 2000
and amended as of June 8, 2001, by and among our company, LTR and Biomed. LTR
owns several patents for proprietary HIV antisense gene therapy technology.
Just prior to the acquisition of LTR, our Board of Directors consisted of
Geoff Williams (President), David A. Miller (Vice
President/Secretary/Treasurer), Dale F. Miller and Ed Cowle. There were
4,047,330 shares of stock outstanding including shares owned by the following
control persons. Geoff Williams owned 351,000 shares (8.7%), David A. Miller
owned 90,500 shares (2.2%), Dale F. Miller owned 91,500 shares (2.2%), Ed Cowle
owned 851,000 shares (21%), H. Deworth Williams owned 1,398,200 shares (34.5%),
and Biomed owned 718,000 shares (17.7%). There were no other control persons
prior to the acquisition. The terms of the transaction were established by
arms-length negotiations between Messrs. Cowle, Miller and H. Deworth Williams
on behalf of our company, and Michael Weiner on behalf of Biomed, and were
approved by our Board of Directors and the Board of Members of Biomed. In
connection with the transaction, 250,000 shares were issued to Walter Keay, an
individual who acted as a financial consultant for us in connection with the
transaction.
47
Immediately following the acquisition, the same control persons owned
collectively 97.9% of Biophan.
In connection with the exchange, we:
o issued 10,759,101 shares of common stock to Biomed in exchange for
all the issued shares of LTR; and
o issued an additional 10,759,101 shares of common stock to a group of
investors, consisting of Ed Cowle, H. Deworth Williams and Geoff
Williams, for cash of $175,000 in order to provide initial working
capital.
Also on December 1, 2000, we acquired intellectual property rights,
including a pending patent to the MRI-compatible pacemaker technology from
Biomed, for future consideration of $500,000. The assignment was consummated
pursuant to, and in accordance with, a transfer agreement and a related
assignment and security agreement, dated December 1, 2000 and subsequently
amended, by and between us and Biomed.
The assignment and the security agreement (i) assigned the rights to the
transferred MRI patents and subsequent improvements, and (ii) provided the same
as collateral for the payment of the $500,000 liability under the transfer
agreement. Both the exchange agreement and the assignment and security agreement
contain provisions for the reversion of the technology to Biomed if:
o we become bankrupt or otherwise seek protection from creditors; or
o in the case of the MRI-compatible technology, we fail to pay the
consideration therefor when due.
As described elsewhere in this prospectus, all of our obligations under
the transfer agreement have been converted into shares of our common stock and
the security agreement has been terminated.
During 2001, we entered into a Commercial Research and Development
Agreement (CRADA) with the National Institutes of Health and the University of
Rochester Cancer Center, wherein these organizations conduct research and
development associated with the antisense technology. This allowed us to put our
full resources into the development of the MRI safety improvements to biomedical
products. In 2002, we decided to discontinue research and development of the HIV
antisense technology, and the CRADA was terminated. While the technology holds
promise and has issued patents, we feel our most promising opportunity is in the
MRI safe solutions we have developed, and we intend to focus our research and
development activities on that technology. We may sell the HIV antisense patents
if an appropriate buyer can be identified.
48
EMPLOYEES
As of February 10, 2004, we had eleven full-time employees.
DESCRIPTION OF PROPERTY
Our headquarters are located at 150 Lucius Gordon Drive, Suite 215, West
Henrietta, NY 14586, in 4,000 square feet of office space leased from an
unrelated party. Current rentals are $4,846 per month, and the lease expires in
September 2004. The coordination of our research and development projects and
the administration of our two wholly owned subsidiary companies, currently
inactive, are directed from this location.
LEGAL PROCEEDINGS
We are not a party to any material legal proceedings and there are no
material legal proceedings pending with respect to our property. We are not
aware of any legal proceedings contemplated by any governmental authorities
involving either us or our property. None of our directors, officers or
affiliates is an adverse party in any legal proceedings involving us or our
subsidiaries, or has an interest in any proceeding which is adverse to us or our
subsidiaries.
49
MANAGEMENT
The officers and directors of Biophan are as follows:
Name Age Title
---- --- -----
Guenter H. Jaensch 65 Chairman of the Board
Michael L. Weiner 56 Director, Chief Executive Officer, President
Robert J. Wood 64 Vice-President, Treasurer, Chief Financial Officer
David A. Miller 49 Secretary
Stuart G. MacDonald 55 Vice-President-Research and Development
Jeffrey L. Helfer 51 Vice-President-Engineering
Robert S. Bramson 65 Director
Steven Katz 55 Director
Ross B. Kenzie 72 Director
The above listed officers and directors will serve until the next annual
meeting of the shareholders or until their death, resignation, retirement,
removal, or disqualification, or until their successors have been duly elected
and qualified. Vacancies in the existing Board of Directors may be filled by
majority vote of the remaining directors. Officers serve at the will of the
Board of Directors.
GUENTER H. JAENSCH, PHD is the former Chairman and CEO of Siemens
Pacesetter, Inc., a manufacturer of pacemakers. During his more than twenty-five
years at Siemens, Dr. Jaensch held various senior executive positions prior to
running Siemens Pacesetter, including President of Siemens Communications
Systems, Inc. from August 1983 to March 1985, Chairman and President of Siemens
Corporate Research and Support, Inc., from April 1982 to September 1991 and
Chairman and CEO of Siemens Pacesetter, Inc. and Head of the Cardiac Systems
Division of Siemens AG Medical Engineering Group from October 1991 to September
1994. Dr. Jaensch holds a Masters Degree in Business Administration and a Ph.D.
in Business and Finance from the University of Frankfurt and taught business and
statistics at the University prior to joining Siemens in 1969. In 1994, he
joined St. Jude Medical as Chairman and CEO of Pacesetter, Inc., a St. Jude
Medical Company, and retired in 1995 to manage his personal investments. Since
December 1997 he has been a director of MRV Communications, a publicly traded
company which is a leading company in the fiber optic technology business. Dr.
Jaensch has been a director of Biophan since March 2002.
MICHAEL L. WEINER began his career at Xerox Corporation in 1975, where he
served in a variety of capacities in sales and marketing, including manager of
software market expansion and manager of sales compensation planning. In 1985,
after a ten year career at Xerox, Mr. Weiner founded Microlytics, a Xerox
spin-off company which developed technology from the Xerox Palo Alto Research
Center into a suite of products with licenses to many companies. In January
1995, Weiner co-founded and became CEO of Manning & Napier Information Services,
a Rochester-based company providing patent analytics, prior art searches, and
other services. He held this position until January of 1999. In February 1999 he
formed Technology Innovations, LLC, to develop and expand certain intellectual
property assets. In August, 2000, Technology Innovations, LLC created a
subsidiary, Biomed Solutions, LLC, to pursue certain biomedical and
nanotechnology opportunities. Mr. Weiner serves on the Boards of Biomed
Solutions, LLC, Technology Innovations, LLC, Speech Compression Technologies, LP
(an R&D partnership commenced in 1989 to pursue compression technologies),
Nanoset, LLC, and Nanocomp, LLC. Mr. Weiner holds six issued patents invented
prior to the formation of Biophan which are owned by other companies that
employed Mr. Weiner prior to the formation of Biophan. These patents do not
involve technology that is competing or will compete with Biophan. Mr. Weiner
has been CEO and a director of Biophan since December 2000.
50
ROBERT J. WOOD is a Certified Public Accountant with extensive experience
in public accounting and business consulting. He began his career at Price
Waterhouse & Co. in 1962 after graduating from St. John Fisher College with a
B.B.A. in Accounting. From 1973 to 2000, he was consecutively owner/partner of
Metzger, Wood & Sokolski, CPAs (through December 1985), Mengel, Metzger, Barr &
Co., LLP (through December 1990), and Wood & Company, CPAs, P.C. (through
November 2000), all in Rochester, New York. In December 2000, his practice was
acquired by a regional CPA firm, Eldredge, Fox and Porretti, LLP and he was
engaged in business consulting until joining Biophan as full-time Chief
Financial Officer in August 2001. He is a member of the New York State Society
of Certified Public Accountants. A portion of Mr. Wood's time is spent assisting
with the fiscal management of Biomed Solutions, LLC, a related company, for
which Biophan is reimbursed.
DAVID A. MILLER was self employed from January 1998 until June 2001. Since
June 2001 he has been employed by Biophan. From January 1998 through June 2000
Mr. Miller managed a retail outlet for his family's antique, gold and jewelry
business. Additionally, from January 1998 until June 2001 he operated a business
providing office support services. Mr. Miller has been an SEC Edgar system
filing agent since November 1999. Mr. Miller has been associated with us since
1996. He has held the office of Corporate Secretary since January 30, 1999.
During the period from April 22, 1998 until December 1, 2000 we were inactive.
Mr. Miller provided office space for us and performed duties associated with
maintaining our corporate existence. His duties included preparing and filing
documents with applicable governmental agencies, maintaining stock records,
stockholder relations, keeping minutes of Board of Directors and stockholder
meetings and electronically filing periodic and special reports with the SEC.
Since December 1, 2000 Mr. Miller has served in a similar manner consistent with
the requirements of the office of Corporate Secretary. He served on the Board of
Directors from April 22, 1998 until February 1, 2001 and held the offices of
Vice-President and Treasurer from April 22, 1998 until December 1, 2000.
STUART G. MACDONALD is experienced in research and development with a
broad engineering and science background, emphasizing a systems approach to
developing complex technology. From January 1995 through December 2000, Mr.
MacDonald was employed at Ortho-Clinical Diagnostics, a Johnson & Johnson
company, in Rochester, New York, holding the position of Director-Engineering
from 1996 to mid-1997 and Vice-president, Clinical Lab Instrumentation R&D from
mid-1997 through December 2000. He was responsible for overall management of the
R&D group, including personnel, administration and financial performance. He
worked at Eastman Kodak Company from 1971 to 1994, rising to the position of
Assistant Director, Clinical Diagnostic Research Labs. Mr. MacDonald has a B.S.
in Mechanical Engineering and Masters of Engineering degree from Cornell
University. He is also licensed as a professional engineer by the State of New
York. Mr. MacDonald was employed by Biophan as Vice-President-Research and
Development in January 2001. A portion of Mr. McDonald's time is spent assisting
with the research program of Biomed Solutions, LLC, a related company, for which
Biophan is reimbursed.
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JEFFREY L. HELFER'S background includes 28 years in new product and
technology development, systems management, new business development, and
regulatory affairs, having served in a number of positions at Eastman Kodak
Company for 19 years until November 1994 and from December 1994 to September
2001 at Ortho-Clinical Diagnostics (OCD) in Rochester, New York, a Johnson &
Johnson company. Most recently, he was program director within OCD's Product
Development and Program Management Center of Excellence, where he was
responsible for systems management of OCD's next-generation clinical chemistry
platform. He also held positions as Program Director and Director of Regulatory
Affairs from April 2000 to September 2001, Director of Engineering from January
1997 to March 2000, Director of New Business Development from February 1995 to
December 1996, and headed up multiple international and corporate initiatives to
improve product performance and business processes. He holds a B.S. from
Rochester Institute of Technology and an M.S. from the University of Rochester,
both in Mechanical Engineering. Mr. Helfer is a Johnson & Johnson certified
Design for Six Sigma Black Belt and a New York State Professional Engineer. Mr.
Helfer was employed by Biophan as Vice-President-Engineering in October 2001. A
portion of Mr. Helfer's time is spent assisting with the research program of
Biomed Solutions, LLC, a related company, for which Biophan is reimbursed.
ROBERT S. BRAMSON is an engineer and patent attorney and since 1996 has
been a partner in Bramson & Pressman, a law firm that focuses on patent and
technology licensing matters. Since 1996 he has also been President of VAI
Management Corp., a consulting firm that specializes in patent and technology
licensing. He is former head of the Computer and Technology law group of
Schnader, Harrison, Segal & Lewis (where he worked from 1968 to 1989); former
Vice President and General Patent and Technology Counsel for Unisys (from 1989
to 1990); founder and former CEO of InterDigital Patents Corporation, a patent
licensing company (from 1992 to 1995); former Licensing Counsel for Abbott
Laboratories (from 1963 to 1966); and has been Adjunct Professor of Patent Law,
Computer Law and (presently) Licensing Law at Temple Law School, Rutgers Law
School and Villanova Law School at different times (from 1980 to date). Mr.
Bramson has been a director of Biophan since July 2001.
STEVEN KATZ is President of Steven Katz & Associates, Inc., a
technology-based management consulting firm specializing in strategic planning,
corporate development, new product planning, technology licensing, and
structuring and securing various forms of financing since 1982. From January
2000 until October 2001, Mr. Katz was President and Chief Operating Officer of
Senesco Technologies, Inc., a public company engaged in the development of
proprietary genes with application to agro-biotechnology. From 1983 to 1984 he
was the co-founder and Executive Vice President of S.K.Y. Polymers, Inc., a
biomaterials company. Prior to S.K.Y. Polymers, Inc., Mr. Katz was Vice
President and General Manager of a non-banking division of Citicorp. From 1976
to 1980 he held various senior management positions at National Patent
Development Corporation, including President of three subsidiaries. Prior
positions were with Revlon, Inc. (1975) and Price Waterhouse & Co. (1969 to
1974). Mr. Katz received a Bachelor of Business Administration degree in
Accounting from the City College of New York in 1969. He is presently a member
of the Board of Directors of USA Technologies, Inc., a publicly held
corporation, and several other private companies. Mr. Katz has been a director
of Biophan since July 2001.
52
ROSS B. KENZIE is a former Chairman and Chief Executive Officer of Goldome
Bank, from which he retired in June 1989. He was previously Executive Vice
President of Merrill Lynch & Co., in the New York worldwide headquarters, and is
a former member of the Merrill Lynch & Co. Board of Directors. He is a former
Director of the Federal Home Loan Bank of New York (from 1984 to 1988) and
served on the boards of the National Council of Savings Institutions (from 1982
to 1986), the Federal Reserve Bank of New York, Buffalo Branch (from 1985 to
1987), and the Savings Banks Association of New York State (from 1984 to 1987).
Mr. Kenzie was a Director of Millard Fillmore Hospitals (from 1982 to 1995)and
is currently Past Chairman Emeritus. He served on the Board of the Kaleida
Health, Education and Research Foundation (from 1998 to 2000) and is currently
on its Investment Committee. He was a Director of the Health Systems Agency of
Western New York (from 1988 to 1991), and was a member of the Western New York
Commission on Health Care Reform (from 1987 to 1990). Mr. Kenzie was a member of
the College Council of the State University College at Buffalo (from 1981 to
1998) and served as Chairman. He was a Director of the College's Foundation and
a member of its Finance Committee (from 1984 to 1998) and is currently on its
Investment Committee. He served on the Council of the Burchfield-Penney Art
Center (from 1990 to 2001) and the Albright Knox Art Gallery (from 1983 to
1985). He is also a member of the Board, and the Chairman of the Investment
Committee of the State University at Buffalo Foundation. Mr. Kenzie currently
serves on the boards of several companies including the publicly held Rand
Capital Corporation and many entrepreneurial ventures that are privately held,
including the Boards of Members of Biomed Solutions LLC and Technology
Innovations, LLC. Mr. Kenzie has been a director of Biophan since December 2000.
COMMITTEES
The Board of Directors has an Audit Committee consisting of Messrs.
Bramson, Katz and Kenzie and a Compensation Committee consisting of Messrs.
Bramson, Katz and Kenzie. The Audit Committee makes recommendations concerning
the engagement of independent public accountants, reviews with the independent
accountants the results of the audit engagement, approves professional services
provided by the accountants including the scope of non-audit services, if any,
and reviews the adequacy of our internal accounting controls. The Compensation
Committee makes recommendations to the Board regarding executive and employee
compensation and benefits.
COMPENSATION OF THE BOARD OF DIRECTORS
Directors who are also our employees do not receive additional
compensation for serving on the Board or its committees. Non-employee directors,
for their services as directors, are paid an annual cash fee of $3,500 and a
per-meeting fee of $1,000. Dr. Jaensch receives an additional $1,000 per month
for serving as Chairman of the Board. In addition, non-employee directors
receive options under our Stock Option Plan. All directors are reimbursed for
their reasonable expenses incurred in attending Board meetings. Steven Katz
receives an additional $3,000 per year for serving as Chairman of the Audit
Committee. Otherwise, no additional compensation is paid to any director for
serving as a member of any committee of the Board. We maintain directors and
officers liability insurance.
53
CONFLICTS OF INTEREST
Messrs. MacDonald, Helfer and Wood each spends a portion of his time on
the business affairs of Biomed, for which Biomed reimburses Biophan a percentage
of their salary and benefits. Our Board of Directors periodically reviews this
arrangement on a regular basis. Currently, Biomed reimburses Biophan for
approximately 20% of the time of Messrs. MacDonald, Helfer and Wood. The Board
of Directors does not believe that any conflicts of interest arise as a result
of this policy, but it monitors the relationship on an ongoing basis.
Michael Weiner devotes essentially his full business time to our company.
His employment agreement with Biophan requires a majority of his time, allowing
him to attend to certain administrative duties of Technology Innovations, its
subsidiary, Biomed, and Speech Compression Technologies, LP, an R&D partnership
holding certain assets. Mr. Weiner is a member and the manager of Biomed and of
Technology Innovations. Ross Kenzie, one of the Biophan directors, is on the
Board of Members of each of Technology Innovations and Biomed. Biomed is in the
business of identifying and acquiring technologies in the biomedical field for
exploitation.
Biomed is an investor in Nanoset, and Mr. Weiner serves on the board of
Nanoset. Subsequent to the formation of Nanoset and Mr. Weiner's joining their
board, Mr. Weiner learned that the nanomagnetic particle technology held by
Nanoset might be applicable to the MRI safety goals of Biophan. Mr. Weiner
brought this technology to the attention of Biophan, which eventually licensed
the technology from Nanoset. Biomed holds a 33% interest in Nanoset. Biophan's
license agreement with Nanoset was negotiated based on arms-length negotiations.
Mr. Weiner and Mr. Kenzie each abstained from voting on whether to approve the
license agreement.
Biomed has agreed that all intellectual property developed by the
employees of Biomed that is in the area of MRI Safe and/or Image Compatible
Technology (MRI Technology) and HIV Antisense shall be assigned to Biophan. Per
this agreement, MRI Technology means the technology necessary to enable medical
devices resistant to radio frequency and static and gradient electromagnetic
fields produced by MRI machines. HIV Antisense is a method of treating HIV.
Our independent directors will make all determinations and decisions
relating to the issue involving Biomed described above, without the vote of
either Mr. Weiner or Mr. Kenzie. In addition, the Board will act to ensure that
Mr. Weiner and Mr. Kenzie discharge their obligations to Biophan in accordance
with their fiduciary duties to Biophan.
LIMITATION ON LIABILITY AND INDEMNIFICATION OF DIRECTORS AND OFFICERS
Under Nevada Revised Statutes Section 78.138, a director or officer is
generally not individually liable to the corporation or its shareholders for any
damages as a result of any act or failure to act in his capacity as a director
or officer, unless it is proven that:
o his act or failure to act constituted a breach of his fiduciary
duties as a director or officer; and
54
o his breach of those duties involved intentional misconduct, fraud or
a knowing violation of law.
This provision is intended to afford directors and officers protection
against and to limit their potential liability for monetary damages resulting
from suits alleging a breach of the duty of care by a director or officer. As a
consequence of this provision, stockholders of Biophan will be unable to recover
monetary damages against directors or officers for action taken by them that may
constitute negligence or gross negligence in performance of their duties unless
such conduct falls within one of the foregoing exceptions. The provision,
however, does not alter the applicable standards governing a director's or
officer's fiduciary duty and does not eliminate or limit the right of Biophan or
any stockholder to obtain an injunction or any other type of non-monetary relief
in the event of a breach of fiduciary duty.
As permitted by Nevada law, Biophan's By-Laws include a provision which
provides for indemnification of a director or officer by us against expenses,
judgments, fines and amounts paid in settlement of claims against the director
or officer arising from the fact that he was an officer or director, provided
that the director or officer acted in good faith and in a manner he or she
believed to be in or not opposed to our best interests. Biophan has purchased
insurance under a policy that insures both Biophan and its officers and
directors against exposure and liability normally insured against under such
policies, including exposure on the indemnities described above. Insofar as
indemnification for liabilities arising under the Securities Act may be
permitted to directors, officers and controlling persons pursuant to the
foregoing provisions, or otherwise, we have been advised that in the opinion of
the Securities and Exchange Commission such indemnification is against public
policy as expressed in the Securities Act and is, therefore, unenforceable.
SCIENTIFIC ADVISORY BOARD
From time to time, we call upon the advice of members of our Scientific
Advisory Board who currently serve without fixed cash compensation but are each
entitled to receive 8,333 options upon completion of each year of membership.
The members of our Board are:
BRADFORD C. BERK, M.D., PH.D. - Since 1998, Dr. Berk has been Director,
Center of Cardiovascular Research; Paul N. Yu Professor and Chief of Cardiology;
Charles A. Dewey Professor and Chairman of Medicine, University of Rochester
Medical Center. Dr. Berk has clinical expertise in adult cardiology and
scientific expertise in cardiovascular medicine, particularly vascular biology.
HERBERT A. HAUPTMAN, PH.D. - In 1970, Dr. Hauptman joined the
crystallographic group of the Hauptman-Woodward Medical Research Institute
(formerly the Medical Foundation of Buffalo) of which he became Research
Director in 1972. He currently serves as President of the Hauptman-Woodward
Medical Research Institute as well as Research Professor in the Department of
Biophysical Sciences and Adjunct Professor in the Department of Computer Science
at the University of Buffalo. He was awarded the 1985 Nobel Prize in Chemistry
and was elected to the National Academy of Sciences in 1988.
55
KEVIN PARKER, M.S., PH.D. - Dean Parker is a Professor of Electrical and
Computer Engineering, Radiology, and Bioengineering at the University of
Rochester. In 1998, Dr. Parker was named Dean of the School of Engineering and
Applied Sciences.
HENRY M. SPOTNITZ, M.D. - Since 1994, Dr. Spotnitz has been Vice-Chairman,
Research and Information Systems Department of Surgery at Columbia Presbyterian
Medical Center.
JIANHUI ZHONG, PH.D. - Professor Zhong joined the University of Rochester
in 1997 and is currently an Associate Professor of Radiology, Physics, and
Biomedical Engineering, and Director of the MRI Research Group at the University
Medical Center.
SPECIAL CONSULTANT TO THE SCIENTIFIC ADVISORY BOARD
RAY KURZWEIL, B.S. - Founder, Chairman, and CEO of Kurzweil Technologies,
Inc., a technology development company, since 1995. President Clinton awarded
Mr. Kurzweil the National Medal of Technology in 1999, for his invention of the
Kurzweil Reading Machine for the Blind. Mr. Kurzweil was inducted into the
National Inventor's Hall of Fame in 2002, and received the Lemelson-MIT Prize in
2001. Mr. Kurzweil also developed Kurzweil Voice Recognition System, and
Kurzweil Music Synthesizer.
EXECUTIVE COMPENSATION
The following table summarizes the annual compensation paid to our named
executive officers during the three years ended February 28, 2003:
Securities
Underlying
Name and Principal Position Year Salary options/SARs
Michael L. Weiner, CEO 2/28/01 $ -- 250,000
Michael L. Weiner, CEO 2/28/02 $150,600 --
Michael L. Weiner, CEO 2/28/03 $175,000 250,000
Robert J. Wood, CFO 2/28/03 $109,461 50,000
Stuart G. MacDonald,
Vice-President-Research 2/28/03 $116,057 100,000
Jeffrey L. Helfer,
Vice-President-Engineering 2/28/03 $113,461 100,000
Columnar information required by Item 402(a)(2) of Regulation SB has been
omitted for categories where there has been no compensation awarded to, earned
by, or paid to, the named executive officers required to be reported in the
table during fiscal years 2001 through 2003.
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STOCK OPTIONS
On June 22, 2001, the Board of Directors adopted the Biophan Technologies,
Inc. 2001 Stock Option Plan. The Option Plan was amended on August 20, 2003. The
Option Plan provides for the grant of incentive and non-qualified stock options
to selected employees, the grant of non-qualified options to selected
consultants and to directors and advisory board members. The Option Plan is
administered by the Compensation Committee of the Board of Directors and
authorizes the grant of options for 7,000,000 shares. The Compensation Committee
determines the individual employees and consultants who participate under the
Plan, the terms and conditions of options, the option price, the vesting
schedule of options and other terms and conditions of the options granted
pursuant thereto. Non-employee directors participate pursuant to the formula set
forth in the Option Plan. Each director receives an initial grant of options to
purchase 20,000 shares, vesting on the first anniversary of the grant, and
additional grants of options to purchase 20,000 shares on each succeeding
anniversary of such director's election. On October 31, 2003, the board of
directors made a special, one-time grant of options to purchase 60,000 shares to
each non-employee director. As of February 28, 2003, we had granted options to
purchase 5,479,995 shares of common stock under the option plan. As of February
10, 2004, options to purchase 3,844,993 shares of common stock were outstanding.
The following table summarizes information concerning stock options
granted to the named executive officers during the last completed fiscal year
ended February 28, 2003:
Number of Percent of total
securities options/SARs
underlying granted to Exercise or
options/SARs employees in base price
Name granted (#) fiscal year ($/Sh) Expiration date
Michael L. Weiner 250,000 25.25% $.43 7/16/12
Robert J. Wood 50,000 5.05% $.43 7/16/12
Stuart G. MacDonald 100,000 10.10% $.43 7/16/12
Jeffrey L. Helfer 100,000 10.10% $.43 7/16/12
No named executive officer exercised options in the fiscal year ended
February 28, 2003. The following table presents the number and values of
exercisable and unexercisable options as of February 28, 2003:
Number of securities Value of unexercised
Shares underlying unexercised in-the-money options/SARs
acquired on Value options/ SARs at FY-end (#) at FY-end ($)
Name exercise realized Exercisable/ Unexercisable Exercisable/ Unexercisable
Michael L. Weiner None -- 266,668/233,332 $4,167/$8,333
Robert J. Wood None -- 56,667/93,333 $833 /$1,667
Stuart G. MacDonald None -- 73,334/126,666 $1,667/$3,333
Jeffrey L. Helfer None -- 73,334/126,666 $1,667/$3,333
EMPLOYMENT AGREEMENTS
Each of Michael L. Weiner, President and Chief Executive Officer; Stuart
G. MacDonald, Vice President of Research and Development; Robert J. Wood,
Treasurer and Chief Financial Officer; and Jeffrey L. Helfer, Vice President of
Engineering has entered into employment agreements with Biophan.
57
Mr. Weiner's employment agreement has an initial term of three years with
subsequent one-year renewal periods. His employment agreement may be terminated
by us for cause or upon his death or disability. In the event of the disability
of Mr. Weiner, termination of his employment agreement by us following a change
in control or termination of his employment agreement by him for good reason,
Mr. Weiner is entitled to receive (i) the unpaid amount of his base salary
earned through the date of termination; (ii) any bonus compensation earned but
not yet paid; and (iii) a severance payment equal to one (1) year of his then
current salary. In addition, Mr. Weiner will be immediately vested in any
options, warrants, retirement plan or agreements then in effect. Good Reason
means (i) a material change of Mr. Weiner's duties, (ii) a material breach by us
under the employment agreement, or (iii) a termination of Mr. Weiner's
employment in connection with a change in control.
As used in Mr. Weiner's employment agreement, "change in control" means
(1) our merger or consolidation with another entity where the members of our
Board do not, immediately after the merger or consolidation, constitute a
majority of the Board of Directors of the entity issuing cash or securities in
the merger or consolidation immediately prior to the merger or consolidation, or
(2) the sale or other disposition of all or substantially all of our assets.
In the event of termination for cause, all of Mr. Weiner's unexercised
warrants and options, whether or not vested, will be canceled, and Mr. Weiner
will not be eligible for severance payments. In the event of voluntary
termination, all of Mr. Weiner's unvested warrants and options will be canceled
and he will have three (3) months from the date of termination to exercise his
rights with respect to the unexercised but vested options. He will not be
eligible for severance payments.
The employment agreements for each of Messrs. MacDonald, Wood and Helfer
are terminable by either us or the employee upon 30 days' notice or by us for
cause (as defined in their employment agreements) or upon the death or
disability of the employee. However, each of them is entitled to receive
severance equal to six months' base salary, payable in six equal consecutive
monthly installments in the event that the employee is terminated by us within
ninety (90) days following a change in control. In addition, under such
circumstances each of them will be immediately vested in any options, warrants,
retirement plan or agreements then in effect.
For purposes of the employment agreements for Messrs. MacDonald, Wood and
Helfer, "change in control" means (1) on the date of the merger or consolidation
of Biophan with another entity where the members of the Board of Directors,
immediately prior to the merger or consolidation, would not, immediately after
the merger or consolidation, constitute a majority of the Board of Directors of
the entity issuing cash or securities in the merger or consolidation; (2) on the
date Michael L. Weiner is terminated as CEO of the Company; or (3) on the date
of the sale or other disposition of all or substantially all of the assets of
Biophan.
58
In the event of termination for cause, all unexercised warrants and
options held by the applicable employee, whether or not vested, will be canceled
and the employee will not be eligible for severance payments. In the event of
voluntary termination, all unvested warrants and options will be canceled and
the employee will have three (3) months from the date of termination to exercise
his rights with respect to the unexercised but vested options.
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS
AND MANAGEMENT
The table below lists the beneficial ownership of our common stock, as of
February 10, 2004, by each person known by us to be the beneficial owner of more
than 5% of our common stock, by each of our directors and officers and by all of
our directors and officers as a group.
Name and Address of Number of Shares
Beneficial Owner Beneficially Owned (1)(2) Percent of Class(2)
(degree)Guenter H. Jaensch (3) 733,334 1.11%
964 Allamanda Drive
Delray Beach, FL 33483
(degree)Michael L. Weiner (4) 7,148,029 10.64%
693 Summit Drive
Webster, NY 14580
Wilson Greatbatch (5) 5,404,502 8.21%
5935 Davison Road
Akron, NY 14001
(degree)Robert S. Bramson (6) 65,000 *
1100 East Hector Street
Suite 410
Consohocken, PA 19428
(degree)Ross B. Kenzie (7) 65,000 *
Cyclorama Bldg. Suite 100
369 Franklin Street
Buffalo, NY 14202
(degree)Steven Katz (8) 110,000 *
20 Rebel Run Drive
East Brunswick, NJ 08816
Robert J. Wood (9) 214,583 *
12 Peachtree Lane
Pittsford, NY 14534
59
Stuart G. MacDonald (10) 266,667 *
4663 East Lake Road
Pultneyville, NY 14538
Jeffrey H. Helfer (11) 306,667 *
1153 Hidden Valley Trail
Webster, NY 14580
David A. Miller 100,500 *
4004 Sunnyside Road
Sandpoint, ID 83864
Technology Innovations, LLC(12) 5,656,501 8.5%
150 Lucius Gordon Drive
Suite 215
West Henrietta, NY 14586
Biomed Solutions, LLC(13) 5,355,857 8.0%
150 Lucius Gordon Drive
Suite 215
West Henrietta, NY 14586
All Officers and Directors as a 9,009,780 13.17%
group (9 persons)
-------------
* Denotes less than one percent.
(degree)Denotes Member of the Board of Directors.
(1) Except as may be set forth below, the persons named in the table have sole
voting and investment power with respect to all shares shown as
beneficially owned by them.
(2) Applicable percentage of ownership is based on 65,489,496 shares
outstanding as of February 10, 2004, together with applicable options for
such shareholder. Beneficial ownership is determined in accordance with
the rules of the SEC and includes voting and investment power with respect
to shares. Shares subject to options or warrants currently exercisable or
exercisable within 60 days after February 10, 2004 are included in the
number of shares beneficially owned and are deemed outstanding for
purposes of computing the percentage ownership of the person holding such
options or warrants, but are not deemed outstanding for computing the
percentage of any other stockholder.
(3) Includes 433,334 shares issuable upon exercise of options and warrants
granted to Dr. Jaensch.
(4) Michael L. Weiner is a member and the manager of Technology Innovations,
LLC, which is the majority owner of Biomed Solutions, LLC. Mr. Weiner is
also the Manager of Biomed. Mr. Weiner's calculation includes 4,175,857
shares owned beneficially and of record by Biomed and 300,644 shares owned
beneficially and of record by Technology Innovations. Includes 1,180,000
shares issuable upon exercise of warrants held by Biomed and 491,667
shares issuable upon exercise of options held by Mr. Weiner.
60
(5) Includes 4,919,509 shares owned of record and beneficially by Greatbatch
Gen-Aid, Ltd., an entity owned by Wilson Greatbatch, and 109,993 shares
owned by E. & W.G. Foundation, a private foundation of which Mr.
Greatbatch is co-trustee. Also includes 225,000 shares issuable upon
exercise of options held by Mr. Greatbatch and 150,000 shares issuable
upon exercise of warrants held by Mr. Greatbatch.
(6) Includes 65,000 shares issuable upon exercise of options held by Mr.
Bramson.
(7) Includes 65,000 shares issuable upon exercise of options held by Mr.
Kenzie. Does not include shares owned beneficially or of record by Biomed
or by Technology Innovations. Mr. Kenzie is the Manager and an equity
member of Biophan Ventures, LLC, which is the 43% equity member in Biomed;
he is also the Manager of Patent Ventures LLC, which is the Class A Member
of Technology Innovations. Mr. Kenzie and Mr. Weiner comprise the Board of
Members of Biomed; Mr. Kenzie serves on the Board of Members of Technology
Innovations.
(8) Includes 110,000 shares issuable upon exercise of options held by Mr.
Katz.
(9) Includes 124,583 shares issuable upon exercise of options and warrants
held by Mr. Wood.
(10) Includes 176,667 shares issuable upon exercise of options and warrants
held by Mr. MacDonald.
(11) Includes 156,667 shares issuable upon exercise of options and warrants
held by Mr. Helfer.
(12) Includes 4,175,857 shares owned beneficially and of record by Biomed and
1,180,000 shares issuable upon exercise of warrants held by Biomed.
Technology Innovations, LLC is the majority owner of Biomed Solutions,
LLC.
(13) Includes 1,180,000 shares issuable upon exercise of warrants held by
Biomed.
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS
(1) Michael L. Weiner, President and Chief Executive Officer of Biophan,
is the Manager and a 42.7% equity member of Technology Innovations,
LLC., a 57% equity member of Biomed Solutions, LLC (formerly
Biophan, LLC). Mr. Weiner is also the Manager of Biomed. He and Ross
Kenzie make up the Board of Members of Biomed. Biomed is the record
owner of 662,857 shares of common stock of Biophan; Technology
Innovations is the record owner of 300,644 shares of common stock of
Biophan. As Manager of Technology Innovations and Biomed, Mr. Weiner
has control over these entities. Mr. Weiner is also on the board of
Nanoset, LLC, an entity owned in part by Biomed Solutions, and with
which we have entered into a technology license agreement.
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(2) On December 1, 2000, Biomed received 10,759,101 shares of Biophan's
common stock in exchange for its shares of LTR Antisense Technology,
Inc. Most of those shares have been distributed to the members of
Biomed and their members.
(3) On December 1, 2000, Biomed transferred its MRI-compatible pacemaker
patent pending and related technology to Biophan for a future
payment of $500,000. This obligation bears interest at 8% per annum
from February 28, 2002, and has been extended several times, to June
1, 2004. After June 1, 2004, principal and interest are payable in
12 equal monthly installments. Since November 30, 2002, this entire
obligation has been convertible into common shares of Biophan at a
conversion price equal to the lowest of (i) the closing bid price on
June 4, 2002; (ii) the closing bid price on the date of exercise; or
(iii) the lowest per share purchase price paid by any third party
between June 4, 2002 and the exercise date. On February 10, 2004,
Biomed transferred $300,000 of this obligation to SBI Brightline
Consulting, LLC and converted the remaining balance of $200,000 into
shares of our common stock common. On the same date, SBI converted
the $300,000 obligation transferred to it into shares of our common
stock.
(4) On June 4, 2002, we executed a line of credit agreement with Biomed
providing for borrowings up to $250,000. On August 19, 2002, the
line was increased by $100,000 and the expiration date thereof for
that portion of the line was set at August 19, 2003. The payment
date of amounts borrowed under the original line was extended to
December 1, 2002. On November 7, 2002, the maturity date of the line
was extended until such time as the financing contemplated by the
Spectrum stock purchase agreement commenced. It was later extended
to June 1, 2004. On February 10, 2004, all outstanding balances
under the line of credit were converted to common stock in
accordance with the terms of the credit agreement.
(5) Biomed holds warrants to purchase a total of 1,180,000 shares of our
common stock. On March 1, 2001, it received warrants to purchase
200,000 shares at an exercise price of $1.00 in consideration of
management effort and expense incurred on our behalf. On June 4,
2002, it received warrants to purchase 100,000 shares at an exercise
price of $1.00 in consideration of the extension of the due date for
the Transfer Agreement payment, and warrants to purchase 75,000
shares at an exercise price of $1.00 in consideration of the grant
of the line of credit. (Wilson Greatbatch also received 150,000
warrants in consideration of the extension of the due date of the
Transfer Agreement payment). On August 19, 2002, Biomed received
warrants to purchase 30,000 shares in consideration of the increase
in the line of credit commitment, and warrants to purchase 275,000
shares for additional extensions of the payment terms of the
Transfer Agreement payment. On that date, the exercise price for all
680,000 warrants then held by Biomed was set at the lowest of (i)
the closing bid price on June 4, 2002; (ii) the closing bid price on
the date of exercise; or (iii) the lowest per share purchase price
paid by any third party between June 4, 2002 and the exercise date.
On November 7, 2002, Biomed was granted warrants to purchase an
additional 500,000 shares at an exercise price of $.50 per share in
consideration of another extension of the Transfer Agreement
payment. Each extension of the Transfer Agreement payment enabled us
to retain the MRI-compatible technology that we acquired under the
Transfer Agreement. In connection with each issuance of warrants to
Biomed, our board of directors determined, without the vote of Mr.
Weiner or Mr. Kenzie, that the consideration received by us was fair
and adequate consideration for the warrants issued.
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(6) During the years ended February 28, 2003 and 2002, Biomed and
Technology Innovations paid expenses on our behalf aggregating
$128,411 and $253,014, respectively. These advances did not bear
interest and were subsequently repaid.
(7) On January 1, 2001, Wilson Greatbatch was granted 250,000 options at
an exercise price of $.50 for his consulting services to us and
8,333 options at an exercise price of $.50 as former Chairman of the
Scientific Advisory Board. As a consultant Mr. Greatbatch assisted
us in the development of our photonic pacemaker by providing design
and engineering services. The board of directors determined that the
value of the consulting services was fair and adequate consideration
for the options issued. We recorded compensation expense of $9,200
with respect to those options. Through his ownership of Greatbatch
Gen-Aid, Ltd. and his co-trusteeship of a private foundation, E.&
W.G. Foundation, he is the beneficial owner of 4,919,509 common
shares of our common stock. He also received consideration from
Biomed in connection with transfer of the MRI-compatible pacemaker
technology to Biophan. On June 4, 2002, he received warrants to
purchase 150,000 shares of our common stock with an exercise price
of $1.00 in consideration of the extension of the payment due under
the Transfer Agreement. Greatbatch Gen-Aid holds a 3.5% membership
interest (11 Units) in Technology Innovations.
On February 28, 2001, we entered into a research and development
agreement with Greatbatch Enterprises Corporation. Mr. Greatbatch is
the CEO and majority stockholder of Greatbatch Enterprises. Under
the agreement, Greatbatch Enterprises undertook certain technology
development and testing, for which we paid Greatbatch Enterprises an
aggregate of $297,000. The agreement terminated in December 2002
with the completion of animal testing by Greatbatch Enterprises.
(8) On March 1, 2002, Dr. Guenter H. Jaensch was granted options to
purchase 250,000 shares at an exercise price of $.10 per share and
on July 16, 2002 was granted additional options to purchase 100,000
shares at an exercise price of $.43 per share, in each case for
consulting services he provided to us. As a consultant, Dr. Jaensch
assisted us in developing our strategic plan, attended trade shows,
and arranged and met with potential customers and strategic
partners. The Board of Directors determined that the value of the
consulting services was fair and adequate consideration for the
options issued. We valued the options at $36,900 and $592,500,
respectively.
63
DESCRIPTION OF SECURITIES
The following summary is a description of our common stock and certain
provisions of our Articles of Incorporation, Bylaws and Nevada law.
GENERAL
Our authorized capital consists of 80,000,000 shares of common stock, par
value $.005 per share.
COMMON STOCK
As of February 10, 2004, we had 65,489,496 shares of common stock
outstanding. Each share of our common stock is entitled to one vote at all
meetings of our stockholders. Our stockholders are not permitted to cumulate
votes in the election of directors. All shares of our common stock are equal to
each other with respect to liquidation rights and dividend rights. There are no
preemptive rights to purchase any additional shares of our common stock. In the
event of our liquidation, dissolution or winding up, holders of our common stock
will be entitled to receive, on a pro rata basis, all of our assets remaining
after satisfaction of all liabilities and preferences of outstanding preferred
stock, if any. Neither our Articles of Incorporation nor our Bylaws contain any
provisions which limit or restrict the ability of another person to take over
our company; however, our Bylaws do permit our Board of Directors to be
classified.
OPTIONS AND WARRANTS
As of February 10, 2004, we had outstanding options to purchase an
aggregate of 3,844,993 shares of our common stock pursuant to our 2001 Stock
Option Plan at a weighted-average exercise price of $.28 per share. These
options are held by directors, officers, key employees and consultants, and as
of February 10, 2004, options to purchase 2,479,161 shares were exercisable.
We also have outstanding warrants to purchase an additional 4,395,569
shares of our common stock having a weighted-average exercise price of $.44 per
share.
CERTAIN STATUTORY PROVISIONS OF THE NEVADA REVISED STATUTES
Sections 78.411 through 78.444 of the Nevada Revised Statutes provide, in
general, that a stockholder acquiring more than 10% of the outstanding voting
shares of a publicly-held Nevada corporation subject to the statutes (Interested
Stockholder) may not engage in certain "Combinations" with the corporation for a
period of three years subsequent to the date on which the stockholder became an
Interested Stockholder.
Section 78.416 defines the term "Combination" to encompass a wide variety
of transactions with or caused by an Interested Stockholder in which the
Interested Stockholder receives or could receive a benefit on other than a pro
rata basis with other stockholders, including mergers, certain asset sales,
certain issuances of additional shares to the Interested Stockholder or
transactions in which the Interested Stockholder receives certain other
benefits.
64
These provisions could have the effect of delaying, deferring or
preventing a change of control of our company. Our stockholders, by adopting an
amendment to our Articles of Incorporation or Bylaws, may elect not to be
governed by these provisions. Neither our Articles of Incorporation nor Bylaws
currently excludes us from these restrictions.
The Nevada Revised Statutes permit a corporation to indemnify its
directors and officers against expenses, judgments, fines and amounts paid in
settlement in cases brought against the director or officer in his capacity as
such, provided the director or officer acted in good faith and in a manner he
reasonably believed to be in or not opposed to the best interests of the
corporation. The exceptions include a breach of the director's duty of loyalty,
acts or omissions not in good faith or which involve intentional misconduct or
knowing a violation of law, and improper personal benefit. Our Bylaws contain a
provision implementing this statute.
TRANSFER AGENT
The transfer agent for our common stock is Continental Stock Transfer &
Trust Company, 17 Battery Place, New York, NY 10004-1123.
SHARES ELIGIBLE FOR FUTURE SALE
Future sales of a substantial number of shares of our common stock in the
public market could adversely affect market prices prevailing from time to time.
Under the terms of this offering, the shares of common stock offered may be
resold without restriction or further registration under the Securities Act of
1933, except that any shares purchased by our "affiliates," as that term is
defined under the Securities Act, may generally only be sold in compliance with
Rule 144 under the Securities Act.
CONCURRENT REGISTRATION
We have filed a registration statement under the Securities Act with
respect to the resale by the holders thereof of up to 12,513,000 shares of our
common stock. Of these shares, up to 6,000,000 shares may be shares that are
purchased by SBI Brightline Consulting, LLC under a stock purchase agreement
described elsewhere in this prospectus. The remaining shares covered by such
registration statement are shares held by SBI and Biomed Solutions, LLC that
were issued in connection with the conversion of our outstanding indebtedness as
described elsewhere in this prospectus. Such registration statement has not
become effective as of the date of this prospectus. Such registration is
separate from the registration of the 12,975,267 shares of our common stock
covered by this prospectus.
SALE OF RESTRICTED SHARES
Certain shares of our outstanding common stock were issued and sold by us
in private transactions in reliance upon exemptions from registration under the
Securities Act and have not been registered for resale. Additional shares may be
issued pursuant to outstanding warrants and options. Such shares may be sold
only pursuant to an effective registration statement filed by us or an
applicable exemption, including the exemption contained in Rule 144 promulgated
under the Securities Act.
65
In general, under Rule 144 as currently in effect, a shareholder,
including one of our affiliates, may sell shares of common stock after at least
one year has elapsed since such shares were acquired from us or our affiliate.
The number of shares of common stock which may be sold within any three-month
period is limited to the greater of: (i) one percent of our then outstanding
common stock, or (ii) the average weekly trading volume in our common stock
during the four calendar weeks preceding the date on which notice of such sale
was filed under Rule 144. Certain other requirements of Rule 144 concerning
availability of public information, manner of sale and notice of sale must also
be satisfied. In addition, a shareholder who is not our affiliate, who has not
been our affiliate for 90 days prior to the sale, and who has beneficially owned
shares acquired from us or our affiliate for over two years may resell the
shares of common stock without compliance with many of the foregoing
requirements under Rule 144.
SELLING STOCKHOLDERS
All of the securities being offered hereunder are being offered by the selling
stockholders. These holders fall into three categories:
o those who have obtained or will obtain their shares in connection
with the terminated Spectrum stock purchase agreement;
o those who obtained their shares (or warrants with underlying common
shares) in a private placement of securities conducted by us; and
o Biomed Solutions, LLC, which can obtain its shares upon exercise of
warrants granted in consideration of loans to, or forbearance upon
amounts due from, us.
SPECTRUM
Spectrum is engaged in the business of investing in publicly traded equity
securities for its own account. Spectrum's principal offices are located at 38
Hertford Street, London, England. We understand that Spectrum's beneficial owner
is Pierce Loughran of London, England. Investment decisions for Spectrum are
made by its board of directors. We have been advised by Spectrum that it does
not currently own any of our securities as of the date of this prospectus.
Following the termination of the common stock purchase agreement, Spectrum has
no commitments or arrangements to purchase or sell any of our securities. There
are no business relationships between Spectrum and us other than those under the
common stock purchase agreement which has been terminated.
CAROLINA FINANCIAL
Carolina has acted as placement agent in connection with the common stock
purchase agreement. Carolina introduced us to Spectrum and assisted us with
structuring the equity line of credit with Spectrum. Carolina's duties as
placement agent were undertaken on a reasonable best efforts basis only.
Carolina will receive warrants for 5% of the shares purchase by Spectrum, at an
exercise price of 110% of the selling price to Spectrum. It made no commitment
to purchase shares from us and did not ensure us of the successful placement of
any securities. Other than the shares underlying its warrants which are
registered for resale hereunder, Carolina does not own any of our shares.
66
The four principals and beneficial owners of Carolina are William Prather,
Robert Cascella, Michael Niedswiecki, and Michael Mascia; they have also been
issued warrants to purchase a total of 121,572 warrants, consisting of 50,000
warrants at an exercise price of $.39 per share, 17,520 shares at an exercise
price of $.41 per share, and 54,052 shares at an exercise price of $.16 per
share. These warrants were granted for their efforts as placement agent in other
private placements undertaken by us and for financial advisory services, and the
underlying common shares have also been registered for resale hereunder. None of
these individuals held any position or office or had any other material
relationship with us or any of our affiliates within the past three years. To
our knowledge, after this offering, none of them will own shares of our common
stock.
None of Spectrum, Carolina or any of their affiliates have held any
positions or offices or had material relationships with us or any of our
affiliates within the past three years other than as a result of the ownership
of our common stock. If, in the future, Spectrum's or Carolina's relationship
with us changes, we will amend or supplement this prospectus to update this
disclosure.
BIOMED
Biomed Solutions, LLC is the New York limited liability company which
transferred the MRI technology and the shares of LTR Anti-sense Technology, Inc.
to us on December 1, 2000. The beneficial owners of Biomed included Michael
Weiner, Ross Kenzie and 50 investors. It is one of our stockholders and its
Manager is Michael L. Weiner, who is our President and Chief Executive Officer
and a Director. Biomed has received warrants to purchase a total of 1,180,000
common shares, partially as consideration for making available a line of credit
to us and for forbearance of payments relating to the MRI technology transfer.
This prospectus covers the shares underlying those warrants, for resale by
Biomed. Following this offering, Biomed will own 4,175,857 shares of our common
stock.
THE PRIVATE PLACEMENT
From September 2002 through January 6, 2003, we raised gross proceeds of
$1,385,275 by selling 5,541,100 shares at a per share price of $.25 to 117
investors. Those investors also received warrants to purchase an additional
2,770,550 shares, half at an exercise price of $.25 per share and half at $.50
per share. These shareholders, except for Westbay Consulting, Inc., were granted
registration rights, and their shares (including the shares underlying the
warrants)are covered by this prospectus. The names of these selling
stockholders, and the number of shares offered hereunder are set forth below.
None of these stockholders held an office or directorship or had any other
material relationship with us during the past 3 years, except that Guenter
Jaensch, Jeffrey L. Helfer, Stuart McDonald and Robert J. Wood are our officers
and/or directors and own the number of shares set forth in Security Ownership of
Certain Beneficial Owners and Management. Except as to these named stockholders,
to the best of our knowledge, each of these stockholders will own less than 1%
of our outstanding shares following completion of this offering and the sale of
the shares registered hereunder.
67
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Securities Held Before
Offering Amount Offered
Position, Office or Amount / %
Name of Shareholder Material Relationship Common Warrant Common Warrant after
Shares Shares Shares Shares Offering
Complete
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Spectrum None 0 0 3,325,757 0 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Carolina Financial None 0 0 0 166,288 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
William Prather Financial
Advisor 0 12,500 0 12,500 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Robert Cascella Financial
Advisor 0 36,358 0 36,358 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Michael Niedswiecki Financial
Advisor 0 36,357 0 36,357 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Michael Mascia Financial
Advisor 0 36,357 0 36,357 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Biomed Solutions, LLC Greater than 10%
Shareholder 662,857(1) 1,180,000 0 1,180,000 4,175,857/
6.3%
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Private Placement
Shareholders
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Bryan, Jennifer
None 25,000 12,500 25,000 12,500 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Buchholz, Rick
None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Erhart, Joseph
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Ronald, Jr.
None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Terry
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Knueve, Michael
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Knueve, Ronald
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Nienberg, Stephen 40,000 20,000 0/0
None 40,000 20,000
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Recker, Greg None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Unverferth, Brad
None 285,000 142,000 285,000 142,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Askins, Randall
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Averesch, Michael
None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Erhart, Brian None 30,000 15,000 30,000 15,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Gerding, William and
Debra None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Hortstman, Dennis
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Unverferth, Jason
None 60,000 30,000 60,000 30,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Unverferth, Mel and
Beverly None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Bilski, Dianna None 35,800 17,900 35,800 17,900 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
68
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Cleary, Brian None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Fortman, Gary J. and
Deters, Jeffrey R. None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Fortman, Gary J.
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Hoellrich, Anthony J.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Hoellrich, Daniel L.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Hoellrich, Douglas D.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Terry L.
None 18,000 9,000 18,000 9,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Scott L.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Klass, Terry
None 32,000 16,000 32,000 16,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Krontz, Gerald E. and
Cherylanne None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Maag, Phillip D.
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Sarka, Robert J.
None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Asad, Susan Sutherland
None 14,000 7,000 14,000 7,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Berger, Charles W., Jr.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Brown, Meagan
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Brown, Grayling
None 16,000 8,000 16,000 8,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Bruskotter, Dennis
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Deters, Jeffrey
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Donnelly, Michael
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Fortman, Christopher &
Fortman, Craig None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Fortman, Karl & Judy
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Gabor, Constance
None 80,000 40,000 80,000 40,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Gudewicz, Patrice
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Gudewicz, Richard
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Hohlbein, Michael
None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Knueve, Ronald & Bonnie
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kreinbrink, John
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Otto, Jon & Karen
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
69
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Rosengarten, Kurt
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Schimmoeller, Craig &
Brenda None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Schroeder, Randal &
Pamela None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Scodellaro, James
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Siefker, Greg
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Steffey, Billie & Rita
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Strauer, Robert
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Utrup, Kurt
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Vorst, Steven
None 150,000 75,000 150,000 75,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Warnecke, Rick
None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Winkle, Roger
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wittlinger, Mona
None 6,000 3,000 6,000 3,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Anstadt, George & Nancy
None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Averesch, Michael
None 120,000 60,000 120,000 60,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Bachmann, Roberta
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Barnes, Alvin None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Brashear, Robert
None 17,000 8,500 17,000 8,500 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Bowman, Donald None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Glendale Investments,
Ltd. None 120,000 60,000 120,000 60,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Butler, Daniel & Sue 0/0
None 20,000 10,000 20,000 10,000
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Cleary, Michael
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Conditioning Concepts
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
DeKalb, Daryl None 118,500 59,250 118,500 59,250 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Dirty Dozen Investing
None 45,000 22,500 45,000 22,500 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Eisler, Craig
None 16,000 8,000 16,000 8,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Ellerbrock, Daniel &
Carol None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Estlack, Fred
None 16,000 8,000 16,000 8,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Fortman, Douglas
None 30,000 15,000 30,000 15,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Garman, Richard
None 80,000 40,000 80,000 40,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
70
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
General Medina
Development None 11,400 5,700 11,400 5,700 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Grenot, Michael
None 50,400 25,200 50,400 25,200 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Helfer, Jeffrey L.
Vice President 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Jaensch, Guenter & Terri Chairman of the Board
300,000 150,000 300,000 150,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Jeary, Richard None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Carl None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Gary None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Ronald None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Timothy M.
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kahle, Timothy R.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Kenzie, Allan & Bette
None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Knueve, Dan None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Knueve, Ed None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Knueve, Ronald & Bonnie
None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Lippco Capital LLC
None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
MacDonald, Stuart
Vice President 60,000 30,000 60,000 30,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Mahley, Mary None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Mahley, Stephen
None 100,000 50,000 100,000 50,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Masters, Vernon
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Moore, Dennis None 12,000 6,000 12,000 6,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Nelson, Laura M.
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Neu, Julie None 10,000 5,000 10,000 5,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Newman, Reginald
None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Nowak, Ronald None 16,000 8,000 16,000 8,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Pierce, Frederick
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Sarka, Robert None 32,000 16,000 32,000 16,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Sarka, Robert & Karen
None 50,000 25,000 50,000 25,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Schimmoeller Family Rev.
Living Trust None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Siefker, Joseph & Doris
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Siefker, Thomas
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Slawson, Kenneth
None 51,000 25,500 51,000 25,500 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Smith, Steven & Mary
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Terens, Frederick
None 16,000 8,000 16,000 8,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
71
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Unverferth, Jeffrey
None 46,000 23,000 46,000 23,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
von der Embse, Barry
None 60,000 30,000 60,000 30,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Warnecke, Kevin & Michele
None 20,000 10,000 20,000 10,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Western Harbor Associates
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wittlinger, David None
664,000 332,000 664,000 332,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wittlinger, Donna
None 12,000 6,000 12,000 6,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wittlinger, Mona
None 26,000 13,000 26,000 13,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wittlinger, Viola
None 80,000 40,000 80,000 40,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wittlinger, Walter
None 40,000 20,000 40,000 20,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
Wood, Robert J. Vice President/
CFO 60,000 30,000 60,000 30,000 0/0
-------------------------- ----------------------- ------------------------------ ----------------------------- ---------------
-----------------
(1) Does not include 3,513,000 shares issued to Biomed on February 10, 2004.
72
PLAN OF DISTRIBUTION
GENERAL
Shares of common stock offered through this prospectus may be sold from
time to time by the selling shareholders; or by pledgees, donees, transferees or
other successors in interest to such other selling shareholders. We will
supplement this prospectus to disclose the names of any pledgees, donees,
transferees, or other successors in interest to such shareholders that intend to
offer common stock through this prospectus.
Sales may be made on the OTC.BB or otherwise at prices and at terms then
prevailing or at prices related to the then current market price, or in
negotiated private transactions, or in a combination of these methods. Each
selling shareholder will act independently of us in making decisions with
respect to the form, timing, manner and size of each sale. We have been informed
by Carolina that there are no existing arrangements between it and any other
stockholder, broker, dealer, underwriter or agent relating to the distribution
of this prospectus.
The common shares may be sold in one or more of the following manners:
o a block trade in which the broker or dealer so engaged will attempt
to sell the shares as agent, but may position and resell a portion
of the block as principal to facilitate the transaction;
o ordinary brokerage transactions and transactions in which the broker
solicits purchases; or
o privately negotiated transactions as permitted by Rule 15a-6 under
the Exchange Act of 1934.
In effecting sales hereunder, selling shareholders may arrange for other
brokers or dealers to participate. Except as disclosed in a supplement to this
prospectus, no broker-dealer will be paid more than a customary brokerage
commission in connection with any sale of the common shares by Spectrum. Brokers
or dealers may receive commissions, discounts or other concessions from the
selling stockholders in amounts to be negotiated immediately prior to the sale.
The compensation to a particular broker-dealer may be in excess of customary
commissions. Profits on any resale of the common shares as a principal by such
broker-dealers and any commissions received by such broker-dealers may be deemed
to be underwriting discounts and commissions under the Securities Act. Any
broker-dealer participating in such transactions as agent may receive
commissions from the selling shareholder, and, if they act as agent for the
purchaser of such common shares, from such purchaser.
In addition, any common shares covered by this prospectus which qualify
for sale pursuant to Rule 144 may be sold under Rule 144 rather than pursuant to
this prospectus.
We will not receive any of the proceeds from the sale of these common
shares, although we have paid the expenses of preparing this prospectus and the
related registration statement of which it is a part.
73
Spectrum is subject to the applicable provisions of the Exchange Act of
1934, including without limitation, Rule 10b-5 and Regulation M thereunder.
Under applicable rules and regulations under the Exchange Act of 1934, any
person engaged in a distribution of the common shares may not simultaneously
purchase such securities for a period beginning when such person becomes a
distribution participant and ending upon such person's completion of
participation in a distribution. In addition, in connection with the
transactions in the common shares, Spectrum will be subject to applicable
provisions of the Exchange Act of 1934 and the rules and regulations under that
Act, including, without limitation, the rules set forth above. These
restrictions may affect the marketability of the common shares.
Each selling stockholder will pay all commissions and their own expenses,
if any, associated with the sale of the common shares, other than the expenses
associated with preparing this prospectus and the registration statement of
which it is a part.
74
LEGAL MATTERS
The validity of the common stock offered hereby has been passed upon by
Boylan, Brown, Code, Vigdor & Wilson, LLP, Rochester, New York. The firm has
been granted options to purchase 40,000 shares of our common stock at $.50 per
share in connection with services rendered prior to the commencement of the
offering contemplated by this prospectus, and warrants to purchase an additional
161,290 shares at $.31 per share as partial consideration for its work in
connection with the offering contemplated by this prospectus.
EXPERTS
The financial statements of Biophan as of February 28, 2003 and for each
of the two years in the period then ended, appearing in this prospectus have
been audited by Goldstein Golub Kessler LLP, Certified Public Accountants, as
set forth in their report thereon appearing elsewhere herein, and are included
in reliance upon such reports given upon the authority of such firm as experts
in accounting and auditing.
WHERE YOU CAN FIND ADDITIONAL INFORMATION
Biophan files current, quarterly and annual reports with the SEC on forms
8-K, 10-QSB and 10-KSB. Biophan has filed with the SEC under the Securities Act
of 1933 a registration statement on Form SB-2 with respect to the shares being
offered in this offering. This prospectus does not contain all of the
information set forth in the registration statement, certain items of which are
omitted in accordance with the rules and regulations of the SEC. The omitted
information may be inspected and copied at the Public Reference Room maintained
by the SEC at Judiciary Plaza, 450 Fifth Street, N.W., Washington, D.C. 20549.
You can obtain information about operation of the Public Reference Room by
calling the SEC at 1-800-SEC-0330. The SEC also maintains an Internet site that
contains reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC at http://www.sec.gov.
Copies of such material can be obtained from the public reference section of the
SEC at prescribed rates. Statements contained in this prospectus as to the
contents of any contract or other document filed as an exhibit to the
registration statement are not necessarily complete and in each instance
reference is made to the copy of the document filed as an exhibit to the
registration statement, each statement made in this prospectus relating to such
documents being qualified in all respect by such reference.
For further information with respect to Biophan and the securities being
offered hereby, reference is hereby made to the registration statement,
including the exhibits thereto and the financial statements, notes, and
schedules filed as a part thereof.
75
FINANCIAL STATEMENTS
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
INDEX TO CONSOLIDATED FINANCIAL STATEMENTS
AUDITED CONSOLIDATED FINANCIAL STATEMENTS:
Independent Auditor's Report F-2
Consolidated Balance Sheet, February 28, 2003 F-3
Consolidated Statements of Operations, Years Ended F-4
February 28, 2003 and 2002, and from August 1, 1968 (Date of Inception)
through February 28, 2003
Consolidated Statement of Stockholders' Deficiency F-5
From August 1, 1968 (Date of Inception) through
February 28, 2003
Consolidated Statements of Cash Flows, Years Ended F-8 February 28, 2003 and
2002 and from August 1, 1968 (Date of Inception) through February 28, 2003
Notes to Consolidated Financial Statements F-10
UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS:
Independent Accountant's Report F-17
Condensed Consolidated Balance Sheets, November 30, 2003 F-18
and February 28, 2003
Condensed Consolidated Statements of Operations, Three Months and Nine F-19
Months Ended November 30, 2003 and 2002, and from August 1,
1968 (Date of Inception) through November 30, 2003
Condensed Consolidated Statements of Cash Flows, Nine Months Ended F-20
November 30, 2003 and 2002 and from August 1, 1968 (Date of Inception)
through November 30, 2003
Notes to Condensed Consolidated Financial Statements F-22
76
INDEPENDENT AUDITOR'S REPORT
To the Board of Directors
Biophan Technologies, Inc.
We have audited the accompanying consolidated balance sheet of Biophan
Technologies, Inc. and Subsidiaries (a development stage company) as of February
28, 2003, and the related consolidated statements of operations, stockholders'
deficiency, and cash flows for each of the two years in the period then ended,
and the amounts in the cumulative column in the consolidated statements of
operations, stockholders' deficiency, and cash flows for the period from August
1, 1968 (date of inception) to February 28, 2003. 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 auditing standards generally accepted
in the United States of America. Those standards require that we plan and
perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement. An audit includes examining, on a
test basis, evidence supporting the amounts and disclosures in the financial
statements. An audit also includes assessing the accounting principles used and
significant estimates made by management, as well as evaluating the overall
financial statement presentation. We believe that our audits provide a
reasonable basis for our opinion.
In our opinion, the consolidated financial statements referred to above present
fairly, in all material respects, the financial position of Biophan
Technologies, Inc. and Subsidiaries as of February 28, 2003 and the results of
their operations and their cash flows for each of the two years in the period
then ended and the amounts included in the cumulative column in the consolidated
statements of operations and cash flows for the period from August 1, 1968 to
February 28, 2003 in conformity with accounting principles generally accepted in
the United States of America.
/s/GOLDSTEIN GOLUB KESSLER LLP
New York, New York
April 10, 2003
77
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED BALANCE SHEET
--------------------------------------------------------------------------------
FEBRUARY 28, 2003
--------------------------------------------------------------------------------
ASSETS
Current assets:
Cash $ 48,935
Investments in marketable securities 302,000
Advances receivable 10,127
Due from related party 24,368
Prepaid expenses 90,923
--------------------------------------------------------------------------------
Total current assets 476,353
--------------------------------------------------------------------------------
Fixed assets - at cost, net 63,232
Other assets:
Intellectual property rights 70,000
Security deposit 2,933
Deferred equity placement costs 70,538
Deferred tax asset, net of valuation allowance of $2,120,000 --
--------------------------------------------------------------------------------
143,471
--------------------------------------------------------------------------------
$ 683,056
================================================================================
LIABILITIES AND STOCKHOLDERS' DEFICIENCY
Current liabilities:
Accounts payable and accrued expenses $ 343,216
Loan payable to stockholder 143,570
Payable to related party 300,000
Due to related party 9,401
--------------------------------------------------------------------------------
Total current liabilities 796,187
--------------------------------------------------------------------------------
Long-term payable to related party, less discount 83,333
--------------------------------------------------------------------------------
Stockholders' deficiency:
Common stock - $.005 par value:
Authorized, 60,000,000 shares
Issued and outstanding, 37,634,693 shares 188,173
Additional paid-in capital 7,588,520
Deficit accumulated during the development stage (7,973,157)
--------------------------------------------------------------------------------
(196,464)
--------------------------------------------------------------------------------
$ 683,056
================================================================================
See notes to consolidated financial statements
78
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF OPERATIONS
--------------------------------------------------------------------------------
Period from
August 1,
1968 (date of
Year ended Year ended inception) to
February 28, February 28, February 28,
2003 2002 2003
---------------------------------------------------------------------------------------------------------
Operating expenses:
Salaries and related $ 648,304 $ 461,629 $ 1,169,794
Research and development 1,373,124 949,124 2,435,292
Professional fees 522,115 1,310,916 1,871,716
Write-down of intellectual property rights 40,000 530,000
General and administrative 582,174 475,520 1,084,254
---------------------------------------------------------------------------------------------------------
Operating loss (3,165,717) (3,197,189) (7,091,156)
---------------------------------------------------------------------------------------------------------
Other income (expense):
Interest expense (447,853) (540,543) (1,001,396)
Interest income 17,083 26,061 44,763
Other income 187,040 42,035 229,075
Other expense (28,805) (36,281) (65,086)
---------------------------------------------------------------------------------------------------------
Total other expenses, net (272,535) (508,728) (792,644)
---------------------------------------------------------------------------------------------------------
Loss from continuing operations (3,438,252) (3,705,917) (7,883,800)
Loss from discontinued operations (89,357)
---------------------------------------------------------------------------------------------------------
Net loss $ (3,438,252) $ (3,705,917) $(7,973,157)
=========================================================================================================
Loss per common share - basic and diluted $ (0.11) $ (0.14)
=========================================================================================
Weighted average shares outstanding 31,731,051 27,000,962
=========================================================================================
See notes to consolidated financial statements
79
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIENCY
--------------------------------------------------------------------------------
PERIOD FROM AUGUST 1, 1968 (DATE OF INCEPTION) TO FEBRUARY 28, 2003
--------------------------------------------------------------------------------
Deficit
Accumulated
Additional During the Stockholders'
Number Common Paid-in Development Equity
of Shares Stock Capital Stage (Deficiency)
------------------------------------------------------------------------------------------------------------------
1969 - 14,130 shares issued for services
for $.05 per share 14,130 $ 70 $ 637 $ 707
1970 - 1,405,000 shares issued for mining
rights for $.05 per share 1,405,000 7,025 63,225 70,250
1970 - 55,500 shares issued for services
for $.05 per share 55,500 278 2,497 2,775
1973 - 10,000 shares issued for services
for $.05 per share 10,000 50 450 500
1976 - 500 shares issued for services
for $.05 per share 500 3 22 25
1978 - 12,000 shares issued for services
for $.05 per share 12,000 60 540 600
1980 - 225,000 shares issued for services
for $.05 per share 225,000 1,125 10,125 11,250
1984 - 20,000 shares issued for services
for $.05 per share 20,000 100 900 1,000
1986 - 10,000 shares issued for services
for $.05 per share 10,000 50 450 500
1990 - 10,000 shares issued for services
for $.05 per share 10,000 50 450 500
1993 - 25,000 shares issued for services
for $.05 per share 25,000 125 1,125 1,250
Net loss from inception through
February 28, 1998 (89,357) (89,357)
------------------------------------------------------------------------------------------------------------------
Balance at February 28, 1998 1,787,130 8,936 80,421 (89,357) -
1999 - 10,000 shares issued for services
for $.05 per share 10,000 50 450 $ 500
See notes to consolidated financial statements
80
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIENCY
PERIOD FROM AUGUST 1, 1968 (DATE OF INCEPTION) TO FEBRUARY 28, 2003
--------------------------------------------------------------------------------
Deficit
Accumulated
Additional During the Stockholders'
Number Common Paid-in Development Equity
of Shares Stock Capital Stage (Deficiency)
------------------------------------------------------------------------------------------------------------------
1999 - 1,000,000 shares issued for services
for $.005 per share 1,000,000 5,000 5,000
Net loss for the year ended
February 28, 1999 (5,500) (5,500)
------------------------------------------------------------------------------------------------------------------
Balance at February 28, 1999 2,797,130 13,986 80,871 (94,857) -
2000 - 1,000,200 shares issued
for services for $.005 per share 1,000,200 5,001 5,001
Net loss for the year ended
February 29, 2000 (5,001) (5,001)
------------------------------------------------------------------------------------------------------------------
Balance at February 29, 2000 3,797,330 18,987 80,871 (99,858) -
2000 - 250,000 shares issued for services
for $.005 per share 250,000 1,250 1,250
2000 - Expenses paid by stockholder 2,640 2,640
2000 - 10,759,101 shares issued for
acquisition of Antisense Technology,
Inc. 10,759,101 53,795 121,205 175,000
2000 - 10,759,101 shares issued for cash
for $.005 per share 10,759,101 53,796 121,204 175,000
Net loss for the year ended
February 28, 2001 (729,130) (729,130)
------------------------------------------------------------------------------------------------------------------
Balance at February 28, 2001 25,565,532 127,828 325,920 (828,988) (375,240)
2001 - 2,399,750 shares issued for cash
for $1.00 per share 2,399,750 11,999 2,387,751 2,399,750
2001 - 468,823 shares issued for interest 468,823 2,344 466,479 468,823
See notes to consolidated financial statements
81
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF STOCKHOLDERS' DEFICIENCY
PERIOD FROM AUGUST 1, 1968 (DATE OF INCEPTION) TO FEBRUARY 28, 2003
--------------------------------------------------------------------------------
------------------------------------------------------------------------------------------------------------------
Deficit
Accumulated
Additional During the Stockholders'
Number Common Paid-in Development Equity
of Shares Stock Capital Stage (Deficiency)
------------------------------------------------------------------------------------------------------------------
2001 - Redemption of 200,000 shares (200,000) (1,000) (1,000)
2001 - 1,315,334 shares issued upon
conversion of bridge loans at $.75
per share 1,315,334 6,576 979,924 986,500
2001 - Offering costs associated with
share issuances for cash (254,467) (254,467)
2002 - Grant of stock options for services 702,800 702,800
Net loss for the year ended
February 28, 2002 (3,705,917) (3,705,917)
------------------------------------------------------------------------------------------------------------------
Balance at February 28, 2002 29,549,439 147,747 4,608,407 (4,534,905) 221,249
2002 - Shares issued for cash for
$.34 per share 993,886 4,969 337,461 342,430
2002 - Shares issued for cash for
$.15 per share 1,192,874 5,964 167,002 172,966
2002 to 2003 - Shares issued for cash for
$.25 per share 5,541,100 27,706 1,357,569 1,385,275
2002 to 2003 - Shares issued as
commissions on offerings 357,394 1,787 (1,787) -
2002 to 2003 Cash commissions on offerings (119,488) (119,488)
Offering costs (45,644) (45,644)
Grant of stock options for services 485,000 485,000
Intrinsic value of beneficial conversion
feature of note payable and MRI liability 800,000 800,000
Net loss for the year ended
February 28,2003 (3,438,252) (3,438,252)
------------------------------------------------------------------------------------------------------------------
Balance at February 28, 2003 37,634,693 $ 188,173 $7,588,520 $(7,973,157) $(196,464)
==================================================================================================================
See notes to consolidated financial statements
82
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF CASH FLOWS
--------------------------------------------------------------------------------
Period from
August 1,
1968 (date of
Year ended Year ended inception) to
February 28, February 28, February 28,
2003 2002 2003
---------------------------------------------------------------------------------------------------------------------
Cash flows from operating activities:
Net loss $(3,438,252) $(3,705,917) $(7,973,157)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation 25,601 14,762 40,530
Realized and unrealized losses on marketable securities 28,805 38,143 66,948
Amortization of interest on convertible notes payable 383,333 - 383,333
Write-down of intellectual property rights 40,000 - 530,000
Amortization of discount on payable to related party - 62,000 75,000
Issuance of common stock for services - 101,108
Issuance of common stock for interest 468,823 468,823
Grant of stock options for services 485,000 702,800 1,187,800
Expenses paid by stockholder - - 2,640
Changes in operating assets and liabilities:
Increase in advances receivable (10,127) - (10,127)
Increase in due from related parties (24,368) - (24,368)
(Increase) decrease in prepaid expenses 896 (91,819) (90,923)
Increase in security deposits - (2,933) (2,933)
Increase in accounts payable and accrued expenses 214,176 18,184 329,885
Decrease in due to related parties (6,948) (153,787) (34,095)
---------------------------------------------------------------------------------------------------------------------
Net cash used in operating activities (2,301,884) (2,649,744) (4,949,536)
---------------------------------------------------------------------------------------------------------------------
Cash flows from investing activities:
Purchases of fixed assets (7,951) (90,811) (103,762)
Sales of marketable securities 540,000 377,270 917,270
Purchases of marketable securities (302,000) (984,218) (1,286,218)
---------------------------------------------------------------------------------------------------------------------
Net cash provided by (used in) investing activities 230,049 (697,759) (472,710)
---------------------------------------------------------------------------------------------------------------------
Cash flows from financing activities:
Proceeds of bridge loans - 986,500 986,500
Loan from stockholder 143,570 - 143,570
Line of credit borrowing from related party 300,000 300,000
Net proceeds from sales of capital stock 1,735,539 2,201,110 4,111,649
Deferred equity placement costs (70,538) - (70,538)
---------------------------------------------------------------------------------------------------------------------
Net cash provided by financing activities 2,108,571 3,187,610 5,471,181
---------------------------------------------------------------------------------------------------------------------
See notes to consolidated financial statements
83
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONSOLIDATED STATEMENT OF CASH FLOWS
--------------------------------------------------------------------------------
Period from
August 1,
1968 (date of
Year ended Year ended inception) to
February 28, February 28, February 28,
2003 2002 2003
-------------------------------------------------------------------------------------------------------------------
Net increase (decrease) in cash and cash equivalents 36,736 (159,893) 48,935
Cash and cash equivalents at beginning of period 12,199 172,092 --
-------------------------------------------------------------------------------------------------------------------
Cash and cash equivalents at end of period $ 48,935 $ 12,199 $ 48,935
===================================================================================================================
Supplemental schedule of noncash investing and financing activities:
Intellectual property acquired through issuance of common
stock and assumption of related party payable -- -- $ 175,000
===================================================================================================================
Acquisition of intellectual property rights -- -- $ 425,000
===================================================================================================================
Issuance of common stock upon conversion of bridge loans -- $ 986,500 $ 986,500
===================================================================================================================
See notes to consolidated financial statements
84
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
--------------------------------------------------------------------------------
FEBRUARY 28, 2003
--------------------------------------------------------------------------------
1. PRINCIPAL BUSINESS ACTIVITY AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:
The consolidated financial statements include the accounts of Biophan
Technologies, Inc. ("Biophan") and its wholly owned subsidiaries, LTR Antisense
Technology, Inc. ("Antisense")and MRIC Drug Delivery Systems, LLC ("MRIC")
(collectively referred to as the "Company"). All significant intercompany
accounts and transactions have been eliminated in consolidation.
The Company is in the development stage and is expected to remain so for at
least the next 12 months. The Company is developing technologies that make
biomedical devices safe for use in an MRI (Magnetic Resonance Imaging) machine.
The Company was incorporated under the laws of the State of Idaho on August 1,
1968. On January 12, 2000, the Company changed its domicile to Nevada by merging
into a Nevada corporation, and on July 19, 2001, changed its name to Biophan
Technologies, Inc.
The Company has not generated any revenue throughout its history. The Company's
ability to continue in business is dependent upon obtaining sufficient financing
or attaining future profitable operations.
On December 1, 2000, the Company acquired LTR Antisense Technology, Inc., a New
York corporation ("LTR"), from Biomed Solutions, LLC (formerly Biophan, LLC), a
New York limited liability company ("Biomed"), in a share for share exchange. As
a result of the exchange, LTR became a wholly owned subsidiary of the Company.
The exchange was consummated pursuant to and in accordance with an Exchange
Agreement, originally dated December 1, 2000 and subsequently amended, by and
among the Company, LTR and Biomed. LTR owns multiple patents for proprietary HIV
antisense gene therapy technology.
In connection with the exchange, the Company (i) issued an aggregate of
10,759,101 shares of common stock to Biomed in exchange for all the issued
shares of LTR and (ii) issued an aggregate of 10,759,101 shares of common stock
to a group of investors for $175,000. Also on December 1, 2000, the Company
acquired intellectual property rights, including a pending patent to the
MRI-compatible pacemaker technology from Biomed (the "Assignment"), for future
consideration of $500,000 ("MRI technology purchase liability payable") The
Assignment was consummated pursuant to, and in accordance with, an Assignment
and Security Agreement, originally dated December 1, 2000 and subsequently
amended, by and between the Company and Biomed.
For purposes of the statement of cash flows, the Company considers all highly
liquid instruments with an original maturity of three months or less to be cash
equivalents.
The Company maintains cash in bank deposit accounts which, at times, exceed
federally insured limits. The Company has not experienced any losses on these
accounts.
Marketable securities that are bought and held principally for the purpose of
selling them in the near term are classified as trading securities. Trading
securities are recorded at fair value, with the change in fair value during the
period included in operations.
Depreciation of fixed assets is provided by the straight- line method over the
estimated useful lives of the related assets. Amortization of acquired
intellectual property rights is provided by the straight-line method over 17
years. Costs for internally developed intellectual property rights with
indeterminate lives are expensed as incurred.
At each balance sheet date, the Company evaluates the period of amortization of
intangible assets. The factors used in evaluating the period of amortization
include: (i) current operating results, (ii) projected future operating results,
and (iii) any other material factors that affect continuity of the business.
85
Deferred tax assets and liabilities are recognized for the future tax
consequences attributable to differences between the financial statement
carrying amounts of existing assets and liabilities and their respective tax
bases. Deferred tax assets and liabilities are measured using enacted rates
expected to apply when the differences are expected to be realized. A valuation
allowance is recognized if it is anticipated that some or all of the deferred
tax asset may not be realized.
Basic loss per common share is computed by dividing net loss by the
weighted-average number of shares of common stock outstanding during the period.
Diluted loss per common share gives effect to dilutive options, warrants and
other potential common stock outstanding during the period. Potential common
stock has not been included in the computation of diluted loss per share, as the
effect would be antidilutive.
The Company has elected to apply Accounting Principles Board ("APB") Opinion No.
25, Accounting for Stock Issued to Employees, and related interpretations in
accounting for its stock options issued to employees (intrinsic value) and has
adopted the disclosure-only provisions of Statement of Financial Accounting
Standards ("SFAS") No. 123, Accounting for Stock-Based Compensation. Had the
Company elected to recognize compensation cost based on the fair value of the
options granted at the grant date as prescribed by SFAS No. 123, the Company's
net loss and loss per common share would have been as follows:
Year ended February 28, 2003 2002
--------------------------------------------------------------------------------
Net loss - as reported $3,438,252 $3,705,917
Add: Stock-based employee compensation
Expense included in reported net loss,
net of related tax effects 458,000 268,000
Deduct: Total stock-based employee
compensation expense determined
under fair value based method for
all awards, net of related tax effects 524,000 280,000
--------------------------------------------------------------------------------
Net loss - pro forma $3,372,252 $3,693,917
================================================================================
Basic and diluted loss
per share - as reported $ .11 $ .14
================================================================================
Basic and diluted loss
per share - pro forma $ .11 $ .14
================================================================================
The Company's assumptions used to calculate the fair values of options issued
during the year ended February 28, 2003 were (i) risk-free interest rates of
3.05% through 4.75%, (ii) expected lives of 5 to 10 years, (iii) expected
volatility of 90%, and (iv) expected dividends of zero.
The Company's assumptions used to calculate the fair values of options issued
during the year ended February 28, 2002 were (i) risk-free interest rates of
4.27% and 4.87%, (ii) expected life of nine years, (iii) expected volatility of
90.%, and (iv) expected dividends of zero.
The preparation of financial statements in conformity with generally accepted
accounting principles requires the use of estimates by management. Actual
results could differ from these estimates.
Management does not believe that any recently issued, but not yet effective,
accounting standards, if currently adopted, would have a material effect on the
accompanying financial statements.
86
2. INVESTMENTS IN MARKETABLE SECURITIES:
Investments in trading securities are summarized as follows at February 28,
2003:
Gross
Unrealized Fair
Cost Gain/Loss Value
--------------------------------------------------------------------------------
Corporate debt securities $302,000 $ - $302,000
================================================================================
There were no unrealized holding losses on trading securities for the year ended
February 28, 2003.
3. PREPAID EXPENSES:
Prepaid expenses at February 28, 2003 consist of the following:
Prepaid consulting fees $ 53,933
Prepaid 18,865
Prepaid supplies 18,125
---------
$ 90,923
=========
4. FIXED ASSETS:
Fixed assets, at cost, consist of the following:
Depreciation/
Amortization
Period
--------------------------------------------------------------------------------
Furniture & Equipment $39,320 5-7 years
Computers 10,283 5 years
Internet Website 54,159 7 years
--------------------------------------------------------------------------------
103,762
Less accumulated depreciation (40,530)
-------------------------------------------------
$63,232
=================================================
Depreciation expense for the years ended February 28, 2003 and 2002 amounted to
$25,601 and $14,762, respectively. Depreciation expense for the period from
August 1, 1968 (Date of Inception) to February 28, 2003 as $40,530.
5. INTELLECTUAL PROPERTY RIGHTS:
Intellectual property rights were acquired on December 1, 2000 and encompass two
areas: (1) The utilization of new proprietary technology to prevent implantable
cardiac pacemakers and other critical and life-sustaining medical devices from
being affected by MRI and other equipment using magnetic fields, radio waves and
similar forms of electromagnetic interference ("EMI"), and (2) the use of
proprietary antisense gene therapy technology to inhibit the spread of human
immunodeficiency virus (HIV-1) infection in conjunction with the use of
lentiviral vectors. In the current year ended February 28, 2003, the stated cost
value of the gene technology rights in the amount of $40,000 was written off.
The Company has discontinued its development efforts in this area.
87
6. LOAN AGREEMENTS:
In June 2002, the Company signed a Loan Agreement with a shareholder providing
for borrowings of up to $400,000 with interest payable at 8% per annum.
Principal and accrued interest become due and payable on December 31, 2003. At
February 28, 2003, $143,570 had been borrowed under this Agreement.
In June 2002, the Company executed a line-of-credit agreement (the "Line") with
Biomed that provided for borrowings up to $250,000. Interest accrues at 8% per
annum. Upon execution of the Line, Biomed received warrants to purchase 325,000
shares of restricted common stock at $1.00 per share. The warrants were valued
at approximately $234,000 which was recorded as a discount against the
Convertible Promissory Note (the "Note") supporting the Line. At issuance, the
Note was convertible into shares of the Company's common stock, at a price below
the market value of such stock. The intrinsic value of the beneficial conversion
feature of the Note was recorded as an additional discount, such that the full
$250,000 issued was discounted, with a corresponding increase to additional
paid-in capital.
On August 19, 2002, the Line was increased by $100,000 and the expiration date
thereof was extended to August 19, 2003. The payment date of amounts borrowed
under the original Line was extended to December 1, 2002. In consideration for
the increase in the Line, Biomed received 30,000 additional warrants to purchase
shares of restricted common stock at a price dependent on the selling price of
the Company's stock, as defined. The exercise price of the warrants issued to
Biomed in exchange for the increase in the line of credit to $350,000 and the
extension of the payment date to December 1, 2002 is the lowest of (i) the
closing bid price on June 4, 2002; (ii) the closing bid price on the date of
exercise; or (iii) the lowest per share purchase price paid by any third party
between June 4, 2002 and the exercise date. The fair value of the warrants - in
accordance with guidance provided by Statement of Financial Accounting Standards
No. 123, Accounting for Stock-Based Compensation - was estimated at the date of
grant using the Black-Scholes option pricing model with the following
assumptions: risk-free interest rate of 5.25; no dividend yield; volatility
factor of the expected market price of the company's common stock of 0.0%, and
an expected life of 2.8 years. The value attributed to the warrants was
insignificant. As a result, these warrants have been allocated no value. The
Company has drawn an additional $50,000 under the Line, which was also fully
discounted as a result of the beneficial conversion feature, which was recorded
as additional paid-in capital. At February 28,2003, the Company has borrowed
$300,000 in aggregate under the Line.
Under the Transfer Agreement dated December 1, 2000, the Company incurred a
liability ("MRI technology purchase liability payable") of $500,000 (including
interest of $75,000) to Biomed in connection with the acquisition of the MRI
intellectual property rights described in Note 4. Biomed maintains a security
interest in the underlying patents until the liability is satisfied. The
intellectual property rights will revert to Biomed if the Company does not
satisfy the liability by June 1, 2004. The stated liability bears interest at an
annual rate of 8%. The balance of the MRI technology purchase liability payable
at February 28, 2002 is $500,000.
At February 28, 2003, the principal amounts of the Company's obligations
approximated their estimated fair values based upon current borrowing rates for
similar issues.
In December 2002, in consideration for extending the maturity date to June 1,
2004 and for prior extensions, the Company and Biomed agreed to make the
$500,000 MRI technology purchase liability payable to Biomed convertible at
Biomed's election into shares of the Company's common stock at a price dependent
on the selling price of the Company's stock, as defined, but below market.
Consequently, the intrinsic value of the beneficial conversion feature of the
liability was recorded as a discount, such that the full $500,000 was
discounted, with a corresponding increase to additional paid-in capital.
7. STOCKHOLDERS' EQUITY:
In July and August 2002, the Company entered into finder's agreements for the
sale of restricted common stock to foreign investors pursuant to the exemption
from registration provided in Regulation S of the 1933 Securities Act. The
Company issued a total of 2,186,760 shares of stock for aggregate net proceeds
of $491,034 under these agreements.
88
Effective August 22, 2002, the Company entered into a finder's agreement with a
domestic consulting firm providing for the sale of restricted shares of common
stock pursuant to Regulation D under the Securities Act. The finder receives a
cash fee of 10% plus stock. The Company issued a total of 5,541,100 shares of
stock for aggregate net proceeds of $1,244,505.
During November 2002, the Company entered into a Stock Purchase Agreement with
an institutional investor whereby the Company agreed to sell up to $3,000,000 of
the Company's common stock. The agreement requires the Company to file with the
Securities and Exchange Commission ("SEC") a Registration Statement covering the
shares issuable under this agreement. The Company can begin selling shares to
the purchaser immediately after the SEC declares the above-mentioned
Registration Statement effective. The Company is in the process of filing for
registration.
8. COMMITMENTS:
The Company is obligated under an operating lease for office space expiring
September 30, 2004. The Company may terminate the lease upon ninety days prior
written notice to the landlord. The aggregate minimum future payments under this
lease are payable as follows:
Year ending February 28,
2004 $ 46,783
2005 25,083
--------------------------------------------------------------------------------
$ 71,866
================================================================================
Rent expense charged to operations under this operating lease aggregated $51,321
and $14,667 for the years ended February 28, 2003 and 2002, respectively. Rent
expense charged to operations for the period from August 1, 1968 (Date of
Inception) to February 28,2003 was $65,988.
9. RELATED PARTY TRANSACTIONS:
Biomed and another related party paid expenses on behalf of the Company
aggregating $128,411 and $253,014 during the years ended February 28, 2003 and
2002, respectively, and $551,561 for the period August 1, 1968 through February
28, 2003. At February 28, 2003, the balance due from a related party is $24,368
and the balance due to a separate related party is $9,401. The amounts due from
and to the related parties do not bear interest, and the Company expects to
collect and repay these respective balances during the next 12 months.
10. STOCK-BASED COMPENSATION PLAN:
The Company has a stock option plan (the "Plan") which provides for the granting
of nonqualified or incentive stock options ("ISO") to officers, key employees,
non-employee directors and consultants. The Plan authorizes the granting of
options to acquire up to 2,500,000 common shares. ISO grants under the Plan are
exercisable at the market value of the Company's stock on the date of such
grant. Nonqualified option grants under the Plan are exercisable at amounts
determined by the board of directors. All options under the Plan are exercisable
at times as determined by the board of directors, not to exceed 10 years from
the date of grant. Additionally, the Plan provides for the granting of
restricted stock to officers and key employees.
89
The following table summarizes activity in stock options:
Weighted-
average
Exercise
Options Price
--------------------------------------------------------------------------------
Outstanding at March 1, 2001 - -
Granted 1,779,997 $ .51
Forfeited - -
Exercised - -
--------------------------------------------------------------------------------
Outstanding at February 28, 2002 1,779,997 $ .51
Granted 739,998 .42
Forfeited 30,000 .50
Exercised - -
--------------------------------------------------------------------------------
Outstanding at February 28, 2003 2,489,995 $ .48
================================================================================
Weighted-average fair value of options granted during the year ended
February 28, 2003 and 2002,
respectively $ .33 $ .90
================================================================================
The following table summarizes information about stock options outstanding and
exercisable at February 28, 2003:
Options Outstanding Options Exercisable
-------------------------------------------------------------------------------------------------
Weighted
Average Weighted- Weighted-
Remaining Average Average
Range of Number Contractual Exercise Number Exercise
Exercise Price Outstanding Life Price Exercisable Price
-------------------------------------------------------------------------------------------------
$.10 - $.43 940,000 7.50 years $.33 546,666 $.27
$.50 - $1.00 1,549,995 7.64 years $.58 1,017,995 $.62
$.10 - $1.00 2,489,995 7.58 years $.48 1,564,661 $.50
At February 28, 2003, 10,005 shares of common stock were reserved for future
issuance of stock options.
11. INCOME TAXES:
As of February 28, 2003, the Company had net operating loss carryforwards of
approximately $5,706,000 for federal income tax purposes, which expire through
2023.
90
The reconciliation of income tax computed at the U.S. federal statutory tax
rates to income tax expense is as follows:
Year Ended February 28, 2003 2002
--------------------------------------------------------------------------------
Tax benefit at U.S. statutory rates 34 % 34 %
Increase in valuation allowance (34)% (34)%
--------------------------------------------------------------------------------
-0-% -0-%
================================================================================
Deferred tax asset is comprised of the following:
February 28, 2003
-----------------
Net operating loss carryforwards $ 1,940,000
Write-down of intellectual property rights 180,000
--------------------------------------------------------------------------------
Total deferred tax asset 2,120,000
Valuation allowance (2,120,000)
--------------------------------------------------------------------------------
Net deferred tax asset $ -0-
================================================================================
91
INDEPENDENT ACCOUNTANT'S REPORT
To the Board of Directors
Biophan Technologies, Inc.
We have reviewed the accompanying condensed consolidated balance sheet of
Biophan Technologies, Inc. and Subsidiaries as of August 31, 2003, and the
related condensed consolidated statements of operations for the three-month and
nine-month periods ended November 30, 2003 and 2002 and the condensed
consolidated statements of cash flows for the nine-month periods ended November
30, 2003 and 2002. These financial statements are the responsibility of the
Company's management.
We conducted our reviews in accordance with standards established by the
American Institute of Certified Public Accountants. A review of interim
financial information consists principally of applying analytical procedures to
financial data and making inquiries of persons responsible for financial and
accounting matters. It is substantially less in scope than an audit conducted in
accordance with generally accepted auditing standards, the objective of which is
the expression of an opinion regarding the consolidated financial statements
taken as a whole. Accordingly, we do not express such an opinion.
Based on our reviews, we are not aware of any material modifications that should
be made to the condensed consolidated financial statements referred to above for
them to be in conformity with accounting principles generally accepted in the
United States of America.
We have previously audited, in accordance with auditing standards generally
accepted in the United States of America, the consolidated balance sheet as of
February 28, 2003, and the related consolidated statements of operations,
stockholders' deficiency, and cash flows for the year then ended (not presented
herein); and in our report dated April 10, 2003, we expressed an unqualified
opinion on those consolidated financial statements. In our opinion, the
information set forth in the accompanying condensed consolidated balance sheet
as of February 28, 2003, is fairly stated, in all material respects, in relation
to the consolidated balance sheet from which it has been derived.
GOLDSTEIN GOLUB KESSLER LLP
New York, New York
January 8, 2004
92
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
November 30, 2003
(Unaudited) February 28, 2003
---------------------------------------------------------------------------------------------
ASSETS
Current Assets:
Cash $ 68,832 $ 48,935
Investments in marketable securities -- 302,000
Advances receivable -- 10,127
Due from related party 74,889 24,368
Prepaid expenses 61,559 90,923
---------------------------------------------------------------------------------------------
Total Current Assets 205,280 476,353
---------------------------------------------------------------------------------------------
Fixed Assets, at cost, net 67,418 63,232
---------------------------------------------------------------------------------------------
Other Assets:
Intellectual property rights 70,000 70,000
Security deposit 2,933 2,933
Deferred equity placement costs -- 70,538
Deferred tax asset, net of valuation
allowance of $2,444,000 and $2,120,000
respectively -- --
---------------------------------------------------------------------------------------------
72,933 143,471
---------------------------------------------------------------------------------------------
$ 345,631 $ 683,056
=============================================================================================
LIABILITIES AND STOCKHOLDERS' DEFICIENCY
Current Liabilities:
Accounts payable and accrued expenses $ 658,836 $ 343,216
Loan payable to stockholder -- 143,570
Payable to related party, less discount 203,402 300,000
Due to related party 4,854 9,401
---------------------------------------------------------------------------------------------
Total Current Liabilities 867,092 796,187
---------------------------------------------------------------------------------------------
Long-term payable to related party,
less discount 333,334 83,333
---------------------------------------------------------------------------------------------
Stockholders' Deficiency:
Common stock, $.005 par value
Authorized, 80,000,000 shares
Issued and outstanding,
46,004,071 shares and
37,634,693 shares, respectively 230,020 188,173
Additional paid-in capital 8,971,650 7,588,520
Deficit accumulated during the
development stage (10,056,465) (7,973,157)
---------------------------------------------------------------------------------------------
(854,795) (196,464)
---------------------------------------------------------------------------------------------
$ 345,631 $ 683,056
=============================================================================================
See Notes to Condensed Consolidated Financial Statements.
93
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(UNAUDITED)
Period from
August 1, 1968
Three Months Ended Nine Months Ended (date of inception)
November 30, November 30, to
2003 2002 2003 2002 November 30, 2003
-----------------------------------------------------------------------------------------------------------------------------------
Revenues:
Development payments $ 75,000 $ -- $ 75,000 $ -- $ 75,000
Operating expenses:
Salaries and related 119,371 146,462 376,874 493,589 1,546,668
Research and development 242,783 195,842 682,671 837,123 3,118,063
Professional fees 109,233 104,784 364,909 374,804 2,136,625
Write-down of intellectual
property rights 530,000
General and administrative 198,727 111,321 423,173 398,930 1,507,427
-----------------------------------------------------------------------------------------------------------------------------------
670,114 558,409 1,847,627 2,104,446 8,938,783
-----------------------------------------------------------------------------------------------------------------------------------
Operating loss (595,114) (558,409) (1,772,627) (2,104,446) (8,863,783)
Other income(expense):
Interest income 113 177 1,377 16,878 46,140
Interest expense (142,886) (162,862) (387,551) (334,422) (1,388,947)
Other income 10,169 47,345 75,493 137,069 304,568
Other expense -- -- (28,805) (65,086)
-----------------------------------------------------------------------------------------------------------------------------------
(132,604) (115,340) (310,681) (209,280) (1,103,325)
Loss from continuing
operations (727,718) (673,749) (2,083,308) (2,313,726) (9,967,108)
-----------------------------------------------------------------------------------------------------------------------------------
Loss from discontinued
operations -- -- -- -- (89,357)
Net loss $ (727,718) $ (673,749) $ (2,083,308) $ (2,313,726) $(10,056,465)
===================================================================================================================================
Loss per common share
Basic and Diluted $ (0.02) $ (0.02) $ (0.05) $ (0.08)
==================================================================================================================
Weighted average shares
outstanding 43,946,562 31,902,380 40,359,446 30,359,831
==================================================================================================================
See Notes to Condensed Consolidated Financial Statements.
94
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(UNAUDITED)
Period from
August 1, 1968
Nine Months Ended (date of inception)
November 30, to
2003 2002 November30,2003
-----------------------------------------------------------------------------------------------------------------
Cash flows used for operating activities:
Net loss $(2,083,308) $(2,313,726) $(10,056,465)
Adjustments to reconcile net loss to net cash
used for operating activities:
Depreciation 17,439 19,191 57,969
Realized and unrealized losses on
marketable securities -- 28,805 66,948
Accrued interest on note payable
converted to common stock 11,998 11,998
Amortization of interest on convertible
notes payable 337,352 300,000 720,685
Write-down of intellectual property rights -- -- 530,000
Amortization of discount on payable to
related party -- -- 75,000
Issuance of common stock for services -- -- 101,108
Issuance of common stock for interest -- -- 468,823
Grant of stock options for services 230,000 138,000 1,417,800
Expenses paid by stockholder -- -- 2,640
Changes in operating assets and liabilities:
(Increase)decrease in advances receivable 10,127 -- --
Increase in due from related
parties (50,521) (16,779) (74,889)
(Increase) decrease in prepaid expenses 29,364 (38,649) (61,559)
Increase in security deposits -- -- (2,933)
Increase in accounts payable and
accrued expenses 315,620 197,740 645,505
Decrease in due to related
parties (4,547) (11,559) (38,642)
-----------------------------------------------------------------------------------------------------------------
(1,186,476) (1,696,977) (6,136,012)
Cash flows used for investing activities:
Purchases of fixed assets (21,625) (7,951) (125,387)
Sales of marketable securities 302,000 540,000 1,219,270
Purchases of marketable securities -- -- (1,286,218)
-----------------------------------------------------------------------------------------------------------------
280,375 532,049 (192,335)
See Notes to Condensed Consolidated Financial Statements.
95
-----------------------------------------------------------------------------------------------------------------
Cash flows provided by financing activities:
Proceeds of bridge loans -- -- 986,500
Loan from stockholder -- 143,570 143,570
Line of credit borrowing from related party 200,950 300,000 500,950
Line of credit payments (55,000) (55,000)
Net proceeds from sales of capital stock 281,663 757,212 4,393,312
Proceeds from exercise of options 427,847 -- 427,847
Deferred equity placement costs 70,538 (20,000) --
-----------------------------------------------------------------------------------------------------------------
925,998 1,180,782 6,397,179
-----------------------------------------------------------------------------------------------------------------
Net increase in cash (19,897) 15,854 68,832
Cash, beginning 48,935 12,199 --
-----------------------------------------------------------------------------------------------------------------
Cash, ending $ 68,832 $ 28,053 $ 68,832
=================================================================================================================
Supplemental schedule of noncash investing
and financing activities:
Intellectual property acquired through
issuance of capital stock and
assumption of related party payable -- -- $ 175,000
=================================================================================================================
Acquisition of intellectual property $ -- $ -- $ 425,000
=================================================================================================================
Issuance of common stock upon conversion
of bridge loans $ 143,570 $ -- $1,130,070
=================================================================================================================
Issuance of common stock upon partial
conversion of line of credit loans $ 183,950 $ -- $ 183,950
=================================================================================================================
See Notes to Condensed Consolidated Financial Statements.
96
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
NOVEMBER 30, 2003
INTERIM FINANCIAL STATEMENTS:
The condensed consolidated financial statements as of November 30, 2003 and for
the three and nine months ended November 30, 2003 and 2002 are unaudited.
However, in the opinion of management of the Company, these financial statements
reflect all adjustments, consisting solely of normal recurring adjustments,
necessary to present fairly the financial position and results of operations for
such interim periods. The results of operations for the interim periods
presented are not necessarily indicative of the results to be obtained for a
full year.
BASIS OF CONSOLIDATION:
The condensed consolidated financial statements include the accounts of Biophan
Technologies, Inc. ("Biophan")and its wholly owned subsidiaries, LTR Antisense
Technology, Inc. ("Antisense") and MRIC Drug Delivery Systems, LLC ("MRIC")
(collectively referred to as the "Company"). All significant intercompany
accounts and transactions have been eliminated in consolidation.
ORGANIZATIONAL HISTORY:
The Company was incorporated under the laws of the State of Idaho on August 1,
1968. On January 12, 2000, the Company changed its domicile to Nevada by merging
into a Nevada corporation, and on July 19, 2001, changed its name to Biophan
Technologies, Inc. The Company's stock currently trades over-the-counter under
the symbol BIPH. Our corporate headquarters are located at 150 Lucius Gordon
Drive, Suite 215, West Henrietta, New York 14586; Tel. (585) 214-2441; website:
www.biophan.com.
On December 1, 2000, the Company acquired LTR Antisense Technology, Inc., a New
York corporation ("LTR"), from Biomed Solutions, LLC (formerly Biophan, LLC), a
New York limited liability company ("Biomed"), in a share for share exchange. As
a result of the exchange, LTR became a wholly owned subsidiary of the Company.
The exchange was consummated pursuant to and in accordance with an Exchange
Agreement, originally dated December 1, 2000 and subsequently amended, by and
among the Company, LTR and Biomed. LTR owns multiple patents for proprietary HIV
antisense gene therapy technology.
In connection with the exchange, the Company (i) issued an aggregate of
10,759,101 shares of common stock to Biomed in exchange for all the issued
shares of LTR and (ii) issued an aggregate of 10,759,101 shares of common stock
to a group of investors for $175,000. Also on December 1, 2000, the Company
acquired intellectual property rights, including a pending patent to the
MRI-compatible pacemaker technology from Biomed (the "Assignment"), for future
consideration of $500,000 ("MRI technology purchase liability payable"). The
Assignment was consummated pursuant to, and in accordance with, an Assignment
and Security Agreement, originally dated December 1, 2000 and subsequently
amended, by and between the Company and Biomed.
PRINCIPAL BUSINESS ACTIVITIES:
The Company is in the development stage and is expected to remain so for at
least the next twelve months.
The Company is developing technologies that make implantable biomedical devices
safe and compatible for use in an MRI (Magnetic Resonance Imaging) machine. Many
implanted biomedical devices are prohibited for use in an MRI machine, including
pacemakers, cardioverter-defibrillators, neurostimulators, bladder control
devices, insulin pumps with wire connected sensors, pain control devices,
intraluminal imaging coils, interventional catheters and guide wires,
endoscopes, and others. The Company plans to provide intellectual property
licenses and critical components to manufacturers of these biomedical devices.
97
ACCOUNTING FOR STOCK OPTIONS:
The Company has elected to apply Accounting Principles Board ("APB") Opinion No.
25, Accounting for Stock Issued to Employees, and related interpretations in
accounting for its stock options issued to employees (intrinsic value) and has
adopted the disclosure-only provisions of Statement of Financial Accounting
Standards ("SFAS") No. 123, Accounting for Stock-Based Compensation. Had the
Company elected to recognize compensation cost based on the fair value of the
options granted at the grant date as prescribed by SFAS No. 123, the Company's
net loss and loss per common share would have been as follows:
Three Months Ended Nine Months Ended
November November
2003 2002 2003 2002
----------------------------------------------------------------------------------------------------------------
Net loss - as reported $(727,718) $(673,749) $(2,083,308) $(2,313,726)
Add - stock based employee
compensation expense included
in reported net loss, net of
related tax effects 30,000 47,000 90,000 140,000
Deduct - Total stock based employee
compensation expense determined
under fair value based method
for all awards, net of related
tax effects 65,000 115,000 179,000 345,000
----------------------------------------------------------------------------------------------------------------
Net loss - pro forma $(762,454) $(741,749) $(2,172,308) $(2,518,726)
================================================================================================================
Basic and diluted loss per
share - as reported $ (.02) $ (.02) $ (.05) $ (.08)
================================================================================================================
Basic and diluted loss per
share - pro forma $ (.02) $ (.02) $ (.05) $ (.08)
================================================================================================================
PREPAID EXPENSES:
Prepaid expenses at November 30, 2003 consist of the following:
Prepaid insurance $ 43,434
Prepaid supplies 18,125
------------------------------------------------------
$ 61,559
======================================================
LOAN AGREEMENTS:
In June 2002, the Company executed a line-of-credit agreement (the "Line") with
Biomed that provided for borrowings up to $250,000. Interest accrues at 8% per
annum. Upon execution of the Line, Biomed received warrants to purchase 325,000
shares of restricted common stock at $1.00 per share. The warrants were valued
at approximately $234,000 which was recorded as a discount against the
Convertible Promissory Note (the "Note") supporting the Line. At issuance, the
Note was convertible into shares of the Company's common stock, at a price below
the market value of such stock. The intrinsic value of the beneficial conversion
feature of the Note was recorded as an additional discount, such that the full
$250,000 issued was discounted, with a corresponding increase to additional
paid-in capital. On August 19, 2002, the Line was increased by $100,000 and the
expiration date thereof was extended to August 19, 2003. The payment date of
amounts borrowed under the original Line was extended to December 1, 2002. The
entire line now expires on June 1, 2004. In consideration for the increase in
the Line, Biomed received 30,000 additional warrants to purchase shares of
restricted common stock at a price dependent on the selling price of the
Company's stock, as defined. The exercise price of the warrants issued to Biomed
in exchange for the increase in the line of credit to $350,000 and the extension
of the payment date to December 1, 2002 is the lowest of (i) the closing bid
price on June 4, 2002; (ii) the closing bid price on the date of exercise; or
(iii) the lowest per share purchase price paid by any third party between June
4, 2002 and the exercise date. The fair value of the warrants - in accordance
with guidance provided by Statement of Financial Accounting Standards No. 123,
Accounting for Stock-Based Compensation - was estimated at the date of grant
using the Black-Scholes option pricing model with the following assumptions:
risk-free interest rate of 5.25; no dividend yield; volatility factor of the
expected market price of the company's common stock of 0.0%, and an expected
life of 2.8 years. The value attributed to the warrants was insignificant. As a
result, these warrants have been allocated no value.
98
On June 30, 2003, we issued 1,268,621 shares of common stock for the conversion
of $183,950 of the $350,000 Line of Credit obligation. Since that time, the
Company has drawn additional amounts under the Line, which amounts were also
fully discounted as a result of the beneficial conversion feature, and recorded
as additional paid-in capital. At November 30, 2003, $262,000 was outstanding
under the Line. The stated liability for financial reporting purposes is
$262,000 less an unamortized discount $58,598, or $203,402.
Under the Transfer Agreement dated December 1, 2000, the Company incurred a
liability ("MRI technology purchase liability payable") of $500,000 (including
interest of $75,000) to Biomed in connection with the acquisition of the MRI
intellectual property rights described above. Biomed maintains a security
interest in the underlying patents until the liability is satisfied. The
intellectual property rights will revert to Biomed if the Company does not
satisfy the liability by June 1, 2004. The stated liability bears interest at an
annual rate of 8%.
In December 2002, in consideration for extending the maturity date to June 1,
2004 and for prior extensions, the Company and Biomed agreed to make the
$500,000 MRI technology purchase liability payable to Biomed convertible at
Biomed's election into shares of the Company's common stock at a price dependent
on the selling price of the Company's stock, as defined, but below market.
Consequently, the intrinsic value of the beneficial conversion feature of the
liability was recorded as a discount, such that the full $500,000 was
discounted, with a corresponding increase to additional paid-in capital. At
November 30, 2003, the balance of the MRI technology purchase liability payable,
net of a discount of $166,666, is $333,334.
At November 30, 2003, the principal amounts of the Company's obligations
approximated their estimated fair values based upon current borrowing rates for
similar issues.
CHANGES IN EQUITY AND SUBSEQUENT EVENT:
During November 2002, the Company entered into a Stock Purchase Agreement with
an institutional investor whereby the Company agreed to sell up to $3,000,000 of
the Company's common stock. The agreement required the Company to file with the
Securities and Exchange Commission ("SEC") a Registration Statement covering the
shares issuable under this agreement. The registration became effective on July
11, 2003. Through November 30, 2003, the Company sold and issued 3,325,757
shares of common stock under the agreement for gross proceeds of $491,190.
Also, during the period from August 13 through October 21, 2003, options for
3,000,000 shares were granted to three consultants, exercisable at prices equal
to 80% of the closing price of the stock on the day prior to exercise. These
options were completely exercised for aggregate proceeds of $427,847.
From December 3, 2003 to January 12, 2004, 11,000,000 shares of common stock
were issued to SBI Brightline, LLC pursuant to the Stock Purchase Agreement
between the Company and SBI. Gross proceeds of $2,900,000 were received, or are
in transit, thereby completing the terms of that financing agreement.
99