UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
|X| Quarterly Report under Section 13 or 15(d)
of the Securities Exchange Act of 1934
For the quarterly period ended: May 31, 2004
|_| Transition Report under Section 13 or 15(d)
of the Exchange Act of 1934
For the transition period from ____ to ____
Commission File No. 0-26057
BIOPHAN TECHNOLOGIES, INC.
-----------------------------------------------------------------
(Exact name of small business issuer as specified in its charter)
Nevada 82-0507874
-------------------------------- -------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization Identification No.)
150 Lucius Gordon Drive, Suite 215
West Henrietta, New York 14586
---------------------------------------- ----------
(Address of principal executive offices) (Zip code)
(585) 214-2441
-------------------------
Issuer's telephone number
Indicate by check mark whether the registrant (1) has filed all reports required
to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during
the preceding 12 months (or for such shorter period that the registrant was
required to file such reports), and (2) has been subject to such filing
requirements for the past 90 days.
|X| Yes |_| No
State the number of shares outstanding of each of the issuer's classes of common
equity, as of the latest practicable date.
Class Outstanding as of July 13, 2004
Common Stock, $.005 par value 67,317,685
Transitional small Business Disclosure Format (Check One): Yes |_| No |X|
1
INDEX
Page
Number
PART I. FINANCIAL INFORMATION
ITEM I. Financial Statements
Report of Independent Registered Public Accounting Firm 3
Condensed Consolidated Balance Sheets, May 31, 2004 (Unaudited)
and February 29, 2004 4
Condensed Consolidated Statements of Operations, Three Months Ended
May 31, 2004 and 2003 (Unaudited), and from August 1,
1968 (Date of Inception) through May 31, 2004 (Unaudited) 5
Condensed Consolidated Statements of Cash Flows, Three Months Ended
May 31, 2004 and 2003 (Unaudited) and from August 1, 1968
(Date of Inception) through May 31, 2004 (Unaudited) 6
Notes to Condensed Consolidated Financial Statements 7
ITEM 2. Plan of Operation 9
ITEM 3. Controls and Procedures 14
PART II. OTHER INFORMATION 14
ITEM 1. Legal Proceedings 14
ITEM 2. Changes in Securities and Use of Proceeds 14
ITEM 3. Defaults Upon Senior Securities 14
ITEM 4. Submission of Matters to a Vote of Security Holders 14
ITEM 5. Other Information 14
ITEM 6. Exhibits and Reports on Form 8-K 15
a. Exhibits 15 b. Reports on Form 8-K 20
SIGNATURES 20
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To the Board of Directors
Biophan Technologies, Inc.
We have reviewed the accompanying condensed consolidated balance sheet of
Biophan Technologies, Inc. and Subsidiaries (the "Company") as of May 31, 2004,
and the related condensed consolidated statements of operations and cash flows
for the three-month periods ended May 31, 2004 and 2003. These interim financial
statements are the responsibility of the Company's management.
We conducted our reviews in accordance with the standards of the Public Company
Accounting Oversight Board (United States). A review of interim financial
information consists principally of applying analytical procedures and making
inquiries of persons responsible for financial and accounting matters. It is
substantially less in scope than an audit conducted in accordance with standards
of the Public Company Accounting Oversight Board, 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 accompanying condensed consolidated interim financial statements
for them to be in conformity with accounting principles generally accepted in
the United States of America.
We have previously audited, in accordance with standards of the Public Company
Accounting Oversight Board, the consolidated balance sheet of Biophan
Technologies, Inc. and Subsidiaries as of February 29, 2004, and the related
consolidated statements of operations, stockholders' deficiency, and cash flows
for the year 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 29, 2004 (not presented herein). In our report dated March
30, 2004, 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 29, 2004, 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
June 30, 2004
3
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
May 31, 2004 February 29,
(Unaudited) 2004
-------------------------------------
ASSETS
Current Assets:
Cash $ 169,185 $ 823,900
Investments in marketable securities 1,150,000 1,150,000
Due from related parties 121,679 34,222
Prepaid expenses 71,812 69,185
-------------------------------------
Total Current Assets 1,512,676 2,077,307
-------------------------------------
Property and equipment, net 64,735 61,214
Other Assets:
Intellectual property rights 70,000 70,000
Security deposit 2,933 2,933
Deferred equity placement costs 41,997 19,891
Deferred tax asset, net of valuation
allowance of $3,233,000 and $2,926,000
respectively -- --
-------------------------------------
114,930 92,824
-------------------------------------
$ 1,692,341 $ 2,231,345
=====================================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable and accrued expenses $ 245,279 $ 254,058
-------------------------------------
Total Current Liabilities 245,279 254,058
-------------------------------------
Stockholders' Equity:
Common stock, $.005 par value
Authorized, 80,000,000 shares
Issued and outstanding,
66,864,610 and 65,945,011
shares respectively 334,323 329,725
Additional paid-in capital 13,756,491 13,339,289
Deficit accumulated during the
development stage (12,643,752) (11,691,727)
-------------------------------------
1,447,062 1,977,287
-------------------------------------
$ 1,692,341 $ 2,231,345
=====================================
See Notes to Condensed Consolidated Financial Statements.
4
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Period from
August 1, 1968
Three Months Ended (date of inception)
May 31, to
2004 2003 May 31, 2004
---------------------------------------------
Revenues:
Development payments $ -- -- $ 75,000
---------------------------------------------
Operating expenses:
Salaries and related 134,704 127,642 1,831,704
Research and development 426,215 238,103 4,102,046
Professional fees 65,872 106,109 2,642,963
Write-down of intellectual property -- -- 530,000
General and administrative 367,895 104,736 2,130,571
---------------------------------------------
994,686 576,590 11,237,284
---------------------------------------------
Operating loss (994,686) (576,590) (11,162,284)
Other income(expense):
Interest expense -- (110,251) (1,730,923)
Interest income 858 902 47,436
Other income 41,803 27,804 356,462
Other expense -- -- (65,086)
---------------------------------------------
42,661 (81,545) (1,392,111)
---------------------------------------------
Loss from continuing operations (952,025) (658,135) (12,554,395)
Loss from discontinued operations -- -- (89,357)
---------------------------------------------
Net loss $ (952,025) $ (658,135) $(12,643,752)
=============================================
Loss per common share
-basic and diluted $ (0.01) $ (0.02)
=============================
Weighted average shares outstanding 66,419,732 37,634,693
=============================
See Notes to Condensed Consolidated Financial Statements.
5
BIOPHAN TECHNOLOGIES, INC.
AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Period from
August 1, 1968
Three Months Ended (date of inception)
May 31, to
2004 2003 May 31, 2004
--------------------------------------------
Cash flows from operating activities:
Net loss $ (952,025) $ (658,135) $(12,643,752)
Adjustments to reconcile net loss to net cash
used in operating activities:
Depreciation 5,509 5,764 69,682
Realized and unrealized losses on
marketable securities -- -- 66,948
Accrued interest on note converted to
common stock -- -- 11,998
Amortization of interest on convertible
notes payable -- 91,232 1,050,950
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 30,000 30,000 1,782,800
Expenses paid by stockholder -- -- 2,640
Changes in operating assets and liabilities:
Decrease in advances receivable -- 5,632 --
Increase in due from related
parties (87,457) (5,037) (121,679)
(Increase) decrease in prepaid expenses (2,627) 39,546 (71,812)
Increase in security deposits -- -- (2,933)
Increase (decrease) in accounts payable and
accrued expenses (8,779) 165,811 231,948
Decrease in due to related
parties -- (95) (43,496)
--------------------------------------------
(1,015,379) (325,282) (8,491,775)
Cash flows from investing activities:
Purchases of property and equipment (9,030) (18,690) (134,417)
Sales of marketable securities -- 302,000 1,219,270
Purchases of marketable securities -- -- (2,436,218)
--------------------------------------------
(9,030) 283,310 (1,351,365)
Cash flows from financing activities:
Proceeds of bridge loans -- -- 986,500
Loan from stockholder -- -- 143,570
Line of credit borrowing from related party -- 50,000 550,950
Line of credit payments -- -- (72,500)
Net proceeds from sales of capital stock -- -- 7,363,849
Proceeds from exercise of options -- -- 427,847
Proceeds from exercise of warrants 391,800 -- 724,644
Deferred equity placement costs (22,106) (13,324) (112,535)
--------------------------------------------
369,964 36,676 10,012,325
--------------------------------------------
Net increase(decrease)in cash (654,715) (5,296) 169,185
--------------------------------------------
Cash, beginning 823,900 48,935 --
--------------------------------------------
Cash, ending $ 169,185 $ 43,639 $ 169,185
============================================
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 $ -- $ -- $ 1,142,068
============================================
Issuance of common stock upon conversion
of related party loans $ -- $ -- $ 978,450
============================================
See Notes to Condensed Consolidated Financial Statements.
6
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
May 31, 2004
INTERIM FINANCIAL STATEMENTS:
The condensed consolidated financial statements as of May 31, 2004 and for the
three months ended May 31, 2004 and 2003 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.
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
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.
On June 3, 2004, the Company acquired a 51% interest in TE Bio LLC ("TE Bio"), a
newly formed limited liability company that acquired an exclusive license to
certain technology from Biomed, to which no value has been assigned. Biomed has
a 46.5% interest in TE Bio. The Company will invest $300,000 per year over three
years in TE Bio and will also provide certain administrative, marketing, and
research and development services. TE Bio has had no operations to date.
7
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 biomedical devices safe for use
in an MRI (Magnetic Resonance Imaging) machine. Many 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, interluminal imaging coils,
interventional catheters and guide wires, endoscopes, and others. The Company
plans to provide intellectual property licenses to manufacturers of these
biomedical devices.
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 May 31, 2004 2003
--------------------------------------------------------------------------------
Net loss - as reported $(952,025) $(658,135)
Add: Stock-based employee compensation
expense included in reported net loss,
net of related tax effects 30,000 30,000
Deduct: Total stock-based employee
compensation expense determined
under fair value based method for
all awards, net of related tax effects (62,000) (50,000)
--------------------------------------------------------------------------------
Net loss - pro forma $(984,025) $(678,135)
================================================================================
Basic and diluted loss
per share - as reported $ (.01) $ (.02)
================================================================================
Basic and diluted loss
per share - pro forma $ (.01) $ (.02)
================================================================================
PREPAID EXPENSES:
Prepaid expenses at May 31, 2004 consist of the following:
Prepaid royalties $25,000
Prepaid legal fees 20,000
Prepaid insurance 8,687
Prepaid supplies 18,125
-------
$71,812
=======
8
CHANGES IN EQUITY:
During the quarter ended May 31, 2004, a total of 919,599 shares of common stock
were issued upon exercise of warrants at prices ranging from $.25 to $1.00.
Proceeds of $391,800 were received increasing the capital stock account by
$4,598 and additional paid-in capital by $387,202. Additional paid-in capital
was also increased by $30,000 of expense related to stock options granted for
services.
9
ITEM 2. 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 interventional 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.
Additionally, our work with image compatibility of devices can reduce image
artifacts of pacemaker lead, so that the device can be imaged. We believe that
this adds the additional patient benefit, and competitive advantage, of being
then able to conduct an MRI angiogram of a pacemaker recipient under MRI. This
would allow a non-invasive procedure where today an invasive procedure is
required. Further, the pacemaker lead can be inserted and positioned under MRI,
which today is not possible.
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 recently conducted research with a major university confirming that there are
serious further dangers posed to pacemaker patients by MRI imaging causing lead
heating, as well as demonstrating the effectiveness of our solutions. 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. We are planning additional studies to demonstrate the potential effects
of thermogenic heat damage on tissue which has the potential to interfere with
proper pacing voltages at the tissue interface where the electrode tip touches
the myocardium. We believe the heating occurs not at the electrode tip, but
slightly away from it, where the electrical flow is impeded by tissue.
On June 3, 2004, we acquired a 51% interest in TE Bio LLC a company developing
an implantable biothermal battery using body heat gradiants to power medical
devices such as pacemakers, defibrillators, and drug pumps. The biothermal
battery technology is based on a patented innovation in the utilization of
thermoelectric materials, using nanoscale-based, thin-film materials to convert
thermal energy produced naturally by the human body into electrical energy. The
resulting power can be used to "trickle charge" batteries for medium-power
devices such as defibrillators, or directly power low-energy devices like
pacemakers. It is enabled by nanotechnology which provides the ability to put
thousands and thousands of small semi-conductor nodes that convert heat to
electricity in a space about the size of one or two postage stamps. We presented
the technology at the NASPE Heart Rhythm Society meeting in San Francisco
earlier this year and received substantial industry interest from major device
manufacturers. We have recruited several consultants experienced in this
technology to assist us in developing it.
Biophan committed $300,000 annually for a three-year period, and marketing and
management support to TE Bio, in exchange for Biophan's 51% interest. TE Bio was
founded by Biomed Solutions, LLC, an affiliate and the company which Biophan
spun out from in December 2000. The independent board of Biophan evaluated the
technology and authorized the acquisition, after conclusion of a third party
feasibility study.
10
Also, on June 4, 2004, we announced that we had acquired from New Scale
Technologies, Inc. the exclusive worldwide distribution rights for the medical
market for New Scale's ceramic "SQUIGGLE(TM) motor", including the multi-billion
dollar drug delivery market. Developed to meet the growing demand for high
precision, low cost actuation devices, the motor is currently on the market
generating revenues and is available for OEM integration today. The motor uses
no metal wire windings (one of the primary causes of image interference under
MRI), is capable of both linear and rotational movement, and can move forward
and backwards several inches at nanometer increments, thereby providing a
controllable drug release environment.
As part of the exclusive distribution agreement, Biophan will provide sales and
marketing to the medical device industry on behalf of New Scale and has also
made a small minority investment in the company. The motor offers several
advantages for driving drug pumps, and other medical applications. Using only
four parts (other motors can have as many as 100 parts), it provides a unique
combination of high reliability, flexibility, and power consumption advantages.
By using ceramic components and no windings, it is very compatible with MRI
imaging.
This product also fits in with our strategic plan to be a provider of
proprietary new technologies to our OEM customers and prospects. While we
continue to provide solutions that will one day enable all biomedical devices to
be MRI-safe and image compatible, we have expanded our focus to bring
additional, proprietary innovations to our customers. We continue to maintain an
ongoing and in-depth dialog with both the research and development and business
development executives at many of the largest manufacturers of biomedical device
companies. This interaction gives us a broad view of the short- and long-term
needs of these companies for support of both their current and future product
lines.
We share gross profit equally with New Scale Technologies, the inventor and
manufacturer of the technology. Biophan provides sales and marketing, and a
$25,000 quarterly advance, reconcilable against current year sales, to New
Scale, which enables New Scale to further develop unique capabilities for the
medical market. The motor is already on the market for non-medical applications
and evaluation units are being sold to customers around the world. The motor is
currently under review by several biomedical device manufacturers of drug pumps
and other devices. Biophan also acquired a minority equity interest in New Scale
for $100,000.
On February 5, 2004, we entered into a second 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
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. Only 6,000,000 shares covered by this stock purchase agreement
were registered for resale by SBI, because we previously had insufficient
authorized shares. SBI is not obligated to purchase the remaining shares covered
by the stock purchase agreement until we have registered the resale of such
shares by SBI and then only upon our election. Our stockholders approved the
proposal to amend our articles of incorporation to increase the number of
authorized shares and we will now decide whether to register additional shares
for resale by SBI, which will give us the right to sell such additional shares
under the stock purchase agreement. Until the shareholder approval, which allows
us to sell shares at the higher, $2 per share price, the SBI transaction was
less attractive. Now that we have the authorization, we have notified SBI that
we wish to exercise the first tranche of 2 million shares by the end of August
2004.
An additional factor influencing our decision to exercise all or part of the
remaining SBI financing involves negotiations with several biomedical device and
pharmaceutical companies, which may involve a combination of R&D development
and/or licensing payments, as well as a strategic investment in equity in our
company. Such an investment, should it occur, may resolve, in whole or in part,
our capital requirements for listing on a major stock exchange, as well as
providing us with working capital to continue our research, and possible
milestone payments. As a result, we intend to be prudent in our exercise of the
SBI line, even with its very attractive fixed price aspects.
11
Therefore, depending on the number of shares of stock that we sell to SBI under
the stock purchase agreement or a potential strategic investment, or a
combination thereof, the capital provided by such sales should enable us to
satisfy the net worth requirements for a planned stock exchange listing.
We estimate that our current working capital and proceeds from the sale of our
common stock pursuant to the SBI stock purchase agreement already registered,
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 $2,250,000
Operating expenses, including administrative
salaries and benefits, officee expenses,
rent expense, legal and accounting, publicity,
investor relations 1,500,000
----------
Total Cash Requirements $3,750,000
==========
These amounts include R&D and marketing for the ceramic motor and biothermal
battery projects, including additional human resources.
We have adopted and are following three major strategic initiatives for fiscal
2005:
(1) Acquisition of Intellectual Assets, (2) Market Expansion, and (3) Strategic
Partnerships.
(1)Biophan currently has an overall estate of 74 patents, inclusive of those
assigned and licensed, and including filed applications and allowed and issued
patents.
o From the perspective of ownership:
o (29) are licensed from Nanoset, LLC, Johns Hopkins University, and
Dr. Deborah Chung; these deal with MRI safety and compatibility, as
well as MRI contrast agents and other nanoparticles technology.
o (2) are licensed by TE Bio, LLC, which is in turn majority
controlled by Biophan; these deal with Biothermal Power technology.
o (43) are directly assigned to Biophan; these deal with MRI safety
and compatibility and a variety of other medical device
opportunities.
o Of the (74):
o (14) have issued as U. S. patents.
o (6) have been allowed and will issue as patents in the near future.
o (54) are patent applications in various stages of prosecution in the
USPTO.
In addition, New Scale Technologies has filed for patent protection on its
Squiggle Motor; Biophan has exclusive marketing and distribution rights
for medical applications of this technology, but this is not reflected in
the above numbers.
12
The patents also include those of our affiliates, such as Nanoset, LLC and TE
Bio LLC. Nanoset's technology can be used to reduce image artifacts on
implantable and interventional medical devices and for a new class of
applications to enhance the uptake, release and monitoring of drugs in medical
device coatings. TE Bio is developing our biothermal battery technology,
contributing to our patent growth.
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,licensed in, or purchased. To ensure the continuing value
of our intellectual assets, we intend to 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 pacemakers, safe for use with MRI and
other diagnostic imaging tools. We have also developed technologies that allow
medical devices to be used for interventional procedures, under MRI, without the
heating problems that can cause tissue damage or imaging problems which can
obscure the outcome of the procedures. Today most interventional procedures are
performed under X-Ray, cat-scan, or fluoroscopy and expose both physicians and
patients to ionizing radiation. Physicians need to wear heavy lead aprons that
can cause back problems, etc., and patients are sometimes exposed to substantial
radiation doses. If the MRI safety and compatibility issues of interventional
devices were solved and devices were on the market, we believe that there would
be a significant migration of procedures, over time, to use with MRI.
Based on discussions underway with several biomedical device manufacturers, and
MRI 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. Since the beginning of 2004 we have expanded our development
and partnering activities related to these technologies to include guidewires,
stents, drug pumps, biopsy needles and other prosthetic and surgical tool
devices, 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 based on our technology. We have used both
surrogate devices (such as copper rings) and actual manufactured implantable
products, in a gel phantom, to demonstrate our ability to accurately image
devices and their interior spaces in a manner that could not be done previously.
Part of our strategic initiative for the current fiscal year will include
expanding our technology offerings to the companies with whom we are already in
discussions or collaborating. These arrangements may include payments for R&D,
licensing, equipment and materials purchases, milestone payments, as well as
possibly strategic investments. Our goal is to reach positive cash flow as soon
as possible.
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.
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. We have begun
discussions with several manufacturers of contrast agents and others in the
diagnostic materials sector.
13
(3) Leveraging strategic partnerships is vital to our mission. In November,
2003, we announced that we had entered into a joint development agreement with
Boston Scientific, a major medical device manufacturer. We have successfully
completed the first phase of a multi-phase development plan with Boston
Scientific, and we are currently working in the second and third phases of this
program. Relationships such as this one help us validate our technology and also
develop 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. In addition, and in line
with our initiative of developing strategic partnerships, we recently acquired a
10% interest in New Scale Technologies, Inc. for $100,000 and signed an
exclusive worldwide distribution agreement for distribution of New Scale's
ceramic motor. The motor offers several advantages for driving drug pumps and
for other medical applications. Because the motor has ceramic components and no
windings, it is compatible with MRI imaging.
In November 2003, we recorded $75,000 as a development payment from Boston
Scientific for prototype development of a prospective product adaptation. The
development activities related to this payment have been completed. We are
currently in the second phase of this agreement and have received $225,000 as an
advance payment for the second and third phases which are underway. We are in
ongoing discussions concerning additional phases of this initiative that, which
if completed and successful, 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.
ITEM 3. CONTROLS AND PROCEDURES
Based on their evaluation as of the end of the period covered by this quarterly
report on Form 10-QSB, our principal executive officer and principal financial
officer, with the participation and assistance of our management, concluded that
our disclosure controls and procedures, as defined in Rule 13a-15(e) promulgated
under the Securities Exchange Act of 1934, were effective in design and
operation. There have been no changes in our system of internal control over
financial reporting in connection with the evaluation by our principal executive
officer and principal financial officer during our fiscal quarter ended May 31,
2004 that have materially affected, or are reasonably likely to materially
affect, our internal control over financial reporting.
14
PART II. OTHER INFORMATION
Item 1. 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.
Item 2. Changes in Securities and Use of Proceeds
During the three months ended May 31, 2004, the Company issued 919,599 shares of
common stock upon exercise of warrants, receiving aggregate gross proceeds of
$391,800. Of the total, 370,700 shares were issued at $.25 per share; 419,750
shares were issued at $.50 per share, and 39,899 shares were issued in
connection with cashless exercise of warrants.
Item 3. Defaults Upon Senior Securities
Not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
Not applicable.
Item 5. Other Information
Not applicable.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibit Index
No.
----
2.1 Articles of Merger Incorporated by reference
to Exhibit 3.2 to Biophan's
Form 10-KSB for the year
ended February 29, 2000
(the "2000 10-KSB")
2.2 Articles of Dissolution Incorporated by reference to
Exhibit 3.3 to the 2000
10-KSB
2.3 Exchange Agreement, dated as of Incorporated by reference
December 1, 2000, by and among to Exhibit 2.3 to Biophan's
Biophan, Biomed Solutions, LLC Registration Statement on
(formerly Biophan, LLC), and LTR Form SB-2 (File No.
Antisense Technology, Inc. 333-102526) (the "Prior
Registration")
3.1 Articles of Incorporation (Nevada) Incorporated by reference to
Exhibit 3.1 to the 2000
10-KSB
3.2 Bylaws (Nevada) Incorporated by reference to
Exhibit 3.2 to Biophan's Form
10-SB filed on May 13,1999.
3.3 Amendment to the Articles of Incorporated by reference
Incorporation to Exhibit 3.1(i)to Biophan's
Form 8-K, filed December 15,
2000.
3.4 Amendment to Exchange Agreement Incorporated by reference to
Exhibit 2 to Biophan's
Form 10-KSB for the year
ended February 28, 2001 and
filed as an exhibit to Form
SB-2a on May 1, 2003.
3.5 Certificate of Amendment to Incorporated by reference
Articles of Incorporation to Exhibit 3.1(i) to
Biophan's Form 8-K on
August 27, 2001.
4.1 Stock Purchase Warrant between Incorporated by reference
Biophan and Biomed Solutions, LLC to Exhibit 4.1 to Biophan's
(formerly Biophan, LLC) Form 10-QSB the period ended
dated for June 4, 2002 May 31, 200
4.2 Restated Stock Purchase Warrant Incorporated by reference to
between Biophan and Biomed Exhibit 4.3 to Biophan's Form
Solutions, LLC, dated January 8, 2003 10-QSB for the period ended
November 30, 2002.
4.3 Stock Purchase Warrant between Incorporated by reference
Biophan and Biomed Solutions, LLC to Exhibit 4.4 to Biophan's
dated November 11, 2002 Form 10-QSB for the period
ended November 30, 2002.
4.4 Form of Stock Purchase Warrant Incorporated by reference
issued to principals of Carolina to Exhibit 4.5 to Biophan's
Financial Services, for a total of Form 10-QSB for the period
121,572 shares ended November 30, 2002.
4.5 Form of Stock Purchase Warrant Incorporated by reference
issued to Carolina Financial to Exhibit 4.6 to Biophan's
services in connection with the Form 10-QSB for the period
Stock Purchase Agreement with ended November 30, 2002
Spectrum Advisors, Ltd
15
4.6 Form of Stock Purchase Warrant Incorporated by reference
issued to investors in private to Exhibit 4.7 to Biophan's
placement of securities, for a Form 10-QSB for the period
total of 2,770,550 shares ended November 30, 2002.
4.7 Registration Rights Agreement Incorporated by reference
dated February 10, 2004 by and to Exhibit 4.9 to Biophan's
among Biophan Technologies, Inc., Registration Statement on Form
Biomed Solutions, LLC and SBI SB-2 (File No. 333-112678) the
Brightline Consulting, LLC 2004 Registration").
10.1 Payment Agreement dated June 3, 2004 Incorporated by reference to
between Biophan and TE Bio LLC Exhibit 99.1 to Form 8-K dated
June 3, 2004.
31.1 Certification of C.E.O. pursuant Filed herewith
to Rule 13a-14(a)
31.2 Certification of C.F.O. pursuant Filed herewith
to Rule 13a-14(a)
32.1 Certification of C.E.O. Pursuant Filed herewith
to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002
32.2 Certification of C.F.O. Pursuant Filed herewith
to 18 U.S.C. Section 1350, as
Adopted Pursuant to Section 906 of
the Sarbanes-Oxley Act of 2002
(b) Reports on Form 8-K
The Company filed a Form 8-K dated May 14, 2004, reporting under Item 9,
Regulation FD Disclosure, that the Company had agreed to acquire a 51% ownership
interest in TE Bio LLC and to perform certain services for TE Bio. The purchase
agreement provides for the Company to invest $300,000 per year for three years.
The Company also filed a Form 8-K dated May 18, 2004, reporting under Item
9, Regulation FD Disclosure, that the Company held an Investor Conference Call
hosted by CEO Michael Weiner. A transcript of the call was attached as an
Exhibit.
SIGNATURES
In accordance with Section 13 or 15(d) of the Exchange Act, the registrant
caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
16
BIOPHAN TECHNOLOGIES,INC.
(Registrant)
Date: July 15, 2004
By: /s/ Michael L. Weiner
----------------------------------------
Name: Michael L. Weiner,
Title: Chief Executive Officer
By: /s/ Robert J. Wood
----------------------------------------
Name: Robert J. Wood
Title: Chief Financial Officer