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: November 30, 2003
[ ] 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
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(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
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(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 January 12, 2004
Common Stock, $.005 par value 57,004,071
Transitional small Business Disclosure Format (Check One): Yes[ ] No[x]
1
INDEX
Page
Number
PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements
Independent Accountant's Report 3
Condensed Consolidated Balance Sheets, November 30, 2003 (Unaudited)
and February 28, 2003 4
Condensed Consolidated Statements of Operations, Three Months and Nine
Months Ended November 30 , 2003 and 2002 (Unaudited), and from August 1,
1968 (Date of Inception) through November 30, 2003 (Unaudited) 5
Condensed Consolidated Statements of Cash Flows, Nine Months Ended
November 30, 2003 and 2002 (Unaudited) and from August 1, 1968
Date of Inception) through November 30, 2003 (Unaudited) 6
Notes to Condensed Consolidated Financial Statements 7
ITEM 2. Plan of Operation 12
ITEM 3. Controls and Procedures 14
PART II. OTHER INFORMATION 15
ITEM 1. Legal Proceedings 15
ITEM 2. Changes in Securities and Use of Proceeds 15
ITEM 3. Defaults Upon Senior Securities 15
ITEM 4. Submission of Matters to a Vote of Security Holders 15
ITEM 5. Other Information 15
ITEM 6. Exhibits and Reports on Form 8-K 15
a. Exhibits 15
b. Reports on Form 8-K 17
SIGNATURES 18
2
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements
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 November 30, 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
3
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
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Total Current Assets 205,280 476,353
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Fixed Assets, at cost, net 67,418 63,232
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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 $2,120,000
respectively - -
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72,933 143,471
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$ 345,631 $ 683,056
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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
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Total Current Liabilities 867,092 796,187
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Long-term payable to related party,
less discount 333,334 83,333
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Stockholders' Deficiency:
Common stock, $.005 par value
Authorized, 80,000,000 shares
Issued and outstanding,
46,004,071 shares and
37,634,693 shares, respectively 230,020 188,173
Additional paid-in capital 8,971,650 7,588,520
Deficit accumulated during the
development stage (10,056,465) (7,973,157)
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(854,795) (196,464)
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$ 345,631 $ 683,056
================================================================================
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
Three Months Ended Nine Months Ended 1, 1968 (date of
November, 30, November 30, inception) 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 2,236,625
Write-down of intellectual
property rights - - - - 530,000
General and administrative 198,727 111,321 423,173 398,930 1,507,427
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670,114 558,409 1,847,627 2,104,446 8,938,783
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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)
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(132,604) (115,340) (310,681) (209,280) (1,103,325)
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Loss from continuing
operations (727,718) (673,749) (2,083,308) (2,313,726) (9,967,108)
Loss from discontinued
operations - - - - (89,357)
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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.
5
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 November 30, 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)
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(1,186,476) (1,696,977) (6,136,012)
Cash flows provided by 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)
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280,375 532,049 (192,335)
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) -
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925,998 1,180,782 6,397,179
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Net increase in cash 19,897 15,854 68,832
Cash, beginning 48,935 12,199 -
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Cash, ending $ 68,832 $ 28,053 $ 68,832
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Supplemental schedule of noncash investing
and financing activities:
Intellectual property acquired through
issuance of capital stock and
assumption of related party payable - - $175,000
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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.
6
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:
7
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.
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 $ (762,718) $ (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 consisted of the following:
8
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.
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
9
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.
Item 2. PLAN OF OPERATION
The following information should be read in conjunction with the consolidated
financial statements and notes thereto appearing elsewhere in this Form
10-QSB. This Quarterly Report on Form 10-QSB contains certain forward-looking
statements within the meaning of Section 27A of the Securities Act of 1933 and
Section 21E of the Securities Exchange Act of 1934. Actual events or results
may differ materially from those projected in the forward-looking statements
as a result of a number of factors including those identified herein and in
the Company's Annual report on Form 10-KSB and other periodic reports and
filings with the Securities and Exchange Commission.
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 life sustaining medical devices to be safe and compatible with MRI
and other equipment that generates powerful magnetic and radio frequency
signals. . 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 imaging
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 manufacturers, once provided with adequate
additional compelling evidence of both the danger and the efficacy of our
solution, will wish to avoid potential liabilities from death and/or injuries
that may occur as a result of devices offered for sale after knowledge of our
solutions was available, and failed to be taken advantage of, and will wish to
incorporate our solution into their products.
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 in
10
six tranches for gross proceeds of $2,900,000.
In addition to the stock purchase agreement with SBI, we have been a party to
a restated stock purchase agreement with Spectrum Advisors LTD. Pursuant to
the Spectrum agreement, we have 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. The purchase price for shares
purchased under the Spectrum agreement is 80% of the average daily volume
weighted average price of our common stock during the trading days relating to
a particular draw. Spectrum is currently committed to purchase shares for
consideration of up to $3 million under the Spectrum agreement. We have
registered for resale by Spectrum 8,960,000 shares of common stock that we
may sell to Spectrum pursuant to the Spectrum agreement. As of the current
date, we have sold Spectrum 3,325,757 shares for aggregate consideration of
$491,190. Effective with the registration of the new SBI Brightline $5.5
million financing, Biophan will terminate the unutilized remainder of the
earlier Spectrum financing, and these shares will be allocated for purchase by
SBI Brightline under the new financing.
We estimate that the equity financing from the sale of our common stock
pursuant to the 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
Partially repay related party loans plus interest 390,000
Pay down past-due accounts payable 200,000
----------------------------------------------------------------
Total Cash Requirements $2,700,000
================================================================
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 licenses, 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
11
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 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.
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. Another example of our
expanding on the use of existing, licensed 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.
12
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 of our technologies.
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.
New Accounting Standards
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.
Application of Critical Accounting Policies and Estimates
The preparation of financial statements and related disclosures in conformity
with accounting principles generally accepted in the United States of America
requires management to make estimates and assumptions that affect the reported
amounts of assets and liabilities, the disclosure of contingent assets and
liabilities at the date of the financial statements and revenues and expenses
13
during the period reported. The following accounting policies involve a
"critical accounting estimate" because they are particularly dependent on
estimates and assumptions made by management about matters that are highly
uncertain at the time the accounting estimates are made. In addition, while we
have used our best estimates based on facts and circumstances available to us
at the time, different estimates reasonably could have been used in the
current period, or changes in the accounting estimates we used are reasonably
likely to occur from period to period which may have a material impact on the
presentation of our financial condition and results of operations. We review
these estimates and assumptions periodically and reflect the effects of
revisions in the period that they are determined to be necessary.
Acquired Intangibles
Acquired intangibles are reviewed for impairment whenever events such as a
significant industry downturn, product discontinuance, product disposition,
technology obsolescence or other changes in circumstances indicate that the
carrying amount may not be recoverable. When such events occur, we compare the
carrying amount of these assets to their undiscounted expected future cash
flows. If this comparison indicates that there is an impairment, the amount of
the impairment is calculated using discounted expected future cash flows. Our
estimates of undiscounted and discounted future cash flows are dependent upon
many factors, including general economic trends, industry trends, and
technological developments. It is reasonably likely that future cash flows
associated with these assets may exceed or fall short of our current
estimates, in which case a different amount for our intangible assets and
the related impairment charge would have resulted. If our actual cash flows
exceed our estimates of future cash flows, there would be no change to our
previously recognized impairment charge although, it may indicate that the
amount of the impairment was greater than needed. If our actual cash flows are
less than our estimates of future cash flows, we may need to recognize an
additional impairment in future periods, which would be limited to the current
carrying value of our acquired intangible assets.
Tax Valuation Allowance
A tax valuation allowance is established, as needed, to reduce net deferred
tax assets to the amount for which recovery is probable. We have established a
full valuation allowance against our net deferred tax assets because our lack
of revenues and our recurring losses as a development stage company cause our
long term financial forecast to have enough uncertainty that we do not meet
the standard of "more likely than not" that is required for measuring the
likelihood of realization of net deferred tax assets. In the event it becomes
more likely than not that some or all of the deferred tax assets will be
realized, our valuation allowance will be adjusted. Depending on the amount
and timing of taxable income we ultimately generate in the future, as well as
other factors, we could recognize no benefit from our deferred tax assets, in
accordance with our current estimate, or we could recognize their full value.
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
14
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 November 30, 2003 that have materially affected, or are
reasonably likely to materially affect, our internal control over financial
reporting.
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
Between July 12, 2003 and November 30, 2003 we issued an aggregate of
3,325,757 shares of our common stock to Spectrum Advisors, Ltd. in connection
with the restated stock purchase agreement dated as of November 22, 2002
between us and Spectrum. We received aggregate proceeds of $491,190 from our
sale of these shares to Spectrum. In connection with such sales, we are
obligated to issue to Carolina Financial Services, LLC warrants to purchase
166,288 shares of our common stock at an average exercise price of $.16.
These transactions were exempt from registration under Section 4(2) of the
Securities Act because they did not involve any public offering.
Item 3. Defaults Upon Senior Securities
This Item is not applicable.
Item 4. Submission of Matters to a Vote of Security Holders
This Item is not applicable
Item 5. Other Information
This Item is not applicable.
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit No. Exhibit Description Location
-------------------------------------------------------------------------------
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
15
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. 333-
Antisense Technology, Inc. 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
(formerly Biophan, LLC) dated June Biophan's Form 10-QSB for
4, 2002 the period ended May 31,
2002.
4.2 Restated Stock Purchase Warrant Incorporated by reference
Biophan and Bonanza Capital to Exhibit 4.2 to
Masterfund LTD Biophan's Form 10-QSB for
the period ended May 31,
2002.
4.3 Restated Stock Purchase Warrant Incorporated by reference
between Biophan and Biomed to Exhibit 4.3 to
Solutions, LLC, dated January 8, Biophan's Form 10-QSB for
2003 the period ended November
30, 2002.
4.4 Stock Purchase Warrant between Incorporated by reference
Biophan and Biomed Solutions, LLC to Exhibit 4.4 to Biophan's
16
dated November 11, 2002 Form 10-QSB for the period
ended November 30, 2002.
4.5 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.
4.6 Form of Stock Purchase Warrant to Incorporated by reference
be 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
4.7 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.
10.1 Stock Purchase Agreement dated Incorporated by reference
October 1, 2003 between Biophan to Exhibit 10.50 to
and SBI Brightline Consulting, Biophan's Form SB-2 on
LLC. October 9, 2003.
10.2 Development Agreement between Incorporated by reference
Biophan and Alfred University to Exhibit 10.51 to
dated July 17, 2003 Biophan's Form SB-2 on
October 9, 2003.
31.1 Certification by Chief Executive Filed herewith
Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002
31.2 Certification by Chief Financial Filed herewith
Officer pursuant to Section 302
of the Sarbanes-Oxley Act of 2002.
32.1 Certification by Chief Executive Filed herewith
Officer and Chief Financial Officer
pursuant to 18 U.S.C. Section 1350,
as adopted pursuant to Section 906
of the Sarbanes-Oxley Act of 2002
(b) Reports on Form 8-K
The Company filed Form 8-K dated October 1, 2003 reporting under Item 5,
Other Events and Regulation FD Disclosure, that the Company had entered
into a Stock Purchase Agreement with SBI Brightline Consulting, LLC
("SBI") obligating SBI to purchase, upon the Company's election, up
to 11,000,000 shares of the Company's common stock for an aggregate
purchase price of $2.9 million.
17
SIGNATURES
In accordance with the requirements of the Exchange Act, the registrant
has duly caused this report to be signed on its behalf by the undersigned,
thereunto duly authorized.
BIOPHAN TECHNOLOGIES,INC.
(Registrant)
Date: January 14, 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
18