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: August 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 October 5, 2004
Common Stock, $.005 par value 69,888,685
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, August 31, 2004 (Unaudited)
and February 29, 2004 4
Condensed Consolidated Statements of Operations, Three Months and
Six Months Ended August 31, 2004 and 2003 (Unaudited), and from
August 1, 1968 (Date of Inception) through August 31, 2004 (Unaudited) 5
Condensed Consolidated Statements of Cash Flows, Six Months Ended
August 31, 2004 and 2003 (Unaudited) and from August 1, 1968
(Date of Inception) through August 31, 2004 (Unaudited) 6
Notes to Condensed Consolidated Financial Statements 7
ITEM 2. Plan of Operation 10
ITEM 3. Controls and Procedures 15
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 16
ITEM 6. Exhibits and Reports on Form 8-K 16
a. Exhibit Index 16
b. Reports on Form 8-K 17
SIGNATURES 18
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 August 31,
2004, and the related condensed consolidated statements of operations for the
three-month and six-month periods ended August 31, 2004 and 2003, and the
statements of cash flows for the six-month periods ended August 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 United States generally accepted accounting
principles.
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' equity, 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
September 27, 2004
3
BIOPHAN TECHNOLOGIES, INC. AND SUBSIDIARIES
(A DEVELOPMENT STAGE COMPANY)
CONDENSED CONSOLIDATED BALANCE SHEETS
August 31, 2004 February 29, 2004
---------------------- -------------------
ASSETS (Unaudited)
-----------
Current Assets:
Cash $ 160,067 $ 823,900
Investments in marketable securities 430,000 1,150,000
Stock subscription receivable 1,100,000 -
Due from related parties 203,583 34,222
Prepaid expenses 118,072 69,185
---------------------- -------------------
2,011,722 2,077,307
Property and equipment, net 77,760 61,214
Other Assets:
Intellectual property rights 70,000 70,000
Investment 100,000 -
Security deposit 2,933 2,933
Deferred equity placement costs - 19,891
Deferred tax asset, net of valuation
allowance of $3,662,000 and $2,926,000,
respectively - -
---------------------- -------------------
172,933 92,824
---------------------- -------------------
$ 2,262,415 $ 2,231,345
====================== ===================
LIABILITIES AND STOCKHOLDERS' EQUITY
Current Liabilities:
Accounts payable and accrued expenses $ 270,767 $ 254,058
Deferred revenue 225,000 -
---------------------- -------------------
495,767 254,058
Stockholders' Equity :
Common stock, $.005 par value
Authorized, 125,000,000 shares
Issued and outstanding, 69,888,685 and
65,945,011 shares, respectively 349,443 329,725
Additional paid-in capital 15,363,162 13,339,289
---------------------- -------------------
15,712,605 13,669,014
Deficit accumulated during the
development stage (13,945,957) (11,691,727)
---------------------- -------------------
1,766,648 1,977,287
---------------------- -------------------
$ 2,262,415 $ 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
(date of
inception)
Three Months Ended Six Months Ended To
August 31, August 31, August 31,
----------------------------------- ------------------------------------- ------------------
2004 2003 2004 2003 2004
----------------- ----------------- ------------------ ------------------ ------------------
Revenues:
Development payments $ - $ - $ - $ - $ 75,000
Operating expenses:
Salaries and related 148,318 129,861 283,022 257,503 1,980,022
Research and development 573,846 201,786 1,000,061 439,889 4,675,892
Professional fees 128,894 149,567 194,766 255,676 2,771,857
Write-down of intellectual
property - - - - 530,000
General and administrative 499,592 119,709 867,487 224,445 2,630,163
----------------- ----------------- ------------------ ------------------ ------------------
1,350,650 600,923 2,345,336 1,177,513 12,587,934
----------------- ----------------- ------------------ ------------------ ------------------
Operating loss (1,350,650) (600,923) (2,345,336) (1,177,513) (12,512,934)
Other income(expense):
Interest expense - (134,413) - (244,664) (1,730,923)
Interest income 5,126 362 5,984 1,264 52,562
Other income 43,319 37,520 85,122 65,324 399,781
Other expense - - - - (65,086)
----------------- ----------------- ------------------ ------------------ ------------------
48,445 (96,531) 91,106 (178,076) (1,343,666)
----------------- ----------------- ------------------ ------------------ ------------------
Loss from continuing operations (1,302,205) (697,454) (2,254,230) (1,355,589) (13,856,600)
Loss from discontinued operations - - - - (89,357)
----------------- ----------------- ------------------ ------------------ ------------------
Net loss $ (1,302,205) $ (697,454) $ (2,254,230) $ (1,355,589) $ (13,945,957)
================= ================= ================== ================== ==================
Loss per common share-basic
and diluted $ (0.02) $ (0.02) $ (0.03) $ (0.04)
================= ================= ================== ==================
Weighted average shares outstanding 67,665,026 39,070,506 67,042,379 38,532,599
================= ================= ================== ==================
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
(date of
Six Months Ended inception)
August 31, to
2004 2003 August 31, 2004
------------------ ------------------ ------------------
Cash flows used for operating activities:
Net loss $ (2,254,230) $ (1,355,589) $ (13,945,957)
Adjustments to reconcile net loss to net cash
provided by operating activities:
Depreciation 11,993 11,528 76,166
Realized and unrealized losses on marketable
securities - - 66,948
Accrued interest on note converted to common stock - 11,998 11,998
Amortization of interest on convertible notes payable - 210,118 1,050,950
Write-down of intellectual property rights - - 530,000
Amortization of discount - related payable - - 75,000
Issuance of common stock for services - - 101,108
Issuance of common stock for interest - - 468,823
Grant of stock options for services 70,000 116,000 1,822,800
Expenses paid by stockholder - - 2,640
Changes in operating assets and liabilities:
(Increase)decrease in advances receivable - 10,127 -
(Increase)decrease in due from related parties (169,361) (34,193) (203,583)
(Increase)decrease in prepaid expenses (48,887) 11,991 (118,072)
Increase in security deposits - - (2,933)
Increase(decrease) in accounts payable and
accrued expenses 16,709 353,566 257,436
Increase(decrease) in due to related parties - 2,042 (43,496)
Increase in deferred revenues 225,000 - 225,000
------------------ ------------------ ------------------
(2,148,776) (662,412) (9,625,172)
------------------ ------------------ ------------------
Cash flows provided by investing activities:
Purchases of fixed assets (28,539) (18,690) (153,926)
Sales of marketable securities 720,000 302,000 1,939,270
Purchase of investment (100,000) - (100,000)
Purchases of marketable securities - - (2,436,218)
------------------ ------------------ ------------------
591,461 283,310 (750,874)
------------------ ------------------ ------------------
Cash flows provided by financing activities:
Proceeds of bridge loans - - 986,500
Loan from stockholder - - 143,570
Line of credit borrowing from related party - 175,000 550,950
Line of credit payments - - (72,500)
Proceeds from sales of capital stock 100,000 192,625 7,463,849
Exercise of options - 20,000 427,847
Exercise of warrants 788,900 - 1,121,744
Short swing profits 26,689 - 26,689
Deferred equity placement costs (22,107) (52,108) (112,536)
------------------ ------------------ ------------------
893,482 335,517 10,536,113
------------------ ------------------ ------------------
Net increase(decrease) in cash (663,833) (43,585) 160,067
Cash, beginning 823,900 48,935 -
------------------ ------------------ ------------------
Cash, ending $ 160,067 $ 5,350 $ 160,067
================== ================== ==================
Supplemental schedule of noncash investing and financing activities:
Common stock issued for subscription receivable $ 1,100,000 $ - $ 1,100,000
================== ================== ==================
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 $ 1,142,068
================== ================== ==================
Issuance of common stock upon conversion
of related party loans $ - $ 183,950 $ 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
AUGUST 31, 2004
INTERIM FINANCIAL STATEMENTS:
The condensed consolidated financial statements as of August 31, 2004 and for
the three-month and six-month periods ended August 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"), its wholly owned subsidiaries, LTR Antisense
Technology, Inc. ("Antisense") and Nanolution, LLC (formerly MRIC Drug Delivery
Systems, LLC) ("Nanolution") and its 51% owned subsidiary TE Bio LLC,
(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.
The Company was inactive until December 1, 2000, when the LTR Antisense
Technology, Inc., a New York corporation ("LTR"), was acquired 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. LTR owns multiple patents for
proprietary HIV antisense gene therapy technology. At the same time, the Company
acquired intellectual property rights, including a pending patent to
MRI-compatible pacemaker technology from Biomed, for future consideration of
$500,000.
PRINCIPAL BUSINESS ACTIVITIES:
The Company is in the development stage and is expected to remain so for at
least the next several quarters.
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.
7
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 Six Months Ended
August 31, August 31,
2004 2003 2004 2003
----------------- --------------- ------------------ ------------------
Net loss - as reported $ (1,302,205) $ (697,454) $ (2,254,230) $ (1,355,589)
Add: Stock-based employee compensation expense
included in reported net loss, net of
related tax effects 40,000 30,000 70,000 60,000
Deduct: Total stock-based employee compensation
expense determined under fair value based
method for all awards, net of related tax
effects (67,000) (64,000) (129,000) (114,000)
----------------- --------------- ------------------ ------------------
Net loss - pro forma $ (1,329,205) $ (731,454) $ (2,313,230) $ (1,409,589)
================= =============== ================== ==================
Basic and diluted loss per share - as reported $ (.02) $ (.02) $ (.03) $ (.04)
================= =============== ================== ==================
Basic and diluted loss per share - pro forma $ (.02) $ (.02) $ (.03) $ (.04)
================= =============== ================== ==================
PREPAID EXPENSES:
Prepaid expenses at August 31, 2004 consist of the following:
Prepaid royalties $ 25,000
Prepaid legal fees 20,000
Prepaid insurance 54,947
Prepaid supplies 18,125
-------
$ 118,072
=======
8
INVESTMENT:
Represents a 10% investment in common stock of New Scale Technologies, Inc.,
stated at cost.
DEFERRED REVENUE:
Represents development payments received from a strategic partner which will be
recognized as revenue upon completion of the deliverables outlined in the
contract.
CHANGES IN EQUITY:
At the Annual Stockholders Meeting on July 13, 2004, stockholders approved an
increase in the authorized shares of common stock from 80,000,000 to
125,000,000.
During the quarter ended August 31, 2004, a total of 1,024,075 shares of common
stock were issued upon exercise of warrants at prices ranging from $.25 to
$1.00. Proceeds of $397,100 were received increasing the capital stock account
by $5,120 and additional paid-in capital by $391,980. Additional paid-in capital
was also increased by $40,000 of expense related to stock options granted for
services and by part payment of $26,689 of profits from a related company owed
pursuant to the "short swing profit" rules of Section 16(b) of the Securities
and Exchange Act of 1934.
During the quarter, the Company exercised the first tranche under the SBI
financing agreement for 2,000,000 shares @ $.60 per share. Of this amount,
$100,000 was received in August and the balance in September 2004. Related
offering expenses of $41,998 were charged to additional paid-in capital.
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 several quarters. Our primary mission is to develop
and commercially exploit technologies for enabling biomedical devices, both
implantable and those used in diagnostic and interventional procedures, to be
safe (not harm the patient or physician) and compatible (allow effective imaging
of the device and its surrounding tissue) with MRI.
We have successfully demonstrated effective solutions for making devices which
use long metal wire leads, such as pacemakers, defibrillators, neurostimulators,
et al. safe for use with MRI and that these solutions provide a meaningful
margin of safety. Our solutions address both the problems of device heating and
induced voltages in pacemakers, defibrillators, and neurostimulators, which are
the two primary problems associated with the use of MRI for patients with these
devices. Today, approximately 3 million people have devices that cause them to
be denied access to MRI when needed, due to safety concerns and regulatory (FDA
and other) contraindications. If manufacturers of these devices incorporated our
solutions into their products, they can be made safe for use with MRI.
Additionally, there is a rapidly growing field of medicine known as minimally
invasive surgery, using devices such as guidewires and catheters to do many
procedures in cardiology, oncology and other specialties. The majority of
procedures are done in catheter labs equipped with X-ray or fluoroscopy devices
for imaging and guiding the procedures. Many of these devices do not offer the
advantages of tissue visualization and discrimination provided by MRI. The
combined problems of device safety (they heat up and may induce electrical
stimulation) and the image artifacts created by these devices in MRI, have
limited the use of MRI machines in this rapidly growing area of medicine. The
desire and need for MRI is demonstrated by the advent of catheter labs which
have both X-ray devices for guiding devices into the body, and MRI machines for
evaluating progress and observing tissue and results. In these new operating
theaters, the patients are moved back and forth on a conveyor belt-like system
between the imaging devices.
For the past four years, Biophan has been actively engaged in solving the
complex problems associated with device safety and imaging under MRI that cause
this odd and expensive combination of devices so that, with the advent of our
solutions, the industry now, for the first time, has the choice to develop MRI
safe and image compatible devices that can be used with MRI.
Biophan has two solutions for resolving the heating of braided metal wire
objects such as pacemaker leads (in which we include pacemaker and defibrillator
leads) and neurostimulator leads (including deep brain stimulation, or DBS,
systems for Parkinson's and epilepsy; systems for pain control, etc.). One
solution is an RF filter, licensed from Johns Hopkins exclusively for
implantable devices, which can resolve lead heating (it is the metal wire lead
connecting a device to the body that is the cause of most of the MRI safety
problems). Additionally, to resolve the problems associated with very long metal
wires such as surgical guidewires and catheters, we have been engaged in
previously secret work within Biophan to develop "anti-antenna geometries" in
these leads. By slightly altering the way the leads are made, we can create
self-canceling attributes that resolve the radio frequency related problems that
cause the heating in the lead. An additional anti-antenna geometry significantly
reduces induced voltages. Together, these solutions allow making an MRI-safe
lead and device. Several broad patents for this innovation were filed several
years ago, and recently the U.S. Patent and Trademark Office allowed a patent
which will issue within the next several weeks. As a result, we have now gone
public with our solutions, and we have demonstrated the success of this approach
to prospective customers and industry experts. We have begun manufacturing
samples of devices modified with this solution, which is extremely cost
effective. We have modified a pacemaker lead for a pacemaker company concerned
with pacemaker safety, which is currently being evaluated by that company.
This modification of the windings of a metal device has broad application. It
can also address a significant limitation associated with virtually all stents,
medical devices used to keep vessels open. It is very difficult to see inside
the stent to determine if blockage is occurring, once the stent is installed in
the body. Currently, no diagnostic systems such as X-ray or fluoroscopy are
effectively able to see inside of a stent.
We have demonstrated that we can make stents visible within an MRI machine using
this method. It works. Researchers in Europe have also demonstrated at
conferences that this approach works, and there are some stents shipping in
Europe using this approach. The solution requires a change in the way most
stents are made. We recently filed nine continuations of our original patent
application, applying this innovation to other devices, such as stents,
guidewires and catheters. The stent, guidewire and catheter businesses are very
large and have many players who compete with one another for competitive
advantage. This solution to both heating and stent imaging has broad
implications.
10
Additionally, our primary work for resolving image artifacts that occur when
imaging devices in the body with MRI uses thin film nanomagnetic particle
coatings, developed by Nanoset, LLC, in collaboration with Biophan. We recently
produced MRI images showing an aluminum rod which could not be seen in the MRI
image, and next to it showed two identical rods which were quite visible, as a
result of having our thin film coating applied. Additionally, the tip of these
rods had a bright "glow", making it easy to spot in the MRI image. This image is
available from our web site at www.biophan.com. This capability is part of the
suite of technologies that can help make MRI a viable solution for
interventional diagnostics and surgery. Once again, we have a solution that
works, covered by both issued and pending patents. We are also working on
coatings that can improve visibility under MRI using thin film coatings
described above. The advantage of a coating solution is that a manufacturer with
a product in the market or in development does not have to radically change the
physical design manufacturing process. Thus, the coating solution, which we are
pursuing, has broad applications for the rapidly growing stent market.
There is considerable industry interest in these approaches to making devices
imageable under MRI. The solution has to be applied to the device itself, and is
not something that can be incorporated in the MRI machine. However, the solution
is of interest to MRI manufacturers we have met with, all of whom benefit from
seeing the aforementioned expansion in the use of MRI for interventional
medicine and expanded diagnostics (as with stents, and other applications). MRI
is also used extensively in oncology, due to its ability to discriminate tissue
types.
Image compatibility also has benefits to the pacemaker device manufacturers. The
goal of making pacemakers safe for MRI is to allow a pacemaker patient who may
need an MRI scan for staging a cancer operation, and subsequent follow-up, or to
diagnose a brain tumor, or back or knee problem, etc. However, a device made
safe will still cause a significant image artifact where the pacing lead enters
the heart or, in the case of a neurostimulator, where that device lead enters to
brain, or the spinal cord, etc. By adding "image compatibility" to a pacemaker
made safe, it may be possible to enable a pacemaker patient to one day have an
MRI angiogram, and avoid having to have an invasive procedure. Similarly, a
patient with a Deep Brain Stimulator (DBS) device can undergo a full power MRI
of the brain if their lead is not only safe, but also image compatible.
As a result of the growing awareness of the problems outlined here and our broad
patent portfolio, we are seeing an increased interest from the medical device
industry in our solutions. We are in various stages of discussions and
negotiations with several companies regarding the utilization of our technology.
The value to our prospective customers is competitive advantage with the
potential to gain increased market share, which is the strategy behind all of
Biophan's initiatives.
On June 3, 2004, we acquired a 51% interest in TE Bio LLC, a company developing
an implantable biothermal battery using body heat gradients 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 from which
Biophan spun out in December 2000. The independent board members of Biophan
evaluated the technology and authorized the acquisition, after conclusion of a
third party feasibility study.
To manage the growing R&D and customer interactions in the MRI technology
business and the biothermal business, we have expanded our staff to support
these projects.
John Lanzafame, an experienced medical device executive, who joined Biophan in
September as President of Biophan's new Nanolution division, focused on
leveraging recent discoveries in nanotechnology such as Biophan's nanomagnetic
particles for the purposes of drug delivery and drug elution from devices. Mr.
Lanzafame has 15 years experience in the medical device industry, most recently
as President of STS Biopolymers, a company specializing in customized surfaces,
including drug eluting coatings for stents and indwelling catheters. STS
Biopolymers was acquired in late 2003 by Angiotech Pharmaceuticals, which
licensed the use of paclitaxel on stents to Boston Scientific. Mr. Lanzafame has
experience in drug delivery, product development and sales and marketing, and
will bring his breadth of experience both to the newly formed drug delivery
division, as well as to assist in development and marketing of the MRI-related
products.
We have retained Tim Bibens, formerly Director of Operations for the Ortho
Clinical Diagnostics, a J & J company, and prior to that a Supply Chain Manager
at Allied Signal, to oversee our MRI safety and image compatibility projects,
reporting to Jeff Helfer, our VP-Engineering.
11
Sarah Cooper, a research fellow and chemical engineer at NASA's Ames Center for
Nanotechnology, has been an active participant in the biothermal battery
project. Ms. Cooper's fellowship ends in September 2004, and we have extended
an offer to her to work with us as a consultant on the biothermal battery
project.
We have retained additional technical consultants to augment our staff's
research and development efforts on the MRI safety and compatibility project and
the biothermal battery project.
We do most of our thin film coating research and development at Alfred
University, in coordination with Nanoset, LLC. To facilitate this, we have
helped Alfred construct a clean room facility to be used for our coating
experiments and sample preparation.
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 $100,000 investment in the company for a 10% interest. 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 dialogue with both 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.
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 unregistered 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 stockholder approval, which allows
us to sell shares at the higher $2 per share price, the SBI transaction was less
attractive. During the quarter ended August 31, 2004, we sold the first tranche
of 2 million shares for $1.2 million.
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
provide 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. One of the companies we are
working with is preparing a term sheet, and one of the terms that is being
negotiated will be an equity investment in the company which will require that
we issue preferred stock. As a result, we are in the process of calling a
special meeting of stockholders to seek approval for reducing the number of
authorized common shares by 15 million and establishing an equal number of
authorized preferred shares.
12
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 or
a potential equity investment from a strategic relationship, will be 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(including R&D and marketing for the
ceramic motor and biothermal battery projects, including additional
human resources) $1,732,000
Operating expenses, including administrative salaries and benefits,
office expenses, rent expense, legal and accounting, publicity,
investor relations 2,204,000
----------
Total Cash Requirements $3,936,000
==========
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 92 patents, inclusive of those
assigned and licensed, and including filed applications and allowed and issued
patents.
From the perspective of ownership:
o 35 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 3 are licensed by TE Bio LLC, which is in turn majority controlled by
Biophan; these deal with biothermal power technology.
o 1 is a patent applied for by New Scale Technologies, Inc. covering a
miniature ceramic motor. Biophan has exclusive marketing and distribution
rights for medical applications of this technology.
o 53 are directly assigned to Biophan; these deal with MRI safety and
compatibility and a variety of other medical device opportunities.
Of the 92:
o 21 have issued as U. S. patents.
o 7 have been allowed and will issue as patents in the near future.
o 64 are patent applications in various stages of prosecution in the USPTO.
The patents also include those licensed from Nanoset, 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.
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, CT 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.
13
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 an 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
possible strategic investments.
An 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 MRI 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. The ability to
bind different, distinct markers to different antigens allows the potential for
highlighting multiple features of interest, making them differentiable under
MRI. We have begun discussions with several manufacturers of contrast agents and
others in the diagnostic materials sector.
(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 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. We are in discussion
with Boston Scientific for an expanded relationship involving license fees,
milestones and royalties.
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 thirteen 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.
14
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 August
31, 2004 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
During the three months ended August 31, 2004, the Company issued 1,024,075
shares of common stock upon exercise of warrants, receiving aggregate gross
proceeds of $397,100. Of the total, 498,000 shares were issued at $.25 per
share; 506,950 shares were issued at $.50 per share, and 19,125 shares were
issued at $1.00 per share. The Company also exercised the first tranche under a
financing agreement with SBI Brightline Consulting, LLC issuing 2,000,000 shares
at $.60 per share for gross proceeds of $1,200,000.
ITEM 3. DEFAULTS UPON SENIOR SECURITIES
Not applicable.
ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
On Tuesday, July 13, 2004, pursuant to proper notice to stockholders, the
Company held its Annual Meeting of Stockholders at the Company's offices in West
Henrietta, New York. At the Meeting, the following directors were elected, by
the indicated vote, to serve as directors until the next Annual Meeting of
Stockholders or until their successors are elected and qualified.
Nominee For Abstain
----------------------------------------------------------------------------
Guenter H. Jaensch 44,959,177 61,189
Michael L. Weiner 44,956,977 63,389
Steven Katz 44,974,191 46,175
Ross B. Kenzie 44,978,561 41,805
Robert S. Bramson 44,972,191 48,175
A proposal was also made to amend the Company's Articles of Incorporation to
increase the number of common shares authorized to be issued from 80,000,000 to
125,000,000 shares. The proposal carried by a vote of 43,924,431 for, 952,235
against and 91,700 abstaining.
A proposal to increase the number of shares reserved for issuance under the 2001
Stock Option Plan from 7,000,000 to 13,000,000 was approved by a vote of
9,178,761 for, 1,312,206 against and 132,514 abstaining.
Lastly, stockholders ratified the appointment of Goldstein Golub Kessler, LLP,
as independent auditors of the Company for the fiscal year ending February 28,
2005 by a vote of 44,928,302 for, 23,050 against and 17,014 abstaining.
15
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.
16
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
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 June 3, 2004, reporting under Item 2,
Acquisition or Disposition of Assets, that the Company executed final agreements
for the acquisition of a 51% ownership interest in TE Bio LLC, a newly formed
limited liability company that acquired an exclusive license to certain
technology from Biomed Solutions, LLC, a related company. On September 21, 2004,
the Company filed a Form 8-K/A, reporting under Item 9.01, Financial Statements
and Exhibits, the audited financial statements of TE Bio LLC and related pro
forma financial information.
The Company filed a Form 8-K dated June 29, 2004, reporting under Item 9,
Regulation FD Disclosure, that the Company's CEO, Michael L. Weiner, presented
at the Strategic Research Institute's Medical Device Investor and Corporate
Development Conference. A transcript of the presentation was attached as an
Exhibit.
17
A Form 8-K dated July 13, 2004 was filed reporting under Item 9, Regulation FD
Disclosure, that at the Annual Stockholders Meeting on July 13, 2004, it was
announced that John Lanzafame, former President of STS Polymers, which was
acquired by Angiotech Pharmaceuticals, is leading Biophan's efforts for the use
of the Company's nanomagnetic particle coating technology for drug delivery
applications. The Company also announced that Nanoset, LLC, its nanomagnetic
particle technology partner, had filed several patents on the technology.
A Form 8-K dated August 19, 2004 was filed reporting under Item 7.01, Regulation
FD Disclosure, that the Company held an Investor Conference Call hosted by CEO
Michael Weiner. A transcript of the conference 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.
BIOPHAN TECHNOLOGIES, INC.
(Registrant)
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
Date: October 6, 2004
18