U.S. SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-QSB
[X] Quarterly report under Section 13 of 15(d) of the Securities Exchange
Act of 1934.
For the quarterly period ended NOVEMBER 30, 2001 or
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[ ] Transition report under Section 13 or 15(d) of the Securities Exchange
Act of 1934 for the transition period from to
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Commission file number 0-19866
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PROTIDE PHARMACEUTICALS, INC.
(Exact name of small business issuer
as specified in its charter)
MINNESOTA 36-3384240
- ------------------------------- ----------------------
(State or other jurisdiction of (I.R.S. Employer
incorporation or organization) Identification Number)
1311 HELMO AVENUE, SAINT PAUL, MINNESOTA 55128
- -------------------------------------------------- ----------------------
(Address of principal executive offices) (Zip Code)
Issuers telephone number, including area code: (651) 730-1500
Check whether the issuer (1) has filed all reports required to be filed by
Section 13 or 15(d) of the Securities Act of 1934 during the past 12 months (or
for such shorter periods that the issuer was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days.
Yes _X_ No___
State the number of shares outstanding of each the issuer's classes of common
equity, as of the latest practicable date.
THE NUMBER OF SHARES OF COMMON STOCK, PAR VALUE $.01 PER SHARE, OUTSTANDING ON
DECEMBER 31, 2001 WAS 3,733,169.
Transitional small business format disclosure:
Yes ___ No_X_
1
Table of Contents
PROTIDE PHARMACEUTICALS, INC.
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Report on Form 10-QSB
for fiscal quarter ended
November 30, 2001
PART I - FINANCIAL INFORMATION Page
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ITEM 1. Financial Statements
Balance Sheet as of August 31, 2001
and November 30, 2001 3
Statement of Operations -- Three months ended
November 30, 2001 and November 30, 2000 5
Statement of Changes in Shareholders' Equity
for the year ended August 31, 2001 and the
three months ended November 30, 2001 6
Statement of Cash Flows -- Three months ended
November 30, 2001 and November 30, 2000 7
Notes to Financial Statements 8
ITEM 2. Management's Discussion and Analysis of Financial
Conditions and Results of Operations 9
PART II-- OTHER INFORMATION 14
2
PART I -- FINANCIAL INFORMATION
ITEM 1 - FINANCIAL STATEMENTS
PROTIDE PHARMACEUTICALS, INC.
BALANCE SHEET
November 30, August 31,
ASSETS 2001 2001
----------- -----------
(Unaudited)
CURRENT ASSETS
Cash and cash equivalents $ 146,145 $ 197,200
Certificates of deposit 175,000 215,000
Trade receivables 23,436 26,448
Accrued interest receivable 5,731 6,074
Inventories 53,940 52,711
Other 2,878 1,593
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Total current assets 407,130 499,026
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EQUIPMENT AND LEASEHOLD IMPROVEMENTS
Laboratory and production equipment 226,937 226,937
Office furniture and equipment 94,822 94,822
Leasehold improvements 138,426 138,426
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460,185 460,185
Less accumulated depreciation 390,719) (383,622)
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69,466 76,563
OTHER ASSETS
Patents, net 47,462 48,340
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TOTAL ASSETS $ 524,058 $ 623,929
========== ==========
See Notes to Financial Statements.
3
PROTIDE PHARMACEUTICALS, INC.
BALANCE SHEET
November 30, August 31,
LIABILITIES AND SHAREHOLDERS' EQUITY 2001 2001
----------- ----------
(Unaudited)
CURRENT LIABILITIES
Accounts payable $ 8,423 $ 12,174
Accrued liabilities 29,057 53,563
Bank note payable - current 71,680 72,157
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Total current liabilities 109,160 137,894
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SHAREHOLDERS' EQUITY
Common stock issued and outstanding 37,332 37,332
Common stock subscribed 2,109 1,577
Additional paid-in capital 5,793,141 5,768,669
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5,832,582 5,807,578
Accumulated deficit (5,417,684) (5,321,543)
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Total shareholders' equity 414,898 486,035
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TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY $ 524,058 $ 623,929
========== ==========
See Notes to Financial Statements.
4
PROTIDE PHARMACEUTICALS, INC.
STATEMENT OF OPERATIONS
(Unaudited)
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Three months ended
November 30,
2001 2000
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REVENUES
Net sales $ 43,695 $ 48,719
Cost of products sold 20,946 20,883
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GROSS MARGIN 22,749 27,836
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OPERATING EXPENSES
Research and development 35,621 35,391
Marketing and sales 29,369 24,933
Administration 54,994 64,716
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Total operating expenses 119,984 125,040
OPERATING LOSS (97,235) (97,204)
OTHER INCOME (EXPENSE)
Interest and investment income 2,116 7,422
Other income 0 20,539
Interest expense (1,022) (1,037)
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Total other income, net 1,094 26,924
NET LOSS ($ 96,141) ($ 70,280)
===========================================================================
BASIC AND DILUTED LOSS PER
COMMON SHARE ($ 0.03) ($ 0.02)
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WEIGHTED AVERAGE NUMBER OF
COMMON SHARES OUTSTANDING 3,733,169 3,683,169
===========================================================================
See Notes to Financial Statements.
5
PROTIDE PHARMACEUTICALS, INC.
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
(Unaudited)
Balance at
Balance at Shares Net loss for November 30,
August 31, 2001 Subscribed the period 2001
- -------------------------------------------------------------------------------------------------
Common Stock
Shares 3,733,169 3,733,269
Amount $ 37,332 $ 37,332
Common Stock Subscribed
Shares 157,659 53,200 2,108,598
Amount $ 1,577 532 $ 2,109
Additional Paid- in Capital $ 5,768,669 24,472 $ 5,793,141
Accumulated Deficit ($5,321,543) (96,141) ($5,417,684)
- -------------------------------------------------------------------------------------------------
Total $ 486,035 $ 25,004 ($ 96,141) $ 418,898
See Notes to Financial Statements.
6
PROTIDE PHARMACEUTICALS, INC.
STATEMENT OF CASH FLOWS
(Unaudited)
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Three months ended
November 30,
----------------------
2001 2000
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CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss for the period ($ 96,141) ($ 70,280)
Adjustments to reconcile net loss to
Net cash used in operating activities:
Depreciation and amortization 7,975 8,153
Changes in assets and liabilities:
(Increase) decrease in:
Accounts receivable 3,012 (2,245)
Accrued interest receivable 343 (1,087)
Inventories (1,229) (7,094)
Other (1,285) (1,171)
Increase (decrease) in:
Accounts payable (3,751) 20,062
Accrued liabilities (24,506) (6,106)
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Net cash used in operating activities (115,582) (59,768)
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CASH FLOWS FROM INVESTING ACTIVITIES:
Maturity of bank certificates of deposit, net 40,000 125,000
Capital expenditures 0 0
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Net cash from investing activities 40,000 125,000
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CASH FLOWS FROM FINANCING:
Proceeds from issuing common stock subscriptions 25,004 0
Principal payments on bank note payable (477) (463)
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Net cash provided by (used in) financing 24,527 (463)
activities
Net increase (decrease) in cash
and cash equivalents (51,055) 64,769
CASH AND CASH EQUIVALENTS:
Beginning of period 197,200 63,935
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End of period $ 146,145 $ 128,074
======================================================================================================
See Notes to Financial Statements.
7
PROTIDE PHARMACEUTICALS, INC.
NOTES TO FINANCIAL STATEMENTS -- NOVEMBER 30, 2001
NOTE A - BASIS OF PRESENTATION
The accompanying financial statements have been prepared in accordance with
generally accepted accounting principles for interim financial information and
with the instructions to Form 10-QSB and Item 310 of Regulation S-B.
Accordingly, they do not include all of the information and footnotes required
by generally accepted accounting principles for complete financial statements.
In the opinion of management, all adjustments (consisting only of normal
recurring adjustments) considered necessary for a fair presentation have been
included.
The organization and business of the Company, accounting policies followed
by the Company and other information is contained in the notes to the Company's
financial statements filed as part of the Company's August 31, 2001 Form 10-KSB.
This quarterly report should be read in connection with such annual report.
NOTE B - CASH AND CASH EQUIVALENTS
For purposes of reporting the statements of cash flows, the Company
considers all highly liquid debt instruments purchased with a maturity of three
months or less to be cash equivalents.
NOTE C - SHORT-TERM INVESTMENTS
As of November 30, 2001 the Company had investments of $175,000 in
certificates of deposit. Certificates of deposit are made only with the highest
rated banks. The Company also utilizes a money market fund, which is restricted
by its charter to Tier 1 instruments, for a portion of its investments. At times
throughout the year, the Company's cash, cash equivalents and certificates of
deposit in financial institutions may exceed FDIC insurance limits. The Company
has not experienced any losses in such accounts.
NOTE D - NOTES PAYABLE BANK
During April 1997 the Company borrowed $100,000 from a local bank with the
proceeds used for financing a portion of the tenant improvements in the
Company's new facility. In February 2001 the loan was renegotiated with a
different Bank. The new loan is secured by a certificate of deposit at this
bank. The interest rate for this loan, currently 5.5%, is tied to the
certificate of deposit rate.
NOTE E - LOSS PER COMMON SHARE
Basic loss per share is computed based upon the weighted average number of
common shares outstanding during the period. Stock options for 307,000 shares
were not included in the computation of diluted loss per share as the results
were antidilutive.
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ITEM 2--MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS
OF OPERATIONS
INTRODUCTION
a. BACKGROUND AND PRODUCTS
In January 2001 Celox Laboratories, Inc. and Protide Pharmaceuticals, Inc.,
merged with the surviving corporation named Protide Pharmaceuticals, Inc.
Protide Pharmaceuticals, Inc. ("Protide" or the "Company") is a
biotechnology company devoted to the discovery, development and
commercialization of technologies and processes in clinical cell therapy and
transfusion medicine, specifically in the areas of cancer, genetic disorders,
cell engineering and transplantation. The focus of Protide is in the area of
gene therapy, cell therapy and contract manufacturing for companies and
educational institutions that are working in these areas.
Celox Laboratories, Inc. will continue to market products that are sold for
research purposes. Celox was formed in 1985 as a Company that researches,
develops, manufactures, and markets cell biology products that are used in the
propagation of cells derived from mammals, including humans, and other species.
These specialized cell growth products are used primarily in academic,
pharmaceutical and other commercial laboratories to improve the growth,
productivity and quality of cell-derived medical and other biological products
such as vaccines, monoclonal antibodies, interferons, and human growth factor.
Since its inception, the Company has pursued a strategy of developing non-serum
based products for the growth of human and other mammalian cells which
management believes will have significant commercial potential.
The Company markets more than 20 different products. The Company's
proprietary products consist of six different serum-free supplements: TCM(TM),
TM-235(TM), TCH(TM), Nephrigen(TM), HemaPro(TM) and VaxMax(TM)and two cell
freezing solutions, Cellvation(TM) and pZerve(TM). VaxMax(TM), introduced in
September of 1993, was developed specifically for use in the production of
veterinary vaccines. Nephrigen(TM) was introduced in fiscal 1998 and is a
serum-free growth medium developed specifically for the culturing of Human
Embryonic Kidney (293) cells. As part of the Nephrigen(TM) system, the Company
also introduced a non-enzymatic dissociation solution that is used instead of an
enzyme such as trypsin. HemaPro(TM) was also introduced in fiscal 1998 and is a
low protein, serum-free medium for clonogenic assays or EX VIVO expansion of
human progenitor cells. The Company intends to obtain IN VITRO diagnostic status
for HemaPro(TM). pZerve(TM) was introduced in 1999 and is used primarily for
cryopreserving human cells. pZerve(TM) is used as a research product only, it is
not for human use. An additional proposed clinical product, ViaStem(TM), has
completed preclinical testing. This product was developed to improve the
preservation of critical cells (e.g., stem cells), which are required for bone
marrow transplantation.
During the first quarter of fiscal 2001 the Company introduced the new
product STEMSOL(TM). STEMSOL(TM) is a sterile filtered, USP Grade Dimethyl
Sulfoxide (DMSO) used in a cryopreservation solution for, among other things,
bone marrow, peripheral-blood stem cells and cord blood preservations and
DMSO/Dextran which is also a sterile filtered, USP Grade Dimethyl Sulfoxide
(DMSO) with Dextran added as a buffer.
The Company has received a Drug Master File classification from the Food
and Drug Administration (FDA) for TCM(TM). This classification will expedite the
FDA approval process for customers who want to use the Company's TCM(TM) product
for manufacturing purposes.
9
The Company also manufactures five basal media formulations, a series of
buffered saline solutions, other cell biology reagents, and a variety of custom
formulations.
During the third quarter of fiscal 2000, the Company entered into an
agreement to manufacture specialized solutions for the processing of pancreatic
islet cells for transplants. During the first quarter of fiscal 2002 an order
was received from a second transplant center for these specialized solutions.
The revenue from this order will be reflected in the second quarter of fiscal
2002.
b. VIASTEM(TM)
In March 1995, the Company filed a patent application for ViaStem(TM) in
the U.S. Patent and Trademark Office. The Company received the U.S. Patent in
early December 1996. This patent provides protection of the Company's
ViaStem(TM) technology through March of 2015. A second U.S. Patent was received
in August 1998. This second patent broadened the patented uses of ViaStem(TM) in
bone marrow transplantation and related therapies. The Company has also filed
the documents needed for an International Patent Application as required by the
Patent Cooperation Treaty. In October 1998 the Company received notice from the
New Zealand and Australian Patent Office that a patent on ViaStem(TM) had been
granted by each of the respective countries. In March 2000 notice was received
from the Patent Office in Canada that a patent had been issued for ViaStem(TM).
The Company received notice from the Russian Patent Office in May 2000 of the
official issue date for the patent for ViaStem(TM) in Russia. In July 2001
Protide received notice from the Japan and Mexican Patent Offices that a patent
on ViaStem(TM) had been granted by each of the respective countries. Initial
reports from other countries that have reviewed the international patent
application have been positive. Due to the unique nature of ViaStem(TM), the
Company pursued the patent process for this product.
On March 31, 2000, Protide Pharmaceuticals, Inc. (the wholly owned
subsidiary of Celox) entered into an agreement with Fairview-University Medical
Center (FUMC), Minneapolis, MN. FUMC will provide collecting, processing and
assaying of human peripheral blood stem cells as part of Protide's clinical
investigation of ViaStem(TM).
During May 2000 the Company submitted an application to the Food and Drug
Administration (FDA) to initiate human clinical trials for ViaStem(TM). This was
the first submission ever made by the Company to the FDA for testing in human
subjects. In August 2000 the Company announced that it had received notice from
the FDA that the clinical trial on had been placed on clinical hold pending
further information. The Company intends to submit the additional requested
information to the FDA in the near future.
c. DISTRIBUTION/MARKETING
The Company continues to sell its products on a direct basis to customers
around the world. In addition the Company has formed the following distribution
avenues:
The Company has a nonexclusive worldwide distribution agreement with ICN
Pharmaceuticals, Inc. (NYSE:ICN), Costa Mesa, CA. Under the agreement, ICN is
marketing Celox' TCM(TM), TCH(TM), TM-235(TM) serum replacement products as well
as Cellvation(TM). The Company has also entered into an agreement with ICN to
custom manufacture certain of the Company's basal media and balanced salt
solutions to ICN for worldwide distribution. ICN manufactures and markets a
broad range of prescription and over-the-counter pharmaceuticals, medical
diagnostic products and biotechnology research products in North and Latin
America, Eastern and Western Europe and the Pacific Rim countries.
10
In 1997, the Company began providing its proprietary products to Sigma
Chemical Company (NASDAQ:SIAL), St. Louis, MO. under a private label
distribution agreement for worldwide distribution.
In 1997, the Company entered into a nonexclusive distribution agreement
with TaKaRa Shuzo Co., Ltd., Biomedical Group, Kyoto, Japan. Under the
agreement, TaKaRa will initially market Celox' proprietary product
Cellvation(TM). TaKaRa's Biomedical Group leads the industry in several areas
owing to the international scope of its research operations which span from the
People's Republic of China to North America and Europe. TaKaRa will market
Cellvation(TM) in Japan, Taiwan, Korea and People's Republic of China.
The Company also has distribution of its products in Japan through
Funakoshi Co., LTD, a well-established Japanese distributor.
In March 2000, the Company entered into an agreement with SciQuest.com,
Inc. (NASDAQ:SQST) to sell its products online. This agreement was canceled in
the third quarter of fiscal 2001 after SciQuest.com made changes to the
agreement which were unfavorable to Protide.
RESULTS OF OPERATIONS
During the quarter ended November 30, 2001, the Company had net sales of
$43,695 which was a decrease of $5,024 or 10% from $48,719 reported in the same
quarter for the prior year. The decrease between years results primarily from
the amount and timing of custom orders as well as orders received from
distributors and customers. A number of contract manufacturing orders were
received at quarter end and will be invoiced during the second quarter of fiscal
2002. The Company has also discontinued some products. In addition, the Company
has been expending substantial efforts relating to the advancement of
ViaStem(TM).
The Company had a net loss of $96,141 for the quarter ended November 30,
2001 compared to a net loss of $70,280 for the same period in the previous year.
The increased loss results primarily from the receipt of a check in the amount
of $20,539 from the KPMG Litigation Settlement Fund in fiscal 2001. This check
was the result of a settlement with the Piper Jaffray Institutional Government
Fund's auditors, KPMG. The check was recognized as other income in the first
quarter of fiscal 2001. On a per share basis, the loss for the current quarter
equaled 3 cents versus a 2 cent loss in the comparable period in fiscal 2001.
The cost of products sold was $20,946 or 48% of net sales for the three
months ended November 30, 2001, as compared to $20,883 or 43% of net sales for
the three months ended November 30, 2000 The increased percentage for the
current quarter results from reduced sales levels which results in a higher
percentage of fixed manufacturing costs as compared to sales. The mix of
products sold also impacts the cost of sales comparisons.
An operating loss of $119,984 was generated for the quarter ended November
30, 2001 compared to an operating loss of $125,040 for the same period in the
previous year. The decrease between years for the three month reporting period
resulted from decreases in administrative expenses with relatively flat expenses
in the research and development area and increased marketing and sales expenses.
11
The Company received interest and investment income of $2,116 during the
quarter ended November 30, 2001 as compared to $7,422 in the prior year.
Investment income is derived primarily from the investment of the proceeds of
the Company's March 1992 initial public offering as well as from subsequent
private placements. The decrease in investment income during the quarter as
compared to the previous year results from significantly lower interest rates
available for investment balances.
Operating expenses decreased $5,056 (4%) to $119,984 from $125,040 for the
quarter ended November 30, 2001 as compared to the prior year. The decrease for
the three month reporting period as compared to the prior fiscal year results
from lower administrative expenses along with an increase in marketing and sales
costs, which fluctuate based on timing of promotional activities, and flat
research and development expenses.
Research and development costs increased by $230 (1%) to $35,621 from
$35,391 in the current quarter as compared to the previous fiscal year. The
small increase for the current quarter reflects similar expenditures in the
areas of salaries and wages and professional fees as compared to the prior year.
The Company expects the costs of research and development to fluctuate based on
the status of preclinical and clinical trials for ViaStem(TM).
Marketing expenses increased by $4,436 (18%) to $29,369 from $24,933 for
the quarter ended November 30, 2001 as compared to the previous year. The
increase for the current quarter as compared to the previous year results
primarily from promotional activities connected with the marketing of
STEMSOL(TM) and DMSO/Dextran, a companion product, during the quarter. The
Company expects that marketing and sales expenses will fluctuate based on
introduction of new products, new studies, and as new advertising materials are
developed.
Administrative expenses decreased by $9,722 (15%) for the quarter ended
November 30, 2001 compared to the previous fiscal year to $54,994 from $64,716.
The decrease for the three month reporting period is due to the amount and
timing of legal and professional fees expended in connection with the
introduction of new products, agreements and matters related to the advancement
of ViaStem(TM).
LIQUIDITY AND CAPITAL RESOURCES
Capital resources on hand at November 30, 2001 include cash and short-term
investments of $321,145 and net working capital of $297,970. This represents a
decrease of $91,055 (22%) in cash and short-term investments and a decrease of
$63,162 (17%) in net working capital as compared to August 31, 2001.
The Company is leasing approximately 9,500 square feet of office,
laboratory and warehouse space in St. Paul, MN under a seven year lease. The
Company moved into the new facility during March 1997. As partial payment for
tenant improvements in the new facility, the Company borrowed $100,000 from a
local bank. In February 2000 the loan was renegotiated with a different bank.
The new loan is secured by a certificate of deposit at this bank. The interest
rate for this loan, currently 5.5%, is tied to the certificate of deposit rate.
The loan is for a one year term with a maturity in February 2001. The balance of
the tenant improvements over this amount was paid with Company funds.
12
During the second quarter of fiscal 2000 the Company raised $175,150 in
additional capital by selling 145,000 units at $1.15 per unit to five investors
through a private placement. Each unit consisted of one share of common stock
and a warrant to purchase an additional two shares of common stock at an
exercise price of $0.10 per share.
During the third quarter of fiscal 2000 additional funds in the amount of
$211,750 were raised by selling units at $1.15 per unit and common stock at
$1.40 per share to other investors in a private placement. The additional funds
raised will be primarily used for advancing ViaStem(TM) through the necessary
testing before FDA approval can be obtained.
During the second quarter of fiscal 2001, an additional 50,000 shares were
issued as a result of a private placement participant exercising warrants.
During the fourth quarter of fiscal 2001, the Company sold subscriptions
for 157,659 units of common stock and a warrant at $0.47 per unit in a private
offering.
The Company sold additional subscriptions for 53,200 units of common stock
and a warrant for $0.47 in the first quarter of fiscal 2002.
The Company intends to pursue additional financing, subject to prevailing
market conditions. There is no guarantee however, that the Company will be able
to successfully raise an adequate amount of additional funds with terms that are
favorable to the Company. In addition, there can be no assurance that the
Company will be able to obtain the necessary FDA approvals for ViaStem(TM).
The Company anticipates spending approximately $30,000 during fiscal 2002
on capital expenditures. Through November 2001 the Company has made no capital
expenditures. The majority of the planned expenditures will be used to fund new
products, research and development and manufacturing growth. The Company
believes that its capital resources on hand at November 30, 2001 together with
revenues from product sales, will be sufficient to meet its cash requirements
for the fiscal year.
FORWARD LOOKING INFORMATION
Information contained in this Form 10-QSB contains " forward-looking
statements" within the meaning of the Private Securities Litigation Reform Act
of 1995, which can be identified by the use of forward-looking terminology such
as "may", "will", "expect", "plan", "anticipate", "estimate" or "continue" or
the negative thereof or other variations thereon or comparable terminology.
There are certain important factors that could cause results to differ
materially from those anticipated by some of these forward-looking statements.
Investors are cautioned that all forward-looking statements involve risks and
uncertainty. The factors, among others, that could cause actual results to
differ materially include the Company's ability to obtain FDA approval for its
clinical products, the ability of the Company to raise additional capital and
the ability to execute its business plan.
13
PART II -- OTHER INFORMATION
ITEM I. -- LEGAL PROCEEDINGS
The Company is not presently involved in any material legal proceedings.
ITEM 2. -- CHANGES IN SECURITIES
None
ITEM 3. -- DEFAULTS UPON SENIOR SECURITIES
None
ITEM 4. -- SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS
None
ITEM 5. -- OTHER INFORMATION
None
ITEM 6. -- (A) EXHIBITS
None
(B) REPORTS ON FORM 8-K
None
SIGNATURES
In accordance with the requirements of the Exchange Act, the Registrant
caused this report to be signed on its behalf by the undersigned, thereunto duly
authorized.
PROTIDE PHARMACEUTICALS, INC.
Dated: January 10, 2002 By: /S/ Milo R. Polovina
-----------------------------
Milo R. Polovina, President & CEO
(Principal Financial Officer)
14