UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB
(Mark One)
[X] Quarterly report under Section 13 or 15(d) of the Securities Exchange Act
of 1934
For the quarterly period ended March 31, 2002
[_] Transition report under Section 13 or 15(d) of the Securities Exchange Act
of 1934
For the transition period from _____ to _____
Commission file number 000-32877
PRO-PHARMACEUTICALS, INC.
(Exact name of small business issuer as specified in its charter)
Nevada 04-3562325
(State or other jurisdiction of (I.R.S. Employer Identification No.)
incorporation or organization)
189 Wells Avenue, Suite 200, Newton, Massachusetts 02459
(Address of principal executive offices)
(617) 559-0033
(Issuer's telephone number)
APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY
PROCEEDINGS DURING THE PRECEDING FIVE YEARS
Check whether the issuer filed all documents and reports required to be filed by
Section 12, 13 or 15(d) of the Exchange Act after the distribution of securities
under a plan confirmed by a court. Yes [_] No [_]
NOT APPLICABLE
APPLICABLE ONLY TO CORPORATE ISSUERS
State the number of shares outstanding of each of the issuer's classes of common
equity, as of the latest practicable date: The total number of shares of Common
Stock, par value $0.001 per share, outstanding as of March 31, 2002 was
15,524,410.
Transitional Small Business Disclosure Format (Check one): Yes [_] No [X]
TABLE OF CONTENTS
Part I -- FINANCIAL INFORMATION
Item 1. Financial Statements (Unaudited)................................. 1
Condensed Balance Sheets..................................... 1
Condensed Statements of Operations........................... 2
Condensed Statements of Cash Flows........................... 3
Notes to Condensed Financial Statements...................... 4
Item 2. Plan of Operation................................................ 8
Part II -- OTHER INFORMATION
Item 1. Legal Proceedings................................................13
Item 2. Changes in Securities............................................13
Item 3. Defaults Upon Senior Securities..................................13
Item 4. Submission of Matters to a Vote of Security Holders..............13
Item 5 Other Information................................................13
Item 6. Exhibits and Reports on Form 8-K.................................14
PART I - FINANCIAL INFORMATION
Item 1. Financial Statements
PRO-PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED BALANCE SHEETS (Unaudited)
March 31, December 31,
2002 2001
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 967,445 $ 1,491,172
Prepaid expenses and other current assets 94,676 80,769
----------- -----------
Total current assets 1,062,121 1,571,941
----------- -----------
PROPERTY AND EQUIPMENT, Net 134,371 111,540
PATENTS 72,668 56,115
DEPOSITS AND OTHER ASSETS 26,951 26,951
----------- -----------
Total assets $ 1,296,111 $ 1,766,547
=========== ===========
LIABILITIES AND STOCKHOLDERS' EQUITY
CURRENT LIABILITIES:
Accounts payable $ 205,516 $ 236,223
Accrued expenses 223,984 119,479
Convertible notes payable 195,000 195,000
Deposits for common stock purchases 156,000 --
----------- -----------
Total current liabilities 780,500 550,702
STOCKHOLDERS' EQUITY:
Common stock, $0.001 par value; 100,000,000 shares authorized, 15,524 15,524
15,524,410 issued and outstanding
Deferred compensation (79,794) (91,575)
Additional paid-in capital 5,690,384 5,450,106
Deficit accumulated during the development stage (5,110,503) (4,158,210)
----------- -----------
Total stockholders' equity 515,611 1,215,845
----------- -----------
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 1,296,111 $ 1,766,547
=========== ===========
See notes to condensed financial statements.
1
PRO-PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF OPERATIONS (Unaudited)
Period From
Inception
(June 10, 2000)
Three Months Ended March 31, To March 31,
2002 2001 2002
OPERATING EXPENSES:
Research and development $ 309,082 $ 33,149 $ 1,302,789
General and administrative 408,087 137,722 1,763,421
------------ ------------ ------------
Total operating expenses (717,169) (170,871) (3,066,210)
INTEREST INCOME 5,671 7,579 30,849
INTEREST EXPENSE (240,795) (197,521) (2,071,787)
------------ ------------ ------------
Net loss $ (952,293) $ (360,813) $ (5,107,148)
============ ============ ============
NET LOSS PER SHARE - BASIC AND DILUTED (0.06) (0.03)
============ ============
WEIGHTED AVERAGE COMMON SHARES OUTSTANDING -
Basic and diluted 15,524,410 12,354,670
============ ============
See notes to condensed finanical statements.
2
PRO-PHARMACEUTICALS, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS (Unaudited)
Period From
Inception
(June 10, 2000)
Three Months Ended March 31, To March 31,
2002 2001 2002
CASH FLOWS FROM OPERATING ACTIVITIES:
Net loss $ (952,293) $ (360,814) $(5,107,148)
Adjustments to reconcile net loss to net
cash used in operating activities:
Depreciation 8,471 4,083 20,627
Amortization of deferred compensation 16,072 -- 163,389
Amortization of debt discount on
convertible notes -- 185,303 1,258,012
Expense related to issuance of warrants
to purchase common stock 235,987 -- 235,987
Writeoff of intangible assets -- -- 107,000
Debt conversion expense -- -- 503,019
Interest expense related to
convertible notes payable 4,808 -- 4,808
Changes in current assets and
liabilities:
Prepaid and other expenses (13,907) (21,500) (94,676)
Deposits and other assets -- -- (26,951)
Accounts payable (30,707) (70,101) 196,488
Accrued expenses 99,697 81,620 219,176
----------- ----------- -----------
Net cash used in operating activities (631,872) (181,409) (2,520,269)
CASH FLOWS FROM INVESTING ACTIVITIES:
Purchases of property and equipment (31,302) -- (154,998)
Increase in patents costs and other assets (16,553) -- (72,668)
----------- ----------- -----------
Net cash used in investing activities (47,855) -- (227,666)
CASH FLOWS FROM FINANCING ACTIVITIES:
Net proceeds from sale of common stock 156,000 1,000 2,385,750
Net proceeds from convertible notes payable -- 814,602 1,320,602
Proceeds from shareholder advances -- 1,000 9,028
----------- ----------- -----------
Net cash provided by financing activities 156,000 816,602 3,715,380
----------- ----------- -----------
NET INCREASE IN CASH AND CASH EQUIVALENTS (523,727) 635,193 967,445
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 1,491,172 204,745 --
----------- ----------- -----------
CASH AND CASH EQUIVALENTS, END OF PERIOD $ 967,445 $ 839,938 $ 967,445
=========== =========== ===========
See notes to condensed financial statements.
3
PRO-PHARMACEUTICALS, INC.
(A Development Stage Company)
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (Unaudited)
March 31, 2002
- --------------------------------------------------------------------------------
1. NATURE OF OPERATIONS, BASIS OF PRESENTATION AND SIGNIFICANT ACCOUNTING
POLICIES
NATURE OF OPERATIONS
Pro-Pharmaceuticals, Inc. (the Company) was established in July 2000. The
Company is in the development stage and is engaged in developing technology that
will reduce toxicity and improve the efficacy of currently existing chemotherapy
drugs by combining the drugs with a number of specific carbohydrate compounds.
The carbohydrate-based drug delivery system may also have applications for drugs
now used to treat other diseases and chronic health conditions.
The Company is devoting substantially all of its efforts toward product
research and development and raising capital. Its product candidates are still
in the research and development stage, with none yet in clinical trials. The
Company is subject to a number of risks similar to those of other
development-stage companies, including dependence on key individuals,
uncertainty of product development and generation of revenues, dependence on
outside sources of capital, risks associated with clinical trials of products,
dependence on third-party collaborators for research operations, lack of
experience in clinical trials, need for regulatory approval of products, risks
associated with protection of intellectual property, and competition with
larger, better-capitalized companies. To date, the Company has raised capital
principally through the issuance of convertible notes and the sale of common
stock through a private placement.
The Company's financial statements have been presented on a going-concern
basis, which contemplates the realization of assets and satisfaction of
liabilities in the normal course of business. The Company is in the development
stage, has incurred a net loss since inception of $5,107,148 and expects to
incur additional losses in the near future. These factors raise substantial
doubt about the Company's ability to continue as going concern. Successful
completion of the Company's development program and, ultimately, the attainment
of profitable operations is dependent upon future events, including maintaining
adequate financing to fulfill its development activities and achieving a level
of sales adequate to support the Company's cost structure. The Company is
actively seeking additional financing to fund future operations and future
significant investments in the business. However, there can be no assurance that
the Company will be able to obtain financing on acceptable terms, or at all.
4
BASIS OF PRESENTATION
The condensed financial statements included herein have been prepared by
the Company pursuant to the rules and regulations of the Securities and Exchange
Commission. Certain information and footnote disclosures normally included in
financial statements prepared in accordance with generally accepted accounting
principles have been condensed or omitted pursuant to such rules and
regulations. These condensed financial statements should be read in conjunction
with the financial statements and the notes thereto included in the Company's
latest annual report on Form 10-KSB.
The condensed financial statements, in the opinion of management, include
all adjustments (consisting of normal recurring adjustments) necessary to
present fairly the Company's financial position and the results of operations.
These results are not necessarily indicative of the results to be expected for
the entire year.
SIGNIFICANT ACCOUNTING POLICIES
The significant accounting policies followed by the Company in preparing
its financial statements are set forth in Note 1 to the financial statements
included in its Form 10-KSB for the year ended December 31, 2001. The Company
has made no changes to these policies during this quarter.
2. NET LOSS PER SHARE
Basic and diluted net loss per share is presented in conformity with
Statement of Financial Accounting Standards (SFAS) No. 128, Earnings per Share,
for all periods presented. In accordance with SFAS No. 128, basic and diluted
net loss per common share was determined by dividing net loss applicable to
common stockholders by the weighted average common shares outstanding during the
period, less shares subject to repurchase. Diluted weighted-average shares are
the same as basic weighted-average shares since the inclusion of 2,078,091
shares issuable pursuant to the exercise of stock options and warrants and
conversion of convertible debt as of March 31, 2002 and December 31, 2001 would
have been antidilutive.
5
3. PROPERTY AND EQUIPMENT
Property and equipment consists of the following at March 31, 2002 and December
31, 2001:
March 31, December 31,
2002 2001
Property and equipment:
Computer and office equipment $ 62,583 $ 56,681
Furniture and fixtures 39,746 39,746
Leasehold improvements 52,669 27,269
--------- ---------
Total 154,998 123,696
Less accumulated depreciation (20,627) (12,156)
--------- ---------
Property and equipment - net $ 134,371 $ 111,540
4. CONVERTIBLE NOTES PAYABLE AND CURRENT EQUITY OFFERING
Subsequent to March 31, 2002, the $195,000 of convertible notes were
extended by the Company for an additional one year period. As consideration for
agreeing to the extension the Company is required to issue 48,750 shares of
common stock to the holders of these notes. The value of these shares will be
recorded as interest expense when issued.
On December 13, 2001, the Company commenced a public offering of 1,428,572
shares of common stock, at a price to the public of $3.50 per share, pursuant to
a registration statement on Form SB-2 as originally filed and declared effective
by the SEC on December 12, 2001, and subsequently amended by Post-Effective
Amendment No. 1 declared effective by the SEC on April 29, 2002. The Company
anticipated concluding the offering on February 11, 2002 but extended the
offering until June 11, 2002. As of April 8, 2002, the Company had received
proceeds for, but not issued, approximately 50,570 shares pursuant to this
public offering. As part of this offering, the Company has received advance
deposits of $156,000 for common stock. These deposits are for shares anticipated
to be issued subsequent to satisfaction of state security law requirements. Such
deposits have been classified as current liabilities since there is the
possibility, should such state requirements not be met, amounts would be
returned to investors.
5. OPTIONS AND WARRANTS
Under an agreement with a shareholder for consulting services the Company
will compensate the shareholder for services rendered with options for the
purchase of 2,000 shares per month beginning on March 1, 2002. Under this
agreement 2,000 options were granted during the three month period ended March
31, 2002. These options were valued by the Company at $4,291 which was
recognized as a
6
general and administrative expense in the statement of operations for the period
ended March 31, 2002.
The Company had previously incurred a liability of approximately $50,000
to finders in connection with its 2001 debt offering. In the first quarter of
2002, in response to certain liquidity issues, the Company settled this
liability in the form of 110,000 warrants. The warrants are exercisable
immediately, have an exercise price of $3.50 per share and a 10 year life. These
warrants were valued by the Company at $235,987 which was recorded as interest
expense in the statement of operations for the period ended March 31, 2002.
6. RECENT ACCOUNTING PRONOUNCEMENTS
On January 1, 2002, the Company adopted Statement of Financial Accounting
Standards (SFAS) No.144, Accounting for the Impairment or Disposal of Long-Lived
Assets, which addresses financial reporting for the impairment or disposal of
long-lived assets. SFAS 144 supersedes SFAS 121 and the accounting and reporting
provisions of APB 30 related to the disposal of a segment of a business. The
adoption of this statement did not have a significant effect on the Company's
financial position or results of operations.
7. CONTINGENCY
GlycoGenesys, Inc. (formerly known as SafeScience, Inc.), former employer
of Dr. David Platt, Chairman and Chief Executive Officer of the Company, alleged
in a letter dated February 15, 2001 that Dr. Platt's activity with the Company
is a violation of a noncompetition covenant he has with GlycoGenesys, Inc. Dr.
Platt responded by letter dated February 19, 2001 denying the allegations and
inviting a meeting to discuss them. Counsel for GlycoGenesys, Inc. indicated a
willingness to resolve these matters but attempts to set up a meeting were
unsuccessful. An evaluation cannot be made at this time of the likelihood of a
favorable or unfavorable outcome, nor can any estimate be made as to the amount
or range, if any, of potential loss. If GlycoGenesys, Inc. makes demands against
the Company with respect to the allegations, the Company intends to vigorously
contest all such allegations.
7
Item 2. Plan of Operation
This quarterly report on Form 10-QSB contains, in addition to historical
information, forward-looking statements. These forward-looking statements are
based on management's current expectations and are subject to a number of
factors and uncertainties which could cause actual results to differ materially
from those described in such statements. We caution investors that actual
results or business conditions may differ materially from those projected or
suggested in forward-looking statements as a result of various factors
including, but not limited to, the following: uncertainties as to the utility
and market for our potential products; uncertainties associated with preclinical
and clinical trials of our drug delivery candidates; our lack of experience in
product development and expected dependence on potential licensees and
collaborators for commercial manufacturing, sales, distribution and marketing of
our potential products; possible development by competitors of competing
products and technologies; lack of assurance regarding patent and other
protection of our proprietary technology; compliance with and change of
government regulation of our activities, facilities and personnel; uncertainties
as to the extent of reimbursement for our potential products by government and
private health insurers; our dependence on key personnel; our history of
operating losses and accumulated deficit; and economic conditions related to the
biotechnology and biopharmaceutical industry, each as discussed in our Annual
Report on Form 10-KSB for the year ended December 31, 2001, filed with the
Securities and Exchange Commission. We cannot assure you that we have identified
all the factors that create uncertainties. Readers should not place undue
reliance on forward-looking statements. We have no obligation to publicly update
forward-looking statements we make in this Form 10-QSB.
Overview
We are currently in the development stage and have not yet generated any
operating revenues. Since the formation in July 2000 of our predecessor,
Pro-Pharmaceuticals, Inc., a Massachusetts corporation, we have been engaged in
research and development activities in connection with identifying and
developing a technology that will reduce toxicity and improve the efficacy of
currently-used drug therapies, including cancer chemotherapies, by combining the
drugs with a number of carbohydrate compounds. Our preliminary studies have
identified certain mannans, a group of polysaccharides, that could be utilized
as a potential drug delivery system. Polysaccharides are molecules consisting of
one or more types of sugars. In the case of mannans, the principal component is
the sugar mannose, which is similar to glucose. We believe that a mannan having
a suitable chemical structure and composition, when attached to or combined with
the active agent of a chemotherapy drug, would increase cellular membrane
fluidity and permeability, thereby assisting delivery of the drug.
Preclinical Animal Studies; Investigational New Drug Application
As discussed below, we have conducted preclinical animal experiments to
study the toxicity and efficacy of 5-Fluorouracil (5-FU) in combination with our
mannan compounds. We are also conducting similar preclinical animal experiments
to study Adriamycin both in combination with our mannan compounds and as
chemically modified with sugar residues via "linkers" of a certain chemical
structure that are our proprietary technology. We named the most promising of
our synthesized Adriamycin sugar derivatives "Galactomycin" (further discussed
below). All of our animal experiments are conducted at independent laboratories.
We intend to include the preclinical data obtained from the 5-FU studies in an
Investigational New Drug application (IND) to be submitted to the FDA. We
conducted a pre-IND meeting with the FDA on May 3, 2002 and were authorized to
submit the IND, which we intend to do shortly.
8
Toxicity Studies
Results of one toxicity study conducted in early 2001 indicate that one of
our mannan compounds, named Davanat-1, may significantly decrease the toxicity
of 5-FU. Ten groups of five animals each were used. In five groups, treated
respectively with a placebo and one of four different mannans provided by us,
the animals showed no signs of toxicity. That was expected because the animals
were not receiving the toxic drug, and the mannans were not expected to be toxic
at all. In four groups, treated respectively with 5-FU alone and 5-FU in
combination with either of three of the mannans, the animals showed signs of
severe toxicity. In one group, treated with 5-FU in combination with the fourth
mannan, Davanat-1, no clinical signs of toxicity were observed. This provides a
preliminary indication of potential reduction in cancer drug toxicity by a
carbohydrate-based addition to the cancer drug.
A second, similar study, also conducted in early 2001, was performed to
test a potential reduction of toxicity of another anticancer drug, Adriamycin,
in combination with each of two mannan compounds selected for the study. Results
indicate that one of the mannan compounds may decrease the toxicity of
Adriamycin. In two groups, treated with Adriamycin alone and Adriamycin in
combination with one mannan, the animals showed signs of severe toxicity. In one
group, treated with the same amount of Adriamycin in combination with the second
mannan, four out of the five animals in the group did not show any clinical
signs of toxicity. Again, this provides a preliminary indication of potential
reduction in cancer drug toxicity by a carbohydrate-based addition to the cancer
drug. The fact that two different cancer drugs with chemically unrelated
structures showed a marked reduction of their toxicity in combination with
particular mannans indicates that there might be some fundamental underlying
biological reasons, related to the mannans rather than to the drugs, for the
reduction in toxicity.
In four subsequent preclinical experiments conducted in June and September
2001, we studied on larger animals the toxicity reduction of 5-FU in combination
with Davanat-1, which had demonstrated toxicity reduction in the prior 5-FU
study. These experiments were performed in accordance with FDA guidelines and
recommendations on rats (acute and long-term toxicity study) and dogs (acute and
long-term toxicity study) measuring the effect of the 5-FU/Davanat-1 combination
on blood structure and survival of these animals. Preliminary results indicate
that the 5-FU/Davanat-1 combination decreased toxicity using this measure
because it resulted in lower animal mortality and decreased loss of blood
structure components in comparison to the results of tests which administered
5-FU alone.
We are presently conducting additional toxicity studies on larger animals
using particularly high Davanat-1 doses.
Efficacy Study
A preliminary study was performed to test a potential change in
therapeutic efficacy of 5-FU in a combination with Davanat-1, which had
decreased toxicity of the drug in healthy animals (see the first study described
in " -- Toxicity Studies," above). The study was motivated by the desire to test
the possibility that Davanat-1 might diminish both toxicity and efficacy in
parallel, if the Davanat-1 were merely competing with 5-FU for binding with
cells, healthy or cancerous. Results of the study demonstrated, however, that
Davanat-1, which may decrease toxicity of 5-FU, may also increase efficacy of
the drug when the drug combined with Davanat-1 is administered into
cancer-carrying animals. In this study, we ascertained a decrease in tumor size
following administration of 5-FU alone as well as administration of the
5-FU/Davanat-1 combination. When the 5-FU/Davanat-1 combination was
administered, the time for the tumor to quadruple in size in the animals
increased from 24 days (5-FU alone administered) to 56 days (5-FU/Davanat-1
combination administered) relative to 12 days for control animals (no drug
administered).
9
At the request of the FDA for a better understanding of the Davanat-1 mode
of therapeutic action, we are currently conducting two additional efficacy
studies using 5-FU and Davanat-1 in combination with leucovorin, another cancer
chemotherapy.
We also conducted a study that involved injecting radiolabeled Davanat-1
(with and without 5-FU) into tumor-free and tumor-bearing animals. The study
provided extensive experimental data with respect to Davanat-1 distribution in
organs and tissues (liver, kidney, lungs, plasma, and tumor) and the capacity of
such organs and tissue to clear Davanat-1 after various time periods. The study
indicated that Davanat-1 may protect the liver from a toxic effect of 5-FU yet
increase the amount, and hence the therapeutic effect, of 5-FU in the tumor. In
other words, we have indications that Davanat-1 may decrease toxicity and
increase efficacy of 5-FU.
Carbohydrate-Cancer Drug Formulations
We are currently developing formulations of carbohydrates linked to
anti-cancer drugs. We have chemically synthesized four novel products that are
carbohydrate derivatives of Adriamycin, and have conducted preclinical animal
experiments, studying both toxicity (on healthy animals) and efficacy (on
cancer-carrying animals). Preliminary results of these experiments indicate that
all four of the synthesized carbohydrate-Adriamycin compounds, and particularly
one, named Galactomycin, are significantly less toxic compared with the original
Adriamycin, and demonstrate therapeutic efficacy as well. In the case of
Galactomycin, the preliminary results indicated a therapeutic efficacy higher
than that for the parent Adriamycin, particularly at repeated administrations.
Unlike repeated injections of Adriamycin which result in a cumulative toxic
effect, Galactomycin at repeated injections apparently increases its therapeutic
effect while retaining low toxicity.
Although the foregoing studies are encouraging, the results achieved in
preclinical studies with animals are often not duplicated in human patients.
Please see "Risk Factors That May Affect Results -- Our product candidates will
be based on novel technologies" in our 2001 Form 10-KSB. We have no products and
have not yet conducted any clinical trials. We have initiated large-scale
production of our mannan for use in forthcoming clinical trials.
Intellectual Property Protection
We have six pending utility patent applications in the United States. The
patent applications cover methods and compositions for reducing side effects in
chemotherapeutic formulations, and improving efficacy and reducing toxicity of
chemotherapeutic agents. Two of our utility patents are filed worldwide under
the Patent Cooperation Treaty.
We filed with the U.S. Patent and Trademark Office (PTO) applications to
register the following trademarks/service marks: ADVANCING DRUGS THROUGH
GLYCOSCIENCE; GLYCO-UPGRADE; PRO-PHARMACEUTICALS, INC.; DAVANAT; UCLT and
UNIVERSAL CARBOHYDRATE LINKER TECHNOLOGY. In February 2002, the PTO issued
Notices of Allowance for two of these marks, ADVANCING DRUGS THROUGH
GLYCOSCIENCE, and GLYCO-UPGRADE. In order to obtain registrations, we must file
evidence of use by August 2002, or we must file an for an extension of time to
provide evidence of use. In January 2002, the PTO informed us that the mark
PRO-PHARMACEUTICALS, INC. has been approved for publication. Unless an
opposition to registration is timely filed, the PTO will issue a Notice of
Allowance for this mark.
10
Plan of Operation
As discussed in our 2001 Form 10-KSB, we were incorporated in January 2001
for the purpose of effecting a business combination with Pro-Pharmaceuticals,
Inc., a Massachusetts corporation engaged in a business we desired to acquire.
The transaction included a merger in which we are the surviving corporation. Our
capital resources to date consist of (i) the proceeds of a private placement of
convertible notes issued and sold by the predecessor Massachusetts company in
anticipation of its being acquired by us; (ii) the proceeds of a private
placement begun in May 2001 of our common stock and stock purchase warrants; and
(iii) the proceeds of our public offering of common stock begun in December
2001. Each is further described below. For further detail as to these offerings,
please refer to our 2001 Form 10-KSB.
In the private placement of convertible notes, which commenced in December
2000 and continued through May 2001, our predecessor Pro-Pharmaceuticals
(Massachusetts) issued convertible notes with an aggregate principal amount of
$1,320,602 to "accredited investors" as such term is defined in Regulation D
promulgated under the Securities Act of 1933. These notes became our corporate
obligations as a result of the merger with Pro-Pharmaceuticals (Massachusetts).
In connection with this convertible note, we issued 660,321 shares of common
stock. Each holder was entitled to receive one-half share of our common stock
for each whole dollar amount of principal. These shares were formally issued in
July 2001. In August 2001, we offered warrants to holders of our outstanding
convertible notes as an inducement to convert. Holders representing $1,125,602
of the outstanding principal and accrued interest chose to convert at a
conversion price of $2.00 per share and received 598,229 common shares and
598,229 warrants. The warrants have an exercise price of $6.50 per share, are
immediately exercisable and expire on October 1, 2005 subject to our right to
accelerate exercise of the warrant under certain circumstances as described in
our 2001 Form 10-KSB. As of March 31, 2002, all but $195,000 aggregate principal
amount of these notes had been converted to shares of our common stock.
In April 2002, we extended the maturity date for the $195,000 of
outstanding notes for one year. In consideration for the extension, 48,750
shares of common stock will be issued to the holders of the outstanding notes.
In May 2001, we began a private placement of securities exempt from
registration pursuant to Rule 506 of Regulation D under the Securities Act of
1933 in order to raise $5,145,000 to cover our expenditures. We terminated this
private placement as of December 3, 2001. As of the termination of this offering
in December 2001, we had received proceeds of $2,237,500 from the sale of the
securities offered in this private placement. Such purchases resulted in our
issuing 689,300 shares of our common stock and warrants to purchase 889,300
shares of our common stock.
On December 13, 2001, we commenced a public offering of 1,428,572 shares
of our common stock, at a price to the public of $3.50 per share, pursuant to a
registration statement on Form SB-2 as originally filed and declared effective
by the SEC on December 12, 2001, and subsequently amended by Post-Effective
Amendment No. 1 declared effective by the SEC on April 29, 2002. We anticipated
concluding the offering on February 11, 2002 but extended the offering until
June 11, 2002. As of April 8, 2002, we had received proceeds for, but not
issued, approximately 50,570 shares pursuant to our public offering.
As of March 31, 2002, we had approximately $967,000 in cash and cash
equivalents. We have budgeted expenditures for the twelve-month period ending
March 31, 2003, of $5,500,000, comprised of anticipated expenditures for
research and development ($4,200,000), general and administrative ($1,100,000),
equipment and leaseholds ($100,000) and contingency allowance ($100,000).
11
For the year ended December 31, 2001, our financial statements have been
presented on a going-concern basis, which contemplates the realization of assets
and satisfaction of liabilities in the normal course of business.
Pro-Pharmaceuticals is in the development stage, has incurred a net loss since
inception of approximately $5,107,000 and expects to incur additional losses in
the near future. Successful completion of our development program and,
ultimately, the attainment of profitable operations is dependent upon future
events, including maintaining adequate financing to fulfill our development
activities and achieving a level of sales adequate to support our cost
structure. We are actively seeking additional financing to fund future
operations and future significant investments in the business. However, there
can be no assurance that we will be able to obtain financing on acceptable
terms, or at all.
Additional funds may be raised through additional equity financings, as
well as borrowings and other resources. With the capital we have raised to date,
and the additional $5,000,000 that we are attempting to raise under our public
offering of common stock that commenced in December 2001, we believe that we
will be able to proceed with our current plan of operations and meet our
obligations for approximately the next twelve months. If we do not raise the
additional funds, we will have to cut our research and development expenditures,
which would substantially slow progress that we might expect to make during the
next twelve months in development of our business including commencement of
clinical trials.
During the next twelve months, we anticipate that our research and
development activities will include commencement of a Phase I first-in-man
clinical trial to determine the safety of our Davanat-1 carbohydrate, as well as
continuing preclinical animal experiments to study toxicity and efficacy of 5-FU
and other cancer chemotherapies both in combination with our mannan compounds
and, in the case of Adriamycin, as chemically modified with sugar residues via
"linkers" of a certain chemical structure that are our proprietary technology.
As we have done to date, we will have our pre-clinical testing done by outside
laboratories. We do not anticipate building in-house research or development
facilities, or hiring staff to conduct those activities. Consequently, we do not
expect to make any purchases or sales of plant or significant equipment during
the next twelve months, and we expect to maintain an employee headcount of three
to four. We currently have three employees, all full-time.
We expect to generate losses from operations for several years due to
substantial additional research and development costs, including costs related
to clinical trials. Our future capital requirements will depend on many factors,
in particular our progress in and scope of our research and development
activities, and the extent to which we are able to enter into collaborative
efforts for research and development and, later, manufacturing and marketing
products. We may need additional capital to the extent we acquire or invest in
businesses, products and technologies. If we should require additional financing
due to unanticipated developments, additional financing may not be available
when needed or, if available, we may not be able to obtain this financing on
terms favorable to us or to our stockholders. Insufficient funds may require us
to delay, scale back or eliminate some or all of our research and development
programs, or may adversely affect our ability to operate as a going concern. If
additional funds are raised by issuing equity securities, substantial dilution
to existing stockholders may result.
12
PART II - OTHER INFORMATION
Item 1. Legal Proceedings
None
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
13
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
Exhibit
Number Description of Document
- ------ -----------------------
3.1 Articles of Incorporation of the Registrant, dated *
January 26, 2001
3.2 Amended and Restated By-laws of the Registrant **
10.1 Assignment and Assumption Agreement, dated April 23, *
2001, by and between Developed Technology Resource,
Inc. and DTR-Med Pharma Corp.
10.2 Stock Exchange Agreement, dated April 25, 2001, by *
and among Developed Technology Resource, Inc.,
DTR-Med Pharma Corp., Pro-Pharmaceuticals, Inc.
(Massachusetts) and the Shareholders (as defined
therein)
10.3 Pro-Pharmaceuticals, Inc. 2001 Stock Incentive Plan **
16 Letter from Scillia Dowling & Natarelli LLC to the ***
Commission, dated February 25, 2002, concerning
change in certifying accountant
21 Subsidiaries of the Registrant None
* Incorporated by reference to the Registrant's Registration Statement on
Form 10-SB, as filed with the Commission on June 13, 2001.
** Incorporated by reference to the Registrant's Quarterly Report on Form
10-QSB for the period ended September 30, 2001, as filed with the
Commission on November 14, 2001.
*** Incorporated by reference to the Registrant's Current Report on Form 8-K
as filed with the Commission on February 25, 2002.
(b) Reports on Form 8-K
1. We filed a report on Form 8-K with the SEC, pursuant to Item 4, on
February 25, 2002, as amended and filed with the SEC as Form 8-K/A on March 8,
2002, concerning changes in our independent auditors.
2. On April 12, 2002, we filed a report on Form 8-K with the SEC, pursuant
to Item 5, concerning restatement of our financial results for the fiscal year
ended December 31, 2000, and the first, second and third quarters of fiscal year
2001.
14
SIGNATURE
In accordance with Section 13 or 15(d) of the Exchange Act, the Registrant
has caused this report to be signed on its behalf by the undersigned, thereunto
duly authorized, on May 14, 2002.
PRO-PHARMACEUTICALS, INC.
Registrant
By: /S/ DAVID PLATT
-------------------------------
Name: David Platt
Title: President, Chief Executive Officer,
Treasurer and Secretary
(Principal Executive Officer and
Principal Financial and Accounting
Officer)
15
EXHIBIT INDEX
Exhibit
Number Description of Document
- ------ -----------------------
3.1 Articles of Incorporation of the Registrant, dated *
January 26, 2001
3.2 Amended and Restated By-laws of the Registrant **
10.1 Assignment and Assumption Agreement, dated April 23, *
2001, by and between Developed Technology Resource,
Inc. and DTR-Med Pharma Corp.
10.2 Stock Exchange Agreement, dated April 25, 2001, by *
and among Developed Technology Resource, Inc.,
DTR-Med Pharma Corp., Pro-Pharmaceuticals, Inc.
(Massachusetts) and the Shareholders (as defined
therein)
10.3 Pro-Pharmaceuticals, Inc. 2001 Stock Incentive Plan **
16 Letter from Scillia Dowling & Natarelli LLC to the ***
Commission, dated February 25, 2002, concerning
change in certifying accountant
21 Subsidiaries of the Registrant None
* Incorporated by reference to the Registrant's Registration Statement on
Form 10-SB, as filed with the Commission on June 13, 2001.
** Incorporated by reference to the Registrant's Quarterly Report on Form
10-QSB for the period ended September 30, 2001, as filed with the
Commission on November 14, 2001.
*** Incorporated by reference to the Registrant's Current Report on Form 8-K
as filed with the Commission on February 25, 2002.
16