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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
August 10, 2007
Date of Report (Date of earliest event reported)
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PRO-PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
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NEVADA 000-32877 04-3562325
(State or Other Jurisdiction (Commission File Number) (IRS Employer
of Incorporation) Identification No.)
7 WELLS AVENUE
NEWTON, MASSACHUSETTS
02459
(Address of Principal Executive Offices) (Zip Code)
(617) 559-0033
(Registrant's telephone number, including area code)
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Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any of the
following provisions (see General Instruction A.2. below):
|_| Written communications pursuant to Rule 425 under the Securities Act
(17 CFR 230.425)
|_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act
(17 CFR 240.14a-12)
|_| Pre-commencement communications pursuant to Rule 14d-2(b) under the
Exchange Act (17 CFR 240.14d-2(b))
|_| Pre-commencement communications pursuant to Rule 13e-4(c) under the
Exchange Act (17 CFR 240.13e-4(c))
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Results of Operations and Financial Condition
Item 2.02. Results of Operations and Financial Condition.
On August 10, 2007, Pro-Pharmaceuticals, Inc. issued a news release regarding
its financial results for the quarter ended June 30, 2007. A copy of the news
release is being furnished as Exhibit 99.1 to this report.
The information in this report, including the Exhibit attached hereto, is
intended to be furnished and shall not be deemed "filed" for purposes of Section
18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise
subject to the liabilities of that section, nor shall it be deemed incorporated
by reference in any filing under the Securities Act of 1933 or the Exchange Act,
except as expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
The list of exhibits called for by this Item is incorporated by reference
to the Index to Exhibits filed with this report.
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
PRO-PHARMACEUTICALS, INC.
By: /s/ Carl L. Lueders
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Carl L. Lueders
Chief Financial Officer
Date: August 10, 2007
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EXHIBIT INDEX
Exhibit
Number Exhibit
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99.1 Pro-Pharmaceuticals News Release- dated August 10, 2007,
furnished herewith
Exhibit 99.1
Pro-Pharmaceuticals Reports Second
Quarter Results
NEWTON, Mass.--(BUSINESS WIRE)--Aug. 10,
2007--Pro-Pharmaceuticals, Inc. (Amex: PRW), a company "Advancing
Drugs Through Glycoscience(R)", today reported its second quarter and
six months financial results, ended June 30, 2007.
For the second quarter of 2007, the Company reported net income of
$36,000, or $0.00 per share, basic and fully diluted, compared with
net income of $230,000, or $0.01 per share basic or ($0.03) per share
fully diluted, for the same period in 2006. Approximately $1,819,000
of the second quarter results were non-cash expenses relating to the
change in fair value of the convertible debentures and warrant
liabilities compared with $2,868,000 in the second quarter of 2006.
For the six months ended June 20, 2007, the Company reported net
loss of $5,538,000, or ($0.15) per share basic and fully diluted,
compared with a net loss of $8,096,000, or ($0.29) per share basic and
fully diluted, for the same period in 2006. Approximately $1,597,000
of the net loss in the six months ended June 30, 2007, were non-cash
expenses relating to the change in fair value of the convertible
debentures and warrant liabilities compared with $3,435,000 in the
same period in 2006.
"We are focusing our resources towards our goal to develop and
commercialize DAVANAT(R)," said David Platt, Ph.D., Chief Executive
Officer, Pro-Pharmaceuticals. "We are working on our 505 (b)(2)
submission to the U.S. Food & Drug Administration (FDA) for DAVANAT(R)
to be co-administered with 5-Fluorouricil (5-FU) intravenously to
treat cancer. We are using Section 505 (b)(2) to obtain more timely
and efficient marketing approval of new formulations of previously
approved therapeutics.
"In addition, we are making progress with our Phase II trials for
the first-line treatment of biliary and colorectal cancer. Early data
is promising. Both trials offer potential orphan drug status. We
recently entered into a research agreement with a global
bio-pharmaceutical company to evaluate the application of DAVANAT(R)
to improve the delivery of their chemotherapeutic compound to treat
cancer. We have retained the services of a business development
executive and are currently in active discussions with more than a
dozen companies for the potential licensing of DAVANAT(R). The need to
improve drug therapies, particularly anti-cancer agents, is
significant and represents a large market opportunity," Dr. Platt
stated.
At June 30, 2007, the Company had cash and cash equivalents of
approximately $2.4 million. The Company expects its cash operating
expense in the third quarter to be approximately $1.2 million. The
Company plans to obtain financing to fund its development activities
through debt or equity financings or collaborations with
pharmaceutical companies.
Research and development expense for the second quarter of 2007
was $668,000, compared with $998,000 for the same quarter in 2006. The
decrease in R&D expense was primarily due to clinical trial start-up
costs in 2006 that did not occur in 2007. Research and development
expense for the six months ended June 30, 2007, was $1,336,000,
compared with $1,452,000 for the same period in 2006. The decrease was
primarily due to costs related to the completion of the Phase II
colorectal cancer trial for the treatment of end-stage patients.
General and Administrative expense for the second quarter of 2007
was $1,104,000, compared with $1,101,000 for the same quarter in 2006.
General and Administrative expense for the six months ended June 30,
2007, was $2,360,000, compared with $2,371,000 for the same period in
2006. The Company recently announced it has reduced planned third
quarter 2007 operating cash expenses by 30% to extend its cash runway,
which primarily resulted from a 50% reduction in payroll expense (with
no change in headcount) and significant reductions in other expenses.
In June, the Company received a notice from the American Stock
Exchange (Amex) that it is reviewing the Company's eligibility for
continued listing. Specifically, the notice cited the Company is not
in compliance with the Amex's minimum of $2 million in stockholders'
equity. The Company submitted a plan to the Amex in July that outlines
the Company's plan to regain compliance with Amex's continued listing
requirements. The Amex has not provided the Company with a timetable
for its formal response to the submitted plan and the plan's
acceptance is at their discretion.
About DAVANAT(R)
DAVANAT(R), the Company's lead product candidate, is a
polysaccharide (carbohydrate polymer) composed of mannose and
galactose (galactomannan). DAVANAT(R)'s mechanism of action is based
upon binding to lectins on the cell surface. It is theorized that
DAVANAT(R) targets specific lectin receptors (Galectins) that are
over-expressed on cancer cells. Current research indicates that
Galectins affect cell development and play important roles in cancer,
including tumor cell survival, angiogenesis and tumor metastasis. This
form of targeted delivery may allow for higher doses of chemotherapy
administration with no increase in toxicity.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals is a development stage pharmaceutical company
engaged in the discovery, development and commercialization of
carbohydrate-based compounds for advanced treatment of cancer, liver,
microbial, cardiovascular and inflammatory diseases. The Company's
initial focus is the development of carbohydrate polymers to enhance
the safety and efficacy of cancer agents. The Company's technology
capitalizes on the natural property of carbohydrates to increase the
efficacy and reduce the toxicity of chemotherapeutics; "rescue" drugs
that were shelved for toxicity or "half-life" issues; increase the
solubility of existing drugs, and develop carbohydrate polymers as new
chemical entities. Founded in 2000, the Company is headquartered in
Newton, Mass. Additional information is available at
www.pro-pharmaceuticals.com.
FORWARD LOOKING STATEMENTS: Any statements in this news release
about future expectations, plans and prospects for the Company,
including without limitation statements containing the words
"believes," "anticipates," "plans," "expects," and similar
expressions, constitute forward-looking statements as defined in the
"safe harbor" provisions of the Private Securities Litigation Reform
Act of 1995. 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 pre-clinical and
clinical trials of our product candidates; our limited 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 bio-pharmaceutical industry. We
cannot assure you that we have identified all the factors that create
uncertainties. Readers should not place undue reliance on
forward-looking statements.
More information about those risks and uncertainties is contained
and discussed in the "Management Discussion and Analysis of Financial
Condition and Results of Operations" and "Risk Factors" sections of
the Company's most recent quarterly or annual report and in the
Company's other reports filed with the Securities and Exchange
Commission. The forward-looking statements represent the Company's
views as of the date of this news release and should not be relied
upon to represent the Company's views as of a subsequent date. While
the Company anticipates that subsequent events may cause the Company's
views to change, the Company disclaims any obligation to update such
forward-looking statements.
Advancing Drugs Through Glycoscience and DAVANAT are registered
trademarks of Pro-Pharmaceuticals.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com