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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
November 13, 2006
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:
|_| 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))
Item 2.02 Results of Operations and Financial Condition.
On November 13, 2006, Pro-Pharmaceuticals, Inc. issued a press release entitled
"Pro-Pharmaceuticals Reports Third Quarter 2006 Results," a copy of which is
furnished with this Current Report on Form 8-K. This information shall not be
deemed to be "filed" for the purposes of Section 18 of the Securities Exchange
Act of 1934, as amended, and shall not be deemed to be incorporated by reference
in any filing under the Securities Act of 1933, as amended, except as expressly
set forth by specific reference in such a filing.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit Number 99.1*
Press Release dated November 13, 2006, entitled "Pro-Pharmaceuticals Reports
Third Quarter 2006 Results"
*filed herewith
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: November 13, 2006
EXHIBIT INDEX
Exhibit
Number Exhibit
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99.1* Press release dated November 13, 2006, entitled
"Pro-Pharmaceuticals Reports Third Quarter 2006 Results"
* filed herewith
Exhibit 99.1
Pro-Pharmaceuticals Reports Third Quarter 2006 Results
NEWTON, Mass.--(BUSINESS WIRE)--Nov. 13, 2006--Pro-Pharmaceuticals, Inc.
(Amex: PRW), a developer of novel carbohydrate therapeutic compounds, today
reported its financial results for the three and nine months ended
September 30, 2006.
For the third quarter of 2006, the Company reported net income of
$720,000, or $0.03 per share basic and $0.02 per share fully diluted,
compared with a net loss of $1,680,000, or ($0.06) per share (basic
and fully diluted), for the same period in 2005. The principal reasons
for net income were $2,613,000 of non-cash net income related to fair
value accounting and interest expense associated with the Company's
convertible debenture.
For the first nine months of 2006, the Company reported a net loss
of $7,773,000 or ($0.28) per share (basic and fully diluted), compared
with a net loss of $4,795,000, or ($0.18) per share (basic & fully
diluted), for the same period in 2005. The principal reasons for the
increase in net loss were $2,127,000 of non-cash charges related to
fair value accounting and interest expense associated with the
Company's convertible debenture and increased general and
administrative expenses.
At September 30, 2006, the Company had cash, cash equivalents and
a certificate of deposit of $8,125,000. The Company made its November
convertible debenture monthly payment of principal and interest in
cash and plans to make its December payment in cash. The Company
believes it has sufficient cash to fund operations through at least
June 2007.
"We continued to make progress in the clinic with our lead product
candidate DAVANAT(R)," said David Platt, Ph.D., Chief Executive
Officer, Pro-Pharmaceuticals. "The pharmacokinetic results from our
Phase I clinical trial for end-stage patients with all solid tumors
show 5-Fluorouracil (5-FU), in combination with DAVANAT(R), remains
significantly longer in the bloodstream, potentially increasing 5-FU's
efficacy without increasing its toxicity. It may also explain why 54%
of these end-stage cancer patients, who had measurable disease, were
stabilized from 2 to 13 months.
"In addition, the results from our Phase II colorectal cancer
trial for end-stage patients led us to initiate a Phase II trial to
evaluate DAVANAT(R) with AVASTIN(R), 5-FU and leucovorin as a first
line treatment for locally advanced, unresectable or metastatic
colorectal cancer in patients unable to tolerate intensive
chemotherapy. We also initiated a Phase II biliary cancer trial to
evaluate DAVANAT(R) with 5-FU as a first-line treatment to improve
patient outcomes in this rare but deadly disease. The biliary cancer
trial may represent an opportunity for orphan drug status approval.
Our two Phase II trials are actively recruiting patients."
Additional information on the two Phase II clinical trials can be
found at www.clinicaltrials.gov website, key word: DAVANAT.
Research and development expense for the third quarter 2006 was
$863,000, compared with $859,000 for the same period in 2005. Research
and development expense for the nine months ended September 30, 2006
was $2,315,000 compared with $2,292,000 for the same period in 2005.
General and administrative expense for the third quarter 2006
increased 26% to $1,066,000 compared with $846,000 for the same period
in 2005. The increase in G&A expense is due principally to the
implementation of SFAS 123R under which the Company now expenses the
fair value of employee stock options and expenses associated with the
convertible debenture. General and administrative expense for the nine
months ended September 30, 2006 increased 32% to $3,437,000 compared
with $2,594,000 for the same period in 2005. The increase consists
primarily of legal expense, the effect of expensing stock options
under the fair value method, and expenses associated with the
Company's convertible debenture.
About DAVANAT(R)
DAVANAT(R), the Company's lead product candidate, is a proprietary
polysaccharide polymer comprised of mannose and galactose
carbohydrates in a CARBOSOME(TM) formation that enables the targeted
delivery of chemotherapy drugs to protein receptors (lectins) on
cancer cells.
Pro-Pharmaceuticals, Inc. - Advancing Drugs Through
Glycoscience(R)
Pro-Pharmaceuticals is a development stage company engaged in the
discovery, development and commercialization of carbohydrate-based
therapeutic compounds for advanced treatment of cancer, liver,
microbial, cardiovascular and inflammatory diseases, and viral
infections. Initially, the product pipeline is principally focused on
increasing the efficacy and decreasing the toxicity of approved
chemotherapy drugs. The Company has been conducting clinical and
pre-clinical studies with its lead product candidate, DAVANAT(R), in
combination with 5-FU, leucovorin, irinotecan, doxorubicin,
oxaliplatin, paclitaxel, cisplatin and bevacizumab (AVASTIN(R)).
Results show that DAVANAT(R) exhibits a broad spectrum of activity
with tested drugs. 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 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. 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.
DAVANAT and Advancing Drugs Through Glycoscience are registered
trademarks of Pro-Pharmaceuticals. CARBOSOME is a trademark of
Pro-Pharmaceuticals. AVASTIN is a trademark of Genentech, Inc.
CONTACT: Pro-Pharmaceuticals, Inc.
Anthony D. Squeglia, 617-559-0033
squeglia@pro-pharmaceuticals.com