UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
November 2, 2006
Date of Report (Date of earliest event reported)
PRO-PHARMACEUTICALS, INC.
(Exact Name of Registrant as Specified in Charter)
| NEVADA | 000-32877 | 04-3562325 | ||
| (State or Other Jurisdiction of Incorporation) |
(Commission File Number) | (IRS Employer 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)
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)) |
Item 7.01. Regulation FD Disclosure.
David Platt, Ph.D., Chief Executive Officer of Pro-Pharmaceuticals, Inc. (“Company”) on November 2, 2006 presented an updated corporate presentation as reflected in the slides attached as Exhibit 99.1 to this Current Report on Form 8-K (this “Report”) at the MASS Opportunities: A Biotechnology Investment Conference at the Hilton Logan Airport Hotel in Boston, Massachusetts.
The information in this Report, including the slides attached hereto as Exhibit 99.1, is being furnished pursuant to this Item 7.01 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, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Report.
By filing this Report and furnishing this information, the Company makes no admission as to the materiality of any information in this Report. The information contained in the slides is summary information that is intended to be considered in the context of the Company’s filings with the Securities and Exchange Commission (the “SEC”) and other public announcements that the Company makes, by press release or otherwise, from time to time. The Company undertakes no duty or obligation to publicly update or revise the information contained in this Report, although it may do so from time to time as its management believes is appropriate. Any such updating may be made through the filing of other reports or documents with the SEC, through press releases or through other public disclosure.
The Company cautions you that information included in the slides attached hereto as Exhibit 99.1 that are not a description of historical facts are forward-looking statements that involve risks, uncertainties, assumptions and other factors that, if they do not materialize or prove to be accurate, could cause the Company’s results to differ materially from historical results or those expressed or implied by such forward-looking statements. Such forward-looking statements are made based on management’s current expectations and beliefs and should not be regarded as a statement or representation by the Company that any of its plans, including its anticipated milestones, will be achieved on time or at all. The potential risks and uncertainties that could cause actual results to differ materially include, but are not limited to: the risk that the Company will be unable to raise sufficient capital to fund the projects necessary to meet its anticipated or stated goals and milestones; the potential to attract a strategic partner and the terms of any related transaction; the ability to timely enroll subjects in the Company’s current and anticipated clinical trials; the potential for DAVANAT® to receive regulatory approval for one or more indications on a timely basis or at all, and the uncertain process of seeking regulatory approval; other difficulties or delays in developing, testing, manufacturing and marketing of and obtaining regulatory approval for DAVANAT®; the market potential for carbohydrate-based compounds, and the Company’s ability to compete in those markets; unexpected adverse side effects or inadequate therapeutic efficacy of DAVANAT® or the Company’s other products that could
delay or prevent regulatory approval or commercialization, or that could result in recalls or product liability claims; the risk that preclinical results are not indicative of the success of subsequent clinical trials and that products will not perform as preclinical data suggests or as otherwise anticipated; the potential for regulatory authorities to require additional preclinical work or other clinical requirements to support regulatory filings; the scope and validity of patent protection for DAVANAT® and the Company’s other product candidates; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at http://www.sec.gov.
You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date when made. All forward-looking statements are qualified in their entirety by this cautionary statement and the Company assumes no obligation to revise or update any forward-looking statement, including any information included in the slides attached hereto as Exhibit 99.1, to reflect events or circumstances arising after the date on which it was made. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933 or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Report.
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.
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 | |
| Carl L. Lueders | ||
| Chief Financial Officer | ||
Date: November 2, 2006
EXHIBIT INDEX
| Exhibit Number |
Exhibit | |
| 99.1 | MASS Opportunities: A Biotechnology Investment Conference Presentation Slides - dated November 2, 2006 |
 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Forward Looking Statements Any statements in this presentation about future expectations, plans and prospects for the Company, including statements containing the words "believes," "anticipates," "plans," "expects," and similar expressions, constitute forward looking statements, which are subject to the safe harbor for such statements in the Private Securities Litigation Reform Act of 1995. Future events could cause actual results to differ materially from those indicated by such statements. Reference is made to the factors discussed in the “Management Discussion and Analysis" and "Risk Factors" sections of the Company's most recent quarterly or annual report filed with the Securities and Exchange Commission. The forward-looking statements herein represent the Company's views as of the date of this presentation 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. 2 * * |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Mission Advancing Drugs Through Glycoscience ® 3 * * |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Key Investment Points • Clinical stage pharmaceutical company – Completed Phase I/II cancer trials w/ DAVANAT ® – Stabilized 35% of end stage patients: 2-13 months – Two ongoing Phase II front line trials • DAVANAT ® increased the half life of 5-FU 8 fold with no increase in toxicity • DAVANAT ® /5-FU model can be applied to other chemotherapy agents 4 |
 Clinical Trial Program – Completed Phase I/II cancer trials w/ DAVANAT ® – Stabilized 35% of end stage patients: 2-13 months – Two ongoing Phase II front line trials * * 5 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Phase I/II End Stage Cancer Trials Summary • 35% stabilized at the highest dose level • Maximum Tolerated Dose & Dose Limiting Toxicity not reached • DAVANAT ® significantly increased half life of 5-FU with no increase in toxicity 6 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Phase I Clinical Trial Summary • DAVANAT ® was well tolerated • Maximum Tolerated Dose and Dose Limiting Toxicity of DAVANAT ® not reached – DAVANAT 280 mg/m² recommended Phase II dose • Pharmacokinetics – Half life of 5-FU alone is 6-22 minutes – Half life of 5-FU with DAVANAT ® is 28-137 minutes – No increase in 5-FU toxicity w/ increased exposure • Stable disease in 14 of 26 efficacy evaluable patients – 7/10 patients stabilized at the highest DAVANAT ® dose level 7 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W SD Stable Disease PD Progressive Disease NM Non-Measurable Disease Cycles Completed Dose, cycle 2 /m2 1+2 3 4 5 6 7 1001 PD 1002 SD 2001 Hepatocellular PD 2002 Hepatocellular SD 3001 PD 3002 SD 3004 PD 3003 PD 5001 SD 2004 SD 3005 PD 4001 PD 4002 Colorectal PD 3006 Prostate NM 2005 Colorectal SD 5003 Colorectal (appendix) NM 5004 SD 4003 PD 2007 Spindle Cell PD 5005 Pancreatic SD 2008 Colorectal SD 2009 Colorectal SD 5006 Billiary SD 2010 Colorectal (cecal) SD 2014 Breast SD 2016 Hepatic PD 2018 Cholangiocarcinoma SD 5008 Pancreatic PD 280 mg 150 mg Patient Number Tumor Type Outcome, end of cycle 2 (RECIST) C Y C L E S Colorectal Colorectal 210 mg 30 mg 60 mg Colorectal 100 mg Colorectal Phase l Patient Summary: Stabilized 70% at Highest Dose Level 8 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Phase II Colorectal Cancer Trial Summary • Trial conducted with end-stage patients • Anti-tumor activity was seen with DAVANAT ® /5-FU – 1 patient experienced Partial Response – 6 patients stabilized • No increase in 5-FU toxicity w/ increased exposure 9 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W DAVANAT ® /5-FU Enrolling Phase II Colorectal Cancer Trial • Indication: First-line treatment of patients who are unable to tolerate irinotecan or oxaliplatin • Regimen: DAVANAT ® /5-FU, Leucovorin, AVASTIN ® – Repeat cycles every 2 weeks to disease progression or toxicity • Objectives: Complete/Partial Response – Stable Disease; Progression Free Survival; Safety; Quality of Life • Design: Multi-center, open label study – Simon Optimal 2-stage design • Patients: Up to 50 patients – Begin enrolling/ dosing patients in Q4 2006 10 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W DAVANAT ® /5-FU Enrolling Phase II Biliary Cancer Trial • Indication: First line treatment of patients with biliary tract cancer • Regimen: DAVANAT ® (280 mg/m²) + 5-FU (600 mg/m²) IV daily x 4 days – Repeat cycles every 28 days to disease progression or toxicity • Objectives: Complete/Partial Response – Stable Disease; Progression Free Survival; Safety;
Quality of Life • Design: Multi-center, open label study – Simon Optimal 2-stage design • Patients: Up to 35 – Begin enrolling/dosing patients in Q4 2006 11 |
 DAVANAT ® Increases the Half Life of 5-FU, 8 Fold with No Increase in Toxicity * * 12 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W DAVANAT ® Increases Half Life of 5-FU in Patients, 8 times 5-FU / DAVANAT – Day 4 5-FU / DAVANAT – Day 1 5-FU – Historical |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W 5-FU in the presence of DAVANAT ® Does Not Change Key Toxicity Markers 0 10 20 30 40 0 10 20 30 40 AUC Hematocrit Hemoglobin Red blood cells White blood cells Platelets |
 The
DAVANAT ® /5-FU Model Can Be Applied To Increasing Efficacy/ Decreasing Toxicity of Other Chemotherapy Agents 15 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W DAVANAT ® with another Chemotherapy Agent 100 1000 10000 0 10 20 30 40 Time post implanatation (Days) Control IR40/DAV6 IR40/DAV30 IR40/DAV120 16 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Mechanism of Action: Targeting Lectins on Cancer Cells • DAVANAT ® binds to lectins • Galectins are a type of lectin that are over- expressed on cancer cells • Galectins affect cell development, differentiation, apoptosis and tumor metastasis 17 |
 P R
O P H A R M A C E U T I C A L S , I N C. A D V A N C I N G D R U G S T H R O U G H G L Y C O S C I E N C E ® Amex: P R W Key Investment Points • Clinical stage pharmaceutical company – Completed Phase I/II cancer trials w/ DAVANAT ® – Stabilized 35% of end stage patients: 2-13 months – Two ongoing Phase II front line trials • DAVANAT ® increased the half life of 5-FU 8 fold with no increase in toxicity • DAVANAT ® /5-FU model can be applied to other chemotherapy agents 18 |