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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
| x | Quarterly report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the quarterly period ended June 30, 2005
| ¨ | Transition report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
For the transition period from to
Commission File No. 000-32877
PRO-PHARMACEUTICALS, INC.
| Nevada | 04-3562325 | |
| (State or other jurisdiction of incorporation) |
(I.R.S. Employer Identification No.) | |
| 189 Wells Avenue, Newton, Massachusetts | 02459 | |
| (Address of Principal Executive Offices) | (Zip Code) | |
(617) 559-0033
(Registrant’s Telephone Number, Including Area Code)
Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. YES x NO ¨
Indicate by check mark whether the registrant is an accelerated filer (as defined in Exchange Act Rule 12b 2). YES ¨ NO x
The number of shares outstanding of the registrant’s common stock as of August 4, 2005 was 27,315,411.
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INDEX TO FORM 10-Q
FOR THE QUARTER ENDED JUNE 30, 2005
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(A Development-Stage Company)
CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) (dollars in thousands)
| June 30, 2005 |
December 31, 2004 |
|||||||
| ASSETS | ||||||||
| CURRENT ASSETS: |
||||||||
| Cash and cash equivalents |
$ | 7,337 | $ | 10,704 | ||||
| Prepaid expenses and other current assets |
210 | 120 | ||||||
| Total current assets |
7,547 | 10,824 | ||||||
| PROPERTY AND EQUIPMENT—NET |
98 | 103 | ||||||
| INTANGIBLE ASSETS—NET |
216 | 156 | ||||||
| DEPOSITS AND OTHER ASSETS |
27 | 27 | ||||||
| TOTAL ASSETS |
$ | 7,888 | $ | 11,110 | ||||
| LIABILITIES AND STOCKHOLDERS’ EQUITY | ||||||||
| CURRENT LIABILITIES: |
||||||||
| Accounts payable |
$ | 246 | $ | 206 | ||||
| Accounts payable - related party |
3 | — | ||||||
| Other accrued expenses |
634 | 799 | ||||||
| Total current liabilities |
883 | 1,005 | ||||||
| CONTINGENCIES (Note 4) |
||||||||
| STOCKHOLDERS’ EQUITY: |
||||||||
| Common stock, $0.001 par value; 100,000,000 shares authorized, 27,315,411 issued and outstanding; Undesignated shares, $.01 par value; 10,000,000 shares authorized, none issued and outstanding |
27 | 27 | ||||||
| Additional paid-in capital |
29,980 | 29,965 | ||||||
| Deferred compensation |
— | (1 | ) | |||||
| Deficit accumulated during the development stage |
(23,002 | ) | (19,886 | ) | ||||
| Total stockholders’ equity |
7,005 | 10,105 | ||||||
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY |
$ | 7,888 | $ | 11,110 | ||||
See notes to unaudited condensed consolidated financial statements.
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(A Development-Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) (dollars in thousands except share and per share amounts)
| Three Months Ended June 30, |
Six Months Ended June 30, |
Cumulative Period from Inception (July 10, 2000) to June 30, 2005 |
||||||||||||||||||
| 2005 |
2004 |
2005 |
2004 |
|||||||||||||||||
| OPERATING EXPENSES: (a) | ||||||||||||||||||||
| Research and development |
$ | 831 | $ | 522 | $ | 1,432 | $ | 1,373 | $ | 8,901 | ||||||||||
| General and administrative |
897 | 915 | 1,749 | 1,937 | 12,159 | |||||||||||||||
| Total operating expenses |
$ | (1,728 | ) | $ | (1,437 | ) | $ | (3,181 | ) | $ | (3,310 | ) | $ | (21,060 | ) | |||||
| INTEREST AND OTHER INCOME |
30 | 32 | 66 | 51 | 309 | |||||||||||||||
| INTEREST AND OTHER EXPENSES: |
||||||||||||||||||||
| Amortization of debt discount on convertible notes |
— | — | — | — | 1,258 | |||||||||||||||
| Debt conversion expense |
— | — | — | — | 503 | |||||||||||||||
| Interest expense on convertible notes |
— | — | — | — | 486 | |||||||||||||||
| Other interest expense |
— | — | — | — | 4 | |||||||||||||||
| Total interest and other expenses |
— | — | — | — | (2,251 | ) | ||||||||||||||
| NET LOSS |
$ | (1,698 | ) | $ | (1,405 | ) | $ | (3,115 | ) | $ | (3,259 | ) | $ | (23,002 | ) | |||||
| NET LOSS PER SHARE—BASIC AND DILUTED |
$ | (0.06 | ) | $ | (0.06 | ) | $ | (0.11 | ) | $ | (0.13 | ) | ||||||||
| WEIGHTED AVERAGE COMMON SHARES OUTSTANDING |
||||||||||||||||||||
| BASIC AND DILUTED |
27,315,411 | 25,227,817 | 27,315,411 | 24,653,558 | ||||||||||||||||
| (a) The following summarizes the allocation of the stock-based compensation charge: |
||||||||||||||||||||
| Research and development |
$ | — | $ | 4 | $ | 1 | $ | 6 | $ | 141 | ||||||||||
| General and administrative |
— | 36 | 15 | 117 | 909 | |||||||||||||||
| Total |
$ | — | $ | 40 | $ | 16 | $ | 123 | $ | 1,050 | ||||||||||
See notes to unaudited condensed consolidated financial statements.
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(A Development-Stage Company)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) (dollars in thousands)
| Six Months Ended June 30, |
Cumulative Period from Inception (July 10, 2000) to June 30, 2005 |
|||||||||||
| 2005 |
2004 |
|||||||||||
| CASH FLOWS FROM OPERATING ACTIVITIES: | ||||||||||||
| Net loss |
$ | (3,115 | ) | $ | (3,259 | ) | $ | (23,002 | ) | |||
| Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||||||
| Depreciation and amortization |
32 | 44 | 259 | |||||||||
| Stock-based compensation expense |
16 | 123 | 1,050 | |||||||||
| Amortization of deferred extension costs through interest expense |
— | — | 167 | |||||||||
| Settlement of accrued interest through issuance of common stock |
— | — | 10 | |||||||||
| Amortization of debt discount on convertible notes |
— | — | 1,258 | |||||||||
| Write-off of intangible assets |
— | — | 116 | |||||||||
| Debt conversion expense |
— | — | 503 | |||||||||
| Interest expense related to issuance of warrants to purchase common stock |
— | — | 236 | |||||||||
| Changes in current assets and liabilities: |
||||||||||||
| Prepaid expenses and other current assets |
(90 | ) | (10 | ) | (207 | ) | ||||||
| Deposits and other assets |
— | — | (27 | ) | ||||||||
| Accounts payable and accrued expenses |
(122 | ) | 320 | 1,001 | ||||||||
| Net cash used in operating activities |
(3,279 | ) | (2,782 | ) | (18,635 | ) | ||||||
| CASH FLOWS FROM INVESTING ACTIVITIES: |
||||||||||||
| Purchases of property and equipment |
(20 | ) | — | (315 | ) | |||||||
| Increase in patents costs and other assets |
(68 | ) | (34 | ) | (266 | ) | ||||||
| Net cash used in investing activities |
(88 | ) | (34 | ) | (581 | ) | ||||||
| CASH FLOWS FROM FINANCING ACTIVITIES: |
||||||||||||
| Net proceeds from issuance of common stock and warrants |
— | 3,984 | 25,309 | |||||||||
| Net proceeds from issuance of convertible notes payable |
— | — | 1,321 | |||||||||
| Repayment of convertible notes payable |
— | — | (86 | ) | ||||||||
| Proceeds from shareholder advances |
— | — | 9 | |||||||||
| Net cash provided by financing activities |
— | 3,984 | 26,553 | |||||||||
| NET INCREASE IN CASH AND CASH EQUIVALENTS |
(3,367 | ) | 1,168 | 7,337 | ||||||||
| CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD |
10,704 | 7,608 | — | |||||||||
| CASH AND CASH EQUIVALENTS, END OF PERIOD |
$ | 7,337 | $ | 8,776 | $ | 7,337 | ||||||
| SUPPLEMENTAL DISCLOSURE—Cash paid for interest |
$ | — | $ | — | $ | 19 | ||||||
| NONCASH FINANCING ACTIVITIES |
||||||||||||
| Issuance of warrants in connection with equity offerings |
$ | — | $ | — | $ | 6,645 | ||||||
| Conversion of accrued expenses into common stock |
— | — | 303 | |||||||||
| Cashless exercise of employee stock options |
— | — | 74 | |||||||||
| Conversion of convertible notes and accrued interest into common stock |
— | — | 1,220 | |||||||||
| Conversion of extension costs related to conversion of convertible notes into common stock |
— | — | 171 | |||||||||
| Issuance of warrants to induce conversion of notes payable |
— | — | 503 | |||||||||
| Issuance of stock to acquire Pro-Pharmaceuticals-NV |
— | — | 107 | |||||||||
See notes to unaudited condensed consolidated financial statements.
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(A DEVELOPMENT-STAGE COMPANY)
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (dollar amounts in thousands)
| 1. | BASIS OF PRESENTATION |
The consolidated financial statements as reported in Form 10-Q reflect all adjustments which are, in the opinion of management, necessary to present fairly the financial position of Pro-Pharmaceuticals, Inc. (the “Company”) as of June 30, 2005 and the results of its operations and cash flows for the three and six months ended June 30, 2005, and June 30, 2004. All adjustments made to the interim financial statements included all those of a normal and recurring nature. The results for interim periods are not necessarily indicative of results which may be expected for any other interim period or for the full year.
The unaudited condensed consolidated financial statements of the Company should be read in conjunction with the Company’s annual report on Form 10-K for the year ended December 31, 2004.
As shown in the consolidated financial statements, the Company incurred net losses of $23,002 for the cumulative period from inception (July 10, 2000) through June 30, 2005. The Company’s net losses have resulted principally from costs associated with research and development expenses, including clinical trial costs, and general and administrative activities. As a result of planned expenditures for future research, discovery, development and commercialization activities and potential legal cost to protect its intellectual property, the Company expects to incur additional losses and use additional cash in its operations for the foreseeable future. From inception (July 10, 2000) through June 30, 2005, the Company has raised $26,630 in capital through (i) the issuance of convertible notes; (ii) the sale of common stock through a public offering; and (iii) the sale of common stock and warrants through private placements. From inception (July 10, 2000) through June 30, 2005, the Company used $18,635 in its operations. At June 30, 2005, the Company had $7,337 of cash and cash equivalents to fund future operations. Management believes there is sufficient cash to fund operations through at least May 2006.
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, need for regulatory approval of products, risks associated with protection of intellectual property, and competition with larger, better-capitalized companies. Successful completion of the Company’s development program and, ultimately, the attainment of profitable operations is dependent upon future events, including obtaining adequate financing to fulfill its development activities and achieving a level of revenues adequate to support the Company’s cost structure. There are no assurances, however, that the Company will be able to obtain additional financing on favorable terms, or at all, or successfully market its products.
| 2. | STOCK-BASED COMPENSATION |
The Company accounts for stock-based compensation to employees and non-employee directors under the intrinsic method in accordance with Accounting Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to Employees,” and the related interpretations. Under APB No. 25, no compensation expense is recognized for stock options and restricted stock awards granted at fair market value and with fixed terms.
Stock or other equity-based compensation granted to non-employees is accounted for under the fair value method in accordance with SFAS No. 123, “Accounting for Stock-Based Compensation,” and the Emerging Issues Task Force (“EITF”) Abstract No. 96-18, “Accounting for Equity Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling, Goods or Services,” and the related interpretations. Under this method, compensation is recorded at the fair value of the consideration received or the fair value of the equity instrument until the final measurement date, which is the earlier of performance completion or vesting. Compensation related to stock appreciation rights and other variable stock option or award plans are remeasured at the end of each reporting period. Fluctuations in the quoted market price of the Company’s stock covered by unvested equity instruments are reflected as an adjustment to deferred compensation and compensation expense over the periods the related service is performed.
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The fair value of the equity instruments granted to non-employees, including options and warrants, is determined using the Black-Scholes option-pricing model. Key assumptions used to apply this option-pricing model are as follows:
| Six Months Ended June 30, |
Cumulative (July 10, 2000) to June
30, | |||||
| 2005 |
2004 |
|||||
| Risk-free interest rate |
3.43%-3.96% | 2.00%-2.27% | 1.51%-3.96% | |||
| Expected life of the options and warrants |
3 years | 3 years | 3 years | |||
| Expected volatility of the underlying stock |
75% | 95% | 95% | |||
| Expected dividend rate |
None | None | None | |||
Had the Company used the fair-value method to measure all stock-based compensation awarded to employees and non-employee directors, the Company’s net loss and basic and diluted loss per share would have been as follows:
| Three Months Ended June 30, |
Six Months Ended June 30, |
Cumulative Inception |
||||||||||||||||||
| 2005 |
2004 |
2005 |
2004 |
|||||||||||||||||
| Net loss—as reported |
$ | (1,698 | ) | $ | (1,405 | ) | $ | (3,115 | ) | $ | (3,259 | ) | $ | (23,002 | ) | |||||
| Deduct employee stock-based compensation determined under the fair-value method |
(39 | ) | (228 | ) | (150 | ) | (457 | ) | (4,077 | ) | ||||||||||
| Net loss—pro forma |
$ | (1,737 | ) | $ | (1,633 | ) | $ | (3,265 | ) | $ | (3,716 | ) | $ | (27,079 | ) | |||||
| Basic and diluted loss per share: |
||||||||||||||||||||
| As reported |
$ | (0.06 | ) | $ | (0.06 | ) | $ | (0.11 | ) | $ | (0.13 | ) | ||||||||
| Pro forma |
$ | (0.06 | ) | $ | (0.06 | ) | $ | (0.12 | ) | $ | (0.15 | ) | ||||||||
Pursuant to the 2001 Pro-Pharmaceuticals, Inc. Employee Stock Incentive Plan, the Company on February 11, 2005, granted to its Chief Financial Officer, in accordance with an employment agreement, options to purchase 150,000 shares of its common stock exercisable at $2.82 per share. Pursuant to the 2003 Pro-Pharmaceuticals, Inc. Non-Employee Director Stock Incentive Plan, the Company on February 24, 2005, granted to each of its non-management directors, in consideration of their service on the Board of Directors in 2004, options ranging from 5,000 to 11,000 per director to purchase shares of the Company’s common stock, exercisable at $2.70 per share. The awards were granted at fair value and with fixed terms.
In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123R, “Share-Based Payment” (SFAS No. 123R). This Statement is a revision of SFAS No. 123, “Accounting for Stock-Based Compensation,” and supercedes Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and its related implementation guidance. SFAS No. 123R focuses primarily on accounting for transactions in which a company obtains employee services in share-based payment transactions. SFAS No. 123R is effective for the Company on January 1, 2006. The Company is evaluating the methods of adoption allowed by SFAS No. 123R and does not yet have an estimate of the effect on its statements of operations of adopting SFAS No. 123R.
| 3. | OTHER ACCRUED EXPENSES |
Other accrued expenses consist of the following:
| June 30, 2005 |
December 31, 2004 | |||||
| Legal and accounting fees |
$ | 131 | $ | 250 | ||
| Scientific and clinical fees |
303 | 374 | ||||
| Accrued payroll and vacation |
185 | 150 | ||||
| Other |
15 | 25 | ||||
| Total |
$ | 634 | $ | 799 | ||
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| 4. | CONTINGENCIES |
In October 2003, the Securities and Exchange Commission began an investigation related to matters alleged by a former employee and in November 2004 expanded it to determine whether statements concerning the Company were false or misleading. On July 27, 2005 the Company received written notification from the SEC that it has terminated its investigation without recommendation of any enforcement action. The Company has been informed that the Commonwealth of Massachusetts has completed its related investigation and does not intend further action.
In January 2004, Dr. Platt, the Company’s Chairman and Chief Executive Officer, filed a lawsuit in Massachusetts Superior Court against GlycoGenesys, Inc. for various claims including breach of contract. In its filing in February 2004, GlycoGenesys asserted counterclaims against the Company and Dr. Platt alleging tortious interference and misappropriation of proprietary rights. The counterclaims seek monetary damages and injunctive relief related to the Company’s intellectual property. In March 2004, the Company and Dr. Platt answered the counterclaims and denied any liability. In June 2004, the Court allowed, without opposition, a motion of GlycoGenesys for leave to file a supplemental counterclaim against the Company for defamation and unfair competition. Pretrial discovery has begun. The Company and Dr. Platt intend to contest these counterclaims vigorously and believe they will ultimately prevail. However, if the Company does not prevail, there could be a material adverse impact on the financial position, results of operations or cash flows of the Company.
Pursuant to Board approval, the Company has agreed to indemnify Dr. Platt for the expenses of his defense of the counterclaims, some of which may be recoverable under insurance. In the first six months of 2005, the Company incurred $124 of expenses in connection with this defense. Through June 30, 2005, the Company has incurred cumulative costs of approximately $292 in legal and related costs in connection with the indemnification. No amount, if any, potentially recoverable from the insurance company has been recorded at June 30, 2005.
* * * * * *
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations (dollar amounts in thousands)
This Management’s Discussion and Analysis of Financial Condition and Results of Operations should be read in conjunction with the financial information included in this Quarterly Report on Form 10-Q, the “Factors That May Affect Future Results” set forth below in this report and in our Annual Report on Form 10-K for the year ended December 31, 2004. The following discussion contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and is subject to the safe harbor created by such Act. Forward-looking statements express our expectations or predictions of future events or results. They are not guarantees and are subject to many risks and uncertainties. There are a number of factors – many beyond our control – that could cause actual events or results to be significantly different from those described in the forward-looking statement. Any or all of our forward-looking statements in this report or in any other public statements we make may turn out to be wrong. Forward-looking statements can be identified by the fact that they do not relate strictly to historical or current facts. They use words such as “anticipate,” “estimate,” “expect,” “project,” “intend,” “plan,” “believe” or words of similar meaning. They may also use words such as “would,” “should,” “could” or “may”. Our actual results could differ materially from the results contemplated by these forward-looking statements as a result of many factors, including those discussed below and elsewhere in this Quarterly Report on Form 10-Q.
Overview
We are a development-stage company engaged in research and development of drug technologies to enable targeted delivery of chemotherapy drugs. We intend initially to “reformulate” existing, widely used chemotherapies with our proprietary carbohydrate compounds. We believe our technology may increase the body’s tolerance to these toxic drugs by targeting the delivery directly to cancerous cells and increasing the efficacy, thereby creating a preferable treatment to existing oncology regimens. Our goal is to develop and commercialize a new generation of reformulated drugs. For additional information, please see “Item 1. Business — Business of Pro-Pharmaceuticals” included in our Annual Report on Form 10-K for the year ended December 31, 2004.
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All of our drug candidates are currently in preclinical and clinical development. To commercialize our drug candidates, we will be required to successfully complete preclinical studies and clinical trials to obtain regulatory approvals. We do not expect to file a New Drug Application (“NDA”) for a drug candidate before 2007 even if development of our drug candidates continues successfully. Any delay in obtaining or failure to obtain required approvals will materially adversely affect our ability to generate revenues from commercial sales relating to our drug candidates. We expect our sources of funding for the next several years to come from financing transactions.
We are devoting substantially all of our efforts toward product research and development, and raising capital. We have no source of revenue and have incurred significant losses to date. We have incurred net losses of $23,002 for the cumulative period from inception (July 10, 2000) through June 30, 2005. Our losses have resulted principally from costs associated with research and development expenses including clinical trial costs, legal expenses associated with protecting our intellectual property and general and administrative activities. As a result of planned expenditures for future research, discovery, development and commercialization activities and potential legal cost to protect our intellectual property, we expect to incur additional operating losses for the foreseeable future.
From inception (July 10, 2000) through June 30, 2005, we have raised $26,630 in capital and used $18,635 in our operations. The capital was raised through (i) the issuance of convertible notes; (ii) the sale of common stock through a public offering; and (iii) the sale of common stock and warrants through private placements. At June 30, 2005 we had $7,337 of cash and cash equivalents, to fund future operations. We believe we have sufficient cash to fund our operations through at least May 2006.
Because we lack revenue and must continue our research and development, we must continually identify new sources of capital and complete financing transactions in order to continue our business. We must also continually monitor the monthly “burn rate” of our capital resources.
Results of Operations
Three Months Ended June 30, 2005 Compared to Three Months Ended June 30, 2004
Research and Development Expenses. Research and development expenses were $831 during the three months ended June 30, 2005, a 59% increase as compared to $522 incurred during the three months ended June 30, 2004. Research and development expenses consist primarily of costs of clinical research organizations (CRO), clinical data management services, outsourcing product development to chemical research laboratories, regulatory and medical consultants, drug manufacturing for clinical trials, salaries, stock based compensation and other personnel related expenses. The $309 increase, was due to costs associated with the Phase II clinical trial of DAVANAT®/5-FU.
We completed dosing patients in our Phase I clinical trial in March of 2005. We began dosing patients in Phase II of DAVANAT®/5-FU clinical trial began in May of 2005. We expect to complete the Phase II clinical trial in 2006.
We expect that our research and development costs will increase in 2005 over 2004 due to expenses associated with the Phase II DAVANAT®/5-FU clinical trial, preparation for the Phase III clinical trial, and development of additional drug candidates.
General and Administrative Expenses. General and administrative expenses were $897 during the three months ended June 30, 2005, or a 2% decrease as compared to $915 incurred during the three months ended June 30, 2004. General and administrative expenses consist primarily of salaries, legal and accounting fees, insurance, investor relations, business development and other office related expenses. Legal expenses decreased by approximately $130 due primarily to lower expenses associated with the patent arbitration proceeding and the former employee lawsuit and were offset largely by increases in payroll expenses. We expect our general and administrative expenses to increase modestly over 2004 levels due to increased business activity and expenses associated with being a public company. We expect decreases in certain legal litigation expenses (patent prosecution rights arbitration and former employee lawsuit) may be offset by increases in legal expenses to defend the GlycoGenesys counterclaim lawsuit.
Interest and Other Income. Interest and other income for the three months ended June 30, 2005 was $30 compared to $32 for the three months ended June 30, 2004, and primarily consists of interest income on short-term investments. The increase in interest income is due to higher average cash balances. Average interest rates in 2005 were comparable to the average interest rates in 2004.
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Six Months Ended June 30, 2005 Compared to Six Months Ended June 30, 2004
Research and Development Expenses. Research and development expenses were $1,432 during the six months ended June 30, 2005, or a 4% increase as compared to $1,373 incurred during the six months ended June 30, 2004. Research and development expenses consist primarily of costs of clinical research organizations (CRO), clinical data management services, outsourcing product development to chemical research laboratories regulatory and medical consultants, drug manufacturing for clinical trials, salaries, stock based compensation and other personnel related expenses. The $59 increase, was due principally to an increase in payroll costs as decreases in costs associated with the Phase I clinical trial were offset by increases in costs associated with the Phase II clinical trial of DAVANAT®/5-FU.
We completed dosing patients in our Phase I clinical trial in March of 2005. We began dosing patients in Phase II of DAVANAT®/5-FU clinical trial in May of 2005. We expect to complete the Phase II clinical trial in 2006.
We expect that our research and development costs will increase in 2005 over 2004 due to (i) expenses associated with the Phase II DAVANAT®/5-FU clinical trial, (ii) preparation for the Phase III clinical trial, and (iii) development of additional drug candidates.
General and Administrative Expenses. General and administrative expenses were $1,749 during the six months ended June 30, 2005, a 10% decrease as compared to $1,937 incurred during the six months ended June 30, 2004. General and administrative expenses consist primarily of salaries, legal and accounting fees, insurance, investor relations, business development and other office related expenses. The decrease of $188 consists primarily of a decrease in legal litigation expenses of approximately $200 due primarily to lower expenses associated with the patent arbitration proceeding and the former employee lawsuit, and a decrease of approximately $100 in stock based compensation offset in part by an increase in payroll related expense. We expect our general and administrative expenses to increase modestly over 2004 levels due to increased business activity and expenses associated with being a public company. We expect decreases in certain legal litigation expenses (patent prosecution rights arbitration and former employee lawsuit) may be offset by increases in legal expenses to defend the GlycoGenesys counterclaim lawsuit.
Interest and Other Income. Interest and other income for the six months ended June 30, 2005 was $66 compared to $51 for the six months ended June 30, 2004, and primarily consists of interest income on short-term investments. The increase in interest income is due to higher average cash balances. Average interest rates in 2005 were comparable to the average interest rates in 2004.
Liquidity and Capital Resources
We are in the development stage and have not generated any revenues. Since our inception on July 10, 2000, we have financed our operations primarily through private placements of convertible debt, shares of common stock and warrants, and a public offering of shares of common stock. As of June 30, 2005, we had raised a total of $26,630 from these offerings and had $7,337 of available cash.
Net cash used in operations increased by $497 to $3,279 for the six months ended June 30, 2005 from $2,782 for the six months ended June 30, 2004. Operating expenses did not materially change in the first half of 2005 relative to the same period in 2004 as decreases in legal litigation expense of approximately $200 were offset by increases in payroll related expenses. The 2004 operating loss was funded by an increase in accounts payable and accrued expenses, net of prepaid expenses of approximately $310 while in the first half of 2005 cash was used for prepaid expenses and to reduce payables and accruals by approximately $215. The combination of these factors resulted in a use of cash to fund working capital needs of approximately $525 in the six months ended June 30, 2005 as compared to the same period in 2004.
Net cash used in investing activities was $88 for the six months ended June 30, 2005 compared to $34 for the six months ended June 30, 2004. The investing activities consist primarily of fixed assets purchases and patent costs. For the six months ended June 30, 2005 $68 was related to patent costs and $20 was related to fixed asset purchases, primarily for computer related equipment. For the first six months of 2004 expenditures were primarily for patent costs.
We believe that our cash on hand at June 30, 2005 of $7,337 will be sufficient to enable us to meet our operating requirements through at least May 2006. We will require more cash to fund our operations over the long-term and believe that we will be able to obtain additional financing. However, there can be no assurance that we will be successful in obtaining such new financing or, if available, that such financing will be on terms favorable to us.
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Payments Due Under Contractual Obligation
The following table summarizes the payments due under our contractual obligations at June 30, 2005, and the effect such obligations are expected to have on liquidity and cash flow in future periods:
| Payments due by period | |||||||||||||||
| Contractual Obligations |
Total |
Less than 1 year |
1-3 years |
3-5 years |
More than 5 years | ||||||||||
| Clinical trial and related scientific contracts |
$ | 902 | $ | 821 | $ | 81 | $ | — | $ | — | |||||
| Operating leases |
82 | 82 | — | — | — | ||||||||||
| Total payments due under contractual obligations |
$ | 984 | $ | 903 | $ | 81 | $ | — | $ | — | |||||
In connection with the operating lease for our office space in Newton, Massachusetts included in the table above, a commercial bank has issued a letter of credit collateralized by cash we have on deposit with the bank of approximately $21. This amount is included in the line item “Deposits and Other Assets” in the unaudited balance sheet contained in this report.
Although we plan to continue the clinical trial and related scientific contracts, these contracts are cancelable upon 30 days notice.
Off-Balance Sheet Arrangements
We have not created, and are not party to, any special-purpose or off-balance sheet entities for the purpose of raising capital, incurring debt or operating parts of our business that are not consolidated into our financial statements. We do not have any arrangements or relationships with entities that are not consolidated into our financial statements that are reasonably likely to materially affect our liquidity or the availability of capital resources.
Application of Critical Accounting Policies and Estimates
The preparation of consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, expenses, and related disclosure of contingent assets and liabilities. On an ongoing basis, we evaluate our estimates, including those related to intangible assets, income taxes, accrued expenses, stock-based compensation, contingencies and litigation. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.
Critical accounting policies are those policies that affect our more significant judgments and estimates used in preparation of our consolidated financial statements. We believe our critical accounting policies include our policies regarding stock-based compensation, accrued expenses and income taxes. For a more detailed discussion of our critical accounting policies, please refer to our annual report on Form 10-K for the fiscal year ended December 31, 2004.
New Accounting Pronouncement
In December 2004, the Financial Accounting Standards Board issued Statement of Financial Accounting Standards No. 123R, “Share-Based Payment” (SFAS No. 123R). This Statement is a revision of SFAS No. 123, “Accounting for Stock-Based Compensation,” and supercedes Accounting Principles Board Opinion No. 25, “Accounting for Stock Issued to Employees,” and its related implementation guidance. SFAS No. 123R focuses primarily on accounting for transactions in which a company obtains employee services in share-based payment transactions. SFAS No. 123R is effective for us on January 1, 2006. We are evaluating the methods of adoption allowed by SFAS No. 123R. We do not yet have an estimate of the effect on our statements of operations of adopting SFAS No. 123R.
RISK FACTORS THAT MAY AFFECT FUTURE RESULTS
An investment in our common stock involves a high degree of risk. You should carefully consider the risks described below and the other information before deciding to invest in our common stock. The risks described below are not the only ones facing our company. Additional risks not presently known to us or that we currently consider immaterial may also adversely affect our business. We have attempted to identify below the major factors that could cause differences between actual and planned or expected results, but we cannot assure you that we have identified all of those factors.
If any of the following risks actually happen, our business, financial condition and operating results could be materially adversely affected. In this case, the trading price of our common stock could decline, and you could lose all or part of your investment.
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Risks Related to Pro-Pharmaceuticals
We Are at an Early Stage of Development With Limited Operating History. We are a development-stage company with a limited operating history, and we have not generated any revenues to date. We have no therapeutic products available for sale, and none are expected to be commercially available for several years, if at all. We may never generate revenue or become profitable, even if we are able to commercialize any products.
We Have Incurred Net Losses to Date and Depend on Outside Capital. Our accumulated deficit as of June 30, 2005 was $23,002. We will need to continue to conduct significant research, development, testing and regulatory compliance activities that, together with projected general and administrative expenses, we expect will result in substantial operating losses for the next several years. Accordingly, we will not be generating sales or other revenue and will remain dependent on outside sources of financing during that time. If we are unable to raise funds from outside sources for our continuing operations, we may be adversely affected.
We may raise capital through public or private equity financings, partnerships, debt financings, bank borrowings, or other sources. Additional funding may not be available on favorable terms or at all. If adequate funds are not available, we may need to significantly curtail operations. To obtain additional funding, we may need to enter into arrangements that require us to relinquish rights to certain technologies, products and/or potential markets. To the extent that additional capital is raised through the sale of equity, or securities convertible into equity, our equity holders may experience dilution of their proportionate ownership of the company.
Based on $7,337 of available cash and cash equivalents as of June 30, 2005, we believe that we have sufficient capital to fund our operations through at least May 2006.
Our Product Candidates Will Be Based on Novel Unproven Technologies. Our product candidates will be based on novel unproven technologies using proprietary carbohydrate compounds in “reformulations” of drugs currently used in the treatment of cancer and other diseases. Carbohydrates are difficult to synthesize, and we may not be able to synthesize carbohydrates that would be usable as delivery vehicles for the anti-cancer drugs we plan to work with.
Our Drug Candidates Are in Pre-Clinical and Clinical Trials, and Results Are Uncertain. We have one product candidate in human clinical trials. Pre-clinical results in animal studies are not necessarily predictive of outcomes in human clinical trials. Clinical trials are expensive, time-consuming and may not be successful. They involve the testing of potential therapeutic agents, or effective treatments, in humans, typically in three phases, to determine the safety and efficacy of the product candidates necessary for an approved drug. Many products in human clinical trials fail to demonstrate the desired safety and efficacy characteristics. Even if our products progress successfully through initial human testing, they may fail in later stages of development. We will be dependent on others to conduct our clinical trials, including clinical research organizations and, possibly, government-sponsored agencies. These trials may not start or be completed as we forecast, or may be unsuccessful.
Our Product Candidates May Not Be Successfully Commercialized. Even if our product candidates are successful in clinical trials, they may not be successfully commercialized. Potential products may fail to receive necessary regulatory approvals, be difficult to manufacture on a large scale, be uneconomical to produce, fail to achieve market acceptance, or be precluded from commercialization by proprietary rights of third parties.
Our Lack of Operating Experience May Cause Us Difficulty in Managing Our Growth. We have limited experience in manufacturing or procuring products in commercial quantities, conducting other later-stage phases of the regulatory approval process, selling pharmaceutical products, or negotiating, establishing and maintaining strategic relationships. Any growth of our company will require us to expand our management and our operational and financial systems and controls. If we are unable to do so, our business and financial condition would be materially harmed. If rapid growth occurs, it may strain our operational, managerial and financial resources.
We Will Depend on Third Parties to Manufacture and Market Our Products. We do not have, and do not now intend to develop, facilities for the manufacture of any of our products for clinical or commercial production. Accordingly, we will need to develop relationships with manufacturers and enter into collaborative arrangements with licensees or have others manufacture our products on a contract basis. We expect to depend on such collaborators to supply us with products manufactured in compliance with standards imposed by the FDA and foreign regulators.
In addition, we have limited experience in marketing, sales or distribution, and we do not intend to develop a sales and marketing infrastructure to commercialize our pharmaceutical products. If we develop commercial products, we will need to rely on licensees, collaborators, joint venture partners or independent distributors to market and sell those products.
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We Depend on Key Individuals to Develop Our Products and Pursue Collaborations. We are highly dependent on Dr. David Platt, President and Chief Executive Officer; Dr. Anatole Klyosov, Consulting Chief Scientist; and Dr. Eliezer Zomer, Executive Vice President, Manufacturing and Product Development. The loss of any of these persons, or failure to attract or retain other key personnel, could prevent us from pursuing collaborations or developing our products and core technologies.
We Are a Counterclaim Defendant in a Lawsuit Instituted by Dr. Platt. Dr. Platt filed a lawsuit in Massachusetts in January 2004 against GlycoGenesys, Inc. for claims including breach of contract. In its answer GlycoGenesys named us as a counterclaim defendant alleging tortious interference and misappropriation of proprietary rights, and seeks monetary damages and injunctive relief related to our intellectual property. In March 2004, we answered the counterclaim and denied any liability. We and Dr. Platt intend to contest these counterclaims vigorously. If we do not prevail there could be a material adverse impact on our financial position, results of operations or cash flows.
Risks Related to the Drug Development Industry
We Will Need Regulatory Approvals to Commercialize Our Products. We currently do not have products approved for sale in the U.S. or any foreign market. We are required to obtain approval from the FDA in order to sell our products in the U.S. and from foreign regulatory authorities in order to sell our products in other countries. The FDA’s review and approval process is lengthy, expensive and uncertain. Extensive pre-clinical and clinical data and supporting information must be submitted to the FDA for each indication for each product candidate in order to secure FDA approval. The FDA could reject an application or require us to conduct additional clinical or other studies as part of the regulatory review process. Delays in obtaining or failure to obtain FDA approvals would prevent or delay the commercialization of our products, which would prevent, defer or decrease our receipt of revenues. If we receive initial regulatory approval, our product candidates will be subject to extensive and rigorous ongoing domestic and foreign government regulation.
Our Competitive Position Depends on Protection of Our Intellectual Property. Development and protection of our intellectual property are critical to our business. If we do not adequately protect our intellectual property, competitors may be able to practice our technologies. Our success depends in part on our ability to obtain patent protection for our products or processes in the United States and other countries, protect trade secrets, and prevent others from infringing on our proprietary rights.
Since patent applications in the United States are maintained in secrecy for at least portions of their pendency periods (published on U.S. patent issuance or, if earlier, 18 months from earliest filing date for most applications) and since other publication of discoveries in the scientific or patent literature often lags behind actual discoveries, we cannot be certain that we are the first to make the inventions to be covered by our patent applications. The patent position of biopharmaceutical firms generally is highly uncertain and involves complex legal and factual questions. The U.S. Patent and Trademark Office has not established a consistent policy regarding the breadth of claims that it will allow in biotechnology patents.
We cannot assure you that all of our patent applications will issue as patents or that the claims of any issued patents will afford meaningful protection for our technologies or products. In addition, patents issued to us or our licensors may be challenged and subsequently narrowed, invalidated or circumvented. Patent litigation is widespread in the biotechnology industry and could harm our business. Litigation might be necessary to protect our patent position or to determine the scope and validity of third-party proprietary rights, and we may not have the required resources to pursue such litigation or to protect our patent rights.
Although we require our scientific and technical employees and consultants to enter into broad assignment of inventions agreements, and all of our employees, consultants and corporate partners with access to proprietary information to enter into confidentiality agreements, these agreements may not be honored.
We are a counterclaim defendant in a lawsuit instituted by Dr. Platt. See “Risks Related to Pro-Pharmaceuticals” above.
Products We Develop Could Be Subject to Infringement Claims Asserted by Others. We cannot assure that products based on our patents or intellectual property that we license from others will not be challenged by a third party claiming infringement of its proprietary rights. If we were not able to successfully defend our patents or licensed rights, we may have to pay substantial damages, possibly including treble damages, for past infringement.
We Face Intense Competition in the Biotechnology and Pharmaceutical Industries. The biotechnology and pharmaceutical industries are intensely competitive. We face direct competition from U.S. and foreign companies focusing on drug delivery technologies, which are rapidly evolving. Our competitors include major, multinational pharmaceutical and chemical companies, specialized biotechnology firms and universities and other research institutions. Many of these competitors have greater financial and other resources, larger research and development staffs and more effective marketing
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and manufacturing organizations, than we do. In addition, academic and government institutions are increasingly likely to enter into exclusive licensing agreements with commercial enterprises, including our competitors, to market commercial products based on technology developed at such institutions. Our competitors may succeed in developing or licensing technologies and products that are more effective or less costly than ours, or succeed in obtaining FDA or other regulatory approvals for product candidates before we do.
Health Care Cost Containment Initiatives and the Growth of Managed Care May Limit Our Returns. Our ability to commercialize our products successfully will be affected by the ongoing efforts of governmental and third-party payors to contain the cost of health care. These entities are challenging prices of health care products and services, denying or limiting coverage and reimbursement amounts for new therapeutic products, and for FDA-approved products considered experimental or investigational, or which are used for disease indications without FDA marketing approval.
Even if we succeed in bringing any products to the market, they may not be considered cost-effective and third-party reimbursement might not be available or sufficient. If adequate third-party coverage is not available, we may not be able to maintain price levels sufficient to realize an appropriate return on our investment in research and product development. In addition, legislation and regulations affecting the pricing of pharmaceuticals may change in ways adverse to us before or after any of our proposed products are approved for marketing.
Our Insurance Coverage May Not Be Adequate in All Circumstances. In the future, we may, in the ordinary course of business, be subject to claims by, and liability to, persons alleging injury as a result of taking products we have under development. If we are successful in having products approved by the FDA, the sale of such products would expose us to additional potential product liability and other claims resulting from their use. This liability may result from claims made directly by consumers or by pharmaceutical companies or others selling such products. Although we currently have insurance coverage for both product liability and professional liability, it is possible that we will not be able to maintain such insurance on acceptable terms. Any inability to maintain insurance coverage on acceptable terms could prevent or limit the commercialization of any products we develop.
Risks Related to Our Stock
Stock Prices for Biopharmaceutical and Biotechnology Companies Are Volatile. The market price for securities of biopharmaceutical and biotechnology companies historically has been highly volatile, and the market from time to time has experienced significant price and volume fluctuations that are unrelated to the operating performance of such companies. Fluctuations in the trading price or liquidity of our common stock may adversely affect our ability to raise capital through future equity financings.
Large Sales Could Reduce the Trading Price of Our Common Stock. We listed our common stock on the American Stock Exchange in September 2003, prior to which our stock traded on the OTC Bulletin Board. Accordingly, there is a limited history of trading of our stock on a national exchange and, based on varying trading volume to date, our stock could be considered “thinly traded.” In 2003 and 2004 we registered, on behalf of certain stockholders, an aggregate of 14,644,946 shares of our common stock and 3,612,497 shares of stock issuable upon exercise of warrants. In general, shares of registered common stock may be re-sold into the public markets without volume or other restrictions. Large sales of our registered shares could place substantial downward pressure on the trading price of our common stock, particularly if the amount sold significantly exceeds the then-current trading volume of our stock.
Downward Pressure on Our Stock Price Could Result if Certain Stockholders Become Short-term Investors. We sold shares of common stock and warrants to purchase common stock in so-called PIPE (Private Investment in Public Equity) transactions in 2003 and 2004 to investors who, as an incentive to purchase our securities in private placements, required us promptly to register their shares (including shares issuable upon exercise of the warrants) for resale into the public markets. We may enter into similar financing transactions in the future with the same or different investors. Because such investors typically receive registered shares well in advance of the expiration of the holding periods under Rule 144 of the Securities Act, they may choose to sell their shares after a short period of holding our stock. If sufficient quantities of stock are sold during a brief interval of time, this could result in downward pressure on the market price for shares of our publicly traded common stock.
Four Principal Stockholders Own Enough Shares to Control the Company. Four of our principal stockholders, David Platt, James Czirr, Offer Binder and Anatole Klyosov, own or control approximately 43% of the outstanding shares of our common stock, and Dr. Platt and Mr. Czirr together own approximately 34%. Some or all of these stockholders, acting in concert, may be able to substantially influence the election of the Board of Directors and other corporate actions requiring stockholder approval, such as recapitalization or other fundamental corporate action, as well as the direction and policies of our company. Such concentration of ownership also could have the effect of delaying, deterring or preventing a change in control of the company that might otherwise be beneficial to stockholders.
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Changes in Laws, Regulations and Financial Accounting Standards May Affect Our Reported Results of Operations. The Sarbanes-Oxley Act of 2002 and related regulations may result in changes in accounting standards or accepted practices within our industry and could add significant new costs to being a public company. New laws, regulations and accounting standards, as well as changes to currently accepted accounting practices, including the expensing of stock options, could adversely affect our reported financial results and negatively affect our stock price. Additional unanticipated expenses incurred to comply with new requirements could also negatively impact our results of operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk
Market risk represents the risk of loss that may impact our financial position, operating results or cash flows due to changes in the U.S. interest rates. The primary objective of our investment activities is to preserve cash until it is required to fund operations. To minimize risk, we maintain our portfolio of cash and cash equivalents in operating bank accounts and money market funds. Since our investments are short-term in duration, we believe that we are not subject to any material market risk exposure. We do not have any interest-bearing debt, foreign currency or other derivative financial instruments.
Item 4. Controls and Procedures
Our management, with the participation of the Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures (as defined in the SEC rules promulgated under the Securities Exchange Act of 1934, as amended) as of June 30, 2005. Based on this evaluation, our CEO and CFO concluded that, as of June 30, 2005, our disclosure controls and procedures were (1) designed to ensure that material information relating to Pro-Pharmaceuticals, Inc., including its consolidated subsidiaries, is made known to our CEO and CFO by others within Pro-Pharmaceuticals, Inc. particularly during the period in which this Report was being prepared, and (2) effective, in that they provide reasonable assurance that information that we are required to disclose in the reports we file under the Securities Exchange Act of 1934, as amended, is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms.
No change in our internal control over financial reporting (as defined in the SEC rules promulgated under the Securities Exchange Act of 1934, as amended) occurred during the quarter ended June 30, 2005 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 1. Legal Proceedings (dollar amounts in thousands)
In October 2003, the Securities and Exchange Commission began an investigation related to matters alleged by a former employee and in November 2004 expanded it to determine whether certain statements made concerning our company were false or misleading. On July 27, 2005 we received written notification from the SEC that it has terminated the investigation without recommendation of any enforcement action. We have been informed that the Commonwealth of Massachusetts has completed its related investigation and does not intend further action.
In January 2004, Dr. Platt, our Chairman and Chief Executive Officer, filed a lawsuit in Massachusetts Superior Court against GlycoGenesys, Inc. for various claims including breach of contract. In its filing in February 2004, GlycoGenesys asserted counterclaims against us and Dr. Platt alleging tortious interference and misappropriation of proprietary rights. The counterclaims seek monetary damages and injunctive relief related to our intellectual property. In March 2004, we and Dr. Platt answered the counterclaims and denied any liability. In June 2004, the Court allowed, without opposition, a motion of GlycoGenesys for leave to file a supplemental counterclaim against us for defamation and unfair competition. We and Dr. Platt intend to contest these counterclaims vigorously and believe we will ultimately prevail. However, if we do not prevail, there could be a material adverse impact on our financial position, results of operations or cash flows.
Pursuant to Board approval, we agreed to indemnify Dr. Platt for the expenses of his defense of the counterclaims, some of which may be recoverable under insurance. In the first six months of 2005, we incurred $124 of expenses in connection with this defense. Through June 30, 2005, we have incurred cumulative costs of approximately $292 in legal and related costs in connection with the indemnification. No amount, if any, potentially recoverable from the insurance company has been recorded at June 30, 2005.
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On January 28, 2005, we filed a request with the U.S. Patent and Trademark Office for an inter partes re-examination of U.S. Patent No. 6,680,306 owned by GlycoGenesys, Inc. because we believe that the invention claimed in this patent is disclosed in literature that preceded it, including our U.S. Patent No. 6,645,946 for DAVANAT®. On April 12, 2005 the U.S. Patent and Trademark Office granted our request because it agrees that the prior publications cited by us, including our DAVANAT® patent, raised a substantial new question of patentability of all of the claims in the GlycoGenesys patent.
Item 4. Submission of Matters to a Vote of Security Holders
The following matters were submitted to a vote of our stockholders at our Annual Meeting of Stockholders held on May 25, 2005, with vote tabulations indicated below.
1. Stockholders who voted elected seven directors to one-year terms. The votes for each director were as follows:
| Name |
Shares For |
Shares Withheld | ||
| Mildred S. Christian |
24,688,583 | 19,058 | ||
| Dale H. Conaway |
24,688,583 | 19,058 | ||
| Burton C. Firtel |
24,688,583 | 19,058 | ||
| David Platt |
24,688,583 | 19,058 | ||
| Steven Prelack |
24,688,583 | 19,058 | ||
| Jerald K. Rome |
24,688,583 | 19,058 | ||
| David H. Smith |
24,688,583 | 19,058 |
2. Stockholders who voted ratified the appointment of Deloitte & Touche LLP as our independent registered public accounting firm for the year ending December 31, 2005 by a vote of 24,690,549 for, 6,725 against and 10,367 abstained.
| Exhibit Number |
Description of Document | |
| 31.1* | Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934 | |
| 31.2* | Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934 | |
| 32.1** | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| 32.2** | Certification Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 | |
| * | Filed herewith. |
| ** | Furnished herewith and not “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. |
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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, thereunto duly authorized, on August 4, 2005.
| PRO-PHARMACEUTICALS, INC. | ||
| By: | /s/ David Platt | |
| Name: | David Platt, Ph.D. | |
| Title: | Chief Executive Officer | |
| /s/ Carl L. Lueders | ||
| Name: | Carl L. Lueders | |
| Title: | Chief Financial Officer | |
17
Exhibit 31.1
Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
I, David Platt, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Pro-Pharmaceuticals, Inc; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | [Paragraph omitted in accordance with SEC transition instruction contained in SEC Release Nos. 34-47986 and 34-49313]; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: August 4,2005 | /s/ David Platt | |||
| Name: | David Platt | |||
| Title: | President and Chief Executive Officer (Principal Executive Officer) | |||
Exhibit 31.2
Certification Pursuant to Rule 13a-14(a) of the Securities Exchange Act of 1934
I, Carl L. Lueders, certify that:
| 1. | I have reviewed this quarterly report on Form 10-Q of Pro-Pharmaceuticals, Inc; |
| 2. | Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report; |
| 3. | Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report; |
| 4. | The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) for the registrant and have: |
| (a) | Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared; |
| (b) | [Paragraph omitted in accordance with SEC transition instructions contained in SEC Release Nos. 34-47986 and 34-49313]; |
| (c) | Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and |
| (d) | Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and |
| 5. | The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions): |
| (a) | All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and |
| (b) | Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting. |
| Date: August 4, 2005 | /s/ Carl L. Lueders | |||
| Name: | Carl L. Lueders | |||
| Title: | Chief Financial Officer (Principal Financial Officer) | |||
Exhibit 32.1
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Pro-Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2005 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, David Platt, Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Date: August 4, 2005 | /s/ David Platt | |||
| Name: | David Platt | |||
| Title: | President and Chief Executive Officer (Principal Executive Officer) | |||
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Pro-Pharmaceuticals, Inc. and will be retained by Pro-Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
CERTIFICATION PURSUANT TO 18 U.S.C. SECTION 1350, AS ADOPTED
PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002
In connection with the Quarterly Report of Pro-Pharmaceuticals, Inc. (the “Company”) on Form 10-Q for the period ended March 31, 2005 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, Carl L. Lueders, Chief Financial Officer of the Company, certify, pursuant to 18 U.S.C. § 1350, as adopted pursuant to § 906 of the Sarbanes-Oxley Act of 2002, that, to my knowledge:
(1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
| Date: August 4, 2005 | /s/ Carl L. Lueders | |||
| Name: | Carl L. Lueders | |||
| Title: | Chief Financial Officer (Principal Financial Officer) | |||
A signed original of this written statement required by Section 906, or other document authenticating, acknowledging, or otherwise adopting the signature that appears in typed form within the electronic version of this written statement required by Section 906, has been provided to Pro-Pharmaceuticals, Inc. and will be retained by Pro-Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.