SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS
Some of the statements contained in this report are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements involve known and unknown risks, uncertainties and other factors which may cause our or our industry’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to statements regarding:
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| • | | inability to raise funds for product research and development; |
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| • | | inability to identify, develop or obtain, and introduce new products; |
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| • | | inability to successfully conduct clinical and preclinical trials for any new products; |
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| • | | competitive pressures from existing competitors and new entrants; |
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| • | | enactment of adverse state or federal legislation or regulation that increases the costs of compliance or requisite regulatory approvals, or adverse findings by a regulator with respect to existing operations; |
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| • | | our ability to obtain required regulatory approvals to develop and market potential products; |
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| • | | our ability to execute our development plan on time and on budget; and |
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| • | | inability to secure partners for development and marketing of pharmaceutical opportunities.
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In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “projects,” “predicts,” “potential” and similar expressions intended to identify forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by such forward-looking statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. Exce pt as otherwise required by law, we expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statement contained in this report to reflect any change in our expectations or any change in events, conditions or circumstances on which any of our forward-looking statements are based. We qualify all of our forward-looking statements by these cautionary statements.
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PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
HEPI Pharmaceuticals, Inc.
(A Development Stage Company)
CONDENSED BALANCE SHEET
| | | | |
| | (Unaudited) | | |
| | September 30, | | December 31, |
| | 2008 | | 2007 |
ASSETS |
| | | | |
CURRENT ASSETS: | | | | |
Cash | $ | 100 | $ | 100 |
| | | | |
Total Current Assets | | 100 | | 100 |
| | | | |
PROPERTY AND EQUIPMENT, NET | | - | | |
| | | | |
OTHER ASSETS | | - | | - |
| | | | |
| $ | 100 | $ | 100 |
| | | | |
LIABILITIES AND STOCKHOLDERS' DEFICIT |
| | | | |
CURRENT LIABILITIES: | | | | |
Accounts Payable | $ | 85,805 | $ | 90,590 |
Advances from Parent Company | | 441,258 | | 320,132 |
Accrued Liabilities | | 44,354 | | 33,713 |
| | | | |
Total Current Liabilities | | 571,417 | | 444,435 |
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LONG TERM LIABILITIES | | - | | - |
| | | | |
TOTAL LIABILITIES | | 571,417 | | 444,435 |
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COMMITMENTS AND CONTINGENCIES | | | | |
| | | | |
STOCKHOLDERS' DEFICIT: | | | | |
Common stock, $.001 par value, | | | | |
3,000 shares authorized | | | | |
100 issued and outstanding | | 1 | | 1 |
Additional Paid-In Capital | | 9 | | 9 |
Deficit Accumulated in the Development Stage | | (571,327) | | (444,345) |
| | | | |
Total Stockholders' Deficit | | (571,317) | | (444,335) |
| | | | |
| $ | 100 | $ | 100 |
The accompanying notes are an integral part of these financial statements.
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HEPI Pharmaceuticals, Inc.
(A Development Stage Company)
CONDENSED STATEMENT OF OPERATIONS
(Unaudited)
| | | | | | | | | | |
| | | | For the | | | | | | For the |
| | For | | period | | For | | For | | period |
| | the | | January 10, | | the | | the | | January 10, |
| | Nine | | 2007 | | Three | | Three | | 2007 |
| | Months | | (inception) | | Months | | Months | | (inception) |
| | Ended | | through | | Ended | | Ended | | through |
| | September 30, | | September 30, | | September 30, | | September 30, | | September 30, |
| | 2008 | | 2007 | | 2008 | | 2007 | | 2008 |
| | | | | | | | | | |
NET SALES | $ | - | $ | - | $ | - | $ | - | $ | - |
| | | | | | | | | | |
OPERATING EXPENSES: | | | | | | | | | | |
Selling | | - | | 500 | | - | | - | | 500 |
General and Administrative | | 44,155 | | 143,085 | | 5,285 | | 40,147 | | 213,517 |
Research and Development | | 57,185 | | 227,414 | | 30,445 | | 71,937 | | 312,955 |
| | | | | | | | | | |
| | | | | | | | | | |
Total Operating Expenses | | 101,340 | | 370,999 | | 35,730 | | 112,084 | | 526,972 |
| | | | | | | | | | |
LOSS FROM | | | | | | | | | | |
OPERATIONS | | (101,340) | | (370,999) | | (35,730) | | (112,084) | | (526,972) |
| | | | | | | | | | |
OTHER INCOME | | | | | | | | | | |
(EXPENSE): | | | | | | | | | | |
Interest Expense - | | | | | | | | | | |
Related Party | | (25,642) | | (10,556) | | (10,222) | | (6,692) | | (44,355) |
| | | | | | | | | | |
Total Other | | | | | | | | | | |
Income (Expense) | | (25,642) | | (10,556) | | (10,222) | | (6,692) | | (44,355) |
| | | | | | | | | | |
NET LOSS | $ | (126,982) | $ | (381,555) | $ | (45,952) | $ | (118,776) | $ | (571,327) |
| | | | | | | | | | |
BASIC LOSS PER SHARE | $ | (1,270) | $ | (3,816) | $ | (460) | $ | (1,188) | | |
| | | | | | | | | | |
WEIGHTED | | | | | | | | | | |
AVERAGE BASIC | | | | | | | | | | |
SHARES | | | | | | | | | | |
OUTSTANDING | | 100 | | 100 | | 100 | | 100 | | |
| | | | | | | | | | |
PROFORMA BASIC | | | | | | | | | | |
LOSS PER SHARE | $ | (0.03) | $ | (0.12) | $ | (0.01) | $ | (0.03) | | |
| | | | | | | | | | |
PROFORMA WEIGHTED | | | | | | | | | | |
AVERAGE BASIC | | | | | | | | | | |
SHARES | | | | | | | | | | |
OUTSTANDING | | 4,226,231 | | 3,185,682 | | 4,226,231 | | 4,226,231 | | |
The accompanying notes are an integral part of these unaudited financial statements.
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HEPI Pharmaceuticals, Inc.
(A Development Stage Company)
STATEMENT OF CASH FLOWS
(Unaudited)
| | | | | | |
| | | | For the | | For the |
| | | | Period | | Period |
| | For the | | January 10, | | January 10, |
| | Nine | | 2007 | | 2007 |
| | Months | | (Inception) | | (Inception) |
| | ended | | through | | through |
| | September 30, | | September 30, | | September 30, |
| | 2008 | | 2007 | | 2008 |
| | | | | | |
Cash Flows from Operating Activities: | | | | | | |
Net Loss | $ | (126,982) | $ | (381,555) | $ | 571,327) |
Adjustments to reconcile net loss to net | | | | | | |
cash used by operating activities: | | | | | | |
Changes in assets and liabilities: | | | | | | |
Increase (Decrease) in accounts payable | | (4,785) | | 90,591 | | 85,805 |
Increase in accrued liabilities | | 10,641 | | 25,556 | | 44,354 |
Net Cash (Used) by Operating Activities | | (121,126) | | (265,408) | | (441,168) |
| | | | | | |
Cash Flows from Investing Activities: | | | | | | |
| | | | | | |
Cash Flow from Financing Activities: | | | | | | |
Proceeds from parent company advances | | 121,126 | | 265,498 | | 441,258 |
Proceeds from sale of common stock | | - | | 10 | | 10 |
Net Cash Provided | | | | | | |
by Financing Activities | | 121,126 | | 265,508 | | 441,268 |
| | | | | | |
Increase (Decrease) in Cash | | - | | 100 | | 100 |
| | | | | | |
Cash at Beginning of Period | | 100 | | - | | - |
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Cash at End of Period | $ | 100 | $ | 100 | $ | 100 |
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Supplemental Disclosures of Cash Flow Information: | | | | |
Cash paid during the period for: | | | | | | |
Interest | $ | - | $ | - | $ | - |
Income Taxes | $ | - | $ | - | $ | - |
The accompanying notes are an integral part of these unaudited financial statements.
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HEPI PHARMACEUTICALS, INC.
NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS
NOTE 1 – DESCRIPTION OF BUSINESS
HEPI Pharmaceuticals, Inc. (the “Company”) was formed on January 10, 2007 under the laws of the State of Delaware. The Company is wholly-owned subsidiary of Health Enhancement Products, Inc., a publicly owned corporation (the “Parent”). The Company’s fiscal year ends on December 31. The purpose of the Company is to develop potential pharmaceutical applications of ProAlgaZyme (PAZ), the Parent’s sole product.
The Company has not yet generated any revenues from planned principal operations and is considered a development stage company as defined in Statement of Financial Accounting Standards No. 7.
NOTE 2 – BASIS OF PRESENTATION
The accompanying unaudited condensed financial statements include only the accounts of HEPI Pharmaceuticals (the “Company”). In the opinion of the Company’s management, the financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the information set forth therein. These financial statements are condensed, and therefore do not include all of the information and footnotes required by accounting principles generally accepted in the United States of America for complete financial statements. The condensed financial statements should be read in conjunction with the company’s December 31, 2007 audited financial statements and supplementary data included in the Form 10KSB.
The results of operations for the three months ended September 30, 2008 are not necessarily indicative of the results to be expected for the fiscal year ending December 31, 2008 or any other period.
The Company incurred a net loss of $44,952 for the three months ended September 30, 2008 and $571,327 during the period January 10, 2007 (inception) through September 30, 2008. In addition, the Company had a working capital deficiency of $571,317 and a stockholders' deficiency of $571,317 at September 30, 2008. These factors raise substantial doubt about the Company's ability to continue as a going concern.
There can be no assurance that sufficient funds required during the next year or thereafter will be generated from operations or that funds will be available from external sources such as debt or equity financings or other potential sources. The lack of additional capital resulting from the inability to generate cash flow from operations or to raise capital from external sources would force the Company to substantially curtail or cease operations and would, therefore, have a material adverse effect on its business. Furthermore, there can be no assurance that any such required funds, if available, will be available on attractive terms or that they will not have a significant dilutive effect on the Company's existing stockholders.
The accompanying financial statements do not include any adjustments related to the recoverability or classification of asset-carrying amounts or the amounts and classification of liabilities that may result should the Company be unable to continue as a going concern.
During the period ending September 30, 2008, the Company relied on the Parent for its financing needs. The Parent does not currently have the ability to provide any further advances to the Company. There can be no assurances that the Parent will in the future be able to provide needed funds.
The Company is attempting to address its lack of liquidity by raising additional funds, either in the form of debt or equity or some combination thereof. While the Company intends to raise several million dollars to fund its operations, including research and development, there can be no assurance that the Company will be able to raise the additional funds it requires.
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NOTE 3 – RESEARCH AND DEVELOPMENT
Research and development costs are expensed as incurred. The Company accounts for research and development expenses under two main categories:
Research Expenses, consisting of salaries, equipment, rental of space and related expenses incurred for product research studies conducted primarily within the Company and by Company personnel. Research expenses were $30,445 for the three months ended September 30, 2008 and $115,414 for the period January 10, 2007 (inception) to September 30, 2008.
Clinical Studies Expenses, consisting of fees, charges, and related expenses incurred in the conduct of clinical studies conducted with Company products by independent external entities. External clinical studies expenses were zero for the quarter ended September 30, 2008, and $197,541 for the period January 10, 2007 (inception) to September 30, 2008.
Due to a lack of funding, we have largely suspended our research efforts. We intend to resume our research activities, subject to receipt of necessary funding. We cannot assure you that we will be able to secure the funds necessary to finance our operations.
NOTE 4 – LOSS PER SHARE
The computation of loss per share is based on the weighted average number of common shares outstanding during the period presented. Since the Company has no common stock equivalents, diluted loss per share is the same as basic loss per share. Pro-forma basic loss per share gives effect to the issuance of an aggregate of 42,262,207 shares of common stock in connection with the proposed distribution, of which approximately 4,226,231 shares will be distributed to the Parent’s shareholders.
NOTE 5 – LOANS PAYABLE - PARENT
Loans payable to our Parent are payable on demand and bear interest at the rate of 10% per annum. As of September 30, 2008, the outstanding principal amount was $441,258. Interest expense of $44,355 for the period January 10, 2007 (inception) to September 30, 2008 is included in the Statement of Operations.
NOTE 6 - STOCKHOLDERS’ DEFICIT
On January 10, 2007, the Company issued 100 shares of common stock for $10 to its founder and Parent.
On February 15, 2007, the Parent’s board of directors declared a distribution in the form of shares of the common stock of the Company, to all shareholders of record of the Company as of March 15, 2007. Each shareholder of record on the record date has received one share of the Company for every 10 shares of common stock of the Parent they owned on the record date. The shares of the Company will be distributed promptly following compliance with applicable laws, including the Parent delivering an information statement to its stockholders pursuant to the requirements of the Securities Exchange Act of 1934 ("Exchange Act") and the effectiveness of the Company's registration under the Exchange Act. The number of shares to be distributed will at the time of distribution represent approximately 10% of the total outstanding shares of the Company. It is anticipated that the remaining 90% of the equity of the Company will be owned by the Parent.
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NOTE 7 - RELATED PARTY TRANSACTIONS
In connection with its formation, the Company entered into a Pharmaceutical Development Agreement with its Parent. Under the Development Agreement, the Company was granted the right to develop the potential pharmaceutical applications of ProAlgaZyme® and its derivatives. In exchange for these rights, the Parent became the sole stockholder of the Company and is entitled to certain payments based on the attainment of specified development milestones and sales revenues.
Research and administrative salaries have been recorded as a loan from the parent company, based upon employees percentage of time spent on the Company functions. Rent expense has been recorded as a loan from the parent company, based upon the square footage occupied by activities of the Company.
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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Overview
We were established in January 2007 as HEPI Pharmaceuticals, Inc. (the “Company”), a wholly owned subsidiary of Health Enhancement Products, Inc. (“HEPI”). Our purpose is to develop potential pharmaceutical applications for HEPI’s primary product,ProAlgaZyme® (PAZ). In connection with our formation, we entered into a Pharmaceutical Development Agreement with HEPI. Under the Development Agreement, HEPI granted us the exclusive right to develop the potential pharmaceutical applications of PAZ and its derivatives. In exchange for these rights, HEPI became our sole stockholder and is entitled to certain payments based on the attainment of specified development milestones and sales revenues.
Plan of Operation
We currently have no cash and are we are exclusively reliant on advances and extensions of credit from our parent company, HEPI, for the resources we need to pursue our strategic goals. HEPI does not currently have sufficient resources to provide us with the funds we need to finance our operations. Accordingly, we need to immediately secure funding in order to continue as a going concern and implement our business strategy. To date, we have not raised any capital from external sources. Developing pharmaceutical products and seeking approvals for such products from regulatory authorities is very costly. We will need to raise a substantial amount of capital almost immediately in order to execute our business plan and fund the development and commercialization of our potential pharmaceutical product candidates.
We may need to finance future cash needs through public or private equity offerings, debt financings or strategic collaboration and licensing arrangements. To the extent that we raise additional funds by issuing equity securities or securities convertible into equity, our stockholders may experience additional dilution, and debt financing, if available, may involve restrictive covenants. If we raise additional funds through collaboration and licensing arrangements, it may be necessary to relinquish some rights to any products we develop, technologies or our development projects or grant licenses on terms that are not favorable to us. We cannot be certain that additional funding will be available on acceptable terms, or at all. If adequate funds are not available from the foregoing sources, we may consider additional strategic financing options, including sales of assets (such as rights to any specialty pharmaceutical products we develop), or we may be req uired to delay, reduce the scope of, or eliminate one or more of our research or development programs or curtail some of our commercialization efforts of our operations. We may seek to access the public or private equity markets whenever conditions are favorable, even if we do not have an immediate need for additional capital.
From inception (January 10, 2007) through September 30, 2008, we incurred research and development expenses associated with clinical testing of ProAlgaZyme® of $312,955. We had general and administrative expenses of $15,000 per quarter due to salaries, benefits and rent. Total general and administrative expenses for the period January 10, 2007 (inception) through September 30, 2008 were approximately $214,000.
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Critical Accounting Policies
The accompanying discussion and analysis of our financial condition and results of operations are based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States of America ("US GAAP"). The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, and expenses, and related disclosure of contingent assets and liabilities. These estimates form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. We base our estimates and judgments on historical experience and all available information. However, future events are subject to change, and the best estimates and judgments routinely require adjustment. US GAAP requires us to make estimates and judgments in several areas, including those related to recording various accrua ls, income taxes, the useful lives of long-lived assets, such as property and equipment and intangible assets, and potential losses from contingencies and litigation. We believe the policies discussed below are the most critical to our financial statements because they are affected significantly by management's judgments, assumptions and estimates.
Accounting Estimates- The preparation of financial statements in conformity with generally-accepted accounting principles in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosures of contingent assets and liabilities at the date of the financial statements, and the reported amount of revenues and expenses during the reporting period. Actual results could differ from those estimated.
Financing Costs. We incurred $10,222 in interest expense on our indebtedness to our parent company for the three months ended September 30, 2008, and $44,355 for the period from inception (January 10, 2007) through September 30, 2008.
Liquidity and Capital Resources
The unaudited condensed financial statements contained in this Quarterly Report have been prepared on a “going concern” basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. We currently have an immediate and urgent need for additional capital. There is a significant risk that we will be unable to continue as a going concern, in which case, our stockholders would suffer a total loss of their investment in our company.
We have incurred significant net losses since inception, including a net loss of $45,952 during the three months ended September 30, 2008 and an aggregate net loss of $571,327 since inception. We have no revenue and do not expect to have revenue for the foreseeable future. Further, since inception, we have incurred negative cash flow from operations. During the nine months ended September 30, 2008, we incurred negative cash flows from operations of $121,126. As of September 30, 2008, we had a cash balance of $100, a working capital deficiency of $571,317 and a stockholders’ deficit of $571,317. We are largely dependent upon our parent company for funding; however, HEPI does not currently have sufficient resources to provide us with the funds we need to finance our operations. We have never raised capital from external sources. If we are unable to raise funds almost immediately, it is highly unlikely we wi ll be able to continue as a going concern. These factors raise substantial doubt about our ability to continue as a going concern.
During the nine months ended September 30, 2008 and the period from inception (January 10, 2007) through September 30, 2008, our operating activities used $121,126 and $441,168 in cash, respectively. Our financing activities generated $121,126 and $441,168 during the nine months ended September 30, 2008 and January 10, 2007 (inception) through September 30, 2008, respectively, primarily due to advances to us made by our Parent.
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If we were to initiate the additional clinical research necessary to complete the development of our product, we would require an additional $3,000,000 in cash over the next 12 months in order to fund our operations, primarily to fund our external research. Based on this cash requirement, we have an immediate and urgent need for additional funding. For the foreseeable future, we do not expect that we will generate sales revenues sufficient to fund our cash requirements. We have never raised funds from external sources. As noted above, if we are unable to raise additional funds almost immediately, it is highly unlikely we will be able to continue as a going concern, in which case you will suffer a total loss of your investment in our company.
Significant elements of income or loss not arising from our continuing operations
We do not expect to experience any significant elements of income or loss other than those arising from our continuing operation.
Seasonality
Our product is directed to the improvement of the health of our consumers, and we do not expect that operating results will be affected materially by seasonal factors. In addition, ProAlgaZyme® is cultivated in a climate-controlled laboratory environment, not subject to seasonal growing effects or influences.
Staffing
We have conducted all of our activities since inception with staffing supplied by HEPI, at agreed upon rates. We currently do not expect to hire our own staff.
Off-Balance Sheet arrangements
We have no off-balance sheet arrangements that would create contingent or other forms of liability.
Item 4. Controls and Procedures
(a)
Evaluation of Disclosure Controls and Procedures. The Company’s management, with the participation of the chief administrative officer (who functions effectively as the chief executive officer) and the principal accounting officer (the chief administrative officer is also the principal financial officer), carried out an evaluation of the effectiveness of the Company’s “disclosure, controls and procedures” (as defined in the Securities Exchange Act of 1934 (the “Exchange Act”) Rules 13a-15(3) and 15-d-15(3)) as of the end of the period covered by this quarterly report (the “Evaluation Date”). Based upon that evaluation, the chief administrative officer and the chief accounting officer concluded that, as of the Evaluation Date, the Company’s disclosure, controls and procedures were effective, to ensure that information required to be disclosed in the reports the Company fil es or submits under the Exchange Act is recorded, processed, summarized and reported within the required time periods and is accumulated and communicated to our management as appropriate to allow timely decisions regarding required disclosures..
(b)
Changes in Internal Control over Financial Reporting. There were no changes in the Company’s internal controls over financial reporting that occurred during the period covered by this quarterly report that has materially affected, or is reasonably likely to materially affect, the Company’s internal control over financial reporting.
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PART II – OTHER INFORMATION
Item 6. Exhibits
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Exhibit Number | Description | |
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31.1 | Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended |
32.1* | Certification of the Principal Executive Officer and Principal Financial Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
*Furnished herewith (all other exhibits are deemed filed).
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SIGNATURES
Pursuant to the requirements of the Securities and Exchange Act of 1934 , the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
HEPI Pharmaceuticals, Inc..
Date: November 13, 2008
By: /s/Janet L Crance
Chief Administrative Officer
(Principal Executive Officer)
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EXHIBIT INDEX
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Exhibit Number | Description | |
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31.1 | Certification of the Principal Executive Officer and Principal Financial Officer pursuant to Rule 13a-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934, as amended |
32.1* | Certification of the Principal Executive Officer and Principal Financial Officer pursuant to U.S.C. Section 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
*Furnished herewith (all other exhibits are deemed filed).