Adynxx, Inc. - Quarter Report: 2005 March (Form 10-Q)
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-QSB/A ON FORM 10-Q
(Mark One)
X QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For quarterly period ended March 31, 2005
___ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from _____ to _____
HEPALIFE TECHNOLOGIES, INC.
(Exact name of registrant as specified in its charter)
Florida
(State or other jurisdiction of incorporation)
000-29819
(Commission File Number)
58-2349413
(I.R.S. Employer Identification No.)
1628 West 1st Avenue, Suite 216, Vancouver, British Columbia, V6J 1G1
(Address of principal executive offices)
(800) 518-4879
(Registrants 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 o
Indicate by check mark whether the registrant is an accelerated filer (as defined in Rule 12b-2 of the Exchange Act).
Yes o No x
Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 70,439,183 shares of Common Stock, par value $.001, were outstanding on January 30, 2006.
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TABLE OF CONTENTS
HEPALIFE TECHNOLOGIES, INC.
FORM 10-Q, QUARTER ENDED MARCH 31, 2005
PART I FINANCIAL INFORMATION
Item 1. Financial Statements
Interim Unaudited Balance Sheet
3
Interim Unaudited Statements of Operations
4
Interim Unaudited Statement of Stockholders Deficiency
5
Interim Unaudited Statements of Cash Flows
9
Notes to Interim Financial Statements
10
Item 2.
Management's Discussion and Analysis of Financial Condition and
Results of Operations
14
Item 3. Quantitative and Qualitative Disclosures About Market Risk
30
Item 4. Controls and Procedures
30
PART II OTHER INFORMATION
Item 1. Legal Proceedings
32
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
32
Item 3. Defaults Upon Senior Securities
32
Item 4. Submission of Matters to a Vote of Security Holders
32
Item 5. Other Information
32
Item 6. Exhibits and Reports on Form 8-K
32
Signatures
34
Certifications
35
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PART I FINANCIAL INFORMATION
In the opinion of management, the accompanying unaudited consolidated financial statements included in this Form 10-Q reflect all adjustments (consisting only of normal recurring accruals) necessary for a fair presentation of the results of operations for the periods are presented. The results of operations for the periods presented are not necessarily indicative of the results to be expected for the full year.
HEPALIFE TECHNOLOGIES, INC.
(A Development Stage Company)
INTERIM BALANCE SHEET
MARCH 31, 2005 AND DECEMBER 31, 2004
(Unaudited)
ASSETS | March 31, 2005 | Dec. 31, 2004 |
Current Assets | ||
Cash | $219,609 | $613,523 |
Total Current Assets | 219,609 | 613,523 |
Equipment , net | 697 | $828 |
Total Assets | $220,306 | $614,351 |
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIENCY) | ||
Current Liabilities | ||
Accounts Payable and Accrued Liabilities | $152,647 | $100,243 |
41,875 | 53,059 | |
Notes Payable Related Party | 950,000 | 1,000,000 |
Total Current Liabilities | 1,144,522 | 1,153,302 |
Stockholders' Equity (Deficiency) | ||
Preferred Stock: $0.10 Par Value; Authorized Shares, 1,000,000 shares; Issued and Outstanding, None | None | None |
Common Stock: $0.001 Par Value; Authorized Shares, 300,000,000; Issued and Outstanding, 69,167,832 Shares | 69,168 | 67,818 |
Additional Paid In Capital | 3,431,402 | 3,141,002 |
Loss Accumulated During the Development Stage | (4,424,786) | (3,747,771) |
Total Stockholders' Equity (Deficiency) | (924,216) | (538,951) |
Total Liabilities and Stockholders Equity (Deficiency) | $220,306 | $614,351 |
See condensed notes to financial statements.
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HEPALIFE TECHNOLOGIES, INC.
(A Development Stage Company)
INTERIM STATEMENTS OF OPERATIONS
FOR THE THREE MONTHS ENDED MARCH 31, 2005 AND 2004,
AND FROM INCEPTION (OCTOBER 21, 1997) TO MARCH 31, 2005
(Unaudited)
For the Three Months Ended March 31, 2005 | For the Three Months Ended March 31, 2004 | From Inception (October 21, 1997) to March 31, 2005 | |
Revenues | $0 | $0 | $0 |
General and administrative | |||
Management fees and consulting fees Related party | 5,953 | 0 | 915,267 |
Investor Relations | 527,948 | 48,211 | 2,624,367 |
Other operating expense Related Party | 79,086 | 27,805 | 569,013 |
Research and Development | 65,423 | 20,700 | 349,869 |
Total General and Administrative Expenses | 678,410 | 96,716 | 4,458,516 |
Other Income | |||
Interest Income | (1,395) | (552) | (33,730) |
Provision for Income Taxes | - | - | - |
Net Loss Available to Common Stockholders | $(677,015) | $(96,164) | $(4,424,786) |
Basic and Diluted Loss Per Common Share | $(0.010) | $(0.002) | (0.099) |
Weighted Average Common Shares Outstanding | 68,014,499 | 64,214,332 | 44,826,402 |
See condensed notes to financial statements.
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HEPALIFE TECHNOLOGIES, INC. | |||||
(A Development Stage Company) | |||||
INTERIM STATEMENT OF STOCKHOLDERS' DEFICIENCY | |||||
from Inception (October 31, 1997) to March 31, 2005 | |||||
(Unaudited) | |||||
Loss accumulated | Total | ||||
Common Stock | Additional | during development | Stockholders' | ||
(Expressed in U.S. Dollars) | Shares | Amount | paid-in capital | stage | equity (deficiency) |
Common stock issued for service rendered | |||||
at $0.00025 per share, October 21, 1997 | 12,000,000 | $ 12,000 | $ (9,000) | $ - | $ 3,000 |
Common stock issued for cash | |||||
at $0.0625 per share during 1997 | 1,200,000 | 1,200 | 73,800 | - | 75,000 |
Comprehensive income | |||||
Income from inception | |||||
(October 21, 1997) to December 31, 1997 | - | - | - | 42 | 42 |
Balance, December 31, 1997 | 13,200,000 | 13,200 | 64,800 | 42 | 78,042 |
Common stock issued for service rendered | |||||
at $0.025 per share, December 15, 1998 | 16,000,000 | 16,000 | 384,000 | - | 400,000 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 1998 | - | - | - | (471,988) | (471,988) |
Balance, December 31, 1998 | 29,200,000 | 29,200 | 448,800 | (471,946) | 6,054 |
Common stock issued for cash | |||||
at $0.025 per share, March 1999 | 12,000,000 | 12,000 | 288,000 | - | 300,000 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 1999 | - | - | - | (121,045) | (121,045) |
Balance, December 31, 1999 | 41,200,000 | 41,200 | 736,800 | (592,991) | 185,009 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 2000 | - | - | - | (80,608) | (80,608) |
Balance, December 31, 2000 | 41,200,000 | 41,200 | 736,800 | (673,599) | 104,401 |
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HEPALIFE TECHNOLOGIES, INC. | |||||
(A Development Stage Company) | |||||
INTERIM STATEMENT OF STOCKHOLDERS' DEFICIENCY | |||||
from Inception (October 31, 1997) to March 31, 2005 | |||||
(Unaudited) | |||||
Loss accumulated | Total | ||||
Common Stock | Additional | during development | Stockholders' | ||
(Expressed in U.S. Dollars) | Shares | Amount | paid-in capital | stage | equity (deficiency) |
Balance, December 31, 2000 | 41,200,000 | 41,200 | 736,800 | (673,599) | 104,401 |
Conversion of debt to equity at $0.015 | |||||
per share, July 31, 2001 | 8,933,332 | 8,933 | 125,067 | - | 134,000 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 2001 | - | - | - | (160,364) | (160,364) |
Balance, December 31, 2001 | 50,133,332 | 50,133 | 861,867 | (833,963) | 78,037 |
Common stock issued for services | |||||
at $0.06 per share, April 23, 2002 | 10,000 | 10 | 590 | - | 600 |
Conversion of debt to equity at $0.05 | |||||
per share, April 26, 2002 | 2,160,000 | 2,160 | 105,840 | - | 108,000 |
Common stock issued for investor | |||||
relations services at $0.05 per share, | |||||
July 25, 2002 | 2,390,000 | 2,390 | 117,110 | - | 119,500 |
Conversion of debt to equity at $0.05 per | |||||
share, December 18, 2002 | 1,920,000 | 1,920 | 94,080 | - | 96,000 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 2002 | - | - | - | (375,472) | (375,472) |
Balance, December 31, 2002 | 56,613,332 | 56,613 | 1,179,487 | (1,209,435) | 26,665 |
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HEPALIFE TECHNOLOGIES, INC. | |||||
(A Development Stage Company) | |||||
INTERIM STATEMENT OF STOCKHOLDERS' DEFICIENCY | |||||
from Inception (October 31, 1997) to March 31, 2005 | |||||
(Unaudited) | |||||
Loss accumulated | Total | ||||
Common Stock | Additional | during development | Stockholders' | ||
(Expressed in U.S. Dollars) | Shares | Amount | paid-in capital | stage | equity (deficiency) |
Balance, December 31, 2002 | 56,613,332 | 56,613 | 1,179,487 | (1,209,435) | 26,665 |
Common stock issued pursuant to | |||||
exercise of stock options during the | |||||
year at between $0.07 to $2.11 per share | 282,500 | 283 | 398,317 | - | 398,600 |
Common stock issued pursuant to | |||||
exercise of share purchase warrants | |||||
in November 2003 at $0.025 per share | 7,300,000 | 7,300 | 175,200 | - | 182,500 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 2003 | - | - | - | (1,102,723) | (1,102,723) |
Balance, December 31, 2003 | 64,195,832 | 64,196 | 1,753,004 | (2,312,158) | (494,958) |
Common stock issued pursuant | |||||
to exercise of stock options during | |||||
the year between $0.07 to $2.11 per share | 1,622,000 | 1,622 | 1,339,998 | - | 1,341,620 |
Common stock issued pursuant | |||||
to exercise of share purchase warrants in | |||||
December 2004 at $0.025 per share | 2,000,000 | 2,000 | 48,000 | - | 50,000 |
Comprehensive income (loss) | |||||
Loss, year ended December 31, 2004 | - | - | - | (1,435,613) | (1,435,613) |
Balance, December 31, 2004 | 67,817,832 | 67,818 | 3,141,002 | (3,747,771) | (538,951) |
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HEPALIFE TECHNOLOGIES, INC. | |||||
(A Development Stage Company) | |||||
INTERIM STATEMENT OF STOCKHOLDERS' DEFICIENCY | |||||
from Inception (October 31, 1997) to March 31, 2005 | |||||
(Unaudited) | |||||
Loss accumulated | Total | ||||
Common Stock | Additional | during development | Stockholders' | ||
(Expressed in U.S. Dollars) | Shares | Amount | paid-in capital | stage | equity (deficiency) |
Balance, December 31, 2004 | 67,817,832 | 67,818 | 3,141,002 | (3,747,771) | (538,951) |
Common stock issued pursuant to | |||||
exercise of stock options at $3.10 per share | 50,000 | 50 | 154,950 | - | 155,000 |
Common stock issued pursuant to | |||||
exercise of stock options at $2.11 per share | 50,000 | 50 | 105,450 | - | 105,500 |
Common stock issued pursuant to | |||||
exercise of share purchase warrants | |||||
at $0.025 per share | 1,250,000 | 1,250 | 30,000 | - | 31,250 |
Comprehensive income (loss) | |||||
Loss, three months ended March 31, 2005 | - | - | - | (677,015) | (677,015) |
Balance, March 31, 2005 | 69,167,832 | $ 69,168 | $ 3,431,402 | $ (4,424,786) | $ (924,216) |
(The accompanying notes are an integral part of these financial statements) |
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HEPALIFE TECHNOLOGIES, INC.
(A Development Stage Company)
INTERIM STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2005 AND 2004, AND
FOR THE PERIOD FROM INCEPTION (OCTOBER 21, 1997) TO MARCH 31, 2005
(Unaudited)
Three Months Ended March 31, 2005 | Three Months Ended March 31, 2004 | From Inception (October 21, 1997) to March 31, 2005 | |
Cash Flows From (Used In) Operating Activities | |||
Net Loss for the Period | $(677,015) | $(96,164) | $(4,424,786) |
Adjustments to Reconcile Net Loss to Net Cash Used In Operating Activities | |||
Common Stock Issued For Services | - | - | 523,100 |
Depreciation | 131 | - | 3,863 |
Conversion of Debt to Equity | 338,000 | ||
Changes in Assets and Liabilities | |||
Increase (Decrease) in Accounts Payable | 41,220 | (1,226) | 194,522 |
Total Adjustments | 41,351 | (1,226) | 1,059,482 |
Net Cash Flows Used In Operating Activities | (635,664) | (97,390) | (3,365,301) |
| |||
Cash Flows From Investing Activities | |||
Purchase of Property and Equipment | - | - | (4,560) |
Net Cash Flows Used In Investing Activities | 0 | 0 | (4,560) |
Cash Flows From (Used In) Financing Activities | |||
Net Proceed From Notes Payable | (50,000) | - | 950,000 |
Proceed From Issuance of Common Stock | 291,750 | 166,650 | 2,639,470 |
Net Cash Flows Provided By Financing Activities | 241,750 | 166,650 | 3,589,470 |
Increase (Decrease) in Cash and Cash Equivalents | (393,914) | 69,260 | 291,609 |
Cash and Cash Equivalents, Beginning of Period | 613,523 | 312,201 | - |
Cash and Cash Equivalents, End of Period | $219,609 | $381,461 | $291,609 |
Supplemental Information | |||
Cash paid for: | |||
Interest | $9,432 | $0 | $61,341 |
Income Taxes | $0 | $0 | $0 |
Noncash investing and financing activities: | |||
Conversion of debt to equity | $0 | $0 | $338,000 |
Common Stock Issued For Services | $0 | $0 | $523,100 |
See condensed notes to financial statements.
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HEPALIFE TECHNOLOGIES, INC.
(A Development Stage Company)
NOTES TO FINANCIAL STATEMENTS
MARCH 31, 2005
NOTE 1. STATEMENT OF INFORMATION FURNISHED
The accompanying unaudited interim financial statements have been prepared in accordance with Form 10-Q instructions and in the opinion of management contains all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the financial position as of March 31, 2005, and the results of operations and cash flows for the three months ended March 31, 2005 and 2004. These results have been determined on the basis of generally accepted accounting principles and practices in the United States and applied consistently with those used in the preparation of the Company's 2004 Annual Report on Form 10-KSB/A.
Certain information and footnote disclosure normally included in the financial statements presented in accordance with generally accepted accounting principles in the United States have been condensed or omitted. It is suggested that the accompanying financial statements be read in conjunction with the accompanying financial statements and notes thereto incorporated by reference in the Company's 2004 Annual Report on Form 10-KSB/A.
NOTE 2. EARNINGS (LOSS) PER SHARE
Basic earnings or loss per share is based on the weighted average number of common shares outstanding. Diluted earnings or loss per share is based on the weighted average number of common shares outstanding and dilutive common stock equivalents. The computation of earnings (loss) per share is net loss available to common stockholders (numerator) divided by the weighted average number of common shares outstanding (denominator). All earnings or loss per share amounts in the financial statements are basic earnings or loss per share, as defined by SFAS No. 128, Earnings Per Share. Diluted earnings or loss per share does not differ materially from basic earnings or loss per share for all periods presented. Convertible securities that could potentially dilute basic earnings or loss per share in the future are not included in the computation of diluted earnings or loss per share because to do so would be antidilutive. All per share and per share information are adjusted retroactively to reflect stock splits and changes in par value.
The computation of basic and diluted loss per share is as follows:
Three months ended March 31, 2005 | Three months ended March 31, 2004 | Inception (October 21, 1997) to March 31, 2005 | |
Numerator-net loss available to common stockholders | $(677,015) | $(96,164) | $(4,424,786) |
Denominator-weighted average number of common shares outstanding | 68,014,499 | 64,214,332 | 44,826,402 |
Basic and diluted loss per common share | $(0.010) | $(0.002) | $(0.099) |
NOTE 3 - RELATED PARTY TRANSACTIONS
Management Fees: During the three months ended March 31, 2005 and 2004, the Company incurred $5,953 (2004 $0) in management fees to directors of the Company. Included in accounts payable related parties at March 31, 2005 is management and consulting fees of $0 incurred in 2005 and $27,000 incurred in previous years.
Notes Payable and Accrued Interest: Notes payable totaled $950,000 as at March 31, 2005, representing unsecured loans of $250,000 and $700,000 (both bearing an interest rate of 8.50%) due to Mr. Harmel S. Rayat, a Director, Secretary/Treasurer and majority shareholder of the Company. Accrued and unpaid
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interest on these notes during the three month period ended March 31, 2005, amounted to $14,875 (2004 - $12,875).
Rent: The Companys principal office is located at 1628 West First Avenue, Suite 216, Vancouver, British Columbia, Canada, V6J 1G1. These premises are owned by a private corporation controlled by a director and majority shareholder of the Company. The fair value of the rent has not been included in the financial statements because the amount is immaterial.
NOTE 4 COOPERATIVE AGREEMENT
Cooperative Agreement
On November 1st, 2002, the Company entered into a Cooperative Research and Development Agreement (the agreement) with the United States Department of Agricultures (USDA) Agricultural Research Service (ARS), and committed a total payment of $292,727 to ARS over two year period, ending February 19, 2005.
On May 24, 2004, the Agreement was extended to September 30, 2007 and required total payments to ARS was amended to $807,828 with a revised schedule of repayment as follows:
- $65,422.80 on or before 8/1/04 (paid in 2004);
- $65,422.80 on or before 11/1/04 (included in accounts payable);
- $65,422.80 on or before 2/1/05 (included in accounts payable);
- $65,422.80 on or before 5/1/05;
- $65,422.80 on or before 8/1/05;
- $65,422.80 on or before 11/1/05;
- $65,422.80 on or before 2/1/06;
- $65,422.80 on or before 5/1/06;
- $65,422.80 on or before 8/1/06; and
- $65,422.80 on or before 8/1/06; and
- $65,422.80 on or before 11/1/06.
As at March 31, 2005, total payments of $349,869 have been paid/accrued.
As amended, the Company, instead of ARS as in the original agreement, has the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications, foreign and domestic, on subject invention owned or co-owned by the U.S Government, subject to certain conditions.
The agreement is for the purpose of funding salaries, equipment, travel and other indirect costs of one post-doctoral researcher, one support scientist, and one technician. The terms of the agreement require the interaction of the Company with ARS personnel on the technical details involved with pig liver cell culture development, providing the necessary funds for the purpose above, preparing and filing any patent applications, and reviewing reports and implementing procedures for the development of an artificial liver device utilizing the pig liver cell line. ARSs responsibilities include hiring the post-doctoral research associate for a two-year period, providing laboratory and office space for the research associate, providing experimental animals (pigs) and slaughter facilities, conducting the research, preparing progress reports on project objectives, and preparing and submitting technical reports for publication.
All rights, title, and interest in any subject invention made solely by ARS employees are owned by ARS, solely by the Company are owned by the Company, and owned jointly between the Company and ARS if made jointly by ARS and the Company. The Company is granted an option to negotiate an exclusive license in each subject invention owned or co-owned by ARS for one or more field (s) of use encompassed by the agreement. The option terminates when the Company fails to (1) submit a complete application for an exclusive license within sixty days of being notified by ARS of an inventions availability for licensing or (2) submit a good faith written response to a written proposal of licensing terms within forty five days of such proposal.
The agreement, or parts thereof, is subject to termination at any time by mutual consent. Either party may
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unilaterally terminate the entire agreement at any time by giving the other party written notice not less than sixty calendar days prior to the desired termination date.
NOTE 5 EQUIPMENT
2004 | |
Computer equipment | $3,471 |
Furniture and fixtures | 1,089 |
4,560 | |
Less: Accumulated depreciation | (3,863) |
$697 | |
Depreciation expense charged to operations as of March 31, 2005 was $131 (2004 $0).
NOTE 6 STOCK OPTION PLAN
On July 12, 2001, the shareholders of Hepalife Technologies, Inc. approved the Companys 2001 Stock Option Plan which has 40,000,000 shares reserved for issuance thereunder, all of which were registered under Form S-8 on May 8, 2003. The objective of this plan is to attract and retain the best personnel, providing for additional performance incentives, and promoting the success of the Company by providing individuals the opportunity to acquire common stock.
In the period ended March 31, 2005, the Company granted an aggregate of 6,000,000 stock options to employees, with exercise prices ranging from $2.38 to $3.10 per share, expiring 10 years from the date of grant, being vested immediately.
Summary of employee stock options information as at March 31, 2005 is as follows:
Shares | Weighted Average Exercise Price | |
Options outstanding at December 31, 2004 | 11,133,000 | $0.48 |
Granted | 6,000,000 | $2.86 |
Options outstanding at March 31, 2005 | 17,133,000 | $1.31 |
Options Outstanding and Exercisable | ||||
Range of Exercise Prices | Number Outstanding | Number exercisable | Weighted Average Remaining Contractual Life (yr.) | Weighted Average Exercise Price |
$0.01 - $1.00 | 8,915,000 | 8,915,000 | 7.90 | $0.07 |
$2.00 - $3.50 | 8,218,000 | 8,218,000 | 9.60 | $2.66 |
17,133,000 | 17,133,000 | 9.55 | $1.31 | |
Had compensation expense for the Company's stock-based compensation plans been determined under SFAS No. 123, based on the fair market value at the grant dates, the Company's pro-forma net loss and pro-forma net loss per share would have been reflected as follows:
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March 31, 2005 | March 31, 2004 | |
Net income (loss) as reported: | $(677,015) | $(96,164) |
Stock-based employee compensation | ||
expense as determined under the | ||
fair value based method | (10,320,000) | (225,311) |
Pro-forma, net (loss) | $(10,997,015) | $(321,475) |
Net (loss) per share basic and diluted: | ||
As reported | $(0.01) | $(0.002) |
Pro-forma | $(0.16) | $(0.005) |
The weighted average fair value of the options granted in the period ended March 31, 2005 was estimated at $1.72 by using the Black-Scholes Option Pricing Model with the following weighted average assumptions: dividend yield of 0%, expected volatility of 93%, risk-free interest rates of 3.5%, and expected lives of three years.
NOTE 7 GOING CONCERN
The Company has incurred net operating losses since inception. The Company faces all the risks common to companies in their early stages of development, including under capitalization and uncertainty of funding sources, high initial expenditure levels, uncertain revenue streams, and difficulties in managing growth. The Companys recurring losses raise substantial doubt about its ability to continue as a going concern. The Companys financial statements do not reflect any adjustments that might result from the outcome of this uncertainty. The Company expects to incur losses from its business operations and will require additional funding during 2005. The satisfaction of our cash hereafter will depend in large part on the Companys ability to successfully raise capital from external sources to pay for planned expenditures and to fund operations.
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Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
Forward-Looking Statements
Except for the historical information presented this report contains forward-looking statements. Such forward-looking statements include statements regarding, among other things, (a) our projected sales and profitability, (b) our growth strategies, (c) anticipated trends in our industry, (d) our future financing plans, and (e) our anticipated needs for working capital. Forward-looking statements, which involve assumptions and describe our future plans, strategies, and expectations, are generally identifiable by use of the words may, will, should, expect, anticipate, estimate, believe, intend, or project or the negative of these words or other variations on these words or comparable terminology. This information may involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. These statements may be found under Managements Discussion and Analysis of Financial Condition and Results of operations, as well as in this report generally. Actual events or results may differ materially from those discussed in forward-looking statements as a result of various factors, including, without limitation, the risks outlined under Risk Factors and matters described in this report generally. In light of these risks and uncertainties, there can be no assurance that the forward-looking statements contained in this filing will in fact occur.
Overview
We are an early stage, research and development based, biotechnology company focused on the identification, development and eventual commercialization of technologies and products for liver toxicity detection and the treatment of various forms of liver dysfunction and disease. We currently do not directly conduct any of our own research and development activities. Rather, once a technology has been identified, we fund the research and development activities relating to the technology with the intention of ultimately, if warranted, licensing, commercializing and marketing the subject technology.
Our sponsored research is being conducted pursuant to our CRADA with the USDA's Agricultural Research Service.
Currently, we are concentrating our efforts on developing an artificial liver device and in-vitro toxicology and pre-clinical drug testing platforms.
Artificial Liver Device
We are working towards optimizing the hepatic functionality of a porcine cell line, and subclones thereof, which we refer to as the PICM-19 Cell Line. The PICM-19 Cell Line was developed and patented by USDA Agricultural Research Service scientists. The hepatic characteristics of the PICM-19 Cell Line have been demonstrated to have potential application in the production of an artificial liver device. U.S. Patent #5,532,156 (Hepatocyte Cell Line Derived from the Epiblast of Pig Blastocysts ) was issued on July 2, 1996, and U.S. Patent 5,866,420 (Artificial liver device) was issued on February 2, 1999, both in the name of The United States of America as represented by the Secretary of Washington, DC.
In-Vitro Toxicology Testing
The PICM-19 Cell Line, grown in-vitro, can synthesize liver specific proteins such as albumin and transferrin and display enhanced liver-specific functions, such as ureagenesis (conversion to ammonia to urea) and cytochrome P450 activity. Consequently, we believe the PICM-19 Cell Line could be an important element in developing in-vitro toxicological and pre-clinical drug testing platforms that could more accurately determine the potential toxicity and metabolism of new pharmacological compounds in the liver.
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Critical Accounting Policies
Our discussion and analysis of our financial condition and results of operations are based on our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires us to make estimates and judgments that affect the reported amounts of assets, liabilities and expenses and related disclosures. We review our estimates on an ongoing basis.
We consider an accounting estimate to be critical if it requires assumptions to be made that were uncertain at the time the estimate was made; and changes in the estimate or different estimates that could have been made could have a material impact on our results of operations or financial condition. While our significant accounting policies are described in more detail in the notes to our financial statements included in this prospectus, we believe the following accounting policies to be critical to the judgments and estimates used in the preparation of our financial statements.
General and Administrative Expenses
Our general and administrative expenses consist primarily of personnel related costs, legal costs, including intellectual property, investor relations, accounting costs, and other professional and administrative costs.
Research and Development Costs
Research and development costs represent costs incurred to develop our technology incurred pursuant to our CRADA with the USDAs Agricultural Research Service and include salaries and benefits for research and development personnel, allocated overhead and facility occupancy costs, contract services and other costs. We charge all research and development expenses to operations as they are incurred. We do not track research and development expenses by project.
Cooperative Agreement
On November 1, 2002, we entered into a CRADA with the USDAs Agricultural Research Service and committed to pay a total of $292,727 to USDAs Agricultural Research Service over a two-year period ending February 19, 2005. On May 24, 2004, we amended the CRADA, and agreed to pay a total of $807,828 through September 30, 2007, of which $153,600 had already been paid under the original agreement.
Effective on November 28, 2002, we amended our CRADA, in writing, to provide for the addition of Dr. Thomas Caperna as a co authorized departmental officers designated representative.
Effective on July 12, 2003, we amended our CRADA, in writing, to reflect the change of our name from Zeta Corporation to Hepalife Technologies, Inc.
In February 2004, we orally amended our CRADA to modify the payment schedule so as to delay payment of installments due in August and November of 2004 and thereafter until and unless funds are actually required.
Contractual Responsibilities under the CRADA
Under the terms of the CRADA, as amended, the USDAs Agricultural Research Service is responsible for:
- Hiring one post-doctoral research associate, one support scientist, and one technician for a 2 to 3 year period.
- Providing laboratory and office space for the research associate.
- Providing a fully equipped cell culture laboratory and protein chemistry laboratory.
- Providing experimental animals (pigs) and slaughter facilities.
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- Acquiring specific laboratory equipment, e.g., rotating cell culture system and supplies to conduct the CRADA objectives.
- Conducting research on the optimization of the PICM-19 Cell Line, or its derivative cell lines (or related pig epiblast-derived cell lines), as an in-vitro pig liver cell model, and adapt the PICM-19 liver Cell Line technology to an extracorporeal liver assist device and to in-vitro formats for metabolic, toxicological, and carcinogenicity assay.
- Preparing progress reports on project objectives.
- Preparing and submit technical reports for publication.
- Providing access to 1850 square feet of laboratory space in the Beltsville Agricultural Research Center for our personnel assigned to work on the project.
- Providing utilities, services, and general support to our personnel, on an as needed and available basis.
We, in turn, our responsible for:
- Providing funds for one post-doctoral research associate, one support scientist, and one technician for a 2 to 3 year period.
- Providing funds for project related laboratory equipment, supplies, and off site research services such as electron microscopy and bioreactor component manufacturing.
- Providing funds for position advertisement and travel expenses for position interviews.
- Providing funds for professional activities of research associate such as travel to meetings and project specific training activities.
- Preparing and filing patent applications.
Generally, the terms of the CRADA also require our interaction with USDAs Agricultural Research Service personnel on the technical details involved with pig liver cell culture development, providing the necessary funds for the purpose above, preparing and filing any patent applications, and reviewing reports and implementing procedures for the development of an artificial liver device utilizing the pig liver cell line. There has not been any material change in the relative responsibilities of the parties to the CRADA since its execution.
Payment Requirements and Budget Under the CRADA
Under the terms of the CRADA, we are obligated to make payments aggregating $807,828.00 to the USDAs Agricultural Research Service over the term of the CRADA, as listed below:
Amount
Date Due
$65,422.80
on or before August 1, 2004;
$65,422.80
on or before November 1, 2004;
$65,422.80
on or before February 1, 2005;
$65,422.80
on or before May 1, 2005;
$65,422.80
on or before August 1, 2005;
$65,422.80
on or before November 1, 2005;
$65,422.80
on or before February 1, 2006;
$65,422.80
on or before May 1, 2006;
$65,422.80
on or before August 1, 2006;
$65,422.80
on or before November 1, 2006
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In February 2004, we orally amended our CRADA to modify the payment schedule so as to delay payment of installments due in August and November of 2004 and thereafter until and unless funds are actually required.
The payments are to fund salaries, equipment, travel and other indirect costs of one post-doctoral researcher, one support scientist, and one technician up to September 30, 2007, as well as funds for the associated laboratory supplies and professional activities involved with conducting the CRADA objectives.
More specifically the agreed to budget for the CRADA contemplates the expenditure of these funds substantially as follows:
BUDGET CATEGORY | AMOUNT |
A. Salaries and Wages | $408,400.00 |
B. Equipment | $28,025.00 |
C. Materials and Supplies | $265,500.00 |
D. Travel 1. Domestic 2. Foreign | $14,000.00 |
E. Facilities | -0- |
F. Other Direct Costs | $11,126.00 |
G. TOTAL DIRECT COSTS | $727,051.00 |
H. Indirect Costs | $80,777.00 |
I. TOTAL COSTS | $807,828.00 |
Research Objectives of the CRADA.
The initial research objectives of the CRADA included:
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Developing feeder-cell-independent and serum-free medium cell culture systems allowing the growth and differentiation of the PICM-19 Cell Line, or subclones or subpopulations of the PICM-19 Cell Line, under defined conditions.
As of the date of this 10-QSB/A, the PICM-19 Cell Line has been assayed for its response to several specific growth factors and cell attachment factors. Two specific growth stimulating factors have been identified and two attachment factors that enable the attachment and maintenance of the PICM-19 Cell Lines have been identified.
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Developing spheroid cultures (self-assembling balls of cells) of the PICM-19 Cell Line without STO feeder cells and testing of rotating cell culture system for production and maintenance of spheroids.
As of the date of this 10-QSB/A,, this objective has been redirected to the testing of PICM-19 Cell Line growth and maintenance on various types of commercially available glass or plastic micro- and macro-spheres. One type each of plastic microsphere and macrosphere has been successfully tested and are now in use in a model flow-through bioreactor that is currently in its testing phase.
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Investigating effects of accessory cells obtained from pig liver on the PICM-19 Cell Line growth, differentiation, and metabolic function.
As of the date of this 10-QSB/A, these studies are not anticipated to be necessary for completion of the CRADA objectives and accordingly, are not longer deemed a priority.
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Assaying the PICM-19 Cell Line and spheroids for liver specific functions by measuring P450 activity, liver enzyme activities, urea production, and ammonia clearance.
As of the date of this 10-QSB/A, P450 activity, urea production, and ammonia clearance activity
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of the PICM-19 cell line and three derivative cell lines (PICM-19H, PICM-19-3BT, PICM-19HA) have been confirmed and completed. Gamma-glutamyltranspeptidase enzyme (a key bile duct enzyme for the processing of inflammatory and anti-inflammatory molecules) activity has been confirmed and completed in the PICM-19 cell line and in two of the three PICM-19 derivative cell lines. Gamma-glutamylcysteine synthetase (a secondary detoxification liver enzyme) activity assays are on-going.
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Assaying the PICM-19 Cell Line liver specific protein synthesis and secretion by protein identification techniques. As of the date of this prospectus, liver specific protein synthesis by the PICM-19 cell line has been completed. Several liver specific proteins secreted by the PICM-19 cells were identified by Western blotting, 2-D gel electrophoresis, and mass spectrophotometric analysis.
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Developing and testing, by in-vitro assay, flow-through bioreactors that enable the growth, differentiation, and maintenance of metabolic function of the PICM-19 Cell Line, or its derivative cell lines, over long term culture (1-3 months). As of the date of this prospectus, three flow-through bioreactor model systems incorporating the PICM-19 cells are being tested for cell viability, ammonia clearance activity, P450 enzyme activity, and urea production activity.
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Developing and testing multi-well cell culture formats for the in-vitro assay of the effects of various test compounds on the metabolism and viability of the PICM-19 Cell Line derived hepatocytes or bile ductules (liver cell channels).
As of the date of this 10-QSB/A, multi-cell cell culture formats have been successfully tested and P-450 enzyme assays are currently being tested and standardized in 6-well, 24-well, and 96-well formats.
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Genetically engineering the PICM-19 Cell Line to create derivative cell lines containing gene reporter constructs, e.g., green fluorescent protein (GFP) based constructs, so that GFP expression is linked to various cell metabolic responses or stimulation of various cell signal transduction pathways.
As of the date of this 10-QSB/A, STO cell lines have been created by genetic engineering that express GFP and the neomycin-resistance gene. The construction of GFP and RFP (red fluorescent protein) mammalian expression vectors under the control of the alpha-fetoprotein promoter is currently underway for use in the genetic engineering of the PICM-19 Cell Line.
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Developing cell transformation assay formats to demonstrate and enable the utilization of the PICM-19 Cell Line for the study of mutagenic or carcinogenic processes.
As of the date of this 10-QSB/A, this aspect of the CRADA has the lowest priority and no work is anticipated on this aspect of the project for at least two years.
Ownership of Developed Technologies Under the CRADA
Under the terms of the CRADA all rights, title and interest in any subject invention made solely by USDAs Agricultural Research Service employees are owned by USDAs Agricultural Research Service, solely by us are owned by us, and any such inventions are owned jointly by us and USDAs Agricultural Research Service if made jointly by USDAs Agricultural Research Service and us. Under the CRADA, we have an option to negotiate an exclusive license in each subject invention owned or co-owned by USDAs Agricultural Research Service for one or more field (s) of use encompassed by the CRADA. The option terminates when and if we fail to:
- submit a complete application for an exclusive license within sixty days of being notified by USDAs Agricultural Research Service of an invention being available for licensing; or
- submit a good faith written response to a written proposal of licensing terms within forty five days of such proposal.
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The USDAs Agricultural Research Service has the first option to prepare and prosecute patent or Plant Variety Protection Certificate applications, on subject inventions that are owned or co-owned by the USDAs Agricultural Research Service, which option may be waived in whole or in part.
Although the termination date of the CRADA is September 30, 2007, the CRADA is subject to earlier termination at any time by mutual consent. Moreover, either party may unilaterally terminate the entire agreement at any time by giving the other party written notice not less than sixty calendar days prior to the desired termination date. To date, we have neither given nor received any such written notice.
Results of Operation
The Company has yet to establish any history of profitable operations. The Company has incurred operating losses of $677,015 and $96,164 for the three months ended March 31, 2005 and March 31, 2004, respectively. As a result, at March 31, 2005, the Company has an accumulated deficit of $4,424,786.
We expect that our revenues will not be sufficient to sustain our operations for the foreseeable future. Our profitability will require the successful completion of our research and development programs, and the subsequent commercialization of the results or of products derived from such research and development efforts. No assurances can be given when this will occur or that we will ever be profitable.
Three Months Ended March 31, 2005 and 2004
We had no revenues in the three months ended March 31, 2005 and 2004. Our general and administrative expenses increased 601% to $678,410 in the three months ended March 31, 2005, from $96,716 in the same period in 2004. This increase was primarily attributable to an increase of $479,737 in investor relations costs.
Interest income increased 153% to $1,395 in the three months ended March 31, 2005, from $552 during the same period in 2004, reflecting higher than average cash balances maintained during most of the second quarterly period in 2005.
We incurred net losses of $677,015 and $96,164 during the three months ended March 31, 2005 and in the same period in 2004, respectively, was principally caused by the increase in our investor relations costs.
Liquidity and Capital Resources
As at March 31, 2005, the Company had a cash balance of $219,609. The Company has financed its operations primarily through cash on hand during the three month period ending March 31, 2005.
Net cash flows used in by operating activities was $635,664 for the three month period ending March 31, 2005, compared to net cash flows used of $97,390 for the same period in 2004, primarily due to an increase in investor relations expenses.
Net cash provided by financing activities was $241,750 for the three months period ending March 31, 2005 compared to $166,650 for the same period in 2004. The Company has financed its operations primarily from cash on hand, through loans from shareholders and proceeds from stock option and warrant exercises.
In addition, as of the date of this amendment, pursuant to our common stock purchase agreement with Fusion Capital, we have the right to receive $25,000 per trading day under the agreement with Fusion Capital unless our stock price equals or exceeds $1.00, in which case the daily amount may be increased under certain conditions as the price of our common stock increases. Fusion Capital shall not have the right or the obligation to purchase any shares of our common stock on any trading days that the market price of our common stock is less than $0.50. Since we initially registered 10,000,000 shares for sale by Fusion Capital pursuant to this prospectus, the selling price of our common stock to Fusion Capital will have to average at least $1.50 per share for us to receive the maximum proceeds of $15.0 million without registering additional shares of common stock. Assuming a purchase price of $1.37 per share (the closing sale price of the common stock on January 19, 2006) and the purchase by Fusion Capital of 10,000,000
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shares under the common stock purchase agreement, proceeds to us would be $13,700,000. Subject to approval by our board of directors, we have the right but not the obligation to issue more than 10,000,000 shares to Fusion Capital. In the event we elect to issue more than 10,000,000 shares offered hereby, we will be required to file a new registration statement and have it declared effective by the U.S. Securities & Exchange Commission.
Although we believe that we have sufficient cash on hand to satisfy our contractual commitments through February 28, 2006, we do not currently have sufficient cash on hand to sustain planned operating activities through the end of 2006. Our ability to continue as a going concern is substantially dependent upon future levels of funding from our funding sources, including Fusion Capital, which are currently uncertain as to amount and timing. Specifically, Fusion Capital shall not have the right or the obligation to purchase any shares of our common stock on any trading days that the market price of our common stock is less than $0.50. If obtaining sufficient financing from Fusion Capital were to prove unavailable or prohibitively dilutive and if we are unable to commercialize and sell products, if any, derived from our research and development efforts, we will need to secure another source of funding in order to satisfy our working capital needs. Even if we are able to access the full $15.0 million under the common stock purchase agreement with Fusion Capital, we may still need additional capital to fully implement our business, operating and development plans. Should the financing we require to sustain our working capital needs be unavailable or prohibitively expensive when we require it, the consequences would be a material adverse effect on our business, operating results, financial condition and prospects. We have no agreements or understandings with any other person regarding any potential financing. The extent to which we will rely on Fusion Capital as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the number of shares outstanding, progress we have made in our business, other opportunities we may wish to pursue, general economic conditions, our capital requirements at the time, and the extent to which we are able to secure working capital from other sources on terms that are more beneficial to us.
At this time, except for our agreement with Fusion Capital, we have no agreements or understandings with any third party regarding any financings.
Related Party Transactions
Management Fees: During the three months ended March 31, 2005 and 2004, the Company incurred $5,953 (2004 $0) in management fees to directors of the Company. Included in accounts payable related parties at March 31, 2005 is management and consulting fees of $0 incurred in 2005 and $27,000 incurred in previous years.
Notes Payable and Accrued Interest: Notes payable totaled $950,000 as at March 31, 2005, representing unsecured loans of $250,000 and $700,000 (both bearing an interest rate of 8.50%) due to Mr. Harmel S. Rayat, a Director, Secretary/Treasurer and majority shareholder of the Company. Accrued and unpaid interest on these notes during the three month period ended March 31, 2005, amounted to $14,875 (2004 - $12,875).
Rent: The Companys principal office is located at 1628 West First Avenue, Suite 216, Vancouver, British Columbia, Canada, V6J 1G1. These premises are owned by a private corporation controlled by a director and majority shareholder of the Company. The fair value of the rent has not been included in the financial statements because the amount is immaterial.
Off Balance Sheet Arrangements
We do not currently have, nor have we ever had, any relationships with unconsolidated entities or financial partnerships, such as entities often referred to as structured finance or special purpose entities, which would have been established for the purpose of facilitating off-balance sheet arrangements or other contractually narrow or limited purposes. In addition, we do not engage in trading activities involving non-exchange traded contracts. As such, we are not materially exposed to any financing, liquidity, market or credit risk that could arise if we had engaged in these relationships.
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Recent Accounting Pronouncements
In November 2004, the FASB issued SFAS No. 151, Inventory Costs-an amendment of ARB No. 43, Chapter 4, which is the result of the FASBs project to reduce differences between U.S. and international accounting standards. SFAS No. 151 requires idle facility costs, abnormal freight, handling costs, and amounts of wasted materials (spoilage) be treated as current-period costs. Under this concept, if the costs associated with the actual level of spoilage or production defects are greater than the costs associated with the range of normal spoilage or defects, the difference would be charged to current-period expense, not included in inventory costs. SFAS No. 151 will be effective for inventory costs incurred during fiscal years beginning after June 15, 2005. The adoption of SFAS No. 151 will not have a material impact on the Companys financial statements.
In December 2004, the FASB issued SFAS No. 153, Exchanges of Nonmonetary Assets, an amendment of APB No. 29, Accounting for Nonmonetary Transactions. SFAS No. 153 requires exchanges of productive assets to be accounted for at fair value, rather than at carryover basis, unless (1) neither the asset received nor the asset surrendered has a fair value that is determinable within reasonable limits or (2) the transactions lack commercial substance. SFAS 153 is effective for nonmonetary asset exchanges occurring in fiscal periods beginning after June 15, 2005. The adoption of FASB No. 153 will not have a material impact on the Companys financial statements.
In December 2004, the FASB issued SFAS No. 123(R), "Accounting for Stock-Based Compensation". SFAS 123(R) establishes standards for the accounting for transactions in which an entity exchanges its equity instruments for goods or services. This Statement focuses primarily on accounting for transactions in which an entity obtains employee services in share-based payment transactions. SFAS 123(R) requires that the fair value of such equity instruments be recognized as expense in the historical financial statements as services are performed. Prior to SFAS 123(R), only certain pro-forma disclosures of fair value were required. SFAS 123(R) shall be effective for the Company as of the beginning of the first interim or annual reporting period that begins after December 15, 2005. The adoption of FASB No. 123(R), will not have a material impact on the Companys financial statements.
Risk Factors
We have sought to identify what we believe to be the most significant risks to our business. However, we cannot predict whether, or to what extent, any of such risks may be realized nor can we guarantee that we have identified all possible risks that might arise. Investors should carefully consider all of such risk factors before making an investment decision with respect to our Common Stock. We provide the following cautionary discussion of risks, uncertainties and possible inaccurate assumptions relevant to our business. These are factors that we think could cause our actual results to differ materially from expected results. Other factors besides those listed here could adversely affect us.
Risks Associated With Our Business
We Have Experienced Significant Losses And Expect Losses To Continue For The Foreseeable Future.
We have yet to establish any history of profitable operations. We have incurred annual operating losses of $1,435,613 and $1,102,723, respectively, during the past two fiscal years of operation. As a result, at March 31, 2005, we had an accumulated deficit of $4,424,786. We had no revenues during the last five fiscal years and we do not expect to generate revenues from our operations for the foreseeable future. Our profitability will require the successful completion of our sponsored research, development efforts and the subsequent commercialization of our products, if any, derived from our sponsored research and development activities regarding our artificial liver device and in-vitro toxicology testing methodologies. No assurances can be given when this will occur or that we will ever be profitable.
We Currently Do Not Have, And May Never Develop, Any Commercialized Products.
We currently do not have any commercialized products or any significant source of revenue. We have invested substantially all of our time and resources over the last three years in identification, research and development of technologies and products for liver toxicity detection and the treatment of various forms of
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liver dysfunction and disease. The technologies, which are the subject of our ongoing sponsored research programs, will require additional development, clinical evaluation, regulatory approval, significant marketing efforts and substantial additional investment (beyond the $807,828 to which we have committed under the terms of our CRADA) before they can provide us with any revenue. We cannot currently estimate with any accuracy the amount of these funds because it may vary significantly depending on the results of our current sponsored research and development activities, product testing, costs of acquiring licenses, changes in the focus and direction of our research and development programs, competitive and technological advances, the cost of filing, prosecuting, defending and enforcing patent claims, the regulatory process, manufacturing, marketing and other costs associated with the commercialization of products following receipt of approval from regulatory bodies and other factors.
Our efforts may not lead to commercially successful products for a number of reasons, including:
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we may not be able to obtain regulatory approvals or the approved indication may be narrower than we seek;
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our technologies or products, if any, derived from our research and development efforts may not prove to be safe and effective in clinical trials;
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physicians may not receive any reimbursement from third-party payors, or the level of reimbursement may be insufficient to support widespread adoption of any products derived from our research and development efforts;
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any products that may be approved may not be accepted in the marketplace by physicians or patients;
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we may not have adequate financial or other resources to complete the development and commercialization of products derived from our research and development efforts;
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we may not be able to manufacture our products in commercial quantities or at an acceptable cost; and
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rapid technological change may make our technologies and products derived from those technologies obsolete.
We Will Require Additional Financing To Sustain Our Operations And Without It We Will Not Be Able To Continue Operations.
Our independent auditors have added an explanatory paragraph to their audit opinion issued in connection with the financial statements for the years ended December 31, 2004 and 2003, relative to our ability to continue as a going concern. Our ability to obtain additional funding will determine our ability to continue as a going concern. Our financial statements do not include any adjustments that might result from the outcome of this uncertainty.
At March 31, 2005, we had a working capital deficit of $924,913. We have an operating cash flow deficit of $1,364,209 in 2004 and $1,022,501 in 2003. Although we believe that we have sufficient financial resources and commitments to sustain our current level of research and development activities through the end of February 28, 2006, any expansion, acceleration or continuation (beyond February 28, 2006) of such activities will require additional capital which may not be available to us, if at all, on terms and conditions that we find acceptable.
On January 20, 2006 we entered into a new common stock purchase agreement with Fusion Capital Fund II, LLC pursuant to which Fusion Capital has agreed, so long as no event of default (as described below) exists, to purchase on each trading day $25,000 of our common stock up to an aggregate of $15.0 million over a 30 month period subject to earlier termination at our discretion. In our discretion, we may elect to sell more of our common stock to Fusion Capital than the minimum daily amount. The purchase price of the shares of common stock will be equal to a price based upon the future market price of the common stock without any fixed discount to the market price. Fusion Capital does not have the right or the obligation to purchase shares of our common stock in the event that the price of our common stock is less than $0.50.
We shall not commence any sale of our common stock to Fusion Capital until a registration statement registering 11,086,351 shares, of which 10,000,000 may be sold to Fusion Capital pursuant to the common stock purchase agreement, has been declared effective by the U.S. Securities and Exchange commission.
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The extent we rely on Fusion Capital as a source of funding will depend on a number of factors including, the prevailing market price of our common stock and the extent to which we are able to secure working capital from other sources, including other debt and equity financings.
We May Not Be Able To Repay Loans We Have Received From Harmel S. Rayat, Our President, Director And Majority Stockholder, To Fund Our Operation.
We have borrowed an aggregate of $1,150,000 from Harmel S. Rayat, our president, director and majority stockholder, pursuant to his $1,600,000 loan commitment to us. The loans are due upon the receipt of the written demand from Mr. Rayat. The loans bear interest at the rate of 8.50% per annum. We do not currently have sufficient capital on hand to repay these loans. We may prepay these loans, at any time, without penalty. We expect to repay these amounts from the proceeds, if any, we receive under the common stock purchase agreement with Fusion Capital. There is no assurance that we will be able to repay all or a part of these loans or obtain any additional loans from Mr. Rayat in the event we do not receive the proceeds from Fusion Capital.
The Success Of Our Sponsored Research And Development Program Is Uncertain And We Expect To Be Engaged In Research And Development Efforts For A Considerable Period Of Time Before We Will Be In A Position, If Ever, To Develop And Commercialize Products Derived From Our Sponsored Research Program.
We expect to continue our current sponsored research and development program through at least 2007. Research and development activities, by their nature, preclude definitive statements as to the time required and costs involved in reaching certain objectives. Actual costs may exceed the amounts ($807,828) we have budgeted and actual time may exceed our expectations. If our research and development requires more funding or time than we anticipate, then we may have to reduce technological development efforts or seek additional financing. There can be no assurance that we will be able to secure any necessary additional financing or that such financing would be available to us on favorable terms. Additional financings could result in substantial dilution to existing stockholders. Even if we are able to fully fund our research and development program, there is no assurance that, even upon successful completion of our program, we will ever be able to commercialize products if any, derived from our research efforts or that we will be able to generate any revenues from operations.
Our Sponsored Research and Development Program Is In The Preliminary Development Stage And The Results We Attain May Not Prove To Be Adequate For Purposes of Developing and Commercializing Any Products Or Otherwise To Support A Profitable Business Venture.
Our sponsored research and development program is in the preliminary development stage. Our program is targeting specifically in-vitro toxicology and drug testing platforms and the development of an artificial liver device. We will require significant further research, development, testing and regulatory approvals and significant additional investment (beyond the $807,828 to which we have committed under the terms of our CRADA) before we will be in a position to attempt to commercialize products derived from our research and development program. We cannot currently estimate with any accuracy the amount of these funds because it may vary significantly depending on the results of our current sponsored research and development activities, product testing, costs of acquiring licenses, changes in the focus and direction of our research and development programs, competitive and technological advances, the cost of filing, prosecuting, defending and enforcing patent claims, the regulatory process, manufacturing, marketing and other costs associated with commercialization of products following receipt of approval from regulatory bodies and other factors.
There can be no assurances that our early stage sponsored research will be successful. The ultimate results of our ongoing research program may demonstrate that the technologies being researched by us may be ineffective, unsafe or unlikely to receive necessary regulatory approvals, if ever. If such results are obtained, we will be unable to create marketable products or generate revenues and we may have to cease operations.
We have not submitted any products or any technologies that are the subject of, or result from, our research and development activities for regulatory approval or clearance. Even if our research is successful, the
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process of obtaining necessary U.S. Food and Drug Administration (FDA) approvals or clearances can take years and is expensive and full of uncertainties. Additionally, approved products are subject to continuing FDA requirements relating to quality control and quality assurance, maintenance of records, reporting of adverse events and product recalls, documentation, labeling and promotion of medical products. Compliance with such continued regulatory oversight may prove to be costly and may limit our ability to attain profitable operations.
We May Not Be Granted An Exclusive License Under Our CRADA With The USDAs Agricultural Research Service.
We are a party to a CRADA with the USDAs Agricultural Research Service which grants us an option to negotiate an exclusive license to any invention or other intellectual property conceived or reduced to practice under the CRADA which is patentable or otherwise protectable under Title 35 of the United States Code or under the patent laws of a foreign country. There can be no assurance that such a license will be granted to us or that we can obtain a license on terms favorable to us. If we do not obtain an exclusive license, our ability to generate revenue would be materially adversely affected.
We expect to enter into additional research agreements and licenses in the future that relate to important technologies that may be necessary for the development and commercialization of related and unrelated products. These agreements and licenses may impose various commercialization, indemnification, royalty, insurance and other obligations on us, which, if we fail to comply, may result in the termination of these agreements and licenses or make the agreements and licenses non-exclusive, which could affect our ability to exploit important technologies that are required for successful development of products, if any, derived from our ongoing sponsored research and development programs.
Our CRADA With The USDAs Agricultural Research Service May Be Terminated By Either Party At Any Time By Giving Written Notice Of Not Less Than Sixty Calendar Days Prior To The Desired Termination Date.
Our current sponsored research and development program is based entirely on our CRADA with the USDAs Agricultural Research Service. The termination date of the CRADA is September 30, 2007. However, the CRADA provides that it may be terminated unilaterally by either us or the USDAs Agricultural Research Service upon written notice of not less than sixty calendar days prior to the desired termination date. This means that the USDAs Agricultural Research Service could terminate the CRADA even if we are not in default under the terms of the Agreement. If the USDAs Agricultural Research Service were to do so, our business and future prospects would be materially adversely affected.
Currently, We Do Not Directly Conduct Any Of Our Research And Development Activities And Therefore We Will Have Minimal Control Over Such Research.
We rely primarily on the USDAs Agricultural Research Service to conduct, monitor and assess our sponsored research. We will have no control over the specifics of and possible direction that the research may take. Accordingly, there can be no assurance that the USDAs Agricultural Research Service will conduct our sponsored research in a manner that will lead to the commercial development of any products.
We are also dependent upon the services of certain key scientific personnel who are not employed by us, including the principal investigators with respect to our on going research regarding both the treatment of liver disease (and related conditions), including the development of an artificial liver device, and in-vitro toxicology testing technologies. The loss of the services provided by such persons could have a materially adverse effect on us, unless qualified replacements could be found. We have no control over whether our principal investigators or other scientific personnel will choose to remain involved with our projects. Since these individuals are not bound by contract to us nor employed by us directly, they might move on to other research or positions.
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We Are Subject To Substantial Government Regulation Which Could Materially Adversely Affect Our Business.
We have yet to develop any products for submission for regulatory approval. If any such products are submitted for approval, they must undergo rigorous preclinical and clinical testing and an extensive regulatory approval process before they can be marketed. This process makes it longer, harder and more costly to bring any products to market; moreover, we cannot guarantee that approval will be granted. The pre-marketing approval process can be particularly expensive, uncertain and lengthy. Many products for which FDA have never been approved for marketing. In addition to testing and approval procedures, extensive regulations also govern marketing, manufacturing, distribution, labeling and record-keeping procedures. If we do not comply with applicable regulatory requirements, such violations could result in warning letters, non-approval, suspensions of regulatory approvals, civil penalties and criminal fines, product seizures and recalls, operating restrictions, injunctions and criminal prosecution.
Delays in, or rejection of, FDA or other government entity approval may also adversely affect our business. Such delays or rejection may be encountered due to, among other reasons, government or regulatory delays, lack of efficacy during clinical trials, unforeseen safety issues, slower than expected rate of patient recruitment for clinical trials, inability to follow patients after treatment in clinical trials, inconsistencies between early clinical trial results and results obtained in later clinical trials, varying interpretations of data generated by clinical trials, or changes in regulatory policy during the period of product development in the United States. In the United States more stringent FDA oversight in product clearance and enforcement activities could result in our experiencing longer approval cycles, more uncertainty, greater risk and significantly higher expenses. Even if regulatory approval for any product is granted, this approval may entail limitations on uses for which any such product may be labeled and promoted. It is possible, for example, that we may not receive FDA approval to market products based on our sponsored research and development efforts for broader or different applications or to market updated products that represent extensions of any such product. In addition, we may not receive FDA approval to export any such product in the future, and countries to which products are to be exported may not approve them for import.
Any manufacturing facilities would also be subject to continual review and inspection. The FDA has stated publicly that compliance with manufacturing regulations will be scrutinized more strictly. A governmental authority may challenge our compliance with applicable federal, state and foreign regulations. In addition, any discovery of previously unknown problems with any of our sponsored research and development efforts or products derived from such research and development, or facilities may result in marketing, sales and manufacturing restrictions, being imposed, as well as possible enforcement actions.
From time to time, legislative or regulatory proposals are introduced that could alter the review and approval process relating to our research and development programs and products, if any, derived from such research. It is possible that the FDA will issue additional regulations further restricting the sale of our products, if any, derived from our research and development efforts. Any change in legislation or regulations that govern the review and approval process relating to could make it more difficult and costly to obtain approval, or to produce, market, and distribute such products, if any, derived from our research and development efforts, even if approved.
We May Be Required To Comply With Rules Regarding Animal Testing and This May Limit the Success of Our Research and Development Program.
Our sponsored research and development efforts involve laboratory animals. We may be adversely affected by changes in laws, regulations or accepted procedures applicable to animal testing or by social pressures that would restrict the use of animals in testing or by actions against our collaborators or us by groups or individuals opposed to such testing.
Our Sponsored Research and Development Program Uses Cells Derived From Pigs, Which Could Prevent The FDA Or Other Health Regulatory Agencies From Approving Products, If Any, Derived From Our Research and Development Efforts.
Because pigs carry genetic material of the porcine endogenous retrovirus (PERV), our use of cells derived from pigs carries a risk of transmitting viruses harmless to pigs, but deadly to humans. This may
25
result in the FDA or other health regulatory agencies not approving products, if any, derived from our sponsored research and development efforts or subsequently banning any further use of any such products should health concerns arise after any such product was approved. At this time, it is unclear whether we will be able to obtain clinical and product liability insurance that covers the PERV risk.
We May Be Liable For Contamination Or Other Harm Caused By Materials That We Handle, And Changes In Environmental Regulations Could Cause Us To Incur Additional Expense.
Our sponsored research and development programs do not generally involve the handling of potentially harmful biological materials or hazardous materials, but they may occasionally do so. The USDAs Agricultural Research Service and we are subject to federal, state and local laws and regulations governing the use, handling, storage and disposal of hazardous and biological materials. If violations of environmental, health and safety laws occur, we could be held liable for damages, penalties and costs of remedial actions. These expenses or this liability could have a significant negative impact on our business, financial condition and results of operations. We may violate environmental, health and safety laws in the future as a result of human error, equipment failure or other causes. Environmental laws could become more stringent over time, imposing greater compliance costs and increasing risks and penalties associated with violations. We may be subject to potentially conflicting and changing regulatory agendas of political, business and environmental groups. Changes to or restrictions on permitting requirements or processes, hazardous or biological material storage or handling might require an unplanned capital investment or relocation. Failure to comply with new or existing laws or regulations could harm our business, financial condition and results of operations.
Even If We Were To Secure Regulatory Approval In The Future For Any Product Derived From Our Sponsored Ongoing Research Efforts, We Lack Sales and Marketing Experience and Will Likely Rely On Third Parties For Such Services.
Our ability to achieve profitability is dependent in part on ultimately obtaining regulatory approvals for products, if any, which are derived from our sponsored research and development efforts, and then entering into agreements for the commercialization of any such products. There can be no assurance that such regulatory approvals will be obtained or such agreements will be entered into. The failure to obtain any such necessary regulatory approvals or to enter into any such necessary agreements could delay or prevent us from achieving profitability and would have a material adverse effect on the business, financial position and results of our operations. Further, there can be no assurance that our operations will become profitable even if products, if any, which are derived from our sponsored research and development efforts, are commercialized.
If FDA and other approvals are ultimately obtained with respect to any product submitted by us in the future for approval, we expect to market and sell any such product through distribution, co-marketing, co-promotion or sublicensing arrangements with third parties. We have no experience in sales, marketing or distribution of biotechnology products and our current management and staff is not trained in these areas. To date, we have no such agreements. To the extent that we enter into distribution, co-marketing, co-promotion or sublicensing arrangements for the marketing and sale of any such products, any revenues received by us will be dependent on the efforts of third parties. If any of such parties were to breach or terminate their agreement with us or otherwise fail to conduct marketing activities successfully, and in a timely manner, the commercialization of products, if any, derived from our research and development efforts would be delayed or terminated.
We May Not Be Able To Attract And Retain Qualified Personnel Either As Employees Or As Consultants; Without Such Personnel, We May Not Be Successful In Commercializing The Results Of Our Ongoing Research And Development Efforts.
Competition for qualified employees among companies in the biotechnology industry is intense. Our future success depends upon our ability to attract, retain and motivate highly skilled employees. Our present management has no clinical or other experience in the development of biotechnology products. Attracting desirable employees will require us to offer competitive compensation packages, including possible stock options. In order to successfully commercialize the results of our ongoing research and development efforts or products, if any, derived from our research program we must substantially expand our personnel,
26
particularly in the areas of clinical trial management, regulatory affairs, business development and marketing. There can be no assurance that we will be successful in hiring or retaining qualified personnel. Managing the integration of new personnel and our growth generally could pose significant risks to our development and progress. The addition of such personnel may result in significant changes in our utilization of cash resources and our development schedule.
We Expect To Operate In A Highly Competitive Market; We May Face Competition From Large, Well-Established Companies With Significant Resources; And, We May Not Be Able To Compete Effectively.
Our commercial success will depend on our ability and the ability of our sublicensees, if any, to compete effectively in product development areas such as, but not limited to, safety, efficacy, ease of use, patient or customer compliance, price, and marketing and distribution. There can be no assurance that competitors will not succeed in developing products that are more effective than any products derived from our research and development efforts or that would render such products obsolete and non-competitive.
The biotechnology industry is characterized by intense competition, rapid product development and technological change. Most of the competition that we encounter will come from companies, research institutions and universities who are researching and developing technologies and potential products similar to or competitive with our own.
These companies enjoy numerous competitive advantages over us, including:
- significantly greater name recognition;
- established relations with healthcare professionals, customers and third-party payors;
- established distribution networks;
- additional lines of products, and the ability to offer rebates, higher discounts or incentives to gain a competitive advantage;
- greater experience in conducting research and development, manufacturing, clinical trials, obtaining regulatory approval for products, and marketing approved products; and
- greater financial and human resources for product development, sales and marketing, and patent litigation.
As a result, we may not be able to compete effectively against these companies or their products.
We May Become Subject To Claims Of Infringement Or Misappropriation Of The Intellectual Property Rights Of Others, Which Could Prohibit Us From Commercializing Products Based On Our Sponsored Research And Development Program, Require Us To Obtain Licenses From Third Parties Or To Develop Non-Infringing Alternatives, And Subject Us To Substantial Monetary Damages And Injunctive Relief.
We do not have any patents regarding any of our sponsored research and development activities. We may not be able to assert any rights, under our CRADA, to any patents held by the USDAs Agriculture Research Service. Third parties could, in the future, assert infringement or misappropriation claims against us with respect to our current sponsored research and development program or future products, if any, derived from our sponsored research and development program. Whether a product infringes a patent involves complex legal and factual issues, the determination of which is often uncertain. Therefore, we cannot be certain that we have not infringed the intellectual property rights of such third parties.
Any infringement or misappropriation claim could cause us to incur significant costs, could place significant strain on our financial resources, divert managements attention from our business and harm our reputation. If the relevant patents were upheld as valid and enforceable and we were found to infringe, we could be prohibited from continuing our research and development activities and from marketing or selling products, if any, derived from our sponsored research and development efforts unless we could obtain licenses to use the technology covered by the patent or are able to design around the patent. We may be unable to obtain a license on terms acceptable to us, if at all, and we may not be able to commercialize any products. A court could also order us to pay compensatory damages for such infringement, plus prejudgment interest and could, in addition, treble the compensatory damages and award attorney fees. These damages could be substantial and could harm our reputation, business, financial condition and
27
operating results. Depending on the nature of the relief ordered by the court, we could become liable for additional damages to third parties.
We May Be Exposed To Product Liability Claims For Which We Do Not Have Any Insurance Coverage.
Because our activities involve the researching, developing and testing of new technologies; and in the future we may be involved either directly or indirectly in the manufacturing and distribution of products, if any, derived from our sponsored research and development efforts, we may be exposed to the financial risk of liability claims in the event that the use of any such product results in personal injury, misdiagnosis or death. We may be subject to claims against us even if the apparent injury is due to the actions of others. There can be no assurance that we will not experience losses due to product liability claims in the future, or that adequate insurance will be available in sufficient amounts, at an acceptable cost, or at all. A product liability claim, product recall or other claim, or claims for uninsured liabilities or in excess of insured liabilities, may have a material adverse effect on our business, financial condition and results of operations. These liabilities could prevent or interfere with our product commercialization efforts. Defending a suit, regardless of merit, could be costly, could divert management attention and might result in adverse publicity, which could result in the withdrawal of, or inability to recruit, clinical trial volunteers, or result in reduced acceptance of products derived from our sponsored research and development activities in the market.
We do not currently carry any insurance. If a claim against us results in a large monetary judgment, which we cannot pay, we may have to cease operations.
Failure To Obtain Third Party Reimbursement For Products Derived From Our Sponsored Research and Development Efforts Could Limit Our Revenue.
In the United States, success in obtaining payment for a new product from third parties, such as insurers, depends greatly on the ability to present data which demonstrates positive outcomes and reduced utilization of other products or services, as well as cost data which shows that treatment costs using the new product are equal to or less than what is currently covered for other products. If we are unable to obtain favorable third party reimbursement and patients are unwilling or unable to pay for such products or services out-of-pocket, it could limit our revenue and harm our business.
Mr. Harmel S. Rayat, Our President, Chief Executive Officer, Chief Financial Officer, Principal Accounting Officer And Director, Is Able To Substantially Influence All Matters Requiring Approval By Our Stockholders, Including The Election Of Directors.
As of January 23, 2006, Mr. Rayat beneficially owned approximately 69% of our outstanding common stock. Accordingly, he is able to substantially influence virtually all matters requiring approval by our stockholders, including the election of directors. Our Articles of Incorporation do not provide for cumulative voting in the election of directors and, therefore, although they are able to vote, our other stockholders should not expect to be able to elect any directors to our board of directors.
We Rely On Our Management, The Loss Of Whose Services Could Have A Material Adverse Affect On Our Business.
We rely upon the services of our board of directors and management, in particular those of Mr. Harmel S. Rayat, the loss of which could have a material adverse affect on our business and prospects. Competition for qualified personnel to serve in a senior management position is intense. If we are not able to retain our directors and management, or attract other qualified personnel, we may not be able to fully implement our business strategy; failure to do so would have a materially adverse impact on our future prospects.
We currently have no employment agreements with any of our officers and directors imposing any specific condition on our officers and directors regarding their continued employment by us. Our officers and directors are also officers, directors and employees of other companies, and we may have to compete with such other companies for their time, attention and efforts. Except for Mr. Rayat, none of our officers and directors is expected to spend more than approximately five (5%) of his time on our business affairs. Mr. Rayat will not be spending his full time and effort on our business affairs because he is engaged in
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other business activities. We do not expect Mr. Rayat to spend more than twenty (20%) of his time on our business affairs. If Mr. Rayats other business activities, from time to time, require more of Mr. Rayats time, he may have less time to spend on our business affairs and our operations could suffer as a result. We do not maintain key man insurance on any of our directors or officers.
Future Sales Of Our Common Stock May Decrease Our Stock Price.
We have previously issued a total of 70,439,183, shares of common stock, of which 55,039,683, are eligible for resale under Rule 144 of the Securities Act. In addition, we have also registered a substantial number of shares of common stock that are issuable upon the exercise of options. If holders of options choose to exercise their purchase rights and sell shares of common stock in the public market all at once or in a short time period, the prevailing market price for our common stock may decline. Future public sales of shares of common stock may adversely affect the market price of our common stock or our future ability to raise capital by offering equity securities.
Our Stock Price Historically Has Been Volatile And May Continue To Be Volatile.
The market price of our common stock has been and is expected to continue to be highly volatile. Factors, many of which are beyond our control, include, in addition to other risk factors described in this section, the announcements of technological innovations by us or other companies, regulatory matters, new or existing products or procedures, concerns about our financial position, operating results, litigation, government regulation, developments or disputes relating to agreements, patents or proprietary rights, and general economic, industry and market conditions may have a significant impact on the market price of our stock. In addition, potential dilutive effects of future sales of shares of common stock by our stockholders and by us, including Fusion Capital pursuant to this prospectus and subsequent sale of common stock by the holders options could have an adverse effect on the market price of our shares.
Volatility in the market price for particular companies has often been unrelated or disproportionate to the operating performance of those companies. Broad market factors may seriously harm the market price of our common stock, regardless of our operating performance. In addition, securities class action litigation has often been initiated following periods of volatility in the market price of a company's securities. A securities class action suit against us could result in substantial costs, potential liabilities, and the diversion of management's attention and resources. To the extent our stock price fluctuates and/or remains low, it could cause you to lose some or all of your investment and impair our ability to raise capital through the offering of additional equity securities.
Our Common Is A "Penny Stock" And Because "Penny Stock Rules Will Apply, You May Find It Difficult To Sell The Shares Of Our Common Stock You Acquired In This Offering.
Our common stock is a penny stock as that term is defined under Rule 3a51-1 of the Securities Exchange Act of 1934. Generally, a "penny stock" is a common stock that is not listed on a securities exchange and trades for less than $5.00 a share. Prices often are not available to buyers and sellers and the market may be very limited. Penny stocks in start-up companies are among the riskiest equity investments. Broker-dealers who sell penny stocks must provide purchasers of these stocks with a standardized risk-disclosure document prepared by the U.S. Securities & Exchange Commission. The document provides information about penny stocks and the nature and level of risks involved in investing in the penny stock market. A broker must also give a purchaser, orally or in writing, bid and offer quotations and information regarding broker and salesperson compensation, make a written determination that the penny stock is a suitable investment for the purchaser, and obtain the purchaser's written agreement to the purchase. Many brokers choose not to participate in penny stock transactions. Because of the penny stock rules, there is less trading activity in penny stock and you are likely to have difficulty selling your shares.
Our Common Shares Are Thinly Traded, So You May Be Unable To Sell At Or Near Ask Prices Or At All If You Need To Sell Your Shares To Raise Money Or Otherwise Desire To Liquidate Your Shares.
Our common shares have historically been sporadically or "thinly-traded" on the OTCBB, meaning that the number of persons interested in purchasing our common shares at or near ask prices at any given time may be relatively small or non-existent. As of January 19, 2006, our average trading volume per day for the past
29
three months was approximately 47,504 shares a day with a high of 246,300 shares traded and a low of 13,491 shares traded. This situation is attributable to a number of factors, including the fact that we are a small company which is relatively unknown to stock analysts, stock brokers, institutional investors and others in the investment community that generate or influence sales volume, and that even if we came to the attention of such persons, they tend to be risk-averse and would be reluctant to follow an unproven company such as ours or purchase or recommend the purchase of our shares until such time as we became more seasoned and viable. As a consequence, there may be periods of several days or more when trading activity in our shares is minimal or non-existent, as compared to a seasoned issuer which has a large and steady volume of trading activity that will generally support continuous sales without an adverse effect on share price. We cannot give you any assurance that a broader or more active public trading market for our common shares will develop or be sustained, or that current trading levels will be sustained.
Compliance With Changing Regulation Of Corporate Governance And Public Disclosure May Result In Additional Expenses.
Keeping abreast of, and in compliance with, changing laws, regulations and standards relating to corporate governance and public disclosure, including the Sarbanes-Oxley Act of 2002, new SEC regulations and, in the event we are ever approved for listing on either NASDAQ or a registered exchange, NASDAQ and stock exchange rules, will require an increased amount of management attention and external resources. We intend to continue to invest all reasonably necessary resources to comply with evolving standards, which may result in increased general and administrative expenses and a diversion of management time and attention from revenue-generating activities to compliance activities.
We Do Not Intend To Pay Dividends For The Foreseeable Future.
We currently intend to retain future earnings, if any, to support the development and expansion of our business and do not anticipate paying cash dividends in the foreseeable future. Our payment of any future dividends will be at the discretion of our board of directors after taking into account various factors, including but not limited to our financial condition, operating results, cash needs, growth plans and the terms of any credit agreements that we may be a party to at the time. Accordingly, investors must rely on sales of their common stock after price appreciation, which may never occur, as the only way to realize their investment. Investors seeking cash dividends should not purchase the units offered by us pursuant to this prospectus.
ITEM 3. Quantitative and Qualitative Disclosures About Market Risk
Our exposure to market risk is confined to our cash equivalents and short-term investments. We invest in high-quality financial instruments; primarily money market funds, federal agency notes, and US Treasury obligations, with the effective duration of the portfolio within one year which we believe are subject to limited credit risk. We currently do not hedge interest rate exposure. Due to the short-term nature of our investments, we do not believe that we have any material exposure to interest rate risk arising from our investments.
ITEM 4. Controls and Procedures
Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended. A companys internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A companys internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and disposition of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the companys assets that could have a material effect on the financial statements.
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An evaluation was performed under the supervision of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of the Companys disclosure controls and procedures (as defined in Securities Exchange Act of 1934 (the Exchange Act) Rules 13a-15(e) and 15d-15(e)) as of the end of the period covered by this report. Based on that evaluation, our management, including our Chief Executive Officer and Chief Financial Officer, concluded that our disclosure controls and procedures were effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms.
Notwithstanding the foregoing, there can be no assurance that our disclosure controls and procedures will detect or uncover all failures of persons associated with us to disclose material information otherwise required to be set forth in our periodic reports. There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. Accordingly, even effective disclosure controls and procedures can only provide reasonable, not absolute, assurance of achieving their control objectives.
There have been no significant changes in internal controls, or in factors that could significantly affect internal controls, subsequent to the date that management, including the Chief Executive Officer and the Chief Financial Officer, completed their evaluation.
.
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PART II Other Information
Item 1. Legal Proceedings
None
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
None
Item 3. Defaults Upon Senior Securities
None
Item 4. Submission of Matters to a Vote of Security Holders
None
Item 5. Other Information
None
Item 6. Exhibits and Reports on Form 8-K
(a) Exhibits
31.1
Certification of the Chief Executive Officer pursuant to Rule 13a-14(a)
31.2
Certification of the Chief Financial Officer pursuant to Rule 13a-14(a)
32.1
Certification by the Chief Executive Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2
Certification by the Chief Financial Officer pursuant to 18 U.S.C. 1350 as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(b) Reports on Form 8-K
January 10, 2005: HepaLife Technologies, Inc. issued a news release to announce that on January 3, 2005, the National Institutes of Health (NIH) released a comprehensive plan (Action Plan for Liver Disease Research) addressing the burden of liver disease in the United States and directing NIH funding and research resources towards the prevention, diagnosis, and management of liver and biliary diseases.
January 21, 2005: At a board of directors meeting held on January 18th, 2005, the Companys Board of Directors agreed to enter into 10 year NonStatutory Stock Option Agreements with certain employees for 4,425,000 out of the 26,962,500 common shares reserved for issuance under the Companys 2001 Stock Option Plan, which was approved by shareholders on July 12th, 2001, and registered under Form S-8 with the U.S. Securities and Exchange Commission on May 8th, 2003.
January 27, 2005: HepaLife Technologies, Inc. issued a news release to further comment on its ongoing and well established Cooperative Research and Development Agreement (CRADA), entered into with the USDA's Agricultural Research Service (ARS) pursuant to the Federal Technology Transfer Act (FTTA).
February 11, 2005: HepaLife Technologies, Inc. issued a news release to announce plans to expand its scientific research team in order to further bolster the Companys ongoing development of the first-of-its-kind artificial liver device, and its proprietary in vitro toxicology and pre-clinical drug testing platforms.
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February 25, 2005: HepaLife Technologies, Inc. issued a news release to announce the addition of research scientist and toxicologist, Mr. Ryan R. Willard.
March 2, 2005: At a Board of Directors meeting held on March 2, 2005, the Companys Directors agreed to enter into a Market Access Services Agreement with National InfoSystems Inc. Also, the Companys Board of Directors agreed to cancel 4,325,000 employee options (2,250,000 in the Ranjit Bhogal, 1,250,000 in the name of Bhupinder Mann and 925,000 in the name of Jeet Sidhu) that were established on January 18, 2005. Also, at a Board of Directors meeting held on March 2, 2005, the Directors agreed to reimburse Mr. Harmel S. Rayat $700,000.00 for investor relations expenses incurred and paid for personally on behalf of the Company during the fourth quarter of calendar 2004 through the issuance of an unsecured promissory note, which is due on September 2, 2006 and bears an interest rate of 8.50%.
March 8, 2005: At a Board of Directors meeting held on March 7th, 2005, the Companys Board of Directors agreed to enter into 10 year NonStatutory Stock Option Agreements with certain employees for 4,000,000 out of the 25,712,500 common shares reserved for issuance under the Companys 2001 Stock Option Plan, which was approved by shareholders on July 12th, 2001. On March 8, 2005, the Company drew down $250,000 from the loan commitment provided by Harmel S. Rayat and issued an unsecured promissory note, which is due on March 8, 2006 and bears an interest rate of 8.50%.
March 18, 2005: At a Board of Directors meeting held on March 17th, 2005, the Companys Board of Directors agreed to enter into 10 year NonStatutory Stock Option Agreements with certain employees for 2,000,000 out of the 21,712,500 common shares reserved for issuance under the Companys 2001 Stock Option Plan, which was approved by shareholders on July 12th, 2001.
March 31, 2005: HepaLife Technologies, Inc. issued a news release to reiterate its previously forecasted expectations of increased drug induced liver injuries, in response to the record number of adverse-events filed with the FDA, according to findings published by USA Today.
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SIGNATURES
Pursuant to the requirements of Sections 13 or 15 (d) 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 on this 30th day of January, 2006.
HepaLife Technologies, Inc.
/s/ Harmel S. Rayat
Harmel S. Rayat
President and Chief Executive Officer
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the registrant and in capacities and on the dates indicated.
Signature
Title
Date
/s/ Harmel S. Rayat
President, Chief Executive Officer
January 30, 2006
Harmel S. Rayat
Principal Financial Officer, Director
/s/ Arian Soheili
Director, Secretary/Treasurer
January 30, 2006
Arian Soheili
/s/ Jasvir Kheleh
Director
January 30, 2006
Jasvir Kheleh
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Exhibit 31.1
CERTIFICATION
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Harmel S. Rayat, certify that:
(1)
I have reviewed this quarterly report on Form 10-Q of HepaLife Technologies, Inc. (the registrant);
(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 registrants other certifying officer(s) 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
(5)
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants 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 registrants internal control over financial reporting.
Date: January 30, 2006
By:
/s/ Harmel S. Rayat
Harmel S. Rayat
President and Chief Executive Officer
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Exhibit 31.2
CERTIFICATION
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
I, Harmel Rayat certify that:
(1)
I have reviewed this quarterly report on Form 10-Q of HepaLife Technologies, Inc. (the registrant);
(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 registrants other certifying officer(s) 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)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) 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, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
(b)
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
(c)
Evaluated the effectiveness of the registrants 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 registrants internal control over financial reporting that occurred during the registrants most recent fiscal quarter (the registrants fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrants internal control over financial reporting; and
(5)
The registrants other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrants auditors and the audit committee of the registrants 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 registrants 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 registrants internal control over financial reporting.
Date: January 30, 2006
By: /s/ Harmel Rayat
Harmel Rayat
Principal Financial Officer
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Exhibit 32.1
Certification by the Chief Executive Officer pursuant to 18 U.S.C. 1350
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report of HepaLife Technologies, Inc. (the Company) on the
Form 10-Q for the period ending March 31, 2005 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Harmel S. Rayat, President and Chief Executive Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss.906 of the Sarbanes-Oxley Act of 2002, that:
(i)
the Report filed by the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(ii)
The information contained in that Report fairly presents, in all material respects, the financial condition and results of operations of the Company on the dates and for the periods presented therein.
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| HEPALIFE TECHNOLOGIES, INC. | ||
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Date: January 30, 2006 |
| By: |
| /s/ Harmel S. Rayat |
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| Harmel S. Rayat |
This certification accompanies this Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. 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 the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
Exhibit 32.2
Certification by the Chief Financial Officer pursuant to 18 U.S.C. 1350
as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
In connection with the Quarterly Report of HepaLife Technologies, Inc. (the Company) on the
Form 10-Q for the period ending March 31, 2005 as filed with the Securities and Exchange Commission on the date hereof (the Report), I, Harmel Rayat, Principal Financial Officer of the Company, certify, pursuant to 18 U.S.C. ss. 1350, as adopted pursuant to ss.906 of the Sarbanes-Oxley Act of 2002, that:
(i)
the Report filed by the Company fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(ii)
The information contained in that Report fairly presents, in all material respects, the financial condition and results of operations of the Company on the dates and for the periods presented therein.
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| HEPALIFE TECHNOLOGIES, INC. | ||
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Date: January 30, 2006 |
| By: |
| /s/ Harmel Rayat |
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|
|
| Harmel Rayat Principal Financial Officer |
This certification accompanies this Report pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended. 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 the Company and will be retained by the Company and furnished to the Securities and Exchange Commission or its staff upon request.
37