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FORM 10-Q

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

     (Mark One)

       
x   QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 

For the quarterly period ended June 30, 2002

OR

       
o   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
 

For the transition period from _________________ to _______________

Commission file number 1-12830

BioTime, Inc.

(Exact name of registrant as specified in its charter)
     
California
(State or other jurisdiction of incorporation
or organization)
  94-3127919
(IRS Employer
Identification No.)

935 Pardee Street
Berkeley, California 94710

(Address of principal executive offices)

(510) 845-9535
(Registrant’s telephone number, including area code)

     Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   X   No ___     

APPLICABLE ONLY TO CORPORATE ISSUERS:

     Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date. 13,490,101 common shares, no par value, as of August 14, 2002.

 


TABLE OF CONTENTS

PART 1— FINANCIAL INFORMATION
Item 1. Financial Statements
CONDENSED BALANCE SHEETS
CONDENSED STATEMENTS OF OPERATIONS
CONDENSED STATEMENTS OF CASH FLOWS
NOTES TO CONDENSED FINANCIAL STATEMENTS
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
PART II — OTHER INFORMATION
Item 2. Changes in Securities and Use of Proceeds.
Item 6. Exhibits and Reports of Form 8-K
Item 6. Exhibits and Reports of Form 8-K
SIGNATURES
PART II — EXHIBIT INDEX
Exhibit 10.20
Exhibit 99.1


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PART 1— FINANCIAL INFORMATION

     Statements made in this Report that are not historical facts may constitute forward-looking statements that are subject to risks and uncertainties that could cause actual results to differ materially from those discussed. Such risks and uncertainties include but are not limited to those discussed in this report under Item 1 of the Notes to Financial Statements, and in BioTime’s Annual Report on Form 10-K filed with the Securities and Exchange Commission. Words such as “expects,” “may,” “will,” “anticipates,” “intends,” “plans,” “believes,” “seeks,” “estimates,” and similar expressions identify forward-looking statements.

Item 1. Financial Statements

BIOTIME, INC,
(A Development Stage Company)

CONDENSED BALANCE SHEETS
(Unaudited)

                     
        June 30,   December 31,
        2002   2001
       
 
 
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $ 501,291     $ 1,652,748  
Prepaid expenses and other current assets
    83,198       109,431  
 
   
     
 
Total current assets
    584,489       1,762,179  
 
EQUIPMENT, Net of accumulated depreciation of $442,852 and $409,331
    134,426       167,946  
DEPOSITS AND OTHER ASSETS
    11,250       11,250  
 
   
     
 
TOTAL ASSETS
  $ 730,165     $ 1,941,375  
 
   
     
 
   
LIABILITIES AND SHAREHOLDERS’ DEFICIT
               
CURRENT LIABILITIES
               
Accounts payable and accrued liabilities
  $ 355,641     $ 309,347  
DEBENTURES, net of discount of $1,422,022 and $1,618,878, respectively
    1,927,978       1,731,122  
 
   
     
 
SHAREHOLDERS’ DEFICIT:
               
Preferred Shares, no par value, undesignated as to Series, authorized 1,000,000 shares; none outstanding
               
Common Shares, no par value, authorized 40,000,000 shares; issued and outstanding 11,637,316 and 11,627,316
    30,637,232       30,602,003  
Contributed Capital
    93,972       93,972  
Deficit accumulated during development stage
    (32,284,658 )     (30,795,069 )
 
   
     
 
Total shareholders’ deficit
    (1,553,454 )     (99,094 )
 
   
     
 
TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIT
  $ 730,165     $ 1,941,375  
 
   
     
 

See notes to condensed financial statements.

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BIOTIME, INC.
(A Development Stage Company)

CONDENSED STATEMENTS OF OPERATIONS
(Unaudited)

                                         
                                    Period from Inception
    Three Months Ended   Six Months Ended   (November 30, 1990) to
    June 30, 2002   June 30, 2001   June 30, 2002   June 30, 2001   June 30, 2002
   
 
 
 
 
REVENUE:                                        
License Fee   $     $     $     $     $ 2,500,000  
Royalty     60,812       29,958       118,047       62,653       322,456  
     
     
     
     
     
 
Total revenue   $ 60,812     $ 29,958     $ 118,047     $ 62,653     $ 2,822,456  
     
     
     
     
     
 
EXPENSES:                                        
Research and development     (343,473 )     (541,894 )     (604,044 )     (1,095,786 )     (22,234,562 )
General and administrative     (290,627 )     (613,490 )     (622,034 )     (1,050,487 )     (14,049,761 )
     
     
     
     
     
 
Total expenses     (634,100 )     (1,155,384 )     (1,226,078 )     (2,146,273 )     (36,284,323 )
     
     
     
     
     
 
INTEREST EXPENSE     (215,349 )             (387,014 )             (665,590 )
OTHER INCOME     5,456       5,402       5,456       11,857       1,867,630  
     
     
     
     
     
 
NET LOSS   $ (783,181 )   $ (1,120,024 )   $ (1,489,589 )   $ (2,071,763 )   $ (32,259,827 )
     
     
     
     
     
 
BASIC AND DILUTED LOSS PER SHARE   $ (0.07 )   $ (0.10 )   $ (0.13 )   $ (0.18 )        
     
     
     
     
         
COMMON EQUIVALENT SHARES USED IN COMPUTING PER SHARE AMOUNTS:                                        
BASIC AND DILUTED     11,637,316       11,566,691       11,630,845       11,455,350          
     
     
     
     
         

See notes to condensed financial statements.

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BIOTIME, INC.
(A Development Stage Company)

CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

                           
      Six Months Ended   Period from
      June 30,   Inception
     
  (November 30, 1990)
      2002   2001   to June 30, 2002
     
 
 
OPERATING ACTIVITIES:
                       
Net loss
  $ (1,489,589 )   $ (2,071,763 )   $ (32,259,827 )
Adjustments to reconcile net loss to net cash used in operating activities:
                       
 
Deferred Revenue
                (1,000,000 )
 
Depreciation
    33,520       36,029       449,392  
 
Debt Discount
    196,856               428,694  
 
Cost of Donation — warrants
                552,000  
 
Cost of Services — options, warrants, and common shares
    (25,160 )     197,178       1,208,324  
 
Supply Reserves
                200,000  
Changes in operating assets and liabilities:
                       
 
Research and development supplies on hand
                (200,000 )
 
Prepaid expenses and other current assets
    86,622       48,122       (22,809 )
 
Deposits and other assets
                (11,250 )
 
Accounts payable
    46,294       (29,187 )     355,641  
 
Deferred revenue
                1,000,000  
 
   
     
     
 
Net cash used in operating activities
    (1,151,457 )     (1,819,621 )     (29,299,835 )
 
   
     
     
 
INVESTING ACTIVITIES:
                       
Sale of investments
                197,400  
Purchase of short-term investments
                (9,946,203 )
Redemption of short-term investments
                9,946,203  
Purchase of equipment and furniture
          (5,116 )     (567,392 )
 
   
     
     
 
Net cash used in investing activities
          (5,116 )     (369,992 )
 
   
     
     
 
FINANCING ACTIVITIES:
                       
Proceeds from issuance of warrants and debentures
                2,350,000  
Borrowings under line of credit
          500,000       1,000,000  
Issuance of preferred shares for cash
                600,000  
Preferred shares placement costs
                (125,700 )
Issuance of common shares for cash
                23,701,732  
Common shares placement costs
                (2,216,497 )
Net proceeds from exercise of common share options and warrants
          199,372       5,011,589  
Contributed capital — cash
                77,547  
Dividends paid on preferred shares
                (24,831 )
Repurchase Common Shares
                (202,722 )
 
   
     
     
 
Net cash provided by financing activities
          699,372       30,171,118  
 
   
     
     
 
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
    (1,151,457 )     (1,125,365 )     501,291  
CASH AND CASH EQUIVALENTS:
                       
At beginning of period
    1,652,748       1,318,338        
 
   
     
     
 
At end of period
  $ 501,291     $ 192,973     $ 501,291  
 
   
     
     
 

(Continued)

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BIOTIME, INC.
(A Development Stage Company)

CONDENSED STATEMENTS OF CASH FLOWS
(Unaudited)

                           
      Six Months Ended   Period from
      June 30,   Inception
     
  (November 30, 1990)
      2002   2001   to June 30, 2002
     
 
 
NONCASH FINANCING AND INVESTING ACTIVITIES:
                       
Receipt of contributed equipment
              $ 16,425  
Issuance of common shares in exchange for shares of common stock of Cryomedical Sciences, Inc. in a stock-for-stock transaction
              $ 197,400  
Issuance of warrants in connection with entering into line of credit
  $ 60,340           $ 60,340  

See notes to condensed financial statements. (Concluded)

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BIOTIME, INC.
(A Development Stage Company)

NOTES TO CONDENSED FINANCIAL STATEMENTS
(unaudited)

1.    ORGANIZATION
 
     General — BioTime, Inc. (the Company) was organized November 30, 1990 as a California corporation. The Company is a biomedical organization, currently in the development stage, which is engaged in the research and development of synthetic plasma expanders, blood volume substitute solutions, and organ preservation solutions, for use in surgery, trauma care, organ transplant procedures, and other areas of medicine.
 
     The condensed balance sheet as of June 30, 2002, the condensed statements of operations for the three months and six months ended June 30, 2002 and 2001 and the period from inception (November 30, 1990) to June 30, 2002, and the statements of cash flows for the six months ended June 30, 2002 and 2001 and the period from inception (November 30, 1990) to June 30, 2002 have been prepared by the Company without audit. In the opinion of management, all adjustments (consisting only of normal recurring adjustments) necessary to present fairly the financial position, results of operations, shareholders’ deficit and cash flows at June 30, 2002 and for all periods presented have been made. The balance sheet as of December 31, 2001 is derived from the Company’s audited financial statements as of that date. The results of operations for the period ended June 30, 2002 are not necessarily indicative of the operating results anticipated for the full year.
 
     Certain information and footnote disclosures normally included in financial statements prepared in accordance with generally accepted accounting principles have been condensed or omitted as permitted by regulations of the Securities and Exchange Commission. Certain previously furnished amounts have been reclassified to conform with presentations made during the current periods. It is suggested that these interim condensed financial statements be read in conjunction with the annual audited financial statements and notes thereto included in the Company’s Form 10-K for the year ended December 31, 2001.
 
     Development Stage Enterprise — Since inception, the Company has been engaged in research and development activities in connection with the development of synthetic plasma expanders, blood volume substitute solutions and organ preservation products. The Company has limited operating revenues and has incurred operating losses of $32,259,827 from inception to June 30, 2002. The successful completion of the Company’s product development program and, ultimately, achieving profitable operations is dependent upon future events including maintaining adequate capital to finance its future development activities, obtaining regulatory approvals for the products it develops and achieving a level of revenues adequate to support the Company’s cost structure.
 
     Certain Significant Risks and Uncertainties — The Company’s operations are subject to a number of factors that can affect its operating results and financial condition. Such factors

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     include but are not limited to the following: the results of clinical trials of the Company’s products; the Company’s ability to obtain United States Food and Drug Administration and foreign regulatory approval to market its products; competition from products manufactured and sold or being developed by other companies; the price of and demand for Company products; the Company’s ability to obtain additional financing and the terms of any such financing that may be obtained; the Company’s ability to negotiate favorable licensing or other manufacturing and marketing agreements for its products; the availability of ingredients used in the Company’s products; and the availability of reimbursement for the cost of the Company’s products (and related treatment) from government health administration authorities, private health coverage insurers and other organizations.
 
2.    SIGNIFICANT ACCOUNTING POLICIES
 
     Financial Statement Estimates — The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Such management estimates include certain accruals. Actual results could differ from those estimates.
 
     Revenue recognition — In April 1997, BioTime and Abbott Laboratories (“Abbott”) entered into an Exclusive License Agreement (the “License Agreement”) under which BioTime granted to Abbott an exclusive license to manufacture and sell BioTime’s proprietary blood plasma volume expander solution Hextend in the United States and Canada for certain therapeutic uses.
 
     Under the License Agreement, Abbott has paid the Company $2,500,000 of license fees based upon achievement of specified milestones. Such fees were recognized as revenue as the milestones were achieved. Up to $37,500,000 of additional license fees will be payable based upon annual net sales of Hextend at the rate of 10% of annual net sales if annual net sales exceed $30,000,000 or 5% if annual net sales are between $15,000,000 and $30,000,000. Abbott’s obligation to pay license fees on sales of Hextend will expire on the earlier of January 1, 2007 or, on a country by country basis, when all patents protecting Hextend in the applicable country expire or any third party obtains certain regulatory approvals to market a generic equivalent product in that country.
 
     In addition to the license fees, Abbott will pay the Company a royalty on annual net sales of Hextend. The royalty rate will be 5% plus an additional .22% for each increment of $1,000,000 of annual net sales, up to a maximum royalty rate of 36%. Abbott’s obligation to pay royalties on sales of Hextend will expire in the United States or Canada when all patents protecting Hextend in the applicable country expire and any third party obtains certain regulatory approvals to market a generic equivalent product in that country.
 
     The Company recognizes such revenues in the quarter in which the sales report is received, rather than the quarter in which the sales took place, as the Company does not have sufficient

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     sales history to accurately predict quarterly sales. Revenues for the three months ended June 30, 2002 include royalties on sales made by Abbott during the three months ended March 31, 2002. Royalties on sales made during the second quarter of 2002 will not be recognized by the Company until the third quarter of fiscal year 2002.
 
     Abbott has agreed that the Company may convert Abbott’s exclusive license to a non-exclusive license or may terminate the license outright if certain minimum sales and royalty payments are not met. In order to terminate the license outright, BioTime would pay a termination fee in an amount ranging from the milestone payments made by Abbott to an amount equal to three times prior year net sales, depending upon when termination occurs. Management believes that the probability of payments of any termination fee by the Company is remote.
 
     Comprehensive Loss — Statement of Financial Accounting Standards No. 130, “Reporting Comprehensive Income,” establishes standards for reporting and displaying comprehensive income and its components (revenues, expenses, gains, and losses) in a full set of general-purpose financial statements. Comprehensive loss was the same as net loss for all periods presented.
 
     Recently issued accounting standards —
 
     Business combinations and goodwill — In June 2001, the Financial Accounting Standards Board (the “FASB”) issued Statement of Financial Accounting Standards No. 141 (SFAS 141”), “Business Combinations” and Statement of Financial Accounting Standards No. 142 (“SFAS 142”), “Goodwill and Other Intangible Assets.” SFAS 141 requires that all business combinations initiated after June 30, 2001 be accounted for under the purchase method and addresses the initial recognition and measurement of goodwill and other intangible assets acquired in a business combination. SFAS 141 addresses the initial recognition and measurement of intangible assets acquired outside of a business combination and the accounting for goodwill and other intangible assets subsequent to their acquisition. SFAS 142 provides that intangible assets with finite useful lives be amortized and that goodwill and intangible assets with indefinite lives will not be amortized, but will rather be tested at least annually for impairment. The Company adopted SFAS 141 on July 1, 2001 and SFAS 142 on January 1, 2002. The adoption of these statements did not have a material impact on the condensed financial statements.
 
     Impairment and disposal of long lived assets — In October 2001, the FASB issued Statement of Financial Accounting Standards No. 144 (“SFAS 144”), “Accounting for the Impairment or Disposal of Long-Lived Assets.” SFAS 144 supersedes SFAS 121, “Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to be Disposed Of,” and the accounting and reporting provisions of Accounting Principles Board Opinion No. 30, “Reporting the Results of Operations — Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions,” and addresses financial accounting and reporting for the impairment of

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     disposal of long-lived assets. The Company adopted SFAS 144 on January 1, 2002. The adoption of this statement did not have a material impact on the condensed financial statements.
 
     Accounting for costs associated with exit or disposal activities — In June 2002, the FASB issued Statement of Financial Accounting Standards No. 146 (“SFAS 146”), “Accounting for Costs Associated with Exit or Disposal Activities,” which addresses accounting for restructuring and similar costs. SFAS 146 supersedes previous accounting guidance, principally Emerging Issues Task Force Issue No. 94-3. The Company will adopt the provisions of SFAS 146 for restructuring activities initiated after December 31, 2002. SFAS 146 requires that the liability for costs associated with an exit or disposal activity be recognized when the liability is incurred. Under Issue 94-3, a liability for an exit cost was recognized the date of the Company’s commitment to an exit plan. SFAS 146 also establishes that the liability should initially be measured and recorded at fair value. Accordingly, SFAS 146 may affect the timing of recognizing future restructuring costs as well as the amounts recognized. The Company does not expect that the adoption of this statement will have a material impact on the condensed financial statements.
 
3.    LINES OF CREDIT AND DEBENTURES
 
     During March, 2001, BioTime entered into a one year Revolving Line of Credit Agreement (the “Credit Agreement”) with Alfred D. Kingsley, an investor and consultant to the Company, under which BioTime could borrow up to $1,000,000 for working capital purposes at an interest rate of 10% per annum. In consideration for making the line of credit available, the Company issued to Mr. Kingsley a fully vested warrant to purchase 50,000 common shares at an exercise price of $8.31. The fair value of this warrant of $254,595 was determined using the Black-Scholes pricing model with the following assumptions: contractual life of 5 years; risk-free interest rate of 5.50%; volatility of 87.55%; and no dividends during the expected term. The fair value amount of the warrant was recorded as deferred financing costs and was being amortized to interest expense over the term of the Credit Agreement.
 
     In August 2001, the Company issued $3,350,000 of debentures to an investor group. As part of the $3,350,000 debenture issuance, Mr. Kingsley agreed to convert the $1,000,000 outstanding balance under the Credit Agreement to $1,000,000 of debentures and purchased an additional $500,000 of debentures for cash. On the date of the conversion of the Credit Agreement to the debentures, the Credit Agreement was terminated, and no additional borrowings are available under that Credit Agreement. Interest on the debentures is payable at an annual rate of 10% and is payable semi-annually. The principal amount of the debentures is due on August 1, 2004. BioTime may prepay the debentures, in whole or in part, at any time without premium or penalty. Under the terms of the debentures, BioTime has agreed to restrict its quarterly cash payments for operating expenses to not more than $450,000 (excluding interest payable on the debentures) plus the amount of cash revenue

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     (excluding interest and dividends) it collects for the quarter. To the extent BioTime’s expenditures during any quarter are less than $450,000 over its revenues, it may expend the difference in one or more subsequent quarters. This spending restriction will expire when the Company obtains at least $5,000,000 in cash through sales of equity securities or pays off the debenture indebtedness in full. The Company has also agreed not to pay any cash dividends on or to redeem or repurchase any of its common shares outstanding until it has paid off the debentures in full. In a recent private placement, the Company received $2.24 million for the sale of equity. Thus, the spending restriction will expire when an additional $2.76 million is obtained through Sales of additional equity securities or when the debenture is paid in full.
 
     Investors who purchased the debentures also received warrants to purchase a total of 515,385 common shares at an exercise price of $6.50. The warrants expire on August 1, 2004. The total fair value of the warrants of $1,596,124 was determined using the Black-Scholes option pricing model with the following assumptions: contractual life of 3 years; risk-free interest rate of 4.04%; volatility of 88%; and no dividends during the expected term. Of the $3,350,000 of proceeds, $1,596,124 has been allocated to the warrants, which includes the unamortized portion ($159,122) of the fair value of the warrant issued in connection with the Credit Agreement. The portion of the proceeds allocated to the debentures is being accreted to interest expense over the term of the debentures using the effective interest rate method. The Company has the right to call the warrants for redemption at a redemption price of $0.01 per share if the closing price of the Company’s common shares equals or exceeds 150% of the exercise price for fifteen consecutive trading days.
 
     On March 27, 2002, BioTime entered into a new Revolving Line of Credit Agreement (the “2002 Credit Agreement”) with Alfred D. Kingsley under which BioTime may borrow up to $300,000 for working capital purposes. Interest on borrowings shall accrue at a rate of 10% per annum and is payable with principal on the maturity date. Amounts borrowed under the 2002 Credit Agreement will be due on March 31, 2003 or when BioTime receives at least $600,000 through the sale of capital stock, loans from other lenders, fees under licensing agreements (excluding royalty payments), or any combination of those sources. Mandatory prepayments of principal will be due to the extent that the Company receives funds from any one or more of those sources in excess of $300,000 but less than $600,000. At June 30, 2002, no amounts were outstanding under the 2002 Credit Agreement.
 
     In connection with entering into the 2002 Credit Agreement on March 27, 2002, the Company issued to Mr. Kingsley a warrant to purchase 30,000 of the Company’s common shares at $4.00 per share. The warrant is fully exercisable and non-forfeitable on the date of grant and expires on March 26, 2007. The fair value of the warrant was $60,390 and was determined using the Black-Scholes option pricing model with the following assumptions: contractual life of 5 years; risk-free interest rate of 4.4%; volatility of 84.6%; and no dividends during the expected term. The fair value of the warrant was included in other current assets at June 30, 2002, and is being amortized over the term of the 2002 Credit Agreement.

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4.    SHAREHOLDERS’ DEFICIT
 
     The Board of Directors of the Company adopted the 1992 Stock Option Plan (the “Plan”) during September 1992. The Plan was approved by the shareholders at the 1992 Annual Meeting of Shareholders on December 1, 1992. Under the Plan, as amended, the Company has reserved 1,800,000 common shares for issuance under options granted to eligible persons. No options may be granted under the Plan more than ten years after the date the Plan was adopted by the Board of Directors, and no options granted under the Plan may be exercised after the expiration of ten years from the date of grant.
 
     Under the Plan, options to purchase common shares may be granted to employees, directors and certain consultants at prices not less than the fair market value at date of grant for incentive stock options and not less than 85% of fair market value for other stock options. These options expire five to ten years from the date of grant and may be fully exercisable immediately, or may be exercisable according to a schedule or conditions specified by the Board of Directors or the Option Committee. As of June 30, 2002, 379,000 shares were available for future grants under the Option Plan; and options to purchase 368,201 shares had been granted and were outstanding at exercise prices ranging from $1.13 to $18.25. Of the options granted to consultants, options to purchase 60,000 common shares vest upon achievement of certain milestones. At June 30, 2002, 5,000 options had vested, and 55,000 options had not vested. The Company recorded a benefit of $23,474 as a result of remeasurement of such options. The benefit recognized on these options during the three months ended June 30, 2002 was recorded as an offset to research and development expense.
 
5.    NET LOSS PER SHARE
 
     Basic loss per share excludes dilution and is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed based on the weighted average number of common shares outstanding plus the dilutive effect of outstanding stock options and warrants. Diluted net loss per common share was the same as basic net loss per common share for all periods presented. As of June 30, 2002 and 2001, the Company had securities outstanding that could potentially dilute basic earnings per share in the future. Such outstanding securities consisted of the following:

                 
    June 30,
   
    2002   2001
   
 
Outstanding investor and consultant warrants
    545,384       50,000  
Outstanding employee options