STRATA Skin Sciences, Inc. - Quarter Report: 2007 June (Form 10-Q)
Table of Contents
UNITED STATES SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
þ | QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30, 2007
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 000 51481
ELECTRO-OPTICAL SCIENCES, INC.
(Exact name of Registrant as specified in its charter)
Delaware | 13-3986004 | |
(State or Other Jurisdiction of Incorporation or Organization) |
(I.R.S. Employer Identification No.) |
|
3 West Main Street, Suite 201 | ||
Irvington, New York | 10533 | |
(Address of Principal Executive offices) | (Zip Code) |
Registrants Telephone Number, including area code:
(914) 591-3783
(914) 591-3783
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 þ No o
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer,
or a non-accelerated filer. See definition of accelerated filer and large accelerated filer in
Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer o Accelerated filer o Non-accelerated filer þ
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the
Exchange Act).
Yes o No þ
As of August 6, 2007, 15,401,882 shares of the Registrants common stock were outstanding.
Electro-Optical Sciences, Inc.
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PART I. FINANCIAL INFORMATION |
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ITEM 1. Financial Statements |
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EX-31.1: CERTIFICATION | ||||||||
EX-31.2: CERTIFICATION | ||||||||
EX-32.1: CERTIFICATION |
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ELECTRO-OPTICAL SCIENCES, INC.
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS
June 30, | December 31, | |||||||
2007 | 2006 | |||||||
(unaudited) | * | |||||||
ASSETS |
||||||||
Current Assets: |
||||||||
Cash and cash equivalents (includes $12,000,000 in certificates of
deposit as of June 30, 2007 and December 31, 2006) |
$ | 15,075,764 | $ | 20,939,527 | ||||
Receivable from sale and licensing of discontinued operations |
500,000 | 487,680 | ||||||
Prepaid expenses and other current assets |
221,568 | 343,634 | ||||||
Total Current Assets |
15,797,332 | 21,770,841 | ||||||
Property and equipment, net |
662,396 | 564,471 | ||||||
Patents and trademarks, net |
128,947 | 100,630 | ||||||
Other assets |
39,758 | 39,758 | ||||||
Total Assets |
$ | 16,628,433 | $ | 22,475,700 | ||||
LIABILITIES AND STOCKHOLDERS EQUITY |
||||||||
Current Liabilities: |
||||||||
Accounts payable (includes related parties of $53,987 as of
December 31, 2006) |
$ | 408,490 | $ | 641,036 | ||||
Accrued expenses (includes related parties of $34,527 as of
December 31, 2006) |
490,830 | 504,670 | ||||||
Other current liabilities |
11,427 | 16,077 | ||||||
Total Current Liabilities |
910,747 | 1,161,783 | ||||||
COMMITMENTS
AND CONTINGENCIES (Note 7) |
||||||||
Stockholders Equity |
||||||||
Common stock $.001 par value; authorized 30,000,000 shares;
issued and outstanding 13,401,704 shares at June 30, 2007 and
13,296,448 shares at December 31, 2006 |
13,402 | 13,296 | ||||||
Additional paid-in capital |
53,019,283 | 52,525,408 | ||||||
Accumulated deficit |
(37,314,999 | ) | (31,224,787 | ) | ||||
Stockholders Equity |
15,717,686 | 21,313,917 | ||||||
Total Liabilities and Stockholders Equity |
$ | 16,628,433 | $ | 22,475,700 | ||||
* | Derived from the audited balance sheet as of December 31, 2006 |
See accompanying notes to the financial statements
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ELECTRO-OPTICAL SCIENCES, INC.
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
CONDENSED STATEMENTS OF OPERATIONS
(unaudited)
Three months ended June 30, | Six months ended June 30, | |||||||||||||||
2007 | 2006 | 2007 | 2006 | |||||||||||||
Operating expenses: |
||||||||||||||||
Research and development |
$ | 1,885,691 | $ | 2,020,643 | $ | 3,839,059 | $ | 4,005,876 | ||||||||
General and administrative |
1,439,172 | 1,080,596 | 2,750,362 | 2,164,283 | ||||||||||||
Operating loss |
(3,324,863 | ) | (3,101,239 | ) | (6,589,421 | ) | (6,170,159 | ) | ||||||||
Interest income |
228,184 | 173,489 | 499,209 | 353,541 | ||||||||||||
Net loss per common
share, basic and diluted: |
$ | (3,096,679 | ) | $ | (2,927,750 | ) | $ | (6,090,212 | ) | $ | (5,816,618 | ) | ||||
Basic and diluted
net loss per common share |
$ | (0.23 | ) | $ | (0.27 | ) | $ | (0.46 | ) | $ | (0.54 | ) | ||||
Basic and diluted
weighted average number
of common shares
outstanding |
13,398,814 | 10,869,393 | 13,384,141 | 10,860,682 | ||||||||||||
See accompanying notes to the financial statements
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ELECTRO-OPTICAL SCIENCES, INC.
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
CONDENSED STATEMENTS OF CASH FLOWS
(unaudited)
Six Months Ended June 30, | ||||||||
2007 | 2006 | |||||||
Cash flows from operating activities: |
||||||||
Net Loss |
$ | (6,090,212 | ) | $ | (5,816,618 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
||||||||
Depreciation and amortization |
104,241 | 48,872 | ||||||
Noncash compensation and amortization of deferred compensation |
239,751 | 573,911 | ||||||
Common stock options issued for consulting fees |
139,703 | |||||||
Amortization of unearned interest income discontinued operations |
(12,320 | ) | ||||||
Changes in operating assets and liabilities: |
||||||||
Decrease in prepaid expenses and other current assets |
122,066 | 1,208 | ||||||
Increase in other assets |
(6,146 | ) | ||||||
(Decrease) increase in accounts payable and accrued expenses |
(246,386 | ) | 7,527 | |||||
Decrease in other current liabilities |
(4,650 | ) | (5,082 | ) | ||||
Net cash used in operating activities |
(5,747,807 | ) | (5,196,328 | ) | ||||
Cash flows from investing activities: |
||||||||
Patent costs |
(39,321 | ) | (10,377 | ) | ||||
Purchases of property and equipment |
(191,162 | ) | (315,930 | ) | ||||
Purchase of marketable securities |
(6,483,335 | ) | ||||||
Net cash used in investing activities |
(230,483 | ) | (6,809,642 | ) | ||||
Cash flows from financing activities: |
||||||||
Proceeds from exercise of stock options |
114,527 | 37,650 | ||||||
Net cash provided by financing activities |
114,527 | 37,650 | ||||||
Net decrease in cash and cash equivalents |
(5,863,763 | ) | (11,968,320 | ) | ||||
Cash and cash equivalents at beginning of period |
20,939,527 | 18,505,030 | ||||||
Cash and cash equivalents at end of period |
$ | 15,075,764 | $ | 6,536,710 | ||||
See accompanying notes to the financial statements
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ELECTRO-OPTICAL SCIENCES, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(In thousands, except for share and per share data)
(unaudited)
NOTES TO CONDENSED FINANCIAL STATEMENTS
(In thousands, except for share and per share data)
(unaudited)
1. ORGANIZATION AND BASIS OF PRESENTATION
Electro-Optical Sciences, Inc., a Delaware corporation (EOS or the Company), is focused on the
design and development of a non-invasive, point-of-care instrument for assisting in the early
diagnosis of melanoma. The Company has entered into a Protocol Agreement with the Food and Drug
Administration (FDA) which is an agreement for the conduct of the pivotal clinical trial and
establishment of the safety and effectiveness of the MelaFind® device. On
October 12, 2006, the Company announced that the FDA informed the Company that when submitted, the
MelaFind® premarket approval, or PMA, application would receive expedited
review. Expedited review means that upon filing a PMA with the FDA, it is placed at the beginning
of the FDAs queue and receives additional review resources. While the expedited review could
shorten the MelaFind® FDA approval process, there can be no assurance that this
will be the case. Upon obtaining premarket approval from the FDA, the Company plans to launch
MelaFind® in the United States. The pivotal clinical trial commenced at the end
of January 2007. If the pivotal trial and FDA approval process proceeds as anticipated, management
believes that PMA approval could come as early as the second half of 2008.
To date the Company has not generated any revenues from MelaFind®. All of the
Companys historical revenues have come from activities and products that have since been
discontinued, including our DIFOTI® product, a non-invasive imaging device for
the detection of dental cavities. The Company discontinued all operations associated with its
DIFOTI® product effective as of April 5, 2005 in order to focus its resources
on the development and commercialization of MelaFind®. As more fully described
in Note 11, in December 2006, the Company sold and licensed its rights to the
DIFOTI® assets and does not expect to have any significant continuing
responsibility for the DIFOTI® business or products.
The Company anticipates that it will continue to incur net losses for the foreseeable future in the
development and commercialization of the Melafind® device. From inception, the
Company has financed operations primarily through the sale of convertible preferred stock and
subsequently sold common stock as part of an initial public offering on October 28, 2005 and a
private placement that closed in November 2006 (refer to Note 8 for further details). Management
believes that the proceeds from these transactions will permit the Company to fund anticipated
levels of operations through mid-2008. However, the Company will require additional funds to
commercialize MelaFind®. The Company faces certain risks and uncertainties
which are present in many emerging medical device companies regarding future profitability, ability
to obtain future capital, protection of patents and intellectual property rights, competition,
rapid technological change, government regulations, changing health care marketplace, recruiting
and retaining key personnel, and reliance on third party manufacturing organizations.
On
July 31, 2007, and as more fully described in Note 12, the
Company entered into a securities
purchase agreement and a registration rights agreement for the private placement of 2,000,178
shares of the Companys common stock and warrants to purchase up to 500,041 shares of the Companys
common stock. Gross proceeds were approximately $11.5 million, and net proceeds totaled
approximately $10.8 million.
The unaudited financial statements included herein have been prepared from the books and records of
the Company pursuant to the rules and regulations of the Securities and Exchange Commission (the
SEC) for reporting on Form 10-Q. The information and note disclosures normally included in
complete financial statements prepared in accordance with generally accepted accounting principles
in the United States (GAAP) have been condensed or omitted pursuant to such rules and
regulations. The interim financial statements should be read in conjunction with the audited
financial statements and notes thereto included in the Companys Annual Report on Form 10-K for the
year ended December 31, 2006.
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The Companys management is responsible for the financial statements included in this document. The
Companys interim financial statements are unaudited. Interim results may not be indicative of the
results that may be expected for the year. However, the Company believes all adjustments
considered necessary for a fair presentation of these interim financial statements have been
included and are of a normal and recurring nature.
2. USE OF ESTIMATES
The preparation of financial statements in conformity with GAAP requires the use of estimates and
assumptions by management that affect reported amounts of assets and liabilities and disclosures of
contingent assets and liabilities at the date of the financial statements and the reported amounts
of revenues and expenses during the reporting period. The most significant estimates relate to
stock based compensation arrangements and accrued expenses. Actual results could differ from these
estimates.
3. RECENTLY ADOPTED ACCOUNTING PRONOUNCEMENTS
In July 2006, the Financial Accounting Standards Board issued Interpretation No. 48, Accounting
for Uncertainty in Income Taxes-an Interpretation of FASB Statement No. 109, (FIN 48) which
clarifies the accounting for uncertainty in tax positions. This Interpretation requires that we
recognize, in our condensed financial statements, the impact of a tax position if that position is
more likely than not of being sustained on audit, based on the technical merits of the position.
The provisions of FIN 48 were effective as of January 1, 2007. We have evaluated our tax positions
and determined that the adoption of this pronouncement did not have a material impact on our
financial position or results of operations. Our tax return net operating loss carryforwards are
significant. The tax years in which losses arose may be subject to audit by the Internal Revenue
Service when such carryforwards are utilized to offset taxable income in future periods.
4. RECENT ACCOUNTING DEVELOPMENTS
In February 2007, the Financial Accounting Standards Board (FASB) issued SFAS No. 159, The Fair
Value Option for Financial Assets and Financial Liabilities, including an amendment to SFAS No.
115 (SFAS No. 159). This statement permits entities to choose to measure many financial
instruments and certain other items at fair value. The objective is to improve financial reporting
by providing entities with the opportunity to mitigate volatility in reporting earnings caused by
measuring related assets and liabilities differently without having to apply complex hedge
accounting provisions. This statement is expected to expand the use of fair value measurements,
which is consistent with the FASBs long-term measurement objectives for accounting for financial
instruments. SFAS No. 159 is effective for fiscal years beginning after November 15, 2007. The
Company does not expect that the adoption of SFAS No. 159 will have a material impact on the
Companys financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements (SFAS 157). This
statement defines fair value, establishes a framework for measuring fair value, and expands
disclosures about fair value measurements. This statement is effective for financial statements
issued for fiscal years beginning after November 15, 2007; however, earlier application is
encouraged. The Company does not expect the adoption of SFAS 157 to have a material impact on its
financial statements
5. NET LOSS PER COMMON SHARE
Net loss per share is presented in accordance with the provisions of SFAS No. 128, Earnings Per
Share (EPS). Basic EPS excludes dilution for potentially dilutive securities and is computed by
dividing net loss attributable to common stockholders by the weighted average number of common
shares outstanding during the period. Diluted EPS gives effect to dilutive options, warrants and
other potential common shares outstanding during the period. Diluted net loss per common share is
equal to the basic net loss per common share since all potentially dilutive securities are
anti-dilutive for each of the periods presented. Potential common stock equivalents excluded
consist of stock options and warrants which are summarized as follows:
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June 30, | ||||||||
2007 | 2006 | |||||||
Common stock options |
1,674,326 | 1,651,705 | ||||||
Warrants |
626,845 | 298,280 | ||||||
Total |
2,301,171 | 1,949,985 | ||||||
6. STOCK-BASED COMPENSATION
The Company has one stock-based compensation plan which allows the Board of Directors to grant
incentives to employees, consultants directors, officers and collaborating scientists in the form
of incentive stock options, nonqualified stock options and restricted stock awards. The Company
also has two other stock-based compensation plans pursuant to which stock options are outstanding.
Effective January 1, 2006, the Company began recording compensation expense associated with stock
options and other forms of equity compensation in accordance with SFAS No. 123 (revised 2004),
Share-Based Payment (SFAS 123R), as interpreted by SEC Staff Accounting Bulletin No. 107. Prior
to January 1, 2006, the Company accounted for stock options according to the provisions of
Accounting Principles Board Opinion No. 25, Accounting for Stock Issued to Employees (APB 25),
and related interpretations, and therefore no related compensation expense was recorded for awards
granted with no intrinsic value. The Company has adopted the modified prospective transition method
provided for under SFAS 123R. Under this transition method, compensation cost associated with stock
options recognized in the three and six month periods ended June 30, 2006 and 2007 includes: (1)
amortization related to the remaining unvested portion of all stock option awards granted prior to
January 1, 2006 over the requisite service period based on the grant-date fair value estimated in
accordance with the original provisions of SFAS 123, Accounting for Stock-Based Compensation, and
(2) amortization related to all stock option awards granted on or subsequent to January 1, 2006,
based on the grant-date fair value estimated in accordance with the provisions of SFAS 123R. For
performance-based grants, a compensation charge is recorded when it is probable that performance or
service conditions will be satisfied. The probability of vesting is updated at each reporting
period, and compensation is adjusted via a cumulative catch-up adjustment or prospectively
depending upon the nature of the change.
The compensation expense recognized in the Statement of Operations in the second quarters of 2007
and 2006 for stock options and restricted stock awards amounted to $113 and $263, respectively.
For the six months ended June 30, 2007 and 2006 compensation expense totaled $379 and $574
respectively. Cash received from options exercised under all share-based payment arrangements for
the three months ended June 30, 2007 and 2006 were $29 and $10, respectively. For the corresponding
six month periods in 2007 and 2006, cash received from option exercises totaled $115 and $38,
respectively.
Details regarding the valuation and accounting for stock options are as follows:
There were 106,316 options granted during the second quarter and no options granted in the first
quarter of 2007.
The fair value of each option award granted after the adoption of SFAS 123R is estimated on the
date of grant using the Black-Scholes option valuation model and assumptions as noted in the
following table:
For the six Months | For the six Months | |||||||
Ended June 30, 2007 | Ended June 30, 2006 | |||||||
Expected life |
5 years | 5 years | ||||||
Expected volatility |
60 | % | 60 | % | ||||
Risk-free interest rate |
4.54-5.02 | % | 5.15 | % | ||||
Dividend Yield |
0 | % | 0 | % |
The expected life of the options is based on the observed and expected time to post-vesting,
forfeiture and exercise. Groups of employees that have similar historical exercise behavior are
considered separately for valuation purposes. The expected volatility is based on implied
volatility from other publicly-traded options and other factors. The risk-free interest rate is
based on the continuous rates provided by the U.S. Treasury with a term equal to the expected life
of the option.
Stock awards under the Companys current plans are granted at prices which are no less than the
market value of the stock on the date of grant. Options granted under the 2005 Stock Incentive Plan
(2005 Plan) are generally time-based or performance-based options, and vesting varies
accordingly. Options under this plan expire five years from the date of grant.
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Since the Company has adopted the 2005 Plan, awards are not granted under the Companys previous
stock option plans; however, additional shares are reserved for issuance pursuant to the 2003 Stock
Incentive Plan (2003 Plan) in connection with a
formula-based option granted to the Companys CEO
Dr. Joseph Gulfo.
The status of the Companys stock option plans at June 30, 2007 is summarized in the following
tables:
Weighted | ||||||||||||||||
Weighted | Average | |||||||||||||||
Average | Remaining | |||||||||||||||
Exercise | Contractual | Aggregate | ||||||||||||||
Number of | Price per | Term in | Intrinsic | |||||||||||||
Shares | Share | Years | Value | |||||||||||||
Outstanding at December 31, 2006 |
1,689,412 | $ | 2.88 | 4.2 | $ | 7,331 | ||||||||||
Granted |
106,316 | 4.82 | 4.5 | |||||||||||||
Exercised |
(105,256 | ) | 1.09 | |||||||||||||
Forfeited or expired |
(16,146 | ) | 6.82 | |||||||||||||
Outstanding at June 30, 2007 |
1,674,326 | 3.08 | 3.9 | $ | 6,262 | |||||||||||
Vested and exercisable at June 30, 2007 |
576,901 | 3.31 | 3.8 | $ | 1,992 | |||||||||||
Options Outstanding | ||||||||||||||||||||
Weighted- | Options Exercisable | |||||||||||||||||||
Average | Weighted | Weighted- | ||||||||||||||||||
Remaining | Average | Average | ||||||||||||||||||
Number | Contractual | Exercise | Number | Exercise | ||||||||||||||||
Range of Exercise Prices | Outstanding | Life | Price | Exercisable | Price | |||||||||||||||
$.01-$.46 |
818,115 | 2.2 years | $ | .46 | 171,753 | $ | .46 | |||||||||||||
$.47-$1.00 |
119,648 | 4.6 years | $ | 1.00 | 119,648 | $ | 1.00 | |||||||||||||
$1.01-$7.75 |
736,563 | 4.1 years | $ | 6.32 | 285,500 | $ | 5.99 | |||||||||||||
$.01-$7.75 |
1,674,326 | 3.9 years | $ | 3.08 | 576,901 | $ | 3.31 | |||||||||||||
During the second quarter of 2007 the weighted average fair value of options granted,
estimated as of the grant date using the Black-Scholes option valuation model, was $2.86. There
were no options granted during the first three months of 2007. The total intrinsic value of
options exercised during the three and six month periods ended June 30, 2007 was $117 and $558,
respectively. For the three and six months ended June 30, 2006, the total intrinsic value of
options exercised was $100, and $228 respectively.
As of June 30, 2007, of the total 1,674,326 options outstanding 1,097,425 have not vested. Of this
total unvested amount, 972,025 will vest upon the attainment of certain milestones, and the balance
will vest over the requisite service period. Based on 15,702,875 shares outstanding (on a
fully-diluted basis) as of June 30, 2007, and assuming such shares remain the total number of
shares outstanding on the date we receive PMA approval of MelaFind®, the number
of shares subject to Dr. Gulfos third stock option is 546,362. This third stock option vests 50%
at the time of PMA approval of MelaFind®, and the remaining 50% in four equal
installments over the one-year period following such PMA approval of MelaFind®.
As of June 30, 2007, there was $2,301 of total unrecognized compensation cost related to unvested
options.
Although no new options are to be granted under the Companys 2003 Stock Incentive Plan, our
shareholders recently approved a 500,000 share increase in the plan in order to satisfy our
contractual obligation under Dr. Gulfos existing employment contract (see Part II Item 4
Submission of Matters to a Vote of Security Holders). Of the 844,559 shares now authorized and
available under the 2003 Stock Incentive Plan, 546,362 have been allocated to Dr. Gulfo as of June
30, 2007, in accordance with the provisions of his contract.
As of June 30, 2007 there were a total of 1,278,787 option shares available; 980,590 shares
available for future grants under the Companys 2005 Stock Incentive Plan and 298,197 under the
2003 Stock Incentive Plan, which is the balance available for allocation to Dr. Gulfo in accordance
with the provisions of his employment contract.
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7. COMMITMENTS AND CONTINGENCIES
In connection with the start of clinical trials, the Company has committed to several clinical
sites a total amount of approximately $150 in contracts that do not exceed one year. These
contracts are cancelable with 30 days prior notice.
The Company is party to two non-cancelable operating leases for office space expiring June 2009 and
November 2010. The leases are subject to escalations for increases in operating expenses. The
approximate aggregate minimum future payments under these leases are due as follows:
2007 | 2008 | 2009 | 2010 | |||
$125
|
$253 | $188 | $105 |
On March 28, 2007 the Company announced the signing of an agreement with LOreal to study and
assess the feasibility of using EOS novel multi-spectral imaging technology for the evaluation and
differentiation of pigmented skin lesions of cosmetic importance. EOS has granted LOreal an option
to take an exclusive license to use EOS technology in the field covered by the research, on terms
to be mutually agreed. The option expires on the earlier to occur of six months after the
completion of the Feasibility Plan, as defined in the agreement, or August 31, 2008. The laboratory
and clinical research will be funded by LOreal. Pursuant to the agreement, LOreal is responsible
for all costs and expenses incurred in connection with the Feasibility Program, and will reimburse
EOS for expenses incurred by EOS with respect to the Feasibility Program.
In August of 2006, the Company engaged Carl Zeiss Jena GmbH on usual commercial terms to build the
lenses and assemblies, as well as provide certain technical consulting, for the
MelaFind® units which will be used in the Companys pivotal clinical trial. We
expect this work to take place throughout 2007.
In January 2006, the Company entered into an agreement with ASKION GmbH (ASKION) to produce and
test commercial-grade MelaFind® hand-held imaging device systems. Under the
agreement, ASKION is to produce up to forty MelaFind® imaging devices for the
Company to be utilized in the Companys pivotal trial which will be conducted under the auspices of
the Protocol Agreement reached with FDA. The Company is required to make payments to ASKION upon
delivery of the MelaFind® systems. The Company expects to maintain a
relationship, which has evolved into a month-to-month agreement, with ASKION and continue with
development activities throughout 2007.
The Company has an employment agreement with its President and Chief Executive Officer, Dr. Gulfo,
which provides for an annual base salary, stock options and performance bonuses at the discretion
of the Board of Directors. The agreement, which provides for automatic one-year renewal terms,
currently runs through the end of 2007. Effective May 31, 2006 the Board of Directors decided to
increase Dr. Gulfos annual base salary to $235, and awarded him a bonus in the amount of $50. On
May 8, 2007, but effective April 1, 2007, the Board of Directors increased Dr. Gulfos annual base
salary to $260 and awarded him a bonus of $60.
The Company is not currently subject to any material legal proceedings, nor to managements
knowledge is any material legal proceeding threatened against the Company.
8. PRIVATE PLACEMENT
On October 31, 2006, the Company entered into securities purchase agreements and a registration
rights agreement with certain accredited investors for the private placement of 2,312,384 shares of
the Companys common stock and warrants to purchase up to 346,857 shares of the Companys common
stock for aggregate gross proceeds of approximately $13.2 million and net proceeds of approximately
$12.5 million. Pursuant to the securities purchase agreements, for a purchase price of $5.70 each
investor received one share of the Companys common stock and a warrant to purchase 0.15 of a share
of the Companys common stock. The warrants are five-year warrants with an exercise price of $6.70
per share. Pursuant to the registration rights agreement, the Company has filed a resale
registration statement covering the shares, including the shares issuable upon the exercise of the
warrants, with the SEC. In the event that the Company fails to meet certain deadlines, as described
in the registration rights agreement, the holders would be entitled to certain monetary damages.
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However, in no event is the Company obligated to make payments in excess of 10% of the aggregate
purchase price of the common shares. The Company has concluded that it is unlikely that the Company
would be required to remit any payments to its investors for failing to maintain its effectiveness.
The Companys resale registration statement on Form S-3 was declared effective by the Securities
and Exchange Commission (file #333-139056) February 12, 2007.
9. WARRANTS
Warrants outstanding at June 30, 2007 include a five-year warrant to purchase 75,000 shares of the
Companys common stock at an exercise price of $7.00 per share issued to one of the Companys
consultants in 2004, and seven-year warrants to purchase an aggregate of 54,988 shares the
Companys common stock at an exercise price of $4.52 per share issued in connection with the sale
of Series C redeemable convertible preferred stock.
In connection with the Companys initial public offering which closed on November 2, 2005, the
Company issued 150,000 warrants to the underwriters to purchase shares of the Companys common
stock at $6.25 per share which became exercisable commencing October 28, 2006 and have a five-year
term.
Additionally, as previously discussed, in connection with the Companys October 31, 2006 financing,
warrants to purchase up to 346,857 shares of the Companys common stock were issued. The warrants
are five-year warrants with an exercise price of $6.70 per share.
10. RELATED PARTY CONSULTING AGREEMENTS
The Company has in place the following consulting agreements with related parties:
Consulting Agreement with Breaux Castleman
In June 2003, the Company entered into a consulting agreement with Breaux Castleman, the Chairman
of the Companys Board of Directors, for consulting services related to the FDA approval of
MelaFind®, and the Companys business and financial strategy. Under this
agreement, Mr. Castleman receives compensation for each month of services rendered. The Company
made payments, pursuant to this consulting agreement, of $6 and $12, respectively, for the three
and six month periods ending June 30, 2007, and $8 and $25 for the comparable periods in 2006.
This consulting agreement is terminable by either party by providing thirty days prior written
notice.
Consulting Agreement with Marek Elbaum, Ph.D.
Pursuant to a consulting agreement effective as of May 31, 2005, the Company retained Marek Elbaum,
Ph.D., the Companys founder and former President and Chief Science and Technology Officer, as the
Companys Chief Scientist. In consideration of the services to be provided, the Company agreed to
pay Dr. Elbaum a monthly fee of $15. The term of this agreement extended for a period of two years
and was automatically renewable for an additional one-year period. In the event of a non-renewal or
in the event that Dr. Elbaums services terminate as a result of his death or disability, the
Company agreed to pay Dr. Elbaum a termination fee of $100. In May of 2007 and effective June 1,
2007, Dr. Elbaum and the Company entered into an amended agreement. Under the terms of the amended
agreement Dr. Elbaum will be paid a monthly fee of $9 for the next 20 months.
Consulting Agreement with Robert Friedman, M.D.
Effective as of June 1, 2005, the Company retained the services of Robert Friedman, M.D., for an
initial term of one year as a consultant, medical advisor to our Board of Directors, and in
connection with the clinical testing of MelaFind®. In consideration for these
services, Dr. Friedman will be paid at a rate of $5 per day.
This consulting agreement automatically renewed effective June 1, 2006, and again June 1, 2007 for
additional one-year terms, and continues to automatically renew for successive one-year terms
unless either party terminates the agreement at least 30 days prior to the expiration of the
agreement. The Company made payments to Dr. Friedman totaling $12 and $12 for the three-and six
month periods ending June 30, 2007, and $10 and $22 respectively for the same periods a year
earlier.
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Consulting Agreement with Gerald Wagner, Ph.D.
On March 24, 2006, the Company entered into an amended and restated consulting agreement with
Gerald Wagner, Ph.D., a member of the Companys Board of Directors and its former Acting Chief
Operating Officer. Under this amended consulting agreement, the Company agreed to pay Dr. Wagner
the annual amount of $180 payable monthly over the term of the agreement. In addition, in
connection with his ongoing engagement as a consultant, Dr. Wagner received a stock option grant of
50,000 shares of the Companys common stock which vested upon commencement of the pivotal trial for
Melafind® in January 2007. The Company recorded a $140 charge to operations
during the quarter ended March 31, 2007.
In addition, in connection with the start of the Companys pivotal clinical trial at the end of
January 2007, Dr. Wagner has transitioned out of his role as our Acting Chief Operating Officer and
has entered into an amendment to his amended and restated consulting contract with the Company.
Under the terms of the amended contract, commencing February 2007 Dr. Wagner will be paid a monthly
retainer of $2.5 and will be paid $2.5 for each additional consulting day. This amended agreement
will end at the option of Dr. Wagner or the Company at any time, by providing fifteen days prior
written notice, or immediately upon the mutual agreement of the Company and Dr. Wagner. The
Company incurred consulting costs pursuant to this agreement of $7.5 and $12.5 in the three and six
month periods ended June 30, 2007
11. SALE AND LICENSING OF DISCONTINUED OPERATIONS
Effective April 5, 2005, the Company decided to discontinue all operations associated with its
DIFOTI® product in order to focus its resources and attention on the
development and commercialization of MelaFind®. In accordance with the
provisions of SFAS No. 144, Accounting for the Impairment or Disposal of Long-lived Assets, the
results of operations of the DIFOTI® business have been excluded from
continuing operations and have been reported as discontinued operations. The assets and liabilities
of the business have been classified as held for sale. During December 2006, the Company entered
into a sale and exclusive licensing agreement with KaVo Dental GmbH (KaVo), a leading dental
equipment manufacturer, which provides for KaVo to further develop and commercialize
DIFOTI®. Upon execution of the agreement, KaVo paid the Company $500. The
second $500 payment was received on July 20, 2007. Beginning in 2008 or earlier, KaVo is required
to pay to the Company a royalty stream based upon the worldwide aggregate net sales of the licensed
product, as defined in the license agreement, or a set minimum. During the year ended December 31,
2006, the Company recorded a gain of $781 on the sale and licensing of its remaining
DIFOTI® assets based upon the cash proceeds and the discounted value of the
second payment. Royalties will be recorded when earned.
12. SUBSEQUENT EVENT
On
July 31, 2007, the Company entered into a securities purchase agreement and a registration rights
agreement with certain accredited investors for the private placement of 2,000,178 shares of the
Companys common stock and warrants to purchase up to 500,041 shares of the Companys common stock
for aggregate gross proceeds of approximately $11.5 million. The private placement closed August
3, 2007. Pursuant to the securities purchase agreement, for a purchase price of $5.75 each
investor will receive one share of the Companys common stock and a warrant to purchase 0.25 of a
share of common stock. The warrants are five-year warrants with an exercise price of $8.00 per
share. The private placement was completed pursuant to an exemption from registration provided by
Section 4(2) of the Securities Act of 1933, as amended, and Regulation D promulgated thereunder.
Pursuant to the terms of the registration rights agreement, the Company has agreed to cause a
resale registration statement covering the shares, including the shares issuable upon exercise of
the warrants, to be filed within 30 days after closing.
The approximately $10.8 million in net proceeds from the closing will be used for general corporate
purposes.
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ITEM 2.
ELECTRO-OPTICAL SCIENCES, INC.
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
MANAGEMENTS DISCUSSION AND ANALYSIS
OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This
managements discussion and analysis of financial condition and
results of operations is intended to provide information to help you
better understand and evaluate our financial condition and results of
operations. We recommend that you read this section in conjunction with our
Financial Statements and Notes to Financial Statements and with our Annual Report on Form 10-K for
the year ended December 31, 2006.
This quarterly report on Form 10-Q, including the following managements discussion and analysis of
financial condition and results of operations, contains forward-looking statements that you should
read in conjunction with the financial statements and notes to financial statements that we have
included elsewhere in this report. These statements are based on our current expectations,
assumptions, estimates and projections about our business and our industry, and involve known and
unknown risks, uncertainties, and other factors that may cause our or our industrys results,
levels of activity, performance or achievements to be materially different from any future results,
levels of activity, performance or achievements expressed or implied in, or contemplated by, the
forward-looking statements. Words such as believe, anticipate, expect, intend, plan,
will, may, should, estimate, predict, potential, continue, or the negative of such
terms or other similar expressions, identify forward-looking statements. Our actual results and the
timing of events may differ significantly from the results discussed in the forward-looking
statements, and you should not place undue reliance on these statements. Factors that might cause
such a difference include those discussed below under the heading Risk Factors, as well as those
discussed elsewhere in this quarterly report on Form 10-Q. We disclaim any intent or obligation to
update any forward-looking statements as a result of developments occurring after the period
covered by this report or otherwise.
Overview
We are a medical device company focused on the design and development of a non-invasive,
point-of-care instrument to assist in the early diagnosis of melanoma. Our flagship product,
MelaFind®, features a hand-held imaging device that emits multiple wavelengths
of light to capture images of suspicious pigmented skin lesions and extract data. We currently do
not have any commercialized products or any significant source of revenue; however, the financial
results for periods prior to December 2006 discussed below account for the revenues and the related
expenses associated with our DIFOTI® product, a non-invasive imaging device for
the detection of dental cavities, as a discontinued operation. We decided to discontinue all
operations associated with our DIFOTI® product effective as of April 5, 2005 in
order to focus our resources and attention on the development and commercialization of
MelaFind®. On December 11, 2006 we announced that we had signed a sales and
exclusive licensing agreement with KaVo, a leading dental equipment manufacturer, to further
develop and commercialize DIFOTI®. In accordance with the terms of the
agreement, KaVo paid us an up-front sum and has made a second payment to us on July 20, 2007. KaVo
will pay us an annual royalty based on the number of systems sold or a set minimum per calendar
year following their commercial re-launch of DIFOTI®. With the completion of
this transaction we do not expect to have any significant continuing responsibility for the
DIFOTI® business.
Unless otherwise indicated, the following discussion relates to our continuing operations.
Our revenue for the foreseeable future will depend on the commercialization of
MelaFind® and may vary substantially from year to year and quarter to quarter.
Our operating expenses may also vary substantially from year to year and quarter to quarter based
on the timing of the pivotal trial that began at the end of January 2007 and its patient
enrollment. We believe that period-to-period comparisons of our results of operations may not be
meaningful and should not be relied on as indicative of our future performance.
We commenced operations in December 1989 as a New York corporation and re-incorporated as a
Delaware corporation in September 1997. Since our inception, we have generated significant losses.
As of June 30, 2007, we had an accumulated deficit of $37.3 million. We expect to continue to spend
significant amounts on the development of MelaFind®.
On October 28, 2005, we completed an initial public offering. We issued 4,000,000 shares of common
stock on October 28, 2005 and 262,300 shares of common stock on November 15, 2005, both issuances
at $5.00 per share. After deducting underwriting discounts and expenses and offering-related expenses, the initial public offering
resulted in net proceeds to the Company of approximately $17.7 million.
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On October 31, 2006, we entered into securities purchase agreements and a registration rights
agreement with certain accredited investors for the private placement of 2,312,384 shares of the
Companys common stock and warrants to purchase up to 346,857 shares of the Companys common stock
for aggregate gross proceeds of approximately $13.2 million and net proceeds of approximately $12.5
million. The transaction closed November 3, 2006. We believe that the proceeds from these two
transactions will be sufficient to fund our anticipated level of operations through mid-2008. We
will however need to raise additional funds in order to achieve significant commercialization of
MelaFind® and generate significant revenues.
Most of our expenditures to date have been for research and development activities and general and
administrative expenses. Research and development expenses represent costs incurred for product
development, clinical trials and activities relating to regulatory filings and manufacturing
development efforts. We expense all of our research and development costs as they are incurred.
Our research and development expenses incurred for the three and six months ended June 30, 2007
were expenses related primarily to the development of MelaFind®. We expect to
incur additional research and development expenses relating to MelaFind® prior
to its commercial launch in the US and selected markets outside the US. We also continue to work
with ASKION, a company that has become an integral member of our MelaFind®
development team. ASKION is currently producing additional MelaFind® systems
for our pivotal clinical trial that started at the end of January 2007, as well as for other
clinical studies of MelaFind®. Our research and development expenses are
subject to the risks and uncertainties associated with clinical trials and the FDA regulatory
review and approval process. As a result, our research and development expenses could exceed our
estimated amounts, possibly materially.
General and administrative expenses consist primarily of salaries and related expenses, general
corporate activities and costs associated with our efforts to obtain PMA approval for
MelaFind® and toward development of a commercial infrastructure to market and
sell MelaFind®. We anticipate that general and administrative expenses will
increase as a result of the expected expansion of our operations, facilities and other activities
associated with the planned expansion of our business, together with the additional costs
associated with operating as a public company. We expect selling, general and administrative
expenses to increase as we develop our sales and marketing capabilities to support placing
MelaFind® in selected markets.
Critical Accounting Policies and Significant Judgments and Estimates
Our managements discussion and analysis of our financial condition and results of operations are
based on our financial statements, which have been prepared in accordance with GAAP. The
preparation of these financial statements requires us to make estimates and assumptions that affect
the reported amounts of assets and liabilities and the disclosure of contingent assets and
liabilities at the date of the financial statements as well as the reported revenues and expenses
during the reporting periods. On an ongoing basis, we evaluate our judgments related to accounting
estimates. We base our estimates on historical experience and on various other factors that we
believe are reasonable under the circumstances, the results of which form the basis for making
judgments about the carrying value of assets and liabilities that are not readily apparent from
other sources. Actual results may differ from these estimates under different assumptions or
conditions.
We believe that the following accounting policies and significant judgments and estimates relating
to revenue recognition, stock-based compensation charges, and accrued expenses are most critical to
aid you in fully understanding and evaluating our reported financial results.
Revenue Recognition
We currently do not have any commercialized products or any source of revenue.
Stock-Based Compensation and Deferred Compensation
Effective January 1, 2006, the Company began recording compensation expense associated with stock
options and other forms of equity compensation in accordance with Statement of Financial Accounting
Standards No. 123 (revised 2004), Share-Based Payment (SFAS 123R), as interpreted by SEC Staff
Accounting Bulletin No. 107. Prior to January 1, 2006, the Company accounted for stock options
according to the provisions of Accounting Principles Board Opinion No. 25, Accounting for Stock
Issued to Employees (APB 25), and related interpretations, and
therefore no related compensation expense was recorded for awards granted with no intrinsic value.
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The Company adopted the modified
prospective transition method provided for under SFAS 123R. Under this transition method,
compensation cost associated with stock options in 2006 and 2007 includes: (1) quarterly
amortization related to the remaining unvested portion of all stock option awards granted prior to
January 1, 2006, over the requisite service period based on the grant-date fair value estimated in
accordance with the original provisions of SFAS 123, Accounting for Stock-Based Compensation; and
(2) quarterly amortization related to all stock option awards granted on or subsequent to January
1, 2006, based on the grant-date fair value estimated in accordance with the provisions of SFAS
123R.
We have also granted to certain employees stock options that vest with the attainment of
development milestones not under the Companys control. Upon the attainment of the relevant
development milestones, there could be a significant compensation charge based on the fair value of
such options.
Options or warrants issued to non-employees for services are recorded at fair value and accounted
for in accordance with Emerging Issues Task Force (EITF) Issue No. 96-18, Accounting for Equity
Instruments That Are Issued to Other Than Employees for Acquiring, or in Conjunction with Selling,
Goods or Services. For equity instruments that are not immediately vested, compensation costs are
measured on the date such instruments vest or a performance commitment is reached, as defined in
EITF 96-18. The costs are classified in the accompanying Statement of Operations based on the
nature of the service performed.
Accrued Expenses
As part of the process of preparing financial statements, we are required to estimate accrued
expenses. This process involves identifying services that have been performed on our behalf and
estimating the level of service performed and the associated cost incurred for such service where
we have not been invoiced or otherwise notified of the actual cost. Examples of estimated accrued
expenses include:
| professional service fees; | ||
| contract clinical service fees; | ||
| fees paid to contract manufacturers in conjunction with the production of clinical components or materials; and | ||
| fees paid to third party data collection organizations and investigators in conjunction with the clinical trials. |
In connection with such service fees, our estimates are most affected by our projections of the
timing of services provided relative to the actual level of services incurred by such service
providers. The majority of our service providers invoice us monthly in arrears for services
performed. In the event that we do not identify certain costs that have begun to be incurred or we
are under or over our estimate of the level of services performed or the costs of such services,
our actual expenses could differ from such estimates. The date on which certain services commence,
the level of services performed on or before a given date, and the cost of such services are often
subjective determinations. We make these judgments based upon the facts and circumstances known to
us in accordance with GAAP. This is done as of each balance sheet date in our financial statements.
Results of Operations (in thousands)
As we work on developing MelaFind®, we continue to spend a majority of our time
and money in research and development related activities. Our overall spending during the first six
months of 2007 has remained relatively consistent with our spending
during the first six months
of 2006. However, as we increase the activity around the pivotal trial for
MelaFind®, prepare for our PMA submission, and begin work towards the
commercial launch of MelaFind® our costs will increase.
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Three Months Ended June 30, 2007 Compared to Three Months Ended June 30, 2006
Research and Development Expense
Research and Development expense for the three months ended June 30, 2007 was $1,886 as compared to
$2,021 for the three months ending June 30, 2006. In general, the second quarter 2007 costs were
consistent with second quarter 2006 with costs decreasing slightly by $135. We noted a similar
trend in the first three months of 2007 as compared to the first three months of 2006. However, the
components of spending within research and development have changed. While production spending
decreased by $257 our clinical trial expenses have increased by $145, and the technical support
services necessary to support our clinical trials increased by $60. Our software development
expenses also increased by $16 mainly in support of our clinical trials. These increases were
offset by decreases in our regulatory spending of $22 and share based compensation of $84
General and Administrative Expense
General and Administrative expense for the three months ended June 30, 2007 was $1,439 as compared
to $1,081 for the three months ended June 30, 2006. The increase
of $358 was the result of the
following: increased marketing expenses of $175 as we begin the work towards a commercial launch
of Melafind®, increased legal fees primarily related to patent work of $26,
travel expense of $51, salaries and bonuses of $128, employee recruiting of $54, and stock
maintenance fees of $28. This was offset by a decrease in share-based compensation of $93 and $24
in accounting related expenses.
Six
Months Ended June 30, 2007 Compared to Six Months Ended June 30, 2006
Research and Development Expense
Research and Development expense for the six months ended June 30, 2007 was $3,839 as compared to
$4,006 for the six months ended June 30, 2006; a decrease of $167. The components of spending are
consistent with the trend noted above. Production spending has decreased by $367 for the six
months ended June 30, 2007, but this decrease was offset by increased clinical trial expenses of
$298 and technical support expenses necessary to support the clinical trial of $101. In addition,
our regulatory spending decreased by $76 and our share-based compensation expense decreased by
$134.
General and Administrative Expense
General and Administrative expense for the six months ended June 30, 2007 was $2,750 as compared to
$2,164 for the six months ended June 30, 2006. The increase of $586 was mainly attributable to
higher marketing costs of $231 reflecting an increase in activity leading to commercial launch of
Melafind®, legal costs of $117 primarily related to new patent costs, an
increase in travel expenses of $111, bonuses and salary increases of $128, and employee recruiting
costs of $73. In addition our rent expense increased $19. Partially offsetting these increases
was a $56 decrease in accounting expenses and a $60 decrease in share-based compensation expense.
Interest Income/Expense
Interest income for the three months and six months ended June 30, 2007 was $228 and $499,
respectively, as compared to $173 and $354, respectively, for the comparable periods a year
earlier.
Liquidity and Capital Resources
Prior to our initial public offering, we financed our operations primarily through the use of
working capital from private placements of equity securities and by applying for and obtaining a
series of National Institute of Health Small Business Innovative Research grants and similar
grants. In October and November of 2005 we sold a total of 4,262,300 shares of common stock in an
initial public offering that resulted in approximately $17.7 million in net proceeds. In addition,
on October 31, 2006 we entered into securities purchase agreements and a registration rights
agreement with certain accredited investors for the private placement of 2,312,384 shares of the
Companys common stock and warrants to purchase up to 346,857 shares of the Companys common stock
for aggregate gross proceeds of approximately $13.2 million and net proceeds of approximately $12.5
million. To date, we have not borrowed (other than by issuing convertible notes, all of which have
been converted into equity) or financed our operations through equipment leases, financing loans or
other debt instruments.
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As of June 30, 2007, we had $15.1 million in cash and cash equivalents as compared to
$20.9 million at December 31, 2006. The decrease was a result of cash used in operating activities
partially offset by interest income produced by our cash and certificates of deposit.
Our cash and cash equivalents at June 30, 2007 are liquid investments in money market funds and
certificates of deposit with a commercial bank.
Cash Flows from Operating Activities
Net cash used in operations was $5.7 million for the six months ended June 30, 2007. For the
corresponding period in 2006, net cash used in operations was $5.2 million. Cash used in operations
was attributable to net losses after an adjustment for non-cash charges related to depreciation and
share-based compensation, and other changes in operating assets and liabilities.
Cash Flows from Investing Activities
For the six months ended June 30, 2007, net cash used in our investing activities was $230 and was
principally related to the purchase of scientific equipment and leasehold improvements in support
of our MelaFind® development. For the corresponding period in 2006, net cash
used by our investing activities was $6.8 million and was principally related to the purchase of
marketable securities.
Cash Flows from Financing Activities
For the six months ended June 30, 2007 and 2006, net cash provided by financing activities was $115
and $38, respectively, and reflects proceeds from the sale of common stock upon the exercise of
options.
Operating Capital and Capital Expenditure Requirements
We face certain risks and uncertainties, which are present in many emerging medical device
companies. At June 30, 2007, we had an accumulated deficit of $37.3 million. To date, we have not
commercialized our principal product, MelaFind®. We anticipate that we will
continue to incur net losses for the foreseeable future as we continue to develop the
MelaFind® system, expand our clinical development team and corporate
infrastructure, and prepare for the potential commercial launch of MelaFind®.
We do not expect to generate significant product revenue until we successfully obtain PMA approval
for and begin selling MelaFind®. In order to achieve significant
commercialization of MelaFind® we will need to obtain additional funding. We
believe that our current cash and cash equivalents and interest we earn on these balances, will be
sufficient to meet our anticipated cash needs for working capital and capital expenditures and
allow us to continue planned operations through mid-2008.
Existing cash and cash generated from our recently completed October 31, 2006 financing and our
2005 initial public offering may not be sufficient to satisfy the liquidity requirements necessary
to commercially launch MelaFind® or to develop additional products. We will
seek to sell additional equity or debt securities or obtain a credit facility. If additional funds
are raised through the issuance of debt securities, these securities could have rights senior to
those associated with our common stock and could contain covenants that would restrict our
operations. Any additional financing may not be available in amounts or on terms acceptable to us,
or at all. If we are unable to obtain this additional financing, we may be required to reduce the
scope of, delay or eliminate some or all of planned product research and development and
commercialization activities, which could harm our business.
Because of the numerous risks and uncertainties associated with the development of medical devices
such as MelaFind®, we are unable to estimate the exact amounts of capital
outlays and operating expenditures associated with our current and anticipated clinical trials. Our
future funding requirements will depend on many factors, including, but not limited to:
| The schedule, costs, and results of our clinical trials; | ||
| The success of our research and development efforts; | ||
| The costs and timing of regulatory approval; |
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| Reimbursement amounts for the use of MelaFind® that we are able to obtain from Medicare and third party payers, or the amount of direct payments we are able to obtain from patients and/or physicians utilizing MelaFind®; | ||
| The cost of commercialization activities, including product marketing and building a domestic direct sales force; | ||
| The emergence of competing or complementary technological developments; | ||
| The costs of filing, prosecuting, defending and enforcing any patent claims and other rights, including litigation costs and the results of such litigation; | ||
| The costs involved in defending any patent infringement actions brought against us by third parties; and | ||
| Our ability to establish and maintain any collaborative, licensing or other arrangements, and the terms and timing of any such arrangements. |
Contractual Obligations
The following table summarizes our outstanding contractual obligations as of June 30, 2007 and the
effect those obligations are expected to have on our liquidity and cash flows in future periods:
Less than | More than | |||||||||||||||||||
Total | 1 year | 1-3 years | 4-5 years | 5 years | ||||||||||||||||
Operating leases |
$ | 724 | $ | 271 | $ | 405 | $ | 48 | |
Included in the total operating leases are two non-cancelable operating leases for space expiring
June 2009 and November 2010. The lease on 5,000 square feet of office and laboratory space expires
in June 2009, and the lease on 2,800 square feet of office space expires November 2010.
In connection with the start of our clinical trials, we have committed to several clinical sites a
total of approximately $150 in contracts that do not exceed one year. These contracts are
cancelable by us with up to 30 days prior notice.
Related Party Transactions
On March 24, 2006, the Company entered into an amended and restated consulting agreement with
Gerald Wagner, Ph.D. which became effective as of April 1, 2006. In connection with his ongoing
engagement as a consultant, Dr. Wagner received a stock option grant of 50,000 shares of the
Companys common stock which vested upon commencement of the pivotal trial for
MelaFind® at the end of January 2007. As Dr. Wagner is a consultant to the
Company we utilize EITF 96-18 to account for this grant. Under this method, we calculate a charge
based on the fair market value of the option at the end of each quarter and adjust that charge each
subsequent quarter until the option vests. Since the pivotal clinical trial began at the end of
January 2007, the Company recognized $140 in compensation expense for this grant.
In addition, on March 24, 2006, Dr. Wagner received another stock option grant of 49,500 shares of
the Companys common stock which vested immediately. The Company recorded a $162 compensation
charge during the first quarter ended March 31, 2006.
The exercise price for these two stock option grants is the closing price per share of the
Companys common stock on the option grant date.
With the start of our pivotal clinical trial, Dr. Wagner has transitioned out of his role as our
Acting Chief Operating Officer and has signed an amendment to his amended and restated consulting
contract with the Company. Under the terms of the amended contract, Dr. Wagner will be paid a
monthly retainer of $2.5 and will be paid $2.5 for each additional
consulting day.
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This amended agreement will end at the option of Dr. Wagner or the Company at any time, by
providing fifteen days prior written notice, or immediately upon the mutual agreement of the
Company and Dr. Wagner.
For a more detailed description of our related party transactions, see our financial statements and
the related notes to our financial statements in Note 10.
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.
Recently Adopted Accounting Pronouncements
In July 2006, the Financial Accounting Standards Board issued Interpretation No. 48, Accounting
for Uncertainty in Income Taxes-an Interpretation of FASB Statement No. 109, (FIN 48) which
clarifies the accounting for uncertainty in tax positions. This Interpretation requires that we
recognize, in our condensed financial statements, the impact of a tax position if that position is
more likely than not of being sustained on audit, based on the technical merits of the position.
The provisions of FIN 48 are effective as of January 1, 2007. We have evaluated our tax positions
and determined that the adoption of this pronouncement did not have a material impact on our
financial position or results of operations. Our tax return net operating loss carryforwards are
significant. The tax years in which losses arose may be subject to audit by the Internal Revenue
Service when such carryforwards are utilized to offset taxable income in future periods.
Recent Accounting Developments
In February 2007, the FASB issued SFAS No. 159, The Fair Value Option for Financial Assets and
Financial Liabilities, including an amendment to SFAS No. 115. This statement permits entities to
choose to measure many financial instruments and certain other items at fair value. The objective
is to improve financial reporting by providing entities with the opportunity to mitigate volatility
in reporting earnings caused by measuring related assets and liabilities differently without having
to apply complex hedge accounting provisions. This statement is expected to expand the use of fair
value measurements, which is consistent with the FASBs long-term measurement objectives for
accounting for financial instruments. SFAS No. 159 is effective for fiscal years beginning after
November 15, 2007. The Company does not expect that the adoption of SFAS No. 159 will have a
material impact on the Companys financial statements.
In September 2006, the FASB issued SFAS No. 157, Fair Value Measurements. This statement defines
fair value, establishes a framework for measuring fair value, and expands disclosures about fair
value measurements. This statement is effective for financial statements issued for fiscal years
beginning after November 15, 2007; however, earlier application is encouraged. The Company does not
expect the adoption of SFAS 157 to have a material impact on its financial statements.
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Risk Factors
Our business and operations entail a variety of serious risks and uncertainties, including those
described in Item 1A of our Form 10-K for the year ended December 31, 2006. In addition, the
following risk factors have changed during the six months ended June 30, 2007:
We have incurred losses for a number of years, and anticipate that we will incur continued losses
for the foreseeable future.
We began operations in December 1989. At that time we provided research services, mostly to US
government agencies, on classified projects. We have financed our operations since 1999 primarily
through the sale of our equity securities and have devoted substantially all of our resources to
research and development relating to MelaFind®. Our net loss for the six months
ended June 30, 2007 was approximately $6.1 million, and as of June 30, 2007, we had an accumulated
deficit of approximately $37.3 million. Our research and
development expenses may continue to increase in
connection with our clinical trials and other development activities related to
MelaFind®. If we receive PMA approval for MelaFind®
from the FDA, we expect to incur significant sales and marketing expenses, which will
require additional funding, and manufacturing expenses. Additionally, our general and
administrative expenses have also increased due to the additional operational and regulatory
responsibilities applicable to public companies. As a result, we expect to continue to incur
significant and increasing operating losses for the foreseeable future. These losses, among other
things, have had and will continue to have an adverse effect on our stockholders equity.
We may be unable to complete the development and commence commercialization of MelaFind®
or other products without additional funding, and we will not be able to achieve
significant commercialization without additional funding.
As of June 30, 2007 we had $15.1 million in cash and cash equivalents. Our operations have consumed
substantial amounts of cash for each of the last seven years. We currently believe that our
available cash and cash equivalents, including the proceeds from our November 2006 financing and
our 2005 initial public offering, will be sufficient to fund our anticipated levels of operations
through mid-2008. However, our business or operations may change in a manner that would consume
available resources more rapidly than we anticipate. We expect to continue to spend substantial
amounts on research and development, including conducting the pivotal clinical trial for
MelaFind®. We will need additional funds to fully commercialize the product,
including development of a direct sales force and expansion of manufacturing capacity. We expect
that our cash used by operations will increase significantly in each of the next several years, and
should we encounter any material delays or impediments, we may need additional funds to complete
the development of MelaFind® and commence commercialization of
MelaFind®, and we will need additional funds to achieve significant
commercialization of MelaFind®. Any additional financing may be dilutive to
stockholders, or may require us to grant a lender a security interest in our assets. The amount of
funding we will need will depend on many factors, including:
| the schedule, costs, and results of our clinical trials; | ||
| the success of our research and development efforts; | ||
| the costs and timing of regulatory approval; | ||
| reimbursement amounts for the use of MelaFind® that we are able to obtain from Medicare and third-party payers, or the amount of direct payments we are able to obtain from patients and/or physicians utilizing MelaFind®; | ||
| the cost of commercialization activities, including product marketing and building a domestic direct sales force; | ||
| the emergence of competing or complementary technological developments; |
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| the costs of filing, prosecuting, defending and enforcing any patent claims and other rights, including litigation costs and the results of such litigation; | ||
| the costs involved in defending any patent infringement actions brought against us by third parties; and | ||
| our ability to establish and maintain any collaborative, licensing or other arrangements, and the terms and timing of any such arrangements. |
Additional financing may not be available to us when we need it, or it may not be available on
favorable terms.
If we are unable to obtain adequate financing on a timely basis, we may be required to
significantly curtail or cease one or more of our development and marketing programs. We could be
required to seek funds through arrangements with collaborators or others that may require us to
relinquish rights to some of our technologies, product candidates or products that we would
otherwise pursue on our own. We also may have to reduce marketing, customer support and other
resources devoted to our products. If we raise additional funds by issuing equity securities, our
then-existing stockholders will experience ownership dilution, could experience declines in our
share price and the terms of any new equity securities may have preferences over our common stock.
Our stock price is likely to be volatile, meaning purchasers of our common stock could incur
substantial losses.
Our stock price is likely to be volatile. Between October 28, 2005 (the date of our initial public
offering) and June 30, 2007, our stock price has ranged from $4.29 to $8.92 per share. The stock
market in general and the market for medical technology companies in particular have experienced
extreme volatility that has often been unrelated to the operating performance of particular
companies. The following factors, in addition to other risk factors described in this section and
general market and economic conditions, may have a significant impact on the market price of our
common stock:
| results of our research and development efforts and our clinical trials; | ||
| the timing of regulatory approval for our products; | ||
| failure of any of our products, if approved, to achieve commercial success; | ||
| the announcement of new products or product enhancements by us or our competitors; | ||
| regulatory developments in the US and foreign countries; | ||
| ability to manufacture our products to commercial standards; | ||
| developments concerning our clinical collaborators, suppliers or marketing partners; | ||
| changes in financial estimates or recommendations by securities analysts; | ||
| public concern over our products; | ||
| developments or disputes concerning patents or other intellectual property rights; | ||
| product liability claims and litigation against us or our competitors; | ||
| the departure of key personnel; | ||
| the strength of our balance sheet; | ||
| variations in our financial results or those of companies that are perceived to be similar to us; |
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| changes in the structure of and third-party reimbursement in the US and other countries; | ||
| changes in accounting principles or practices; | ||
| general economic, industry and market conditions; and | ||
| future sales of our common stock. |
A decline in the market price of our common stock could cause you to lose some or all of your
investment and may adversely impact our ability to attract and retain employees and raise capital.
In addition, stockholders may initiate securities class action lawsuits if the market price of our
stock drops significantly. Whether or not meritorious, litigation brought against us could result
in substantial costs and could divert the time and attention of our management. Our insurance to
cover claims of this sort, if brought, may not be adequate.
If our directors, executive officers, and principal stockholders choose to act together, they may
have the ability to influence all matters submitted to stockholders for approval.
As of June 30, 2007, our directors, executive officers, holders of more than 10 % of our common
stock, and their affiliates in the aggregate, beneficially owned approximately 5.6% of our
outstanding common stock. As a result, these stockholders, subject to any fiduciary duties owed to
our other stockholders under Delaware law, could be able to exercise a controlling influence over
matters requiring stockholder approval, including the election of directors and approval of
significant corporate transactions, and will have significant control over our management and
policies. Some of these persons or entities may have interests that are different from yours. For
example, these stockholders may support proposals and actions with which you may disagree or which
are not in your interests. The concentration of ownership could delay or prevent a change in
control of our company or otherwise discourage a potential acquirer from attempting to obtain
control of our company, which in turn could reduce the price of our common stock. In addition,
these stockholders, some of whom have representatives sitting on our Board of Directors, could use
their voting influence to maintain our existing management and directors in office, delay or
prevent changes of control of our company, or support or reject other management and board
proposals that are subject to stockholder approval, such as amendments to our employee stock plans
and approvals of significant financing transactions.
If we fail to maintain the adequacy of our internal controls, our ability to provide accurate
financial statements could be impaired and any failure to maintain our internal controls and
provide accurate financial statements could cause our stock price to decrease substantially.
We face increased legal, accounting, administrative and other costs and expenses as a
public company. The Sarbanes-Oxley Act of 2002 (SOX), as well as new rules subsequently implemented
by the SEC, the Public Company Accounting Oversight Board and the NASDAQ Capital Market, require
changes in the corporate governance practices of public companies. We expect these new rules and
regulations to increase our legal and financial compliance costs, to divert management attention
from operations and strategic opportunities, and to make legal, accounting and administrative
activities more time-consuming and costly. On June 30, 2007 our market capitalization exceeded $75
million. As a result we must have our independent registered public accounting firm attest to our
compliance with Section 404 of SOX for the year ending December 31, 2007. In addition we will be
an accelerated filer effective December 31, 2007. We have
retained a consultant experienced in SOX to assist us and
we are in the process of instituting changes to our internal procedures to satisfy the requirements
of the SOX. We are evaluating our internal controls systems in order to allow us to report on, and
our independent registered public accounting firm to attest to, our internal controls, as required
by Section 404 of the SOX. While we believe we have made substantial progress on satisfying the
requirements, and anticipate being able to fully implement the requirements relating to internal
controls and all other aspects of Section 404 of the SOX in a timely fashion, we cannot be certain
as to the timing of completion of our evaluation, testing and remediation actions or the impact of
the same on our operations. As a small company with limited capital and human resources, we will
need to divert managements time and attention away from our business in order to ensure compliance
with these regulatory requirements. Implementing these changes may require new information
technologies systems, the auditing of our internal controls, and compliance training for our
directors, officers and personnel. Such efforts would require a potentially significant expense. If
we fail to maintain the adequacy of our internal controls as such standards are modified,
supplemented or amended from time to time, we may not be able to
provide accurate financial statements and comply with the SOX. Any failure to maintain the adequacy of our internal
controls and provide accurate financial statements could cause the trading price of our common
stock to decrease substantially.
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ITEM 3.
Quantitative and Qualitative Disclosures about Market Risk
Our exposure to market risk is confined to our cash and cash equivalents. 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
Evaluation of disclosure controls and procedures
Based on their evaluation as of June 30, 2007, our Chief Executive Officer and Chief Financial
Officer have concluded that our disclosure controls and procedures as defined in Rules 13a-15(e)
and 15d-15(e) of the Securities Exchange Act of 1934, as amended, were sufficiently effective to
ensure that the information required to be disclosed by us in this Quarterly Report on Form 10-Q
was recorded, processed, summarized and reported within the time periods specified in the SECs
rules and Form l0-Q.
Change in internal control over financial reporting
There were no changes in our internal control over financial reporting during the quarter ended
June 30, 2007 that have materially affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
Limitations on the effectiveness of controls
Our disclosure controls and procedures are designed to provide reasonable, not absolute, assurance
that the objectives of our disclosure control system are met. Because of inherent limitations in
all control systems, no evaluation of controls can provide absolute assurance that all control
issues, if any, within a company have been detected.
ITEM 4T. Controls and Procedures
Not applicable.
PART II. OTHER INFORMATION
Item 1. Legal Proceedings.
We are not currently subject to any material legal proceedings, nor, to our knowledge, is any
material legal proceeding threatened against us. From time to time, we may be a party to certain
legal proceedings, incidental to the normal course of our business.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Not applicable.
Item 3. Defaults Upon Senior Securities.
Not applicable.
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Item 4. Submission of Matters to a Vote of Security Holders.
The 2007 Annual Meeting of Stockholders of the Company was held on May 21, 2007.
Our stockholders voted on proposals to elect directors, ratify the selection by the audit committee
of our Board of Directors of Eisner LLP as the Companys independent registered public accounting
firm for the fiscal year ending December 31, 2007, approve an amendment to our 2003 Stock Incentive
Plan and to ratify an amendment to our 2005 Stock Incentive Plan
All nominees for election to the Board as Directors were elected to serve until the 2008 Annual
Meeting of Stockholders and until their respective successors are elected and qualified, or until
such directors earlier death, resignation or removal. The stockholders also ratified the selection
of the independent registered public accounting firm by the audit committee of our Board of
Directors. The number of votes cast for, against or withheld and the number of abstentions with
respect to each proposal is set forth below:
Proposal 1 | Shares For | Shares Withheld | ||||||
Election of Directors |
||||||||
Joseph V. Gulfo, MD |
10,596,494 | 65,175 | ||||||
Breaux Castleman |
10,036,919 | 624,750 | ||||||
Sidney Braginsky |
10,614,924 | 46,745 | ||||||
Gorge C. Chryssis |
10,614,784 | 46,885 | ||||||
Martin D. Cleary |
10,614,751 | 46,918 | ||||||
Dan W. Lufkin |
10,614,924 | 46,745 | ||||||
Gerald Wagner, Ph.D. |
10,414,703 | 246,966 |
Proposal 2 | Shares For | Shares Against | Shares Abstaining | |||||||||
Ratification of Eisner LLP |
10,613,642 | 46,466 | 1,561 | |||||||||
Proposal 3 | Shares For | Shares Against | Shares Abstaining | |||||||||
Amend 2003 Stock Incentive
Plan |
6,947,803 | 1,236,574 | 177,976 | |||||||||
Proposal 4 | Shares For | Shares Against | Shares Abstaining | |||||||||
Amend 2005 Stock Incentive
Plan |
7,940,799 | 246,626 | 174,748 |
Item 5. Other Information.
(a) Not applicable.
(b) Not applicable.
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Item 6. Exhibits
Exhibit | ||
Number | Exhibit Title | |
3.1
|
Fourth Amended and Restated Certificate of Incorporation of the Registrant.(1) | |
3.2
|
Third Amended and Restated Bylaws of the Registrant.(2) | |
4.1
|
Specimen Stock Certificate.(2) | |
4.2
|
Second Amended and Restated Investors Rights Agreement dated as of October 26, 2004 by and among the Registrant and the parties listed therein.(3) | |
4.3
|
Form of Warrant.(7) | |
4.4
|
Form of Warrant.(13) | |
10.1*
|
Form of Indemnification Agreement for directors and executive officers.(2) | |
10.2*
|
1996 Stock Option Plan.(3) | |
10.3*
|
2003 Stock Incentive Plan, as amended.(3) | |
10.4*
|
2005 Stock Incentive Plan.(2) | |
10.5*
|
Employment Agreement dated as of January 5, 2004 between the Registrant and Joseph V. Gulfo.(3) | |
10.6
|
Consulting Agreement dated as of May 31, 2005 between the Registrant and Marek Elbaum.(3) | |
10.7
|
Lease Agreement dated as of December 16, 1998, by and between the Registrant and Bridge Street Properties LLC, for office space located at One Bridge Street, Irvington, New York.(3) | |
10.8
|
First Amendment to the Lease Agreement dated as of May 17, 2001 by and between the Registrant and Bridge Street Properties LLC.(3) | |
10.9
|
Second Amendment to the Lease Agreement dated as of June 19, 2003 by and between the Registrant and Bridge Street Properties LLC.(3) | |
10.10
|
Lease Agreement dated as of November 23, 2004, by and between the Registrant and Bridge Street Properties LLC, for office space located at 3 West Main Street, Irvington, New York.(3) | |
10.11*
|
Consulting Agreement dated as of June 1, 2005 between the Registrant and Gerald Wagner Consulting, LLC.(1) | |
10.12*
|
Consulting Agreement dated as of June 20, 2003 between the Registrant and Breaux Castleman, as amended.(1) | |
10.13
|
Consulting Agreement dated as of June 1, 2005 between the Registrant and Robert Friedman, M.D.(1) | |
10.14
|
Task Order Agreement dated as of July 13, 2005 between the Registrant and Battelle Memorial Institute.(2) |
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Exhibit | ||
Number | Exhibit Title | |
10.15
|
Third Amendment dated as of June 6, 2005, by and between the Registrant and Bridge Street Properties LLC, for office space located at 1 Bridge Street, Irvington, New York.(1) | |
10.16
|
Production Agreement between the Registrant and ASKION GmbH dated as of January 25, 2006.(4) | |
10.17*
|
Amended and Restated Consulting Agreement effective as of April 1, 2006 between the Registrant and Gerald Wagner Consulting LLC.(11) | |
10.18*
|
Resignation Agreement, dated April 24, 2006, between the Registrant and Karen Krumeich.(5) | |
10.19*
|
Employment Offer Letter, dated April 24, 2006, between the Registrant and Richard I. Steinhart.(5) | |
10.20*
|
Employment Offer Letter, dated May 30, 2006, between the Registrant and Christiano S. Butler.(6) | |
10.21
|
Securities Purchase Agreement among the Registrant and the purchasers identified on the signature pages thereto, dated as of October 31, 2006.(8) | |
10.22
|
Securities Purchase Agreement among the Registrant and the purchasers identified on the signature pages thereto, dated as of October 31, 2006.(8) | |
10.23
|
Registration Rights Agreement among the Registrant and the purchasers identified on the signature pages thereto, dated as of October 31, 2006.(8) | |
10.24
|
Placement Agency Agreement by and between the Registrant and Jefferies & Company, Inc., dated as of October 31, 2006.(7) | |
10.25
|
Licensing Agreement between the Registrant and KaVo Dental GmbH, dated as of December 5, 2006.(9) | |
10.26*
|
Amendment No. 1 to Amended and Restated Consulting Agreement dated as of January 30, 2007 by and among the Registrant, Gerald Wagner and Gerald Wagner Consulting LLC. (10) | |
10.27
|
Research and Feasibility Agreement between the Registrant and LOreal S.A. dated as of March 26, 2007. (12) | |
10.28
|
Securities Purchase Agreement among the Registrant and the purchasers identified on the signature pages thereto, dated as of July 31, 2007.(13) | |
10.29
|
Registration Rights Agreement among the Registrant and the purchasers identified on the signature pages thereto, dated as of July 31, 2007.(13) |
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Exhibit | ||
Number | Exhibit Title | |
31.1#
|
Certification of Chief Executive Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
31.2#
|
Certification of Chief Financial Officer Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. | |
32.1#
|
Certification of Chief Executive Officer and Chief Financial Officer Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. | |
* | Indicates management compensatory plan, contract or arrangement | |
(1) | Incorporated by reference to the Registrants Registration Statement on Form S-1, as amended (File No. 333-125517), as filed on July 15, 2005. | |
(2) | Incorporated by reference to the Registrants Registration Statement on Form S-1, as amended (File No. 333-125517), as filed on August 8, 2005. | |
(3) | Incorporated by reference to the Registrants Registration Statement on Form S-1, as amended (File No. 333-125517), as filed on June 3, 2005. | |
(4) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on January 31, 2006. | |
(5) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on April 27, 2006. | |
(6) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on June 2, 2006. | |
(7) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on November 1, 2006. | |
(8) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on November 8, 2006. | |
(9) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on December 11, 2006. | |
(10) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on January 31, 2007. | |
(11) | Incorporated by reference to the Registrants Annual Report on Form 10-K filed on March 29, 2006. | |
(12) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on March 28, 2007. | |
(13) | Incorporated by reference to the Registrants Current Report on Form 8-K filed on August 1, 2007. | |
# | Filed herewith. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused
this report to be signed on its behalf by the undersigned, thereunto duly authorized.
ELECTRO-OPTICAL SCIENCES, INC. |
||||
By: | /s/ Richard I. Steinhart | |||
Richard I. Steinhart | ||||
Vice President and Chief Financial Officer (Principal Accounting and Financial Officer) |
||||
Date: August 9, 2007
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EXHIBIT INDEX
Exhibit No. | Description | |
31.1
|
Certification by the Chief Executive Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 | |
31.2
|
Certification by the Chief Financial Officer pursuant to Rule 13a-14(a) under the Securities Exchange Act of 1934 | |
32.1
|
Certification Pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 |
28