Attached files
file | filename |
---|---|
EX-32.1 - Inspyr Therapeutics, Inc. | v221497_ex32-1.htm |
EX-31.1 - Inspyr Therapeutics, Inc. | v221497_ex31-1.htm |
EX-32.2 - Inspyr Therapeutics, Inc. | v221497_ex32-2.htm |
EX-31.2 - Inspyr Therapeutics, Inc. | v221497_ex31-2.htm |
Washington, D.C. 20549
FORM 10-Q
(Mark one)
x
|
Quarterly Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934
|
For the Quarterly Period Ended March 31, 2011
Or
¨
|
Transition Report Under Section 13 or 15(d) of the Securities Exchange Act of 1934
|
Commission File Number 333-153829
GENSPERA, INC.
(Exact name of registrant as specified in its charter)
Delaware
|
20-0438951
|
|
State or other jurisdiction of
incorporation or organization
|
(I.R.S. Employer
Identification No.)
|
|
2511 N Loop 1604 W, Suite 204
San Antonio, TX
|
78258
|
|
(Address of principal executive offices)
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(Zip Code)
|
Registrant’s telephone number, including area code (210) 479-8112
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. x Yes ¨ No
Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). ¨ Yes ¨ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See the definitions of “large accelerated filer,” “accelerated filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act.
Large accelerated filer o
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Accelerated filer o
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Non-accelerated filer o (Do not check if a small reporting company)
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Smaller reporting company x
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Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
o Yes x No
As of May 6, 2011, Registrant had 21,387,024 common shares, $0.0001 par value, issued and outstanding.
GenSpera, Inc.
Table of Contents
Page
|
||||
PART I -
|
FINANCIAL INFORMATION
|
2 | ||
Item 1.
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Financial Statements
|
2 | ||
Balance Sheets as of March 31, 2011 (Unaudited) and December 31, 2010
|
2 | |||
Statements of Operations (Unaudited)
|
3 | |||
Three months ended March 31, 2011 and 2010 and for the period from November 21, 2003 (inception) to March 31, 2011
|
||||
Statements of Changes in Stockholders' Equity (Unaudited)
|
4 | |||
For the period from November 21, 2003 (inception) to March 31, 2011
|
||||
|
||||
Statements of Cash Flows (Unaudited)
|
6 | |||
Three months ended March 31, 2011 and 2010 and for the period from November 21, 2003 (inception) to March 31, 2011
|
||||
Notes to Financial Statements (Unaudited)
|
7 | |||
Item 2.
|
Management's Discussion and Analysis of Financial Condition and Results of Operations
|
12 | ||
Item 3.
|
Quantitative and Qualitative Disclosures about Market Risk
|
17 | ||
Item 4.
|
Controls and Procedures
|
17 | ||
PART II -
|
OTHER INFORMATION
|
18 | ||
Item 1.
|
Legal Proceedings
|
18 | ||
Item 1A.
|
Risk Factors
|
18 | ||
Item 2.
|
Unregistered Sales of Equity Securities and Use of Proceeds
|
25 | ||
Item 3.
|
Defaults Upon Senior Securities
|
26 | ||
Item 4.
|
(Removed and Reserved)
|
26 | ||
Item 5.
|
Other Information
|
27 | ||
Item 6.
|
Exhibits
|
27 |
ADVISEMENT
We urge you to read this entire Quarterly Report, including the “Risk Factors” section, the financial statements, and related notes included herein. As used in this Quarterly Report, unless the context otherwise requires, the words “we,” “us,”“our,” “the Company,” “GenSpera” and “Registrant” refer to GenSpera, Inc. Also, any reference to “common shares,” or “common stock,” refers to our $.0001 par value common stock. The information contained herein is current as of the date of this Quarterly Report (March 31, 2011), unless another date is specified.
We prepare our interim financial statements in accordance with United States generally accepted accounting principles. Our financials and results of operations for the three month period ended March 31, 2011 are not necessarily indicative of our prospective financial condition and results of operations for the pending full fiscal year ending December 31, 2011. The interim financial statements presented in this Quarterly Report as well as other information relating to our company contained in this Quarterly Report should be read in conjunction and together with the reports, statements and information filed by us with the United States Securities and Exchange Commission (“SEC”).
NOTE REGARDING FORWARD-LOOKING STATEMENTS
This Quarterly Report contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Any statements about our expectations, beliefs, plans, objectives, assumptions or future events or performance are not historical facts and may be forward-looking. These forward-looking statements include, but are not limited to, statements about:
·
|
the development of our drug candidates, including when we expect to undertake, initiate and complete clinical trials of our product candidates;
|
·
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the regulatory approval of our drug candidates;
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·
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our use of clinical research centers and other contractors;
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·
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our ability to sell, license or market any of our products;
|
·
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our history of operating losses;
|
·
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our ability to compete against other companies;
|
·
|
our ability to secure adequate protection for our intellectual property;
|
·
|
our ability to attract and retain key personnel;
|
·
|
our ability to obtain adequate financing; and
|
·
|
the volatility of our stock price.
|
These statements are often, but not always, made through the use of words or phrases such as “anticipate,” “estimate,” “plan,” “project,” “continuing,” “ongoing,” “expect,” “believe,” “intend” and similar words or phrases. Accordingly, these statements involve estimates, assumptions and uncertainties that could cause actual results to differ materially from those expressed in them. Discussions containing these forward-looking statements may be found throughout this Form 10-Q, including Part I, the section entitled “Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These forward-looking statements involve risks and uncertainties, including the risks discussed in Part II, Item 1A of this Report, under the caption “Risk Factors” that could cause our actual results to differ materially from those in the forward-looking statements. We undertake no obligation to publicly release any revisions to the forward-looking statements or reflect events or circumstances after the date of this document. The risks discussed in this report should be considered in evaluating our prospects and future financial performance.
1
PART I
FINANCIAL INFORMATION
ITEM 1. FINANCIAL STATEMENTS
GENSPERA INC.
(A Development Stage Company)
CONDENSED BALANCE SHEETS
March 31,
|
December 31,
|
|||||||
2011
|
2010
|
|||||||
Assets
|
(Unaudited)
|
|||||||
Current assets:
|
||||||||
Cash
|
$ | 6,750,447 | $ | 3,671,151 | ||||
Total current assets
|
6,750,447 | 3,671,151 | ||||||
Fixed assets, net of accumulated depreciation of $4,666 and $3,874
|
11,167 | 11,959 | ||||||
Prepaid fees
|
76,458 | 3,500 | ||||||
Intangible assets, net of accumulated amortization of $47,278 and $43,029
|
164,890 | 169,139 | ||||||
Total assets
|
$ | 7,002,962 | $ | 3,855,749 | ||||
Liabilities and stockholders' equity
|
||||||||
Current liabilities:
|
||||||||
Accounts payable and accrued expenses
|
$ | 225,024 | $ | 139,169 | ||||
Accrued interest - stockholder
|
13,605 | 12,517 | ||||||
Convertible note payable - stockholder
|
105,000 | 105,000 | ||||||
Total current liabilities
|
343,629 | 256,686 | ||||||
Warrant derivative liabilities
|
1,860,442 | 2,314,033 | ||||||
Total liabilities
|
2,204,071 | 2,570,719 | ||||||
Commitments and contingencies
|
||||||||
Stockholders' equity:
|
||||||||
Preferred stock, par value $.0001 per share; 10,000,000 shares authorized, none issued and outstanding
|
- | - | ||||||
Common stock, par value $.0001 per share; 80,000,000 shares authorized, 20,023,402 and 17,604,465 shares issued and outstanding, respectively
|
2,002 | 1,760 | ||||||
Common stock subscribed
|
- | 611,846 | ||||||
Additional paid-in capital
|
19,594,976 | 15,120,792 | ||||||
Deficit accumulated during the development stage
|
(14,798,087 | ) | (14,449,368 | ) | ||||
Total stockholders' equity
|
4,798,891 | 1,285,030 | ||||||
Total liabilities and stockholders' equity
|
$ | 7,002,962 | $ | 3,855,749 |
See accompanying notes to unaudited condensed financial statements.
2
GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF LOSSES
FOR THE THREE MONTHS ENDED MARCH 31, 2011 AND 2010
AND FOR THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2011
(Unaudited)
Cumulative Period from November 21, 2003 (date of inception) to
|
||||||||||||
Three Months ended March 31,
|
March 31,
|
|||||||||||
2011
|
2010
|
2011
|
||||||||||
Operating expenses:
|
||||||||||||
General and administrative expenses
|
$ | 632,050 | $ | 395,880 | $ | 5,519,686 | ||||||
Research and development
|
421,116 | 354,065 | 8,176,523 | |||||||||
Research and development grant received
|
(244,479 | ) | - | (488,958 | ) | |||||||
Total operating expenses
|
808,687 | 749,945 | 13,207,251 | |||||||||
Loss from operations
|
(808,687 | ) | (749,945 | ) | (13,207,251 | ) | ||||||
Finance cost
|
- | - | (518,675 | ) | ||||||||
Gain (loss) on change in fair value of derivative liability
|
453,590 | (1,423,492 | ) | (1,086,614 | ) | |||||||
Interest income, net
|
6,378 | 3,373 | 14,453 | |||||||||
Loss before provision for income taxes
|
(348,719 | ) | (2,170,064 | ) | (14,798,087 | ) | ||||||
Provision for income taxes
|
- | - | - | |||||||||
Net loss
|
$ | (348,719 | ) | $ | (2,170,064 | ) | $ | (14,798,087 | ) | |||
Net loss per common share, basic and diluted
|
$ | (0.02 | ) | $ | (0.14 | ) | ||||||
Weighted average shares outstanding
|
19,359,196 | 15,649,956 |
See accompanying notes to unaudited condensed financial statements.
3
GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENT OF STOCKHOLDERS' (DEFICIT) EQUITY
FROM DATE OF INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2011
(Unaudited)
Deficit
|
||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||
Additional
|
Common
|
During the
|
Stockholders'
|
|||||||||||||||||||||
Common Stock
|
Paid-in
|
Stock
|
Development
|
Equity
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Subscribed
|
Stage
|
(Deficit)
|
|||||||||||||||||||
Balance, November 21, 2003
|
- | $ | - | $ | - | $ | - | $ | - | $ | - | |||||||||||||
Sale of common stock to founders at $0.0001 per share in November, 2003
|
6,100,000 | 610 | (510 | ) | - | - | 100 | |||||||||||||||||
Contributed services
|
- | - | 120,000 | - | - | 120,000 | ||||||||||||||||||
Net loss
|
- | - | - | - | (125,127 | ) | (125,127 | ) | ||||||||||||||||
Balance, December 31, 2003
|
6,100,000 | 610 | 119,490 | - | (125,127 | ) | (5,027 | ) | ||||||||||||||||
Contributed services
|
- | - | 192,000 | - | - | 192,000 | ||||||||||||||||||
Stock based compensation
|
- | - | 24,102 | - | - | 24,102 | ||||||||||||||||||
Net loss
|
- | - | - | - | (253,621 | ) | (253,621 | ) | ||||||||||||||||
Balance, December 31, 2004
|
6,100,000 | 610 | 335,592 | - | (378,748 | ) | (42,546 | ) | ||||||||||||||||
Contributed services
|
- | - | 48,000 | - | - | 48,000 | ||||||||||||||||||
Stock based compensation
|
- | - | 24,100 | - | - | 24,100 | ||||||||||||||||||
Net loss
|
- | - | - | - | (126,968 | ) | (126,968 | ) | ||||||||||||||||
Balance, December 31, 2005
|
6,100,000 | 610 | 407,692 | - | (505,716 | ) | (97,414 | ) | ||||||||||||||||
Contributed services
|
- | - | 144,000 | - | - | 144,000 | ||||||||||||||||||
Stock based compensation
|
- | - | 42,162 | - | - | 42,162 | ||||||||||||||||||
Net loss
|
- | - | - | - | (245,070 | ) | (245,070 | ) | ||||||||||||||||
Balance, December 31, 2006
|
6,100,000 | 610 | 593,854 | - | (750,786 | ) | (156,322 | ) | ||||||||||||||||
Shares sold for cash at $0.50 per share in November, 2007
|
1,300,000 | 130 | 649,870 | - | - | 650,000 | ||||||||||||||||||
Shares issued for services
|
735,000 | 74 | 367,426 | - | - | 367,500 | ||||||||||||||||||
Contributed services
|
- | - | 220,000 | - | - | 220,000 | ||||||||||||||||||
Stock based compensation
|
- | - | 24,082 | - | - | 24,082 | ||||||||||||||||||
Exercise of options for cash at $0.003 per share in March and June, 2007
|
900,000 | 90 | 2,610 | - | - | 2,700 | ||||||||||||||||||
Net loss
|
- | - | - | - | (691,199 | ) | (691,199 | ) | ||||||||||||||||
Balance, December 31, 2007
|
9,035,000 | 904 | 1,857,842 | - | (1,441,985 | ) | 416,761 | |||||||||||||||||
Exercise of options for cash at $0.50 per share on March 7,2008
|
1,000,000 | 100 | 499,900 | - | - | 500,000 | ||||||||||||||||||
Sale of common stock and warrants at $1.00 per share - July and August 2008
|
2,320,000 | 232 | 2,319,768 | - | - | 2,320,000 | ||||||||||||||||||
Cost of sale of common stock and warrants
|
- | - | (205,600 | ) | - | - | (205,600 | ) | ||||||||||||||||
Shares issued for accrued interest
|
31,718 | 3 | 15,856 | - | - | 15,859 | ||||||||||||||||||
Shares issued for services
|
100,000 | 10 | 49,990 | - | - | 50,000 | ||||||||||||||||||
Stock based compensation
|
- | - | 313,743 | - | - | 313,743 | ||||||||||||||||||
Contributed services
|
- | - | 50,000 | - | - | 50,000 | ||||||||||||||||||
Beneficial conversion feature of convertible debt
|
- | - | 20,675 | - | - | 20,675 | ||||||||||||||||||
Net loss
|
- | - | - | - | (3,326,261 | ) | (3,326,261 | ) |
See accompanying notes to unaudited condensed financial statements.
4
GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENT OF STOCKHOLDERS' (DEFICIT) EQUITY
FROM DATE OF INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2011
(Unaudited)
Deficit
|
||||||||||||||||||||||||
Accumulated
|
||||||||||||||||||||||||
Additional
|
Common
|
During the
|
Stockholders'
|
|||||||||||||||||||||
Common Stock
|
Paid-in
|
Stock
|
Development
|
Equity
|
||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Subscribed
|
Stage
|
(Deficit)
|
|||||||||||||||||||
Balance, December 31, 2008
|
12,486,718 | 1,249 | 4,922,174 | - | (4,768,246 | ) | 155,177 | |||||||||||||||||
Cumulative effect of change in accounting principle
|
- | - | (444,161 | ) | - | (290,456 | ) | (734,617 | ) | |||||||||||||||
Warrants issued for extension of debt maturities
|
- | - | 51,865 | - | - | 51,865 | ||||||||||||||||||
Stock based compensation
|
- | - | 1,530,536 | - | - | 1,530,536 | ||||||||||||||||||
Common stock issued for services
|
86,875 | 10 | 104,109 | - | - | 104,119 | ||||||||||||||||||
Sale of common stock and warrants at $1.50 per share - February 2009
|
466,674 | 46 | 667,439 | - | - | 667,485 | ||||||||||||||||||
Sale of common stock and warrants at $1.50 per share - April 2009
|
33,334 | 3 | 49,997 | - | - | 50,000 | ||||||||||||||||||
Sale of common stock and warrants at $1.50 per share - June 2009
|
1,420,895 | 142 | 2,038,726 | - | - | 2,038,868 | ||||||||||||||||||
Sale of common stock and warrants at $1.50 per share - July 2009
|
604,449 | 60 | 838,024 | - | - | 838,084 | ||||||||||||||||||
Sale of common stock and warrants at $1.50 per share - September 2009
|
140,002 | 14 | 202,886 | - | - | 202,900 | ||||||||||||||||||
Common stock and warrants issued as payment of placement fees
|
53,334 | 5 | (5 | ) | - | - | - | |||||||||||||||||
Common stock and warrants issued upon conversion of note and accrued interest
|
174,165 | 18 | 174,147 | - | - | 174,165 | ||||||||||||||||||
Net loss
|
- | - | - | - | (5,132,827 | ) | (5,132,827 | ) | ||||||||||||||||
Balance, December 31, 2009
|
15,466,446 | 1,547 | 10,135,737 | - | (10,191,529 | ) | (54,245 | ) | ||||||||||||||||
Stock based compensation
|
- | - | 1,165,450 | - | - | 1,165,450 | ||||||||||||||||||
Sale of common stock and warrants at $1.65 per share - February and March 2010
|
533,407 | 53 | 806,157 | - | - | 806,210 | ||||||||||||||||||
Sale of common stock and warrants at $2.00 per share - May 2010
|
1,347,500 | 135 | 2,655,365 | - | - | 2,655,500 | ||||||||||||||||||
Common stock and warrants issued as payment of placement fees
|
43,632 | 4 | (4 | ) | - | - | - | |||||||||||||||||
Common stock issued as payment for patents and license
|
20,000 | 2 | 46,798 | - | - | 46,800 | ||||||||||||||||||
Common stock and warrants subscribed
|
- | - | - | 611,846 | - | 611,846 | ||||||||||||||||||
Salaries paid with common stock
|
43,479 | 4 | 99,996 | - | - | 100,000 | ||||||||||||||||||
Exercise of options and warrants
|
150,001 | 15 | 124,986 | - | - | 125,001 | ||||||||||||||||||
Reclassification of derivative liability upon exercise of warrants
|
- | - | 86,307 | - | - | 86,307 | ||||||||||||||||||
Net loss
|
- | - | - | - | (4,257,839 | ) | (4,257,839 | ) | ||||||||||||||||
Balance, December 31, 2010
|
17,604,465 | 1,760 | 15,120,792 | 611,846 | (14,449,368 | ) | 1,285,030 | |||||||||||||||||
Stock based compensation
|
- | - | 99,422 | - | - | 99,422 | ||||||||||||||||||
Sale of common stock and warrants at $1.80 per share - January and February 2011
|
2,241,605 | 224 | 4,034,659 | (611,846 | ) | - | 3,423,037 | |||||||||||||||||
Common stock and warrants issued as payment of placement fees
|
61,498 | 6 | (6 | ) | - | - | - | |||||||||||||||||
Common stock and warrants issued as payment of accrued consulting fees
|
33,334 | 3 | 59,997 | - | - | 60,000 | ||||||||||||||||||
Common stock and warrants issued as payment of consulting fees
|
82,500 | 9 | 293,615 | - | - | 293,624 | ||||||||||||||||||
Cost of sales of common stock and warrants
|
- | - | (13,503 | ) | - | - | (13,503 | ) | ||||||||||||||||
Net loss
|
- | - | - | - | (348,719 | ) | (348,719 | ) | ||||||||||||||||
Balance, March 31, 2011
|
20,023,402 | $ | 2,002 | $ | 19,594,976 | $ | - | $ | (14,798,087 | ) | $ | 4,798,891 |
See accompanying notes to unaudited condensed financial statements.
5
GENSPERA, INC.
(A Development Stage Company)
CONDENSED STATEMENTS OF CASH FLOWS
FOR THE THREE MONTHS ENDED MARCH 31, 2011 AND 2010
AND FOR THE PERIOD FROM INCEPTION (NOVEMBER 21, 2003) TO MARCH 31, 2011
(Unaudited)
Cumulative Period
from November 21, 2003 (date of inception) to |
||||||||||||
Three months ended March 31,
|
March 31,
|
|||||||||||
2011
|
2010
|
2011
|
||||||||||
Cash flows from operating activities:
|
||||||||||||
Net loss
|
$ | (348,719 | ) | $ | (2,170,064 | ) | $ | (14,798,087 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities:
|
||||||||||||
Depreciation and amortization
|
5,041 | 4,629 | 51,944 | |||||||||
Stock based compensation
|
316,588 | 186,742 | 4,062,382 | |||||||||
Common stock issued for acquisition of license
|
- | - | 28,800 | |||||||||
Warrants issued for financing costs
|
- | - | 467,840 | |||||||||
Change in fair value of derivative liability
|
(453,591 | ) | 1,423,492 | 1,086,613 | ||||||||
Contributed services
|
- | - | 774,000 | |||||||||
Amortization of debt discount
|
- | - | 20,675 | |||||||||
Changes in assets and liabilities:
|
||||||||||||
Increase in accounts payable and accrued expenses
|
146,943 | 154,960 | 325,053 | |||||||||
Cash used in operating activities
|
(333,738 | ) | (400,241 | ) | (7,980,780 | ) | ||||||
Cash flows from investing activities:
|
||||||||||||
Acquisition of property and equipment
|
- | - | (15,833 | ) | ||||||||
Acquisition of intangibles
|
- | - | (194,168 | ) | ||||||||
Cash used in investing activities
|
- | - | (210,001 | ) | ||||||||
Cash flows from financing activities:
|
||||||||||||
Proceeds from sale of common stock and warrants
|
3,423,037 | 806,210 | 14,724,730 | |||||||||
Proceeds from exercise of warrants
|
- | 50,001 | 125,001 | |||||||||
Cost of common stock and warrants sold
|
(10,003 | ) | (13,503 | ) | ||||||||
Proceeds from convertible notes - stockholder
|
- | - | 155,000 | |||||||||
Repayments of convertible notes - stockholder
|
- | - | (50,000 | ) | ||||||||
Cash provided by financing activities
|
3,413,034 | 856,211 | 14,941,228 | |||||||||
Net increase in cash
|
3,079,296 | 455,970 | 6,750,447 | |||||||||
Cash, beginning of period
|
3,671,151 | 2,255,311 | - | |||||||||
Cash, end of period
|
$ | 6,750,447 | $ | 2,711,281 | $ | 6,750,447 | ||||||
Supplemental cash flow information:
|
||||||||||||
Cash paid for interest
|
$ | - | $ | - | ||||||||
Cash paid for income taxes
|
$ | - | $ | - | ||||||||
Non-cash financing activities:
|
||||||||||||
Common stock units issued as payment of accrued consulting fees
|
$ | 60,000 | $ | - | ||||||||
Common stock units issued as payment of placement fees
|
110,695 | - | ||||||||||
Common stock and warrants issued as payment of consulting fees
|
293,624 | - | ||||||||||
Derivative liability reclassified to equity upon exercise of warrants
|
- | 58,791 |
See accompanying notes to unaudited condensed financial statements.
6
GENSPERA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
FOR THE THREE MONTHS ENDED MARCH 31, 2011 AND 2010
AND FOR THE PERIOD FROM NOVEMBER 21, 2003
(INCEPTION) TO MARCH 31, 2011
(Unaudited)
NOTE 1 - SUMMARY OF ACCOUNTING POLICIES
A summary of the significant accounting policies applied in the preparation of the accompanying financial statements follows.
Business and Basis of Presentation
GenSpera Inc. (“we”, “us”, “our company”, “our”, “GenSpera” or the “Company”) was formed under the laws of the State of Delaware in 2003. We are a development stage entity, as defined by the Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 915. GenSpera, Inc. is a pharmaceutical company focused on the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder and kidney cancer. Our operations are based in San Antonio, Texas.
To date, we have generated no sales revenues, have incurred significant expenses and have sustained losses. Consequently, our operations are subject to all the risks inherent in the establishment of a new business enterprise. For the period from inception on November 21, 2003 through March 31, 2011, we have accumulated losses of $14,798,087.
Liquidity
As of March 31, 2011, we had working capital (current assets in excess of current liabilities) of $6,406,818. Our cash flow used in operations was $333,738 and $400,241 for the three months ended March 31, 2011 and 2010, respectively. At March 31, 2011, we had cash on hand of approximately $6,750,000 and raised approximately $3,423,000 in the first quarter of 2011. Based upon current cash flow projections, management believes the Company will have sufficient capital resources to meet projected cash flow requirements through April 2012.
Use of Estimates
The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying disclosures. Although these estimates are based on management's best knowledge of current events and actions the Company may undertake in the future, actual results may differ from those estimates.
Research and Development
Research and development costs include expenses incurred by the Company for research and development of therapeutic agents for the treatment of cancer and are charged to operations as incurred. Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, clinical trials and compensation and consulting costs.
GenSpera incurred net research and development expenses of $176,637, $354,065 and $7,687,565 for the three months ended March 31, 2011 and 2010, and from November 21, 2003 (inception) through March 31, 2011, respectively.
7
Loss Per Share
We use ASC 260, “Earnings Per Share” for calculating the basic and diluted loss per share. We compute basic loss per share by dividing net loss and net loss attributable to common shareholders by the weighted average number of common shares outstanding. Basic and diluted loss per share are the same, in that any potential common stock equivalents would have the effect of being anti-dilutive in the computation of net loss per share. There were 10,604,824 common share equivalents at March 31, 2011 and 8,003,903 at March 31, 2010. For the three months ended March 31, 2011 and 2010, these potential shares were excluded from the shares used to calculate diluted earnings per share as their inclusion would reduce net loss per share.
Fair value of financial instruments
Our short-term financial instruments, including cash, accounts payable and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on management’s estimates, reasonably approximate their book value. The fair value of long term convertible notes is based on management estimates and reasonably approximates their book value after comparison to obligations with similar interest rates and maturities. The fair value of the Company’s derivative instruments is determined using option pricing models.
Fair value measurements
We follow the guidance established pursuant to ASC 820 which established a framework for measuring fair value and expands disclosure about fair value measurements. ASC 820 defines fair value as the amount that would be received for an asset or paid to transfer a liability (i.e., an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. ASC 820 also establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. ASC 820 describes the following three levels of inputs that may be used:
Level 1: Quoted prices (unadjusted) in active markets that are accessible at the measurement date for identical assets and liabilities. The fair value hierarchy gives the highest priority to Level 1 inputs.
Level 2: Observable prices that are based on inputs not quoted on active markets but corroborated by market data.
Level 3: Unobservable inputs when there is little or no market data available, thereby requiring an entity to develop its own assumptions. The fair value hierarchy gives the lowest priority to Level 3 inputs.
The table below summarizes the fair values of our financial liabilities as of March 31, 2011:
Fair Value at
|
Fair Value Measurement Using
|
|||||||||||||||
March 31,
2011
|
Level 1
|
Level 2
|
Level 3
|
|||||||||||||
Warrant derivative liability
|
$
|
1,860,442
|
$
|
—
|
$
|
—
|
$
|
1,860,442
|
||||||||
$
|
1,860,442
|
$
|
—
|
$
|
—
|
$
|
1,860,442
|
8
The table below sets forth a summary of changes in the fair value of the Company’s Level 3 financial liabilities (warrant derivative liability) for the three months ended March 31, 2011.
2011
|
|
|||
Balance at beginning of year
|
$
|
2,314,033
|
||
Change in fair value of warrant liability
|
(453,591
|
)
|
||
Balance at end of period
|
$
|
1,860,442
|
The following is a description of the valuation methodologies used for these items:
Warrant derivative liability — these instruments consist of certain of our warrants with anti-dilution provisions. These instruments were valued using pricing models which incorporate the Company’s stock price, volatility, U.S. risk free rate, dividend rate and estimated life.
Income Taxes
We utilize ASC 740 “Income Taxes” which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Under this method, deferred income taxes are recognized for the tax consequences in future years of differences between the tax bases of assets and liabilities and their financial reporting amounts at each year-end based on enacted tax laws and statutory tax rates applicable to the periods in which the differences are expected to affect taxable income.
Stock-Based Compensation
We account for our stock based compensation under ASC 718 “Compensation – Stock Compensation” using the fair value based method. Under this method, compensation cost is measured at the grant date based on the value of the award and is recognized over the service period, which is usually the vesting period. This guidance establishes standards for the accounting for transactions in which an entity exchanges it equity instruments for goods or services. It also addresses transactions in which an entity incurs liabilities in exchange for goods or services that are based on the fair value of the entity’s equity instruments or that may be settled by the issuance of those equity instruments.
We use the fair value method for equity instruments granted to non-employees and use the Black-Scholes model for measuring the fair value of options. The stock based fair value compensation is determined as of the date of the grant or the date at which the performance of the services is completed (measurement date) and is recognized over the vesting periods.
Recent Accounting Pronouncements
Recent accounting pronouncements issued by the FASB (including its Emerging Issues Task Force), the AICPA, and the SEC did not, or are not believed by management to, have a material impact on the Company's present or future financial statements.
NOTE 2 - CAPITAL STOCK AND STOCKHOLDER’S EQUITY
We are authorized to issue 80,000,000 shares of common stock with a par value of $.0001 per share and 10,000,000 shares of preferred stock with a par value of $.0001 per share.
On January 21, 2011, pursuant to a securities purchase agreement (the “Securities Purchase Agreement”), we sold 2,074,914 units resulting in gross proceeds to the Company of $3,734,840 (“Offering”). The price per unit was $1.80. Each unit consists of: (i) one (1) share of the Company’s common stock, par value $.0001 (“Shares”), and (ii) one half (1/2) Common Stock Purchase Warrant (“Warrant(s)”). Of these units, 339,915 were subscribed at December 31, 2010 with gross proceeds to the Company of $611,847 recorded in the December 31, 2010 financial statements as Common Stock Subscribed.
9
The Warrants have a term of five years and entitle the holders to purchase the Company’s common shares at a price per share of $3.30. In the event the shares underlying the Warrants are not subject to a registration statement, the warrants may be exercised on a cashless basis after 12 months from the issuance date. The Warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. The Warrants do not contain any price protection provisions. The Warrants are callable by the Company assuming the following: (i) the Common Stock trades above $5.50 for ten (10) consecutive days; (ii) the daily average minimum volume over such ten (10) days is 15,000 or greater; and (iii) there is an effective registration statement covering the underlying shares. The Securities Purchase Agreement also grants the investors certain piggy-back registration rights.
In connection with the Offering, we incurred placement agent and finder’s fees in the amount of $114,295 in cash and issued warrants to purchase a total of 63,498 shares at an average exercise price per share of $3.26. Of the fees incurred, $110,695 was reinvested in the Offering on the same terms and conditions as the investors, resulting in the issuance of 61,498 units.
On February 16, 2011, pursuant to a securities purchase agreement, we sold an additional 166,691 units resulting in gross proceeds to the Company of $300,044. The units contain the same terms as the January 21, 2011 units described above. In connection with the offering, we incurred placement agent and finder’s fees in the amount of $6,403 in cash and issued warrants to purchase a total of 3,558 shares at an exercise price per share of $2.16.
As a result of the offerings, the reinvestment of fees, and the issuance of placement agent and finder’s warrants, we issued a total of 2,303,103 shares and 1,218,610 common stock purchase warrants.
During March, 2011, we issued 33,334 units as payment of accrued consulting fees in the amount of $60,000. These fees had been accrued at December 31, 2010.
During March, 2011, we issued 82,500 shares of common stock and 144,000 warrants as payment of consulting fees. The warrants have an exercise price of $3.30 per share and have the same terms as the warrants issued with the offerings described above. The common shares have been valued at $144,375 based on the market price of our common stock. The warrants have been valued at $149,249, determined using the Black-Scholes method based on the following weighted average assumptions: (1) risk free interest rate of 2.25%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the warrants of 5 years. Of the aggregate value of the stock and warrants of $293,624, we have recorded a prepayment of $76,458 at March 31, 2011, with the balance of $217,166 charged to expense during the three months ended March 31, 2011.
On March 1, 2011, we granted 39,000 common stock options to a director. The options have an exercise price of $1.90 per share. The options will vest quarterly over one year. The options lapse if unexercised after five years. The options have a grant date fair value of $20,416, determined using the Black-Scholes method based on the following weighted average assumptions: (1) risk free interest rate of 0.225%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the options of 0.625 years. During the three months ended March 31, 2011 we have recorded an expense of $1,701 related to the fair value of the options that are expected to vest.
During January 2011, we granted a total of 25,000 common stock options for legal and consulting services. The options have an exercise price of $1.90 per share. Of these options, 5,000 vested upon grant and 20,000 vests quarterly during 2011. The options and warrants lapse if unexercised after five years. We have recorded an expense of $12,948 during the three months ended March 31, 2011 related to the fair value of the options and warrants that vested or are expected to vest, determined using the Black-Scholes method based on the following weighted average assumptions: (1) risk free interest rate of 2.25%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 90%; and (4) an expected life of the warrants of 4.9 years.
10
During the three months ended March 31, 2011 we have recorded an expense of $73,142 related to the fair value of the options granted to our chief executive officer and chief operating officer in prior years that vested or are expected to vest.
During the three months ended March 31, 2011 we have recorded an expense of $11,631 related to the fair value of the options granted to directors and consultants in prior years that vested or are expected to vest.
NOTE 3 – DERIVATIVE LIABILITY
At March 31, 2011, we recalculated the fair value of our warrants subject to derivative accounting and have determined that their fair value at March 31, 2011 is $1,860,442. The value of the warrants was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.75%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the warrants of 2 years. We have recorded a credit of $453,591 during the three months ended March 31, 2011 related to the change in fair value during that period.
On April 29, 2011, we sold 1,363,622 units resulting in gross proceeds of $2,249,750. The price per unit was $1.65. Each unit consists of: (i) one (1) share of the common stock, par value $.0001, and (ii) one half (1/2) common stock purchase warrant. The warrants have a term of five years and entitle the holders to purchase the common shares at a price per share of $3.15. In the event the shares underlying the warrants are not subject to a registration statement, the warrants may be exercised on a cashless basis after 12 months from the issuance date. The warrants also contain provisions providing for an adjustment in the underlying number of shares and exercise price in the event of stock splits or dividends and fundamental transactions. The warrants do not contain any price protection provisions. The warrants are callable assuming the following: (i) our common stock trades above $6.50 for ten (10) consecutive days; (ii) the daily average minimum volume over such ten (10) days is 15,000 or greater; and (iii) there is an effective registration statement covering the underlying shares. We also granted the investors certain piggy-back registration rights.
In connection with the offering, we incurred finder’s fees in the amount of $60,000 in cash and issued warrants to purchase a total of 36,364 shares at an exercise price per share of $3.15. The warrants have the same terms and conditions as the investor warrants.
As a result of the offering and the finder’s warrants, we issued a total of 1,363,622 shares and 718,175 common stock purchase warrants.
11
ITEM 2.
|
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
Our Management’s Discussion and Analysis of Financial Condition and Results of Operations (MD&A) is provided in addition to the accompanying consolidated financial statements and notes to assist readers in understanding our results of operations, financial condition, and cash flows. MD&A is organized as follows:
·
|
Overview — Discussion of our business and plan of operations, overall analysis of financial and other highlights affecting the company in order to provide context for the remainder of MD&A.
|
|
·
|
Significant Accounting Policies — Accounting policies that we believe are important to understanding the assumptions and judgments incorporated in our reported financial results and forecasts.
|
|
·
|
Results of Operations — Analysis of our financial results comparing the quarter ended March 31, 2011 to the comparable period of 2010.
|
|
·
|
Liquidity and Capital Resources — An analysis of changes in our balance sheets and cash flows, and discussion of our financial condition and potential sources of liquidity.
|
The various sections of this MD&A contain a number of forward-looking statements. Words such as “expects,” “goals,” “plans,” “believes,” “continues,” “may,” and variations of such words and similar expressions are intended to identify such forward-looking statements. In addition, any statements that refer to projections of our future financial performance, our anticipated growth and trends in our businesses, and other characterizations of future events or circumstances are forward-looking statements. Such statements are based on our current expectations and could be affected by the uncertainties and risk factors described throughout this filing and particularly in the “Overview” section (see also “Risk Factors” in Part II, Item 1A of this Form 10-Q). Our actual results may differ materially.
Management's Plan of Operation
We are pursuing a business plan related to the development of targeted cancer therapeutics for the treatment of cancerous tumors, including breast, prostate, bladder, and kidney cancer. We are considered to be in the development stage as defined by Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 915 “Development Stage Entities”.
Business Strategy
Our business strategy is to develop a series of therapeutics based on our target-activated pro-drug technology platform and bring them through Phase I/II clinical trials. At that point, we plan to license the rights to further development of the drug candidates to major pharmaceutical companies. We believe that major pharmaceutical companies see significant value in drug candidates that have passed one or more phases of clinical trials, and these organizations have the resources and expertise to finalize drug development and market the drugs.
Plan of Operation
We have identified 4 prodrug candidates: G-202, G-114, G-115 and G-301 (formerly designated as Ac-GKAFRR-L12ADT). In our technology a prodrug is defined as an inactive form of a tumor-killing agent that is converted into an active form only within the tumor, thus minimizing side effects and maximizing anti-tumor efficacy. All of our drugs are based upon a unique cytotoxin called thapsigargin, which is isolated from the Mediterranean plant, Thapsia garganica.
Management believes that the best way to increase shareholder value is to remain focused on the efficient clinical development of G-202, already in Phase I clinical trials, as our highest priority. In addition to the development of G-202, we are also engaged in the preclinical development of G-115. It is anticipated that the development of the remaining candidates will not commence until we have sufficient resources to devote to their development.
Clinical Development of G-202
On June 23, 2009, we submitted our first IND for G-202 to the FDA. On September 4, 2009, we received approval from the FDA for our IND in order to commence clinical trials. Although we have received approval from the FDA to commence trials, the outcome of the trials is uncertain and, if we are unable to satisfactorily complete such trials, or if such trials yield unsatisfactory results, we will be unable to commercialize our proposed products. Over the next twelve months we plan to focus on clinical trials of G-202 in cancer patients.
For the manufacture of G-202, we have secured a stable supply of source material (Thapsia garganica seeds) from which thapsigargin is isolated, have a sole source agreement with a European supplier, Thapsibiza, SL, and have obtained the proper import permits from the USDA for these materials. We have also identified a clinically and commercially viable formulation for G-202 and have manufactured sufficient G-202 to supply our Phase I clinical needs. In anticipation of the upcoming G-202 Phase II clinical trials, we will complete manufacture of GMP grade G-202 over the next three months. The costs for manufacture of this clinical batch of drug are included in the current projected expenditures.
12
We anticipate that the Phase I clinical trial of G-202 will continue through the second quarter of 2011. The purpose of the Phase I study of G-202 is to evaluate safety, understand the pharmacokinetics (the process by which a compound is absorbed, distributed, metabolized, and eliminated by the body) of the drug candidate in humans, and to determine an appropriate dosing regimen for the subsequent clinical studies. This is accomplished by exposing successive cohorts of three patients to escalating doses of the drug until a Maximally Tolerated Dose (MTD) is identified. We are currently conducting the Phase I study in refractory cancer patients (those who have relapsed after former treatments) with any type of solid tumors. This strategy is intended to facilitate enrollment and perhaps give us a glimpse of safety across a wider variety of patients. We expect to enroll up to 30 patients in this Phase I study at: (i) Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins (Michael Carducci, MD as Principal Investigator); (ii) University of Wisconsin Carbone Cancer Center (George Wilding, MD as Principal Investigator); and (iii) Cancer Therapy and Research Center at the University of Texas Health Science Center in San Antonio (Devalingam Mahalingam, MD as Principal Investigator). The Phase I clinical protocol has been modified to accommodate enrollment of up to 18 additional patients in a Phase IB component of the study to evaluate the drug’s safety and tolerability and possible efficacy in a broader patient population consisting primarily of prostate cancer patients who have previously failed treatment with chemotherapeutic agents. It is expected that the Phase IB component of the study may give us an earlier glimpse of true anti-tumor activity as well as provide information on how to best design the subsequent Phase II study in this later stage prostate cancer patient population. It is anticipated that the ongoing Phase I clinical trial will be completed in the second quarter of 2011 whereas the Phase IB component of the trial will continue through the third and fourth quarters of 2011.
Upon completion of the dose escalation component of the Phase I clinical trial, we expect to conduct several Phase II clinical trials to determine the therapeutic efficacy of G-202 in cancer patients. The Phase II studies can be started while the Phase IB trial in late stage post-chemotherapy prostate cancer patients is ongoing. Although we believe that G-202 will be useful across a wide variety of cancer types, it is usually most efficient and medically prudent to evaluate a drug candidate in separate Phase II studies, each enrolling patients with a specific tumor type per individual study.. We are developing a Phase II clinical protocol for the treatment of castrate-resistant pre-chemotherapy prostate cancer patients to be conducted in the US with additional sites in the UK. This trial will have an advantage of demonstrating approval by European regulatory agencies for the use of G-202 in patients and is expected to launch in Q3 2011. We are also evaluating Phase II trial designs in other tumor types and expect to conduct up to four separate concurrent Phase II studies in different tumor types.
Development of G-115
We began development of G-115 in the fourth quarter of 2010 with an anticipated filing of an IND in the third quarter of 2011. The extra costs for preclinical development of G-115 to an IND submission may total up to $2.5 million. Because we wished to assure funding for an aggressive G-202 Phase II clinical program, we deferred full development of G-115 until we received additional monies via financings during the first four months of 2011. We now expect to file an IND in the United States or equivalent Clinical Trial Application (CTA) in Europe in the first quarter of 2012.
Anticipated Expenditures
We have budgeted $7,531,000 in cash expenditures for the twelve month period following March 31, 2011, including (1) $1,179,000 to cover our projected general and administrative expense during this period; and (2) $6,352,000 for research and development activities. Based on our cash at March 31, 2011 and cash received during April from the sale of our securities, we believe we have sufficient cash on hand to fund our operations until May 2012, after which time we will need to undertake additional financings. These assumptions are based upon operations focused on completion of the G-202 Phase I clinical program, initiation of several G-202 Phase II clinical trials, full pre-clinical development of G-115, and initiation of a Phase I clinical trial for G-115.
We anticipate that we will license G-202 to a third party during or after Phase II clinical studies. In the event we are not able or decide not to license G-202, we will proceed with Phase III Clinical trials. We estimate that Phase III Clinical trials will cost approximately $25 million and will be completed in the fourth quarter of 2015. If all goes as planned, we may expect marketing approval in the second half of 2016 with an additional $3 million spent to get the NDA approved. We do not expect material net cash inflows from our own marketing efforts before late 2016. The Phase III estimated costs are subject to major revision because we have not yet obtained any efficacy data for our drug in patients and therefore cannot accurately predict what may be the optimal Phase III patient population. The estimates will become more refined as we obtain more clinical data.
The amounts and timing of our actual expenditures and possible financings may vary significantly from our expectations depending upon numerous factors, including our results of operations and clinical trials, financial condition and capital requirements. Accordingly, we will retain the discretion to allocate the available funds among the identified uses described above, and we reserve the right to change the allocation of available funds among the uses described above.
13
Significant Accounting Policies
Our financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. The preparation of these financial statements requires management to make estimates and assumptions that affect the reported amounts of assets, liabilities, revenues and expenses. Note 1 of the Notes to Financial Statements describes the significant accounting policies used in the preparation of the financial statements. Certain of these significant accounting policies are considered to be critical accounting policies, as defined below. We do not believe that there have been significant changes to our accounting policies during the three months ended March 31, 2011, as compared to those policies disclosed in the March 31, 2010 quarterly report and December 31, 2010 financial statements, except as disclosed in the notes to financial statements or through the three month period ended March 31, 2011.
A critical accounting policy is defined as one that is both material to the presentation of our financial statements and requires management to make difficult, subjective or complex judgments that could have a material effect on our financial condition and results of operations. Specifically, critical accounting estimates have the following attributes: 1) we are required to make assumptions about matters that are highly uncertain at the time of the estimate; and 2) different estimates we could reasonably have used, or changes in the estimate that are reasonably likely to occur, would have a material effect on our financial condition or results of operations.
Estimates and assumptions about future events and their effects cannot be determined with certainty. We base our estimates on historical experience and on various other assumptions believed to be applicable and reasonable under the circumstances. These estimates may change as new events occur, as additional information is obtained and as our operating environment changes. These changes have historically been minor and have been included in the financial statements as soon as they became known. Based on a critical assessment of our accounting policies and the underlying judgments and uncertainties affecting the application of those policies, management believes that our financial statements are fairly stated in accordance with accounting principles generally accepted in the United States, and present a meaningful presentation of our financial condition and results of operations. We believe the following critical accounting policies reflect our more significant estimates and assumptions used in the preparation of our financial statements:
Use of Estimates — These financial statements have been prepared in accordance with accounting principles generally accepted in the United States and, accordingly, require management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Specifically, our management has estimated the expected economic life and value of our licensed technology, our net operating loss for tax purposes and our stock, option and warrant expenses related to compensation to employees and directors and consultants. Actual results could differ from those estimates.
Cash and Equivalents — Cash equivalents are comprised of certain highly liquid investments with maturity of three months or less when purchased. We maintain our cash in bank deposit accounts, which at times, may exceed federally insured limits. We have not experienced any losses in such accounts.
Intangible and Long-Lived Assets — We follow Financial Accounting Standards Board (“FASB”) Accounting Standards Codification (“ASC”) Topic 360, "Property, Plant and Equipment ", which established a "primary asset" approach to determine the cash flow estimation period for a group of assets and liabilities that represents the unit of accounting for a long lived asset to be held and used. Long-lived assets to be held and used are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The carrying amount of a long-lived asset is not recoverable if it exceeds the sum of the undiscounted cash flows expected to result from the use and eventual disposition of the asset. Long-lived assets to be disposed of are reported at the lower of carrying amount or fair value less cost to sell. We have not recognized any impairment losses.
Research and Development Costs — Research and development costs include expenses incurred by the Company for research and development of therapeutic agents for the treatment of cancer and are charged to operations as incurred.
Stock Based Compensation — We account for our share-based compensation under the provisions of ASC Topic 718 “Compensation – Stock Compensation”.
Fair Value of Financial Instruments — Our short-term financial instruments, including cash, accounts payable and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on management’s estimates, reasonably approximate their book value. The fair value of long term convertible notes is based on management estimates and reasonably approximates their book value after comparison to obligations with similar interest rates and maturities. The fair value of the Company’s derivative instruments is determined using option pricing models.
Recent Accounting Pronouncements
For a discussion of new accounting pronouncements affecting the Company, refer to Note 1 of Notes to Financial Statements.
14
Result of Operations for the First Quarter of 2011 Compared to the First Quarter of 2010
Our results of operations have varied significantly from year to year and quarter to quarter and may vary significantly in the future.
Revenue
We did not have revenue for the three months ended March 31, 2011 and 2010, respectively. We do not anticipate any revenues during 2011.
Operating Expenses
Operating expense totaled $808,687 and $749,945 for the three months ended March 31, 2011 and 2010, respectively. The increase in operating expenses is primarily the result of increased general and administrative expenses.
Three Months Ended
March 31,
|
||||||||
2011
|
2010
|
|||||||
Operating expenses
|
||||||||
General and administrative expenses
|
$
|
632,050
|
$
|
395,880
|
||||
Research and development
|
421,116
|
354,065
|
||||||
Research and development grant received
|
(244,479
|
)
|
--
|
|||||
Total operating expense
|
$
|
808,687
|
$
|
749,945
|
General and Administrative Expenses
General and Administrative Expenses (“G&A”) expenses totaled $632,050 and $395,880 for the three months ended March 31, 2011 and 2010, respectively. The increase of $236,170 or 60% for the three months ended March 31, 2011 compared to the same period in 2010 was primarily attributable to a number of factors, including an increase in consulting fees of approximately $248,000 (of which $233,000 was stock based expense), an increase in professional and other fees of approximately $62,000 and an increase in travel and entertainment expense of approximately $22,000, all partially offset by a decrease in compensation expense of approximately $89,000.
Research and Development Expenses
Research and development expenses totaled $421,116 and $354,065 for the three months ended March 31, 2011 and 2010, respectively. The increase of $67,051 or 19% for the three months ended March 31, 2011 compared to the same period in 2010 was primarily attributable to a number of factors, including an increase in development expense of approximately $179,000 related to more advanced clinical trials in the current period, partially offset by a decrease in compensation expense of approximately $114,000.
Our research and development expenses consist primarily of expenditures for toxicology and other studies, manufacturing, clinical trials and compensation and consulting costs. Under the planning and direction of key personnel, we expect to outsource all of our Good Laboratory Practices (“GLP”) preclinical development activities (e.g., toxicology) and Good Manufacturing Practices (“GMP”) manufacturing and clinical development activities to contract research organizations (“CROs”) and contract manufacturing organizations (“CMOs”). Manufacturing will be outsourced to organizations with approved facilities and manufacturing practices.
Research and Development Grant
During 2010 we were awarded two Federal grants, totaling approximately $489,000, through the Patient Protection and Affordable Care Act, which supports investments in qualifying therapeutic discovery projects. Of this amount, we received $244,479 during the fourth quarter of 2010 and the balance of $244,479 during the first quarter of 2011. We will not receive any additional funding under these grants.
15
Other Income (Expenses)
Other income (expenses) totaled $459,968 and $(1,420,119) for the three months ended March 31, 2011 and 2010, respectively.
Three Months Ended
March 31,
|
||||||||
2011
|
2010
|
|||||||
Other expense:
|
||||||||
Change in fair value of derivative liability
|
453,590
|
(1,423,492
|
)
|
|||||
Interest income, net
|
6,378
|
3,373
|
||||||
Total other income (expenses)
|
$
|
459,968
|
$
|
(1,420,119
|
)
|
Change in fair value of derivative liability
Change in fair value of derivative liability totaled $453,590 of income during the three months ended March 31, 2011 and $1,423,492 of expense for the three months ended March 31, 2010.
The change in the fair value of our warrant derivative liability resulted primarily from the changes in our stock price and the volatility of our common stock during the reported periods. Refer to Note 3 to the financial statements for further discussion on our warrant liabilities.
At March 31, 2011, we recalculated the fair value of our warrants subject to derivative accounting and have determined that their fair value at March 31, 2011 is $1,860,442. The value of the warrants was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 0.75%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 89%; and (4) an expected life of the warrants of 2 years. We have recorded a credit of $453,591 during the three months ended March 31, 2011 related to the change in fair value during that period.
During the three months ended March 31, 2010, 33,334 of our warrants subject to derivative accounting were exercised into common stock. We have recorded an expense of $21,119 at the date of exercise related to the change in fair value from January 1, 2010 to the date of exercise. As a result of the exercise of the warrants, we have reclassified $58,791 of our warrant derivative liability to paid in capital.
At March 31, 2010, we recalculated the fair value of our remaining warrants subject to derivative accounting and have determined that their fair value at March 31, 2010 is $3,655,387. The value of the warrants was determined using the Black-Scholes method based on the following assumptions: (1) risk free interest rate of 1%; (2) dividend yield of 0%; (3) volatility factor of the expected market price of our common stock of 99%; and (4) an expected life of the warrants of 2 years. We have recorded an expense of $1,402,373 during the three months ended March 31, 2010 related to the change in fair value during that period.
Interest income, net
We had net interest income of $6,378 and $3,373 for the three months ended March 31, 2011 and 2010, respectively. The increase in net interest income of $3,005 for the three months ended March 31, 2011 compared to the same period in 2010 was attributable to an increase in interest earned on deposits.
Liquidity and Capital Resources
Since our inception, we have financed our operations primarily through the private placement of our securities. Our currently monthly cash burn rate is $390,000. This will increase to $760,000 in the third and fourth quarters of 2011, which is primarily due to increases in Phase II clinical activities. We anticipate that our available cash and expected income will be sufficient to finance most of our current activities for at least the next 14 months from March 31, 2011.
Three Months Ended
March 31,
|
||||||||
2011
|
2010
|
|||||||
Cash & Cash Equivalents
|
$
|
6,750,447
|
$
|
2,711,281
|
||||
Net cash used in operating activities
|
$
|
(333,738
|
)
|
$
|
(400,241
|
)
|
||
Net cash provided by financing activities
|
$
|
3,413,034
|
$
|
856,211
|
16
Total cash was $6,750,447 and $2,711,281 at March 31, 2011 and 2010, respectively. The increase of $4,039,166 at March 31, 2011 compared to the same period in 2010 was primarily attributable to capital raised through equity sales in the first quarter of 2011.
Net Cash Used in Operating Activities
In our operating activities we used cash of $333,738 and $400,241 for the three months ended March 31, 2011 and 2010, respectively. The decrease of $66,503 in cash used for the three months ended March 31, 2011 compared to the same period in 2010 was primarily attributable to a decrease in net loss, after adjustment for noncash items.
Net Cash Provided by Financing Activities
Cash provided by financing activities was $3,413,034 and $856,211 for the three months ended March 31, 2011 and 2010, respectively.
Listed below are key financing transactions w