Apollo Endosurgery, Inc. - Quarter Report: 2012 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the quarterly period ended June 30, 2012
OR
o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For the transition period from to
Commission File Number: 000-50344
LPATH, INC.
(Exact name of registrant as specified in its charter)
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Nevada |
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16-1630142 |
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(State or other jurisdiction of |
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(I.R.S. Employer |
4025 Sorrento Valley Blvd., San Diego, CA 92121
(Address of principal executive offices, including zip code)
(858) 678-0800
(Registrant’s telephone number, including area code)
Indicate by check mark whether the registrant (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes x No o
Indicate by check mark whether the registrant 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 during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o
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 definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
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Large accelerated filer o |
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Accelerated filer o |
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Non-accelerated filer o |
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Smaller reporting company x |
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(Do not check if a smaller reporting company) |
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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). Yes o No x
The number of shares of issuer’s outstanding Class A common stock as of August 9, 2012 was 73,736,990.
LPATH, INC.
FORM 10-Q
June 30, 2012
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Management’s Discussion and Analysis of Financial Condition and Results of Operations |
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LPATH, INC.
Condensed Consolidated Balance Sheets
(Unaudited)
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June 30, |
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December 31, |
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2012 |
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2011 |
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ASSETS |
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Current Assets: |
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Cash and cash equivalents |
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$ |
18,243,723 |
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$ |
14,410,630 |
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Accounts receivable |
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642,526 |
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1,334,583 |
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Prepaid expenses and other current assets |
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129,265 |
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331,828 |
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Total current assets |
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19,015,514 |
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16,077,041 |
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Equipment and leasehold improvements, net |
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233,181 |
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176,067 |
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Patents, net |
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1,705,634 |
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1,610,752 |
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Deposits and other assets |
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77,350 |
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79,350 |
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Total assets |
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$ |
21,031,679 |
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$ |
17,943,210 |
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LIABILITIES AND STOCKHOLDERS’ EQUITY |
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Current Liabilities: |
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Accounts payable |
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$ |
759,528 |
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$ |
2,215,152 |
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Accrued compensation |
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283,435 |
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448,753 |
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Accrued expenses |
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1,613,321 |
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1,320,033 |
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Deferred contract revenue, current portion |
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7,850,071 |
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6,081,934 |
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Deferred rent, short-term portion |
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7,424 |
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5,378 |
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Total current liabilities |
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10,513,779 |
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10,071,250 |
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Deferred rent, long-term portion |
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105,461 |
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107,936 |
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Deferred contract revenue, long-term portion |
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— |
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3,535,000 |
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Warrants |
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3,700,000 |
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3,600,000 |
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Total liabilities |
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14,319,240 |
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17,314,186 |
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Stockholders’ Equity: |
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Common stock - $.001 par value; 200,000,000 shares authorized; 73,736,990 and 60,602,315 issued and outstanding at June 30, 2012 and December 31, 2011, respectively |
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73,737 |
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60,602 |
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Additional paid-in capital |
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46,800,515 |
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40,729,515 |
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Accumulated deficit |
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(40,161,813 |
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(40,161,093 |
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Total stockholders’ equity |
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6,712,439 |
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629,024 |
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Total liabilities and stockholders’ equity |
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$ |
21,031,679 |
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$ |
17,943,210 |
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See accompanying notes to the condensed consolidated financial statements.
LPATH, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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Six Months Ended |
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Three Months Ended |
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June 30, |
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June 30, |
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2012 |
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2011 |
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2012 |
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2011 |
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Revenues: |
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Grant and royalty revenue |
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$ |
400,620 |
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$ |
964,385 |
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$ |
219,795 |
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$ |
338,311 |
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Research and development revenue under collaborative agreements |
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3,683,113 |
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3,354,494 |
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1,106,035 |
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1,202,234 |
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Total revenues |
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4,083,733 |
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4,318,879 |
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1,325,830 |
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1,540,545 |
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Expenses: |
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Research and development |
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4,634,390 |
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3,308,340 |
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1,532,874 |
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1,378,567 |
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General and administrative |
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1,754,750 |
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1,546,814 |
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872,864 |
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794,231 |
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Total expenses |
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6,389,140 |
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4,855,154 |
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2,405,738 |
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2,172,798 |
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Loss from operations |
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(2,305,407 |
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(536,275 |
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(1,079,908 |
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(632,253 |
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Other income (expense), net |
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4,687 |
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(39,501 |
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33,259 |
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4,109 |
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Change in fair value of warrants |
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2,300,000 |
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300,000 |
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400,000 |
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2,000,000 |
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Total other income (expense) |
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2,304,687 |
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260,499 |
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433,259 |
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2,004,109 |
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Net income (loss) |
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$ |
(720 |
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$ |
(275,776 |
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$ |
(646,649 |
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$ |
1,371,856 |
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Earnings (loss) per share |
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Basic |
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$ |
— |
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$ |
— |
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$ |
(0.01 |
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$ |
0.02 |
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Diluted |
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$ |
— |
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$ |
— |
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$ |
(0.01 |
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$ |
0.02 |
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Weighted-average shares outstanding used in the calculation |
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Basic |
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71,889,187 |
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62,810,735 |
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76,866,247 |
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62,943,125 |
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Diluted |
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71,889,187 |
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62,810,735 |
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76,866,247 |
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65,584,540 |
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See accompanying notes to the condensed consolidated financial statements.
LPATH, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
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Six Months Ended |
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June 30, |
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2012 |
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2011 |
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Cash flows from operating activities: |
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Net loss |
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$ |
(720 |
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$ |
(275,776 |
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Adjustments to reconcile net loss to net cash (used in) provided by operating activities: |
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Stock-based compensation expense |
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257,730 |
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390,920 |
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Change in fair value of warrants |
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(2,300,000 |
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(300,000 |
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Depreciation and amortization |
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47,182 |
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37,216 |
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Changes in operating assets and liabilities: |
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Accounts receivable |
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692,057 |
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14,521,078 |
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Prepaid expenses and other current assets |
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202,563 |
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70,899 |
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Accounts payable and accrued expenses |
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(1,322,988 |
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(917,917 |
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Deferred contract revenue |
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(1,766,863 |
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(1,500,000 |
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Other |
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11,589 |
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(37,513 |
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Net cash (used in) provided by operating activities |
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(4,179,450 |
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11,988,907 |
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Cash flows from investing activities: |
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Equipment and leasehold improvement expenditures |
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(91,740 |
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(97,928 |
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Patent expenditures |
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(107,663 |
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(77,322 |
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Net cash used in investing activities |
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(199,403 |
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(175,250 |
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Cash flows from financing activities: |
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Proceeds from sale of common stock and warrants, net |
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8,211,946 |
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— |
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Proceeds from options and warrants exercised |
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— |
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34,090 |
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Net cash provided by financing activities |
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8,211,946 |
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34,090 |
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Net increase in cash and cash equivalents |
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3,833,093 |
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11,847,747 |
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Cash and cash equivalents at beginning of period |
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14,410,630 |
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6,803,506 |
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Cash and cash equivalents at end of period |
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$ |
18,243,723 |
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$ |
18,651,253 |
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Supplemental disclosures of cash flow information: |
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Cash paid during the period for: |
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Income taxes |
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$ |
1,600 |
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$ |
1,600 |
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Supplemental Schedule of Non-cash Investing and Financing Activities: |
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Change in fair value of warrant liability |
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$ |
(2,300,000 |
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$ |
(300,000 |
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See accompanying notes to the condensed consolidated financial statements.
LPATH, INC.
Notes to Condensed Consolidated Financial Statements
June 30, 2012
Note 1 — BASIS FOR PRESENTATION
The unaudited condensed consolidated balance sheet of Lpath, Inc. (“Lpath” or “the company”) as of December 31, 2011 was derived from audited financial statements, but does not contain all disclosures required by accounting principles generally accepted in the United States of America, and certain information and disclosures normally included have been condensed or omitted pursuant to the rules and regulations of the SEC.
In the opinion of management, all adjustments considered necessary for a fair presentation have been included. Except as otherwise disclosed, all such adjustments are of a normal recurring nature. Operating results for the three month and six month periods ended June 30, 2012 are not necessarily indicative of the results that may be expected for the year ending December 31, 2012. For further information, refer to the consolidated financial statements and notes included in the company’s annual report on Form 10-K for the year ended December 31, 2011.
The preparation of the consolidated financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Note 2—SALE OF COMMON STOCK
In March 2012, Lpath closed a public offering in which it sold 12,358,663 units, with each unit consisting of one share of the company’s Class A common stock and 0.5 of a warrant to purchase one share of the company’s Class A common stock, for aggregate gross proceeds of $9,269,000, before deducting placement agent fees and other estimated offering expenses of $1,057,000. The purchase price for each unit was $0.75. Each warrant issued has an exercise price of $1.10 per share, is exercisable immediately and will expire five years from the date of issuance. Each warrant may be exercised using a cashless exercise procedure at the holder’s sole discretion and includes provisions providing for adjustments to the number of shares exercisable thereunder upon stock dividends, stock splits and similar events.
Note 3 — RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS
In 2010, Lpath entered into an agreement providing Pfizer Inc. (“Pfizer”) with an exclusive option for a worldwide license to develop and commercialize iSONEP™ (“the Pfizer Agreement”), Lpath’s lead monoclonal antibody product candidate that is being evaluated for the treatment of wet age-related macular degeneration (“wet AMD”) and other ocular disorders.
Under the terms of the agreement, Pfizer provided Lpath with an up-front option payment of $14 million in addition to sharing the cost of the planned trials. The up-front payment was received in January 2011. Following completion of the trials, Pfizer has the right to exercise its option for worldwide rights to iSONEP for an undisclosed option fee and, if Pfizer exercises its option, Lpath will be eligible to receive development, regulatory, and commercial milestone payments that could total up to $497.5 million; in addition, Lpath will be entitled to receive tiered double-digit royalties based on sales of iSONEP. As part of the agreement, Lpath has granted to Pfizer a time-limited right of first refusal for ASONEP™, Lpath’s product candidate that is being evaluated for the treatment of cancer.
We recognized revenue under the Pfizer Agreement as follows:
Pfizer revenues
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Six Months Ended |
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Three Months Ended |
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June 30, |
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June 30, |
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2012 |
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2011 |
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2012 |
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2011 |
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Cost reimbursements |
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$ |
1,916,250 |
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$ |
1,179,494 |
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$ |
16,218 |
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$ |
452,234 |
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Amortization of development fees |
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1,766,863 |
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1,500,000 |
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1,089,817 |
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750,000 |
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$ |
3,683,113 |
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$ |
2,679,494 |
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$ |
1,106,035 |
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$ |
1,202,234 |
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In connection with the termination in 2010 of the License Agreement dated October 28, 2008 by and between the company and Merck KGaA, the company has received payment from Merck KGaA in the second quarter of 2011 in the amount of $675,000 to discharge certain payment obligations that survived termination of the License Agreement. Payment of this amount became certain and determinable in the first quarter of 2011 and, as such, was recognized as revenue in that period.
Note 4 — SHARE-BASED PAYMENTS
The company recognized share-based compensation expense as follows:
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Six Months Ended |
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Three Months Ended |
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June 30, |
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June 30, |
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2012 |
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2011 |
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2012 |
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2011 |
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Research and development |
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$ |
66,111 |
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$ |
111,534 |
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$ |
42,025 |
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$ |
45,111 |
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General and administrative |
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191,619 |
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279,386 |
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107,681 |
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98,176 |
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Total share-based compensation expense |
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$ |
257,730 |
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$ |
390,920 |
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$ |
149,706 |
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$ |
143,287 |
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As of June 30, 2012, there was a total of $1.1 million unrecognized compensation expense related to unvested stock-based compensation under the Lpath, Inc. Amended and Restated 2005 Equity Incentive Plan. That expense is expected to be recognized over a weighted average period of 2.6 years. Because of its net operating loss carryforwards, the company did not realize any tax benefits for the tax deductions from share-based payment arrangements during the periods ended June 30, 2012 and 2011.
Note 5 — FAIR VALUE MEASUREMENTS
Lpath has issued warrants, of which some are classified as equity and some as liabilities. The following table includes warrants classified as liabilities either because they have “down-round” protection or due to cash settlement provisions. The company’s recurring fair value measurements at June 30, 2012 were as follows:
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Fair Value as of |
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Significant |
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Liabilities: |
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Warrants expiring August 2013 |
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$ |
400,000 |
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$ |
400,000 |
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Warrants expiring March 2017 |
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3,300,000 |
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3,300,000 |
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$ |
3,700,000 |
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$ |
3,700,000 |
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The warrants issued in March 2012 (and expiring in March 2017), provide that in the event of a fundamental transaction, as defined by the warrant agreement, the company may, under certain circumstances, be obligated to settle the March 2012 warrants for cash equal to the value of the warrants determined in accordance with the warrant agreement.
Recurring Level 3 Activity, Reconciliation, and Basis for Valuation
The table below provides a reconciliation of the beginning and ending balances for the liabilities measured at fair value using significant unobservable inputs (Level 3). The table reflects net gains and losses for the six months ended June 30, 2012 for all financial assets and liabilities categorized as Level 3.
Fair Value Measurements Using Significant Unobservable Inputs (Level 3):
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Liabilities: |
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Warrant liability as of January 1, 2012 |
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$ |
3,600,000 |
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Exercise of warrants |
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(1,100,000 |
) | |
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Issuance of warrants |
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3,500,000 |
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Change in fair value of warrants |
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(2,300,000 |
) | |
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Warrant liability as of June 30, 2012 |
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$ |
3,700,000 |
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The company determined the fair value of the warrant liability for certain warrants, as applicable, using a Black-Scholes model with consideration given to their “down-round” protection provisions that reduce the exercise price if the company issues new warrants or equity at a price lower than the stated exercise price. The model considered amounts and timing of future possible equity and warrant issuances and historical volatility of the company’s stock price.
The following table summarizes Lpath warrants outstanding as of June 30, 2012, inclusive of warrants classified as equity and as liabilities:
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Warrant Expiration Date |
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Number |
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Exercise Price |
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October 31, 2012 |
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531,394 |
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$ |
0.16 |
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November 16, 2012 |
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3,627,968 |
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$ |
1.00 |
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February 28, 2013 |
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50,000 |
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$ |
2.00 |
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August 12, 2013 |
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2,062,381 |
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$ |
1.12 |
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August 15, 2013 |
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88,111 |
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$ |
1.12 |
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August 18, 2013 |
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14,091 |
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$ |
1.12 |
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March 27, 2014 |
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50,000 |
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$ |
1.00 |
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June 24, 2014 |
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40,000 |
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$ |
0.80 |
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December 24, 2015 |
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40,000 |
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$ |
0.80 |
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March 9, 2017 |
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208,227 |
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$ |
0.75 |
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March 9, 2017 |
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6,179,327 |
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$ |
1.10 |
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Total: |
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12,891,499 |
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Weighted average: |
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$ |
1.03 |
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The terms of all outstanding warrants permit the company, upon exercise of the warrants, to settle the contract by the delivery of unregistered shares. During the six months ended June 30, 2012, there were cashless exercises of 3,378,370 warrants in exchange for issuance of registered 759,966 shares of common stock, and 4,458,934 warrants expired.
Note 6 — EARNINGS PER SHARE
Basic and diluted earnings per share were calculated as follows:
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Six Months Ended |
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Three Months Ended |
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June 30, |
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June 30, |
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2012 |
|
2011 |
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2012 |
|
2011 |
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Net income (loss) |
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$ |
(720 |
) |
$ |
(275,776 |
) |
$ |
(646,649 |
) |
$ |
1,371,856 |
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Weighted average number of shares used in basic earnings (loss) per share |
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71,889,187 |
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62,810,735 |
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76,866,247 |
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62,943,125 |
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| ||||
|
Additional dilutive shares from the assumed exercise of outstanding: |
|
|
|
|
|
|
|
|
| ||||
|
Options |
|
— |
|
— |
|
— |
|
1,347,513 |
| ||||
|
Restricted stock units |
|
— |
|
— |
|
— |
|
167,619 |
| ||||
|
Warrants |
|
— |
|
— |
|
— |
|
1,126,283 |
| ||||
|
Weighted average number of shares used in diluted earnings (loss) per share |
|
71,889,187 |
|
62,810,735 |
|
76,866,247 |
|
65,584,540 |
| ||||
Options to purchase 312,000 shares of common stock, warrants to purchase 2,137,277 shares of common stock, and 56,698 restricted stock units were outstanding during the quarter ended June 30, 2011, but were not included in the computation of diluted earnings per share because they were anti-dilutive.
Item 2. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
This discussion and analysis of our financial condition and results of operations should be read in conjunction with our financial condensed consolidated statements and notes thereto included in this quarterly report on Form 10-Q (the “Quarterly Report”) and the audited financial statements and notes thereto included in our annual report on Form 10-K for the year ended December 31, 2011 (the “2011 Annual Report”), as filed with the Securities and Exchange Commission (the “SEC”). In addition to historical information, this discussion and analysis contains forward-looking statements that involve risks, uncertainties, and assumptions. Our actual results may differ materially from those anticipated in these forward-looking statements as a result of certain factors including but not limited to those identified in the 2011 Annual Report in the section entitled “Market Risks.”
Overview
We are a biotechnology company focused on the discovery and development of lipidomic-based therapeutics. Lipidomics is an emerging field of medical science whereby bioactive signaling lipids are targeted to treat important human diseases. We have three product candidates, iSONEP™, ASONEP™, and Lpathomab™. iSONEP is a monoclonal antibody against sphingosine-1-phosphate (“S1P”) formulated for treating retinal diseases. iSONEP has completed Phase 1 clinical trials and demonstrated promising results in treating patients afflicted with wet age-related macular degeneration. Studies conducted in models of human ocular disease indicate that iSONEP may also be useful in treating other ocular diseases including diabetic retinopathy and glaucoma. ASONEP (another formulation of the same S1P-targeted antibody) completed a Phase 1 clinical trial in 2010, and we believe that it holds promise for the treatment of cancer and other diseases. Lpathomab™ is an antibody against lysophosphatidic acid (“LPA”), a key bioactive lipid that has been long recognized as a valid disease target. Lpathomab is in pre-clinical testing in various animal models of disease relating to the central nervous system and to fibrosis. Our ability to generate novel antibodies against bioactive lipids is based on our ImmuneY2™ technology, a series of proprietary processes we have developed. We are currently applying the Immune Y2 process to other lipid-signaling agents that are validated targets for disease treatment, thereby potentially creating a further pipeline of monoclonal antibody-based drug candidates.
In December 2010, we entered into an agreement providing Pfizer Inc. (“Pfizer”) the rights to develop and commercialize iSONEP (the “Pfizer Agreement”). Under the terms of that agreement, Pfizer provided us with an upfront payment of $14 million and will share the cost of two human proof-of-concept clinical trials of iSONEP. The first trial (called “PEDigree”) is designed to test iSONEP as a treatment for patients with Pigment Epithelial Detachment (“PED”), a complication of wet-AMD. The second, and larger, trial (“Nexus”) is designed to further study iSONEP as a treatment for wet-AMD. We began enrolling patients in the PEDigree and Nexus trials in September 2011 and October 2011, respectively.
In January 2012, we temporarily suspended dosing patients in our PED and wet-AMD trials. We took this action because we learned from the FDA that it had determined that our fill-and-finish contractor, Formatech, Inc., was not in compliance with FDA’s current Good Manufacturing Practice (“cGMP”) requirements during the period in August 2010 that the iSONEP clinical vials were filled. After we suspended dosing, we were notified by the FDA that the iSONEP trials were being placed on clinical hold. The FDA has not informed us regarding any specific non-compliance issues at Formatech that may have affected our drug product. iSONEP has been well tolerated by all patients in our Phase 1 trial and by all patients treated thus far in our PED and wet-AMD trials.
We have manufactured the additional drug substance required to complete the trials, and have completed the fill/finish process with an alternate contractor. We believe we will be prepared to resume dosing patients in the third quarter of 2012, subject to receipt of FDA approval. As a result of the clinical hold, the projected costs to complete the iSONEP trials have increased significantly. These cost increases are related to manufacturing additional clinical drug supply and the cost of activities required to restart the clinical trials. Pfizer has requested that we consider potential alternatives to offset a portion of the increased costs, including the possibility of incorporating the PEDigree study into the Nexus study. We are continuing our discussions with Pfizer on this issue, but no final decision has been made. Because of these ongoing discussions, we plan to restart the larger Nexus trial as soon as possible after the FDA lifts the clinical hold, and have deprioritized the smaller PEDigree trial.
The actual time required to complete our clinical trials will depend on a number of factors outside of our direct control, including those discussed in the section of our Annual Report on Form 10-K entitled, “Risk Factors—We may have delays in completing our clinical trials and we may not complete them all.” Pfizer has the right to exercise its option for exclusive worldwide rights to iSONEP. If Pfizer exercises its option, we will receive an option fee as well as potential development, regulatory, and commercial milestone payments. In addition, if iSONEP eventually becomes a commercial product, we will be entitled to receive double-digit royalties, tiered based on annual sales of iSONEP. As part of the Pfizer Agreement, we granted to Pfizer a time-limited right of first refusal for ASONEP.
Lpath has incurred significant accumulated losses since its inception. As of June 30, 2012, we had an accumulated deficit of approximately $40.2 million. We expect that the cost of our ongoing research and development activities as currently planned, including general and
administrative expenses, will approximate $21 million to $24 million through the second quarter of 2014 (including the manufacture of additional iSONEP necessary to resume our trials). This estimate includes the expenses to conduct the clinical trials for iSONEP, as well as to complete the manufacture of clinical material and initiate Phase 2a clinical trials for ASONEP. In addition, this estimate includes the expenses to conduct cell-line development, the first step in developing the manufacturing process, for our third product candidate, Lpathomab. In order to complete preclinical development and file an Investigational New Drug (“IND”) application for Lpathomab, we will need to obtain approximately $4 million to $6 million of additional funding. As has been the case with our other development programs, that funding may come from a number of potential sources, including grants, equity financing, or partnerships. We expect our expenditures to increase as we continue the advancement of our product development programs. The lengthy process of completing clinical trials and seeking regulatory approval for one product candidate typically requires expenditures in excess of approximately $100 million, according to industry data. Any failure by us or delay in completing clinical trials, or in obtaining regulatory approvals, would cause our research and development expenses not reimbursable under the Pfizer agreement to increase and, in turn, could have a material adverse effect on our results of operations.
Results of Operations
Grant and Royalty Revenue. Grant and royalty revenue for the quarter ended June 30, 2012 was $220,000 compared to $338,000 for the quarter ended June 30, 2011. For the first half of 2012, grant and royalty revenue was $401,000 compared to $964,000 in the first half of 2011. The 2012 decrease in grant revenue is attributable to reduced reimbursable costs for outside services in 2012 compared to 2011.
Research and Development Revenue Under Collaborative Agreement. As described in Note 3 to the condensed consolidated financial statements, in December 2010 we entered into an agreement with Pfizer that provides financial support for our iSONEP and ASONEP development programs. We recognized revenues as follows:
|
|
|
Six Months Ended |
|
Three Months Ended |
| ||||||||
|
|
|
June 30, |
|
June 30, |
| ||||||||
|
|
|
2012 |
|
2011 |
|
2012 |
|
2011 |
| ||||
|
Cost reimbursements |
|
$ |
1,916,250 |
|
$ |
1,179,494 |
|
$ |
16,218 |
|
$ |
452,234 |
|
|
Amortization of development fees |
|
1,766,863 |
|
1,500,000 |
|
1,089,817 |
|
750,000 |
| ||||
|
|
|
$ |
3,683,113 |
|
$ |
2,679,494 |
|
$ |
1,106,035 |
|
$ |
1,202,234 |
|
In connection with the termination in 2010 of the License Agreement dated October 28, 2008 by and between the company and Merck KGaA, the company received payment from Merck KGaA in the second quarter of 2011 in the amount of $675,000 to discharge certain payment obligations that survived termination of the License Agreement. That payment became certain and determinable in the first quarter of 2011 and, as such, was recognized as revenue in that period.
Research and Development Expenses. Research and development expenses increased to $1,533,000 for the second quarter of 2012 from $1,379,000 for the second quarter of 2011, an increase of $154,000. Employee compensation expense increased by $179,000 in the second quarter of 2012 compared to 2011 due to increased staffing in our research and development functions.
Research and development expense increased to $4,634,000 in the first half of 2012 from $3,308,000 in 2011, an increase of $1,326,000. Outside services and lab supplies increased by $978,000 in the first half of 2012. The increase was driven by the costs associated with remanufacturing the drug substance used in our clinical trials. Employee compensation expense increased by $293,000 in the first half of 2012 compared to 2011 due to increased staffing in our research and development functions.
General and Administrative Expenses. General and administrative expenses were $873,000 for the quarter ended June 30, 2012 compared to $794,000 for the same period in 2011, an increase of $79,000. The increase in 2012 is due principally to increases in our occupancy costs.
General and administrative expenses were $1,755,000 in the first half of 2012 compared to $1,547,000 in 2011, an increase of $208,000. Occupancy costs increased $101,000. Employee compensation expense increased during the first half of 2012 compared to 2011 by $56,000, due to merit increases.
Change in Fair Value of Warrants. Various factors are considered in the pricing models we use to value the warrants, including the company’s current stock price, the remaining life of the warrants, the volatility of the company’s stock price, and the risk-free interest rate. Future changes in these factors will have a significant impact on the computed fair value of the warrant liability. The most significant factor in the valuation model is the company’s stock price. Lpath’s stock is very thinly traded and relatively small transactions can impact the company’s quoted stock price significantly. As such, we expect future changes in the fair value of the warrants to continue to vary significantly from quarter to quarter. Management cautions that the $2,300,000 net change in fair value of the warrants credited to the results of operations, recognized during the six months ended June 30, 2012, and all similar changes in the future, should not be given undue importance when considering the financial condition of Lpath and the results of its operations. Management does not believe that these adjustments, which are required by current generally accepted accounting principles, reflect economic activities or financial obligations undertaken by the company.
Liquidity and Capital Resources
As of June 30, 2012, Lpath had cash and cash equivalents totaling $18.2 million. Since Lpath’s inception, its operations have been financed primarily through the private placement of equity and debt securities and funds received from corporate partners pursuant to research and development collaboration agreements. In March 2012, Lpath closed a public offering in which it sold 12,358,663 units, with each unit consisting of one share of the company’s Class A common stock and 0.5 of a warrant to purchase one share of the company’s Class A common stock, for aggregate gross proceeds of $9,269,000, before deducting placement agent fees and other estimated offering expenses of $1,057,000. From inception through June 30, 2012, Lpath had received net proceeds of approximately $49.6 million from the sale of equity securities and the issuance of convertible promissory notes. In addition, Lpath had received a total of $34.4 million from corporate partners. During the first half of 2012, Lpath received $2.6 million in funding from a research and development arrangement with Pfizer.
Under the Pfizer research and development agreement, Pfizer and Lpath share ongoing development costs of iSONEP. As of June 30, 2012, Pfizer has paid us approximately $19.8 million. We expect to receive an additional $0.2 million in the third quarter of 2012. Under the terms of the agreement, we will fund the next $6.0 million of iSONEP project costs, which began in the second quarter of 2012.
Net cash used in investing activities during the six months ended June 30, 2012 was $199,000. Of the amount used for investing activities in the first half of 2012, $108,000 was invested in the prosecution of patents compared to $77,000 in during the comparable period in 2011. As provided for in the agreement with Pfizer, in 2011, Pfizer has assumed financial responsibility to prosecute certain patents related to technology underlying the Pfizer Agreement.
We believe our cash on hand as of June 30, 2012 together with amounts to be received pursuant to the Pfizer Agreement and NIH grants should be sufficient to fund our ongoing research and development activities, as currently planned, through the second quarter of 2014. This estimate includes the expenses to conduct the clinical trials for iSONEP, as well as to initiate a Phase 2a clinical trial for ASONEP. In addition, this estimate includes the expenses to conduct cell-line development, the first step in developing the manufacturing process, for our third product candidate, Lpathomab. In order to complete preclinical development and file an IND application for Lpathomab, we will need to obtain approximately $4 million to $6 million of additional funding. As has been the case with our other development programs, that funding may come from a number of potential sources, including grants, equity financing, or partnerships. We expect our expenditures to increase as we continue the advancement of our product development programs. The lengthy process of completing clinical trials and seeking regulatory approval for one product candidate typically requires expenditures in excess of approximately $100 million, according to industry data. Any failure by us or delay in completing clinical trials, or in obtaining regulatory approvals, would cause our research and development expenses to increase and, in turn, could have a material adverse effect on our results of operations.
If Pfizer exercises its option to continue the clinical development of iSONEP, we will receive an option fee as well as potential development, regulatory, and commercial milestone payments and royalties. If received, those payments could provide significant funding to support our drug discovery and development activities. However, we cannot assure you that we will be successful in maintaining our commercial relationship with Pfizer, that Pfizer will exercise its option to commercialize iSONEP, or that iSONEP will achieve the developmental, regulatory, and commercial milestones necessary to entitle us to future payments under the Pfizer Agreement on a timely basis, or at all. As a result, we may be required to secure substantial additional capital to continue to fund our planned drug discovery and development projects beyond the second quarter of 2014.
Until we can generate significant cash from operations, we expect to continue to fund our operations with cash resources generated from a combination of proceeds of offerings of our equity and debt securities, license agreements, and NIH grants. However, we may not be successful in obtaining cash from new or existing collaboration agreements or licenses, or in receiving milestone or royalty payments under those agreements. In addition, we cannot be sure that additional financing will be available when needed or that, if available, financing will be obtained on terms favorable to us or to our stockholders. Having insufficient funds may require us to
delay, scale back, or eliminate some or all of our development programs, relinquish some or even all rights to product candidates at an earlier stage of development, or renegotiate less favorable terms than we would otherwise choose. Failure to obtain adequate financing also may adversely affect our ability to operate as a going concern. If we raise additional funds from the issuance of equity securities, substantial dilution to our existing stockholders would likely result. If we raise additional funds by incurring debt financing, the terms of the debt may involve significant cash payment obligations as well as covenants and specific financial ratios that may restrict our ability to operate our business.
Critical Accounting Policies, Estimates, and Judgments
Our consolidated financial statements are prepared in accordance with accounting principles that are generally accepted in the United States. The preparation of these consolidated financial statements requires us to make estimates and judgments that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting period. We continually evaluate our estimates and judgments, the most critical of which are those related to revenue recognition, valuation of long-lived assets and warrant liability, share-based compensation, the timing of the achievement of drug development milestones, and income taxes. We base our estimates and judgments on historical experience and other factors that we believe to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known.
Besides the estimates identified above that are considered critical, we make many other accounting estimates in preparing our condensed consolidated financial statements and related disclosures. All estimates, whether or not deemed critical, affect reported amounts of assets, liabilities, revenues and expenses, as well as disclosures of contingent assets and liabilities. These estimates and judgments are also based on historical experience and other factors that are believed to be reasonable under the circumstances. Materially different results can occur as circumstances change and additional information becomes known, even for estimates and judgments that are not deemed critical.
For further information, refer to the consolidated financial statements and notes thereto included in the company’s annual report on Form 10-K for the year ended December 31, 2011.
Item 4. CONTROLS AND PROCEDURES
We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in our reports filed pursuant to the Securities Exchange Act of 1934, as amended (the “Exchange Act”) is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosure.
Under the supervision of our Chief Executive Officer and our Chief Financial Officer, and with the participation of all members of management, we conducted an evaluation of our disclosure controls and procedures, as such term is defined under Rule 13a-15(e) promulgated under the Exchange Act. Based on this evaluation, our principal executive officer and our principal financial officer concluded that our disclosure controls and procedures were designed and operating effectively as of the end of the period covered by this Quarterly Report on Form 10-Q.
Our management, including our Chief Executive Officer and our Chief Financial Officer, cannot be certain that our disclosure controls and procedures or our internal controls will prevent all instances of errors and fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the company have been detected.
Changes in Internal Control Over Financial Reporting
In connection with the evaluation required by Exchange Act Rule 13a-15(d), our management, including our Chief Executive Officer and our Chief Financial Officer, concluded that no changes in our internal control over financial reporting occurred during the period covered by this report that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
None.
Item 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
None.
Item 3. DEFAULTS UPON SENIOR SECURITIES
None.
Item 4. MINE SAFETY DISCLOSURE
Not applicable
None.
(a) Exhibits:
The following exhibit index shows those exhibits filed with this report and those incorporated herein by reference:
|
2.1 |
|
Agreement and Plan of Reorganization, by and between Neighborhood Connections, Inc., Neighborhood Connections Acquisition Corporation, and Lpath Therapeutics Inc. dated July 15, 2005 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on December 6, 2005 and incorporated herein by reference). |
|
|
|
|
|
2.2 |
|
Acquisition Agreement and Plan of Merger, dated as of March 19, 2004, between Neighborhood Connections, Inc. and JCG, Inc. (filed as Exhibit 2.1 to the Current Report on Form 8-K filed on March 22, 2004 and incorporated herein by reference). |
|
|
|
|
|
3.1 |
|
Amendment to Articles of Incorporation filed December 1, 2005 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on December 6, 2005 and incorporated herein by reference). |
|
|
|
|
|
3.2 |
|
Articles of Incorporation filed on September 18, 2002 (filed as Exhibit 3.1 to Amendment No. 1 to the Annual Report on Form 10-KSB/A for the year ended December 31, 2003 (the “2003 Amended 10-KSB”) (filed on March 25, 2004 and incorporated herein by reference). |
|
|
|
|
|
3.3 |
|
Amendment to Articles of Incorporation filed on December 27, 2002 (filed as Exhibit 3.3 to the Current Report on Form 8-K/A filed on January 9, 2006 and incorporated herein by reference). |
|
|
|
|
|
3.4 |
|
Amended and Restated By-laws (filed as Exhibit 3.4 to the Quarterly Report on Form 10-QSB filed on November 13, 2006 and incorporated herein by reference). |
|
|
|
|
|
3.5 |
|
Amended and Restated Bylaws, as amended on April 3, 2007 (conformed) (filed as Exhibit 3.5 to the Registration Statement on Form SB-2, SEC File No. 144199 (the “June 2007 SB-2”) and incorporated herein by reference). |
|
|
|
|
|
3.6 |
|
Amendment to Articles of Incorporation filed on June 8, 2007 (filed as Exhibit 3.6 to the June 2007 SB-2 and incorporated herein by reference). |
|
|
|
|
|
4.1 |
|
Form of Warrant issued to purchasers of Convertible Secured Promissory Notes as amended by the Omnibus Amendment to Convertible Secured Promissory Notes and Warrants dated November 30, 2005 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on December 6, 2005 and incorporated herein by reference). |
|
4.2 |
|
Form of Warrant issued pursuant to the Common Stock and Warrant Purchase Agreement dated March 28, 2006 (filed as Exhibit 4.7 to the registration statement on Form SB-2 filed on March 30, 2006, SEC File No. 333-132850, and incorporated herein by reference). |
|
|
|
|
|
4.3 |
|
Form of Warrant issued pursuant to the Securities Purchase Agreement dated April 6, 2007 (April 2007 Warrants) (filed as Exhibit 4.7 to the June 2007 SB-2 and incorporated herein by reference). |
|
|
|
|
|
4.4 |
|
Form of Warrant issued pursuant to the Securities Purchase Agreement dated June 13, 2007 (June 2007 Warrants) (filed as Exhibit 4.8 to the June 2007 SB-2 and incorporated herein by reference). |
|
|
|
|
|
4.5 |
|
Form of Warrant issued pursuant to the Securities Purchase Agreement dated August 12, 2008 (August 2008 Warrants) (filed as Exhibit 4.10 to the registration statement on Form S-1 filed on September 11, 2008, SEC File No. 333-153423 and incorporated herein by reference). |
|
|
|
|
|
4.6 |
|
Form of Warrant issued pursuant to the Securities Purchase Agreement, dated November 16, 2010, by and between Lpath, Inc. and each purchaser identified therein (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on November 18, 2010 and incorporated herein by reference). |
|
|
|
|
|
4.7 |
|
Form of Common Stock Purchase Warrant for Investors in the Units. (filed as an exhibit to Form 8-K filed with the SEC on March 6, 2012 and incorporated herein by reference.) |
|
|
|
|
|
4.8 |
|
Form of Common Stock Purchase Warrant for Placement Agents of the Units. (filed as an exhibit to Form 8-K filed with the SEC on March 6, 2012 and incorporated herein by reference.) |
|
|
|
|
|
4.9 |
|
Form of Warrant for Griffin Securities, Inc. (filed as an exhibit to Form 8-K filed with the SEC on March 6, 2012 and incorporated herein by reference.) |
|
|
|
|
|
10.1 |
|
Lease dated May 31, 2011 between Sorrento Science Park, LLC and Lpath, Inc. for 4025 Sorrento Valley Blvd. San Diego, California 92121 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on June 3, 2011 and incorporated herein by reference). |
|
|
|
|
|
10.2 |
|
Research Agreement dated January 28, 2004 between Medlyte, Inc. and San Diego State University, together with Amendments No. 1 and No. 2 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on December 6, 2005 and incorporated herein by reference). |
|
|
|
|
|
10.3 |
|
Assignment Agreement dated June 9, 2005 between Lpath Therapeutics Inc. and LPL Technologies, Inc. (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on December 6, 2005 and incorporated herein by reference). |
|
|
|
|
|
10.4 |
|
Research Collaboration Agreement dated August 2, 2005 between Lpath Therapeutics Inc. and AERES Biomedical Limited (filed as Exhibit 10.4 to the Current Report on Form 8-K/A filed on January 9, 2006 and incorporated herein by reference) (portions of this exhibit have been omitted pursuant to a request for confidential treatment). |
|
|
|
|
|
10.5 |
|
Lpath, Inc. Amended and Restated 2005 Equity Incentive Plan (filed as Appendix A to the company’s Schedule 14-A Proxy Statement filed on August 28, 2007 and incorporated herein by reference).+ |
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|
|
|
|
10.6 |
|
Assignment and Assumption Agreement dated December 1, 2005 by and between Lpath, Inc. and Lpath Therapeutics, Inc. (filed as an exhibit to the Annual Report on Form 10-KSB for the year ended December 31, 2005 filed with the SEC on March 16, 2006 and incorporated herein by reference). |
|
|
|
|
|
10.7 |
|
Form of Employment Agreement between Lpath, Inc. and Scott R. Pancoast dated as of January 1, 2006 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on March 29, 2006 and incorporated herein by reference).+ |
|
|
|
|
|
10.8 |
|
Form of Employment Agreement between Lpath, Inc. and Gary Atkinson dated as of February 6, 2006 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on March 29, 2006 and incorporated herein by reference).+ |
|
10.9 |
|
Form of Consultant Agreement between Lpath, Inc. and Roger Sabbadini dated as of February 1, 2006 (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on March 29, 2006 and incorporated herein by reference).+ |
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|
|
|
|
10.10 |
|
Development and Manufacturing Services Agreement dated August 16, 2006 between Lpath Inc. and Laureate Pharma, Inc. (filed as Exhibit 10.13 to the Quarterly Report on Form 10-QSB for the quarter ended September 30, 2006 filed on November 13, 2006 and incorporated herein by reference) (portions of this exhibit have been omitted pursuant to a request for confidential treatment). |
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|
|
|
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10.11 |
|
Securities Purchase Agreement, dated as of April 6, 2007, by and among Lpath, Inc. and each investor identified therein (filed as Exhibit 10.14 to the June 2007 SB-2 and incorporated herein by reference). |
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|
|
|
|
10.12 |
|
Registration Rights Agreement, dated as of April 6, 2007, by and among Lpath, Inc. and each investor identified therein (filed as Exhibit 10.15 to the June 2007 SB-2 and incorporated herein by reference). |
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|
|
|
|
10.13 |
|
License Agreement dated August 8, 2006 between Lonza Biologics PLC and Lpath, Inc. (filed as an exhibit to the Quarterly Report on Form 10-QSB for the quarterly period ended September 30, 2007 filed with the SEC on November 13, 2007 and incorporated herein by reference)(portions of this exhibit have been omitted pursuant to a request for confidential treatment). |
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|
|
|
|
10.14 |
|
Securities Purchase Agreement, dated August 12, 2008, by and among Lpath, Inc. and each of the investors identified therein (filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 25, 2009 and incorporated herein by reference) (filed as Exhibit 10.17 to the 2008 S-1 and incorporated herein by reference). |
|
|
|
|
|
10.15 |
|
Registration Rights Agreement, dated August 12, 2008, by and among Lpath, Inc. and each of the investors identified therein (filed as Exhibit 10.18 to the 2008 S-1 and incorporated herein by reference). |
|
|
|
|
|
10.16 |
|
License Agreement, dated as of October 28, 2008, by and between Lpath, Inc. and Merck KgaA (filed as an exhibit to the Annual Report on Form 10-K for the year ended December 31, 2008 filed with the SEC on March 25, 2009 and incorporated herein by reference) (portions of this exhibit have been omitted pursuant to a request for confidential treatment). |
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|
|
|
|
10.17 |
|
Securities Purchase Agreement, dated November 16, 2010, by and between Lpath, Inc. and each purchaser identified therein (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on November 18, 2010 and incorporated herein by reference). |
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|
|
|
|
10.18 |
|
Registration Rights Agreement, dated November 16, 2010, by and between Lpath, Inc. and each purchaser identified therein (filed as an exhibit to the Current Report on Form 8-K filed with the SEC on November 18, 2010 and incorporated herein by reference). |
|
|
|
|
|
10.19 |
|
Option, License and Development Agreement, dated as of December 16, 2010, by and between Lpath, Inc. and Pfizer Inc. (filed as Exhibit 10.19 to the Annual Report on Form 10-K for the year ended December 31, 2010 filed with the SEC on March 23, 2011 and incorporated herein by reference) (portions of this exhibit have been omitted pursuant to a request for confidential treatment). |
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|
|
|
|
10.20 |
|
Form of Placement Agent Agreement. (filed as an exhibit to Form 8-K filed with the SEC on March 6, 2012 and incorporated herein by reference.) |
|
|
|
|
|
10.21 |
|
Form of Subscription Agreement for U.S. investors. (filed as an exhibit to Form 8-K filed with the SEC on March 6, 2012 and incorporated herein by reference.) |
|
|
|
|
|
10.22 |
|
Financial Advisor Agreement, dated as of December 30, 2011 by and between Lpath, Inc. and Griffin Securities, Inc. (filed as an exhibit to Form 8-K filed with the SEC on March 6, 2012 and incorporated herein by reference.) |
|
|
|
|
|
21.1 |
|
List of Subsidiaries of Registrant (filed as an exhibit to the Annual Report on Form 10-KSB for the year ended December 31, 2005 filed with the SEC on March 16, 2006 and incorporated herein by reference). |
|
31.1 |
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Section 302 Certification by Chief Executive Officer of Lpath, Inc. |
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31.2 |
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Section 302 Certification by Chief Financial Officer of Lpath, Inc. |
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32.1 |
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Section 906 Certification by Chief Executive Officer and Chief Financial Officer of Lpath, Inc. |
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101.INS* |
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XBRL Instance Document |
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101.SCH* |
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XBRL Taxonomy Extension Schema Document |
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101.CAL* |
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XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF* |
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XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB* |
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XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE* |
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XBRL Taxonomy Extension Presentation Linkbase Document |
+ Management contract or compensation plan or arrangement
* In accordance with Regulation S-T, the XBRL-related information in Exhibit 101 shall be deemed “furnished” and not “filed.”
(c) Financial Statement Schedules
All financial statement schedules are omitted because they are not applicable or the required information is shown in the consolidated financial statements or other notes hereto.
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed below by the following persons on behalf of the Registrant and in the capacities and on the dates indicated.
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Lpath, Inc. |
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Date: August 13, 2012 |
/S/ SCOTT R. PANCOAST |
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Scott R. Pancoast |
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President and Chief Executive Officer |
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(Principal Executive Officer) |
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/S/ GARY J. G. ATKINSON, |
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Gary J. G. Atkinson, |
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Vice President and Chief Financial Officer |
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(Principal Financial and Accounting Officer) |