Document and Entity Information
Document and Entity Information | 6 Months Ended |
Jun. 30, 2016 | |
Document and Entity Information | |
Entity Registrant Name | LPATH, INC |
Entity Central Index Key | 1,251,769 |
Document Type | S4 |
Document Period End Date | Jun. 30, 2016 |
Amendment Flag | false |
Entity Filer Category | Smaller Reporting Company |
Consolidated Balance Sheets
Consolidated Balance Sheets | Dec. 31, 2014USD ($) |
Current Assets: | |
Cash and cash equivalents | $ 17,282,325 |
Accounts receivable | 727,178 |
Prepaid expenses and other current assets | 413,260 |
Total current assets | 18,422,763 |
Equipment and leasehold improvements, net | 221,148 |
Patents, net | 2,236,909 |
Deposits and other assets | 77,350 |
Total assets | 20,958,170 |
Current Liabilities: | |
Accounts payable | 2,865,165 |
Accrued compensation | 848,583 |
Accrued expenses | 383,623 |
Deferred contract revenue | 125,000 |
Deferred rent, short-term portion | 33,744 |
Total current liabilities | 4,256,115 |
Deferred rent, long-term portion | 35,629 |
Warrants | 850,000 |
Total liabilities | 5,141,744 |
Stockholders' Equity: | |
Common stock | 19,225 |
Additional paid-in capital | 81,830,410 |
Accumulated deficit | (66,033,209) |
Total stockholders' equity | 15,816,426 |
Total liabilities and stockholders' equity | $ 20,958,170 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Consolidated Balance Sheets | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 2,368,221 | 2,369,449 | 19,224,708 |
Common stock, shares outstanding | 2,368,221 | 2,369,449 | 19,224,708 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | ||||||
Grant and royalty revenue | $ 9,243 | $ 13,329 | $ 18,851 | $ 26,964 | $ 52,020 | $ 631,840 |
Research and development revenue under collaborative agreements | 734,292 | 1,504,558 | 1,547,743 | 4,448,623 | ||
Total revenues | 9,243 | 747,621 | 18,851 | 1,531,522 | 1,599,763 | 5,080,463 |
Expenses: | ||||||
Research and development | 935,620 | 2,916,637 | 1,927,530 | 5,672,125 | 8,513,974 | 18,126,701 |
General and administrative | 1,734,561 | 1,101,676 | 2,698,070 | 2,152,419 | 3,946,147 | 4,758,831 |
Total expenses | 2,670,181 | 4,018,313 | 4,625,600 | 7,824,544 | 12,460,121 | 22,885,532 |
Loss from operations | (2,660,938) | (3,270,692) | (4,606,749) | (6,293,022) | (10,860,358) | (17,805,069) |
Other income, net | 40 | 40 | 52 | 18 | ||
Change in fair value of warrants | 600,000 | 850,000 | 850,000 | 1,250,000 | ||
Net loss | $ (2,660,938) | $ (2,670,652) | $ (4,606,749) | $ (5,442,982) | $ (10,010,306) | $ (16,555,051) |
Basic and diluted net loss per share | $ (1.11) | $ (1.80) | $ (1.93) | $ (3.77) | $ (0.39) | $ (1) |
Weighted-average shares outstanding used in the calculation | 2,390,861 | 1,482,144 | 2,391,698 | 1,445,396 | 25,734,836 | 16,555,654 |
Consolidated Statement of Chang
Consolidated Statement of Changes in Stockholders' Equity - USD ($) | Common Stock | Additional Paid-in Capital | Accumulated Deficit | Total |
Balance at Dec. 31, 2013 | $ 13,388 | $ 59,432,943 | $ (49,478,158) | $ 9,968,173 |
Balance (in shares) at Dec. 31, 2013 | 13,387,914 | |||
Increase (Decrease) in Stockholders' Equity | ||||
Common stock issued for cash, net of issuance costs | $ 5,767 | 21,231,675 | 21,237,442 | |
Common stock issued for cash, net of issuance costs (in shares) | 5,766,875 | |||
Stock options exercised | $ 1 | 249 | 250 | |
Stock options exercised (in shares) | 715 | |||
Stock-based compensation | $ 69 | 1,165,543 | 1,165,612 | |
Stock-based compensation (in shares) | 69,204 | |||
Net loss | (16,555,051) | (16,555,051) | ||
Balance at Dec. 31, 2014 | $ 19,225 | 81,830,410 | (66,033,209) | $ 15,816,426 |
Balance (in shares) at Dec. 31, 2014 | 19,224,708 | 19,224,708 | ||
Increase (Decrease) in Stockholders' Equity | ||||
Common stock issued for cash, net of issuance costs | $ 13,670 | 3,706,815 | $ 3,720,485 | |
Common stock issued for cash, net of issuance costs (in shares) | 13,669,616 | |||
Stock options exercised | $ 83 | 47,595 | 47,678 | |
Stock options exercised (in shares) | 82,616 | |||
Stock-based compensation | $ 161 | 957,547 | 957,708 | |
Stock-based compensation (in shares) | 161,658 | |||
Net loss | (10,010,306) | (10,010,306) | ||
Balance at Dec. 31, 2015 | $ 33,139 | $ 86,542,367 | $ (76,043,515) | $ 10,531,991 |
Balance (in shares) at Dec. 31, 2015 | 33,138,598 | 2,369,449 | ||
Increase (Decrease) in Stockholders' Equity | ||||
Net loss | $ (4,606,749) | |||
Balance at Jun. 30, 2016 | $ 6,268,958 | |||
Balance (in shares) at Jun. 30, 2016 | 2,368,221 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | ||||
Net loss | $ (4,606,749) | $ (5,442,982) | $ (10,010,306) | $ (16,555,051) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Share-based compensation expense | 345,294 | 465,975 | 953,019 | 1,236,274 |
Change in fair value of warrants | (850,000) | (850,000) | (1,250,000) | |
Depreciation and amortization | 672,278 | 142,398 | 466,988 | 216,088 |
Changes in operating assets and liabilities: | ||||
Accounts receivable | (2,256) | (4,767) | 720,190 | 582,859 |
Prepaid expenses and other current assets | (256,928) | 116,145 | 55,979 | (120,783) |
Accounts payable and accrued expenses | (260,294) | (1,440,947) | (3,046,676) | 1,101,210 |
Deferred contract revenue | (125,000) | (125,000) | (373,000) | |
Other | (19,342) | (13,579) | (32,731) | (24,008) |
Net cash used in operating activities | (4,127,997) | (7,152,757) | (11,868,537) | (15,186,411) |
Cash flows from investing activities: | ||||
Equipment and leasehold improvement expenditures | (21,117) | (21,117) | (105,611) | |
Patent expenditures | (95,872) | (146,581) | (270,035) | (430,304) |
Net cash used in investing activities | (95,872) | (167,698) | (291,152) | (535,915) |
Cash flows from financing activities: | ||||
Proceeds from sale of common stock and warrants, net | 1,845,821 | 3,720,485 | 21,237,442 | |
Proceeds from options and warrants exercised | 47,676 | 47,678 | 250 | |
Payment for restricted stock tax liability on net settlement | (1,577) | (1,180) | (1,183) | (84,680) |
Net cash provided (used in) by financing activities | (1,577) | 1,892,317 | 3,766,980 | 21,153,012 |
Net increase (decrease) in cash and cash equivalents | (4,225,446) | (5,428,138) | (8,392,709) | 5,430,686 |
Cash and cash equivalents at beginning of period | 8,889,616 | 17,282,325 | 17,282,325 | 11,851,639 |
Cash and cash equivalents at end of period | 4,664,170 | 11,854,187 | 8,889,616 | 17,282,325 |
Cash paid during the year for: | ||||
Income taxes | $ 1,600 | 1,600 | 1,600 | 1,600 |
Supplemental disclosure of non-cash investing and financing activities: | ||||
Change in fair value of warrants | $ (850,000) | $ (850,000) | $ (1,250,000) |
THE COMPANY AND A SUMMARY OF IT
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | ||
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | Note 1 — BASIS FOR PRESENTATION The unaudited condensed consolidated balance sheet of Lpath, Inc. (“Lpath” or “the company”) as of December 31, 2015 was derived from our 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 period ended June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016 or for any future financial period. 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, 2015. 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, 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. Reverse Stock Split On June 8, 2016, the company’s board of d irectors and the company’s stockholders approved a 1 -for-14 reverse split of the company’s issued and outstanding common stock. The reverse split was effective on June 10, 2016. Fractional shares created by the reverse stock split were rounded up to the nearest whole share. All issued and outstanding common stock, options exercisable for common stock, warrants exercisable for common stock, restricted stock units, and per share amounts contained in the company’s condensed consolidated financial statements have been retroactively adjusted to reflect this reverse stock split for all periods presented. | Note 1—THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES Organization and Business Lpath, Inc. (“Lpath,” “we,” or “the company”) is a biotechnology company focused on the discovery and development of lipidomic-based therapeutic antibodies, an emerging field of medical science that targets bioactive signaling lipids to treat a wide range of human diseases. We have developed three drug candidates, advancing each of them into clinical trials, and built evidence to support our approach of targeting bioactive lipids to treat a wide range of diseases. On July 17, 2014, Lpath changed its state of incorporation from the State of Nevada to the State of Delaware (the “Reincorporation”) pursuant to a plan of conversion, dated July 17, 2014 (the “Plan of Conversion”). The Reincorporation was accomplished by the filing of (i) articles of conversion with the Secretary of State of the State of Nevada, and (ii) a certificate of conversion and a certificate of incorporation with the Secretary of State of the State of Delaware. Pursuant to the Plan of Conversion, Lpath also adopted new bylaws. The Reincorporation did not affect any of the company’s material contracts with any third parties, and the company’s rights and obligations under such material contractual arrangements continue to be rights and obligations of the company after the Reincorporation. The Reincorporation did not result in any change in headquarters, business, jobs, management, location of any of the offices or facilities, number of employees, assets, liabilities or net worth (other than as a result of the costs incident to the Reincorporation) of Lpath. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of Lpath, Inc. and its wholly-owned subsidiary, Lpath Therapeutics Inc. All significant intercompany balances and transactions have been eliminated in consolidation. Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash deposits, money market deposits, and certificates of deposit. Concentration of Credit Risk Financial instruments that potentially subject the company to a significant concentration of credit risk consist of cash and cash equivalents. The company maintains its cash balances with one major commercial bank in non-interest bearing accounts. Accounts at FDIC-insured institutions are insured by the FDIC up to $250,000 . The company invests its excess cash in money market mutual funds and in certificates of deposit of federally insured financial institutions. The company has established guidelines relative to diversification of its cash investments and their maturities that are intended to secure safety and liquidity. To date, the company has not experienced any impairment losses on its cash equivalents. The company has not experienced any losses on its deposits of cash and cash equivalents, short-term and long-term investments. The company’s accounts receivable are derived from entities located in the United States. The company performs ongoing credit evaluation of its debtors, does not require collateral, and maintains allowances for potential credit losses on customer accounts when deemed necessary. To date, there have been no such losses and the company has not recorded an allowance for doubtful accounts. Equipment and Leasehold Improvements Equipment and leasehold improvements are recorded at cost. Equipment depreciation is computed using the straight-line method over the estimated useful asset lives, which range from three to five years. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remainder of the lease term. Repairs and maintenance are charged to expense as incurred. Patents Legal and filing costs directly associated with obtaining patents are capitalized. Upon issuance of a patent, amortization is computed using the straight-line method over the estimated remaining useful life of the patent. Long-lived Assets The company accounts for the impairment and disposition of long-lived assets for events or changes in circumstances which indicate that their carrying value may not be recoverable. The company recorded charges for impairments of patents totaling $298,709 and $61,314 in 2015 and 2014, respectively. Deferred Rent Rent expense is recorded on a straight-line basis over the term of the lease. The difference between rent expense and amounts paid under the lease agreement is recorded as deferred rent. Lease incentives, including tenant improvement allowances, are also recorded as deferred rent and amortized on a straight-line basis over the lease term. Stock-based Compensation Expense Compensation expense is measured based on the fair value of the award at the grant date, including estimated forfeitures, and is adjusted to reflect actual forfeitures and the outcomes of certain conditions. Compensation issued to non-employees is remeasured quarterly and income or expense is recognized during their vesting terms. Revenue Recognition Lpath has and may in the future enter into collaborations where we receive non-refundable up-front payments. Generally, these payments secure licenses to Lpath drug candidates. Non-refundable payments are recognized as revenue when the company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured, and the company has no further performance obligations under the license agreement. Multiple-element arrangements, such as license and development arrangements, are analyzed to determine whether the deliverables, which often include a license together with performance obligations such as research and development responsibilities and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting. The company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have stand-alone value or (ii) have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting, and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. If the company is involved in a steering committee as part of a multiple-element arrangement that is accounted for as a single unit of accounting, the company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the company expects to complete its aggregate performance obligations. When the company receives reimbursement for research costs under collaborative agreements, such reimbursements are recognized as revenue as the underlying costs are incurred. Whenever the company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The company recognizes revenue using the relative performance method provided that the company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement, the performance obligations are provided on a best-efforts basis and the company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period the company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. If the company cannot reasonably estimate when its performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until the company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the company is expected to complete its performance obligations under an arrangement. Collaboration agreements may also contain substantive milestone payments. Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: · the milestone payments are non-refundable; · achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; · substantive company effort is involved in achieving the milestone; · the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and · a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone and, therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and would be recognized as revenue, as such performance obligations are performed under either the relative performance or straight-line methods, as applicable, and in accordance with these policies as described above. Grant Revenue. Lpath recognizes grant revenue as the related research expenses are incurred, up to contractual limits. Royalty Revenue. Lpath recognizes royalty revenue from licensed products when earned in accordance with the terms of the license agreements. The licensee’s net sales figures used for calculating royalties include deductions for costs of unsaleable returns, cash discounts, freight, postage, and insurance. Research and Development Research and development costs are charged to expense when incurred. Employee Benefit Plan The company has a 401(k) defined contribution plan that provides benefits for most employees. An employee is eligible to participate in this plan after one month of service. The plan provides for full vesting of benefits over five years. Company contributions to the plan are made at the discretion of the Board of Directors and aggregated $96,182 and $108,534 in 2015 and 2014, respectively. Income Taxes Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. A net deferred tax asset related primarily to federal and state net operating loss and research and development credit carryforwards has been fully reserved due to uncertainties regarding Lpath’s ability to realize these tax benefits in future periods. Consequently, no income tax benefit has been recorded for the years ended December 31, 2015 and 2014. Lpath periodically evaluates its tax positions to determine whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities. Lpath has not incurred any interest or penalties as of December 31, 2015 with respect to income tax matters. Lpath does not expect that there will be unrecognized tax benefits of a significant nature that will increase or decrease within 12 months of the reporting date. Comprehensive Income (Loss) Comprehensive income (loss) is comprised of net loss and certain changes in equity that are excluded from net loss. At December 31, 2015 and 2014, Lpath had no reportable differences between net loss and comprehensive loss. Per Share Data Basic net income (loss) per common share is computed by dividing net income (loss) for the period by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number of common and common dilutive equivalent shares, such as stock options, restricted stock units, restricted stock awards, warrants, and convertible securities outstanding during the period. Anti-dilutive common stock equivalents were excluded from the calculation of diluted income (loss) per share as follows: Years Ended December 31, 2015 2014 Stock options Warrants Restricted stock units Total Impact of Recently Issued Accounting Standards In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which eliminates the current requirement to present deferred tax liabilities and assets as current and noncurrent in a classified balance sheet. Instead, entities will be required to classify all deferred tax assets and liabilities as noncurrent. ASU 2015-17 will be effective for fiscal years beginning after December 15, 2017, and early adoption is permitted. The company does not expect the adoption of this ASU will have a significant impact on its financial statements. In May 2014, the FASB issued ASU 2014-09, Revenues from Contracts with Customers (Topic 606). This guidance applies to any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards. The core principle of this guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance supersedes existing revenue recognition guidance, including most industry-specific guidance, as well as certain related guidance on accounting for contract costs. For nonpublic entities, this guidance is effective for annual reporting periods beginning after December 15, 2018. Limited early adoption options are permitted. The company is currently evaluating the impact of this ASU on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. ASU 2014-15 defines management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern and to provide related footnote disclosures. The guidance in ASU 2014-15 is effective for annual reporting periods beginning after December 15, 2016, with early application permitted. The company is currently evaluating the impact of this ASU on its financial statements. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). Under this guidance, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The company is currently evaluating the impact of this ASU on its financial statements. |
GOING CONCERN UNCERTAINTY
GOING CONCERN UNCERTAINTY | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
GOING CONCERN UNCERTAINTY | ||
GOING CONCERN UNCERTAINTY | Note 2 – GOING CONCERN UNCERTAINTY The accompanying consolidated financial statements have been prepared assuming that the company will continue as a going concern. Lpath utilized cash in operations of $4.1 million during the six-months ended June 30, 2016 and $11.9 million during the year ended December 31, 2015. These conditions raise substantial doubt about the company’s ability to continue as a going concern. Management’s plans with regard to these matters are discussed below. The a ccompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. As of June 30, 2016, the company had cash and cash equivalents totaling $4.7 million. The company may also receive limited additional funding from future awards of National Institutes of health (“ NIH ”) or the US Department of Defense ( “ DoD ” ) grants. Potential additional near term sources of cash may include the proceeds from the sale of Lpath common stock under the MLV agreement. As they are currently planned, however, the company does not believe that its existing cash resources will be sufficient to meet its operating plan for the full 12 month period after the date of this filing. To help extend the company’s operating window, the company has reduced its headcount and limited its research and product development activities . Based on its current plans and available resources, the company believe s it can maintain our current operations through the end of November 2016. The company estimate s that at Nov ember 30, 2016 the costs to wind-down its operations in an orderly manner would be approximately $2. 0 million. As a result, to continue to fund the company’s ongoing operations, including its drug discovery and development projects, beyond November 30, 2016, the company would need to secure significant additional capital. Moreover, its expenses may exceed its current plans and expectations, which would require the company to secure additional capital or wind-down its operations sooner than anticipated. The company’s board of d irectors has engaged a financial advisory firm to explore its r available strategic alternatives, including possible mergers and business combinations, a sale of part or all of its assets, collaboration and licensing arrangements and/or equity and debt financings. This strategic process is both active and ongoing, and includes a range of interactions with potential transaction counterparties. The company believe s it is in its stockholders’ best interests at this time to continue to pursue one or more of these transactions, or other strategic alternatives the company may identify in the near term. Although the company is actively pursuing its strategic alternatives, there is no assurance that it will be able to successfully negotiate and consummate a transaction on a timely basis, or at all. Further, the company’s expenses may exceed its current plans and expectations, which could require it to complete a transaction or wind-down its operations sooner than anticipated. Additionally, any transaction the company consummate s may offer limited value for its existing drug candidates and proprietary technology and may not enhance stockholder value or provide the expected benefits. If the company is unable to successfully complete a strategic transaction or secure additional capital on a timely basis and on terms that are acceptable to its stockholders, the company may be required to cease its operations altogether. | Note 2 – GOING CONCERN UNCERTAINTY The accompanying consolidated financial statements have been prepared assuming that the company will continue as a going concern. Lpath utilized cash in operations of $11.9 and $15.2 million during the years ended December 31, 2015 and 2014, respectively. These conditions raise substantial doubt about the company’s ability to continue as a going concern. Management’s plans with regard to these matters are discussed below. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. As of December 31, 2015, the company had cash and cash equivalents totaling $8.9 million. We may also receive limited additional funding from future awards of NIH grants. As they are currently planned, however, we do not believe that our existing cash resources will be sufficient to meet our operating plan for the full 12 month period after the date of this filing. Accordingly, the report from our independent registered public accounting firm accompanying the financial statements included in this Annual Report on Form 10-K contains an emphasis of a matter regarding our ability to continue as a going concern. To help extend our operating window, w e have reduced our headcount and limited our research and product development activities . Based on our current plans and available resources, we believe we can maintain our current operations through the end of the third quarter of 2016. We estimate that the costs to wind-down our operations in an orderly manner will cost approximately $2.5 million. As a result, we need to secure significant additional capital to continue to fund our operations and our drug discovery and development projects beyond the third quarter of 2016. Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated. Our Board of Directors has engaged a financial advisory firm to explore our available strategic alternatives, including possible mergers and business combinations, a sale of part or all of our assets, collaboration and licensing arrangements and/or equity and debt financings. This strategic process is both active and ongoing, and includes a range of interactions with potential transaction counterparties. We believe it is in our stockholders’ best interests at this time to continue to pursue one or more of these transactions, or other strategic alternatives we may identify in the near term. Although we are actively pursuing our strategic alternatives, there is no assurance that we will be able to successfully negotiate and consummate a transaction on a timely basis, or at all. Further, our expenses may exceed our current plans and expectations, which could require us to complete a transaction or wind-down our operations sooner than anticipated. Additionally, any transaction we consummate may offer limited value for our existing drug candidates and proprietary technology and may not enhance stockholder value or provide the expected benefits. If we are unable to successfully complete a strategic transaction or otherwise secure additional capital on a timely basis and on terms that are acceptable to our stockholders, we may be required to cease our operations altogether. |
RESEARCH AND DEVELOPMENT COLLAB
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS | ||
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS | 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. On May 20, 2015, Lpath announced that its Phase 2 "Nexus" clinical trial evaluating iSONEP™ in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy. On August 9, 2015, Pfizer’s option to obtain worldwide rights to iSONEP expired, unexercised, which resulted in the termination of the Pfizer Agreement. Consequently, all rights that Pfizer held in the iSONEP program have reverted to Lpath. Lpath has no plans for further development of iSONEP. As part of the agreement, Lpath 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. That right of first refusal expired on August 9, 2015, concurrently with the expiration of Pfizer’s option to acquire the license to iSONEP. Pfizer has no further obligations to fund clinical trial costs incurred after the expiration date of the Pfizer Agreement. The company recognized revenue under the Pfizer Agreement as follows: Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Cost reimbursements $ - $ $ - $ Amortization of license and development fees - - $ - $ $ - $ | Note 3—RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT 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. On May 20, 2015, Lpath announced that its Phase 2 "Nexus" clinical trial evaluating iSONEP™ in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy. On August 9, 2015, Pfizer’s option to obtain worldwide rights to iSONEP expired, unexercised, which resulted in the termination of the Pfizer Agreement. Consequently, all rights that Pfizer held in the iSONEP program have reverted to Lpath. Lpath has no plans for further development of iSONEP. As part of the Pfizer A greement, Lpath 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. That right of first refusal expired on August 9, 2015, concurrently with the expiration of Pfizer’s option to acquire the license to iSONEP. Pfizer has no further obligations to fund clinical trial costs incurred after the expiration date of the Pfizer Agreement. The company recognized revenue under the Pfizer Agreement as follows: Year Ended December 31, 2015 2014 Cost reimbursements $ $ Amortization of license and development fees $ $ |
COMPOSITION OF CERTAIN FINANCIA
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | 12 Months Ended |
Dec. 31, 2015 | |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | Note 4—COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS 2015 2014 Equipment and leasehold improvements: Office furniture and fixtures $ $ Laboratory equipment Computer equipment and software Leasehold improvements Accumulated depreciation Equipment, net $ $ Patents: Patents $ $ Accumulated amortization Patents, net $ $ |
FAIR VALUE MEASUREMENTS
FAIR VALUE MEASUREMENTS | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
FAIR VALUE MEASUREMENTS | ||
FAIR VALUE MEASUREMENTS | Note 5 — FAIR VALUE MEASUREMENTS Lpath has issued warrants, of which some are classified as equity and some as liabilities. 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. The company’s recurring fair value measurements at June 30, 2016 were as follows: Significant Unobservable Fair Value as of Inputs June 30, 2016 (Level 3) Liabilities: Warrants expiring March 2017 $ - $ - The company determined the fair value of the warrant liability for certain warrants, as applicable, using a Black-Scholes model. The model considered amounts and timing of future possible equity and warrant issuances and volatility of the company’s stock price equal to 100% , as specified in the underlying warrants. The fair value of the warrants at June 30, 2016 was zero . There was no change in the fair value of the warrants during the three months ended June 30, 2016. The terms of all outstanding warrants permit the company, upon exercise of the warrants, to settle the contract by the delivery of unregistered shares. As of June 30, 2016 there were 327,575 warrants outstanding with a weighted-average exercise price of $58.94 per share expiring through September 2019. | Note 5—FAIR VALUE MEASUREMENTS The company measures fair value in accordance with the applicable accounting standards in the FASB Codification. Fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: · Level 1—unadjusted quoted prices in active markets for identical assets or liabilities that the company has the ability to access as of the measurement date. · Level 2—inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability, or indirectly observable through corroboration with observable market data. · Level 3—unobservable inputs for the asset or liability are only used when there is little, if any, market activity for the asset or liability at the measurement date. This hierarchy requires the company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Recurring Fair Value Estimates Lpath has issued warrants, of which some are classified as equity and some as liabilities. 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. The fair value and significant unobservable inputs (level 3) of the March 2012 warrants was zero as of December 31, 2015. 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). Fair value measurements using significant unobservable inputs (Level 3): Liabilities: Warrant liability as of January 1, 2015 $ Change in fair value of warrants Warrant liability as of December 31, 2015 $ - The company determined the fair value of the warrant liability for certain warrants, as applicable, using a Black-Scholes model. The model considered amounts and timing of future possible equity and warrant issuances and volatility of the company’s stock price equal to 100% , as specified in the underlying warrants. |
RESEARCH AND LICENSE AGREEMENTS
RESEARCH AND LICENSE AGREEMENTS | 12 Months Ended |
Dec. 31, 2015 | |
RESEARCH AND LICENSE AGREEMENTS | |
RESEARCH AND LICENSE AGREEMENTS | Note 6 —RESEARCH AND LICENSE AGREEMENTS In August 2005, Lpath entered into a collaboration agreement (the “AERES Agreement”) with AERES Biomedical Limited (“AERES”) to “humanize” the company’s Sphingomab monoclonal antibody. Humanization under this agreement with AERES involves utilizing proprietary processes owned by AERES for the purpose of modifying Sphingomab antibodies originally contained in mice for potential human acceptance in a clinical trial. The humanized version of Sphingomab that was produced from the collaboration with AERES is called Sonepcizumab. In 2014, AERES’ rights and obligations pursuant to the AERES Agreement with Lpath were transferred to Medical Research Council Technology (“MRCT”) by means of a Deed of Novation, which obligates MRCT to perform and be bound by the terms of the AERES Agreement. No amounts were paid to AERES or MRCT during 201 5 and 201 4 . Lpath could owe MRCT certain additional contingent amounts when drug candidates based on Sonepcizumab pass through the levels of the FDA drug review and approval process. MRCT will be entitled to a royalty, not to exceed 4% , on any revenues generated by the ultimate commercialization of any drug candidate based on Sonepcizumab. |
STOCKHOLDERS' EQUITY
STOCKHOLDERS' EQUITY | 12 Months Ended |
Dec. 31, 2015 | |
STOCKHOLDERS' EQUITY | |
STOCKHOLDERS' EQUITY | Note 7 —STOCKHOLDERS’ EQUITY Common Stock In March 2014, the company entered into an at-the-market issuance sales agreement (the “Sales Agreement”) with MLV & Co. (the “MLV Agreement”). Subject to limitations set by the SEC, the company may from time to time, at the company’s option, issue and, through MLV, sell shares of its common stock having an aggregate offering price of up to $23 million under the MLV Agreement. Sales of common stock through MLV, if any, will be made by any method that is deemed an “at-the-market” offering as defined in Rule 415 promulgated under the Securities Act of 1933, as amended, including by means of ordinary brokers’ transactions at market prices, in block transactions or as otherwise agreed by the Lpath and MLV. Subject to the terms and conditions of the MLV Agreement, MLV will use commercially reasonable efforts to sell the common stock based upon the company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). Lpath is not obligated to make any sales of its common stock under the MLV Agreement. Any shares sold will be sold pursuant to the company’s effective shelf registration statement on Form S-3 (the “Shelf Registration Statement”). The company will pay MLV a commission of up to 3.0% of the gross proceeds. The MLV Agreement will terminate upon the earlier of the sale of all common stock subject to the MLV Agreement or termination of the MLV Agreement by the company or MLV. During 2015, the company sold 13,674,916 shares at sales prices ranging from $0.34 to $0.21 per share, resulting in $3,722,000 in net proceeds. During the year ended December 31, 2014, the company sold 2,161,833 shares at sales prices ranging from $3.50 to $5.16 per share, resulting in $9,730,000 in net proceeds. There have been no sales of shares through the MLV Agreement subsequent to December 31, 2015. Under the SEC’s rules, the company will not be eligible to sell any shares under the Shelf Registration Statement and the accompanying MLV Agreement immediately following the filing of this Annual Report on Form 10-K. Because the market value of the company’s common stock held by non-affiliate stockholders is less than $75 million, the SEC limits the amount of stock the company may only offer and sell during any 12 month period to a maximum of one-third of the market value of the common stock held by company’s non-affiliate stockholders. The company is required to select a new measurement date for its market value each time it files an Annual Report on Form 10-K. Accordingly, based on the current market value of the company’s common stock and its sales under the MLV Agreement within the past 12 months, the company has no current eligibility to make sales under the Shelf Registration Statement and the accompanying MLV Agreement. In September 2014, Lpath sold 3,605,042 registered shares of common stock and warrants to purchase 3,605,042 unregistered shares of common stock in a direct offering at a purchase price of $3.475 per share-and-warrant-share combination. The warrants have an exercise price of $3.36 per underlying share, are immediately exercisable, and terminate on the five -year anniversary of issuance. Each warrant may be exercised using a cashless exercise procedure if the resale of the underlying shares are not covered by an effective registration statement. Net proceeds of this offering totaled $11,500,000 after deducting placement agent fees and other expenses of the offering. Maxim Group LLC (“Maxim”) acted as the exclusive placement agent for the offering. Maxim received a placement agent fee of $751,651 and an unregistered warrant to purchase 54,076 unregistered shares of common stock (the “Maxim Warrant”) as well as the reimbursement of fees and expenses up to $60,000 . The Maxim Warrant has an exercise price of $3.36 per share, is immediately exercisable, and will terminate on August 23, 2018. In October 2014, pursuant to the terms of a registration rights agreement the company entered into in connection with the direct offering discussed above, the company registered for resale 3,605,042 shares of common stock issuable upon exercise of the warrants issued in the direct offering discussed above. The shares were registered on Form S-3 and the registration statement was declared effective by the Securities and Exchange Commission on October 23, 2014. Preferred Stock Lpath is authorized to issue up to 15,000,000 shares of preferred stock, with a par value of $0.001 per share. As of December 31, 2015 and 2014, there were no preferred stock shares issued or outstanding. Equity Incentive Plan In November 2005, the company adopted the Lpath, Inc. 2005 Stock Option and Stock Purchase Plan, which permitted stock option grants to employees, outside consultants, and directors. In October 2007, Lpath’s stockholders approved the amendment of this plan which was concurrently renamed the Lpath, Inc. Amended and Restated 2005 Equity Incentive Plan (the “Plan”). There are 2,500,000 shares of common stock authorized for grant under the Plan. The Plan allows for grants of incentive stock options with exercise prices of at least 100% of the fair market value of Lpath’s common stock, nonqualified options with exercise prices of at least 85% of the fair market value of the company’s common stock, restricted stock, and restricted stock units. All stock options granted to date have a ten -year life and vest over zero to five years. Restricted stock units granted have a five -year life and vest over zero to four years, or upon the achievement of specified clinical trial milestones. As of December 31, 2015, a total of 1,429,128 shares of common stock were available for future grant under the Plan. The following table presents stock-based compensation as included in the company’s consolidated statements of operations: 2015 2014 Stock-based compensation expense by type of award: Stock options $ $ Restricted stock units Total stock-based compensation expense $ $ Effect of stock-based compensation expense on Research and development General and administrative Total stock-based compensation expense $ $ Fair value is determined at the date of grant for employee options and restricted stock units, and at the date at which the grantee’s performance is complete for non-employee options and restricted stock units. Compensation cost is recognized over the vesting period based on the fair value of the options and restricted stock units. Because of the company’s net operating losses for tax purposes, it did not realize any tax benefits for the tax deductions from share-based payment arrangements during the years ended December 31, 2015 and 2014. Stock Options As of December 31, 2015, there was $1,221,000 of total unrecognized compensation expense, net of estimated forfeitures, related to unvested options granted under the Plan. That expense is expected to be recognized over a weighted-average period of 5.9 years. The company uses the Black-Scholes valuation model to estimate the fair value of stock options at the grant date. The Black-Scholes valuation model uses the option exercise price as well as estimates and assumptions related to the expected price volatility of the company’s stock, the rate of return on risk-free investments, the expected period during which the options will be outstanding, and the expected dividend yield for the company’s stock to estimate the fair value of a stock option on the grant date. The weighted-average valuation assumptions were determined as follows: · Expected stock price volatility: The estimated expected volatility is based on a weighted-average calculation of a peer group and the company’s historical volatility. · Risk-free interest rate: The company bases the risk-free interest rate on the interest rate payable on U.S. Treasury debt securities. · Expected term of options: The expected term of options granted is derived using assumed exercise rates based on historical exercise patterns and represents the period of time that options granted are expected to be outstanding. · Expected annual dividends: The estimate for annual dividends is zero because the company has not historically paid, and does not intend for the foreseeable future to pay, a dividend. The estimated fair value of stock options granted was determined using a Black-Scholes valuation model with the following weighted average assumptions: 2015 2014 Risk free interest rate Expected life (years) Expected share price volatility Expected dividend rate A summary of the stock option activity under the plan as of December 31, 2015 and 2014, and changes during the years then ended, is presented below: Weighted- Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term (Years) Value Outstanding at January 1, 2014 $ Granted Exercised Expired Forfeited Outstanding at December 31, 2014 Granted Exercised Expired Forfeited Outstanding at December 31, 2015 $ — Vested and exercisable at December 31, 2015 $ $ — The aggregate intrinsic value in the table above represents the total intrinsic value which would have been received by the stock option holders had all option holders exercised their options as of that date. The aggregate intrinsic value is calculated as the difference between the fair market value of the company’s common stock on December 31, 2015 of $0.23 and the exercise price of stock options, multiplied by the number of shares subject to such stock options. At December 31, 2015, all of the company’s outstanding stock options had strike prices above the company’s market price of $0.23. The total intrinsic value of options exercised during the years ended December 31, 2015 and 2014 was $159,000 and $3,000 , respectively. Cash received from option exercises during the years ended December 31, 2015 and 2014 was approximately $48,000 and $250 , respectively. Upon stock option exercises, the company issues new shares of common stock. Restricted Stock Units As of December 31, 2015, there was $387,000 of total unrecognized stock-based compensation expense related to unvested restricted stock units granted under the Plan. The company expects to recognize that expense over a weighted-average period of 1.9 years. The following table summarizes the restricted stock units activity of the company during 2015 and 2014: Weighted- Total Average Restricted Grant Date Stock Units Fair Value Outstanding January 1, 2014 $ Granted Shares issued Forfeited Outstanding December 31, 2014 Granted Shares issued Forfeited Outstanding December 31, 2015 $ Warrants Lpath has issued warrants, of which some are classified as equity and some as liabilities. 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. The following warrants contained such provisions, and therefore, pursuant to the applicable criteria, they were not indexed to the company’s own stock: Number of Exercise Warrant Expiration Dates Shares Price per Share March 2017 $ March 2017 $ The warrant liability reflected on Lpath’s balance sheet is a consequence of current generally accepted accounting principles, arising from the implementation of ASC 815. The company believes there is no foreseeable circumstance under which Lpath can be required to make any cash payment to settle any warrant liability that would be carried on the consolidated balance sheet. The following table summarizes Lpath warrants outstanding as of December 31, 2015: Number of Exercise Price Warrant Expiration Date Shares per Share January 21, 2017 $ March 9, 2017 $ March 9, 2017 $ May 30, 2017 $ September 15, 2017 $ September 25, 2019 $ September 26, 2019 $ Total: Weighted average: $ 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 2015, 4,000 warrants were granted, no warrants were exercised, and 5,715 warrants expired. During 2014, 3,669,118 warrants were granted, no warrants were exercised, and 12,858 warrants expired. |
INCOME TAXES
INCOME TAXES | 12 Months Ended |
Dec. 31, 2015 | |
INCOME TAXES | |
INCOME TAXES | Note 8 —INCOME TAXES As of December 31, 201 5 , Lpath had federal and California net operating loss (“NOL”) carryforwards of approximately $82 million and $74 million, respectively, that will expire beginning in 201 6 and continue expiring through 203 5 . Portions of these NOL carryforwards may be used to offset future taxable income, if any. As of December 31, 201 5 , Lpath also has federal and California research and development tax credit carryforwards of $1.8 million and $0.8 million, respectively, available to offset future taxes. The federal credits begin expiring in 201 6 , and the state credits do not expire. The c ompany's ability to use its net operating loss and research and development credit carryforwards may be substantially limited due to ownership change limitations that may have occurred or that could occur in the future, as required by Section 382 of the Internal Revenue Code of 1986, as amended, as well as similar state provisions. The c ompany has not completed a study to assess whether an ownership change has occurred or whether there have been multiple ownership changes since the Company became a “loss corporation” under the definition of Section 382. Due to the existence of the valuation allowance, it is not expected that any possible limitation will have an impact on the results of operations or financial position of the c ompany. Significant components of the company’s deferred tax assets and liabilities are as follows: 2015 2014 Deferred tax assets: Federal and state net operating loss carryforwards $ $ Research and development credit carryforwards Stock-based compensation Deferred contract revenue — Other, net Deferred tax liabilities: State taxes Patent costs Total deferred tax assets Valuation allowance Net deferred tax assets $ — $ — Realization of the deferred tax assets is dependent upon the generation of future taxable income, the amount and timing of which are uncertain. Accordingly, the net deferred tax assets have been fully offset by a valuation allowance. As a result of the company’s significant operating loss carryforwards and the corresponding valuation allowance, no income tax provision/benefit has been recorded as of December 31, 201 5 and 201 4 . The provision for income taxes using the statutory federal income tax rate of 34% as compared to the company’s effective tax rate is summarized as follows: 2015 2014 Federal tax benefit at statutory rate $ $ State tax benefit, net Change in fair value of warrants Research and development credits — Employee stock-based compensation Other permanent differences Decrease in valuation allowance Provision for income taxes $ — $ — |
OPERATING LEASE
OPERATING LEASE | 12 Months Ended |
Dec. 31, 2015 | |
OPERATING LEASE | |
OPERATING LEASE | Note 9 —OPERATING LEASE Lpath leases an 11,960 square foot laboratory and office facility in San Diego, California. The lease expires in November 2016. Monthly lease payments are $28,268 , with annual escalations of 3% . The lease grants the Company the right to extend the lease for an additional five -year term. Lpath’s rent expense totaled $390,000 and $385,000 for the years ended December 31, 201 5 and 201 4 , respectively. Lpath’s sublease income amounted to $12,000 for the years ended December 31, 201 5 and 201 4 . |
RELATED-PARTY TRANSACTIONS
RELATED-PARTY TRANSACTIONS | 12 Months Ended |
Dec. 31, 2015 | |
RELATED-PARTY TRANSACTIONS | |
RELATED-PARTY TRANSACTIONS | Note 10 —RELATED-PARTY TRANSACTIONS Lpath subleases a portion of its facility to Western States Investment Corporation (“WSIC”), owned by one of Lpath’s largest stockholders. The terms of the sublease, in general, are the same as the terms of the company’s direct lease. In addition, certain Lpath employees provide investment oversight, accounting, and other administrative services to WSIC. Certain WSIC employees also provide services to Lpath. Lpath and WSIC reimburse each other for costs incurred on behalf of the other entity. Lpath’s sublease income amounted to $11,652 for the years ended December 31, 201 5 and 201 4 . During 2015 and 201 4 , WSIC billed Lpath $12,008 and $39,300 , respectively, for administrative expenses. As of December 31, 201 5 , Lpath owed WSIC $948 for services provided to Lpath. As of December 31, 201 4 , WSIC owed Lpath $2,900 for facility expenses and Lpath owed WSIC $7,100 for services provided to Lpath. |
THE COMPANY AND A SUMMARY OF 17
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES (Policies) | 12 Months Ended |
Dec. 31, 2015 | |
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | |
Organization and Business | Organization and Business Lpath, Inc. (“Lpath,” “we,” or “the company”) is a biotechnology company focused on the discovery and development of lipidomic-based therapeutic antibodies, an emerging field of medical science that targets bioactive signaling lipids to treat a wide range of human diseases. We have developed three drug candidates, advancing each of them into clinical trials, and built evidence to support our approach of targeting bioactive lipids to treat a wide range of diseases. On July 17, 2014, Lpath changed its state of incorporation from the State of Nevada to the State of Delaware (the “Reincorporation”) pursuant to a plan of conversion, dated July 17, 2014 (the “Plan of Conversion”). The Reincorporation was accomplished by the filing of (i) articles of conversion with the Secretary of State of the State of Nevada, and (ii) a certificate of conversion and a certificate of incorporation with the Secretary of State of the State of Delaware. Pursuant to the Plan of Conversion, Lpath also adopted new bylaws. The Reincorporation did not affect any of the company’s material contracts with any third parties, and the company’s rights and obligations under such material contractual arrangements continue to be rights and obligations of the company after the Reincorporation. The Reincorporation did not result in any change in headquarters, business, jobs, management, location of any of the offices or facilities, number of employees, assets, liabilities or net worth (other than as a result of the costs incident to the Reincorporation) of Lpath. |
Basis of Presentation | Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of Lpath, Inc. and its wholly-owned subsidiary, Lpath Therapeutics Inc. All significant intercompany balances and transactions have been eliminated in consolidation. |
Estimates | Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents Cash and cash equivalents consist of cash deposits, money market deposits, and certificates of deposit. |
Concentration of Credit Risk | Concentration of Credit Risk Financial instruments that potentially subject the company to a significant concentration of credit risk consist of cash and cash equivalents. The company maintains its cash balances with one major commercial bank in non-interest bearing accounts. Accounts at FDIC-insured institutions are insured by the FDIC up to $250,000 . The company invests its excess cash in money market mutual funds and in certificates of deposit of federally insured financial institutions. The company has established guidelines relative to diversification of its cash investments and their maturities that are intended to secure safety and liquidity. To date, the company has not experienced any impairment losses on its cash equivalents. The company has not experienced any losses on its deposits of cash and cash equivalents, short-term and long-term investments. The company’s accounts receivable are derived from entities located in the United States. The company performs ongoing credit evaluation of its debtors, does not require collateral, and maintains allowances for potential credit losses on customer accounts when deemed necessary. To date, there have been no such losses and the company has not recorded an allowance for doubtful accounts. |
Equipment and Leasehold Improvements | Equipment and Leasehold Improvements Equipment and leasehold improvements are recorded at cost. Equipment depreciation is computed using the straight-line method over the estimated useful asset lives, which range from three to five years. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remainder of the lease term. Repairs and maintenance are charged to expense as incurred. |
Patents | Patents Legal and filing costs directly associated with obtaining patents are capitalized. Upon issuance of a patent, amortization is computed using the straight-line method over the estimated remaining useful life of the patent. |
Long-lived Assets | Long-lived Assets The company accounts for the impairment and disposition of long-lived assets for events or changes in circumstances which indicate that their carrying value may not be recoverable. The company recorded charges for impairments of patents totaling $298,709 and $61,314 in 2015 and 2014, respectively. |
Deferred Rent | Deferred Rent Rent expense is recorded on a straight-line basis over the term of the lease. The difference between rent expense and amounts paid under the lease agreement is recorded as deferred rent. Lease incentives, including tenant improvement allowances, are also recorded as deferred rent and amortized on a straight-line basis over the lease term. |
Stock-based Compensation Expense | Stock-based Compensation Expense Compensation expense is measured based on the fair value of the award at the grant date, including estimated forfeitures, and is adjusted to reflect actual forfeitures and the outcomes of certain conditions. Compensation issued to non-employees is remeasured quarterly and income or expense is recognized during their vesting terms. |
Revenue Recognition | Revenue Recognition Lpath has and may in the future enter into collaborations where we receive non-refundable up-front payments. Generally, these payments secure licenses to Lpath drug candidates. Non-refundable payments are recognized as revenue when the company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured, and the company has no further performance obligations under the license agreement. Multiple-element arrangements, such as license and development arrangements, are analyzed to determine whether the deliverables, which often include a license together with performance obligations such as research and development responsibilities and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting. The company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have stand-alone value or (ii) have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting, and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. If the company is involved in a steering committee as part of a multiple-element arrangement that is accounted for as a single unit of accounting, the company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the company expects to complete its aggregate performance obligations. When the company receives reimbursement for research costs under collaborative agreements, such reimbursements are recognized as revenue as the underlying costs are incurred. Whenever the company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The company recognizes revenue using the relative performance method provided that the company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement, the performance obligations are provided on a best-efforts basis and the company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period the company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. If the company cannot reasonably estimate when its performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until the company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the company is expected to complete its performance obligations under an arrangement. Collaboration agreements may also contain substantive milestone payments. Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: · the milestone payments are non-refundable; · achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; · substantive company effort is involved in achieving the milestone; · the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and · a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone and, therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and would be recognized as revenue, as such performance obligations are performed under either the relative performance or straight-line methods, as applicable, and in accordance with these policies as described above. |
Grant Revenue | Grant Revenue. Lpath recognizes grant revenue as the related research expenses are incurred, up to contractual limits. |
Royalty Revenue | Royalty Revenue. Lpath recognizes royalty revenue from licensed products when earned in accordance with the terms of the license agreements. The licensee’s net sales figures used for calculating royalties include deductions for costs of unsaleable returns, cash discounts, freight, postage, and insurance. |
Research and Development | Research and Development Research and development costs are charged to expense when incurred. |
Employee Benefit Plan | Employee Benefit Plan The company has a 401(k) defined contribution plan that provides benefits for most employees. An employee is eligible to participate in this plan after one month of service. The plan provides for full vesting of benefits over five years. Company contributions to the plan are made at the discretion of the Board of Directors and aggregated $96,182 and $108,534 in 2015 and 2014, respectively. |
Income Taxes | Income Taxes Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. A net deferred tax asset related primarily to federal and state net operating loss and research and development credit carryforwards has been fully reserved due to uncertainties regarding Lpath’s ability to realize these tax benefits in future periods. Consequently, no income tax benefit has been recorded for the years ended December 31, 2015 and 2014. Lpath periodically evaluates its tax positions to determine whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities. Lpath has not incurred any interest or penalties as of December 31, 2015 with respect to income tax matters. Lpath does not expect that there will be unrecognized tax benefits of a significant nature that will increase or decrease within 12 months of the reporting date. |
Comprehensive Income (Loss) | Comprehensive Income (Loss) Comprehensive income (loss) is comprised of net loss and certain changes in equity that are excluded from net loss. At December 31, 2015 and 2014, Lpath had no reportable differences between net loss and comprehensive loss. |
Per Share Data | Per Share Data Basic net income (loss) per common share is computed by dividing net income (loss) for the period by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number of common and common dilutive equivalent shares, such as stock options, restricted stock units, restricted stock awards, warrants, and convertible securities outstanding during the period. Anti-dilutive common stock equivalents were excluded from the calculation of diluted income (loss) per share as follows: Years Ended December 31, 2015 2014 Stock options Warrants Restricted stock units Total |
Impact of Recently Issued Accounting Standards | Impact of Recently Issued Accounting Standards In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which eliminates the current requirement to present deferred tax liabilities and assets as current and noncurrent in a classified balance sheet. Instead, entities will be required to classify all deferred tax assets and liabilities as noncurrent. ASU 2015-17 will be effective for fiscal years beginning after December 15, 2017, and early adoption is permitted. The company does not expect the adoption of this ASU will have a significant impact on its financial statements. In May 2014, the FASB issued ASU 2014-09, Revenues from Contracts with Customers (Topic 606). This guidance applies to any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards. The core principle of this guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance supersedes existing revenue recognition guidance, including most industry-specific guidance, as well as certain related guidance on accounting for contract costs. For nonpublic entities, this guidance is effective for annual reporting periods beginning after December 15, 2018. Limited early adoption options are permitted. The company is currently evaluating the impact of this ASU on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. ASU 2014-15 defines management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern and to provide related footnote disclosures. The guidance in ASU 2014-15 is effective for annual reporting periods beginning after December 15, 2016, with early application permitted. The company is currently evaluating the impact of this ASU on its financial statements. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). Under this guidance, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The company is currently evaluating the impact of this ASU on its financial statements. |
THE COMPANY AND A SUMMARY OF 18
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | ||
Anti-dilutive common stock equivalents were excluded from the calculation of diluted loss per share as follows | Six Months Ended June 30, 2016 2015 Stock options Warrants Restricted stock units Total | Years Ended December 31, 2015 2014 Stock options Warrants Restricted stock units Total |
RESEARCH AND DEVELOPMENT COLL19
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS | ||
Schedule of recognized revenue under the Pfizer Agreement | Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Cost reimbursements $ - $ $ - $ Amortization of license and development fees - - $ - $ $ - $ | The company recognized revenue under the Pfizer Agreement as follows: Year Ended December 31, 2015 2014 Cost reimbursements $ $ Amortization of license and development fees $ $ |
COMPOSITION OF CERTAIN FINANC20
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS | |
Schedule of composition of certain financial statement captions | 2015 2014 Equipment and leasehold improvements: Office furniture and fixtures $ $ Laboratory equipment Computer equipment and software Leasehold improvements Accumulated depreciation Equipment, net $ $ Patents: Patents $ $ Accumulated amortization Patents, net $ $ |
FAIR VALUE MEASUREMENTS (Tables
FAIR VALUE MEASUREMENTS (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
FAIR VALUE MEASUREMENTS | |
Fair value measurements using significant unobservable inputs (Level 3) | Liabilities: Warrant liability as of January 1, 2015 $ Change in fair value of warrants Warrant liability as of December 31, 2015 $ - |
STOCKHOLDERS' EQUITY (Tables)
STOCKHOLDERS' EQUITY (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
STOCKHOLDERS' EQUITY | ||
Schedule of recognized share-based compensation expense | Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative Total share-based compensation expense $ $ $ $ | 2015 2014 Stock-based compensation expense by type of award: Stock options $ $ Restricted stock units Total stock-based compensation expense $ $ Effect of stock-based compensation expense on Research and development General and administrative Total stock-based compensation expense $ $ |
Schedule of assumptions used to calculate estimated fair value of stock options granted using the Black-Scholes valuation model | 2015 2014 Risk free interest rate Expected life (years) Expected share price volatility Expected dividend rate | |
Summary of stock option activity under the plan and changes during the years then ended | Weighted- Weighted Average Average Remaining Aggregate Number Exercise Contractual Intrinsic of Shares Price Term (Years) Value Outstanding at January 1, 2014 $ Granted Exercised Expired Forfeited Outstanding at December 31, 2014 Granted Exercised Expired Forfeited Outstanding at December 31, 2015 $ — Vested and exercisable at December 31, 2015 $ $ — | |
Summary of restricted stock units activity | Weighted- Total Average Restricted Grant Date Stock Units Fair Value Outstanding January 1, 2014 $ Granted Shares issued Forfeited Outstanding December 31, 2014 Granted Shares issued Forfeited Outstanding December 31, 2015 $ | |
Summary of warrants outstanding not indexed to the company's own stock | Number of Exercise Warrant Expiration Dates Shares Price per Share March 2017 $ March 2017 $ | |
Summary of warrants outstanding | Number of Exercise Price Warrant Expiration Date Shares per Share January 21, 2017 $ March 9, 2017 $ March 9, 2017 $ May 30, 2017 $ September 15, 2017 $ September 25, 2019 $ September 26, 2019 $ Total: Weighted average: $ |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 12 Months Ended |
Dec. 31, 2015 | |
INCOME TAXES | |
Schedule of significant components of the company's deferred tax assets and liabilities | 2015 2014 Deferred tax assets: Federal and state net operating loss carryforwards $ $ Research and development credit carryforwards Stock-based compensation Deferred contract revenue — Other, net Deferred tax liabilities: State taxes Patent costs Total deferred tax assets Valuation allowance Net deferred tax assets $ — $ — |
Summary of reconciliation of the provision for income taxes using the statutory federal income tax rate and the effective tax rate | 2015 2014 Federal tax benefit at statutory rate $ $ State tax benefit, net Change in fair value of warrants Research and development credits — Employee stock-based compensation Other permanent differences Decrease in valuation allowance Provision for income taxes $ — $ — |
THE COMPANY AND A SUMMARY OF 24
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES (Details) | 12 Months Ended | |
Dec. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | |
Organization and Business | ||
Number of drug candidates in clinical development | item | 3 | |
Concentration of Credit Risk | ||
Number of major commercial banks where cash balances are maintained in non-interest bearing accounts | item | 1 | |
Federal insurance limit on deposit accounts | $ 250,000 | |
Long-lived Assets | ||
Charges for impairments of patents | $ 298,709 | $ 61,314 |
Employee Benefit Plan | ||
Requisite service period for employees to be eligible to participate in the plan | 1 month | |
Vesting period | 5 years | |
Contributions to the 401(k) plan made at the discretion of the board of directors | $ 96,182 | $ 108,534 |
Minimum | Equipment | ||
Equipment and Leasehold Improvements | ||
Estimated useful assets lives | 3 years | |
Maximum | Equipment | ||
Equipment and Leasehold Improvements | ||
Estimated useful assets lives | 5 years |
THE COMPANY AND A SUMMARY OF 25
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES - Anti-dilutive securities and other (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | ||||
Income tax benefit | $ 0 | $ 0 | ||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 485,414 | 474,903 | 6,516,418 | 5,970,147 |
Stock options | ||||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 128,870 | 110,714 | 1,451,298 | 740,954 |
Warrants | ||||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 327,575 | 327,955 | 4,585,644 | 4,587,359 |
Restricted stock units | ||||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 28,969 | 36,234 | 479,476 | 641,834 |
GOING CONCERN UNCERTAINTY (Deta
GOING CONCERN UNCERTAINTY (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Dec. 31, 2013 | |
GOING CONCERN UNCERTAINTY | |||||
Cash utilized in operating activities | $ 4,127,997 | $ 7,152,757 | $ 11,868,537 | $ 15,186,411 | |
Cash | $ 4,664,170 | $ 11,854,187 | $ 8,889,616 | $ 17,282,325 | $ 11,851,639 |
Period for which cash resources may be insufficient | 12 months | 12 months | |||
Estimated wind-down costs of operations | $ 2,500,000 |
RESEARCH AND DEVELOPMENT COLL27
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Research and development collaborative agreements | ||||
Total recognized revenue | $ 734,292 | $ 1,504,558 | $ 1,547,743 | $ 4,448,623 |
Collaboration agreement | Pfizer Inc. | ||||
Research and development collaborative agreements | ||||
Cost reimbursements | 671,792 | 1,379,558 | 1,422,743 | 4,075,623 |
Amortization of license and development fees | 62,500 | 125,000 | 125,000 | 373,000 |
Total recognized revenue | $ 734,292 | $ 1,504,558 | $ 1,547,743 | $ 4,448,623 |
COMPOSITION OF CERTAIN FINANC28
COMPOSITION OF CERTAIN FINANCIAL STATEMENT CAPTIONS (Details) - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Equipment and Leasehold Improvements | |||
Equipment and leasehold improvements, gross | $ 787,646 | $ 769,482 | |
Accumulated depreciation | (638,375) | (548,334) | |
Equipment, net | $ 105,990 | 149,271 | 221,148 |
Patents: | |||
Patents | 2,438,875 | 2,467,547 | |
Accumulated amortization | (306,746) | (230,638) | |
Patents, net | $ 1,599,003 | 2,132,129 | 2,236,909 |
Office furniture and fixtures | |||
Equipment and Leasehold Improvements | |||
Equipment and leasehold improvements, gross | 9,435 | 9,435 | |
Laboratory equipment | |||
Equipment and Leasehold Improvements | |||
Equipment and leasehold improvements, gross | 612,159 | 593,027 | |
Computer equipment and software | |||
Equipment and Leasehold Improvements | |||
Equipment and leasehold improvements, gross | 141,150 | 142,118 | |
Leasehold improvements | |||
Equipment and Leasehold Improvements | |||
Equipment and leasehold improvements, gross | $ 24,902 | $ 24,902 |
FAIR VALUE MEASUREMENTS - Recur
FAIR VALUE MEASUREMENTS - Recurring Fair Value (Details) | Dec. 31, 2015USD ($) |
Recurring | Significant Unobservable Inputs (Level 3) | Warrants | March 2017 | |
Liabilities: | |
Fair value of liabilities | $ 0 |
FAIR VALUE MEASUREMENTS - Unobs
FAIR VALUE MEASUREMENTS - Unobservable inputs (Details) - Warrants - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Liabilities: | ||
Balance at the beginning of the period | $ 0 | $ 850,000 |
Change in fair value of warrants | (850,000) | |
Balance at the end of the period | $ 0 | |
Volatility of stock price as specified in the underlying warrants (as a percent) | 100.00% | 100.00% |
RESEARCH AND LICENSE AGREEMEN31
RESEARCH AND LICENSE AGREEMENTS (Details) - AERES - Collaboration agreement - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Research and license agreements | ||
Accrued license fee paid | $ 0 | $ 0 |
Maximum | ||
Research and license agreements | ||
Percentage of royalty | 4.00% | 4.00% |
STOCKHOLDERS' EQUITY - Common a
STOCKHOLDERS' EQUITY - Common and Preferred Stock (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Oct. 31, 2014 | Sep. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2015 | Dec. 31, 2014 | |
Shares issued to purchase registered shares | 3,605,042 | ||||
Shares issued to purchase unregistered shares | 3,605,042 | ||||
Sales price (in dollars per share) | $ 3.475 | ||||
Aggregate gross proceeds from units issued | $ 11,500,000 | ||||
Shares and warrants registered for resale | 3,605,042 | ||||
Preferred Stock | |||||
Preferred stock, shares authorized | 15,000,000 | ||||
Preferred stock, par value (in dollars per share) | $ 0.001 | ||||
Preferred stock, shares issued | 0 | 0 | |||
Preferred stock, shares outstanding | 0 | 0 | |||
Warrants | |||||
Exercise price per share (in dollars per share) | $ 3.36 | ||||
Expiration period of warrants | 5 years | ||||
MLV | |||||
Aggregate offering price | $ 23,000,000 | ||||
Commission payable as a percentage of gross proceeds | 3.00% | ||||
Common stock, shares issued | 13,674,916 | 2,161,833 | |||
Net proceeds | $ 3,722,000 | $ 9,730,000 | |||
Number of shares issued subsequent to reporting period | 0 | ||||
Aggregate market value of common stock held by non-affiliates | $ 75,000,000 | ||||
Maximum market value of stock that may be sold in a 12 month period | 33.00% | ||||
MLV | Minimum | |||||
Sales price (in dollars per share) | $ 0.21 | $ 3.50 | |||
MLV | Maximum | |||||
Sales price (in dollars per share) | $ 0.34 | $ 5.16 | |||
Maxim | |||||
Placement agent fees and other offering expenses | $ 751,651 | ||||
Maxim | Maximum | |||||
Reimbursement of fees and expenses | $ 60,000 | ||||
Maxim | Warrants | |||||
Exercise price per share (in dollars per share) | $ 3.36 | ||||
Warrants to purchase common stock | 54,076 |
STOCKHOLDERS' EQUITY - Equity I
STOCKHOLDERS' EQUITY - Equity Incentive Plan (Details) - shares | 1 Months Ended | |
Oct. 31, 2007 | Dec. 31, 2015 | |
Common Stock | ||
Stockholders' equity | ||
Number of shares authorized | 2,500,000 | |
Stock available for future grant (in shares) | 1,429,128 | |
Stock options | ||
Stockholders' equity | ||
Expiration term | 10 years | |
Stock options | Minimum | ||
Stockholders' equity | ||
Vesting period | 0 years | |
Stock options | Maximum | ||
Stockholders' equity | ||
Vesting period | 5 years | |
Incentive stock options | Minimum | ||
Stockholders' equity | ||
Exercise price of common stock as a percentage of fair market value | 100.00% | |
Nonqualified options | Minimum | ||
Stockholders' equity | ||
Exercise price of common stock as a percentage of fair market value | 85.00% | |
Restricted stock units | ||
Stockholders' equity | ||
Expiration term | 5 years | |
Restricted stock units | Minimum | ||
Stockholders' equity | ||
Vesting period | 0 years | |
Restricted stock units | Maximum | ||
Stockholders' equity | ||
Vesting period | 4 years |
STOCKHOLDERS' EQUITY - Stock-ba
STOCKHOLDERS' EQUITY - Stock-based compensation (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based compensation expense | ||||||
Total share-based compensation expense | $ 170,557 | $ 214,916 | $ 345,294 | $ 465,975 | $ 953,019 | $ 1,236,274 |
Research and development | ||||||
Share-based compensation expense | ||||||
Total share-based compensation expense | 65,399 | 91,051 | 141,810 | 215,088 | 432,083 | 466,517 |
General and administrative | ||||||
Share-based compensation expense | ||||||
Total share-based compensation expense | $ 105,158 | $ 123,865 | $ 203,484 | $ 250,887 | 520,936 | 769,757 |
Restricted stock units | ||||||
Share-based compensation expense | ||||||
Total share-based compensation expense | 483,939 | 729,003 | ||||
Stock options | ||||||
Share-based compensation expense | ||||||
Total share-based compensation expense | $ 469,080 | $ 507,271 |
STOCKHOLDERS' EQUITY - Stock Op
STOCKHOLDERS' EQUITY - Stock Options and RSUs (Details) - USD ($) | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | Sep. 30, 2014 | |
Additional disclosures | |||||
Weighted average period to recognize unrecognized share-based compensation expense | 2 years 2 months 12 days | ||||
Fair market value of common stock (in dollars per share) | $ 3.475 | ||||
Cash received from option exercises | $ 47,676 | $ 47,678 | $ 250 | ||
Stock options | |||||
Weighted-average valuation assumptions | |||||
Estimated annual dividends | $ 0 | ||||
Risk free interest rate (as a percent) | 1.50% | 0.90% | |||
Expected life (years) | 5 years 3 months 4 days | 3 years 1 month 6 days | |||
Expected share price volatility (as a percent) | 91.90% | 64.30% | |||
Estimated dividend rate (as a percent) | 0.00% | 0.00% | |||
Number of Shares | |||||
Outstanding at the beginning of the period (in shares) | 1,451,298 | 740,954 | 740,954 | 334,981 | |
Granted | 934,000 | 474,350 | |||
Exercised (in shares) | (82,616) | (715) | |||
Expired (in shares) | (102,533) | (4,287) | |||
Forfeited (in shares) | (38,507) | (63,375) | |||
Outstanding at the end of the period (in shares) | 1,451,298 | 740,954 | |||
Vested and exercisable at the end of the period (in shares) | 535,111 | ||||
Weighted Average Exercise Price | |||||
Outstanding at the beginning of the period (in dollars per share) | $ 2.64 | $ 4.35 | $ 4.35 | $ 4.16 | |
Granted | 1.34 | 4.45 | |||
Exercised (in dollars per share) | 0.58 | 0.35 | |||
Expired (in dollars per share) | 4.53 | 0.35 | |||
Forfeited (in dollars per share) | 3.21 | 4.45 | |||
Outstanding at the end of the period (in dollars per share) | 2.64 | $ 4.35 | |||
Vested and exercisable at the end of the period (in dollars per share) | $ 4.04 | ||||
Weighted Average Remaining Contractual Term | |||||
Outstanding at the end of the period | 7 years 8 months 9 days | ||||
Vested and exercisable at the end of the period | 5 years 7 months 28 days | ||||
Additional disclosures | |||||
Unrecognized compensation expense | $ 1,221,000 | ||||
Weighted average period to recognize unrecognized share-based compensation expense | 5 years 10 months 24 days | ||||
Fair market value of common stock (in dollars per share) | $ 0.23 | ||||
Total intrinsic value of options exercised (in dollars) | $ 159,000 | $ 3,000 | |||
Cash received from option exercises | 48,000 | $ 250 | |||
Restricted stock units | |||||
Additional disclosures | |||||
Total unrecognized stock-based compensation expense | $ 387,000 | ||||
Weighted average period to recognize unrecognized share-based compensation expense | 1 year 10 months 24 days | ||||
Total Restricted Stock Units | |||||
Outstanding at the beginning of the period (in shares) | 479,476 | 641,834 | 641,834 | 721,788 | |
Granted (in shares) | 19,667 | 15,000 | |||
Shares issued | (166,779) | (81,829) | |||
Forfeited (in shares) | (15,246) | (13,125) | |||
Outstanding at the end of the period (in shares) | 479,476 | 641,834 | |||
Weighted Average Grant-Date Fair Value | |||||
Outstanding at the beginning of the period (in dollars per share) | $ 5.40 | $ 5.55 | $ 5.55 | $ 5.66 | |
Granted (in dollars per share) | 2.87 | 2.92 | |||
Shares issued (in dollars per share) | 5.75 | 6.11 | |||
Forfeited (in dollars per share) | 4.68 | 4.97 | |||
Outstanding at the end of the period (in dollars per share) | $ 5.40 | $ 5.55 |
STOCKHOLDERS' EQUITY - Warrants
STOCKHOLDERS' EQUITY - Warrants (Details) - Warrants | 12 Months Ended | ||
Dec. 31, 2015$ / shares$ / itemshares | Dec. 31, 2014shares | Sep. 30, 2014$ / shares | |
Stockholder's equity | |||
Number of Shares | 4,585,644 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 3.36 | ||
Number of warrants granted (in shares) | 4,000 | 3,669,118 | |
Number of warrants exercised (in shares) | 0 | 0 | |
Number of warrants expired (in shares) | 5,715 | 12,858 | |
Weighted average | |||
Stockholder's equity | |||
Exercise price per share (in dollars per share) | $ / shares | $ 4.21 | ||
March 2,017 | |||
Stockholder's equity | |||
Number of Shares not indexed to entity's own stock | 29,750 | ||
Exercise price per share not indexed to entity's own stock (in dollars per share) | $ / item | 5.25 | ||
March 2,017 | |||
Stockholder's equity | |||
Number of Shares not indexed to entity's own stock | 882,776 | ||
Exercise price per share not indexed to entity's own stock (in dollars per share) | $ / item | 7.70 | ||
January 21, 2017 | |||
Stockholder's equity | |||
Number of Shares | 4,000 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 4 | ||
March 9, 2017 | |||
Stockholder's equity | |||
Number of Shares | 29,750 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 5.25 | ||
March 9, 2017 | |||
Stockholder's equity | |||
Number of Shares | 882,776 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 7.70 | ||
May 30, 2017 | |||
Stockholder's equity | |||
Number of Shares | 6,000 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 4 | ||
September 15, 2017 | |||
Stockholder's equity | |||
Number of Shares | 4,000 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 4 | ||
September 25, 2019 | |||
Stockholder's equity | |||
Number of Shares | 3,605,042 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 3.36 | ||
September 26, 2019 | |||
Stockholder's equity | |||
Number of Shares | 54,076 | ||
Exercise price per share (in dollars per share) | $ / shares | $ 3.36 |
INCOME TAXES - NOL Carryforward
INCOME TAXES - NOL Carryforwards (Details) $ in Millions | Dec. 31, 2015USD ($) |
Federal | |
Net operating loss (NOL) carryforwards | |
Net operating loss (NOL) carryforwards | $ 82 |
CALIFORNIA | State | |
Net operating loss (NOL) carryforwards | |
Net operating loss (NOL) carryforwards | $ 74 |
INCOME TAXES - Tax Credit Carry
INCOME TAXES - Tax Credit Carryforwards (Details) - Research and development $ in Millions | Dec. 31, 2015USD ($) |
Federal | |
Tax credit carryforwards | |
Tax credit carryforwards | $ 1.8 |
State | CALIFORNIA | |
Tax credit carryforwards | |
Tax credit carryforwards | $ 0.8 |
INCOME TAXES - Deferred Taxes a
INCOME TAXES - Deferred Taxes and Provision (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Deferred tax assets: | ||
Federal and state net operating loss carryforwards | $ 34,568,000 | $ 30,935,000 |
Research and development credit carryforwards | 2,609,000 | 1,812,000 |
Stock-based compensation | 718,000 | 1,729,000 |
Deferred contract revenue | 54,000 | |
Other, net | 63,000 | 149,000 |
Deferred tax assets | 37,958,000 | 34,679,000 |
Deferred tax liabilities: | ||
State taxes | (2,540,000) | (2,459,000) |
Patent costs | (913,000) | (958,000) |
Deferred tax liabilities | (3,453,000) | (3,417,000) |
Total deferred tax assets | 34,505,000 | 31,262,000 |
Valuation allowance | (34,505,000) | (31,262,000) |
Net deferred tax assets | $ 0 | 0 |
Statutory federal income tax rate | ||
Statutory federal income tax rate (as a percent) | 34.00% | |
Reconciliation of effective tax rate | ||
Federal tax benefit at statutory rate | $ 3,404,000 | 5,629,000 |
State tax benefit, net | 721,000 | 1,028,000 |
Change in fair value of warrants | 289,000 | 425,000 |
Research and development credits | 596,000 | |
Employee stock-based compensation | (1,764,000) | (56,000) |
Other permanent differences | (3,000) | 9,000 |
Decrease in valuation allowance | (3,243,000) | (7,035,000) |
Provision for income taxes | $ 0 | $ 0 |
OPERATING LEASE (Details)
OPERATING LEASE (Details) | 12 Months Ended | |
Dec. 31, 2015USD ($)item | Dec. 31, 2014USD ($) | |
OPERATING LEASE | ||
Area of laboratory and office facility in San Diego, California (in square foot) | item | 11,960 | |
Monthly lease payments | $ 28,268 | |
Percentage of annual escalations | 3.00% | |
Additional extended lease term | 5 years | |
Total rent expenses | $ 390,000 | $ 385,000 |
Sublease income | $ 12,000 | $ 12,000 |
RELATED-PARTY TRANSACTIONS (Det
RELATED-PARTY TRANSACTIONS (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2015 | Dec. 31, 2014 | |
Related-party transactions | ||
Sublease income | $ 12,000 | $ 12,000 |
WSIC | ||
Related-party transactions | ||
Sublease income | 11,652 | 11,652 |
Administrative expenses | 12,008 | 39,300 |
Amount due for facility expenses | 2,900 | |
Amount due for services received | $ 948 | $ 7,100 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) | Jun. 30, 2016 | Dec. 31, 2015 | Jun. 30, 2015 | Dec. 31, 2014 | Dec. 31, 2013 |
Current Assets: | |||||
Cash and cash equivalents | $ 4,664,170 | $ 8,889,616 | $ 11,854,187 | $ 17,282,325 | $ 11,851,639 |
Accounts receivable | 9,244 | 6,988 | 727,178 | ||
Prepaid expenses and other current assets | 614,209 | 357,281 | 413,260 | ||
Total current assets | 5,287,623 | 9,253,885 | 18,422,763 | ||
Equipment and leasehold improvements, net | 105,990 | 149,271 | 221,148 | ||
Patents, net | 1,599,003 | 2,132,129 | 2,236,909 | ||
Deposits and other assets | 77,160 | 77,160 | 77,350 | ||
Total assets | 7,069,776 | 11,612,445 | 20,958,170 | ||
Current Liabilities: | |||||
Accounts payable | 462,693 | 294,010 | 2,865,165 | ||
Accrued compensation | 246,072 | 546,578 | 848,583 | ||
Accrued expenses | 75,766 | 204,237 | 383,623 | ||
Deferred rent | 16,287 | 35,629 | 33,744 | ||
Total current liabilities | 800,818 | 1,080,454 | 4,256,115 | ||
Total liabilities | 800,818 | 1,080,454 | 5,141,744 | ||
Stockholders' Equity: | |||||
Common stock - $.001 par value; 100,000,000 shares authorized; 2,368,221 and 2,369,449 issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 2,368 | 2,369 | 19,225 | ||
Additional paid-in capital | 86,916,854 | 86,573,137 | 81,830,410 | ||
Accumulated deficit | (80,650,264) | (76,043,515) | (66,033,209) | ||
Total stockholders' equity | 6,268,958 | 10,531,991 | 15,816,426 | $ 9,968,173 | |
Total liabilities and stockholders' equity | $ 7,069,776 | $ 11,612,445 | $ 20,958,170 |
Condensed Consolidated Balanc43
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Consolidated Balance Sheets | |||
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 2,368,221 | 2,369,449 | 19,224,708 |
Common stock, shares outstanding | 2,368,221 | 2,369,449 | 19,224,708 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Revenues: | ||||||
Grant and royalty revenue | $ 9,243 | $ 13,329 | $ 18,851 | $ 26,964 | $ 52,020 | $ 631,840 |
Research and development revenue under collaborative agreements | 734,292 | 1,504,558 | 1,547,743 | 4,448,623 | ||
Total revenues | 9,243 | 747,621 | 18,851 | 1,531,522 | 1,599,763 | 5,080,463 |
Expenses: | ||||||
Research and development | 935,620 | 2,916,637 | 1,927,530 | 5,672,125 | 8,513,974 | 18,126,701 |
General and administrative | 1,734,561 | 1,101,676 | 2,698,070 | 2,152,419 | 3,946,147 | 4,758,831 |
Total expenses | 2,670,181 | 4,018,313 | 4,625,600 | 7,824,544 | 12,460,121 | 22,885,532 |
Loss from operations | (2,660,938) | (3,270,692) | (4,606,749) | (6,293,022) | (10,860,358) | (17,805,069) |
Other income, net | 40 | 40 | 52 | 18 | ||
Change in fair value of warrants | 600,000 | 850,000 | 850,000 | 1,250,000 | ||
Net loss | $ (2,660,938) | $ (2,670,652) | $ (4,606,749) | $ (5,442,982) | $ (10,010,306) | $ (16,555,051) |
Basic and diluted net loss per share | $ (1.11) | $ (1.80) | $ (1.93) | $ (3.77) | $ (0.39) | $ (1) |
Weighted-average shares outstanding used in the calculation | 2,390,861 | 1,482,144 | 2,391,698 | 1,445,396 | 25,734,836 | 16,555,654 |
Condensed Consolidated Statem45
Condensed Consolidated Statements of Cash Flows - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Cash flows from operating activities: | ||||
Net loss | $ (4,606,749) | $ (5,442,982) | $ (10,010,306) | $ (16,555,051) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||||
Share-based compensation expense | 345,294 | 465,975 | 953,019 | 1,236,274 |
Change in fair value of warrants | (850,000) | (850,000) | (1,250,000) | |
Depreciation and amortization | 672,278 | 142,398 | 466,988 | 216,088 |
Changes in operating assets and liabilities: | ||||
Accounts receivable | (2,256) | (4,767) | 720,190 | 582,859 |
Prepaid expenses and other current assets | (256,928) | 116,145 | 55,979 | (120,783) |
Accounts payable and accrued expenses | (260,294) | (1,440,947) | (3,046,676) | 1,101,210 |
Deferred contract revenue | (125,000) | (125,000) | (373,000) | |
Other | (19,342) | (13,579) | (32,731) | (24,008) |
Net cash used in operating activities | (4,127,997) | (7,152,757) | (11,868,537) | (15,186,411) |
Cash flows from investing activities: | ||||
Equipment and leasehold improvement expenditures | (21,117) | (21,117) | (105,611) | |
Patent expenditures | (95,872) | (146,581) | (270,035) | (430,304) |
Net cash used in investing activities | (95,872) | (167,698) | (291,152) | (535,915) |
Cash flows from financing activities: | ||||
Proceeds from sale of common stock and warrants, net | 1,845,821 | 3,720,485 | 21,237,442 | |
Proceeds from options and warrants exercised | 47,676 | 47,678 | 250 | |
Payment for restricted stock tax liability on net settlement | (1,577) | (1,180) | (1,183) | (84,680) |
Net cash provided (used in) by financing activities | (1,577) | 1,892,317 | 3,766,980 | 21,153,012 |
Net increase (decrease) in cash and cash equivalents | (4,225,446) | (5,428,138) | (8,392,709) | 5,430,686 |
Cash and cash equivalents at beginning of period | 8,889,616 | 17,282,325 | 17,282,325 | 11,851,639 |
Cash and cash equivalents at end of period | 4,664,170 | 11,854,187 | 8,889,616 | 17,282,325 |
Cash paid during the year for: | ||||
Income taxes | $ 1,600 | 1,600 | 1,600 | 1,600 |
Supplemental disclosure of non-cash investing and financing activities: | ||||
Change in fair value of warrants | $ (850,000) | $ (850,000) | $ (1,250,000) |
BASIS FOR PRESENTATION
BASIS FOR PRESENTATION | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES | ||
BASIS FOR PRESENTATION | Note 1 — BASIS FOR PRESENTATION The unaudited condensed consolidated balance sheet of Lpath, Inc. (“Lpath” or “the company”) as of December 31, 2015 was derived from our 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 period ended June 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016 or for any future financial period. 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, 2015. 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, 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. Reverse Stock Split On June 8, 2016, the company’s board of d irectors and the company’s stockholders approved a 1 -for-14 reverse split of the company’s issued and outstanding common stock. The reverse split was effective on June 10, 2016. Fractional shares created by the reverse stock split were rounded up to the nearest whole share. All issued and outstanding common stock, options exercisable for common stock, warrants exercisable for common stock, restricted stock units, and per share amounts contained in the company’s condensed consolidated financial statements have been retroactively adjusted to reflect this reverse stock split for all periods presented. | Note 1—THE COMPANY AND A SUMMARY OF ITS SIGNIFICANT ACCOUNTING POLICIES Organization and Business Lpath, Inc. (“Lpath,” “we,” or “the company”) is a biotechnology company focused on the discovery and development of lipidomic-based therapeutic antibodies, an emerging field of medical science that targets bioactive signaling lipids to treat a wide range of human diseases. We have developed three drug candidates, advancing each of them into clinical trials, and built evidence to support our approach of targeting bioactive lipids to treat a wide range of diseases. On July 17, 2014, Lpath changed its state of incorporation from the State of Nevada to the State of Delaware (the “Reincorporation”) pursuant to a plan of conversion, dated July 17, 2014 (the “Plan of Conversion”). The Reincorporation was accomplished by the filing of (i) articles of conversion with the Secretary of State of the State of Nevada, and (ii) a certificate of conversion and a certificate of incorporation with the Secretary of State of the State of Delaware. Pursuant to the Plan of Conversion, Lpath also adopted new bylaws. The Reincorporation did not affect any of the company’s material contracts with any third parties, and the company’s rights and obligations under such material contractual arrangements continue to be rights and obligations of the company after the Reincorporation. The Reincorporation did not result in any change in headquarters, business, jobs, management, location of any of the offices or facilities, number of employees, assets, liabilities or net worth (other than as a result of the costs incident to the Reincorporation) of Lpath. Basis of Presentation The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“GAAP”). The consolidated financial statements include the accounts of Lpath, Inc. and its wholly-owned subsidiary, Lpath Therapeutics Inc. All significant intercompany balances and transactions have been eliminated in consolidation. Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect reported amounts of assets and liabilities, disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting period. By their nature, estimates are subject to an inherent degree of uncertainty and, as such, actual results may differ from those estimates. Cash and Cash Equivalents Cash and cash equivalents consist of cash deposits, money market deposits, and certificates of deposit. Concentration of Credit Risk Financial instruments that potentially subject the company to a significant concentration of credit risk consist of cash and cash equivalents. The company maintains its cash balances with one major commercial bank in non-interest bearing accounts. Accounts at FDIC-insured institutions are insured by the FDIC up to $250,000 . The company invests its excess cash in money market mutual funds and in certificates of deposit of federally insured financial institutions. The company has established guidelines relative to diversification of its cash investments and their maturities that are intended to secure safety and liquidity. To date, the company has not experienced any impairment losses on its cash equivalents. The company has not experienced any losses on its deposits of cash and cash equivalents, short-term and long-term investments. The company’s accounts receivable are derived from entities located in the United States. The company performs ongoing credit evaluation of its debtors, does not require collateral, and maintains allowances for potential credit losses on customer accounts when deemed necessary. To date, there have been no such losses and the company has not recorded an allowance for doubtful accounts. Equipment and Leasehold Improvements Equipment and leasehold improvements are recorded at cost. Equipment depreciation is computed using the straight-line method over the estimated useful asset lives, which range from three to five years. Leasehold improvements are amortized over the shorter of their estimated useful lives or the remainder of the lease term. Repairs and maintenance are charged to expense as incurred. Patents Legal and filing costs directly associated with obtaining patents are capitalized. Upon issuance of a patent, amortization is computed using the straight-line method over the estimated remaining useful life of the patent. Long-lived Assets The company accounts for the impairment and disposition of long-lived assets for events or changes in circumstances which indicate that their carrying value may not be recoverable. The company recorded charges for impairments of patents totaling $298,709 and $61,314 in 2015 and 2014, respectively. Deferred Rent Rent expense is recorded on a straight-line basis over the term of the lease. The difference between rent expense and amounts paid under the lease agreement is recorded as deferred rent. Lease incentives, including tenant improvement allowances, are also recorded as deferred rent and amortized on a straight-line basis over the lease term. Stock-based Compensation Expense Compensation expense is measured based on the fair value of the award at the grant date, including estimated forfeitures, and is adjusted to reflect actual forfeitures and the outcomes of certain conditions. Compensation issued to non-employees is remeasured quarterly and income or expense is recognized during their vesting terms. Revenue Recognition Lpath has and may in the future enter into collaborations where we receive non-refundable up-front payments. Generally, these payments secure licenses to Lpath drug candidates. Non-refundable payments are recognized as revenue when the company has a contractual right to receive such payment, the contract price is fixed or determinable, the collection of the resulting receivable is reasonably assured, and the company has no further performance obligations under the license agreement. Multiple-element arrangements, such as license and development arrangements, are analyzed to determine whether the deliverables, which often include a license together with performance obligations such as research and development responsibilities and steering committee services, can be separated or whether they must be accounted for as a single unit of accounting. The company recognizes up-front license payments as revenue upon delivery of the license only if the license has stand-alone value and the fair value of the undelivered performance obligations, typically including research and/or steering committee services, can be determined. If the fair value of the undelivered performance obligations can be determined, such obligations would then be accounted for separately as performed. If the license is considered to either (i) not have stand-alone value or (ii) have stand-alone value but the fair value of any of the undelivered performance obligations cannot be determined, the arrangement would then be accounted for as a single unit of accounting, and the license payments and payments for performance obligations are recognized as revenue over the estimated period of when the performance obligations are performed. If the company is involved in a steering committee as part of a multiple-element arrangement that is accounted for as a single unit of accounting, the company assesses whether its involvement constitutes a performance obligation or a right to participate. Steering committee services that are determined to be performance obligations are combined with other research services or performance obligations required under an arrangement, if any, in determining the level of effort required in an arrangement and the period over which the company expects to complete its aggregate performance obligations. When the company receives reimbursement for research costs under collaborative agreements, such reimbursements are recognized as revenue as the underlying costs are incurred. Whenever the company determines that an arrangement should be accounted for as a single unit of accounting, it must determine the period over which the performance obligations will be performed and revenue will be recognized. Revenue will be recognized using either a relative performance or straight-line method. The company recognizes revenue using the relative performance method provided that the company can reasonably estimate the level of effort required to complete its performance obligations under an arrangement and such performance obligations are provided on a best-efforts basis. Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the relative performance method, as of each reporting period. If the company cannot reasonably estimate the level of effort required to complete its performance obligations under an arrangement, the performance obligations are provided on a best-efforts basis and the company can reasonably estimate when the performance obligation ceases or the remaining obligations become inconsequential and perfunctory, then the total payments under the arrangement, excluding royalties and payments contingent upon achievement of substantive milestones, would be recognized as revenue on a straight-line basis over the period the company expects to complete its performance obligations. Revenue is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line basis, as of the period ending date. If the company cannot reasonably estimate when its performance obligation either ceases or becomes inconsequential and perfunctory, then revenue is deferred until the company can reasonably estimate when the performance obligation ceases or becomes inconsequential. Revenue is then recognized over the remaining estimated period of performance. Significant management judgment is required in determining the level of effort required under an arrangement and the period over which the company is expected to complete its performance obligations under an arrangement. Collaboration agreements may also contain substantive milestone payments. Substantive milestone payments are considered to be performance bonuses that are recognized upon achievement of the milestone only if all of the following conditions are met: · the milestone payments are non-refundable; · achievement of the milestone involves a degree of risk and was not reasonably assured at the inception of the arrangement; · substantive company effort is involved in achieving the milestone; · the amount of the milestone payment is reasonable in relation to the effort expended or the risk associated with achievement of the milestone; and · a reasonable amount of time passes between the up-front license payment and the first milestone payment as well as between each subsequent milestone payment. Determination as to whether a payment meets the aforementioned conditions involves management’s judgment. If any of these conditions are not met, the resulting payment would not be considered a substantive milestone and, therefore, the resulting payment would be considered part of the consideration for the single unit of accounting and would be recognized as revenue, as such performance obligations are performed under either the relative performance or straight-line methods, as applicable, and in accordance with these policies as described above. Grant Revenue. Lpath recognizes grant revenue as the related research expenses are incurred, up to contractual limits. Royalty Revenue. Lpath recognizes royalty revenue from licensed products when earned in accordance with the terms of the license agreements. The licensee’s net sales figures used for calculating royalties include deductions for costs of unsaleable returns, cash discounts, freight, postage, and insurance. Research and Development Research and development costs are charged to expense when incurred. Employee Benefit Plan The company has a 401(k) defined contribution plan that provides benefits for most employees. An employee is eligible to participate in this plan after one month of service. The plan provides for full vesting of benefits over five years. Company contributions to the plan are made at the discretion of the Board of Directors and aggregated $96,182 and $108,534 in 2015 and 2014, respectively. Income Taxes Deferred taxes are provided on a liability method whereby deferred tax assets are recognized for deductible temporary differences, and deferred tax liabilities are recognized for taxable temporary differences. Temporary differences are the differences between the reported amounts of assets and liabilities and their tax bases. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in tax laws and rates on the date of enactment. A net deferred tax asset related primarily to federal and state net operating loss and research and development credit carryforwards has been fully reserved due to uncertainties regarding Lpath’s ability to realize these tax benefits in future periods. Consequently, no income tax benefit has been recorded for the years ended December 31, 2015 and 2014. Lpath periodically evaluates its tax positions to determine whether it is more likely than not that a tax position will be sustained upon examination by the appropriate taxing authorities. Lpath has not incurred any interest or penalties as of December 31, 2015 with respect to income tax matters. Lpath does not expect that there will be unrecognized tax benefits of a significant nature that will increase or decrease within 12 months of the reporting date. Comprehensive Income (Loss) Comprehensive income (loss) is comprised of net loss and certain changes in equity that are excluded from net loss. At December 31, 2015 and 2014, Lpath had no reportable differences between net loss and comprehensive loss. Per Share Data Basic net income (loss) per common share is computed by dividing net income (loss) for the period by the weighted-average number of common shares outstanding during the period. Diluted net income (loss) per share is computed by dividing the net income (loss) for the period by the weighted-average number of common and common dilutive equivalent shares, such as stock options, restricted stock units, restricted stock awards, warrants, and convertible securities outstanding during the period. Anti-dilutive common stock equivalents were excluded from the calculation of diluted income (loss) per share as follows: Years Ended December 31, 2015 2014 Stock options Warrants Restricted stock units Total Impact of Recently Issued Accounting Standards In November 2015, the FASB issued ASU 2015-17, Balance Sheet Classification of Deferred Taxes, which eliminates the current requirement to present deferred tax liabilities and assets as current and noncurrent in a classified balance sheet. Instead, entities will be required to classify all deferred tax assets and liabilities as noncurrent. ASU 2015-17 will be effective for fiscal years beginning after December 15, 2017, and early adoption is permitted. The company does not expect the adoption of this ASU will have a significant impact on its financial statements. In May 2014, the FASB issued ASU 2014-09, Revenues from Contracts with Customers (Topic 606). This guidance applies to any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards. The core principle of this guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This guidance supersedes existing revenue recognition guidance, including most industry-specific guidance, as well as certain related guidance on accounting for contract costs. For nonpublic entities, this guidance is effective for annual reporting periods beginning after December 15, 2018. Limited early adoption options are permitted. The company is currently evaluating the impact of this ASU on its financial statements. In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements – Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity's Ability to Continue as a Going Concern. ASU 2014-15 defines management's responsibility to evaluate whether there is substantial doubt about an organization's ability to continue as a going concern and to provide related footnote disclosures. The guidance in ASU 2014-15 is effective for annual reporting periods beginning after December 15, 2016, with early application permitted. The company is currently evaluating the impact of this ASU on its financial statements. In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842). Under this guidance, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within that reporting period, and requires a modified retrospective adoption, with early adoption permitted. The company is currently evaluating the impact of this ASU on its financial statements. |
GOING CONCERN UNCERTAINTY47
GOING CONCERN UNCERTAINTY | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
GOING CONCERN UNCERTAINTY | ||
GOING CONCERN UNCERTAINTY | Note 2 – GOING CONCERN UNCERTAINTY The accompanying consolidated financial statements have been prepared assuming that the company will continue as a going concern. Lpath utilized cash in operations of $4.1 million during the six-months ended June 30, 2016 and $11.9 million during the year ended December 31, 2015. These conditions raise substantial doubt about the company’s ability to continue as a going concern. Management’s plans with regard to these matters are discussed below. The a ccompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. As of June 30, 2016, the company had cash and cash equivalents totaling $4.7 million. The company may also receive limited additional funding from future awards of National Institutes of health (“ NIH ”) or the US Department of Defense ( “ DoD ” ) grants. Potential additional near term sources of cash may include the proceeds from the sale of Lpath common stock under the MLV agreement. As they are currently planned, however, the company does not believe that its existing cash resources will be sufficient to meet its operating plan for the full 12 month period after the date of this filing. To help extend the company’s operating window, the company has reduced its headcount and limited its research and product development activities . Based on its current plans and available resources, the company believe s it can maintain our current operations through the end of November 2016. The company estimate s that at Nov ember 30, 2016 the costs to wind-down its operations in an orderly manner would be approximately $2. 0 million. As a result, to continue to fund the company’s ongoing operations, including its drug discovery and development projects, beyond November 30, 2016, the company would need to secure significant additional capital. Moreover, its expenses may exceed its current plans and expectations, which would require the company to secure additional capital or wind-down its operations sooner than anticipated. The company’s board of d irectors has engaged a financial advisory firm to explore its r available strategic alternatives, including possible mergers and business combinations, a sale of part or all of its assets, collaboration and licensing arrangements and/or equity and debt financings. This strategic process is both active and ongoing, and includes a range of interactions with potential transaction counterparties. The company believe s it is in its stockholders’ best interests at this time to continue to pursue one or more of these transactions, or other strategic alternatives the company may identify in the near term. Although the company is actively pursuing its strategic alternatives, there is no assurance that it will be able to successfully negotiate and consummate a transaction on a timely basis, or at all. Further, the company’s expenses may exceed its current plans and expectations, which could require it to complete a transaction or wind-down its operations sooner than anticipated. Additionally, any transaction the company consummate s may offer limited value for its existing drug candidates and proprietary technology and may not enhance stockholder value or provide the expected benefits. If the company is unable to successfully complete a strategic transaction or secure additional capital on a timely basis and on terms that are acceptable to its stockholders, the company may be required to cease its operations altogether. | Note 2 – GOING CONCERN UNCERTAINTY The accompanying consolidated financial statements have been prepared assuming that the company will continue as a going concern. Lpath utilized cash in operations of $11.9 and $15.2 million during the years ended December 31, 2015 and 2014, respectively. These conditions raise substantial doubt about the company’s ability to continue as a going concern. Management’s plans with regard to these matters are discussed below. The accompanying consolidated financial statements do not include any adjustments that might result from the outcome of this uncertainty. As of December 31, 2015, the company had cash and cash equivalents totaling $8.9 million. We may also receive limited additional funding from future awards of NIH grants. As they are currently planned, however, we do not believe that our existing cash resources will be sufficient to meet our operating plan for the full 12 month period after the date of this filing. Accordingly, the report from our independent registered public accounting firm accompanying the financial statements included in this Annual Report on Form 10-K contains an emphasis of a matter regarding our ability to continue as a going concern. To help extend our operating window, w e have reduced our headcount and limited our research and product development activities . Based on our current plans and available resources, we believe we can maintain our current operations through the end of the third quarter of 2016. We estimate that the costs to wind-down our operations in an orderly manner will cost approximately $2.5 million. As a result, we need to secure significant additional capital to continue to fund our operations and our drug discovery and development projects beyond the third quarter of 2016. Moreover, our expenses may exceed our current plans and expectations, which would require us to secure additional capital or wind-down our operations sooner than anticipated. Our Board of Directors has engaged a financial advisory firm to explore our available strategic alternatives, including possible mergers and business combinations, a sale of part or all of our assets, collaboration and licensing arrangements and/or equity and debt financings. This strategic process is both active and ongoing, and includes a range of interactions with potential transaction counterparties. We believe it is in our stockholders’ best interests at this time to continue to pursue one or more of these transactions, or other strategic alternatives we may identify in the near term. Although we are actively pursuing our strategic alternatives, there is no assurance that we will be able to successfully negotiate and consummate a transaction on a timely basis, or at all. Further, our expenses may exceed our current plans and expectations, which could require us to complete a transaction or wind-down our operations sooner than anticipated. Additionally, any transaction we consummate may offer limited value for our existing drug candidates and proprietary technology and may not enhance stockholder value or provide the expected benefits. If we are unable to successfully complete a strategic transaction or otherwise secure additional capital on a timely basis and on terms that are acceptable to our stockholders, we may be required to cease our operations altogether. |
RESEARCH AND DEVELOPMENT COLL48
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS | ||
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS | 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. On May 20, 2015, Lpath announced that its Phase 2 "Nexus" clinical trial evaluating iSONEP™ in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy. On August 9, 2015, Pfizer’s option to obtain worldwide rights to iSONEP expired, unexercised, which resulted in the termination of the Pfizer Agreement. Consequently, all rights that Pfizer held in the iSONEP program have reverted to Lpath. Lpath has no plans for further development of iSONEP. As part of the agreement, Lpath 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. That right of first refusal expired on August 9, 2015, concurrently with the expiration of Pfizer’s option to acquire the license to iSONEP. Pfizer has no further obligations to fund clinical trial costs incurred after the expiration date of the Pfizer Agreement. The company recognized revenue under the Pfizer Agreement as follows: Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Cost reimbursements $ - $ $ - $ Amortization of license and development fees - - $ - $ $ - $ | Note 3—RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT 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. On May 20, 2015, Lpath announced that its Phase 2 "Nexus" clinical trial evaluating iSONEP™ in patients with wet age-related macular degeneration (wet AMD) did not meet its primary or key secondary endpoints. Wet AMD patients who had not responded adequately to existing anti-vascular endothelial growth factor (VEGF) therapies including Lucentis®, Avastin® and Eylea® did not show any statistically significant improvement in visual acuity when treated with iSONEP as an adjunctive or monotherapy. On August 9, 2015, Pfizer’s option to obtain worldwide rights to iSONEP expired, unexercised, which resulted in the termination of the Pfizer Agreement. Consequently, all rights that Pfizer held in the iSONEP program have reverted to Lpath. Lpath has no plans for further development of iSONEP. As part of the Pfizer A greement, Lpath 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. That right of first refusal expired on August 9, 2015, concurrently with the expiration of Pfizer’s option to acquire the license to iSONEP. Pfizer has no further obligations to fund clinical trial costs incurred after the expiration date of the Pfizer Agreement. The company recognized revenue under the Pfizer Agreement as follows: Year Ended December 31, 2015 2014 Cost reimbursements $ $ Amortization of license and development fees $ $ |
SHARE-BASED PAYMENTS
SHARE-BASED PAYMENTS | 6 Months Ended |
Jun. 30, 2016 | |
SHARE-BASED PAYMENTS | |
SHARE-BASED PAYMENTS | Note 4 — SHARE-BASED PAYMENTS The company recognized share-based compensation expense as follows: Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative Total share-based compensation expense $ $ $ $ As of June 30, 2016, there was a total of $0.8 million in unrecognized compensation expense related to unvested share-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 2.2 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 three months ended June 30, 2016 and 2015. |
FAIR VALUE MEASUREMENTS50
FAIR VALUE MEASUREMENTS | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
FAIR VALUE MEASUREMENTS | ||
FAIR VALUE MEASUREMENTS | Note 5 — FAIR VALUE MEASUREMENTS Lpath has issued warrants, of which some are classified as equity and some as liabilities. 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. The company’s recurring fair value measurements at June 30, 2016 were as follows: Significant Unobservable Fair Value as of Inputs June 30, 2016 (Level 3) Liabilities: Warrants expiring March 2017 $ - $ - The company determined the fair value of the warrant liability for certain warrants, as applicable, using a Black-Scholes model. The model considered amounts and timing of future possible equity and warrant issuances and volatility of the company’s stock price equal to 100% , as specified in the underlying warrants. The fair value of the warrants at June 30, 2016 was zero . There was no change in the fair value of the warrants during the three months ended June 30, 2016. The terms of all outstanding warrants permit the company, upon exercise of the warrants, to settle the contract by the delivery of unregistered shares. As of June 30, 2016 there were 327,575 warrants outstanding with a weighted-average exercise price of $58.94 per share expiring through September 2019. | Note 5—FAIR VALUE MEASUREMENTS The company measures fair value in accordance with the applicable accounting standards in the FASB Codification. Fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, there exists a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value as follows: · Level 1—unadjusted quoted prices in active markets for identical assets or liabilities that the company has the ability to access as of the measurement date. · Level 2—inputs other than quoted prices included within Level 1 that are directly observable for the asset or liability, or indirectly observable through corroboration with observable market data. · Level 3—unobservable inputs for the asset or liability are only used when there is little, if any, market activity for the asset or liability at the measurement date. This hierarchy requires the company to use observable market data, when available, and to minimize the use of unobservable inputs when determining fair value. Recurring Fair Value Estimates Lpath has issued warrants, of which some are classified as equity and some as liabilities. 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. The fair value and significant unobservable inputs (level 3) of the March 2012 warrants was zero as of December 31, 2015. 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). Fair value measurements using significant unobservable inputs (Level 3): Liabilities: Warrant liability as of January 1, 2015 $ Change in fair value of warrants Warrant liability as of December 31, 2015 $ - The company determined the fair value of the warrant liability for certain warrants, as applicable, using a Black-Scholes model. The model considered amounts and timing of future possible equity and warrant issuances and volatility of the company’s stock price equal to 100% , as specified in the underlying warrants. |
EARNINGS PER SHARE
EARNINGS PER SHARE | 6 Months Ended |
Jun. 30, 2016 | |
EARNINGS PER SHARE | |
EARNINGS PER SHARE | Note 6 — EARNINGS PER SHARE Basic net loss per common share is calculated by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding during the period, without consideration for potentially dilutive securities. Because the company reported a net loss for the six months ended June 30, 2016 and 2015, diluted net loss per common share is the same as basic net loss per common share for those periods. Anti-dilutive common stock equivalents excluded from the calculation of diluted loss per share were as follows: Six Months Ended June 30, 2016 2015 Stock options Warrants Restricted stock units Total |
RESEARCH AND DEVELOPMENT COLL52
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENTS | ||
Schedule of recognized revenue under the Pfizer Agreement | Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Cost reimbursements $ - $ $ - $ Amortization of license and development fees - - $ - $ $ - $ | The company recognized revenue under the Pfizer Agreement as follows: Year Ended December 31, 2015 2014 Cost reimbursements $ $ Amortization of license and development fees $ $ |
SHARE-BASED PAYMENTS (Tables)
SHARE-BASED PAYMENTS (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
SHARE-BASED PAYMENTS | ||
Schedule of recognized share-based compensation expense | Six Months Ended Three Months Ended June 30, June 30, 2016 2015 2016 2015 Research and development $ $ $ $ General and administrative Total share-based compensation expense $ $ $ $ | 2015 2014 Stock-based compensation expense by type of award: Stock options $ $ Restricted stock units Total stock-based compensation expense $ $ Effect of stock-based compensation expense on Research and development General and administrative Total stock-based compensation expense $ $ |
FAIR VALUE MEASUREMENTS (Tabl54
FAIR VALUE MEASUREMENTS (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
FAIR VALUE MEASUREMENTS | |
Schedule of recurring fair value measurements | Significant Unobservable Fair Value as of Inputs June 30, 2016 (Level 3) Liabilities: Warrants expiring March 2017 $ - $ - |
EARNINGS PER SHARE (Tables)
EARNINGS PER SHARE (Tables) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
EARNINGS PER SHARE | ||
Anti-dilutive common stock equivalents were excluded from the calculation of diluted loss per share as follows | Six Months Ended June 30, 2016 2015 Stock options Warrants Restricted stock units Total | Years Ended December 31, 2015 2014 Stock options Warrants Restricted stock units Total |
BASIS FOR PRESENTATION (Details
BASIS FOR PRESENTATION (Details) | Jun. 08, 2016 |
Class A common stock | |
Reverse split ratio of common stock | 0.071 |
GOING CONCERN UNCERTAINTY (De57
GOING CONCERN UNCERTAINTY (Details) | Nov. 30, 2016USD ($) | Jun. 30, 2016USD ($)item | Jun. 30, 2015USD ($) | Dec. 31, 2015USD ($) | Dec. 31, 2014USD ($) | Dec. 31, 2013USD ($) |
Cash utilized in operating activities | $ 4,127,997 | $ 7,152,757 | $ 11,868,537 | $ 15,186,411 | ||
Cash | $ 4,664,170 | $ 11,854,187 | $ 8,889,616 | $ 17,282,325 | $ 11,851,639 | |
Period for which cash resources may be insufficient | 12 months | 12 months | ||||
Estimated wind-down costs of operations | $ 2,500,000 | |||||
Minimum number of business transactions being explored as strategic alternatives | item | 1 | |||||
Forecast | ||||||
Estimated wind-down costs of operations | $ 2,000,000 |
RESEARCH AND DEVELOPMENT COLL58
RESEARCH AND DEVELOPMENT COLLABORATIVE AGREEMENT (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Research and development collaborative agreements | ||||
Total recognized revenue | $ 734,292 | $ 1,504,558 | $ 1,547,743 | $ 4,448,623 |
Collaboration agreement | Pfizer Inc. | ||||
Research and development collaborative agreements | ||||
Cost reimbursements | 671,792 | 1,379,558 | 1,422,743 | 4,075,623 |
Amortization of license and development fees | 62,500 | 125,000 | 125,000 | 373,000 |
Total recognized revenue | $ 734,292 | $ 1,504,558 | $ 1,547,743 | $ 4,448,623 |
SHARE-BASED PAYMENTS (Details)
SHARE-BASED PAYMENTS (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Share-based compensation expense | ||||||
Total share-based compensation expense | $ 170,557 | $ 214,916 | $ 345,294 | $ 465,975 | $ 953,019 | $ 1,236,274 |
Unrecognized compensation expense related to unvested share-based compensation | 800,000 | $ 800,000 | ||||
Weighted average period to recognize unrecognized share-based compensation expense | 2 years 2 months 12 days | |||||
Research and development | ||||||
Share-based compensation expense | ||||||
Total share-based compensation expense | 65,399 | 91,051 | $ 141,810 | 215,088 | 432,083 | 466,517 |
General and administrative | ||||||
Share-based compensation expense | ||||||
Total share-based compensation expense | $ 105,158 | $ 123,865 | $ 203,484 | $ 250,887 | $ 520,936 | $ 769,757 |
FAIR VALUE MEASUREMENTS - Rec60
FAIR VALUE MEASUREMENTS - Recurring Fair Value (Details) - USD ($) | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Liabilities: | ||||||
Change in fair value of warrants | $ (600,000) | $ (850,000) | $ (850,000) | $ (1,250,000) | ||
Warrants | ||||||
Liabilities: | ||||||
Volatility of stock price as specified in the underlying warrants (as a percent) | 100.00% | 100.00% | ||||
Change in fair value of warrants | $ 0 | |||||
Number of warrants outstanding (in shares) | 327,575 | 327,575 | ||||
Weighted-average exercise price of warrant outstanding (in dollars per share) | $ 58.94 | $ 58.94 | ||||
Warrants | Recurring | March 2017 | ||||||
Liabilities: | ||||||
Fair value of liabilities | $ 0 | $ 0 | ||||
Warrants | Recurring | Significant Unobservable Inputs (Level 3) | March 2017 | ||||||
Liabilities: | ||||||
Fair value of liabilities | $ 0 | $ 0 |
EARNINGS PER SHARE (Details)
EARNINGS PER SHARE (Details) - shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Dec. 31, 2015 | Dec. 31, 2014 | |
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 485,414 | 474,903 | 6,516,418 | 5,970,147 |
Stock options | ||||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 128,870 | 110,714 | 1,451,298 | 740,954 |
Warrants | ||||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 327,575 | 327,955 | 4,585,644 | 4,587,359 |
Restricted stock units | ||||
Anti-dilutive securities excluded from the calculation of diluted income (loss) per share | ||||
Anti-dilutive common stock equivalents (in shares) | 28,969 | 36,234 | 479,476 | 641,834 |