Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2019 | Aug. 06, 2019 | |
Document and Entity Information | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2019 | |
Document Fiscal Year Focus | 2019 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | EYEGATE PHARMACEUTICALS INC | |
Entity Current Reporting Status | Yes | |
Entity Central Index Key | 0001372514 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Trading Symbol | EYEG | |
Entity Common Stock, Shares Outstanding | 45,675,737 | |
Entity Emerging Growth Company | true | |
Entity Shell Company | false | |
Entity Ex Transition Period | true | |
Entity Small Business | true |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Current Assets: | ||
Cash and Cash Equivalents | $ 4,465,086 | $ 8,004,237 |
Prepaid Expenses and Other Current Assets | 551,652 | 455,760 |
Right-of-Use Assets | 109,512 | 0 |
Current Portion of Refundable Tax Credit Receivable | 1,639 | 18,436 |
Total Current Assets | 5,127,889 | 8,478,433 |
Property and Equipment, Net | 30,182 | 43,518 |
Restricted Cash | 45,000 | 45,000 |
Goodwill | 1,525,896 | 1,525,896 |
Intangible Assets and In-Process R&D, Net | 4,143,564 | 4,156,064 |
Other Assets | 23,011 | 31,706 |
Total Assets | 10,895,542 | 14,280,617 |
Current Liabilities: | ||
Accounts Payable | 96,580 | 63,654 |
Accrued Expenses | 737,725 | 1,114,728 |
Lease Liabilities | 109,512 | 0 |
Deferred Revenue | 2,686,000 | |
Total Current Liabilities | 943,817 | 3,864,382 |
Non-Current Liabilities: | ||
Contingent Consideration | 1,210,000 | 1,210,000 |
Deferred Tax Liability | 269,968 | 269,968 |
Total Non-Current Liabilities | 1,479,968 | 1,479,968 |
Total Liabilities | 2,423,785 | 5,344,350 |
Commitments and Contingencies (Note 10) | ||
Stockholders' Equity: | ||
Preferred Stock, $0.01 Par Value: 9,994,184 shares authorized; 3,750 designated Series A, 0 shares issued and outstanding at June 30, 2019 and December 31, 2018; 10,000 designated Series B, 0 shares issued and outstanding at June 30, 2019 and December 31, 2018; 10,000 shares designated Series C, 4,092 shares issued and outstanding at June 30, 2019 and December 31, 2018 | 41 | 41 |
Common Stock, $0.01 Par Value: 120,000,000 shares authorized; 45,675,737 and 45,578,878 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively | 456,758 | 437,939 |
Additional Paid-In Capital | 101,996,431 | 101,514,154 |
Accumulated Deficit | (94,116,661) | (93,150,198) |
Accumulated Other Comprehensive Income | 135,188 | 134,331 |
Total Stockholders' Equity | 8,471,757 | 8,936,267 |
Total Liabilities and Stockholders' Equity | $ 10,895,542 | $ 14,280,617 |
CONDENSED CONSOLIDATED BALANC_2
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2019 | Dec. 31, 2018 |
Common Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 |
Common Stock, Shares, Issued | 45,675,737 | 45,578,878 |
Common Stock, Shares, Outstanding | 45,675,737 | 45,578,878 |
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Preferred Stock, Shares Authorized | 9,994,184 | 9,994,184 |
Series A Preferred Stock | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Preferred Stock Designated Shares | 3,750 | 3,750 |
Series B Preferred Stock | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Preferred Stock, Shares Issued | 0 | 0 |
Preferred Stock, Shares Outstanding | 0 | 0 |
Preferred Stock Designated Shares | 10,000 | 10,000 |
Series C Preferred Stock [Member] | ||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 |
Preferred Stock, Shares Issued | 4,092 | 4,092 |
Preferred Stock, Shares Outstanding | 4,092 | 4,092 |
Preferred Stock Designated Shares | 10,000 | 10,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||
Collaboration Revenue | $ 0 | $ 242,012 | $ 2,686,000 | $ 1,338,020 |
Operating Expenses: | ||||
Research and Development | (763,896) | (1,837,799) | (1,485,373) | (4,358,808) |
General and Administrative | (1,105,904) | (1,202,531) | (2,241,787) | (2,156,579) |
Total Operating Expenses | (1,869,800) | (3,040,330) | (3,727,160) | (6,515,387) |
Operating Loss Before Other Expense | (1,869,800) | (2,798,318) | (1,041,160) | (5,177,367) |
Other Income, Net: | ||||
Interest Income | 32,636 | 18,367 | 74,913 | 18,393 |
Interest Expense | (108) | (304) | (216) | (608) |
Total Other Income, Net | 32,528 | 18,063 | 74,697 | 17,785 |
Net Loss | $ (1,837,272) | $ (2,780,255) | $ (966,463) | $ (5,159,582) |
Net Loss per Common Share- Basic and Diluted | $ (0.04) | $ (0.07) | $ (0.02) | $ (0.19) |
Weighted Average Shares Outstanding- Basic and Diluted | 43,800,288 | 37,484,329 | 43,785,475 | 27,426,668 |
Net Loss | $ (1,837,272) | $ (2,780,255) | $ (966,463) | $ (5,159,582) |
Other Comprehensive Loss: | ||||
Foreign Currency Translation Adjustments | 1,355 | 2,006 | 857 | 3,240 |
Comprehensive Loss | $ (1,835,917) | $ (2,778,249) | $ (965,606) | $ (5,156,342) |
CONDENSED CONSOLIDATED STATEM_2
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) - USD ($) | Series B Preferred StockCommon Stock | Series B Preferred StockAdditional Paid-in Capital | Series B Preferred StockPreviously Reported | Series B Preferred Stock | Series C Preferred StockCommon StockPreviously Reported | Series C Preferred StockCommon Stock | Series C Preferred StockAdditional Paid-in Capital | Series C Preferred StockPreviously Reported | Series C Preferred Stock | Common StockPreviously Reported | Common Stock | Additional Paid-in CapitalPreviously Reported | Additional Paid-in Capital | Accumulated Other Comprehensive IncomePreviously Reported | Accumulated Other Comprehensive Income | Accumulated DeficitPreviously Reported | Accumulated DeficitRestatement Adjustment | Accumulated Deficit | Previously Reported | Restatement Adjustment | Total |
Cumulative Effect of Change in Accounting Principle (Note 2) | $ 9,477,880 | $ 9,477,880 | |||||||||||||||||||
Balance at Dec. 31, 2017 | $ 6 | $ 6 | $ 0 | $ 0 | $ 172,573 | $ 172,573 | $ 89,589,681 | $ 89,589,681 | $ 127,473 | $ 127,473 | $ (91,816,655) | $ (82,338,775) | $ (1,926,922) | $ 7,550,958 | |||||||
Balance (in shares) at Dec. 31, 2017 | 600 | 600 | 17,257,255 | 17,257,255 | 0 | ||||||||||||||||
Stock-Based Compensation | 290,856 | 290,856 | |||||||||||||||||||
Issuance of Stock in Offering, Net of Offering Costs of $1,141,238 | $ 65 | 147,299 | 9,961,398 | 10,108,762 | |||||||||||||||||
Issuance of Stock in Offering, Net of Offering Costs of $1,141,238 (in shares) | 14,730,000 | 6,536 | |||||||||||||||||||
Conversion of Stock into Common Stock | $ 4,000 | $ (3,994) | $ (6) | $ 76,388 | $ (76,364) | $ (24) | |||||||||||||||
Conversion of Stock into Common Stock(in shares) | 400,000 | (600) | 7,638,750 | (2,444) | |||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises | 23,569 | 730,656 | 754,225 | ||||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises (in shares) | 2,356,875 | ||||||||||||||||||||
Foreign Currency Translation Adjustment | 3,240 | 3,240 | |||||||||||||||||||
Net Income (Loss) | (5,159,582) | (5,159,582) | |||||||||||||||||||
Balance at Jun. 30, 2018 | $ 0 | $ 42,382,880 | $ 41 | $ 423,829 | 100,492,233 | 130,713 | (87,498,357) | 13,548,459 | |||||||||||||
Balance (in shares) at Jun. 30, 2018 | 0 | 4,092 | 42,382,880 | ||||||||||||||||||
Balance at Mar. 31, 2018 | $ 6 | $ 0 | $ 172,573 | 89,694,834 | 128,707 | (84,718,102) | 5,278,018 | ||||||||||||||
Balance (in shares) at Mar. 31, 2018 | 600 | 0 | 17,257,255 | ||||||||||||||||||
Stock-Based Compensation | 145,309 | 145,309 | |||||||||||||||||||
Issuance of Stock in Offering, Net of Offering Costs of $1,141,238 | $ 65 | $ 147,299 | 10,001,792 | 10,149,156 | |||||||||||||||||
Issuance of Stock in Offering, Net of Offering Costs of $1,141,238 (in shares) | 6,536 | 14,730,000 | |||||||||||||||||||
Conversion of Stock into Common Stock | $ 4,000 | $ (3,994) | $ (6) | $ 76,388 | $ (76,364) | $ (24) | |||||||||||||||
Conversion of Stock into Common Stock(in shares) | 400,000 | (600) | 7,638,750 | (2,444) | |||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises | $ 23,569 | 730,656 | 754,225 | ||||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises (in shares) | 2,356,875 | ||||||||||||||||||||
Foreign Currency Translation Adjustment | 2,006 | 2,006 | |||||||||||||||||||
Net Income (Loss) | (2,780,255) | (2,780,255) | |||||||||||||||||||
Balance at Jun. 30, 2018 | $ 0 | $ 42,382,880 | $ 41 | $ 423,829 | 100,492,233 | 130,713 | (87,498,357) | 13,548,459 | |||||||||||||
Balance (in shares) at Jun. 30, 2018 | 0 | 4,092 | 42,382,880 | ||||||||||||||||||
Balance at Dec. 31, 2018 | $ 41 | $ 437,939 | 101,514,154 | 134,331 | (93,150,198) | 8,936,267 | |||||||||||||||
Balance (in shares) at Dec. 31, 2018 | 4,092 | 45,578,878 | |||||||||||||||||||
Stock-Based Compensation | 469,096 | 32,000 | |||||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises | $ 1,000 | 31,000 | |||||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises (in shares) | 100,000 | ||||||||||||||||||||
Cancellation and Correction of Restricted Stock Par Value | $ 17,819 | (17,819) | |||||||||||||||||||
Cancellation and Correction of Restricted Stock Par Value (in shares) | (3,141) | ||||||||||||||||||||
Foreign Currency Translation Adjustment | 857 | 857 | |||||||||||||||||||
Net Income (Loss) | (966,463) | (966,463) | |||||||||||||||||||
Balance at Jun. 30, 2019 | $ 41 | $ 456,758 | 101,996,431 | 135,188 | (94,116,661) | 8,471,757 | |||||||||||||||
Balance (in shares) at Jun. 30, 2019 | 4,092 | 45,675,737 | |||||||||||||||||||
Balance at Mar. 31, 2019 | $ 41 | $ 455,758 | 101,729,241 | 133,833 | (92,279,389) | 10,039,484 | |||||||||||||||
Balance (in shares) at Mar. 31, 2019 | 4,092 | 45,575,737 | |||||||||||||||||||
Stock-Based Compensation | 236,190 | 236,190 | |||||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises | $ 1,000 | 31,000 | |||||||||||||||||||
Issuance of Shares of Common Stock from Warrant Exercises (in shares) | 100,000 | ||||||||||||||||||||
Cancellation and Correction of Restricted Stock Par Value | (32,000) | ||||||||||||||||||||
Foreign Currency Translation Adjustment | 1,355 | (1,355) | |||||||||||||||||||
Net Income (Loss) | (1,837,272) | (1,837,272) | |||||||||||||||||||
Balance at Jun. 30, 2019 | $ 41 | $ 456,758 | $ 101,996,431 | $ 135,188 | $ (94,116,661) | 8,471,757 | |||||||||||||||
Balance (in shares) at Jun. 30, 2019 | 4,092 | 45,675,737 | |||||||||||||||||||
Cumulative Effect of Change in Accounting Principle (Note 2) | $ 469,096 |
CONDENSED CONSOLIDATED STATEM_3
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended |
Jun. 30, 2018 | Jun. 30, 2018 | |
CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS' EQUITY (DEFICIT) | ||
Offering Costs | $ 1,141,238 | $ 1,141,238 |
CONDENSED CONSOLIDATED STATEM_4
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Operating Activities: | ||
Net Loss | $ (966,463) | $ (5,159,582) |
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities: | ||
Depreciation and Amortization of Intangible Assets | 25,836 | 15,932 |
Amortization of Right-of-Use Assets | 79,641 | 0 |
Stock-Based Compensation | 469,096 | 290,856 |
Changes in Operating Assets and Liabilities: | ||
Prepaid Expenses and Other Current Assets | (95,893) | 14,746 |
Refundable Tax Credit Receivable | 16,672 | 10,076 |
Other Assets | 8,695 | 0 |
Accounts Payable | 32,927 | (350,064) |
Lease Liabilities | (79,641) | 0 |
Deferred Revenue | (2,686,000) | 577,208 |
Unbilled Revenue | 0 | (689,928) |
Accrued Expenses | (373,860) | (768,996) |
Net Cash Used in Operating Activities | (3,568,990) | (6,059,752) |
Financing Activities: | ||
Proceeds from Stock Offerings, Net of Offering Costs | 0 | 10,108,762 |
Exercise of Warrants | 32,000 | 754,225 |
Equipment Financing Payments | (3,143) | (6,322) |
Net Cash Provided by Financing Activities | 28,857 | 10,856,665 |
Effect of Exchange Rate Changes on Cash | 982 | 1,861 |
Net (Decrease) Increase in Cash | (3,539,151) | 4,798,774 |
Cash, Including Restricted Cash, Beginning of Period | 8,049,237 | 7,851,029 |
Cash, Including Restricted Cash, End of Period | 4,510,086 | 12,649,803 |
Supplemental Disclosures of Noncash Operating and Financing Activities | ||
Creation of Right-of-Use Assets and Related Lease Liabilities | 189,153 | 0 |
Conversion of Preferred Stock into Common Stock | $ 0 | $ 36,637 |
Cancellation and Correction of Restricted Stock Par Value | 17,819 | 0 |
Organization, Business
Organization, Business | 6 Months Ended |
Jun. 30, 2019 | |
Organization, Business | |
Organization, Business | 1. Organization, Business EyeGate Pharmaceuticals, Inc. (“EyeGate” or the “Company”), a Delaware corporation, began operations in December 2004 and is a clinical-stage specialty pharmaceutical company that is focused on developing and commercializing products for treating diseases and disorders of the eye. The Company accomplishes this by leveraging its two proprietary platform technologies, crosslinked thiolated carboxymethyl hyaluronic acid (“CMHA-S”) and the iontophoresis drug delivery system. The Company’s first platform is for the development of products using CMHA-S, a modified form of the natural polymer hyaluronic acid, which is a gel that possesses unique physical and chemical properties such as hydrating and healing properties when applied to the ocular surface. The ability of CMHA-S to adhere longer to the ocular surface, resist degradation and protect the ocular surface makes it well-suited for treating various ocular surface injuries. Secondly, the Company has been developing EGP‑437, which incorporates a reformulated topically active corticosteroid, Dexamethasone Phosphate, that is delivered into the ocular tissues through the Company’s proprietary innovative drug delivery system, the EyeGate® II Delivery System (“EGP‑437 Combination Product”). As of June 30, 2019, there were 45,675,737 shares of Common Stock outstanding, no shares of Series A Preferred Stock outstanding, no shares of Series B Preferred Stock outstanding, and 4,092 shares of Series C Preferred Stock outstanding. Since its inception, EyeGate has devoted substantially all of its efforts to business planning, research and development, and raising capital. The accompanying Condensed Consolidated Financial Statements have been prepared assuming that EyeGate will continue as a going concern, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. At June 30, 2019, EyeGate had Cash and Cash Equivalents of $4,465,086, and an Accumulated Deficit of $94,116,661. EyeGate has incurred losses and negative cash flows since inception, and future losses are anticipated. The Company anticipates having sufficient cash to fund planned operations through October 31, 2019, however, the acceleration or reduction of cash outflows by Company management can significantly impact the timing for raising additional capital to complete development of its products. To continue development, EyeGate will need to raise additional capital through equity financing, license agreements, and/or additional U.S. government grants. Although historically the Company has been successful at raising capital, additional capital may not be available on terms favorable to EyeGate, if at all. On May 13, 2019, the SEC declared effective EyeGate's registration statement on Form S‑3, registering a total of $50,000,000 of its securities for sale to the public from time to time in what is known as a “shelf offering”. The Company does not know if any future offerings, including offerings pursuant to its shelf registration statement, will succeed. Accordingly, no assurances can be given that Company management will succeed in these endeavors. The Company’s recurring losses from operations have caused management to determine there is substantial doubt about the Company’s ability to continue as a going concern. The Condensed Consolidated Financial Statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities or any other adjustments that might be necessary should the Company be unable to continue as a going concern. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation and Principles of Consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its subsidiaries, EyeGate Pharma S.A.S. and Jade Therapeutics, Inc. (“Jade”), collectively referred to as “the Company”. All inter-company balances and transactions have been eliminated in consolidation. These Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Certain information and disclosures normally included in Condensed Consolidated Financial Statements prepared in accordance with U.S. GAAP have been condensed or eliminated. Accordingly, these unaudited Condensed Consolidated Financial Statements should be read in conjunction with the annual financial statements of the Company as of and for the year ended December 31, 2018. Unaudited Interim Financial Information The accompanying interim financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which consist of normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end balance sheet was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for an interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The Company makes significant estimates and assumptions in recording the accruals for its clinical trial and research activities, establishing the useful lives of intangible assets and property and equipment, and conducting impairment reviews of long-lived assets. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Although the Company monitors and regularly assesses these estimates, actual results could differ significantly from these estimates. The Company records changes in estimates in the period that it becomes aware of the change. Research and Development Expenses The Company expenses research and development (“R&D”) expenditures as incurred. R&D expenses are comprised of costs incurred in performing R&D activities, including salaries, benefits, facilities, research-related overhead, sponsored research costs, contracted services, license fees, expenses related to generating, filing, and maintaining intellectual property, and other external costs. Because the Company believes that, under its current process for developing its products, the viability of the products is essentially concurrent with the establishment of technological feasibility, no costs have been capitalized to date. In-process Research and Development The Company records in-process R&D projects acquired in asset acquisitions that have not reached technological feasibility and which have no alternative future use. For in-process R&D projects acquired in business combinations, the Company capitalizes the in-process R&D project and periodically evaluates this asset for impairment until the R&D process has been completed. Once the R&D process is complete, the Company amortizes the R&D asset over its remaining useful life. At June 30, 2019 and December 31, 2018, there is $3,912,314 of in-process R&D, as part of intangible assets and in-process R&D on the Condensed Consolidated Balance Sheets. Intangible Assets The Company records intangible assets acquired in asset acquisitions of proprietary technology. The Company capitalizes intangible assets, amortizes them over the estimated useful life, and periodically evaluates the assets for impairment. At June 30, 2019 and December 31, 2018, there is $231,250 and $243,750 of net intangible assets, respectively, as part of intangible assets and in-process R&D on the Condensed Consolidated Balance Sheets. Accrued Clinical Expenses As part of the Company’s process of preparing the Condensed Consolidated Financial Statements, the Company is required to estimate its accrued expenses. This process includes reviewing open contracts and purchase orders, communicating with its applicable personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice monthly in arrears for services performed. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at the time. The Company periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary. Related Party Transactions The Company has entered into certain related-party transactions, making payments for services to one vendor, nine consultants and two public universities for the six months ended June 30, 2019, all of whom also are stockholders of the Company. These transactions generally are ones that involve a stockholder or option holder of the Company to whom we also make payments during the year, typically as a consultant or a service provider. The amounts recorded or paid are not material to the accompanying Condensed Consolidated Financial Statements, with the exception of payments related to manufacturing services to one vendor in the amount of approximately $185,000 during the six months ended June 30, 2019. Net Loss per Share – Basic and Diluted Basic and diluted net loss per share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding for the period, which, for basic net loss per share, does not include unvested restricted common stock that has been issued but is subject to forfeiture of 1,806,218 shares for the three and six months ended June 30, 2019 and 57,510 shares for the three and six months ended June 30, 2018. Dilutive common equivalent shares consist of stock options, warrants, and preferred stock and are calculated using the treasury stock method, which assumes the repurchase of common shares at the average market price during the period. Under the treasury stock method, options and warrants will have a dilutive effect when the average price of common stock during the period exceeds the exercise price of options or warrants. Common equivalent shares do not qualify as participating securities. In periods where the Company records a net loss, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. June 30, June 30, 2019 2018 (unaudited) (unaudited) Common Stock Warrants 40,744,086 42,255,336 Employee Stock Options 2,777,416 2,106,035 Preferred Stock 12,787,500 12,787,500 Total Shares of Potential Common Stock Equivalents 56,309,002 57,148,871 Fair Value of Financial Instruments The carrying amounts of all current assets and current liabilities approximate their fair values due to the short-term nature of these items. As of June 30, 2019 and December 31, 2018, the fair value of the Company’s contingent consideration was $1,210,000 and $1,210,000, respectively. At June 30, 2019 and December 31, 2018, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. Revenue Recognition The Company’s revenues are generated primarily through arrangements which generally contain multiple elements, or deliverables, including licenses and R&D activities to be performed by the Company on behalf of the licensor or grantor. Payments to EyeGate under these arrangements typically include one or more of the following: (1) nonrefundable, upfront license fees, (2) funding of discovery research efforts on a full-time equivalent basis, (3) reimbursement of research, development and intellectual property costs, (4) milestone payments, and (5) royalties on future product sales. On July 9, 2015, the Company entered into an exclusive, worldwide licensing agreement with a subsidiary of Bausch Health Companies, Inc. (“BHC”), through which the Company granted to BHC an exclusive, worldwide commercial and manufacturing right to the Company’s EGP‑437 Combination Product in the field of anterior uveitis, as well as a right of last negotiation to license its EGP‑437 Combination Product for indications other than anterior uveitis (the “BHC Agreement”). Under the BHC Agreement, BHC paid to the Company an initial upfront payment of $1.0 million and the Company was eligible to receive milestone payments totaling up to $32.5 million, upon and subject to the achievement of certain specified development and commercial progress of the EGP‑437 Combination Product for the treatment of anterior uveitis. The Company received milestone payments totaling $5.4 million. The Company received payments both when it crossed certain thresholds on the way to each milestone, as well as once it achieved each milestone. The Company is entitled to retain all of these payments. Effective March 14, 2019, this license agreement was voluntarily terminated by BHC reinstating to the Company all of the rights and privileges of the EGP‑437 platform. Upon termination of this agreement, all amounts remaining in deferred revenue were recognized as revenue, as the Company no longer had any remaining performance obligations. On February 21, 2017, the Company entered into another exclusive, worldwide licensing agreement with a subsidiary of BHC (the “New BHC Agreement”), through which the Company granted BHC exclusive, worldwide commercial and manufacturing rights to its EGP‑437 Combination Product in the field of ocular iontophoretic treatment for post-operative ocular inflammation and pain in ocular surgery patients (the “New Field”). Under the New BHC Agreement, BHC paid the Company an initial upfront payment of $4.0 million, and the Company was eligible to receive milestone payments totaling up to approximately $99.0 million, upon and subject to the achievement of certain specified developmental and commercial progress of the EGP‑437 Combination Product for the New Field. The Company received milestone payments totaling $3.4 million. The Company received payments both when it crossed certain thresholds on the way to each milestone, as well as once it achieved each milestone. The Company is entitled to retain all of these payments. Effective March 14, 2019, this license agreement was voluntarily terminated by BHC reinstating to the Company all of the rights and privileges of the EGP‑437 platform. Upon termination of this agreement, all amounts remaining in deferred revenue were recognized as revenue, as the Company no longer had any remaining performance obligations. In May 2014, the FASB issued ASU No. 2014‑09, Revenues from Contracts with Customers (“Topic 606”), as subsequently amended, that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most recent revenue recognition guidance, including industry-specific guidance. The core principle of the revenue model is that an entity recognizes 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 standard is effective for public companies for years ending after December 15, 2017, with early adoption permitted. The Company did not elect to early adopt and adopted the new standard on January 1, 2018, using the modified retrospective method, which resulted in a cumulative effect adjustment in the amount of $9.5 million to beginning 2018 accumulated deficit and to deferred and unbilled revenue for the BHC contracts impacted by the adoption of the new standard. The changes to the method and/or timing of the Company’s revenue recognition associated with the adoption of the new standard primarily relate to the determination that there is one performance obligation in each contract with BHC and that the license combined with the R&D services is the performance obligation. The Company recognizes revenue when its customer obtains control of promised services, in an amount that reflects the consideration which the Company expects to receive in exchange for those services. To determine whether arrangements are within the scope of this guidance, the Company performs the following five steps: (i) identifies the contract with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the Company satisfies its performance obligation. The Company applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Upon adoption of ASU No. 2014‑09, the Company recognizes revenue from the transaction price applied to each single performance obligation over time as milestones are reached for each performance obligation. The Company only recognizes revenue on those milestones that are within the Company’s control and any constrained variable consideration that requires regulatory approval will only be included in the transaction price when performance is complete. The below table represents the changes in the Company’s contract liabilities: June 30, December 31, 2019 2018 Contract Liabilities: Deferred Revenue $ — $ 2,686,000 Six Months Ended June 30, 2019 Revenue recognized in the period from: Amounts included in contract liability at the beginning of the period $ 2,686,000 In addition, the Company may receive government grant funds for specified ocular therapeutic research activities. Revenue under these grants will be recorded when the Company performs the activities specified by the terms of each grant and is entitled to the funds. Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016‑02, Leases , which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. Under ASU No. 2016‑02, lessees are required to recognize for all leases at the commencement date a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and the right-to-use assets, which are asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. The Company adopted the new standard effective January 1, 2019 using the modified retrospective method. As a result, the Company recorded right-of-use leased assets and corresponding liabilities of approximately $0.137 million on January 1, 2019. On January 26, 2017, the FASB issued ASU No. 2017‑04, Intangibles — Goodwill and Other , which simplifies the accounting for goodwill impairment. The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. All other goodwill impairment guidance will remain largely unchanged. Entities will continue to have the option to perform a qualitative assessment to determine if a quantitative impairment test is necessary. The same one-step impairment test will be applied to goodwill at all reporting units, even those with zero or negative carrying amounts. Entities will be required to disclose the amount of goodwill at reporting units with zero or negative carrying amounts. The new standard is effective for the Company on January 1, 2020. The new standard is required to be applied prospectively. Early adoption is permitted for any impairment tests performed after January 1, 2017. The Company did not early adopt ASU No. 2017‑04 prior to its December 2018 impairment evaluation and is evaluating the effect that ASU No. 2017‑04 will have on its Consolidated Financial Statements and related disclosures. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2019 | |
Property and Equipment | |
Property and Equipment | 3. Property and Equipment Property and equipment at June 30, 2019 and December 31, 2018 consists of the following: Estimated June 30, Useful Life 2019 December 31, (Years) (unaudited) 2018 Laboratory Equipment 3 $ 62,576 $ 62,576 Office Furniture 5 14,430 14,430 Leasehold Improvements 2 22,569 22,569 Total Property and Equipment, Gross 99,575 99,575 Less: Accumulated Depreciation 69,393 56,057 Total Property and Equipment, Net $ 30,182 $ 43,518 Depreciation expense was $6,668 and $7,966 for the three months ended June 30, 2019 and 2018, respectively, and $13,336 and $15,932 for the six months ended June 30, 2019 and 2018, respectively. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2019 | |
Accrued Expenses | |
Accrued Expenses | 4. Accrued Expenses Accrued expenses at June 30, 2019 and December 31, 2018 consist of the following: June 30, 2019 December 31, (unaudited) 2018 Payroll and Benefits $ 488,245 $ 722,178 Professional Fees 122,398 165,894 Clinical Trials 118,010 212,540 Consulting 7,500 9,401 Short-Term Portion of Capital Financing Obligation 1,572 4,715 Total Accrued Expenses $ 737,725 $ 1,114,728 |
Debt
Debt | 6 Months Ended |
Jun. 30, 2019 | |
Debt | |
Debt | 5. Debt The Company has no indebtedness other than trade and accounts payable and capital financing obligations in the ordinary course of business at June 30, 2019 and December 31, 2018. |
Intangible Assets and In-Proces
Intangible Assets and In-Process R&D | 6 Months Ended |
Jun. 30, 2019 | |
Intangible Assets and In-Process R&D | |
Intangible Assets and In-Process R&D | 6. Intangible Assets and In-Process R&D Intangible assets at June 30, 2019 consist of the rights to trade-secrets and know-how related to the manufacturing of the EyeGate Ocular Bandage Gel (“OBG”). During the third quarter of 2018, the Company entered into an intellectual property license agreement with SentrX Animal Care, Inc. (“SentrX”) with respect to certain rights relating to the manufacturing of the EyeGate OBG product. The intangible assets were recorded at $250,000, representing the upfront payment paid to SentrX. Additionally, SentrX is eligible to receive milestone payments totaling up to $4.75 million, upon and subject to the achievement of certain specified development and commercial milestones. These future milestone payments to SentrX will increase the carrying value of the intangible assets. The Company’s intangible assets are amortized on a straight-line basis over the estimated useful lives. Additionally, in-process R&D at June 30, 2019 and December 31, 2018 consists of projects acquired from the acquisition of Jade that have not reached technological feasibility and which have no alternative future use. Once the R&D process is complete, the Company will amortize the R&D asset over its remaining useful life , or if the Company determines not to continue with R&D, write such assets off. The Company periodically evaluates these assets for impairment. Intangible assets and in-process R&D at June 30, 2019 and December 31, 2018 consists of the following: Estimated Useful June 30, 2019 December 31, Life (Years) (unaudited) 2018 Trade Secrets 10 $ 250,000 $ 250,000 Less: Accumulated Amortization (18,750) (6,250) Intangible Assets, Net 231,250 243,750 In-Process R&D 3,912,314 3,912,314 Total Intangible Assets and In-Process R&D, Net $ 4,143,564 $ 4,156,064 Amortization expense on intangible assets was $6,250 and $0 for the three months ended June 30, 2019 and 2018, respectively, and $12,500 and $0 for the six months ended June 30, 2019 and 2018, respectively. |
Capital Stock
Capital Stock | 6 Months Ended |
Jun. 30, 2019 | |
Capital Stock | |
Capital Stock | 7. Capital Stock On May 24, 2016, the Company entered into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC (the “Sales Agent”), to create an at the market equity program under which the Company can from time to time offer and sell up to 1,319,289 shares of its Common Stock through the Sales Agent. On February 21, 2017, the Company authorized the Sales Agent to restart sales under the ATM Agreement for maximum aggregate gross proceeds of up to $3,285,798. During the first quarter of 2017, the Company sold 642,150 shares of Common Stock under this agreement for total net proceeds to the Company, after deducting the placement agent fees and offering expenses, of approximately $1.8 million. No further shares of Common Stock were sold pursuant to the ATM Agreement. The ATM Agreement terminated automatically pursuant to its terms on May 24, 2019. On June 14, 2017, the Company completed a public offering of 5,336,667 shares of Common Stock and 1,995 shares of Series B Preferred Stock (convertible into 1,330,000 shares of Common Stock), along with warrants to purchase 6,666,667 shares of Common Stock. The total net proceeds to the Company from the offering, after deducting the placement agent fees and offering expenses, were approximately $8.8 million. Additionally, the investors received, for each share of Common Stock, or for each share of Common Stock issuable upon conversion of a share of Series B Preferred Stock purchased in the public offering, warrants to purchase one share of Common Stock at an exercise price of $1.50 per share, which totaled warrants to purchase an aggregate of 6,666,667 shares of Common Stock. The warrants issued to investors became initially exercisable immediately upon issuance and terminate on June 14, 2022, five years following the date of issuance. Concurrently with the closing of the public offering, a holder elected to convert 675 shares of Series B Preferred Stock into 450,000 shares of Common Stock. Subsequently, on June 15, 2017 and April 9, 2018, holders converted 1,320 shares of Series B Preferred stock into 880,000 shares of Common Stock. On April 17, 2018, the Company completed a public offering of 14,730,000 shares of Common Stock and 6,536.4 shares of Series C Preferred Stock (convertible into 20,426,250 shares of Common Stock), along with warrants to purchase 35,156,250 shares of Common Stock. The total net proceeds to the Company from the offering, after deducting the placement agent fees and offering expenses, were approximately $10.1 million. Additionally, the investors received, for each share of Common Stock, or for each share of Common Stock issuable upon conversion of a share of Series C Preferred Stock purchased in the public offering, warrants to purchase one share of Common Stock at an exercise price of $0.32 per share, which totaled warrants to purchase an aggregate of 35,156,250 shares of Common Stock. The warrants issued to investors became initially exercisable immediately upon issuance and terminate on April 17, 2023, five years following the date of issuance. Concurrently with the closing of the public offering, a holder elected to convert 1,400 shares of Series C Preferred Stock into 4,375,000 shares of Common Stock. Subsequently, on April 18, 2018, April 23, 2018, and April 30, 2018, holders converted 1,044.4 shares of Series C Preferred stock into 3,263,750 shares of Common Stock. At June 30, 2019, the Company had 120,000,000 authorized shares of Common Stock, $0.01 par value, of which 45,675,737 shares were outstanding. At June 30, 2019, the Company had 9,994,184 authorized shares of Preferred Stock, $0.01 par value, of which 3,750 shares were designated as Series A Preferred Stock and 0 shares are issued and outstanding, 10,000 shares were designated as Series B Preferred Stock and 0 shares are issued and outstanding, and 10,000 shares were designated as Series C Preferred Stock and 4,092 shares are issued and outstanding. At June 30, 2019, there were 0 shares of Common Stock underlying the outstanding shares of Series A Preferred Stock, 0 shares of Common Stock underlying the outstanding shares of Series B Preferred Stock, and 12,787,500 shares of Common Stock underlying the outstanding shares of Series C Preferred Stock. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2019 | |
Warrants | |
Warrants | 8. Warrants The following is a summary of warrant activity for the six months ended June 30, 2019 and 2018: Weighted Average Weighted Average Number of Exercise Remaining Warrants Price Term in Years Outstanding at December 31, 2018 40,844,086 $ 1.00 4.05 Exercised (100,000) 0.32 3.80 Outstanding at June 30, 2019 40,744,086 1.00 Outstanding at December 31, 2017 9,455,961 3.26 4.23 Issued 35,156,250 0.32 4.80 Exercised (2,356,875) 0.32 4.80 Outstanding at June 30, 2018 42,255,336 $ 0.98 4.56 All of the warrant agreements provide for a cashless exercise in the event a registration statement covering the issuance of the shares of common stock underlying the warrants is not effective, whereby the number of warrants to be issued will be reduced by the number of shares which could be purchased from the proceeds of the exercise of the respective warrant. The outstanding warrants expire from 2020 through 2025. |
Equity Incentive Plan
Equity Incentive Plan | 6 Months Ended |
Jun. 30, 2019 | |
Equity Incentive Plan | |
Equity Incentive Plan | 9. Equity Incentive Plan In 2005, the Company approved the 2005 Equity Incentive Plan (the “2005 Plan”). The 2005 Plan provides for the granting of options, restricted stock or other stock-based awards to employees, officers, directors, consultants and advisors. During 2010, the maximum number of shares of Common Stock that may be issued pursuant to the 2005 Plan was increased to 891,222 shares. The Board of Directors (the “Board”) is responsible for administration of the 2005 Plan. The Company’s Board determines the term of each option, the option exercise price, the number of shares for which each option is granted and the rate at which each option is exercisable. Incentive stock options may be granted to any officer or employee at an exercise price per share of not less than the fair value per common share on the date of the grant (not less than 110% of fair value in the case of holders of more than 10% of the Company’s voting stock) and with a term not to exceed ten years from the date of the grant (five years for incentive stock options granted to holders of more than 10% of the Company’s voting stock). Nonqualified stock options may be granted to any officer, employee, consultant or director at an exercise price per share of not less than the par value per share. Following adoption of the 2014 Equity Incentive Plan (the “2014 Plan”), no further grants were made under the 2005 Plan. General terms of the 2014 Plan remain the same as that of the 2005 Plan. The Company’s Board adopted the 2014 Plan and the Employee Stock Purchase Plan (the “ESPP”) and the Company’s Stockholders approved the 2014 Plan and the ESPP Plan in February 2015. As of June 30, 2019, the maximum number of shares of Common Stock that may be issued pursuant to the 2014 Plan and the ESPP was 8,390,123 and 170,567 shares, respectively. In January 2019, the number of shares of common stock issuable under the 2014 Plan automatically increased by 350,000 shares pursuant to the terms of the 2014 Plan. These additional shares are included in the total of 8,390,123 shares issuable under the 2014 Plan. The following is a summary of stock option activity under the Plans for the six months ended June 30, 2019 and 2018: Weighted-Average Number of Weighted- Average Contractual Life Options Exercise Price (In Years) Outstanding at December 31, 2018 2,076,153 $ 2.28 6.51 Granted 750,000 0.48 Expired (48,737) 1.08 Outstanding at June 30, 2019 2,777,416 $ 1.81 7.10 Exercisable at June 30, 2019 1,651,546 $ 2.65 5.62 Vested and Expected to Vest at June 30, 2019 2,777,416 $ 1.81 7.10 Outstanding at December 31, 2017 1,893,003 $ 2.49 5.40 Granted 275,500 0.57 Forfeited (1,500) 0.83 Expired (60,968) 0.80 Outstanding at June 30, 2018 2,106,035 $ 2.29 4.66 Exercisable at June 30, 2018 1,429,484 $ 2.65 3.95 Vested and Expected to Vest at June 30, 2018 2,106,035 $ 2.29 4.66 During the six months ended June 30, 2019 and June 30, 2018, the Board approved the grant of options to purchase 750,000 and 275,500 shares of its Common Stock, respectively. All option grants were pursuant to the 2014 Plan. In general, options granted under the 2014 Plan vest with respect to one-third of the underlying shares on the one-year anniversary of the grant date and the remainder ratably over a 24‑month period. For the six months ended June 30, 2019 and 2018, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions: 2019 2018 Risk-Free Interest Rate 1.82 % 1.82 % Expected Life 5.00 years 7.00 years Expected Volatility 152 % 159 % Expected Dividend Yield % % Using the Black-Scholes Option Pricing Model, the estimated weighted average fair value of an option to purchase one share of common stock granted during the six months ended June 30, 2019 and 2018 was $0.47 and $0.55, respectively. The following is a summary of restricted stock activity for the six months ended June 30, 2019 and June 30, 2018: Weighted- Average Number of Weighted- Average Remaining Shares Grant Date Fair Value Recognition Period Nonvested Outstanding at December 31, 2018 1,822,132 $ 0.59 Vested (12,773) 1.52 Forfeited (3,141) $ 1.52 Nonvested Outstanding at June 30, 2019 1,806,218 $ 0.58 1.77 Nonvested Outstanding at December 31, 2017 103,000 1.52 Vested (45,490) 1.52 Nonvested Outstanding at June 30, 2018 57,510 $ 1.52 1.60 During the six months ended June 30, 2019, 3,141 shares of restricted stock, which had not vested, were forfeited and returned to the Company. No shares were forfeited during the three months ended June 30, 2019, or the three and six months ended June 30, 2018. The total stock-based compensation expense for employees and non-employees is included in the accompanying Condensed Consolidated Statements of Operations and as follows: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and Development $ 58,611 $ 49,897 $ 123,150 $ 106,975 General and Administrative 177,579 95,412 345,946 183,881 Total Stock-Based Compensation Expense $ 236,190 $ 145,309 $ 469,096 $ 290,856 The fair value of options granted for the six months ended June 30, 2019 and June 30, 2018 was approximately $368,200 and $151,200, respectively. As of June 30, 2019 and June 30, 2018, there was approximately $1,122,000 and $805,000 of total unrecognized compensation expense related to unvested stock-based compensation arrangements granted, which cost is expected to be recognized over a weighted-average period of 2.00 and 1.57 years, respectively. The aggregate intrinsic value of stock options outstanding and exercisable at June 30, 2019 and June 30, 2018 was approximately $0 and $0, respectively. At June 30, 2019, there were 4,033,056 shares available under the 2014 Plan and 117,090 shares available under the Company’s ESPP. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies | |
Commitments and Contingencies | 10. Commitments and Contingencies Leases The Company is a party to a real property operating lease for the rental of office space in Waltham, Massachusetts of up to 4,516 square feet, that is used for its corporate headquarters. This lease terminates in December 2019. On July 6, 2016, the Company entered into a real property operating lease for office and laboratory space of approximately 2,300 square feet in Salt Lake City, Utah. This lease was amended during the second quarter of 2019 to extend its termination until June 2020. Operating lease assets and liabilities are recognized at the lease commencement date. Operating lease liabilities represent the present value of lease payments not yet paid. Operating lease assets represent the Company’s right to use an underlying asset and are based upon the operating lease liabilities adjusted for prepayments or accrued lease payments. To determine the present value of lease payments not yet paid, the Company estimated incremental secured borrowing rates corresponding to the maturities of the leases. The Company estimated a rate of 10% based on prevailing financial market conditions, comparable company and credit analysis, and management judgment. The Company recognizes expense for its leases on a straight-line basis over the lease term. Maturities of lease liabilities were as follows as of June 30, 2019: Operating Leases Remainder of 2019 $ 86,390 2020 27,682 Less: Imputed Interest (4,560) Present Value of Lease Liabilities $ 109,512 License Agreements The Company is a party to five license agreements as described below. These license agreements require the Company to pay royalties or fees to the licensor based on revenue or milestones related to the licensed technology. On February 15, 1999, the Company entered in to an exclusive worldwide license agreement with the University of Miami School of Medicine to license technology relating to the Company’s EyeGate® II Delivery System. This agreement, which was amended in December 2005, requires the Company to pay to the University of Miami an annual license fee of $12,500. This license also requires payments to the University of Miami upon the Company’s achievement of certain milestones. Unless terminated pursuant to the license agreement, this license will expire 12 years after the date of the first commercial sale of a product containing the licensed technology. On July 23, 1999, the Company entered into a perpetual Transaction Protocol agreement with Francine Behar-Cohen to acknowledge the Company’s right to use certain patents that Ms. Behar-Cohen had certain ownership rights with respect to and which are used in the Company’s EGP‑437 Combination Product. The agreement also provides for the Company to pay Ms. Behar-Cohen a fee based on a percentage of the pre-tax turnover generated from sales of the Company’s EGP‑437 Combination Product relating to its inclusion of the EyeGate® II Delivery System. The fees due under the agreement expired in January 2018, but the Company continues to maintain its rights under the agreement. On September 12, 2013, Jade entered into an agreement with BioTime, Inc. granting to it the exclusive worldwide right to commercialize cross-linked thiolated carboxymethyl hyaluronic acid (“CMHA-S”) for ophthalmic treatments in humans. The agreement calls for a license issue fee paid to BioTime of $50,000 and requires the Company (through its Jade subsidiary) to pay an annual fee of $30,000 and royalties to BioTime based on revenue relating to any product incorporating the CMHA-S technology. The agreement expires when patent protection for the CMHA-S technology lapses, which is expected to occur in the U.S. in 2028. On June 17, 2016, the Company entered into an exclusive worldwide license agreement with the University of Utah Research Foundation to further the commercial development of the NASH technology, together with alkylated HA. The agreement calls for payments due to the University of Utah, consisting of a license grant fee of $15,000 due within 30 days of signing, and an annual licensing fee, initially $5,000, and escalating ratably up to $20,000 in 2021. On September 26, 2018, the Company entered into an intellectual property licensing agreement (the “SentrX Agreement”) with SentrX, a veterinary medical device company that develops and manufactures veterinary wound care products. Under the SentrX Agreement, the Company will in-license the rights to trade-secrets and know-how related to the manufacturing of its EyeGate OBG. The SentrX Agreement will enable the Company to pursue a different vendor with a larger capacity for manufacturing and an FDA-inspected facility for commercialization of a product for human use. Under the SentrX Agreement, the Company paid SentrX an upfront payment of $250,000 recorded as intangible assets on the Condensed Consolidated Balance Sheet. SentrX is eligible to receive milestone payments totaling up to $4.75 million, upon and subject to the achievement of certain specified developmental and commercial milestones. These future milestone payments to SentrX will increase the carrying value of the intangible assets. |
Employee Benefit Plans
Employee Benefit Plans | 6 Months Ended |
Jun. 30, 2019 | |
Employee Benefit Plans | |
Employee Benefit Plans | 11. Employee Benefit Plans The Company has an employee benefit plan for its United States-based employees under Section 401(k) of the Internal Revenue Code. The Plan allows all eligible employees to make contributions up to a specified percentage of their compensation. Under the Plan, the Company may, but is not obligated to, match a portion of the employee contribution up to a defined maximum. As a result of the 401(k) plan compliance review for the year ended December 31, 2018, the Company will contribute approximately $29,700 to eligible employees. The Company has accrued an estimate for contributions likely due as a result of the 401(k) plan compliance review for the year ended December 31, 2019. The Company made no matching contribution for the six months ended June 30, 2019 and 2018. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Basis of Presentation and Principles of Consolidation | Basis of Presentation and Principles of Consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its subsidiaries, EyeGate Pharma S.A.S. and Jade Therapeutics, Inc. (“Jade”), collectively referred to as “the Company”. All inter-company balances and transactions have been eliminated in consolidation. These Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Certain information and disclosures normally included in Condensed Consolidated Financial Statements prepared in accordance with U.S. GAAP have been condensed or eliminated. Accordingly, these unaudited Condensed Consolidated Financial Statements should be read in conjunction with the annual financial statements of the Company as of and for the year ended December 31, 2018. |
Unaudited Interim Financial Information | Unaudited Interim Financial Information The accompanying interim financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which consist of normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end balance sheet was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for an interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The Company makes significant estimates and assumptions in recording the accruals for its clinical trial and research activities, establishing the useful lives of intangible assets and property and equipment, and conducting impairment reviews of long-lived assets. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Although the Company monitors and regularly assesses these estimates, actual results could differ significantly from these estimates. The Company records changes in estimates in the period that it becomes aware of the change. |
Research and Development Expenses | Research and Development Expenses The Company expenses research and development (“R&D”) expenditures as incurred. R&D expenses are comprised of costs incurred in performing R&D activities, including salaries, benefits, facilities, research-related overhead, sponsored research costs, contracted services, license fees, expenses related to generating, filing, and maintaining intellectual property, and other external costs. Because the Company believes that, under its current process for developing its products, the viability of the products is essentially concurrent with the establishment of technological feasibility, no costs have been capitalized to date. |
In-process Research and Development | In-process Research and Development The Company records in-process R&D projects acquired in asset acquisitions that have not reached technological feasibility and which have no alternative future use. For in-process R&D projects acquired in business combinations, the Company capitalizes the in-process R&D project and periodically evaluates this asset for impairment until the R&D process has been completed. Once the R&D process is complete, the Company amortizes the R&D asset over its remaining useful life. At June 30, 2019 and December 31, 2018, there is $3,912,314 of in-process R&D, as part of intangible assets and in-process R&D on the Condensed Consolidated Balance Sheets. |
Intangible Assets | Intangible Assets The Company records intangible assets acquired in asset acquisitions of proprietary technology. The Company capitalizes intangible assets, amortizes them over the estimated useful life, and periodically evaluates the assets for impairment. At June 30, 2019 and December 31, 2018, there is $231,250 and $243,750 of net intangible assets, respectively, as part of intangible assets and in-process R&D on the Condensed Consolidated Balance Sheets. |
Accrued Clinical Expenses | Accrued Clinical Expenses As part of the Company’s process of preparing the Condensed Consolidated Financial Statements, the Company is required to estimate its accrued expenses. This process includes reviewing open contracts and purchase orders, communicating with its applicable personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice monthly in arrears for services performed. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at the time. The Company periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary. |
Related Party Transactions | Related Party Transactions The Company has entered into certain related-party transactions, making payments for services to one vendor, nine consultants and two public universities for the six months ended June 30, 2019, all of whom also are stockholders of the Company. These transactions generally are ones that involve a stockholder or option holder of the Company to whom we also make payments during the year, typically as a consultant or a service provider. The amounts recorded or paid are not material to the accompanying Condensed Consolidated Financial Statements, with the exception of payments related to manufacturing services to one vendor in the amount of approximately $185,000 during the six months ended June 30, 2019. |
Net Loss per Share - Basic and Diluted | Net Loss per Share – Basic and Diluted Basic and diluted net loss per share is computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding for the period, which, for basic net loss per share, does not include unvested restricted common stock that has been issued but is subject to forfeiture of 1,806,218 shares for the three and six months ended June 30, 2019 and 57,510 shares for the three and six months ended June 30, 2018. Dilutive common equivalent shares consist of stock options, warrants, and preferred stock and are calculated using the treasury stock method, which assumes the repurchase of common shares at the average market price during the period. Under the treasury stock method, options and warrants will have a dilutive effect when the average price of common stock during the period exceeds the exercise price of options or warrants. Common equivalent shares do not qualify as participating securities. In periods where the Company records a net loss, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. June 30, June 30, 2019 2018 (unaudited) (unaudited) Common Stock Warrants 40,744,086 42,255,336 Employee Stock Options 2,777,416 2,106,035 Preferred Stock 12,787,500 12,787,500 Total Shares of Potential Common Stock Equivalents 56,309,002 57,148,871 |
Fair Value of Financial Instruments | Fair Value of Financial Instruments The carrying amounts of all current assets and current liabilities approximate their fair values due to the short-term nature of these items. As of June 30, 2019 and December 31, 2018, the fair value of the Company’s contingent consideration was $1,210,000 and $1,210,000, respectively. At June 30, 2019 and December 31, 2018, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP. |
Revenue Recognition | Revenue Recognition The Company’s revenues are generated primarily through arrangements which generally contain multiple elements, or deliverables, including licenses and R&D activities to be performed by the Company on behalf of the licensor or grantor. Payments to EyeGate under these arrangements typically include one or more of the following: (1) nonrefundable, upfront license fees, (2) funding of discovery research efforts on a full-time equivalent basis, (3) reimbursement of research, development and intellectual property costs, (4) milestone payments, and (5) royalties on future product sales. On July 9, 2015, the Company entered into an exclusive, worldwide licensing agreement with a subsidiary of Bausch Health Companies, Inc. (“BHC”), through which the Company granted to BHC an exclusive, worldwide commercial and manufacturing right to the Company’s EGP‑437 Combination Product in the field of anterior uveitis, as well as a right of last negotiation to license its EGP‑437 Combination Product for indications other than anterior uveitis (the “BHC Agreement”). Under the BHC Agreement, BHC paid to the Company an initial upfront payment of $1.0 million and the Company was eligible to receive milestone payments totaling up to $32.5 million, upon and subject to the achievement of certain specified development and commercial progress of the EGP‑437 Combination Product for the treatment of anterior uveitis. The Company received milestone payments totaling $5.4 million. The Company received payments both when it crossed certain thresholds on the way to each milestone, as well as once it achieved each milestone. The Company is entitled to retain all of these payments. Effective March 14, 2019, this license agreement was voluntarily terminated by BHC reinstating to the Company all of the rights and privileges of the EGP‑437 platform. Upon termination of this agreement, all amounts remaining in deferred revenue were recognized as revenue, as the Company no longer had any remaining performance obligations. On February 21, 2017, the Company entered into another exclusive, worldwide licensing agreement with a subsidiary of BHC (the “New BHC Agreement”), through which the Company granted BHC exclusive, worldwide commercial and manufacturing rights to its EGP‑437 Combination Product in the field of ocular iontophoretic treatment for post-operative ocular inflammation and pain in ocular surgery patients (the “New Field”). Under the New BHC Agreement, BHC paid the Company an initial upfront payment of $4.0 million, and the Company was eligible to receive milestone payments totaling up to approximately $99.0 million, upon and subject to the achievement of certain specified developmental and commercial progress of the EGP‑437 Combination Product for the New Field. The Company received milestone payments totaling $3.4 million. The Company received payments both when it crossed certain thresholds on the way to each milestone, as well as once it achieved each milestone. The Company is entitled to retain all of these payments. Effective March 14, 2019, this license agreement was voluntarily terminated by BHC reinstating to the Company all of the rights and privileges of the EGP‑437 platform. Upon termination of this agreement, all amounts remaining in deferred revenue were recognized as revenue, as the Company no longer had any remaining performance obligations. In May 2014, the FASB issued ASU No. 2014‑09, Revenues from Contracts with Customers (“Topic 606”), as subsequently amended, that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most recent revenue recognition guidance, including industry-specific guidance. The core principle of the revenue model is that an entity recognizes 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 standard is effective for public companies for years ending after December 15, 2017, with early adoption permitted. The Company did not elect to early adopt and adopted the new standard on January 1, 2018, using the modified retrospective method, which resulted in a cumulative effect adjustment in the amount of $9.5 million to beginning 2018 accumulated deficit and to deferred and unbilled revenue for the BHC contracts impacted by the adoption of the new standard. The changes to the method and/or timing of the Company’s revenue recognition associated with the adoption of the new standard primarily relate to the determination that there is one performance obligation in each contract with BHC and that the license combined with the R&D services is the performance obligation. The Company recognizes revenue when its customer obtains control of promised services, in an amount that reflects the consideration which the Company expects to receive in exchange for those services. To determine whether arrangements are within the scope of this guidance, the Company performs the following five steps: (i) identifies the contract with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the Company satisfies its performance obligation. The Company applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Upon adoption of ASU No. 2014‑09, the Company recognizes revenue from the transaction price applied to each single performance obligation over time as milestones are reached for each performance obligation. The Company only recognizes revenue on those milestones that are within the Company’s control and any constrained variable consideration that requires regulatory approval will only be included in the transaction price when performance is complete. The below table represents the changes in the Company’s contract liabilities: June 30, December 31, 2019 2018 Contract Liabilities: Deferred Revenue $ — $ 2,686,000 Six Months Ended June 30, 2019 Revenue recognized in the period from: Amounts included in contract liability at the beginning of the period $ 2,686,000 In addition, the Company may receive government grant funds for specified ocular therapeutic research activities. Revenue under these grants will be recorded when the Company performs the activities specified by the terms of each grant and is entitled to the funds. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the FASB issued ASU No. 2016‑02, Leases , which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. Under ASU No. 2016‑02, lessees are required to recognize for all leases at the commencement date a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and the right-to-use assets, which are asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. The Company adopted the new standard effective January 1, 2019 using the modified retrospective method. As a result, the Company recorded right-of-use leased assets and corresponding liabilities of approximately $0.137 million on January 1, 2019. On January 26, 2017, the FASB issued ASU No. 2017‑04, Intangibles — Goodwill and Other , which simplifies the accounting for goodwill impairment. The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. All other goodwill impairment guidance will remain largely unchanged. Entities will continue to have the option to perform a qualitative assessment to determine if a quantitative impairment test is necessary. The same one-step impairment test will be applied to goodwill at all reporting units, even those with zero or negative carrying amounts. Entities will be required to disclose the amount of goodwill at reporting units with zero or negative carrying amounts. The new standard is effective for the Company on January 1, 2020. The new standard is required to be applied prospectively. Early adoption is permitted for any impairment tests performed after January 1, 2017. The Company did not early adopt ASU No. 2017‑04 prior to its December 2018 impairment evaluation and is evaluating the effect that ASU No. 2017‑04 will have on its Consolidated Financial Statements and related disclosures. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Summary of Significant Accounting Policies | |
Schedule of unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share | In periods where the Company records a net loss, unvested restricted common stock and potential common stock equivalents are not included in the calculation of diluted net loss per share as their effect would be anti-dilutive. June 30, June 30, 2019 2018 (unaudited) (unaudited) Common Stock Warrants 40,744,086 42,255,336 Employee Stock Options 2,777,416 2,106,035 Preferred Stock 12,787,500 12,787,500 Total Shares of Potential Common Stock Equivalents 56,309,002 57,148,871 |
Schedule of changes in the contract liabilities | The below table represents the changes in the Company’s contract liabilities: June 30, December 31, 2019 2018 Contract Liabilities: Deferred Revenue $ — $ 2,686,000 Six Months Ended June 30, 2019 Revenue recognized in the period from: Amounts included in contract liability at the beginning of the period $ 2,686,000 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Property and Equipment | |
Schedule of property and equipment | Property and equipment at June 30, 2019 and December 31, 2018 consists of the following: Estimated June 30, Useful Life 2019 December 31, (Years) (unaudited) 2018 Laboratory Equipment 3 $ 62,576 $ 62,576 Office Furniture 5 14,430 14,430 Leasehold Improvements 2 22,569 22,569 Total Property and Equipment, Gross 99,575 99,575 Less: Accumulated Depreciation 69,393 56,057 Total Property and Equipment, Net $ 30,182 $ 43,518 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Accrued Expenses | |
Schedule of accrued expenses | Accrued expenses at June 30, 2019 and December 31, 2018 consist of the following: June 30, 2019 December 31, (unaudited) 2018 Payroll and Benefits $ 488,245 $ 722,178 Professional Fees 122,398 165,894 Clinical Trials 118,010 212,540 Consulting 7,500 9,401 Short-Term Portion of Capital Financing Obligation 1,572 4,715 Total Accrued Expenses $ 737,725 $ 1,114,728 |
Intangible Assets and In-Proc_2
Intangible Assets and In-Process R&D (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Intangible Assets and In-Process R&D | |
Schedule of intangible assets and in-process R&D | Intangible assets and in-process R&D at June 30, 2019 and December 31, 2018 consists of the following: Estimated Useful June 30, 2019 December 31, Life (Years) (unaudited) 2018 Trade Secrets 10 $ 250,000 $ 250,000 Less: Accumulated Amortization (18,750) (6,250) Intangible Assets, Net 231,250 243,750 In-Process R&D 3,912,314 3,912,314 Total Intangible Assets and In-Process R&D, Net $ 4,143,564 $ 4,156,064 |
Warrants (Tables)
Warrants (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Warrants | |
Schedule of warrant activity | The following is a summary of warrant activity for the six months ended June 30, 2019 and 2018: Weighted Average Weighted Average Number of Exercise Remaining Warrants Price Term in Years Outstanding at December 31, 2018 40,844,086 $ 1.00 4.05 Exercised (100,000) 0.32 3.80 Outstanding at June 30, 2019 40,744,086 1.00 Outstanding at December 31, 2017 9,455,961 3.26 4.23 Issued 35,156,250 0.32 4.80 Exercised (2,356,875) 0.32 4.80 Outstanding at June 30, 2018 42,255,336 $ 0.98 4.56 |
Equity Incentive Plan (Tables)
Equity Incentive Plan (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Equity Incentive Plan | |
Schedule of stock option activity | The following is a summary of stock option activity under the Plans for the six months ended June 30, 2019 and 2018: Weighted-Average Number of Weighted- Average Contractual Life Options Exercise Price (In Years) Outstanding at December 31, 2018 2,076,153 $ 2.28 6.51 Granted 750,000 0.48 Expired (48,737) 1.08 Outstanding at June 30, 2019 2,777,416 $ 1.81 7.10 Exercisable at June 30, 2019 1,651,546 $ 2.65 5.62 Vested and Expected to Vest at June 30, 2019 2,777,416 $ 1.81 7.10 Outstanding at December 31, 2017 1,893,003 $ 2.49 5.40 Granted 275,500 0.57 Forfeited (1,500) 0.83 Expired (60,968) 0.80 Outstanding at June 30, 2018 2,106,035 $ 2.29 4.66 Exercisable at June 30, 2018 1,429,484 $ 2.65 3.95 Vested and Expected to Vest at June 30, 2018 2,106,035 $ 2.29 4.66 |
Schedule of weighted average assumptions | For the six months ended June 30, 2019 and 2018, the fair value of each option grant has been estimated on the date of grant using the Black-Scholes Option Pricing Model with the following weighted-average assumptions: 2019 2018 Risk-Free Interest Rate 1.82 % 1.82 % Expected Life 5.00 years 7.00 years Expected Volatility 152 % 159 % Expected Dividend Yield % % |
Schedule of restricted stock activity | The following is a summary of restricted stock activity for the six months ended June 30, 2019 and June 30, 2018: Weighted- Average Number of Weighted- Average Remaining Shares Grant Date Fair Value Recognition Period Nonvested Outstanding at December 31, 2018 1,822,132 $ 0.59 Vested (12,773) 1.52 Forfeited (3,141) $ 1.52 Nonvested Outstanding at June 30, 2019 1,806,218 $ 0.58 1.77 Nonvested Outstanding at December 31, 2017 103,000 1.52 Vested (45,490) 1.52 Nonvested Outstanding at June 30, 2018 57,510 $ 1.52 1.60 |
Schedule of stock based compensation expense | The total stock-based compensation expense for employees and non-employees is included in the accompanying Condensed Consolidated Statements of Operations and as follows: Three Months Ended Six Months Ended June 30, June 30, 2019 2018 2019 2018 Research and Development $ 58,611 $ 49,897 $ 123,150 $ 106,975 General and Administrative 177,579 95,412 345,946 183,881 Total Stock-Based Compensation Expense $ 236,190 $ 145,309 $ 469,096 $ 290,856 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 6 Months Ended |
Jun. 30, 2019 | |
Commitments and Contingencies | |
Schedule of maturities of lease Liabilities | Maturities of lease liabilities were as follows as of June 30, 2019: Operating Leases Remainder of 2019 $ 86,390 2020 27,682 Less: Imputed Interest (4,560) Present Value of Lease Liabilities $ 109,512 |
Organization, Business (Details
Organization, Business (Details) - USD ($) | Jun. 30, 2019 | May 13, 2019 | Dec. 31, 2018 |
Subsidiary, Sale of Stock [Line Items] | |||
Common Stock, Shares, Outstanding | 45,675,737 | 45,578,878 | |
Cash and Cash Equivalents, at Carrying Value | $ 4,465,086 | $ 8,004,237 | |
Retained Earnings (Accumulated Deficit) | $ (94,116,661) | $ (93,150,198) | |
Capital Units, Authorized | 50,000,000 | ||
Series A Preferred Stock | |||
Subsidiary, Sale of Stock [Line Items] | |||
Preferred Stock, Shares Outstanding | 0 | 0 | |
Series B Preferred Stock | |||
Subsidiary, Sale of Stock [Line Items] | |||
Preferred Stock, Shares Outstanding | 0 | 0 | |
Series C Preferred Stock | |||
Subsidiary, Sale of Stock [Line Items] | |||
Preferred Stock, Shares Outstanding | 4,092 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Net Loss per Share - Basic and Diluted (Details) - shares | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Potential Common Stock Equivalents | 56,309,002 | 57,148,871 |
Common Stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Potential Common Stock Equivalents | 40,744,086 | 42,255,336 |
Preferred Stock [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Potential Common Stock Equivalents | 12,787,500 | 12,787,500 |
Employee Stock Option | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Total Shares of Potential Common Stock Equivalents | 2,777,416 | 2,106,035 |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Contract Liabilities (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Contract with Customer, Liability [Abstract] | ||
Amounts included in contract liability at the beginning of the period | $ 2,686,000 | |
Deferred Revenue | ||
Contract with Customer, Liability [Abstract] | ||
Deferred Revenue | $ 2,686,000 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Additional Information (Details) - USD ($) | Jul. 09, 2015 | Feb. 21, 2017 | Jun. 30, 2019 | Jan. 01, 2019 | Dec. 31, 2018 | Jun. 30, 2018 | Jan. 01, 2018 |
Money Market Funds Fair Value | $ 1,210,000 | ||||||
Contingent Consideration Funds Fair Value | $ 1,210,000 | ||||||
Business Combination, Recognized Identifiable Assets Acquired and Liabilities Assumed, Finite-Lived Intangibles | 3,912,314 | 3,912,314 | |||||
New Accounting Pronouncement or Change in Accounting Principle, Cumulative Effect of Change on Equity or Net Assets | $ 9,500,000 | ||||||
Contract with Customer, Liability, Revenue Recognized | 2,686,000 | ||||||
Intangible Assets and Inprocess Research And Development | 231,250 | 243,750 | |||||
Payments to Related Parties | $ 185,000 | ||||||
New Accounting Pronouncements Corresponding Liabilities Balance | $ 137,000 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number | 1,806,218 | 57,510 | |||||
Operating Lease, Right-of-Use Asset | $ 109,512 | $ 0 | |||||
New Valeant Agreement | |||||||
Proceeds From Upfront Payment | $ 1,000,000 | $ 4,000,000 | |||||
Contract with Customer, Liability, Revenue Recognized | 32,500,000 | 99,000,000 | |||||
Revenue Recognition Milestone Payment | $ 5,400,000 | $ 3,400,000 |
Property and Equipment (Details
Property and Equipment (Details) - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 99,575 | $ 99,575 |
Less: Accumulated Depreciation | 69,393 | 56,057 |
Total Property and Equipment, Net | 30,182 | 43,518 |
Laboratory Equipment | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 62,576 | 62,576 |
Property, Plant and Equipment, Useful Life | 3 years | |
Office Furniture | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 14,430 | 14,430 |
Property, Plant and Equipment, Useful Life | 5 years | |
Leasehold Improvements | ||
Property, Plant and Equipment [Line Items] | ||
Total Property and Equipment, Gross | $ 22,569 | $ 22,569 |
Property, Plant and Equipment, Useful Life | 2 years |
Property and Equipment - Additi
Property and Equipment - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Property and Equipment | ||||
Depreciation | $ 6,668 | $ 7,966 | $ 13,336 | $ 15,932 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Accrued Expenses | ||
Payroll and Benefits | $ 488,245 | $ 722,178 |
Professional Fees | 122,398 | 165,894 |
Clinical Trials | 118,010 | 212,540 |
Consulting | 7,500 | 9,401 |
Short-Term Portion of Capital Financing Obligation | 1,572 | 4,715 |
Total Accrued Expenses | $ 737,725 | $ 1,114,728 |
Intangible Assets and In-Proc_3
Intangible Assets and In-Process R&D (Details) - Trade Secrets - USD ($) | 6 Months Ended | |
Jun. 30, 2019 | Dec. 31, 2018 | |
Trade Secrets | $ 250,000 | $ 250,000 |
Less: Accumulated Amortization | (18,750) | (6,250) |
Intangible Assets, Net | 231,250 | 243,750 |
In-Process R&D | 3,912,314 | 3,912,314 |
Total Intangible Assets and In-Process R&D, Net | $ 4,143,564 | $ 4,156,064 |
Estimated Useful Life (Years) | 10 years |
Intangible Assets and In-Proc_4
Intangible Assets and In-Process R&D - Additional Information (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Sep. 26, 2018 | |
Intangible Assets, Net (Excluding Goodwill) | $ 4,143,564 | $ 4,143,564 | $ 4,156,064 | |||
Amortization of Intangible Assets | 6,250 | $ 0 | 12,500 | $ 0 | ||
SentrX Animal Care Inc | ||||||
Intangible Assets, Net (Excluding Goodwill) | 250,000 | 250,000 | $ 250,000 | |||
Intangible Assets Expected Milestone Payable | $ 4,750,000 | $ 4,750,000 | $ 4,750,000 |
Capital Stock (Details)
Capital Stock (Details) - USD ($) | Apr. 18, 2018 | Apr. 17, 2018 | Jun. 15, 2017 | Jun. 14, 2017 | Feb. 21, 2017 | May 24, 2016 | Jun. 30, 2018 | Mar. 31, 2017 | Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 |
Class of Stock [Line Items] | |||||||||||
Common Stock, Shares Authorized | 120,000,000 | 120,000,000 | |||||||||
Common Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | |||||||||
Common Stock, Shares, Outstanding | 45,675,737 | 45,578,878 | |||||||||
Preferred Stock, Shares Authorized | 9,994,184 | 9,994,184 | |||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | |||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 20,426,250 | 1,330,000 | |||||||||
Proceeds from Issuance or Sale of Equity | $ 10,100,000 | $ 8,800,000 | |||||||||
Sale of Stock, Number of Shares Issued in Transaction | 1,319,289 | ||||||||||
Sale of Stock, Consideration Received on Transaction | $ 3,285,798 | ||||||||||
Proceeds from Issuance of Common Stock | $ 1,800,000 | $ 0 | $ 10,108,762 | ||||||||
Warrant | |||||||||||
Class of Stock [Line Items] | |||||||||||
Warrant Term | 5 years | 5 years | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.32 | $ 1.50 | |||||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 35,156,250 | 6,666,667 | |||||||||
Common Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 14,730,000 | 5,336,667 | 642,150 | ||||||||
Convertible Preferred Stock, Shares Issued upon Conversion | 3,263,750 | 4,375,000 | 880,000 | 450,000 | |||||||
Series A Preferred Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | |||||||||
Preferred Stock, Shares Issued | 0 | 0 | |||||||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||||||||
Common Stock, Other Shares, Outstanding | 0 | ||||||||||
Preferred Stock Designated Shares | 3,750 | 3,750 | |||||||||
Series B Preferred Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Preferred Stock, Par or Stated Value Per Share | $ 0.01 | $ 0.01 | |||||||||
Stock Issued During Period, Shares, New Issues | 1,995 | ||||||||||
Preferred Stock, Shares Issued | 0 | 0 | |||||||||
Preferred Stock, Shares Outstanding | 0 | 0 | |||||||||
Conversion of Stock, Shares Converted | 1,320 | 675 | |||||||||
Common Stock, Other Shares, Outstanding | 0 | ||||||||||
Preferred Stock Designated Shares | 10,000 | 10,000 | |||||||||
Series C Preferred Stock | |||||||||||
Class of Stock [Line Items] | |||||||||||
Stock Issued During Period, Shares, New Issues | 6,536.4 | 6,536 | 6,536 | ||||||||
Preferred Stock, Shares Issued | 4,092 | ||||||||||
Preferred Stock, Shares Outstanding | 4,092 | ||||||||||
Conversion of Stock, Shares Converted | 1,044.4 | 1,400 | |||||||||
Common Stock, Other Shares, Outstanding | 12,787,500 | ||||||||||
Preferred Stock Designated Shares | 10,000 |
Warrants (Details)
Warrants (Details) - $ / shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding at end the of year | 1,806,218 | 57,510 | ||
Warrant | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding at Beginning | 40,844,086 | 9,455,961 | 9,455,961 | |
Issued | 35,156,250 | |||
Exercised | (100,000) | (2,356,875) | ||
Outstanding at end the of year | 40,744,086 | 42,255,336 | 40,844,086 | 9,455,961 |
Weighted Average Exercise Price, Outstanding at Beginning of the year | $ 1 | $ 3.26 | $ 3.26 | |
Weighted Average Exercise Price, Exercised | 0.32 | 0.32 | ||
Weighted Average Exercise Price, Outstanding at end the of year | $ 1 | $ 0.98 | $ 1 | $ 3.26 |
Weighted Average Remaining Term in Years, Outstanding | 3 years 6 months 18 days | 4 years 6 months 22 days | 4 years 18 days | 4 years 2 months 23 days |
Weighted Average Remaining Term in Years, Issued | 4 years 9 months 18 days | |||
Weighted Average Remaining Term in Years, Exercised | 3 years 9 months 18 days | 4 years 9 months 18 days |
Equity Incentive Plan - Stock O
Equity Incentive Plan - Stock Option Activity (Details) - $ / shares | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Equity Incentive Plan | ||||
Number of Options, Outstanding beginning of year | 2,076,153 | 1,893,003 | 1,893,003 | |
Number of Options, Granted | 750,000 | 275,500 | ||
Number of Options, Forfeited | (1,500) | |||
Number of Options, Expired | (48,737) | (60,968) | ||
Number of Options, Outstanding at end of period | 2,777,416 | 2,106,035 | 2,076,153 | 1,893,003 |
Number of Options, Exercisable at end of period | 1,651,546 | 1,429,484 | ||
Number of Options, Vested and expected to vest at end of period | 2,777,416 | 2,106,035 | ||
Weighted- Average Exercise Price, Outstanding at beginning of year | $ 2.28 | $ 2.49 | $ 2.49 | |
Weighted- Average Exercise Price, Granted | 0.48 | 0.57 | ||
Weighted- Average Exercise Price, Forfeited | 0.83 | |||
Weighted- Average Exercise Price, Expired | 1.08 | 0.80 | ||
Weighted- Average Exercise Price, Outstanding at end of period | 1.81 | 2.29 | $ 2.28 | $ 2.49 |
Weighted- Average Exercise Price, Exercisable at end of period | 2.65 | 2.65 | ||
Weighted- Average Exercise Price, Vested and expected to vest at end of period | $ 1.81 | $ 2.29 | ||
Weighted-Average Contractual Life (In Years), Outstanding | 7 years 1 month 6 days | 4 years 7 months 28 days | 6 years 6 months 4 days | 5 years 4 months 24 days |
Weighted-Average Contractual Life (In Years), Exercisable at end of period | 5 years 7 months 13 days | 3 years 11 months 12 days | ||
Weighted-Average Contractual Life (In Years), Vested and expected to vest at end of period | 7 years 1 month 6 days | 4 years 7 months 28 days |
Equity Incentive Plan - Weighte
Equity Incentive Plan - Weighted-Average Assumptions (Details) | 6 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | |
Equity Incentive Plan | ||
Risk-Free Interest Rate | 1.82% | 1.82% |
Expected Life | 5 years | 7 years |
Expected Volatility | 152.00% | 159.00% |
Expected Dividend Yield | 0.00% | 0.00% |
Equity Incentive Plan - Restric
Equity Incentive Plan - Restricted Stock Activity (Details) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2018 | |
Number of Shares Forfeited | (17,819) | 0 | |
Outstanding at end the of year | 1,806,218 | 57,510 | |
Restricted Stock | |||
Outstanding at Beginning | 1,822,132 | 103,000 | 103,000 |
Number of Shares Vested | (12,773) | (45,490) | |
Number of Shares Forfeited | (3,141) | ||
Outstanding at end the of year | 1,806,218 | 57,510 | 1,822,132 |
Weighted- Average Grant Date Fair Value Outstanding at Beginning | $ 0.59 | $ 1.52 | $ 1.52 |
Weighted- Average Grant Date Fair Value Vested | 1.52 | 1.52 | |
Weighted- Average Grant Date Fair Value Forfeited | 1.52 | ||
Weighted- Average Grant Date Fair Value Outstanding at end | $ 0.58 | $ 1.52 | $ 0.59 |
Weighted- Average Remaining Recognition Period Outstanding | 1 year 9 months 7 days | 1 year 7 months 6 days |
Equity Incentive Plan - Stock-b
Equity Incentive Plan - Stock-based Compensation (Details) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Jun. 30, 2019 | Jun. 30, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total Stock-Based Compensation Expense | $ 236,190 | $ 145,309 | $ 469,096 | $ 290,856 |
Research and Development Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total Stock-Based Compensation Expense | 58,611 | 49,897 | 123,150 | 106,975 |
General and Administrative Expense [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Total Stock-Based Compensation Expense | $ 177,579 | $ 95,412 | $ 345,946 | $ 183,881 |
Equity Incentive Plan - Additio
Equity Incentive Plan - Additional Information (Details) - USD ($) | 6 Months Ended | 12 Months Ended | ||
Jun. 30, 2019 | Jun. 30, 2018 | Dec. 31, 2010 | Jul. 10, 2018 | |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized | $ 1,122,000 | $ 805,000 | ||
Employee Service Share-based Compensation, Nonvested Awards, Compensation Cost Not yet Recognized, Period for Recognition | 2 years | 1 year 6 months 26 days | ||
Share Based Compensation Arrangement By Share Based Payment Award Options Outstanding And Exercisable Intrinsic Value | $ 0 | $ 0 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 750,000 | 275,500 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 891,222 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 10 years | |||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Vested in Period, Fair Value | $ 368,200 | $ 151,200 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Grants in Period, Weighted Average Grant Date Fair Value | $ 0.47 | $ 0.55 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period | 17,819 | 0 | ||
One-year anniversary [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 0.33% | |||
24-month period [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Rights, Percentage | 0.67% | |||
Holders Owing More Than Ten Percentage Voting Rights [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Award Vesting Period | 5 years | |||
Holders Owing More Than Ten Percentage Voting Rights [Member] | Minimum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Percentage of Exercise Price | 110.00% | |||
Equity Incentive Plan 2014 [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 8,390,123 | |||
Equity Incentive Plan 2014 [Member] | Maximum [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 8,390,123 | |||
ESPP [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 117,090 | |||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Authorized | 170,567 | |||
2014 Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 4,033,056 | |||
Excess Stock, Shares Authorized | 350,000 | |||
Restricted Stock | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Forfeited in Period | 3,141 |
Commitments and Contingencies -
Commitments and Contingencies - Maturities of Lease Liabilities (Details) - USD ($) | Jun. 30, 2019 | Dec. 31, 2018 |
Commitments and Contingencies | ||
Remainder of 2019 | $ 86,390 | |
2020 | 27,682 | |
Less: Imputed Interest | (4,560) | |
Present Value of Lease Liabilities | $ 109,512 | $ 0 |
Commitments and Contingencies_2
Commitments and Contingencies - Additional Information (Details) | Sep. 12, 2013USD ($) | Jun. 17, 2016USD ($) | Feb. 15, 1999USD ($) | Jun. 30, 2019USD ($)ft² | Dec. 31, 2018USD ($) | Sep. 26, 2018USD ($) | Jul. 06, 2016ft² |
Commitments and Contingencies [Line Items] | |||||||
Area of Land | ft² | 2,300 | ||||||
Lease Expiration Period | 12 years | ||||||
Payment of annual fee | $ 30,000 | ||||||
Intangible Assets, Net (Excluding Goodwill) | $ 4,143,564 | $ 4,156,064 | |||||
Cease Payments Not Yet Paid Based On Prevailing Financial Market Conditions | 10.00% | ||||||
License [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Cost of Goods and Services Sold | $ 50,000 | $ 15,000 | $ 12,500 | ||||
Minimum [Member] | License [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Cost of Goods and Services Sold | 5,000 | ||||||
Maximum [Member] | License [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Cost of Goods and Services Sold | $ 20,000 | ||||||
Licensor [Member] | |||||||
Commitments and Contingencies [Line Items] | |||||||
Area of Land | ft² | 4,516 | ||||||
SentrX Animal Care Inc | |||||||
Commitments and Contingencies [Line Items] | |||||||
Intangible Assets, Net (Excluding Goodwill) | $ 250,000 | $ 250,000 | |||||
Intangible Assets Expected Milestone Payable | $ 4,750,000 | $ 4,750,000 |
Employee Benefit Plans (Details
Employee Benefit Plans (Details) - USD ($) | Dec. 31, 2018 | Jun. 30, 2019 | Jun. 30, 2018 |
Employee Benefit Plans | |||
Defined Benefit Plan, Plan Assets, Contributions by Employer | $ 29,700 | $ 0 | $ 0 |