UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended ~~September~~June 30, ~~2017~~2019

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File No. 001-36672

EYEGATE PHARMACEUTICALS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Delaware

98-0443284

(State or other jurisdiction of

Incorporation or organization)

(I.R.S. Employer

Identification No.)

271 Waverley Oaks Road

Suite 108

Waltham, MA 02452

(Address of Principal Executive Offices, including zip code)

(781) 788-8869

(Registrant’s telephone number, including area code)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading symbol(s)		Name of each exchange on which registered
Common Stock, $0.01 par value		EYEG		The Nasdaq Capital Market

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. x Yes ¨ No

Indicate by check mark whether the registrant has submitted electronically ~~and posted on its corporate Web site, if any,~~ every Interactive Data File required to be submitted ~~and posted~~ pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to ~~submit and post such files)~~submit). x Yes ¨ No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer”, “accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large Accelerated filer	¨	Accelerated filer	¨

Non-accelerated filer	¨ ~~(Do not check if a smaller reporting company)~~x	Smaller reporting company	x

		Emerging growth company	x

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.x

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act.)

¨ Yes x No

At ~~November 10, 2017,~~August 6, 2019, there were ~~17,204,778~~45,675,737 shares of the registrant’s common stock outstanding.

EYEGATE PHARMACEUTICALS, INC.

Table of Contents

QUARTERLY REPORT ON FORM 10-Q

For the Period Ended ~~September~~June 30, ~~2017~~2019

INDEX

		Page
PART I - FINANCIAL INFORMATION

Item 1.	Financial Statements.	3

	Condensed Consolidated Balance Sheets as of ~~September~~June 30, ~~2017~~2019 (unaudited) and December 31, ~~2016~~2018	3

	Condensed Consolidated Statements of Operations and Comprehensive Loss (unaudited) for the Three and ~~Nine~~Six Months Ended ~~September~~June 30, ~~2017~~2019 and ~~2016~~2018	4

	Condensed Consolidated Statement of Stockholders’ Equity (Deficit) (unaudited) for the ~~Nine~~Three and Six Months Ended ~~September~~June 30, ~~2017~~2019 and 2018	5

	Condensed Consolidated Statements of Cash Flows (unaudited) for the ~~Nine~~Six Months Ended ~~September~~June 30, ~~2017~~2019 and ~~2016~~2018	67

	Notes to Condensed Consolidated Financial Statements	78

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations.	1920

Item 3.	Quantitative and Qualitative Disclosures about Market Risk.	2930

Item 4.	Controls and Procedures.	2930

PART II - OTHER INFORMATION

Item 1.	Legal Proceedings.	3031

Item 1A.	Risk Factors.	3031

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds.	3031

Item 3.	Defaults Upon Senior Securities.	3031

Item 4.	Mine Safety ~~Disclosure.~~Disclosures.	3031

Item 5.	Other Information.	3031

Item 6.	Exhibits.	3031

SIGNATURES		3132

FORWARD-LOOKING STATEMENTS

This Quarterly Report on Form 10-Q contains statements that are not statements of historical fact and are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, or the Securities Act, and Section 21E of the Securities Exchange Act of 1934, as amended, or the Exchange Act. The forward-looking statements are principally, but not exclusively, contained in “Item 2: Management’s Discussion and Analysis of Financial Condition and Results of Operations.” These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Forward-looking statements include, but are not limited to, statements about management’s confidence or expectations, and our plans, objectives, expectations and intentions that are not historical facts. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “could,” “would,” “expects,” “plans,” “anticipates,” “believes,” “goals,” “sees,” “estimates,” “projects,” “predicts,” “intends,” “think,” “potential,” “objectives,” “optimistic,” “strategy,” and similar expressions intended to identify forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We discuss many of these risks in detail under the heading “Item 1A. Risk Factors” beginning on page 2322 of our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission, or the SEC, on ~~February 23, 2017,~~March 1, 2019, or the Annual Report. You should carefully review all of these factors, as well as other risks described in our public filings, and you should be aware that there may be other factors, including factors of which we are not currently aware, that could cause these differences. Also, these forward-looking statements represent our estimates and assumptions only as of the date of this report. We may not update these forward-looking statements, even though our situation may change in the future, unless we have obligations under the federal securities laws to update and disclose material developments related to previously disclosed information.

EyeGate Pharmaceuticals, Inc. is referred to herein as “we,” “our,” “us,” and “the Company.”

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements.

EYEGATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

	September 30, 2017 (unaudited)			December 31, 2016			June 30, 2019 (unaudited)			December 31, 2018
ASSETS
Current Assets:
Cash and Cash Equivalents	$	9,244,570		$	3,635,224		$	4,465,086		$	8,004,237
License and Grant Fees Receivable		602,000			37,349
Prepaid Expenses and Other Current Assets		360,305			464,981			551,652			455,760
Right-of-Use Assets								109,512			-
Current Portion of Refundable Tax Credit Receivable		21,691			16,484			1,639			18,436
Total Current Assets		10,228,566			4,154,038			5,127,889			8,478,433
Property and Equipment, Net		24,431			38,040			30,182			43,518
Restricted Cash		45,000			45,000			45,000			45,000
Goodwill and In-Process R&D		5,438,210			5,438,210
Goodwill								1,525,896			1,525,896
Intangible Assets and In-Process R&D, Net								4,143,564			4,156,064
Other Assets		323,206			55,314			23,011			31,706
Total Assets	$	16,059,413		$	9,730,602		$	10,895,542		$	14,280,617
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts Payable	$	658,615		$	1,412,128		$	96,580		$	63,654
Accrued Expenses		1,724,272			1,670,930			737,725			1,114,728
Lease Liabilities								109,512			-
Deferred Revenue		10,254,600			4,225,000			-			2,686,000
Total Current Liabilities		12,637,487			7,308,058			943,817			3,864,382
Non-Current Liabilities:
Contingent Consideration		1,210,000			1,210,000			1,210,000			1,210,000
Deferred Tax Liability		1,525,896			1,525,896			269,968			269,968
Long-Term Portion of Capital Lease Obligation		6,585			16,069
Total Non-Current Liabilities		2,742,481			2,751,965			1,479,968			1,479,968
Total Liabilities		15,379,968			10,060,023			2,423,785			5,344,350
Commitments and Contingencies (Note 9)
Stockholders’ Equity (Deficit):
Preferred Stock, $0.01 par value: 9,995,828 shares authorized; 3,750 designated Series A, 0 shares issued and outstanding at September 30, 2017 and December 31, 2016; 10,000 designated Series B, 600 and 0 issued and outstanding at September 30, 2017 and December 31, 2016, respectively		6			-
Common Stock, $0.01 par value: 100,000,000 shares authorized; 17,204,778 and 10,130,883 shares issued and outstanding at September 30, 2017 and December 31, 2016, respectively		172,048			101,309
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		89,366,634			78,106,645			101,996,431			101,514,154
Accumulated Deficit		(88,985,623	)		(78,598,738	)		(94,116,661	)		(93,150,198	)
Stockholder Note Receivable		-			(58,824	)
Accumulated Other Comprehensive Income		126,380			120,187			135,188			134,331
Total Stockholders’ Equity (Deficit)		679,445			(329,421	)
Total Liabilities and Stockholders’ Equity (Deficit)	$	16,059,413		$	9,730,602
Total Stockholders’ Equity								8,471,757			8,936,267
Total Liabilities and Stockholders’ Equity							$	10,895,542		$	14,280,617

See Accompanying Notes to the Condensed Consolidated Financial Statements.

EYEGATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(unaudited)

	Three Months Ended						Nine Months Ended						Three Months Ended						Six Months Ended
	September 30, 2017			September 30, 2016			September 30, 2017			September 30, 2016			June 30, 2019			June 30, 2018			June 30, 2019			June 30, 2018
Collaboration Revenue	$	74,696		$	274,289		$	407,518		$	508,889		$	-		$	242,012		$	2,686,000		$	1,338,020
Operating Expenses:
Research and Development		(3,175,978	)		(2,449,445	)		(7,253,171	)		(5,844,951	)		(763,896	)		(1,837,799	)		(1,485,373	)		(4,358,808	)
General and Administrative		(1,038,822	)		(1,201,804	)		(3,540,857	)		(4,309,737	)		(1,105,904	)		(1,202,531	)		(2,241,787	)		(2,156,579	)
Total Operating Expenses		(4,214,800	)		(3,651,249	)		(10,794,028	)		(10,154,688	)		(1,869,800	)		(3,040,330	)		(3,727,160	)		(6,515,387	)
Operating Loss		(4,140,104	)		(3,376,960	)		(10,386,510	)		(9,645,799	)
Other (Expense) Income, Net:
Operating Loss Before Other Expense														(1,869,800	)		(2,798,318	)		(1,041,160	)		(5,177,367	)
Other Income, Net:
Interest Income		40			298			537			3,423			32,636			18,367			74,913			18,393
Interest Expense		(304	)		-			(912	)		-			(108	)		(304	)		(216	)		(608	)
Total Other (Expense) Income, Net		(264	)		298			(375	)		3,423
Total Other Income, Net														32,528			18,063			74,697			17,785
Net Loss	$	(4,140,368	)	$	(3,376,662	)	$	(10,386,885	)	$	(9,642,376	)	$	(1,837,272	)	$	(2,780,255	)	$	(966,463	)	$	(5,159,582	)
Net Loss per Common Share- Basic and Diluted	$	(0.24	)	$	(0.36	)	$	(0.78	)	$	(1.13	)	$	(0.04	)	$	(0.07	)	$	(0.02	)	$	(0.19	)
Weighted Average Shares Outstanding- Basic and Diluted		17,204,778			9,269,535			13,267,501			8,499,709			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		3,272			715			6,193			(344	)		1,355			2,006			857			3,240
Comprehensive Loss	$	(4,137,096	)	$	(3,375,947	)	$	(10,380,692	)	$	(9,642,720	)	$	(1,835,917	)	$	(2,778,249	)	$	(965,606	)	$	(5,156,342	)

See Accompanying Notes to the Condensed Consolidated Financial Statements.

EYEGATE PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENT OF STOCKHOLDERS’ EQUITY (DEFICIT)

~~Nine Months Ended September 30, 2017~~

(unaudited)

Convertible Preferred
Stock
Common Stock
Additional
Paid In

Stockholders’
Notes

Accumulated
Other
Comprehensive
Accumulated
Total
Stockholders’

Shares Amount Shares Amount Capital Receivable Income Deficit Equity (Deficit)

Balance at December 31, 2016 - $ - 10,130,883 $ 101,309 $ 78,106,645 $ (58,824 ) $ 120,187 $ (78,598,738 ) $ (329,421 )

Stock-Based Compensation 700,833 700,833

Cancellation of Stockholder Note Receivable 58,824 58,824

Issuance of Common Stock in Offerings, Net of Offering Costs of $1,086,736 5,978,817 59,788 8,551,895 8,611,683

Issuance of Series B Preferred Stock, Net of Offering Costs of $246,333 1,995 20 1,977,480 1,977,500

Conversion of Series B Preferred Stock (1,395 ) (14 ) 930,000 9,300 (9,286 ) -

Exercise of Common Stock Options 61,078 611 40,107 40,718

Issuance of Restricted Stock 104,000 1,040 (1,040 ) -

Foreign Currency Translation Adjustment 6,193 6,193

Net Loss (10,386,885 ) (10,386,885 )

Balance at September 30, 2017 600 $ 6 17,204,778 $ 172,048 $ 89,366,634 $ - $ 126,380 $ (88,985,623 ) $ 679,445
Additional
Accumulated
Other
Total
Series C Preferred Stock Common Stock Paid-In Comprehensive Accumulated Stockholders’
Shares Amount Shares Amount Capital Income Deficit Equity
Balance at March 31, 2019 4,092 $ 41 45,575,737 $ 455,758 $ 101,729,241 $ 133,833 $ (92,279,389 ) $ 10,039,484

Stock-Based Compensation 236,190 236,190

Issuance of Shares of Common Stock from Warrant Exercises 100,000 1,000 31,000 32,000

Foreign Currency Translation Adjustment 1,355 1,355

Net Loss (1,837,272 ) (1,837,272 )

Balance at June 30, 2019 4,092 $ 41 45,675,737 $ 456,758 $ 101,996,431 $ 135,188 $ (94,116,661 ) $ 8,471,757
Series B Preferred Stock Series C Preferred Stock Common Stock Additional Paid Accumulated
Other
Comprehensive Accumulated Total
Stockholders’
Shares Amount Shares Amount Shares Amount In Capital Income Deficit Equity
Balance at March 31, 2018 600 $ 6 - $ - 17,257,255 $ 172,573 $ 89,694,834 $ 128,707 $ (84,718,102 ) $ 5,278,018

Stock-Based Compensation 145,309 145,309

Issuance of Stock in Offering, Net of Offering Costs of $1,141,238 6,536 65 14,730,000 147,299 10,001,792 10,149,156

Conversion of Series B Preferred Stock into Common Stock (600 ) (6 ) 400,000 4,000 (3,994 ) -

Conversion of Series C Preferred Stock into Common Stock (2,444 ) (24 ) 7,638,750 76,388 (76,364 ) -

Issuance of Shares of Common Stock from Warrant Exercises 2,356,875 23,569 730,656 754,225

Foreign Currency Translation Adjustment 2,006 2,006

Net Loss (2,780,255 ) (2,780,255 )

Balance at June 30, 2018 - $ - 4,092 $ 41 42,382,880 $ 423,829 $ 100,492,233 $ 130,713 $ (87,498,357 ) $ 13,548,459
See Accompanying Notes to the Condensed Consolidated Financial Statements.

5

EYEGATE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED ~~STATEMENTS~~STATEMENT OF ~~CASH FLOWS~~STOCKHOLDERS’ EQUITY (DEFICIT)
(unaudited)

Nine Months Ended September 30,
2017 2016
Operating Activities
Net Loss $ (10,386,885 ) $ (9,642,376 )
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Depreciation and Amortization 13,608 649
Stock-Based Compensation 700,833 390,469
Loss on Cancellation of Stockholder Note Receivable 91,054 -
Changes in Operating Assets and Liabilities:
Prepaid Expenses and Other Current Assets (194,364 ) (35,748 )
Refundable Tax Credit Receivable (3,173 ) 9,786
License and Grant Receivable (564,650 ) 2,378,635
Other Assets (1,083 ) (15,364 )
Accounts Payable (753,513 ) 704,912
Deferred Revenue 6,029,600 48,324
Accrued Expenses 53,342 (200,829 )
Net Cash Used in Operating Activities (5,015,231 ) (6,361,542 )

Investing Activities
Acquisition of Jade (Net of Cash Acquired) - 185,746
Restricted Cash - (25,000 )
Equipment Purchased Under Capital Lease - (11,000 )
Net Cash Provided by Investing Activities - 149,746

Financing Activities
Proceeds from Stock Offerings 11,922,252 3,768,698
Stock Issuance Costs (1,333,069 ) (323,814 )
Exercise of Common Stock Options 40,718 56,206
Equipment Financing Payments (9,484 ) -
Net Cash Provided by Financing Activities 10,620,417 3,501,090
Effect of Exchange Rate Changes on Cash 4,160 (1,053 )
Net Increase (Decrease) in Cash 5,609,346 (2,711,759 )
Cash, Beginning of Period 3,635,224 8,394,133
Cash, End of Period $ 9,244,570 $ 5,682,374
Supplemental Disclosure of Noncash Investing and Financing Activities
Conversion of Preferred Stock into Common Stock $ 9,300 $ 6,890
Issuance of Common Stock to Acquire Jade Therapeutics, Inc. $ - $ 2,909,766
Contingent Liability in Connection with the Jade Acquisition $ - $ 1,210,000
Property and Equipment Acquired Under Capital Lease $ - $ 31,576
Additional
Accumulated
Other
Total
Series C Preferred Stock Common Stock Paid-In Comprehensive Accumulated Stockholders’
Shares Amount Shares Amount Capital Income Deficit Equity
Balance at December 31, 2018 4,092 $ 41 45,578,878 $ 437,939 $ 101,514,154 $ 134,331 $ (93,150,198 ) $ 8,936,267

Stock-Based Compensation 469,096 469,096

Cancellation and Correction of Restricted Stock Par Value (3,141 ) 17,819 (17,819 ) -

Issuance of Shares of Common Stock from Warrant Exercises 100,000 1,000 31,000 32,000

Foreign Currency Translation Adjustment 857 857

Net Loss (966,463 ) (966,463 )

Balance at June 30, 2019 4,092 $ 41 45,675,737 $ 456,758 $ 101,996,431 $ 135,188 $ (94,116,661 ) $ 8,471,757
Series B Preferred Stock Series C Preferred Stock Common Stock Additional Paid Accumulated
Other
Comprehensive Accumulated Total
Stockholders’
Shares Amount Shares Amount Shares Amount In Capital Income Deficit Equity (Deficit)
Balance at December 31, 2017, as filed 600 $ 6 - $ - 17,257,255 $ 172,573 $ 89,589,681 $ 127,473 $ (91,816,655 ) $ (1,926,922 )

Cumulative effect of change in accounting principle (note 2) 9,477,880 9,477,880

Balance at January 1, 2018 600 6 - - 17,257,255 172,573 89,589,681 127,473 (82,338,775 ) 7,550,958

Stock-Based Compensation 290,856 290,856

Issuance of Stock in Offering, Net of Offering Costs of $1,141,238 6,536 65 14,730,000 147,299 9,961,398 10,108,762

Conversion of Series B Preferred Stock into Common Stock (600 ) (6 ) 400,000 4,000 (3,994 ) -

Conversion of Series C Preferred Stock into Common Stock (2,444 ) (24 ) 7,638,750 76,388 (76,364 ) -

Issuance of Shares of Common Stock from Warrant Exercises 2,356,875 23,569 730,656 754,225

Foreign Currency Translation Adjustment 3,240 3,240

Net Loss (5,159,582 ) (5,159,582 )

Balance at June 30, 2018 - $ - 4,092 $ 41 42,382,880 $ 423,829 $ 100,492,233 $ 130,713 $ (87,498,357 ) $ 13,548,459

See Accompanying Notes to the Condensed Consolidated Financial Statements.

6

EYEGATE PHARMACEUTICALS, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Six Months Ended June 30,
2019 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 -
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 -
Accounts Payable 32,927 (350,064 )
Lease Liabilities (79,641 ) -
Deferred Revenue (2,686,000 ) 577,208
Unbilled Revenue - (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 - 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 $ -
Conversion of Preferred Stock into Common Stock $ - $ 36,637
Cancellation and Correction of Restricted Stock Par Value $ 17,819 $ -
See Accompanying Notes to the Condensed Consolidated Financial Statements.
7
EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

~~1. 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. ~~EyeGate’s~~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 ~~product in clinical trials~~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, EGP-437,~~Dexamethasone Phosphate, that is delivered into the ocular tissues ~~though its~~through the Company’s proprietary ~~iontophoresis~~innovative drug delivery system, the EyeGate® II Delivery ~~System. The Company is developing the EyeGate® II Delivery~~ System ~~and~~ (“EGP-437 ~~combination product (together, the “EGP-437~~Combination Product”) for the treatment of various inflammatory conditions of the eye, including anterior uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris and/or ciliary body, post-cataract surgery for inflammation and pain, and macular edema, an abnormal thickening of the macula associated with the accumulation of excess fluids in the retina. Effective March 7, 2016, the Company acquired all of the capital stock of Jade Therapeutics, Inc. (“Jade”), a privately-held company developing locally-administered, polymer-based products designed to treat poorly-served ophthalmic indications (the “Jade Acquisition”). ~~EyeGate and Jade are an integrated line of business developing ophthalmic solutions for a variety of ocular diseases and disorders.~~

OnAs of June 30, ~~2016, the Company completed a registered direct offering of 441,000~~2019, there were 45,675,737 shares of Common Stock ~~and 2,776.5~~outstanding, no shares of Series A Preferred Stock (convertible into 1,234,000 shares of Common Stock), along with a concurrent private placement of warrants to purchase Common Stock. The total net proceeds to the Company from this offering, after deducting the placement agent fees and offering expenses, were approximately $3.4 million. The warrants were initially exercisable on December 30, 2016, and expire on December 30, 2021. On February 21, 2017, the Company authorized the restart of sales under the At The Market Offering Agreement between the Company and H.C. Wainwright & Co., LLC (the “ATM Agreement”) and subsequently sold 642,150 shares of Common Stock during the first quarter of 2017. No shares of Common Stock were sold pursuant to the ATM Agreement during the second or third quarters of 2017. The total net proceeds to the Company from this offering, after deducting the placement agent fees and offering expenses, were approximately $1.8 million. On June 14, 2017, the Company completed a public offering of 5,336,667 shares of Common Stock and 1,995outstanding, no shares of Series B Preferred Stock ~~(convertible into 1,330,000~~outstanding, and 4,092 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. The warrants became exercisable upon issuance, and expire on June 14, 2022.~~See~~ ~~Note 5, “Capital Stock”.~~
~~Effective July 31, 2015, the Company’s Common~~Series C Preferred Stock ~~began trading on The Nasdaq Capital Market under the symbol “EYEG”.~~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 ~~September~~June 30, ~~2017,~~2019, EyeGate had Cash and Cash Equivalents of ~~$9,244,570,~~$4,465,086, and an Accumulated Deficit of ~~$88,985,623.~~$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 ~~for approximately eight months,~~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 ~~successfully completed its IPO, a follow-on offering, a registered direct offering, a public offering, and sales under the ATM Agreement,~~has been successful at raising capital, additional capital may not be available on terms favorable to EyeGate, if at all. On May ~~6, 2016,~~13, 2019, the SEC declared effective EyeGate’s registration statement on Form S-3, registering a total of ~~$100,000,000~~$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.

78

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

~~2. 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, ~~2016.~~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 ~~include~~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 ~~business combinations~~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 ~~annually~~periodically evaluates this asset for impairment until the R&D process has been ~~completed or abandoned.~~completed. Once the R&D process is complete, the Company amortizes the R&D asset over its remaining useful life. At ~~September~~June 30, ~~2017, the Company had recorded~~2019 and December 31, 2018, there is $3,912,314 asof in-process R&D, ~~in connection with the Jade Acquisition~~as part of intangible assets and in-process R&D on the ~~balance sheet. As of September 30, 2017, the Company determined that there were no indications of impairment.~~
Condensed Consolidated Balance Sheets.
89

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019
2. Summary of Significant Accounting Policies - (continued)
Intangible Assets

~~2. Summary~~The Company records intangible assets acquired in asset acquisitions of ~~Significant Accounting Policies - (continued)~~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, ~~eight~~nine consultants and atwo public ~~university,~~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.~~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

~~The computation of Net Loss per Common Share -~~ Basic and ~~Diluted,~~diluted net loss per share is ~~based on~~computed by dividing net loss available to common shareholders by the weighted-average number of common shares outstanding ~~of Common Stock. In computing diluted~~for the period, which, for basic net loss per share, ~~no effect~~does not include unvested restricted common stock that has been ~~given~~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 ~~issuable upon~~during the ~~conversion~~period exceeds the exercise price of options or ~~exercise of~~warrants. Common equivalent shares do not qualify as participating securities. In periods where the ~~following dilutive securities, as the Company’s~~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 ~~make the effect~~be anti-dilutive.

September 30,
2017
(unaudited)

September 30,
2016
(unaudited)

June 30,
2019
(unaudited)

June 30,
2018
(unaudited)

Common Stock Warrants 9,519,403 2,852,736 40,744,086 42,255,336
Employee Stock Options 1,858,300 1,533,311 2,777,416 2,106,035
Preferred Stock 400,000 545,000 12,787,500 12,787,500
Total Shares of Common Stock Issuable 11,777,703 4,931,047
Total Shares of Potential Common Stock Equivalents 56,309,002 57,148,871

Fair Value of Financial Instruments

The carrying amounts of ~~Accounts Receivable~~all current assets and ~~Accounts Payable~~current liabilities approximate their fair values due to the short-term nature of these ~~financial instruments.~~items. As of ~~September~~June 30, ~~2017,~~2019 and December 31, ~~2016,~~2018, the fair value of the Company’s ~~money market funds and~~ contingent consideration was ~~$750,946 and~~ $1,210,000 ~~and $1,500,882~~ and $1,210,000, respectively.

At ~~September~~June 30, ~~2017~~2019 and December 31, ~~2016,~~2018, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with ~~FASB Accounting Standards Codification (“ASC”) Topic 820,~~~~Fair Value Measurement~~.U.S. GAAP.

910

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

~~2. Summary of Significant Accounting Policies - (continued)~~
2. Summary of Significant Accounting Policies - (continued)

Revenue Recognition

~~The Company follows Accounting Standards Update (“ASU”) 2009-13,~~ ~~Multiple-Deliverable Revenue Arrangements,~~ ~~and ASU 2010-17,~~~~Revenue Recognition-Milestone Method~~ ~~in connection with its accounting for collaboration arrangements.~~ 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.

When evaluating multiple element arrangements, Company management considers whether the deliverables under the arrangement represent separate units of accounting. This evaluation requires subjective determinations and requires Company management to make judgments about individual deliverables, including whether such deliverable is separable from the other aspects of the contractual relationship. In determining a unit of accounting, Company management evaluates certain criteria, including whether the deliverable has standalone value, based on the consideration of the relevant facts and circumstances for each arrangement. The consideration received is allocated among each separate unit of accounting using the relative selling price method, and the applicable revenue recognition criteria is applied to each separate unit.
The Company generally expects to recognize revenue attributable to a future license obtained on a straight-line basis over the Company’s contractual or estimated performance period, which is typically the term of the Company’s R&D obligation. If Company management cannot reasonably estimate when the Company’s performance obligation ends, then revenue is deferred until Company management can reasonably estimate when the performance obligation ends. The periods over which revenue should be recognized are subject to estimates by management and may change over the course of the R&D agreement. Such a change could have a material impact on the amount of revenue the Company records in future periods. At the inception of arrangements that include milestone payments, Company management evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone. This evaluation includes an assessment of whether (a) the consideration is commensurate with either (1) the entity’s performance to achieve the milestone, or (2) the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting from the entity’s performance to achieve the milestone, (b) the consideration relates solely to past performance, and (c) the consideration is reasonable relative to all of the deliverables and payment terms within the arrangement.
Company management evaluates factors such as the scientific, regulatory, commercial and other risks that must be overcome to achieve the respective milestone, the level of effort and investment required to achieve the respective milestone and whether the milestone consideration is reasonable relative to all deliverables and payment terms in the arrangement in making this assessment. The Company has concluded that the clinical and development milestones pursuant to its R&D arrangements are substantive.
The Company aggregates its milestones into four categories: (i) clinical and development milestones, (ii) the chemistry, manufacturing and controls (“CMC”) validation, (iii) regulatory milestones, and (iv) commercial milestones. Clinical and development milestones are typically achieved when a product candidate advances into a defined phase of clinical research or completes such phase or when a contractually specified clinical trial enrollment target is attained. CMC validation milestones are typically achieved when the validation paperwork is finalized. Regulatory milestones are typically achieved upon acceptance of the submission for marketing approval of a product candidate or upon approval to market the product candidate by the FDA or other global regulatory authorities. For example, a milestone payment may be due to the Company upon the FDA’s acceptance of an NDA. Commercial milestones are typically achieved when an approved pharmaceutical product reaches certain defined levels of net sales by the licensee, such as when a product first achieves global sales or annual sales of a specified amount.
Revenues from clinical and development, CMC and regulatory milestone payments (if the milestones are deemed substantive and the milestone payments are nonrefundable) are recognized upon successful accomplishment of the milestones. Revenue from commercial milestone payments are accounted for as royalties and are recorded as Revenue upon achievement of the milestone, assuming all other revenue recognition criteria are met.
10
~~EYEGATE PHARMACEUTICALS, INC.~~
~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~
~~September 30, 2017~~
~~2. Summary of Significant Accounting Policies - (continued)~~
Payments or reimbursements resulting from the Company’s R&D activities are recognized as the services are performed and are presented on a gross basis so long as there is persuasive evidence of an arrangement, the fee is fixed or determinable, and collection of the related receivable is reasonably assured. Amounts received prior to satisfying the above revenue recognition criteria are recorded as Deferred Revenue on the Condensed Consolidated Balance Sheet.
On July 9, 2015, the Company entered into an exclusive, worldwide licensing agreement with a subsidiary of ~~Valeant Pharmaceuticals International,~~Bausch Health Companies, Inc. (“~~Valeant”~~BHC”), through which the Company granted to ~~Valeant~~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 ~~“Valeant~~“BHC Agreement”). There are four principal R&D milestones under the Valeant Agreement: (i) the Phase 3 Clinical Trial, (ii) the Endothelial Cell Count Safety Trial (a trial to determine that treatment has not adversely affected a patient’s corneal endothelial cell density), (iii) the CMC Validation, and (iv) the New Drug Application, or “NDA”, filing with the FDA (collectively, the “Four Milestones”, and each individually, a “Milestone”). Under the ~~Valeant~~BHC Agreement, ~~Valeant~~BHC paid to the Company an initial upfront payment of $1.0 million and the Company iswas eligible to receive ~~certain other~~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 ~~the initial up-front payment in 2015, which it recorded as Deferred Revenue on its Condensed Consolidated Balance Sheet, and later in 2015 began receiving certain additional~~milestone payments ~~based on R&D progress, to continue over several years.~~totaling $5.4 million. The Company ~~receives~~received payments both when it ~~crosses~~crossed certain thresholds on the way to each ~~Milestone (each, a “Progress Payment”),~~milestone, as well as once it ~~achieves~~achieved each ~~Milestone.~~milestone. The Company is entitled to retain all of these payments. ~~The~~Effective March 14, 2019, this license agreement was voluntarily terminated by BHC reinstating to the Company defers each Progress Payment, capitalizes each payment on its Condensed Consolidated Balance Sheet as Deferred Revenue, and recognizes these payments in the aggregate as Revenue once it achieves the Milestone to which the Progress Payment relates. The Company recognizes the initial upfront payment as Revenue ratably as it completes eachall of the ~~Four Milestones,~~rights and privileges of the ~~amount~~EGP-437 platform. Upon termination of this agreement, all amounts remaining in deferred revenue were recognized being the total upfront payment times the percentage represented by the proportionate share of fair value of each Milestone relative to the total fair value of all Milestones. Accordingly, the Deferred Revenue account on the Condensed Consolidated Balance Sheet is reduced as ~~Revenue is recognized in the Condensed Consolidated Statement of Operations and Comprehensive Loss. Due to longer enrollment time,~~revenue, as the Company ~~expects to begin recognizing Revenue with respect to the Valeant Agreement Progress Payments in the second quarter of 2018.~~no longer had any remaining performance obligations.

On February 21, 2017, the Company entered into another exclusive, worldwide licensing agreement with a subsidiary of ~~Valeant~~BHC (the “New ~~Valeant~~BHC Agreement”), through which the Company granted ~~Valeant~~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 ~~Valeant~~BHC Agreement, ~~Valeant~~BHC paid the Company an initial upfront payment of $4.0 million, and the Company iswas 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 ~~has~~ received milestone payments totaling ~~$1.428 million through~~$3.4 million. The Company received payments both when it crossed certain thresholds on the ~~third quarter~~way to each milestone, as well as once it achieved each milestone. The Company is entitled to retain all of ~~2017.~~ 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 ~~accordance~~May 2014, the FASB issued ASU No. 2014-09,Revenues from Contracts with ~~its~~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 ~~policy,~~guidance, including industry-specific guidance. The core principle of the ~~initial upfront payment and milestone payments have been recorded as Deferred Revenue.~~ 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 ~~expects~~did not elect to ~~begin recognizing Revenue with respect~~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 ~~New Valeant Agreement Progress Payments~~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 ~~first quarter of 2018. In addition,~~license combined with the ~~Company~~R&D services is ~~eligible under~~ the ~~New Valeant Agreement to receive royalties based on a specified percent of net sales of its EGP-437 Product for the New Field throughout the world, subject to adjustment in certain circumstances.~~performance obligation.

11

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

~~2. Summary of Significant Accounting Policies - (continued)~~
2. Summary of Significant Accounting Policies - (continued)

The Company ~~receives government grant funds from two sources:~~recognizes revenue when its customer obtains control of promised services, in an amount that reflects the ~~U.S. Department~~consideration which the Company expects to receive in exchange for those services. To determine whether arrangements are within the scope of ~~Defense (“DoD”)~~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 ~~National Science Foundation (“NSF”).~~Company satisfies its performance obligation. The Company applies the five-step model to contracts when it is ~~paid by~~probable that the ~~DoD after~~Company will collect the consideration it ~~performs specified, agreed-upon research, and~~is entitled to in exchange for the goods or services it ~~records these grant funds~~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 ~~Revenue as it performs the research.~~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 generally paid by the NSF before it performs specified, agreed-upon research. The Company records these NSF funds on our Condensed Consolidated Balance Sheet as Deferred Revenue when invoiced, and recognize these amounts as Revenue ratably as the research is performed, typically over a six-month period.complete.

The ~~DoD and NSF have each committed to~~below table represents the changes in the Company’s contract liabilities:
June 30,
2019 December 31,
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 ~~to Jade~~ for specified ocular therapeutic research ~~activities (together,~~activities. Revenue under these grants will be recorded when the ~~“U.S. Government Grants”) to be conducted through 2017, which have been fully funded as of September 30, 2017. The~~ Company ~~recognizes grant funds as Revenue when it~~ performs the activities specified by the terms of ~~the~~each grant and is entitled to the funds.
Recent Accounting Pronouncements

~~In November 2016, FASB issued ASU No. 2016-18,~~~~Restricted Cash~~, which clarifies guidance and presentation related to restricted cash in the statement of cash flows, including stating that restricted cash should be included within cash and cash equivalents on the statement of cash flows. The standard is effective for fiscal years beginning after December 15, 2017, with early adoption permitted, and is to be applied retrospectively. The Company did not elect to adopt this standard early and is currently evaluating the effect that the new guidance will have on its financial statements and related disclosures.
In February 2016, the FASB issued ASU No. 2016-02,Leases ~~(“ASU 2016-02”)~~, 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 ~~will be~~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 ~~does~~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 ~~expect~~ 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 ~~this standard~~ASU No. 2017-04 prior to its December 2018 impairment evaluation and ~~currently has leases (~~~~see~~ ~~Note 9) that will be in place at the effective date. The Company~~ is ~~currently~~ evaluating the effect that ~~the new guidance~~ASU No. 2017-04 will have on its ~~financial statements~~Consolidated Financial Statements and related disclosures.

~~In May 2014, the FASB issued ASU No. 2014-09,~~~~Revenue from Contracts with Customers (Topic 606)~~ (”ASU 2014-09”), 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 current 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. The guidance also specifies the accounting for certain incremental costs of obtaining a contract, and costs to fulfill a contract with a customer. Entities have the option of applying either a full retrospective approach to all periods presented, or a modified approach that reflects differences prior to the date of adoption as an adjustment to equity. In April 2015, the FASB deferred the effective date of this guidance until January 1, 2018. The Company is not early adopting this standard. The Company’s sole revenue activities currently relate to the Valeant Agreements and its U.S. Government Grants. The Company has commenced its implementation analysis, including identification of revenue streams and reviews of customer contracts under ASU 2014-09’s framework. The analysis includes reviewing current accounting policies and practices to identify potential differences that would result from applying the requirements under this new standard. The Company has reviewed its contracts with Valeant. ASU 2014-09 requires increased disclosure, which in turn is expected to require certain new processes. The determination of the impact of adoption of ASU 2014-09 on the Company’s financial condition, results of operations, cash flows and disclosures, is ongoing, and, as such, the Company is not able to reasonably estimate the effect that the adoption of the new standard will have on its financial statements. Based on a preliminary assessment of this ASU, the Company anticipates that the adoption of the new standard will have a material effect. The Company has determined that it will elect the modified retrospective transition method, meaning the cumulative effect of applying the new guidance is recognized at the date of initial application as an adjustment to the opening accumulated deficit balance. The Company continues to monitor additional changes, modifications, clarifications or interpretations being undertaken by the FASB, which may impact the Company’s current conclusions.
12
EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2019
3. Property and Equipment
Property and equipment at June 30, 2019 and December 31, 2018 consists of the following:

Estimated
Useful Life
(Years)

June 30,
2019
(unaudited)

December 31,
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.
4. Accrued Expenses
Accrued expenses at June 30, 2019 and December 31, 2018 consist of the following:

June 30,
2019
(unaudited)

December 31,
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
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.
13

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

~~3. Property and Equipment~~
6. Intangible Assets and In-Process R&D

~~Property~~Intangible assets at June 30, 2019 consist of the rights to trade-secrets and ~~equipment~~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 ~~September~~$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, ~~2017 (unaudited)~~2019 and December 31, ~~2016~~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 Life
(Years)

September 30,
2017

December 31,
2016

Laboratory Equipment 3 $ 42,576 $ 42,576
Less: Accumulated Depreciation 18,145 4,536
$ 24,431 $ 38,040

Estimated Useful
Life (Years)
June 30,
2019
(unaudited) December 31,
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

~~Depreciation~~Amortization expense on intangible assets was ~~$4,536~~$6,250 and ~~$404~~$0 for the ~~three-month periods~~three months ended ~~September~~June 30, ~~2017~~2019 and ~~2016,~~2018, respectively, and ~~$13,608~~$12,500 and ~~$649~~$0 for the ~~nine-month periods~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016,~~2018, respectively.

~~4. Accrued Expenses~~
~~Accrued expenses consist of the following:~~

September 30,
2017
(unaudited)

December 31,
2016

Clinical Trials $ 977,882 $ 770,158
Payroll and Benefits 564,525 668,802
Professional Fees 163,703 174,342
Short-Term Portion of Capital Lease Obligation 12,645 12,645
Consulting 5,517 44,983
Total Accrued Expenses $ 1,724,272 $ 1,670,930
~~5. 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. Effective June 26, 2016, the Company halted indefinitely all future offers and sales of its Common Stock pursuant to the ATM Agreement. On June 30, 2016, the Company closed on the sale of its equity securities in connection with a registered direct offering, described below, and as a result, the Company was restricted from issuing any shares pursuant to the ATM Agreement for a period of 90 days following the close of the ATM Agreement. This restriction lapsed on September 28, 2016. 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, ~~from this offering,~~ 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 during the second or third quarters of 2017. On June 14, 2017, the Company closed on the sale of its equity securities in connection with a public offering, described below, and as a result, the Company is restricted from issuing any sharesterminated automatically pursuant to the ATM Agreement for a period of twenty-four months following the closing date of the offering. However, this restriction is suspended for any sale of shares of Common Stock under the ATM Agreement that is above $3.00 per share.
13
~~EYEGATE PHARMACEUTICALS, INC.~~
~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~
~~September 30, 2017~~
~~5. Capital Stock - (continued)~~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. 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, a holder converted 720 shares of Series B Preferred stock into 480,000 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.
14
EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2019
7. Capital Stock - (continued)
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 ~~each of September~~June 30, ~~2017 and December 31, 2016,~~2019, the Company had ~~100,000,000~~120,000,000 authorized shares of Common Stock, $0.01 par value, of which ~~17,204,778 and 10,130,883~~45,675,737 shares ~~respectively,~~ were outstanding. At ~~each of September~~June 30, ~~2017 and December 31, 2016,~~2019, the Company had ~~9,995,828 and 9,997,223~~9,994,184 authorized shares of Preferred Stock, $0.01 par value, ~~respectively,~~ of which 3,750 shares were designated as Series A Preferred Stock and 0 shares are issued and outstanding, ~~and~~ 10,000 shares were designated as Series B Preferred Stock and ~~600 and~~ 0 shares ~~respectively,~~are issued and outstanding, and 10,000 shares were designated as Series C Preferred Stock and 4,092 shares are issued and outstanding. ~~The reduction in shares of authorized Preferred Stock is a result of 1,395 shares of Series B Preferred Stock, which were converted to Common Stock and retired during the nine months ended September~~At June 30, ~~2017. At each of September 30, 2017 and December 31, 2016,~~2019, there were 0 shares of Common Stock underlying the outstanding shares of Series A Preferred Stock, ~~and 400,000 and~~ 0 shares of Common Stock underlying the outstanding shares of Series B Preferred Stock, ~~respectively~~.
~~6. Warrants~~
~~At September 30, 2017,~~and 12,787,500 shares of Common Stock underlying the ~~following warrants were outstanding:~~  outstanding shares of Series C Preferred Stock.

Number of
Awards

Weighted
Average
Exercise
Price

Weighted
Average
Remaining
Term in Years

Outstanding at December 31, 2016 2,852,736 $ 7.45 4.26
Issued 6,666,667 ¹ 1.50 ² 4.71
Outstanding at September 30, 2017 9,519,403 $ 3.28 4.50

18. ~~Consists of 6,666,667 warrants to purchase 6,666,667 shares of Common Stock issued in connection with the Company’s public offering on June 14, 2017.~~Warrants

2 ~~Warrant exercise price for a full share of Common Stock.~~
The following is a summary of warrant activity for the six months ended June 30, 2019 and 2018:

Number of
Warrants
Weighted Average
Exercise Price Weighted Average
Remaining 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 3.55

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.

~~7. Stockholder Notes Receivable~~
In 2007, a Stockholder of the Company was issued various promissory notes totaling $58,824 for the sale of Common Stock. The notes were full recourse and collateralized by the shares of Common Stock sold. The amended notes bore compound interest at 0.93% effective October 1, 2012, and as of October 1, 2016 these notes had matured.
On September 5, 2017, these notes were forgiven by the Company in the amount of $91,054, which included accrued interest of $32,230. These amounts are recorded in General and Administrative on the Condensed Consolidated Statements of Operations and Comprehensive Loss.
1415

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019
~~8. 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 ~~September~~June 30, ~~2017,~~2019, the maximum number of shares of Common Stock that may be issued pursuant to the 2014 Plan and the ESPP ~~is 1,690,123~~was 8,390,123 and 170,567 shares, respectively.

In January ~~2017,~~2019, the number of shares of common stock issuable under the 2014 Plan automatically increased by ~~405,235~~350,000 shares pursuant to the terms of the 2014 Plan. Additionally, in June 2017, the number of shares of common stock issuable under the 2014 Plan was increased by 250,000 shares and issuable under the ESPP was increased by 100,000 shares, as approved by the Company’s Stockholders. These additional shares are included in the total of ~~1,690,123~~8,390,123 shares issuable under the 2014 ~~Plan and 170,567 shares issuable under the ESPP.~~Plan.

The following is a summary of stock option activity under the Plans for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016:~~2018:

Number of
Options

Weighted- Average
Exercise Price

Weighted-Average
Contractual Life
(In Years)

Outstanding at December 31, 2016 1,509,711 $ 2.85 5.04
Granted 482,950 1.44 9.60
Exercised (61,078 ) 0.67
Expired (73,283 ) 2.19
Outstanding at September 30, 2017 1,858,300 $ 2.62 5.61
Exercisable at September 30, 2017 1,188,317 $ 2.68 4.56
Vested and Expected to Vest at September 30, 2017 1,188,317 $ 2.68 4.56

Outstanding at December 31, 2015 1,277,367 $ 2.75 4.94
Granted 355,071 2.81 9.50
Exercised (86,765 ) 0.65
Forfeited (12,362 ) 3.93
Outstanding at September 30, 2016 1,533,311 $ 2.91 6.44
Exercisable at September 30, 2016 907,445 $ 2.84 4.09
Vested and Expected to Vest at September 30, 2016 907,445 $ 2.84 4.09

Number of
Options

Weighted- Average
Exercise Price

Weighted-Average
Contractual Life
(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

~~On January 31, 2017,~~During the six months ended June 30, 2019 and June 30, 2018, the Board approved the grant of options to purchase ~~36,000~~750,000 and 275,500 shares of its Common Stock, respectively. All option grants were pursuant to ~~three consultants~~the 2014 Plan. In general, options granted under the 2014 Plan vest with respect to one-third of the ~~Company. On February 6, 2017,~~underlying shares on the ~~Board approved~~one-year anniversary of the grant ~~of options to purchase 15,450 shares of its Common Stock to three employees. On May 18, 2017,~~date and the Board approved the grant of options to purchase 63,000 shares of its Common Stock to two employees and four consultants of the Company. On June 21, 2017, the Board approved the grant of options to purchase 350,000 shares of its Common Stock to six members of the Board, six employees, and one consultant of the Company. On June 30, 2017, the Board approved the grant of options to purchase 1,500 shares of its Common Stock to three employees of the Company. On September 28, 2017, the Board approved the grant of options to purchase 17,000 shares of its Common Stock to two employees of the Company.remainder ratably over a 24-month period.

1516

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

~~8. Equity Incentive Plan - (continued)~~
On February 6, 2017, the Board approved the grant of 104,000 shares of restricted stock to eight employees. These vest 33.33% on the one-year anniversary of the grant date, and the remainder ratably over the 24-month period following the one-year anniversary. As of September 30, 2017, none of these shares were vested.
On January 25, 2016, the Board approved the grant of options to purchase 48,300 shares of its Common Stock to two executives and seven members of the Board. On March 7, 2016, in connection with the Jade Acquisition, the Board approved the grant of options to purchase 47,786 shares of its Common Stock to two executives. On March 29, 2016, the Board approved the grant of options to purchase 114,438 shares of its Common Stock. On April 25, 2016, the Board approved the grant of options to purchase 41,732 shares of its Common Stock. In the third quarter of 2016, the Board approved the grant of options to purchase 102,815 shares of its Common Stock.
All grants were issued pursuant to the 2014 Plan. In general, grants under the 2014 Plan vest 33.33% on the one-year anniversary of the grant date, and the remainder ratably over the 24-month period following the one-year anniversary.
9. Equity Incentive Plan - (continued)

For the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016,~~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:

2017 2016 2019 2018
Risk-Free Interest Rate 1.82% 1.82% 1.82% 1.82%
Expected Life 7.28 years 7.00 years 5.00 years 7.00 years
Expected Volatility 171% 65% 152% 159%
Expected Dividend Yield 0% 0% 0% 0%

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 ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016~~2018 was ~~$1.46~~$0.47 and ~~$2.94,~~$0.55, respectively.

The following is a summary of restricted stock activity for the six months ended June 30, 2019 and June 30, 2018:

Number of
Shares

Weighted- Average
Grant Date Fair Value

Weighted- Average
Remaining
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
September 30,

Nine Months Ended
September 30,

2017 2016 2017 2016
Research and Development $ 57,544 $ 17,092 $ 165,538 $ 35,692
General and Administrative 131,148 135,973 535,295 354,777
$ 188,692 $ 153,065 $ 700,833 $ 390,469

Three Months Ended
June 30,

Six Months Ended
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 ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~September~~June 30, ~~2016~~2018 was approximately ~~$550,000~~$368,200 and ~~$720,000, respectively. The fair value of restricted stock granted for the nine months ended September 30, 2017 and September 30, 2016 was approximately $158,000 and $0,~~$151,200, respectively. As of ~~September~~June 30, ~~2017~~2019 and ~~September~~June 30, ~~2016,~~2018, there iswas approximately ~~$1,113,000~~$1,122,000 and ~~$1,209,000~~$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 ~~2.12~~2.00 and ~~2.35~~1.57 years, respectively. The aggregate intrinsic value of stock options outstanding and exercisable at ~~September~~June 30, ~~2017~~2019 and ~~September~~June 30, ~~2016 is approximately $242,000 and $597,000, respectively. The intrinsic value of stock options exercised during the nine months ended September 30, 2017 and September 30, 2016~~2018 was approximately ~~$78,000~~$0 and ~~$207,000,~~$0, respectively.

At ~~September~~June 30, ~~2017,~~2019, there were ~~170,416 options~~4,033,056 shares available under the 2014 ~~Plan.~~Plan and 117,090 shares available under the Company’s ESPP.

1617

EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
~~September~~June 30, ~~2017~~2019

10. Commitments and Contingencies
~~9. 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 ~~2017. On October 4, 2017, the Company entered into an amendment to extend the terms of this lease through 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 ~~terminates in~~was amended during the second quarter of 2019 to extend its termination until June ~~2019.~~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 isestimated a ~~party to two nominal equipment capital~~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 ~~agreements, one for a three-year term and one for a two-year term, for the use~~term.
Maturities of ~~scientific instruments in its Salt Lake City laboratory.~~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 ~~six~~five license agreements as described below. ~~Four of the six~~These license agreements require the Company to pay royalties or fees to the licensor based on ~~Revenue related to the licensed technology, and the agreements with Valeant require Valeant to pay royalties to the Company 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~~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 ~~are required~~expired in January 2018, but the Company continues to ~~be paid until January 2018.~~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.~~lapses, which is expected to occur in the U.S. in 2028.

On July 9, 2015, the Company entered into an exclusive worldwide licensing agreement with a subsidiary of Valeant through which EyeGate has granted Valeant exclusive, worldwide commercial and manufacturing rights to its EGP-437 Product in the field of anterior uveitis, as well as a right of last negotiation to license the EGP-437 Product for other indications. Under the agreement, Valeant paid the Company an upfront payment of $1.0 million. The Company is eligible to receive milestone payments totaling up to $32.5 million, upon and subject to the achievement of certain specified developmental and commercial milestones. In addition, the Company is eligible to receive royalties based on a specified percent of net sales of the Product throughout the world, subject to adjustment in certain circumstances.
18
EYEGATE PHARMACEUTICALS, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2019
10. Commitments and Contingencies - (continued)

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.

17
~~EYEGATE PHARMACEUTICALS, INC.~~
~~NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS~~
~~September 30, 2017~~
~~9. Commitments and Contingencies - (continued)~~
On ~~February 21, 2017,~~September 26, 2018, the Company entered into an ~~exclusive, worldwide~~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 ~~subsidiary~~larger capacity for manufacturing and an FDA-inspected facility for commercialization of ~~Valeant (the “New Valeant Agreement”), through which~~a product for human use. Under the SentrX Agreement, the Company granted Valeant exclusive, worldwide commercial and manufacturing rights to its EGP-437 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 Valeant Agreement, Valeant paid ~~the Company~~SentrX an ~~initial~~ upfront payment of ~~$4.0 million, and~~$250,000 recorded as intangible assets on the ~~Company~~Condensed Consolidated Balance Sheet. SentrX is eligible to receive milestone payments totaling up to ~~approximately $99.0~~$4.75 million, upon and subject to the achievement of certain specified developmental and commercial ~~progress~~milestones. These future milestone payments to SentrX will increase the carrying value of the EGP-437 Product for the New Field. In addition, the Company is eligible under the New Valeant Agreement to receive royalties based on a specified percent of net sales of its EGP-437 Product for the New Field throughout the world, subject to adjustment in certain circumstances.intangible assets.

~~10. 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 ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016.~~2018.

1819

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations.

The following section of this Quarterly Report on Form 10-Q entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations” contains statements that are not statements of historical fact and are forward-looking statements within the meaning of federal securities laws. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Factors that may cause our actual results to differ materially from those in the forward-looking statements include those factors described in “Item 1A. Risk Factors” beginning on page 2322 of our Annual Report on Form 10-K as filed with the Securities and Exchange Commission ~~or the SEC,~~ on ~~February 23, 2017.~~March 1, 2019. You should carefully review all of these factors, as well as the comprehensive discussion of forward-looking statements on page 1 of this Quarterly Report on Form 10-Q.

EyeGate Pharmaceuticals, Inc. is referred to herein as “we,” “our,” “us,” and “the Company”. Jade Therapeutics, Inc., a wholly owned subsidiary of the Company, is referred to herein as “Jade”.

Business Overview

We are a clinical-stage specialty pharmaceutical company focused on developing and commercializing products for treating diseases and disorders of the eye. We accomplish this by leveraging our two proprietary platform technologies, crosslinked thiolated carboxymethyl hyaluronic acid (“CMHA-S”) and iontophoresis drug delivery system. Our ~~first~~CMHA-S platform is based on ~~CMHA-S,~~ a modified form of the natural polymer hyaluronic acid (“HA”), which is a gel that possesses unique physical and chemical properties such as hydrating and promoting wound healing when applied to the ocular surface. We believe that the ability of CMHA-S to adhere longer to the ocular surface, while hydrating and promoting wound healing, makes it well-suited for treating various ocular surface ~~injuries.~~injuries from dry eye to corneal wounds.

~~Hyaluronic acid~~HA is a naturally occurring polymer that is important in many physiological processes, including wound healing, tissue homeostasis, and joint lubrication. To create this hydrogel, the HA is modified to create CMHA that is then crosslinked together through the thiol groups to CMHA-S. Crosslinking slows degradation of the HA backbone and provides a matrix for incorporating therapeutic agents. Variations in the number of thiols per molecule, the molecular weight of the polymer, the concentration of the polymer, the type of crosslinking, and incorporation of active ingredients, provides a highly versatile platform that can be tailored to a specific application and formulated as eye drops, gels, or films.

Our first CMHA-S-based product candidate, ~~the~~ EyeGate ~~OBG,~~Ocular Bandage Gel (“OBG”), is a topically applied 0.75% CMHA-S eye drop formulation that has completed ~~its first-in-man~~three in-man clinical ~~trial.~~ trials. We announced positive topline data from the initial trial and follow-on trial evaluating the ability of OBG to manage ocular surface re-epithelialization following photorefractive keratectomy (“PRK”) surgery. We also announced positive topline data from our first clinical trial focused on treating patients with punctate epitheliopathies (“PE”). We initiated a pivotal study for the indication of PRK in the second quarter of 2019 with topline data expected by year end 2019. Assuming positive data from this study, we plan to file for commercialization for this indication shortly thereafter. Additionally, the FDA approved the initiation of a follow-on trial for the indication of PE in the third quarter of 2019, with topline data expected by year end 2019. OBG eye drops create a thin, durable and protective coating to the damaged surface of the eye, serving to facilitate and manage corneal re-epithelization. OBG is intended for the protection of the ocular surface and the management of corneal epithelial wounds, defects, and epitheliopathies.
Preclinical studies suggest that the specific CMHA-S chemical modification comprising ~~the EyeGate~~ OBG creates a favorable set of attributes, including prolonged retention time on the ocular surface, and a smooth continuous clear barrier without blur that can minimize mechanical lid friction, reduce repeat injury, and mechanically protect the ocular surface, allowing ~~accelerated corneal re-epithelization. It is intended~~ for the management of corneal ~~epithelial wounds/defects and epitheliopathies, and to accelerate re-epithelization of the ocular surface following surgery, infections, and other traumatic and non-traumatic conditions.~~
~~EyeGate OBG is being developed pursuant to a~~~~de novo~~ 510(k) regulatory pathway for devices submitted for marketing clearance to the U.S. Food and Drug Administration, or FDA. We believe that EyeGate OBG is the first and only eye drop being developed in the U.S. to target acceleration of corneal re-epithelization. We anticipate initiating a second trial in the fourth quarter of 2017, for which we expect to report top-line data in the first quarter of 2018. Assuming positive results from this trial and a subsequent pivotal trial we expect to initiate in the second quarter of 2018 and to report topline data from in the third quarter of 2018, we plan to file~~de novo~~ ~~510(k) and CE mark applications in the fourth quarter of 2018 with potential commercial launch in 2019.~~
The ~~same crosslinked HA in EyeGate OBG~~gel is presently available commercially as a veterinary device indicated for use in the management of superficial ~~noninfectious~~ corneal ulcers. Manufactured by SentrX Animal Care and sold in the U.S. by Bayer Animal Health as Remend® Corneal Repair, the product has been used successfully for more than five years in dogs, cats and horses, without adverse effects. The composition of the veterinary product is identical to that of the ~~EyeGate~~ OBG. We have obtained a license from BioTime, Inc. for the exclusive worldwide right to commercialize CMHA-S for ophthalmic treatments in humans. We paid BioTime $50,000 and are required to pay an annual fee of $30,000 and royalties to BioTime based on revenue relating to any product incorporating the CMHA-S technology. Our license agreement expires when patent protection for the CMHA-S technology lapses, which is expected to occur in the U.S. in ~~2027.~~2028. We do not have the rights to the CMHA-S platform for animal health or veterinary medicine.

OBG is being developed pursuant to ade novo 510(k) regulatory pathway for devices submitted for marketing clearance to the U.S. Food and Drug Administration (“FDA”). We plan to develop OBG for two indications, management of corneal re-epithelization post PRK surgery and for evaluating the potential to help clinicians better manage patients with PE due to pathologies such as dry eye. We believe that OBG is the first and only eye drop being developed in the U.S. to target the management of corneal re-epithelization.
1920

~~Our other product candidate from our second platform is~~In addition, we have been developing EGP-437, which incorporates a reformulated topically active corticosteroid, ~~dexamethasone phosphate,~~Dexamethasone Phosphate, that is delivered into the ocular tissues through our proprietary innovative ~~iontophoresis~~ drug delivery system, the EyeGate® II Delivery ~~System. The EyeGate® II Delivery~~ System features a compact and easy-to-use device that we believe has the potential to deliver drugs non-invasively and quickly into the ocular tissues through the use of iontophoresis, which can accelerate the onset of action, dramatically reduce dosing frequency compared to regular eye drops, and sustain the duration of therapeutic effect. Iontophoresis employs the use of a low electrical current that promotes the migration of a charged drug substance across biological membranes. The EyeGate® II Delivery System is easy-to-use, taking only a few minutes to deliver medication. More than 2,400 treatments have been administered to date using our EyeGate® II Delivery System in clinical trials. (“EGP-437 is currently in clinical development for the treatment of various inflammatory conditions of the eye. Current programs include the treatment of ocular inflammation and pain in post-surgical cataract patients, with a Phase 2b trial commencing in the third quarter of 2017, and the treatment of uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris and/or ciliary body, with a Phase 3 trial currently enrolling. We expect to report top-line data from the cataract surgery trial in the first quarter of 2018, and for the uveitis trial in the second quarter of 2018.
Combination Product”). EGP-437 is being developed ~~pursuant to a new drug application, or NDA,~~ under the ~~Section~~ 505(b)(2) New Drug Application (“NDA”) regulatory pathway for drugs submitted for approval to the U.S. Food and Drug Administration, or FDA, which enables an applicant to rely, in part, on the FDA’s findings of safety and efficacy for an existing product, or published literature, in support of its NDA. In the case of EGP-437, the existing reference product is dexamethasone eye drops. Based on guidance provided by the FDA, we believe that if the planned confirmatory Phase 3 trial of EGP-437 in anterior uveitis meets non-inferiority criteria, the results of that trial, along with data from our previously completed Phase 3 trial in anterior uveitis, will be sufficient to support a NDA filing in the second half of 2018. We also believe, based on guidance provided by the FDA, that the design of the ongoing confirmatory Phase 3 anterior uveitis trial is acceptable and that the nonclinical work completed to date is sufficient to support a NDA filing.
Medical products containing a combination of new drugs, biological products, or medical devices may be regulated as “combination products” in the U.S. A combination product generally is defined as a product comprised of components from two or more regulatory categories, such as drug/device, device/biologic, or drug/biologic. Each component of a combination product is subject to the requirements established by the FDA for that type of component, whether a new drug, biologic, or device. In order to facilitate premarket review of combination products, the FDA designates one of its centers to have primary jurisdiction for the premarket review and regulation of both components. We expect that the Center for Drug Evaluation and Research will have primary jurisdiction over our EGP-437 combination product. The determination whether a product is a combination product or two separate products is made by the FDA on a case-by-case basis. We have had discussions with the FDA about the status of our EGP-437 combination product as a combination product and we have been advised that the FDA considers our product a combination drug/device.

We have been developing EGP-437 for the treatment of various inflammatory conditions of the eye, including the treatment of ocular inflammation and pain in post-surgical cataract patients and anterior uveitis, a debilitating form of intraocular inflammation of the anterior portion of the uvea, such as the iris and/or ciliary body. We announced topline data for the Phase 2b cataract surgery trial in the first quarter of 2018 and although EGP-437 demonstrated a higher rate of success compared to vehicle at all time points, the co-primary endpoints of proportion of subjects with an anterior chamber cell (“ACC”) count of zero at Day 7 and the proportion of subjects with a pain score of zero at Day 1 did not show statistical significance. Additionally, we announced topline data for the confirmatory Phase 3 uveitis trial in the third quarter of 2018 and although EGP-437 showed clinical efficacy, defined as a reduction in ACC score throughout the study, it did not demonstrate non-inferiority to the prednisolone acetate ophthalmic solution control group. We will continue to review the data and will be assessing our strategic options for EGP-437 going forward.
We entered into two exclusive global license agreements with ~~subsidiaries~~a subsidiary of ~~Valeant Pharmaceuticals International,~~Bausch Health Companies, Inc. (“~~Valeant”~~BHC”)~~, through which we have granted Valeant exclusive, worldwide commercial and manufacturing rights to the combination of our EyeGate® II Delivery System and~~ for our EGP-437 ~~product~~Combination Product in the fields of anterior uveitis and ~~ocular iontophoretic~~for the treatment ~~for~~of post-operative ocular inflammation and pain in ocular surgery ~~patients,~~patients. Effective March 14, 2019, BHC voluntarily terminated these license agreements reinstating to us all of the rights and privileges of the EGP-437 platform.
On March 20, 2018, we received a written notification (the “Notice Letter”) from Nasdaq indicating that we were not in compliance with Nasdaq Listing Rule 5550(a)(2), as ~~well as a right of last negotiation to license~~ the ~~combination product~~closing bid price for ~~other indications. We are responsible~~our Common Stock was below the $1.00 per share requirement for the ~~clinical development~~last 30 consecutive business days. The Notice Letter stated that we have 180 calendar days, or until September 17, 2018 (the “Initial Compliance Period”), to regain compliance with the minimum bid price requirement. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we can regain compliance if the closing bid price of our Common Stock is at least $1.00 for a minimum of 10 consecutive business days. We did not achieve compliance with the minimum bid price requirement by the end of the ~~product~~Initial Compliance Period, however, in accordance with Nasdaq Listing Rule 5810(c)(3)(A), on the ~~U.S.~~last day of the Initial Compliance Period we filed for ~~the indications licensed, together~~extension and were granted a second 180-day compliance period, or until March 18, 2019, to regain compliance.
On March 19, 2019, we received written notification from Nasdaq indicating that based upon our continued non-compliance with the ~~costs associated therewith. Valeant has~~bid price rule as of March 18, 2019, our common stock would be subject to delisting from The Nasdaq Capital Market on March 28, 2019, unless we timely request a hearing before the ~~right~~Nasdaq Hearings Panel (the “Panel”). We timely requested a hearing and presented our plan to ~~develop~~evidence future compliance with the ~~product in~~bid price rule before the ~~fields outside~~Panel on May 2, 2019. The Panel granted our request for continued listing of our common stock on The Nasdaq Capital Market pursuant to an extension through September 16, 2019, subject to the ~~U.S. and has agreed to fund 100% of~~condition that we regain compliance with the Bid Price Rule by such date. If we do not regain compliance with the Bid Price Rule by September 16, 2019 or, based on any ~~costs associated therewith.~~significant events that occur during the extension period, the Panel reconsiders the extension, Nasdaq would delist our common stock from The Nasdaq Capital Market.

Throughout our history, we have not generated significant revenue. We have ~~never~~generally not been profitable and from inception through ~~September~~June 30, ~~2017,~~2019, our net losses from operations have aggregated ~~$89.0~~$94.1 million. Our ~~Net Loss~~net loss was approximately ~~$10.4~~$0.966 million and ~~$9.6~~$5.2 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016, respectively.~~June 30, 2018. We expect to incur significant expenses and increasing operating losses for the foreseeable future as we continue the development and clinical trials of and seek regulatory approval for our ~~EGP-437 Product for the treatment of uveitis as well as other indications, and the~~ EyeGate OBG, our lead product candidate for corneal epithelial defects, and any other product candidates we advance to clinical development. If we obtain regulatory approval for EyeGate OBG, we expect to incur significant expenses in order to create an infrastructure to support the commercialization of EyeGate OBG including sales, marketing and distribution functions.
20

We will need additional financing to support our continuing operations. We will seek to fund our operations through public or private equity, debt financings, license and development agreements, or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition and our ability to pursue our business strategy. These conditions raise substantial doubt about our ability to continue as a going concern. We will need to generate significant revenue to achieve profitability, and we may never do so.

~~We were~~EyeGate Pharmaceuticals, Inc. was formed in Delaware on December 26, 2004. We were originally incorporated in 1998 under the name of Optis France S.A. in Paris, France. At that time, the name of the French corporation was changed to EyeGate Pharma S.A.S. and became a subsidiary of EyeGate Pharmaceuticals, Inc. Jade was formed in Delaware on December 31, 2012. EyeGate Pharma S.A.S. and Jade are wholly-owned subsidiaries of EyeGate Pharmaceuticals, Inc.

21

Financial Overview

Revenues

To date, we have recognized ~~Collaboration Revenue~~collaboration revenue from several U.S. government grants made to Jade for ocular therapeutic research (collectively, the “U.S. Government Grants”)~~. While we receive cash amounts~~, as well as from ~~Valeant~~BHC as ~~progress payments~~performance obligations toward milestones ~~these~~ are ~~not yet recorded as Revenue.~~met. See Note 2, ~~“Significant~~“Summary of Significant Accounting Policies”. We expect to continue to incur significant operating losses as we fund research and clinical trial activities relating to our ocular therapeutic assets, consisting of ~~EGP-437, our iontophoretic delivery technology, and~~ our CMHA-S-based ~~products.~~products, or any other product candidate that we may develop. There can be no guarantee that the losses incurred to fund these activities will succeed in generating revenue.

Research and Development Expenses

We expense all research and development expenses as they are incurred. Research and development expenses primarily include:
· non-clinical development, preclinical research, and clinical trial and regulatory-related costs;
· expenses incurred under agreements with sites and consultants that conduct our clinical trials;
· expenses related to generating, filing, and maintaining intellectual property; and
· employee-related expenses, including salaries, bonuses, benefits, travel and stock-based compensation expense.

Substantially all of our research and development expenses to date have been incurred in connection with our EyeGate OBG and EGP-437 Combination ~~Product and the EyeGate OBG.~~Product. We expect our research and development expenses to ~~increase~~remain consistent for the near future as we advance ~~EGP-437~~EyeGate OBG and ~~EyeGate OBG~~any other product candidate through clinical development, including the conduct of our planned clinical trials. The process of conducting clinical trials necessary to obtain regulatory approval is costly and time consuming. We are unable to estimate with any certainty the costs we will incur in the continued development of our ~~EGP-437 Combination Product~~EyeGate OBG and ~~EyeGate OBG.~~any other product candidate that we may develop. Clinical development timelines, the probability of success and development costs can differ materially from expectations.

We may never succeed in achieving marketing approval for our product candidates.

The costs of clinical trials may vary significantly over the life of a project including, but not limited to, the following:
· per patient trial costs;
· the number of sites included in the trials;
· the countries in which the trials are conducted;
· the length of time required to enroll eligible patients;
· the number of patients that participate in the trials;
· the number of doses that patients receive;
· the cost of comparative agents used in trials;
· the drop-out or discontinuation rates of patients;
· potential additional safety monitoring or other studies requested by regulatory agencies;
· the duration of patient follow-up; and
· the efficacy and safety profile of the product candidate.

We do not expect our product candidates to be commercially available, if at all, for the next several years.

General and Administrative Expenses

General and administrative expenses consist primarily of salaries and related benefits, including stock-based compensation. Our general and administrative expenses consisted primarily of payroll expenses for our full-time employees. Other general and administrative expenses include professional fees for auditing, tax, patent costs and legal services.

We expect that general and administrative expenses will remain consistent for the near future until commercialization of our CMHA-S based products, which could lead to an increase in these expenses.

Total Other Income (Expense)

Total other income (expense) consists primarily of interest income we earn on interest-bearing accounts, and interest expense incurred on our outstanding financing arrangements.

22

Critical Accounting Policies and Significant Judgments and Estimates

Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with accounting principles generally accepted in the United States, or U.S. GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the expenses during the reporting periods. We evaluate these estimates and judgments on an ongoing basis. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Our actual results may differ materially from these estimates under different assumptions or conditions.

While our ~~critical~~significant accounting policies are discussed in more detail in Note 2 to our financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, we believe that the following accounting policies ~~below~~ are ~~particularly important in~~the most critical for fully understanding and evaluating our financial condition and results of operations.

Accrued Research and Development Expenses

As part of the process of preparing financial statements, we are required to estimate and accrue research and development expenses. This process involves the following:

· communicating with our applicable personnel to identify services that have been performed on our behalf and estimating the level of service performed and the associated cost incurred for the service when we have not yet been invoiced or otherwise notified of actual cost;
· estimating and accruing expenses in our financial statements as of each balance sheet date based on facts and circumstances known to us at the time; and
· periodically confirming the accuracy of our estimates with selected service providers and making adjustments, if necessary.

Examples of estimated research and development expenses that we accrue include:
· fees paid to contract research organizations and investigative sites in connection with clinical studies;
· fees paid to contract manufacturing organizations in connection with non-clinical development, preclinical research, and the production of clinical study materials; and
· professional service fees for consulting and related services.

We base our expense accruals related to non-clinical development, preclinical studies, and clinical trials on our estimates of the services received and efforts expended pursuant to contracts with organizations/consultants that conduct and manage clinical studies on our behalf. The financial terms of these agreements vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts may depend on many factors, such as the successful enrollment of patients, site initiation and the completion of clinical study milestones. Our service providers invoice us as milestones are achieved and monthly in arrears for services performed. In accruing service fees, we estimate the time period over which services will be performed and the level of effort to be expended in each period. If we do not identify costs that we have begun to incur or if we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates. To date, we have not experienced significant changes in our estimates of accrued research and development expenses after a reporting period.

However, due to the nature of estimates, we cannot assure you that we will not make changes to our estimates in the future as we become aware of additional information about the status or conduct of our clinical studies and other research activities.

Stock-Based Compensation

We have issued options to purchase our common stock and restricted stock. Stock-based compensation cost is measured at the grant date based on the fair value of the award and is recognized as expense over the requisite service/vesting period. Determining the appropriate fair value model and calculating the fair value of stock-based payment awards require the use of highly subjective assumptions, including the expected life of the stock-based payment awards and stock price volatility.

We estimate the grant date fair value of stock options and the related compensation expense, using the Black-Scholes option valuation model. This option valuation model requires the input of subjective assumptions including: (1) expected life (estimated period of time outstanding) of the options granted, (2) volatility, (3) risk-free rate and (4) dividends. In general, the assumptions used in calculating the fair value of stock-based payment awards represent management’s best estimates, but the estimates involve inherent uncertainties and the application of management judgment. As a result, if factors change and we use different assumptions, our stock-based compensation expense could be materially different in the future.

23

Revenue Recognition

~~The Valeant Agreements entitle us to initial up-front payments,~~Our revenues are generated primarily through arrangements which we received in 2015 and 2017, and recorded as Deferred Revenue on our Condensed Consolidated Balance Sheet, as well as certain additional payments, based on R&D progress and paid over several years. Under the Valeant Agreements, there are R&D Milestones,generally contain multiple elements, or deliverables, ~~for which we receive additional payments. We receive payments both when we cross certain thresholds~~including licenses and R&D activities to be performed by us on the path to each Milestone (each, a “Progress Payment”), as well as once we finally achieve each Milestone. We are entitled to retain all of these payments once received. We defer all Progress Payments and capitalize these payments on our Condensed Consolidated Balance Sheet as Deferred Revenue, and we recognize these payments as Revenue once we achieve the Milestone to which the Progress Payment relates. The upfront payments are recognized as Revenue ratably as we complete eachbehalf of the ~~R&D Milestones, the amount recognized being the amount~~licensor or grantor. Payments to us under these arrangements typically include one or more of the following: (1) nonrefundable, upfront ~~payment times the percentage represented by the proportionate share~~license fees, (2) funding of ~~fair value~~discovery research efforts on a full-time equivalent basis, (3) reimbursement of ~~each Milestone relative to the total fair value of the all the R&D Milestones. Accordingly, the Deferred Revenue account~~research, development and intellectual property costs, (4) milestone payments, and (5) royalties on ~~our Condensed Consolidated Balance Sheet is reduced as Revenue is recognized in our Condensed Consolidated Statement of Operations and Comprehensive Loss.~~
We receive U.S. Government Grant funds from two sources: the U.S. Department of Defense (“DoD”) and the National Science Foundation (“NSF”). We are paid by the DoD after we perform specified, agreed-upon research, and we record these grant funds as Revenue as we perform the research. We are generally paid by the NSF every six months, before we perform specified, agreed-upon research. The NSF funds are recorded on the Condensed Consolidated Balance Sheet as Deferred Revenue when invoiced, and recognized as Revenue ratably as the research is performed, typically over a six-month period. The U.S. Government Grants from the DOD and NSF have been fully funded as of September 30, 2017.
~~Recent Accounting Pronouncements~~future product sales.

In May 2014, the FASB issued ASU No. 2014-09,~~Revenue~~Revenues from Contracts with Customers ~~(Topic 606)~~(“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 ~~current~~ 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. ~~The guidance also specifies the accounting~~This standard is effective for ~~certain incremental costs of obtaining a contract, and costs to fulfill a contract~~public companies for years ending after December 15, 2017, with ~~a customer. Entities have the option of applying either a full retrospective approach to all periods presented, or a modified approach that reflects differences prior to the date of~~early adoption as an adjustment to equity. In April 2015, the FASB deferred the effective date of this guidance until January 1, 2018. We are not early adopting this standard. Our sole revenue is from our Valeant Agreements and U.S. Government Grants.permitted.

We ~~have commenced our implementation analysis, including identification~~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 ~~streams and reviews~~for the BHC contracts impacted by the adoption of ~~customer contracts under ASU 2014-09’s framework. Our analysis includes reviewing current accounting policies and practices to identify potential differences that would result from applying~~ the ~~requirements under this~~ new standard. ~~We have reviewed~~The changes to the method and/or timing of our ~~contracts~~revenue recognition associated with Valeant. ASU 2014-09 requires increased disclosure, which in turn is expected to require certain new processes. The determination of the impact of adoption of ASU 2014-09 on our financial condition, results of operations, cash flows and disclosures, is ongoing, and, as such, we are not able to reasonably estimate the effect that the adoption of the new standard ~~will have on~~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.
Under this new guidance, we recognize revenue when our ~~financial statements. Based on our preliminary assessment~~customer obtains control of promised services, in an amount that reflects the consideration which we expect to receive in exchange for those services. To determine whether arrangements are within the scope of this ~~ASU,~~new guidance, we ~~anticipate~~perform the following five steps: (i) identify the contract with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) we satisfy our performance obligation. We apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services we transfer to the customer. Upon adoption of ASU No. 2014-09, we recognize revenue from the ~~new standard~~transaction price applied to each single performance obligation over time as milestones are reached for each performance obligation. We only recognize revenue on those milestones that are within our control and any constrained variable consideration that requires regulatory approval will ~~have a material effect. We expect to use~~only be included in the ~~modified retrospective transition method, meaning~~transaction price when performance is complete.
In addition, we may receive government grant funds for specified ocular therapeutic research activities. Revenue under these grants will be recorded when we perform the ~~cumulative effect~~activities specified by the terms of ~~applying the new guidance is recognized at the date of initial application as an adjustment~~each grant and are entitled to the ~~opening accumulated deficit balance. We continue to monitor additional changes, modifications, clarifications or interpretations being undertaken by the FASB, which may impact our current conclusions.~~
funds.

24
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. We did not early adopt this standard and have leases (see Note 10) in place at the effective date. We evaluated the effect of the new guidance and adopted the new standard effective January 1, 2019 using the modified retrospective method. As a result, we 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 us 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. We did not early adopt ASU No. 2017-04 prior to our December 2017 impairment evaluation and are evaluating the effect that ASU No. 2017-04 will have on our Consolidated Financial Statements and related disclosures.
25

Other Information

JOBS Act

On April 5, 2012, the Jumpstart Our Business Startups Act of 2012, or the JOBS Act, was enacted. Section 107 of the JOBS Act provides that an “emerging growth company” can take advantage of the extended transition period provided in Section 7(a)(2)(B) of the Securities Act, for complying with new or revised accounting standards. In other words, an “emerging growth company” can delay the adoption of certain accounting standards until those standards would otherwise apply to private companies. We have irrevocably elected not to avail ourselves of this extended transition period and, as a result, we will adopt new or revised accounting standards on the relevant dates on which adoption of such standards is required for other public companies.

We ~~are in the process of evaluating~~have evaluated the benefits of relying on other exemptions and reduced reporting requirements provided by the JOBS Act. Subject to certain conditions set forth in the JOBS Act, as an “emerging growth company,” we ~~intend to~~ rely on certain of these exemptions, including without limitation, (i) providing an auditor’s attestation report on our system of internal controls over financial reporting pursuant to Section 404(b) of the Sarbanes-Oxley Act and (ii) complying with any requirement that may be adopted by the Public Company Accounting Oversight Board (“PCAOB”) regarding mandatory audit firm rotation or a supplement to the auditor’s report providing additional information about the audit and the financial statements, known as the auditor discussion and analysis. We will remain an “emerging growth company” until the earliest of (a) the last day of the fiscal year in which we have total annual gross revenues of $1 billion or more, (b) the last day of our fiscal year following the fifth anniversary of the date of the completion of our initial public offering, or December 31, 2020, (c) the date on which we have issued more than $1 billion in nonconvertible debt during the previous three years or (d) the date on which we are deemed to be a large accelerated filer under the rules of the SEC.

Results of Operations

Comparison of Three Months ended ~~September~~June 30, ~~2017~~2019 and ~~2016~~2018

The following table summarizes the results of our operations for the three months ended ~~September~~June 30, ~~2017~~2019 and ~~2016:~~2018:

Three Months Ended September 30, Three Months Ended June 30,
2017 2016 Change 2019 2018 Change
Collaboration Revenue $ 74,696 $ 274,289 $ (199,593 ) $ - $ 242,012 $ (242,012 )
Operating Expenses:
Research and Development (3,175,978 ) (2,449,445 ) (726,533 ) 763,896 1,837,799 (1,073,903 )
General and Administrative (1,038,822 ) (1,201,804 ) 162,982 1,105,904 1,202,531 (96,627 )
Total Operating Expenses (4,214,800 ) (3,651,249 ) (563,551 ) 1,869,800 3,040,330 (1,170,530 )
Other (Expense) Income, Net: (264 ) 298 (562 )
Other Income, Net 32,528 18,063 14,465
Net Loss $ (4,140,368 ) $ (3,376,662 ) $ (763,706 ) $ (1,837,272 ) $ (2,780,255 ) $ 942,983

Collaboration Revenue. Collaboration Revenue was ~~$0.075~~$0 million for the three months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$0.274~~$0.242 million for the three months ended ~~September~~June 30, ~~2016, reflecting~~2018. The revenue generated in the ~~Collaboration Revenue we generate from the U.S. Government Grants in accordance with our contracted agreements. These grants were fully funded as~~second quarter of ~~September 30, 2017.~~2018 related to BHC milestone payments earned.

Research and Development Expenses.  Research and Development Expenses were ~~$3.176~~$0.764 million for the three months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$2.449~~$1.838 million for the three months ended ~~September~~June 30, ~~2016.~~2018. The ~~increase~~decrease of ~~$0.727~~$1.074 million was primarily due to ~~increases~~decreases in clinical and other activity related to ~~the Phase 2b trial for post-cataract surgery inflammation~~EGP-437, personnel related costs, as well as OBG manufacturing work and ~~pain and the EyeGate OBG,~~market research costs. These decreases were partially offset by ~~a decrease~~an increase in costs related to the ~~EGP-437 Phase 3 trial for~~initiation of the ~~treatment~~PRK pivotal study during the second quarter of ~~anterior uveitis.~~2019.

General and Administrative Expenses.  General and Administrative Expenses were ~~$1.039~~$1.106 million for the three months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$1.202~~$1.203 million for the three months ended ~~September~~June 30, ~~2016.~~2018. The decrease of ~~$0.163~~$0.097 million was ~~mainly~~primarily due to ~~lower~~decreases in professional fees ~~incurred during~~and corporate costs, partially offset by an increase in personnel related costs.
Other Income, Net.Other Income, Net was $0.033 million for the ~~third quarter of 2017 as~~three months ended June 30, 2019, compared to $0.018 million for the ~~third quarter of 2016.~~three months ended June 30, 2018 due to more favorable interest rates on our cash balances.

2526

Comparison of ~~Nine~~Six Months ended ~~September~~June 30, ~~2017~~2019 and ~~2016~~2018

The following table summarizes the results of our operations for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016:~~2018:

Nine Months Ended September 30, Six Months Ended June 30,
2017 2016 Change 2019 2018 Change
Collaboration Revenue $ 407,518 $ 508,889 $ (101,371 ) $ 2,686,000 $ 1,338,020 $ 1,347,980
Operating Expenses:
Research and Development (7,253,171 ) (5,844,951 ) (1,408,220 ) 1,485,373 4,358,808 (2,873,435 )
General and Administrative (3,540,857 ) (4,309,737 ) 768,880 2,241,787 2,156,579 85,208
Total Operating Expenses (10,794,028 ) (10,154,688 ) (639,340 ) 3,727,160 6,515,387 (2,788,227 )
Other (Expense) Income, Net: (375 ) 3,423 (3,798 )
Other Income, Net: 74,697 17,785 56,912
Net Loss $ (10,386,885 ) $ (9,642,376 ) $ (744,509 ) $ (966,463 ) $ (5,159,582 ) $ 4,193,119

Collaboration Revenue. Collaboration Revenue was ~~$0.408~~$2.686 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$0.509~~$1.338 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016, reflecting the Jade Acquisition~~2018. The revenue recognized in the first ~~quarter~~six months of ~~2016~~2019 was a result of the termination of the license agreements with BHC and no further revenue will be recognized related to these agreements. The revenue generated in the ~~accompanying Collaboration Revenue we generate from~~first six months of 2018 related to the ~~U.S. Government Grants in accordance with our contracted agreements. These grants were fully funded as of September 30, 2017.~~BHC milestone payments earned.

Research and Development Expenses.  Research and Development Expenses were ~~$7.253~~$1.485 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$5.845~~$4.359 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016.~~2018. The ~~increase~~decrease of ~~$1.408~~$2.873 million was primarily due to ~~increases~~decreases in clinical and other activity related to ~~the Phase 2b trial for post-cataract surgery inflammation and pain, the EyeGate OBG,~~EGP-437, personnel related costs, as well as ~~personnel related costs from the expansion of operations following the Jade Acquisition in the first quarter of 2016.~~OBG manufacturing work and market research costs. These ~~increases~~decreases were partially offset by ~~a decrease~~an increase in ~~clinical activity~~costs related to the ~~EGP-437 Phase 3 trial for~~initiation of the ~~treatment~~PRK pivotal study during the second quarter of ~~anterior uveitis.~~2019.

General and Administrative Expenses.  General and Administrative Expenses were ~~$3.541~~$2.242 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$4.310~~$2.157 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016.~~2018. The ~~decrease~~increase of ~~$0.769~~$0.085 million was ~~mainly~~primarily due to ~~decreases~~an increase in personnel related costs, partially offset by a decrease in professional ~~fees, including costs incurred during~~fees.
Other Income, Net.Other Income, Net was $0.075 million for the ~~first quarter of 2016 related~~six months ended June 30, 2019, compared to $0.018 million for the ~~Jade Acquisition.~~six months ended June 30, 2018 due to more favorable interest rates on our cash balances.

2627

Liquidity and Capital Resources

Since becoming a public company in 2015, we have financed our operations from four registered offerings of our Common Stock and Convertible Preferred Stock, payments from ~~our Valeant~~the BHC License Agreements and the U.S. Government Grants, and sales through our At The Market Offering Agreement. From inception through ~~September~~June 30, ~~2017,~~2019, we have raised a total of approximately ~~$84.5~~$94.6 million from such sales of our equity and debt securities, both as a public company and prior to our IPO, as well as approximately ~~$10.8~~$14.9 million in payments received under our license agreements and U.S. Government Grants.

On February 21, 2017, we received the initial $4.0 million upfront payment from Valeant as provided under the New Valeant Agreement related to our EGP-437 Product in the field of ocular iontophoretic treatment for post-operative ocular inflammation and pain in ocular surgery patients. Through ~~September~~June 30, ~~2017,~~2019, we have received cash payments of ~~$9.653~~$13.8 million under the ~~Valeant~~BHC Agreements, which are presented as Collaboration Revenue on our Condensed Consolidated Statement of Operations and Comprehensive Loss, or Deferred or Unbilled Revenue on our Condensed Consolidated Balance ~~Sheet.~~Sheets. Additionally, on January 1, 2018, $9.5 million was recorded as a reduction to our opening accumulated deficit balance on our Condensed Consolidated Balance Sheets upon the adoption of ASU No. 2014-09.

On May 24, 2016, we 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 we can from time to time offer and sell up to 1,319,289 shares of its Common Stock through the Sales Agent. Effective as of June 26, 2016, we halted indefinitely all future offers and sales of our Common Stock pursuant to the ATM Agreement. On June 30, 2016, we closed on the sale of our equity securities in connection with a registered direct offering, described below, and as a result, we were restricted from issuing any shares pursuant to the ATM Agreement for a period of 90 days following June 30, 2016. This restriction lapsed on September 28, 2016. On February 21, 2017, we authorized the Sales Agent to restart sales under the ATM Agreement for maximum aggregate proceeds of up to $3,285,798. During the first quarter of 2017, we sold 642,150 shares of Common Stock under this agreement for total net proceeds to us, ~~from this offering,~~ after deducting the placement agent fees and offering expenses, of approximately $1.8 million. ~~We did not sell any~~No further shares of Common Stock were sold pursuant to the ATM Agreement. The ATM Agreement during the second or third quarters of 2017. On June 14, 2017, we closed on the sale of our equity securities in connection with a public offering, described below, and as a result, we are restricted from issuing any sharesterminated automatically pursuant to the ATM Agreement for a period of twenty-four months following the closing date of the offering. However, this restriction is suspended for any sale of shares of Common Stock under the ATM Agreement that is above $3.00 per share.its terms on May 24, 2019.

On June 14, 2017, we 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 offering was priced at $1.50 per share of Common Stock (or share of Common Stock issuable upon conversion of a share of Series B Convertible Preferred Stock) and warrant. The total net proceeds to us from this 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. As of ~~September~~June 30, ~~2017, a holder~~2019, holders of the Series B Preferred Stock had converted ~~1,395~~all 1,995 shares of Series B Preferred Stock into an aggregate of ~~930,000~~1,330,000 shares of Common Stock.
On April 17, 2018, we completed a public offering of 14,730,000 shares of Common Stock and 6,536.4 shares of Series C Convertible Preferred Stock (convertible into 20,426,250 shares of Common Stock), along with warrants to purchase 35,156,250 shares of Common Stock. The offering was priced at $0.32 per share of Common Stock (or share of Common Stock issuable upon conversion of a share of Series C Convertible Preferred Stock) and warrant. The total net proceeds to us 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 Convertible 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 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 Convertible 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 Convertible Preferred stock into 3,263,750 shares of Common Stock.

At ~~September~~June 30, ~~2017,~~2019, we had unrestricted cash and cash equivalents totaling ~~$9,244,570.~~$4,465,086.

The following table sets forth the primary ~~sources and~~ uses of cash for the ~~nine~~six months ended ~~September~~June 30, ~~2017~~2019 and ~~2016:~~2018:

Nine Months Ended September 30, Six Months Ended June 30,
2017 2016 2019 2018
Net Cash Used in Operating Activities $ (5,015,231 ) $ (6,361,542 ) $ (3,568,990 ) $ (6,059,752 )
Net Cash Provided by Investing Activities - 149,746
Net Cash Provided by Financing Activities 10,620,417 3,501,090 $ 28,857 $ 10,856,665
28

Comparison of ~~Nine~~Six Months Ended ~~September~~June 30, ~~2017~~2019 and ~~2016~~2018

Operating Activities. Net cash used in operating activities was ~~$5.015~~$3.569 million for the ~~nine~~six months ended ~~September~~June 30, ~~2017,~~2019, compared to ~~$6.362~~$6.060 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016. The primary use~~2018. During the first six months of ~~Cash was to fund operating losses~~2019, we recorded a net loss of ~~$10.387~~$0.966 million, decreases in ~~2017,~~deferred revenue of $2.686 million and accrued expenses of $0.374 million; partially offset by stock-based compensation expense of $0.469 million. During the ~~positive impact~~first six months of ~~receiving cash payments from Valeant~~2018, we recorded a net loss of ~~$5.428~~$5.160 million, as well as decreases in accounts payable and accrued expenses of $1.119 million, and ~~the U.S. Government, some~~unbilled revenue of ~~which is classified as Deferred Revenue on the Condensed Consolidated Balance Sheet,~~$0.690 million; partially offset by an increase in deferred revenue of $0.577 million and ~~some~~stock-based compensation expense of ~~which is included in Collaboration Revenue in the Condensed Consolidated Statement of Operations and Comprehensive Loss.~~
~~Investing Activities.~~ There was no net cash provided by investing activities for the nine months ended September 30, 2017, compared to $0.150 million for the nine months ended September 30, 2016. On March 7, 2016, we acquired Jade Therapeutics, Inc., a Common Stock and Cash transaction that required the use of $0.186 million in cash (net of cash acquired).$0.291 million.

Financing Activities. ~~We received $10.620 million in~~Net cash ~~from~~provided by financing activities ~~for the nine months ended September 30, 2017, compared to $3.501~~was $0.029 million for the ~~nine~~six months ended ~~September~~June 30, ~~2016. This increase~~2019, compared to $10.857 million for the six months ended June 30, 2018. During the six months ended June 30, 2019, we received $0.032 million from the exercise of ~~$7.119 million was mainly due to~~warrants. During the six months ended June 30, 2018, we received net proceeds ~~received~~of $10.109 million from ~~sales under our ATM Agreement~~a stock offering and $0.754 million from the exercise of ~~$1.824 million, as well as net proceeds received from our public offering of $8.765 million.~~warrants.
27
Funding Requirements and Other Liquidity Matters

Our CMHA-S-based product pipeline and our EGP-437 Combination Product ~~and our CMHA-S-based product pipeline~~ are still in various stages of clinical development. We expect to continue to incur significant expenses and ~~increasing~~ operating losses for the ~~near~~foreseeable future. We anticipate that our expenses will increase substantially if and as we:

·• seek marketing approval for our ~~EGP-437 Combination Product and our~~ CMHA-S-based ~~products;~~products or any other products that we successfully develop;
·• establish a sales and marketing infrastructure to commercialize our CMHA-S-based products in the United States, if approved; and
·• add operational, financial and management information systems and personnel, including personnel to support our product development and future commercialization efforts.

Until such time, if ever, as we can generate substantial product revenue, we expect to finance our cash needs through a combination of equity offerings, debt financings, collaborations, strategic alliances and licensing arrangements. We do not have any committed external source of funds. To the extent that we raise additional capital through the sale of equity or convertible debt securities, the ownership interest of our Stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of a Common Stockholder. Debt financing, if available, may involve agreements that include covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we raise additional funds through collaborations, strategic alliances or licensing arrangements with pharmaceutical partners, we may have to relinquish valuable rights to our technologies, future revenue streams, research programs or product candidates, including our ~~EGP-437 Product~~CMHA-S-based products and our ~~CMHA-S-based products,~~EGP-437 Combination Product, or grant licenses on terms that may not be favorable to us. If we are unable to raise additional funds through equity or debt financings when needed, we may be required to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market ~~the EGP-437 Product and~~our CMHA-S-based products or any other products that we would otherwise prefer to develop and market ourselves.

Based on our cash on hand at ~~September~~June 30, ~~2017 and cash we expect to receive over the remainder of 2017,~~2019, we believe we will have sufficient cash to fund planned operations ~~for approximately eight months.~~through October 31, 2019. However, the acceleration or reduction of cash outflows by management can significantly impact the timing for raising additional capital to complete development of ~~our~~its products. To continue development, we will need to raise additional capital through debt and/or equity financing, or access additional funding through grants. Although we successfully completed ~~the IPO, follow-on, registered direct offering,~~several public ~~offering, and sales under the ATM Agreement,~~offerings, additional capital may not be available on terms favorable to us, if at all. On May ~~6, 2016,~~13, 2019, the SEC declared effective our registration statement on Form S-3, registering a total of ~~$100,000,000~~$50,000,000 of our securities for sale to the public from time to time in what is known as a “shelf offering”. We do not know if our future offerings, including offerings pursuant to ~~our~~any shelf registration statement, will succeed. Accordingly, no assurances can be given that management will be successful in these endeavors. Our recurring losses from operations have caused management to determine there is substantial doubt about our ability to continue as a going concern. Our 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 we be unable to continue as a going concern.

Off-Balance Sheet Arrangements

We ~~had no~~do not have any material off-balance sheet arrangements as of ~~September~~June 30, ~~2017.~~2019.

2829

Contractual Obligations and Commitments

The following table summarizes our contractual obligations as of ~~September~~June 30, ~~2017:~~2019:

Total
Less than
1 year
1-3 years
More than
3 years
Total
Less than
1 year
1-3 years
More than
3 years

Leases (1) $ 374,496 $ 180,751 $ 193,745 $ - $ 114,073 $ 114,073 $ - $ -
Licensing Agreement (2) 257,500 52,500 105,000 100,000 342,500 47,500 90,000 205,000
Purchase Obligations (3) 1,223,772 1,223,772 - -
Total (4) $ 1,855,768 $ 1,457,023 $ 298,745 $ 100,000
Total (3) $ 456,573 $ 161,573 $ 90,000 $ 205,000

(1) Lease obligations reflect our obligation to make payments in connection with operating leases for our office ~~space and capital leases with respect to laboratory equipment.~~space.
(2) Licensing Agreement obligations represent our commitments under license agreements, including those made by us under our license agreements with the University of Miami School of Medicine, the University of Utah Research Foundation and BioTime.
(3) Purchase Obligations relate to a Master Service Agreement with a contract research organization (“CRO”). The CRO will provide clinical research services for Phase 3 trials in patients with non-infectious anterior segment uveitis.
~~(4)~~ This table does not include (a) anticipated expenditures under supply agreements for periods for which we are not yet bound under binding purchase orders, and (b) contracts that are entered into in the ordinary course of business that are not material in the aggregate in any period presented above.

In addition, in the course of normal business operations, we have agreements with contract service providers to assist in the performance of our research and development and manufacturing activities. Expenditures to contract research organizations vary based on the study and phases during the clinical development stages. Subject to required notice periods and our obligations under binding purchase orders, we can elect to discontinue the work under these agreements at any time. We could also enter into additional collaborative research, contract research, manufacturing, and supplier agreements in the future, which may require upfront payments and even long-term commitments of cash.
Item~~Item~~ 3. Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

Item~~Item~~ 4. Controls and Procedures.
This Report includes the certifications of our President and Chief Executive Officer (who is our principal executive officer) and our Chief Financial Officer (who is our principal financial and accounting officer) required by Rule 13a-14 of the Exchange Act.See Exhibits 31.1 and 31.2. This Item 4 includes information concerning the controls and control evaluations referred to in those certifications.

Evaluation of Disclosure Controls and Procedures

Disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) are designed to ensure that information required to be disclosed in reports filed or submitted under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in SEC rules and forms and that such information is accumulated and communicated to management, including the President and Chief Executive Officer, to allow timely decisions regarding required disclosures.

In connection with the preparation of this Quarterly Report on the Form 10-Q, the Company’s Management, under the supervision of, and with the participation of, our President and Chief Executive Officer and our ~~Interim~~ Chief Financial Officer, conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures as of ~~September~~June 30, ~~2017.~~2019. Our disclosure controls and procedures are designed to provide reasonable assurance that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and our management necessarily was required to apply its judgment in evaluating and implementing our disclosure controls and procedures. Based upon the evaluation described above, our President and Chief Executive Officer and our ~~Interim~~ Chief Financial Officer have concluded that they believe that our disclosure controls and procedures were effective as of the end of the period covered by this report.

Changes in Internal Control over Financial Accounting and Reporting

Our management, with the participation of the Chief Executive Officer and the ~~Interim~~ Chief Financial Officer, has evaluated whether any change in our internal control over financial accounting and reporting occurred during the ~~third~~ quarter ended ~~September~~June 30, ~~2017.~~2019. Management concluded that no changes to our internal control over financial accounting and reporting occurred during the ~~three months~~quarter ended ~~September~~June 30, ~~2017~~2019 that have materially affected, or are reasonably likely to materially affect, our internal control over financial accounting and reporting. Additionally, our management does not anticipate the adoption of ASU 2014-09 to have a material impact on our internal control over financial accounting and reporting as a result of (i) the adoption, (ii) the implementation on a going forward basis, and (iii) developing information for disclosure.

2930

PART II - OTHER INFORMATION

Item 1.    Legal Proceedings.

While we are not currently a party to any legal proceedings, from time to time we may be a party to a variety of legal proceedings that arise in the normal course of our business.

Item 1A.    Risk Factors.

Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, ~~2016,~~2018 filed with the SEC on ~~February 23, 2017,~~March 1, 2019 contains risk factors identified by the Company. There have been no material changes to the risk factors we previously disclosed. Our operations could also be affected by additional factors that are not presently known to us or by factors that we currently consider immaterial to our business.

Item 2.Unregistered Sales of Equity Securities and Use of ~~Proceeds~~Proceeds.

Unregistered Sales of Equity Securities

None.

Purchase of Equity Securities

We did not purchase any of our registered equity securities during the period covered by this Quarterly Report on Form 10-Q.

Item 3.Defaults Upon Senior Securities.

Not applicable.

Item 4.Mine Safety ~~Disclosures.~~Disclosure.

Not applicable.

Item 5.Other Information.

None.

Item 6.Exhibits.

The exhibits filed as part of this Quarterly Report on Form 10-Q are set forth on the Exhibit Index immediately preceding such exhibits and are incorporated herein by reference.

3031

SIGNATURES

Pursuant to the requirements of Section 13 and 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Date: ~~November 14, 2017~~August 8, 2019 By: /s/ Stephen From

President and Chief Executive Officer
(Principal executive officer)

Date: ~~November 14, 2017~~August 8, 2019 By: /s/ Sarah Romano

~~Interim~~ Chief Financial Officer
(Principal financial and accounting officer)

3132

EXHIBIT INDEX

The following exhibits are filed as part of this Quarterly Report on Form 10-Q. Where such filing is made by incorporation by reference to a previously filed document, such document is identified.

Exhibit
Number Description of Exhibit
31.1** Certification of principal executive officer pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2** Certification of principal financial and accounting officer pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1** Certification of principal executive officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2** Certification of principal financial and accounting officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS XBRL Instance Document

101.SCH XBRL Taxonomy Extension Schema Document

101.CAL XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF XBRL Taxonomy Extension Definition Linkbase Document

101.LAB XBRL Taxonomy Extension Labels Linkbase Document

101.PRE XBRL Taxonomy Extension Presentation Linkbase Document

** This certification shall not be deemed “filed” for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed to be incorporated by reference into any filing under the Securities Act.

3233

	Convertible Preferred Stock						Common Stock				Additional Paid In			Stockholders’ Notes			Accumulated Other Comprehensive		Accumulated			Total Stockholders’
	Shares			Amount			Shares		Amount		Capital			Receivable			Income		Deficit			Equity (Deficit)

Balance at December 31, 2016		-		$	-			10,130,883	$	101,309	$	78,106,645		$	(58,824	)	$	120,187	$	(78,598,738	)	$	(329,421	)

Stock-Based Compensation												700,833											700,833

Cancellation of Stockholder Note Receivable															58,824								58,824

Issuance of Common Stock in Offerings, Net of Offering Costs of $1,086,736								5,978,817		59,788		8,551,895											8,611,683

Issuance of Series B Preferred Stock, Net of Offering Costs of $246,333		1,995			20							1,977,480											1,977,500

Conversion of Series B Preferred Stock		(1,395	)		(14	)		930,000		9,300		(9,286	)										-

Exercise of Common Stock Options								61,078		611		40,107											40,718

Issuance of Restricted Stock								104,000		1,040		(1,040	)										-

Foreign Currency Translation Adjustment																		6,193					6,193

Net Loss																				(10,386,885	)		(10,386,885	)

Balance at September 30, 2017		600		$	6			17,204,778	$	172,048	$	89,366,634		$	-		$	126,380	$	(88,985,623	)	$	679,445

									Additional		Accumulated Other					Total
	Series C Preferred Stock				Common Stock				Paid-In		Comprehensive		Accumulated			Stockholders’
	Shares		Amount		Shares		Amount		Capital		Income		Deficit			Equity
Balance at March 31, 2019		4,092	$	41		45,575,737	$	455,758	$	101,729,241	$	133,833	$	(92,279,389	)	$	10,039,484

Stock-Based Compensation										236,190							236,190

Issuance of Shares of Common Stock from Warrant Exercises						100,000		1,000		31,000							32,000

Foreign Currency Translation Adjustment												1,355					1,355

Net Loss														(1,837,272	)		(1,837,272	)

Balance at June 30, 2019		4,092	$	41		45,675,737	$	456,758	$	101,996,431	$	135,188	$	(94,116,661	)	$	8,471,757

	Series B Preferred Stock						Series C Preferred Stock						Common Stock				Additional Paid			Accumulated Other Comprehensive		Accumulated			Total Stockholders’
	Shares			Amount			Shares			Amount			Shares		Amount		In Capital			Income		Deficit			Equity
Balance at March 31, 2018		600		$	6			-		$	-			17,257,255	$	172,573	$	89,694,834		$	128,707	$	(84,718,102	)	$	5,278,018

Stock-Based Compensation																		145,309								145,309

Issuance of Stock in Offering, Net of Offering Costs of $1,141,238								6,536			65			14,730,000		147,299		10,001,792								10,149,156

Conversion of Series B Preferred Stock into Common Stock		(600	)		(6	)								400,000		4,000		(3,994	)							-

Conversion of Series C Preferred Stock into Common Stock								(2,444	)		(24	)		7,638,750		76,388		(76,364	)							-

Issuance of Shares of Common Stock from Warrant Exercises														2,356,875		23,569		730,656								754,225

Foreign Currency Translation Adjustment																					2,006					2,006

Net Loss																							(2,780,255	)		(2,780,255	)

Balance at June 30, 2018		-		$	-			4,092		$	41			42,382,880	$	423,829	$	100,492,233		$	130,713	$	(87,498,357	)	$	13,548,459

	Nine Months Ended September 30,
	2017			2016
Operating Activities
Net Loss	$	(10,386,885	)	$	(9,642,376	)
Adjustments to Reconcile Net Loss to Net Cash Used in Operating Activities:
Depreciation and Amortization		13,608			649
Stock-Based Compensation		700,833			390,469
Loss on Cancellation of Stockholder Note Receivable		91,054			-
Changes in Operating Assets and Liabilities:
Prepaid Expenses and Other Current Assets		(194,364	)		(35,748	)
Refundable Tax Credit Receivable		(3,173	)		9,786
License and Grant Receivable		(564,650	)		2,378,635
Other Assets		(1,083	)		(15,364	)
Accounts Payable		(753,513	)		704,912
Deferred Revenue		6,029,600			48,324
Accrued Expenses		53,342			(200,829	)
Net Cash Used in Operating Activities		(5,015,231	)		(6,361,542	)

Investing Activities
Acquisition of Jade (Net of Cash Acquired)		-			185,746
Restricted Cash		-			(25,000	)
Equipment Purchased Under Capital Lease		-			(11,000	)
Net Cash Provided by Investing Activities		-			149,746

Financing Activities
Proceeds from Stock Offerings		11,922,252			3,768,698
Stock Issuance Costs		(1,333,069	)		(323,814	)
Exercise of Common Stock Options		40,718			56,206
Equipment Financing Payments		(9,484	)		-
Net Cash Provided by Financing Activities		10,620,417			3,501,090
Effect of Exchange Rate Changes on Cash		4,160			(1,053	)
Net Increase (Decrease) in Cash		5,609,346			(2,711,759	)
Cash, Beginning of Period		3,635,224			8,394,133
Cash, End of Period	$	9,244,570		$	5,682,374
Supplemental Disclosure of Noncash Investing and Financing Activities
Conversion of Preferred Stock into Common Stock	$	9,300		$	6,890
Issuance of Common Stock to Acquire Jade Therapeutics, Inc.	$	-		$	2,909,766
Contingent Liability in Connection with the Jade Acquisition	$	-		$	1,210,000
Property and Equipment Acquired Under Capital Lease	$	-		$	31,576

	Six Months Ended June 30,
	2019			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			-
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			-
Accounts Payable		32,927			(350,064	)
Lease Liabilities		(79,641	)		-
Deferred Revenue		(2,686,000	)		577,208
Unbilled Revenue		-			(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		-			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		$	-
Conversion of Preferred Stock into Common Stock	$	-		$	36,637
Cancellation and Correction of Restricted Stock Par Value	$	17,819		$	-

	September 30, 2017 (unaudited)		September 30, 2016 (unaudited)		June 30, 2019 (unaudited)		June 30, 2018 (unaudited)
Common Stock Warrants		9,519,403		2,852,736		40,744,086		42,255,336
Employee Stock Options		1,858,300		1,533,311		2,777,416		2,106,035
Preferred Stock		400,000		545,000		12,787,500		12,787,500
Total Shares of Common Stock Issuable		11,777,703		4,931,047
Total Shares of Potential Common Stock Equivalents						56,309,002		57,148,871

	June 30, 2019		December 31, 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

	Estimated Useful Life (Years)	June 30, 2019 (unaudited)		December 31, 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

	June 30, 2019 (unaudited)		December 31, 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

	Estimated Useful Life (Years)	September 30, 2017		December 31, 2016
Laboratory Equipment	3	$	42,576	$	42,576
Less: Accumulated Depreciation			18,145		4,536
		$	24,431	$	38,040

	Estimated Useful Life (Years)	June 30, 2019 (unaudited)			December 31, 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

	Number of Awards			Weighted Average Exercise Price			Weighted Average Remaining Term in Years
Outstanding at December 31, 2016		2,852,736		$	7.45			4.26
Issued		6,666,667	¹		1.50	²		4.71
Outstanding at September 30, 2017		9,519,403		$	3.28			4.50

	Number of Warrants			Weighted Average Exercise Price		Weighted Average Remaining 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		3.55

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

	Number of Options			Weighted- Average Exercise Price		Weighted-Average Contractual Life (In Years)
Outstanding at December 31, 2016		1,509,711		$	2.85		5.04
Granted		482,950			1.44		9.60
Exercised		(61,078	)		0.67
Expired		(73,283	)		2.19
Outstanding at September 30, 2017		1,858,300		$	2.62		5.61
Exercisable at September 30, 2017		1,188,317		$	2.68		4.56
Vested and Expected to Vest at September 30, 2017		1,188,317		$	2.68		4.56

Outstanding at December 31, 2015		1,277,367		$	2.75		4.94
Granted		355,071			2.81		9.50
Exercised		(86,765	)		0.65
Forfeited		(12,362	)		3.93
Outstanding at September 30, 2016		1,533,311		$	2.91		6.44
Exercisable at September 30, 2016		907,445		$	2.84		4.09
Vested and Expected to Vest at September 30, 2016		907,445		$	2.84		4.09

	Number of Shares			Weighted- Average Grant Date Fair Value		Weighted- Average Remaining 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

	Three Months Ended September 30,				Nine Months Ended September 30,
	2017		2016		2017		2016
Research and Development	$	57,544	$	17,092	$	165,538	$	35,692
General and Administrative		131,148		135,973		535,295		354,777
	$	188,692	$	153,065	$	700,833	$	390,469

	Three Months Ended June 30,				Six Months Ended 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

	Operating Leases
Remainder of 2019	$	86,390
2020		27,682
Less: Imputed Interest		(4,560	)
Present Value of Lease Liabilities	$	109,512

	Three Months Ended September 30,									Three Months Ended June 30,
	2017			2016			Change			2019			2018			Change
Collaboration Revenue	$	74,696		$	274,289		$	(199,593	)	$	-		$	242,012		$	(242,012	)
Operating Expenses:
Research and Development		(3,175,978	)		(2,449,445	)		(726,533	)		763,896			1,837,799			(1,073,903	)
General and Administrative		(1,038,822	)		(1,201,804	)		162,982			1,105,904			1,202,531			(96,627	)
Total Operating Expenses		(4,214,800	)		(3,651,249	)		(563,551	)		1,869,800			3,040,330			(1,170,530	)
Other (Expense) Income, Net:		(264	)		298			(562	)
Other Income, Net											32,528			18,063			14,465
Net Loss	$	(4,140,368	)	$	(3,376,662	)	$	(763,706	)	$	(1,837,272	)	$	(2,780,255	)	$	942,983

	Total		Less than 1 year		1-3 years		More than 3 years		Total		Less than 1 year		1-3 years		More than 3 years
Leases (1)	$	374,496	$	180,751	$	193,745	$	-	$	114,073	$	114,073	$	-	$	-
Licensing Agreement (2)		257,500		52,500		105,000		100,000		342,500		47,500		90,000		205,000
Purchase Obligations (3)		1,223,772		1,223,772		-		-
Total (4)	$	1,855,768	$	1,457,023	$	298,745	$	100,000
Total (3)									$	456,573	$	161,573	$	90,000	$	205,000

(1)	Lease obligations reflect our obligation to make payments in connection with operating leases for our office ~~space and capital leases with respect to laboratory equipment.~~space.
(2)	Licensing Agreement obligations represent our commitments under license agreements, including those made by us under our license agreements with the University of Miami School of Medicine, the University of Utah Research Foundation and BioTime.
(3)	Purchase Obligations relate to a Master Service Agreement with a contract research organization (“CRO”). The CRO will provide clinical research services for Phase 3 trials in patients with non-infectious anterior segment uveitis.
~~(4)~~	This table does not include (a) anticipated expenditures under supply agreements for periods for which we are not yet bound under binding purchase orders, and (b) contracts that are entered into in the ordinary course of business that are not material in the aggregate in any period presented above.

Exhibit
Number		Description of Exhibit

31.1**		Certification of principal executive officer pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2**		Certification of principal financial and accounting officer pursuant to Rules 13a-15(e) and 15d-15(e), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**		Certification of principal executive officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

32.2**		Certification of principal financial and accounting officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

101.INS		XBRL Instance Document

101.SCH		XBRL Taxonomy Extension Schema Document

101.CAL		XBRL Taxonomy Extension Calculation Linkbase Document

101.DEF		XBRL Taxonomy Extension Definition Linkbase Document

101.LAB		XBRL Taxonomy Extension Labels Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document