(Former name, former address and former fiscal year, if changed since last report)

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. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). 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.

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. ☒

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

As of November ~~2, 2018,~~4, 2019, the registrant had ~~32,024,223~~41,149,781 shares of common stock, $0.001 par value per share, outstanding.

	September 30, 2018			December 31, 2017			September 30, 2019			December 31, 2018
Assets
Current assets:
Cash and cash equivalents	$	15,841		$	9,224		$	22,551		$	8,043
Short-term investments		49,101			28,416			—			32,835
Prepaid expenses		3,247			1,445			1,468			2,049
Other current assets		—			116			27			17
Total current assets		68,189			39,201			24,046			42,944
Property and equipment, net		778			885			655			790
Operating lease right-of-use asset								806			—
Restricted cash		360			360			360			360
Other assets		54			47			—			26
Total assets	$	69,381		$	40,493		$	25,867		$	44,120
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	11,910		$	5,384		$	1,429		$	6,869
Accrued liabilities		2,744			4,716			2,698			2,923
Current portion of long-term debt		—			3,200			5,833			556
Current portion of operating lease liabilities								483			—
Current portion of deferred rent		211			199			—			128
Other current liabilities		—			20			375			—
Total current liabilities		14,865			13,519			10,818			10,476
Long-term debt		9,911			4,809			4,329			9,419
Operating lease liabilities								961			—
Deferred rent		524			610			—			605
Deferred revenue		—			140
Total liabilities		25,300			19,078			16,108			20,500
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at September 30, 2018 and December 31, 2017		—			—
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2018 and December 31, 2017; 32,024,223 and 25,354,651 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively		32			25
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at September 30, 2019 and December 31, 2018								—			—
Common stock, $0.001 par value; 100,000,000 shares authorized at September 30, 2019 and December 31, 2018; 41,149,781 and 32,119,227 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively								41			32
Additional paid-in capital		229,293			145,618			244,279			230,475
Accumulated deficit		(185,240	)		(124,220	)		(234,561	)		(206,887	)
Accumulated other comprehensive loss		(4	)		(8	)
Total stockholders’ equity		44,081			21,415			9,759			23,620
Total liabilities and stockholders’ equity	$	69,381		$	40,493		$	25,867		$	44,120

	Three Months Ended September 30,						Nine Months Ended September 30,						Three Months Ended September 30,						Nine Months Ended September 30,
	2018			2017			2018			2017			2019			2018			2019			2018
License and collaboration revenue	$	—		$	155		$	—		$	290
Collaboration revenue													$	141		$	—		$	231		$	—
Operating expenses:
Research and development		20,083			16,050			50,805			35,118			2,728			20,083			14,353			50,805
General and administrative		3,873			2,298			10,508			7,259			3,781			3,873			13,169			10,508
Total operating expenses		23,956			18,348			61,313			42,377			6,509			23,956			27,522			61,313
Loss from operations		(23,956	)		(18,193	)		(61,313	)		(42,087	)		(6,368	)		(23,956	)		(27,291	)		(61,313	)
Other income (expense), net		84			(143	)		133			(395	)
Other (expense) income, net														(168	)		84			(383	)		133
Net loss	$	(23,872	)	$	(18,336	)	$	(61,180	)	$	(42,482	)	$	(6,536	)	$	(23,872	)	$	(27,674	)	$	(61,180	)
Net loss per share of common stock — basic and diluted	$	(0.75	)	$	(0.72	)	$	(2.02	)	$	(1.68	)	$	(0.17	)	$	(0.75	)	$	(0.75	)	$	(2.02	)
Weighted average shares outstanding — basic and diluted		32,024,223			25,338,462			30,292,909			25,299,910			38,414,751			32,024,223			36,747,314			30,292,909

Net loss	$	(23,872	)	$	(18,336	)	$	(61,180	)	$	(42,482	)
Unrealized (loss) gain on available-for-sale investments		(5	)		15			4			5
Comprehensive loss	$	(23,877	)	$	(18,321	)	$	(61,176	)	$	(42,477	)

	Three and Nine Months Ended September 30, 2019
										Total
	Common Stock				Additional		Accumulated			Stockholders'
	Shares		Amount		Paid-In-Capital		Deficit			Equity
Balance at December 31, 2018		32,119,227	$	32	$	230,475	$	(206,887	)	$	23,620
Issuance of common shares from at-the-market sales agreement		4,660,966		5		6,622		—			6,627
Exercise of stock options		2,727		—		1		—			1
Share-based compensation expense		—		—		1,247		—			1,247
Net loss		—		—		—		(15,404	)		(15,404	)
Balance at March 31, 2019		36,782,920		37		238,345		(222,291	)		16,091
Issuance of common shares from at-the-market sales agreement		945,974		1		1,272		—			1,273
Issuance of common shares under employee stock purchase plan		17,252		—		15		—			15
Share-based compensation expense		—		—		1,256		—			1,256
Net loss		—		—		—		(5,734	)		(5,734	)
Balance at June 30, 2019		37,746,146		38		240,888		(228,025	)		12,901
Issuance of common shares from at-the-market sales agreement		3,370,000		3		2,416		—			2,419
Exercise of stock options		13,635		—		5		—			5
Vesting of restricted stock units		20,000		—		—		—			—
Share-based compensation		—		—		970		—			970
Net loss		—		—		—		(6,536	)		(6,536	)
Balance at September 30, 2019		41,149,781	$	41	$	244,279	$	(234,561	)	$	9,759

	Three and Nine Months Ended September 30, 2018
										Accumulated
										Other				Total
	Common Stock				Additional		Accumulated			Comprehensive				Stockholders'
	Shares		Amount		Paid-In-Capital		Deficit			Loss				Equity
Balance at December 31, 2017		25,354,651	$	25	$	145,618	$	(124,220	)	$	(8	)		$	21,415
Cumulative effect of accounting change		—		—		—		151			8				159
Issuance of common shares from follow-on public offering		6,538,462		7		79,574		—			—				79,581
Exercise of stock options		53,920		—		237		—			—				237
Share-based compensation expense		—		—		1,138		—			—				1,138
Net loss		—		—		—		(16,607	)		—		��		(16,607	)
Balance at March 31, 2018		31,947,033		32		226,567		(140,676	)		—				85,923
Issuance of common shares under employee stock purchase plan		7,386		—		45		—			—				45
Exercise of stock options		69,804		—		196		—			—				196
Share-based compensation expense		—		—		1,199		—			—				1,199
Net loss		—		—		—		(20,701	)		—				(20,701	)
Balance at June 30, 2018		32,024,223		32		228,007		(161,377	)		—				66,662
Share-based compensation		—		—		1,286		—			—				1,286
Net loss		—		—		—		(23,872	)		—				(23,872	)
Balance at September 30, 2018		32,024,223	$	32	$	229,293	$	(185,249	)	$	—			$	44,076

	Nine Months Ended September 30,						Nine Months Ended September 30,
	2018			2017			2019			2018
Operating activities
Net loss	$	(61,180	)	$	(42,482	)	$	(27,674	)	$	(61,180	)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		141			135			160			141
Share-based compensation expense		3,623			2,420			3,473			3,623
Non-cash interest expense		107			159			141			107
Accretion of debt discount		95			158			46			95
Amortization and accretion on available-for-sale investments, net		(514	)		6			(115	)		(514	)
Changes in operating assets and liabilities:
Prepaid expenses and other current assets		(1,686	)		(125	)		571			(1,686	)
Other assets		(7	)		(61	)
Other assets and liabilities								306			(81	)
Accounts payable and accrued liabilities		4,554			3,694			(5,665	)		4,554
Deferred revenue		—			(15	)
Deferred rent		(74	)		121
Net cash used in operating activities		(54,941	)		(35,990	)		(28,757	)		(54,941	)
Investing activities
Maturities of available-for-sale investments								32,950			59,970
Purchase of available-for-sale investments		(80,137	)		(40,614	)		—			(80,137	)
Maturities of available-for-sale investments		59,970			53,082
Acquisition of property and equipment		(34	)		(306	)		(25	)		(34	)
Net cash (used in) provided by investing activities		(20,201	)		12,162
Net cash provided by (used in) investing activities								32,925			(20,201	)
Financing activities
Proceeds from at-the-market sales agreement, net of issuance costs								10,319			—
Proceeds from follow-on public offering, net of issuance costs		79,581			5,057			—			79,581
Proceeds from exercise of stock options		433			196			6			433
Proceeds from shares issued under employee stock purchase plan		45			40			15			45
Proceeds from long-term debt		10,000			—			—			10,000
Payments made on long-term debt		(8,300	)		—			—			(8,300	)
Net cash provided by financing activities		81,759			5,293			10,340			81,759
Net increase (decrease) in cash, cash equivalents and restricted cash		6,617			(18,535	)
Net increase in cash, cash equivalents and restricted cash								14,508			6,617
Cash, cash equivalents and restricted cash, beginning of period		9,584			35,184			8,403			9,584
Cash, cash equivalents and restricted cash, end of period	$	16,201		$	16,649		$	22,911		$	16,201
Supplemental schedule of noncash investing and financing activities
Tenant improvements paid by landlord	$	—		$	637

Clearside Biomedical, Inc. (the “Company”) is a ~~late-stage~~ clinical biopharmaceutical company developing first-in-class ~~drug~~pharmacological therapies to ~~treat blinding diseases of the eye.~~restore and preserve vision for people with serious eye diseases. The Company’s current product candidates focus on treatments for diseases affecting the retina and choroid and are injected into the suprachoroidal space (“SCS”) using its proprietary SCS ~~Microinjector, and focus on the treatment of diseases affecting the retina and choroid, especially diseases associated with macular edema.~~Microinjector™. Incorporated in the State of Delaware on May 26, 2011, the Company has its corporate headquarters in Alpharetta, Georgia.

The Company’s activities since inception have primarily consisted of developing product and technology rights, raising capital and performing research and development activities. The Company has no current source of revenue to sustain present activities and does not expect to generate meaningful revenue until and unless the Company receives regulatory approval of and successfully commercializes its product candidates. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts, regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals.

The Company has funded its operations primarily through the ~~proceeds of its public offerings of common stock,~~ sale of convertible preferred stock and common stock and the issuance of long-term debt. On ~~March 12, 2018,~~June 30, 2017, the Company ~~closed~~entered into an at-the-market sales agreement (“the ATM agreement”) with Cowen and Company LLC (“Cowen”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock having an aggregate offering price of up to $50.0 million through Cowen acting as sales agent. During the nine months ended September 30, 2019, the Company sold 9.0 million shares of its common stock for net proceeds of $10.3 million under the ATM agreement. The Company’s registration statement on Form S-3 contemplated under the ATM agreement was declared effective by the SEC on July 13, 2017. The registration statement on Form S-3 includes a ~~follow-on public~~prospectus supplement covering the offering ~~in which it sold 6,538,462~~up to $18.5 million of shares of common stock ~~at a public offering price of $13.00 per share, resulting~~over the 12 months ending March 15, 2020 in ~~net proceeds of $79.6 million after deducting underwriting discounts and commissions and estimated offering expenses.~~ accordance with the ATM agreement.

On ~~May 14, 2018,~~October 22, 2019, the Company entered into a ~~second amended and restated loan agreement, which provides for up to $20.0 million in term loans, of which~~License Agreement (the “License Agreement”) with Bausch Health Ireland Limited (“Bausch”). Under the License Agreement, the Company ~~borrowed~~has granted an exclusive license to Bausch for the commercialization and development of XIPERE^TM, the Company’s proprietary suspension of the corticosteroid triamcinolone acetonide formulated for administration to the back of the eye, in the United States and Canada. Under the License Agreement, the Company received an upfront payment of $5.0 million (see Note 13 Subsequent Events).

In connection with the entry by the Company into the License Agreement, on October 18, 2019, the Company entered into a Third Amendment to Second Amended and Restated Loan and Security Agreement (the “3^rd Amendment”) with Silicon Valley Bank (“SVB”). Pursuant to the 3^rd Amendment, the Company repaid $5.0 million of the outstanding principal balance of the $10.0 million ~~on May 14, 2018~~term loan. In addition, the Company agreed that if the Company’s cash and cash equivalents balance with SVB falls below $10.0 million, then the Company will transfer to a pledged account an amount of cash and cash equivalents equal to the sum of the then-outstanding principal balance of the term loan plus an amount for a final payment fee of $340,441 (see Note 5)5 Long-Term Debt).

The Company will ~~continue to~~ need to obtain additional ~~financing~~resources to fund future operations, including ~~completing the development and commercialization of its primary product candidates. The Company will also need to obtain additional financing~~ to conduct additional clinical trials ~~for the regulatory approval of its product candidates if requested by regulatory bodies,~~ and to complete the development of ~~any additional~~its product ~~candidates that might be acquired.~~candidates. If any such products were to receive regulatory approval, the Company ~~would~~may need to prepare for the potential commercialization of its product candidates, ~~and fund~~which could include additional collaborations with third parties for the commercial launch of the products, if the Company decides to commercialize the products on its own. Moreover, the Company’s fixed expenses such as rent and other contractual commitments are substantial and are expected to increase in the future.products.

The Company had cash and cash equivalents ~~and short-term investments~~ of ~~$64.9~~$22.6 million as of September 30, ~~2018.~~ 2019. The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can obtain approval from the U.S. Food and Drug Administration (the “FDA”) to market and then generate significant revenue from any of its product candidates. In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will ~~continue as it conducts~~continue. The Company will need additional resources to fund its ~~research~~operations and ~~development activities. Until the Company can generate a sufficient amount of revenue, the Company~~ may finance future cash needs through public or private equity offerings, license agreements, debt financings, collaborations, strategic alliances and marketing or distribution arrangements. The Company has incurred losses and negative cash flows since inception and expects operating losses and negative cash flows to continue into the foreseeable future. Absent raising additional funds, based

Based on ~~the Company’s~~its current license agreements, research and development plans ~~including~~and forecasted expenses, the ~~discontinuation of~~Company expects that its ~~clinical development program for combination therapy in retinal vein occlusion, planned reductions of certain administrative expenses and~~ ~~the Company’s timing expectations with respect to the submission of a New Drug Application (“NDA”) for its product candidate~~ ~~XIPERE for the treatment of patients with macular edema associated with non-infectious uveitis, the Company’s~~ existing cash and cash equivalents ~~and short-term investments, combined with anticipated available borrowing capacity under its debt facility~~ as of the filing date, November 8, ~~2018,~~2019, will ~~be sufficient~~enable it to fund its operating expenses and capital expenditure requirements into the third quarter of 2020. The Company’s ability to fund its operations into the ~~first~~third quarter of ~~2020.~~2020 gives effect to the potential restriction of cash pursuant to the Second Amended and Restated Loan and Security Agreement, as amended by the 3^rd Amendment. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date these financial statements are being issued. Accordingly, the Company has plans to mitigate its going concern risk by raising additional capital, potentially in a combination of equity or debt financings, license agreements or by potentially entering into additional collaborations, partnering and other strategic arrangements. The Company has based this estimate on assumptions that may prove to be wrong, and the Company could exhaust its capital resources sooner than it expects.

The Company’s financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern.

The Company’s financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”).

The accompanying balance sheet as of September 30, ~~2018,~~2019, statements of operations ~~and comprehensive loss~~ for the three and nine months ended September 30, 2019 and 2018, statements of stockholders’ equity for the three and ~~2017~~nine months ended September 30, 2019 and 2018 and statements of cash flows for the nine months ended September 30, ~~2018~~2019 and ~~2017~~2018 are unaudited. The unaudited interim financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include normal recurring adjustments, necessary for the fair presentation of the Company’s financial position as of September 30, ~~2018 and~~2019, its results of its operations for the three and nine months ended September 30, 2019 and 2018, its changes in stockholders’ equity for the three and ~~2017~~nine months ended September 30, 2019 and 2018 and its cash flows for the nine months ended September 30, ~~2018~~2019 and ~~2017.~~2018. The financial data and other information disclosed in these notes related to the three and nine months ended September 30, ~~2018~~2019 and ~~2017~~2018 are unaudited. The results for the ~~three and~~ nine months ended September 30, ~~2018~~2019 are not indicative of results to be expected for the year ending December 31, ~~2018,~~2019, any other interim periods or any future year or period. These unaudited financial statements should be read in conjunction with the audited financial statements and related footnotes, which are included in the Company’s Annual Report on Form 10-K for the year ended December 31, ~~2017.~~2018.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include the accounting for useful lives to calculate depreciation and amortization, clinical ~~trial estimates and related accrued liabilities,~~expense accruals, share-based compensation expense and income tax valuation allowance. Actual results could differ from these estimates.

Research and development costs are charged to expense as incurred and ~~include, but are not limited to:~~include:

Costs for certain development activities, such as clinical trials, are recognized based on an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations, or information provided to the Company by its vendors on their actual costs incurred. Payments for these activities are based on the terms of the individual arrangements, which may differ from the patterns of costs incurred, and are reflected in the financial statements as prepaid or accrued expense. ~~No material adjustments to these estimates have been recorded in these financial statements.~~

Compensation cost related to share-based awards granted to employees is measured based on the estimated fair value of the award at the grant date. The Company estimates the fair value of stock options using a Black-Scholes option pricing model. Compensation expense for options granted to non-employees is determined as the fair value of consideration received or the fair value of the equity instruments issued, whichever is more reliably measured. The fair value of ~~awards~~restricted stock units granted ~~to non-employees~~ is ~~re-measured each period until~~measured based on the ~~related service is complete.~~market value of the Company’s common stock on the date of grant. Share-based compensation costs are expensed on a straight-line basis over the relevant vesting period.

Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six-month withholding period prior to the purchase date.

All share-based compensation costs are recorded in general and administrative or research and development costs in the statements of operations ~~and comprehensive loss~~ based upon the underlying employees’ roles within the Company.

Cash equivalents consist of short-term, highly liquid investments with an original term of three months or less at the date of purchase.

Short-term investments are investments with original maturities of between 90 and 365 days when purchased and are comprised of commercial paper and treasury bills. The Company classifies its short-term investments as available-for-sale securities. Short-term investments are recorded at fair value and unrealized gains and losses are recorded within ~~accumulated other comprehensive income (loss) until realized.~~interest income. In addition, the Company evaluates the short-investments with unrealized losses to determine whether such losses are other-than-temporary.

Concentration of Credit Risk Arising From Cash Deposits in Excess of Insured Limits

The Company maintains its cash in bank deposits that at times may exceed federally insured limits. The Company has not experienced any loss in such accounts. The Company believes it is not exposed to any significant risks with respect to its cash balances.

In ~~May 2014,~~February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, Leases (ASC 842), and subsequently issued updates as part of ASU ~~2014-09,~~2018-11, ~~Revenue from Contracts with Customers~~Leases, Targeted Improvements. ~~Under ASU 2014-09, companies are required~~The new guidance requires organizations that lease assets with lease terms of more than 12 months to recognize ~~revenue to depict~~assets and liabilities for the ~~transfer of goods or services to customers in amounts that reflect the consideration (that is, payment) to which the company expects to be entitled in exchange for~~rights and obligations created by those goods or services. The new standard also results in enhanced disclosures about revenue, provide guidance for transactions that were not previously addressed comprehensively (for example, service revenue and contract modifications) and modifies guidance for multiple-element arrangements.

leases on their balance sheets. The Company adopted the ~~standard~~ASC 842 effective January 1, ~~2018~~2019 using the ~~modified retrospective~~optional transition ~~method. After evaluating its current~~method, did not restate any prior periods and ~~prior license agreements, as well as its other collaboration agreements,~~adopted the package of practical expedients. Under the package of practical expedients permitted by the new standard, the Company ~~recorded~~does not have to reassess whether any expired contracts are or contain leases, the ~~remaining $160,000~~classification of ~~deferred revenue under those agreements as a cumulative adjustment to accumulated deficit.~~leases or whether initial direct costs should be capitalized. The adoption of the new standard resulted in the recognition of a right-of use asset of $1.0 million and lease obligations of $1.7 million on the Company’s balance sheet as of January 1, 2019. The adoption did not have a material impact on the Company’s ~~financial statements and related disclosures.~~

~~In August 2016,~~ ~~the FASB~~ ~~issued ASU 2016-15,~~ ~~Statement of Cash Flows Classification of Certain Cash Receipts and Cash Payments~~. The update addresses eight specific cash flow matters with the objective of reducing diversity in practice in how certain cash receipts and payments are classified in the statement of cash flows. The update is effective for annual periods beginning after December 15, 2017, and interim periods within the period. The Company adopted the standard effective January 1, 2018, and the adoption did not have a material impact on its financial statements and related disclosures.

~~In November 2016, the FASB issued ASU 2016-18,~~ ~~Restricted Cash,~~ which addresses diversity in practice in the classification and presentation of a change in restricted cash on the statement of cash flows. The amendments in this update require that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. The Company adopted the standard effective January 1, 2018, resulting in a change to the presentation of restricted cash on the statements of operations or cash flows.

Contents~~In May 2017, the FASB issued ASU 2017-9, Compensation-Stock Compensation: Scope of Stock Compensation Modification Accounting~~. The ASU was issued to provide clarity and reduce both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation—Stock Compensation, to a change to the terms or conditions of a share-based payment award. The amendments in this update provide guidance about which changes to the terms or conditions of a share-based

payment award require an entity to apply modification accounting in Topic 718. The update is effective for annual periods beginning after December 15, 2017, and interim periods thereafter. The Company adopted ASU 2017-9 effective January 1, 2018, and the impact on its ~~financial statements and related disclosure would depend on any future modifications to its share-based awards.~~

~~In February 2016, the FASB issued ASU 2016-02,~~ ~~Leases (ASC 842),~~ which requires lessees to recognize most leases on the balance sheet. This is expected to increase both reported assets and liabilities. For public companies, the standard will be effective for the first interim reporting period within annual periods beginning after December 15, 2018, although early adoption is permitted. Lessees and lessors will be required to apply the new standard at the beginning of the earliest period presented in the financial statements in which they first apply the new guidance, using a modified retrospective transition method. The requirements of this standard include a significant increase in required disclosures. The Company is currently assessing the impact that adopting this new accounting standard will have on its financial statements and related disclosures.

In June 2018, the FASB issued ASU ~~No.~~ 2018-07, Compensation-Stock Compensation: Improvements to Nonemployee Shared-Based Payment Accounting. The ASU update expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. ~~The new standard is effective for fiscal years and interim periods beginning after December 15, 2018. Early adoption is permitted, but no earlier than an entity’s adoption date of ASU 2014-09,~~ ~~Revenue from Contracts with Customers~~. The Company ~~is currently assessing~~adopted ASU 2018-07 effective January 1, 2019, and the adoption did not have a material impact ~~that adopting this new accounting standard will have~~ on its financial statements and related disclosures.

Property and equipment, net consisted of the following (dollar amounts in thousands):

	Estimated Useful Lives (Years)	September 30, 2018			December 31, 2017			Estimated Useful Lives (Years)	September 30, 2019			December 31, 2018
Furniture and fixtures	5	$	338		$	303		5	$	400		$	382
Machinery and equipment	5		121			121		5		121			121
Computer equipment	3		32			41		3		19			19
Leasehold improvements	Lesser of useful life or remaining lease term		667			667		Lesser of useful life or remaining lease term		684			677
			1,158			1,132				1,224			1,199
Less: Accumulated depreciation			(380	)		(247	)			(569	)		(409	)
		$	778		$	885			$	655		$	790

	September 30,		December 31,		September 30,		December 31,
	2018		2017		2019		2018
Accrued research and development	$	1,109	$	3,360	$	403	$	1,263
Accrued bonuses		875		920
Accrued employee costs						1,950		1,191
Accrued marketing						31		47
Accrued professional fees		40		62		178		63
Accrued vacation		118		113
Accrued interest payable		72		58		—		76
Accrued expense		530		203		136		283
	$	2,744	$	4,716	$	2,698	$	2,923

In September 2016, the Company entered into an amended and restated loan and security agreement, which was subsequently amended on October 31, 2017 (as amended, the “1^st A&R loan agreement”) with ~~Silicon Valley Bank (“SVB”),~~SVB, MidCap Funding XII Trust and MidCap Financial Trust, which amended and restated in its entirety the Company’s prior loan and security agreement. The 1^st A&R loan agreement provided for new term loans of up to $15.0 million, with a floating interest rate equal to 7% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, or (ii) 0.50%.

Under the terms of the 1^st A&R loan agreement, an initial tranche of $8.0 million was advanced on September 28, 2016. The draw period for the remaining $7.0 million available under the 1^st A&R loan agreement expired on March 31, 2018. The Company was required to pay accrued interest only on the outstanding $8.0 million balance through December 31, 2017, followed by 30 equal payments of principal and accrued interest. The Company had the option to prepay the outstanding balance of the term loans in full, subject to a prepayment fee of 2% of the original principal amount of the aggregate term loans for any prepayments through May 31, 2020. A final payment of $0.5 million was due at maturity of the loan on June 1, 2020, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default, and was being accreted in long-term debt over the life of the loan. Of the $8.0 million borrowed, $5.3 million was used to repay all amounts outstanding under the ~~prior~~original loan agreement.

Closing costs incurred in the refinancing portion of the loan were recorded as expense while the financing costs for the new portion of the loan are recorded in long-term debt and being accreted over the life of the loan. Upon repayment of the original loan agreement, all remaining closing costs associated with the original loan agreement were being accreted to long-term debt over the life of the 1^st A&R loan agreement.

On May 14, 2018, the Company entered into a second amended and restated loan and security agreement (the “2^nd A&R Loan Agreement”) with SVB, MidCap Funding III Trust and MidCap Financial Trust (together, “MidCap” and collectively with SVB, the “Lenders”), which amended and restated in its entirety the 1^st A&R loan agreement. The 2^nd A&R Loan Agreement ~~provides~~provided for new term loans of up to $20.0 million, with a floating interest rate equal to 6.50% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month ~~the~~that immediately precedes the month in which the interest will accrue, or (ii) 1.89%. The 2^nd A&R Loan Agreement includes, among other things, the ability of the Lenders to accelerate the payment of the term loan in the event of material adverse change and restrictions on the Company’s ability to sell, assign, license, transfer or otherwise dispose of its assets, including intellectual property assets, without the prior written consent of the Lenders.

The Company borrowed an initial tranche of $10.0 million on May 14, 2018, of which $7.0 million was used to repay all amounts outstanding under the 1^st A&R loan agreement, including fees associated with the final payment. The prepayment fees were waived. Of the remaining $10.0 million ~~available~~ under the 2^nd A&R Loan Agreement, $5.0 million ~~is no longer~~became available for draw asbut was not drawn by the ~~SAPPHIRE clinical trial did not meet its primary endpoint. The~~Company, and the other $5.0 million ~~(the “Term C Loan”) will become~~is not available ~~when the Lenders have received evidence, in form and substance reasonably satisfactory to them, that the U.S. Food and Drug Administration (the “FDA”) has accepted the Company’s NDA~~ for ~~its product candidate~~ draw.~~XIPERE~~ ~~for the treatment~~

As of ~~patients with macular edema associated with non-infectious uveitis. Once the draw period for the Term C Loan has commenced,~~September 30, 2019, the Company ~~may draw funds at its discretion until the earlier of (i) March 31, 2019 and (ii) the occurrence of an event of default.~~ ~~The Company is~~was required to pay accrued interest only on ~~all amounts outstanding~~the $10 million borrowed under the 2^ndn^d A&R Loan Agreement through October 31, 2019, ~~(or if the Term C Loan is made during the applicable draw period, through December 31, 2019),~~ followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. The Company ~~has~~had the option to prepay the outstanding balance ~~of the term loans~~ in full, subject to a prepayment fee of ~~3% of the original principal amount of each term loan for any prepayment prior the first anniversary of the date such term loan is funded or~~ 2% of the original principal amount ~~of each term loan~~ for any prepayment ~~on or after the first anniversary of the date such term loan is funded but~~ prior to October 1, 2022. A final payment of 5.50% of the aggregate borrowed amount iswas due at maturity of the loan on October 1, 2022, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default.

The ~~Company accounted for the 2~~^nd ~~A&R Loan Agreement as a modification in accordance with the guidance in ASC 470-50,~~ ~~Debt~~. Amounts paid to lenders and closing costs incurred in the refinancing portion of the loan were recorded as expense while the financing costs for the new portion of the loan, which consists of the final payment, are being accreted over the life of the loan and recorded in long-term debt. Upon repayment of the 1^st ~~A&R loan agreement, all remaining closing costs associated with the 1~~^st ~~A&R loan agreement are being accreted to long-term debt over the life of the 2~~^nd ~~A&R Loan Agreement.~~

~~The term loans~~borrowings under the 2^nd A&R Loan Agreement are secured by substantially all of the Company’s ~~assets, except that~~assets.

On October 18, 2019, the ~~collateral does not include any~~Company entered into the 3^rd Amendment with the Lenders. Pursuant to the 3^rd Amendment, the Company repaid $5.0 million of the outstanding principal balance of the $10.0 million term loan. The Company did not pay any final payment or termination fees in connection with the $5.0 million prepayment. In addition, the Company and the Lenders agreed to modify the term loan repayment schedule. As amended, the term loan repayment schedule provides for interest only payments through April 30, 2020, or if the Company completes a specified financial milestone, October 31, 2020, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. In addition, the Company agreed that if the Company’s ~~intellectual property. However, pursuant~~cash and cash equivalents balance with SVB falls below $10.0 million, the Company will transfer to a pledged account an amount of cash and cash equivalents equal to the ~~terms~~sum of the then-outstanding principal balance of the term loan plus a ~~negative pledge arrangement,~~final payment fee of $340,441. As a result of the 3^rd Amendment, as of September 30, 2019, the Company has ~~agreed not~~reflected in current liabilities the amount of principal it expects to ~~encumber any of its intellectual property.~~pay within the next 12 months.

Interest expense on the borrowings under the loan agreements described above was ~~$220,000~~$223,000 and ~~$168,000~~$220,000 for the three months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively, and ~~$566,000~~$676,000 and ~~$486,000~~$566,000 for the nine months ended September 30, 2019 and 2018, ~~and~~

~~2017,~~ respectively. Accretion of the scheduled final payment was $47,000 ~~and $53,000~~ for each of the three months ended September 30, 2019 and 2018, and ~~2017, respectively,~~$141,000 and $107,000 ~~and $159,000~~ for the nine months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively. Accretion of the deferred debt issuance costs was $16,000 ~~and $53,000~~ for each of the three months ended September 30, 2019 and 2018, and ~~2017, respectively,~~$47,000 and $95,000 ~~and $158,000~~ for the nine months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively.

As of September 30, ~~2018,~~2019, the scheduled payments for the 2^nd2nd A&R Loan Agreement, ~~including~~as amended, and the scheduled final payment in 2022, were as follows (in thousands):

Year Ending December 31,	Principal		Interest and Final Payment		Total		Principal		Interest and Final Payment		Total
2018	$	—	$	214	$	214
2019		556		845		1,401	$	5,000	$	107	$	5,107
2020		3,333		651		3,984		1,333		392		1,725
2021		3,333		365		3,698		2,000		234		2,234
2022		2,778		638		3,416		1,667		405		2,072
	$	10,000	$	2,713	$	12,713	$	10,000	$	1,138	$	11,138

The Company’s amended and restated certificate of incorporation authorizes the Company to issue 100,000,000 shares of $0.001 par value common stock. As of September 30, ~~2018~~2019 and December 31, ~~2017,~~2018, there were ~~32,024,223~~41,149,781 and ~~25,354,651~~32,119,227 shares of common stock outstanding, respectively.

In September 2016, in connection with the 1^st A&R loan agreement (see Note 5)5 Long-Term Debt), the Company issued warrants ~~to the Lenders~~ to purchase up to 29,796 shares of common stock at a price per share of $10.74. The warrants expire in September 2026, or earlier upon the occurrence of specified mergers or acquisitions of the Company, and are immediately exercisable. The warrants were recorded in equity and had a weighted average remaining life of ~~8.0~~7.00 years as of September 30, ~~2018.~~2019.

Share-based compensation is accounted for in accordance with the provisions of ASC 718, Compensation-Stock Compensation.

The Company has granted stock option awards to employees, directors and consultants from its 2011 Stock Incentive Plan (the “2011 Plan”) and its 2016 Equity Incentive Plan (the “2016 Plan”). The estimated fair value of options granted is determined as of the date of grant using the Black-Scholes option pricing model. The resulting fair value is recognized ratably over the requisite service period, which is generally the vesting period of the awards. ~~Options granted to non-employees are re-measured at each financial reporting period until required services are performed.~~

Share-based compensation expense for options granted under the 2011 Plan and the 2016 Plan is reflected in the statements of operations ~~and comprehensive loss~~ as follows (in thousands):

	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended September 30,				Nine Months Ended September 30,
	2018		2017		2018		2017		2019		2018		2019		2018
Research and development	$	491	$	345	$	1,405	$	1,002	$	243	$	491	$	1,066	$	1,365
General and administrative		791		539		2,206		1,395		543		791		2,166		2,246
Total	$	1,282	$	884	$	3,611	$	2,397	$	786	$	1,282	$	3,232	$	3,611

The following table summarizes the activity related to stock options during the nine months ended September 30, ~~2018:~~2019:

Weighted

Number of

Average

Shares

Exercise Price

Options outstanding at January 1, 2018

3,075,349

$
6.17

Granted

679,500

8.32

Exercised

(123,724
)

3.51

Forfeited

(64,875
)

8.72

Options outstanding at September 30, 2018

3,566,250

6.62

Options exercisable at December 31, 2017

1,114,286

3.94

Options exercisable at September 30, 2018

1,393,998

5.15

				Weighted
	Number of			Average
	Shares			Exercise Price
Options outstanding at December 31, 2018		3,463,096		$	6.62
Granted		1,892,600			1.26
Exercised		(16,362	)		0.40
Forfeited		(1,146,450	)		5.00
Options outstanding at September 30, 2019		4,192,884			4.67

Options exercisable at December 31, 2018		1,583,749			5.63

Options exercisable at September 30, 2019		2,204,649			5.61

As of September 30, ~~2018,~~2019, the Company had ~~$12.0~~$5.0 million of unrecognized compensation expense related to unvested stock options, which is expected to be recognized over a weighted average period of ~~2.8~~2.4 years.

The Company has granted restricted stock units (“RSUs”) to employees from the 2016 Plan. The shares underlying the RSU awards have vesting terms of eight months to two years from the date of grant subject to the employees’ continuous service and subject to accelerated vesting in specified circumstances.

The fair value of the RSUs granted is measured based on the market value of the Company’s common stock on the date of grant and is recognized ratably over the requisite service period, which is generally the vesting period of the awards.

The following table summarizes the activity related to RSUs during the nine months ended September 30, 2019:

The Company recorded $45,000 and $0.2 million of share-based compensation expense for the three and nine months ended September 30, 2019, respectively, for the RSUs. As of September 30, 2019, the Company had $1.0 million of unrecognized compensation expense related to the RSUs, which is expected to be recognized over a weighted average period of 1.4 years.

In January 2016, the Company’s board of directors adopted and approved, and in January 2016 the Company’s stockholders approved, the Clearside Biomedical, Inc. 2016 Employee Stock Purchase Plan (the “2016 ESPP”) which became effective on June 1, 2016. The first offering period for the 2016 ESPP commenced January 1, 2017. The 2016 ESPP is considered a compensatory plan and the fair value of the discount and the look-back period are estimated using the Black-Scholes option pricing model and expense is recognized over the six month withholding period prior to the purchase date. The Company has issued a total of ~~17,078~~39,539 shares of common stock purchased under the 2016 ESPP. The Company has recorded ~~$4,000~~$2,000 and ~~$5,000~~$4,000 of share-based compensation expense for the three months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively, and ~~$12,000~~$15,000 and ~~$23,000~~$12,000 for the nine months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively, in the statements of operations ~~and comprehensive loss~~ for the estimated number of shares to be purchased on the next purchase date following the conclusion of the applicable reporting period.

In November 2016, the Company signed an office lease agreement to lease approximately 20,000 square feet of office space in Alpharetta, Georgia for its corporate headquarters. The lease agreement is for a 6.5 year term with a renewal option for one additional five-year term. Rental payments are $35,145 per month subject to an increase of 3% per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. In addition, the lease agreement requires payment of the pro-rata share of the annual operating expenses associated with the premises. The Company relocated to this ~~new~~ space in March 2017.

In August 2018, the Company signed an office lease agreement to lease approximately 3,500 square feet of office space in Berkeley, California for its commercial operations. The lease agreement is for a two-year term with a renewal option for an additional one-year term. The Company has determined that it will not exercise the renewal option for the Berkeley lease. Rental payments are $12,775 per month subject to a 3% increase per year. Rent expense under this lease is recognized on a straight-line basis over the term of the lease. The Company will pay a pro-rata share of the annual operating expenses associated with the premises.

The Company’s operating leases included on the balance sheet are as follows (in thousands):

The Company recognizes a right-of-use asset for the right to use the underlying asset for the lease term, and a lease liability, which represents the present value of the Company’s obligation to make payments over the lease term. The renewal option is not included in the calculation of the right-of-use asset and the lease liabilities as the Company has not yet determined if the Alpharetta, Georgia lease will be renewed. The present value of the lease payments is calculated using an incremental borrowing rate as the Company’s leases do not provide an implicit interest rate. At September 30, 2019, the Company’s weighted average discount rate was 5.3% and the weighted average lease term was 2.4 years.

Total future undiscounted minimum lease payments were as follows at September 30, ~~2018~~2019 (in thousands):

Year Ending December 31,
2018	$	147
2019		600	$	157
2020		550		574
2021		472		496
Thereafter		860
2022				511
2023				393
Total minimum lease payments	$	2,629	$	2,131

Equipment leases with an initial term of 12 months or less are not recorded with operating lease liabilities. The Company recognizes expense for these on a straight-line basis over the lease term. The equipment leases were deemed to be immaterial.

Rent expense was ~~$79,000~~$100,000 and ~~$58,000~~$79,000 for the three months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively, and ~~$195,000~~$300,000 and ~~$156,000~~$195,000 for the nine months ended September 30, 2019 and 2018, ~~and 2017,~~ respectively. Cash payments included in operating activities on the statement of cash flows for operating lease liabilities were $386,000 for the nine months ended September 30, 2019.

In the course of the Company’s normal business operations, it has agreements with contract service providers to assist in the performance of its research and development, clinical research and manufacturing. Substantially all of these contracts are on an as needed basis.

In August 2014, the Company entered into a royalty-bearing license agreement with NovaMedica LLC (“NovaMedica”). Under this agreement, the Company granted to NovaMedica the right to use the Company’s intellectual property to develop and commercialize the intended products (the “Covered Products”) and to have the exclusive right to sell those products in Russia and specified adjacent territories involving the use of the corticosteroid triamcinolone acetonide as the sole active pharmaceutical ingredient for administration in the SCS. In connection with this royalty-bearing license, NovaMedica made an upfront payment to the Company of $200,000. The Company is currently developing product candidates that, when completed, would be subject to this license giving NovaMedica the exclusive right to then sell the products in the specified geographic territories. In mid-December 2015, the Company received positive results from the Phase 2 clinical trial relating to the product candidate and determined, based on these results, that the intellectual property could become commercially feasible. Beginning in the first quarter of 2016, the Company began recognizing the $200,000 to revenue over the period of time estimated to complete clinical development and commercialization of the Covered Products and the beginning of the first set of patent expirations in 2027. On January 1, 2018, upon the adoption of ASU 2014-09, the Company accelerated the recognition of the deferred revenue and recorded the remaining balance of $160,000 as a cumulative adjustment to accumulated deficit. The Company recorded $5,000 and $15,000 of license revenue during the three and nine months ended September 30, 2017, respectively, from this license agreement. NovaMedica is jointly owned by Rusnano MedInvest LLC and Domain Russia Investments Limited.

The Company has periodically entered into other short-term collaboration agreements, generally with performance obligations of one to two months, to evaluate the potential use of its proprietary SCS Microinjector with third-party product candidates for the treatment of various diseases. Funds received from these collaboration agreements are recognized as revenue over the term of the agreement. The Company recorded ~~$150,000~~$141,000 and ~~$275,000~~$231,000 of revenue from these collaboration agreements during the three and nine months ended September 30, ~~2017,~~2019, respectively. In addition, the Company recorded $0.4 million of deferred revenue in other current liabilities from these collaboration agreements as of September 30, 2019.

~~The following table summarizes the Company’s available-for-sale investments (in thousands):~~

The Company records certain financial assets and liabilities at fair value in accordance with the provisions of ASC Topic 820, Fair Value Measurements and Disclosures, on fair value measurements. As defined in the guidance, fair value, defined as an exit price, represents the amount that would be received to sell an asset or pay to transfer a liability in an orderly transaction between market participants. As a result, fair value is a market-based approach that should be determined based on assumptions that market

participants would use in pricing an asset or a liability. As a basis for considering these assumptions, the guidance defines a three-tier value hierarchy that prioritizes the inputs used in the valuation methodologies in measuring fair value.

The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value.

The Company’s material financial instruments at September 30, ~~2018~~2019 and December 31, ~~2017~~2018 consisted primarily of cash and cash equivalents, short-term investments and long-term debt. The fair ~~value~~values of cash and cash equivalents, ~~government bonds,~~ other current assets and accounts payable approximate their respective carrying values due to the short term nature of these instruments and are classified as Level 1 in the fair value hierarchy. The fair value of long-term debt approximates the carrying value due to variable interest rates that correspond to market ~~rates.~~rates and is classified as Level 1 in the fair value hierarchy. The Company has determined its short-term investments, comprised of commercial paper, ~~certificates of deposit, and corporate bonds,~~ to be Level 2 in the fair value hierarchy. The fair value was determined using a market approach, based on prices and other relevant information generated by market transactions involving similar assets. The short-term investments consist of investments with original maturity dates from date of acquisition of 90 to 365 days and are classified as available-for-sale.

There were no significant transfers between Levels 1, 2 and 3 during the nine months ended September 30, ~~2018~~2019 and the year ended December 31, ~~2017.~~2018.

The following tables summarize the fair value of financial assets that are measured at fair value and the classification by level of input within the fair value hierarchy (in thousands):

	September 30, 2018								September 30, 2019
	Level 1		Level 2		Level 3		Recorded Value		Level 1		Level 2		Level 3		Recorded Value
Financial Assets:
Cash and money markets	$	15,841	$	—	$	—	$	15,841	$	22,551	$	—	$	—	$	22,551
Restricted cash money market		360		—		—		360		360		—		—		360
Treasury bills		11,941		—		—		11,941
Commercial paper		—		37,160		—		37,160
Total financial assets	$	28,142	$	37,160	$	—	$	65,302	$	22,911	$	—	$	—	$	22,911

	December 31, 2017								December 31, 2018
	Level 1		Level 2		Level 3		Recorded Value		Level 1		Level 2		Level 3		Recorded Value
Financial Assets:
Cash and money markets	$	9,224	$	—	$	—	$	9,224	$	8,042	$	—	$	—	$	8,042
Restricted cash money market		360		—		—		360		360		—		—		360
Government bonds		11,238		—		—		11,238
Certificates of deposit		—		1,960		—		1,960
Corporate bonds		—		5,064		—		5,064
Treasury bills										7,490		—		—		7,490
Commercial paper		—		10,154		—		10,154		—		25,346		—		25,346
Total financial assets	$	20,822	$	17,178	$	—	$	38,000	$	15,892	$	25,346	$	—	$	41,238

Basic net loss per share is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period, without consideration of the dilutive effect of potential common stock equivalents. Diluted net loss per share gives effect to all dilutive potential shares of common stock outstanding during this period. For all periods presented, the Company’s potential common stock equivalents, which included stock options and stock purchase warrants, have been excluded from the computation of diluted net loss per share as their inclusion would have the effect of reducing the net loss per share. Therefore, the denominator used to calculate both basic and diluted net loss per share is the same in all periods presented. The Company’s potential common stock equivalents that have been excluded from the computation of diluted net loss per share for all periods presented because of their antidilutive effect consisted of the following:

	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended September 30,				Nine Months Ended September 30,
	2018		2017		2018		2017		2019		2018		2019		2018
Outstanding stock options		3,566,250		2,274,290		3,566,250		2,274,290		4,192,884		3,220,500		4,192,884		3,220,500
Non-vested restricted stock units										1,319,300		—		1,319,300		—
Stock purchase warrants		29,796		29,796		29,796		29,796		29,796		29,796		29,796		29,796
		3,596,046		2,304,086		3,596,046		2,304,086		5,541,980		3,250,296		5,541,980		3,250,296

On October 22, 2019, the Company entered into the License Agreement with Bausch. Pursuant to the License Agreement, the Company has granted an exclusive license to Bausch to develop, manufacture, distribute, promote, market and commercialize XIPERE using the Company’s proprietary microneedle (the “Device”), as well as specified other steroids, corticosteroids and NSAIDs in combination with the Device (“Other Products”), subject to specified exceptions, in the United States and Canada for the treatment of ophthalmology indications, including non-infectious uveitis.

Pursuant to the License Agreement, Bausch made an upfront payment of $5.0 million, which is subject to a refund if the License Agreement is terminated in specified circumstances. In addition, Bausch has agreed to make additional payments of up to $15.0 million upon the achievement of specified pre-launch development and regulatory milestones and up to an aggregate of $56.0 million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specified additional indications of XIPERE and (ii) specified levels of annual net sales (as defined in the License Agreement). Further, during the applicable royalty term, the Company will also be entitled to receive tiered royalties at increasing percentages, from the high-teens to twenty percent, based on the achievement of certain annual net sales thresholds in the United States and Canada, as well as a lower royalty on annual net sales of Other Products, in each case subject to reductions in specified circumstances; provided that the Company will not receive any royalties on the first $30.0 million of cumulative net sales of all products.

The Company is responsible for all development expenses for XIPERE until the Company’s New Drug Application (“NDA”) for XIPERE is approved by the FDA, subject to specified exceptions, as well as manufacturing costs in connection with the NDA. The Company is also responsible for all clinical and development expenses conducted to satisfy the FDA’s requests in the complete response letter issued on October 18, 2019 related to the NDA and any subsequent complete response letter related to the NDA (the “CRL-related expenses”). If XIPERE is approved by the FDA, Bausch will be responsible for all expenses following such approval; provided that the Company will be responsible for the CRL-related expenses and for one-half of the costs of any post-approval clinical trials required by the FDA, up to a specified maximum amount.

On October 18, 2019, the Company entered into a 3^rd Amendment with its Lenders. Pursuant to the 3^rd Amendment, among other things, the Company repaid $5.0 million of the outstanding principal balance of its $10.0 million term loan on October 18, 2019. In addition, the Company agreed that if the Company’s cash and cash equivalents balance with SVB falls below $10.0 million, then the Company will transfer to a pledged account an amount of cash and cash equivalents equal to the sum of the then-outstanding principal balance of the term loan plus an amount for a final payment fee of $340,441 (see Note 5 Long-Term Debt).

On October 18, 2019, the Company entered into a Consent and Fourth Amendment to the 2^nd A&R Loan Agreement (the “4^th Amendment”) with SVB. Pursuant to the 4^th Amendment, among other things, SVB consented to the Company’s entry into the License Agreement.

On August 29, 2019, the Company entered into an option and license agreement with REGENXBIO, Inc. (“REGENXBIO”) pursuant to which the Company granted REGENXBIO an exclusive option to enter into a commercial license agreement (the “Option”) granting REGENXBIO an exclusive, worldwide and sublicensable license to the Company’s SCS Microinjector for the delivery of adeno-associated virus-based gene therapies for the treatment of wet age-related macular degeneration, diabetic retinopathy and other conditions for which anti-vascular endothelial growth factor treatment is currently the standard of care. REGENXBIO exercised the Option on October 29, 2019 and has agreed to pay the Company an option fee equal to $2.0 million, less a credit of $0.5 million previously received under a technology access agreement, within 30 days. In addition, REGENXBIO has agreed to pay the Company up to an aggregate of $34.0 million in milestone payments upon the achievement of specified development milestones and up to an aggregate of $102.0 million in sales-based milestone payments, as well as mid-single digit royalties on net sales of products using the SCS Microinjector during the royalty term.

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

Certain statements contained in this Quarterly Report on Form 10-Q may constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The words or phrases “would be,” “will allow,” “intends to,” “will likely result,” “are expected to,” “will continue,” “is anticipated,” “estimate,” “project,” or similar expressions, or the negative of such words or phrases, are intended to identify “forward-looking statements.” We have based these forward-looking statements on our current expectations and projections about future events. Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to these differences include those below and elsewhere in this Quarterly Report on Form 10-Q ~~particularly in Part II – Item 1A, “Risk Factors,”~~ and our other filings with the Securities and Exchange Commission, or ~~SEC.~~SEC, particularly in Part II – Item 1A, “Risk Factors”. Statements made herein are as of the date of the filing of this Form 10-Q with the SEC and should not be relied upon as of any subsequent date. Unless otherwise required by applicable law, we do not undertake, and we specifically disclaim, any obligation to update any forward-looking statements to reflect occurrences, developments, unanticipated events or circumstances after the date of such statement.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited financial statements and related notes that appear in Item 1 of this Quarterly Report on Form 10-Q and with our audited financial statements and related notes for the year ended December 31, ~~2017~~2018 appearing in our Annual Report on Form 10-K filed with the SEC on March ~~16, 2018.~~15, 2019.

We are a ~~late-stage~~ clinical biopharmaceutical company developing first-in-class ~~drug~~pharmacological therapies to ~~treat blinding diseases of the eye.~~restore and preserve vision for people with serious eye diseases. Our current product candidates ~~are injected into~~focus on diseases affecting the retina, which is the tissue that lines the inside of the eye and is primarily responsible for vision, and the choroid, which is the layer adjacent to the retina that supplies the retina with blood, oxygen and nourishment.

Our suprachoroidal injection platform is a novel, patented non-surgical approach for delivering pharmacotherapy to the back of the eye in the anatomic structure known as the suprachoroidal space, or SCS. The elasticity of the SCS ~~using~~allows for migration when fluid is injected between the choroid and sclera and allows the fluid to spread spherically toward the posterior regions of the eye where it is absorbed into adjacent tissue. We are able to precisely administer drugs into the SCS with our proprietary ~~SCS Microinjector, and focus on the treatment of diseases affecting the retina and choroid, especially diseases associated with macular edema. With the~~microinjector that utilizes a needle that is approximately 1 millimeter in length.

Our suprachoroidal injection ~~procedure,~~technology is used in conjunction with our proprietary formulations of existing drugs and novel therapies to create a therapeutic platform of product candidates ~~are more directly administered~~ to ~~the retina and choroid as compared to other ocular drug administration techniques such as intravitreal injections. We believe treatment of~~treat several serious eye disease via suprachoroidal injection may provide a number of benefits, including lower frequency of administration and faster onset of therapeutic effect. We hold the exclusive rights to develop and commercialize drugs for treatment via injection into the SCS.diseases. Our most advanced product candidates are based on commonly used ophthalmic drugs, which we believe will allow us to more efficiently and predictably pursue the regulatory approval of these product candidates under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act.

~~We are developing our~~ lead product candidate, ~~XIPERE™,~~XIPERE, is a proprietary, preservative-free ~~formulation~~suspension of the corticosteroid triamcinolone acetonide ~~to be administered suprachoroidally~~formulated for administration via suprachoroidal injection. Based in part on the ~~treatment of patients with macular edema associated with non-infectious uveitis. In March 2018, we announced~~ positive ~~topline~~ results from our ~~PEACHTREE~~ Phase 3 PEACHTREE clinical trial, ~~of XIPERE for the treatment of macular edema associated with non-infectious uveitis. We enrolled 160 patients~~ in the trial, of which 96 patients were randomized to the treatment arm to receive two 4.0 mg doses of XIPERE 12 weeks apart, and 64 patients were randomized to the control arm to undergo two sham procedures at the same 12-week intervals. Patients were evaluated every four weeks for a total of 24 weeks, and a total of 155 patients, or 97% of those enrolled, completed the full evaluation period of the trial. The trial met the primary endpoint with 47% of XIPERE patients gaining at least 15 letters in best corrected visual acuity, or BCVA, as measured using the Early Treatment of Diabetic Retinopathy Study, or ETDRS, scale, from baseline at week 24, compared to 16% of patients in the control arm. This improvement was statistically significant, with a p-value of less than 0.001. The improvement in BCVA from baseline was better in the treatment arm than the control arm at each monthly evaluation. The mean improvement from baseline was maintained throughout the evaluation period, with 9.6 letters gained at week 4 and 13.8 letters gained at week 24 in the treatment arm, compared to 1.3 letters gained at week 4 and 3.0 letters gained at week 24 in the control arm. These differences in mean improvement in BCVA between the XIPERE arm and the control arm at week 24 were also statistically significant with a p-value of less than 0.001.

Suprachoroidal administration of XIPERE resulted in a mean reduction from baseline of 153 microns in central subfield thickness, or CST, of the retina at week 24 in the treatment arm compared to an 18 micron mean reduction in the control arm, a result that was also statistically significant with a p-value of less than 0.001.

XIPERE was generally well tolerated in the trial, with no treatment-related serious adverse events reported. Through 24 weeks, corticosteroid-related elevated intraocular pressure, or IOP, adverse events were reported for approximately 11.5% (11/96) of patients in the XIPERE treatment arm, compared to 15.6% (10/64) of patients in the control arm, when including patients who received corticosteroid rescue medication. Specifically, 72% ~~(46/64) of patients in the control arm were administered rescue medication, with 38 of the 46 receiving various forms of local corticosteroid treatments, such as intravitreal OZURDEX~~ ~~(dexamethasone intravitreal implant) and periocular and intravitreal triamcinolone acetonide. Of those 38 control arm patients receiving local corticosteroid rescue medication, 10 patients, or 26.3%, experienced elevated IOP adverse events.~~ ~~In addition, over the course of this 24-week trial, adverse events involving changes in cataract grading from baseline were similar in each arm, with approximately 7.3% and 6.3% of patients in~~

~~the XIPERE treatment arm and control arm showing adverse event changes in cataract grading, respectively. Further, no cataract surgeries resulted from this trial.~~

Additionally, commonly evaluated signs of inflammation using the Standardization of Uveitis Nomenclature, or SUN, scales resolved in at least two-thirds of treatment arm patients. For example, 68% of patients in the treatment arm with any level of vitreous haze at baseline had vitreous haze scores of zero by the final visit at week 24, compared to 23% of patients in the control arm. Resolution of anterior chamber cells and anterior chamber flare was 72% and 74%, respectively, for patients in the XIPERE treatment arm compared to 17% and 20%, respectively, for patients in the control arm. For patients with baseline scores of 2+ vitreous haze based on the SUN scale, 40.9% of patients experienced resolution in the XIPERE treatment arm compared to 0% of patients in the control arm at week 24. Resolution on the SUN scales is defined as achieving a score of zero on the applicable SUN scale, implying no measurable inflammation was present.

With respect to durability of treatment effect, approximately 85% of the patients in the treatment arm did not receive rescue therapy, remaining on XIPERE treatment over the 24 weeks of the trial, compared to approximately 28% of patients in the control arm.

In the treatment arm, 52% of patients could read 70 or more ETDRS letters, the minimum legal limit to qualify for a driver’s license in most states, at week 24, compared to 22% of patients in the control arm.

~~Based on the results from PEACHTREE and all of the other information from our development related to XIPERE for the treatment of uveitis,~~December 2018, we ~~intend to submit~~submitted a New Drug Application, or NDA, to the U.S. Food and Drug Administration, or FDA, for XIPERE for the treatment of ~~patients with~~ macular edema associated with ~~non-infectious uveitis~~uveitis. On February 19, 2019 we received notification from the FDA that it had accepted the XIPERE NDA for review and had determined that the application was sufficiently complete to permit a substantive review. On October 18, 2019, we received a Complete Response Letter, or CRL, from the FDA regarding the NDA for XIPERE. As part of the complete NDA review, the FDA did not identify any efficacy issues, and there were no requests for further clinical efficacy studies. As anticipated, the CRL included the FDA’s request for additional stability data and reinspection of the drug product manufacturer to resolve the FDA’s prior observations. The CRL included one new request for additional data on clinical use of the final to-be-marketed SCS Microinjector™ delivery system. We currently expect that this device use assessment will be conducted by at least three physicians in 30 patients, per the ~~end~~FDA’s request. We believe that these recommendations cited in the CRL can be addressed in a timely manner that will enable us to resubmit the NDA in the first quarter of ~~2018.~~2020. We expect the Prescription Drug User Fee Act, or PDUFA, goal date for the resubmitted NDA will be six months from the FDA’s receipt of the resubmission. We will be requesting a meeting with the FDA to discuss and confirm our plans for addressing the recommendations contained in the CRL.

On October 22, 2019, we entered into an exclusive license agreement with Bausch Health Ireland Limited, or Bausch, for the commercialization and development of XIPERE in the United States and Canada, or the License Agreement. Pursuant to the License Agreement, Bausch paid us an upfront payment of $5.0 million, which is subject to a refund if the License Agreement is terminated in specified circumstances. In addition, Bausch has agreed to make additional payments of up to $15.0 million upon the achievement of specified pre-launch development and regulatory milestones and up to an aggregate of $56.0 million in additional milestone payments upon the achievement of (i) specified regulatory approvals for specified additional indications of XIPERE and (ii) specified levels of annual net sales (as defined in the License Agreement). Further, during the applicable royalty term, we will also be entitled to receive tiered royalties at increasing percentages, from the high-teens to twenty percent, based on XIPERE achieving certain annual net sales

thresholds in the United States and Canada, as well as a lower royalty on annual net sales of other products, in each case subject to reductions in specified circumstances; provided that we will not receive any royalties on the first $30.0 million of cumulative net sales of all products.

We ~~have also been developing~~intend to continue discussions with potential collaborators for the commercialization and development of XIPERE in ~~combination~~other countries around the world.

On August 29, 2019, we entered into an option and license agreement with REGENXBIO, Inc., or REGENXBIO, pursuant to which we granted REGENXBIO an exclusive option, or the Option, to enter into a commercial license agreement granting REGENXBIO an exclusive, worldwide and sublicensable license to our SCS Microinjector for the delivery of adeno-associated virus-based gene therapies for the treatment of wet age-related macular degeneration, diabetic retinopathy and other conditions for which anti-vascular endothelial growth factor, or anti-VEGF ~~agent for~~treatment is currently the ~~treatment~~standard of ~~retinal vein occlusion, or RVO,~~care. REGENXBIO exercised the Option on October 29, 2019 and has agreed to pay us an option fee equal to $2.0 million, less a ~~sight-threatening disorder resulting from the blockage~~credit of $0.5 million previously received under a ~~retinal vein. We have been exploring whether suprachoroidal XIPERE together with an intravitreal injection~~technology access agreement, within 30 days. In addition, REGENXBIO has agreed to make additional payments to us of ~~an anti-VEGF agent can provide earlier improved visual acuity, reduced macular edema and reduced injection frequency, in each case as compared~~up to ~~administration of an intravitreal anti-VEGF agent alone.~~

We completed a Phase 2 clinical trial, which we refer to as TANZANITE, in 46 patients with RVO. In this trial, 23 patients in the combination arm initially received suprachoroidal XIPERE together with an intravitreal injection of the anti-VEGF agent Eylea, or intravitreal Eylea, and 23 patients in the control arm initially received intravitreal Eylea alone. The objective of the trial was to determine whether patients receiving suprachoroidal XIPERE together with intravitreal Eylea could sustain improvements in visual acuity and reductions in macular edema over the three months of the clinical trial while requiring fewer additional Eylea treatments than patients receiving intravitreal Eylea alone. Patients in each arm were evaluated at months one, two and three after the initial treatment using pre-specified criteria to determine if they continued to experience macular edema or reductions in visual acuity and therefore required additional intravitreal Eylea treatments. The primary objective of the trial was met, with patients in the combination arm requiring an aggregate of ~~60% fewer additional Eylea treatments than patients~~$34.0 million upon the achievement of specified development milestones and up to $102.0 million in sales-based milestone payments, as well as mid-single digit royalties on net sales of products using the Eylea alone control arm over three months, a result that was statistically significant (p=0.013). In addition, based on a post-hoc analysis, 18 of the 23 patients, or 78%, in the combination arm of the trial did not require additional treatmentsSCS Microinjector during the three-month trial compared to 7 of the 23 patients, or 30%, in the control arm, a result that was also statistically significant (p=0.003). In the same Phase 2 trial, patients in the combination arm experienced greater improvement in visual acuity than those in the Eylea alone control arm, with a mean BCVA improvements at months one, two and three of 16, 20 and 19 letters, respectively, compared to improvements of 11, 12 and 11 letters, respectively. In addition, 52% of patients receiving XIPERE together with intravitreal Eylea recovered three lines of vision by month 1, compared to 39% of patients receiving intravitreal Eylea alone. We also extended our evaluation of the patients who participated in the trial and did not receive any additional Eylea treatment during the initial three-month evaluation period to further assess the durability of suprachoroidal XIPERE in combination with intravitreal Eylea for an additional six months following completion of the trial. Of the 32 eligible patients, the medical records of 31 patients were obtained for review. Based on combined data from TANZANITE and the extended evaluation period, 17 of the 23 patients in the combination arm, or 74%, did not receive any additional treatment over the nine-month period, compared to only 4 of 23 patients, or 17%, in the control arm.royalty term.

~~Based~~In the last several months, our research and development team has performed additional analyses on our proprietary suprachoroidal suspension of axitinib, or CLS-AX, an inhibitor of vascular endothelial growth factor receptor-1, -2 and -3 which may benefit patients who sub-optimally respond to current anti-VEGF therapies. In preclinical testing, we observed the ~~results of TANZANITE~~potential for durability benefits which may maintain visual gains and after incorporating feedback from an end-of-Phase 2 meeting with the FDA held in late 2016, we began to enroll patients in a Phase 3 clinical trial, which we refer to as SAPPHIRE, in the first quarter of 2017. In June 2018, we completed enrollment of 460 patients in SAPPHIRE, a multicenter, randomized, masked, controlled ~~trial, to assess the efficacy and safety of suprachoroidal~~ ~~XIPERE~~ ~~together with~~ ~~intravitreal Eylea~~reduce treatment burden in patients with ~~RVO. Patients in the combination treatment arm received suprachoroidal~~ ~~XIPERE~~ ~~together with~~ ~~intravitreal~~ ~~Eylea at the beginning of the trial,~~ ~~intravitreal~~ ~~Eylea alone at week 4 and suprachoroidal~~ ~~XIPERE~~ ~~together with~~ ~~intravitreal~~ ~~Eylea at weeks 12 and 24. Patients in the control arm received~~ ~~intravitreal~~ Eylea alone at the beginning of the trial and follow-up intravitreal Eylea alone every four weeks through and including week 24. The primary endpoint of this trial was to determine the proportion of patients in each arm with a BCVA improvement of at

~~least 15 letters from baseline at eight weeks after initial treatment. Several secondary efficacy and safety endpoints were also evaluated.~~

~~In addition, in~~ the third quarter of 2017, we began the start-up activities for a second Phase 3 clinical trial in patients with RVO, which we refer to as TOPAZ. We enrolled the first patient in TOPAZ in March 2018. Similar to the SAPPHIRE trial, TOPAZ is a multicenter, randomized, masked, controlled ~~Phase 3 trial to assess the efficacy and safety of suprachoroidal~~ ~~XIPERE~~ ~~together with an~~ ~~intravitreal anti-VEGF agent (either Lucentis or Avastin)~~ ~~in patients with RVO. Patients in the combination treatment arm would receive suprachoroidal~~ ~~XIPERE~~ ~~together with~~ ~~an intravitreal~~ ~~anti-VEGF agent at the beginning of the trial,~~ ~~intravitreal~~ ~~anti-VEGF agent alone at week 4 and suprachoroidal~~ ~~XIPERE~~ ~~together with~~ ~~intravitreal~~ ~~anti-VEGF agent at weeks 12 and 24. Patients in the control arm would receive~~ ~~intravitreal~~ ~~anti-VEGF agent alone at the beginning of the trial and follow-up intravitreal anti-VEGF agent alone every four weeks through and including week 24.~~

On November 5, 2018, we announced that the primary endpoint of SAPPHIRE was not achieved, as approximately 50% of patients in both the combination arm and the control arm experienced a BCVA improvement of at least 15 letters from baseline at eight weeks after initial treatment. In light of the 8-week topline data, we plan to discontinue SAPPHIRE and TOPAZ, as well as the clinical development of ~~XIPERE in combination with anti-VEGF agent for the treatment of RVO~~.

angiogenic retinal diseases. We are also developing XIPERE for the treatment of diabetic macular edema, or DME. In April 2017, we completed enrollment of 20 patients with DME in an open-label, multi-center Phase 1/2 clinical trial, which we refer toadvancing CLS-AX as HULK, to obtain safety data and to observe efficacy outcomes from administering a combination of intravitreal Eylea and suprachoroidal XIPERE, as well as suprachoroidal XIPERE alone, over a six-month evaluation period. In November 2017, we announced preliminary results from the HULK trial. In the trial, we observed a mean change in visual acuity improvement from baseline for patients receiving XIPERE, with a greater improvement in treatment naïve eyes. Anatomic improvement was observed in all treated eyes, with more than two-thirds of those eyes achieving a greater than 50% reduction in excess central retinal thickness from baseline, based on monthly measurements through six months after initial treatment. In the treatment naïve group, 40% of patients did not require retreatment over the entire six months, with an additional 20% requiring only one retreatment. XIPERE was well tolerated in the trial, including in patients who received multiple injections, with a low incidence of ocular side effects such as elevated IOP.

In May 2018, we completed a Phase 2 clinical trial, which we refer to as TYBEE, evaluating the safety and efficacy of administering a combination of intravitreal Eylea and suprachoroidal XIPERE to patients with DME, as compared to intravitreal Eylea alone. A total of 71 patients were randomly assigned on a 1:1 basis to receive either quarterly treatments of suprachoroidal XIPERE together with intravitreal Eylea at months 0 and 3 in the combination arm or four monthly treatments of intravitreal Eylea plus a sham suprachoroidal procedure at months 0, 1, 2 and 3 in the control arm, with patients in both arms receiving intravitreal Eylea treatment at months 4 and 5 as needed. Patient follow-up in TYBEE was six months after initial treatment.

Patients in each arm of this trial achieved a statistically significant mean improvement in BCVA as measured by the ETDRS letter scale from baseline over six months with an average of 12.3 and 13.5 ETDRS letters gained in the combination arm and in the control arm, respectively, each with a p-value of less than 0.001. When comparing the two arms, the difference in improvement in BCVA was not statistically significant.

Patients receiving suprachoroidal XIPERE together with intravitreal Eylea achieved a mean reduction from baseline of 208 microns in CST of the retina at six months. There was a 177 micron mean reduction in CST from baseline in the control arm. Each of these changes from baseline were statistically significant with p-values less than 0.001. In addition, 93% of patients in the combination arm had a greater than 50% reduction in excess CST at six months, compared to 73% of patients in the control arm. Patients in the combination arm also achieved a significantly greater resolution in their macular edema at week 4 as compared to the control arm at week 4 (p<0.03), an improvement that was maintained throughout the remainder of the 24-week trial.

Suprachoroidal XIPERE in combination with intravitreal Eylea was generally well tolerated in the TYBEE trial, with no treatment-related serious adverse events reported through the 24-week evaluation period. Elevated IOP adverse events were reported for 8.3% (3/36) of patients in the combination arm, compared to 2.9% (1/35) of patients in the control arm. Both the combination and control arms reported cataract adverse events, with approximately 5.6% (2/36) of patients in the combination arm and 2.9% (1/35) of patients in the control arm developing cataracts.

~~We have consulted with~~ our ~~scientific and medical advisors to evaluate a path forward in our DME program. Based on their advice, and in light of the results of SAPPHIRE in RVO, we have decided to cease any clinical~~lead internal development of XIPERE in combination with an anti-VEGF therapy. We believe there is a potential role for XIPERE as monotherapy in DME, RVO and other potential indications outside of uveitis, similar to the approval and use of other steroids for these indications.

Finally, we continue nonclinical efforts, both internally and with multiple collaborators, in other ocular diseases and technologies, such as gene therapy, that may benefit from a suprachoroidal treatment approach,asset and expect to ~~report additional results from preclinical studies next year.~~

If any of our product candidates are approved, we plan to commercialize them with a specialty team of 30 to 40 sales and medical marketing professionals to target the approximately 1,900 uveitis and retina specialistssubmit an Investigational New Drug application for CLS-AX in ~~the United States, and we may also pursue collaborations with third parties to commercialize any of our drugs approved for marketing outside the United States.~~mid-2020.

We have incurred net losses since our inception in May 2011. Our operations to date have been limited to organizing and staffing our company, raising capital, undertaking preclinical studies and other research and development initiatives, ~~and, beginning in 2013,~~ conducting clinical trials and preparing to commercialize XIPERE for the treatment of ~~our most advanced drug candidates.~~macular edema associated with uveitis, prior to entering into the License Agreement with Bausch as described above. To date, we have not generated any revenue, other than license and collaboration revenue, and we have primarily financed our operations through public offerings and private placements of our equity securities, issuances of convertible promissory notes and loan agreements. As of September 30, ~~2018,~~2019, we had an accumulated deficit of ~~$185.2~~$234.6 million. We recorded net losses of ~~$23.9~~$6.5 million and ~~$18.3~~$23.9 million for the three months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively, and ~~$61.2~~net losses of $27.7 million and ~~$42.5~~$61.2 million for the nine months ended September 30, ~~2018~~2019 and ~~2017,~~2018, respectively. We anticipate that a substantial portion of our capital resources and efforts in the foreseeable future will be focused on completing the necessary clinical development ~~for~~of, and obtaining regulatory approval ~~and preparing for potential commercialization~~ of, our product candidates.

We expect to continue to incur significant ~~and increasing~~ operating losses at least for the next several years. We do not expect to generate product or license and collaboration revenue unless and until we successfully complete necessary development of, ~~and~~ obtain regulatory approval for and successfully commercialize one or more of our product ~~candidates.~~candidates, either on our own or together with a third party. Our net losses may fluctuate significantly from quarter to quarter and year to year, depending on the timing of our clinical trials and our expenditures on other research and development activities. ~~We anticipate that our~~Our clinical trial expenses ~~will decrease as we~~have decreased significantly following our decision to discontinue ~~our SAPPHIRE and TOPAZ~~late-stage clinical ~~trials.~~trials of XIPERE for indications other than uveitis. However, we will ~~however~~ continue our efforts to seek to discover, research and develop additional product candidates and seek regulatory approvals in additional regions for XIPERE for the treatment of non-infectious uveitis and other developmental efforts necessary to seek such approvals. We anticipate that our general and administrative expenses will increase substantially as we:

Based on our current plans and forecasted expenses, we expect that our existing cash and cash equivalents as of the filing date, November 8, 2019, will enable us to fund our operating expenses and capital expenditure requirements into the third quarter of 2020. Our ability to fund our operations into the third quarter of 2020 gives effect to the potential restriction of cash pursuant to the Loan Agreement, as amended by the 3rd Amendment (each as defined below). This expectation does not give effect to any additional development milestone payments we might receive in connection with our license agreements for XIPERE or any other future license or collaboration agreement.

We have not generated any revenue from the sale of any drugs, and we do not expect to generate any revenue unless or until we obtain regulatory approval of and commercialize our product ~~candidates. In 2014, we executed~~candidates, either on our own or with a ~~license agreement~~third party.

We have periodically entered into short-term collaboration agreements, generally with ~~NovaMedica LLC, or NovaMedica. In connection with this agreement, we received an up-front payment~~performance obligations of ~~$200,000 from NovaMedica. We deferred recognizing these payments through 2015. In the first quarter of 2016, we began recognizing revenue related~~one to ~~the NovaMedica payment. In the first quarter of 2018, upon our adoption ASU 2014-09,~~ ~~Revenue from Contracts with Customers, the remaining $160,000 of deferred revenue was recorded as a cumulative adjustment to our accumulated deficit.~~

~~We may enter into additional collaboration agreements~~two months, to evaluate the potential use of our proprietary SCS Microinjector with third-party product candidates for the treatment of

various ~~eye~~ diseases. Funds received from these collaboration agreements are recognized as revenue generally over the term of the agreement or upon completion of performance obligations within the agreement.

Since our inception, we have focused on our development programs. Research and development expenses consist primarily of costs incurred for the research and development of our preclinical and clinical product candidates, which include:

depreciation expense for assets used in research and development activities.

•

~~depreciation expense for assets used in research and development activities.~~

We expense research and development costs to operations as incurred. The costs for some of our development activities, such as clinical trials, are recognized based on the terms of underlying agreements, as well as an evaluation of the progress to completion of specific tasks using data such as patient enrollment, clinical site activations and additional information provided to us by our vendors about their actual costs occurred.

Expenses related to activities, such as manufacturing and stability and toxicology studies, that are supportive of a product candidate itself, are classified as direct preclinical costs. Expenses related to clinical trials and similar activities, including costs associated with CROs, are classified as direct clinical costs. ~~Expenses~~Unallocated costs are expenses related to preclinical activities and activities that support more than one development program ~~or activity,~~ such as salaries, share-based compensation and ~~depreciation, are not classified as direct clinical costs or preclinical costs and are separately classified as unallocated.~~depreciation.

For the three and nine months ended September 30, 2018, ~~and 2017,~~ substantially all of our research and development expenses were related to the preclinical and clinical development of our product ~~candidates.~~candidate.

The following table shows our research and development expenses by program, including those that have been discontinued, for the three and nine months ended September 30, ~~2018~~2019 and ~~2017~~2018 (in thousands).

	Three Months Ended September 30,				Nine Months Ended September 30,				Three Months Ended September 30,				Nine Months Ended September 30,
	2018		2017		2018		2017		2019		2018		2019			2018
XIPERE (uveitis program)	$	2,068	$	3,331	$	6,650	$	9,534	$	427	$	2,068	$	2,129		$	6,649
XIPERE (RVO program)		14,148		8,593		33,001		16,292		118		14,148		4,298			33,001
XIPERE (DME program)		419		1,909		2,674		2,853		3		419		(133	)		2,675
Wet AMD program		—		—		—		247
Total		16,635		13,833		42,325		28,926		548		16,635		6,294			42,325
Unallocated		3,448		2,217		8,480		6,192		2,180		3,448		8,059			8,480
Total research and development expense	$	20,083	$	16,050	$	50,805	$	35,118	$	2,728	$	20,083	$	14,353		$	50,805

Our expenses related to clinical trials are based on estimates of patient enrollment and related expenses at clinical investigator sites as well as estimates for the services received and efforts expended under contracts with research institutions, consultants and CROs that conduct and manage clinical trials on our behalf. We generally accrue expenses related to clinical trials based on contracted amounts applied to the level of patient enrollment and activity according to the protocol. If future timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we would modify our estimates of accrued expenses accordingly on a prospective basis. ~~Historically, any such modifications have not been material.~~

During the nine months ended September 30, 2019, we recorded all estimated remaining accrued expenses reported by our CRO in connection with the termination of our development program for retinal vein occlusion, or RVO.

Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. ~~However, it~~It is difficult to determine with certainty the duration and completion costs of our current or future preclinical programs and clinical trials of our product candidates, or if, when or to what extent we will generate revenues from the commercialization and sale of any of our product candidates that obtain regulatory approval. We may never succeed in achieving regulatory approval for any of our product candidates.

The duration, costs and timing of clinical trials and development of our product candidates will depend on a variety of factors that may include, ~~but are not limited to, the following:~~among others:

the number of doses that patients receive;

•

~~the number of doses that patients receive;~~

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 profiles of the product candidates.

In addition, the probability of success for each product candidate will depend on numerous factors, including competition, manufacturing capability and commercial viability. We will determine which programs to pursue and how much to fund each program in response to the scientific and clinical success of each product candidate, as well as an assessment of each product candidate’s commercial potential.

General and Administrative

General and administrative expenses consist primarily of salaries and other related costs, including share-based compensation, for personnel in executive, finance and administrative functions. General and administrative costs historically included commercial pre-launch preparations for XIPERE, and also include facility related costs not otherwise included in research and development expenses, as well as professional fees for legal, patent, consulting, and accounting and audit services.

We anticipate that our general and administrative expenses will increase in the future to support our continued research and development activities and the potential commercialization of our product candidates. Additionally, we anticipate increased costs related to services associated with maintaining compliance with ~~Nasdaq~~ ~~listing rules and SEC requirements, including compliance with the Sarbanes-Oxley Act, director and officer insurance, and investor and public relations costs.~~

Other Income (Expense)

Other income consists of interest income earned on our cash and cash equivalents and short-term investments. Interest income is not considered significant to our financial statements.

Other expense primarily consists of interest expense under our loan agreements for the three and nine months ended September 30, ~~2018~~2019 and ~~2017.~~2018.

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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 have been prepared in accordance with accounting principles generally accepted in the United States of America, or U.S. GAAP. The preparation of these financial statements requires us to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, disclosure of contingent assets and liabilities as of the dates of the balance sheets and the reported amounts of expenses during the reporting periods. In accordance with U.S. GAAP, we evaluate our estimates and judgments on an ongoing basis. Significant estimates include assumptions used in the determination of share-based compensation and some of our research and development expenses. 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. Actual results may differ from these estimates under different assumptions or conditions.

We define our critical accounting policies as those accounting principles generally accepted in the United States of America that require us to make subjective estimates and judgments about matters that are uncertain and are likely to have a material impact on our financial condition and results of operations, as well as the specific manner in which we apply those principles. During the nine months ended September 30, ~~2018,~~2019, there were no significant changes to our critical accounting policies disclosed in our audited financial statements for the year ended December 31, ~~2017,~~2018, which are included in our Annual Report on Form 10-K, as filed with the SEC on March ~~16, 2018,~~15, 2019, other than our adoption of ASU ~~2014-09,~~2016-02, ~~Revenue from Contracts with Customers~~Leases, as described in Note 2 to our financial statements included in this report.

Results of Operations for the Three Months Ended September 30, ~~2018~~2019 and ~~2017~~2018

The following table sets forth our results of operations for the three months ended September 30, ~~2018~~2019 and ~~2017.~~2018.

	Three Months Ended September 30,						Period-to-Period			Three Months Ended September 30,						Period-to-Period
	2018			2017			Change			2019			2018			Change
	(in thousands)									(in thousands)
License and collaboration revenue	$	—		$	155		$	(155	)
Collaboration revenue										$	141		$	—		$	141
Operating expenses:
Research and development		20,083			16,050			4,033			2,728			20,083			(17,355	)
General and administrative		3,873			2,298			1,575			3,781			3,873			(92	)
Total operating expenses		23,956			18,348			5,608			6,509			23,956			(17,447	)
Loss from operations		(23,956	)		(18,193	)		(5,763	)		(6,368	)		(23,956	)		17,588
Other income (expense), net		84			(143	)		227
Other (expense) income, net											(168	)		84			(252	)
Net loss	$	(23,872	)	$	(18,336	)	$	(5,536	)	$	(6,536	)	$	(23,872	)	$	17,336

Revenue. In the three months ended September 30, ~~2017,~~2019, we recognized ~~$5,000~~$141,000 of revenue associated with collaboration agreements to evaluate the potential use of our ~~agreement~~proprietary SCS Microinjector with ~~NovaMedica and $150,000~~third-party product candidates for the treatment of ~~revenue associated with other collaboration agreements.~~various diseases.

Research and development. Research and development expense ~~increased~~decreased by ~~$4.0~~$17.4 million, from ~~$16.1 million for the three months ended September 30, 2017 to~~ $20.1 million for the three months ended September 30, ~~2018.~~2018 to $2.7 million for the three months ended September 30, 2019. This was primarily attributable to ~~an increase in costs related~~a $14.0 million decrease due to ~~our~~closing down two late-stage clinical ~~program in RVO. Costs for~~trials, SAPPHIRE and TOPAZ, that were part of our RVO ~~program increased $5.6~~program. Additionally, there was a $1.0 million which included purchases of clinical drug supply for SAPPHIRE and TOPAZ. We also incurred a $0.5 million increase in regulatory costs in preparation for an NDA submission, a $0.5 million increase in employee-related costsdecrease due to an increase in headcount and a $0.4 million increase in other research and development activities. These increases were partially offset by a $1.5 million decrease in clinical costs for our uveitis program, asthe completion of the PEACHTREE ~~was completed~~trial during the first quarter of 2018, ~~and~~ a ~~$1.5~~$0.4 million decrease in costs related to our DME program, as the TYBEE trial was completed in the second quarter of ~~2018.~~2018, a $0.5 million decrease in regulatory expenses as the NDA submission for XIPERE was completed in the fourth quarter of 2018, a $0.6 million decrease in costs related to device and drug manufacturing and a $0.5 million decrease in employee related costs.

General and administrative. General and administrative expenses ~~increased~~decreased by ~~$1.6 million,~~$92,000, from ~~$2.3 million for the three months ended September 30, 2017 to~~ $3.9 million for the three months ended September 30, ~~2018. The increase~~2018 to $3.8 million for the three months ended September 30, 2019. This was primarily attributable to a ~~$0.7 million increase in employee-related costs, an increase~~decrease of ~~$0.5~~$0.4 million in marketing-related expenses ~~as we prepare~~related to the change of our business strategy to seek partners for ~~potential commercialization of~~ XIPERE rather than commercialize XIPERE on our own and ~~an increase~~a decrease of $0.2 million in patent-related ~~expenses.~~expenses offset by increases of $0.4 million in professional fees and $0.2 million in directors and officers insurance premiums.

Other (expense) income, ~~(expense),~~ net. Other (expense) income, ~~(expense),~~ net for each of the three months ended September 30, ~~2018~~2019 and ~~2017~~2018 primarily consisted of interest on long-term debt, the amortization of financing costs, the accretion of warrants and the final payment related to our loan agreements, offset in part by interest income from our short-term investments. The decline from 2018 to 2019 was

the result of higher interest income on short-term investment balances following our public offering of common stock in the first quarter of 2018, which balances decreased over time.

Results of Operations for the Nine Months Ended September 30, ~~2018~~2019 and ~~2017~~2018

The following table sets forth our results of operations for the nine months ended September 30, ~~2018~~2019 and ~~2017.~~2018.

	Nine Months Ended September 30,						Period-to-Period			Nine Months Ended September 30,						Period-to-Period
	2018			2017			Change			2019			2018			Change
	(in thousands)									(in thousands)
License and collaboration revenue	$	—		$	290		$	(290	)
Collaboration revenue										$	231		$	—		$	231
Operating expenses:
Research and development		50,805			35,118			15,687			14,353			50,805			(36,452	)
General and administrative		10,508			7,259			3,249			13,169			10,508			2,661
Total operating expenses		61,313			42,377			18,936			27,522			61,313			(33,791	)
Loss from operations		(61,313	)		(42,087	)		(19,226	)		(27,291	)		(61,313	)		34,022
Other income (expense), net		133			(395	)		528
Other (expense) income, net											(383	)		133			(516	)
Net loss	$	(61,180	)	$	(42,482	)	$	(18,698	)	$	(27,674	)	$	(61,180	)	$	33,506

Revenue. In the nine months ended September 30, ~~2017,~~2019, we recognized ~~$15,000~~$231,000 of revenue associated with collaboration agreements to evaluate the potential use of our ~~agreement~~proprietary SCS Microinjector with ~~NovaMedica and $275,000~~third-party product candidates for the treatment of ~~revenue associated with other collaboration agreements.~~various diseases.

Research and development. Research and development expense ~~increased~~decreased by ~~$15.7~~$36.5 million, from ~~$35.1 million for the nine months ended September 30, 2017 to~~ $50.8 million for the nine months ended September 30, ~~2018.~~2018 to $14.4 million for the nine months ended September 30, 2019. This was primarily attributable to ~~an increase in costs related~~a $28.7 million decrease due to ~~our clinical program in RVO. Costs for our RVO program increased $16.7 million, which included purchases of clinical drug supply for~~closing down the SAPPHIRE and ~~start-up costs and purchases~~TOPAZ trials, including the one-time credit of ~~clinical drug supply for TOPAZ. We also incurred~~$2.6 million upon reconciliation of final trial costs. Additionally, there was a ~~$0.9~~$4.5 million ~~increase in regulatory costs in preparation for an NDA submission, a $1.0 million increase in employee-related costs~~decrease due to an increase in headcount and a $0.7 million increase for other research and development activities. These increases were partially offset by a $2.3 million decrease in clinical costs for our uveitis program, asthe completion of the PEACHTREE ~~was completed~~trial during the first quarter of 2018, a ~~$0.6~~$2.8 million decrease in costs related to ~~device and drug manufacturing~~our DME program, as the TYBEE trial was completed in the second quarter of 2018, and a ~~$0.2~~$0.9 million decrease in ~~our wet AMD program, which~~regulatory expenses as the NDA submission for XIPERE was ~~discontinued~~completed in the ~~first~~fourth quarter of ~~2017.~~2018. These decreases were partially offset by a $0.6 million increase in employee-related costs and a $0.6 million increase in nonclinical activities.

General and administrative. General and administrative expenses increased by ~~$3.2~~$2.7 million, from ~~$7.3 million for the nine months ended September 30, 2017 to~~ $10.5 million for the nine months ended September 30, ~~2018.~~2018 to $13.2 million for the nine months ended September 30, 2019. The increase was primarily attributable to a $1.8 million increase in employee-related costs, including accrued expenses related to the resignation of our former CEO, and an increase of ~~$1.1~~$0.5 million in marketing-related expenses as we ~~prepare~~prepared for the potential commercialization of ~~XIPERE and an increase of $0.2 million in professional fees.~~XIPERE.

Other (expense) income, ~~(expense),~~ net. Other (expense) income, ~~(expense),~~ net for each of the ~~nine months~~nine-month periods ended September 30, ~~2018~~2019 and ~~2017~~2018 primarily consisted of interest on long-term debt, the amortization of financing costs, the accretion of warrants and the final payment related to our loan agreements, offset in part by interest income from our short-term investments. The ~~improvement for~~decline from 2018 ~~compared~~ to ~~2017~~2019 was the result of higher interest income on short-term investment balances ~~with the net proceeds of~~following our public offering of common stock in the first quarter of ~~2018.~~2018, which balances decreased over time.

We have funded our operations primarily through the proceeds of public offerings of our common stock, sales of convertible preferred stock and the issuance of long-term debt. As of September 30, ~~2018,~~2019, we had cash and cash equivalents of $22.6 million. On October 22, 2019, we entered into the License Agreement with Bausch, pursuant to which we received an upfront payment of $5.0 million, which is subject to a refund if the License Agreement is terminated in specified circumstances. On October 29, 2019, REGENXBIO exercised the Option and ~~short-term investments~~has agreed to pay us an option fee equal to $2.0 million, less a credit of ~~$64.9 million.~~$0.5 million previously received under a technology access agreement, within 30 days. We invest any cash in excess of our immediate requirements primarily with a view to liquidity and capital preservation. As of September 30, ~~2018,~~2019, our funds were held in cash and money market ~~funds, commercial paper and treasury bills.~~funds.

On March 12, 2018, we closed a follow-on public offering in which we sold 6,538,462 shares of common stock at a public offering price of $13.00 per share, resulting in net proceeds of $79.6 million after deducting underwriting discounts and commissions and estimated offering expenses.

On June 30, 2017, we entered into an at-the-market sales agreement, or the ATM agreement, with Cowen and Company LLC, or Cowen, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate

offering price of up to $50.0 million through Cowen acting as our sales agent. ~~As of~~During the ~~date of this report,~~nine months ended September 30, 2019, we ~~have not~~ sold ~~any~~9.0 million shares of our common stock for net proceeds of $10.3 million under the ~~at-the-market facility.~~ATM agreement. Our registration statement on Form S-3 contemplated under the ATM agreement was declared effective by the SEC on July 13, 2017. The registration statement on Form S-3 includes a prospectus supplement covering the offering up to $18.5 million of shares of common stock over the 12 months ending March 15, 2020 in accordance with the ATM agreement.

On September 28, 2016, we entered into an amended and restated loan and security agreement with Silicon Valley Bank, or SVB, and entities affiliated with MidCap Financial Services, which we refer to collectively with SVB as the Lenders. The amended and restated loan and security agreement provided for new term loans of up to $15.0 million, with a floating interest rate equal to 7% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately preceded the month in which the interest was to accrue, or (ii) 0.50%. We borrowed an initial tranche of $8.0 million on September 28, 2016, of which $5.3 million was used to repay all amounts outstanding under our prior loan agreement with SVB. The draw period for the remaining $7.0 million available under the amended and restated loan and security agreement expired on March 31, 2018. In connection with the amended and restated loan and security agreement, we issued warrants to the Lenders to purchase up to 29,796 shares of common stock at a price per share of $10.74. The warrants expire in September 2026, or earlier upon the occurrence of specified mergers or acquisitions of our company, and are immediately exercisable.

On May 14, 2018, we entered into a second amended and restated loan and security agreement with the Lenders, or the Loan Agreement, which amended and restated in its entirety the prior amended and restated loan and security agreement with the Lenders. The Loan Agreement provides for new term loans of up to $20.0 million, with a floating interest rate equal to 6.5% plus the greater of (i) the 30-day U.S. LIBOR, as reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue or (ii) 1.89%.

We borrowed an initial tranche of $10.0 million on May 14, 2018, of which $7.0 million was used to repay all amounts outstanding under the amended and restated loan and security agreement, including the fees payable in connection with the final payment. The prepayment fees were waived. Of the remaining $10.0 million, $5.0 million ~~is no longer~~became available ~~for~~but we elected not to draw asit, and the ~~SAPPHIRE clinical trial did not meet its primary endpoint. The~~ other $5.0 million ~~or the Term C~~

~~Loan, will~~did not become available for ~~draw when~~draw. On October 18, 2019, we entered into a third amendment to the ~~Lenders have received evidence,~~Loan Agreement, or the 3^rd Amendment, with our Lenders. Under the 3rd Amendment, among other things, we repaid $5.0 million of the outstanding principal balance of the $10.0 million term loan on October 18, 2019. We did not pay any final payment or termination fees in ~~form and substance reasonably satisfactory to them, that~~connection with the ~~FDA has accepted our NDA for~~ $5.0 million prepayment.~~XIPERE~~ ~~for~~

Under the ~~treatment of~~ ~~patients with macular edema associated with non-infectious uveitis. Once the draw period for the Term C~~ Loan ~~has commenced,~~Agreement, as amended, we ~~may draw funds at our discretion until March 31, 2019 or, if earlier, an event of default.~~ We are required to pay accrued interest only on the $5.0 million remaining outstanding ~~amounts~~ balance through April 30, 2020, or if we complete a specified financial milestone, October 31, ~~2019, or if the Term C Loan is made during the applicable draw period, through December 31, 2019,~~2020, followed by consecutive equal monthly payments of principal and interest in arrears continuing through the maturity date of October 1, 2022. We have the option to prepay the outstanding balance ~~of the term loans~~ in full, subject to a prepayment fee of ~~3% of the original principal amount of each term loan for any prepayment prior the first anniversary of the date such term loan is funded or~~ 2% of the original principal amount ~~of each term loan~~ for any prepayment ~~on or after the first anniversary of the date such term loan is funded but~~ prior to October 1, 2022. A final payment of 5.50% of the aggregate borrowed amount is due at maturity of the loan on October 1, 2022, or upon the prepayment of the facility or the acceleration of amounts due under the facility as a result of an event of default.In addition, we agreed that if our cash and cash equivalents balance with SVB falls below $10.0 million, we will transfer to a pledged account an amount of cash and cash equivalents equal to the sum of the then-outstanding principal balance of the term loan plus a final payment fee of $340,441.

The ~~term loans~~amounts due under the Loan Agreement are secured by substantially all of our assets, except that the collateral does not include any of our intellectual property. However, pursuant to the terms of a negative pledge arrangement, we have agreed not to encumber any of our intellectual property.assets.

Our primary uses of capital are, and we expect will continue to be, compensation and related expenses, ongoing costs related to our ~~upcoming~~ NDA submission ~~commercial launch preparation~~ for XIPERE, research and development costs to build our product candidate pipeline, legal and other regulatory expenses and general overhead costs.

The successful development of our product candidates is highly uncertain. As such, at this time, we cannot reasonably estimate or know the nature, timing and estimated costs of the efforts that will be necessary to complete the remainder of the development of XIPERE or any future product candidates. We are also unable to predict when, if ever, material net cash inflows will commence from product sales. This is due to the numerous risks and uncertainties associated with developing drugs, including the uncertainty of:

~~launching commercial sales~~23

Table of ~~the products, if and when approved, whether alone or in collaboration with others.~~Contents

•

launching commercial sales of the products, if and when approved, whether alone or in collaboration with others.

A change in the outcome of any of these variables with respect to the development of any of our product candidates would significantly change the costs and timing associated with the development of that candidate.

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 and potential collaboration, license and development agreements. WeOther than potential payments we may receive under our agreements with Bausch and REGENXBIO, we do not currently have any committed external source of funds, ~~and,~~though, as described above, we may also be able to sell ~~up to $50.0 million of~~ our common stock under the ~~at-the-market sales~~ATM agreement with Cowen subject to the terms of that agreement and depending on market conditions. To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect your rights as a common stockholder. Debt financing and preferred equity 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 additional collaborations, strategic alliances or marketing, distribution or licensing arrangements with third parties, including any future collaboration or licensing arrangement for XIPERE, we may be required to relinquish ~~valuable~~additional rights to our technologies, future revenue streams, research programs or product candidates or to 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 drug development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

We also incur costs as a public company, ~~that we have not previously incurred or have previously incurred at lower rates,~~ including ~~increased~~ costs and expenses for fees to members of our board of directors, ~~increased~~accounting and finance personnel costs, ~~increased~~ directors and officers insurance premiums, audit and legal fees, investor relations fees and expenses for compliance with reporting requirements under the Exchange Act and rules implemented by the SEC and Nasdaq.

Outlook

We have suffered recurring losses and negative cash flows from operations since inception and anticipate incurring additional losses until such time, if ever, that we can obtain FDA approval to market and then generate significant revenue from XIPERE. We will need additional financing to fund our operations. These conditions raise substantial doubt about our ability to continue as a going concern within one year after the date of this report. We have plans to mitigate this going concern risk, which primarily consist of raising additional capital, potentially in a combination of equity or debt financings, or potentially entering into additional collaborations, partnerships and other strategic arrangements.

Based on our current ~~research~~plans and ~~development plans, including the discontinuation of clinical development of XIPERE together with an anti-VEGF agent for the treatment of RVO, our plans to reduce certain administrative~~forecasted expenses, ~~and our timing expectations related to the progress of our upcoming NDA submission,~~ we expect that our existing cash and cash equivalents ~~and short-term investments, combined with anticipated available borrowing capacity under our second amended and restated loan and security agreement,~~as of the filing date, November 8, 2019, will enable us to fund our operating expenses and capital expenditure requirements into the ~~first~~third quarter of 2020. Our ability to fund our operations into the third quarter of 2020 gives effect to the potential restriction of cash pursuant to the Loan Agreement, as amended, by the 3^rd Amendment. This expectation does not give effect to any additional development milestone payments we might receive under the agreements with Bausch or REGENXBIO or in connection with any other potential license or collaboration agreement for XIPERE or any future product candidates. We have based this estimate on assumptions that may prove to be wrong, and we could exhaust our capital resources sooner than we expect.

Our financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should we be unable to continue as a going concern.

Table of Contents

Cash Flows

The following is a summary of the net cash flows provided by (used in) our operating, investing and financing activities (in thousands):

	Nine Months Ended September 30,						Nine Months Ended September 30,
	2018			2017			2019			2018
Net cash (used in) provided by:
Operating activities	$	(54,941	)	$	(35,990	)	$	(28,757	)	$	(54,941	)
Investing activities		(20,201	)		12,162			32,925			(20,201	)
Financing activities		81,759			5,293			10,340			81,759
Net change in cash and cash equivalents	$	6,617		$	(18,535	)	$	14,508		$	6,617

During the nine months ended September 30, ~~2018~~2019 and ~~2017,~~2018, our operating activities used net cash of ~~$54.9~~$28.8 million and ~~$36.0~~$54.9 million, respectively. The use of cash in each period primarily resulted from our net ~~losses.~~losses, offset in part by non-cash share-based compensation expense. The ~~increase~~decrease in net loss for the nine months ended September 30, ~~2018~~2019 as compared to the nine months ended September 30, ~~2017~~2018 was primarily attributable to ~~the higher~~lower research and development expenses as a result of the completion of the PEACHTREE and TYBEE trials in the prior year and the discontinuation of the SAPPHIRE and TOPAZ trials, partially offset by increased commercialization activities ~~described above.~~related to XIPERE. The nine months ended September 30, 2019 also included a net cash outflow of $5.4 million from the decrease in our accounts payable balance, which was the result of payments we made in connection with winding down the clinical trials.

During the nine months ended September 30, ~~2018 and 2017,~~2019, our net cash ~~(used in)~~ provided by investing activities was ~~$(20.2)~~$32.9 million and ~~$12.2 million, respectively. In each period,~~was due to maturities of short-term, available-for-sale investments. During the nine months ended September 30, 2018, our net cash ~~flows~~ used in investing activities ~~related primarily~~was $20.2 million and was due to the net amount of purchases and maturities of short-term, available-for-sale investments.

During the nine months ended September 30, ~~2018~~2019 and ~~2017,~~2018, our net cash provided by financing activities was $10.3 million and $81.8 million, ~~and $5.3~~respectively. The net cash provided by financing activities for the nine months ended September 30, 2019 was comprised of net proceeds of $10.3 million ~~respectively.~~from the sales of shares of common stock under the ATM agreement. The net cash provided by financing activities for the nine months ended September 30, 2018 was comprised of the net proceeds of $79.6 million received from our March 2018 public offering of common stock, the net proceeds of $10.0 million from the second amended and restated loan and security agreement and $0.4 million of proceeds from the exercise of stock options, offset in part by $8.3 million paid to satisfy our obligations under the prior loan agreement, and $0.4 million of proceeds from the exercise of stock options. During the nine months ended September 30, 2017, our net cash provided by financing activities was primarily comprised of the net proceeds received from the underwriters’ exercise of their option to purchase additional shares in January 2017 as part of our public offering of common stock that initially closed in December 2016.agreement.

~~The following table summarizes our significant contractual obligations as~~As of September 30, ~~2018, which consisted of~~2019, there were no significant changes to our contractual obligations, ~~under the leases for our corporate headquarters in Alpharetta, Georgia and additional office space in Berkeley, California, obligations under~~other than the Loan Agreement, ~~and the obligations under a manufacturing supply agreement, or the Supply Agreement, with Gerresheimer Regensburg GmbH, a company incorporated under the laws~~as amended (see Note 5 Long-Term Debt), from those presented as of ~~Germany, or Gerresheimer.~~December 31, 2018 in our Annual Report on Form 10-K.

Payments due by period (in thousands)

Less than

More than

Total

1 year

1-3 years

3-5 years

5 years

Operating lease obligations

$
2,629

$
147

$
1,150

$
957

$
375

Long-term debt obligations

12,713

214

5,385

7,114

—

Manufacturing supply agreement⁽¹⁾

519

519

—

—

—

Total

$
15,861

$
880

$
6,535

$
8,071

$
375

We did not have during the periods presented, and we do not currently have, any off-balance sheet arrangements, as defined under SEC rules.

See Item 1, “Financial Statements – Note 2, Significant Accounting Policies” for a discussion of recent accounting pronouncements and their effect on us.

We are an “emerging growth company,” as defined in the Jumpstart Our Business Startups Act of 2012, or the JOBS Act. Section 107(b) of the JOBS Act provides that an emerging growth company can take advantage of an extended transition period for complying with new or revised accounting standards. Thus, 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. ~~In addition, the JOBS Act defers the requirement to have the independent auditor assess the internal controls over financial reporting under Section 404(b)~~

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

The market risk inherent in our financial instruments and in our financial position represents the potential loss arising from adverse changes in interest rates. As of September 30, ~~2018~~2019 and December 31, ~~2017,~~2018, we had cash and cash equivalents of ~~$15.8~~$22.6 million and ~~$9.2~~$8.0 million, respectively. We generally hold our cash in interest-bearing money market accounts. As of September 30, ~~2018~~2019, we had no short-term investments and as of December 31, ~~2017,~~2018, we had short-term investments of ~~$49.1 million and $28.4 million, respectively.~~$32.8 million. The short-term investments included commercial paper ~~certificates of deposit,~~and treasury ~~bills, corporate bonds and government bonds.~~bills. Our primary exposure to market risk is interest rate sensitivity, which is affected by changes in the general level of U.S. interest rates. Due to the short-term maturities of our cash equivalents and short-term investments and the low risk profile of our investments, an immediate 100 basis point change in interest rates would not have a material effect on the fair market value of our cash equivalents and short-term investments.

We do not engage in any hedging activities against changes in interest rates. ~~As of September 30, 2018, our~~Our outstanding debt instruments carried a floating interest rate that is 6.5% plus the greater of (i) the 30-day U.S. LIBOR, reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue or (ii) 1.89%. As of December 31, 2017, our outstanding debt instruments carried a floating interest rate that is 7.0% plus the greater of (i) the 30-day U.S. LIBOR, reported in the Wall Street Journal on the last business day of the month that immediately precedes the month in which

~~the interest will accrue or (ii) 0.50%.~~ We estimate that a one percentage point increase in the applicable interest rate under our loan agreements would have resulted in a $75,000 and ~~$60,000~~$100,000 increase in interest expense for the nine months ended September 30, ~~2018~~2019 and the year ended December 31, ~~2017,~~2018, respectively.

We do not have any foreign currency or other material derivative financial instruments.

The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”), refers to controls and procedures that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that such information is accumulated and communicated to a company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure.

In designing and evaluating our disclosure controls and procedures, management recognizes that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Additionally, in designing disclosure controls and procedures, our management necessarily was required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions; over time, controls may become inadequate because of changes in conditions, or the degree of compliance with policies or procedures may deteriorate. Because of the inherent limitations in a control system, misstatements due to error or fraud may occur and not be detected.

Our management, with the participation of our Chief Executive Officer and our Chief Financial Officer, has evaluated the effectiveness of our disclosure controls and procedures as of the end of the period covered by this report. Based on that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that our disclosure controls and procedures were effective as of the end of the period covered by this report at the reasonable assurance level.

There has been no change in our internal control over financial reporting during the quarter ended September 30, ~~2018~~2019 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

From time to time, we may be subject to litigation and claims arising in the ordinary course of business. We are not currently a party to any material legal proceedings and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results, cash flows or financial condition.

Our business is subject to risks and events that, if they occur, could adversely affect our financial condition and results of operations and the trading price of our securities. ~~Except for~~In addition to the ~~updated risk factor~~other information set forth ~~immediately~~in this quarterly report on Form 10-Q, you should carefully consider the factors described below ~~our risk factors have not changed materially from those described~~and in “Part I, Item 1A. Risk Factors” of our Annual Report on Form 10-K for the fiscal year ended December 31, ~~2017,~~2018, filed with the Securities and Exchange Commission on March ~~16, 2018.~~

~~We contract with third parties for the manufacture of XIPERE, including our SCS Microinjector, for preclinical and clinical studies and expect~~15, 2019. Except as described below, there have been no material changes to ~~continue to do so for commercialization. This reliance on third parties increases~~ the risk factors described in that we will not have sufficient quantities of XIPERE, including our SCS Microinjector, or such quantities at an acceptable cost, which could delay, prevent or impair our development or commercialization efforts.report.

We do not have any manufacturing facilities or personnel. We currently procure the active pharmaceutical ingredient in XIPERE on a purchase order basis from a third-party manufacturer, but we do not have a commercial supply agreement in place with that manufacturer.

In ~~addition, we have entered into a supply agreement with Gerresheimer, pursuant to which we obtain each of the components~~light of our ~~SCS Microinjector. Some~~receipt of a CRL from the FDA regarding our ~~current suppliers, including Gerresheimer,~~NDA for XIPERE, the U.S. regulatory requirements and timing for XIPERE approval are ~~based outside of~~uncertain, and we may never obtain regulatory approval in the United States. In addition, some of the facilities of our third-party manufacturers have only undergone a limited number of FDA inspections or no inspections. We expect to continue to rely on third parties as we proceed with preclinical and clinical studies using XIPERE with our SCS Microinjector, as well as for commercial manufacture, if any of our product candidates receives marketing approval. This reliance on third parties increases the risk that we will not have sufficient quantities of XIPERE including our SCS Microinjector or such quantities at an acceptable cost or quality, which could delay, prevent or impair our ability to timely conduct our clinical trials or our other development or commercialization efforts.

We also expect to rely on third-party manufacturers or collaborators for the manufacture of commercial supply of any other product candidates for which we obtain marketing approval. We may be unable to establish any agreements with third-party manufacturers or collaborators or to do so on acceptable terms.

~~Reliance on third-party manufacturers or collaborators entails additional risks, including:~~

Our product candidates, including our proprietary drug formulations packaged together with our SCS Microinjector, are regulated under the drug regulations of the Federal Food, Drug, and Cosmetic Act, or FDCA. Third-party manufacturers may not be able to comply with current good manufacturing practices, or cGMP, regulations, regulations applicable to drug/device combination products, including applicable provisions of the FDA’s drug cGMP regulations, device cGMP requirements embodied in the Quality System Regulation, or QSR, or similar regulatory requirements outside the United States. For example, in preparation for NDA submissionFDA for XIPERE for the treatment of ~~patients with~~ macular edema associated with ~~non-infectious uveitis,~~uveitis. The NDA was accepted for review by the FDA in February 2019, and a PDUFA goal date was assigned for October 19, 2019. In August 2019, we ~~conducted audits~~announced that the FDA requested certain items related to chemistry, manufacturing and controls and that we expected to receive a CRL from the FDA. On October 18, 2019, the FDA issued a CRL regarding the NDA, indicating that their review was complete and the NDA was not ready for approval in its present form. As a result, the approval of our ~~third-party manufacturers, which identified items that require correction prior~~NDA for XIPERE has been delayed and may never occur.

In its CRL, the FDA requested additional stability data for the triamcinolone acetonide suspension, reinspection of the drug manufacturer and additional data on clinical use of the final to-be-marketed SCS Microinjector™ delivery system. We [intend to request] [have requested] a meeting with the ~~FDA’s Pre-Approval Inspection of those manufacturing facilities.~~FDA to discuss and confirm our plans for addressing the recommendations contained in the CRL. While we believe that the recommendations cited in the CRL can be addressed in a timely manner that will enable us to resubmit the NDA in the first quarter of 2020, we cannot predict the outcome of any interactions with the FDA nor can we guarantee when, or if, we will be successful in receiving regulatory approval for XIPERE.

The U.S. regulatory requirements and timing for XIPERE approval are ~~working~~uncertain at this time, and we may never obtain regulatory approval of XIPERE or any of our other product candidates in the United States. If we do not obtain approval for XIPERE or are delayed in obtaining such approval, it would have a material adverse effect on our operations and financial condition.

We have granted an exclusive license to Bausch for the commercialization and development of XIPERE in the United States and Canada, and we intend to seek one or more partners for the commercialization of XIPERE in other jurisdictions around the world. If we are unable to secure additional commercialization partners, or if our partners fail to successfully commercialize XIPERE in their respective markets, our business and prospects will be materially harmed.

Our business prospects and our ability to generate product revenue related to XIPERE, if any, will be heavily dependent on the efforts of third parties with whom we have entered, or will enter, into arrangements to perform sales, marketing and distribution services for XIPERE in the United States and internationally. For instance, we have granted an exclusive license to Bausch for the commercialization and development of XIPERE in the United States and Canada. Pursuant to our agreement with Bausch, we are entitled to receive payments based on the achievement of specified sales and regulatory milestones and tiered royalties based on annual net sales of XIPERE. The successful or timely achievement of many of these ~~manufacturers~~milestones is outside of our control because the relevant activities will be conducted by Bausch. We expect to ~~remediate~~depend to a large degree on the payments from Bausch and future potential commercialization partners in order to fund our operations, and a failure to receive such payments may cause us to:

We intend to enter into similar arrangements with third parties for the commercialization of XIPERE in other jurisdictions outside of the United States and Canada. We may be unsuccessful in entering into such commercialization arrangements with third parties or may be unable to do so on terms that are favorable to us. Our product revenue related to XIPERE, if any, or the profitability of such product revenue, may be lower, perhaps substantially lower, than if we directly marketed and sold XIPERE. Such revenue will be heavily dependent on the commercialization efforts of our partners, and we may have little or no control over such third parties. Any disputes with our commercialization partners concerning the adequacy of their efforts will substantially divert the attention of our senior management from other business activities and will require us to incur substantial legal costs to fund litigation or arbitration proceedings. If we are unable to establish licensing or collaboration arrangements with additional partners or if our partners fail to exercise commercially reasonable efforts to market and sell XIPERE in their respective licensed jurisdictions or are otherwise ineffective in doing so, our business will be materially harmed, and we may not be able to adequately remedy the harm through negotiation, litigation, arbitration or termination of the commercialization agreements.

If we fail to maintain compliance with the listing requirements of The Nasdaq Global Market, we may be delisted and the price of our common stock and our ability to access the capital markets could be negatively impacted.

Our common stock is currently listed on The Nasdaq Global Market. To maintain the listing of our common stock on The Nasdaq Global Market, we are required to meet certain listing requirements, including, among others, either: (i) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors and 10% or more stockholders) of at least $5 million and stockholders’ equity of at least $10 million; or (ii) a minimum closing bid price of $1.00 per share, a market value of publicly held shares (excluding shares held by our executive officers, directors, affiliates and 10% or more stockholders) of at least $15 million and a total market value of listed securities of at least $50.0 million.

On October 4, 2019, we received a notice, or the Notice, from the Nasdaq Listing Qualifications Staff that we were not in compliance with Nasdaq Listing Rule 5550(a)(2), or the Rule, as the closing bid price of our common stock was below $1.00 for the prior 30 consecutive business days. In accordance with Nasdaq Listing Rule 5810(c)(3)(A), we have a period of 180 calendar days from the Notice, or until April 1, 2020, to regain compliance with the Rule. To regain compliance, the closing bid price of our common stock must be at least $1.00 for a minimum of ten consecutive business days before April 1, 2020. If we do not regain compliance with the Rule during the compliance period, our common stock will be subject to delisting, at which time we may appeal any delisting determination. In addition to our failure to meet the minimum bid price requirement, our stockholders’ equity as of September 30, 2019 was below $10 million.

We may fail to regain compliance with the Rule or to satisfy one or more additional Nasdaq Global Market requirements for continued listing of our common stock in the future. There can be no assurance that we ~~or they~~ will be ~~able to remediate those issues~~successful in ~~a timely manner or at all. Our failure, or~~maintaining the ~~failure~~listing of our ~~third-party manufacturers,~~common stock on the Nasdaq Global Market, or, if transferred, on the Nasdaq Capital Market. This could impair the liquidity and market price of our common stock. In addition, the delisting of our common stock from a national exchange could have a material adverse effect on our ability to ~~comply with applicable regulations~~access the capital markets, and any limitation on market liquidity or reduction in the price of our common stock as a result of that delisting could result in sanctions being imposed on us, including clinical holds, a refusal to file determination by the FDA, fines, injunctions, civil penalties, delays, suspension or withdrawal of approvals, license revocation, seizures or recalls of product candidates, operating restrictions and criminal prosecutions, any of which could significantlyadversely affect our ability to ~~achieve regulatory approval~~raise capital on terms acceptable to us, or at all.

Our product candidates that we may develop may compete with other drugs and devices for access to manufacturing facilities. There are a limited number of manufacturers that operate under the drug and device cGMP regulations applicable to our product candidates and that might be capable of manufacturing for us. Any performance failure on the part of our existing or future manufacturers could delay clinical development or marketing approval. We do not currently have arrangements in place for redundant supply or a second source for bulk drug substance or our SCS Microinjector. If our current contract manufacturers cannot perform as agreed, we may be required to replace such manufacturers. Although we believe that there are several potential alternative manufacturers who could manufacture our drugs and the components of our SCS Microinjector, we may incur added costs and delays in identifying and qualifying any such replacement. For example, the FDA could require supplemental data if a new supplier is relied upon for the active pharmaceutical ingredient used in our products. Any interruption or delay in the supply of components and materials, or our inability to obtain components or materials from alternate sources at acceptable prices in a timely manner, could impair our ability to meet the demand of our customers and cause them to cancel orders.

Our current and anticipated future dependence upon others for the manufacture of our product candidates may compromise our future profit margins and our ability to commercialize any product candidates that receive marketing approval on a timely and competitive basis.

On November 8, 2019, we entered into a settlement agreement with NovaMedica LLC, or NovaMedica, to terminate our licensing agreement dated August 29, 2014. Pursuant to the settlement agreement, we and NovaMedica agreed to terminate the licensing agreement, effective immediately, and NovaMedica retained no rights to our intellectual property previously licensed to them. In addition, NovaMedica paid us a termination fee of $115,000 and we refunded the upfront payment of $200,000 that we received from NovaMedica in connection with the licensing agreement.

Pursuant to the requirements 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.

Delaware	45-2437375
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
900 North Point Parkway, Suite 200 Alpharetta, GA	30005
(Address of principal executive offices)	(Zip Code)


Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock, par value $0.001 per share	CLSD	The Nasdaq Stock Market LLC

		Page
	PART I - FINANCIAL INFORMATION
Item 1.	Financial Statements	2
	Balance Sheets as of September 30, ~~2018~~2019 (unaudited) and December 31, ~~2017~~2018	2
	Statements of Operations ~~and Comprehensive Loss~~ for the three and nine months ended September 30, ~~2018~~2019 and ~~2017~~ 2018 (unaudited)	3
	Statements of Stockholders’ Equity for the three and nine months ended September 30, 2019 and 2018 (unaudited)	4
	Statements of Cash Flows for the nine months ended September 30, ~~2018~~2019 and ~~2017~~2018 (unaudited)	45
	Notes to the Financial Statements	56
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	1417
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	2426
Item 4.	Controls and Procedures	2526
	PART II - OTHER INFORMATION
Item 1.	Legal Proceedings	2627
Item 1A.	Risk Factors	2627
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	2729
Item 5.	Other Information	29
Item 6.	Exhibits	2830
Signatures		2931

Exhibit No.		Description

3.1		Amended and Restated Certificate of Incorporation (incorporated herein by reference to Exhibit 3.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016).

3.2		Amended and Restated Bylaws (incorporated herein by reference to Exhibit 3.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37783) filed with the SEC on June 7, 2016).

10.1*#		Consent and Second Amendment to Second Amended and Restated Loan and Security Agreement, by and between the Registrant and Silicon Valley Bank, dated as of August 29, 2019.

31.1*		Certification of Principal Executive Officer under Section 302 of the Sarbanes-Oxley Act.

31.2*		Certification of Principal Financial Officer under Section 302 of the Sarbanes-Oxley Act.

32.1**		Certifications of Principal Executive Officer and Principal Financial Officer under Section 906 of the Sarbanes-Oxley Act.

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 Label Linkbase Document

101.PRE		XBRL Taxonomy Extension Presentation Linkbase Document

	Clearside Biomedical, Inc.

Date: November 8, ~~2018~~2019	By:	/s/ Charles A. Deignan
		Charles A. Deignan
		Chief Financial Officer
		(On behalf of the Registrant and as Principal Financial Officer)

Large accelerated filer	☐	Accelerated filer	☒

Non-accelerated filer	☐	Smaller reporting company	☒

~~Emerging growth company~~	☒		Emerging growth company	☒

	September 30, 2019
Operating lease right-of-use asset	$	806

Liabilities
Current portion of operating lease liabilities	$	483
Operating lease liabilities		961
Total operating lease liabilities	$	1,444

	September 30, 2018
	Amortized		Unrealized			Fair
	Cost		Losses			Value
Commercial paper	$	37,160	$	—		$	37,160
Treasury bills		11,945		(4	)		11,941
Total available-for-sale investments	$	49,105	$	(4	)	$	49,101

	Payments due by period (in thousands)
			Less than						More than
	Total		1 year		1-3 years		3-5 years		5 years
Operating lease obligations	$	2,629	$	147	$	1,150	$	957	$	375
Long-term debt obligations		12,713		214		5,385		7,114		—
Manufacturing supply agreement⁽¹⁾		519		519		—		—		—
Total	$	15,861	$	880	$	6,535	$	8,071	$	375