Clearside Biomedical, Inc 10-K for FY2020

About this 10-K

Headline figures

Clearside Biomedical, Inc. (CLSDQ)

10-K 2021-03-15 For: 2020-12-31

Added on April 06, 2026

Clearside Biomedical, Inc filed this 10-K on March 15, 2021, covering the fiscal year ended December 31, 2020 (FY2020).

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

Fiscal year ended December 31, 2020, as reported in this filing, compared with the same period a year earlier where the filing states it.

Revenue: $7.89M; up 263.3% from $2.17M a year earlier
Net loss: $18.21M; compared with a net loss of $30.77M a year earlier

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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
Item 1.	Business	4
Item 1A.	Risk Factors	25
Item 1B.	Unresolved Staff Comments	57
Item 2.	Properties	57
Item 3.	Legal Proceedings	57
Item 4.	Mine Safety Disclosures	57

	PART II
Item 5.	Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities	57
Item 6.	Selected Financial Data	57
Item 7.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	58
Item 7A.	Quantitative and Qualitative Disclosures About Market Risk	68
Item 8.	Financial Statements and Supplementary Data	69
Item 9.	Changes in and Disagreements with Accountants on Accounting and Financial Disclosure	90
Item 9A.	Controls and Procedures	90
Item 9B.	Other Information	90

	PART III
Item 10.	Directors, Executive Officers and Corporate Governance	92
Item 11.	Executive Compensation	92
Item 12.	Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters	92
Item 13.	Certain Relationships and Related Transactions, and Director Independence	92
Item 14.	Principal Accountant Fees and Services	92

	PART IV
Item 15.	Exhibits, Financial Statement Schedules	93
Item 16	Form 10-K Summary	95
Signatures		96

	Year Ended December 31,
	2020		2019			2018
	(in thousands)
XIPERE (uveitis program)	$	3,841	$	2,947		$	8,803
XIPERE (RVO program)		84		2,323			44,432
XIPERE (DME program)		—		(133	)		3,062
CLS-AX (wet AMD program)		2,169		67			3
Total program expense		6,094		5,204			56,300
Unallocated		8,979		10,454			11,991
Total research and development expense	$	15,073	$	15,658		$	68,291

	Year Ended
	December 31,						Period-to-Period
	2020			2019			Change
	(in thousands)
License and other revenue	$	7,894		$	2,173		$	5,721
Operating expenses:
Research and development		15,073			15,658			(585	)
General and administrative		10,756			16,819			(6,063	)
Total operating expenses		25,829			32,477			(6,648	)
Loss from operations		(17,935	)		(30,304	)		12,369
Other expense		(275	)		(466	)		191
Net loss	$	(18,210	)	$	(30,770	)	$	12,560

	Year Ended December 31,
	2020			2019			2018
	(in thousands)
Net cash (used in) provided by:
Operating activities	$	(13,120	)	$	(27,068	)	$	(79,200	)
Investing activities		(55	)		32,925			(3,760	)
Financing activities		7,867			8,695			81,779
Net change in cash and cash equivalents	$	(5,308	)	$	14,552		$	(1,181	)


	Page
Report of independent registered public accounting firm	70
Balance sheets as of December 31, 2020 and 2019	71
Statements of operations for the years ended December 31, 2020, 2019 and 2018	72
Statements of stockholders’ equity (deficit) for the years ended December 31, 2020, 2019 and 2018	73
Statements of cash flows for the years ended December 31, 2020, 2019 and 2018	74
Notes to financial statements	75

										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 under follow-on offering		6,548,712		7		79,557		—			—			79,564
Issuance of common shares under employee stock purchase plan		12,595		—		50		—			—			50
Exercise of stock options		203,269		—		465		—			—			465
Share-based compensation expense		—		—		4,785		—			—			4,785
Net loss		—		—		—		(82,818	)		—			(82,818	)
Balance at December 31, 2018		32,119,227		32		230,475		(206,887	)		—			23,620
Issuance of common shares under at-the-market sales agreement		8,976,940		9		10,310		—			—			10,319
Issuance of common shares under private placement		3,178,367		3		3,321		—			—			3,324
Issuance of common shares under employee stock purchase plan		52,476		—		45		—			—			45
Exercise of stock options		16,362		—		7					—			7
Vesting and settlement of restricted stock units		70,000		—		—		—			—			—
Share-based compensation expense		—		—		4,612		—			—			4,612
Net loss		—		—		—		(30,770	)		—			(30,770	)
Balance at December 31, 2019		44,413,372		44		248,770		(237,657	)		—			11,157
Issuance of common shares under at-the-market sales agreement		6,176,415		6		11,952		—			—			11,958
Issuance of common shares under employee stock purchase plan		35,359		—		31		—			—			31
Exercise of stock options		254,466		2		225		—			—			227
Vesting and settlement of restricted stock units		981,329		—		—		—			—			—
Share-based compensation expense		—		—		3,600		—			—			3,600
Net loss		—		—		—		(18,210	)		—			(18,210	)
Balance at December 31, 2020		51,860,941	$	52	$	264,578	$	(255,867	)	$	—		$	8,763

	Estimated Useful Lives (Years)	December 31,
		2020			2019
Furniture and fixtures	5	$	337		$	337
Machinery and equipment	5		176			121
Computer equipment	3		13			13
Leasehold improvements	Lesser of useful life or remaining lease term		667			667
Total property and equipment			1,193			1,138
Less: Accumulated depreciation			(777	)		(597	)
Property and equipment, net		$	416		$	541

				Weighted
	Number of			Average
	Shares			Exercise Price

Options outstanding at December 31, 2019		4,104,450		$	4.63
Granted		1,100,250			2.31
Exercised		(254,466	)		0.89
Cancelled/Forfeited		(702,041	)		6.49
Options outstanding at December 31, 2020		4,248,193			3.95

Options exercisable at December 31, 2019		2,452,764			5.44

Options exercisable at December 31, 2020		2,355,900			4.96

				Weighted Average
	Number of			Grant Date
	Shares			Fair Value
Non-vested RSUs outstanding at December 31, 2019		1,269,300		$	0.87
Granted		486,000			2.39
Vested		(981,329	)		0.91
Forfeited		(6,700	)		0.91
Non-vested RSUs outstanding at December 31, 2020		767,271			1.78

	December 31, 2020
Operating lease right-of-use asset	$	528

Liabilities
Current portion of operating lease liabilities	$	373
Operating lease liabilities		616
Total operating lease liabilities	$	989

Year ending December 31,
2021	$	392
2022		407
2023		316
Total minimum lease payments		1,115
Less imputed interest		(126	)
Total operating lease liabilities	$	989

	December 31, 2020
	Level 1		Level 2		Level 3		Recorded Value
Financial Assets:
Cash and money markets	$	17,287	$	—	$	—	$	17,287
Restricted cash money market		360		—		—		360
Total financial assets	$	17,647	$	—	$	—	$	17,647

	December 31, 2019
	Level 1		Level 2		Level 3		Recorded Value
Financial Assets:
Cash and money markets	$	22,595	$	—	$	—	$	22,595
Restricted cash money market		360		—		—		360
Total financial assets	$	22,955	$	—	$	—	$	22,955

Exhibit number		Description of document

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).

4.1		Specimen stock certificate evidencing shares of Common Stock (incorporated herein by reference to Exhibit 4.1 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916) filed with the SEC on March 18, 2016).

4.2		Third Amended and Restated Investor Rights Agreement, dated as of November 23, 2015, by and among the Registrant and certain of its stockholders (incorporated herein by reference to Exhibit 4.2 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on January 8, 2016).

4.3		Form of Warrant to Purchase Common Stock issued to lenders in September 2016 in connection with Amended and Restated Loan and Security Agreement (incorporated herein by reference to Exhibit 4.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783), filed with the Commission on October 4, 2016).

4.4		Description of Common Stock of Clearside Biomedical, Inc. (incorporated herein by reference to Exhibit 4.4 to the Registrant’s Annual Report on Form 10-K (File No. 001-37783), filed with the Commission on March 13, 2020).

4.5		Registration Rights Agreement, by and among the Registrant and the Investors named therein, dated as of November 22, 2019 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Current Report on Form 8-K (File No. 001-37783), filed with the Commission on November 25, 2019).

10.1	#	License Agreement, by and among the Registrant, Emory University and The Georgia Tech Research Corporation, dated as of July 4, 2012, as amended by the First Amendment to License Agreement, dated April 2, 2014 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on January 8, 2016).

10.2	+	2011 Stock Incentive Plan, as amended to date (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on January 8, 2016).

10.3	+	Form of Incentive Stock Option Grant Notice and Incentive Stock Option Agreement under 2011 Stock Incentive Plan (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on January 8, 2016).

10.4	+	Form of Nonqualified Stock Option Grant Notice and Nonqualified Stock Option Agreement under 2011 Stock Incentive Plan (incorporated herein by reference to Exhibit 10.5 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on January 8, 2016).

10.5	+	2016 Equity Incentive Plan (incorporated herein by reference to Exhibit 4.7 to the Registrant’s Registration Statement on Form S-8 (File No. 333-212014), file with the Commission on June 14, 2016).

10.6	+	Form of Stock Option Grant Notice and Stock Option Agreement under 2016 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.7 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on March 18, 2016).

10.7	+	Form of Restricted Stock Unit Grant Notice and Restricted Stock Unit Award Agreement under 2016 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.8 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on March 18, 2016).

10.8	+	Form of Indemnification Agreement with non-employee directors (incorporated herein by reference to Exhibit 10.9 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on January 8, 2016).

10.9	+	Form of 2016 Employee Stock Purchase Plan (incorporated herein by reference to Exhibit 10.12 to Amendment No. 1 to the Registrant’s Registration Statement on Form S-1 (File No. 333-208916), filed with the Commission on March 18, 2016).

10.10		Office Lease Agreement, dated November 21, 2016, by and between the Registrant and BRE/COH GA LLC (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783), filed with the Commission on November 23, 2016).

10.11		Second Amendment to License Agreement, by and among the Registrant, Emory University and The Georgia Tech Research Corporation, dated December 12, 2016 (incorporated herein by reference to Exhibit 10.21 to the Registrant’s Annual Report on Form 10-K (File No. 001-37783), filed with the Commission on March 16, 2017).

10.12		Sales Agreement, dated June 30, 2017, by and between the Registrant and Cowen and Company, LLC (incorporated by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783), filed with the SEC on July 3, 2017).

10.13	+	Amended and Restated Executive Employment Agreement, by and between Clearside Biomedical, Inc. and Charles A. Deignan, dated as of August 3, 2017 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on November 9, 2017).

10.14	+	Amended and Restated Non-Employee Director Compensation Policy (incorporated herein by reference to Exhibit 10.4 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on November 9, 2017).

10.15		Supply Agreement, by and among the Registrant and Gerresheimer Regensburg GmbH, dated as of May 8, 2018 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on August 8, 2018).

10.16	+	Change in Control Equity Acceleration Plan, amending the Registrant’s 2016 Equity Incentive Plan (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on August 8, 2018.)

10.17		Third Amendment to License Agreement, by and among the Registrant, Emory University and The Georgia Tech Research Corporation, dated April 1, 2018 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on August 8, 2019).

10.18	##	License Agreement, by and between the Registrant and Bausch Health Ireland Limited, dated as of October 22, 2019 (incorporated herein by reference to Exhibit 10.26 to the Registrant’s Annual Report on Form 10-K (File No. 001-37783), filed with the Commission on March 13, 2020).

10.19	##	First Amendment to License Agreement, by and between the Registrant and Bausch Health Ireland Limited, dated as of April 27, 2020. (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on August 10, 2020).

10.20	+	Letter Agreement, by and between the Registrant and George Lasezkay, dated April 16, 2019 (incorporated herein by reference to Exhibit 10.1 to the Registrant’s Current Report on Form 8-K (File No. 001-37783), filed with the Commission on April 17, 2019).

10.21	+	Amendment to Offer Letter Agreement, by and between the Registrant and George Lasezkay, dated as of August 6, 2019 (incorporated herein by reference to Exhibit 10.3 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on August 8, 2019).

10.22	##	Option and License Agreement by and between the Registrant and REGENXBIO Inc., dated as of August 29, 2019 (incorporated herein by reference to Exhibit 10.30 to the Registrant’s Annual Report on Form 10-K (File No. 001-37783), filed with the Commission on March 13, 2020).

10.23	##	License Agreement by and between the Registrant and Arctic Vision (Hong Kong) Limited, dated as of March 20, 2020 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on May 8, 2020).

10.24	+	Executive Employment Agreement, by and between the Registrant and Thomas Ciulla, dated as of June 24, 2019 (incorporated herein by reference to Exhibit 10.2 to the Registrant’s Quarterly Report on Form 10-Q (File No. 001-37783), filed with the Commission on August 10, 2020).

23.1	*	Consent of Ernst & Young LLP, independent registered public accounting firm.

24.1	*	Power of Attorney (included on signature page).

31.1	*	Certification of Principal Executive Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

31.2	*	Certification of Principal Financial Officer pursuant to Rules 13a-14(a) and 15d-14(a) promulgated under the Securities Exchange Act of 1934, as adopted pursuant to section 302 of the Sarbanes-Oxley Act of 2002.

32.1	*^	Certification of Principal Executive Officer and Principal Financial Officer pursuant to Rules 13a-14(b) and 15d-14(b) promulgated under the Securities Exchange Act of 1934 and 18 U.S.C. Section 1350, as adopted pursuant to section 906 of The Sarbanes-Oxley Act of 2002.

99.1	*	Resolutions adopted by the Board of Directors of the Registrant setting forth the information with respect to the Ratification required under Section 204 of the Delaware General Corporation Law.

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

*		Filed herewith.
+		Indicates management contract or compensatory plan.
#		Confidential treatment has been granted with respect to portions of this exhibit (indicated by asterisks) and those portions have been separately filed with the Securities and Exchange Commission.
^		These certifications are being furnished solely to accompany this Annual Report pursuant to 18 U.S.C. Section 1350, and are not being filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and are not to be incorporated by reference into any filing of the Registrant, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
##		Pursuant to Item 601(b)(10)(iv) of Regulation S-K promulgated by the Securities and Exchange Commission, certain portions of this exhibit (indicated by asterisks) have been omitted. The Registrant hereby agrees to furnish supplementally to the Securities and Exchange Commission, upon its request, an unredacted copy of this exhibit.



	CLEARSIDE BIOMEDICAL, INC.

	By:	/s/ George Lasezkay, Pharm.D., J.D.
March 15, 2021		George Lasezkay, Pharm.D., J.D. President and Chief Executive Officer



Signature	Title		Date

/s/ George Lasezkay, Pharm.D., J.D. George Lasezkay, Pharm.D., J.D.	President, Chief Executive Officer and Director (Principal Executive Officer)	March 15, 2021

/s/ Charles A. Deignan Charles A. Deignan	Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer)	March 15, 2021

/s/ William D. Humphries William D. Humphries	Director	March 15, 2021

/s/ Richard Croarkin Richard Croarkin	Director	March 15, 2021

/s/ Jeffrey L. Edwards Jeffrey L. Edwards	Director	March 15, 2021

/s/ Nancy J. Hutson Nancy J. Hutson	Director	March 15, 2021

/s/ Christy L. Shaffer, Ph.D. Christy L. Shaffer, Ph.D.	Director	March 15, 2021

/s/Clay B. Thorp Clay B. Thorp	Director	March 15, 2021

	/s/ George Lasezkay, Pharm.D., J.D.
	George Lasezkay, Pharm.D., J.D.
	President and Chief Executive Officer
	(principal executive officer)

	/s/ Charles A. Deignan
	Charles A. Deignan
	Chief Financial Officer
	(principal financial officer)

Number of Shares	Date of Issuance	Price Per Share
17,237	October 5, 2020	$1.6000
39,561	October 8, 2020	$1.5500
69,712	October 9, 2020	$1.5958