10-Q

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 2023

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

Commission File Number: 001-37783

Clearside Biomedical, Inc.

(Exact Name of Registrant as Specified in its Charter)


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)

(678) 270-3631

Registrant’s telephone number, including area code

N/A

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

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


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

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 May 10, 2023, the registrant had 61,666,130 shares of common stock, $0.001 par value per share, outstanding.


		Page
	PART I - FINANCIAL INFORMATION


Item 1.	Financial Statements (unaudited)
	Consolidated Balance Sheets as of March 31, 2023 and December 31, 2022	3
	Consolidated Statements of Operations for the three months ended March 31, 2023 and 2022	4
	Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2023 and 2022	5
	Consolidated Statements of Cash Flows for the three months ended March 31, 2023 and 2022	6
	Notes to the Consolidated Financial Statements	7
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	22
Item 4.	Controls and Procedures	22
	PART II - OTHER INFORMATION
Item 1.	Legal Proceedings	24
Item 1A.	Risk Factors	24
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	24
Item 6.	Exhibits	25
Signatures		26

PART I – FINANCIAL INFORMATION

Item 1. Financial Statements

CLEARSIDE BIOMEDICAL, INC.

Consolidated Balance Sheets

(in thousands, except share and per share data)

(unaudited)


	March 31, 2023			December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	41,419		$	48,258
Prepaid expenses		762			704
Other current assets		386			439
Total current assets		42,567			49,401
Property and equipment, net		1,041			755
Operating lease right-of-use asset		1,057			1,117
Other assets		30			30
Total assets	$	44,695		$	51,303
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable	$	1,594		$	1,050
Accrued liabilities		2,754			4,179
Current portion of operating lease liabilities		356			349
Deferred revenue		280			205
Total current liabilities		4,984			5,783
Liability related to the sales of future royalties, net		36,144			33,977
Operating lease liabilities		867			936
Total liabilities		41,995			40,696
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.001 par value; 10,000,000 shares authorized and no shares issued at March 31, 2023 and December 31, 2022		—			—
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2023 and December 31, 2022; 61,364,299 and 60,639,827 shares issued and outstanding at March 31, 2023 and December 31, 2022, respectively		61			61
Additional paid-in capital		300,357			298,984
Accumulated deficit		(297,718	)		(288,438	)
Total stockholders’ equity		2,700			10,607
Total liabilities and stockholders’ equity	$	44,695		$	51,303

See accompanying notes to the consolidated financial statements

CLEARSIDE BIOMEDICAL, INC.

Consolidated Statements of Operations

(in thousands, except share and per share data)

(unaudited)


	Three Months Ended March 31,
	2023			2022
License and other revenue	$	4		$	347
Operating expenses:
Research and development		4,451			4,536
General and administrative		3,158			3,457
Total operating expenses		7,609			7,993
Loss from operations		(7,605	)		(7,646	)
Other income		492			2
Non-cash interest expense on liability related to the sales of future royalties		(2,167	)		—
Net loss	$	(9,280	)	$	(7,644	)
Net loss per share of common stock — basic and diluted	$	(0.15	)	$	(0.13	)
Weighted average shares outstanding — basic and diluted		61,169,486			60,064,209

See accompanying notes to the consolidated financial statements.

CLEARSIDE BIOMEDICAL, INC.

Consolidated Statements of Stockholders’ Equity

(in thousands, except share data)

(unaudited)


	Three Months Ended March 31, 2023
										Total
	Common Stock				Additional		Accumulated			Stockholders'
	Shares		Amount		Paid-In-Capital		Deficit			Equity
Balance at December 31, 2022		60,639,827	$	61	$	298,984	$	(288,438	)	$	10,607
Issuance of common shares under at-the-market sales agreement		214,128		—		295		—			295
Vesting and settlement of restricted stock units		471,390		—		—		—			—
Issuance of common shares under employee stock purchase plan		38,954		—		37		—			37
Share-based compensation expense		—		—		1,041

SEC Form 10-Q filed by Clearside Biomedical Inc.