CLSD Clearside Biomedical Inc

 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): May 09, 2024

 

 

Clearside Biomedical, Inc.

(Exact name of Registrant as Specified in Its Charter)

 

 

Delaware			001-37783	45-2437375
(State or Other Jurisdiction of Incorporation)			(Commission File Number)	(IRS Employer Identification No.)
900 North Point Parkway Suite 200
Alpharetta, Georgia				30005
(Address of Principal Executive Offices)				(Zip Code)

 

Registrant’s Telephone Number, Including Area Code: 678 270-3631

 

(Former Name or Former Address, if Changed Since Last Report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

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 is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

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. ☐

 

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Item 2.02 Results of Operations and Financial Condition.

On May 9, 2024, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended March 31, 2024, as well as information regarding a conference call to discuss these financial results and the Registrant’s recent corporate highlights. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any of the Registrant’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit
Number		Exhibit Description
99.1		Press Release, dated May 9, 2024
104		Cover Page Interactive Data File (embedded with the Inline XBRL document)

 

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SIGNATURES

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 hereunto duly authorized.

			Clearside Biomedical, Inc.
Date:	May 9, 2024	By:	/s/Charles A. Deignan
			Charles A. Deignan
			Chief Financial Officer

 

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Clearside Biomedical Announces First Quarter 2024
Financial Results and Provides Corporate Update
 

- Phase 2b ODYSSEY Trial in Wet AMD Remains on Track
with Topline Data Expected Q3 2024 -
 

- Strengthened Management Team and Board of Directors with Two Key Additions -
 

- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -

 

ALPHARETTA, Ga., May 9, 2024 -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the first quarter ended March 31, 2024, and provided a corporate update.

 

“As we near the midpoint of 2024, I am excited to highlight key aspects of our program and the steps we have taken to position Clearside for an important year,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “Our lead clinical program, CLS-AX (axitinib injectable suspension), is focused on the multi-billion-dollar market for wet AMD. Our target profile for CLS-AX is to maintain visual acuity without the need for retreatment for potentially up to 6 months. The data readout from our Phase 2b ODYSSEY clinical trial remains on track for the end of the third quarter of this year. Importantly, ODYSSEY is a 36-week study designed to re-dose patients with CLS-AX at 6 months, or earlier if needed. This will provide valuable data in a chronic disease for patients treated with more than one dose of CLS-AX, as we begin planning our CLS-AX Phase 3 clinical development program.”

 

Dr. Lasezkay continued, “We have an outstanding team at Clearside that has been strategically expanded over the past several months. We added Dr. Victor Chong, a well-respected, board-certified retinal specialist, as our Chief Medical Officer. Victor’s extensive major pharmaceutical company experience, most recently at Johnson & Johnson, is extremely valuable as he spearheads our product development activities led by the upcoming ODYSSEY data analysis and the planning for our Phase 3 program. In addition, we appointed Tony Gibney, a seasoned biotechnology executive, to our Board of Directors. Tony has broad expertise in business strategy, collaborations, finance, and M&A, including recent and relevant ophthalmology experience at Iveric Bio. We look

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forward to their contributions as we advance our pipeline and continue our efforts to increase the adoption of suprachoroidal delivery.”

 

Key Highlights

 

First Quarter 2024 Financial Results

 

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Conference Call & Webcast Details

Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing 888-645-4404 (U.S.) or 862-298-0702 (international) and requesting the Clearside call. The Company suggests participants join 15 minutes in advance of the event.

 

About Clearside Biomedical, Inc.

 

Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s patented SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina, or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2b clinical testing. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic

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therapeutic innovations. For more information, please visit clearsidebio.com and follow us on LinkedIn and X.

 

Cautionary Note Regarding Forward-Looking Statements

 

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as “believe”, “expect”, “may”, “plan”, “potential”, “will”, and similar expressions, and are based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the clinical development of CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial, the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector® and Clearside’s ability to fund its operations into the third quarter of 2025. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, Clearside’s reliance on third parties over which it may not always have full control and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2023, filed with the U.S. Securities and Exchange Commission (SEC) on March 12, 2024 and Clearside’s other Periodic Reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are based on information available to Clearside as of the date of this release, and Clearside assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.

 

Investor and Media Contacts:

Jenny Kobin

Remy Bernarda

ir@clearsidebio.com

(678) 430-8206

 

-Financial Tables Follow-

 

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CLEARSIDE BIOMEDICAL, INC.

Selected Financial Data

(in thousands, except share and per share data)

(unaudited)

Statements of Operations Data		Three Months Ended March 31,
		2024				2023
License and other revenue		$	230			$	4
Operating expenses:
Research and development			5,615				4,451
General and administrative			2,824				3,158
Total operating expenses			8,439				7,609
Loss from operations			(8,209	)			(7,605	)
Interest income			348				492
Other expense			(1,499	)			—
Non-cash interest expense on liability    related to the sales of future royalties			(2,403	)			(2,167	)
Net loss		$	(11,763	)		$	(9,280	)
Net loss per share of common stock — basic and diluted		$	(0.17	)		$	(0.15	)
Weighted average shares outstanding — basic and diluted			69,853,227				61,169,486

 

Balance Sheet Data	March 31,					December 31,
	2024					2023
Cash and cash equivalents	$	35,355				$	28,920
Total assets		40,142					34,018
Liabilities related to the sales of future royalties, net		44,391					41,988
Warrant liabilities		11,039					—
Total liabilities		61,952					49,930
Total stockholders’ deficit		(21,810	)				(15,912	)

 

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v3.24.1.u1

Document And Entity Information	May 09, 2024
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	May 09, 2024
Entity Registrant Name	Clearside Biomedical, Inc.
Entity Central Index Key	0001539029
Entity Emerging Growth Company	false
Entity File Number	001-37783
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	45-2437375
Entity Address, Address Line One	900 North Point Parkway
Entity Address, Address Line Two	Suite 200
Entity Address, City or Town	Alpharetta
Entity Address, State or Province	GA
Entity Address, Postal Zip Code	30005
City Area Code	678
Local Phone Number	270-3631
Written Communications	false
Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, par value $0.001 per share
Trading Symbol	CLSD
Security Exchange Name	NASDAQ

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