8-K

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): July 17, 2025

    

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:

☐Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

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. ☐

Item 2.05 Costs Associated with Exit or Disposal Activities.

On July 17, 2025, Clearside Biomedical, Inc. (the “Company”) announced that it is exploring strategic alternatives to enhance shareholder value, and that in connection with such process and in order to extend the Company’s resources, the Company is implementing a plan pursuant to which all Clearside employees will have their employment with the Company terminated and will transition into consulting roles with the Company. The reduction in force is expected to be completed during the third quarter of 2025.

The Company estimates that it will incur charges of approximately $3.4 million for severance and other employee termination-related costs in the third quarter of 2025. The estimated charges that the Company expects to incur are subject to a number of assumptions, and actual results may differ materially from these estimates. The Company may also incur additional costs not currently contemplated due to events that may occur as a result of, or that are associated with, its workforce reduction.

Item 5.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers.

In connection with the workforce reduction, each of George Lasezkay, the Company’s President and Chief Executive Officer, Charles A. Deignan, the Company’s Chief Financial Officer, and Victor Chong, the Company’s Chief Medical Officer plan to enter into a Separation Agreement with the Company (collectively, the “Separation Agreements”), pursuant to which each executive’s employment with the Company will cease effective as of July 18, 2025 (the “Separation Date”). Each Separation Agreement provides for severance benefits for each of Dr. Lasezkay, Mr. Deignan and Dr. Chong as follows: (a) an amount equal to 39 weeks, 31 weeks and 26 weeks, respectively, of their respective annual base salaries in effect as of the Separation Date, less applicable deductions, payable in a lump sum on the Company’s first regular payroll date following the effective date of the Separation Agreement, (b) payment of the cost of COBRA premiums to continue health insurance coverage for up to 9 months, 7 months and 6 months, respectively, (c) the opportunity to retain the Company-issued laptop computer provided to the executive during employment after the Separation Date, and (d) for Dr. Lasezkay, an extended period of up to 12 months from the end of the Consulting Period (as defined below) to exercise his stock options. The foregoing severance benefits are contingent upon the executive timely executing their Separation Agreement (including general release of claims set forth therein), allowing the Separation Agreement to become fully effective in accordance with its terms, and complying fully with their obligations to the Company.

In addition, each of Dr. Lasezkay, Mr. Deignan and Dr. Chong plan to enter into Consulting Agreements with the Company (collectively, the “Consulting Agreements”) with the Company, effective as of the Separation Date, pursuant to which they will perform consulting services for the Company consistent with their respective executive roles. Each Consulting Agreement has a term from July 18, 2025 until the earlier of (i) the closing of a Change in Control or Corporate Transaction (as defined in the Company’s 2016 Equity Incentive Plan); and (ii) December 31, 2025 (which date may be extended on a monthly basis by the Company in its sole discretion), unless earlier terminated by either party thereto (such period during which the Consulting Agreement is in effect, the “Consulting Period”). Each of Dr. Lasezkay, Mr. Deignan and Dr. Chong will receive hourly compensation and continued vesting of equity awards pursuant to the terms of his respective Consulting Agreement. In addition, in the event that any of Dr. Lasezkay, Mr. Deignan and Dr. Chong is continuing to provide services under his respective Consulting Agreement through the consummation of a Change in Control or Corporate Transaction (as defined in the Company’s 2016 Equity Incentive Plan) subject to specified terms, and provided that such executive has not been given an offer of employment with any acquirer in such Change in Control or Corporate Transaction on substantially similar terms as under such executive’s prior employment agreement with the Client, then any such executive will be eligible to receive (i) an additional payment equal to $0.9 million, $0.6 million and $0.7 million, respectively, and (ii) accelerated vesting of equity awards such that any then-unvested equity awards held by the executive shall be deemed vested and exercisable as of the consummation of the applicable Change in Control or Corporate Transaction.

Dr. Lasezkay will continue to serve as the Company’s principal executive officer and Mr. Deignan will continue to serve as the Company’s principal financial officer and principal accounting officer. Dr. Lasezkay will also continue to serve as director on the Company’s board of directors.

The foregoing description of the Separation Agreements and Consulting Agreements do not purport to be complete and are qualified by reference to the full text of each agreement, copies of which will be filed as exhibits to the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2025.

Item 8.01 Other Events.

On July 17, 2025, the Company issued a press release announcing that it had commenced a process to explore and evaluate strategic alternatives to enhance shareholder value, a copy of which is filed as Exhibit 99.1 hereto.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits


Exhibit Number		Description
99.1		Press Release dated July 17, 2025.
104		Cover Page Interactive Data File (embedded with the Inline XBRL document)

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.


Date: July 17, 2025	CLEARSIDE BIOMEDICAL, INC.



	By:	/s/ Charles A. Deignan
	Name:	Charles A. Deignan
	Title:	Chief Financial Officer

Clearside Biomedical Announces Plan to Explore Strategic Alternatives to Advance its Proprietary Suprachoroidal Space (SCS®) Delivery Platform and Promising Ophthalmology Pipeline

- Proven In-Office, Repeatable, Non-Surgical Procedure for the Targeted Delivery of a Wide Variety of Therapies for Serious Retinal Diseases -

- CLS-AX Phase 3-Ready Asset with Global Investigator Support and FDA Alignment on Pivotal Trial Program in wet AMD -

- Validated Delivery Platform with Five Commercial and Late-Stage Development Suprachoroidal Licensing Collaborations -

ALPHARETTA, Ga., July 17, 2025 -- 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 announced plans to explore a full range of strategic alternatives to advance its SCS platform and drug development pipeline to maximize stockholder value. The Company has retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support it with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of the Company’s assets and technologies, collaboration, partnership, merger, acquisition, joint ventures, or other strategic transactions.

“We strongly believe that our proprietary suprachoroidal delivery platform provides an effective and reliable way to target challenging retinal diseases that need longer lasting treatments,” said George Lasezkay, PharmD, JD, President and Chief Executive Officer. “Our SCS Microinjector® enables a proven in-office, repeatable, non-surgical procedure for the targeted delivery of a wide variety of therapies to the macula, retina, and choroid. Based on our retinal expertise and intellectual property, we delivered the first commercial product using our SCS platform, which is now approved and commercialized in the U.S., approved in Singapore and Australia, and is currently under regulatory review in China and Canada.”

Dr. Lasezkay further stated, “We have successfully produced positive and highly competitive Phase 2b clinical data for CLS-AX for the treatment of wet AMD. We are proud of the fact that the CLS-AX ODYSSEY Phase 2b trial is the only TKI clinical trial to

date to achieve positive safety and efficacy results from multiple TKI dosing in wet AMD patients. Further, in February 2025, we conducted a successful end of Phase 2 meeting with the FDA through which we gained alignment on a Phase 3 development plan for CLS-AX in wet AMD. In addition, our clinical development collaboration partners continue to make progress in advancing their later-stage suprachoroidal clinical programs utilizing our SCS Microinjector in various ophthalmic disorders.”

Dr. Lasezkay continued, “Clearside’s innovative and pioneering achievements demonstrating the safety, simplicity and effectiveness of delivering drugs to the suprachoroidal space are the direct result of the many years of significant contributions by the current Clearside team and many of our past employees. I am proud of and grateful for their hard work and dedicated commitment to improving the lives of patients suffering from the burden of disabling, blinding diseases.”

“Given the current unpredictable economic environment and challenging fundraising conditions in the biopharmaceutical industry, we are taking the necessary next steps to evaluate strategic alternatives for the Company. In order to facilitate this process and conserve cash, while continuing our support of the Company’s SCS Microinjector® licensees, all Clearside employees, including the Chief Executive Officer, Chief Financial Officer, and Chief Medical Officer, will transition into consulting roles with the Company this week. In addition, we will pause all internal research and development programs during this process,” concluded Dr. Lasezkay.

No agreement providing for any strategic transaction has been reached and there can be no assurance that this process will result in any such transaction. Clearside has not set a timetable for the strategic review process. Clearside does not intend to provide updates until the Board approves a specific action or otherwise determines that disclosure is appropriate or required.

Company Highlights

SCS Injection Platform:

•

The SCS Microinjector is a proven in-office, repeatable, non-surgical procedure for the targeted 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 has formulation expertise in developing small molecule suspensions that can be delivered into the suprachoroidal space, and commercial scale manufacturing capability for the SCS Microinjector that includes ISO certification.

•

The Company successfully navigated the U.S. Food & Drug Administration (FDA) drug/device regulatory pathway to obtain commercial approval for its first product,

XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use for the treatment of uveitic macular edema.

•

A permanent CPT code is assigned in the U.S. for suprachoroidal injections permitting physicians to receive higher reimbursement for administering any drug into the SCS versus the reimbursement of the current practice of injecting drugs into the vitreous.

Internal Pipeline - CLS-AX Program:

•

CLS-AX (axitinib injectable suspension) is a proprietary suspension of axitinib for suprachoroidal injection. CLS-AX is being developed for the treatment of neovascular age-related macular degeneration (wet AMD).

•

Axitinib is a tyrosine kinase inhibitor (TKI) that achieves pan-VEGF blockade, directly inhibiting VEGF receptors-1, -2, and -3 with high potency and specificity. Clearside believes this broad VEGF blockade may have efficacy advantages over existing retinal therapies by acting at a different level of the angiogenesis cascade and may benefit patients who sub-optimally respond to current, more narrowly focused anti-VEGF therapies.

•

Age-related macular degeneration causes a progressive loss of central vision and is the most common cause of legal blindness in individuals over age 55. Wet AMD is generally caused by abnormal blood vessels that leak fluid or blood into the macula, the part of the retina responsible for central vision, and accounts for the majority of vision loss in patients with this disorder.

•

Suprachoroidal injection of CLS-AX has demonstrated meaningful potential in Phase 1/2a and Phase 2b wet AMD clinical trials. These data strongly support the potential efficacy, safety and versatility of CLS-AX to treat this chronic disease.

•

Clearside conducted a successful End-of-Phase 2 meeting with the FDA and aligned on the essential components of a Phase 3 program.

•

The Phase 3 program is designed to maximize the commercial potential for CLS-AX with the potential to provide physicians and their patients with dosing flexibility similar to the current standard of care anti-VEGF biologics, but with the extended durability of a TKI. This combination of dosing flexibility and durability may improve outcomes and reduce the treatment burden for patients suffering from these potentially blinding retinal disorders, as well as their caregivers.

Internal Pipeline – Preclinical Small Molecule Programs:

•

Clearside is evaluating various small molecules for a range of retinal diseases with high unmet medical need.

•

Clearside is evaluating preclinical data on two approaches targeting Geographic Atrophy (GA) – improving choroidal perfusion and modulating pro-inflammatory cells. GA is a progressive, late-stage form of dry age-related macular degeneration characterized by well-defined areas of retinal cell loss in the macula, leading to irreversible central vision impairment. Delivery of small molecules via suprachoroidal

injection enables comprehensive drug coverage of both the retina and choroid, while also potentially minimizing systemic and anterior segment side effects.

•

Clearside is evaluating preclinical data on the combination of a steroid plus a TKI (axitinib formulation) for the treatment of Diabetic Macula Edema (DME). DME is the most common cause of vision loss in individuals with diabetes, in which fluid accumulates in the central part of the retina causing swelling and vision distortion due to leaky blood vessels damaged by prolonged high blood sugar.

External Licensing Agreements:

•

Clearside strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic agents including gene therapies and anti-tumor agents.

•

Clearside’s innovative SCS Microinjector is being used in commercial ophthalmic products and promising clinical development programs by Aura Biosciences, Bausch + Lomb, BioCryst Pharmaceuticals, REGENXBIO and its global partner AbbVie, and Arctic Vision and its commercial partner Santen.

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®) to improve patient outcomes. 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), is in development for the treatment of neovascular age-related macular degeneration (wet AMD). Planning for a Phase 3 program is underway. In addition, Clearside is evaluating various small molecules for the potential long-acting treatment of geographic atrophy (GA). 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 therapeutic innovations. For more information, please visit clearsidebio.com or 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, including the planned Phase 3 trial design, the potential benefits of CLS-AX, Clearside’s suprachoroidal delivery technology and Clearside’s SCS Microinjector®, and Clearside’s pursuit of strategic alternatives and the entry into or completion of any strategic alternative transaction. 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, Clearside's ability to raise additional capital, and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2024, filed with the U.S. Securities and Exchange Commission (SEC) on March 27, 2025 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

Source: Clearside Biomedical, Inc.