8-K
false000153902900015390292024-04-152024-04-15

 

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): April 15, 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:

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

On April 15, 2024, the Board of Directors (the “Board”) of Clearside Biomedical, Inc. (the “Company”) appointed Anthony S. Gibney to serve as a director of the Company. Mr. Gibney will serve as a Class III director whose term will expire at the 2025 annual meeting of stockholders. There is no arrangement or understanding between Mr. Gibney and any other person pursuant to which he was selected as a director of the Company, and there is no family relationship between Mr. Gibney and any of the Company’s other directors or executive officers. The Company is not aware of any transaction involving Mr. Gibney requiring disclosure under Item 404(a) of Regulation S-K. Additional information about Mr. Gibney is set forth below.

 

Anthony S. Gibney, age 53, most recently served as the Executive Vice President, Chief Business & Strategy Officer of IVERIC bio, Inc. from December 2021 until the acquisition of IVERIC bio, Inc. by Astellas Pharma Inc. in July 2023. Prior to that, Mr. Gibney served as Chief Financial Officer and Chief Business Officer at Fog Pharmaceuticals, Inc., where he oversaw its business development, strategy and finance functions, from May 2020 to December 2021, and as Executive Vice President and Chief Business Officer at Achillion Pharmaceuticals, Inc. from August 2018 until its sale to Alexion Pharmaceuticals, Inc. in May 2020. Before Achillion, Mr. Gibney was a Managing Director and co-head of the Biotechnology Investment Banking team at Leerink Partners LLC, and Managing Director of Merrill Lynch’s Healthcare Group. Mr. Gibney has served on the board of directors of LAPIX Therapeutics, Inc. since January 2024 and on the board of directors of InflaRx N.V., where he previously served on the board of directors from February 2018 to June 2019, since May 2021. Mr. Gibney received a B.A. in Economics and a B.A. in History from Yale University.

 

In accordance with the Company’s compensation policy for non-employee directors, upon his commencement of service as a director, Mr. Gibney will be granted an option to purchase 45,000 shares of the Company’s common stock with an exercise price per share equal to the closing price of the Company’s common stock on the date of grant. This option will vest and become exercisable in 36 equal monthly installments subject to Mr. Gibney’s continuous service through such vesting dates. Additionally, Mr. Gibney will be entitled to receive a $40,000 annual retainer for his service as director. At each annual stockholder meeting following which Mr. Gibney’s term as a director continues, Mr. Gibney will be entitled to receive an additional stock option to purchase 30,000 shares of the Company’s common stock, which option will vest in full and become exercisable on the earlier of the date immediately prior to the next annual stockholder meeting or 12 months following the date of grant. Mr. Gibney has also entered into the Company’s standard form of indemnification agreement.

Item 7.01 Regulation FD Disclosure.

On April 15, 2024, the Company issued a press release announcing the appointment of Mr. Gibney to the Board. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information set forth in this Item 7.01 and contained in the press release furnished as Exhibit 99.1 shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), and is not incorporated by reference into any of the Company’s filings under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as shall be expressly set forth by specific reference in any such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit

Number

 

Exhibit Description

99.1

 

Press Release, dated April 16, 2024.

104

 

Cover Page Interactive Data File (embedded within 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: April 16, 2024

CLEARSIDE BIOMEDICAL, INC.

By:

/s/ Charles A. Deignan

Name:

Charles A. Deignan

Title:

Chief Financial Officer

 


EX-99.1

Exhibit 99.1

https://cdn.kscope.io/5b7428d94cbd5cccba43e8451f9a0719-img171462827_0.jpg 

 

Clearside Biomedical Appoints Seasoned Biotechnology Executive Anthony S. Gibney to its Board of Directors

 

- Appointment Adds Broad Expertise in Business Strategy, Collaborations, Finance, and M&A with Recent Ophthalmic Experience -
 

ALPHARETTA, Ga., April 16, 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®), announced today that Anthony S. Gibney has been appointed to the Company's Board of Directors, effective April 15, 2024.

 

“We are delighted to welcome Tony to our Board of Directors as we build on our leadership in delivering therapeutics to the suprachoroidal space,” said Clay Thorp, Chair of the Clearside Board of Directors. “We believe Tony’s significant experience driving value for biotech companies through successful pipeline development, financing, partnering and M&A will be an invaluable resource to the Clearside team as we enter this pivotal growth phase of the company.”

 

George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer of Clearside, commented, “Tony’s deep understanding of the biotech business, combined with his recent and relevant experience at Iveric Bio, will provide critical insight and guidance for our strategic and business development initiatives as we look towards a potential Phase 3 program for our lead clinical program, CLS-AX in wet AMD, and explore opportunities for suprachoroidal pipeline expansion.”

 

“I am honored to join the Board of Directors as Clearside offers a differentiated approach in the ophthalmology space,” said Mr. Gibney. “I look forward to partnering with the leadership team and Board to generate value based on the opportunity for CLS-AX in retinal diseases and Clearside’s innovative suprachoroidal delivery platform that I believe has broad potential to improve outcomes for individuals living with a number of sight-threatening diseases.”

 

Anthony S. Gibney is an experienced biotechnology executive and former investment banker who brings over 25 years of experience dedicated to advising biotechnology companies in the U.S. and Europe on business strategy, collaboration transactions, financings, and mergers and acquisitions. Most recently, Mr. Gibney served as the


 

Executive Vice President, Chief Business & Strategy officer of Iveric Bio, Inc. until the company’s acquisition by Astellas Pharma Inc. in July 2023. Prior to that, Mr. Gibney served as Chief Financial Officer and Chief Business Officer at Fog Pharmaceuticals, Inc., where he oversaw its business development, strategy and finance functions, and he served as Executive Vice President and Chief Business Officer at Achillion Pharmaceuticals, where he led the sale of Achillion to Alexion Pharmaceuticals, Inc. in 2020. Before Achillion, Mr. Gibney was a Managing Director and Co-head of the biotechnology investment banking team at Leerink Partners LLC, and Managing Director of Merrill Lynch’s healthcare group. He currently serves on the boards of directors of LAPIX Therapeutics, Inc. and InflaRx N.V. Mr. Gibney received a B.A. in Economics and a B.A. in History from Yale University.

 

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 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 reporting of results from the ODYSSEY clinical trial, the potential benefits of Mr. Gibney joining the Board of Directors and the potential benefits of CLS-AX and other product candidates using


 

Clearside’s SCS Microinjector®. 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

 

 

Source: Clearside Biomedical, Inc.