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): September 26, 2018

 

 

Registrant's telephone number, including area code: (678) 270-3631

Not Applicable

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 (see General Instruction A.2 below):

☐ 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))

 

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

On September 26, 2018, Evgeny Zaytsev provided notice to the board of directors (the “Board”) of Clearside Biomedical, Inc. (the “Company”) of his decision to resign from the Board and the Company’s Compensation Committee, effective immediately. Dr. Zaytsev’s decision to resign was not the result of any disagreement with the Company.

 

Also on September 26, 2018, the Board appointed Jeffrey L. Edwards to serve as a director of the Company and as a member of the Company’s Compensation Committee.  Mr. Edwards will serve as a Class I director whose term will expire at the 2020 annual meeting of stockholders.  There is no arrangement or understanding between Mr. Edwards and any other person pursuant to which he was selected as a director of the Company, and there is no family relationship between Mr. Edwards and any of the Company’s other directors or executive officers.  The Company is not aware of any transaction involving Mr. Edwards requiring disclosure under Item 404(a) of Regulation S-K. Additional information about Mr. Edwards is set forth below.

Jeffrey L. Edwards, age 58, retired from Allergan, Inc., a multi-specialty health care company, in February 2015 after nearly 22 years at Allergan. From September 2005 to August 2014, he served as Executive Vice President, Finance and Business Development, Chief Financial Officer at Allergan. From 2003 to 2005 he served as Allergan’s Corporate Vice President, Corporate Development and previously served as Senior Vice President, Treasury, Tax and Investor Relations. Prior to joining Allergan, Mr. Edwards was with Banque Paribas from 1992 to 1993 and Security Pacific National Bank from 1983 to 1992, where he held various senior-level positions in the credit and business development functions. Mr. Edwards currently serves on the board of directors of FibroGen, Inc. and Bio-Rad Laboratories, Inc., both of which are publicly traded biopharmaceutical companies. Mr. Edwards received a Bachelor of Arts in Sociology from Muhlenberg College and completed the Advanced Management Program at the Harvard Business School.

In accordance with the Company’s compensation policy for non-employee directors, upon his commencement of service as a director, Mr. Edwards will be granted a nonqualified stock option to purchase 22,500 shares of the Company’s common stock.  The stock option will have an exercise price per share equal 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. Edwards’s Continuous Service (as defined in the Company’s 2016 Equity Incentive Plan) through such vesting dates.  Additionally, Mr. Edwards will be entitled to receive a $40,000 annual retainer for his service as director and a $6,000 annual retainer for his service on the Compensation Committee.  At each annual stockholder meeting following which Mr. Edwards’s term as a director continues, Mr. Edwards will be entitled to receive an additional nonqualified stock option to purchase 11,250 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. Edwards has also entered into the Company’s standard form of indemnification agreement.    

 

 

Item 7.01             Regulation FD Disclosure.

 

On September 26, 2018, the Company issued a press release announcing the resignation of Dr. Zaytsev and the appointment of Mr. Edwards to the Board.  A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report. The information 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 Exhibits. 

 

(d) Exhibits

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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.

 

 

Exhibit 99.1

 

 

Clearside Biomedical Appoints Jeffrey Edwards to Board of Directors

Succeeds Retiring Director, Evgeny Zaytsev

 

ALPHARETTA, GA, September 26, 2018 (GLOBE NEWSWIRE) – Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, today announced that Jeffrey Edwards has been appointed to its Board of Directors, effective immediately.

 

Mr. Edwards, a veteran of the global pharmaceuticals industry, spent 21 years at Allergan, Inc. in positions of increasing responsibility, including Executive Vice President, Finance and Business Development & Chief Financial Officer from 2005 to 2014, continuing as a non-executive officer of the company until his retirement in February 2015.  From 2003 to 2005, Mr. Edwards served as Allergan’s Corporate Vice President, Corporate Development and previously served as its Senior Vice President, Treasury, Tax and Investor Relations.  Prior to joining Allergan, Mr. Edwards was with Banque Paribas and Security Pacific National Bank, where he held various senior-level positions in the credit and business development functions.  He has extensive corporate governance experience and currently serves on the Boards of Directors of the publicly traded companies Bio-Rad Laboratories, Inc. and FibroGen, Inc., as well as on the Board of Directors of Viamet Pharmaceuticals Holdings, LLC, a privately held biopharmaceutical company.  Mr. Edwards received a Bachelor of Arts degree in Sociology from Muhlenberg College and completed the Advanced Management Program at the Harvard Business School.

 

"Jeff is a proven financial executive with extensive commercial, corporate development and public company management experience, and I would like to welcome him on behalf of everyone at Clearside,” said William D. Humphries, Chairman of Clearside’s Board of Directors.  “As we prepare to submit our first NDA, increase our commercial readiness and advance our late-stage pipeline, Jeff’s strategic, operational and financial expertise will be a tremendous asset to our team and to our shareholders.”

 

Mr. Edwards succeeds Evgeny Zaytsev, M.D., who has resigned from Clearside’s Board of Directors.

 

“On behalf of everyone at Clearside, I would like to thank Evgeny for his many contributions to the company, both before and after it went public,” said Mr. Humphries.  “Evgeny championed an anchor investment in the company’s Series B financing by RMI Partners, a venture capital company with a strategic focus on investments supporting the development of innovative biopharmaceutical products and medical technologies, and he joined Clearside’s board in August 2014.  In the time that I have worked with Evgeny, he has earned my deep personal admiration and great professional respect.  I wish him continued success.”  

 

About Clearside

 

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases.  Clearside’s proprietary suprachoroidal treatment approach offers unprecedented access to the back of the eye where sight-threatening disease

 

 

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often occurs.  The company’s unique platform for eye disease treatments is inherently flexible and intended to work with established medicines, new formulations of medicines, as well as future innovations. Clearside’s pipeline includes advanced and pre-clinical product candidates in diseases where macular edema is a common complication, including uveitis, retinal vein occlusion (“RVO”) and diabetic macular edema (“DME”).  Clearside’s most advanced program is in non-infectious uveitis and it expects to submit a New Drug Application to the U.S. Food and Drug Administration for use of suprachoroidal CLS-TA for the treatment of macular edema associated with non-infectious uveitis by the end of 2018.  The company is also conducting two ongoing Phase 3 trials of suprachoroidal CLS-TA with an intravitreal anti-VEGF agent in patients with RVO.  In addition, Clearside recently announced positive topline results from a Phase 2 clinical trial of suprachoroidal CLS-TA used with EYLEA® (aflibercept) in patients with DME, and is continuing to analyze additional data from the trial as it becomes available.  Clearside  is headquartered in Alpharetta, GA.  For more information, please visit http://www.clearsidebio.com.  Follow @clearsidebio on Twitter and Linkedin.

 

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 expectations regarding the clinical development of Clearside’s product candidates, and the timing of a potential submission of an NDA with the FDA. 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, 2017, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 16, 2018, 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.

 

Contacts:

 

Stephen Kilmer

Investor Relations

(678) 430-8206

stephen.kilmer@clearsidebio.com

 

Charles Deignan

Chief Financial Officer

(678) 270-4005

charlie.deignan@clearsidebio.com