clsd-8k_20190407.htm

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, DC 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 7, 2019

 

 

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, GA 30005

(Address of principal executive offices, including zip code)

 

(678) 270-3631

(Registrant’s telephone number, including area code)

 

N/A

(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))

 

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 account 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.

 

(b)                                 Resignation of Daniel White as President and Chief Executive Officer and as a Board Member

 

On April 7, 2019, Daniel White resigned as the President and Chief Executive Officer of Clearside Biomedical, Inc. (the “Company”) and as a member of the Company’s board of directors (the “Board”). 

 

In connection with Mr. White’s resignation, the Board approved the following severance benefits for Mr. White, contingent upon him signing a separation agreement containing a release and certain restrictive covenants: (a) an amount equal to 18 months of his annual base salary, less applicable deductions, payable in accordance with the Company’s normal payroll schedule; (b) reimbursement of the cost of health insurance premiums for 18 months or, if shorter, until he obtains reasonably comparable health insurance coverage; (c) acceleration of vesting of each equity award held by him to the extent the award would have vested had he remained employed for 18 months following his resignation; and (d) an extended exercise period for each equity award held by him such that he may exercise vested shares under his outstanding equity awards until the earlier of 90 days following the Company’s 2020 annual meeting of stockholders or the expiration date of the applicable equity award.

 

(c)                                  Appointment of George Lasezkay as Interim Chief Executive Officer

 

On April 7, 2019, the Board appointed George Lasezkay, Pharm.D., J.D. as the Company’s Interim Chief Executive Officer. In connection with Dr. Lasezkay’s appointment as Interim Chief Executive Officer, Jeffrey Edwards replaced Dr. Lasezkay as a member of the Audit Committee and Clay Thorp replaced Dr. Lasezkay as Chair of the Nominating and Corporate Governance Committee on April 7, 2019.

 

There is no arrangement or understanding between Dr. Lasezkay and any other person pursuant to which he was selected as an officer of the Company, and there is no family relationship between Dr. Lasezkay and any of the Company’s other directors or executive officers. Additional information about Dr. Lasezkay is set forth below:

 

George Lasezkay, Pharm.D., J.D., age 67, has served as a director of the Company since August 2017. Dr. Lasezkay has served as an Adjunct Professor, Pharmaceutical Law and Policy at the University of San Diego School of Law since January 2013.  He previously served as Executive Vice President and General Counsel of Acucela Inc., a pharmaceutical company, from August 2015 to July 2016.  Prior to Acucela, Dr. Lasezkay served as President of Horizon Pharma Consulting Group from 2005 to December 2015.  Prior to Horizon, Dr. Lasezkay served in various roles of increasing responsibility at Allergan, Inc. a global pharmaceutical and medical aesthetics company, from 1989 to 2002, most recently as the Corporate Vice President for Corporate Development from 1996 to 2002. Dr. Lasezkay received his B.S. and Pharm.D. degrees from the University of Buffalo, a J.D. degree from the University of Southern California Gould School of Law and a Certificate, Dispute Resolution from Pepperdine University School of Law.

 

In connection with his appointment as Interim Chief Executive Officer, on April 7, 2019, the Company granted Dr. Lasezkay an option to purchase 250,000 shares of the Company’s common stock. The shares underlying this stock option will vest in six equal monthly installments beginning on May 7, 2019, subject to Dr. Lasezkay’s continuous service through each such date. The exercise price for the stock option is $1.40 per share, which was the closing price of the Company’s common stock on the Nasdaq Global Market on April 5, 2019, the last trading day prior to the date of grant.

 

Item 7.01. Regulation FD Disclosure.

 

On April 8, 2019, the Company issued a press release announcing the resignation of Mr. White and the appointment of Dr. Lasezkay as the Interim Chief Executive Officer. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report on Form 8-K.

 

Item 9.01.                                        Financial Statements and Exhibits.

 

(d)                                 Exhibits.

 

Exhibit

 

 

Number

 

Description

99.1

 

Press Release, dated April 8, 2019



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.

 

 

 

 

By:

/s/ Charles A. Deignan

 

Date: April 11, 2019

 

Charles A. Deignan

 

 

Chief Financial Officer

 

clsd-ex991_22.htm

Exhibit 99.1

 

 

Clearside Biomedical Appoints Dr. George Lasezkay as Interim CEO

 

ALPHARETTA, Ga., April 8, 2019 -- Clearside Biomedical, Inc. (NASDAQ:CLSD),
a biopharmaceutical company dedicated to developing treatments that restore and preserve vision for people with serious eye diseases, announced today that its Board of Directors has appointed seasoned biopharmaceutical executive George Lasezkay, Pharm.D., J.D. to the position of Interim Chief Executive Officer, effective immediately. Dr. Lasezkay, a current member of the Clearside Board of Directors, succeeds Daniel H. White, who resigned as President and CEO and as a member of the Board of Directors to pursue other opportunities. The Board is initiating a search to identify a permanent CEO.

 

William Humphries, Chairman of the Clearside Board of Directors, said, “We believe there is tremendous potential in our proprietary suprachoroidal space (SCS) injection platform, as evidenced by the acceptance of our New Drug Application (NDA) for XIPERE™ (triamcinolone acetonide ophthalmic suspension) for Suprachoroidal Injection. We want to thank Daniel for his visionary contributions, including licensing the original scientific technology, building our versatile therapeutic platform, leading our IPO and other financings, and hiring an experienced team to bring these important innovative products to market.”

 

“We are at an important stage in the evolution of our Company, so we are pleased to have Dr. George Lasezkay serve as CEO on an interim basis as we conduct a search for our next CEO. George has broad expertise in ophthalmology established during his tenure at Allergan, Inc., where he served on the company’s Executive Committee. With proven management experience and substantial industry knowledge, we believe George will help lead our team as we prepare for commercialization of our first product and look to leverage our unique platform through pipeline expansion and partnerships. We expect to benefit from his combination of clinical, legal, business development and executive expertise, and his diverse experience working with a number of emerging biopharmaceutical companies,” Mr. Humphries concluded.

 

Dr. Lasezkay, Interim CEO, stated “We are excited about our suprachoroidal drug delivery platform and potential approval of our first agent for the treatment of macular edema associated with uveitis, which would be a significant milestone for Clearside. We also believe the platform has broad applicability in other eye diseases and continue to explore utilizing suprachoroidal administration with other small molecules and gene therapy. I am confident in the capabilities of the Clearside team and look forward to working with them to ensure the long-term success of XIPERE, prudently build our ophthalmic pipeline, and work with potential partners to leverage our platform and provide international reach.”

 

 

 

 


 

About George Lasezkay, Pharm.D., J.D.

 

Dr. Lasezkay has an accomplished history of success in the life sciences industry. For the past 15 years, he has served as an independent director on the boards of a number of domestic and foreign emerging biopharmaceutical companies, including serving as a director of Clearside since August 2017.

 

Previously, Dr. Lasezkay served as Executive Vice President and General Counsel at Acucela Inc., a development stage company that specializes in identifying and developing novel ophthalmic therapeutics. For the 10 years prior to joining Acucela, he was President of Horizon Pharma Group, a private life sciences consultancy practice. Prior to Horizon, Dr. Lasezkay was Corporate Vice President for Corporate Development at Allergan, Inc., the global pharmaceutical and medical aesthetics company. His 13 years of progressive experience at Allergan involved a number of executive leadership positions, including being a member of the company’s Executive Committee, Assistant General Counsel for Commercial Affairs, and General Counsel for the Asia-Pacific Region.

 

Dr. Lasezkay has played a critical role in developing corporate strategy and has been responsible for a wide variety of licensing, research and development collaboration and acquisition transactions involving new technologies, products and companies. He also has a multi-disciplinary background in private firm and in-house legal practice, hospital pharmacy practice, clinical pharmacokinetics consultation and clinical drug research.

 

Dr. Lasezkay earned his B.S. Pharmacy and Doctor of Pharmacy degrees from the State University of New York at Buffalo, and a J.D. degree from the University of Southern California Gould School of Law.

 

About Clearside Biomedical

 

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 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 such as gene therapy. Clearside is headquartered in Alpharetta, GA. For more information, please visit http://www.clearsidebio.com.

 

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 potential attributes and benefits of Clearside’s product candidates, the potential approval and commercialization of XIPERE in the United States and Clearside’s future developments with Dr. Lasezkay as the Interim CEO. 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, 2018, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 15, 2019, 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:


Jenny Kobin (919) 423-4799

Remy Bernarda (415) 203-6386
ir@clearsidebio.com

 

Charles Deignan

Chief Financial Officer

(678) 270-4005

charlie.deignan@clearsidebio.com

 

Source: Clearside Biomedical, Inc.