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 23, 2018
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 Office) (Zip Code)
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. ☒
| Item 7.01 | Regulation FD Disclosure. |
On April 23, 2018, members of management of Clearside Biomedical, Inc. (the “Company”) will hold meetings to review, among other things, the Company’s product candidate pipeline and recent clinical results. The presentation that will be used in the meetings contains certain new charts of clinical data from the Company’s pivotal Phase 3 clinical trial of suprachoroidal CLS-TA in patients with macular edema associated with non-infectious uveitis, which charts are furnished as Exhibit 99.1 to this Current Report on Form 8-K.
The information in this Item 7.01 of this Current Report on Form 8-K (including Exhibit 99.1) is being furnished and 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 liabilities of that Section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit No. |
Description | |
| 99.1 | Clinical Data Charts. | |
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 23, 2018 | CLEARSIDE BIOMEDICAL, INC. | |||||
| By: | /s/ Charles A. Deignan | |||||
| Name: | Charles A. Deignan | |||||
| Title: | Chief Financial Officer | |||||
Percent Subjects Resolution of Signs of Uveitis % Subjects Displaying Change to Zero at Week 24 There was at least a 50% difference in each of these measures Anterior Chamber Cells Anterior Chamber Flare Vitreous Haze Active Control Active Control Active Control Exhibit 99.1
Patient Rescue: Kaplan-Meier 85-90% of subjects in the CLS-TA arm were not rescued, while a majority of subjects in the control arm were rescued, before the end of the study Proportion of Patients Not Rescued Time to Rescue (days) CLS-TA Control + Censored