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): November 20, 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))
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 8.01 Other Events.
Clearside Biomedical, Inc. (the “Company”) was recently informed by its commercial contract manufacturer for XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), that the U.S. Food and Drug Administration has requested that the manufacturer complete certain manufacturing activities within its facility. These activities are not specifically related to XIPERE, but Clearside expects a delay in the production of the drug product stability data needed to resubmit its New Drug Application (“NDA”). Based on current information from the manufacturer, the Company now expects to resubmit the XIPERE NDA in the second quarter of 2020.
On November 20, 2019, members of management of the Company will present at the Stifel 2019 Healthcare Conference on, among other things, the Company’s product candidate pipeline and clinical and regulatory status. A copy of the presentation that is being presented at the conference is available on the Company’s website at www.clearsidebio.com, and is filed as Exhibit 99.1 to this Current Report on Form 8-K, the contents of which are incorporated herein by reference.
Item 9.01 Financial Statements and Exhibits.
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: November 20, 2019 | | Charles A. Deignan |
| | Chief Financial Officer |
