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 8, 2020
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.
On April 8, 2020, Clearside Biomedical, Inc. (the “Company”) will be posting an updated corporate presentation on its website. A copy of the presentation is filed as Exhibit 99.1 to this Current Report on Form 8-K, the contents of which are incorporated herein by reference.
Among other things, the updated presentation includes a slide related to the Company’s entry into the License Agreement (the “Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”), as previously disclosed on the Company’s Current Report on Form 8-K filed with the U.S. Securities and Exchange Commission on March 13, 2020.
Pursuant to the Agreement, the Company has granted an exclusive license to Arctic Vision to develop, distribute, promote, market and commercialize XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension), subject to specified exceptions, in China, Hong Kong, Macau, Taiwan and South Korea (the “Territory”). Arctic Vision has agreed to use commercially reasonable efforts to pursue development and commercialization of XIPERE for indications associated with uveitis in the Territory. In addition, upon receipt of the Company’s consent, Arctic Vision will have the right, but not the obligation, to develop and commercialize XIPERE for additional indications in the Territory.
The slide related to the Agreement in the updated presentation includes a description of the following terms of the Agreement:
| • | the Company has received a $4.0 million upfront payment from Arctic Vision; |
| • | the Company is eligible to receive up to an additional $31.5 million in aggregate milestone payments for pre-specified approval, development and sales milestone events; and |
| • | the Company will also be entitled to receive tiered royalties of ten to twelve percent of net sales based on achieving certain annual net sales thresholds in the Territory, which, subject to customary reductions, will be payable on a product-by-product and country-by-country basis, commencing at launch in such country and lasting until the latest of (i) the date that all valid claims within the licensed patent rights covering XIPERE have expired, (ii) the date of the loss of marketing or regulatory exclusivity of XIPERE in a given country, or (iii) ten years from the first commercial sale of XIPERE in a given country. |
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: April 8, 2020 | | Charles A. Deignan |
| | Chief Financial Officer |
