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): February 27, 2017
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.) |
1220 Old Alpharetta Road, Suite 300
Alpharetta, Georgia 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)) |
| Item 7.01 | Regulation FD Disclosure. |
On February 27, 2017, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing the redirection of its resources from its wet age-related macular degeneration (“wet AMD”) research to its diabetic macular edema (“DME”) clinical development program, as described below.
A copy of the press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information set forth in this Item 7.01 and 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 Registrant’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 8.01 | Other Events. |
In the press release described above, the Registrant announced that it has initiated a strategic realignment of its research resources from its pre-clinical development program for axitinib for the treatment of wet AMD toward its ongoing clinical development program for Zuprata, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide, together with an anti-VEGF agent, for the treatment of DME. While the Registrant plans to continue to investigate axitinib and other compounds for the treatment of wet AMD, it no longer expects to submit an Investigational New Drug application to the U.S. Food and Drug Administration.
| Item 9.01 | Financial Statements and Exhibits. |
(d) Exhibits
| Exhibit |
Exhibit Description | |
| 99.1 | Press Release, dated February 27, 2017, “Clearside Biomedical, Inc. Redirects Pre-Clinical AMD Research Resources Toward Ongoing DME Clinical Development Program” | |
2
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: February 27, 2017 | Charles A. Deignan Chief Financial Officer | |||||
3
EXHIBIT INDEX
| Exhibit |
Exhibit Description | |
| 99.1 | Press Release, dated February 27, 2017, “Clearside Biomedical, Inc. Redirects Pre-Clinical AMD Research Resources Toward Ongoing DME Clinical Development Program” | |
4
Exhibit 99.1
Clearside Biomedical, Inc. Redirects Pre-Clinical AMD Research Resources Toward Ongoing DME Clinical Development Program
Alpharetta, GA (February 27, 2017) - Clearside Biomedical, Inc. (NASDAQ:CLSD), a late-stage biopharmaceutical company developing first-in-class drug therapies to treat back-of-the-eye diseases, today announced that it has initiated a strategic realignment of its research and development resources from its pre-clinical development program for axitinib for the treatment of wet age-related macular degeneration (“wet AMD”) toward its ongoing clinical development program for the treatment of diabetic macular edema (“DME”) assessing ZuprataTM, its proprietary suspension formulation of the corticosteroid triamcinolone acetonide.
In mid-2016, Clearside announced that it had selected axitinib as the lead compound for the treatment of wet AMD through suprachoroidal administration due to its potency in targeting the VEGF and PDGF receptors, and because of its long half-life when administered suprachoroidally.
However, recent trial results from other industry participants that are pursuing combination therapy agents for wet AMD have led Clearside to reconsider the viability of further development of its proprietary suspension formulation of axitinib. Accordingly, while the Company plans to continue to investigate axitinib and other compounds for the treatment of wet AMD, it no longer expects to submit an Investigational New Drug application to the U.S. Food and Drug Administration for axitinib. Instead, Clearside will shift research and development resources away from wet AMD towards its more advanced DME program.
“Clearside is fortunate to have built a well-diversified pipeline targeting the restoration and preservation of vision,” said Daniel H. White, Clearside’s Chief Executive Officer and President. “Historically, corticosteroids have shown promise in the treatment of DME, but the results have been confounded by side effects like cataracts and elevated intraocular pressure. We believe that the encouraging results that we have observed in our RVO and Uveitis programs suggest that suprachoroidally injected Zuprata may exhibit similar benefits in treating DME. Clearside will, however, continue to explore potential opportunities for the use of suprachoroidal delivery in the wet AMD space.”
In November 2016, Clearside announced the enrollment of the first patient in a Phase 1/2 clinical trial (“HULK”) assessing the administration of Zuprata, either alone or together with EYLEA® (aflibercept), for the treatment of DME. Suprachoroidally injected Zuprata for the treatment of DME is part of Clearside’s pipeline of drug treatments for unmet or underserved blinding eye diseases where the pathologies manifest in the choroid or retina.
About Clearside
Clearside Biomedical, Inc., headquartered in Alpharetta, GA, is a late-stage ophthalmic biopharmaceutical company that envisions a world without blindness. Clearside relentlessly pursues transformative, elegant, precise solutions to restore and preserve vision. Clearside is developing therapies for eye diseases using a proprietary treatment approach offering high
access for the pharmacological candidates to the back of the eye through suprachoroidal injection. This new treatment paradigm offers potentially meaningful therapeutic benefit to patients suffering from sight threatening diseases like uveitis, RVO and DME. To learn more about how Clearside seeks to change ophthalmology treatment, please visit us at 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 clinical development of Clearside’s product candidates. 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 Quarterly Report on Form 10-Q for the quarter ended September 30, 2016, filed with the U.S. Securities and Exchange Commission (“SEC”) on November 14, 2016 and Clearside’s other reports filed with the SEC from time to time. 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
Charles Deignan
Chief Financial Officer
678-270-4005
charlie.deignan@clearsidebio.com
Stephen Kilmer
Investor & Media Relations
678-270-3631
stephen.kilmer@clearsidebio.com