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 6, 2019

 

 

Clearside Biomedical, Inc.

(Exact name of registrant as specified in its charter)

 

 

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:

 

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. ☒

 

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Item 2.02  Results of Operations and Financial Condition.

 

On November 6, 2019, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended September 30, 2019, as well as information regarding a conference call to discuss these financial results and the Registrant’s recent corporate highlights. A copy of this press release is furnished herewith as Exhibit 99.1 to this Current Report and is incorporated herein by reference.

 

In accordance with General Instruction B.2. of Form 8-K, the information in this Item 2.02, and Exhibit 99.1 hereto, 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 liability of that section, nor shall it be deemed incorporated by reference in 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, regardless of any incorporation language in such a filing, except as expressly set forth by specific reference in such a filing.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

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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.

 

 

 

Exhibit 99.1

 

Clearside Biomedical Announces Third Quarter 2019
Financial Results and Provides Corporate Update

– Recent Partnerships Support the Broad Applicability of Suprachoroidal Space Injection Platform to Potentially Treat Multiple Ocular Diseases –

– Suprachoroidal Axitinib IND Submission Targeted for Mid-2020 –  

– Management to Host Webcast and Conference Call Today at 4:30 P.M. ET –  

 

ALPHARETTA, Ga., November 6, 2019 -- Clearside Biomedical, Inc. (NASDAQ:CLSD), a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases, today reported financial results for the third quarter of 2019 and provided a corporate update.

 

“With three recent partnerships and plans to expand our internal development pipeline, we have made meaningful progress on our overall strategy to broaden the reach of our suprachoroidal space injection platform,” said George Lasezkay, Pharm.D., J.D., Clearside’s Chief Executive Officer. “Last quarter, we announced our plans to out-license rights to XIPERE™ (triamcinolone acetonide suprachoroidal injectable suspension) rather than commercialize it on our own, to create external collaborations with other companies enabling access to our platform and to build an internal pipeline in areas such as gene therapy and small molecules.”

 

“We have now signed deals with Bausch Health, REGENXBIO and Aura Biosciences that will benefit Clearside in a number of ways: 1) we have eliminated the inherent risks and investment related to building and maintaining a commercial infrastructure for XIPERE ourselves; 2) we are entitled to receive $7 million of non-dilutive capital in upfront payments and are eligible to receive over $200 million in potential future development and sales milestones and royalty payments; and 3) we have expanded the use of our platform to other indications including choroidal melanoma, wet age-related macular degeneration (AMD), and diabetic retinopathy. We look forward to completing the next steps on XIPERE and continuing to expand our pipeline through partner collaborations and planned internal research and development efforts,” concluded Dr. Lasezkay.

 

Thomas A. Ciulla, M.D., MBA, Chief Medical Officer of Clearside, commented, “With a renewed focus on research and development, our team has spent the last several months performing additional analysis on our proprietary suspension of axitinib (CLS-AX) for suprachoroidal injection and we are now planning to advance this as our next internal development program. Axitinib directly inhibits receptor tyrosine kinases, including vascular endothelial growth factor (VEGF) receptor-1, -2, and -3 with high potency and specificity, and pan-VEGF inhibition may benefit patients who sub-optimally respond to current anti-VEGF therapy. Further, our preclinical testing of CLS-AX using our

 

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proprietary microinjector demonstrated reduced growth of experimental neovascularization with decreased fluorescein leakage, and delivered the compound directly to affected tissues with durable drug levels, suggesting the potential to maintain visual gains and reduce clinical treatment burden in patients with angiogenic retinal diseases. Based on our current and planned non-clinical research, we are targeting submission of an Investigational New Drug (IND) application for CLS-AX in mid-2020.”

 

Clearside is working to address the issues raised by the U.S. Food and Drug Administration (FDA) in the complete response letter received last month regarding XIPERE. The Company currently expects to resubmit its New Drug Application (NDA) in the first quarter of 2020 and believes the FDA will review the NDA within six months of receipt of the resubmission.

 

Key Highlights

 

Third Quarter 2019 Financial Results

 

Clearside’s research and development expenses for the quarter ended September 30, 2019 were $2.7 million, compared to $20.1 million for the quarter ended September 30, 2018. The $17.4 million decrease was primarily attributable to closing down two late-stage clinical trials in early 2019. General and administrative expenses were $3.8 million for the quarter ended September 30, 2019, compared to $3.9 million for the quarter ended September 30, 2018.

 

Net loss for the quarter ended September 30, 2019 was $6.5 million, or $0.17 per share of common stock, compared to $23.9 million for the quarter ended September 30, 2018, or $0.75 per share of common stock. The decrease in net loss was primarily related to lower clinical development costs.

 

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Cash and cash equivalents totaled $22.6 million as of September 30, 2019.

 

Conference Call & Webcast Details

 

Clearside’s management will host a webcast and conference call today at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update. The live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. The live call can be accessed by dialing (844) 263-8310 (domestic) or (213) 358-0959 (international) and entering conference code: 1137365. An archive of the webcast will be available for three months.

 

About Clearside Biomedical

 

Clearside Biomedical, Inc. is a biopharmaceutical company dedicated to developing and delivering treatments that restore and preserve vision for people with serious back of the eye diseases. Clearside’s proprietary SCS Microinjector™ targeting the suprachoroidal space (SCS) offers unique access to the macula, retina and choroid where sight-threatening disease often occurs. The Company’s SCS injection platform is an inherently flexible, in-office, non-surgical procedure, intended to provide targeted delivery to the site of disease and to work with both established and new formulations of medications, as well as future therapeutic innovations such as gene therapy. For more information, please visit 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 statements regarding the timing for resubmitting the XIPERE NDA and submitting the IND for CLS-AX, plans to expand Clearside’s internal pipeline and enter into other licensing arrangements, the potential benefits of CLS-AX and the SCS injection platform and the potential approval of XIPERE for the treatment of macular edema associated with uveitis. 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, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2019, filed with the SEC on August 8, 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.

 

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Investor and Media Contacts:

Jenny Kobin

Remy Bernarda

ir@clearsidebio.com

(678) 430-8206

 

 

 

-Financial Tables Follow-

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CLEARSIDE BIOMEDICAL, INC.

Selected Financial Data

(in thousands, except share and per share data)

(unaudited)

 

 

 

 

 

 

 

Source: Clearside Biomedical, Inc.