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): August 10, 2020

 

 

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 August 10, 2020, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended June 30, 2020, 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 Second Quarter 2020
Financial Results and Provides Corporate Update

 

- IND Accepted by FDA for Suprachoroidal CLS-AX (axitinib injectable suspension) -

- Expanded Internal Suprachoroidal Pipeline with Two New Preclinical Programs -

- Engaged New Contract Manufacturer for XIPERE™ -

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

 

ALPHARETTA, Ga., August 10, 2020 -- 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 second quarter ended June 30, 2020 and provided a corporate update on key initiatives.

 

Key Highlights

 

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Upcoming Events and Projected Milestones

 

George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer, commented, “Over the past year, we have worked purposefully and diligently to reorient Clearside from a single product company to one that has multiple relevant and promising opportunities targeting the suprachoroidal space. We have made important progress in our key clinical and preclinical programs and we are positioning ourselves to have a strong year in 2021 with potential approval of XIPERE and initial patient data from our CLS-AX program.”

 

Dr. Lasezkay continued, “Our IND application for CLS-AX was accepted and we are preparing to initiate a Phase 1/2a trial in wet AMD later this year to assess the safety and

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tolerability of our proprietary suspension of axitinib delivered via our SCS Microinjector. We also continue to expand our internal suprachoroidal pipeline with two new preclinical programs: a ‘therapeutic biofactory’ program which is our second, non-viral vector, suprachoroidal gene therapy preclinical program; and a small molecule preclinical program utilizing a suprachoroidal integrin inhibitor suspension. We look forward to advancing our expanded internal development pipeline over the next year.”

 

“We have also engaged a new, U.S.-based contract manufacturing organization (CMO) for XIPERE, which we believe will allow for a more efficient and predictable process for NDA resubmission and review. We were recently notified by our previous CMO that it is no longer willing to serve as our commercial supplier for XIPERE. While this news was unexpected, we had proactively begun evaluating alternative manufacturers given previously disclosed delays due to manufacturing and facility issues. Therefore, we were able to quickly engage a new CMO and rapidly initiate manufacturing technology transfer activities,” said Dr. Lasezkay.

 

“This transition is a positive step forward to achieving XIPERE approval as the new CMO provides Clearside and our licensees with an experienced and reliable partner for the manufacture of registration batches and future commercial supplies of XIPERE, if approved. The new CMO has an established track record with respect to FDA inspections, has extensive experience with production of small molecule suspensions, steroids and ophthalmic products, and is prepared to move quickly to produce the necessary batches of XIPERE to support our NDA resubmission. We expect to resubmit the XIPERE NDA as quickly as possible after the transfer of the manufacturing process has been completed and the required three-month stability data is generated. Although we are still in the process of finalizing the timelines with the new CMO, our current expectation is that resubmission will occur no later than the first half of 2021,” Dr. Lasezkay concluded.

 

Second Quarter 2020 Financial Results

 

Clearside’s license revenue for the second quarter of 2020 was $0.4 million, compared to $45,000 for the second quarter of 2019.

 

Research and development expenses for the second quarter of 2020 were $3.3 million, compared to $0.7 million for the second quarter of 2019. The $2.6 million increase was attributable to vendor credits of $2.6 million received in the second quarter of 2019 upon reconciliation of final costs from the closure of two late-stage clinical trials.

 

General and administrative expenses for the second quarter of 2020 were $2.6 million, compared to $5.0 million for the second quarter of 2019. The $2.4 million decrease was

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primarily attributable to reduced employee and marketing expenses resulting from executive management changes and the out-licensing of XIPERE commercialization.

 

Net loss for the second quarter of 2020 was $5.8 million, or $0.13 per share of common stock, compared to a net loss of $5.7 million, or $0.15 per share of common stock, for the second quarter of 2019.

 

As of June 30, 2020, Clearside’s cash and cash equivalents totaled $15.1 million. During the second quarter of 2020, due to various restrictions and other limiting covenants, the Company elected to make an early payoff of its outstanding $5.0 million principal balance under its bank loan, plus $0.3 million reflecting the final payment fee and accrued interest. Based on Clearside’s current research and development plans and expected near-term partnership milestone payments, Clearside believes it will have sufficient resources to fund its planned operations into the second quarter of 2021.

 

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: 2290836. 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^® targets the suprachoroidal space (SCS^®) and 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

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based on Clearside’s current beliefs and expectations. These forward-looking statements include statements regarding the timelines for resubmitting the NDA for XIPERE, initiation of future clinical trials, future management and data presentations, manufacturing expectations with respect to XIPERE and Clearside’s ability to fund its operations into the second quarter of 2021, including the receipt of potential milestone payments. 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, uncertainties regarding the COVID-19 pandemic and other risks and uncertainties that are described in Clearside’s Annual Report on Form 10-K for the year ended December 31, 2019, filed with the U.S. Securities and Exchange Commission (“SEC”) on March 13, 2020, Clearside’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2020 to be filed with the SEC on August 10, 2020 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.

 

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)