UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
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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:
Securities registered pursuant to Section 12(b) of the Act:
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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 2.02 Results of Operations and Financial Condition.
On August 14, 2023, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended June 30, 2023, 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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Exhibit |
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Exhibit Description |
99.1 |
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104 |
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Cover Page Interactive Data File (embedded with the Inline XBRL document) |
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.
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Clearside Biomedical, Inc. |
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Date: |
August 14, 2023 |
By: |
/s/Charles A. Deignan |
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Charles A. Deignan |
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Chief Financial Officer |
Exhibit 99.1
Clearside Biomedical Announces Second Quarter 2023
Financial Results and Provides Corporate Update
- Phase 2b ODYSSEY Trial of CLS-AX in Wet AMD Progressing as Planned
with Nearly 30 Sites Now Open -
- Proprietary Suprachoroidal Injection Platform Featured in Peer-Reviewed Publication
and at ARVO, ASRS and OIS Scientific Meetings -
- Management to Host Webcast and Conference Call Today at 4:30 P.M. ET -
ALPHARETTA, Ga., August 14, 2023 -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), today reported financial results for the second quarter ended June 30, 2023 and provided a corporate update.
“The last several months have been very productive for Clearside with the initiation of ODYSSEY, our Phase 2b clinical trial with CLS-AX, which we believe has the potential to be up to a twice-a-year treatment for wet AMD,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “We are enrolling patients through a broad network of U.S. clinical sites, and we now have nearly all of our planned 30 sites currently open to enroll participants in the trial. We expect to report topline data in the third quarter of 2024. Our differentiated treatment approach utilizes our SCS Microinjector®, a proven, non-surgical, non-implant way to deliver our proprietary formulation of axitinib, the most potent tyrosine kinase inhibitor in development for patients with wet AMD.”
“We continue to be encouraged by the acceptance of suprachoroidal administration as an innovative and safe form of ophthalmic drug delivery. With an approved product in the U.S., our Asia-Pacific partner’s recent NDA submission in Australia, the continued clinical progress by REGENXBIO/AbbVie and Aura Biosciences using our SCS Microinjector, and multiple presentations at prominent medical meetings, including ARVO and ASRS, Clearside is the leader in suprachoroidal delivery of therapeutic agents to the back of the eye,” concluded Dr. Lasezkay.
Key Highlights
Second Quarter 2023 Financial Results
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 (877) 545-0320 (U.S.) or 973-528-0002 (international) and entering conference code: 895559. The Company suggests participants join 15 minutes in advance of the event.
About Clearside Biomedical, Inc.
Clearside Biomedical, Inc. is a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Clearside’s SCS injection platform, utilizing the Company’s proprietary SCS Microinjector®, enables an in-office, repeatable, non-surgical procedure for the targeted and compartmentalized delivery of a wide variety of therapies to the macula, retina or choroid to potentially preserve and improve vision in patients with sight-threatening eye diseases. Clearside is developing its own pipeline of small molecule product candidates for administration via its SCS Microinjector. The Company’s lead program, CLS-AX (axitinib injectable suspension), for the treatment of neovascular age-related macular degeneration (wet AMD), is in Phase 2 clinical testing. Clearside developed and gained approval for its first product, XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use, which is available in the U.S. through a commercial partner. Clearside also strategically partners its SCS injection platform with companies utilizing other ophthalmic therapeutic innovations. 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 clinical development of CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial, the potential for CLS-AX to be a twice-a-year treatment for wet AMD and other potential benefits of CLS-AX and other product candidates using Clearside’s SCS Microinjector® and Clearside’s ability to fund its operations into the third quarter of 2024. 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, 2022, filed with the U.S. Securities and Exchange Commission (SEC) on March 14, 2023 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-
CLEARSIDE BIOMEDICAL, INC.̶
Selected Financial Data
(in thousands, except share and per share data)
(unaudited)
Statements of Operations Data |
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Three Months Ended June 30, |
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Six Months Ended June 30, |
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2023 |
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2022 |
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2023 |
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2022 |
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License and other revenue |
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$ |
1,018 |
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$ |
384 |
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$ |
1,022 |
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$ |
731 |
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Operating expenses: |
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Cost of goods sold |
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213 |
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— |
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213 |
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— |
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Research and development |
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4,948 |
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5,430 |
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9,399 |
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9,966 |
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General and administrative |
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3,127 |
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2,791 |
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6,285 |
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6,248 |
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Total operating expenses |
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8,288 |
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8,221 |
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15,897 |
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16,214 |
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Loss from operations |
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(7,270 |
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(7,837 |
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(14,875 |
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(15,483 |
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Other income |
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458 |
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24 |
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950 |
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26 |
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Non-cash interest expense on liability related to the sales of future royalties |
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(2,294 |
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— |
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(4,461 |
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— |
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Net loss |
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$ |
(9,106 |
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$ |
(7,813) |
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$ |
(18,386 |
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$ |
(15,457 |
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Net loss per share of common stock — basic and diluted |
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$ |
(0.15 |
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$ |
(0.13 |
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$ |
(0.30 |
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$ |
(0.26) |
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Weighted average shares outstanding — basic and diluted |
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61,654,520 |
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60,150,348 |
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61,413,343 |
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60,107,517 |
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Balance Sheet Data |
June 30, |
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December 31, |
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2023 |
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2022 |
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Cash and cash equivalents |
$ |
35,005 |
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$ |
48,258 |
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Accounts receivable |
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255 |
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— |
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Total assets |
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39,185 |
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51,303 |
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Liabilities related to the sales of future royalties, net |
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38,088 |
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33,977 |
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Total liabilities |
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44,158 |
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40,696 |
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Total stockholders’ (deficit) equity |
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(4,973 |
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10,607 |
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Source: Clearside Biomedical, Inc.