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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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 May 11, 2023, Clearside Biomedical, Inc. (the “Registrant”) issued a press release announcing its financial results for the quarter ended March 31, 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: |
May 11, 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 First Quarter 2023
Financial Results and Provides Corporate Update
- Phase 2b ODYSSEY Trial of CLS-AX in Wet AMD Expected to Open Enrollment in Q2 2023 -
- Positive Safety Data, Duration and Biologic Effect of CLS-AX Over 6 Months in OASIS Phase 1/2a Extension Study Highlighted in Presentations at Recent Medical Meetings -
- Management to Host Webcast and Conference Call Today at 8:30 A.M. ET -
ALPHARETTA, Ga., May 11, 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 first quarter ended March 31, 2023 and provided a corporate update.
“We have delivered a productive start to 2023 as we continue executing on our near-term plan to advance CLS-AX (axitinib injectable suspension) for the treatment of wet AMD,” said George Lasezkay, Pharm.D., J.D., Clearside’s President and Chief Executive Officer. “In February, we announced positive data from the OASIS Phase 1/2a Extension Study demonstrating an excellent safety profile for CLS-AX with promising duration and biologic effect over 6 months in treatment-experienced, anti-VEGF sub-responder wet AMD participants. This data was recently presented at the ARVO Annual Meeting in New Orleans.”
“We are now looking to build upon the OASIS results in ODYSSEY, our Phase 2b clinical trial of CLS-AX in wet AMD patients, which will open for enrollment this quarter, with topline results expected in Q3 2024. The recently announced ODYSSEY trial design was based on input from our enhanced Scientific Advisory Board and other experienced retinal physicians, while taking into account the recent FDA draft guidance for wet AMD drug development. In conducting the ODYSSEY trial, we believe that CLS-AX has the potential to demonstrate an important reduction in treatment burden while maintaining stable visual acuity in patients with wet AMD. Importantly, we also believe that the number of participants, the duration, and the outcome measures of the ODYSSEY trial will provide the necessary clinical data to inform the design of a CLS-AX Phase 3 program,” concluded Dr. Lasezkay.
Key Highlights
First Quarter 2023 Financial Results
Conference Call & Webcast Details
Clearside’s management will host a webcast and conference call today at 8:30 a.m. Eastern Time to discuss the financial results and provide a corporate update. Registration for the live and archived webcast may be accessed on the Clearside website under the Investors section: Events and Presentations. To participate via telephone, please register in advance using the link provided in the event listing. The Company suggests participants log in 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, timeline for initiating the ODYSSEY Phase 2b clinical trial for CLS-AX, the expected timing of topline results from the ODYSSEY clinical trial, the potential benefits of CLS-AX and other product candidates using Clearside’s SCS Microinjector® and Clearside’s ability to fund its operations into the second 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 March 31, |
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2023 |
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2022 |
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License and other revenue |
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$ |
4 |
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$ |
347 |
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Operating expenses: |
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Research and development |
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4,451 |
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4,536 |
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General and administrative |
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3,158 |
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3,457 |
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Total operating expenses |
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7,609 |
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7,993 |
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Loss from operations |
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(7,605 |
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(7,646 |
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Other income |
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492 |
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2 |
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Non-cash interest expense on liability related to the sales of future royalties |
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(2,167 |
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— |
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Net loss |
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$ |
(9,280 |
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$ |
(7,644 |
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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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Weighted average shares outstanding — basic and diluted |
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61,169,486 |
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60,064,209 |
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Balance Sheet Data |
March 31, |
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December 31, |
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2023 |
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2022 |
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Cash and cash equivalents |
$ |
41,419 |
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$ |
48,258 |
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Total assets |
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44,695 |
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51,303 |
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Liabilities related to the sales of future royalties, net |
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36,144 |
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33,977 |
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Total liabilities |
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41,995 |
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40,696 |
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Total stockholders’ equity |
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2,700 |
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10,607 |
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Source: Clearside Biomedical, Inc.