| Item 2.02 | Results of Operations and Financial Condition. |
On February 2, 2023, Clearside Biomedical, Inc. (the “Company”) issued a press release which included the following disclosure:
“As of December 31, 2022, we had approximately $48.3 million of cash and cash equivalents. This amount is an unaudited and preliminary estimate that (i) represents the most current information available to management as of the date of this prospectus supplement, (ii) is subject to completion of financial closing and auditing procedures that could result in significant changes to the estimated amounts and (iii) does not present all information necessary for an understanding of our financial condition as of, and our results of operations for the year ended, December 31, 2022. Accordingly, you should not place undue reliance on this preliminary estimate.”
| Item 7.01 | Regulation FD Disclosure. |
The Company will host a conference call on February 2, 2023 to discuss positive results from the extension study of the Company’s OASIS Phase 1/2a clinical trial of CLS-AX in wet AMD. The information regarding the conference call is included in the press release described below. A copy of the presentation to be presented on the conference call is attached as Exhibit 99.1 to this Current Report on Form 8-K. The presentation may be accessed on the Company’s website under the “Investors” section.
The information in this Item 7.01 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and 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 liabilities of that section, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.
On February 2, 2023, the Company issued a press release announcing positive results from the extension study of the Company’s OASIS Phase 1/2a clinical trial of CLS-AX in wet AMD. A copy of the press releases is filed as Exhibit 99.2 to this Current Report on Form 8-K and is incorporated herein by reference.
Caution Concerning Forward Looking Statements
This Current Report on Form 8-K may contain forward-looking statements made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21 E of the Exchange Act. Forward-looking statements include all statements that do not relate solely to historical or current facts, and can be identified by the use of words such as “may,” “will,” “expect,” “project,” “estimate,” “anticipate,” “plan,” “believe,” “potential,” “should,” “continue” or the negative versions of those words or other comparable words. These forward-looking statements include statements clinical development of the Company’s product candidates, expectations regarding future clinical trials, the preliminary financial results as of December 31, 2022 and future expectations and plans and prospects for the Company. These forward-looking statements are based on information currently available to the Company and its current plans or expectations, and are subject to a number of uncertainties and risks that could significantly affect current plans. Actual results and performance could differ materially from those projected in the forward-looking statements as a result of many factors, including the uncertainties related to market conditions and uncertainties inherent in the initiation of future clinical trials. The Company’s forward-looking statements also involve assumptions that, if they prove incorrect, would cause its results to differ materially from those expressed or implied by such forward-looking statements. These and other risks concerning the Company’s business are described in additional detail in the Company’s Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (the “Commission”) on March 11, 2022, the Company’s Quarterly Report on Form 10-Q filed with the Commission on November 9, 2022, and in the Company’s other Periodic and Current Reports filed with the Commission. The Company is under no obligation to (and expressly disclaims any such obligation to) update or alter its forward-looking statements, whether as a result of new information, future events or otherwise.
