The Company |
9 Months Ended |
|---|---|
Sep. 30, 2025 | |
| Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
| The Company | 1. The Company Clearside Biomedical, Inc. (the “Company”) is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®). Incorporated in the State of Delaware on May 26, 2011, the Company has its corporate headquarters in Alpharetta, Georgia. The Company’s activities since inception have primarily consisted of developing product and technology rights, raising capital and performing research and development activities. The Company is subject to a number of risks and uncertainties similar to those of other life science companies at a similar stage of development, including, among others, the need to obtain adequate additional financing, successful development efforts including regulatory approval of products, compliance with government regulations, successful commercialization of potential products, protection of proprietary technology and dependence on key individuals. Reverse Stock Split On August 29, 2025, the Company held a special meeting of stockholders at which its stockholders approved a proposal to effect an amendment to the Company’s Amended and Restated Certificate of Incorporation to implement a reverse stock split and a corresponding reduction in the total number of authorized shares of the Company’s common stock. On September 4, 2025, the Company’s board of directors approved the filing of a certificate of amendment to the Company’s Restated Certificate of Incorporation with the Secretary of State of the State of Delaware to affect the one-for-fifteen (1:15) reverse stock split of its outstanding common stock and a corresponding reduction in the total number of authorized shares of the Company’s common stock (the “Reverse Stock Split”). On September 12, 2025, the Company effected the Reverse Stock Split. Pursuant to their terms, a proportionate adjustment was made to the per share exercise price and number of shares issuable under all of the Company’s outstanding options and warrants, and the number of shares authorized for issuance pursuant to the Company’s equity incentive plans have been reduced proportionately. No fractional shares were issued as a result of the Reverse Stock Split. Stockholders of record who would have otherwise been entitled to receive a fractional share received a cash payment in lieu thereof. The Reverse Stock Split affected all stockholders proportionately and did not affect any stockholder’s percentage ownership of the Company’s common stock (except to the extent that the Reverse Stock Split resulted in any stockholder owning only a fractional share). Liquidity The Company had cash and cash equivalents of $6.8 million as of September 30, 2025. In July 2025, the Company announced plans to explore a full range of strategic alternatives to advance its SCS platform and drug development pipeline to maximize stockholder value. The Company has retained Piper Sandler, a leading investment bank with substantial experience in the biotechnology industry, to support it with the strategic evaluation process. Strategic alternatives under consideration include the sale, license, monetization and/or divestiture of one or more of the Company’s assets and technologies, collaboration, partnership, merger, acquisition, joint ventures, or other strategic transactions. If a strategic alternative is not available, the Company will be required to take additional actions to fund the Company’s operations, or it may be forced to file for bankruptcy or wind down its operations. In addition, in July 2025, the Company implemented a plan pursuant to which all of the Company’s employees had their employment with the Company terminated and transitioned into consulting roles with the Company (the "Reduction in Force"). The Company incurred charges of $2.3 million for severance and other employee termination related costs during the three months ended September 30, 2025 of which $1.2 million was recorded in research and development expenses and $1.1 million was recorded in general and administrative expenses. The Company expects to incur approximately $0.1 million in additional costs for other employee termination related costs. As part of the strategic alternative process, the Company has paused all internal research and development programs which can be resumed if the Company is able to raise additional capital. Historically, the Company has funded its operations primarily through the sale of common stock and convertible preferred stock, the issuance of warrants, the issuance of long-term debt, and license agreements. On September 4, 2025, the Company entered into an Omnibus Amendment Agreement (the “Amendment”) with Royalty Sub (as defined below) and with entities managed by HCR (as defined below). Pursuant to the Amendment, Royalty Sub received an additional payment of $2.9 million, representing $3.0 million to which the Royalty Sub was entitled, less $0.1 million of transaction expenses, from HCR, which Royalty Sub then paid to the Company in exchange for the remaining assets related to the Company's SCS Microinjector technology. See Note 5 for further details. On February 6, 2024, the Company entered into a securities purchase agreement with institutional investors and an existing stockholder, pursuant to which the Company issued and sold, in a registered direct offering (the “Registered Direct Offering”): (i) an aggregate of 740,740 shares of its common stock; and (ii) warrants to purchase up to 740,740 shares of common stock (the “Warrants”). The combined purchase price of each share and accompanying Warrant was $20.25. The exercise price for the Warrants is $24.30 per share. The Warrants are currently exercisable and will expire on August 9, 2029. The net proceeds to the Company from the Registered Direct Offering were $13.9 million. On January 31, 2024 (the “Amendment Effective Date”), the Company entered into a fourth amendment to the license agreement (as amended, the “Emory License Agreement”) with Emory University and Georgia Tech Research Corporation (collectively, the “Licensor”) pursuant to which the parties agreed to reduce the Sublicense Percentage (as defined in the Emory License Agreement) from a low double digit percentage to a high single digit percentage that the Company will pay the Licensor applicable to any fees or payments paid to the Company by any Sublicensee (as defined in the Emory License Agreement) of the Licensed Patents and/or Licensed Technology (each as defined in the Emory License Agreement), excluding (i) amounts paid to the Company by a Sublicensee to reimburse the Company for certain research and development costs pursuant to a written agreement between the Company and such Sublicensee, (ii) the value of intellectual property transferred or granted to the Company if necessary or helpful to the development or commercialization of Licensed Products (as defined in the Emory License Agreement) and (iii) amounts paid for shares of the Company’s stock. The payment to Licensor of any such Sublicense Percentage is due within 30 days of receipt by the Company of a qualifying payment from a Sublicensee, provided however, with respect to any qualifying payments received by the Company from a Sublicensee after July 1, 2023 but prior to January 1, 2025, the payment to Licensor of any such Sublicensee Percentage was due to Licensor by March 31, 2025. The parties also agreed to a revised annual license maintenance fee due each year (the “Maintenance Fee”) starting in 2023 through 2028, as follows: $0.3 million for 2023 through 2025, $0.4 million for 2026 and for 2027 and $0.5 million for 2028. The annual Maintenance Fee payments are due on October 1st of each year. In May 2023, the Company entered into a Controlled Equity OfferingSM Sales Agreement (the "Sales Agreement") with Cantor Fitzgerald & Co. ("Cantor") under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, having an aggregate offering price of up to $50.0 million through Cantor as its sales agent. During the nine months ended September 30, 2025, the Company sold 109,957 shares of its common stock for net proceeds of $1.4 million under the Sales Agreement. During the nine months ended September 30, 2024, the Company sold 22,656 shares of its common stock under the Sales Agreement for net proceeds of $0.5 million. The Company has suffered recurring losses and negative cash flows from operations since inception and anticipates incurring additional losses until such time, if ever, that it can generate significant revenue. The Company has no current source of revenue to sustain present activities. The Company does not expect to generate other meaningful revenue until and unless the Company's licensees successfully commercialize XIPERE and the Company has fulfilled its obligations under the Purchase and Sale Agreement (as defined below), its other licensees receive regulatory approval and successfully commercialize its product candidates, or the Company commercializes its product candidates either on its own or with a third party. In the absence of product or other revenues, the amount, timing, nature or source of which cannot be predicted, the Company’s losses will continue as it conducts its research and development activities. The Company will continue to need to obtain additional financing to fund future operations, including completing the development, partnering and potential commercialization of its primary product candidates. The Company will need to obtain financing to complete the development and conduct clinical trials for the regulatory approval of its product candidates if requested by regulatory bodies. If such product candidates were to receive regulatory approval, the Company would need to obtain financing to prepare for the potential commercialization of its product candidates, if the Company decides to commercialize the products on its own. These conditions raise substantial doubt about the Company’s ability to continue as a going concern within one year after the date the consolidated financial statements are issued. Based on its current plans and forecasted expenses, the Company does not expect its cash and cash equivalents will enable the Company to fund its planned operating expenses for the next 12 months from the date of this filing. Accordingly, the Company’s consolidated financial statements have been prepared on a going concern basis, which contemplates the realization of assets and satisfaction of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of recorded asset amounts or the amounts and classification of liabilities that might result should the Company be unable to continue as a going concern. Until the Company can generate sufficient revenue, the Company will need to finance future cash needs through public or private equity offerings, license agreements, debt financings or restructurings, collaborations, strategic alliances and marketing or distribution arrangements. |