ALPHARETTA, Ga., Feb. 07, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. ("Clearside" or the "Company") (NASDAQ:CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that it has entered into a securities purchase agreement with institutional investors and an existing stockholder, providing for the purchase and sale of 11,111,111 shares of common stock and accompanying warrant to purchase up to 11,111, ...

Financial Data and Key Metrics Changes - As of September 30, 2023, the company's cash and cash equivalents totaled approximately $29 million, with a new licensing agreement with BioCryst expected to provide $5 million in non-dilutive capital [77][50]. - The company anticipates having sufficient resources to fund operations into the fourth quarter of 2024, which includes the completion of the ODYSSEY trial and the related top-line data announcement [50]. Business Line Data and Key Metrics Changes - The ODYSSEY Phase 2b clinical trial for CLS-AX has completed recruitment, exceeding the target of 60 patients, with randomization expected to be completed by mid-December 2023 [71][80]. - The partnership with BioCryst focuses on developing avoralstat for diabetic macular edema, a significant market opportunity [72]. Market Data and Key Metrics Changes - Bausch & Lomb announced that XIPERE has been granted a permanent Category 1 CPT code in the U.S., which is expected to facilitate better access and adoption of the product [70][75]. - Arctic Vision completed enrollment in its Phase 3 clinical trial for XIPERE in China, which is a critical milestone for the company [70][76]. Company Strategy and Development Direction - The company aims to establish CLS-AX as a best-in-class approach for long-term maintenance therapy for wet AMD, leveraging its suprachoroidal delivery method [45]. - The suprachoroidal approach is seen as a proven method with a clean safety profile, and the company has five collaboration partners targeting this space for various retinal diseases [79]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ODYSSEY trial, highlighting the potential for CLS-AX to provide a treatment duration of four to six months, which could position it favorably in the market [60][92]. - The company is committed to the current trial design of ODYSSEY and has made adjustments based on FDA draft guidelines, including using aflibercept as a comparator [90]. Other Important Information - The company has received positive feedback from the medical community regarding its CLS-AX program, with leading retinal physicians presenting data at major ophthalmic meetings [4]. - The partnership with BioCryst is expected to enhance the company's external development pipeline, particularly in the treatment of diabetic macular edema [39]. Q&A Session Summary Question: What is the status of the ODYSSEY trial recruitment? - The company reported a very healthy recruitment rate, exceeding the target of 60 patients, with good participation across all sites [14][80]. Question: What are the potential inflection points for the REGENXBIO and Aura partnership? - The next significant inflection point is the decision on when to enter Phase 3 trials for REGENXBIO, with positive Phase 2 data encouraging further development [57]. Question: Can you clarify the responsibilities in the BioCryst partnership? - The company will collaborate with BioCryst on IND enabling studies through next year, after which BioCryst will take over the development of avoralstat [58]. Question: What are the expectations for the ODYSSEY trial data? - Management is hopeful for a treatment duration of five to six months and believes that the data will guide future FDA proposals for Phase 3 trials [60][65].

Use of Estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and reported amounts of income and expenses during the reporting periods. Significant items subject to such estimates and assumptions include revenue recognition, the accounting for useful lives to calculate ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q2 2023 Results Conference Call August 14, 2023 4:30 PM ET Company Participants Jenny Kobin - IR George Lasezkay - CEO Charlie Deignan - CFO Conference Call Participants Jon Wolleben - JMP Securities Shawn Kim - Jones Trading Rohit Bhasin - Needham & Company Jack Padavano - Stifel Yi Chen - H.C. Wainwright Operator Greetings, and welcome to the Clearside Biomedical Second Quarter 2023 Financial Results and Corporate Update Call. [Operator Instructions] Please note, t ...

FORM 10-Q | --- | --- | |------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Clearside Biomedical, \n(Exact Name of Registrant as \nDelaware | Inc. \nSpecified in its Charter) \n45-2437375 | | (State or other jurisdiction of incorporation or organization) | (I.R.S. Employer Identification No.) | | 900 North Point Parkway, Suite 200 Alpharetta, GA (Address of principal executive offices) | ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q1 2023 Earnings Conference Call May 11, 2023 8:30 AM ET Company Participants Jenny Kobin - Investor Relations George Lasezkay - President and Chief Executive Officer Charles Deignan - Chief Financial Officer Conference Call Participants Serge Belanger - Needham & Company Annabel Samimy - Stifel Andreas Argyrides - Wedbush Securities Yi Chen - H.C. Wainwright Operator Good day and thank you for standing by. Welcome to the Clearside Biomedical First Quarter 2023 Finan ...

Title of each class Trading Symbol(s) Name of each exchange on which registered Common Stock, par value $0.001 per share CLSD The Nasdaq Stock Market LLC Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐ In ...

Novel SCS Microinjector® shows a demonstrated ability for precise delivery into the suprachoroidal space SCS injection procedure commercially accepted by retinal physicians following launch of XIPERE® • Thousands of SCS injections performed Safety profile comparable to intravitreal injections1 • No Serious Adverse Events (SAEs) involving lens injury, suprachoroidal hemorrhage, or endophthalmitis have been observed 6 clinical trials ongoing including partner programs Sources: Clearside data on file | 1Kurup, ...

Clinical Trials and Product Development - The company is focused on the commercialization of XIPERE through licensing partners, with ongoing and planned preclinical studies and clinical trials for product candidates[11]. - The company anticipates potential delays in clinical trials due to regulatory requirements, which could impact the timeline for obtaining marketing approvals[30]. - The ODYSSEY trial initiation has been delayed by one quarter due to FDA draft guidance, necessitating protocol amendments[30]. - The company acknowledges the high risk of failure in clinical trials, which could significantly affect its financial position and stock price[26]. - The company is building a pipeline of product candidates for back-of-the-eye diseases via suprachoroidal injection, but may face challenges in developing safe and effective candidates[26]. - Clinical trial data may change as more patient data become available, and preliminary results should be viewed with caution until final data is confirmed[25]. - The company may need to conduct additional clinical trials if initial results are not positive, which could delay marketing approvals[30]. - The company plans to initiate the Phase 2b clinical trial of CLS-AX in the second quarter of 2023, following the completion of the Phase I/2a clinical trial[169]. - CLS-AX demonstrated a favorable safety profile with no serious adverse events reported, and a 77% - 85% reduction in treatment burden compared to the average monthly injections prior to CLS-AX administration[172]. - The full extension data for Cohorts 3 and 4 showed promising durability, indicating significant improvements in treatment intervals for participants[172]. Financial Position and Funding - The company faces uncertainties regarding its cash resources and future financing needs, which could impact its operational capabilities[11]. - The company expects to rely significantly on payments from Bausch and future commercialization partners to fund operations, with potential consequences including delays or reductions in research and development programs if payments are not received[39]. - The company may need to raise additional capital to fund development or commercialization activities if it decides to undertake these independently, which may not be available on acceptable terms[59]. - The company will continue to require additional financing to fund future operations and product development[146]. - As of December 31, 2022, the company reported a net loss of $32,947,000, compared to a net income of $376,000 in 2021[142]. - The total stockholders' equity as of December 31, 2022, was $10,607,000, down from $37,975,000 in 2021[142]. - The company has broad discretion over the use of cash and cash equivalents, which may not align with investor preferences[155]. - The company does not anticipate paying cash dividends in the foreseeable future, focusing instead on capital appreciation[156]. Collaborations and Licensing - The company has granted an exclusive license to Bausch for the commercialization and development of XIPERE in the United States and Canada, with milestone payments and tiered royalties based on annual net sales[37]. - The company is committed to maintaining collaborations with other companies to enhance its product development efforts[11]. - Collaborations with third parties for the development and commercialization of XIPERE may pose risks, including collaborators not performing their obligations as expected or failing to achieve regulatory approvals[41]. - If the company cannot establish additional collaborations, it may need to alter future development and commercialization plans, potentially leading to reduced scope or increased expenditures[56]. - The company is required to use commercially reasonable efforts to develop and commercialize licensed products under the Emory/GT License, which includes obligations for milestone payments and royalties[109]. - If the company fails to comply with its licensing obligations, it risks losing critical technology related to the SCS Microinjector, which could impair its ability to market products[109]. Competition and Market Dynamics - The company faces significant competition in seeking collaborations, which may affect the ability to negotiate timely and acceptable terms for future partnerships[58]. - The company’s product candidates may fail to achieve market acceptance necessary for commercial success, impacting revenue generation[62]. - CLS-AX competes with established anti-VEGF drugs such as Lucentis, Avastin, and Susvimo, which are approved for treating wet AMD and other ocular conditions[65]. - The company faces competition from other injectable and implantable corticosteroids, including Bristol-Myers Squibb's Kenalog and Allergan's Ozurdex, which may affect market share[71]. - Competitors may develop safer, more effective, or less expensive products, which could hinder the company's market entry and pricing strategy[75]. - The company must navigate unfavorable pricing regulations and reimbursement policies that could impact the demand for its products[77]. - Cost containment trends in the healthcare industry may lead to reduced coverage and reimbursement for the company's products, affecting profitability[78]. - There may be significant delays in obtaining coverage and reimbursement for newly approved drugs, which could limit market access[82]. Intellectual Property and Regulatory Risks - The company has proprietary rights to several trademarks, including XIPERE and SCS Microinjector, which are crucial for its business[13]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to file all necessary patent applications in a timely manner[95]. - Changes in U.S. patent law and potential future legislation could weaken the company's ability to obtain and enforce patents, impacting its competitive position[102]. - The company may become involved in costly legal proceedings to protect its intellectual property, which could be time-consuming and unsuccessful[103]. - The company must protect its trade secrets and proprietary information, as breaches could harm its competitive position[124]. - Regulatory approvals for the company's product candidates are subject to comprehensive regulation by the FDA and other authorities, and failure to obtain these approvals could materially impair revenue generation[127]. - The process of obtaining marketing approvals is expensive and may take years, with potential delays due to regulatory changes or additional data requirements[128]. - If the FDA does not allow the company to pursue the Section 505(b)(2) regulatory pathway, it may face increased time and financial resources needed for approval[132]. Operational and Management Risks - The company does not have its own manufacturing capabilities and relies on third parties for clinical and commercial supplies, which increases the risk of delays or impairments in development and commercialization efforts[51]. - The reliance on third-party manufacturers entails risks such as regulatory compliance failures and potential breaches of manufacturing agreements[52]. - The company is highly dependent on the expertise of its executive officers and senior management, and the loss of key personnel could impede its business strategy[92]. - The company incurs significant costs as a public entity, which may increase due to compliance with evolving laws and regulations[184]. - The company is subject to various risks and uncertainties typical of life science companies, including regulatory approvals and commercialization challenges[144]. Economic and Market Conditions - Adverse global economic conditions and geopolitical tensions may negatively affect the company's business, financial condition, and results of operations[187]. - The company is subject to evolving threats from cyberattacks and security breaches, which could materially disrupt clinical and product development activities[175].

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2022 Earnings Conference Call March 9, 2023 4:30 PM ET Company Participants Jenny Kobin - Investor Relations George Lasezkay - President and Chief Executive Officer Charles Deignan - Chief Financial Officer Conference Call Participants Annabel Samimy - Stifel Serge Belanger - Needham & Company Jonathan Wolleben - JMP Securities Yi Chen - H.C. Wainwright Operator Good day and thank you for standing by and welcome to the Clearside Biomedical Fourth Quarter 2022 Fina ...