Group 1: Earnings Performance - Clearside Biomedical reported a quarterly loss of $0.10 per share, better than the Zacks Consensus Estimate of a loss of $0.14, and an improvement from a loss of $0.15 per share a year ago, resulting in an earnings surprise of 28.57% [1] - The company has surpassed consensus EPS estimates three times over the last four quarters [2] - The current consensus EPS estimate for the upcoming quarter is -$0.14, with expected revenues of $0.25 million, and for the current fiscal year, it is -$0.60 on revenues of $0.99 million [7] Group 2: Revenue Performance - Clearside Biomedical posted revenues of $0.09 million for the quarter ended June 2024, missing the Zacks Consensus Estimate by 64.43%, and a decline from year-ago revenues of $1.02 million [2] - The company has topped consensus revenue estimates two times over the last four quarters [2] Group 3: Stock Performance and Outlook - Clearside Biomedical shares have lost about 6.8% since the beginning of the year, while the S&P 500 has gained 12% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating expected performance in line with the market in the near future [6] - The outlook for the industry, specifically the Medical - Biomedical and Genetics sector, is currently in the top 30% of Zacks industries, suggesting potential for better performance compared to lower-ranked industries [8]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 Commission File Number: 001-37783 Clearside Biomedical, Inc. (Exact Name of Registrant as Specified in its Charter) Delaware 45-2437375 (State or other jurisdiction of incorporation or organiz ...

Revenue Performance - License and other revenue for Q2 2024 was $90,000, a decrease from $1.0 million in Q2 2023[5]. Expenses - Research and development expenses for Q2 2024 were $4.6 million, down from $4.9 million in Q2 2023, primarily due to reductions in the CLS-AX program and SCS Microinjector development[5]. - Total operating expenses for Q2 2024 were $7.68 million, compared to $8.29 million in Q2 2023[12]. - Non-cash interest expense remained constant at $2.3 million in both Q2 2024 and Q2 2023[5]. Financial Performance - Net loss for Q2 2024 was $7.6 million, or $0.10 per share, compared to a net loss of $9.1 million, or $0.15 per share, in Q2 2023[5]. - As of June 30, 2024, Clearside's cash, cash equivalents, and short-term investments totaled $29.4 million, expected to fund operations into Q3 2025[6]. Clinical Trials and Partnerships - Topline data from the Phase 2b ODYSSEY clinical trial of CLS-AX is expected in late Q3 2024[2]. - Clearside's Asia-Pacific partner, Arctic Vision, reported positive results from its Phase 3 trial for XIPERE, with NDAs accepted for review in Australia and Singapore[3]. - 87.7% of eyes treated with XIPERE did not require additional corticosteroid injections for 6 months after a single dose[2]. - Clearside's gene therapy partner, REGENXBIO, plans to initiate a global pivotal trial in H1 2025 for diabetic retinopathy[3].

ALPHARETTA, Ga., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced that management will present a corporate update at the H.C. Wainwright 4th Annual Ophthalmology Virtual Conference which will be available on demand on Thursday, August 15, 2024, at 7:00 a.m. ET. Victor Chong, MD, MBA, Chief Medical Officer, will also participate in a panel ...

ALPHARETTA, Ga., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that its second quarter 2024 financial results will be reported on Monday, August 12, 2024, after the close of the financial markets. In lieu of a second quarter 2024 conference call, the Company hosted a Suprachoroidal Delivery Key Opinion Leader Webinar on Wednesday ...

ALPHARETTA, Ga., Aug. 01, 2024 (GLOBE NEWSWIRE) -- Clearside Biomedical, Inc. (Nasdaq: CLSD), a biopharmaceutical company revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS®), announced today that its second quarter 2024 financial results will be reported on Monday, August 12, 2024, after the close of the financial markets. In lieu of a second quarter 2024 conference call, the Company hosted a Suprachoroidal Delivery Key Opinion Leader Webinar on Wednesday ...

Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on revolutionizing the delivery of therapies to the back of the eye through the suprachoroidal space (SCS) [4] - The company has developed a patented SCS Microinjector that allows for a non-surgical procedure to deliver therapies to the macula, retina, or choroid [4] Product Development - The lead program, CLS-AX (axitinib injectable suspension), is currently in Phase 2b clinical testing for the treatment of neovascular age-related macular degeneration (wet AMD) [2] - Clearside's first product, XIPERE® (triamcinolone acetonide injectable suspension), is approved for suprachoroidal use and is available in the U.S. through a commercial partner [2][8] Strategic Partnerships - Clearside partners with companies to utilize its SCS injection platform alongside other ophthalmic therapeutic innovations [2] - Arctic Vision holds exclusive rights for the commercialization and development of XIPERE in several regions, including Greater China and South Korea [6][8] Clinical Trial Results - Arctic Vision reported positive topline results from its Phase 3 clinical trial of ARCATUS® (ARVN001) for Uveitic Macular Edema (UME) in China, meeting both primary and secondary endpoints [11][12] - In the trial, 38.5% of ARVN001-treated patients gained 15 or more letters in vision compared to 9.4% in the sham group, with a significant reduction in central subfield thickness (CST) [12] Market Potential - Uveitis affects approximately 350,000 patients in the U.S. and over one million globally, with a significant portion developing uveitic macular edema [9] - The uveitis market is projected to grow to nearly $550 million in the U.S. and over $1 billion globally by 2024 [9]

Clearside Biomedical, Inc. Conference Call Summary Company Overview - **Company**: Clearside Biomedical, Inc. (NASDAQ:CLSD) - **Focus**: Suprachoroidal drug delivery system for retinal diseases - **Key Product**: XIPERE, the first FDA-approved product for suprachoroidal administration Key Industry Insights - **Suprachoroidal Delivery**: - Recognized as a versatile and innovative method for drug administration in retinal diseases, offering advantages over traditional intravitreal and subretinal injections [6][12] - The SCS Microinjector has been validated through thousands of clinical injections and is supported by a comprehensive intellectual property portfolio [6][7] Core Points Discussed 1. **Pipeline and Product Development**: - CLS-AX, a tyrosine kinase inhibitor for wet AMD, is completing Phase IIb trials, with data expected in late Q3 2024 [7][30] - XIPERE is being commercialized in the U.S. by Bausch & Lomb and is seeking approval in Canada and Australia [9] - Collaborations with companies like Aura, REGENXBIO, AbbVie, and BioCryst to expand the application of the SCS Microinjector [10] 2. **Real-World Efficacy**: - The PEACHTREE study showed that 86.5% of patients did not require rescue therapy within six months after receiving XIPERE [16] - Real-world data from the IRIS Registry supports the efficacy of XIPERE, with a similar low rate of rescue therapy needed [25] 3. **Safety Profile**: - Suprachoroidal injections are believed to have a lower risk of endophthalmitis compared to intravitreal injections, with no reported cases after over 10,000 injections [27] - The procedure is quick, taking about 10 seconds longer than intravitreal injections, and is associated with fewer complications [28] 4. **Market Positioning**: - CLS-AX is positioned to compete with leading products like VABYSMO and EYLEA, with potential for less frequent dosing (2-3 times a year) compared to competitors [31] - The company aims to leverage its experience with the SCS Microinjector to expedite the approval process for CLS-AX [30] 5. **Future Directions**: - Plans to expand into geographic atrophy treatment, which is more common than wet AMD, with a focus on targeting the choroidal disease aspect [37][39] - Exploration of gene therapy applications using the suprachoroidal delivery method, which may offer advantages in terms of safety and efficacy [41][42] Additional Considerations - **Patient Selection and Procedure**: - Emphasis on careful patient selection, particularly for those with high myopia or glaucoma history [17] - The procedure requires specific techniques to minimize discomfort and ensure successful delivery [21] - **Regulatory and Reimbursement Landscape**: - The CPT code for SCS injections aids in physician reimbursement, reflecting a favorable economic model for the procedure [28] - **Clinical Insights**: - Discussions highlighted the importance of real-world treatment criteria versus clinical trial criteria, advocating for flexibility in treatment approaches [50][56] Conclusion Clearside Biomedical is positioned as a leader in the suprachoroidal drug delivery space, with a robust pipeline and strategic collaborations. The company is focused on expanding its product offerings while ensuring safety and efficacy in real-world applications, potentially transforming treatment paradigms for retinal diseases.

Core Insights - Clearside Biomedical is focused on the potential of suprachoroidal drug delivery, positioning itself as a leader in this innovative space with a proprietary SCS Microinjector that has been validated through numerous clinical injections [7][10][37] - The company has developed the first FDA-approved product for suprachoroidal administration, XIPERE, which is currently being commercialized in the U.S. and is seeking approval in Canada and Australia [12][37] - The pipeline includes CLS-AX, a tyrosine kinase inhibitor for wet AMD, which is completing Phase IIb trials, with data expected in late Q3 2024 [8][11][56] Company Overview - Clearside Biomedical has established multiple strategic collaborations to enhance its capabilities in the suprachoroidal space, including partnerships with Aura, REGENXBIO, AbbVie, and BioCryst [13][14] - The company has a comprehensive intellectual property portfolio surrounding its microinjector platform, which supports various drug categories for retinal diseases [7][10] Product Development - The SCS Microinjector has been used in over 10,000 injections without reported cases of endophthalmitis, indicating a favorable safety profile compared to traditional intravitreal injections [40] - XIPERE has shown promising real-world efficacy, with approximately 86.5% of patients not requiring rescue therapy within six months, comparable to clinical trial results [30][37] Market Potential - The market for geographic atrophy is considered larger than that for wet AMD, with ongoing research into improving treatment efficacy and duration [58] - The company aims to leverage its expertise in suprachoroidal delivery to develop therapies targeting geographic atrophy, which is increasingly recognized as a choroidal disease [62][66] Future Outlook - Clearside Biomedical plans to initiate a Phase III study for CLS-AX, which is expected to provide data that could facilitate its approval and integration into clinical practice [55][56] - The company is exploring the potential of gene therapy applications through its suprachoroidal delivery system, which may offer advantages over traditional methods [66][68]

Core Insights - Clearside Biomedical, Inc. is hosting a virtual key opinion leader (KOL) event on July 24, 2024, focusing on the advancements in suprachoroidal drug delivery for retinal diseases, particularly neovascular age-related macular degeneration (wet AMD) [5][6]. Company Overview - Clearside Biomedical is a biopharmaceutical company that specializes in delivering therapies to the back of the eye through the suprachoroidal space (SCS) using its patented SCS Microinjector [9]. - The company's lead product, CLS-AX (axitinib injectable suspension), is currently in Phase 2b clinical testing for the treatment of wet AMD [4]. - Clearside's first approved product, XIPERE® (triamcinolone acetonide injectable suspension), is available in the U.S. through a commercial partner [4]. Clinical Development - The event will showcase the broad applicability of the SCS delivery method and its differentiation in the retinal treatment landscape, along with ongoing clinical programs and future development opportunities for Clearside [6]. - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, indicating a commitment to expanding its therapeutic offerings [4]. Expert Participation - The event will feature presentations from retinal specialists, including Victor Chong, MD, MBA, Chief Medical Officer of Clearside, and other notable experts in the field [5][11][12].