Clearside Biomedical, Inc. (CLSD) came out with a quarterly loss of $0.17 per share versus the Zacks Consensus Estimate of a loss of $0.14. This compares to loss of $0.15 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of -21.43%. A quarter ago, it was expected that this company would post a loss of $0.10 per share when it actually produced a loss of $0.08, delivering a surprise of 20%.Over the last four quarters, the company has ...

- Phase 2b ODYSSEY Trial in Wet AMD Remains on Track with Topline Data Expected Q3 2024 - - Strengthened Management Team and Board of Directors with Two Key Additions - - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET - Dr. Lasezkay continued, "We have an outstanding team at Clearside that has been strategically expanded over the past several months. We added Dr. Victor Chong, a well-respected, board-certified retinal specialist, as our Chief Medical Officer. Victor's extensive major p ...

ALPHARETTA, Ga., April 30, 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 first quarter 2024 financial results will be reported on Thursday, May 9, 2024 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. The l ...

ALPHARETTA, Ga., April 30, 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 first quarter 2024 financial results will be reported on Thursday, May 9, 2024 after the close of the financial markets. Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. The l ...

ALPHARETTA, Ga., April 16, 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 Anthony S. Gibney has been appointed to the Company's Board of Directors, effective April 15, 2024. "We are delighted to welcome Tony to our Board of Directors as we build on our leadership in delivering therapeutics to the suprachoroidal space," said Clay Thorp, ...

ALPHARETTA, Ga., April 02, 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 George Lasezkay, Pharm.D., J.D., President and Chief Executive Officer, and Victor Chong, M.D., MBA, Chief Medical Officer, will participate in a Fireside Chat at the 23rd Annual Needham Virtual Healthcare Conference on Wednesday, April 10, 2024, at 3:00 p.m. ET. ...

ALPHARETTA, Ga., March 18, 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 Victor Chong, M.D., MBA was appointed Chief Medical Officer on March 14, 2024. Dr. Chong is a board-certified retinal specialist with more than 25 years of experience as a retinal physician and navigating all phases of ophthalmic drug development. George Lasezkay ...

Clearside Biomedical, Inc. (NASDAQ:CLSD) Q4 2023 Earnings Conference Call March 12, 2022 4:30 PM ET Company Participants Jenny Kobin - IR George Lasezkay - CEO Charlie Deignan - CFO Conference Call Participants Annabel Samimy - Stifel Operator Greetings, and welcome to the Clearside Biomedical Q4 2023 Financial Results and Corporate Update Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] Please note, th ...

PART I [Item 1. Business](index=8&type=section&id=Item%201.%20Business) Clearside Biomedical, Inc. is a biopharmaceutical company focused on developing and commercializing therapies for retinal diseases using its proprietary suprachoroidal space (SCS) injection platform and SCS Microinjector - Clearside Biomedical is a biopharmaceutical company leveraging its proprietary SCS injection platform and SCS Microinjector to deliver therapies to the back of the eye for sight-threatening diseases[25](index=25&type=chunk)[116](index=116&type=chunk)[476](index=476&type=chunk) - **XIPERE** (triamcinolone acetonide injectable suspension) was approved by the U.S. FDA in October 2021, marking the first approved therapeutic delivered into the SCS and the first therapy for macular edema associated with uveitis[23](index=23&type=chunk)[116](index=116&type=chunk)[477](index=477&type=chunk) - The company's lead internal product candidate, **CLS-AX** (axitinib injectable suspension), is a tyrosine kinase inhibitor (TKI) for wet AMD, currently in a Phase 2b clinical trial (ODYSSEY) with topline data expected in Q3 2024[153](index=153&type=chunk)[159](index=159&type=chunk)[168](index=168&type=chunk) - The SCS Microinjector has been used in thousands of injections in clinical trials and is commercially accepted, with over **1,200 retinal physicians trained** in the U.S. following XIPERE's launch[29](index=29&type=chunk) - A permanent Category 1 CPT code for suprachoroidal injection of pharmacologic agents was granted on January 1, 2024, which is expected to facilitate better access, insurance coverage, and adoption of the procedure[146](index=146&type=chunk)[131](index=131&type=chunk) - Clearside has established collaborations with Bausch + Lomb (XIPERE commercialization in US/Canada), Arctic Vision (XIPERE commercialization in Asia Pacific), REGENXBIO (AAV-based gene therapy delivery), Aura Biosciences (ocular oncology), and BioCryst Pharmaceuticals (plasma kallikrein inhibitor for DME)[31](index=31&type=chunk)[176](index=176&type=chunk)[188](index=188&type=chunk)[191](index=191&type=chunk)[199](index=199&type=chunk)[208](index=208&type=chunk)[215](index=215&type=chunk) - The company's patent estate includes **28 granted U.S. patents** and over **80 European and international patents** covering SCS delivery technology, devices, and drug formulations, with expected expiration dates between 2027 and 2042[38](index=38&type=chunk)[156](index=156&type=chunk) - As of December 31, 2023, Clearside Biomedical had **30 full-time employees**, all located in the United States[142](index=142&type=chunk) [Overview](index=8&type=section&id=Overview) Clearside Biomedical is a biopharmaceutical company focused on revolutionizing therapy delivery to the back of the eye via the suprachoroidal space (SCS) - Clearside Biomedical is a biopharmaceutical company focused on revolutionizing therapy delivery to the back of the eye via the suprachoroidal space (SCS)[25](index=25&type=chunk) - The company leverages its SCS injection platform for internal R&D targeting retinal diseases and external collaborations with other ophthalmic therapeutic companies[23](index=23&type=chunk) - **XIPERE**, the first approved therapeutic delivered into the SCS, was approved by the U.S. FDA in October 2021 for macular edema associated with uveitis[23](index=23&type=chunk) [Our Suprachoroidal Space (SCS) Injection Platform](index=8&type=section&id=Our%20Suprachoroidal%20Space%20(SCS)%20Injection%20Platform) The SCS injection platform is a novel, patented approach for targeted and compartmentalized delivery of pharmacotherapy to the macula, retina, or choroid, using a proprietary SCS Microinjector - The SCS injection platform is a novel, patented approach for targeted and compartmentalized delivery of pharmacotherapy to the macula, retina, or choroid, using a proprietary SCS Microinjector[25](index=25&type=chunk)[137](index=137&type=chunk) - This non-surgical method uses a one-millimeter needle to inject fluid into the SCS, allowing it to spread posteriorly and precisely target affected cells, potentially improving vision and minimizing harm to non-diseased tissues[137](index=137&type=chunk)[144](index=144&type=chunk)[47](index=47&type=chunk) - Compared to intravitreal injections, SCS delivery offers potential benefits such as a non-surgical procedure, lower administration frequency, limited exposure to non-targeted tissues, faster therapeutic onset, and an improved safety profile[144](index=144&type=chunk) [Our SCS Microinjector](index=10&type=section&id=Our%20SCS%20Microinjector) The SCS Microinjector is designed for targeted drug delivery into the SCS, aiming to improve efficacy and compartmentalization while reducing toxic effects on healthy cells - The SCS Microinjector is designed for targeted drug delivery into the SCS, aiming to improve efficacy and compartmentalization while reducing toxic effects on healthy cells[55](index=55&type=chunk) - It consists of a syringe and two 30-gauge hollow microneedles (approx. 1mm each) within a custom hub, optimizing insertion and suprachoroidal administration[30](index=30&type=chunk) - The device has been used in thousands of clinical injections and is commercially accepted, with over **1,200 retinal physicians trained** in the U.S. following XIPERE's launch[29](index=29&type=chunk) - A permanent Category 1 CPT code for suprachoroidal injection was granted on January 1, 2024, expected to enhance access, insurance coverage, and adoption[146](index=146&type=chunk) [Our Pipeline](index=12&type=section&id=Our%20Pipeline) [Clearside Developed Programs](index=12&type=section&id=Clearside%20Developed%20Programs) [CLS-AX (axitinib injectable suspension)](index=12&type=section&id=CLS-AX%20(axitinib%20injectable%20suspension)) CLS-AX is Clearside's most advanced internal product candidate, a proprietary suspension of the TKI axitinib for suprachoroidal injection, targeting wet AMD, aiming for longer-duration maintenance therapy with pan-VEGF blockade and a favorable safety profile, with Phase 2b ODYSSEY trial topline data anticipated in Q3 2024 - **CLS-AX** is a proprietary suspension of the Tyrosine Kinase Inhibitor (TKI) axitinib for suprachoroidal injection, developed as a long-acting therapy for wet Age-related Macular Degeneration (AMD)[153](index=153&type=chunk) - Axitinib offers pan-VEGF blockade by inhibiting VEGF receptors-1, -2, and -3, potentially providing efficacy advantages over existing therapies that primarily target VEGF-A[162](index=162&type=chunk) - Preclinical studies showed CLS-AX delivered via SCS injection was well-tolerated, demonstrated durability over several months, and achieved up to **eleven times higher drug levels** in affected tissues compared to intravitreal administration[171](index=171&type=chunk) - The Phase 1/2a OASIS clinical trial (n=27) for wet AMD met primary endpoints, showing CLS-AX was well-tolerated with no serious adverse events, inflammation, vasculitis, or vitreous floaters[163](index=163&type=chunk)[165](index=165&type=chunk)[167](index=167&type=chunk) - OASIS extension study data showed promising durability, with **77%-85% reduction in treatment burden** compared to pre-CLS-AX injections, and stable mean BCVA and CST to the six-month timepoint[173](index=173&type=chunk) - OASIS Extension Study: Duration Without Additional Therapy (n=12) | Duration Without Additional Therapy | Number of Participants (n=12) | | :---------------------------------- | :---------------------------- | | ≥ 3 Months | 11/12 (92%) | | ≥ 4 Months | 10/12 (83%) | | ≥ 6 Months | 8/12 (67%) | | > 6 Months | 6/12 (50%) | - The randomized, controlled, double-masked Phase 2b ODYSSEY clinical trial for CLS-AX in wet AMD began enrolling participants in May 2023, completed randomization in December 2023, and expects topline data in Q3 2024[168](index=168&type=chunk) [XIPERE (triamcinolone acetonide injectable suspension) for suprachoroidal use](index=17&type=section&id=XIPERE%20(triamcinolone%20acetonide%20injectable%20suspension)%20for%20suprachoroidal%20use) XIPERE, a proprietary, preservative-free suspension of triamcinolone acetonide, is Clearside's first FDA-approved product for macular edema associated with uveitis, offering a targeted anti-inflammatory treatment via SCS injection to minimize systemic side effects - **XIPERE** is a proprietary, preservative-free suspension of the corticosteroid triamcinolone acetonide (TA) approved by the FDA for suprachoroidal use[181](index=181&type=chunk) - It is approved for the treatment of macular edema associated with uveitis, a condition affecting approximately **one-third of uveitis patients** and a leading cause of vision loss[182](index=182&type=chunk) - SCS delivery of XIPERE aims to treat ocular inflammation effectively while minimizing significant side effects like cataract formation and elevated intraocular pressure (IOP) often seen with other local corticosteroid deliveries[181](index=181&type=chunk) [External Collaborations Pipeline](index=17&type=section&id=External%20Collaborations%20Pipeline) [License agreement for commercialization of XIPERE in United States and Canada](index=17&type=section&id=License%20agreement%20for%20commercialization%20of%20XIPERE%20in%20United%20States%20and%20Canada) Clearside has an exclusive license agreement with Bausch + Lomb for the commercialization of XIPERE in the United States and Canada, including upfront, regulatory, and sales-based milestone payments, along with tiered royalties on net sales, though Clearside's rights to these payments have been sold to HCR - Clearside granted Bausch + Lomb an exclusive license to develop, manufacture, distribute, promote, market, and commercialize XIPERE and other specified steroids/NSAIDs using the SCS Microinjector in the U.S. and Canada[188](index=188&type=chunk)[880](index=880&type=chunk) - Bausch paid Clearside an upfront payment of **$5.0 million**, a **$5.0 million** milestone upon FDA approval of XIPERE, and an additional **$10.0 million** for pre-launch activities[183](index=183&type=chunk)[665](index=665&type=chunk) - The agreement includes potential additional milestone payments up to **$55.0 million** for regulatory approvals of new indications and specified annual net sales levels, plus tiered royalties from high-teens to twenty percent on net sales (after the first **$45.0 million** of cumulative net sales)[183](index=183&type=chunk)[665](index=665&type=chunk) - Clearside's rights to these royalties and milestone payments have been sold to HealthCare Royalty Management, LLC (HCR) under a Purchase and Sale Agreement[183](index=183&type=chunk)[665](index=665&type=chunk) [License agreement for commercialization of XIPERE in China, Hong Kong, Macau, Taiwan and South Korea, India, ASEAN Countries, Australia and New Zealand](index=19&type=section&id=License%20agreement%20for%20commercialization%20of%20XIPERE%20in%20China,%20Hong%20Kong,%20Macau,%20Taiwan%20and%20South%20Korea,%20India,%20ASEAN%20Countries,%20Australia%20and%20New%20Zealand) Clearside has an exclusive license agreement with Arctic Vision for XIPERE's commercialization in a broad Asia Pacific territory, including China, South Korea, India, ASEAN countries, Australia, and New Zealand, with Arctic Vision actively developing XIPERE (branded as Arcatus) in these regions, and Clearside receiving upfront and milestone payments and tiered royalties, though these rights are also subject to the HCR royalty sale - Clearside granted Arctic Vision an exclusive license to develop and commercialize XIPERE in China, Hong Kong, Macau, Taiwan, South Korea, India, ASEAN Countries, Australia, and New Zealand[191](index=191&type=chunk)[185](index=185&type=chunk)[785](index=785&type=chunk)[883](index=883&type=chunk) - Arctic Vision paid an upfront payment of **$4.0 million** and a **$4.0 million** milestone upon FDA approval of XIPERE in the U.S., plus **$3.0 million** for territory expansion[193](index=193&type=chunk)[185](index=185&type=chunk)[785](index=785&type=chunk)[635](index=635&type=chunk) - Arctic Vision is pursuing development of XIPERE (branded as Arcatus), having dosed the first patient in a Phase 1 trial for diabetic macular edema in China and completed enrollment in a Phase 3 trial for uveitic macular edema in China[192](index=192&type=chunk) - The agreement includes potential development and sales milestone payments up to **$22.5 million** and tiered royalties of **10% to 12%** of net sales in the Arctic Territory[193](index=193&type=chunk)[635](index=635&type=chunk) - Clearside's rights to these royalties and milestone payments have been sold to HealthCare Royalty Management, LLC (HCR)[193](index=193&type=chunk)[635](index=635&type=chunk) [Gene Therapy](index=20&type=section&id=Gene%20Therapy) Clearside is expanding its SCS injection platform into gene therapy through collaborations, believing it offers a safer, targeted, and non-surgical alternative for ocular gene therapy delivery, avoiding risks associated with subretinal surgery and enhancing patient access to care - Clearside's platform offers potential for safer, targeted ocular gene therapy without the risks of surgery and subretinal administration, enhancing access to care[195](index=195&type=chunk) - Preclinical studies have shown SCS injection can administer both viral and non-viral gene therapy, achieving expression in the retina and choroid in rabbits and non-human primates[197](index=197&type=chunk) - Suprachoroidal administration avoids retinal detachment and is an office-based procedure, making it potentially more accessible than current surgical gene therapy deliveries[187](index=187&type=chunk)[195](index=195&type=chunk) [REGENXBIO, Inc.](index=20&type=section&id=REGENXBIO,%20Inc.) Clearside has partnered with REGENXBIO for the use of its SCS Microinjector in AAV-based gene therapies for retinal diseases, with REGENXBIO conducting Phase 2 clinical trials (AAVIATE for wet AMD and ALTITUDE for diabetic retinopathy) using SCS delivery, showing promising interim data - Clearside granted REGENXBIO an exclusive, worldwide license to its SCS Microinjector for in-office delivery of AAV-based gene therapies for wet AMD, diabetic retinopathy, and other anti-VEGF-treated conditions[199](index=199&type=chunk)[852](index=852&type=chunk) - REGENXBIO is conducting Phase 2 clinical trials: AAVIATE for wet AMD and ALTITUDE for diabetic retinopathy, evaluating SCS delivery of ABBV-RGX-314[201](index=201&type=chunk) - Data from the ALTITUDE trial showed prevention of disease progression in non-proliferative DR patients at one year (dose level 2)[201](index=201&type=chunk) - Data from the AAVIATE trial demonstrated stable vision and retinal anatomy, with a meaningful reduction in anti-VEGF treatment burden at six months[201](index=201&type=chunk) - Clearside received an option fee of **$2.0 million** (net **$1.5 million**) and a **$3.0 million** development milestone, with eligibility for up to **$31.0 million** in additional development milestones and **$102.0 million** in sales-based milestones, plus mid-single digit royalties[206](index=206&type=chunk)[852](index=852&type=chunk) - Clearside's rights to these royalties and milestone payments have been sold to HealthCare Royalty Management, LLC (HCR)[206](index=206&type=chunk)[852](index=852&type=chunk) [Ocular Oncology](index=22&type=section&id=Ocular%20Oncology) Clearside is exploring the application of its SCS Microinjector in ocular oncology, particularly for choroidal melanoma, offering a potential non-surgical alternative to highly invasive treatments like radiotherapy, aiming to improve safety and access for patients - Ocular cancers, such as choroidal melanoma, are rare, life-threatening conditions with approximately **11,000 patients per year** in the U.S. and Europe[202](index=202&type=chunk)[203](index=203&type=chunk) - Current treatments like radiotherapy are highly invasive and often result in major vision loss and comorbidities, highlighting a need for less invasive options[202](index=202&type=chunk)[203](index=203&type=chunk) - The SCS Microinjector offers a potential non-surgical alternative for delivering oncology drug candidates, aiming to improve safety and expand access for choroidal melanoma treatment[215](index=215&type=chunk) [Aura Biosciences, Inc.](index=22&type=section&id=Aura%20Biosciences,%20Inc.) Clearside has a licensing agreement with Aura Biosciences for the use of its SCS Microinjector to deliver Aura's viral-like drug conjugate, bel-sar, for choroidal melanoma, with recent Phase 2 clinical trial updates showing positive safety and efficacy, leading to the initiation of a global Phase 3 trial - Clearside licensed its SCS Microinjector to Aura Biosciences for delivering Aura's proprietary drug candidates, including bel-sar, into the SCS for ocular cancers like choroidal melanoma[215](index=215&type=chunk) - Clearside received **$1.6 million** in upfront license fees and development milestones, and is eligible for up to **$19.5 million** in additional development/regulatory milestones, plus low to mid-single digit royalties on net sales[215](index=215&type=chunk) - Aura reported positive Phase 2 clinical safety and efficacy updates for bel-sar via SCS administration, showing an **80% tumor control rate** and **90% visual acuity preservation rate** at 12 months for patients in specific cohorts[215](index=215&type=chunk) - Aura initiated its global Phase 3 clinical trial (CoMpass) for bel-sar in December 2023[215](index=215&type=chunk) - Clearside's rights to these royalties and milestone payments have been sold to HealthCare Royalty Management, LLC (HCR)[215](index=215&type=chunk) [BioCryst Pharmaceuticals, Inc.](index=22&type=section&id=BioCryst%20Pharmaceuticals,%20Inc.) Clearside entered into a license agreement with BioCryst Pharmaceuticals for the exclusive, worldwide use of its SCS Microinjector to deliver BioCryst's avoralstat, a plasma kallikrein inhibitor, for diabetic macular edema (DME), including an upfront payment, potential clinical, regulatory, and sales-based milestones, and tiered royalties, with Clearside responsible for supplying the SCS Microinjectors - Clearside granted BioCryst Pharmaceuticals an exclusive, worldwide license to its SCS Microinjector for delivering BioCryst's avoralstat (plasma kallikrein inhibitor) for diabetic macular edema (DME)[208](index=208&type=chunk)[693](index=693&type=chunk)[816](index=816&type=chunk) - Clearside received an upfront license fee of **$5.0 million** and is eligible for up to **$30.0 million** in clinical/regulatory milestones and up to **$47.5 million** in sales-based milestones (up to **$2.0 billion** in sales)[218](index=218&type=chunk)[564](index=564&type=chunk)[854](index=854&type=chunk) - BioCryst will pay tiered mid-single digit royalties on annual global net product sales, with the highest rate for sales over **$1.5 billion**[218](index=218&type=chunk)[564](index=564&type=chunk)[854](index=854&type=chunk) - BioCryst is responsible for all development, regulatory, and commercialization activities for avoralstat, while Clearside supplies the SCS Microinjectors[209](index=209&type=chunk)[668](index=668&type=chunk) - Clearside's rights to these royalties and milestone payments have been sold to HealthCare Royalty Management, LLC (HCR)[218](index=218&type=chunk)[564](index=564&type=chunk)[854](index=854&type=chunk) [Royalty Purchase and Sale Agreement](index=24&type=section&id=Royalty%20Purchase%20and%20Sale%20Agreement) Clearside, through its subsidiary Royalty Sub, sold certain rights to future royalty and milestone payments from its license agreements (Arctic Vision, Bausch, Aura, REGENXBIO, BioCryst) to HealthCare Royalty Management, LLC (HCR) for up to $65 million, including an initial payment and potential additional milestone payments, with a cap on total payments to HCR - Clearside's wholly-owned subsidiary, Royalty Sub, sold rights to receive royalty and milestone payments from its license agreements (Arctic Vision, Bausch, Aura, REGENXBIO, and future out-license agreements for XIPERE/SCS Microinjector) to HCR for up to **$65 million**[28](index=28&type=chunk)[210](index=210&type=chunk)[610](index=610&type=chunk) - Royalty Sub received an initial payment of **$32.1 million** (net of expenses) and an additional **$12.5 million** was initially held in escrow, which was later waived and released to HCR[211](index=211&type=chunk)[224](index=224&type=chunk)[830](index=830&type=chunk)[831](index=831&type=chunk) - The agreement includes a potential **$20 million** milestone payment to Royalty Sub upon achieving a second pre-specified sales milestone related to 2024 XIPERE sales[211](index=211&type=chunk)[830](index=830&type=chunk) - Payments to HCR will cease when HCR receives **2.5 times** the aggregate payments if the second milestone is met by Dec 31, 2024 (Initial Cap), or **3.4 times** if not (Alternative Cap)[211](index=211&type=chunk)[611](index=611&type=chunk) - After the Purchase and Sale Agreement expires, all rights to receive the Royalties return to Royalty Sub[213](index=213&type=chunk)[611](index=611&type=chunk) [Manufacturing](index=26&type=section&id=Manufacturing) Clearside Biomedical relies entirely on Contract Manufacturing Organizations (CMOs) for the formulation and production of its drug candidates and the SCS Microinjector - Clearside does not own manufacturing facilities and utilizes CMOs for drug candidate formulation, production, and SCS Microinjector manufacturing[225](index=225&type=chunk)[336](index=336&type=chunk) - Active pharmaceutical ingredients are procured from third-party suppliers[225](index=225&type=chunk) - A supply agreement with Gerresheimer Regensburg GmbH is in place for the SCS Microinjector, with an initial five-year term and three-year renewal increments[226](index=226&type=chunk)[689](index=689&type=chunk) [Competition](index=26&type=section&id=Competition) Clearside faces intense competition in the biotechnology and pharmaceutical industries from major companies, specialty firms, and research institutions, with its products competing with existing therapies and new treatments for eye diseases, and competition also extending to devices for SCS access and the recruitment of personnel and clinical trial participants - The biotechnology and pharmaceutical industries are characterized by rapidly advancing technologies, intense competition, and a strong emphasis on proprietary drugs[32](index=32&type=chunk) - **XIPERE** competes with other commercially available forms of triamcinolone acetonide (TA) and other topical, injectable, and implantable corticosteroids, none of which are approved specifically for macular edema associated with uveitis[227](index=227&type=chunk)[395](index=395&type=chunk) - Key competitors for XIPERE include Bristol-Myers Squibb (Kenalog, used off-label), Alcon (Triesence), Allergan (Ozurdex), Bausch (Retisert), and Alimera (Yutiq)[227](index=227&type=chunk)[395](index=395&type=chunk) - **CLS-AX** faces competition from anti-VEGF drugs (current standard of care for wet AMD), including Genentech's Lucentis, Avastin, Susvimo, and Vabysmo, as well as Regeneron's Eylea and Novartis' Beovu[228](index=228&type=chunk)[34](index=34&type=chunk)[383](index=383&type=chunk) - Other companies like Ocular Therapeutics and Eyepoint are investigating TKIs for ocular use, and gene therapies from REGENXBIO, Adverum, and 4D Molecular Therapeutics could also compete with CLS-AX[222](index=222&type=chunk)[35](index=35&type=chunk)[396](index=396&type=chunk)[397](index=397&type=chunk) - The SCS Microinjector faces competition from other devices being developed by companies like Oxular Limited and Everads to access ocular posterior tissues via the SCS[43](index=43&type=chunk)[398](index=398&type=chunk) - Competitive factors include efficacy, safety, administration method, convenience, price, and availability of coverage/reimbursement; competitors with greater resources or earlier regulatory approval pose significant challenges[231](index=231&type=chunk)[398](index=398&type=chunk)[400](index=400&type=chunk) [Intellectual property](index=28&type=section&id=Intellectual%20property) Clearside's success relies heavily on its intellectual property portfolio, which includes 28 granted U.S. patents and over 80 international patents covering SCS delivery devices, methods, and drug formulations, and the company also licenses key patents from Emory University and Georgia Tech Research Corporation, with recent amendments to the Georgia Tech License Agreement adjusting sublicense percentages and annual maintenance fees - Clearside's intellectual property portfolio includes **28 granted U.S. patents** and over **80 European and international patents** broadly directed to the SCS Microinjector, SCS drug administration, and product candidates[156](index=156&type=chunk)[38](index=38&type=chunk) - Patents and applications related to SCS delivery technology, drug candidates, and therapeutic uses are expected to expire between **2027 and 2042**[38](index=38&type=chunk) - The company licenses 8 issued U.S. patents, 4 pending U.S. applications, and 23 issued foreign patents related to microneedle drug delivery from Georgia Tech Research Corporation and Emory University[38](index=38&type=chunk) - An amendment to the Georgia Tech License Agreement on January 31, 2024, reduced the sublicense percentage payable to the Licensor from a low double-digit to a high single-digit percentage for payments received after July 1, 2023[52](index=52&type=chunk)[51](index=51&type=chunk)[563](index=563&type=chunk)[694](index=694&type=chunk) - Revised annual license maintenance fees were agreed upon, ranging from **$250,000** (2023-2025) to **$500,000** (2028)[58](index=58&type=chunk)[563](index=563&type=chunk)[695](index=695&type=chunk) - Clearside's trademark portfolio includes numerous registered and pending trademarks in various countries for its business and products[59](index=59&type=chunk) [Government regulation](index=31&type=section&id=Government%20regulation) Clearside's product development and commercialization are subject to extensive regulation by the FDA in the U.S. and comparable foreign authorities, including rigorous preclinical and clinical testing, NDA submission, and post-approval requirements like cGMP compliance and marketing restrictions, while also navigating complex laws regarding fraud and abuse, data privacy, and healthcare reform, which impact pricing, coverage, and reimbursement - Drug and device products, including combination products like Clearside's, are regulated by the FDA under the Food, Drug and Cosmetic Act (FDCA) and its implementing regulations[67](index=67&type=chunk)[60](index=60&type=chunk) - The regulatory process involves preclinical studies, IND application, multi-phase clinical trials (Phase 1, 2, 3), NDA submission, FDA review and approval, and cGMP compliance for manufacturing[149](index=149&type=chunk)[62](index=62&type=chunk)[63](index=63&type=chunk)[64](index=64&type=chunk)[79](index=79&type=chunk)[70](index=70&type=chunk)[72](index=72&type=chunk) - Post-approval requirements include ongoing FDA surveillance, recordkeeping, periodic reporting, advertising/promotion regulations, and potential post-marketing studies or Risk Evaluation and Mitigation Strategies (REMS)[73](index=73&type=chunk)[74](index=74&type=chunk)[75](index=75&type=chunk)[81](index=81&type=chunk)[152](index=152&type=chunk)[302](index=302&type=chunk) - Clearside may pursue the Section 505(b)(2) NDA pathway, which allows reliance on existing safety/effectiveness data, potentially reducing the need for some preclinical or clinical trials[89](index=89&type=chunk)[271](index=271&type=chunk) - The company is subject to federal and state fraud and abuse laws (e.g., Anti-Kickback Statute, False Claims Act, HIPAA) and data privacy laws (e.g., HIPAA, EU GDPR, CCPA, CPRA), which impose strict compliance requirements and potential penalties[102](index=102&type=chunk)[103](index=103&type=chunk)[104](index=104&type=chunk)[105](index=105&type=chunk)[106](index=106&type=chunk)[108](index=108&type=chunk)[109](index=109&type=chunk)[117](index=117&type=chunk)[119](index=119&type=chunk)[120](index=120&type=chunk)[121](index=121&type=chunk)[324](index=324&type=chunk)[326](index=326&type=chunk) - Coverage and reimbursement policies from third-party payors (government and private) are critical for commercial success, with a new Category 1 CPT code for SCS injection potentially facilitating better access[113](index=113&type=chunk)[123](index=123&type=chunk)[131](index=131&type=chunk)[448](index=448&type=chunk)[401](index=401&type=chunk) - Healthcare reform initiatives, including the Affordable Care Act and the Inflation Reduction Act, aim to control costs and may impact reimbursement for products, potentially reducing revenues[125](index=125&type=chunk)[126](index=126&type=chunk)[127](index=127&type=chunk)[139](index=139&type=chunk)[140](index=140&type=chunk)[367](index=367&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk)[333](index=333&type=chunk)[334](index=334&type=chunk) - The Foreign Corrupt Practices Act (FCPA) prohibits improper payments to foreign officials, impacting international operations and collaborations[130](index=130&type=chunk)[134](index=134&type=chunk)[292](index=292&type=chunk) [Employees and Human Capital Resources](index=48&type=section&id=Employees%20and%20Human%20Capital%20Resources) - As of December 31, 2023, Clearside Biomedical had **30 full-time employees**, all located in the United States[142](index=142&type=chunk) - The company emphasizes recruiting and retaining talented employees by fostering an inclusive and diverse work environment with meaningful compensation, benefits, and wellness programs[141](index=141&type=chunk) - None of the employees are represented by a labor union or covered by a collective bargaining agreement, and the company considers its relationship with employees to be good[142](index=142&type=chunk) [Corporate Information](index=48&type=section&id=Corporate%20Information) - Clearside Biomedical, Inc. was incorporated in Delaware in May 2011[135](index=135&type=chunk) - Its principal executive offices are located in Alpharetta, Georgia[135](index=135&type=chunk) [Available Information](index=48&type=section&id=Available%20Information) - The company's annual reports (Form 10-K), quarterly reports (Form 10-Q), current reports (Form 8-K), and amendments are available free of charge on its website (www.clearsidebio.com) and the SEC's website (www.sec.gov)[235](index=235&type=chunk)[236](index=236&type=chunk) [Item 1A. Risk Factors](index=49&type=section&id=Item%201A.%20Risk%20Factors) Clearside Biomedical faces significant risks from substantial losses, funding needs, market acceptance challenges for its novel SCS platform, uncertain product development, third-party dependencies, intellectual property vulnerabilities, extensive regulatory compliance, and stock volatility - The company has incurred significant losses since inception (**$32.5 million** in 2023, **$32.9 million** in 2022) and expects to continue incurring losses, requiring substantial additional funding beyond Q3 2025 to complete CLS-AX development and pursue business objectives[239](index=239&type=chunk)[356](index=356&type=chunk)[357](index=357&type=chunk)[478](index=478&type=chunk)[479](index=479&type=chunk) - The SCS injection approach is novel and may fail to achieve and sustain market acceptance by physicians, patients, and third-party payors, even with XIPERE's FDA approval[20](index=20&type=chunk)[259](index=259&type=chunk)[262](index=262&type=chunk)[276](index=276&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process with a high risk of failure, including potential delays, negative results, or unforeseen side effects that could prevent regulatory approval or commercialization[20](index=20&type=chunk)[284](index=284&type=chunk)[286](index=286&type=chunk)[313](index=313&type=chunk) - Reliance on third-party collaborators for development and commercialization of XIPERE and other product candidates, and on CMOs for manufacturing, introduces risks of non-performance, delays, and loss of control over critical activities[20](index=20&type=chunk)[300](index=300&type=chunk)[317](index=317&type=chunk)[320](index=320&type=chunk)[336](index=336&type=chunk)[337](index=337&type=chunk) - The company's ability to obtain and maintain patent protection for its technology and product candidates is crucial but faces risks from challenges, infringement claims, and changes in patent law, potentially leading to expensive litigation or loss of exclusivity[20](index=20&type=chunk)[223](index=223&type=chunk)[234](index=234&type=chunk)[240](index=240&type=chunk)[241](index=241&type=chunk)[242](index=242&type=chunk)[345](index=345&type=chunk)[346](index=346&type=chunk)[349](index=349&type=chunk)[497](index=497&type=chunk)[498](index=498&type=chunk)[501](index=501&type=chunk)[502](index=502&type=chunk)[503](index=503&type=chunk) - Extensive and evolving regulatory requirements, including those for drug-device combination products, post-marketing surveillance, fraud and abuse, data privacy, and healthcare reform, pose significant compliance challenges and could lead to penalties, delays, or restrictions on commercialization[275](index=275&type=chunk)[289](index=289&type=chunk)[290](index=290&type=chunk)[292](index=292&type=chunk)[302](index=302&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk)[307](index=307&type=chunk)[308](index=308&type=chunk)[309](index=309&type=chunk)[310](index=310&type=chunk)[324](index=324&type=chunk)[326](index=326&type=chunk)[327](index=327&type=chunk)[330](index=330&type=chunk)[367](index=367&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk)[370](index=370&type=chunk) - The common stock's trading price may be volatile due to operating results, industry trends, competition, and macroeconomic conditions, with potential for dilution from future equity issuances and risks related to Nasdaq listing compliance[384](index=384&type=chunk)[387](index=387&type=chunk)[389](index=389&type=chunk)[390](index=390&type=chunk)[391](index=391&type=chunk) [Risks Related to Our Financial Position and Capital Needs](index=49&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) - Clearside has incurred net losses of **$32.5 million** in 2023 and **$32.9 million** in 2022, with an accumulated deficit of **$320.9 million** as of December 31, 2023[239](index=239&type=chunk)[478](index=478&type=chunk) - The company expects to incur significant operating losses for several more years and may never achieve or maintain profitability, as successful development and commercialization of product candidates are highly uncertain[239](index=239&type=chunk)[354](index=354&type=chunk)[356](index=356&type=chunk)[479](index=479&type=chunk) - Substantial additional funding will be required beyond Q3 2025 to complete clinical development of CLS-AX and other business objectives, with financing potentially coming from equity offerings, debt, or collaborations, which could dilute stockholders or impose restrictive covenants[357](index=357&type=chunk)[363](index=363&type=chunk)[342](index=342&type=chunk)[479](index=479&type=chunk)[598](index=598&type=chunk)[765](index=765&type=chunk) - The Royalty Purchase and Sale Agreement with HCR, where rights to future royalties and milestones were sold for up to **$65 million**, includes a cap on payments to HCR (**2.5x or 3.4x** initial payments) and various covenants, a violation of which could materially affect financial condition[252](index=252&type=chunk)[254](index=254&type=chunk)[255](index=255&type=chunk)[364](index=364&type=chunk) - Adverse macroeconomic conditions, including inflation, interest rate increases, and geopolitical events, could negatively impact operations, liquidity, and the ability to raise capital[256](index=256&type=chunk)[257](index=257&type=chunk)[258](index=258&type=chunk)[480](index=480&type=chunk)[455](index=455&type=chunk) [Risks Related to the Development of Our Product Candidates](index=53&type=section&id=Risks%20Related%20to%20the%20Development%20of%20Our%20Product%20Candidates) - The SCS injection approach is novel and may not gain adequate patient benefit or acceptance from physicians, patients, or third-party payors, despite XIPERE's FDA approval[259](index=259&type=chunk)[262](index=262&type=chunk)[276](index=276&type=chunk) - The successful development of product candidates like CLS-AX is highly uncertain, with no guarantee of safety or efficacy in humans or regulatory approval[278](index=278&type=chunk)[284](index=284&type=chunk) - Clinical drug development is a lengthy, expensive, and uncertain process, with high risk of failure at any stage due to unforeseen events, negative results, or side effects[284](index=284&type=chunk)[286](index=286&type=chunk)[313](index=313&type=chunk) - Delays or difficulties in patient enrollment for clinical trials could significantly delay regulatory approvals or require abandonment of programs, increasing development costs[296](index=296&type=chunk)[299](index=299&type=chunk) - The company's strategy to build a pipeline of product candidates may not be successful, as identified candidates may not be safe, effective, or suitable for clinical development[283](index=283&type=chunk) - Limited resources may lead to focusing on certain product candidates or indications, potentially missing more profitable opportunities[314](index=314&type=chunk) [Risks Related to Our Dependence on Third Parties](index=61&type=section&id=Risks%20Related%20to%20Our%20Dependence%20on%20Third%20Parties) - Dependence on third-party collaborators for XIPERE's development and commercialization (e.g., Bausch) means Clearside's revenue generation is largely outside its control, and failure of these collaborations could materially harm the business[300](index=300&type=chunk)[317](index=317&type=chunk) - Risks with collaborators include discretion over efforts, non-performance, delays in clinical trials, development of competing products, disagreements, and potential termination of agreements[318](index=318&type=chunk) - Reliance on Contract Research Organizations (CROs) for clinical trials reduces direct control, but Clearside remains responsible for regulatory compliance (GCPs) and data integrity, with potential for delays or rejection of applications if CROs fail to perform[320](index=320&type=chunk)[321](index=321&type=chunk)[322](index=322&type=chunk)[335](index=335&type=chunk) - The company relies on third-party manufacturers for clinical and commercial supplies of drug candidates and the SCS Microinjector, increasing risks of insufficient quantities, unacceptable costs, or quality issues, and potential delays if manufacturers fail to comply with cGMP regulations[336](index=336&type=chunk)[337](index=337&type=chunk)[339](index=339&type=chunk)[360](index=360&type=chunk) - Inability to establish additional collaborations for product candidates may force Clearside to curtail development, delay commercialization, or undertake activities at its own expense, requiring additional capital[362](index=362&type=chunk)[375](index=375&type=chunk) [Risks Related to the Commercialization of Our Product Candidates](index=68&type=section&id=Risks%20Related%20to%20the%20Commercialization%20of%20Our%20Product%20Candidates) - If Clearside does not out-license commercialization rights, it must establish its own sales and distribution capabilities, which is expensive, time-consuming, and risky, potentially leading to lower product revenues and profitability[377](index=377&type=chunk)[378](index=378&type=chunk)[379](index=379&type=chunk) - XIPERE and other approved product candidates may fail to achieve sufficient market acceptance by physicians, patients, and third-party payors due to the novelty of SCS injection, competition, pricing, or perceived advantages of alternative treatments[380](index=380&type=chunk) - The company faces substantial competition from major pharmaceutical and biotechnology companies, as well as smaller firms, with greater resources and expertise, potentially leading to competitors developing or commercializing products more successfully or rapidly[382](index=382&type=chunk)[398](index=398&type=chunk)[400](index=400&type=chunk) - XIPERE and CLS-AX face competition from existing anti-VEGF drugs, other corticosteroids, and emerging gene therapies, with off-label use of cheaper alternatives (e.g., Kenalog, Avastin) posing significant pricing pressure[395](index=395&type=chunk)[398](index=398&type=chunk) - Unfavorable pricing regulations, third-party coverage, and reimbursement policies (including Medicare and Medicaid) or healthcare reform initiatives could limit market access, reduce reimbursement levels, and adversely affect revenues[401](index=401&type=chunk)[402](index=402&type=chunk)[403](index=403&type=chunk)[404](index=404&type=chunk)[449](index=449&type=chunk)[450](index=450&type=chunk)[451](index=451&type=chunk) - Product liability lawsuits related to XIPERE or product candidates could result in substantial liabilities, decreased demand, reputational harm, and significant costs, potentially exceeding current insurance coverage[452](index=452&type=chunk)[453](index=453&type=chunk)[493](index=493&type=chunk) [Risks Related to Our Intellectual Property](index=76&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) - Inability to obtain and maintain broad patent protection for technology and product candidates, or if licensed patents are not maintained, could allow competitors to commercialize similar drugs, impairing Clearside's ability to compete[497](index=497&type=chunk)[498](index=498&type=chunk)[501](index=501&type=chunk) - Patent prosecution is expensive and time-consuming, with uncertainties regarding issuance, scope, validity, and enforceability of patents, and potential for challenges (e.g., opposition, inter partes review) that could narrow or invalidate rights[498](index=498&type=chunk)[501](index=501&type=chunk)[502](index=502&type=chunk)[503](index=503&type=chunk) - Changes in U.S. or foreign patent law (e.g., Leahy-Smith Act, European unitary patent system) could diminish patent value, increase prosecution costs, and create uncertainty regarding enforcement[242](index=242&type=chunk)[243](index=243&type=chunk)[366](index=366&type=chunk)[501](index=501&type=chunk)[502](index=502&type=chunk) - The company may become involved in expensive and time-consuming lawsuits to protect or enforce its patents, or defend against third-party infringement claims, which could result in monetary damages, loss of rights, or delays in commercialization[345](index=345&type=chunk)[346](index=346&type=chunk)[347](index=347&type=chunk)[348](index=348&type=chunk)[349](index=349&type=chunk) - Failure to comply with obligations under existing intellectual property licenses (e.g., Emory/GT License) could lead to loss of critical license rights, impacting product development and commercialization[351](index=351&type=chunk) - Some in-licensed intellectual property may be subject to U.S. government rights (Bayh-Dole Act), including non-exclusive licenses for governmental purposes and potential 'march-in rights' or domestic manufacturing requirements[263](index=263&type=chunk) - Inability to protect trade secrets through non-disclosure agreements could harm competitive position if proprietary information is disclosed or independently developed by competitors[264](index=264&type=chunk)[265](index=265&type=chunk) - Trademarks may be infringed or challenged, forcing rebranding and loss of brand recognition[249](index=249&type=chunk) [Risks Related to Regulatory Approval of Our Product Candidates and Other Legal Compliance Matters](index=84&type=section&id=Risks%20Related%20to%20Regulatory%20Approval%20of%20Our%20Product%20Candidates%20and%20Other%20Legal%20Compliance%20Matters) - Failure or delays in obtaining regulatory approvals (FDA, EMA, etc.) for product candidates will prevent commercialization and materially impair revenue generation, as the approval process is expensive, lengthy, and uncertain[266](index=266&type=chunk)[269](index=269&type=chunk)[270](index=270&type=chunk) - If the FDA does not permit the Section 505(b)(2) regulatory pathway for product candidates as anticipated, it could lead to significantly longer development times, higher costs, and greater risks, potentially delaying or preventing approval[271](index=271&type=chunk)[272](index=272&type=chunk)[273](index=273&type=chunk)[274](index=274&type=chunk) - Co-packaging drug-device combination products adds complexity and may require additional time or separate device authorization submissions, causing delays[275](index=275&type=chunk)[289](index=289&type=chunk) - Failure to obtain marketing approval in international jurisdictions would prevent product candidates from being marketed abroad, with varying regulatory requirements and potential for delays[290](index=290&type=chunk) - International operations are subject to additional risks, including differing regulatory requirements, economic instability, foreign currency fluctuations, and compliance with anti-corruption laws like the FCPA[291](index=291&type=chunk)[292](index=292&type=chunk) - Approved products are subject to continuous post-marketing regulation, and non-compliance or unanticipated problems (e.g., adverse events, manufacturing issues) could lead to restrictions, recalls, withdrawal from the market, or significant penalties[302](index=302&type=chunk)[303](index=303&type=chunk)[304](index=304&type=chunk)[306](index=306&type=chunk)[307](index=307&type=chunk) - Misconduct by employees, contractors, or partners (e.g., non-compliance with FDA regulations, healthcare fraud and abuse laws) could result in substantial civil/criminal penalties, exclusion from government programs, and reputational harm[310](index=310&type=chunk)[312](index=312&type=chunk)[324](index=324&type=chunk) - Recently enacted and future healthcare legislation (e.g., Affordable Care Act, Inflation Reduction Act) may increase the difficulty and cost of obtaining marketing approval, restrict post-approval activities, and negatively impact pricing and reimbursement[330](index=330&type=chunk)[331](index=331&type=chunk)[332](index=332&type=chunk)[333](index=333&type=chunk)[334](index=334&type=chunk)[367](index=367&type=chunk)[368](index=368&type=chunk)[369](index=369&type=chunk) - Governments outside the U.S. often impose strict price controls, which could delay commercial launch and negatively impact revenues[370](index=370&type=chunk) [Risks Related to Ownership of Our Common Stock](index=101&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) - The trading price of Clearside's common stock is volatile and influenced by operating results, industry trends, economic conditions, and company announcements, potentially leading to substantial losses for investors[384](index=384&type=chunk) - The issuance of additional stock and equity-linked securities (e.g., warrants) in financings or acquisitions will dilute existing stockholders and could depress the stock price[387](index=387&type=chunk)[389](index=389&type=chunk)[405](index=405&type=chunk) - Failure to maintain Nasdaq listing requirements (e.g., minimum bid price) could result in delisting, reducing liquidity and market price, and negatively impacting the ability to raise equity financing[390](index=390&type=chunk)[391](index=391&type=chunk) - Sales of a substantial number of common stock shares by stockholders could cause a significant decline in market price[392](index=392&type=chunk) - Provisions in corporate charter documents and Delaware law (e.g., staggered board, no stockholder written consent, anti-takeover provisions) may prevent or frustrate attempts to change management or acquire a controlling interest, potentially lowering the stock price[406](index=406&type=chunk)[407](index=407&type=chunk)[393](index=393&type=chunk) - The company's amended and restated certificate of incorporation designates the Delaware Court of Chancery as the exclusive forum for certain litigation, which may limit stockholders' ability to choose a favorable judicial forum[409](index=409&type=chunk) - As a 'smaller reporting company,' Clearside has reduced disclosure and governance requirements, which may make its common stock less attractive to some investors and affect trading prices[410](index=410&type=chunk)[411](index=411&type=chunk)[412](index=412&type=chunk)[802](index=802&type=chunk) - The company does not anticipate paying cash dividends in the foreseeable future, making capital appreciation the sole source of gains for investors[414](index=414&type=chunk)[469](index=469&type=chunk) [General Risk Factors](index=106&type=section&id=General%20Risk%20Factors) - Compromises to information technology systems or data (internal or third-party) from cybersecurity threats could lead to regulatory investigations, litigation, fines, business disruptions, reputational harm, and financial losses[417](index=417&type=chunk)[418](index=418&type=chunk)[419](index=419&type=chunk)[424](index=424&type=chunk) - Remote work and business transactions (e.g., acquisitions) increase cybersecurity risks and vulnerabilities[420](index=420&type=chunk)[421](index=421&type=chunk) - Failure to comply with environmental, health, and safety laws and regulations could result in fines, penalties, or substantial costs, and potential liability from hazardous materials use[427](index=427&type=chunk)[428](index=428&type=chunk)[429](index=429&type=chunk) - Changes in tax laws (e.g., Tax Act, CARES Act, Inflation Reduction Act) could adversely affect business and financial condition, impacting corporate tax rates, foreign earnings, and deductibility of expenses[430](index=430&type=chunk) - The company's ability to use federal and state Net Operating Loss (NOL) carryforwards to offset future taxable income may be limited by ownership changes under Section 382 of the Code, potentially increasing tax liabilities[432](index=432&type=chunk)[434](index=434&type=chunk)[162](index=162&type=chunk)[875](index=875&type=chunk) - Failure to maintain proper and effective internal controls over financial reporting could impair the ability to produce accurate financial statements, leading to stock price decline and regulatory sanctions[435](index=435&type=chunk)[436](index=436&type=chunk)[437](index=437&type=chunk) - Being a public company incurs significant legal, accounting, and compliance costs, and evolving regulations may divert management's attention and resources[438](index=438&type=chunk)[439](index=439&type=chunk) - Climate change, extreme weather events, and other natural disasters could adversely affect business operations[441](index=441&type=chunk) - Adverse global economic conditions and geopolitical tensions (e.g., conflicts in Ukraine, Middle East) could negatively impact business, financial condition, and liquidity by increasing costs, limiting capital access, and disrupting supply chains[455](index=455&type=chunk) [Item 1B. Unresolved Staff Comments](index=112&type=section&id=Item%201B.%20Unresolved%20Staff%20Comments) Clearside Biomedical, Inc. has no unresolved staff comments from the SEC - The company has no unresolved staff comments[456](index=456&type=chunk) [Item 1C. Cybersecurity](index=112&type=section&id=Item%201C.%20Cybersecurity) Clearside Biomedical has implemented various information security processes to identify, assess, and manage cybersecurity risks to its critical systems and data, with oversight from the audit committee, and the cybersecurity function, led by the Senior Director of IT, employs technical, physical, and organizational measures, and utilizes third-party service providers for threat management and risk assessments - Clearside maintains information security processes to identify, assess, and manage material cybersecurity risks to its critical computer networks, hosted services, communication systems, hardware, software, and data (including intellectual property, confidential information, and clinical trial data)[442](index=442&type=chunk) - Cybersecurity risk management is integrated into the company's overall risk management processes, with the cybersecurity function prioritizing and mitigating threats likely to materially impact the business[443](index=443&type=chunk)[457](index=457&type=chunk) - Measures include incident detection and response, a vendor risk management program, employee training, data encryption, access controls, physical security, network security controls, systems monitoring, cyber insurance, and asset management[457](index=457&type=chunk) - Third-party service providers are used to assist in identifying, assessing, and managing cybersecurity threats, including professional services firms, threat intelligence providers, and cybersecurity software providers[458](index=458&type=chunk) - The board of directors, through the audit committee, oversees the company's cybersecurity risk management processes, receiving annual updates and timely notifications of significant incidents[446](index=446&type=chunk)[462](index=462&type=chunk) - The Senior Director of Information Technology, with over **23 years of IT management experience**, leads the cybersecurity function, with the CFO approving budgets and processes[459](index=459&type=chunk)[460](index=460&type=chunk) [Item 2. Properties](index=114&type=section&id=Item%202.%20Properties) Clearside Biomedical's principal offices are located in Alpharetta, Georgia, occupying approximately 14,000 square feet under a lease extending until November 2026 with a renewal option, and the company believes its current facilities are adequate and plans to expand as needed - Clearside's principal offices are in Alpharetta, Georgia, occupying approximately **14,000 square feet**[463](index=463&type=chunk) - The office space is leased under an agreement with an initial term until November 2026, with a renewal option for an additional three-year term[463](index=463&type=chunk)[628](index=628&type=chunk) - The company believes its current leased facilities are suitable and adequate for its needs and plans to add or expand facilities as employee numbers grow[464](index=464&type=chunk) [Item 3. Legal Proceedings](index=114&type=section&id=Item%203.%20Legal%20Proceedings) Clearside Biomedical is not currently involved in any material legal proceedings and is unaware of any pending or threatened legal actions that could significantly impact its business, operating results, or financial condition - Clearside Biomedical is not currently a party to any material legal proceedings[465](index=465&type=chunk) - The company is not aware of any pending or threatened legal proceedings that could have a material adverse effect on its business, operating results, or financial condition[465](index=465&type=chunk) [Item 4. Mine Safety Disclosures](index=114&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) Clearside Biomedical, Inc. is not subject to the disclosure requirements of Item 4, Mine Safety Disclosures - Item 4, Mine Safety Disclosures, is not applicable to Clearside Biomedical, Inc[466](index=466&type=chunk) PART II [Item 5. Market for Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities](index=115&type=section&id=Item%205.%20Market%20for%20Registrant%27s%20Common%20Equity,%20Related%20Stockholder%20Matters%20and%20Issuer%20Purchases%20of%20Equity%20Securities) Clearside Biomedical's common stock is listed on The Nasdaq Global Market under the symbol "CLSD", with 74,721,139 shares outstanding held by 7 record holders as of March 5, 2024, and the company has never declared or paid cash dividends, intending to retain earnings for business development, with no recent sales of unregistered securities or issuer purchases of equity securities - Clearside Biomedical's common stock is listed on The Nasdaq Global Market under the symbol "CLSD"[469](index=469&type=chunk) - As of March 5, 2024, there were **74,721,139 shares** of common stock outstanding, held by **7 record holders**[4](index=4&type=chunk)[470](index=470&type=chunk) - The company has never declared or paid any cash dividends on its common stock and anticipates retaining all future earnings for business operation and expansion[469](index=469&type=chunk)[414](index=414&type=chunk) - There have been no recent sales of unregistered securities or purchases of equity securities by the issuer or affiliated parties[471](index=471&type=chunk)[472](index=472&type=chunk) [Item 6. [Reserved]](index=115&type=section&id=Item%206.%20%5BReserved%5D) Item 6 is reserved and contains no information - Item 6 is reserved[473](index=473&type=chunk) [Item 7. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=116&type=section&id=Item%207.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Clearside Biomedical, with XIPERE approved and CLS-AX in Phase 2b, reports significant operating losses, relies on license revenue, anticipates needing additional capital beyond Q3 2025, and applies critical accounting policies with complex estimates amid macroeconomic and cybersecurity risks - Clearside Biomedical is a biopharmaceutical company focused on revolutionizing therapies for retinal diseases through its SCS injection platform, with XIPERE approved and CLS-AX in Phase 2b clinical trials[476](index=476&type=chunk)[477](index=477&type=chunk) - The company has an accumulated deficit of **$320.9 million** as of December 31, 2023, and recorded net losses of **$32.5 million** in 2023 and **$32.9 million** in 2022[478](index=478&type=chunk) - Revenue is primarily generated from upfront and milestone payments related to license agreements, with no significant product revenue expected until further product commercialization[478](index=478&type=chunk)[482](index=482&type=chunk) - Research and development expenses increased by **$1.2 million** (from **$19.6 million** in 2022 to **$20.8 million** in 2023), primarily due to costs for the CLS-AX ODYSSEY trial and related manufacturing[582](index=582&type=chunk)[505](index=505&type=chunk) - General and administrative expenses increased by **$0.1 million** in 2023, mainly due to higher professional fees offset by lower patent and insurance costs[639](index=639&type=chunk) - Other income increased in 2023 due to higher interest rates on cash and cash equivalents[688](index=688&type=chunk) - Non-cash interest expense from the royalty purchase and sale agreement increased significantly in 2023 due to a full year of imputed interest compared to five months in 2022[716](index=716&type=chunk) - The company expects existing cash and cash equivalents to fund operations into Q3 2025 but will require additional capital to complete CLS-AX clinical development[479](index=479&type=chunk)[598](index=598&type=chunk)[765](index=765&type=chunk) - Critical accounting policies involve significant estimates and judgments, particularly for royalty financing obligations, revenue recognition (milestone payments, licenses), accrued expenses, share-based compensation, and tax valuation allowances[512](index=512&type=chunk)[513](index=513&type=chunk)[514](index=514&type=chunk)[517](index=517&type=chunk)[521](index=521&type=chunk)[523](index=523&type=chunk)[530](index=530&type=chunk)[531](index=531&type=chunk)[600](index=600&type=chunk) - Macroeconomic conditions (inflation, interest rates, geopolitical conflicts) and cybersecurity threats are identified as potential risks to business growth and financial results[480](index=480&type=chunk)[134](index=134&type=chunk)[549](index=549&type=chunk) [Overview](index=116&type=section&id=Overview) Clearside Biomedical is a biopharmaceutical company focused on revolutionizing therapies for retinal diseases through its SCS injection platform, with XIPERE approved and CLS-AX in Phase 2b clinical trials - Clearside Biomedical is a biopharmaceutical company focused on revolutionizing therapies for retinal diseases through its SCS injection platform, with XIPERE approved and CLS-AX in Phase 2b clinical trials[476](index=476&type=chunk)[477](index=477&type=chunk) - The company has an accumulated deficit of **$320.9 million** as of December 31, 2023, and recorded net losses of **$32.5 million** in 2023 and **$32.9 million** in 2022[478](index=478&type=chunk) - The company expects to incur significant operating losses for several more years and will require additional capital beyond Q3 2025 to complete CLS-AX clinical development[479](index=479&type=chunk)[765](index=765&type=chunk) [Macroeconomic Considerations](index=116&type=section&id=Macroeconomic%20Considerations) - Unfavorable macroeconomic conditions, including rising inflation, increased interest rates by the U.S. Federal Reserve, and geopolitical conflicts (Ukraine, Russia, Middle East), create global economic uncertainty[480](index=480&type=chunk) - These conditions may negatively affect business growth, financial results, and could harm the company's business, financial condition, and results of operations[480](index=480&type=chunk) [Components of Operating Results](index=118&type=section&id=Components%20of%20Operating%20Results) - Revenue is primarily generated from license agreements, including technology access, upfront payments, regulatory and commercial milestone payments, and royalties[482](index=482&type=chunk) - Research and development (R&D) costs are expensed as incurred, covering preclinical activities, clinical trials, regulatory applications, physician training, intellectual property licenses, and facility costs[483](index=483&type=chunk)[484](index=484&type=chunk)[486](index=486&type=chunk) - R&D expenses are estimated based on patient enrollment, clinical site activations, and vendor data, with adjustments made for changes in clinical trial protocols or scope of work[484](index=484&type=chunk)[485](index=485&type=chunk) - General and administrative expenses include salaries, share-based compensation for executive/finance/administrative personnel, facility costs, and professional fees (legal, patent, consulting, accounting)[508](index=508&type=chunk) - Other income consists of gains on extinguishment of the Paycheck Protection Program (PPP) Loan and accrued interest, and interest income from cash and cash equivalents[509](index=509&type=chunk) - Non-cash interest expense on the liability related to the sales of future royalties includes imputed interest on the liability's carrying value and amortization of issuance costs[511](index=511&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=121&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) - The preparation of financial statements requires significant estimates and judgments, particularly for royalty financing obligations, share-based compensation, and research and development expenses[512](index=512&type=chunk)[513](index=513&type=chunk) - Revenue recognition follows ASC 606, involving identifying performance obligations, determining transaction price (including variable consideration like milestone payments), allocating price, and recognizing revenue as obligations are satisfied[514](index=514&type=chunk)[515](index=515&type=chunk)[516](index=516&type=chunk)[517](index=517&type=chunk)[519](index=519&type=chunk)[520](index=520&type=chunk)[568](index=568&type=chunk) - Accrued expenses, especially for clinical trials, are estimated based on contract terms, patient enrollment, and progress of specific tasks, with periodic adjustments[521](index=521&type=chunk)[522](index=522&type=chunk) - Share-based compensation is measured at fair value using the Black-Scholes option pricing model for stock options and the market value for restricted stock units (RSUs), expensed over the vesting period[523](index=523&type=chunk)[524](index=524&type=chunk)[525](index=525&type=chunk)[527](index=527&type=chunk)[528](index=528&type=chunk)[793](index=793&type=chunk)[836](index=836&type=chunk) - The liability related to the sales of future royalties is

- Phase 2b ODYSSEY Wet AMD Trial Remains on Track with Topline Data Expected in Q3 2024 - - Management to Host Webcast and Conference Call Today at 4:30 P.M. ET - Dr. Lasezkay continued, "Our proprietary SCS Microinjector® enables reliable, simple, in-office, nonsurgical drug delivery into the suprachoroidal space targeted directly to the site of disease in the back of the eye. This trusted delivery method, combined with axitinib's differentiated mechanism of action and high potency, offers the potential fo ...