Core Insights - After-hours trading in the biotech and therapeutics sector saw significant price movements, particularly among small- and mid-cap companies, driven by clinical updates and strategic announcements [1] Company Summaries - **Cyclerion Therapeutics, Inc. (CYCN)**: Shares surged 48.01% to $4.47 after announcing a strategic relaunch focused on neuropsychiatric therapies, including a licensing agreement with MIT for its treatment-resistant depression program. The stock had closed at $3.02, down 0.66% during regular trading. A Phase 2 trial for the TRD program is expected to start in 2026, with initial data anticipated in 2027 [2][3] - **Clearside Biomedical Inc. (CLSD)**: The stock rose 6.82% to $4.23 after a regular session close of $3.96, despite a 9.79% decline during the day. The increase followed presentations at the EURETINA Congress regarding its Phase 2b ODYSSEY trial for wet age-related macular degeneration. The next key catalyst is the initiation of the Phase 3 trial, incorporating FDA feedback [3][4] - **Reviva Pharmaceuticals Holdings Inc. (RVPH)**: Shares increased by 11.50% to $0.32 after closing at $0.287, following a 6.61% decline during regular trading. The price action comes ahead of the company's participation in the Lytham Partners Fall 2025 Investor Conference [4][5] - **Acumen Pharmaceuticals, Inc. (ABOS)**: The stock advanced 5.69% to $1.30 after a regular session close of $1.23, despite a 3.91% decline during the day. The company reported that topline data from its Phase 2 ALTITUDE-AD trial is on track for late 2026 and plans to decide on advancing a preclinical candidate in early 2026 [5][6] - **PepGen Inc. (PEPG)**: Shares rose 5.13% to $2.05 after closing at $1.95, following an 8.02% decline during the day. The company completed patient dosing in its Phase 1 FREEDOM-DM1 trial and is on track to report topline data in early Q4 2025 [6][7] - **Corcept Therapeutics Inc. (CORT)**: The stock gained 4.54% to $87.10 after a regular session close of $83.32. The company announced it will present late-breaking data from its Phase 3 ROSELLA trial at the 2025 ESMO Annual Meeting. Two upcoming PDUFA dates were confirmed for relacorilant in hypercortisolism and platinum-resistant ovarian cancer [7][8][9]

Core Insights - Clearside Biomedical is showcasing its SCS Microinjector platform and CLS-AX program at the 25th EURETINA Congress, highlighting its potential for treating multiple retinal diseases [1][3] Group 1: SCS Microinjector Platform - The SCS delivery platform is designed for targeted treatment of retinal diseases such as wet AMD, diabetic retinopathy, and ocular cancer [2] - The SCS Microinjector allows for the delivery of various drug candidates into the suprachoroidal space, aiming to improve efficacy and reduce toxic effects on non-diseased cells [8][9] Group 2: CLS-AX Program - CLS-AX is a proprietary suspension of axitinib for suprachoroidal injection, which may offer advantages over existing retinal therapies by achieving pan-VEGF blockade [6][7] - The program includes a Phase 3 trial for wet AMD and a streamlined Phase 2 trial for non-proliferative diabetic retinopathy [3] Group 3: Upcoming Presentations - Dr. Sobha Sivaprasad will present Phase 2b results from the ODYSSEY trial and updates on the Phase 3 program for neovascular age-related macular degeneration [4] - Victor Chong will discuss the evolution of suprachoroidal drug delivery and participate in a panel at the Ophthalmology Futures Retina Forum [5]

Core Insights - Clearside Biomedical, Inc. reported a quarterly loss of $0.06 per share, outperforming the Zacks Consensus Estimate of a loss of $0.12, marking a 50% earnings surprise [1] - The company achieved revenues of $0.49 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 87.07%, compared to revenues of $0.09 million a year ago [2] - The stock has underperformed, losing approximately 59.7% since the beginning of the year, while the S&P 500 has gained 7.8% [3] Financial Performance - Over the last four quarters, Clearside Biomedical has surpassed consensus EPS estimates four times [2] - The current consensus EPS estimate for the upcoming quarter is -$0.08 on revenues of $0.26 million, and for the current fiscal year, it is -$0.38 on revenues of $3.22 million [7] Market Outlook - The company's earnings outlook is crucial for assessing future stock performance, with a favorable trend in estimate revisions leading to a Zacks Rank 2 (Buy) [6] - The Medical - Biomedical and Genetics industry is currently ranked in the bottom 43% of over 250 Zacks industries, which may impact stock performance [8]

[PART I - FINANCIAL INFORMATION](index=2&type=section&id=PART%20I%20-%20FINANCIAL%20INFORMATION) This section details the unaudited financial statements, management's analysis of financial condition, and related disclosures [Item 1. Financial Statements (unaudited)](index=3&type=section&id=Item%201.%20Financial%20Statements%20(unaudited)) This section presents the unaudited consolidated financial statements and detailed notes on the company's financial position and performance [Consolidated Balance Sheets](index=3&type=section&id=Consolidated%20Balance%20Sheets%20as%20of%20June%2030%2C%202025%20and%20December%2031%2C%202024) Total assets and cash significantly decreased, while liabilities and accumulated deficit increased, reflecting a challenging financial position Consolidated Balance Sheets (in thousands) | Metric | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | Change (in thousands) | % Change | | :---------------------- | :--------------------------- | :------------------------------- | :-------------------- | :------- | | Cash and cash equivalents | $9,376 | $20,020 | $(10,644) | -53.17% | | Total current assets | $11,785 | $21,274 | $(9,489) | -44.60% | | Total assets | $15,332 | $25,126 | $(9,794) | -39.00% | | Total current liabilities | $3,047 | $4,794 | $(1,747) | -36.44% | | Total liabilities | $64,066 | $63,981 | $85 | 0.13% | | Accumulated deficit | $(367,993) | $(355,275) | $(12,718) | 3.58% | | Total stockholders' deficit | $(48,734) | $(38,855) | $(9,879) | 25.43% | [Consolidated Statements of Operations](index=4&type=section&id=Consolidated%20Statements%20of%20Operations%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Net loss decreased for both three and six months ended June 30, 2025, due to increased license revenue and reduced research and development expenses Consolidated Statements of Operations (in thousands) | Metric (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Change (3M) | % Change (3M) | | :-------------------- | :------------------------------- | :------------------------------- | :---------- | :------------ | | License and other revenue | $492 | $90 | $402 | 446.67% | | Research and development | $1,584 | $4,603 | $(3,019) | -65.58% | | General and administrative | $2,476 | $3,077 | $(601) | -19.53% | | Total operating expenses | $4,060 | $7,680 | $(3,620) | -47.14% | | Net loss | $(4,495) | $(7,594) | $3,099 | -40.81% | | Net loss per share (basic and diluted) | $(0.06) | $(0.10) | $0.04 | -40.00% | | Metric (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change (6M) | % Change (6M) | | :-------------------- | :----------------------------- | :----------------------------- | :---------- | :------------ | | License and other revenue | $2,822 | $320 | $2,502 | 781.88% | | Cost of goods sold | $248 | $0 | $248 | N/A | | Research and development | $6,047 | $10,218 | $(4,171) | -40.82% | | General and administrative | $5,300 | $5,901 | $(601) | -10.18% | | Total operating expenses | $11,595 | $16,119 | $(4,524) | -28.07% | | Net loss | $(12,718) | $(19,357) | $6,639 | -34.30% | | Net loss per share (basic and diluted) | $(0.16) | $(0.27) | $0.11 | -40.74% | [Consolidated Statements of Stockholders' Deficit](index=5&type=section&id=Consolidated%20Statements%20of%20Stockholders'%20Deficit%20for%20the%20three%20and%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Accumulated deficit and total stockholders' deficit increased due to net losses, partially offset by common stock issuances Consolidated Statements of Stockholders' Deficit (in thousands) | Metric (in thousands) | June 30, 2025 | December 31, 2024 | Change | | :-------------------- | :------------ | :---------------- | :----- | | Common Stock (Shares) | 78,495,760 | 76,578,383 | 1,917,377 | | Common Stock (Amount) | $78 | $77 | $1 | | Additional Paid-In Capital | $319,181 | $316,343 | $2,838 | | Accumulated Deficit | $(367,993) | $(355,275) | $(12,718) | | Total Stockholders' Deficit | $(48,734) | $(38,855) | $(9,879) | [Consolidated Statements of Cash Flows](index=6&type=section&id=Consolidated%20Statements%20of%20Cash%20Flows%20for%20the%20six%20months%20ended%20June%2030%2C%202025%20and%202024) Net cash decreased due to operating activities and a shift to net cash outflow from financing activities, contrasting with the prior year's inflow Consolidated Statements of Cash Flows (in thousands) | Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :---------------------- | :----------------------------- | :----------------------------- | :----- | | Net cash used in operating activities | $(10,559) | $(13,531) | $2,972 | | Net cash used in investing activities | $(9) | $(11,494) | $11,485 | | Net cash (used in) provided by financing activities | $(76) | $14,343 | $(14,419) | | Net decrease in cash and cash equivalents | $(10,644) | $(10,682) | $38 | | Cash and cash equivalents, end of period | $9,376 | $18,238 | $(8,862) | [Notes to the Consolidated Financial Statements](index=7&type=section&id=Notes%20to%20the%20Consolidated%20Financial%20Statements) These notes detail the company's operations, accounting policies, financial instruments, and recent events, including a going concern warning and strategic review [1. The Company](index=7&type=section&id=1.%20The%20Company) Clearside Biomedical, a biopharmaceutical company, faces significant liquidity challenges, initiated a strategic review, and implemented a reduction in force, raising substantial doubt about its going concern - Clearside Biomedical, Inc. is a biopharmaceutical company specializing in therapies delivered to the back of the eye via the suprachoroidal space (SCS®)[20](index=20&type=chunk)[105](index=105&type=chunk) - As of June 30, 2025, the Company had cash and cash equivalents of **$9.4 million**[22](index=22&type=chunk)[159](index=159&type=chunk) - In July 2025, the Company announced plans to explore a full range of strategic alternatives to maximize stockholder value, including potential sale, license, or merger of assets[22](index=22&type=chunk)[100](index=100&type=chunk)[121](index=121&type=chunk) - A 'Reduction in Force' was implemented in July 2025, terminating all employees and transitioning them to consulting roles, with estimated severance costs of **$2.6 million** in Q3 2025[22](index=22&type=chunk)[101](index=101&type=chunk)[102](index=102&type=chunk) - The Company has suffered recurring losses and negative cash flows since inception, and its current cash and cash equivalents are not expected to fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[28](index=28&type=chunk)[30](index=30&type=chunk)[123](index=123&type=chunk) [2. Significant Accounting Policies](index=9&type=section&id=2.%20Significant%20Accounting%20Policies) This section outlines the company's accounting principles, including revenue recognition, R&D expensing, share-based compensation, and accounting for royalty and warrant liabilities - Revenue from license agreements, including upfront payments, milestone payments, and royalties, is recognized under ASC 606 as performance obligations are satisfied[37](index=37&type=chunk) - Research and development costs are expensed as incurred, including employee-related expenses, CRO/CMO costs, clinical trial activities, and regulatory application costs[39](index=39&type=chunk)[44](index=44&type=chunk) - Warrant liabilities are measured at fair value using a simulation model, with changes recognized in other income (expense) in the consolidated statements of operations[49](index=49&type=chunk) - The Company adopted ASU 2023-09 (Income Taxes) on January 1, 2025, which did not have a material impact, and is evaluating ASU 2024-03 (Expense Disaggregation) for future impact[50](index=50&type=chunk)[52](index=52&type=chunk) [3. Property and Equipment, Net](index=15&type=section&id=3.%20Property%20and%20Equipment%2C%20Net) Net property and equipment decreased from $3.2 million to $3.1 million, primarily due to accumulated depreciation Property and Equipment, Net (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :-------------------- | :--------------------------- | :------------------------------- | | Furniture and fixtures | $249 | $249 | | Machinery and equipment | $1,759 | $1,756 | | Computer equipment | $20 | $20 | | Leasehold improvements | $476 | $476 | | Work in process | $1,876 | $1,870 | | Total property and equipment | $4,380 | $4,371 | | Less: Accumulated depreciation | $(1,315) | $(1,146) | | Property and equipment, net | $3,065 | $3,225 | [4. Accrued Liabilities](index=15&type=section&id=4.%20Accrued%20Liabilities) Accrued liabilities significantly decreased from $3.0 million to $1.5 million, mainly due to a reduction in accrued employee costs Accrued Liabilities (in thousands) | Category | June 30, 2025 (in thousands) | December 31, 2024 (in thousands) | | :------------------------ | :--------------------------- | :------------------------------- | | Accrued research and development | $451 | $545 | | Accrued income taxes | $692 | $0 | | Accrued employee costs | $194 | $2,159 | | Accrued professional fees | $116 | $37 | | Accrued expense | $84 | $226 | | Total Accrued Liabilities | $1,537 | $2,967 | [5. Royalty Purchase and Sale Agreement](index=15&type=section&id=5.%20Royalty%20Purchase%20and%20Sale%20Agreement) The company sold future royalty and milestone rights to HCR for up to $65 million, with the related liability increasing to $55.7 million at a 21.8% effective interest rate - The Company sold rights to future royalty and milestone payments from license agreements (Arctic Vision, Bausch, Aura, REGENXBIO, BioCryst) to HealthCare Royalty Management, LLC (HCR) for up to **$65 million**[55](index=55&type=chunk) - The Purchase and Sale Agreement expires when HCR receives payments equal to **3.4 times** the aggregate amount of payments made under the agreement (Cap Amount)[58](index=58&type=chunk) Royalty Purchase and Sale Agreement (in thousands) | Metric (in thousands) | Amount | | :-------------------- | :----- | | Balance at December 31, 2023 | $41,988 | | Non-cash interest expense (2024) | $9,779 | | Balance at December 31, 2024 | $51,767 | | Payments (2025) | $(1,500) | | Non-cash interest expense (2025) | $5,435 | | Balance at June 30, 2025 | $55,702 | | Effective interest rate | 21.8% | [6. Common Stock](index=17&type=section&id=6.%20Common%20Stock) Authorized common stock increased from 200 million to 400 million shares, and outstanding common stock rose to 78.5 million shares by June 30, 2025 - The Company's authorized common stock increased from **200,000,000** to **400,000,000** shares as of June 30, 2025, following stockholder approval on May 30, 2025[62](index=62&type=chunk) Common Stock | Metric | June 30, 2025 | December 31, 2024 | | :---------------------- | :------------ | :---------------- | | Shares issued and outstanding | 78,495,760 | 76,578,383 | [7. Common Stock Warrants](index=17&type=section&id=7.%20Common%20Stock%20Warrants) Warrant liabilities decreased from $6.7 million to $4.8 million, driven by a decline in stock price and increased uncertainty from the strategic alternatives announcement - In February 2024, the Company issued warrants to purchase **11,111,111** shares of common stock at an exercise price of **$1.62** per share, expiring August 9, 2029[64](index=64&type=chunk)[65](index=65&type=chunk) Common Stock Warrants (in thousands) | Metric (in thousands) | Amount | | :-------------------- | :----- | | Fair value of warrants at issuance (Feb 9, 2024) | $10,327 | | Change in fair value during the period (2024) | $(3,635) | | Fair value of warrants at December 31, 2024 | $6,692 | | Change in fair value during the period (2025) | $(1,927) | | Fair value of warrants at June 30, 2025 | $4,765 | - The fair value of warrant liabilities declined significantly after June 30, 2025, due to a drop in the traded stock price and increased uncertainty following the July 2025 strategic alternatives announcement[67](index=67&type=chunk) [8. Share-Based Compensation](index=18&type=section&id=8.%20Share-Based%20Compensation) Share-based compensation expense decreased for both three and six months ended June 30, 2025, with $4.0 million unrecognized for stock options and $0.2 million for RSUs Share-Based Compensation Expense (in thousands) | Share-Based Compensation Expense (in thousands) | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------------------------------- | :------------------------------- | :------------------------------- | :----------------------------- | :----------------------------- | | Stock Options | $621 | $864 | $1,236 | $1,666 | | Restricted Stock Units (RSUs) | $69 | $253 | $174 | $510 | | Employee Stock Purchase Plan (ESPP) | $4 | $3 | $5 | $6 | | Total | $694 | $1,120 | $1,415 | $2,182 | - As of June 30, 2025, the Company had **$4.0 million** of unrecognized compensation expense for unvested stock options, expected to be recognized over **2.6 years**[71](index=71&type=chunk) - As of June 30, 2025, the Company had **$0.2 million** of unrecognized compensation expense for RSUs, expected to be recognized over **0.6 years**[73](index=73&type=chunk) [9. Commitments and Contingencies](index=20&type=section&id=9.%20Commitments%20and%20Contingencies) The company has office lease commitments and ongoing annual maintenance fees under the Georgia Tech License Agreement, totaling $1.5 million through 2028 - The Company leases approximately **14,000 square feet** of office space in Alpharetta, Georgia, with monthly rental payments of **$30,747**, increasing **3%** annually, under a four-year term with a renewal option[76](index=76&type=chunk) Georgia Tech License Agreement Maintenance Fee (in thousands) | Year Ending December 31, | Georgia Tech License Agreement Maintenance Fee (in thousands) | | :----------------------- | :---------------------------------------------------------- | | 2025 | $250 | | 2026 | $350 | | 2027 | $400 | | 2028 | $500 | | Total | $1,500 | [10. License and Other Agreements](index=20&type=section&id=10.%20License%20and%20Other%20Agreements) The company holds exclusive license agreements for XIPERE with Bausch + Lomb and Arctic Vision, and for its SCS Microinjector with BioCryst, with associated royalties and milestones largely sold to HCR - Bausch + Lomb holds an exclusive license for XIPERE in the United States and Canada, with potential milestone payments up to **$55.0 million** and tiered royalties from high-teens to twenty percent[82](index=82&type=chunk)[84](index=84&type=chunk) - Arctic Vision has an exclusive license for XIPERE in the Arctic Territory (China, Hong Kong, Macau, Taiwan, South Korea, India, ASEAN, Australia, New Zealand), with potential development and sales milestones up to **$22.0 million** and tiered royalties of ten to twelve percent[86](index=86&type=chunk)[87](index=87&type=chunk)[88](index=88&type=chunk) - BioCryst Pharmaceuticals holds an exclusive, worldwide license for the SCS Microinjector with avoralstat, with potential clinical and regulatory milestones up to **$30.0 million**, sales-based milestones up to **$47.5 million**, and tiered mid-single digit royalties[89](index=89&type=chunk)[90](index=90&type=chunk) - The Company's rights to royalties and milestone payments from these agreements have been sold pursuant to the Purchase and Sale Agreement described in Note 5[84](index=84&type=chunk)[87](index=87&type=chunk)[90](index=90&type=chunk) [11. Fair Value Measurements](index=23&type=section&id=11.%20Fair%20Value%20Measurements) Financial instruments like cash are Level 1 in the fair value hierarchy, while warrant liabilities are Level 3 due to significant unobservable inputs - Cash and cash equivalents, other current assets, and accounts payable are classified as **Level 1** in the fair value hierarchy[93](index=93&type=chunk) - Warrant liabilities are classified as **Level 3** in the fair value hierarchy due to significant unobservable inputs in their valuation[93](index=93&type=chunk) [12. Related Party Transactions](index=23&type=section&id=12.%20Related%20Party%20Transactions) The company engaged in transactions with related parties, including a vendor, BioCryst Pharmaceuticals, and Aura Biosciences, resulting in recorded payables, expenses, and license revenue - The Company had **$0.5 million** in accounts payable and **$0.3 million** in accrued expense with a vendor whose CEO was a board member until January 2025[95](index=95&type=chunk) - License and other revenue from BioCryst License Agreement, where BioCryst's board chair also serves on the Company's board, was **$0.3 million** for the three months ended June 30, 2025 (vs. **$81,000** in 2024) and **$0.3 million** for the six months ended June 30, 2025 (vs. **$0.2 million** in 2024)[96](index=96&type=chunk) - License and other revenue from Aura License Agreement, where Aura's CFO is a board member, was **$0.1 million** for both the three and six months ended June 30, 2025[97](index=97&type=chunk) [13. Net Loss Per Share](index=23&type=section&id=13.%20Net%20Loss%20Per%20Share) Basic and diluted net loss per share are identical as all potential common stock equivalents were antidilutive and excluded from diluted EPS calculation - Basic and diluted net loss per share are the same for all periods because all potential common stock equivalents were antidilutive[98](index=98&type=chunk) Antidilutive Securities | Antidilutive Securities | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :---------------------- | :----------------------------- | :----------------------------- | | Outstanding stock options | 14,330,189 | 12,767,330 | | Non-vested restricted stock units | 126,508 | 437,305 | | Common stock warrants | 11,140,907 | 11,140,907 | | Total | 25,597,604 | 24,345,542 | [14. Subsequent Event](index=23&type=section&id=14.%20Subsequent%20Event) In July 2025, the company announced a strategic review and implemented a reduction in force, transitioning employees to consulting roles, with estimated severance costs of $2.6 million - On July 17, 2025, the Company announced plans to explore a full range of strategic alternatives to maximize stockholder value for its SCS platform and drug development pipeline[100](index=100&type=chunk) - A 'Reduction in Force' was implemented in July 2025, terminating all employees and transitioning them into consulting roles to extend company resources[100](index=100&type=chunk)[101](index=101&type=chunk) - The Company estimates approximately **$2.6 million** in charges for severance and other employee termination-related costs in the third quarter of 2025[102](index=102&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=26&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) This section provides management's perspective on financial performance, liquidity, and outlook, highlighting the strategic review, pipeline, and significant financial challenges [Overview](index=26&type=section&id=Overview) Clearside Biomedical is a biopharmaceutical company focused on SCS® injection platform for eye therapies, with XIPERE® as its first approved product for macular edema associated with uveitis - Clearside Biomedical is a biopharmaceutical company focused on delivering therapies to the back of the eye through its proprietary suprachoroidal space (SCS®) injection platform[105](index=105&type=chunk) - XIPERE® (triamcinolone acetonide injectable suspension) was approved by the U.S. FDA in October 2021 as the first therapeutic delivered into the SCS and the first therapy for macular edema associated with uveitis[106](index=106&type=chunk) [Clinical Development Pipeline](index=27&type=section&id=Clinical%20Development%20Pipeline) All internal R&D programs are paused due to the strategic review, while CLS-AX for wet AMD achieved positive Phase 2b results and has FDA alignment for Phase 3, alongside preclinical candidates and external collaborations - All internal research and development programs have been paused during the strategic review process to extend resources[108](index=108&type=chunk) - CLS-AX (axitinib injectable suspension) for wet AMD, the most advanced product candidate, achieved positive topline results in the ODYSSEY Phase 2b clinical trial, demonstrating stable vision and retinal thickness, and reduced injection frequency by **84%**[109](index=109&type=chunk)[111](index=111&type=chunk)[112](index=112&type=chunk)[114](index=114&type=chunk) - The Company gained FDA alignment on essential components for a potential Phase 3 program for CLS-AX, which would include two pivotal, non-inferiority trials with aflibercept 2 mg as a comparator[116](index=116&type=chunk) - The preclinical pipeline includes small molecules for geographic atrophy (GA) and CLS-AX combinations for diabetic retinopathy and diabetic macular edema[117](index=117&type=chunk) - The Company maintains external collaborations with Bausch + Lomb, Arctic Vision, REGENXBIO, Inc., Aura Biosciences, and BioCryst Pharmaceuticals to expand the reach of its suprachoroidal injection platform[118](index=118&type=chunk) [Operating Outlook and Strategic Review](index=29&type=section&id=Operating%20Outlook%20and%20Strategic%20Review) The company has recurring net losses and an accumulated deficit of $368.0 million, with a strategic review underway as current cash is insufficient for the next 12 months, raising substantial doubt about its going concern - The Company has incurred net losses since inception, with an accumulated deficit of **$368.0 million** as of June 30, 2025[120](index=120&type=chunk) - Net losses were **$4.5 million** and **$12.7 million** for the three and six months ended June 30, 2025, respectively, a reduction from **$7.6 million** and **$19.4 million** in the prior year periods[120](index=120&type=chunk) - A strategic review is being conducted to explore alternatives to maximize stockholder value, including asset sales, licenses, mergers, or other transactions[121](index=121&type=chunk) - Based on current plans, the Company does not believe its cash and cash equivalents will fund operations for the next 12 months, raising substantial doubt about its ability to continue as a going concern[123](index=123&type=chunk) [Macroeconomic Conditions](index=31&type=section&id=Macroeconomic%20Conditions) Unfavorable macroeconomic conditions, including inflation, interest rate hikes, and global conflicts, could negatively impact the company's business and financial results - Unfavorable macroeconomic conditions, including rising inflation, increased interest rates, and global conflicts, may negatively affect the Company's business and financial results[124](index=124&type=chunk) [Recent Developments](index=31&type=section&id=Recent%20Developments) Recent developments include the strategic review, a reduction in force with $2.6 million in severance costs, and Nasdaq delisting risk due to minimum bid price non-compliance, which the company plans to appeal - The Company implemented a reduction in force in July 2025, terminating all employees and transitioning them to consulting roles, with estimated severance costs of **$2.6 million** in Q3 2025[125](index=125&type=chunk) - The Company received a Nasdaq delisting notification for failing to meet the **$1.00** minimum bid price requirement by August 6, 2025, and intends to appeal the determination[126](index=126&type=chunk) - A reverse stock split proposal (1-for-5 to 1-for-15) will be put to stockholders to raise the per share trading price and maintain Nasdaq listing[126](index=126&type=chunk) [Components of Operating Results](index=31&type=section&id=Components%20of%20Operating%20Results) This section details operating results components, including license revenue, cost of goods sold, R&D and G&A expenses, interest income, other income, non-cash interest expense, and income tax expense - Revenue is primarily generated from license agreements, including technology access, upfront payments, regulatory/commercial milestones, and royalties, with some payments recorded as non-cash revenue until obligations under the Purchase and Sale Agreement are fulfilled[127](index=127&type=chunk)[128](index=128&type=chunk) - Research and development expenses are expensed as incurred and include employee costs, CRO/CMO fees, preclinical/clinical activities, regulatory applications, physician training, intellectual property licenses, facility costs, and depreciation[130](index=130&type=chunk)[134](index=134&type=chunk) - Other income, net, primarily reflects expenses allocated to warrants and changes in their fair value[137](index=137&type=chunk) - Non-cash interest expense on liability related to future royalties consists of imputed interest and amortization of issuance costs[138](index=138&type=chunk) [Critical Accounting Policies and Significant Judgments and Estimates](index=34&type=section&id=Critical%20Accounting%20Policies%20and%20Significant%20Judgments%20and%20Estimates) Financial statements rely on significant estimates for royalty financing, warrant liabilities, and R&D expenses, with no material changes to critical accounting policies during the period - Significant estimates and judgments are required for royalty financing obligations, warrant liabilities valuation, and research and development expenses[140](index=140&type=chunk) - No significant changes to critical accounting policies were made during the six months ended June 30, 2025[141](index=141&type=chunk) [Results of Operations for the Three Months Ended June 30, 2025 and 2024](index=35&type=section&id=Results%20of%20Operations%20for%20the%20Three%20Months%20Ended%20June%2030%2C%202025%20and%202024) Net loss significantly decreased to $4.5 million from $7.6 million for the three months ended June 30, 2025, due to increased license revenue and reduced R&D and G&A expenses Results of Operations for the Three Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | % Change | | :-------------------- | :------------ | :------------ | :----- | :------- | | License and other revenue | $492 | $90 | $402 | 446.7% | | Research and development | $1,584 | $4,603 | $(3,019) | -65.6% | | General and administrative | $2,476 | $3,077 | $(601) | -19.5% | | Total operating expenses | $4,060 | $7,680 | $(3,620) | -47.1% | | Loss from operations | $(3,568) | $(7,590) | $4,022 | -53.0% | | Interest income | $115 | $419 | $(304) | -72.6% | | Other income, net | $1,720 | $1,917 | $(197) | -10.3% | | Non-cash interest expense on liability related to the sales of future royalties | $(2,762) | $(2,340) | $(422) | 18.0% | | Net loss | $(4,495) | $(7,594) | $3,099 | -40.8% | - The **$3.0 million** decrease in R&D expenses was primarily due to the completion of the CLS-AX Phase 2b clinical trial (**$1.6 million** decrease), reduced employee costs (**$0.8 million** decrease), and a research and development tax credit (**$0.4 million** decrease)[144](index=144&type=chunk) - The **$0.6 million** decrease in G&A expenses was mainly due to lower employee-related costs[145](index=145&type=chunk) [Results of Operations for the Six Months Ended June 30, 2025 and 2024](index=36&type=section&id=Results%20of%20Operations%20for%20the%20Six%20Months%20Ended%20June%2030%2C%202025%20and%202024) Net loss decreased to $12.7 million from $19.4 million for the six months ended June 30, 2025, driven by increased license revenue, including Arctic Vision milestones, and reduced R&D expenses Results of Operations for the Six Months Ended June 30, 2025 and 2024 (in thousands) | Metric (in thousands) | June 30, 2025 | June 30, 2024 | Change | % Change | | :-------------------- | :------------ | :------------ | :----- | :------- | | License and other revenue | $2,822 | $320 | $2,502 | 781.9% | | Cost of goods sold | $248 | $0 | $248 | N/A | | Research and development | $6,047 | $10,218 | $(4,171) | -40.8% | | General and administrative | $5,300 | $5,901 | $(601) | -10.2% | | Total operating expenses | $11,595 | $16,119 | $(4,524) | -28.1% | | Loss from operations | $(8,773) | $(15,799) | $7,026 | -44.5% | | Interest income | $278 | $767 | $(489) | -63.8% | | Other income, net | $1,927 | $418 | $1,509 | 360.0% | | Non-cash interest expense on liability related to the sales of future royalties | $(5,435) | $(4,743) | $(692) | 14.6% | | Loss before income taxes | $(12,003) | $(19,357) | $7,354 | -38.0% | | Income tax expense | $715 | $0 | $715 | N/A | | Net loss | $(12,718) | $(19,357) | $6,639 | -34.3% | - License and other revenue for the six months ended June 30, 2025, included **$1.5 million** in milestones from Arctic Vision and **$1.3 million** from other training, services, and SCS Microinjector kit sales[151](index=151&type=chunk) - The **$4.2 million** decrease in R&D expenses was primarily due to a **$3.4 million** decrease in CLS-AX program costs (completion of ODYSSEY trial), **$0.5 million** in reduced employee costs, and a **$0.4 million** R&D tax credit, partially offset by a **$0.4 million** increase in GA program costs[153](index=153&type=chunk) [Liquidity and Capital Resources](index=38&type=section&id=Liquidity%20and%20Capital%20Resources) Liquidity is severely constrained with $9.4 million in cash, requiring additional financing as current resources are insufficient for the next 12 months, raising substantial doubt about its going concern - As of June 30, 2025, the Company had cash and cash equivalents of **$9.4 million**[159](index=159&type=chunk) - In February 2024, the Company raised **$13.9 million** net proceeds from a registered direct offering of common stock and warrants[161](index=161&type=chunk) - During the six months ended June 30, 2025, the Company sold **1,649,796** shares of common stock for net proceeds of **$1.4 million** under an at-the-market (ATM) sales agreement[163](index=163&type=chunk) - The Company's primary uses of capital are compensation, R&D costs, legal/regulatory expenses, and general overhead, and it will require additional financing to fund future operations[164](index=164&type=chunk)[166](index=166&type=chunk) - The successful development of product candidates is highly uncertain, and the Company cannot reasonably estimate the nature, timing, and costs of future development efforts[165](index=165&type=chunk) [Outlook](index=40&type=section&id=Outlook) The company anticipates continued losses and requires additional financing, with current cash insufficient for the next 12 months, leading to paused R&D and substantial doubt about its going concern - The Company expects to incur additional losses and will need further financing to fund operations, potentially through equity/debt offerings, royalty monetization, or strategic arrangements[171](index=171&type=chunk) - Current cash and cash equivalents are not expected to fund operations for the next 12 months, leading to a pause in all internal R&D programs to conserve cash[172](index=172&type=chunk) - These factors raise substantial doubt about the Company's ability to continue as a going concern[173](index=173&type=chunk) [Cash Flows](index=40&type=section&id=Cash%20Flows) Net cash used in operating activities decreased, investing activities significantly decreased, and financing shifted from inflow to outflow, resulting in a $10.6 million net decrease in cash Cash Flows (in thousands) | Activity (in thousands) | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | Change | | :---------------------- | :----------------------------- | :----------------------------- | :----- | | Operating activities | $(10,559) | $(13,531) | $2,972 | | Investing activities | $(9) | $(11,494) | $11,485 | | Financing activities | $(76) | $14,343 | $(14,419) | | Net change in cash and cash equivalents | $(10,644) | $(10,682) | $38 | - Net cash used in operating activities decreased by **$3.0 million**, primarily due to reduced R&D and G&A expenses[174](index=174&type=chunk) - Net cash used in investing activities decreased significantly by **$11.5 million**, mainly due to no purchases of short-term investments in 2025 compared to **$11.0 million** in 2024[175](index=175&type=chunk) - Financing activities shifted from providing **$14.3 million** in 2024 (registered direct offering) to using **$76,000** in 2025 (royalty purchase payments partially offset by ATM sales)[176](index=176&type=chunk)[177](index=177&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=42&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Clearside Biomedical is not required to provide detailed quantitative and qualitative disclosures about market risk - The Company is a smaller reporting company and is not required to provide quantitative and qualitative disclosures about market risk[178](index=178&type=chunk) [Item 4. Controls and Procedures](index=42&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2025, with no material changes in internal control over financial reporting during the quarter - The Company's disclosure controls and procedures were evaluated and deemed effective at a reasonable assurance level as of June 30, 2025[181](index=181&type=chunk) - No material changes in internal control over financial reporting occurred during the quarter ended June 30, 2025[182](index=182&type=chunk) [PART II - OTHER INFORMATION](index=43&type=section&id=PART%20II%20-%20OTHER%20INFORMATION) This section covers legal proceedings, risk factors, equity sales, other information, and exhibits related to the company's operations [Item 1. Legal Proceedings](index=43&type=section&id=Item%201.%20Legal%20Proceedings) The company is not a party to any material legal proceedings and is unaware of any pending actions that could significantly impact its business or financial condition - The Company is not currently a party to any material legal proceedings[184](index=184&type=chunk) [Item 1A. Risk Factors](index=43&type=section&id=Item%201A.%20Risk%20Factors) This section highlights critical risks, including insufficient working capital, going concern doubts, uncertainty of strategic alternatives, and Nasdaq delisting risk [Risks Related to Our Financial Position and Capital Needs](index=43&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Capital%20Needs) Insufficient working capital raises substantial doubt about the company's going concern ability, and the strategic review may not yield a favorable transaction, potentially leading to bankruptcy - The Company does not have sufficient working capital to fund planned operations for the next twelve months, raising substantial doubt about its ability to continue as a going concern[186](index=186&type=chunk)[188](index=188&type=chunk) - The strategic alternatives exploration may not result in any transaction or enhance stockholder value, and failure could lead to bankruptcy or winding down operations[187](index=187&type=chunk)[189](index=189&type=chunk)[190](index=190&type=chunk) - The reduction in force implemented in July 2025 is expected to incur approximately **$2.6 million** in severance costs[186](index=186&type=chunk) [Risks Related to Ownership of Our Common Stock](index=45&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) The company faces Nasdaq delisting risk due to its common stock trading below the $1.00 minimum bid price, with no assurance that an appeal or reverse stock split will regain compliance - The Company received a Nasdaq notification for non-compliance with the **$1.00** minimum bid price requirement and expects delisting notice, which it intends to appeal[193](index=193&type=chunk) - A reverse stock split (1-for-5 to 1-for-15) is proposed to raise the per share trading price and maintain Nasdaq listing[193](index=193&type=chunk) - Failure to regain Nasdaq compliance could reduce liquidity, decrease market price, deter investors, and negatively impact the company's ability to raise equity financing[194](index=194&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=45&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reported no unregistered sales or issuer purchases of equity securities during the period - No unregistered sales of equity securities occurred[195](index=195&type=chunk) - No issuer purchases of equity securities occurred[195](index=195&type=chunk) [Item 5. Other Information](index=45&type=section&id=Item%205.%20Other%20Information) No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter - No directors or officers adopted, modified, or terminated Rule 10b5-1 or non-Rule 10b5-1 trading arrangements during the quarter ended June 30, 2025[196](index=196&type=chunk) [Item 6. Exhibits](index=46&type=section&id=Item%206.%20Exhibits) This section lists all exhibits filed as part of the Form 10-Q, including corporate governance documents, officer agreements, and Sarbanes-Oxley Act certifications - Exhibits include amendments to the Certificate of Incorporation and Bylaws, separation and consulting agreements for George Lasezkay, Charles Deignan, and Victor Chong, and certifications under Sections 302 and 906 of the Sarbanes-Oxley Act[197](index=197&type=chunk)[198](index=198&type=chunk) [Signatures](index=47&type=section&id=Signatures) The report was officially signed on August 8, 2025, by Charles A. Deignan, Chief Financial Officer, for Clearside Biomedical, Inc - The report was signed by Charles A. Deignan, Chief Financial Officer, on August 8, 2025[202](index=202&type=chunk)

Core Insights - Clearside Biomedical, Inc. has received approval from Health Canada for XIPERE® (triamcinolone acetonide injectable suspension) for suprachoroidal use in treating uveitic macular edema (UME) [1] - XIPERE is now approved in multiple markets including the United States, Canada, Australia, and Singapore, with ongoing regulatory review in China [2] Product Overview - XIPERE is a proprietary corticosteroid suspension designed for administration to the suprachoroidal space, specifically targeting macular edema associated with uveitis [3] - The product is commercially available in the U.S. and is exclusively licensed for commercialization and development in the U.S. and Canada to Bausch + Lomb, while Arctic Vision holds the license for Greater China and other regions [3] Technology and Platform - Clearside's suprachoroidal space (SCS®) injection platform provides innovative access to the back of the eye, enhancing the delivery of therapies and potentially improving treatment efficacy [4] - The SCS Microinjector® is designed to deliver various drug candidates into the suprachoroidal space, aiming to minimize toxic effects on non-diseased cells [4] Company Background - Clearside Biomedical focuses on revolutionizing therapy delivery to the back of the eye, with a pipeline that includes small molecule product candidates for administration via the SCS Microinjector [5] - The company's lead program, CLS-AX (axitinib injectable suspension), is prepared for Phase 3 trials targeting neovascular age-related macular degeneration (wet AMD) [5]

Core Insights - Clearside Biomedical, Inc. is exploring a range of strategic alternatives to enhance its SCS platform and drug development pipeline, aiming to maximize stockholder value [1][2][3] - The company has retained Piper Sandler to assist in the strategic evaluation process, considering options such as asset sales, licensing, collaborations, and mergers [1][2] - Clearside's SCS Microinjector is a validated delivery platform for therapies targeting serious retinal diseases, with five commercial and late-stage development collaborations [1][4][10] Company Highlights - The SCS Microinjector enables a non-surgical, repeatable procedure for targeted delivery of therapies to the macula, retina, and choroid, potentially preserving and improving vision in patients with sight-threatening eye diseases [4][10] - Clearside's lead program, CLS-AX, is in development for the treatment of wet age-related macular degeneration (AMD) and has shown positive Phase 2b clinical data [2][8][10] - The company has successfully navigated the FDA regulatory pathway for its first product, XIPERE, which is approved for suprachoroidal use [8][10] Internal Pipeline - CLS-AX is a proprietary axitinib injectable suspension being developed for wet AMD, with a Phase 3 program planned to maximize its commercial potential [8][10] - The company is also evaluating small molecules for treating geographic atrophy (GA) and diabetic macular edema (DME), addressing high unmet medical needs in retinal diseases [8][10] External Collaborations - Clearside has established partnerships with various companies utilizing its SCS injection platform for other ophthalmic therapeutic innovations, including gene therapies and anti-tumor agents [10][13]

Core Insights - Clearside Biomedical is advancing the delivery of therapies to the back of the eye through its proprietary suprachoroidal space (SCS) injection platform, which will be highlighted at the upcoming Clinical Trials at the Summit (CTS) Meeting [1][2] Company Overview - Clearside Biomedical, Inc. is a biopharmaceutical company focused on improving patient outcomes by utilizing its SCS injection platform for targeted delivery of therapies to treat sight-threatening eye diseases [7] - The company’s lead product, CLS-AX (axitinib injectable suspension), is in development for neovascular age-related macular degeneration (wet AMD) and is preparing for a Phase 3 program [7] Technology and Innovation - The SCS Microinjector is a patented device that allows for in-office, repeatable, non-surgical procedures to deliver a variety of therapies directly to the macula, retina, or choroid [5][7] - CLS-AX is designed as a longer-acting therapy that achieves pan-VEGF blockade, potentially offering advantages over existing anti-VEGF therapies by targeting different levels of the angiogenesis cascade [4][5] Clinical Development - The company is showcasing multiple presentations related to its SCS delivery platform and its development partners at the CTS Meeting, including updates on CLS-AX for neovascular AMD and ABBV-RGX-314 for diabetic retinopathy [3][4] - Early clinical trials for CLS-AX have shown it to be well tolerated with a positive safety profile, indicating its potential for prolonged duration and targeted delivery [4]

Core Viewpoint - Clearside Biomedical, Inc. (CLSD) has been upgraded to a Zacks Rank 2 (Buy), indicating a positive trend in earnings estimates which is a significant factor influencing stock prices [1][3]. Earnings Estimates and Stock Price Movement - The Zacks rating system is based on changes in earnings estimates, which are strongly correlated with near-term stock price movements [4][6]. - Institutional investors utilize earnings estimates to determine the fair value of stocks, leading to price movements based on their buying or selling activities [4]. Company Performance Indicators - The upgrade for Clearside Biomedical suggests an improvement in the company's underlying business, which is expected to be reflected in a higher stock price [5]. - The Zacks Consensus Estimate for Clearside Biomedical has increased by 15.1% over the past three months, with an expected earnings per share of -$0.42 for the fiscal year ending December 2025, representing a year-over-year change of 10.6% [8]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a strong historical performance, particularly for Zacks Rank 1 stocks which have generated an average annual return of +25% since 1988 [7]. - The upgrade to Zacks Rank 2 places Clearside Biomedical in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [10].

Summary of Clearside Biomedical Conference Call Company Overview - Clearside Biomedical focuses on delivering therapeutic agents to the suprachoroidal space, pioneering a proprietary injection procedure and device for this purpose [4][5] - Established partnerships with Oral Biosciences and REGENXBIO for developing treatments for choroidal melanoma and retinal diseases [5][6] - Commercialization partnerships with Bausch and Lomb and Arctic Vision for their FDA-approved product XIPERE, which delivers triamcinolone to the suprachoroidal space [6] Core Product and Development - XIPERE has shown better performance in terms of duration and effect than predicted by pharmacokinetic models, leading to increased acceptance among physicians [10][14] - Development of CLS AX (axitinib) for wet AMD, with successful completion of phase 2b ODICEY trial, positioning it as a phase 3 ready product [7][8] - The product aims for flexible dosing with a duration comparable to biologics, targeting a market need for variability in patient responses [16][26] Competitive Landscape - CLS AX is positioned against current TKI competitors that offer a six-month duration, with Clearside aiming for a three to six-month duration to accommodate patient variability [15][21] - The company believes its product has a better efficacy profile due to a lower IC50 and a more favorable redosing criteria compared to competitors [19][20] - Emphasis on the absence of ocular serious adverse events (SAEs) in their trials, which contrasts with some competitors [20] Regulatory Strategy - The phase 3 trial is designed to last two years, with a primary endpoint at 52 weeks, allowing for two cycles of treatment [31][32] - The trial design aims to minimize variability by excluding patients with high variability in results, which has been accepted by regulatory agencies [39][42] - The company is focused on a non-inferiority design with good masking to mitigate regulatory risks associated with treatment failures [48][49] Funding and Future Plans - Ongoing outreach to strategic partners and potential investors to fund the advancement of CLS AX into phase 3 trials [50] - The company is exploring various funding options, including combinations of investors and strategic partnerships [50] Additional Insights - The acceptance of suprachoroidal injections is increasing, with over 15,000 injections performed and more than 100 peer-reviewed publications supporting the procedure [14] - The company believes that the flexibility in dosing frequency will be appealing to physicians and align with real-world clinical practices [44][45]

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) to improve patient outcomes [3] - The company utilizes a patented SCS Microinjector for an in-office, repeatable, non-surgical procedure aimed at targeted delivery of therapies to the macula, retina, or choroid [3] - Clearside is developing a pipeline of small molecule product candidates for administration via its SCS Microinjector, with its lead program, CLS-AX, in development for treating neovascular age-related macular degeneration (wet AMD) [3] Product Development - The company is planning a Phase 3 program for its lead product, CLS-AX (axitinib injectable suspension) [3] - Clearside is also evaluating various small molecules for potential long-acting treatment of geographic atrophy (GA) [3] - The first product developed by Clearside, XIPERE (triamcinolone acetonide injectable suspension), has been approved for suprachoroidal use and is available in the U.S. through a commercial partner [3] Upcoming Events - Management will participate in a fireside chat at the Stifel 2025 Virtual Ophthalmology Forum on May 27, 2025, at 9:00 a.m. ET [1] - A live and archived webcast of the event will be accessible on the Clearside website under the Investors section, with the archive available for three months [2]