FORM 10-K ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE TRANSITION PERIOD FROM TO CalciMedica, Inc. (Exact name of Registrant as specified in its Charter) Securities registered pursuant to Section 12(b) of the Act: i We obtained industry, market and competitive position data in this report from our own internal estimates and r ...

Preclinical data show that therapeutic treatment with Auxora in a rat model of AKI improves kidney function as measured by glomerular filtration rate LA JOLLA, Calif., Feb. 28, 2024 /PRNewswire/ -- CalciMedica Inc. (CalciMedica or the Company) (Nasdaq: CALC), a clinical-stage biopharmaceutical company focused on developing novel calcium release-activated calcium (CRAC) channel inhibition therapies for acute and chronic inflammatory and immunologic diseases, today announced that data from its most recent pr ...

$20.4 million in upfront financing with the potential to receive up to an additional approximately $34.2 million for an aggregate of up to approximately $55 million Upfront net proceeds to provide funds to expand Auxora™ clinical development to include planned Phase 2 acute kidney injury (AKI) trial expected to begin in 1H 2024 Aggregate net proceeds (assuming exercise of all accompanying warrants) expected to be sufficient to fund CalciMedica through subsequent, potentially pivotal, clinical trials and ot ...

We are a clinical-stage biopharmaceutical company focused on developing therapeutics that treat serious illnesses driven by inflammatory and immunologic processes and direct cellular damage. Our product candidates act upon calcium released-activated calcium channels ("CRAC") and would constitute a new class of drugs. We focus on the discovery and development of CRAC channel inhibitors. Clinical and preclinical data have demonstrated that the inhibition of CRAC channels may have a therapeutic effect based on ...

[PART I—FINANCIAL INFORMATION](index=5&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) [Item 1. Financial Statements (Unaudited)](index=5&type=section&id=Item%201.%20Financial%20Statements%20(Unaudited)) This section presents CalciMedica's unaudited condensed consolidated financial statements for the periods ended June 30, 2023, detailing the reverse merger's impact and key accounting policies [Condensed Consolidated Balance Sheets](index=5&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) As of June 30, 2023, total assets significantly increased to **$20.2 million** from **$3.3 million** due to the merger, shifting stockholders' equity from a **$71.3 million** deficit to a **$16.2 million** positive balance Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2023 (unaudited) | December 31, 2022 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $19,084 | $1,327 | | Total current assets | $20,045 | $1,730 | | **Total assets** | **$20,245** | **$3,349** | | **Liabilities & Equity** | | | | Total current liabilities | $4,024 | $4,780 | | Warrant liability | $0 | $2,645 | | Convertible promissory notes | $0 | $5,157 | | **Total liabilities** | **$4,024** | **$12,582** | | **Total stockholders' equity (deficit)** | **$16,221** | **($71,304)** | [Condensed Consolidated Statements of Operations and Comprehensive Loss](index=6&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations%20and%20Comprehensive%20Loss) The company reported a **$6.3 million** net loss for Q2 2023 and a **$25.6 million** net loss for the six months ended June 30, 2023, driven by increased operating expenses from merger-related costs Statement of Operations Summary (in thousands) | Metric | Three Months Ended June 30, 2023 | Three Months Ended June 30, 2022 | Six Months Ended June 30, 2023 | Six Months Ended June 30, 2022 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,814 | $2,259 | $10,305 | $5,184 | | General and administrative | $2,769 | $1,330 | $18,618 | $2,616 | | **Total operating expenses** | **$6,583** | **$3,589** | **$28,923** | **$7,800** | | Loss from operations | ($6,583) | ($3,589) | ($28,923) | ($7,800) | | **Net loss** | **($6,304)** | **($3,030)** | **($25,592)** | **($6,660)** | [Condensed Consolidated Statements of Cash Flows](index=9&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) For the six months ended June 30, 2023, net cash used in operations was **$17.5 million**, while financing activities provided **$20.7 million**, resulting in a **$17.6 million** net increase in cash Cash Flow Summary for Six Months Ended June 30 (in thousands) | Cash Flow Activity | 2023 | 2022 | | :--- | :--- | :--- | | Net cash used in operating activities | ($17,547) | ($5,842) | | Net cash provided by (used in) investing activities | $14,502 | ($4) | | Net cash provided by financing activities | $20,653 | $1,307 | | **Net increase (decrease) in cash** | **$17,608** | **($4,539)** | [Notes to the Condensed Consolidated Financial Statements](index=10&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) These notes detail the Graybug merger as a reverse recapitalization, significant accounting policies, fair value measurements, and confirm sufficient liquidity for operations beyond 12 months - The merger with Graybug on March 20, 2023, was accounted for as a **reverse recapitalization**, with Private CalciMedica treated as the accounting acquirer[222](index=222&type=chunk) - As of June 30, 2023, the company had **$19.1 million** in cash and cash equivalents, expected to fund operations beyond 12 months from the financial statement issuance date[229](index=229&type=chunk) - The company recorded one-time charges of **$10.5 million** for accelerated Graybug stock awards and **$5.7 million** in severance related to the merger during the six months ended June 30, 2023[263](index=263&type=chunk) Net Loss Per Share (Basic and Diluted) | Period | Net Loss (in thousands) | Weighted Average Shares | Net Loss Per Share | | :--- | :--- | :--- | :--- | | **Three Months Ended June 30, 2023** | $(6,304) | 5,661,933 | $(1.11) | | **Three Months Ended June 30, 2022** | $(3,030) | 82,923 | $(36.55) | | **Six Months Ended June 30, 2023** | $(25,592) | 3,255,868 | $(7.86) | | **Six Months Ended June 30, 2022** | $(6,660) | 80,812 | $(82.42) | [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=27&type=section&id=Item%202.%20Management's%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's clinical-stage biopharmaceutical focus, significant increase in operating expenses and net loss due to merger costs, and liquidity sufficient into H2 2024, with future capital needs for commercialization - The company is a clinical-stage biopharmaceutical firm focused on developing CRAC channel inhibitors, with its lead product candidate, Auxora, in a Phase 2b trial for acute pancreatitis (CARPO) with topline results expected in **H1 2024**[8](index=8&type=chunk) - The net loss for the six months ended June 30, 2023, was **$25.6 million**, including **$16.2 million** in one-time merger-related charges (**$10.5 million** for accelerated stock vesting and **$5.7 million** for severance)[11](index=11&type=chunk)[27](index=27&type=chunk) - As of June 30, 2023, the company had **$19.1 million** in cash and cash equivalents, believed sufficient to fund operations into **H2 2024**[38](index=38&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Total operating expenses increased **83%** to **$6.6 million** for Q2 2023 and **271%** to **$28.9 million** for the six-month period, primarily due to merger-related G&A costs Comparison of Operating Expenses for the Three Months Ended June 30 (in thousands) | Expense Category | 2023 | 2022 | Change Amount | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,814 | $2,259 | $1,555 | 69% | | General and administrative | $2,769 | $1,330 | $1,439 | 108% | | **Total operating expenses** | **$6,583** | **$3,589** | **$2,994** | **83%** | Comparison of Operating Expenses for the Six Months Ended June 30 (in thousands) | Expense Category | 2023 | 2022 | Change Amount | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $10,305 | $5,184 | $5,121 | 99% | | General and administrative | $18,618 | $2,616 | $16,002 | 612% | | **Total operating expenses** | **$28,923** | **$7,800** | **$21,123** | **271%** | - The **$16.0 million** increase in G&A expenses for the six-month period was primarily driven by a one-time charge for accelerated stock option vesting (**$8.6 million**) and a one-time severance charge (**$4.1 million**) due to the Merger[25](index=25&type=chunk) [Liquidity and Capital Resources](index=33&type=section&id=Liquidity%20and%20Capital%20Resources) Operations have been funded by **$149.7 million**; as of June 30, 2023, **$19.1 million** in cash is expected to fund operations into H2 2024, but additional capital is needed for full development - Cash used in operating activities was **$17.6 million** for the six months ended June 30, 2023, compared to **$5.8 million** for the same period in 2022[33](index=33&type=chunk)[36](index=36&type=chunk) - Cash provided by financing activities for the six months ended June 30, 2023, was **$20.7 million**, including **$14.9 million** net cash from the Merger and **$10.3 million** from a private placement, offset by **$4.5 million** in transaction costs[34](index=34&type=chunk) - Management believes **$19.1 million** in cash and cash equivalents as of June 30, 2023, will fund operations into **H2 2024**, but substantial additional capital is required for full development and commercialization[38](index=38&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=37&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk) As a smaller reporting company, CalciMedica is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, CalciMedica is not required to provide quantitative and qualitative disclosures about market risk[52](index=52&type=chunk) [Item 4. Controls and Procedures](index=37&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls were ineffective as of June 30, 2023, due to a material weakness in accounting for convertible notes and warrant liability, with remediation efforts underway - Management concluded that disclosure controls and procedures were **not effective** as of the end of the reporting period[53](index=53&type=chunk) - A **material weakness** was identified in internal controls related to accounting for the valuation of convertible promissory notes and warrant liability[53](index=53&type=chunk)[54](index=54&type=chunk) - Remediation steps have been initiated, including enhancing access to accounting literature and identifying third-party professionals for complex valuation model consultation[53](index=53&type=chunk) [PART II—OTHER INFORMATION](index=38&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) [Item 1. Legal Proceedings](index=38&type=section&id=Item%201.%20Legal%20Proceedings) Four lawsuits against former Graybug directors regarding merger disclosures were voluntarily dismissed after supplemental filings, resolved via a settlement agreement for a mootness fee - Four lawsuits were filed against Graybug and its directors related to the Merger, alleging misrepresentations and/or omissions in the proxy statement[57](index=57&type=chunk) - After Graybug filed supplemental disclosures, plaintiffs voluntarily dismissed their complaints, and a settlement agreement was executed to resolve a mootness fee demand[57](index=57&type=chunk) - The company believes no pending litigation could have a **material adverse effect** on its results of operations or financial condition[57](index=57&type=chunk) [Item 1A. Risk Factors](index=39&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant investment risks, including limited operating history, ongoing losses, dependence on Auxora's success, clinical development uncertainties, reliance on third parties, and a material weakness in internal controls - The company is a clinical-stage biopharmaceutical company with a limited operating history, an accumulated deficit of **$137.3 million** as of June 30, 2023, and anticipates continued significant losses[69](index=69&type=chunk) - The business is highly dependent on the success of its lead product candidate, Auxora, and may fail to develop it successfully or obtain regulatory approval[74](index=74&type=chunk) - A **material weakness** in internal control over financial reporting was recently identified, potentially impacting financial reporting accuracy and investor confidence if not remediated[161](index=161&type=chunk)[68](index=68&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=83&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) The company reports no unregistered sales of equity securities for the period covered by this report - The company reports **no unregistered sales** of equity securities for the period[171](index=171&type=chunk) [Item 3. Defaults Upon Senior Securities](index=83&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) The company reports no defaults upon senior securities - None reported[172](index=172&type=chunk) [Item 4. Mine Safety Disclosures](index=83&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company's operations - Not applicable[173](index=173&type=chunk) [Item 5. Other Information](index=83&type=section&id=Item%205.%20Other%20Information) The company reports no other information for this item - None reported[166](index=166&type=chunk) [Item 6. Exhibits](index=84&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Quarterly Report on Form 10-Q, including corporate governance documents, financing agreements, and officer certifications - A list of exhibits filed with the report is provided, including corporate governance documents, financing agreements, and required certifications[177](index=177&type=chunk)[178](index=178&type=chunk)

Equity-Based Compensation Stock-based compensation expense represents the cost of the grant date fair value of employee stock options recognized over the requisite service period of the awards (usually the vesting period) on a straight-line basis. For periods prior to the Merger, there was no active market for our common stock, we estimate the fair value of our common stock on the date of grant based on then current facts and circumstances. We estimate the fair value of stock option grants using the Black-S ...

To the extent that the Section 505(b)(2) applicant is relying on the FDA's prior findings of safety or effectiveness for an already approved product, the applicant is required to certify to the FDA concerning any patents listed for the approved product in the Orange Book to the same extent that an ANDA applicant would. Thus, approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until any non-patent exclusivity, such as exclusivity for o ...

[PART I—FINANCIAL INFORMATION](index=4&type=section&id=PART%20I%E2%80%94FINANCIAL%20INFORMATION) This section presents Graybug Vision, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2022 [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements) This section presents Graybug Vision, Inc.'s unaudited condensed consolidated financial statements as of June 30, 2022, detailing a net loss of $18.4 million and an accumulated deficit of $187.6 million [Condensed Consolidated Balance Sheets](index=4&type=section&id=Condensed%20Consolidated%20Balance%20Sheets) The balance sheet as of June 30, 2022, shows total assets of $54.0 million and stockholders' equity of $49.7 million Condensed Consolidated Balance Sheet Highlights (in thousands) | Metric | June 30, 2022 (unaudited) | December 31, 2021 | | :--- | :--- | :--- | | **Assets** | | | | Cash and cash equivalents | $13,872 | $13,364 | | Short-term investments | $36,817 | $50,306 | | Total current assets | $51,727 | $67,078 | | **Total assets** | **$54,022** | **$69,088** | | **Liabilities & Equity** | | | | Total current liabilities | $4,330 | $4,057 | | **Total liabilities** | **$4,330** | **$4,065** | | Accumulated deficit | $(187,578) | $(169,188) | | **Total stockholders' equity** | **$49,692** | **$65,023** | [Condensed Consolidated Statements of Operations](index=5&type=section&id=Condensed%20Consolidated%20Statements%20of%20Operations) The company reported a net loss of $8.2 million for the three months and $18.4 million for the six months ended June 30, 2022 Statement of Operations Summary (in thousands, except per share data) | Metric | Three Months Ended June 30, 2022 | Three Months Ended June 30, 2021 | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $4,058 | $4,166 | $10,115 | $10,614 | | General and administrative | $4,243 | $3,575 | $8,370 | $8,615 | | **Loss from operations** | **$(8,301)** | **$(7,741)** | **$(18,485)** | **$(19,229)** | | **Net loss** | **$(8,241)** | **$(7,708)** | **$(18,390)** | **$(19,157)** | | Net loss per share | $(0.38) | $(0.36) | $(0.86) | $(0.91) | [Condensed Consolidated Statements of Cash Flows](index=8&type=section&id=Condensed%20Consolidated%20Statements%20of%20Cash%20Flows) Net cash used in operating activities was $10.7 million for the six months ended June 30, 2022 Cash Flow Summary (in thousands) | Activity | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | | :--- | :--- | :--- | | Net cash used in operating activities | $(10,663) | $(17,045) | | Net cash provided by (used in) investing activities | $11,240 | $(9,096) | | Net cash (used in) provided by financing activities | $(69) | $587 | | **Net increase (decrease) in cash** | **$508** | **$(25,554)** | [Notes to the Condensed Consolidated Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Consolidated%20Financial%20Statements) Key notes detail the company's strategic review, RainBio acquisition, and new lease accounting standards adoption - On June 28, 2022, the company announced a comprehensive review of strategic alternatives, including potential acquisition, sale, merger, or asset divestiture. Subsequently, on August 11, 2022, all clinical development was put on hold to conserve capital[34](index=34&type=chunk) - Management believes the company's current cash, cash equivalents, and short-term investments are adequate to meet its cash needs for at least 12 months from the report's issuance date[37](index=37&type=chunk) - In March 2022, the company acquired RainBio, Inc. for approximately **$2.2 million**, which was expensed as in-process research and development (IPR&D). The deal includes potential future contingent payments of up to **$17.5 million** upon achieving certain milestones[65](index=65&type=chunk)[66](index=66&type=chunk) - The company adopted new lease accounting standard ASC 842 on January 1, 2022, resulting in the recognition of an operating lease right-of-use asset of **$0.6 million** and an operating lease liability of **$0.6 million**[50](index=50&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=20&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations) Management discusses the company's financial condition, strategic decision to halt clinical development, and H1 2022 results - On June 28, 2022, the company initiated a review of strategic alternatives, and on August 11, 2022, it halted all clinical development of GB-102, GB-401, and GB-501 to conserve capital pending the review's outcome[91](index=91&type=chunk) - As of June 30, 2022, the company had **$50.7 million** in cash, cash equivalents, and short-term investments and an accumulated deficit of **$187.6 million**[89](index=89&type=chunk) - The company believes its existing cash will fund operations into the fourth quarter of 2023, based on an operating plan that is subject to change pending the strategic review[121](index=121&type=chunk) - In July 2022, the company regained compliance with Nasdaq's minimum bid price requirement after its stock price closed at or above $1.00 for ten consecutive business days[92](index=92&type=chunk) [Results of Operations](index=24&type=section&id=Results%20of%20Operations) Total operating expenses decreased by 4% to $18.5 million for the six months ended June 30, 2022 Comparison of Operating Results (in thousands) | Metric | Six Months Ended June 30, 2022 | Six Months Ended June 30, 2021 | Change Amount | Change % | | :--- | :--- | :--- | :--- | :--- | | Research and development | $10,115 | $10,614 | $(499) | (5%) | | General and administrative | $8,370 | $8,615 | $(245) | (3%) | | **Total operating expenses** | **$18,485** | **$19,229** | **$(744)** | **(4%)** | | **Net loss** | **$(18,390)** | **$(19,157)** | **$767** | **(4%)** | - The decrease in R&D expenses for the six-month period was primarily due to the completion of the GB-102 Phase 2b clinical trial extension in May 2021, offset by a **$2.2 million** expense for the acquisition of in-process R&D from RainBio, Inc. in March 2022[117](index=117&type=chunk) - The decrease in G&A expenses for the six-month period was mainly due to a **$1.4 million** write-off of deposits on fixed-asset purchase commitments in March 2021, partially offset by increased stock compensation and professional services in 2022[118](index=118&type=chunk) [Liquidity and Capital Resources](index=26&type=section&id=Liquidity%20and%20Capital%20Resources) As of June 30, 2022, the company held $50.7 million in cash and investments, expected to fund operations into Q4 2023 - The company's cash, cash equivalents, and short-term investments totaled **$50.7 million** as of June 30, 2022[119](index=119&type=chunk) - The company believes its existing cash will fund operating expenses and capital requirements into the fourth quarter of 2023, based on a revised operating plan that no longer includes the cost of Phase 3 trials for GB-102 without a partner[121](index=121&type=chunk)[128](index=128&type=chunk) - Future funding needs will depend on the outcome of the strategic review and many factors, including the scope of R&D, costs of clinical trials, and potential collaborations or licenses[131](index=131&type=chunk) [Item 3. Quantitative and Qualitative Disclosures About Market Risk](index=32&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20About%20Market%20Risk) As a smaller reporting company, Graybug Vision is not required to provide market risk disclosures - As a smaller reporting company, Graybug Vision is not required to provide quantitative and qualitative disclosures about market risk[145](index=145&type=chunk) [Item 4. Controls and Procedures](index=32&type=section&id=Item%204.%20Controls%20and%20Procedures) Management concluded disclosure controls and procedures were effective as of June 30, 2022, with no material internal control changes - The CEO and CFO concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report[146](index=146&type=chunk) - No changes in internal control over financial reporting occurred during the quarter ended June 30, 2022, that have materially affected, or are reasonably likely to materially affect, internal controls[147](index=147&type=chunk) [PART II—OTHER INFORMATION](index=33&type=section&id=PART%20II%E2%80%94OTHER%20INFORMATION) This section provides other information relevant to the company's financial reporting [Item 1. Legal Proceedings](index=33&type=section&id=Item%201.%20Legal%20Proceedings) The company is not currently a party to any material legal proceedings - As of the filing date, the company is not involved in any material legal proceedings[150](index=150&type=chunk) [Item 1A. Risk Factors](index=33&type=section&id=Item%201A.%20Risk%20Factors) This section outlines significant risks including strategic review uncertainty, funding needs, clinical trial failures, and stock volatility - The company may not be successful in its strategic review to find a merger, sale, or other transaction, and failure could lead to liquidation where shareholders might receive significantly less than the market value of their shares[153](index=153&type=chunk)[154](index=154&type=chunk) - The company has a history of significant losses, expects to incur more, and will need substantial additional funding to support operations. Without a strategic transaction, further development of its lead product candidate, GB-102, is unlikely[155](index=155&type=chunk)[156](index=156&type=chunk) - The company faces risks from its unproven therapeutic approach, potential failure of clinical trials to demonstrate safety and efficacy, and serious adverse side effects identified during development[158](index=158&type=chunk) - The company is heavily reliant on third parties for manufacturing and may encounter difficulties in production, scale-up, and quality control, particularly for its novel and complex gene therapies[160](index=160&type=chunk) - The stock price has been and may continue to be volatile, and the company faces the risk of delisting from Nasdaq if it fails to meet the minimum bid requirement[162](index=162&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=84&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds) No unregistered sales of equity securities occurred, and there was no material change in the planned use of IPO proceeds - There were no unregistered sales of equity securities in the reported period[474](index=474&type=chunk) - The company raised approximately **$92.0 million** in net proceeds from its IPO in September/October 2020. There has been no material change in the planned use of these proceeds[475](index=475&type=chunk)[476](index=476&type=chunk) [Item 3. Defaults Upon Senior Securities](index=84&type=section&id=Item%203.%20Defaults%20Upon%20Senior%20Securities) There have been no defaults upon senior securities - None[477](index=477&type=chunk) [Item 4. Mine Safety Disclosures](index=84&type=section&id=Item%204.%20Mine%20Safety%20Disclosures) This item is not applicable to the company - Not applicable[478](index=478&type=chunk) [Item 5. Other Information](index=84&type=section&id=Item%205.%20Other%20Information) No other information is reported for this item - None[479](index=479&type=chunk) [Item 6. Exhibits](index=85&type=section&id=Item%206.%20Exhibits) This section lists exhibits filed with the Form 10-Q, including SOX certifications and Inline XBRL documents - The exhibits filed include certifications from the CEO and CFO pursuant to Sections 302 and 906 of the Sarbanes-Oxley Act[481](index=481&type=chunk)[482](index=482&type=chunk)[483](index=483&type=chunk) - Inline XBRL data files are included as exhibits, providing interactive data for the financial statements[483](index=483&type=chunk)

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number 001-39538 GRAYBUG VISION, INC. (Exact name of Registrant as specified in its Charter) Delaware 45-2120079 (State or other jurisdicti ...

| --- | --- | |-------------------------------------------------------------------------|-------| | | | | Intrastromal delivery of AAV-IDUA for MPS1-associated corneal clouding | | | Parisa Zamiri, MD, PhD | | | 2022 ASCRS Annual Meeting | | Legal Disclaimer Any reproduction or distribution of this presentation, in whole or in part, without the prior consent of Graybug Vision, Inc. is prohibited. These slides and the accompanying oral presentation contain forward-looking statements within the meaning of the ...