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 ...

Financial Performance - The company incurred a net loss of $35.8 million for the year ended December 31, 2021, compared to a net loss of $27.5 million for 2020, resulting in an accumulated deficit of $169.2 million as of December 31, 2021[248]. - The company expects to continue incurring significant and increasing operating losses for the foreseeable future, particularly as it pursues clinical trials for its product candidates, including GB-102 and GB-401[249]. - As of December 31, 2021, the company had cash, cash equivalents, and short-term investments of $63.7 million, which is believed to be sufficient to fund operations beyond the next 12 months[255]. - The company has no product sales and does not expect to generate sales of any product candidate for several years, indicating a need for substantial additional funding to support ongoing operations and growth strategies[251]. Clinical Trials and Development - The company has not yet successfully initiated or completed any Phase 3 clinical trials nor commercialized any pharmaceutical products, which may complicate future evaluations of its prospects[243]. - The company anticipates that expenses will increase substantially as it seeks marketing approvals and expands its sales, marketing, and distribution capabilities[249]. - The company relies heavily on the success of its wet AMD product candidates, particularly GB-102, and any failure in clinical trials could materially harm its business[243]. - The company may face challenges in scaling up manufacturing processes and capabilities, which could delay or prevent the commercialization of its product candidates[246]. - The company has invested substantial resources in the development of GB-102 for wet AMD, but the success of this product candidate is uncertain and heavily dependent on obtaining marketing approval[263]. - The Phase 2b clinical trial of GB-102 showed that patients on the 1 mg dose had a mean Best Corrected Visual Acuity (BCVA) approximately 9 letters lower than the control arm receiving Eylea, which may affect FDA approval chances[271]. - In the Phase 1/2a trial, 88% of patients did not require additional supportive therapy for six months or longer, while only 48% achieved this in the Phase 2b trial, indicating variability in results[275]. - The company terminated the development of the 2 mg dose of GB-102 due to safety concerns, including serious adverse events related to medication presence in the anterior chamber[276]. - In the 12-month treatment phase of the Phase 2b trial, no drug-related, non-ocular adverse events were reported in the GB-102 1 mg arm, and no treatment-emergent adverse events led to drug discontinuation[285]. - The company is actively seeking partnerships to license commercial rights to GB-102 in exchange for funding further clinical trials, but there is no guarantee of securing such partnerships[262]. - The success of GB-102 and other product candidates will depend on various factors, including successful completion of clinical trials and acceptance by the medical community[264]. - The company may face significant delays or inability to commercialize product candidates if it does not achieve necessary clinical trial outcomes in a timely manner[267]. Impact of COVID-19 - The ongoing COVID-19 pandemic may adversely affect the company's business, results of operations, and financial condition[243]. - The ongoing COVID-19 pandemic has significantly disrupted business operations and clinical trials, with potential adverse effects on financial condition and results of operations[289][291][294]. - Delays in clinical trials due to COVID-19 could lead to increased development costs and hinder the ability to obtain necessary regulatory approvals for product candidates[295][300]. - The impact of the COVID-19 pandemic on global economic and capital markets may adversely affect the company's liquidity and access to capital[295]. - The company has modified business practices, including remote work for the majority of office-based employees since March 2020, which may expose the company to increased cybersecurity risks[292][293]. - The company may face challenges in patient enrollment for clinical trials, which could delay or prevent necessary regulatory approvals[302][304]. Manufacturing and Supply Chain - The company currently relies on third parties for the production of GB-102 and other product candidates for preclinical testing and clinical trials, including the supply of active pharmaceutical ingredients and raw materials[316]. - The company intends to build its own manufacturing capabilities but may continue to contract with third parties if it is more advantageous[318]. - The company faces risks related to reliance on third-party manufacturers, including lack of control over regulatory compliance and potential breaches of agreements[319]. - Any failure to comply with quality assurance standards and regulatory requirements could result in sanctions, including clinical holds and fines, adversely affecting the company's business[321]. - The company has no experience manufacturing product candidates at a commercial scale, which may delay or prevent the development and commercialization of approved products[326]. - Changes in manufacturing methods may introduce additional costs or delays, impacting the ability to commercialize product candidates[327]. Competition and Market Dynamics - The company is developing GB-102 as an alternative to existing anti-VEGF drugs, which include Eylea, Avastin, Lucentis, Beovu, and PDS, indicating a direct competition with these established therapies[341]. - The current standard of care for wet AMD includes well-established therapies such as Eylea, Avastin, and Lucentis, which are widely accepted by physicians and patients[340]. - The company faces substantial competition from major pharmaceutical and biotechnology companies, which may result in others commercializing products before the company does[339]. - The company may experience significant delays in obtaining coverage and reimbursement for newly approved drugs, which could adversely affect revenue generation[350]. - Collaborations with third parties are intended for clinical development and commercialization of GB-102, but the success of these collaborations is uncertain[358]. - The company anticipates that product candidates currently in clinical development could represent additional competition if approved[342]. - The company may face challenges in recruiting and retaining effective sales and marketing personnel, which could inhibit commercialization efforts[337]. - The company currently does not have any collaboration agreements in place, which may limit its ability to capitalize on market potential[362]. Intellectual Property and Legal Risks - The company’s patent position is critical for protecting its product candidates, and any inadequacies could lead to increased competition[369]. - The patent prosecution process is expensive and time-consuming, and the company may not be able to file all necessary patent applications in a timely manner[370]. - The company does not control the prosecution of certain licensed patents, which may affect its ability to enforce its intellectual property rights[371]. - The U.S. patent system has undergone changes that may weaken the company's ability to obtain patent protection, particularly for applications filed after March 2013[379][380]. - The company may face challenges in protecting its intellectual property rights in foreign jurisdictions, which could harm its business prospects[383]. - Compliance with federal regulations related to patents developed through government funding may limit the company's exclusive rights and ability to contract with non-U.S. manufacturers[385]. - The company may face significant litigation costs and delays in product development due to potential patent infringement claims from third parties[386]. - The pharmaceutical industry is characterized by extensive litigation regarding patents, which could adversely affect the company's ability to operate[388]. - If the company is found to infringe on third-party patents, it may incur substantial monetary damages and significant delays in bringing product candidates to market[389]. - The company’s current clinical candidates will be subject to the Hatch-Waxman Amendments, allowing generic companies to submit Abbreviated New Drug Applications (ANDAs) that could challenge the company's patents[391]. - The company could face antitrust challenges from the U.S. Federal Trade Commission regarding patent litigation settlements, which may result in significant expenses or penalties[393]. - The company may not be able to enforce its intellectual property rights effectively in foreign jurisdictions, which could allow competitors to develop similar products[394]. - Changes in foreign intellectual property laws may adversely affect the company's ability to protect its patents and other intellectual property rights[395]. - Compulsory licensing laws in some countries could limit the company's revenue opportunities by requiring it to grant licenses to third parties[400]. Regulatory Compliance - Clinical trials must comply with regulatory requirements, and any negative outcomes could lead to suspension or termination of trials, impacting commercial prospects[408]. - The company has not submitted for regulatory approval for GB-102 or any other product candidate, which is necessary for commercialization[414]. - The regulatory approval process is expensive and time-consuming, with no guarantee of success, potentially delaying revenue generation[415]. - Brexit may impact the regulatory framework for pharmaceutical products in the UK, affecting the approval of product candidates[423]. - Ongoing regulations and post-marketing restrictions may limit how the company manufactures and markets its products, impairing revenue generation[427]. - The company is required to comply with extensive FDA requirements, including quality control and manufacturing procedures conforming to current good manufacturing practices[428]. - If undesirable side effects are identified post-approval, the company may face significant revenue loss and adverse operational impacts[429]. - Regulatory authorities may impose additional restrictions on marketing, labeling, and promotion of products, potentially affecting sales and competitiveness[432]. - The company will be subject to ongoing FDA obligations and regulatory reviews, which may result in significant expenses and limit commercialization capabilities[432]. - The FDA has the authority to require post-market studies or clinical trials to evaluate safety risks, which could delay product availability[432]. - Non-compliance with regulatory requirements may lead to severe penalties, including fines, product recalls, and withdrawal of regulatory approvals[437]. - The company plans to seek FDA approval through the Section 505(b)(2) regulatory pathway for GB-401, which may expedite the development program[441]. - The company intends to rely on the FDA's prior conclusions regarding the safety and effectiveness of previously approved drugs to support its product candidates[441]. - Non-compliance with European Union safety monitoring requirements may also result in significant financial penalties[440]. - The discovery of new problems with products or manufacturing processes may lead to restrictions and adverse outcomes affecting market presence[439]. Partnerships and Collaborations - The company is seeking a partner to fund further clinical trials of GB-102 for wet AMD, highlighting the uncertainty of its development without such a partnership[243]. - The company lacks sufficient capital resources to complete the development of GB-102 without a partner, which is critical for successful commercialization[334]. - Establishing sales, marketing, and distribution capabilities poses risks, including potential delays in product launch and lower revenues under third-party arrangements[335]. - Significant competition exists in seeking appropriate collaborators, and the likelihood of reaching definitive agreements depends on various factors including clinical trial results and market potential[364]. - If suitable collaborations are not reached in a timely manner, the company may have to curtail product development or increase expenditures to undertake activities independently[365][366]. - The company relies on third parties for clinical development, which may lead to delays if those parties do not meet deadlines or perform satisfactorily[367][368]. - The company has obligations under its license agreement with Johns Hopkins University (JHU), including minimum royalty payments and commercialization efforts, which are critical for developing its product candidates[402]. - Breaching obligations under the license agreement with JHU could result in the loss of rights necessary for developing and commercializing key product candidates[403]. - The company relies on unpatented trade secrets and confidentiality agreements to protect its proprietary information, but these measures may not provide adequate protection[405]. - Enforcement of trade secret claims is expensive and uncertain, potentially harming the company's competitive position if competitors independently discover its trade secrets[406].

| --- | --- | |---------------------------------------------------------|-------| | | | | | | | Graybug Vision | | | | | | SVB Leerink 11 th Annual Global Healthcare Conference | | | February 17, 2022 | | © 2022 Graybug Vision 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 "safe harbor" ...

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 September 30, 2021 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 jurisd ...

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 June 30, 2021 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 jurisdictio ...

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, 2021 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 452120079 (State or other jurisdictio ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 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 452120079 (State or other jurisdiction of ...