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" ...

Financial Performance - Net loss for the three months ended September 30, 2021, was $7,989,000, compared to a net loss of $4,716,000 for the same period in 2020, indicating an increase in loss of approximately 69%[21] - Comprehensive loss for the nine months ended September 30, 2021, was $27,136,000, compared to $18,382,000 for the same period in 2020, representing an increase of approximately 47%[24] - The net loss for the nine months ended September 30, 2021, was $27.146 million, compared to a net loss of $18.379 million for the same period in 2020[33] - The company reported a net loss of $8.0 million for the three months ended September 30, 2021, compared to a net loss of $4.7 million for the same period in 2020, representing a 70% increase in losses[74] - The company incurred a net loss of $8.0 million for Q3 2021, compared to $4.7 million for Q3 2020, and a total net loss of $27.1 million for the nine months ended September 30, 2021, compared to $18.4 million for the same period in 2020[149] Assets and Liabilities - Total current assets decreased to $74,496,000 as of September 30, 2021, down from $99,240,000 as of December 31, 2020, representing a decline of approximately 25%[19] - Total liabilities decreased to $4,502,000 as of September 30, 2021, down from $7,008,000 as of December 31, 2020, a reduction of about 36%[19] - Cash and cash equivalents decreased to $11,452,000 as of September 30, 2021, down from $33,418,000 as of December 31, 2020, a decline of about 66%[19] - The accumulated deficit increased to $(160,513,000) as of September 30, 2021, compared to $(133,367,000) as of December 31, 2020, reflecting an increase in deficit of approximately 20%[19] - As of September 30, 2021, the accumulated deficit was $160.5 million, with cash, cash equivalents, and short-term investments totaling $72.6 million[74] Operating Expenses - Total operating expenses for the three months ended September 30, 2021, were $8,017,000, up from $6,821,000 in the same period of 2020, reflecting an increase of about 17.5%[21] - General and administrative expenses surged to $4.0 million for the three months ended September 30, 2021, a 94% increase from $2.1 million in 2020, driven by higher stock-based compensation and insurance costs[99] - For the nine months ended September 30, 2021, total operating expenses were $27.2 million, a 32% increase from $20.7 million in 2020[102] - General and administrative expenses for the nine months ended September 30, 2021, reached $12.6 million, up from $5.2 million in 2020, primarily due to increased stock-based compensation and insurance costs[106] Research and Development - Research and development expenses for the nine months ended September 30, 2021, were $14,635,000, compared to $15,474,000 for the same period in 2020, showing a decrease of approximately 5.4%[21] - Research and development expenses decreased to $4.0 million for the three months ended September 30, 2021, down 15% from $4.8 million in 2020, mainly due to reduced clinical trial expenses[96] - The company expects to continue incurring significant and increasing operating losses for the foreseeable future due to ongoing research and development activities[150] - The company anticipates substantial increases in expenses related to clinical trials, regulatory approvals, and commercialization efforts for its product candidates[155] Funding and Capital Needs - The company plans to seek additional funding to advance its research and development programs and meet its obligations[39] - The company expects to finance its future cash needs through equity offerings, debt financings, or other capital sources, as it anticipates continued losses until substantial product revenue is generated[111] - The company has no credit facility or committed sources of capital, indicating a potential need for additional funds to meet operational needs[116] - The company may need to raise additional capital to support its operations and growth strategy, and failure to do so could delay or eliminate product development programs[155] Clinical Trials and Product Development - GB-102, the lead product candidate, demonstrated durable clinical evidence of disease control in approximately 88% of patients in a Phase 1/2a clinical trial[72] - The company has stopped further development of GB-103 due to the observed 12-month duration of GB-102 in clinical trials[72] - 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, raising concerns about FDA approval[175] - The company has not yet successfully initiated or completed any Phase 3 clinical trials nor commercialized any pharmaceutical products, making future prospects difficult to evaluate[149] - Clinical trials are inherently uncertain, and positive results in early trials do not guarantee success in later-stage trials[179] Impact of COVID-19 - The ongoing COVID-19 pandemic has not significantly impacted the company's financial condition or operations to date, but future effects remain uncertain[77] - The pandemic has caused delays in clinical trials and may impact the ability to monitor patients due to clinic closures[195] - The company anticipates that disruptions in supply chains could delay the start of clinical trials for product candidates[195] - The pandemic has negatively impacted capital markets, which may affect the company's liquidity and access to capital[196] Cybersecurity and Operational Risks - The majority of office-based employees have been working remotely since March 2020, which has increased cybersecurity risks[193] - Cybersecurity breaches could result in significant business disruptions and damage to the company's reputation[215]

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 ...

PART I—FINANCIAL INFORMATION [Item 1. Financial Statements](index=4&type=section&id=Item%201.%20Financial%20Statements.) Unaudited condensed financial statements for Q1 2021 show decreased cash and total assets, increased accumulated deficit, and a larger net loss compared to Q1 2020 Condensed Balance Sheet Data (in thousands) | Metric | March 31, 2021 (unaudited) | December 31, 2020 | | :--- | :--- | :--- | | Cash and cash equivalents | $10,589 | $33,418 | | Total current assets | $88,821 | $99,240 | | Total assets | $90,852 | $101,794 | | Total liabilities | $6,290 | $7,008 | | Accumulated deficit | $(144,816) | $(133,367) | | Total stockholders' equity | $84,562 | $94,786 | Condensed Statements of Operations (in thousands, except per share data) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Research and development | $6,448 | $6,085 | | General and administrative | $5,040 | $1,711 | | Total operating expenses | $11,488 | $7,796 | | Loss from operations | $(11,488) | $(7,796) | | Net loss | $(11,449) | $(7,794) | | Net loss per common share | $(0.54) | $(6.61) | Condensed Statements of Cash Flows (in thousands) | Metric | Three Months Ended March 31, 2021 | Three Months Ended March 31, 2020 | | :--- | :--- | :--- | | Net cash used in operating activities | $(9,264) | $(10,711) | | Net cash (used in) provided by investing activities | $(13,657) | $16,853 | | Net cash provided by (used in) financing activities | $92 | $(840) | | Net (decrease) increase in cash and cash equivalents | $(22,829) | $5,302 | [Notes to the Condensed Financial Statements](index=9&type=section&id=Notes%20to%20the%20Condensed%20Financial%20Statements) Notes detail the company's organization, IPO, going concern, and accounting policies, highlighting the **$92.0 million** IPO proceeds and cash sufficiency for **12 months** after pausing GB-102 trials - In September 2020, the company completed its IPO, raising net proceeds of **$92.0 million**[34](index=34&type=chunk) - The company has an accumulated deficit of **$144.8 million** as of March 31, 2021. Management believes its existing cash will fund operations for more than **12 months**, largely due to the decision in March 2021 to not proceed with the significant investment required for two Phase 3 clinical trials for GB-102[36](index=36&type=chunk)[37](index=37&type=chunk)[38](index=38&type=chunk) - As of March 31, 2021, the company had approximately **$3.1 million** in commitments with CROs and CMOs due within three to 12 months. During the quarter, the company terminated several contracts, resulting in the cancellation of **$3.7 million** in commitments and recognizing **$2.2 million** in related expenses[56](index=56&type=chunk) - Total unrecognized stock-based compensation expense related to unvested stock awards was **$13.4 million** as of March 31, 2021, expected to be recognized over a weighted-average term of **3.3 years**[66](index=66&type=chunk) [Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations](index=16&type=section&id=Item%202.%20Management%27s%20Discussion%20and%20Analysis%20of%20Financial%20Condition%20and%20Results%20of%20Operations.) Management discusses GB-102's clinical-stage status requiring partner funding, analyzes increased Q1 2021 net loss from higher G&A, and notes current cash for **12 months** but future financing needs [Overview](index=16&type=section&id=Overview) Graybug, a clinical-stage biopharmaceutical company, requires partner funding for its lead candidate GB-102, reporting a **$11.4 million** net loss for Q1 2021 and **$144.8 million** accumulated deficit - The company's lead product candidate, GB-102, requires funding by a partner for further clinical trials following the analysis of Phase 2b trial data[73](index=73&type=chunk) Financial Position as of March 31, 2021 | Metric | Amount (in millions) | | :--- | :--- | | Net Loss (Q1 2021) | $11.4 | | Accumulated Deficit | $144.8 | | Cash, cash equivalents and short-term investments | $85.7 | [Results of Operations](index=19&type=section&id=Results%20of%20Operations) Net loss increased to **$11.4 million** in Q1 2021 from **$7.8 million** in Q1 2020, primarily due to a **195%** rise in G&A expenses, including a **$1.35 million** write-off Comparison of Operating Results (in thousands) | Metric | Q1 2021 | Q1 2020 | Change ($) | Change (%) | | :--- | :--- | :--- | :--- | :--- | | Research and development | $6,448 | $6,085 | $363 | 6% | | General and administrative | $5,040 | $1,711 | $3,329 | 195% | | **Total operating expenses** | **$11,488** | **$7,796** | **$3,692** | **47%** | | **Net loss** | **$(11,449)** | **$(7,794)** | **$(3,655)** | **47%** | - The increase in R&D expenses was mainly due to fees from canceling clinical supply orders for the GB-102 Phase 3 trial and higher compensation costs, partially offset by lower clinical trial expenses as the Phase 2b treatment phase completed in December 2020[97](index=97&type=chunk) - The sharp increase in G&A expenses was primarily due to a **$1.35 million** write-off of deposits on fixed assets purchase commitments, higher stock-based compensation, increased headcount, and higher directors and officers insurance costs after becoming a public company[99](index=99&type=chunk)[100](index=100&type=chunk) [Liquidity and Capital Resources](index=20&type=section&id=Liquidity%20and%20Capital%20Resources) As of March 31, 2021, the company held **$85.7 million** in cash, sufficient for over **12 months** due to pausing GB-102 Phase 3 trials, but requires additional financing for R&D programs - As of March 31, 2021, the company had **$85.7 million** in available cash, cash equivalents, and short-term investments and an accumulated deficit of **$144.8 million**[103](index=103&type=chunk) - The company believes its existing cash will fund operations for over **12 months**, as the current operating plan no longer includes the cost of commencing Phase 3 clinical trials for GB-102 in 2021[105](index=105&type=chunk) - The company will require additional financing to advance its product candidates and will seek funds through equity offerings, debt financings, or collaborations, but may be unable to raise capital on favorable terms, if at all[108](index=108&type=chunk) [Item 3. Quantitative and Qualitative Disclosures about Market Risk](index=25&type=section&id=Item%203.%20Quantitative%20and%20Qualitative%20Disclosures%20about%20Market%20Risk.) As a smaller reporting company, Graybug Vision, Inc. is not required to provide quantitative and qualitative disclosures about market risk - As a smaller reporting company, Graybug Vision, Inc. is not required to provide quantitative and qualitative disclosures about market risk[128](index=128&type=chunk) [Item 4. Controls and Procedures](index=25&type=section&id=Item%204.%20Controls%20and%20Procedures.) Management concluded that the company's disclosure controls and procedures were effective as of March 31, 2021, with no material changes in internal control over financial reporting during the quarter - Management concluded that the company's disclosure controls and procedures were effective as of the end of the period covered by the report (March 31, 2021)[129](index=129&type=chunk) - There were no changes in internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, the company's internal control over financial reporting[130](index=130&type=chunk) PART II—OTHER INFORMATION [Item 1. Legal Proceedings](index=26&type=section&id=Item%201.%20Legal%20Proceedings.) The company is not a party to any material legal proceedings as of the filing date - As of the filing date, the company is not party to any material legal proceedings[133](index=133&type=chunk) [Item 1A. Risk Factors](index=26&type=section&id=Item%201A.%20Risk%20Factors.) The company faces significant risks including its clinical-stage status, substantial losses, need for additional funding, heavy reliance on GB-102 requiring a partner, and challenges in development, regulatory approval, and intellectual property [Risks Related to Financial Position and Need For Additional Capital](index=28&type=section&id=Risks%20Related%20to%20Our%20Financial%20Position%20and%20Need%20For%20Additional%20Capital) As a clinical-stage company with no approved products, the company has **$144.8 million** in accumulated losses, expects increasing losses, and requires substantial additional funding to avoid development delays - The company has incurred significant operating losses since inception, with an accumulated deficit of **$144.8 million** as of March 31, 2021, and expects to incur continued and increasing losses[142](index=142&type=chunk) - The company requires substantial additional funding to support its operations. If unable to raise capital when needed, it could be forced to delay, reduce, or eliminate product development or commercialization efforts[148](index=148&type=chunk) [Risks Related to Product Development, Regulatory Approval and Commercialization](index=30&type=section&id=Risks%20Related%20to%20Product%20Development%2C%20Regulatory%20Approval%20and%20Commercialization) Product development, regulatory approval, and commercialization risks include GB-102's unproven approach, the need for partner funding, potential clinical trial failures, and challenges in market acceptance - The company requires a partner to fund any further clinical trials of GB-102 for wet AMD. Without such a partnership, further development of GB-102 for wet AMD or DME, and GB-103 for diabetic retinopathy, is unlikely[166](index=166&type=chunk) - The Phase 2b clinical trial of GB-102 showed a lower average Best Corrected Visual Acuity (BCVA) compared to the Eylea control arm. If repeated in a Phase 3 trial, it is unlikely the FDA would approve the product based on non-inferiority[177](index=177&type=chunk) - The active ingredient in GB-102, sunitinib, has a boxed warning for liver damage (hepatotoxicity) in its approved oncology indications, which may complicate regulatory approval or market acceptance, even though no such toxicity has been observed in the company's trials[201](index=201&type=chunk)[202](index=202&type=chunk) [Risks Related to Manufacturing](index=41&type=section&id=Risks%20Related%20to%20Manufacturing) Reliance on third-party CMOs for product candidate manufacturing poses risks in quality control, regulatory compliance, and supply chain, with no commercial-scale experience, potentially delaying development and commercialization - The company currently relies on third parties for the production of its product candidates, which creates risks related to lack of direct control over regulatory compliance and quality assurance[213](index=213&type=chunk)[214](index=214&type=chunk) - The company has no experience manufacturing its product candidates at a commercial scale and may be unable to successfully scale up manufacturing in sufficient quality and quantity, which would delay or prevent development and commercialization[221](index=221&type=chunk) [Risks Related to Intellectual Property](index=50&type=section&id=Risks%20Related%20to%20Our%20Intellectual%20Property) Success depends on obtaining and maintaining patent protection, facing risks of challenges, non-infringing alternatives, sunitinib patent expiration in **2021**, and potential termination of the Johns Hopkins University license - The company's ability to protect its product candidates depends on obtaining and maintaining valid and enforceable patents, which is an uncertain process involving complex legal and factual questions[268](index=268&type=chunk) - Sunitinib, the active ingredient in GB-102 and GB-103, is expected to lose patent protection in **2021**, which could allow new competitors with similar products to challenge the company's business[285](index=285&type=chunk) - The company's licensed patents from Johns Hopkins University, developed with U.S. government funding, are subject to federal regulations, including potential "march-in" rights that could allow the government to grant licenses to third parties[282](index=282&type=chunk) [Risks Related to Ownership of Our Common Stock](index=69&type=section&id=Risks%20Related%20to%20Ownership%20of%20Our%20Common%20Stock) Risks for common stock ownership include price volatility, dilution from future equity, significant control by principal stockholders (**~79%**), and reduced disclosure as an "emerging growth" and "smaller reporting" company, with no anticipated dividends - The market price of the company's stock may be volatile due to factors such as clinical trial results, regulatory developments, and market conditions[385](index=385&type=chunk) - As of March 31, 2021, executive officers, directors, and 5% or greater stockholders beneficially owned approximately **79%** of the company's voting stock, giving them significant control over corporate actions[395](index=395&type=chunk) - The company is an "emerging growth company" and a "smaller reporting company," which allows it to take advantage of reduced reporting requirements, potentially making its common stock less attractive to investors[397](index=397&type=chunk) [Item 2. Unregistered Sales of Equity Securities and Use of Proceeds](index=74&type=section&id=Item%202.%20Unregistered%20Sales%20of%20Equity%20Securities%20and%20Use%20of%20Proceeds.) No unregistered sales of equity securities occurred, and **$92.0 million** net IPO proceeds are being used as described in the prospectus with no material changes - The company received net proceeds of approximately **$92.0 million** from its IPO in September/October 2020[413](index=413&type=chunk) - There has been no material change in the planned use of proceeds from the IPO as described in the prospectus[414](index=414&type=chunk)

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 ...

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, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to | --- | --- | --- | |---------------------------------------------------------------------------------------|------------------------------------------ ...