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Graybug Vision, Inc. (GRAY)

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Previous Close5.53
Open6.57
Bid5.68 x 1300
Ask5.70 x 900
Day's Range5.00 - 6.97
52 Week Range3.43 - 37.88
Volume24,035,494
Avg. Volume1,522,534
Market Cap123.598M
Beta (5Y Monthly)N/A
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Earnings DateMar 04, 2021
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1y Target Est4.75
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  • Graybug Vision Reports Full Data Analysis After One Year Treatment Of GB-102 In Wet AMD
    Benzinga

    Graybug Vision Reports Full Data Analysis After One Year Treatment Of GB-102 In Wet AMD

    Graybug Vision Inc (NASDAQ: GRAY) has provided full-data analysis from the 12-month treatment Phase of its Phase 2b ALTISSIMO trial evaluating GB-102 to treat wet age-related macular degeneration (wet AMD). GB-102 is a proprietary formulation of sunitinib malate injected twice a year intravitreally. The ALTISSIMO full-data analysis focused on the GB-102 1mg arm compared to aflibercept and the pre-enrollment period, excluding results from the GB-102 2mg arm. Overall, GB-102 1mg was safe and well-tolerated. No drug-related serious adverse events or vision-threatening inflammation were reported. The majority of drug-related adverse events were mild to moderate. The particle migration to the anterior chamber in patients treated with GB-102 1mg was reduced by 79% compared to GB-102 1mg patients in the ADAGIO Phase 1/2a trial (4/51 injections vs. 3/8), and no surgical interventions were required. As previously reported, patients in the GB-102 1mg trial arm (n=21) had a median time to first supportive therapy of five months, and 48% of patients did not require supportive treatment for at least six months. An additional analysis showed the injection frequency was reduced by 58% compared to patients' treatment before enrollment in the trial. The company is also working on a GB-401 implant program for glaucoma that will enter a Phase 1 trial in the first half of 2022. Graybug expects to report the results from the ongoing six-month extension period of ALTISSIMO by the end of this year. The company also said it would pause developing GB-103 and GB-102 for diabetic macular edema and utilize the cash to advancing GB-401 through Phase 1 clinical development. The company's management will host a webcast and conference call at 8 a.m. ET today to discuss the ALTISSIMO clinical results. Price Action: GRAY shares are trading 7.4% lower at $4.38 on the last check Wednesday. See more from BenzingaClick here for options trades from BenzingaVeru's FC2 Prescription Sales Boost Q2 RevenuesModerna Inks 25M COVID-19 Shots Supply Pact With Australia© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

  • Graybug Vision Announces First Quarter 2021 Financial Results and Recent Corporate Developments
    GlobeNewswire

    Graybug Vision Announces First Quarter 2021 Financial Results and Recent Corporate Developments

    REDWOOD CITY, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided an update on recent corporate developments and reported financial results for the quarter ended March 31, 2021. Recent Corporate Developments Full-data analysis from 12-month treatment phase of ALTISSIMO Phase 2b trial in wet AMD— GB-102 1mg has shown competitive durability and anatomical control versus aflibercept; trend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patients.Six-month observational trial extension of ALTISSIMO still underway— 14 of 28 patients enrolled have completed at least five months of the extension period without requiring additional supportive therapy, with six of those having completed all six months. Seeking partner for funding of additional wet AMD clinical trials— Enhanced formulations of GB-102 being developed and preclinical work progressing in parallel.Clinical focus shifting to advancement of GB-401 implant for glaucoma— Disclosed development of implant technology for GB-401 with potential application to GB-102. Anticipated Milestones Complete six-month observational trial extension of ALTISSIMO by June 2021, with topline data expected in 3Q 2021.Expected to present full results of ALTISSIMO trial at a medical conference in 4Q 2021.Submit Investigational New Drug (IND) application for GB-401, an injectable formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, in the first half of 2022.Commence a Phase 1 trial for GB-401 implant in glaucoma in the first half of 2022. First Quarter 2021 Financial Results Net loss for the quarter ended March 31, 2021 was $11.4 million compared to $7.8 million for the same period in 2020. Research and development expense for the quarter ended March 31, 2021 was $6.4 million compared to $6.1 million for the same period in 2020. The increase was primarily due to fees incurred upon the cancellation of clinical supply orders for the GB-102 Phase 3 trial and increased compensation costs, offset in part by a reduction in clinical trial expenses due to the completion of the treatment phase of the ALTISSIMO trial in December 2020. General and administrative expense for the quarter ended March 31, 2021 was $5.0 million compared to $1.7 million for the same period in 2020. The increase in 2021 was primarily due to the write-off of deposits on fixed assets purchase commitments, an increase in stock-based compensation and an increase in headcount, and the increased cost of additional directors and officers insurance as a result of becoming a public company. As of March 31, 2021, the company’s cash, cash equivalents, and short-term investments totaled $85.7 million, compared to $95.0 million as of December 31, 2020. The decrease was primarily due to the loss from operations of $11.5 million. The company’s current cash and investments are sufficient to support its currently planned operations into the first half of 2023. About Graybug Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug’s other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained-release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 including, but not limited to, statements regarding the company’s clinical pipeline, its ability to identify a partner to advance the development of GB-102 for wet AMD, the timing or outcomes of its interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through preclinical or clinical development, its ability to timely secure a partner to fund further development of GB-102 on reasonable terms if at all, its ability to achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, the company’s operating results and use of cash, the company’s operations as a public company, the company’s management and board of directors, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading “Risk Factors” in the company’s annual report on Form 10-K filed for the year ended December 31, 2020, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor ContactIR@graybug.vision(650) 487-2409Media Contactmedia@graybug.vision(404) 384-0067 GRAYBUG VISION, INC.Condensed Statements of Operations(In thousands, except share and per share amounts; unaudited) Three Months Ended March 31, 2021 2020 Operating expenses: 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) Interest income 39 108 Change in fair value of preferred stock tranche obligation — (106) Net loss (11,449) (7,794) Cumulative dividends on convertible preferred stock — (1,299) Net loss attributable to common stockholders $(11,449) $(9,093) Net loss per common share—basic and diluted $(0.54) $(6.61) Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted 21,020,378 1,375,177 GRAYBUG VISION, INC.Condensed Balance Sheets(In thousands) March 31, December 31, 2021 2020 (unaudited) (audited) Assets Current assets: Cash and cash equivalents$10,589 $33,418 Short-term investments 75,099 61,615 Prepaid expenses and other current assets 3,133 4,207 Total current assets 88,821 99,240 Property and equipment, net 2,002 1,946 Prepaid expenses and other non-current assets 29 608 Total assets$90,852 $101,794 Liabilities, Convertible Preferred Stock and Stockholders’ Equity Current liabilities: Accounts payable$1,956 $2,513 Accrued research and development 2,097 1,356 Other current liabilities 2,225 3,128 Total current liabilities 6,278 6,997 Deferred rent, long term portion 12 11 Total liabilities 6,290 7,008 Commitments and contingencies Convertible preferred stock Stockholders’ Equity: Preferred stock — — Common stock 2 2 Additional paid-in capital 229,376 228,155 Accumulated deficit (144,816) (133,367) Accumulated other comprehensive loss — (4) Total stockholders’ equity 84,562 94,786 Total liabilities, convertible preferred stock and stockholders’ equity$90,852 $101,794

  • Graybug Vision Reports Full-Data Analysis from 12-Month Treatment Phase of ALTISSIMO Phase 2b Trial in Wet AMD
    GlobeNewswire

    Graybug Vision Reports Full-Data Analysis from 12-Month Treatment Phase of ALTISSIMO Phase 2b Trial in Wet AMD

    GB-102 1mg has shown competitive durability and anatomical control versus afliberceptTrend in mean BCVA of GB-102 1mg compared to aflibercept driven primarily by a subgroup of patientsDeveloping enhanced formulations and seeking partner funding for additional clinical trials of GB-102 Focus on advancing GB-401 implant for glaucoma Current cash sufficient to support planned operations into 2023 Management to host webcast/conference call today at 8 a.m. ET REDWOOD CITY, Calif., May 12, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve, today provided full-data analysis from the 12-month treatment phase of its Phase 2b ALTISSIMO trial of GB-102 for the treatment of wet age-related macular degeneration (wet AMD), Graybug’s proprietary formulation of sunitinib malate injected twice-a-year intravitreally. The ALTISSIMO trial is a masked and controlled Phase 2b dose-ranging study of two doses of GB-102 with a single control arm of patients on aflibercept, conducted across 33 study sites in the United States. The primary endpoint is median time to first supportive therapy with a vascular endothelial growth factor (VEGF) inhibitor, and secondary endpoints are safety and pharmacodynamics, measured as mean change of best-corrected visual acuity (BCVA) and mean change of central subfield thickness (CST) of the retina. The ALTISSIMO full-data analysis focused on the GB-102 1mg arm as compared to aflibercept and the pre-enrollment period, excluding results from the GB-102 2mg arm. As previously reported, the development of GB-102 2mg was terminated in 2020 following an interim safety analysis. The trial was not powered to assess non-inferiority to aflibercept. Overall, GB-102 1mg was safe and well-tolerated. No drug-related serious adverse events or vision-threatening inflammation were reported. The majority of drug-related adverse events were mild to moderate. Particle migration to the anterior chamber in patients treated with GB-102 1mg was reduced by 79% as compared to GB-102 1mg patients in the ADAGIO Phase 1/2a trial (4/51 injections vs. 3/8), and no surgical interventions were required. As previously reported, patients in the GB-102 1mg trial arm (n=21) had a median time to first supportive therapy of five months, and 48% of patients did not require supportive therapy for at least six months. An additional analysis showed the injection frequency was reduced by 58% compared to patients’ treatment prior to enrollment in the trial. “Given the constantly changing landscape of long-acting drug delivery, GB-102 has the potential to significantly reduce the treatment burden for patients compared to the current standard of care,” said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug. “The ALTISSIMO results support further exploration of enhanced formulations of GB-102 for the treatment of wet AMD.” Although ALTISSIMO was not powered to show statistical significance, control of CST in patients treated with twice-a-year GB-102 1mg compared with baseline was similar to bi-monthly aflibercept, while BCVA trended lower in GB-102 1mg patients as compared with aflibercept. This trend in visual acuity was primarily driven by six patients: two patients whose disease was not well-controlled despite frequent anti-VEGF treatment prior to enrollment, two patients who experienced adverse events unrelated to GB-102, and two patients who experienced adverse events related to dispersion of GB-102 microparticles. Over the past 18 months, Graybug continued to optimize its technology platform and initiated the development of additional formulations, which have the potential to preserve the durability of GB-102 microparticles while minimizing the risk of dispersion. These new and enhanced formulations, including injectable implants, also have the potential to simplify the drug reconstitution process as well as minimize the injection technique variability. They have already been incorporated into the development programs of both GB-102 and GB-401. Graybug anticipates that its GB-401 implant program for glaucoma will enter a Phase 1 trial in the first half of 2022. “We are encouraged by the ALTISSIMO full-data analysis that indicates favorable safety, extended durability, and pharmacodynamics of GB-102, and are in the process of designing an additional trial in wet AMD with enhanced formulations of GB-102 while looking for a partner to fund its further clinical development,” said Fred Guerard, PharmD, Chief Executive Officer, Graybug Vision. “We will pause development of GB-103 and GB-102 for diabetic macular edema while we devote our current cash to advancing GB-401 through Phase 1 clinical development. Our opportunistic in-licensing efforts will continue targeting technologies addressing high unmet medical needs in ophthalmology.” Graybug expects to report the results from the on-going six-month extension period of ALTISSIMO in the fourth quarter of 2021. Conference Call and Webcast Graybug’s management will host a webcast and conference call at 8 a.m. ET / 5 a.m. PT today, May 12, 2021, to discuss the ALTISSIMO clinical results. The live call may be accessed by dialing (844) 955-2748 (domestic) and (929) 517-0407 (international) and entering the conference ID# 5461708 or via webcast from the IR Events & Presentations page of the Investors and Media section of Graybug’s website at https://investors.graybug.vision/news-events/events-presentations. Following the live event, a replay will be available at the same location. About Graybug Graybug is a clinical-stage biopharmaceutical company focused on developing transformative medicines for the treatment of diseases of the retina and optic nerve. The company’s proprietary ocular delivery technologies are designed to maintain effective drug levels in ocular tissue for six months and potentially longer, improving disease management, reducing healthcare burdens and ultimately delivering better clinical outcomes. Graybug’s lead product candidate, GB-102, a formulation of the pan-vascular endothelial growth factor (VEGF) inhibitor, sunitinib malate targeting a six-month or longer dosing regimen, inhibits multiple neovascular pathways for the intravitreal treatment of retinal diseases, including wet age-related macular degeneration. Graybug’s other product candidates developed using its proprietary technologies also include GB-401, an injectable sustained release formulation of a beta-adrenergic blocker prodrug, for primary open-angle glaucoma, with a dosing regimen of once every six months or longer, and GB-103, a longer-acting version of GB-102, designed to maintain therapeutic drug levels in the retinal tissue for 12 months with a single injection. Founded in 2011 on the basis of technology licensed from the Johns Hopkins University School of Medicine, Graybug is headquartered in Redwood City, California. For more information, please visit www.graybug.vision. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to statements regarding the company’s clinical pipeline, its ability to identify a partner to advance the development of GB-102 for wet AMD, the timing or outcomes of its interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through preclinical or clinical development, its ability to timely secure a partner to fund further development of GB-102 on reasonable terms if at all, achieve its anticipated milestones within the timing outlined above or at all, its ability to conduct planned operations within the evolving constraints arising from the COVID-19 pandemic, and the timing, cost, and results of its clinical trials. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties described under the heading “Risk Factors” in the company’s annual report on Form 10-K for the year ended December 31, 2020, and the other reports the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof. Investor ContactIR@graybug.vision(650) 487-2409Media Contactmedia@graybug.vision(404) 384-0067