GRAY

GRAY US Stock
$5.13
Open: $4.92 High: $5.44 Low: $4.88 Close: $5.12
Range: 2021-06-23 - 2021-06-24
Volume: 2,155,505
Market: Open
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GRAY
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  • Is the Options Market Predicting a Spike in Graybug Vision (GRAY) Stock?

    Investors need to pay close attention to Graybug Vision (GRAY) stock based on the movements in the options market lately.

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  • Is Graybug Vision, Inc. (GRAY) A Good Stock To Buy?

    Last year we predicted the arrival of the first US recession since 2009 and we told in advance that the market will decline by at least 20% in (Recession is Imminent: We Need A Travel Ban NOW). In these volatile markets we scrutinize hedge fund filings to get a reading on which direction each stock […]

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  • 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.

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  • 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

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  • 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

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  • Graybug Vision to Report Full-Data Analysis of the 12-month Treatment Phase of its Phase 2b ALTISSIMO Trial

    REDWOOD CITY, Calif., May 05, 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 announced it will host a conference call and webcast to discuss the full-data analysis of the 12-month treatment phase of its Phase 2b ALTISSIMO trial on Wednesday, May 12, 2021 at 8 a.m. Eastern time (5 a.m. Pacific time). The event will be available live 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 results of the Phase 2b ALTISSIMO trial, the company’s clinical pipeline, interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, 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, and the timing 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 most recent annual and quarterly reports, 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

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  • Clear Channel Outdoor, Babcock & Wilcox See Activist Action

    Ares Management lifted its stake in outdoor-advertising firm Clear Channel Outdoor. Vintage Capital essentially exited a position in energy-services firm Babcock & Wilcox.

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  • Is Graybug Vision Stock a Buy Right Now? This Is What You Need to Know

    Stocks go up, stocks go down, you can't explain that… Or maybe you can, if the stock happens to be a biotech that just flunked a clinical trial. Which leads us nicely to Graybug Vision (GRAY). Or not so nicely if you happen to be an investor. Shares cratered by a dispiriting 51% yesterday after the eye disease drug maker released preliminary data from the Phase 2b ALTISSIMO trial of GB-102 - the company’s twice-yearly intravitreal injection of sunitinib - and candidate for the treatment of wet age-related macular degeneration (wet AMD). Investors were let down by a different set of data, which showed that the Best-corrected visual acuity (BCVA) of the 1mg GB-102 arm, came in 9 letters below the control arm of Eylea, Regeneron’s competing product. On the plus side, after participants took 1mg of GB-102, the treatment displayed promising duration data with approximately 48% of patients staying treatment-free for over 6 months. Additionally, 62% of patients did not need any treatment for at least 4 months or more, with an overall median duration of 5 months. GB-102’s safety profile was favorable, too. Despite being a secondary endpoint in the Phase 2b trial, BCVA is a major primary endpoint for registrational Phase 3 studies in wet AMD, and therefore, a potential key element in the treatment’s overall success. Given that GB-102 showed very stable BCVA in the previous Phase 1/2 studies, Leerink analyst Marc Goodman considers the result a “negative surprise.” “Management doesn’t have a good explanation for this result and will need to investigate this unexpected outcome further, but we are not surprised that the stock is off significantly, as investors are also clearly disappointed by the vision results,” Goodman said. “While we look forward to seeing additional granular data from the ALTISSIMO trial before making any changes to the numbers, we are lowering our POS [probability of success] today from 50% to 25%.” The disappointing data also results in a cut to Goodman’s price target, which is reduced from $45 to $23. Despite the severe haircut, the figure still represents possible upside of a hefty 210%. To this end, Goodman’s rating stays an Outperform (i.e. Buy). (To watch Goodman’s track record, click here) Since the data was published, other Street analysts have been less forgiving, with several downgrading the stock’s rating. Nevertheless, based on 3 Buys and 2 Holds, the stock still boasts a Moderate Buy consensus rating, backed by a bullish $19.60 average price target. Gains of ~165% could be in the cards, should the target be met over the next 12 months. (See GRAY stock analysis on TipRanks) To find good ideas for healthcare stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights. Disclaimer: The opinions expressed in this article are solely those of the featured analyst. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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  • Why Is Graybug Vision Stock Plunging Today?

    Graybug Vision Inc (NASDAQ: GRAY) shares are dropping after preliminary data from Phase 2b ALTISSIMO trial of GB-102 for wet age-related macular degeneration (wet AMD). Investors are reacting to the mean change of best-corrected visual acuity (BCVA) from the baseline that was lower in GB-102 1mg than aflibercept arm. The mean change from baseline for BCVA for all 20 completers was approximately nine letters lower across all time points versus the study control arm. The study was designed to evaluate two separate doses of GB-102, 1mg, and 2mg, injected every six months compared with Regeneron Pharmaceuticals Inc's (NASDAQ: REGN) Eylea (aflibercept) injected every two months. After interim safety analysis, the 2mg dose was discontinued after the initial dose, and all patients were switched to 1mg for their second dose. The median time to first supportive therapy was five months for GB-102 1mg (primary endpoint of the study). Central subfield thickness of the retina in the GB-102 1mg arm was consistent with the study control arm. GB-102, the company's lead product candidate, is a microparticle depot formulation of sunitinib malate, injected intravitreally. Sunitinib is marketed as Sutent by Pfizer Inc (NYSE: PFE). Piper Sandler has downgraded GRAY to Neutral with a price target of $10 from $27 earlier. Price Action: GRAY shares fell 48.2% at $7.65 in market trading hours on the last check Tuesday. Latest Ratings for GRAY DateFirmActionFromTo Mar 2021SVB LeerinkMaintainsOutperform Mar 2021Piper SandlerDowngradesOverweightNeutral Dec 2020Cantor FitzgeraldInitiates Coverage OnOverweight View More Analyst Ratings for GRAY View the Latest Analyst Ratings See more from BenzingaClick here for options trades from BenzingaJ&J Facing Supply Issues, Shaky To Meet EU Q2 Vaccine Deliveries: ReutersFDA Ok's Roche's Companion Diagnostic For Pfizer's Lorbrena In Lung Cancer© 2021 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.

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  • Graybug Vision Reports Preliminary Topline Results from Phase 2b ALTISSIMO Trial

    Median time to first supportive therapy was 5 months for GB-102 1mg48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 monthsControl of retinal thickness was consistent across all trial arms Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept armNo drug-related serious adverse eventsClinical monitoring is ongoing to observe durability beyond 6 months REDWOOD CITY, Calif., March 09, 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 preliminary topline data 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 microparticle depot formulation of sunitinib malate injected 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 pharmacodynamics measures of mean change of best-corrected visual acuity (BCVA) from baseline and mean change of central subfield thickness (CST) of the retina from baseline. The trial was originally designed to evaluate two separate doses of GB-102, 1mg and 2mg, injected every 6 months as compared with aflibercept injected every 2 months. Based on the results of an interim safety analysis, the 2mg dose was discontinued after the initial dose, and all patients in that arm were switched to 1mg for their second dose. Analysis of the ALTISSIMO 1mg arm shows the primary endpoint of median time to first supportive therapy was 5 months. Furthermore, 48% of patients did not require supportive therapy for at least 6 months, and 62% of patients for at least 4 months or more, at least once during the trial. Overall, the 1mg dose performed better than the 2mg dose. Overall, GB-102 1mg was well-tolerated. There were no drug-related serious adverse events, and the majority of drug-related adverse events were mild to moderate. Medication was detected in the anterior chamber in less than 10% of GB-102 1mg injections, and no adverse event required surgical intervention. There was no vision-threatening inflammation observed, and there was no increase in intraocular pressure reported. CST and BCVA were measured as secondary endpoints. CST in the GB-102 1mg arm was consistent with the study control arm. The mean change from baseline for BCVA for all 20 completers was approximately 9 letters lower across all time points, on average, than that observed in the study control arm. At the end of the treatment phase, patients were surveyed as to their satisfaction with their treatment compared to their treatment prior to entering the trial. Over 80% of responding patients who had been treated with GB-102 reported that they were equally or more satisfied with their treatment, similar to the satisfaction expressed by patients treated with aflibercept. ALTISSIMO is continuing through a six-month extension in which 28 of the 50 patients who completed their Month 12 visit were eligible and agreed to continue masked clinical monitoring. Patients will continue with monthly visits until the point at which they require additional supportive therapy, up to a maximum of 6 months. As of today, 22 patients have successfully completed 2 months or more of this six-month extension period without the need for further treatment. Graybug will determine next steps after completing the full analysis of the ALTISSIMO results, which is anticipated to occur in the second quarter. “We are very grateful to all patients, investigators and staff who participated in the ALTISSIMO trial, and look forward to the read-out of the extension trial data,” said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug. 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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, interactions with regulatory authorities, its ability to advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, 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, and the timing 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

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  • Graybug Vision Announces Full Year 2020 Financial Results and Recent Corporate Developments

    REDWOOD CITY, Calif., March 04, 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 full year ended December 31, 2020. “We are very pleased with Graybug’s achievements in 2020. Amidst a challenging pandemic, we completed our initial public offering and advanced our lead product candidate GB-102 in retinal disease through the treatment phase of its Phase 2b ALTISSIMO trial in wet age-related macular degeneration (wet AMD). I am excited to share that we are now on track to report topline data from our ALTISSIMO trial by the end of this month,” said Frederic Guerard, PharmD, Chief Executive Officer of Graybug. Recent Corporate Developments Completion of 12-month treatment phase of ALTISSIMO trial in wet AMD — 50 patients out of the 56 initially enrolled completed the 12-month treatment phase of the three-arm, randomized, and masked trial of GB-102 in December 2020. Six patients did not complete the study for reasons unrelated to their treatments. Topline data for this 12-month treatment phase are expected to be announced in March 2021.Initiation of 6-month observational trial extension of ALTISSIMO — 28 of the 50 patients who completed their Month 12 visit were eligible and agreed to continue masked clinical monitoring until the point at which they require additional supportive therapy, up to a maximum of six months. As of today, 22 patients have successfully completed two months or more of this six-month extension period without the need for further treatment.Named Bettina Maunz as Chief People Officer — Ms. Maunz is building and leading the human resources function as a member of Graybug’s executive team and serves as Head of Communications. Anticipated Milestones in 2021 Communicate topline data for the 12-month treatment phase of ALTISSIMO in March 2021, with full results to be presented at a medical conference expected in 3Q 2021.Complete 6-month observational trial extension of ALTISSIMO by June 2021, with topline data expected in 3Q 2021.Initiate two pivotal Phase 3 trials for GB-102 in patients with wet AMD in the second half of 2021.Initiate Phase 2b trial for GB-102 in patients with diabetic macular edema (DME) in the second half of 2021.Submit Investigational New Drug (IND) application for GB-401, an injectable depot 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 second half of 2021.Commence a Phase 1 trial for GB-401 in the second half of 2021. Full Year 2020 Financial Results Net loss for 2020 was $27.5 million compared to $37.0 million for 2019. Net loss for 2020 included a non-cash gain of $2.2 million resulting from the modification and expiration of the liability related to the preferred stock tranche obligation that was permanently eliminated in connection with the company’s initial public offering, or IPO, in September 2020. Excluding this gain, the 2020 net loss would have been $29.7 million. Research and development expense for 2020 was $21.0 million compared to $30.6 million for 2019. The decrease in 2020 was primarily due to the fact that the company did not engage in any primary manufacturing activities in 2020 compared with 2019, during which the company manufactured the clinical supplies for the ALTISSIMO clinical trial that commenced later in the third quarter of 2019. General and administrative expense for 2020 was $8.9 million compared to $6.9 million for 2019. The increase in 2020 was primarily due to additional professional services, related in part to preparing for and becoming a public company, and the related increased cost of additional D&O insurance. As of December 31, 2020, the company’s cash, cash equivalents, and short-term investments totaled $95.0 million, compared to $36.0 million as of December 31, 2019. The increase was due to the receipt of $92.1 million in net proceeds from the company’s IPO. The company’s current cash and investments are sufficient to support its planned operations into the first quarter of 2022. 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, 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 cash positions, the company’s operations as a public company, the company’s management and board of directors, and the timing 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 quarterly report on Form 10-Q for the three months ended September 30, 2020, its annual report on Form 10-K to be 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)(2020 unaudited) Year Ended December 31, 2020 2019 Operating expenses: Research and development $20,962 $30,580 General and administrative 8,870 6,922 Total operating expenses 29,832 37,502 Loss from operations (29,832) (37,502)Interest income 143 393 Change in fair value of preferred stock tranche obligation 2,158 72 Net loss (27,531) (37,037)Cumulative dividends on convertible preferred stock (7,189) (7,055)Net loss attributable to common stockholders $(34,720) $(44,092)Net loss per common share—basic and diluted $(5.25) $(33.41)Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted 6,618,445 1,319,912 GRAYBUG VISION, INC.Condensed Balance Sheets(In thousands)(2020 unaudited) December 31, 2020 2019 Assets Current assets: Cash and cash equivalents $33,418 $15,870 Short-term investments 61,615 20,086 Prepaid expenses and other current assets 4,207 315 Total current assets 99,240 36,271 Property and equipment, net 1,946 1,975 Prepaid expenses and other non-current assets 608 2,414 Total assets $101,794 $40,660 Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit) Current liabilities: Accounts payable $2,513 $4,636 Accrued research and development 1,356 2,333 Other current liabilities 3,128 3,124 Preferred stock tranche obligation — 2,158 Total current liabilities 6,997 12,251 Deferred rent, long term portion 11 — Total liabilities 7,008 12,251 Commitments and contingencies Convertible preferred stock — 131,363 Stockholders’ Equity (Deficit): Preferred stock — — Common stock 2 — Additional paid-in capital 228,155 2,879 Accumulated deficit (133,367) (105,836)Accumulated other comprehensive (loss) income (4) 3 Total stockholders’ equity (deficit) 94,786 (102,954)Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $101,794 $40,660

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  • Graybug Vision to Participate in SVB Leerink Global Healthcare Conference

    REDWOOD CITY, Calif., Feb. 17, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat at the SVB Leerink 10th Annual Global Healthcare Conference on Wednesday, February 24, 2021 at 3:40 p.m. ET / 12:40 p.m. PT. A live webcast of the fireside chat will be available on 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 webcast, a replay will be available at the same location for 14 days. About Graybug Vision 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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. Investor ContactIR@graybug.vision(650) 487-2409Media Contactmedia@graybug.vision(404) 384-0067

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  • Graybug Vision Appoints Bettina Maunz as Chief People Officer, Expanding the Company’s Executive Team

    REDWOOD CITY, Calif., Feb. 01, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the appointment of Bettina Maunz as Chief People Officer. In addition to building and leading the human resources function for Graybug Vision, Ms. Maunz will serve as Head of Communications and be a member of the company’s executive team. “We are delighted for Bettina to join Graybug as Chief People Officer. Her leadership, culture and communications experience will be important assets to our team,” said Frederic Guerard, PharmD, Chief Executive Officer of Graybug Vision. “Her passion for building high-performing teams and driving employee engagement will be a strong contributor to our future success.” “I am excited to be joining Graybug as its first Chief People Officer,” stated Bettina Maunz. “I believe the company is at an inflection point and I look forward to partnering with the executive team in shaping Graybug’s culture as well as attracting and retaining the right talent to fully leverage Graybug’s potential.” Bettina has served as a consultant to Graybug since August 2019 and played an integral role in the planning and successful execution of the company’s IPO in September 2020. Prior to Graybug, Bettina held the position of VP, Group Head of Enterprise Communications at Novartis, where she led the development and implementation of the enterprise communications strategy with a focus on driving company-wide culture change in partnership with the executive team and human resources department. Prior to that, Bettina served as VP, Global Head of Communications at Alcon and was President of the Alcon Foundation. During her tenure, she established the Global Communications function, played a key role in the company’s culture and business transformation, as well as defined and executed Alcon’s corporate social responsibility strategy partnering with leading non-profit organizations to enhance access to quality eye care in developing markets as well as local communities. Bettina also served in leadership positions at CIBA Vision, Novartis Pharma and Serono International earlier in her career. About Graybug Vision 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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. Investor ContactIR@graybug.vision(650) 487-2409Media Contactmedia@graybug.vision(404) 384-0067

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  • Graybug Vision Completes Treatment Phase of ALTISSIMO Trial in Wet AMD with 12-Month Topline Data Expected in Second Quarter 2021

    REDWOOD CITY, Calif., Jan. 07, 2021 (GLOBE NEWSWIRE) -- Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage biopharmaceutical company focused on developing transformative medicines to treat chronic vision-threatening diseases of the retina and optic nerve, today announced the last patient visit in its GB-102 Phase 2b ALTISSIMO core trial (the 12-month treatment phase) in wet age-related macular degeneration (wet AMD). ALTISSIMO 12-month topline data are expected to be announced in the second quarter of 2021, with full results to be presented at a medical conference later in the year.Of the 56 patients enrolled in ALTISSIMO, 50 patients completed the 12-month treatment phase, while the remaining six patients withdrew for reasons unrelated to their treatment. Furthermore, 58 percent of patients who completed their Month 12 visit were eligible and agreed to continue clinical monitoring in a six-month extension of the trial. The goal of this six-month extension period is to observe further durability of GB-102 in wet AMD patients.“We are pleased with the completion of treatment in ALTISSIMO which is expected to provide important data regarding the duration of treatment, safety and tolerability of GB-102 in wet AMD,” said Parisa Zamiri, MD, PhD, Chief Medical Officer of Graybug Vision. “Wet AMD is a leading cause of vision loss among the elderly with outcomes adversely affected by the high treatment burden of approved medications which need to be injected up to 12 times per year. The findings of this trial, designed to measure the durability of a twice-per-year dosing, may potentially demonstrate the need for fewer treatments per year, and we look forward to sharing the topline results in the second quarter of 2021.”Graybug’s lead product candidate, GB-102, is a proprietary microparticle depot formulation of the pan-vascular endothelial growth factor (pan-VEGF) inhibitor, sunitinib malate, designed to be administered intravitreally twice per year. GB-102 seeks to reduce the need for frequent intravitreal injections by expanding treatment duration to six months, and potentially longer, thus reducing the burden of current anti-VEGF treatments which require up to 12 injections per year.About GB-102 Phase 2b Clinical Trial in Wet AMD (ALTISSIMO)ALTISSIMO comprises a 12-month, multicenter, prospective, masked, randomized trial comparing GB-102 administered every six months to aflibercept administered every two months in patients with anti-VEGF-responsive wet AMD, followed by an additional six-month observational period. The objective of the ALTISSIMO Phase 2b core trial is to assess the safety, tolerability, and pharmacodynamic profile of GB-102. The findings will inform the design of Graybug’s pivotal Phase 3 clinical trial program in wet AMD expected to initiate in the second half of 2021.About Wet AMDWet AMD is one of the most common retinal diseases, leading to vision decline caused by excess VEGF. VEGF is a protein produced by cells that stimulates the formation of abnormal new blood vessels behind the retina, called choroidal neovascularization. The leakage of fluid and protein from the vessels causes retinal degeneration and leads to severe and rapid loss of vision. Early intervention is essential to treat wet AMD. The prevalence of wet AMD in the United States is estimated at 1.5 million people and approximately 25 million people are affected by wet AMD worldwide.About Graybug VisionGraybug 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 StatementsThis 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 advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, its ability to achieve its anticipated milestones, including the completion of the ALTISSIMO trial, 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 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 quarterly report on Form 10-Q for the three months ended September 30, 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 Contact IR@graybug.vision (650) 487-2409 Media Contact media@graybug.vision (404) 384-0067

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  • Here's Why We're Not Too Worried About Graybug Vision's (NASDAQ:GRAY) Cash Burn Situation

    Even when a business is losing money, it's possible for shareholders to make money if they buy a good business at the...

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  • Is Graybug Vision (GRAY) A Good Stock To Buy Now?

    Before we spend countless hours researching a company, we like to analyze what insiders, hedge funds and billionaire investors think of the stock first. This is a necessary first step in our investment process because our research has shown that the elite investors’ consensus returns have been exceptional. In the following paragraphs, we find out […]

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  • Graybug Vision to Participate in the 32nd Annual Piper Sandler Healthcare Conference

    REDWOOD CITY, Calif., Nov. 16, 2020 (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 announced that Fred Guerard, PharmD, Chief Executive Officer of Graybug Vision, will participate in a fireside chat in advance of the virtual Piper Sandler Healthcare Conference, being held December 1-3, 2020.A recording of the fireside chat will be accessible beginning November 23, 2020 by visiting IR Events & Presentations in the Investors and Media section of the company’s website at https://investors.graybug.vision/news-events/events-presentations. The recording will be available on the Graybug website for 14 days following the conference.About Graybug VisionGraybug 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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.Investor Contact IR@graybug.vision (650) 487-2409 Media Contact media@graybug.vision (404) 384-0067

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  • Graybug Vision Announces Financial Results for the Three and Nine Months Ended September 30, 2020 and Recent Corporate Developments

    REDWOOD CITY, Calif., Nov. 12, 2020 (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 three and nine months ended September 30, 2020. “Graybug continues to make important progress in advancing its programs in retinal diseases and glaucoma. We have now completed our initial public offering, raising over $92 million in net proceeds, which provides us with significant financial strength to execute our business strategy,” said Frederic Guerard, PharmD, Chief Executive Officer of Graybug Vision. “We are particularly excited about our lead product candidate, GB-102, currently in Phase 2b clinical development, which seeks to reduce the current need for up to 12 intravitreal injections per year to two or, potentially, fewer treatments per year,” Fred concluded.Recent Corporate Developments * Successfully completed initial public offering — On September 24, 2020, Graybug priced its upsized IPO of 5,625,000 shares of common stock at a public offering price of $16.00 per share, following which the underwriters exercised their option to purchase an additional 843,750 shares, resulting in total gross proceeds of $103.5 million. * Completed GB-102 Phase 2a safety trial in macular edema — Final safety and tolerability results confirm the satisfactory safety profile of GB-102 1mg with no ocular serious adverse events or dose-limiting toxicity reported. * Named three new members to the Board of Directors — Graybug appointed Christina Ackermann, Eric Bjerkholt, and Julie Eastland to its Board of Directors in September 2020. Each new member brings deep expertise as leaders in health care and biotechnology, as well as significant strategic and operational experience, to the board. * Named Robert Breuil as Chief Financial Officer — In September 2020, Robert Breuil, joined Graybug. He brings over 20 years of experience in the biopharmaceutical and drug delivery sectors, as well as experience serving as the CFO of three public companies since 2003. * Leading ophthalmologists and retina experts joined Scientific Advisory Board — In August 2020, Graybug appointed a distinguished group of ophthalmic thought leaders to provide external scientific counsel on the company’s research and development programs aiming to address critical unmet medical needs in retinal diseases and glaucoma. Graybug’s Scientific Advisory Board members are David S. Boyer, M.D., Frederick L. Ferris III, M.D., Jeffrey S. Heier, M.D., Arshad M. Khanani, M.D., M.A., Carl D. Regillo, M.D., F.A.C.S., and Rishi P. Singh, M.D. Anticipated Milestones in 2021 * Complete GB-102 Phase 2b ALTISSIMO trial in patients with wet age-related macular degeneration (wet AMD), with topline data expected in the first half of 2021. * Initiate two pivotal GB-102 Phase 3 trials in patients with wet AMD in the second half of 2021. * Initiate GB-102 Phase 2b trial in patients with diabetic macular edema (DME) in the second half of 2021. * Submit Investigational New Drug (IND) application for GB-401, an injectable depot 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 second half of 2021.Financial Results for the Three Months Ended September 30, 2020As of September 30, 2020, Graybug’s cash and investments totaled $95.0 million, compared to $36.0 million as of December 31, 2019. The increase was due to the receipt of $79.5 million in net proceeds from Graybug’s IPO, completed in September 2020. In October 2020, the underwriters exercised their over-allotment option resulting in additional net proceeds of $12.6 million, resulting in total net proceeds from the offering of $92.1 million.Net loss for the quarter ended September 30, 2020 was $4.7 million compared to $10.2 million for the third quarter ended September 30, 2019. Net loss for the quarter ended September 30, 2020 included a non-cash gain of $2.1 million resulting from the modification and expiration of the liability related to the preferred stock tranche obligation that was permanently eliminated in connection with the IPO. Excluding this amount, our net loss would have been $6.8 million.        Research and development expense for the third quarter of 2020 was $4.8 million compared to $8.4 million for the third quarter of 2019. The higher level of expense in the third quarter of 2019 was primarily due to the manufacturing of clinical supplies for the ALTISSIMO clinical trial that commenced later in the third quarter of 2019.General and administrative expense for the third quarter of 2020 was $2.1 million compared to $2.0 million for the third quarter of 2019.Financial Results for the Nine Months Ended September 30, 2020Net loss for the nine months ended September 30, 2020 was $18.4 million, compared to $26.8 million for the same period in 2019. The decrease was primarily due to a $7.1 million decrease in research and development expense and the non-cash gain of $2.2 million resulting primarily from the modification and expiration of the liability related to the preferred stock tranche obligation, partially offset by a $0.8 million increase in general and administrative expense.Research and development expense for the nine months ended September 30, 2020 was $15.5 million, compared to $22.6 million for the same period in 2019. The was primarily due to the completion of manufacturing of all clinical supplies required for the commencement of our Phase 2b, or ALTISSIMO, trial for GB-102 during 2019. We did not engage in any primary manufacturing activities in the nine-month period ended September 30, 2020.General and administrative expenses for the nine months ended September 30, 2020 was $5.2 million, compared to $4.4 million for the same period in 2019. The increase was primarily due to additional professional services related in part to the preparation for our IPO.The change in fair value of preferred stock tranche obligation for the nine months ended September 30, 2020 relates to the fair value adjustments of $2.2 million primarily due to the $2.1 million gain recognized in connection with our IPO. In September 2020, the preferred stock tranche obligation expired upon the effectiveness of the registration statement for our IPO, resulting in a corresponding elimination of the associated liability.About GraybugGraybug 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 microparticle depot 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 is also using its proprietary technologies to develop GB-401, an injectable depot 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 StatementsThis 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 advance GB-102, GB-103, GB-401, or any future product candidate through clinical development, 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 cash positions, the company’s operations as a public company, the company’s management and board of directors, and the timing 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 quarterly report on Form 10-Q for the three months ended September 30, 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 Contact IR@graybug.vision (650) 487-2409 Media Contact media@graybug.vision (404) 384-0067    GRAYBUG VISION, INC. Condensed Statements of Operations (in thousands, except share and per share amounts) (Unaudited)  Three Months Ended  September 30,  Nine Months Ended September 30,    2020  2019  2020  2019  Operating expenses:                 Research and development $4,757  $8,403  $15,474  $22,570  General and administrative  2,064   1,962   5,183   4,404  Total operating expenses  6,821   10,365   20,657   26,974  Loss from operations  (6,821)  (10,365)  (20,657)  (26,974) Interest income 3  160  120  211  Change in fair value of preferred stock tranche obligation  2,102   —   2,158   —  Net loss  (4,716)  (10,205)  (18,379)  (26,763) Cumulative dividends on convertible preferred stock  (2,396)  (2,048)  (7,189)  (4,633) Net loss attributable to common stockholders $(7,112) $(12,253) $(25,568) $(31,396) Net loss per common share—basic and diluted $(2.52) $(9.30) $(13.74) $(24.10) Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted  2,818,349   1,317,497   1,861,229   1,302,687                    GRAYBUG VISION, INC. Condensed Balance Sheets (in thousands) (Unaudited)  September 30, 2020  December 31, 2019           Assets         Current assets:         Cash and cash equivalents $94,968  $15,870  Short-term investments  —   20,086  Prepaid expenses and other current assets  138   315  Total current assets  95,106   36,271  Property and equipment, net  1,788   1,975  Prepaid expenses and other non-current assets  1,491   2,414  Total assets $98,385  $40,660  Liabilities, Convertible Preferred Stock and Stockholders’ Equity (Deficit)         Current liabilities:         Accounts payable $4,562  $4,636  Accrued research and development  1,023   2,333  Other current liabilities  2,156   3,124  Preferred stock tranche obligation  —   2,158  Total current liabilities  7,741   12,251  Deferred rent, long term portion  10   —  Total liabilities  7,751   12,251  Commitments and contingencies         Convertible preferred stock  —   131,363  Stockholders’ Equity (Deficit):         Common stock  2   —  Additional paid-in capital  214,847   2,879  Accumulated deficit  (124,215)  (105,836) Accumulated other comprehensive income  —   3  Total stockholders’ equity (deficit)  90,634   (102,954) Total liabilities, convertible preferred stock and stockholders’ equity (deficit) $98,385  $40,660

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  • Needham: 3 Strong Value Stocks to Buy Now

    Sometimes, you must look under the hood to find out what brings together disparate stocks. What do an upwardly mobile tech company, a biotech that just held its IPO, and an aftermarket computer memory company have in common? Not too much, at first glance. But the analysts from Needham have spotted a common thread.These are all value stocks. That is, they all show significant upside from their current price point. Needham’s analysts see them fitting a classic value profile: a low cost now, for a stock that is primed to make strong gains in the mid- to long-term.We ran the three through TipRanks database to find out what makes each story compelling in its own way – and to find out why Needham sees 30% or more upside for all three.Smart Global Holdings (SGH)First up is Smart Global Holdings, a holding company whose subsidiaries inhabit the memory chip niche, manufacturing memory systems for desktop and laptop computers as well as smartphones. The company is involved in DRAM, Flash, and hybrid technologies, and grows through targeted acquisitions.The most recent of those acquisition was of Cree, a manufacturer of LED chips and components. The merger, completed last week, was worth $300 million, and brings Cree’s product line into Smart’s portfolio.SGH shows a divergence between share value and fiscal performance during the corona period. Revenues and earnings both gained in 1H20 – with modest growth at the top line and stronger growth in EPS – yet the shares have not regained traction since the mid-winter swoon. SGH stock is down 35% year-to-date.And that’s the value proposition. The company is selling cheap, and its recent acquisition offers the prospect of new profits going forward, at least according to Needham analyst Rajvindra Gill. “SGH has a history of acquisitions and with them comes a track record of improving gross margins for the acquired business units (a range of +400-570bps), and ultimately for the firm overall. The most recent acquisition should boost overall gross margins for SGH, in our view, considering the high starting point of the gross margin at Cree's LED unit," Gill noted. Gill gives the stock a $39 price target, suggesting a 59% upside and supporting his Buy rating. (To watch Gill’s track record, click here)The consensus view on SGH is a Strong Buy, based on 3 Buys and 1 Hold. Shares are selling for $24.56 and have an average price target of $36.25, indicating room for 47% upside growth in the next 12 months. (See SGH stock analysis on TipRanks)Cerence, Inc. (CRNC)Next on our list is Cerence, an AI development company with a strong presence in the automotive industry. Cerence is deeply involved in the creation of viable autonomous vehicle technology. The company’s tech builds the ‘brain’ of the system, letting the car learn from and respond to changing road and driving conditions, and putting together an interface to change the way drivers interact with their cars.While truly autonomous cars are still years away, several of Cerence’s technologies are already becoming commonplace. Voice recognition, for example, is already a feature in some models’ driver interfaces, and Cerence boasts that its tech is found in over 325 million cars on the road today.It’s a boast, but it’s reflected in both the share price and recent results. Cerence has showed stable revenues for the past four quarters, encompassing the ‘corona half’ that started this year. The top line held steady between $74 million and $86 million for the past year – and the highest and lowest values both came during the corona downturn. Earnings have shown a rising trend during this time.The share price is also on a strongly positive trend. CRNC is up 180% this year – nearly quadrupling its price over that period. It’s an impressive performance from this mid-cap software tech company.Analyst Rajvindra Gill, quoted above, is impressed enough to rate the stock a Buy along with an $82 price target. This figure implies a 30% upside from current levels. (To watch Gill’s track record, click here)In his comments, Gill says, “We view Cerence as the top beneficiary of the integration of AI-based voice assistants and vehicles in the near future. Our top-down market analysis shows over 60% penetration of cloud voice-based technologies (excluding pre-payments and legacy connected) over the next 3-5 years. We believe Cerence is a market share leader in voice AI, which represents an excellent opportunity for top-line expansion. Market leadership, the most comprehensive in-car and in-cloud solution for vehicle OEMs, good revenue visibility, the ability to layer ASPs, and a 5-year management plan to greatly improve operations after its spin-off from Nuance Communications, combine to make Cerence's shares attractive, in our view."Overall, CRNC shares get a Moderate Buy rating from the analyst consensus on Wall Street. The stock has 7 recent reviews, breaking down to 6 Buys and 1 Sell. The average price target here is $59.71, just below the current share price of $63.35. The stock’s recent appreciation has pushed it past the average target; the analysts will have to reevaluate their price targets here. (See CRNC stock analysis on TipRanks)Graybug Vision (GRAY)Last on Needham’s value list is Graybug, a biopharmaceutical firm conducting clinical-stage research on medications to treat chronic diseases of the retina and optic nerve. The company focuses on long-term treatments, with drugs to be administered no more than twice per year – and provide relief from vision loss due to age-related macular degeneration and diabetic macular edema. Graybug’s IPO in September was notably successful; the company started trading at $16 per share, above the $15 originally planned, and sold almost 1 million more shares than first announced. Biotech firms are famously mercurial as stock investments. They tend to run deep losses for long periods, as medical research is both expensive and impossible to short cut. The rewards, however, are real, as one popular drug, or a treatment that is perceived as essential, can bring in tremendous profits once it goes on the market. That’s the value Needham sees here.Starting coverage on this stock for Needham is analyst Serge Belanger, who says of GRAY, “Anti-VEGF therapies generate ~$12B in WW sales as the standard of care for retinal diseases despite 40%-50% of patients experiencing inadequate responses and a treatment burden that impacts patient compliance. We believe [the company's] GB-102 can disrupt the anti-VEGF market with a differentiated mechanism of action and longer-dosing intervals. Upcoming ph 2b trial data in 1H21 represent the most near-term value-driving catalyst.”In line with his outlook, Belanger rates the stock a Buy. His $30 price target represents an impressive 96% upside potential for the year ahead. (To watch Belanger’s track record, click here)Wall Street agrees that GRAY is a buying proposition. The stock has 6 recent reviews, and all are Buys, making the Strong Buy consensus rating unanimous. Shares are selling for $15.32, and the $32.50 average price target implies an upside of 115%. (See GRAY stock analysis on TipRanks)To find good ideas for stocks trading at attractive valuations, visit TipRanks’ Best Stocks to Buy, a newly launched tool that unites all of TipRanks’ equity insights.Disclaimer: The opinions expressed in this article are solely those of the featured analysts. The content is intended to be used for informational purposes only. It is very important to do your own analysis before making any investment.

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  • AffaMed Therapeutics Announces Merger with EverInsight Therapeutics and Appoints Dayao Zhao, M.D., Ph.D. as CEO

    Combined company led by Dr. Zhao creates robust and potentially first-in-class pipeline of drug candidates in growing ophthalmology and CNS marketsSHANGHAI, China, Oct. 14, 2020 (GLOBE NEWSWIRE) -- AffaMed Therapeutics (“AffaMed”), a biopharmaceutical company focused on developing and commercializing transformative therapeutics to address ophthalmologic and central nervous system (CNS) disorders with high unmet medical need for patients in Greater China and beyond, today announced a definitive merger agreement with biopharmaceutical company EverInsight Therapeutics (“EverInsight”). This merger brings together complementary businesses to expand AffaMed’s advanced portfolio of existing assets, adding EverInsight’s pipeline of innovative therapeutic candidates in CNS and ophthalmology and further strengthening the company’s global R&D capabilities. The combined company, which will retain the AffaMed Therapeutics name and the entity, will focus on the development of therapeutics for ophthalmologic and CNS disorders in Greater China and beyond. The two companies were both incubated by CBC Group (formerly known as C-Bridge Capital) and have established partnerships and licensing agreements with leading global biopharmaceutical companies.Dayao Zhao, M.D., Ph.D., has been appointed as Chief Executive Officer of the combined company and will also join the Board of Directors when the merger is complete. Wei Fu, Chief Executive Officer of CBC Group, will serve as the Chairman of the Board.“Under the leadership of Dr. Zhao alongside our high caliber management team with deep expertise in global biopharmaceutical development, AffaMed is poised to become the leading global company dedicated to therapeutics in ophthalmology, neurology and psychiatry based in China,” said Wei Fu. “We look forward to leveraging our combined R&D capabilities to advance this strong portfolio of therapeutic candidates as we work to create synergy and value for our shareholders.”“EverInsight brings with it a strong team and portfolio in neurological and psychiatric disorders, including its neurosteroid nasal spray, PH94B, which is moving into Phase 3 development for social anxiety disorder with licensing rights from VistaGen Therapeutics in Greater China, Korea, and Southeast Asia,” said Dr. Zhao. “With this significant merger, AffaMed is well on its way to leading the charge to efficiently bring innovation to patients in Greater China from the rest of the world, positioned as the partner of choice in ophthalmologic diseases and neurological and psychiatric disorders, all growing disease areas with high unmet medical need in the region.”Dr. Zhao brings to this role decades of biopharmaceutical leadership, having most recently served as CEO of EverInsight, and prior to that CEO of Eucure Pharmaceuticals, where he built a first-in-class clinical development team that implemented programs worldwide. From 2016 to 2019, Dr. Zhao was the General Manager of Pfizer’s China R&D Center overseeing 1,400 scientists located across Shanghai, Wuhan, and Beijing. He was also head of the Development China organization, which is responsible for all clinical development in China for the global markets. From 2011 to 2015, Dr. Zhao was the head of China R&D for Johnson and Johnson’s (JNJ) pharmaceutical division, and prior to JNJ, he was the Group Vice President at Genzyme, heading up its Japan-Asia Pacific R&D where he was responsible for Clinical Development, Pharmacovigilance, Medical Affairs and Regulatory Affairs. Prior to his position at Genzyme, Dr. Zhao had worked for more than 12 years in both discovery and clinical development at Pfizer Central Research and led the CNS clinical development team in North America at Novartis. Dr. Zhao received a Ph.D. from Harvard Medical School and M.D. degree from Peking University Medical School.AffaMed’s existing portfolio has strong presence in ophthalmology, including rights in China and Singapore for biosimilars referencing ranibizumab (Lucentis®), and aflibercept (Eylea®) from Samsung Bioepis. AffaMed also has the Greater China right of first negotiation and refusal for GB-102, an investigative twice-per-year intravitreal pan-VEGF inhibitor in Phase 2b development for the treatment of wet age-related macular degeneration, by Graybug Vision (NASDAQ: GRAY).In early October, AffaMed entered into an exclusive licensing agreement with Kissei Pharmaceutical Co., Ltd. to develop and commercialize KDT-3594, an agent for Parkinson's Disease, in Greater China and Southeast Asia. After the merger, the combined company will continue to in-license late stage assets to augment its portfolio in ophthalmology, and neurological and psychiatric disorders.About AffaMed Therapeutics AffaMed Therapeutics is a biopharmaceutical company focused on developing and commercializing transformative pharmaceutical products that address critical unmet medical needs in ophthalmology, and neurological and psychiatric disorders for patients in Greater China and around the world. The management team of AffaMed Therapeutics has deep industry expertise and an extensive track record of high-quality clinical development, regulatory affairs, CMC, business development and operations both in China and with leading global pharmaceutical companies. AffaMed Therapeutics was founded and funded by the CBC Group in 2019.About EverInsight TherapeuticsEverInsight Therapeutics is a biopharmaceutical company focused on the development and commercialization of innovative drugs in ophthalmology, and neurological and psychiatric disorders in Greater China and globally. EverInsight was founded and funded by CBC Group in 2019.About CBC GroupCBC Group (formerly C-Bridge Capital) is one of the largest and most active healthcare-dedicated investment firms in Asia focused on platform-building and buyout opportunities across three core areas within the healthcare sector: pharmaceutical & biotech, medtech and healthcare services. CBC's operationally intensive approach empowers healthcare sector champions to make transformative changes to enable sustainable long-term growth, fulfill unmet medical needs and continuously improve the standard of living and quality of care in China and the rest of Asia. Founded in 2014, CBC has a strong team of investment, healthcare and portfolio management professionals based across Singapore, Shanghai, Beijing, Hong Kong and New York.The CBC Group team comprises of a group of talented professionals including seasoned investors, senior executives and professionals from the healthcare industry, as well as professional legal, financial and other operational support. As entrepreneurs who empower other entrepreneurs, CBC Group aims to achieve shared growth and alignment with portfolio companies through its differentiated portfolio management model, which includes assisting with operations management, alternative financing channels, team building, strategy formulation and business expansion. For more information, please visit www.cbridgecap.com.Media Contacts Media in US and Europe: Darcie Robinson Westwicke, an ICR company (203) 919-7905 darcie.robinson@icrinc.com Media in China: Edmond Lococo ICR Asia +86 138-1079-1408 edmond.lococo@icrinc.com

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