GRAY Graybug Vision Inc.
Upcoming Catalysts
| Drug | Stage | Catalyst Date |
|---|---|---|
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GB-102 (ALTISSIMO)
Wet age-related macular degeneration
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Phase 2b
Phase 2b
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|
Drug Pipeline
| Drug | Stage | Notes |
|---|---|---|
|
GB-102
Diabetic macular edema (DME)
|
Phase 2b
Phase 2b
|
Phase 2b trial to be initiated 2H 2021.
|
|
GB-102
Wet age-related macular degeneration (AMD)
|
Phase 3
Phase 3
|
Phase 3 trials to be initiated 2H 2021.
|
Latest News
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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 Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067
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- Median time to first supportive therapy was 5 months for GB-102 1mg
- 48% of patients in the GB-102 1 mg arm were rescue-free for at least 6 months
- Control of retinal thickness was consistent across all trial arms
- Mean best-corrected visual acuity with GB-102 1mg trended lower than aflibercept arm
- No drug-related serious adverse events
- Clinical 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 Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067 - Median time to first supportive therapy was 5 months for GB-102 1mg
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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 Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(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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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 Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067 -
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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 Contact
[email protected]
(650) 487-2409Media Contact
[email protected]
(404) 384-0067