Graybug Vision Announces Financial Results for the Three and Six Months Ended June 30, 2021, and Recent Corporate Developments
Graybug Vision, Inc. (Nasdaq: GRAY) reported its financial results for the quarter and six months ending June 30, 2021. The company incurred a net loss of $7.7 million for the quarter and $19.2 million for the six-month period, showing increases from $5.9 million and $13.7 million respectively in 2020. Research and development expenses decreased slightly at $10.6 million, while general and administrative expenses rose to $8.6 million, primarily due to increased stock-based compensation and insurance costs. The company’s cash position stands at $78.2 million, projected to fund operations into 2023.
- 60% of GB-102 1 mg patients required no supportive therapy during the six-month extension period of ALTISSIMO Phase 2b trial.
- Current cash and investments of $78.2 million are sufficient to support operations into 2023.
- Net loss increased to $7.7 million in Q2 2021 from $5.9 million in Q2 2020.
- General and administrative expenses rose significantly to $8.6 million from $3.1 million in the same period in 2020.
REDWOOD CITY, Calif., Aug. 11, 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 three and six months ended June 30, 2021.
Recent Corporate Developments
- Completed six-month extended observation period of ALTISSIMO Phase 2b trial in wet AMD— 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 required additional supportive therapy, up to a maximum of six months. 25 of those patients completed their first visit at Month 13. In June 2021, the last patient exited the extension period, with
60% of GB-102 1 mg patients requiring no supportive therapy during the six-month extension period. - Seeking partner for funding of additional wet AMD clinical trials— Enhanced formulations of GB-102 are being developed to further reduce or eliminate microparticle dispersion, and pre-clinical development is progressing in parallel.
- Pursuing expansion of pipeline with focus on early-stage novel therapeutics addressing unmet needs— In-licensing efforts targeted at capital-efficient development opportunities are expected to both leverage and expand current platform technologies.
Anticipated Milestones
- Provide topline data analysis of ALTISSIMO six-month extended observation period in September 2021.
- Present 12-month ALTISSIMO Phase 2b clinical trial data at the American Academy of Ophthalmology (AAO) meeting, November 12-15, 2021.
Financial Results for the Three Months Ended June 30, 2021
Net loss for the quarter ended June 30, 2021 was
Research and development expense for the quarter ended June 30, 2021 was
General and administrative expense for the quarter ended June 30, 2021 was
Financial Results for the Six Months Ended June 30, 2021
Net loss for the six months June 30, 2021 was
Research and development expense for the six months ended June 30, 2021 was
General and administrative expense for the six months ended June 30, 2021 was
As of June 30, 2021, the company’s cash and cash equivalents, and short-term and long-term investments totaled
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 timely identify a partner to fund further development of GB-102 for wet AMD on reasonable terms if at all, its ability to successfully execute one or more other licensing arrangements, 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 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, in its subsequent quarterly reports on Form 10-Q, and in 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 | Media Contact |
| IR@graybug.vision | media@graybug.vision |
| (650) 487-2409 | (404) 384-0067 |
GRAYBUG VISION, INC.
Condensed Statements of Operations
(In thousands, except share and per share amounts)
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2021 | 2020 | 2021 | 2020 | |||||||||||||
| Operating expenses: | ||||||||||||||||
| Research and development | $ | 4,166 | $ | 4,632 | $ | 10,614 | $ | 10,717 | ||||||||
| General and administrative | 3,575 | 1,408 | 8,615 | 3,119 | ||||||||||||
| Total operating expenses | 7,741 | 6,040 | 19,229 | 13,836 | ||||||||||||
| Loss from operations | (7,741 | ) | (6,040 | ) | (19,229 | ) | (13,836 | ) | ||||||||
| Interest income | 33 | 9 | 72 | 117 | ||||||||||||
| Change in fair value of preferred stock tranche obligation | — | 162 | — | 56 | ||||||||||||
| Net loss | (7,708 | ) | (5,869 | ) | (19,157 | ) | (13,663 | ) | ||||||||
| Cumulative dividends on convertible preferred stock | — | (3,494 | ) | — | (4,793 | ) | ||||||||||
| Net loss attributable to common stockholders | $ | (7,708 | ) | $ | (9,363 | ) | $ | (19,157 | ) | $ | (18,456 | ) | ||||
| Net loss per common share—basic and diluted | $ | (0.36 | ) | $ | (6.79 | ) | $ | (0.91 | ) | $ | (13.40 | ) | ||||
| Weighted-average number of shares outstanding used in computing net loss per common share—basic and diluted | 21,148,743 | 1,379,644 | 21,084,915 | 1,377,431 | ||||||||||||
GRAYBUG VISION, INC.
Condensed Balance Sheets
(In thousands)
| June 30, 2021 | December 31, 2020 (audited) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents | $ | 7,864 | $ | 33,418 | ||||
| Short-term investments | 65,722 | 61,615 | ||||||
| Prepaid expenses and other current assets | 2,465 | 4,207 | ||||||
| Total current assets | 76,051 | 99,240 | ||||||
| Property and equipment, net | 2,006 | 1,946 | ||||||
| Prepaid expenses and other non-current assets | 136 | 608 | ||||||
| Long-term investments | 4,628 | — | ||||||
| Total assets | $ | 82,821 | $ | 101,794 | ||||
| Liabilities and Stockholders’ Equity | ||||||||
| Current liabilities: | ||||||||
| Accounts payable | $ | 2,101 | $ | 2,513 | ||||
| Accrued research and development | 396 | 1,356 | ||||||
| Other current liabilities | 1,644 | 3,128 | ||||||
| Total current liabilities | 4,141 | 6,997 | ||||||
| Deferred rent, long term portion | 13 | 11 | ||||||
| Total liabilities | 4,154 | 7,008 | ||||||
| Commitments and contingencies | ||||||||
| Stockholders’ Equity: | ||||||||
| Preferred stock | — | — | ||||||
| Common stock | 2 | 2 | ||||||
| Additional paid-in capital | 231,183 | 228,155 | ||||||
| Accumulated deficit | (152,524 | ) | (133,367 | ) | ||||
| Accumulated other comprehensive loss | 6 | (4 | ) | |||||
| Total stockholders’ equity | 78,667 | 94,786 | ||||||
| Total liabilities and stockholders’ equity | $ | 82,821 | $ | 101,794 | ||||
FAQ
What were the financial results for Graybug Vision for Q2 2021?
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What is the expected timeline for data analysis from the ALTISSIMO trial?
What are the increases in general and administrative expenses reported by Graybug Vision?
What were the results of the GB-102 Phase 2b trial?
