Graybug Vision Announces First Quarter 2021 Financial Results and Recent Corporate Developments
May 12 2021 - 7:30AM
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) 487-2409 |
Media
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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