Graybug Vision Announces Financial Results for the Three and Six Months Ended June 30, 2021, and Recent Corporate Developments
August 11 2021 - 4:05PM
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
$7.7 million, compared to $5.9 million for the same period in
2020.
Research and development expense for the quarter
ended June 30, 2021 was $4.2 million, compared to $4.6 million for
the same period in 2020. The decrease was primarily due to a
reduction in clinical trial expenses due to the completion of the
treatment phase of the GB-102 Phase 2b clinical trial in December
2020, offset in part by an increase in compensation costs.
General and administrative expense for the quarter
ended June 30, 2021 was $3.6 million, compared to $1.4 million for
the same period in 2020. The increase in 2021 was primarily due to
a $0.8 million increase in stock-based compensation, a $0.6 million
increase in the cost of directors and officers insurance as a
result of becoming a public company, and an increase in
headcount.
Financial Results for the Six Months Ended
June 30, 2021
Net loss for the six months June 30, 2021 was $19.2
million, compared to $13.7 million for the same period in 2020.
Research and development expense for the six months
ended June 30, 2021 was $10.6 million, compared to $10.7 million
for the same period in 2020. While there was little overall change
in research and development expenses, clinical trial expenses
decreased in 2021 due to the completion of the treatment phase of
the GB-102 Phase 2b clinical trial in December 2020, which was
largely offset by fees incurred upon the cancellation of clinical
supply orders for the GB-102 Phase 3 clinical trial and an increase
in compensation costs.
General and administrative expense for the six
months ended June 30, 2021 was $8.6 million, compared to $3.1
million for the same period in 2020. The increase in 2021 was
primarily due to a $1.5 million increase in stock-based
compensation, a $1.3 million increase in the cost of directors and
officers insurance as a result of becoming a public company, a $1.3
million write-off of deposits on fixed assets purchase commitments,
and an increase in headcount.
As of June 30, 2021, the company’s cash and cash
equivalents, and short-term and long-term investments totaled $78.2
million. Management believes the company’s current cash and
investments are sufficient to support its currently planned
operations into 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 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 |
|
|
|
|
|
|
|
|
|
|
Graybug Vision (NASDAQ:GRAY)
Historical Stock Chart
From Mar 2024 to Apr 2024
Graybug Vision (NASDAQ:GRAY)
Historical Stock Chart
From Apr 2023 to Apr 2024