Graybug Vision Announces Financial Results for the Three and Nine Months Ended September 30, 2021, and Recent Corporate Developments
November 11 2021 - 4:04PM
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, 2021.
Recent Corporate Developments
- Analysis of
Data from Six-Month Extension Study of the ALTISSIMO Phase 2b Trial
in Wet AMD — 58% of the patients who completed the
12-month treatment phase, or Core Study, were eligible and agreed
to enter the observational phase, or Extension Study, with 11
patients participating in the GB-102 1mg arm. The Extension Study
provided up to an additional six months for patients to demonstrate
longer duration, which resulted in 55% of GB-102 1mg patients
enrolled in the Extension Study experiencing a treatment duration
of 12 months or longer, while maintaining visual acuity and central
retinal thickness.
- Seeking
partner for funding of additional GB-102 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 ophthalmic needs — In-licensing efforts
targeted at capital-efficient development opportunities are
expected to both leverage and expand current platform
technologies.
Upcoming Events
- Presentation of
corporate overview at the Retina Showcase at Eyecelerator@AAO 2021
on November 11, 2021, at 1:50 p.m. CST, followed by a panel
discussion.
- Presentation of
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 September
30, 2021
Net loss for the quarter ended September 30, 2021 was $8.0
million, compared to $4.7 million for the same period in 2020. 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 company’s
initial public offering in September 2020. Excluding this gain, net
loss for the quarter ended September 30, 2020 would have been $6.8
million.
Research and development expense for the quarter ended September
30, 2021 was $4.0 million, compared to $4.8 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 and
extension phases of the GB-102 Phase 2b clinical trial in December
2020 and June 2021, respectively, offset in part by an increase in
compensation costs.
General and administrative expense for the quarter ended
September 30, 2021 was $4.0 million, compared to $2.1 million for
the same period in 2020. The increase in 2021 was primarily due to
a $0.7 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 Nine Months Ended September
30, 2021
Net loss for the nine months September 30, 2021 was $27.1
million, compared to $18.4 million for the same period in 2020. Net
loss for the nine months ended September 30, 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 in September 2020. Excluding this
gain, net loss for the nine months ended September 30, 2020 would
have been $20.6 million.
Research and development expense for the nine months ended
September 30, 2021 was $14.6 million, compared to $15.5 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 and extension phases of the GB-102 Phase 2b clinical
trial in December 2020 and June 2021, respectively, which was
offset, in part, 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 nine months ended
September 30, 2021 was $12.6 million, compared to $5.2 million for
the same period in 2020. The increase in 2021 was primarily due to
a $2.2 million increase in stock-based compensation, a $1.9 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 September 30, 2021, the company’s cash and cash
equivalents, and short-term investments totaled $72.6 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. Founded in 2011 on the basis of technology licensed from
the Johns Hopkins University School of Medicine, with offices in
Baltimore, Maryland, and 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-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 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)
|
|
Three Months EndedSeptember 30, |
|
Nine Months EndedSeptember 30, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,021 |
|
|
$ |
4,757 |
|
|
$ |
14,635 |
|
|
$ |
15,474 |
|
General and administrative |
|
|
3,996 |
|
|
|
2,064 |
|
|
|
12,611 |
|
|
|
5,183 |
|
Total operating expenses |
|
|
8,017 |
|
|
|
6,821 |
|
|
|
27,246 |
|
|
|
20,657 |
|
Loss from operations |
|
|
(8,017 |
) |
|
|
(6,821 |
) |
|
|
(27,246 |
) |
|
|
(20,657 |
) |
Interest income |
|
|
28 |
|
|
|
3 |
|
|
|
100 |
|
|
|
120 |
|
Change in fair value of preferred
stock tranche |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
obligation |
|
|
— |
|
|
|
2,102 |
|
|
|
— |
|
|
|
2,158 |
|
Net loss |
|
|
(7,989 |
) |
|
|
(4,716 |
) |
|
|
(27,146 |
) |
|
|
(18,379 |
) |
Cumulative dividends on
convertible preferred stock |
|
|
— |
|
|
|
(2,396 |
) |
|
|
— |
|
|
|
(7,189 |
) |
Net loss attributable to common
stockholders |
|
$ |
(7,989 |
) |
|
$ |
(7,112 |
) |
|
$ |
(27,146 |
) |
|
$ |
(25,568 |
) |
Net loss per common share—basic
and diluted |
|
$ |
(0.38 |
) |
|
$ |
(2.52 |
) |
|
$ |
(1.28 |
) |
|
$ |
(13.74 |
) |
Weighted-average number of shares
outstanding |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
used in computing net loss per common share— |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted |
|
|
21,287,498 |
|
|
|
2,818,349 |
|
|
|
21,153,185 |
|
|
|
1,861,229 |
|
GRAYBUG VISION,
INC.Condensed Balance Sheets(In
thousands)
|
|
September 30,2021 |
|
|
December 31,2020 |
|
|
|
|
|
|
|
(audited) |
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
11,452 |
|
|
$ |
33,418 |
|
Short-term investments |
|
|
61,102 |
|
|
|
61,615 |
|
Prepaid expenses and other current assets |
|
|
1,942 |
|
|
|
4,207 |
|
Total current assets |
|
|
74,496 |
|
|
|
99,240 |
|
Property and equipment, net |
|
|
2,113 |
|
|
|
1,946 |
|
Prepaid expenses and other
non-current assets |
|
|
29 |
|
|
|
608 |
|
Total assets |
|
$ |
76,638 |
|
|
$ |
101,794 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,066 |
|
|
$ |
2,513 |
|
Accrued research and development |
|
|
264 |
|
|
|
1,356 |
|
Other current liabilities |
|
|
2,160 |
|
|
|
3,128 |
|
Total current liabilities |
|
|
4,490 |
|
|
|
6,997 |
|
Deferred rent, long term portion |
|
|
12 |
|
|
|
11 |
|
Total liabilities |
|
|
4,502 |
|
|
|
7,008 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
232,641 |
|
|
|
228,155 |
|
Accumulated deficit |
|
|
(160,513 |
) |
|
|
(133,367 |
) |
Accumulated other comprehensive income (loss) |
|
|
6 |
|
|
|
(4 |
) |
Total stockholders’ equity |
|
|
72,136 |
|
|
|
94,786 |
|
Total liabilities and stockholders’ equity |
|
$ |
76,638 |
|
|
$ |
101,794 |
|
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