Graybug Vision Reports Financial Results for the Three and Nine Months Ended September 30, 2022
November 10 2022 - 4:58PM
Graybug Vision, Inc. (Nasdaq: GRAY) (“Graybug” or the “Company”), a
clinical-stage biopharmaceutical company focused historically on
developing transformative medicines for ocular diseases, today
reported financial results for the three and nine months ended
September 30, 2022.
Financial Results for the Three Months Ended September
30, 2022
Net loss for the quarter ended September 30, 2022 was $9.8
million compared to $8.0 million for the same period in 2021.
Research and development expense for the quarter ended September
30, 2022 was $3.2 million compared to $4.0 million for the same
period in 2021. The decrease was primarily due to the August 2022
decision to terminate 20 of its 28 employees and wind-down the
GB-102 and GB-401 research and development programs.
Restructuring, impairment and other costs of terminated programs
for the quarter ended September 30, 2022 were $2.4 million. This
charge results from the termination of all development activities
relating to the GB-102 and GB-401 programs and comprises impairment
of capital equipment, severance and termination benefits, and other
restructuring costs.
General and administrative expense for the quarter ended
September 30, 2022 was $4.3 million compared to $4.0 million for
the same period in 2021. The increase was primarily due to an
increase in stock-based compensation.
Financial Results for the Nine Months Ended September
30, 2022
Net loss for the nine months ended September 30, 2022 was $28.2
million compared to $27.1 million for the same period in 2021.
Research and development expense for the nine months ended
September 30, 2022 was $13.4 million compared to $14.6 million for
the same period in 2021. The decrease was primarily due to the
completion of the extension phase of the GB-102 Phase 2b clinical
trial in May 2021 and a decrease in personnel costs due to
severance expense incurred in the first half of 2021, offset in
part by a $2.2 million increase due to in-process research and
development related to the March 2022 acquisition of RainBio, Inc.,
and an increase in nonclinical expense related to the
since-terminated GB-401 program.
General and administrative expense for the nine months ended
September 30, 2022 was $12.7 million compared to $12.6 million for
the same period in 2021. While general and administrative expenses
remained essentially unchanged, the March 2021 decrease in the
write-off of deposits on fixed assets purchase commitments was
largely offset by an increase in stock-based compensation and an
increase in professional services expenses, primarily related to
legal and accounting.
As of September 30, 2022, the Company’s cash, cash equivalents,
and short-term investments totaled $43.6 million. Subject to the
outcome of the previously announced strategic review, which is
still ongoing, management believes Graybug’s current cash and
investments are sufficient to support its currently planned
operations beyond 2023.
About Graybug
Graybug has historically been a clinical-stage biopharmaceutical
company focused on developing transformative medicines for ocular
diseases. In August 2022, the Company announced that it had
terminated all activities related to its two lead development
programs: GB-102, a microparticle formulation of a
pan-VEGF inhibitor, sunitinib, for the treatment of wet age-related
macular degeneration, and GB-401, an implant
formulation containing a novel prodrug of timolol for the treatment
of primary open angle glaucoma (POAG). The Company’s two remaining
product candidates are both at the preclinical or earlier stage:
GB-501 is an adeno-associated virus (AAV) gene
therapy with Orphan Drug Designation (ODD) and Rare Pediatric
Disease Designation (RPDD) being developed to treat corneal
clouding caused by mucopolysaccharidosis type 1 (MPS1), a lysosomal
storage disorder, and GB-701 is being developed as
a long-acting formulation of a potent factor B inhibitor targeting
the complement cascade that plays a role in age-related macular
degeneration. Founded in 2011 based on technology licensed from the
Johns Hopkins University School of Medicine, Graybug has offices in
Redwood City, California and Baltimore, Maryland. 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 strategic review process,
the timing, cost or expense required to pursue any strategic
alternative, the ability to successfully consummate one or more
strategic transactions on terms that maximize shareholder value,
its ability to advance GB-501, GB-701, or any future product
candidate through preclinical or clinical development, achieve its
anticipated milestones, license or sell any of its remaining
product candidates, or accurately predict the timing or magnitude
of its future cash requirements and the resulting depletion of its
cash resources. 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, 2021, 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 Consolidated Statements of
Operations(In thousands, except share and per
share amounts; unaudited)
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
2022 |
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
$ |
3,249 |
|
|
$ |
4,021 |
|
|
$ |
13,364 |
|
|
$ |
14,635 |
|
General and administrative |
|
4,299 |
|
|
|
3,996 |
|
|
|
12,669 |
|
|
|
12,611 |
|
Restructuring, impairment, and other costs of terminated
programs |
|
2,435 |
|
|
|
— |
|
|
|
2,435 |
|
|
|
— |
|
Total operating expenses |
|
9,983 |
|
|
|
8,017 |
|
|
|
28,468 |
|
|
|
27,246 |
|
Loss from operations |
|
(9,983 |
) |
|
|
(8,017 |
) |
|
|
(28,468 |
) |
|
|
(27,246 |
) |
Interest income |
|
171 |
|
|
|
28 |
|
|
|
266 |
|
|
|
100 |
|
Net loss |
|
(9,812 |
) |
|
|
(7,989 |
) |
|
|
(28,202 |
) |
|
|
(27,146 |
) |
Net loss per share—basic and
diluted |
$ |
(0.46 |
) |
|
$ |
(0.38 |
) |
|
$ |
(1.32 |
) |
|
$ |
(1.28 |
) |
Weighted-average number of
shares outstanding used in computing net loss per share—basic and
diluted |
|
21,536,622 |
|
|
|
21,287,498 |
|
|
|
21,443,252 |
|
|
|
21,153,185 |
|
GRAYBUG VISION,
INC.Condensed Consolidated Balance
Sheets(In thousands)
|
September 30, 2022 |
|
|
December 31, 2021 |
|
(unaudited) |
|
(audited) |
Assets |
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
Cash and cash equivalents |
$ |
10,170 |
|
|
$ |
13,364 |
|
Short-term investments |
|
33,457 |
|
|
|
50,306 |
|
Assets held for sale |
|
350 |
|
|
|
— |
|
Prepaid expenses and other current assets |
|
1,094 |
|
|
|
3,408 |
|
Total current assets |
|
45,071 |
|
|
|
67,078 |
|
Property and equipment,
net |
|
— |
|
|
|
1,981 |
|
Operating lease right-of-use
asset |
|
290 |
|
|
|
— |
|
Prepaid expenses and other
non-current assets |
|
— |
|
|
|
29 |
|
Total assets |
$ |
45,361 |
|
|
$ |
69,088 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
Accounts payable |
$ |
498 |
|
|
$ |
527 |
|
Accrued research and development |
|
200 |
|
|
|
304 |
|
Operating lease liability |
|
302 |
|
|
|
— |
|
Other current liabilities |
|
2,762 |
|
|
|
3,226 |
|
Total current liabilities |
|
3,762 |
|
|
|
4,057 |
|
Deferred rent, long term portion |
|
— |
|
|
|
8 |
|
Total liabilities |
|
3,762 |
|
|
|
4,065 |
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
Common stock |
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
239,110 |
|
|
|
234,225 |
|
Accumulated deficit |
|
(197,390 |
) |
|
|
(169,188 |
) |
Accumulated other comprehensive loss |
|
(123 |
) |
|
|
(16 |
) |
Total stockholders’ equity |
|
41,599 |
|
|
|
65,023 |
|
Total liabilities and stockholders’ equity |
$ |
45,361 |
|
|
$ |
69,088 |
|
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