Graybug Vision Reports Full Year 2021 Financial Results and Recent Corporate Developments
March 10 2022 - 7:30AM
Graybug Vision, Inc. (Nasdaq: GRAY), a clinical-stage
biopharmaceutical company focused on developing transformative
medicines for the treatment of ocular diseases, today provided an
update on recent corporate developments and reported financial
results for the full year ended December 31, 2021.
“Graybug made important progress in advancing its
retina (GB-102) and glaucoma (GB-401) programs in 2021. We
developed a new enhanced formulation of GB-102 that capitalizes on
the duration demonstrated by our Phase 2b ALTISSIMO trial, where
half of patients were controlled for six months after a single
intravitreal (IVT) injection,” said Frederic Guerard, PharmD, Chief
Executive Officer of Graybug Vision. “We are in ongoing discussions
to partner GB-102 for its next clinical trial, while finalizing the
preparation of an IND application for our GB-401 implant
formulation, and pursuing other novel ocular therapeutics.”
Recent Corporate Developments
- Completed
ALTISSIMO Phase 2b trial in wet age-related macular degeneration
(wet AMD) — Final results confirm unprecedented duration
in an aflibercept-controlled clinical trial. GB-102 1mg
demonstrated six-month duration in 48% of patients and 12 months in
30% of patients, with well-controlled central subretinal thickness
(CST), as compared to aflibercept. Best corrected visual acuity
(BCVA) of patients in the GB-102 1mg arm trended lower than
aflibercept’s, mainly driven by 4 subjects. These subjects had a
combination of high anti-VEGF need prior to enrollment, particle
dispersion during the study, or adverse events unrelated to the
drug, which we expect to address in the next trial with optimized
inclusion and rescue criteria, and our new enhanced
formulation.
- Ongoing
partnering discussions to support funding of additional GB-102
wet-AMD clinical trials — New enhanced formulation of
GB-102 to further reduce or eliminate microparticle dispersion has
been developed, and design of future Phase 2 trial to evaluate
safety, efficacy, and durability has been finalized.
- Developed
lead GB-401 formulation and custom pre-loaded applicator —
Expanded biodegradable polymer platform technology with implant
formulation of GB-401, which has the potential to be administered
IVT once every six months with a pre-loaded applicator to reduce
elevated intraocular pressure in glaucoma patients, is currently in
a repeat-dose GLP-tox study.
- 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.
Anticipated Milestones
- Enhanced GB-102
formulation ready for Phase 2 trial in patients with wet AMD as
soon as second half of 2022.
- Initiate GB-401, a
proprietary implant formulation of a beta-adrenergic receptor
inhibitor designed for IVT injection once every six months, Phase 1
trial in first half 2023.
Full Year 2021 Financial Results
Net loss for 2021 was $35.8 million compared to
$27.5 million for 2020. Net loss for 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, or IPO, in September 2020. Excluding this
gain, the 2020 net loss would have been $29.7 million.
Research and development expense for 2021 was $18.9
million compared to $21.0 million for 2020. The decrease in 2021
was primarily due to a reduction in clinical trial expenses due to
the completion of the treatment phase of the GB-102 Phase 2b
ALTISSIMO clinical trial in December 2020, offset in part by an
increase in compensation costs.
General and administrative expense for 2021 was
$17.0 million compared to $8.9 million for 2020. The increase in
2021 was primarily due to a $2.8 million increase in stock-based
compensation, a $1.8 million increase in the cost of directors and
officers insurance as a result of becoming a public company and a
$1.3 million write-off of deposits on fixed assets purchase
commitments.
As of December 31, 2021, the company’s cash, cash
equivalents, and short-term investments totaled $63.7 million,
compared to $95.0 million as of December 31, 2020. The decrease was
primarily due to our net loss in 2021 of $35.8 million. The
company’s current cash and investments are sufficient to support
its planned operations into the second half of 2023.
R&D Day for Investors
Management plans to host an Investor R&D Day on
March 30, 2022 from 11 a.m. to 12:45 p.m. ET. The meeting will
feature updates on the company’s advancing pipeline of
transformative medicines for the treatment of ocular diseases.
Speakers will include Graybug management and key opinion leaders in
ophthalmology. A link to attendee registration and additional
details about the meeting will be coming soon and will be made
available in the Investors and Media section of the company’s
website at
https://investors.graybug.vision/news-events/events-presentations.
About Graybug
Graybug is a clinical-stage biopharmaceutical
company focused on developing transformative medicines for the
treatment of ocular diseases. 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, a proprietary implant formulation
of a beta-adrenergic blocker prodrug, for primary open-angle
glaucoma, with a dosing regimen of once every six months. 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 quarterly report on Form 10-Q for the three months ended
September 30, its annual report on Form 10-K to be filed for the
year ended December 31, 2021, and 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)(2021 unaudited)
|
|
Year Ended December 31, |
|
|
|
2021 |
|
|
2020 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
18,903 |
|
|
$ |
20,962 |
|
General and administrative |
|
|
17,044 |
|
|
|
8,870 |
|
Total operating expenses |
|
|
35,947 |
|
|
|
29,832 |
|
Loss from operations |
|
|
(35,947 |
) |
|
|
(29,832 |
) |
Interest income |
|
|
126 |
|
|
|
143 |
|
Change in fair value of
preferred stock tranche obligation |
|
|
— |
|
|
|
2,158 |
|
Net loss |
|
|
(35,821 |
) |
|
|
(27,531 |
) |
Cumulative dividends on
convertible preferred stock |
|
|
— |
|
|
|
(7,189 |
) |
Net loss attributable to
common stockholders |
|
$ |
(35,821 |
) |
|
$ |
(34,720 |
) |
Net loss per common
share—basic and diluted |
|
$ |
(1.69 |
) |
|
$ |
(5.25 |
) |
Weighted-average number of
shares outstanding used in computing net loss per common
share—basic and diluted |
|
|
21,199,291 |
|
|
|
6,618,445 |
|
GRAYBUG VISION,
INC.Condensed Balance Sheets(In
thousands)(2021 unaudited)
|
|
December 31, |
|
|
|
2021 |
|
|
2020 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
13,364 |
|
|
$ |
33,418 |
|
Short-term investments |
|
|
50,306 |
|
|
|
61,615 |
|
Prepaid expenses and other current assets |
|
|
3,408 |
|
|
|
4,207 |
|
Total current assets |
|
|
67,078 |
|
|
|
99,240 |
|
Property and equipment,
net |
|
|
1,981 |
|
|
|
1,946 |
|
Prepaid expenses and other
non-current assets |
|
|
29 |
|
|
|
608 |
|
Total assets |
|
$ |
69,088 |
|
|
$ |
101,794 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
527 |
|
|
$ |
2,513 |
|
Accrued research and development |
|
|
304 |
|
|
|
1,356 |
|
Other current liabilities |
|
|
3,226 |
|
|
|
3,128 |
|
Total current liabilities |
|
|
4,057 |
|
|
|
6,997 |
|
Deferred rent, long term portion |
|
|
8 |
|
|
|
11 |
|
Total liabilities |
|
|
4,065 |
|
|
|
7,008 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Stockholders’ Equity: |
|
|
|
|
|
|
|
|
Common stock |
|
|
2 |
|
|
|
2 |
|
Additional paid-in capital |
|
|
234,225 |
|
|
|
228,155 |
|
Accumulated deficit |
|
|
(169,188 |
) |
|
|
(133,367 |
) |
Accumulated other comprehensive loss |
|
|
(16 |
) |
|
|
(4 |
) |
Total stockholders’ equity |
|
|
65,023 |
|
|
|
94,786 |
|
Total liabilities and stockholders’ equity |
|
$ |
69,088 |
|
|
$ |
101,794 |
|
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