Graybug Vision Announces Full Year 2020 Financial Results and Recent Corporate Developments
March 04 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 full year ended December 31,
2020.
“We are very pleased with Graybug’s achievements in 2020. Amidst
a challenging pandemic, we completed our initial public offering
and advanced our lead product candidate GB-102 in retinal disease
through the treatment phase of its Phase 2b ALTISSIMO trial in wet
age-related macular degeneration (wet AMD). I am excited to share
that we are now on track to report topline data from our ALTISSIMO
trial by the end of this month,” said Frederic Guerard, PharmD,
Chief Executive Officer of Graybug.
Recent Corporate Developments
- Completion
of 12-month treatment phase of ALTISSIMO trial in wet AMD
— 50 patients out of the 56 initially enrolled completed the
12-month treatment phase of the three-arm, randomized, and masked
trial of GB-102 in December 2020. Six patients did not complete the
study for reasons unrelated to their treatments. Topline data for
this 12-month treatment phase are expected to be announced in March
2021.
- Initiation
of 6-month observational trial extension of ALTISSIMO — 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 require additional supportive therapy, up to a
maximum of six months. As of today, 22 patients have
successfully completed two months or more of this six-month
extension period without the need for further treatment.
- Named
Bettina Maunz as Chief People Officer — Ms. Maunz is
building and leading the human resources function as a member of
Graybug’s executive team and serves as Head of Communications.
Anticipated Milestones in 2021
- Communicate topline
data for the 12-month treatment phase of ALTISSIMO in March 2021,
with full results to be presented at a medical conference expected
in 3Q 2021.
- Complete 6-month
observational trial extension of ALTISSIMO by June 2021, with
topline data expected in 3Q 2021.
- Initiate two pivotal
Phase 3 trials for GB-102 in patients with wet AMD in the second
half of 2021.
- Initiate Phase 2b
trial for GB-102 in patients with diabetic macular edema (DME) in
the second half of 2021.
- Submit
Investigational New Drug (IND) application for GB-401, an
injectable depot 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 second half of 2021.
- Commence a Phase 1
trial for GB-401 in the second half of 2021.
Full Year 2020 Financial Results
Net loss for 2020 was $27.5 million compared to $37.0 million
for 2019. 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 2020 was $21.0 million
compared to $30.6 million for 2019. The decrease in 2020 was
primarily due to the fact that the company did not engage in any
primary manufacturing activities in 2020 compared with 2019, during
which the company manufactured the clinical supplies for the
ALTISSIMO clinical trial that commenced later in the third quarter
of 2019.
General and administrative expense for 2020 was $8.9 million
compared to $6.9 million for 2019. The increase in 2020 was
primarily due to additional professional services, related in part
to preparing for and becoming a public company, and the related
increased cost of additional D&O insurance.
As of December 31, 2020, the company’s cash, cash equivalents,
and short-term investments totaled $95.0 million, compared to $36.0
million as of December 31, 2019. The increase was due to the
receipt of $92.1 million in net proceeds from the company’s IPO.
The company’s current cash and investments are sufficient to
support its planned operations into the first quarter of 2022.
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 microparticle depot 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 is also using its proprietary technologies to develop
GB-401, an injectable depot 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 advance GB-102, GB-103, GB-401, or any future
product candidate through 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 cash positions, the company’s
operations as a public company, the company’s management and board
of directors, and the timing 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, 2020, its annual
report on Form 10-K to be 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)(2020 unaudited)
|
|
Year Ended December 31, |
|
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
$ |
20,962 |
|
|
$ |
30,580 |
|
General and administrative |
|
|
8,870 |
|
|
|
6,922 |
|
Total operating expenses |
|
|
29,832 |
|
|
|
37,502 |
|
Loss from operations |
|
|
(29,832 |
) |
|
|
(37,502 |
) |
Interest income |
|
|
143 |
|
|
|
393 |
|
Change in fair value of preferred
stock tranche obligation |
|
|
2,158 |
|
|
|
72 |
|
Net loss |
|
|
(27,531 |
) |
|
|
(37,037 |
) |
Cumulative dividends on
convertible preferred stock |
|
|
(7,189 |
) |
|
|
(7,055 |
) |
Net loss attributable to common
stockholders |
|
$ |
(34,720 |
) |
|
$ |
(44,092 |
) |
Net loss per common share—basic
and diluted |
|
$ |
(5.25 |
) |
|
$ |
(33.41 |
) |
Weighted-average number of shares
outstanding used in computing net loss per common share—basic and
diluted |
|
|
6,618,445 |
|
|
|
1,319,912 |
|
GRAYBUG VISION,
INC.Condensed Balance Sheets(In
thousands)(2020 unaudited)
|
|
December 31, |
|
|
|
2020 |
|
|
2019 |
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
33,418 |
|
|
$ |
15,870 |
|
Short-term investments |
|
|
61,615 |
|
|
|
20,086 |
|
Prepaid expenses and other current assets |
|
|
4,207 |
|
|
|
315 |
|
Total current assets |
|
|
99,240 |
|
|
|
36,271 |
|
Property and equipment, net |
|
|
1,946 |
|
|
|
1,975 |
|
Prepaid expenses and other
non-current assets |
|
|
608 |
|
|
|
2,414 |
|
Total assets |
|
$ |
101,794 |
|
|
$ |
40,660 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
2,513 |
|
|
$ |
4,636 |
|
Accrued research and development |
|
|
1,356 |
|
|
|
2,333 |
|
Other current liabilities |
|
|
3,128 |
|
|
|
3,124 |
|
Preferred stock tranche obligation |
|
|
— |
|
|
|
2,158 |
|
Total current liabilities |
|
|
6,997 |
|
|
|
12,251 |
|
Deferred rent, long term
portion |
|
|
11 |
|
|
|
— |
|
Total liabilities |
|
|
7,008 |
|
|
|
12,251 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
— |
|
|
|
131,363 |
|
Stockholders’ Equity
(Deficit): |
|
|
|
|
|
|
|
|
Preferred stock |
|
|
— |
|
|
|
— |
|
Common stock |
|
|
2 |
|
|
|
— |
|
Additional paid-in capital |
|
|
228,155 |
|
|
|
2,879 |
|
Accumulated deficit |
|
|
(133,367 |
) |
|
|
(105,836 |
) |
Accumulated other comprehensive (loss) income |
|
|
(4 |
) |
|
|
3 |
|
Total stockholders’ equity (deficit) |
|
|
94,786 |
|
|
|
(102,954 |
) |
Total liabilities, convertible preferred stock and stockholders’
equity (deficit) |
|
$ |
101,794 |
|
|
$ |
40,660 |
|
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