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, 2020.
“Graybug continues to make important progress in advancing its
programs in retinal diseases and glaucoma. We have now completed
our initial public offering, raising over $92 million in net
proceeds, which provides us with significant financial strength to
execute our business strategy,” said Frederic Guerard, PharmD,
Chief Executive Officer of Graybug Vision. “We are particularly
excited about our lead product candidate, GB-102, currently in
Phase 2b clinical development, which seeks to reduce the current
need for up to 12 intravitreal injections per year to two or,
potentially, fewer treatments per year,” Fred concluded.
Recent Corporate
Developments
- Successfully
completed initial public offering — On September 24, 2020,
Graybug priced its upsized IPO of 5,625,000 shares of common stock
at a public offering price of $16.00 per share, following which the
underwriters exercised their option to purchase an additional
843,750 shares, resulting in total gross proceeds of $103.5
million.
- Completed
GB-102 Phase 2a safety trial in macular edema — Final
safety and tolerability results confirm the satisfactory safety
profile of GB-102 1mg with no ocular serious adverse events or
dose-limiting toxicity reported.
- Named three
new members to the Board of Directors — Graybug appointed
Christina Ackermann, Eric Bjerkholt, and Julie Eastland to its
Board of Directors in September 2020. Each new member brings deep
expertise as leaders in health care and biotechnology, as well as
significant strategic and operational experience, to the
board.
- Named Robert
Breuil as Chief Financial Officer — In September 2020,
Robert Breuil, joined Graybug. He brings over 20 years of
experience in the biopharmaceutical and drug delivery sectors, as
well as experience serving as the CFO of three public companies
since 2003.
- Leading
ophthalmologists and
retina
experts joined
Scientific Advisory Board — In August 2020,
Graybug appointed a distinguished group of ophthalmic thought
leaders to provide external scientific counsel on the company’s
research and development programs aiming to address critical unmet
medical needs in retinal diseases and glaucoma. Graybug’s
Scientific Advisory Board members are David S. Boyer, M.D.,
Frederick L. Ferris III, M.D., Jeffrey S. Heier, M.D., Arshad M.
Khanani, M.D., M.A., Carl D. Regillo, M.D., F.A.C.S., and Rishi P.
Singh, M.D.
Anticipated Milestones in
2021
- Complete GB-102
Phase 2b ALTISSIMO trial in patients with wet age-related macular
degeneration (wet AMD), with topline data expected in the first
half of 2021.
- Initiate two pivotal
GB-102 Phase 3 trials in patients with wet AMD in the second half
of 2021.
- Initiate GB-102
Phase 2b trial 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.
Financial Results for the Three Months
Ended September 30, 2020
As of September 30, 2020, Graybug’s cash and investments totaled
$95.0 million, compared to $36.0 million as of December 31, 2019.
The increase was due to the receipt of $79.5 million in net
proceeds from Graybug’s IPO, completed in September 2020. In
October 2020, the underwriters exercised their over-allotment
option resulting in additional net proceeds of $12.6 million,
resulting in total net proceeds from the offering of $92.1
million.
Net loss for the quarter ended September 30, 2020 was $4.7
million compared to $10.2 million for the third quarter ended
September 30, 2019. 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 IPO. Excluding this amount, our net loss
would have been $6.8 million.
Research and development expense for the third quarter of 2020 was
$4.8 million compared to $8.4 million for the third quarter of
2019. The higher level of expense in the third quarter of 2019 was
primarily due to the manufacturing of clinical supplies for the
ALTISSIMO clinical trial that commenced later in the third quarter
of 2019.
General and administrative expense for the third quarter of 2020
was $2.1 million compared to $2.0 million for the third quarter of
2019.
Financial Results for the Nine Months Ended September
30, 2020
Net loss for the nine months ended September 30, 2020 was $18.4
million, compared to $26.8 million for the same period in 2019. The
decrease was primarily due to a $7.1 million decrease in research
and development expense and the non-cash gain of $2.2 million
resulting primarily from the modification and expiration of the
liability related to the preferred stock tranche obligation,
partially offset by a $0.8 million increase in general and
administrative expense.
Research and development expense for the nine months ended
September 30, 2020 was $15.5 million, compared to $22.6 million for
the same period in 2019. The was primarily due to the completion of
manufacturing of all clinical supplies required for the
commencement of our Phase 2b, or ALTISSIMO, trial for GB-102 during
2019. We did not engage in any primary manufacturing activities in
the nine-month period ended September 30, 2020.
General and administrative expenses for the nine months ended
September 30, 2020 was $5.2 million, compared to $4.4 million for
the same period in 2019. The increase was primarily due to
additional professional services related in part to the preparation
for our IPO.
The change in fair value of preferred stock tranche obligation
for the nine months ended September 30, 2020 relates to the fair
value adjustments of $2.2 million primarily due to the $2.1 million
gain recognized in connection with our IPO. In September 2020, the
preferred stock tranche obligation expired upon the effectiveness
of the registration statement for our IPO, resulting in a
corresponding elimination of the associated liability.
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, 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.
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Investor
ContactIR@graybug.vision(650) 487-2409 |
Media
Contactmedia@graybug.vision(404) 384-0067 |
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GRAYBUG VISION,
INC.Condensed Statements of
Operations(in thousands, except share and per
share amounts)(Unaudited)
|
|
Three Months Ended September 30, |
|
|
Nine Months EndedSeptember 30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
$ |
4,757 |
|
|
$ |
8,403 |
|
|
$ |
15,474 |
|
|
$ |
22,570 |
|
General and administrative |
|
|
2,064 |
|
|
|
1,962 |
|
|
|
5,183 |
|
|
|
4,404 |
|
Total operating expenses |
|
|
6,821 |
|
|
|
10,365 |
|
|
|
20,657 |
|
|
|
26,974 |
|
Loss from operations |
|
|
(6,821 |
) |
|
|
(10,365 |
) |
|
|
(20,657 |
) |
|
|
(26,974 |
) |
Interest income |
|
3 |
|
|
160 |
|
|
120 |
|
|
211 |
|
Change in fair value of preferred
stock tranche obligation |
|
|
2,102 |
|
|
|
— |
|
|
|
2,158 |
|
|
|
— |
|
Net loss |
|
|
(4,716 |
) |
|
|
(10,205 |
) |
|
|
(18,379 |
) |
|
|
(26,763 |
) |
Cumulative dividends on
convertible preferred stock |
|
|
(2,396 |
) |
|
|
(2,048 |
) |
|
|
(7,189 |
) |
|
|
(4,633 |
) |
Net loss attributable to common
stockholders |
|
$ |
(7,112 |
) |
|
$ |
(12,253 |
) |
|
$ |
(25,568 |
) |
|
$ |
(31,396 |
) |
Net loss per common share—basic
and diluted |
|
$ |
(2.52 |
) |
|
$ |
(9.30 |
) |
|
$ |
(13.74 |
) |
|
$ |
(24.10 |
) |
Weighted-average number of shares
outstanding used in computing net loss per common share—basic and
diluted |
|
|
2,818,349 |
|
|
|
1,317,497 |
|
|
|
1,861,229 |
|
|
|
1,302,687 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
GRAYBUG VISION,
INC.Condensed Balance Sheets(in
thousands)(Unaudited)
|
|
September 30,2020 |
|
|
December 31,2019 |
|
|
|
|
|
|
|
|
|
Assets |
|
|
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
94,968 |
|
|
$ |
15,870 |
|
Short-term investments |
|
|
— |
|
|
|
20,086 |
|
Prepaid expenses and other current assets |
|
|
138 |
|
|
|
315 |
|
Total current assets |
|
|
95,106 |
|
|
|
36,271 |
|
Property and equipment, net |
|
|
1,788 |
|
|
|
1,975 |
|
Prepaid expenses and other
non-current assets |
|
|
1,491 |
|
|
|
2,414 |
|
Total assets |
|
$ |
98,385 |
|
|
$ |
40,660 |
|
Liabilities, Convertible
Preferred Stock and Stockholders’ Equity (Deficit) |
|
|
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
|
|
Accounts payable |
|
$ |
4,562 |
|
|
$ |
4,636 |
|
Accrued research and development |
|
|
1,023 |
|
|
|
2,333 |
|
Other current liabilities |
|
|
2,156 |
|
|
|
3,124 |
|
Preferred stock tranche obligation |
|
|
— |
|
|
|
2,158 |
|
Total current liabilities |
|
|
7,741 |
|
|
|
12,251 |
|
Deferred rent, long term portion |
|
|
10 |
|
|
|
— |
|
Total liabilities |
|
|
7,751 |
|
|
|
12,251 |
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
Convertible preferred stock |
|
|
— |
|
|
|
131,363 |
|
Stockholders’ Equity
(Deficit): |
|
|
|
|
|
|
|
|
Common stock |
|
|
2 |
|
|
|
— |
|
Additional paid-in capital |
|
|
214,847 |
|
|
|
2,879 |
|
Accumulated deficit |
|
|
(124,215 |
) |
|
|
(105,836 |
) |
Accumulated other comprehensive income |
|
|
— |
|
|
|
3 |
|
Total stockholders’ equity (deficit) |
|
|
90,634 |
|
|
|
(102,954 |
) |
Total liabilities, convertible preferred stock and stockholders’
equity (deficit) |
|
$ |
98,385 |
|
|
$ |
40,660 |
|
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