Adverum Reports First Quarter 2021 Results
May 06 2021 - 4:00PM
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene
therapy company targeting unmet medical needs in ocular and rare
diseases, today reported financial results for the first quarter
ended March 31, 2021.
“Our management team and Board are focused on conducting a
thorough review of patient safety data from the ADVM-022 program to
inform our next steps,” said Laurent Fischer, M.D., chief
executive officer at Adverum Biotechnologies. “At ARVO last
weekend, long-term data from the OPTIC trial were presented,
demonstrating ADVM-022’s durability in patients with
treatment-experienced neovascular or wet age-related macular
degeneration. As part of our broader mission to advance the field
of gene therapy, we are committed to the work our team is doing on
behalf of patients who need new treatment options for ocular
diseases.”
Recent Developments
- On April 28, 2021, Adverum announced a Suspected Unexpected
Serious Adverse Reaction (SUSAR) of hypotony (clinically-relevant
decrease in ocular pressure), with panuveitis and loss of vision in
the treated eye, in its INFINITY clinical trial evaluating ADVM-022
for the treatment of diabetic patients with macular edema. The
company has unmasked the study and is assessing and monitoring this
patient and all patients treated with ADVM-022 and is working
closely with investigators, the data monitoring committee (DMC),
the scientific advisory board, and healthcare authorities. The
patient impacted by the SUSAR event is undergoing in-person
assessments with leading retina specialists across the U.S. who are
working with Adverum to gain an understanding of the causes of the
SUSAR and to develop a treatment plan for the patient. In addition,
all patients who have received ADVM-022 have been requested to see
their treating physician for an evaluation, including ophthalmic
and advanced imaging assessments to collect additional data.
Adverum, working with its expert advisors, is conducting a thorough
review of data from the ADVM-022 program, taking into account
learnings from the SUSAR, and plans to report its findings as the
analysis progresses.
- At ARVO in May 2021, long-term OPTIC clinical data were
presented (March 10, 2021 cutoff date, n=30) that continue to
demonstrate the potential of ADVM-022 to greatly reduce the
anti-VEGF injection burden for patients with wet AMD. All
ADVM-022-related ocular adverse events (AE) were mild (80%) to
moderate (20%) in OPTIC patients with wet AMD. No clinical or
fluorescein evidence of posterior inflammation and no vasculitis,
retinitis, choroiditis, vascular occlusions, or endophthalmitis
were observed. The OPTIC data presentation is available on the
Publications section of Adverum’s website.
- In light of the announced SUSAR, the company is evaluating its
timelines and capital allocation priorities with an aim to extend
its cash runway beyond prior guidance.
Financial Results for the Three Months Ended March 31,
2021
- Cash, cash equivalents and short-term
investments were $404.0 million as of March 31, 2021,
compared to $429.7 million as of December 31, 2020.
- License revenue was $7.5 million for the three
months ended March 31, 2021, compared to no revenue for the same
period in 2020. License revenue for the three months ended March
31, 2021 was due to an upfront payment received on a license
agreement.
- Research and development expenses were $20.0
million for the three months ended March 31, 2021, compared to
$14.8 million for the same period in 2020. Research and development
expenses increased primarily due to higher personnel-associated
costs, material production costs, and clinical trial expenses.
Stock-based compensation expense included in research and
development expenses was $2.3 million for the first quarter of
2021.
- General and administrative expenses were $16.2
million for the three months ended March 31, 2021, compared to $9.0
million for the same period in 2020. General and administrative
expenses increased primarily due to higher personnel-associated
costs, professional services costs, and depreciation expense for
Adverum’s Redwood City facility. Stock-based compensation expense
included in general and administrative expenses was $4.9 million
for the first quarter of 2021.
- Net loss was $28.4 million, or $0.29 per basic
and diluted share, for the three months ended March 31, 2021,
compared to $22.9 million, or $0.31 per basic and diluted share,
for the same period in 2020.
COVID-19To date, Adverum has experienced
limited impact from COVID-19 on its operations and ongoing clinical
programs, including the OPTIC and INFINITY clinical trials. The
company is continuing to monitor and attempt to address or limit
the potential impacts of COVID-19 on its employees and operations,
patient safety, continued participation of patients enrolled in the
company’s clinical studies, protocol compliance, data quality, and
overall study integrity.
About Adverum BiotechnologiesAdverum
Biotechnologies (Nasdaq: ADVM) is a clinical-stage gene therapy
company targeting unmet medical needs in serious ocular and rare
diseases. Adverum is advancing the clinical development of its
novel gene therapy candidate, ADVM-022, as a one-time, intravitreal
injection for the treatment of patients with wet age-related
macular degeneration and diabetic macular edema. For more
information, please visit www.adverum.com.
Forward-looking Statements Statements contained
in this press release regarding the events or results that may
occur in the future are “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995.
Such statements include but are not limited to statements regarding
the potential efficacy and safety of ADVM-022 in wet AMD and
diabetic macular edema (DME). Actual results could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include risks inherent to, without limitation: Adverum’s novel
technology, which makes it difficult to predict the time and cost
of product candidate development and obtaining regulatory approval;
the results of early clinical trials not always being predictive of
future results; and the potential for Adverum’s recent announcement
of a SUSAR of hypotony with panuveitis and loss of vision in the
treated eye, in its INFINITY clinical trial evaluating ADVM-022
gene therapy for the treatment of DME and any future complications
or side effects in connection with use of ADVM-022 to delay or
prevent regulatory advancement or approval for ADVM-022. Risks and
uncertainties facing Adverum are described more fully in Adverum’s
Annual Report on Form 10-K for the year ended December 31, 2020,
Adverum’s Quarterly Report on Form 10-Q for the quarter ended March
31, 2021, and any subsequent filings with the SEC, especially under
the heading “Risk Factors.” All forward-looking statements
contained in this press release speak only as of the date on which
they were made. Adverum undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
Adverum
Biotechnologies, Inc. |
|
Consolidated Balance
Sheets |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
March
31 |
|
December
31, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
(Unaudited) |
|
|
(1) |
|
|
Assets |
|
|
|
|
|
Current
assets: |
|
|
|
|
|
Cash and cash equivalents |
|
$ |
45,422 |
|
|
$ |
62,424 |
|
|
Short-term investments |
|
|
358,596 |
|
|
|
367,305 |
|
|
Prepaid expenses and other current assets |
|
5,837 |
|
|
|
4,709 |
|
|
Total current assets |
|
|
409,855 |
|
|
|
434,438 |
|
|
Property and
equipment, net |
|
|
28,379 |
|
|
|
27,725 |
|
|
Operating
lease right-of-use asset |
|
|
19,044 |
|
|
|
19,376 |
|
|
Restricted
cash |
|
|
3,780 |
|
|
|
999 |
|
|
Deposit and
other long-term assets |
|
|
493 |
|
|
|
29 |
|
|
Total assets |
|
$ |
461,551 |
|
|
$ |
482,567 |
|
|
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
Accounts payable |
|
|
2,056 |
|
|
|
2,810 |
|
|
Lease liability, current portion |
|
|
4,512 |
|
|
|
4,473 |
|
|
Accrued expenses and other current liabilities |
|
|
13,355 |
|
|
|
13,588 |
|
|
Total current liabilities |
|
|
19,923 |
|
|
|
20,871 |
|
|
Lease
liability, net of current portion |
|
|
25,694 |
|
|
|
26,235 |
|
|
Other
noncurrent liabilities |
|
|
1,114 |
|
|
|
1,114 |
|
|
Total liabilities |
|
|
46,731 |
|
|
|
48,220 |
|
|
Stockholders' equity: |
|
|
|
|
|
Common stock |
|
|
10 |
|
|
|
10 |
|
|
Additional paid-in capital |
|
|
946,098 |
|
|
|
937,134 |
|
|
Accumulated other comprehensive loss |
|
|
(316 |
) |
|
|
(261 |
) |
|
Accumulated deficit |
|
|
(530,972 |
) |
|
|
(502,536 |
) |
|
Total
stockholders' equity |
|
|
414,820 |
|
|
|
434,347 |
|
|
Total liabilities and stockholders' equity |
$ |
461,551 |
|
|
$ |
482,567 |
|
|
|
|
|
|
|
|
(1) Derived from Adverum’s annual audited consolidated financial
statements.
Adverum
Biotechnologies, Inc. |
|
Consolidated
Statements of Operations |
|
(In thousands except
per share data) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
License
revenue |
|
$ |
7,500 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
Research and
development |
|
|
19,980 |
|
|
|
14,751 |
|
|
General and
administrative |
|
|
16,163 |
|
|
|
9,040 |
|
|
Total
operating expenses |
|
|
36,143 |
|
|
|
23,791 |
|
|
Operating
loss |
|
|
(28,643 |
) |
|
|
(23,791 |
) |
|
Other
income, net |
|
|
207 |
|
|
|
885 |
|
|
Net
loss |
|
|
(28,436 |
) |
|
|
(22,906 |
) |
|
Net loss per
share — basic and diluted |
|
$ |
(0.29 |
) |
|
$ |
(0.31 |
) |
|
Weighted-average common shares outstanding - basic and diluted |
|
|
97,750 |
|
|
|
73,797 |
|
|
|
|
|
|
|
|
Investor Relations Contacts
Myesha Lacy
Adverum Biotechnologies, Inc.
T: 650-649-1257
E: mlacy@adverum.com
Amy Figueroa
Adverum Biotechnologies, Inc.
T: 650-823-2704
E: afigueroa@adverum.com
Media Contact
Andrea Cohen
Sam Brown Inc.
T: 917-209-7163
E: andreacohen@sambrown.com
Adverum Biotechnologies (NASDAQ:ADVM)
Historical Stock Chart
From Mar 2024 to Apr 2024
Adverum Biotechnologies (NASDAQ:ADVM)
Historical Stock Chart
From Apr 2023 to Apr 2024