Adverum Reports Second Quarter 2021 Results
August 05 2021 - 4:05PM
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 second quarter
ended June 30, 2021.
“Adverum has an experienced team and is well capitalized to
execute our current plans to prioritize the development of ADVM-022
in wet age-related macular degeneration,” said Laurent Fischer,
M.D., president and chief executive officer at Adverum
Biotechnologies. “Based on our current focus and timelines, we are
able to extend our cash runway into 2024. The long-term data from
OPTIC in patients with wet AMD show the potential for the low dose
of ADVM-022 to offer durable, disease-modifying treatment following
a single, in-office intravitreal injection. The current standard of
care for wet AMD requires frequent anti-VEGF injections in the eye,
which are a burden for patients, caregivers, and healthcare systems
and make access challenging for many patients. Our team is
committed to patient safety and moving forward with the best
possible path to deliver ADVM-022 to patients with wet AMD, and
potentially delivering a durable new treatment alternative to
frequent injections for these patients in the future.”
Recent Developments
- At the Association for Research in Vision and Ophthalmology
(ARVO) meeting in May, long-term OPTIC clinical data (n=30, March
10, 2021 data cut) were presented demonstrating the potential of
ADVM-022 to greatly reduce the anti-VEGF intravitreal (IVT)
injection burden for patients with wet AMD. Data demonstrated
long-term durability and maintained efficacy with a majority of
patients free of supplemental injection following a single,
in-office IVT injection of ADVM-022 in difficult-to-treat patients
with wet AMD.
- Adverum is no longer planning to develop ADVM-022 for diabetic
macular edema (DME) or at the high dose (6 x 10^11 vg/eye). No
similar clinically-relevant events like the dose-limiting toxicity
(DLT) at the high dose in DME patients have been observed to date
in patients with wet AMD, and patients in OPTIC have reached a
follow-up period of between 1 and 2.5 years post treatment.
- Adverum is in active discussions to sublease the company’s
174,000-square-foot Good Manufacturing Practices (GMP) commercial
manufacturing facility in Research Triangle Park, NC. Adverum will
leverage its contract manufacturing organization (CMO) partners for
ongoing supply of ADVM-022.
Anticipated Milestones for ADVM-022:
- Plan to present long-term OPTIC data in wet AMD in 2H21,
including 52-week data from Cohort 4 (high dose of 6 x 10^11 vg/eye
with steroid eye drop prophylaxis, n=9), at a medical
conference
- Plan to present INFINITY data in DME in 2H21 at a medical
conference
- Plan to complete data analysis by YE21 to develop a protocol
and seek investigator and regulatory feedback on a Phase 2 clinical
trial in wet AMD to evaluate low doses (2 x 10^11 vg/eye and lower)
of ADVM-022 and alternative prophylactic regimens
Financial Results for the Three Months Ended June 30,
2021
- Cash, cash equivalents and short-term
investments were $363.8 million as of June 30, 2021,
compared to $404.0 million as of March 31, 2021. Adverum expects
this quarter-end cash position to fund operations into 2024, 18
months beyond prior guidance of mid-2022. Adverum’s cash runway
extension is based on current development and manufacturing plans
for ADVM-022, including conducting a Phase 2 trial instead of two
Phase 3 trials in wet AMD, not pursuing future development in DME,
and continuing to utilize contract CMO partners in lieu of
establishing a GMP commercial manufacturing facility.
- Research and
development expenses were $22.6 million for the three
months ended June 30, 2021, compared to $19.2 million for the same
period in 2020. Research and development expenses increased
primarily due to higher personnel-associated costs, rent expense,
clinical trial expenses, consultant and contractor fees, and
laboratory costs, partially offset by decreased material production
costs. Stock-based compensation expense included in research and
development expenses was $2.6 million for the second quarter of
2021, compared to $1.7 million for the same period in 2020.
- General and
administrative expenses were $21.9 million for the three
months ended June 30, 2021, compared to $10.6 million for the same
period in 2020. General and administrative expenses increased
primarily due to higher professional services costs, including
proxy related fees, personnel-associated costs, and rent for new
leases commenced in the second quarter of 2021. Stock-based
compensation expense included in general and administrative
expenses was $5.7 million for the second quarter of 2021, compared
to $3.1 million for the same period in 2020.
- Net loss was $44.3 million, or $0.45 per basic
and diluted share, for the three months ended June 30, 2021,
compared to $29.2 million, or $0.36 per basic and diluted share,
for the same period in 2020.
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 evaluating its novel gene therapy candidate,
ADVM-022, as a one-time, intravitreal injection for the treatment
of patients with wet age-related macular degeneration. For more
information, please visit www.adverum.com.
Forward-looking StatementsStatements 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 expected current cash runway into 2024, and the statements
under the caption “Anticipated Milestones for ADVM-022.” 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 dose-limiting toxicity at the
high dose in DME patients in our INFINITY trial, 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) |
|
|
|
|
|
|
|
June
30 |
|
December
31 |
|
|
2021 |
|
|
|
2020 |
|
|
|
(Unaudited) |
|
(1) |
Assets |
|
|
|
|
Current
assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
47,299 |
|
|
$ |
62,424 |
|
Short-term investments |
|
|
316,544 |
|
|
|
367,305 |
|
Lease incentive receivables |
|
|
16,196 |
|
|
|
- |
|
Prepaid expenses and other current assets |
|
6,233 |
|
|
|
4,709 |
|
Total current assets |
|
|
386,272 |
|
|
|
434,438 |
|
Property and
equipment, net |
|
|
31,589 |
|
|
|
27,725 |
|
Operating
lease right-of-use asset |
|
|
101,876 |
|
|
|
19,376 |
|
Restricted
cash |
|
|
6,282 |
|
|
|
999 |
|
Deposit and
other long-term assets |
|
|
128 |
|
|
|
29 |
|
Total assets |
|
$ |
526,147 |
|
|
$ |
482,567 |
|
|
|
|
|
|
Liabilities and stockholders' equity |
|
|
|
|
Current
liabilities: |
|
|
|
|
Accounts payable |
|
|
2,259 |
|
|
|
2,810 |
|
Lease liability, current portion |
|
|
4,185 |
|
|
|
4,473 |
|
Accrued expenses and other current liabilities |
|
|
14,086 |
|
|
|
13,588 |
|
Total current liabilities |
|
|
20,530 |
|
|
|
20,871 |
|
Lease
liability, net of current portion |
|
|
125,361 |
|
|
|
26,235 |
|
Other
noncurrent liabilities |
|
|
1,114 |
|
|
|
1,114 |
|
Total liabilities |
|
|
147,005 |
|
|
|
48,220 |
|
Stockholders' equity: |
|
|
|
|
Common stock |
|
|
10 |
|
|
|
10 |
|
Additional paid-in capital |
|
|
954,854 |
|
|
|
937,134 |
|
Accumulated other comprehensive loss |
|
|
(417 |
) |
|
|
(261 |
) |
Accumulated deficit |
|
|
(575,305 |
) |
|
|
(502,536 |
) |
Total
stockholders' equity |
|
|
379,142 |
|
|
|
434,347 |
|
Total liabilities and stockholders' equity |
$ |
526,147 |
|
|
$ |
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 June 30, |
|
Six months ended June 30, |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
2021 |
|
|
|
2020 |
|
|
|
|
|
|
|
|
|
|
License
revenue |
|
$ |
- |
|
|
$ |
- |
|
|
$ |
7,500 |
|
|
$ |
- |
|
|
|
|
|
|
|
|
|
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and
development |
|
|
22,608 |
|
|
|
19,177 |
|
|
|
42,588 |
|
|
|
33,928 |
|
General and
administrative |
|
|
21,930 |
|
|
|
10,598 |
|
|
|
38,093 |
|
|
|
19,638 |
|
Total
operating expenses |
|
|
44,538 |
|
|
|
29,775 |
|
|
|
80,681 |
|
|
|
53,566 |
|
Operating
loss |
|
|
(44,538 |
) |
|
|
(29,775 |
) |
|
|
(73,181 |
) |
|
|
(53,566 |
) |
Other
income, net |
|
|
205 |
|
|
|
575 |
|
|
|
412 |
|
|
|
1,460 |
|
Net
loss |
|
|
(44,333 |
) |
|
|
(29,200 |
) |
|
|
(72,769 |
) |
|
|
(52,106 |
) |
Net loss per
share — basic and diluted |
|
$ |
(0.45 |
) |
|
$ |
(0.36 |
) |
|
$ |
(0.74 |
) |
|
$ |
(0.68 |
) |
Weighted-average common shares outstanding - basic and diluted |
|
|
98,018 |
|
|
|
80,229 |
|
|
|
97,885 |
|
|
|
77,010 |
|
|
|
|
|
|
|
|
|
|
Investor Inquiries
Amy Figueroa, CFA
Vice President, Investor Relations and Corporate Communications
Adverum
E: afigueroa@adverum.com
T: 650- 649-1257
Media Inquiries
Andrea Cohen
Sam Brown Inc.
E: andreacohen@sambrown.com
T: 917-209-7163
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