Adverum Biotechnologies Reports Second Quarter 2017 Financial Results and Provides Update
August 08 2017 - 4:01PM
Adverum Biotechnologies, Inc. (Nasdaq:ADVM), a leading gene therapy
company advancing novel medicines that have the potential to
address unmet needs in serious rare and ocular diseases, today
reported financial results for the second quarter ended June 30,
2017 and provided a corporate update.
“We are making important progress with our development and
regulatory initiatives to transform Adverum into a clinical-stage
company by the end of this year,” said Amber Salzman, Ph.D.,
president and chief executive officer of Adverum
Biotechnologies. “Since the beginning of this year, we have
held meetings with the FDA, paving the way to advancing our three
lead gene therapy programs toward the clinic. We plan to begin
patient enrollment in a Phase 1/2 clinical trial for alpha-1
antitrypsin deficiency in the fourth quarter of this year. We
believe we have multiple options for building value with our robust
pipeline, in house manufacturing process and assay development
expertise, and a platform of leading AAV vector technology,
including novel vector development capabilities.”
Recent Highlights
- In June 2017, Adverum appointed Athena Countouriotis, M.D. as
senior vice president and chief medical officer. Dr. Countouriotis
has significant experience leading clinical development teams and
programs, from preclinical through clinical stages of development
and approval. Over the course of her career, she has been involved
in multiple clinical programs, with a focus on orphan oncology
indications, which have supported regulatory approvals in the
United States and Europe.
- In May 2017, Adverum presented new preclinical data on the
Company’s next-generation vectors at the Association for Research
in Vision and Ophthalmology (ARVO) and American Society of Gene
& Cell Therapy (ASGCT) 2017 annual meetings. These
presentations highlighted the work underway to leverage Adverum’s
leading capabilities in novel vector development.
2017 Outlook
- For ADVM-043, Adverum’s gene therapy product candidate for
treating alpha-1 antitrypsin (A1AT) deficiency, the Company met
with the U.S. Food and Drug Association (FDA) in July 2017 and
plans to begin enrolling patients in a Phase 1/2 trial in the
fourth quarter of 2017.
- For ADVM-053, Adverum’s gene therapy product candidate for
treating hereditary angioedema (HAE), the Company held a
pre-investigational new drug (IND) meeting in the first quarter of
2017 and is planning to file an IND application with the FDA.
- For ADVM-022, Adverum’s intravitreal injection gene therapy
product candidate for wAMD, the Company held a pre-IND meeting with
the FDA in the first quarter of 2017 and is planning to file an IND
application with the FDA.
- Adverum plans to attend the following upcoming
conferences: ° BioCentury’s NewsMakers Conference in New
York on September 8, 2017 ° Discovery on Target in
Boston, September 25 – 29, 2017 ° Cell & Gene
Therapy CEO in New York on September 25, 2017
- Adverum’s cash, cash equivalents and marketable securities
of $197.4 million as of June 30, 2017 are expected to fund the
three lead gene therapy programs through the end of 2019 and
through the achievement of meaningful clinical data in patients for
at least one of the Company’s lead programs.
Financial Results for the Three Months Ended June 30,
2017
- Cash, cash equivalents and marketable
securities were $197.4 million as of June 30, 2017,
compared to $209.5 million as of March 31, 2017 and $222.2 million
as of December 31, 2016.
- Revenues, consisting of revenue from
collaborative research, were $0.5 million for the three months
ended June 30, 2017, compared to $0.3 million for the
same period in 2016.
- Research and development expenses
were $8.5 million for the three months ended June
30, 2017, compared to $8.0 million for the same period in 2016.
This increase was due to an overall increase in research and
development activities for the Company’s three lead gene therapy
programs.
- General and administrative expenses
were $4.1 million for the three months ended June
30, 2017, compared to $5.1 million for the same period in
2016. This decrease was primarily due to lower professional fees as
the 2016 period included Annapurna acquisition-related
expenses.
- Net loss attributable to common stockholders
was $11.4 million or $0.27 per basic and diluted
share, for the three months ended June 30, 2017, compared
to $61.7 million, or $1.76 per basic and diluted share, for
the same period in 2016. The net loss for the three months ended
June 30, 2016 included a non-cash goodwill impairment charge of
$49.1 million in connection with the Annapurna transaction that
closed in May 2016.
About Adverum Biotechnologies,
Inc.Adverum is a gene therapy company advancing novel
medicines that may offer life-changing benefits to patients living
with serious rare and ocular diseases. Adverum has a robust
pipeline that includes product candidates designed to treat rare
diseases alpha-1 antitrypsin (A1AT) deficiency and hereditary
angioedema (HAE) as well as wet age-related macular degeneration
(wAMD). Leveraging a next-generation adeno-associated virus
(AAV)-based directed evolution platform, the Company generates
product candidates designed to provide durable efficacy by inducing
sustained expression of a therapeutic protein. Adverum has
collaboration agreements with Regeneron Pharmaceuticals to
research, develop, and commercialize gene therapy products for
ophthalmic diseases and Editas Medicine to explore the delivery of
genome editing medicines for the treatment of inherited retinal
diseases. Adverum’s core capabilities include clinical development
and in-house manufacturing expertise, specifically in process
development and assay development. For more information please
visit www.adverum.com.
Forward-Looking StatementsStatements contained
in this press release regarding matters that are not historical
facts 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 Adverum’s
plans, potential opportunities, expectations, projections, goals,
objectives, milestones, strategies, product pipeline, financial
condition and results of operations, the sufficiency of its cash,
cash equivalents and marketable securities, as well as the
advancement of, and anticipated development and regulatory
milestones and plans related to, Adverum’s product candidates and
preclinical and clinical studies, and the commercial potential of
its product candidates, all of which are based on certain
assumptions made by Adverum on current conditions, expected future
developments and other factors Adverum believes are appropriate in
the circumstances. Adverum may not consummate any plans or product
or clinical development goals in a timely manner, or at all, or
otherwise carry out the intentions or meet the expectations or
projections disclosed in its forward-looking statements, and you
should not place undue reliance on these forward-looking
statements. Actual results and the timing of events could differ
materially from those anticipated in such forward-looking
statements as a result of various risks and uncertainties, which
include, without limitation, the risk that Adverum’s resources will
not be sufficient for Adverum to conduct or continue planned
development programs and planned clinical trials, the risk of a
delay in the enrollment of patients in Adverum’s clinical studies
or in the manufacturing of products to be used in such clinical
studies, the risk that Adverum will not be able to successfully
develop or commercialize any of its product candidates and the risk
that Adverum will be delayed in receiving or fail to receive
required regulatory approvals. Risks and uncertainties facing
Adverum are described more fully in Adverum’s periodic reports
filed with the SEC. 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. |
|
CONDENSED CONSOLIDATED BALANCE
SHEETS |
|
(Unaudited) |
|
(In thousands) |
|
|
|
|
|
|
|
|
|
|
|
|
June 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
$ |
197,418 |
|
|
$ |
222,170 |
|
Receivable from collaborative partner |
|
|
- |
|
|
|
886 |
|
Prepaid
expenses and other current assets |
|
|
2,223 |
|
|
|
2,218 |
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
|
199,641 |
|
|
|
225,274 |
|
Property
and equipment, net |
|
|
3,798 |
|
|
|
4,169 |
|
Deposits
and other long-term assets |
|
|
140 |
|
|
|
140 |
|
Intangible assets |
|
|
5,000 |
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
208,579 |
|
|
$ |
234,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
6,351 |
|
|
$ |
7,925 |
|
Restructuring liabilities |
|
|
- |
|
|
|
25 |
|
Current
portion of deferred rent |
|
|
112 |
|
|
|
96 |
|
Current
portion of deferred revenue |
|
|
1,850 |
|
|
|
1,850 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
|
8,313 |
|
|
|
9,896 |
|
|
|
|
|
|
|
|
|
|
Deferred
rent, less current portion |
|
|
293 |
|
|
|
352 |
|
Deferred
revenue, less current portion |
|
|
6,174 |
|
|
|
7,099 |
|
Deferred
tax liability |
|
|
1,250 |
|
|
|
1,250 |
|
Other
liabilities |
|
|
369 |
|
|
|
386 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
|
16,399 |
|
|
|
18,983 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
192,180 |
|
|
|
215,600 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
208,579 |
|
|
$ |
234,583 |
|
|
|
|
|
|
|
|
ADVERUM BIOTECHNOLOGIES, INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Unaudited) |
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June 30, |
|
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
|
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
463 |
|
|
$ |
307 |
|
|
$ |
925 |
|
|
$ |
572 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
8,492 |
|
|
|
7,955 |
|
|
|
17,553 |
|
|
|
15,410 |
|
|
General and administrative |
|
4,064 |
|
|
|
5,114 |
|
|
|
12,053 |
|
|
|
13,432 |
|
|
Impairment of goodwill and intangible assets |
|
- |
|
|
|
49,120 |
|
|
|
- |
|
|
|
49,120 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
12,556 |
|
|
|
62,189 |
|
|
|
29,606 |
|
|
|
77,962 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(12,093 |
) |
|
|
(61,882 |
) |
|
|
(28,681 |
) |
|
|
(77,390 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
663 |
|
|
|
222 |
|
|
|
1,152 |
|
|
|
338 |
|
|
Net loss before income tax benefit |
|
(11,430 |
) |
|
|
(61,660 |
) |
|
|
(27,529 |
) |
|
|
(77,052 |
) |
|
Income tax benefit |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net loss attributable to |
|
|
|
|
|
|
|
|
|
|
|
|
common stockholders |
$ |
(11,430 |
) |
|
$ |
(61,660 |
) |
|
$ |
(27,529 |
) |
|
$ |
(77,052 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common |
|
|
|
|
|
|
|
|
|
|
|
|
stockholders, basic and diluted |
$ |
(0.27 |
) |
|
$ |
(1.76 |
) |
|
$ |
(0.65 |
) |
|
$ |
(2.50 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, |
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted |
|
43,009 |
|
|
|
35,044 |
|
|
|
42,579 |
|
|
|
30,825 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contacts for Adverum:
Leone Patterson
Chief Financial Officer
650-665-7222
lpatterson@adverum.com
Charles Butler
Vice President, Investor Relations &
Corporate Communications
650-272-6260
cbutler@adverum.com
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