Adverum Biotechnologies Reports Third Quarter 2017 Financial Results and Provides Corporate Update
November 08 2017 - 4:01PM
Adverum Biotechnologies, Inc. (Nasdaq:ADVM), a leading gene therapy
company targeting unmet medical needs in serious rare and ocular
diseases, today reported financial results for the third quarter
ended September 30, 2017 and provided a corporate update.
“We continue to make progress advancing our gene therapy
programs to reach our goal of transforming 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. “To accomplish this goal, this quarter we plan to
begin patient enrollment in ADVANCE, a Phase 1/2 clinical trial for
ADVM-043 for alpha-1 antitrypsin deficiency. Looking ahead, we plan
to file two INDs with the FDA in the second half of 2018, for
ADVM-022 in wet AMD and ADVM-053 in hereditary angioedema. We are
well positioned and well capitalized to accelerate the development
of our pipeline of novel gene therapies in 2018.”
Recent Progress
- For ADVM-043, Adverum’s gene therapy product candidate for
treating alpha-1 antitrypsin (A1AT) deficiency, the Company plans
to begin patient enrollment in the ADVANCE Phase 1/2 trial in the
fourth quarter of 2017. Site activation is underway at five
leading centers in the United States and Adverum continues to
prepare for release of ADVM-043 drug product to the sites to
support first patient dosing. In addition, the Company is working
closely with the Alpha-1 Foundation to identify potential patients
for this trial. This multi-center, open-label, dose-escalation
clinical trial plans to evaluate ADVM-043 in three cohorts of
patients receiving intravenous administration and one cohort
receiving intrapleural administration. The trial is designed to
assess the safety and protein expression of ADVM-043, and further
details about the study can be found at ClinicalTrials.gov under
trial identifier number NCT02168686. The Company expects to report
preliminary data from this trial in the second half of 2018.
- For ADVM-022, Adverum’s intravitreally-administered gene
therapy product candidate for the treatment of wet age-related
macular degeneration (wAMD), the Company is conducting an ongoing
preclinical study to assess the durability of protein expression in
non-human primates and expects to report efficacy at 12 months in
the first half of 2018. The Company also plans to file an
Investigational New Drug (IND) application with the U.S. Food and
Drug Administration (FDA) in the second half of 2018.
- Also for ADVM-022, Adverum data were presented at the Targeting
Ocular Disorders and the Retina Society conferences in September
2017. The additional long-term data continued to demonstrate
sustained expression of anti-VEGF protein following a single
intravitreal injection of ADVM-022. Pharmacokinetic data on one
non-human primate showed sustained expression for 52 weeks. In a
separate ongoing study, sustained expression for at least seven
months was observed in seven non-human primates.
- For ADVM-053, Adverum’s gene therapy product candidate for
treating hereditary angioedema (HAE), the Company also plans to
file an IND application with the FDA in the second half of
2018.
- In September 2017, Adverum appointed Eric G. Carter, M.D.,
Ph.D. to its board of directors. Dr. Carter is a pharmaceutical
industry executive with over 20 years of global research and
development experience in multiple therapeutic areas. Most
recently, Dr. Carter served as senior vice president, chief medical
officer, and global head of clinical and non-clinical development
of Allergan from 2011 until its acquisition by Actavis
Pharmaceuticals in 2015.
Upcoming Events
- Adverum plans to attend the following upcoming conferences:
- Piper Jaffray’s 29th Annual Healthcare Conference in New York
on November 28, 2017 at 12:10 – 12:30 p.m. ET
- Barclays’ Gene Editing and Gene Therapy Summit in New York on
November 30, 2017 at 9:00 – 9:20 a.m. ET
- Cell Therapy Manufacturing and Gene Therapy Congress in
Amsterdam, December 6-7, 2017
Financial Results for the Three Months Ended September
30, 2017
- Cash, cash equivalents and marketable
securities were $186.6 million as of September 30,
2017, compared to $197.4 million as of June 30, 2017 and $222.2
million as of December 31, 2016. The Company’s current cash
position is 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.
- Revenues, consisting of revenue from
collaborative research, were $0.5 million for the three months
ended September 30, 2017, compared to $0.4 million for
the same period in 2016.
- Research and development expenses
were $10.3 million for the three months
ended September 30, 2017, compared to $8.4 million for the
same period in 2016. This increase was due to an overall increase
in research and development activities for the Company’s gene
therapy programs, primarily for material production costs for
ADVM-043.
- General and administrative expenses
were $4.8 million for the three months
ended September 30, 2017, compared to $6.1
million for the same period in 2016. This decrease was
primarily due to lower salary expense, professional fees, and
stock-based compensation expenses.
- Net loss attributable to common stockholders
was $13.8 million, or $0.32 per basic and diluted
share, for the three months ended September 30, 2017,
compared to $14.3 million, or $0.35 per basic and diluted
share, for the same period in 2016.
About Adverum Biotechnologies,
Inc.Adverum is a leading gene therapy company targeting
unmet medical needs in 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, Adverum 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) |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2017 |
|
|
2016 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash,
cash equivalents and marketable securities |
|
$ |
186,642 |
|
|
$ |
222,170 |
|
Receivable from collaborative partner |
|
|
- |
|
|
|
886 |
|
Prepaid
expenses and other current assets |
|
|
2,881 |
|
|
|
2,218 |
|
Total
current assets |
|
|
189,523 |
|
|
|
225,274 |
|
Property
and equipment, net |
|
|
3,347 |
|
|
|
4,169 |
|
Deposits
and other long-term assets |
|
|
340 |
|
|
|
140 |
|
Intangible assets |
|
|
5,000 |
|
|
|
5,000 |
|
Total
assets |
|
$ |
198,210 |
|
|
$ |
234,583 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
7,642 |
|
|
$ |
7,925 |
|
Restructuring liabilities |
|
|
- |
|
|
|
25 |
|
Current
portion of deferred rent |
|
|
121 |
|
|
|
96 |
|
Current
portion of deferred revenue |
|
|
1,850 |
|
|
|
1,850 |
|
Total
current liabilities |
|
|
9,613 |
|
|
|
9,896 |
|
|
|
|
|
|
|
|
|
|
Deferred
rent, less current portion |
|
|
257 |
|
|
|
352 |
|
Deferred
revenue, less current portion |
|
|
5,711 |
|
|
|
7,099 |
|
Deferred
tax liability |
|
|
1,250 |
|
|
|
1,250 |
|
Other
liabilities |
|
|
387 |
|
|
|
386 |
|
Total
liabilities |
|
|
17,218 |
|
|
|
18,983 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
180,992 |
|
|
|
215,600 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
198,210 |
|
|
$ |
234,583 |
|
|
|
|
|
|
|
|
ADVERUM BIOTECHNOLOGIES, INC. |
|
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
|
(Unaudited) |
|
(In thousands, except per share
amounts) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September
30, |
|
|
|
2017 |
|
|
2016 |
|
|
|
2017 |
|
2016 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
463 |
|
|
$ |
395 |
|
|
$ |
1,388 |
|
|
$ |
967 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
10,272 |
|
|
|
8,362 |
|
|
|
27,825 |
|
|
|
23,772 |
|
|
General and administrative |
|
4,762 |
|
|
|
6,146 |
|
|
|
16,815 |
|
|
|
19,578 |
|
|
Impairment of goodwill and intangible assets |
|
- |
|
|
|
394 |
|
|
|
- |
|
|
|
49,514 |
|
|
Total operating expenses |
|
15,034 |
|
|
|
14,902 |
|
|
|
44,640 |
|
|
|
92,864 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(14,571 |
) |
|
|
(14,507 |
) |
|
|
(43,252 |
) |
|
|
(91,897 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
742 |
|
|
|
206 |
|
|
|
1,894 |
|
|
|
544 |
|
|
Net loss before income tax benefit |
|
(13,829 |
) |
|
|
(14,301 |
) |
|
|
(41,358 |
) |
|
|
(91,353 |
) |
|
Income tax benefit |
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
Net loss attributable to |
|
|
|
|
|
|
|
|
|
|
|
|
common stockholders |
$ |
(13,829 |
) |
|
$ |
(14,301 |
) |
|
$ |
(41,358 |
) |
|
$ |
(91,353 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share attributable to common |
|
|
|
|
|
|
|
|
|
|
|
|
stockholders, basic and diluted |
$ |
(0.32 |
) |
|
$ |
(0.35 |
) |
|
$ |
(0.97 |
) |
|
$ |
(2.66 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, |
|
|
|
|
|
|
|
|
|
|
|
|
basic and diluted |
|
43,381 |
|
|
|
41,416 |
|
|
|
42,849 |
|
|
|
34,382 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact for Adverum:
Leone Patterson
Chief Financial Officer
650-665-7222
lpatterson@adverum.com
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