Adverum Biotechnologies Reports Third Quarter 2018 Financial Results and Provides Corporate Update
November 08 2018 - 4:10PM
Adverum Biotechnologies, Inc. (Nasdaq: ADVM), a clinical-stage gene
therapy company targeting unmet medical needs in ophthalmology and
rare diseases, today reported financial results for the third
quarter ended September 30, 2018 and provided a corporate update.
“2018 has been a year focused on progressing our internal drug
development including obtaining an open IND and Fast Track
designation for our ADVM-022 wet AMD program,” said Leone
Patterson, chief executive officer of Adverum Biotechnologies. “I
am also pleased to announce the appointment of Mehdi Gasmi, Ph.D.
to president and chief scientific officer. Under Mehdi’s
leadership, the Adverum team worked together to design the
Company’s first proprietary gene therapy candidate, ADVM-022,
designed as a single intravitreal injection treatment for patients
living with wet AMD. We look forward to initiating the OPTIC Phase
1 trial, with ADVM-022, this quarter targeting its initial
indication, wet AMD. Our team is deeply committed to
advancing our technology in ophthalmology and rare diseases to
improve the quality of life for patients, and our strong cash
position enables us to fund operations at least through the first
half of 2020.”
“I am very excited about this opportunity and to continue
leading the Adverum organization with Leone and the rest of the
executive team,” said Mehdi Gasmi, Ph.D., president and chief
scientific officer of Adverum Biotechnologies. “I am pleased with
our recent accomplishments in translating our wet AMD program into
the clinic and I look forward to continuing to develop
transformational gene therapies to benefit patients living with
serious unmet medical needs.”
Recent Updates
- In November 2018, appointed Mehdi Gasmi, Ph.D. to president and
chief scientific officer. Dr. Gasmi has over 22 years of
experience in gene therapy and is an expert in the design,
development and manufacturing of lentiviral and recombinant AAV
vectors for clinical applications. He has worked at multiple gene
therapy organizations, including Chiron (Novartis), Cell Genesys,
Ceregene, Genethon, University of California, San Diego and City of
Hope
- In November 2018, announced the Company discontinued the
development of ADVM-043, an investigational AAVrh.10-based gene
therapy for the treatment of A1AT deficiency and announced that the
Company will not submit an Investigational New Drug (IND)
application for ADVM-053, an AAVrh.10-based gene therapy for the
treatment of hereditary angioedema (HAE). The Company plans
to conduct additional preclinical studies to determine the best
gene therapy candidate to advance for the rare disease
programs
- In October 2018, announced appointment of Leone Patterson as
chief executive officer and a member of the Board of Directors
- In October 2018, presented long-term, durable preclinical
efficacy data on ADVM-022 (AAV.7m8-aflibercept) in a model of wet
age-related macular degeneration (wet AMD) at European Society of
Gene and Cell Therapy (ESGCT) 26th Annual Congress. Data presented
demonstrated that a single intravitreal (IVT) administration of
ADVM-022 delivering a continuous supply of aflibercept may provide
an effective long-term treatment option for neovascularization
associated with wet AMD. The data showed a single IVT
administration of ADVM-022 provided robust expression of
aflibercept at levels on par with current standard of care,
sustained for approximately two years post-dose in non-human
primates
- In September 2018, received Fast Track designation for ADVM-022
in wet AMD from the U.S. Food and Drug Administration (FDA). Fast
Track is a process designed to facilitate the development and
expedite the review of drugs to treat serious conditions and fill
an unmet medical need. Despite the availability of anti-VEGF
therapies, patients still have a significant unmet need as the
frequency of injections is burdensome and undertreatment may lead
to vision loss
- In late August 2018, announced that the IND application for
ADVM-022 in patients went active
Future Outlook - Planned Pipeline
Milestones
Wet AMD Program
- Initiate the OPTIC Phase 1 clinical trial for ADVM-022 in
patients with wet AMD in the fourth quarter of 2018
Rare Disease Programs
- Provide an update on rare disease programs in the first half of
2019
Upcoming EventsAdverum plans to attend the
following upcoming conferences:
- Piper Jaffray’s 30th Annual Healthcare Conference in New York,
November 27-28, 2018
- J.P. Morgan’s 37th Annual Healthcare Conference in San
Francisco, January 7-10, 2019
Financial Results for the Three Months Ended September
30, 2018
- Cash, cash equivalents and marketable
securities were $217.9 million as of September 30,
2018, compared to $234.9 million as of June 30, 2018 and $190.5
million as of December 31, 2017. Adverum expects this quarter-end
cash position to fund operations at least through the first half of
2020
- Revenue, consisting of revenue from
collaborative research, was $0.8 million for the three months
ended September 30, 2018 and $0.5 million for the same period
in 2017. The increase was related to research services provided to
Editas under Adverum’s collaboration agreement
- Research and development expenses
were $14.5 million for the three months
ended September 30, 2018, compared to $10.3 million for the
same period in 2017. This was primarily due to an overall increase
in research and development activities, including clinical trial
expenses for ADVM-043, clinical trial initiation expenses for
ADVM-022, and material production costs for the wet AMD and rare
disease programs
- General and administrative expenses
were $4.8 million for each of the three months
ended September 30, 2018 and 2017
- Impairment of intangible asset was $5.0
million for the three months ended September 30, 2018. This
non-cash charge was related to the Company’s intangible asset for
ADVM-043 and was due to the Company’s recent decision to
discontinue its development of ADVM-043. The in-process
research and development (IPR&D) asset originated from the
Annapurna acquisition in May 2016
- Income tax benefit was $1.3 million for the
three months ended September 30, 2018 and related to the change in
the deferred tax liabilities balance due to the intangible asset
impairment charge
- Net loss attributable to common stockholders
was $21.0 million, or $0.34 per basic and diluted
share, for the three months ended September 30, 2018,
compared to $13.8 million, or $0.32 per basic and diluted
share, for the same period in 2017
About Adverum Biotechnologies,
Inc.Adverum is a clinical-stage gene therapy company
targeting unmet medical needs in ophthalmology and rare diseases.
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 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 under the
caption “Future Outlook - Planned Pipeline Milestones,”
expectations as to the ability of Adverum’s quarter-end cash
position to fund operations at least through the first half of 2020
and expectations on the timing for initiating the OPTIC clinical
trial and the Company’s plans to conduct additional preclinical
studies to determine the best gene therapy candidate to advance for
the rare disease programs, 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 be able to 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 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, as well as the risks and uncertainties facing Adverum
described more fully in Adverum’s periodic reports filed with the
Securities and Exchange Commission (SEC), especially under the
caption “Risk Factors” in its latest Quarterly Report on Form 10-Q
filed with the SEC on November 8, 2018. 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 |
|
(In thousands) |
|
(Unaudited) |
|
|
|
|
|
|
|
|
|
|
|
|
September 30, |
|
|
December 31, |
|
|
|
2018 |
|
|
2017 |
|
ASSETS |
|
|
|
|
|
|
|
|
Current
assets: |
|
|
|
|
|
|
|
|
Cash and
cash equivalents |
|
$ |
159,673 |
|
|
$ |
70,519 |
|
Short-term investments |
|
|
58,209 |
|
|
|
119,966 |
|
Prepaid
expenses and other current assets |
|
|
4,292 |
|
|
|
3,256 |
|
|
|
|
|
|
|
|
|
|
Total
current assets |
|
|
222,174 |
|
|
|
193,741 |
|
Property
and equipment, net |
|
|
2,594 |
|
|
|
3,024 |
|
Restricted cash |
|
|
999 |
|
|
|
- |
|
Deposits
and other long-term assets |
|
|
140 |
|
|
|
140 |
|
Intangible asset |
|
|
- |
|
|
|
5,000 |
|
|
|
|
|
|
|
|
|
|
Total
assets |
|
$ |
225,907 |
|
|
$ |
201,905 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND STOCKHOLDERS'
EQUITY |
|
|
|
|
|
|
|
|
Current
liabilities: |
|
|
|
|
|
|
|
|
Accounts
payable and accrued liabilities |
|
$ |
9,513 |
|
|
$ |
8,695 |
|
Current
portion of deferred rent |
|
|
482 |
|
|
|
129 |
|
Current
portion of deferred revenue |
|
|
70 |
|
|
|
1,850 |
|
|
|
|
|
|
|
|
Total
current liabilities |
|
|
10,065 |
|
|
|
10,674 |
|
|
|
|
|
|
|
|
|
|
Deferred
rent, less current portion |
|
|
102 |
|
|
|
222 |
|
Deferred
revenue, less current portion |
|
|
- |
|
|
|
5,250 |
|
Deferred
tax liability |
|
|
- |
|
|
|
1,250 |
|
Other
non-current liabilities |
|
|
187 |
|
|
|
481 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
|
10,354 |
|
|
|
17,877 |
|
|
|
|
|
|
|
|
|
|
Stockholders’ equity |
|
|
215,553 |
|
|
|
184,028 |
|
|
|
|
|
|
|
|
|
|
Total
liabilities and stockholders’ equity |
|
$ |
225,907 |
|
|
$ |
201,905 |
|
|
|
|
|
|
|
|
ADVERUM BIOTECHNOLOGIES, INC. |
CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS |
(In thousands, except per share
amounts) |
(Unaudited) |
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
|
2018 |
|
2017 |
|
2018 |
|
2017 |
|
|
|
|
|
|
|
|
|
|
|
|
|
Collaboration
and license revenue |
$ |
833 |
|
|
$ |
463 |
|
|
$ |
1,542 |
|
|
$ |
1,388 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
14,480 |
|
|
|
10,272 |
|
|
|
38,491 |
|
|
|
27,825 |
|
General and administrative |
|
4,826 |
|
|
|
4,762 |
|
|
|
19,373 |
|
|
|
16,815 |
|
Impairment of intangible asset |
|
5,000 |
|
|
|
- |
|
|
|
5,000 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
24,306 |
|
|
|
15,034 |
|
|
|
62,864 |
|
|
|
44,640 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating loss |
|
(23,473 |
) |
|
|
(14,571 |
) |
|
|
(61,322 |
) |
|
|
(43,252 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Other income (expense), net |
|
1,265 |
|
|
|
742 |
|
|
|
3,104 |
|
|
|
1,894 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss before income tax benefit |
|
(22,208 |
) |
|
|
(13,829 |
) |
|
|
(58,218 |
) |
|
|
(41,358 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
Income tax benefit |
|
1,250 |
|
|
|
- |
|
|
|
1,250 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(20,958 |
) |
|
$ |
(13,829 |
) |
|
$ |
(56,968 |
) |
|
$ |
(41,358 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share, basic and diluted |
$ |
(0.34 |
) |
|
$ |
(0.32 |
) |
|
$ |
(0.94 |
) |
|
$ |
(0.97 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted-average common shares outstanding, |
|
|
|
|
|
|
|
|
|
|
|
basic and diluted |
|
62,454 |
|
|
|
43,381 |
|
|
|
60,856 |
|
|
|
42,849 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contact for Adverum:
Katherine Bock
Vice President Investor Relations
& Corporate Communications
650-656-9347
kbock@adverum.com
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