Adverum Biotechnologies Reports Recent Business Progress and Third Quarter 2019 Financial Results
08 November 2019 - 8:01AM
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 third quarter
ended September 30, 2019 and provided a corporate update. The
company will host a conference call and webcast today at 1:30 pm
PT/4:30 pm ET to discuss the results and recent business progress.
“The third quarter was important for Adverum, as we reported
sustained benefits from a single intravitreal injection of ADVM-022
in our first cohort of treatment-experienced patients with wet
AMD,” said Leone Patterson, chief executive officer, Adverum
Biotechnologies. “This is the first time that a single intravitreal
injection gene therapy has provided sustained efficacy for these
patients, who previously required frequent ocular anti-VEGF
injections to maintain their vision. We are very encouraged by
these early data, particularly that none of the six patients in the
first cohort, who received ADVM-022 at a dose of 6x10^11 vg/eye,
required any anti-VEGF rescue injections through a median follow-up
of 34 weeks. We are now dosing patients in the third cohort of
OPTIC with ADVM-022 at a dose of 2x10^11 vg/eye using prophylactic
steroid eye drops instead of prophylactic oral steroids. Our goal
is to provide wet AMD patients with a life-changing treatment that
removes the need for frequent anti-VEGF injections.”
Recent Updates
- Announced the appointment of Peter Soparkar as chief legal
officer in October 2019
- Began dosing patients in the third cohort (n=9, dose of 2x10^11
vg/eye) of the OPTIC phase 1 trial of ADVM-022 in October 2019
- Presented additional data from the first cohort of patients
(n=6, dose of 6x10^11 vg/eye) during a podium presentation at the
American Academy of Ophthalmology (AAO) Annual Meeting in October
2019. In treatment-experienced patients previously requiring
frequent anti-VEGF injections to maintain vision, data demonstrated
that a single intravitreal injection of ADVM-022 was sufficient to
maintain vision and improve retinal anatomy, with zero rescue
injections required for any of the six patients with a median
follow-up of 34 weeks
- Presented 24-week data for the first cohort of patients in the
OPTIC phase 1 trial in a podium presentation at the Retina Society
Annual Meeting in September 2019
Future Plans
- In the first quarter of 2020, begin enrollment in the fourth
cohort of patients in the OPTIC trial (n=9, dose of 6x10^11 vg/eye)
using prophylactic steroid eye drops instead of prophylactic oral
steroids
- Present 52-week data from the first cohort of patients (n=6,
dose of 6x10^11 vg/eye) in the OPTIC trial as well as 24-week data
from the second cohort of patients (n=6, dose of 2x10^11 vg/eye) in
the first half of 2020
- Submit an IND application for the treatment of ADVM-022 in
diabetic retinopathy (DR), a key VEGF-driven cause of vision loss
among working-age adults, in the first half of 2020
- Expects to be able to occupy its new corporate headquarters in
Redwood City, CA, by the end of this year, allowing for the
expansion of in-house process development capabilities to the
1000-liter production scale
Financial Results for the Three Months Ended September
30, 2019
- Cash, cash equivalents and short-term
investments were $162.0 million as of September 30, 2019,
compared to $205.1 million as of December 31, 2018. Adverum
expects this quarter-end cash position to fund operations into
2021
- Revenue of $0.3 million for the three months
ended September 30, 2019 related to a development milestone that
was achieved under an existing license agreement
- Research and development expenses were $9.9
million for the three months ended September 30, 2019, compared to
$14.5 million for the same period in 2018. Research and development
expenses decreased primarily due to reduced activities for the
development of product candidates ADVM-043 (for A1AT deficiency)
and ADVM-053 (for hereditary angioedema), lower material production
costs for ADVM-022 and ADVM-053 and lower personnel expenses,
partially offset primarily by increased facilities costs related to
the company’s new facility
- General and administrative expenses were $7.4
million for the three months ended September 30, 2019, compared to
$4.8 million for the same period in 2018. General and
administrative expenses increased primarily due to higher
consultant and professional service expenses, personnel costs, and
increased facilities costs related to the company’s new
facility
- Net loss was $16.1 million, or $0.25 per basic
and diluted share, for the three months ended September 30, 2019,
compared to $21.0 million, or $0.34 per basic and diluted share,
for the same period in 2018. The 2018 period included a $5.0
million non-cash charge for the impairment of an intangible asset
related to the discontinued development of ADVM-043. The in-process
research and development (IPR&D) asset originated from the
Annapurna acquisition in May 2016
Conference Call
InformationIndividuals can participate in today’s
conference call at 1:30 pm PT (4:30 pm ET) by dialing
1-866-420-8347 (domestic) or 1-409-217-8241 (international) and
refer to the “Adverum Biotechnologies Third Quarter 2019 Earnings
Call.” The webcast will be accessible under Events and
Presentations in the Investors section of the company's website.
The archived audio webcast will be available on the Adverum website
following the call, and will be available for 30 days.
About Adverum Biotechnologies,
Inc.Adverum Biotechnologies (Nasdaq: ADVM) is a
clinical-stage gene therapy company targeting unmet medical needs
for 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 its lead indication, wet age-related
macular degeneration. For more information, please visit
www.adverum.com.
Forward-looking
Statements Statements 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 regarding: Adverum’s plans for
advancing ADVM-022; the expected timing of reporting clinical data;
the expected timing of filing an IND for diabetic retinopathy;
expected timing of being able to occupy Adverum’s new facility; and
Adverum’s expectations that its current cash position will fund its
operations into 2021. All of these statements 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 achieve any of these a timely
manner, or at all, or otherwise carry out the intentions or meet
the expectations 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: risks inherent with conducting
clinical trials which may delay or cancel the reporting of data or
filing an IND; the incurrence of unexpected expenses; and 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. Risks and uncertainties facing Adverum are
described more fully in Adverum’s Form 10-Q filed with the SEC on
November 7, 2019, particularly 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.
Investor and Media Inquiries:
Investors:Myesha LacyAdverum BiotechnologiesVice President,
Investor Relations and Corporate
Communicationsmlacy@adverum.com1-650-304-3892
Media:Cherilyn Cecchini, M.D.Account
Supervisorccecchini@lifescipublicrelations.com 1-646-876-5196
|
|
Adverum
Biotechnologies, Inc. |
Condensed
Consolidated Balance Sheets |
(In thousands) |
(Unaudited) |
|
|
|
|
|
September
30, |
|
December
31, |
|
2019 |
|
2018 |
|
|
|
|
|
|
Assets |
|
|
|
Current
assets: |
|
|
|
Cash and cash equivalents |
$ |
73,171 |
|
|
$ |
154,949 |
|
Short-term investments |
|
88,814 |
|
|
|
50,130 |
|
Prepaid expenses and other current assets |
|
5,617 |
|
|
|
3,675 |
|
Total
current assets |
|
167,602 |
|
|
|
208,754 |
|
Operating
lease right-of-use asset |
|
21,511 |
|
|
|
- |
|
Property and
equipment, net |
|
15,249 |
|
|
|
3,586 |
|
Restricted
cash |
|
999 |
|
|
|
999 |
|
Deposit and
other long-term assets |
|
164 |
|
|
|
156 |
|
Total assets |
$ |
205,525 |
|
|
$ |
213,495 |
|
Liabilities and stockholders' equity |
|
|
|
Current
liabilities: |
|
|
|
Accounts payable |
$ |
3,382 |
|
|
$ |
1,707 |
|
Accrued expenses and other current liabilities |
|
10,320 |
|
|
|
8,784 |
|
Lease liability, current portion |
|
4,044 |
|
|
|
- |
|
Deferred rent, current portion |
|
- |
|
|
|
228 |
|
Total
current liabilities |
|
17,746 |
|
|
|
10,719 |
|
Deferred
rent, net of current portion |
|
- |
|
|
|
1,366 |
|
Lease
liability, net of current portion |
|
23,380 |
|
|
|
- |
|
Other
noncurrent liabilities |
|
185 |
|
|
|
243 |
|
Total
liabilities |
|
41,311 |
|
|
|
12,328 |
|
Commitments
and contingencies |
|
|
|
Stockholders' equity: |
|
|
|
Preferred stock |
|
- |
|
|
|
- |
|
Common stock |
|
7 |
|
|
|
6 |
|
Additional paid-in capital |
|
531,056 |
|
|
|
522,503 |
|
Accumulated other comprehensive loss |
|
(745 |
) |
|
|
(799 |
) |
Accumulated deficit |
|
(366,104 |
) |
|
|
(320,543 |
) |
Total
stockholders' equity |
|
164,214 |
|
|
|
201,167 |
|
Total liabilities and stockholders' equity |
$ |
205,525 |
|
|
$ |
213,495 |
|
|
|
|
|
|
Adverum
Biotechnologies, Inc. |
Condensed
Consolidated Statements of Operations and Comprehensive Loss |
(In thousands except
per share data) |
(unaudited) |
|
|
|
|
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2019 |
|
2018 |
|
2019 |
|
2018 |
|
|
|
|
|
|
|
|
|
|
Collaboration and license revenue |
$ |
250 |
|
|
$ |
833 |
|
|
$ |
250 |
|
|
$ |
1,542 |
|
Operating
expenses: |
|
|
|
|
|
|
|
Research and
development |
|
9,944 |
|
|
|
14,480 |
|
|
|
29,045 |
|
|
|
38,491 |
|
General and
administrative |
|
7,389 |
|
|
|
4,826 |
|
|
|
20,097 |
|
|
|
19,373 |
|
Impairment
of intangible asset |
|
- |
|
|
|
5,000 |
|
|
|
- |
|
|
|
5,000 |
|
Total
operating expenses |
|
17,333 |
|
|
|
24,306 |
|
|
|
49,142 |
|
|
|
62,864 |
|
Operating
loss |
|
(17,083 |
) |
|
|
(23,473 |
) |
|
|
(48,892 |
) |
|
|
(61,322 |
) |
Other
income, net |
|
965 |
|
|
|
1,265 |
|
|
|
3,331 |
|
|
|
3,104 |
|
Net loss
before income tax benefit |
|
(16,118 |
) |
|
|
(22,208 |
) |
|
|
(45,561 |
) |
|
|
(58,218 |
) |
Income tax
benefit |
|
- |
|
|
|
1,250 |
|
|
|
- |
|
|
|
1,250 |
|
Net
loss |
|
(16,118 |
) |
|
|
(20,958 |
) |
|
|
(45,561 |
) |
|
|
(56,968 |
) |
Other
comprehensive loss: |
|
|
|
|
|
|
|
Net
unrealized gain on marketable securities |
|
4 |
|
|
|
53 |
|
|
|
27 |
|
|
|
129 |
|
Foreign
currency translation adjustment |
|
(11 |
) |
|
|
- |
|
|
|
27 |
|
|
|
(21 |
) |
Comprehensive loss |
$ |
(16,125 |
) |
|
$ |
(20,905 |
) |
|
$ |
(45,507 |
) |
|
$ |
(56,860 |
) |
Net loss per
share — basic and diluted |
$ |
(0.25 |
) |
|
$ |
(0.34 |
) |
|
$ |
(0.71 |
) |
|
$ |
(0.94 |
) |
Weighted-average common shares used to compute net loss per share -
basic and diluted |
|
64,484 |
|
|
|
62,454 |
|
|
|
63,764 |
|
|
|
60,856 |
|
|
|
|
|
|
|
|
|
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