Alector Reports Third Quarter 2021 Financial Results
05 November 2021 - 7:05AM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported third quarter
2021 financial results and summarized recent portfolio and business
updates. As of September 30, 2021, Alector’s cash, cash equivalents
and investments totaled $777.9 million.
“During the third quarter, Alector reached a significant
inflection point, validating our immuno-neurology approach and
advancing our lead programs as we strive to help patients with
neurodegenerative diseases,” said Arnon Rosenthal, Ph.D.,
co-founder and Chief Executive Officer of Alector. “We reported
12-month Phase 2 data for our lead therapeutic candidate, AL001, in
which progranulin levels in frontotemporal dementia patients
reverted to normal, and for the first time, showed encouraging
early evidence of a slowing of disease progression across diverse
datapoints. The signing of a collaborative agreement with GSK will
further enable us to develop our progranulin franchise programs to
their full potential in frontotemporal dementia, amyotrophic
lateral sclerosis, Parkinson’s disease and Alzheimer’s disease.
These achievements, alongside steady progress across our portfolio,
are moving us ever closer to realizing our mission of harnessing
the innate immune system to halt the destruction of
neurodegenerative diseases.”
Clinical Updates
Progranulin Franchise
- In September, Alector initiated a Phase 2 clinical trial of
AL001 in amyotrophic lateral sclerosis (ALS) patients with a
C9orf72 genetic mutation. The six-month, randomized, double-blind,
placebo-controlled, multicenter study is expected to enroll
approximately 45 adult participants with C9orf72-associated ALS.
The primary endpoint of the study is safety, tolerability,
pharmacokinetics and pharmacodynamics of AL001, including plasma
and cerebrospinal fluid (CSF) progranulin levels. The Phase 2 will
also gather data on changes to multiple liquid biomarkers. ALS is
the first of several indications beyond frontotemporal dementia
where elevating progranulin levels is thought to have potential
neuroprotective benefits.
- AL001 received orphan drug designation from the European
Commission for the treatment of frontotemporal dementia. Orphan
drug designation in the EU may be granted for medicines in
development for debilitating or life-threatening conditions that
affect fewer than five in 10,000 people in the EU and provides
benefits to the sponsor such as protocol assistance, reduced
regulatory fees and extended market exclusivity. AL001 has
previously received Fast Track and Orphan Drug designations from
the U.S. Food and Drug Administration.
- Twelve-month data from the open-label INFRONT-2 Phase 2
clinical trial of AL001 in patients with frontotemporal dementia
with a progranulin mutation (FTD-GRN) were presented at the
Alzheimer’s Association International Conference (AAIC) held in
July 2021. AL001 showed a favorable safety profile, successful
elevation of progranulin levels and encouraging evidence that
treatment may slow disease progression.(1)
- In July, Alector and
GlaxoSmithKline (GSK) entered into a global collaboration to
co-develop and co-commercialize AL001 and AL101 for the treatment
of neurodegenerative diseases, including FTD-GRN, as well as other
forms of FTD, ALS, Alzheimer’s disease and Parkinson’s disease.
Under the terms of the agreement, Alector will receive $700 million
in upfront payments, $500 million of which was received in August
2021 with a second payment to occur in the first quarter of
2022.
Alzheimer’s Disease Portfolio
- Two posters were presented at the 2021 AAIC for Alector’s AL002
program providing data from a Phase 1 study in healthy volunteers
and details on the design of the ongoing INVOKE-2 Phase 2 clinical
trial. AL002 is Alector’s first-in-class monoclonal antibody that
binds to the TREM2 receptor to optimize microglial activity in the
brain. Alector is developing AL002 as a potential treatment for
Alzheimer’s disease in collaboration with AbbVie.
Corporate News
- Sam Jackson, M.D., MBA, and Linda Rubinstein joined Alector’s
executive leadership team assuming the roles of interim Chief
Medical Officer and interim Chief Financial Officer, respectively.
- Dr. Jackson joined Alector in 2020 as Senior Vice President,
Clinical Sciences overseeing Alector’s clinical science and
clinical operations functions.
- Ms. Rubinstein brings significant industry and financial
experience to Alector, having served as Chief Financial Officer or
interim Chief Financial Officer to numerous biotechnology
companies.
- Elizabeth Garofalo, M.D., a veteran biopharmaceutical executive
with more than 25 years of experience in global clinical
development and regulatory affairs with a focus on neurology, was
appointed to Alector’s Board of Directors.
Third Quarter 2021 Financial Results
Revenue. Collaboration revenue for the
quarter ended September 30, 2021, was $182.4
million, compared to $5.9 million for the same
period in 2020. In August, Alector received $500 million as part of
the collaboration agreement with GSK. The increase in 2021
third quarter revenue was mainly due to the recognition of
$179.8 million of the upfront payment from GSK.
R&D Expenses. Total research and
development expenses for the quarter ended September 30, 2021,
were $43.1 million, compared to $43.8 million for the
quarter ended September 30, 2020. The decrease in R&D expenses
was attributable to timing of manufacturing of drug supply and
clinical trials start-up costs.
G&A Expenses. Total general and
administrative expenses for the quarter ended September 30, 2021,
were $13.0 million, compared to $15.8
million for the same period in 2020. This decrease was
primarily due to reduced legal fees.
Net Income (Loss). For the quarter
ended September 30, 2021, Alector reported a net
income of $126.6 million, or $1.56 net income per share,
compared to a net loss of $52.7 million, or $0.67 net loss per
share, for the same period in 2020.
Cash Position. Cash, cash equivalents, and
marketable securities were $777.9 million as
of September 30, 2021.
About AlectorAlector is a
clinical-stage biotechnology company pioneering immuno-neurology, a
novel therapeutic approach for the treatment of neurodegenerative
diseases. Immuno-neurology targets immune dysfunction as a root
cause of multiple pathologies that are drivers of degenerative
brain disorders. Alector has discovered and is developing a broad
portfolio of innate immune system programs, designed to
functionally repair genetic mutations that cause dysfunction of the
brain’s immune system and enable the rejuvenated immune cells to
counteract emerging brain pathologies. Alector’s immuno-neurology
product candidates are supported by biomarkers and target
genetically defined patient populations in frontotemporal dementia
and Alzheimer’s disease. This scientific approach is also the basis
for the company’s immuno-oncology programs. Alector is
headquartered in South San Francisco, California. For additional
information, please visit www.alector.com.
(1) Paul, Robert, et al, “AAIC 2021 “Twelve month Results from
the INFRONT-2 Phase 2 Open-label Clinical Study of AL001 in
Frontotemporal Dementia Patients with a Progranulin Mutation
(FTD-GRN)”(2) Guerreiro, et al. “TREM2 Variants in Alzheimer’s
Disease” NEJM. 2013; and Jonsson, et al. “Variant of TREM2
associated with the risk of Alzheimer's disease” NEJM 2013
Forward-Looking StatementsThis press release
contains forward-looking statements within the meaning of the
Private Securities Litigation Reform Act of 1995. Such statements
are subject to numerous important factors, risks and uncertainties
that may cause actual events or results to differ materially from
current expectations and beliefs, including but not limited to
risks and uncertainties related to market conditions, Alector and
its business as set forth in our Quarterly Report on Form 10-Q, as
filed on November 4, 2021 with the Securities and Exchange
Commission (“SEC”), as well as the other documents Alector files
from time to time with the SEC. These documents contain and
identify important factors that could cause the actual results for
Alector to differ materially from those contained in Alector’s
forward-looking statements. Any forward-looking statements
contained in this press release speak only as of the date hereof,
and Alector specifically disclaims any obligation to update any
forward-looking statement, except as required by law.
Selected Consolidated Balance Sheet
Data(in thousands)
|
|
September 30, |
|
December 31, |
|
|
2021 |
|
2020 |
|
|
|
|
|
|
|
Cash,
cash equivalents, and marketable securities |
|
$ |
777,850 |
|
$ |
413,308 |
Total
assets |
|
|
854,226 |
|
|
488,251 |
Total
current liabilities (excluding deferred revenue) |
|
|
38,132 |
|
|
44,202 |
Deferred revenue (including current portion) |
|
|
439,212 |
|
|
132,303 |
Total
liabilities |
|
|
518,336 |
|
|
220,721 |
Total
stockholders’ equity |
|
|
335,890 |
|
|
267,530 |
Consolidated Statement of Operations
Data(in thousands, except share and per share
data)
|
|
|
Three Months Ended September
30, |
Nine Months Ended September
30, |
|
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
|
|
2020 |
|
Collaboration revenue |
|
$ |
182,413 |
|
|
$ |
5,904 |
|
|
$ |
193,091 |
|
|
$ |
16,245 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
43,066 |
|
|
|
43,819 |
|
|
|
136,617 |
|
|
|
112,486 |
|
General and administrative |
|
|
13,018 |
|
|
|
15,834 |
|
|
|
38,105 |
|
|
|
46,175 |
|
Total operating expenses |
|
|
56,084 |
|
|
|
59,653 |
|
|
|
174,722 |
|
|
|
158,661 |
|
Income (loss) from
operations |
|
|
126,329 |
|
|
|
(53,749 |
) |
|
|
18,369 |
|
|
|
(142,416 |
) |
Other income,
net |
|
|
268 |
|
|
|
1,045 |
|
|
|
910 |
|
|
|
4,367 |
|
Net income
(loss) |
|
$ |
126,597 |
|
|
$ |
(52,704 |
) |
|
$ |
19,279 |
|
|
$ |
(138,049 |
) |
Net income
(loss) per share:Net income (loss) per share, basic |
|
$ |
1.56 |
|
|
$ |
(0.67 |
) |
|
$ |
0.24 |
|
|
$ |
(1.78 |
) |
Net income (loss)
per share, diluted |
|
$ |
1.49 |
|
|
$ |
(0.67 |
) |
|
$ |
0.23 |
|
|
$ |
(1.78 |
) |
Weighted-average shares used in calculating:Basic
net income (loss) per share |
|
|
80,964,701 |
|
|
|
78,771,930 |
|
|
|
80,048,758 |
|
|
|
77,340,896 |
|
Diluted net income
(loss) per share |
|
|
85,232,690 |
|
|
|
78,771,930 |
|
|
|
82,871,254 |
|
|
|
77,340,896 |
|
Alector ContactsMichelle CorralVP,
Communications and Investor
Relations650-808-7016michelle.corral@alector.com
1AB (media)Dan Budwick973-271-6085dan@1abmedia.com
Argot Partners (investors)Laura Perry/Eric KasperArgot
Partners212.600.1902alector@argotpartners.com
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