Alector Reports 2020 Fourth Quarter and Full Year Financial Results and Provides Business Update
February 25 2021 - 4:05PM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today announced business
updates and financial results for the fourth quarter
ended December 31, 2020.
“In 2020, we made significant progress across all of our key
clinical programs,” said Arnon Rosenthal, Ph.D., co-founder and
chief executive officer of Alector. “As we look ahead to 2021, we
will be sharing additional findings from our ongoing Phase 2 study
evaluating AL001 in people with frontotemporal dementia at a
medical conference this year and are pleased to be advancing our
two Alzheimer’s disease development programs. Our progress across
our immuno-neurology programs continues to put us one step closer
to potentially offering new therapeutic options for the millions of
patients living with various forms of dementia. In addition, we
continue to progress research targets that could have broad
implications across neurodegenerative diseases and various forms of
cancer, underscoring the broad potential of our research
platform.”
2020 and Recent Clinical Pipeline Highlights and
Business Updates
Progranulin Portfolio:
- In July 2020, Alector dosed
the first participant in INFRONT-3, a randomized,
placebo-controlled, pivotal Phase 3 trial evaluating AL001 in
people at risk for or with frontotemporal dementia due to a
progranulin gene mutation
(FTD-GRN). The ongoing
trial is evaluating the efficacy and safety of AL001 in at-risk and
symptomatic participants with FTD-GRN. Participants in the trial
will be given the option to continue receiving treatment in an
open-label extension study.
- Alector plans to present updated data from the ongoing
Phase 2 open-label study evaluating AL001, in 2021. The
Company plans to present additional data in pre-symptomatic and
symptomatic FTD-GRN participants at medical conferences in 2021.
The data will include updated findings on safety, fluid and imaging
biomarkers and clinical outcomes assessments, while also providing
additional insights to the mechanism of action and safety of AL001
in this population.
- In January 2021, the Company
announced plans to evaluate AL001 in people with amyotrophic
lateral sclerosis (ALS) caused by C9orf72
repeats, which share TDP-43 pathology with
FTD-GRN. The Phase 2 study is planned for
2021.
- In January 2020, a Phase 1a
study evaluating AL101 was initiated
in healthy volunteers. The U.S. Food and Drug
Administration also granted Fast
Track designation to AL101 for the treatment of patients
with FTD-GRN in February
2020. The Company anticipates reporting preliminary
findings from the Phase 1a study in 2021.
Alzheimer’s Disease Portfolio:
- In January 2021, the Company
announced that the first participant was
dosed in INVOKE-2, Phase 2 trial evaluating AL002 in people with
early Alzheimer’s disease. The randomized, double-blind,
placebo-controlled, dose-ranging, multi-center Phase 2 study will
enroll approximately 265 participants with early Alzheimer’s
disease (AD) at up to 90 sites globally. The program is being
developed in collaboration with AbbVie.
- Data from the Phase 1b study evaluating AL003 in
participants with Alzheimer’s disease is expected in 2021.
Alector initiated the Phase 1b study in January 2020 and completed
enrollment in 2020. The AL003 clinical development program is also
being developed in collaboration with AbbVie. Preliminary results
from the study are expected to be presented at a scientific medical
meeting in 2021.
Early-Stage Pipeline with Potential in Neurodegenerative
Diseases and Oncology
- In March 2020, the Company entered into a
collaboration with Innovent Biologics to
develop and commercialize AL008 for oncology indications in
China. Planning for the first-in-human study for AL008 is
underway. AL008 is a novel, investigational, antibody product
candidate with a dual mechanism of action that combines inhibition
of the CD47-SIRP-alpha (SIRPα) pathway, with stimulation of
activating Fc receptors that has the potential to yield a
best-in-class product.
- Plans are currently underway to initiate a
first-in-human study of a product candidate in our AL009
development program, the Company’s latest prioritized
investigational product candidate. Our AL009 program is
developing a first-in-class multi-Siglec inhibitor that works to
enhance the innate and adaptive immune system response by blocking
a critical glycan checkpoint pathway that drives immune inhibition.
The product candidate is initially being developed for oncology
indications, but may also have therapeutic application in certain
neurodegenerative disorders, such as AD.
- The Company continues to plan for a first-in-human
study for AL044, targeting the MS4A4A
receptor within the next 18 months. MS4A4A is a
major risk gene for AD that encodes a transmembrane receptor
protein that is expressed selectively in microglia in the brain and
is associated with control of microglia functionality and potential
viability.
Ongoing COVID-19 Response Activities:
- Alector continues to actively monitor the evolving COVID-19
pandemic and its ongoing impact on business and clinical
operations.
Fourth Quarter and Full Year 2020 Financial
Results
Revenue. Collaboration revenue for the
quarter ended December 31, 2020, was $4.9
million, compared to $6.0 million for the same
period in 2019. Collaboration revenue for the year ended December
31, 2020, was $21.1 million compared to $21.2 million for the same
period in 2019. Alector recognizes revenue from the upfront
payments under an agreement with AbbVie over time as the services
are provided. Revenues are recognized as the program costs are
incurred by measuring actual costs incurred to date compared to the
overall total expected costs to satisfy the performance obligation.
Changes in estimates for revenue recognized over time are
recognized on a cumulative basis.
R&D Expenses. Total research and
development expenses for the quarter ended December 31, 2020,
were $44.4 million, compared to $25.8
million for the same period in 2019. Total research and
development expenses for the year ended December 31, 2020, were
$156.9 million compared to $100.5 million for the same period in
2019. This increase was mainly driven by an increase in expenses to
support the advancement of the clinical and pre-clinical programs
across several therapeutic programs and an increase in
personnel-related expenses.
G&A Expenses. Total general and
administrative expenses for the quarter ended December 31, 2020,
were $13.2 million, compared to $12.6
million for the same period in 2019. Total general and
administrative expenses for the year ended December 31, 2020 were
$59.4 million compared to $35.1 million for the same period in
2019. This increase was primarily due to an increase in
personnel-related expenses due to increased headcount and an
increase in legal costs associated with our arbitration
proceedings.
Net Loss. For the quarter ended December
31, 2020, Alector reported a net loss of $52.2
million, compared to a net loss of $30.5 million for the
same period in 2019. For the year ended December 31, 2020, Alector
reported a net loss of $190.2 million, compared to a net loss of
$105.4 million for the same period in 2019.
Cash Position. Cash, cash equivalents, and
marketable securities were $413.3 million as
of December 31, 2020. The Company believes that its cash and
investments as of December 31, 2020, will be sufficient to
fund its anticipated operations through mid-2022.
About Alector
Alector is a clinical stage biotechnology company
pioneering immuno-neurology, a novel therapeutic approach for the
treatment of neurodegenerative diseases. The Company 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.
Immuno-neurology targets immune dysfunction as a root cause of
multiple pathologies that are drivers of degenerative brain
disorders. The Company’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.
Forward-Looking Statements
This 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
Alector’s Quarterly Report on Form 10-K filed with
the Securities and Exchange Commission (the “SEC”)
on February 25, 2021, 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)
|
December 31, |
|
December 31, |
|
2020 |
|
2019 |
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
$ |
413,308 |
|
$ |
353,073 |
Total assets |
|
488,251 |
|
|
421,913 |
Total current liabilities
(excluding deferred revenue) |
|
44,202 |
|
|
31,805 |
Deferred revenue (including
current portion) |
|
132,303 |
|
|
153,401 |
Total liabilities |
|
220,721 |
|
|
227,170 |
Total stockholders’
equity |
|
267,530 |
|
|
194,743 |
|
|
|
|
|
|
Consolidated Statement of Operations
Data(in thousands, except share and per share
data)
|
Three Months Ended December
31, |
|
Twelve Months Ended December
31, |
|
|
2020 |
|
2019 |
|
2020 |
|
2019 |
|
Collaboration revenue |
$ |
4,853 |
|
$ |
6,001 |
|
$ |
21,098 |
|
$ |
21,219 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
44,383 |
|
|
25,762 |
|
|
156,869 |
|
|
100,528 |
|
General and administrative |
|
13,228 |
|
|
12,581 |
|
|
59,403 |
|
|
35,095 |
|
Total operating expenses |
|
57,611 |
|
|
38,343 |
|
|
216,272 |
|
|
135,623 |
|
Loss from
operations |
|
(52,758 |
) |
|
(32,342 |
) |
|
(195,174 |
) |
|
(114,404 |
) |
Other income,
net |
|
579 |
|
|
1,815 |
|
|
4,946 |
|
|
9,019 |
|
Net loss |
$ |
(52,179 |
) |
$ |
(30,527 |
) |
$ |
(190,228 |
) |
$ |
(105,385 |
) |
Net loss per
share, basic and diluted |
$ |
(0.66 |
) |
$ |
(0.45 |
) |
$ |
(2.45 |
) |
$ |
(1.71 |
) |
Shares used in
computing net loss per share, basic and diluted |
|
78,998,656 |
|
|
67,879,914 |
|
|
77,758,806 |
|
|
61,734,492 |
|
Source: Alector, Inc.
Contacts
Media Erica JeffersonVice President, Communications and Public
AffairsAlector, Inc.301-928-4650erica.jefferson@alector.com
1AB Dan Budwick973-271-6085 dan@1abmedia.comor
Investors: Alector, Inc. ir@alector.com
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