Alector Reports Second Quarter 2020 Financial Results and Provides Corporate Update
August 11 2020 - 4:05PM
Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today announced corporate
updates and financial results for the second quarter
ended June 30, 2020.
“I am proud of the continued progress across our portfolio, most
notably the initiation of our pivotal Phase 3 trial evaluating
AL001 for the treatment of people with frontotemporal dementia,”
said Arnon Rosenthal, Ph.D., co-founder and chief executive officer
of Alector. “We are encouraged by the findings from the Phase 2
study of AL001 and look forward to sharing additional data after
longer-term treatment and follow up. Our novel immuno-neurology
approach and commitment to delivering transformative new therapies
to people living with devastating forms of degenerative brain
diseases are at the core of what we do. We have taken significant
steps to ensure that we will continue to be in a position to
achieve our goals, and ultimately, deliver therapies to the people
who need them.”
Clinical Pipeline Highlights and Corporate
Update
Progranulin Portfolio:
- Announced dosing of first
participant in pivotal Phase 3 trial evaluating AL001 in people at
risk for or with frontotemporal dementia due to a progranulin gene
mutation (FTD-GRN). In July 2020, Alector announced that
the first participant was dosed in INFRONT-3, a global, pivotal
Phase 3 trial, evaluating the efficacy and safety of AL001 in
pre-symptomatic and symptomatic participants with FTD-GRN. The
trial will enroll up to 180 participants at approximately 50
centers globally.
- Presented preliminary findings
from AL001 Phase 1b and Phase 2 open label studies at the
Alzheimer’s Association International Conference (AAIC).
In July 2020, Alector presented promising preliminary data from the
Phase 1b and Phase 2 open-label studies evaluating the long-term
dosing of AL001 in patients with FTD-GRN at the virtual AAIC. The
data demonstrated that AL001 was well-tolerated in both studies.
Additionally, in the Phase 2 study, treatment with AL001 led to
sustained restoration of plasma progranulin (PGRN) levels in all
FTD-GRN participants back to the normal range. These preliminary
findings also showed that the majority of symptomatic FTD-GRN
participants (six out of the eight) experienced a decrease in
neurofilament light chain levels (NfL), an exploratory biomarker of
neurodegeneration, from baseline at the last measured time point.
Alector plans to continue this 96-week open-label Phase 2 study and
present additional data from study participants, including findings
on safety, fluid and imaging biomarkers, and clinical outcomes
assessments, at a later date.
Alzheimer’s Disease Portfolio:
- Continued progress for multiple Alzheimer’s disease
clinical programs:
- In collaboration with its partner
AbbVie, Alector plans to initiate a Phase 2 study evaluating AL002
in patients with Alzheimer’s disease in the second half of 2020.
- Alector continues to advance the Phase
1b trial of AL003 in Alzheimer’s disease, also being developed in
collaboration with AbbVie.
- Alector plans to initiate Phase 1
development for AL014 in the first half of 2021. AL014 is the
latest prioritized candidate that targets MS4A4A, a transmembrane
receptor protein that is expressed selectively in microglia in the
brain and is associated with control of microglia functionality and
potential viability.
Notable Clinical and Early-Stage Research:
- Published new findings from the AL002 program in
leading research journal. In June 2020, Alector announced
the publication of preclinical and Phase 1 data demonstrating the
potential of AL002 as a treatment for Alzheimer’s disease in The
Journal of Experimental Medicine.
- Published research showing role of Trem2 in a multiple
sclerosis disease model. In August 2020, Alector
researchers and academic collaborators published findings
highlighting the role of Trem2 as induced by AL002a (a murine
specific Trem2 antibody) in promoting myelin debris clearance and
remyelination in a cuprizone mouse model of multiple sclerosis in
Acta Neuropathologica.
Ongoing COVID-19 Response Activities:
- Alector continues to actively monitor the evolving impact of
COVID-19 on its business and clinical operations, with a primary
focus on the health and safety of clinical trial participants,
clinical trial site teams and employees.
- To help mitigate the potential effects of the ongoing COVID-19
pandemic on current participant recruitment activities, the Company
has implemented a number of activities to enhance clinical trial
continuation and patient recruitment including: increased remote
support for clinical sites and study staff; evaluation of the
availability of in-home dosing and monitoring services for trial
participants; and concierge travel support for trial participants
who prefer to visit clinical sites in person. A targeted disease
education campaign is also planned to help drive awareness of FTD
and the AL001 Phase 3 clinical trial.
Second Quarter 2020 Financial Results
Revenue. Collaboration revenue for the
quarter ended June 30, 2020, was $3.2 million, compared
to $6.9 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 June 30, 2020,
were $34.1 million, compared to $25.6
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 June 30, 2020,
were $15.7 million, compared to $8.4
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 ongoing arbitration proceedings for certain intellectual
property matters.
Net Loss. For the quarter ended June 30,
2020, Alector reported a net loss of $45.3 million,
compared to a net loss of $24.6 million for the same
period in 2019.
Cash Position. Cash, cash equivalents, and
marketable securities were $503.6 million as of June
30, 2020. The Company believes that its cash and investments as of
June 30, 2020, will be sufficient to fund its anticipated
operations through 2022.
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 is developing a broad portfolio
of 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.
The Company’s product candidates are supported by biomarkers and
target genetically defined patient populations in frontotemporal
dementia and Alzheimer’s disease. Alector is
headquartered in South San Francisco, California. For
additional information, please visit www.alector.com.
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
Alector’s Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission (the “SEC”)
on August 11, 2020, 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)
|
|
June 30, |
|
December 31, |
|
|
2020 |
|
2019 |
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable securities |
|
$ |
503,640 |
|
$ |
353,073 |
Total assets |
|
|
572,030 |
|
|
421,913 |
Total current liabilities (excluding deferred revenue) |
|
|
33,117 |
|
|
31,805 |
Deferred revenue (including current portion) |
|
|
143,060 |
|
|
153,401 |
Total liabilities |
|
|
216,699 |
|
|
227,170 |
Total stockholders’ equity |
|
|
355,331 |
|
|
194,743 |
Consolidated Statement of Operations
Data(in thousands, except share and per share
data)
|
|
Three Months Ended June 30, |
|
|
Six Months Ended June
30, |
|
|
|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
Collaboration revenue |
|
$ |
3,170 |
|
|
$ |
6,917 |
|
|
$ |
10,341 |
|
|
$ |
12,522 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
34,062 |
|
|
|
25,640 |
|
|
|
68,667 |
|
|
|
46,247 |
|
General and administrative |
|
|
15,697 |
|
|
|
8,429 |
|
|
|
30,341 |
|
|
|
14,188 |
|
Total operating expenses |
|
|
49,759 |
|
|
|
34,069 |
|
|
|
99,008 |
|
|
|
60,435 |
|
Loss from operations |
|
|
(46,589 |
) |
|
|
(27,152 |
) |
|
|
(88,667 |
) |
|
|
(47,913 |
) |
Other income, net |
|
|
1,263 |
|
|
|
2,592 |
|
|
|
3,322 |
|
|
|
4,793 |
|
Net loss |
|
$ |
(45,326 |
) |
|
$ |
(24,560 |
) |
|
$ |
(85,435 |
) |
|
$ |
(43,120 |
) |
Net loss per share, basic and
diluted |
|
$ |
(0.58 |
) |
|
$ |
(0.36 |
) |
|
$ |
(1.11 |
) |
|
$ |
(0.77 |
) |
Shares used in computing net
loss per share, basic and diluted |
|
|
78,415,195 |
|
|
|
67,327,975 |
|
|
|
76,617,938 |
|
|
|
55,643,352 |
|
Source: Alector, Inc.
Contacts
MediaErica JeffersonVice President, Communications and Public
AffairsAlector, Inc.301-928-4650erica.jefferson@alector.com
1ABDan Budwick973-271-6085dan@1abmedia.comor
Investors:Alector, Inc.ir@alector.com
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