Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology and innate immuno-oncology,
today reported third quarter 2022 financial results and recent
portfolio and business updates. As of September 30, 2022, Alector’s
cash, cash equivalents and investments totaled $758.3 million.
Commentary on the Quarter:
“In the third quarter, we expanded our first-in-class clinical
immuno-neurology pipeline with AL044, a biologic targeting MS4A, a
brain immune checkpoint molecule and a genetic risk factor for
Alzheimer’s disease. We also continued to advance our INFRONT-3
Phase 3 pivotal study of latozinemab for frontotemporal dementia
with progranulin mutations, or FTD-GRN, and our INVOKE-2 Phase 2
Alzheimer’s disease study with AL002, which activates TREM2
receptor signaling,” said Arnon Rosenthal, Ph.D., Chief Executive
Officer of Alector. “We will be reporting new data from the Phase 1
study of AL101 later this year at CTAD in addition to follow-up
data from the INFRONT-2 Phase 2 trial in patients with symptomatic
FTD-C9orf72 in 2023.”
“We anticipate biomarker data from the AL044 healthy volunteer
study and completion of enrollment in our INVOKE-2 study in 2023.
We believe that our immuno-neurology drug candidates, which are
designed to regulate key aspects of microglial proliferation,
survival, migration, lysosomal function and immune response, could
prove important in effectively treating neurodegeneration either as
stand-alone therapies or potentially in combination with anti-beta
amyloid drugs.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and
Development at Alector, added, “Our immuno-oncology pipeline
continues to advance as well. We remain on track to submit an IND
for AL009, Alector’s first-in-class multi-Siglec inhibitor, by the
end of the year.”
“We are also thrilled to have expanded our talented leadership
team over the past quarter as we welcomed Peter Heutink, Ph.D., as
Chief Scientific Officer,” said Dr. Kenkare-Mitra. “Peter’s
expertise in the human genetics of neurodegenerative disease is
important to our efforts at Alector.”
Clinical Programs
Immuno-Neurology PortfolioProgranulin
Assets (Latozinemab, AL101)
- Enrollment is ongoing globally in the INFRONT-3 randomized,
placebo-controlled, pivotal Phase 3 trial evaluating the efficacy
and safety of latozinemab (AL001) in at-risk and symptomatic
patients with FTD-GRN. The first patient has been enrolled in the
open-label extension study.
- The company expects to report follow-up data from the INFRONT-2
Phase 2 clinical trial of latozinemab in frontotemporal dementia
patients with a C9orf72 genetic mutation (FTD-C9orf72) in 2023.
- Alector will present a poster, Repeat IV and SC dosing of the
Anti-Sortilin Antibody AL101, with data from the Phase 1 trial of
AL101 in healthy volunteers at the 15th Clinical Trials on
Alzheimer’s Disease (CTAD) conference, being held in San Francisco,
California from November 29 to December 2, 2022. AL101 is intended
to elevate progranulin levels in a manner similar to latozinemab,
and the company plans to investigate AL101 for the treatment of
Alzheimer’s disease (AD) and Parkinson’s disease (PD).
- Latozinemab and AL101 are being developed in collaboration with
GSK.
TREM2 Asset (AL002)
- Enrollment in the INVOKE-2 Phase 2 study of AL002 continues.
The INVOKE-2 Phase 2 clinical trial is designed to evaluate the
efficacy and safety of AL002 in slowing disease progression in
individuals with early AD. AL002 is being developed in
collaboration with AbbVie and targets Triggering Receptor Expressed
on Myeloid cells 2 (TREM2) to increase TREM2 signaling and the
functionality of microglia, which are brain-specific immune
cells.
Novel MS4A Asset (AL044)
- The company
commenced its first-in-human Phase 1 trial of AL044, the first
clinical-stage drug candidate to target MS4A, a major genetic risk
factor for AD and an immune checkpoint expressed on microglia. The
study, initiated in September of this year, is investigating the
safety profile, pharmacokinetics (PK), pharmacodynamics (PD) and
target engagement of AL044 in healthy adults. Safety and biomarker
data from this study are anticipated in 2023. The company views
MS4A as a master inhibitory checkpoint for the brain’s immune
system and believes its inhibition will activate microglia in a
disease-selective manner to broadly counteract Alzheimer’s disease
and potentially orphan neurodegenerative indications.
Immuno-Oncology Portfolio Multi-Siglec
and SIRPα Assets (AL009,
AL008)
- Alector anticipates submitting an IND for its AL009 innate
immuno-oncology program before the end of the year. The company
will present a poster, Characterization of suppressive myeloid
cells in solid tumors to refine disease selection in a Phase 1
study of the multi-Siglec inhibitor AL009, at the Society for
Immunotherapy of Cancer (SITC) 37th Annual Meeting being held in
Boston, Massachusetts and virtually from November 8 to 12, 2022.
AL009 is a dual function biologic that inhibits multiple Siglec
receptors on myeloid cells and simultaneously activates a
stimulating receptor on the same cells. The company plans to
prioritize tumor types that have immunosuppressive phenotypes and
expects to study AL009 as a monotherapy and in combination with
standard of care.
- The company plans to
utilize data and documentation from a regulatory filing previously
submitted by Innovent to Chinese authorities for AL008 to support a
potential IND submission in the U.S. AL008 is a novel innate
immuno-oncology candidate with a dual mechanism of action,
targeting SIRP-alpha (SIRPα) to inhibit the CD47-
SIRPα pathway and activating Fc receptors to promote
immuno-stimulatory pathways that drive anti-tumor immunity.
Recent Corporate Updates
- Peter Heutink, Ph.D., began his role as Alector’s Chief
Scientific Officer in October. Leveraging nearly 30 years of
experience in the neurodegenerative disease space, Dr. Heutink
provides scientific oversight of the company’s significant research
pipeline and helps drive business strategy.
Third Quarter 2022 Financial Results
Revenue. Collaboration revenue for the quarter
ended September 30, 2022, was $14.9 million, compared to $182.4
million for the same period in 2021. The decrease of $167.6 million
was due to $173.4 million collaboration revenue recognized from
AL001 FTD-GRN license provided as part of the GSK Agreement in
2021.
R&D Expenses. Total research and
development expenses for the quarter ended September 30, 2022, were
$48.3 million, compared to $43.1 million for the quarter ended
September 30, 2021. The increase in R&D expenses was mainly
driven by increased personnel-related expenses as well as an
increase in AL002 expenses.
G&A Expenses. Total general and
administrative expenses for the quarter ended September 30, 2022,
were $14.3 million, compared to $13.0 million for the same period
in 2021. The increase is primarily due to personnel-related
expenses.
Net Income (Loss). For the quarter ended
September 30, 2022, Alector reported net loss of $46.1 million, or
$0.56 net loss per share, compared to a net income of $126.6
million, or $1.56 net income per share, for the same period in
2021.
Cash Position. Cash, cash equivalents, and
investments were $758.3 million as of September 30, 2022.
Management anticipates that this will be sufficient to fund current
operations through 2024.
About AlectorAlector is a clinical-stage
biotechnology company pioneering immuno-neurology, a novel
therapeutic approach for the treatment of neurodegenerative
diseases, and innate immuno-oncology. 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 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 innate 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. Forward-looking
statements in this press release include, but are not limited to,
statements regarding our business plans, business strategy, product
candidates, planned preclinical studies, clinical trials, expected
milestones, expectations of our collaborations, and financial and
cash guidance. Such statements are subject to numerous risks and
uncertainties, including but not limited to risks and uncertainties
as set forth in Alector’s Quarterly Report on Form 10-Q, as filed
on November 8, 2022, 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, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
Cash, cash equivalents, and marketable securities |
|
$ |
758,306 |
|
$ |
735,251 |
Total assets |
|
|
837,038 |
|
|
814,658 |
Total current liabilities (excluding deferred revenue) |
|
|
41,205 |
|
|
48,752 |
Deferred revenue (including current portion) |
|
|
506,041 |
|
|
425,218 |
Total liabilities |
|
|
583,934 |
|
|
513,934 |
Total stockholders’ equity |
|
|
253,104 |
|
|
300,724 |
Consolidated Statement of Operations
Data(in thousands, except share and per share
data)
|
|
Three Months Ended September 30, |
|
|
Nine Months Ended September 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
2022 |
|
|
2021 |
|
Collaboration revenue |
|
$ |
14,852 |
|
|
|
$ |
182,413 |
|
|
$ |
119,177 |
|
|
$ |
193,091 |
|
Operating expense: |
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
48,348 |
|
|
|
|
43,066 |
|
|
|
155,925 |
|
|
|
136,617 |
|
General and administrative |
|
|
14,252 |
|
|
|
|
13,018 |
|
|
|
45,648 |
|
|
|
38,015 |
|
Total operating expenses |
|
|
62,600 |
|
|
|
|
56,084 |
|
|
|
201,573 |
|
|
|
174,722 |
|
Income (loss) from
operations |
|
|
(47,748 |
) |
|
|
|
126,329 |
|
|
|
(82,396 |
) |
|
|
18,369 |
|
Other income, net |
|
|
2,333 |
|
|
|
|
268 |
|
|
|
4,047 |
|
|
|
910 |
|
Net income (loss) before income
tax |
|
|
(45,415 |
) |
|
|
|
126,597 |
|
|
|
(78,349 |
) |
|
|
19,279 |
|
Income tax expense |
|
|
733 |
|
|
|
|
|
|
|
|
2,533 |
|
|
|
|
|
Net income (loss) |
|
$ |
(46,148 |
) |
|
|
$ |
126,597 |
|
|
$ |
(80,882 |
) |
|
$ |
19,279 |
|
Net income (loss) per
share: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per
share |
|
$ |
(0.56 |
) |
|
|
$ |
1.56 |
|
|
$ |
(0.98 |
) |
|
$ |
0.24 |
|
Diluted net income (loss) per
share |
|
$ |
(0.56 |
) |
|
|
$ |
1.49 |
|
|
$ |
(0.98 |
) |
|
$ |
0.23 |
|
Weighted-average shares used in
calculating: |
|
|
|
|
|
|
|
|
|
|
|
|
Basic net income (loss) per
share |
|
|
82,602,842 |
|
|
|
|
80,964,701 |
|
|
|
82,367,936 |
|
|
|
80,048,758 |
|
Diluted net income (loss) per
share |
|
|
82,602,842 |
|
|
|
|
85,232,690 |
|
|
|
82,367,936 |
|
|
|
82,871,254 |
|
Contacts:
1AB (media) Dan Budwick 973-271-6085 dan@1abmedia.com
Argot Partners (investors) Laura Perry/Carrie McKim Argot
Partners 212.600.1902 alector@argotpartners.com
Alector (NASDAQ:ALEC)
Historical Stock Chart
From Apr 2024 to May 2024
Alector (NASDAQ:ALEC)
Historical Stock Chart
From May 2023 to May 2024