Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering immuno-neurology, today reported first quarter
2022 financial results and recent portfolio and business updates.
As of March 31, 2022, Alector’s cash, cash equivalents, and
marketable securities totaled $868.6 million.
“We made significant progress in the first quarter, highlighted
by the presentation of 12-month data from our INFRONT-2 Phase 2
clinical trial of latozinemab in patients with symptomatic
FTD-C9orf72, in which treatment with latozinemab demonstrated
target engagement and resulted in increases in progranulin levels
above physiological levels in all patients,” said Arnon Rosenthal,
Ph.D., Chief Executive Officer of Alector. “Data from the
FTD-C9orf72 cohort builds upon the results observed in our studies
to date in patients with symptomatic FTD-GRN. The totality of the
data supports our approach of elevating progranulin levels to
address a range of neurodegenerative diseases including FTD, ALS,
Parkinson’s disease and Alzheimer’s disease. We look forward to
evaluating latozinemab and AL101 in multiple indications as part of
our progranulin franchise in partnership with GlaxoSmithKline.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and
Development at Alector, added, “In parallel to advancing and
expanding our progranulin franchise, we continue to make progress
in our Alzheimer’s and oncology programs. Our INVOKE-2 Phase 2
clinical trial evaluating AL002 in slowing disease progression in
individuals with early Alzheimer’s disease is ongoing, and we also
expect to initiate a Phase 1 trial for AL044, which targets MS4A, a
major risk locus for Alzheimer’s disease, in the second half of
2022. Additionally, we presented exciting preclinical data from our
AL009 immuno-oncology program at the 2022 AACR Annual Meeting, with
a Phase 1 trial slated to begin within the next year. This clinical
momentum, coupled with the addition of veteran neurodegeneration
expert, Gary Romano, as Chief Medical Officer, puts Alector in a
strong position to execute our goal of halting the destruction
caused by neurodegenerative diseases.”
Recent Clinical Updates
Progranulin Franchise Portfolio
- Twelve-month data from the INFRONT-2
Phase 2 clinical trial of latozinemab in frontotemporal dementia
patients (FTD) with a C9orf72 genetic mutation (FTD-C9orf72) were
presented at the AD/PD™ 2022 International Conference on
Alzheimer’s and Parkinson’s Diseases and related neurological
disorders. Latozinemab treatment was well tolerated and resulted in
a two- to three-fold increase in progranulin above physiological
levels in cerebrospinal fluid (CSF) and plasma respectively, and a
decrease in the neurodegeneration biomarker GFAP. When compared to
a matched control cohort from the ALLFTD consortium, treatment with
latozinemab in FTD-C9orf72 patients resulted in a trend towards an
annual delay of disease progression of approximately 54 percent as
measured by the CDR® plus NACC FTLD-SB scale. These data support
the company’s efforts to expand the progranulin franchise into
additional neurodegenerative disease indications.
- Enrollment is ongoing in INFRONT-3,
a randomized, placebo-controlled, pivotal Phase 3 trial evaluating
the efficacy and safety of latozinemab in at-risk and symptomatic
patients with FTD due to a progranulin gene mutation (FTD-GRN).
Participants in the trial will be given the option to continue
receiving treatment in an open-label extension study.
- In partnership with GSK, the company
made a strategic, non-safety related decision to close enrollment
in the Phase 2a biomarker trial of latozinemab in people with
amyotrophic lateral sclerosis (ALS) who carry a C9orf72 mutation.
In light of the evolving ALS landscape, the company is currently
evaluating plans for a potential Phase 2b study for patients with
all forms of ALS, including the C9orf72 mutation.
- Alector completed
enrollment in the ongoing Phase 1 clinical trial to test multiple
doses of AL101 administered intravenously and subcutaneously.
AL101, the second drug candidate in the company’s progranulin
franchise, is designed to elevate progranulin levels, similar to
AL001, with the potential for easier administration and/or less
frequent dosing for the treatment of more prevalent
neurodegenerative diseases, including Alzheimer’s disease and
Parkinson’s disease. The company expects to report data from the
Phase 1 trial in the second half of 2022.
Alzheimer’s Disease Portfolio
- The INVOKE-2 Phase 2 clinical trial
evaluating the efficacy and safety of AL002 in slowing disease
progression in individuals with early Alzheimer’s disease is
ongoing. AL002 targets Triggering Receptor Expressed on Myeloid
cells 2 (TREM2) to increase TREM2 signaling and the functionality
of the microglia brain specific immune cells. It is being developed
in collaboration with AbbVie.
- AL003 is being developed to treat
patients with Alzheimer’s disease in collaboration with AbbVie.
AL003 focuses on modulating checkpoint receptors on the brain’s
immune cells, targeting sialic acid binding Ig-like lectin 3
(SIGLEC 3, also called CD33). In 2021, we presented data from the
Phase 1 trial of AL003 in healthy volunteers and Alzheimer’s
disease patients. Alector is currently reviewing potential next
steps for the AL003 program together with AbbVie.
- Alector expects to initiate a Phase 1 clinical trial for AL044
in the second half of 2022. AL044 targets MS4A, a major risk locus
for Alzheimer’s disease. MS4A gene family members encode a
transmembrane protein that is expressed selectively in myeloid
cells in the brain and is associated with control of microglia
functionality and potentially with microglia viability.
Immuno-oncology Portfolio
- At the 2022 American Association for Cancer Research (AACR)
Annual Meeting, Alector presented preclinical data from its
first-in-class AL009 innate immuno-oncology program. 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 findings demonstrated that AL009 led to
repolarization of myeloid cells and activation of innate and
adaptive immunity against tumors. Pharmacologically relevant doses
of AL009 appeared well-tolerated in initial non-human primate
studies. IND enabling studies are ongoing, and a Phase 1 clinical
study of AL009 in patients with advanced solid tumors is expected
to begin within the next year.
Recent Corporate News
- Gary Romano, M.D., Ph.D., will join Alector’s executive
leadership team as Chief Medical Officer (CMO) on May 23, 2022, and
Marc Grasso, M.D., joined as Chief Financial Officer (CFO).
- Dr. Romano is a board-certified
neurologist, neurodegeneration expert and recognized clinical
leader in the industry with a demonstrated track record in
progressing the development of therapeutics for multiple
neuroscience indications. As CMO, Dr. Romano will lead the
company’s global clinical development strategy, including oversight
of the clinical development, clinical operations, biometrics and
digital science and medical affairs functions.
- Dr. Grasso brings extensive biotechnology industry leadership
experience, including a successful track record in finance and
corporate development. As CFO, Dr. Grasso leads all aspects of the
company’s financial operations and plays a critical role in
supporting corporate strategy.
First Quarter 2022 Financial Results
Revenue. Collaboration revenue for the quarter
ended March 31, 2022, was $24.5 million, compared to $4.1 million
for the same period in 2021. This increase was primarily due to
revenue recognized from the GSK Agreement.
R&D Expenses. Total research and
development expenses for the quarter ended March 31, 2022, were
$53.0 million, compared to $45.7 million for the quarter ended
March 31, 2021. The increase in R&D expenses was mainly driven
by increased personnel-related expenses, as well as increased
spending to support advancement of several clinical and preclinical
programs.
G&A Expenses. Total general and
administrative expenses for the quarter ended March 31, 2022, were
$15.6 million, compared to $11.0 million for the same period in
2021 was primarily due to an increase in personnel-related expenses
and increase in legal expenses from the arbitration award in 2021
that reduced expenses.
Net Loss. For the quarter ended March 31, 2022,
Alector reported a net loss of $44.6 million, or $0.54 per share,
compared to a net loss of $52.2 million, or $0.66 per share, for
the same period in 2021.
Cash Position. Cash, cash equivalents, and
marketable securities were $868.6 million as of March 31, 2022.
Management expects that this will be sufficient to fund current
operations into mid-2024.
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.
Forward-Looking StatementsThis 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 Annual Report on Form 10-K, as filed on
February 24, 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)
|
|
March 31, |
|
December 31, |
|
|
2022 |
|
2021 |
|
|
|
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
|
$ |
868,571 |
|
|
$ |
735,251 |
|
Total assets |
|
|
954,457 |
|
|
|
814,658 |
|
Total current liabilities
(excluding deferred revenue) |
|
|
47,267 |
|
|
|
48,752 |
|
Deferred revenue (including
current portion) |
|
|
600,744 |
|
|
|
425,218 |
|
Total liabilities |
|
|
686,920 |
|
|
|
513,934 |
|
Total stockholders’
equity |
|
|
267,537 |
|
|
|
300,724 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations
Data(in thousands, except share and per share
data)
|
|
Three Months Ended March 31, |
|
|
2022 |
|
2021 |
Collaboration revenue |
|
$ |
24,474 |
|
|
$ |
4,110 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
Research and development |
|
|
53,043 |
|
|
|
45,733 |
|
General and administrative |
|
|
15,554 |
|
|
|
11,012 |
|
Total operating expenses |
|
|
68,597 |
|
|
|
56,745 |
|
Loss from
operations |
|
|
(44,123 |
) |
|
|
(52,635 |
) |
Other income,
net |
|
|
264 |
|
|
|
464 |
|
Loss before income
tax |
|
|
(43,859 |
) |
|
|
(52,171 |
) |
Income tax
expense |
|
|
758 |
|
|
|
— |
|
Net loss |
|
$ |
(44,617 |
) |
|
$ |
(52,171 |
) |
Net loss per
share, basic and diluted |
|
$ |
(0.54 |
) |
|
$ |
(0.66 |
) |
Shares used in
computing net loss per share basic and diluted |
|
|
82,102,191 |
|
|
|
79,386,836 |
|
Contacts:
1AB (media)Dan Budwick973-271-6085 dan@1abmedia.com
Argot Partners (investors)Eric Kasper/Carrie McKimArgot
Partners212.600.1902alector@argotpartners.com
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