Alector, Inc. (Nasdaq: ALEC), a clinical-stage biotechnology
company pioneering the discovery and development of
immuno-neurology therapeutics, today reported fourth quarter and
full year 2021 financial results and summarized recent portfolio
and business updates. As of December 31, 2021, Alector’s cash, cash
equivalents and investments totaled $735.3 million. In addition,
the company received a $200 million payment from partner
GlaxoSmithKline (GSK) in January 2022.
“Over the past year, we made important strides in advancing our
clinical and preclinical pipeline of candidates harnessing the
innate immune system to address genetically validated targets
against neurodegenerative diseases,” said Arnon Rosenthal, Ph.D.,
co-founder and Chief Executive Officer of Alector. “We shared the
largest data set to date in individuals with frontotemporal
dementia and established a transformative collaboration with
GlaxoSmithKline designed to expand and accelerate the development
of our progranulin franchise candidates, AL001 and AL101. We are
building on this momentum in 2022; with three new INDs on the
horizon, we expect to end the year with seven therapeutic
candidates in clinical trials. With our strong balance sheet,
expanded leadership team, growing development capabilities,
maturing pipeline and productive research platform, we are
well-positioned to execute our mission.”
Recent Clinical Updates and 2022 Milestones
Progranulin Programs: AL001 and AL101 Alector
is developing monoclonal antibodies AL001 and AL101 to elevate
levels of progranulin in the brain in partnership with GSK.
Mutations resulting in progranulin deficiencies are known to be a
causal factor for frontotemporal dementia (FTD) and a risk factor
for amyloid lateral sclerosis (ALS), Alzheimer’s disease and
Parkinson’s disease. In July 2021, Alector entered into a global
collaboration with GSK to co-develop and co-commercialize AL001 and
AL101. Alector is actively enrolling the INFRONT-3 Phase 3 pivotal
clinical study of AL001 in at-risk and symptomatic carriers of
frontotemporal dementia with a progranulin mutation (FTD-GRN).
- In January 2022, the journal Trends in Pharmacological Sciences
published a review article in press, “Progranulin as a therapeutic
target in neurodegenerative diseases” by Alector authors as part of
the journal’s special issue, “Advances in neuro-immunology based
therapeutic opportunities”.
- In November 2021, Alector presented data from the INFRONT-2
Phase 2 open-label clinical study of AL001 in patients with
symptomatic FTD-GRN at the 14th Clinical Trials on Alzheimer’s
Disease (CTAD) medical meeting.
- AL001 restored progranulin to normal levels for the entire
duration of treatment. In addition, multiple biomarkers known to be
elevated in FTD-GRN decreased toward normal levels following
treatment with AL001. Clinical outcome assessments of AL001-treated
patients showed slowing of clinical progression by 48% compared to
a matched control cohort of participants from the Genetic FTD
Initiative (GENFI2).
- The totality of the Phase 2 data and consistent response across
diverse endpoints support the continued evaluation of AL001 in the
ongoing INFRONT-3 Phase 3 study.
- AL001 was generally well tolerated when administered monthly
for a year or more.
- Twelve-month data from Alector’s INFRONT-2 Phase 2 clinical
trial of AL001 in a cohort of patients with FTD with a C9orf72
genetic mutation have been accepted for presentation at the
International Conference on Alzheimer’s and Parkinson’s Diseases
(ADPD) in March 2022.
- In November 2021 Alector presented interim results from the
AL101 first-in-human study of healthy volunteers. The study
established that AL101 was effectively distributed into the central
nervous system (CNS) and showed proof of mechanism, with increases
in progranulin levels observed in the periphery and the brain
persisting for one month.
- AL101 was found to be generally well tolerated with single-dose
IV or SC administration.
- The AL101 Phase 1 study is continuing to enroll additional
cohorts to test further dosages of AL101 administered intravenously
or subcutaneously and is expected to be completed by the end of
2022.
Alzheimer’s Disease PortfolioAL002 and AL003
are Alector’s clinical-stage immuno-neurology antibodies being
advanced for the treatment of Alzheimer’s disease. AL002 is
intended to optimize microglial activity in the brain to combat
Alzheimer’s disease by binding to the TREM2 receptor to stimulate
microglia activity. AL003 blocks the Siglec3, or CD33, checkpoint
inhibitor to increase microglia activity. Both are being developed
in collaboration with AbbVie.
- In November 2021, Alector presented Phase 1 data for AL003 in
healthy volunteers and participants with Alzheimer’s disease at
CTAD. AL003 was found to be well tolerated when administered
monthly at doses up to and including 15 mg/kg. AL003 demonstrated
target engagement of CD33 in both blood and CNS compartments at
well tolerated doses.
- In the fourth quarter 2021, Alector reported that Amyloid
Related Imaging Abnormalities (ARIA) have been observed in the
ongoing AL002 INVOKE-2 Phase 2 clinical trial in Alzheimer’s
disease.
- While the large majority of ARIA cases observed were
asymptomatic and non-serious, a small number of serious adverse
events occurred in participants carrying two identical alleles of
the APOE (apolipoprotein E) gene mutation. In addition to protocol
amendments voluntarily put in place last year to mitigate risks
associated with ARIA, Alector plans to voluntarily amend the Phase
2 trial protocol to exclude APOE e4/e4 homozygotes and to
discontinue dosing of APOE e4/e4 homozygotes currently on study.
The potential impact, if any, of this protocol amendment on timing
to complete enrollment of the INVOKE-2 Phase 2 clinical trial is
being assessed.
Early-Stage Pipeline in Neurodegenerative Diseases and
Oncology In 2022 Alector plans to advance three novel
therapeutic candidates, including the company’s first
immuno-oncology agents, into first-in-human clinical studies.
- A Phase 1 clinical study of treatment with AL008 in patients
with advanced solid tumors is expected to begin in the first half
of 2022 in China. This first-in-human study will be led by
Alector’s regional partner, Innovent Biologics. AL008 is a novel
innate immuno-oncology candidate with a dual mechanism of action
that combines inhibition of the CD47-SIRP-alpha (SIRPα) pathway
with stimulation of activating Fc receptors.
- In November 2021, Alector presented preclinical data from its
AL009 immuno-oncology program at the Society for Immunotherapy of
Cancer’s (SITC) 36th Annual Meeting. In vivo, AL009 led to
dose-dependent increases in immune stimulatory molecules consistent
with the repolarization of myeloid-derived suppressive cells to a
proinflammatory state. A Phase 1 clinical study of AL009 in
patients with advanced solid tumors is expected to begin in the
second half of 2022. AL009 is a first-in-class multi SIGLEC
inhibitor.
- Alector plans to initiate the first-in-human study for AL044 in
the second half of 2022. AL044 targets MS4A, a risk gene
family for Alzheimer’s disease. MS4A is expressed selectively in
microglia and is associated with control of microglia functionality
and potential viability.
Recent Corporate News
- In January 2022, Alector received the remaining $200 million
from its $700 million committed upfront payment from the GSK
collaboration agreement signed by the two companies in July 2021.
Under the terms of the agreement, Alector will also be eligible for
up to $1.5 billion in potential development, regulatory and
commercial milestone payments, as well as profit-sharing in the
U.S. and royalties on any ex-U.S. sales.
- Alector expanded its management team with the appointments of
Sara Kenkare-Mitra, Ph.D., as Alector’s President and Head of
Research and Development, and Marc Grasso, M.D., as Chief Financial
Officer.
- Dr. Kenkare-Mitra joined Alector in December 2021 from
Genentech, where she served as Senior Vice President of Development
Sciences. Dr. Kenkare-Mitra brings more than 23 years of experience
overseeing the transition of molecules from discovery to the clinic
and throughout clinical development.
- Dr. Grasso joined Alector from Kura Oncology, where he served
as Chief Financial Officer and Chief Business Officer. Prior to
Kura, he spent over twenty years in investment banking advising
biotechnology and pharmaceutical companies.
Fourth Quarter and Full Year 2021 Financial
Results
Revenue. Collaboration revenue for the
quarter ended December 31, 2021, was $14.0
million, compared to $4.9 million for the same
period in 2020. Collaboration revenue for the year
ended December 31, 2021, was $207.1 million compared
to $21.1 million for the same period in 2020. The
increase in year-over-year collaborative revenue was primarily
driven by the strategic collaboration with GSK.
R&D Expenses. Total research and
development expenses for the quarter ended December 31, 2021,
were $52.8 million compared to $44.4 million for the
quarter ended December 31, 2020. Total research and development
expenses for the year ended December 31, 2021,
were $189.4 million compared to $156.9
million for the same period in 2020. This change in 2021
R&D expenses was mainly driven by increased spending to support
advancement of several clinical and preclinical programs, as well
as increased personnel-related expenses.
G&A Expenses. Total general and
administrative expenses for the quarter ended December 31, 2021,
were $16.9 million compared to $13.2
million for the same period in 2020. This increase was
primarily due to an increase in personnel-related expenses. Total
general and administrative expenses for the year
ended December 31, 2021, were $55.0
million compared to $59.4 million for the same
period in 2020. This decrease was primarily due to a decrease in
legal costs associated with Alector’s arbitration proceedings in
2020 partially offset by an increase in personnel-related
expenses.
Net Loss. For the quarter
ended December 31, 2021, Alector reported a net loss
of $55.6 million, or $0.68 per share, compared to a net loss
of $52.2 million, or $0.66 per share, for the same period
in 2020. For the year ended December 31, 2021, Alector
reported a net loss of $36.3 million, or $0.45 net loss per
share, compared to a net loss of $190.2 million, or $2.45 net
loss per share, for the same period in 2020.
Cash Position. Cash, cash equivalents, and
marketable securities were $735.3 million as
of December 31, 2021. In addition, the company received a $200
million payment from partner GSK in January 2022.
Cash Guidance. Alector continues to anticipate
that the company’s existing cash, cash equivalents, and marketable
securities, including the net proceeds received from GSK in January
2022, are sufficient to fund projected 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 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 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) |
|
|
|
|
|
|
|
December 31, |
|
December 31, |
|
|
2021 |
|
2020 |
Cash, cash equivalents, and marketable securities |
|
$ |
735,251 |
|
|
$ |
413,308 |
|
Total assets |
|
|
814,658 |
|
|
|
488,251 |
|
Total current liabilities
(excluding deferred revenue) |
|
|
48,218 |
|
|
|
44,202 |
|
Deferred revenue (including
current portion) |
|
|
425,218 |
|
|
|
132,303 |
|
Total liabilities |
|
|
513,934 |
|
|
|
220,721 |
|
Total stockholders’ equity |
|
|
300,724 |
|
|
|
267,530 |
|
|
|
|
|
|
|
|
|
|
|
Consolidated Statement of Operations
Data(in thousands, except share and per share
data) |
|
|
|
|
|
|
|
|
Three Months Ended December
31, |
|
|
Twelve Months Ended December
31, |
|
|
|
2021 |
|
|
2020 |
|
|
2021 |
|
|
2020 |
|
Collaboration revenue |
|
$ |
13,994 |
|
|
$ |
4,853 |
|
|
$ |
207,085 |
|
|
$ |
21,098 |
|
Operating
expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research and development |
|
|
52,790 |
|
|
|
44,383 |
|
|
|
189,407 |
|
|
|
156,869 |
|
General and administrative |
|
|
16,933 |
|
|
|
13,228 |
|
|
|
55,038 |
|
|
|
59,403 |
|
Total operating expenses |
|
|
69,723 |
|
|
|
57,611 |
|
|
|
244,445 |
|
|
|
216,272 |
|
Loss from
operations |
|
|
(55,729 |
) |
|
|
(52,758 |
) |
|
|
(37,360 |
) |
|
|
(195,174 |
) |
Other income,
net |
|
|
121 |
|
|
|
579 |
|
|
|
1,031 |
|
|
|
4,946 |
|
Net loss |
|
$ |
(55,608 |
) |
|
$ |
(52,179 |
) |
|
$ |
(36,329 |
) |
|
$ |
(190,228 |
) |
Net loss per
share, basic and diluted |
|
$ |
(0.68 |
) |
|
$ |
(0.66 |
) |
|
$ |
(0.45 |
) |
|
$ |
(2.45 |
) |
Shares used in
computing net loss per share basic and diluted |
|
|
81,510,894 |
|
|
|
78,998,656 |
|
|
|
80,416,936 |
|
|
|
77,758,806 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alector Contacts1AB (media)Dan
Budwick973-271-6085dan@1abmedia.com
Argot Partners (investors)Eric Kasper/Carrie McKimArgot
Partners212.600.1902alector@argotpartners.com
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