Alector, Inc. (Nasdaq: ALEC), a late-stage clinical biotechnology
company focused on developing therapies to counteract the
devastating progression of neurodegeneration, today reported fourth
quarter and full year 2024 financial results and recent portfolio
and business updates. As of December 31, 2024, Alector’s cash,
cash equivalents and investments totaled $413.4 million.
“Alector is entering a potentially transformative period for the
company, as we continue to advance our clinical programs toward key
milestones while also driving the development of our wholly owned,
early-stage pipeline,” said Arnon Rosenthal, Ph.D., Chief Executive
Officer of Alector. “We look forward to reporting topline data from
the pivotal INFRONT-3 Phase 3 trial of latozinemab targeting
frontotemporal dementia with a granulin gene mutation by the fourth
quarter. Additionally, we expect to complete enrollment in the
PROGRESS-AD Phase 2 trial of AL101/GSK4527226 in participants with
early Alzheimer’s disease by mid-2025. With our broad and diverse
portfolio of genetically validated drug candidates for the
treatment of neurodegenerative diseases, backed by a strong
financial position that will fund operations through 2026, Alector
is well-positioned to advance our mission to deliver transformative
therapies for patients with neurodegenerative brain disorders.”
Sara Kenkare-Mitra, Ph.D., President and Head of Research and
Development at Alector, added, “We are making significant progress
in advancing Alector’s preclinical and research pipeline. By
leveraging our expertise in neuroscience and drug discovery, and
selectively applying our proprietary Alector Brain Carrier
technology platform, we are able to enhance brain delivery and
biodistribution of therapeutic cargo to potentially improve safety
and efficacy. We are currently selecting lead candidates for two
programs, ADP037-ABC, targeting amyloid beta, and ADP050-ABC,
replacing GCase. We aim to advance these programs toward
IND-enabling studies later this year, with plans to enter the
clinic in 2026.”
Recent Clinical Updates
Progranulin Programs (latozinemab
(AL001) and AL101/GSK4527226) Being Developed in Collaboration with
GSK
Latozinemab
- The pivotal, randomized, double-blind, placebo-controlled
INFRONT-3 Phase 3 clinical trial of latozinemab targeting
frontotemporal dementia with a granulin gene mutation (FTD-GRN) is
ongoing. Topline data are anticipated by the fourth quarter of
2025.
- Latozinemab is a novel investigational human monoclonal
antibody (mAb) designed to block and downregulate the sortilin
receptor to elevate the level of progranulin (PGRN) in the brain.
It has been granted Orphan Drug, Breakthrough Therapy and Fast
Track designations, and the company believes it is the most
advanced PGRN-elevating candidate in development for this
condition.
AL101/GSK4527226
- PROGRESS-AD, a global, randomized, double-blind,
placebo-controlled Phase 2 clinical trial evaluating
AL101/GSK4527226 in early Alzheimer’s disease (AD) continues to
enroll well, with substantial progress toward its target enrollment
of 282 participants. Alector and GSK plan to complete trial
enrollment by mid-2025.
- AL101/GSK4527226 is an investigational human mAb designed to
block and downregulate the sortilin receptor to elevate the level
of PGRN in the brain in a manner that is similar to investigational
latozinemab but with different pharmacokinetic and pharmacodynamic
properties, making it suitable for the potential treatment of more
prevalent neurodegenerative diseases.
Preclinical and Research
Pipeline
Alector is advancing a preclinical and early research pipeline
focused on removing toxic proteins, replacing deficient proteins,
and restoring immune and nerve cell function. Leveraging its deep
expertise in drug development and proprietary technologies,
including protein engineering, antibody discovery, and its Alector
Brain Carrier (ABC) platform for blood-brain barrier transport, the
company is progressing a curated portfolio of programs targeting
genetically validated disease mechanisms. This approach has led to
a suite of innovative programs with the potential to make a
significant impact on neurodegeneration.
- ADP037-ABC is a proprietary anti-amyloid beta
(Aβ) antibody paired with the company’s ABC for the treatment of
AD. It is designed to remove brain Aβ plaques, with the potential
to reduce the incidence and/or severity of amyloid-related imaging
abnormalities (ARIA) and enable subcutaneous delivery. It targets a
validated epitope, specific to brain Aβ plaques, combined with an
optimized antibody constant region to enhance phagocytosis of Aβ
plaques. By leveraging ABC technology, ADP037-ABC aims to clear Aβ
efficiently, thereby reducing plaque accumulation and potentially
slowing disease progression while minimizing ARIA.
- ADP050-ABC is a GCase replacement therapy
paired with the company’s proprietary ABC for GBA gene mutation
carriers with Parkinson’s disease (PD) and Lewy body dementia. In
these patients, mutations in the GBA gene lead to deficient GCase
activity. ADP050-ABC uses Alector-engineered GCase, which is
proprietary and has been designed to have a longer half-life and to
break down glucocerebroside, a lipid that accumulates in neurons
and contributes to neurodegeneration. This mechanism aims to reduce
cellular dysfunction and slow disease progression.
- ADP056 is a Reelin modulator designed to block
tau pathology and promote synaptic function in AD. Reelin, a large,
secreted protein, regulates neuronal function and tau accumulation.
Gain-of-function Reelin variants protect against familial AD
through a mechanism that appears to uncouple amyloid and tau
pathology. ADP056 is designed to mimic these protective effects of
the Reelin mutation.
- ADP063-ABC and ADP064-ABC are
therapeutic candidates paired with the company’s proprietary ABC
that target tau pathology in AD through distinct approaches. First,
ADP063-ABC will focus on combining a proprietary anti-tau antibody
directed to a validated tau epitope with ABC and an optimized
antibody constant region. It is designed to block the spread of tau
aggregates and has the potential for subcutaneous delivery. Second,
ADP064-ABC will focus on using an anti-tau siRNA combined with ABC,
which aims to prevent the synthesis of the tau mRNA and protein.
Both approaches seek to leverage a highly brain-penetrant approach
to remove toxic tau and potentially slow cognitive decline in
AD.
- In December 2024, Alector and co-recipient University of
Luxembourg were awarded a $1.7 million grant from The Michael J.
Fox Foundation for Parkinson’s Research (MJFF) for collaborative
research on glycoprotein nonmetastatic melanoma protein B (GPNMB),
a PD target.
- Alector plans to hold an educational webinar in the second
quarter of 2025 to present additional preclinical data on the
company’s anti-amyloid beta and GCase programs, as well as
advancements in ABC.
TREM2 Program (AL002)
- On April 5, 2025, Alector plans to
present the results from the INVOKE-2 Phase 2 clinical trial, which
evaluated the safety and efficacy of AL002, a TREM2 agonist, in
individuals with early AD, during an oral presentation at the
AD/PD™ 2025 International Conference on Alzheimer’s and Parkinson’s
Diseases, taking place in Vienna, Austria. While the trial did not
meet its primary endpoint, Alector remains committed to advancing
the understanding of AD pathophysiology and the development of
effective therapeutics for the disease.
Fourth Quarter 2024 Financial Results
Revenue. Collaboration revenue for the
quarter ended December 31, 2024, was $54.2 million,
compared to $15.2 million for the same period in 2023.
Collaboration revenue for the year ended December 31, 2024,
was $100.6 million, compared to $97.1 million for the
same period in 2023. The increase in year-over-year collaborative
revenue was primarily due to an increase in revenue recognized for
the AL002 and latozinemab programs. Collaboration revenue under the
AbbVie Agreement was fully recognized as of December 31, 2024.
R&D Expenses. Total research and
development expenses for the quarter ended December 31, 2024,
were $46.5 million, compared to $47.7 million for
the quarter ended December 31, 2023. Total research and
development expenses for the year ended December 31, 2024,
were $185.9 million compared to $192.1 million for
the same period in 2023. The decrease in year-over-year R&D
expenses was mainly due to the Company’s strategy to prioritize
selected programs.
G&A Expenses. Total general and
administrative expenses for the quarter ended December 31,
2024, were $15.0 million compared to $14.9
million for the quarter ended December 31, 2023. Total
general and administrative expenses for the year
ended December 31, 2024, were $59.6 million compared
to $56.7 million for the year ended December 31,
2023. The increase in year-over-year G&A expenses is primarily
due to the impairment of the right-of-use asset and the leasehold
improvements as the Company approved a plan to transition
operations from our laboratory and offices in Newark, California to
our South San Francisco Headquarters.
Net Loss. For the quarter
ended December 31, 2024, Alector reported a net loss
of $2.1 million, or $0.02 net loss per share,
compared to a net loss of $41.4 million,
or $0.49 net loss per share, for the same period in 2023.
For the year ended December 31, 2024, Alector reported a net
loss of $119.0 million or $1.23 net loss per
share, compared to a net loss of $130.4
million or $1.56 net loss per share, for the same
period in 2023.
Cash Position. Cash, cash equivalents, and
investments were $413.4 million as of December 31,
2024. Management expects that this will be sufficient to fund
current operations through 2026.
2025 Guidance. Management anticipates, for
the year ending 2025, collaboration revenue to be between $5
million and $15 million, total research and development
expenses to be between $175 million and $185
million, and total general and administrative expenses to be
between $55 million and $65 million.
Fourth Quarter and Full Year 2024 Conference
Call
Alector’s management team will host a conference call to discuss
Alector’s results for the fourth quarter and full year 2024, as
well as provide a business update. The conference call will be
webcast and accessible via the investor relations section of
Alector’s website at www.alector.com.
To access the call, please use the following information:
Date: Wednesday, February 26, 2025Time: 4:30 p.m.
ET, 1:30 p.m. PT
The event will be webcast live under the investor relations
section of Alector’s website
at https://investors.alector.com/events-and-presentations/events and
following the event a replay will be archived there for 30 days.
Interested parties participating by phone will need to register
using this online form. After registering for dial-in details,
all phone participants will receive an auto-generated e-mail
containing a link to the dial-in number along with a personal PIN
number to use to access the event by phone.
About AlectorAlector is a late-stage clinical
biotechnology company focused on developing therapies to counteract
the devastating progression of neurodegenerative diseases.
Leveraging the principles of genetics, immunology and neuroscience,
the company is advancing a portfolio of genetically validated
programs that aim to remove toxic proteins, replace missing
proteins, and restore immune and nerve cell function. Supported by
biomarkers, Alector’s product candidates seek to treat a range of
indications, including frontotemporal dementia, Alzheimer’s
disease, Parkinson's disease, and Lewy body dementia. The company
is also developing Alector Brain Carrier (ABC), a proprietary
blood-brain barrier platform, which is being selectively applied to
its next-generation product candidates and research pipeline. ABC
aims to enhance the delivery of therapeutics, achieve deeper brain
penetration and efficacy at lower doses, and ultimately improve
patient outcomes while reducing costs. Alector is headquartered in
South San Francisco, California. For more 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, blood-brain barrier technology platform, research and
preclinical pipeline, planned and ongoing preclinical studies and
clinical trials, anticipated timing of and detail regarding release
of data for INFRONT-3, expected milestones, expectations of our
collaborations, expectations of our interactions with regulatory
authorities, 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-K filed for 2024, 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, |
|
2024 |
|
2023 |
|
|
|
|
|
|
Cash, cash equivalents, and
marketable securities |
$ |
413,397 |
|
$ |
548,861 |
Total assets |
|
468,303 |
|
|
621,827 |
Total current liabilities
(excluding deferred revenue) |
|
101,396 |
|
|
94,973 |
Deferred revenue (including
current portion) |
|
195,832 |
|
|
293,820 |
Total liabilities |
|
341,503 |
|
|
487,669 |
Total stockholders’
equity |
|
126,800 |
|
|
134,158 |
|
|
|
|
|
|
Consolidated Statement of Operations Data |
(in thousands, except share and per share data) |
|
|
Three Months EndedDecember
31, |
|
Twelve Months EndedDecember
31, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Collaboration revenue |
$ |
54,240 |
|
|
$ |
15,190 |
|
|
$ |
100,558 |
|
|
$ |
97,062 |
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
|
46,461 |
|
|
|
47,723 |
|
|
|
185,940 |
|
|
|
192,115 |
|
General and administrative |
|
15,028 |
|
|
|
14,920 |
|
|
|
59,615 |
|
|
|
56,687 |
|
Total operating expenses |
|
61,489 |
|
|
|
62,643 |
|
|
|
245,555 |
|
|
|
248,802 |
|
Loss from operations |
|
(7,249 |
) |
|
|
(47,453 |
) |
|
|
(144,997 |
) |
|
|
(151,740 |
) |
Other income, net |
|
5,223 |
|
|
|
7,685 |
|
|
|
26,076 |
|
|
|
26,561 |
|
Net loss before income
tax |
|
(2,026 |
) |
|
|
(39,768 |
) |
|
|
(118,921 |
) |
|
|
(125,179 |
) |
Income tax expense |
|
48 |
|
|
|
1,666 |
|
|
|
128 |
|
|
|
5,212 |
|
Net loss |
$ |
(2,074 |
) |
|
$ |
(41,434 |
) |
|
$ |
(119,049 |
) |
|
$ |
(130,391 |
) |
Net loss per share, basic and
diluted |
$ |
(0.02 |
) |
|
$ |
(0.49 |
) |
|
$ |
(1.23 |
) |
|
$ |
(1.56 |
) |
Shares used in computing net
loss per share basic and diluted |
|
98,319,416 |
|
|
|
84,384,151 |
|
|
|
96,588,177 |
|
|
|
83,733,730 |
|
|
Alector Contacts:
AlectorKatie Hogan 202-549-0557katie.hogan@alector.com
Argot Partners (media)David Rosen (212)
600-1494alector@argotpartners.com
Argot Partners (investors)Laura Perry
212-600-1902alector@argotpartners.com
Alector (NASDAQ:ALEC)
Historical Stock Chart
From Jan 2025 to Feb 2025
Alector (NASDAQ:ALEC)
Historical Stock Chart
From Feb 2024 to Feb 2025